H-046-011920-00 BS-2600M&BS-2800M Manual English)

Operator’s Manual
©2021-2024 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator’s Manual, the issue date is 2024-01.
i
Copyright
Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called
Mindray) owns the intellectual property rights to this Mindray product and this manual.
This manual may refer to information protected by copyright or patents and does not
convey any license under the patent rights or copyright of Mindray, or of others.
Mindray intends to maintain the contents of this manual as confidential information.
Disclosure of the information in this manual in any manner whatsoever without the
written permission of Mindray is strictly forbidden.
Release, amendment, reproduction, distribution, rental, adaptation, translation or any
other derivative work of this manual in any manner whatsoever without the written
permission of Mindray is strictly forbidden.
, , , , BeneView,
WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China
and other countries. All other trademarks that appear in this manual are used only
for informational or editorial purposes. They are the property of their respective owners.
ii
Copyright
Responsibility on the Manufacturer Party

Contents of this manual are subject to change without prior notice.
All information contained in this manual is believed to be correct. Mindray shall not be
liable for errors contained herein or for incidental or consequential damages in
connection with the furnishing, performance, or use of this manual.
Mindray is responsible for the effects on safety, reliability and performance of this
product, only if:
 all installation operations, expansions, changes, modifications and repairs of this
product are conducted by Mindray authorized personnel;
 the electrical installation of the relevant room complies with the applicable
national and local requirements; and
 the product is used in accordance with the instructions for use.
Warning
It is important for the hospital or organization that employs this equipment to carry out a
reasonable service/maintenance plan. Neglect of this may result in machine breakdown or
personal injury.
Note
This equipment must be operated by skilled/trained clinical professionals.
iii
Copyright
Warranty
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,
EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE.
Exemptions
Mindray's obligation or liability under this warranty does not include any transportation
or other charges or liability for direct, indirect or consequential damages or delay
resulting from the improper use or application of the product or the use of parts or
accessories not approved by Mindray or repairs by people other than Mindray
authorized personnel.
This warranty shall not extend to:
 Malfunction or damage caused by improper use or man-made failure.
 Malfunction or damage caused by unstable or out-of-range power input.
 Malfunction or damage caused by force majeure such as fire and earthquake.
 Malfunction or damage caused by improper operation or repair by unqualified or
unauthorized service people.
 Malfunction of the instrument or part whose serial number is not legible enough.
 Others not caused by instrument or part itself.
Customer service department

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Address: Mindray Building, Keji 12th Road South, High-tech
industrial park, Nanshan, Shenzhen 518057,P.R.China
Website: www.mindray.com
E-mail Address: [email protected]
Tel: +86 755 81888998
Fax: +86 755 26582680
EC - Representative
EC-Representative: Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestraβe 80, 20537 Hamburg, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726
iv
Preface
This manual contains the instructions necessary to operate the product safely and in
accordance with its function and intended use. Please read this manual thoroughly
before using the product. This manual is based on the maximum configuration and
therefore some contents may not apply to your product. If you have any questions,
please contact us.
Observance of this manual is a prerequisite for proper performance and correct

operation, and it ensures patient’s and operator’s safety. All graphics including screens
and printouts in this manual are for illustration purpose only and must not be used for
any other purposes. The screens and printouts on the product should prevail.
Letter M in “M#” appearing in this manual and on the software stands for module,
which means configured analyzer. The product can be operated via both mouse and
touchscreen. This manual describes operating instructions based on the use of mouse.
I
Preface
II
Contents
Intellectual Property Statement ............................................................................................................ ii

Responsibility on the Manufacturer Party ........................................................................................... iii
Warranty ................................................................................................................................................ iv
Exemptions ................................................................................................................................ iv
Customer service department .................................................................................................. iv
EC - Representative ................................................................................................................... iv
Preface ········································································································································ I
Contents ······································································································································ I
1 Safety Information ················································································································· 1-1
Safety Symbols .................................................................................................................................. 1-2

1.1 Summary of Hazards................................................................................................................... 1-3
Introduction ............................................................................................................................. 1-3
Electric Shock Hazards .......................................................................................................... 1-3
Moving Parts Hazards ............................................................................................................ 1-3
Photometer Lamp Hazards .................................................................................................... 1-4
Laser Beam Hazards .............................................................................................................. 1-4
Sample, Calibrator and Control Hazards ............................................................................... 1-4
Reagent and Wash Solution Hazards .................................................................................... 1-4
Waste Hazards........................................................................................................................ 1-5
System Disposal Hazards ...................................................................................................... 1-5
Fire and Explosion Hazards ................................................................................................... 1-5
Removal of Analyzer from Use for Repair or Disposal ......................................................... 1-5
Cleaning and Decontamination ............................................................................................. 1-6
Software and Cybersecurity ................................................................................................... 1-6
Notification of Adverse Events .............................................................................................. 1-7
1.2 Precautions on Use...................................................................................................................... 1-8
Introduction ............................................................................................................................. 1-8
Intended Use ........................................................................................................................... 1-8
Environment Precautions ....................................................................................................... 1-8
Installation Precautions ......................................................................................................... 1-8
Electromagnetic Noise Precautions ...................................................................................... 1-9
Operating Precautions.......................................................................................................... 1-10
Maintenance and Servicing Precautions ............................................................................ 1-11
Test Parameter Configuration Precautions ........................................................................ 1-11
ISE Module Precautions ....................................................................................................... 1-11
Sample Precautions ............................................................................................................. 1-12
I
Contents – Volume I
Reagent, Calibrator and Control Precautions ..................................................................... 1-12

Rack Feeder System Precautions........................................................................................ 1-13
Data Archiving Precautions ................................................................................................. 1-13
External Equipment Precautions ......................................................................................... 1-13
External Vacuum Pump Precautions................................................................................... 1-13
Tube and Liquid Container Precautions .............................................................................. 1-14
Shielding Cover ..................................................................................................................... 1-14
1.3 Labels and Silkscreen ................................................................................................................ 1-15
Introduction ........................................................................................................................... 1-15
1.3.1 Labels and Silkscreen ................................................................................................. 1-15
1.3.2 Warning Labels ............................................................................................................ 1-22
1.4 Abbreviations ............................................................................................................................. 1-27
2 System Description ················································································································ 2-1
2.1 Installation Requirements and Procedure .................................................................................. 2-2

2.1.1 Installation Requirements............................................................................................. 2-2
2.1.2 Installation Procedure ................................................................................................... 2-6
2.2 System Overview ......................................................................................................................... 2-7
2.2.1 System Structure ........................................................................................................... 2-7
2.2.2 Sample Handling System ............................................................................................. 2-9
2.2.3 Reagent Handling System .......................................................................................... 2-16
2.2.4 Reaction System ......................................................................................................... 2-21
2.2.5 Cuvette Wash Station.................................................................................................. 2-22
2.2.6 Photometric System ................................................................................................... 2-23
2.2.7 Mixer Assembly ........................................................................................................... 2-23
2.2.8 Operation Unit .............................................................................................................. 2-25
2.2.9 Output Unit ................................................................................................................... 2-25
2.2.10 Accessories and Consumables ............................................................................... 2-26
2.2.11 Data Management Software .................................................................................... 2-26
2.3 Optional Modules....................................................................................................................... 2-27
2.3.1 Introduction ................................................................................................................. 2-27
2.3.2 ISE Module ................................................................................................................... 2-27
2.3.3 Water Supply Module .................................................................................................. 2-27
2.3.4 External Vacuum Pump .............................................................................................. 2-29
2.3.5 HbA1c Sample Probe .................................................................................................. 2-30
2.3.6 Displayer Arm .............................................................................................................. 2-30
2.3.7 Handheld Barcode Reader .......................................................................................... 2-30
2.3.8 Other Optional Modules .............................................................................................. 2-30
2.4 Software Description ................................................................................................................. 2-31
2.4.1 Main Screen ................................................................................................................. 2-31
2.4.2 Using a Mouse ............................................................................................................. 2-34
2.4.3 Using a Touchscreen................................................................................................... 2-35
2.4.4 Using Online Help ........................................................................................................ 2-35
2.5 System Specifications ............................................................................................................... 2-37
2.5.1 Technical Parameters ................................................................................................. 2-37
II
2.5.2 Power Supply ............................................................................................................... 2-41

2.5.3 Environmental Requirements ..................................................................................... 2-41
2.5.4 Dimensions and Weight .............................................................................................. 2-42
2.5.5 Input Device ................................................................................................................. 2-42
2.5.6 Output Device .............................................................................................................. 2-42
2.5.7 Noise Level .................................................................................................................. 2-42
2.5.8 Communication Interfaces ......................................................................................... 2-42
2.5.9 Safety Classification ................................................................................................... 2-43
2.5.10 Major Performance Indexes ..................................................................................... 2-43
2.5.11 Contraindication ........................................................................................................ 2-45
2.5.12 EMC Requirements ................................................................................................... 2-45
3 General Operating Procedure ·································································································· 3-1
3.1 General Operating Procedure ...................................................................................................... 3-2

3.2 Check before Powering On.......................................................................................................... 3-3
3.2.1 Checking Water Supply ................................................................................................. 3-3
3.2.2 Checking Power Supply ................................................................................................ 3-3
3.2.3 Checking Printing Paper ............................................................................................... 3-3
3.2.4 Checking Waste Tanks and Tubing .............................................................................. 3-3
3.2.5 Checking Probes and Mixers ........................................................................................ 3-3
3.2.6 Checking Rack Feeder System ..................................................................................... 3-4
3.2.7 Checking CD80 Detergent and Probe Wash solutions ............................................... 3-4
3.3 Powering On ................................................................................................................................. 3-5
3.3.1 Turning On Water Supply, Water Supply Module and External Vacuum Pump ......... 3-5
3.3.2 Powering On the System .............................................................................................. 3-5
3.3.3 Starting the Operating Software ................................................................................... 3-5
3.4 Checking System Status ............................................................................................................. 3-7
3.4.1 Checking Analyzer Status ............................................................................................. 3-7
3.4.2 Checking Alarm Status ................................................................................................. 3-9
3.4.3 Checking Maintenance Status ..................................................................................... 3-9
3.4.4 Checking Subsystems ................................................................................................ 3-10
3.4.5 Checking Reagent/Consumable Status ..................................................................... 3-11
3.5 Preparing Reagents ................................................................................................................... 3-14
3.5.1 Loading Biochemical Reagents.................................................................................. 3-14
3.5.2 Loading Concentrated Wash Solution ....................................................................... 3-17
3.5.3 Loading Reagent Probe Wash Solution ..................................................................... 3-18
3.5.4 Loading Sample Probe Wash Solution ...................................................................... 3-19
3.5.5 Loading Physiological Saline...................................................................................... 3-20
3.5.6 Emptying Waste Cap Container (when decapping module configured).................. 3-21
3.5.7 Pad Overview ............................................................................................................... 3-22
3.5.8 Reagent Loading Via Pad ........................................................................................... 3-26
3.6 Calibration .................................................................................................................................. 3-30
3.6.1 Requesting Calibrations .............................................................................................. 3-30
3.6.2 Loading Calibrators ..................................................................................................... 3-32
3.6.3 Running Calibrations ................................................................................................... 3-32
III
3.7 Quality Control ........................................................................................................................... 3-34

3.7.1 Requesting Control Test ............................................................................................. 3-34
3.7.2 Loading Control Samples ........................................................................................... 3-35
3.7.3 Running Control Samples ........................................................................................... 3-35
3.7.4 Auto quality control ..................................................................................................... 3-36
3.8 Ordering Routine Samples ........................................................................................................ 3-37
3.8.1 Routine Sample Orders ............................................................................................... 3-37
3.8.2 Loading Routine Samples ........................................................................................... 3-40
3.8.3 Running Routine Samples (Sequential mode)........................................................... 3-41
3.8.4 Running Routine Samples (Bar code mode and Rack ID mode) .............................. 3-42
3.9 Ordering STAT Samples ............................................................................................................ 3-43
3.9.1 Ordering STAT Samples .............................................................................................. 3-43
3.9.2 Loading STAT Samples ............................................................................................... 3-45
3.9.3 Starting Analysis ......................................................................................................... 3-46
3.10 Test Status and Test Control .................................................................................................. 3-48
3.10.1 Checking Reagent/Consumable Status................................................................... 3-48
3.10.2 Viewing Status of Racks ........................................................................................... 3-48
3.10.3 Sampling Stop ........................................................................................................... 3-49
3.10.4 Reagent Stop ............................................................................................................. 3-50
3.10.5 Emergency Stop ........................................................................................................ 3-50
3.11 Home the System .................................................................................................................... 3-51
3.12 Sleep and Wake Up .................................................................................................................. 3-52
3.12.1 Sleep .......................................................................................................................... 3-52
3.12.2 Wake Up ..................................................................................................................... 3-52
3.13 Masking/Unmasking Module.................................................................................................. 3-53
3.13.1 Masking/Unmasking Module ................................................................................... 3-53
3.14 View Software Version ............................................................................................................ 3-54
3.15 Daily Maintenance ................................................................................................................... 3-55
3.16 Shutdown and Log off ............................................................................................................. 3-56
3.16.1 Log off........................................................................................................................ 3-56
3.16.2 Shut down .................................................................................................................. 3-56
3.17 Check after Powering Off ........................................................................................................ 3-57
4 Setup ···································································································································· 4-1
4.1 Tests Setup .................................................................................................................................. 4-2

4.1.1 Introduction ................................................................................................................... 4-2
4.1.2 Import Tests .................................................................................................................. 4-2
4.1.3 View the Version of Tests ............................................................................................. 4-4
4.1.4 Open Tests Setup .......................................................................................................... 4-4
4.1.5 Test Configuration ......................................................................................................... 4-5
4.1.6 Masking/Unmasking Tests ........................................................................................... 4-6
4.1.7 Deleting Tests ................................................................................................................ 4-7
4.1.8 Display Settings ............................................................................................................. 4-7
4.1.9 Adjusting Measurement Order of Tests ....................................................................... 4-8
4.1.10 Analysis Parameters ................................................................................................... 4-8
IV
4.1.11 Check Parameters..................................................................................................... 4-15

4.1.12 Calibration Parameters ............................................................................................. 4-21
4.1.13 Editing Closed-Reagent Tests .................................................................................. 4-23
4.1.14 Slope and Offset Adjustment ................................................................................... 4-24
4.1.15 Reagent Management Mode .................................................................................... 4-25
4.1.16 Carryover Setup ......................................................................................................... 4-25
4.1.17 Panels ........................................................................................................................ 4-27
4.1.18 Special Calculations ................................................................................................. 4-29
4.1.19 Reference/Critical Range Setup ............................................................................... 4-31
4.1.20 Auto Rerun Setup ...................................................................................................... 4-34
4.1.21 Serum Index............................................................................................................... 4-36
4.1.22 Research Result Setup .............................................................................................. 4-36
4.1.23 LIS Result Interception .............................................................................................. 4-37
4.2 Sample Analysis Setup .............................................................................................................. 4-40
4.2.1 Sample Order Settings ................................................................................................ 4-40
4.2.2 Rack Supply and Retrieval Settings............................................................................ 4-40
4.2.3 SI Index Settings.......................................................................................................... 4-41
4.2.4 Auto Release Sample .................................................................................................. 4-41
4.2.5 Inventory Alarm Limit Settings ................................................................................... 4-41
4.2.6 Customizing Patient Demographics .......................................................................... 4-41
4.2.7 Auto Backup ................................................................................................................ 4-42
4.2.8 Sample Position Traceability Settings ....................................................................... 4-42
4.3 System Setup ............................................................................................................................. 4-43
4.3.1 Instrument Setup Options........................................................................................... 4-43
4.3.2 LIS Settings.................................................................................................................. 4-45
4.3.3 Sample Bar Code Reader ............................................................................................ 4-45
4.3.4 Sample Rack Settings ................................................................................................. 4-45
4.3.5 User Administration .................................................................................................... 4-45
4.3.6 Auto Startup Settings .................................................................................................. 4-47
4.3.7 Dictionary Setup .......................................................................................................... 4-47
4.3.8 Screen Saver Settings ................................................................................................. 4-48
4.3.9 Reagent Barcode Settings .......................................................................................... 4-49
4.3.10 Print Setup ................................................................................................................. 4-49
4.3.11 Date and time ............................................................................................................ 4-51
4.3.12 Select Language........................................................................................................ 4-51
4.3.13 Remote Download Settings ...................................................................................... 4-52
4.3.14 Scanner Model Setup................................................................................................ 4-52
4.3.15 Decapping Module Settings ..................................................................................... 4-52
4.3.16 Test Alias ................................................................................................................... 4-52
5 Reagents&Consumables ········································································································· 5-1
5.1 View Reagents/Consumables .................................................................................................... 5-2

5.1.1 Reagent Overview.......................................................................................................... 5-2
5.1.2 Reagent List ................................................................................................................... 5-3
5.1.3 Consumable List ........................................................................................................... 5-3
V
5.1.4 Reagent Carousel .......................................................................................................... 5-4

5.2 Reagent Requirements ................................................................................................................ 5-5
5.2.1 Requirements Settings.................................................................................................. 5-5
5.2.2 Reagent Requirement Forecast .................................................................................... 5-5
5.3 Reagent Bar Code Reader ........................................................................................................... 5-6
5.3.2 Reagent Bar Code Setup ............................................................................................... 5-7
5.3.3 Loading Bar-Coded Reagents ....................................................................................... 5-8
5.4 Customizing Reagent Display ..................................................................................................... 5-9
5.5 Sorting Reagents ....................................................................................................................... 5-10
5.5.1 Smart Sort on Reagent Overview Screen................................................................... 5-10
5.5.2 Sorting Reagents on Reagent List Screen ................................................................. 5-10
5.6 Masking/Unmasking Reagent .................................................................................................. 5-11
5.7 Reagent Inventory Check .......................................................................................................... 5-12
5.7.1 Introduction ................................................................................................................. 5-12
5.7.2 Checking Reagent Inventory ....................................................................................... 5-12
5.8 Printing Reagent Information .................................................................................................... 5-13
5.8.1 Printing Reagent list and Reagent Use Record ......................................................... 5-13
5.9 On-line Load of Reagents .......................................................................................................... 5-14
5.9.1 Introduction ................................................................................................................. 5-14
5.9.2 On-line Load of Reagents ........................................................................................... 5-14
5.10 Off-line Load of Reagents ....................................................................................................... 5-15
5.10.1 Introduction ............................................................................................................... 5-15
5.10.2 Off-line Load of Reagents ......................................................................................... 5-15
5.11 On-Line Replacement of Reagents ......................................................................................... 5-16
5.11.1 Introduction ............................................................................................................... 5-16
5.11.2 On-Line Replacement of Reagents .......................................................................... 5-16
5.12 Off-Line Replacement of Reagents ........................................................................................ 5-17
5.12.1 Introduction ............................................................................................................... 5-17
5.12.2 Off-line Replacement of Reagents ........................................................................... 5-17
5.13 Unloading Reagents ................................................................................................................ 5-18
5.13.1 Introduction ............................................................................................................... 5-18
5.13.2 Unloading Biochemical Reagents ............................................................................ 5-18
6 Calibration ···························································································································· 6-1
6.1 Overview ....................................................................................................................................... 6-2

6.2 Calibration Setup ......................................................................................................................... 6-3
6.2.1 Defining a Calibrator ..................................................................................................... 6-3
6.2.2 Editing a Calibrator ........................................................................................................ 6-4
6.2.3 Setting up Calibrator Concentrations........................................................................... 6-4
6.2.4 Setting up Calibration Rules ......................................................................................... 6-5
6.2.5 Calibrator Management ................................................................................................ 6-6
6.3 Calibrator Dilution Setup ............................................................................................................. 6-7
6.3.1 Introduction ................................................................................................................... 6-7
6.3.2 Setting up Calibrator Dilution Factors .......................................................................... 6-7
6.3.3 Editing Calibrator Dilution Factors ............................................................................... 6-8
VI
6.4 Calibration Status ........................................................................................................................ 6-9

6.5 Calibration .................................................................................................................................. 6-10
6.6 Reagent Blank ............................................................................................................................ 6-14
6.6.1 Mixed Blank Absorbance and Blank Response ......................................................... 6-14
6.6.2 Requesting a Reagent Blank ....................................................................................... 6-14
6.6.3 Recalling Reagent Blank Results ................................................................................ 6-15
6.7 Auto Calibration ......................................................................................................................... 6-17
6.7.1 Auto Calibration Setup ................................................................................................ 6-17
6.7.2 Auto Calibration Reminder.......................................................................................... 6-17
6.7.3 Removing Auto Calibration ......................................................................................... 6-17
6.8 Extending Calibration Time ....................................................................................................... 6-18
6.8.1 Extending Calibration Time......................................................................................... 6-18
6.8.2 Removing an Extended Status ................................................................................... 6-18
6.9 Calibration Override ................................................................................................................... 6-19
6.9.1 Overriding a Calibration .............................................................................................. 6-19
6.9.2 Removing Cal Overridden Status ............................................................................... 6-19
6.10 Reject ........................................................................................................................................ 6-20
6.10.1 Rejecting a Calibration .............................................................................................. 6-20
6.10.2 Removing Reject Status............................................................................................ 6-20
6.11 Recalling Calibration Results .................................................................................................. 6-21
6.11.1 Recalling Calibration Results.................................................................................... 6-21
6.11.2 Calibration Curve ....................................................................................................... 6-21
6.11.3 Calibration Reaction Curve ....................................................................................... 6-23
6.11.4 Archiving Calibration Results ................................................................................... 6-25
6.11.5 Calibration Trends ..................................................................................................... 6-25
Contents ······································································································································ I
7 Quality Control······················································································································· 7-1
7.1 Overview ....................................................................................................................................... 7-2

7.1.1 Introduction ................................................................................................................... 7-2
7.1.2 Quality Control Operating Procedure ........................................................................... 7-2
7.1.3 QC Alarms ...................................................................................................................... 7-2
7.1.4 QC Result Flags ............................................................................................................. 7-2
7.1.5 Control Status ................................................................................................................ 7-3
7.1.6 Control Analysis Mode .................................................................................................. 7-3
7.2 QC Evaluation ............................................................................................................................... 7-4
7.2.1 Introduction ................................................................................................................... 7-4
7.2.2 Evaluation of Single Controls ....................................................................................... 7-4
7.2.3 Two-Control Evaluation ................................................................................................. 7-5
7.3 QC Setup....................................................................................................................................... 7-7
7.3.1 Defining/Editing a Control ............................................................................................ 7-7
VII
7.3.2 Selection of Tests.......................................................................................................... 7-8

7.3.3 Setting up Control Positions and Concentrations ....................................................... 7-8
7.3.4 Setting up QC Rules ...................................................................................................... 7-9
7.3.5 Managing Controls ........................................................................................................ 7-9
7.4 Quality Control ........................................................................................................................... 7-11
7.4.1 QC Setup ...................................................................................................................... 7-11
7.5 Auto Quality Control................................................................................................................... 7-12
7.5.1 Auto QC Setup ............................................................................................................. 7-12
7.5.2 Auto Quality Control .................................................................................................... 7-13
7.5.3 Removing Auto QC Status .......................................................................................... 7-13
7.6 Recalling Control Results .......................................................................................................... 7-14
7.6.1 QC Overview ................................................................................................................ 7-14
7.6.2 Control Sample Results .............................................................................................. 7-14
7.6.3 Recalling L-J Chart ...................................................................................................... 7-15
7.6.4 Recalling Twin-Plot Chart ........................................................................................... 7-17
7.6.5 Recalling QC Data........................................................................................................ 7-19
7.6.6 Recalling QC Summary ............................................................................................... 7-21
8 Sample Ordering and Processing ····························································································· 8-1
8.1 Sample Bar Code ......................................................................................................................... 8-2

8.1.2 Sample Bar Code Setup ................................................................................................ 8-3
8.2 Sample Ordering and Processing ............................................................................................... 8-5
8.2.1 Adding Samples ............................................................................................................ 8-5
8.2.2 Adding/Modifying Tests ............................................................................................... 8-6
8.2.3 Rerunning Samples ....................................................................................................... 8-6
8.2.4 Ordering Samples with Increased or Decreased Volume ......................................... 8-10
8.2.5 Ordering Diluted Samples ........................................................................................... 8-11
8.2.6 Sample Analysis Mode ............................................................................................... 8-12
8.2.7 Sample Blank ............................................................................................................... 8-15
8.2.8 Sample Management .................................................................................................. 8-16
8.3 Serum Index ............................................................................................................................... 8-18
8.3.1 Theory of Serum Index ................................................................................................ 8-18
8.3.2 Serum Index Setup ...................................................................................................... 8-19
8.3.3 Auto Serum Index ........................................................................................................ 8-20
8.3.4 Running SI Test............................................................................................................ 8-20
8.4 Clear Sample Orders .................................................................................................................. 8-21
8.4.1 Clearing Sample Orders .............................................................................................. 8-21
8.5 Release Sample Position........................................................................................................... 8-22
8.6 Sample and Test Lists ............................................................................................................... 8-23
8.6.1 Sample List and Test List ........................................................................................... 8-23
8.7 Optimizing Result Display ......................................................................................................... 8-24
8.7.1 Optimizing Result Display ........................................................................................... 8-24
8.8 Results Recall............................................................................................................................. 8-25
8.8.1 Displaying Current Results ......................................................................................... 8-25
VIII
8.8.2 Recalling Results ......................................................................................................... 8-26

8.8.3 Viewing Abnormal Sample ......................................................................................... 8-27
8.8.4 Review Sample Results ............................................................................................... 8-27
8.8.5 Viewing/Editing Patient Demographics ..................................................................... 8-28
8.8.6 Reaction Curve ............................................................................................................ 8-28
8.8.7 Transmitting Results to LIS Host ............................................................................... 8-30
8.8.8 Printing Results ........................................................................................................... 8-31
8.8.9 Editing Results ............................................................................................................. 8-33
8.8.10 Deleting Results ........................................................................................................ 8-34
8.8.11 Customizing Result Display ...................................................................................... 8-34
8.8.12 Recalculating Results ............................................................................................... 8-36
8.8.13 Compensating Results.............................................................................................. 8-37
8.8.14 Archiving Results ...................................................................................................... 8-37
8.9 Test Statistics ............................................................................................................................ 8-38
8.10 Result Statistics ....................................................................................................................... 8-40
8.11 Charge Statistics ..................................................................................................................... 8-42
8.11.1 Charge setup ............................................................................................................. 8-42
8.11.2 Search charges.......................................................................................................... 8-42
9 Use of ISE Module ·················································································································· 9-1

9.1.1 Introduction ................................................................................................................... 9-2
9.1.2 Precautions on Use ....................................................................................................... 9-2
9.2 Principles of Measurement ......................................................................................................... 9-4
9.3 ISE Test Parameters .................................................................................................................... 9-5
9.3.1 Introduction ................................................................................................................... 9-5
9.3.2 Viewing ISE Test Parameters ....................................................................................... 9-6
9.3.3 Defining Print Name ...................................................................................................... 9-7
9.3.4 Modifying/Configuring ISE Test Parameters ............................................................... 9-7
9.3.5 Summary of ISE Test Parameters ................................................................................ 9-7
9.4 Preparing ISE Reagents for Measurement ............................................................................... 9-12
9.4.1 Introduction ................................................................................................................. 9-12
9.4.2 Loading Buffer Solution .............................................................................................. 9-12
9.4.3 Loading ISE Detergent ................................................................................................ 9-12
9.5 Calibration and Results Recall .................................................................................................. 9-13
9.5.1 Introduction ................................................................................................................. 9-13
9.5.2 Calibration Setup ......................................................................................................... 9-13
9.5.3 Calibration Status and Alarm ..................................................................................... 9-13
9.5.4 Requesting a Calibration............................................................................................. 9-14
9.5.6 Results Recall .............................................................................................................. 9-15
9.5.7 Extending ISE Calibration Time .................................................................................. 9-16
9.6 Quality Control and Results Recall ........................................................................................... 9-17
9.6.1 Quality Control and Results Recall ............................................................................. 9-17
9.7 Sample Ordering and Results Recall ........................................................................................ 9-18
IX
9.7.1 Sample Ordering and Results Recall .......................................................................... 9-18

9.7.2 Recalling Reaction Data .............................................................................................. 9-19
9.8 ISE Prime Cycle .......................................................................................................................... 9-20
9.8.1 Introduction ................................................................................................................. 9-20
9.8.2 Defining/Modifying ISE Prime Times ......................................................................... 9-20
9.9 Daily Maintenance ..................................................................................................................... 9-21
9.9.1 Daily Maintenance ....................................................................................................... 9-21
9.10 Troubleshooting ISE Module ................................................................................................... 9-22
9.10.1 Troubleshooting ISE Module .................................................................................... 9-22
10 LIS ···································································································································· 10-1
10.1 Overview ................................................................................................................................... 10-2

10.2 LIS Communication ................................................................................................................. 10-3
10.2.1 Introduction ............................................................................................................... 10-3
10.2.2 Host Communication Parameters ........................................................................... 10-3
10.2.3 Defining Channel Number of Tests .......................................................................... 10-6
10.3 Ordering Samples with LIS Host ............................................................................................. 10-7
10.3.1 Ordering Functions.................................................................................................... 10-7
10.4 Result Transmission ................................................................................................................ 10-9
10.4.1 Result Transmission Setup ....................................................................................... 10-9
10.4.2 Manually Sending Results to LIS Host ..................................................................... 10-9
10.5 Troubleshooting LIS .............................................................................................................. 10-10
11 Maintenance ······················································································································ 11-1
11.1 Overview ................................................................................................................................... 11-2

11.1.1 Introduction ............................................................................................................... 11-2
11.1.2 Accessory Information ............................................................................................. 11-2
11.1.3 Materials required and tools .................................................................................... 11-4
11.2 Maintenance Screen ................................................................................................................ 11-6
11.2.1 Maintenance Screen Overview ................................................................................. 11-6
11.2.2 Maintenance Setup ................................................................................................... 11-8
11.2.3 Maintenance History ................................................................................................. 11-8
11.3 Scheduled Maintenance .......................................................................................................... 11-9
11.3.1 Introduction ............................................................................................................... 11-9
11.3.2 Maintenance Schedule ............................................................................................. 11-9
11.3.3 Scheduled Maintenance Procedures ....................................................................... 11-9
11.3.4 Maintenance Log ...................................................................................................... 11-9
11.4 Daily maintenance ................................................................................................................. 11-13
11.4.1 Check DI Water Connection.................................................................................... 11-13
11.4.2 Check Waste Connection ....................................................................................... 11-13
11.4.3 Check Inventory of CD80 Detergent and Probe Wash Solution ........................... 11-14
11.4.4 Check Sample/Reagent Syringe............................................................................. 11-15
11.4.5 Check Sample Probe Wash Solution ..................................................................... 11-16
11.4.6 Check Mixer Installation Position .......................................................................... 11-17
11.4.7 Clean ISE Electrodes ............................................................................................... 11-18
X
11.4.8 Special Wash Probes/Mixers ................................................................................. 11-19

11.5 Weekly Maintenance ............................................................................................................. 11-20
11.5.1 Weekly Special Wash and Cuvette Check ............................................................. 11-20
11.5.2 Ultrasonic Cleaning of Sample Probe .................................................................... 11-21
11.6 Two-Week Maintenance ........................................................................................................ 11-22
11.6.1 Clean ISE Tubes....................................................................................................... 11-22
11.7 Monthly Maintenance ............................................................................................................ 11-24
11.7.1 Clean Cuvette Wash Station ................................................................................... 11-24
11.7.2 Clean Wash Wells.................................................................................................... 11-24
11.7.3 Clean ISE SIC/Drain Outlet...................................................................................... 11-25
11.7.4 Wash R1/R2 Physiological Saline Bottle ............................................................... 11-27
11.8 Three-Month Maintenance .................................................................................................... 11-28
11.8.1 Dilution Ratio Self-calibration of Diluted Wash Solution ...................................... 11-28
11.8.2 Probe Interior Wash Pressure Adjustment ............................................................ 11-28
11.8.3 Whole Unit Circulating Water Wash Pressure Adjustment ................................... 11-29
11.8.4 Clean DI Water Tank ................................................................................................ 11-29
11.8.5 Clean Dust Screens of External Vacuum Pump .................................................... 11-31
11.8.6 Clean Dust Screens ................................................................................................. 11-33
11.9 Six-Month Maintenance ........................................................................................................ 11-35
11.9.1 Replace Lamp.......................................................................................................... 11-35
11.10 When Appropriate Maintenance ......................................................................................... 11-37
11.10.1 Check Probes/Mixers/Wash Wells ...................................................................... 11-37
11.10.2 Clean Probes/Mixers Exterior .............................................................................. 11-38
11.10.3 Replace Cuvettes .................................................................................................. 11-39
11.10.4 Cuvette Check ....................................................................................................... 11-41
11.10.5 Lamp Hour Inquiry ................................................................................................ 11-42
11.10.6 Clean Analyzer Panels .......................................................................................... 11-43
11.10.7 Reagent Barcode Maintenance ............................................................................ 11-43
11.10.8 Rack Barcode Maintenance ................................................................................. 11-44
11.10.9 Clean Sample Probe Interior ................................................................................ 11-46
11.10.10 Clean Reagent Probe Interior ............................................................................. 11-48
11.10.11 Replace Sample Probe ....................................................................................... 11-49
11.10.12 Replace Reagent probe ...................................................................................... 11-51
11.10.13 Replace Sample Mixer ........................................................................................ 11-51
11.10.14 Replace Reagent Mixer ....................................................................................... 11-52
11.10.15 Remove Air Bubbles in Syringe .......................................................................... 11-53
11.10.16 Water Prime......................................................................................................... 11-54
11.10.17 Replace ISE electrodes ....................................................................................... 11-54
11.10.18 Storing Electrodes............................................................................................... 11-57
11.10.19 Prime Buffer Solution ......................................................................................... 11-59
11.10.20 Waste Discharge ................................................................................................. 11-60
11.10.21 Service Life Query of Wearing Parts .................................................................. 11-61
11.10.22 Generate Daily Maintenance Report .................................................................. 11-61
11.11 Shutdown Maintenance ...................................................................................................... 11-62
XI
12 Alarms and Troubleshooting ······························································································· 12-1
12.1 Classification of Logs ............................................................................................................. 12-2

12.1.1 Introduction ............................................................................................................... 12-2
12.1.2 Edit Logs .................................................................................................................... 12-2
12.2 Viewing and Handling Logs .................................................................................................... 12-3
12.2.1 Description of Error Log Screen ............................................................................... 12-3
12.2.2 Description of Edit Log Screen ................................................................................. 12-4
12.3 Error Troubleshooting .............................................................................................................. 12-5
12.3.1 Introduction ............................................................................................................... 12-5
12.3.2 Error Indications ........................................................................................................ 12-5
12.4 Data Alarm ............................................................................................................................... 12-7
12.4.1 Result Flags ............................................................................................................... 12-7
12.5 Troubleshooting Procedure .................................................................................................. 12-24
12.5.1 Error Alerts and View .............................................................................................. 12-24
12.5.2 Software Screen Prompt ........................................................................................ 12-26
12.5.3 Troubleshooting ...................................................................................................... 12-27
12.5.4 Clear Errors .............................................................................................................. 12-29
12.6 Troubleshooting ..................................................................................................................... 12-30
12.6.1 No Alarm Troubleshooting ..................................................................................... 12-30
12.6.2 Troubleshooting Alarms ......................................................................................... 12-30
13 Operation Theories ············································································································· 13-1
13.1 Overview ................................................................................................................................... 13-2

13.2 Principles of Measurement ..................................................................................................... 13-3
13.2.1 Introduction ............................................................................................................... 13-3
13.3 Endpoint Measurements ......................................................................................................... 13-4
13.3.1 Introduction ............................................................................................................... 13-4
13.3.2 Calculation of Reaction Absorbance ....................................................................... 13-4
13.3.3 Calculation of Blank Absorbance ............................................................................. 13-4
13.3.4 Calculation of K Factor ............................................................................................. 13-4
13.3.5 Calculation of Response........................................................................................... 13-5
13.3.6 Sample Blanked Response ....................................................................................... 13-5
13.4 Fixed-time Measurements ...................................................................................................... 13-6
13.4.1 Introduction ............................................................................................................... 13-6
13.5 Kinetic Measurements ............................................................................................................ 13-8
13.5.1 Introduction ............................................................................................................... 13-8
13.5.2 Data Calculation in Kinetic Measurements ............................................................. 13-8
13.5.3 Determination of Linearity Range ............................................................................ 13-8
13.5.5 Evaluation for Linearity ........................................................................................... 13-10
13.5.6 Enzyme Linearity Range Extension ........................................................................ 13-11
13.6 Calibration Math Model and Factors .................................................................................... 13-12
13.6.1 Linear Calibrations .................................................................................................. 13-12
XII
13.6.2 Non-Linear Calibrations .......................................................................................... 13-13

13.7 Prozone Check ....................................................................................................................... 13-15
13.7.1 Introduction ............................................................................................................. 13-15
13.7.2 Prozone Check Parameters .................................................................................... 13-15
Vocabulary ·································································································································· 1
Index ········································································································································ 11
Electronic Interface ···················································································································· 13
Bibliography ······························································································································ 14
XIII
XIV
1 Safety Information
This chapter provides you with safety symbols used in this manual and their meanings,
summarizes the safety hazards and operating precautions that should be considered
seriously when the instrument is being operated, and lists the labels and silkscreen
that have been applied to the instrument and their indications.
1-1
Safety Symbols
Safety symbols are used in this manual in order to remind you of the instructions
necessary to operate the product safely and in accordance with its function and
intended use. A safety symbol and text constitutes a notice as shown in the table below:
Symbol Description
Caution, risk of danger
Biohazard
1-2
1.1 Summary of Hazards

Introduction
Observe the following safety precautions when using the product. Ignoring any of
these safety precautions may lead to personal injury or equipment damage.
WARNING
If the product is used in a manner not specified by our company, the protection provided by
the product may be impaired.
Electric Shock Hazards

Observe the following instructions to prevent electric shock.
WARNING
 When the MAIN POWER is turned on, users other than the servicing personnel
authorized by our company must not open the rear cover or side cover.
 Spillage of reagent or sample on the product may cause equipment failure and even
electric shock. Do not place sample and reagent on the product. In case of spillage,
switch off the power immediately, remove the spillage and contact our Customer
Service Department or your local distributor.
Moving Parts Hazards

Observe the following instructions to prevent personal injury caused by moving parts.
WARNING
 When the system is in operation, do not touch such moving parts as sample probe,
reagent probes, mixers, cuvette wash station, rack supply push-in part, and rack storage
push-in part.
 Do not put your fingers or hands into any open part when the system is in operation.
 Do not load sample racks when the rack supply push-in part is moving forwards, and do
not unload sample racks when the rack retrieval push-in part is moving.
1-3
Photometer Lamp Hazards

Observe the following instructions to prevent personal injury caused by photometer
lamp.
WARNING
 Light sent by the photometer lamp may hurt your eyes. Do not remove the lamp when
the system is in operation or standby.
 If you want to replace the photometer lamp, perform the Replace Lamp procedure on
the Biochemistry Maintenance window. Do not touch the lamp before the countdown is
finished, or you may get burned.
Laser Beam Hazards

Observe the following instructions to prevent personal injury caused by laser beam.
WARNING
Light sent by the bar code reader may hurt your eyes. Do not stare into the laser beam
radiated from the bar code reader when the system is in operation.
Sample, Calibrator and Control Hazards

Observe the following instructions to protect against the biohazardous infection by
samples, calibrators and control samples.
BIOHAZARD
 Inappropriately handling samples, controls and calibrators may lead to biohazardous
infection. Do not touch samples, mixtures or waste with your bare hands. Wear gloves
and lab coat and, if necessary, goggles and a mask.
 In case your skin contacts the sample, control or calibrator, follow the standard
laboratory safety procedure and consult a doctor.
Reagent and Wash Solution Hazards

Observe the following instructions to protect against the biohazardous infection by
reagents and wash solution.
WARNING
Reagents and concentrated wash solution are corrosive to human skins. Exercise caution
when using reagents and concentrated wash solution. In case your skin or clothes contact
them, wash them off with soap and clean water. If reagents or wash solution spills into your
eyes, rinse them with water and consult an oculist.
1-4
Waste Hazards
Observe the following instructions to prevent environmental pollution and personal
injury caused by waste.
BIOHAZARD
 Some substances contained in reagent, control, wash solution and waste are subject to
regulations of contamination and disposal. Dispose of the waste in accordance with
your local or national rule for biohazard waste disposal and consult the manufacturer
or distributor of the reagents for details.
 Solid wastes such as reagent bottles and reaction cuvettes are subject to
contamination regulations, and should be disposed of in accordance with your local or
national rule for waste disposal.
 Wear gloves and lab coat and, if necessary, goggles and a mask.
 Handle the waste tank cap, waste tube, waste sensor and waste tank carefully to avoid
spilling the waste.
System Disposal Hazards

Observe the following instructions to dispose of the waste analyzer.
WARNING
Materials of the analyzer are subject to contamination regulations. Dispose of a waste
analyzer in accordance with your local or national rule for waste disposal.
Fire and Explosion Hazards

Observe the following instructions to prevent fire and explosion.
WARNING
Ethanol is flammable substance. Please exercise caution while using ethanol around the
instrument in order to prevent fire and explosion.
Removal of Analyzer from Use for Repair or Disposal

To minimize or eliminate the hazards involved in repair, transportation, disposal
process, please observe the following instruction.
WARNING
When the analyzer is not in use, for example, in repair, transportation or disposal process,
please clean and sterilize the parts that may cause biohazards(sample probes, reagent
probes and mixers, etc.) and remind the person who handles the device of the related
hazards.
1-5
Cleaning and Decontamination
CAUTION
Appropriate decontamination should be carried out in accordance with laboratory safety
regulations if reagent, sample or other liquids are spilled onto the equipment. In case of
large-amount liquid ingression, please contact our customer service department or the
local distributor.
No decontamination or cleaning agents can be used which could cause a HAZARD as a
result of a reaction with parts of the equipment or with material contained in it. Strong acid
or alkaline solutions are forbidden to clean the equipment.
If there is any doubt about the compatibility of the decontamination or cleaning agents with
parts of the equipment or with material contained in it, please contact our customer service
department or the local distributor.
CAUTION
Recommended detergent: water and 75% ethanol.
Prohibited detergent: materials that may corrode metals, for example, 3% hydrogen
peroxide.
The user shall perform regular cleaning to the cover of the analyzer. Use the specified
materials to clean the equipment only. For any damage to the instrument or other accidents
caused by using materials other than specified, Mindray will not provide any warranty.
Mindray does not claim the validity of the listed chemicals in infection control. For effective
control of infection, please consult the Infection Prevention Department of the hospital or
the epidemic professionals.
Disinfection may damage the system to some extent. It is recommended to perform
disinfection only when necessary according to your laboratory protocol.
Do not use any cleaning agents which could cause a HAZARD as a result of a reaction with
parts of the equipment or with material contained in it.
If you accidentally spill hazardous material (for example, samples and reagents) on the
instrument, clean and disinfect the instrument. Recommended detergents and
disinfectants include water and 75% ethanol. Do not use materials that may corrode metals
(for example, 3% hydrogen peroxide). Wear proper personal protective equipment (e.g.
gloves, lab coat, etc.) and follow safe laboratory procedures when handling them and the
contacted areas in the laboratory.
Software and Cybersecurity
WARNING
Data should be transmitted in a closed network or virtual isolated network environment.
The laboratory is responsible for the security of the virtual isolated network environment.
Make sure that the network authorization information (such as user information and
password) is secure and not obtained by unauthorized persons.
Please use Microsoft firewall and kill the virus regularly.
1-6
Notification of Adverse Events
NOTE
As a health care provider, you may report the occurrence of certain events to SHENZHEN
MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD., and possibly to the competent authority
of the Member state in which the user and / or patient is established.
These events, include device-related death and serious injury or illness. In addition, as part
of our Quality Assurance Program, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,
LTD. requests to be notified of device failures or malfunctions. This information is required
to ensure that SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. provides only
the highest quality products.
1-7
1.2 Precautions on Use

Introduction
To use the product safely and efficiently, pay attention to the following operating
precautions.
Intended Use
WARNING
The instrument is an automated chemistry analyzer for in vitro diagnostic use in clinical
laboratories and designed for in vitro quantitative determination of clinical chemistries in
serum, plasma, urine and cerebrospinal fluid samples.
When drawing a clinical conclusion, please also refer to patients’ clinical symptoms and
other test results.
Environment Precautions
CAUTION
Evaluate the electromagnetic environment prior to operating the system.
Please install and operate the system in an environment specified by this manual. Installing
and operating the system in other environment may lead to unreliable results and even
equipment damage.
To relocate the system, please contact our Customer Service Department or your local
distributor.
Installation Precautions
WARNING
The product is a permanently connected equipment, and it is switched on and off via a
switch or breaker. Before installing the system, ensure that the building in which the
equipment will be located has been equipped with a switch or breaker that complies with
IEC 61010-1+AMD1, is in close proximity to the equipment and within easy reach of you,
and is marked as the disconnecting device for the equipment.
NOTE
The safety of any system incorporating the equipment is the responsibility of the assembler
of the system.
1-8
Electromagnetic Noise Precautions
CAUTION
The IVD MEDICAL EQUIPMENT complies with the emission and immunity requirements
described in this part of IEC 61326.
This equipment is not intended for use in residential environments and may not provide
adequate protection to radio reception in such environments.
This equipment is designed for use in a PROFESSIONAL HEALTHCARE FACILITY
ENVIRONMENT. It is likely to perform incorrectly if used in a HOME HEALTHCARE
ENVIRONMENT. If it is suspected that performance is affected by electromagnetic
interference, correct operation may be restored by increasing the distance between the
equipment and the source of the interference.
The electromagnetic environment should be evaluated prior to operation of the device.
Do not use this device in proximity to sources of strong electromagnetic radiation (e.g.
unshielded intentional RF sources), as these can interfere with proper operation.
CAUTION
It is the manufacturer’s responsibility to provide equipment electromagnetic compatibility
information to the customer or user.
It is the user’s responsibility to ensure that a compatible electromagnetic environment for
the equipment can be maintained in order that the device will perform as intended.
The calculation formula to determine the separation distance between an IVD MEDICAL
EQUIPMENT and a mobile phone is given by d = 6/E ∙√P, where d is the minimum separation
distance in metres, P is the maximum power in watts, and E is the immunity test level in
V/m.
1-9
Operating Precautions
CAUTION
 Take the clinical symptoms or other test results of the patient into considerations when
making a diagnosis based on the measuring results produced by the system.
 Operate the system strictly as instructed by this manual. Inappropriate use of the
system may lead to unreliable test results or even equipment damage or personal injury.
 When using the system for the first time, first run calibrations, and then QC tests to
make sure the system is in proper state.
 Be sure to run QC tests every time when you use the system, otherwise the result may
be unreliable.
 Do not uncover the reagent carousel when the system is in operation. Keep the reagent
carousel cover closed.
 The operation unit is a personal computer with the operating software installed.
Installing other software or hardware on the computer may interfere with the system
operation. Do not run other software when the system is working.
 Computer virus may destroy the operating software or test data. Do not use the
computer for other purposes or connect it to the Internet. If the computer is infected by
virus, please install anti-virus software to check for and clear virus.
 Do not touch the displayer, mouse or keyboard with wet hands or hands with chemicals.
 Do not place the MAIN POWER to ON again within 10 seconds since placing it to OFF;
otherwise the system may enter the protection status. If it does so, place the MAIN
POWER to OFF and place it to ON again.
 Do not start measurement after starting up the system until lamp incubation is finished
and the status becomes Standby.
 Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority of the country in which the user and/or the
patient is established.
1-10
Maintenance and Servicing Precautions
CAUTION
 Maintain the system strictly as instructed by this manual. Inappropriate maintenance
may lead to unreliable results, equipment damage or personal injury.
 To wipe off dust from the system surface, use a soft, clean and wet (not too wet) cloth
soaked with soap water rather than organic solvents such as ethanol. After cleaning,
wipe the surface dry with dry cloth.
 Switch off all the powers and disconnect the power plug before cleaning. Take
necessary measures to prevent water ingression, otherwise equipment damage or
personal injury may be caused.
 Replacement of such major parts as photometer lamp, sample probes, reagent probes,
mixers and syringe assembly must be followed by a calibration.
 If the system fails and needs servicing, contact our Customer Service Department or
your local distributor. The system may need to be stopped or transported during
servicing, which will probably cause biohazards, electric shock hazards and moving part
hazards. Exercise caution when prepare the system for servicing.
 Replacement of the photometer lamp should be done when the system power has been
switched off for at least 5 minutes.
Test Parameter Configuration Precautions
CAUTION
To define such parameters as sample volume, reagent volume and wavelength, follow the
instructions in this manual and the instructions of reagents.
ISE Module Precautions
CAUTION
To prevent ISE electrodes from being damaged due to water scarcity, if the system, when
equipped with an ISE module, will be powered off for less than 3 days, execute the Water
Prime procedure before shutting down the system; if the system will be powered off for
over 3 days, perform the Store Electrodes maintenance.
Only the electrodes are activated can they be used again after storage; when activating the
electrodes, place them horizontally and make sure the serum can flow through them while
priming the serum.
1-11
Sample Precautions
CAUTION
 Use samples that are completely free of insoluble substances like fibrin or suspended
matter; otherwise the sample probe may be blocked.
 Medicines, anticoagulants or preservative in the samples may lead to unreliable results.
 Hemolysis, icterus or lipemia in the samples may lead to unreliable test results; running
SI test, therefore, is recommended.
 Store the samples properly. Improper storage may change the compositions of samples
and lead to unreliable results.
 Sample volatilization may lead to unreliable results. Do not leave the sample open for a
long period.
 The system has a specific requirement on the sample volume. Refer to this manual for
proper sample volume.
 Load samples to correct positions on the sample rack before the analysis begins;
otherwise reliable results may not be obtained.
Reagent, Calibrator and Control Precautions
CAUTION
 Use proper reagents, calibrators and controls on the system.
 Select appropriate reagents according to the performance characteristics of the system.
Consult the reagent suppliers, our company or our authorized distributor for details, if
you are not sure about your reagent choice.
 Store and use the reagents, calibrators and controls strictly as instructed by the
suppliers; otherwise, reliable results or best performance of the system may not be
obtained. Improper storage of reagents, calibrators and controls may lead to unreliable
results and bad performance of the system even in validity period.
 Perform calibration after changing the reagents, otherwise reliable results may not be
obtained.
 Contamination caused by carryover among reagents may lead to unreliable test results.
Consult the reagent suppliers for details.
 Do not use expired reagent, control or calibrator.
 Note: For reagent expiration date, see the label on the reagent bottle or the label on the
reagent box. Use the reagent within its expiration date.
1-12
Rack Feeder System Precautions
BIOHAZARD
Do not take away the sample rack from track feeder system during test running to prevent
skin damage or infection due to contact with the moving parts.
CAUTION
Do not open the upper cover of buffer area during test running when SDM is turned on. If it
is opened, re-switch on SDM and rerun operating software.
If blue light of rack supply unit and rack storage unit is flickering, do not move the Rack
carrier otherwise the instrument may be stopped or racks may topple over.
Data Archiving Precautions
NOTE
The system automatically stores the data to the built-in hard disk. Data loss, however, is
still possible due to mis-deletion or physical damage of the hard disk. You are
recommended to regularly archive the data to such medium as CDs.
To avoid data loss caused by unexpected power failure, a UPS (uninterrupted power supply)
is recommended.
External Equipment Precautions
WARNING
For operating instructions and precautions of the computer and printer, please refer to their
operation manuals.
External equipment connected to the analogue and digital interfaces must be complied
with relevant safety and EMC standards (e.g., IEC 60950 Safety of Information Technology
Equipment Standard and CISPR 22 EMC of Information Technology Equipment Standard
(CLASS B)). Any person, who connects additional equipment to the signal input or output
ports and configures an IVD system, is responsible for ensuring that the system works
normally and complies with the safety and EMC requirements. If you have any questions,
consult the technical services department of your local representative.
External Vacuum Pump Precautions
WARNING
Make sure the vacuum pump tubing is connected properly without any twists or sharp
angles so that it can work normally.
Tubing and cables connected to the vacuum pump must be protected to prevent damage
and breaks due to human or other causes.
Set the vacuum pump on a solid flat platform or ground.
1-13
Tube and Liquid Container Precautions
WARNING
When the tube or the part that contain liquid become aged or damaged, please stop its use
immediately and contact our customer service department or your local distributor to
check and replace it.
Shielding Cover
WARNING
Check if the shielding cover is properly supported every day. When it is closed by hand, the
shielding cover should be closed stably without automatic opening. Please check the
shielding cover daily, in case it falls off suddenly.
1-14
1.3 Labels and Silkscreen

Introduction
The following non-warning and warning labels and silkscreen are used on the product
for system identification and operating instruction.
For the label marked with , please consult the related documentations in order to
find out the nature of the potential HAZARDS and any actions which have to be taken
to avoid them.
Check the labels regularly for cleanliness and integrity. If any of the labels becomes
vague or peels off, contact our Customer Service Department or your local distributor
for replacement.
The general meaning assigned to geometric shapes, safety colors and contrast colors
for safety signs are as follows:
Geometric Meaning Safety color Contrast Graphical

shape color symbol color
Prohibition Red White Black
Mandatory Blue White White
Warning Yellow Black Black
Warning Yellow Black Black
1.3.1 Labels and Silkscreen

Symbol Meaning
Serial Number
Date of Manufacture
Manufacturer
CE marking
Authorized Representative in the

European Community
1-15
Symbol Meaning
The following definition of the WEEE
label applies to EU member states
only: The use of this symbol
indicates that this product should not
be treated as household waste. By
ensuring that this product is
disposed of correctly, you will help
prevent bringing potential negative
consequences to the environment
and human health. For more detailed
information with regard to returning
and recycling this product, please
consult the distributor from whom
you purchased the product.
In Vitro diagnostic medical device
Biological risks
Caution
Laser radiation
“ON” (Power)
“OFF” (Power)
“ON” for a part of equipment
“OFF” for a part of equipment
Computer Network
Protective conductor terminal
Alternating current
1-16
Symbol Meaning
Standby
Indicating the device is on and
standby. Press this button to turn on
the power of the computer.
Indicators for rack supply unit
1 for rack supply unit 1; 2 for rack
supply unit 2.
indicates the status of

STAT area.
Indicators for rack storage unit

1 for rack storage unit 1 and 2 for
rack storage unit 2.
Shielding cover warning

This label reminds you of keeping the
shielding cover closed while the
system is running tests to prevent
injury caused by probes and various
liquids.
Main power switch
Power switch of sample delivery

module
Toggle the power switch upwards to
turn on the power supply of the
sample delivery module, and vice
versa.
Main power switch of M1
When the switch is placed to upper
position, the power is on and the
instrument is started. When the
switch is placed to lower position, the
power is off, and all modules
including reagent refrigerating
system are shut down.
Main power switch of M2
When the switch is placed to upper
position, the power is on and the
instrument is started. When the
switch is placed to lower position, the
power is off, and all modules
including reagent refrigerating
system are shut down.
On means power is on.
Off means power is off.
1-17
Symbol Meaning
Unique device
identifier
Interfaces for fluid connection

This symbol located on the fluid connection interfaces indicates the connection of
fluid tubing.
The fluidic interfaces for standard configuration are shown as follows:
The fluidic interfaces for customized configuration are shown as follows:
First reagent carousel

This symbol located on the first reagent carousel and its cover indicates the carousel
for holding R1 and R3 and the carousel cover.
1-18
Second reagent carousel

This symbol located on the second reagent carousel and its cover indicates the
carousel for holding R2 and R4 and the carousel cover.
Reagent load buttons

This symbol located at the lower-left corner of the first reagent carousel indicates
control of the second and first carousels.
Syringe
This symbol located below the syringes indicates the sample syringes and reagent
syringes.
Wash tubes
This symbol located near the cuvette wash station indicates the wash tubes.
51B
41B
71B 61B
31B
21B
11B 51A 61A

81B 12B 41A 11A
82B 31A 21A
52B 52A 62A

42B
72B 62B 42A 12A
32B
22B 32A 22A
Sample Probe Cleanser and DA/DB Detergent

This symbol located near the wash well of sample probe indicates probe cleanser(DC),
alkaline detergent(DB) and acid detergent(DA).
1-19
CD80 Detergent and ISE Buffer Indicator
This symbol located on the front panel indicates the status of the indicators of CD80
detergent and ISE buffer.
Replacement of Lamp
This symbol located on rear shell indicates the replacement process of lamp.
Power Supply
This label located close to power socket indicating rated voltage, alternating current
and frequency.
Or
1-20
Reagent Carousel Cover Lock

This symbol is located on the reagent carousel.
Rotate to to close and then to to open the reagent carousel cover.
Handle with caution
The combination of arm and extension presents a potential pinch hazard at all
points/positions where the arm and extension can come into contact. The arm has a
wide range of motion both up/down and side to side -- consider potential pinch points
that may cause personal injury.
1-21
1.3.2 Warning Labels

Biohazard warning
This label indicating the risk of biohazardous infection is located in the following
positions:
 Sample handling area of the sample delivery module
 Sample probe wash well
 High-concentration waste outlet
 High concentration waste tank
 Between indicators of rack storage unit
 In the middle of the cover above rack carriage
 Sample Aspiration position(Near front track)
 ISE Sample dispensing position
 Near waste cap container
Moving parts warning

This symbol and text indicating the hazardous moving parts is located in the following
positions:
 Probes R11 and R12
 Probes R21 and R22
 Reagent mixer
 Sample probe
 Rack supply unit 2
 Front track
 In the middle of the cover above rack carriage
Probe Collision Warning

This symbol and text located on the transparent cover of the front track reminds you
of not opening the cover to prevent from damaging the sample probe.
1-22
Moving parts warning-SDM

This symbol and text located on the panel close to push-back device of rack storage
unit and STAT lane.
Laser warning
This symbol and text located near the sample bar code reader, rack bar code reader
and reagent bar code reader reminds you of not staring into the laser beam.
Photometer lamp warning

This symbol and text located near the lamp reminds you of not touching the lamp
before it gets cool.
Vacuum pump connection warning

This symbol and text located near the external vacuum pump and the built-in vacuum
pump reminds you of connecting the inlet and outlet tubing correctly.
1-23
Shielding cover warning

This label located on the middle inside of the shielding cover reminds you of keeping
the shielding cover closed while the system is running tests to prevent injury caused
by probes, mixers and various liquids.
This label located on the outside of the shielding cover reminds user of not opening
the cover while the analyser is running to prevent injury and test interruption.
Risk of Electrical Shock

This symbol is located near the power supply unit, AC drive board socket, waste pump,
cuvette wash pump cable joint, temperature protection switch, circulating water heater,
heater cable joint, reaction carousel heater, ultrasonic board output and reflux bar of
the analyzer, indicating the risk of electrical shock.
Risk of Electrical Shock

The label located on the cables of circulating water heater, cuvette cleaning fluid heater
and wash solution heater indicating the risk of electrical shock.
Water supply unit shell

This symbol located on the shell of water supply unit reminds you of not pressing the
shell.
1-24
Mind your head

This symbol located close to the handheld barcode reader on the displayer arm. Be
careful not to bump your head.
Do not connect other devices other than those allowed by Mindray

This symbol can be seen when you open the door of computer cabinet, which is located
near the sockets for PC, displayer and switch. Devices other than those allowed by
Mindray are forbidden to connect to these sockets.
Do not push and pull

This symbol is located on the reagent carousel drive assembly and rack carriage side
cover. Do not push and pull rack carriage and reagent carousel drive assembly.
Do not disassemble
This symbol is located on the shield of SDM power supply unit. Do not disassemble
this unit otherwise electrical shock or other risks may be incurred. Do not disassemble
the instrument as well. If reparation is required, please contact our customer service
department or your local distributor.
1-25
Do not open the cover

This symbol is located on the cover above the rack carriage. Turn off the SDM power
switch before opening it.
UV Radiation
This label is placed on the sheet metal above the waste cap container and on the door
outside of it. Avoid eye and skin exposure to the UV radiation.
1-26
1.4 Abbreviations
The following abbreviations are used
Abbreviations Definition
CV Coefficient of Variation
DA Detergent acid
DB Detergent base
DC Probe cleanser
dBA Decibel weighted against the A-frequency response
curve. This curve approximate the audible range of the
human ear.
EMC ElectroMagnetic Compatibility
EN European standard
i.e. Id est-that is to say
IEC International Electrical Commission
IVD IN Vitro Diagnostic
LIS Laboratory Information System
QC Quality Control
RH Relative Humidity
SD Standard Deviation
STAT Short Turn-Around Time
μL Microliter. 1ml= 1000μL
1-27
1-28
2 System Description
This chapter describes the system from the installation, hardware, software and
specifications perspectives, including:
 Installation requirements and methods of the instrument
 Hardware components
 Optional modules that can be configured with the instrument
 Introduction and operation of software screens
 Technical specifications
2-1
2.1 Installation Requirements and Procedure

2.1.1 Installation Requirements
CAUTION
Install the instrument in a place meeting the requirements presented in this section;
otherwise, it will not perform as promised.
Installation environment
 The system is for indoor use only.
 The bearing platform (or ground) should be level (with gradient less than 1/200).
 The bearing platform (or ground) should be able to support at least “number of
analyzer * 600kg (analyzer + front track) + 300kg (sample delivery module)”.
 The installation site should be well ventilated.
 The installation site should be free of dust.
 The installation side should not be in direct sun.
 The installation site should be kept away from a heat or draft source.
 The installation site should be free of corrosive gas and flammable gas.
 The bearing platform (of ground) should be free of vibration.
 The installation site should be kept away from large noise and power supply
interference.
 Keep the system away from brush-type motors and electrical contact device that
is frequently switched on and off.
 Do not use such devices as mobile phones and radio transmitter near the system.
 The system should be installed in a place with altitude height between -400 and
4000 meters. An external vacuum pump should be employed for altitude height
above 2000 meters.
Power supply
 Connect the system to a power supply meeting the requirements specified in this
manual. For more information, refer to 2.5 System Specifications(page 2-37).
 The system is provided with a three-wire power cord, which has good grounding
performance.
 The system should be connected to a properly grounded power junction box.
WARNING
Make sure the power junction box is grounded correctly. Improper grounding may lead to
electric shock or equipment damage. Check if the power junction box outputs voltage
meeting the specified requirements and has a proper fuse installed.
Temperature and humidity

 Ambient temperature: 15°C-30°C
 Humidity: 35%RH-85%RH, without condensation.
2-2
CAUTION
Operating the system in an environment other than the specified may lead to unreliable
test results. If the temperature or relative humidity does not meet the above-
mentioned requirements, use air-conditioning equipment.
The refrigerated reagent compartment is at a low temperature. When both the ambient
temperature and the humidity are at a relatively high level (though within the specified
range), natural condensation can cause condensate water to be produced on the
surface of the reagent compartment or the reagent bottles. In this case, use air-
conditioning equipment.
Water supply and drainage

 The supplied water must meet the following requirement: its resistivity must be
no less than 1MΩ.cm@25°C (conductivity no larger than 1μS/cm@25°C).
CAUTION
The supplied water must meet the requirements; otherwise, insufficiently purified
water may result in misleading test results.
The temperature of supplied water must meet the requirements of water supply;
otherwise, too low or too high temperature may affect the stability of the test results.
 Flow: no less than “number of analyzers * 72L/H” for continuous flow, and
“number of analyzers * 4L/M” for transient peak flow.
 Temperature: The temperature of supplied water is within 10°C -30°C.
 If you use water supply equipment, make sure that the water supply pressure is
within 100kPa-392kPa and the length of the inlet tubing is no longer than 10m.
 Make sure that the outlet is no less than 50mm wide and no greater than 100mm
high, and the length of the waste tubing does not exceed 5 meters. When using
the high-concentration waste tank provided with the instrument, ensure the tube
is no longer than 2m.
BIOHAZARD
Dispose of the waste liquid according to the local regulations.
After installing the instrument, connect it with the fluidic components as instructed in
the figure below.
BIOHAZARD
Wear gloves and lab coat, if necessary, goggles and a mask.
CAUTION
When connecting the tubes, exercise caution to avoid folding or pressing them.
When sewer is used to discharge the liquid waste, seal the drain after the outlet of the tube
is put into it so as to avoid overflowing of the foam produced by the liquid waste.
2-3
Fluidic connection diagram
Fluidic interfaces
No. Name
2 4 High-concentration waste
outlet
High concentrati on
waste tank ful l
dete ction control cable
socket
1 Low-concentration waste
2 High-concentration waste
3 Deionized water
4 High-concentration waste sensor Ex ternal vacuum pump inlet Connector for
5 Optional external vac uum pump control external vac uum
6 5
6 External vacuum pump c onfigured pump c ontrol cable
Low-concentration waste
outlet Inlet tube connector
Sta
3
Wa Wat
Le
ge
n
nda
rd
Opt
ste
Vac
er
Se
1 Extern al vacuu m pu mp
configured
d ion uu ns Stand ard waste tank
al m or
Inlet and outlet of fluidic system(Back, look inside the instrument)
High concentration waste

Connector for external Low- tank is full
Inlet tube concentration High-concentration
vacuum pump control cable
External vacuum pump inlet Detection control cable
connector waste outlet waste outlet
socket
Fluidic inlet High-

W ater supply m odule(OP 01) External and outlet concentrati
vacuum panel on waste
pump control high-level
cable floater
cable
Filter
Filter
W ater supply m odule(Optional )
Low High
concentra concentra
tion tion
OU T1 OU T2 IN Discharge Discharge
port port
Water unit High-concentration waste tank

(CAN10)
External water tank
External Vacuum
Pump(Optional)
Connection diagram of inlet and outlet

of whole unit
The analyzers are connected to a water supply module through connectors. High-/low-
concentration waste produced by the analyzers are drained to the same waste tank or
to relevant waste tank and sewer.
Space and accessibility requirements

Install the instrument according to the clearance requirements as shown in the figure
below.
WARNING
Do not place the instrument in a position where the power cut-off device is not easily
accessible.
2-4
System clearances
Wall
700
1170
500
Analyzer 2 Analyzer 1 SDM 500 Operation
unit
Front
1600×2＋850
500
500
Unit: mm
Recommended computer configuration
WARNING
When reinstalling or upgrading the Windows operating system, please first contact the
Customer Service Department or your local distributor for correct software version since
operating system is subject to change.
Recommended computer configuration
Item Description
CPU CPU Frequency 3.2GHz or above
Quad Core or above
Random access memory At least 8 GB or above
(RAM)
Hard drive 500 GB or above
Network adapter Two Network cards. (at least one gigabit network card)
The computer is connected to the chemistry analyzer
through a network adapter. If you are going to connect the
computer with the LIS or Internet, you should prepare
another network adapter.
Compatible with 100BASE-T standard.
Interfaces One serial port used to communicate with LIS and one
PCIE extension interface (used to insert one PCIE serial
port card for another two or more serial ports to
communicate with SDM and the analyzer.)
2 network ports
2 or more USB ports
VGA or other types of displayer interfaces
Serial port: compatible with RS232 standard
Operating system The operating system installed on the computer must be
an activated version Microsoft Windows 10 (64 bit)
Professional.
Application software Except for the operating system, other application
software must not be installed or reserved on the
computer. If an anti-virus application has been installed,
then remove the automatic scheduled scanning and add
the operating software and BSLOG to the trust list.
Displayer 17 inches or above
2-5
Item Description
Automatic Disable the Automatically synchronize with an Internet
synchronization with time server option.
Internet time server
Automatic updates Turn off the automatic updates.
Auto awake and If you are going to use the auto awake/shutdown function,
shutdown setup perform necessary settings for BIOS and network
adapters while referring to their operation manuals.
Other Mouse, keyboard and built-in speaker
Recommended printer configuration

You are suggested to choose one of the following printers for use with the computer:
 Ink jet printer
 Laser printer
2.1.2 Installation Procedure
WARNING
The system should be unpacked and installed only by technicians of or authorized by our
company.
The system should be unpacked and installed by technicians of or authorized by our

company. Before the technicians arrive, prepare a proper site to install the system.
Before installation
When you receive the package, check it carefully. If you find any signs of mishandling
or damage, file a claim immediately with our Customer Service Department or your
local distributor.
After opening the package, check the delivered goods against the packing list, and then
visually check the system appearance. If you find anything missing or damaged, alert
our Customer Service Department or your local distributor immediately.
System relocation
If you want to relocate your system, contact our Customer Service Department or your
local distributor.
2-6
2.2 System Overview

2.2.1 System Structure
The chemistry analyzer consists of the analyzing unit (analyzing module and optional
modules, including ISE module, sample delivery module, front track, HbA1c sample
probe, ultrasonic cleaning module, decapping module, display arm, water supply
module, external vacuum pump, and handheld bar code reader), operation unit
(computer system), output unit (optional: printer), accessories (power cord), and
consumables (Cuvettes, Na, K, Cl, reference electrodes).
Configuration 1: 1 analyzing unit, optional: 1 sample delivery module, 1 ISE module, 1
water supply module, 1 external vacuum pump, 1 front track, 1 HbA1c sample probe, 2
ultrasonic cleaning modules, 1 displayer arm, 1 handheld barcode reader and 1
decapping module.
Configuration 2: 2 analyzing units, optional: 1 sample delivery module, 1 or 2 ISE
modules, 1 or 2 water supply modules, 2 external vacuum pumps, 2 front tracks, 1 or 2
HbA1c sample probes, 1 displayer arm, 2 or 4 ultrasonic cleaning modules, 1 handheld
barcode reader and 1 decapping module.
Configuration 3: 1 analyzing unit, optional: 1 ISE module, 1 water supply module, 1
external vacuum pump, 1 HbA1c sample probe, 2 ultrasonic cleaning modules, 1 hand-
held barcode reader.
The analyzing unit, determines various clinical tests in samples and displays the test
results. It is composed of the following components:
 Sample handling system
 Reagent handling system
 Reaction system
 Cuvette wash station
 Photometric system
 Mixer assembly
 ISE
The sample delivery module and the front track constitute the rack feeder system. The
module, connected to the right of the analyzers, feeds sample at high speed through
tracks.
The decapping module is composed of decapping delivery unit, decapping upper
gripper, decapping lower gripper, waste cap disposal unit, waste cap container and
auxiliary mechanism.
The operation unit, a computer configured with the operating software, controls the
analyzing unit to finish tests and produce test results.
The output unit is a displayer used to display test information and result. Printer is
optional, used to print out test results and other data.
Accessories and consumables are components that are required for sample
processing and should be replenished regularly, including cuvettes and Na, K, Cl,
reference electrodes.
2-7
Front view 1
(4)
(1) (2) (3) (5)
(1) Analyzing module 1 (3) Sample delivery module (SDM)

(2) Analyzing module 2 (4) Operation unit
(5) Printer
Front view 2
(1) (2) (3) (4) (5) (6) (7)
(8) (9) (10) (11) (12) (13) (14) (15)
(1) Reagent carousel 2 (8) Reagent Carousel 1

(2) Probe R22 (9) Probe R12
(3) Probe R21 (10) Probe R11
(4) Sample Mixer (11) Reaction Carousel
(5) Wash Station (12) Sample probe wash well
(6) Shielding cover (13) Sample probe
(7) Reagent Mixer (14) Suction device
2-8
(15) Front track

Consumable indicators
Indicators and statuses

Indicator Description Status
Constantly flickering Off
on
CD80 CD80 CD80 in use CD80 -
detergent insufficient.
status Need to
replenish
1 CD80-1 status CD80-1 in CD80-1 CD80-1

use insufficient. not in use
Need to
replenish
2 CD80-2 status CD80-2 in CD80-2 CD80-2
use insufficient. not in use
Need to
replenish
ISE ISE buffer ISE buffer ISE buffer -
solution solution in solution
use insufficient.
Need to
replenish
2.2.2 Sample Handling System

The sample delivery module is responsible for storing racks to be tested, retrieving the
racks when tests are complete, storing the racks that have finished sample aspirating,
and preparing the racks for rerunning.
The sample delivery module consists of:
 Rack supply unit
 Rack buffer unit
 Rack storage unit
 Control buttons
 Decapping module (if configured)
 Sample information detection module (vision camera, after the decapping module
being configured)
2-9
Sample delivery module
(1)
(2)
(3)
(4)
(1) Retrieval area (2) Loading area

(3) STAT Delivery area (4) Test control buttons
Rack supply unit (Loading area)

This unit is used to load racks to be tested. The system delivers the racks automatically
from this unit to the rack transfer unit when analysis starts. There are two rack supply
units, which can accommodate two Rack carriers. Each Rack carrier can hold 15 racks
and each rack 10 samples.
1# Rack carrier control button and 2# control button
In barcode mode or rack ID mode, put the 1# or 2# Rack carrier into rack supply unit 1
or 2 and then press the corresponding button to start test.
The status of the button includes:
 On(blue): awaiting rack delivery
 On (Orange): stopping the delivery of the current Rack carrier.
 Flickering (blue): feeding in racks. Do not move the Rack carrier in the rack supply
unit.
 Off: stop or no feed-in mission.
Note
When the indicator is flickering blue, do not move the rack carrier in the rack supply unit.
To ensure correct sampling sequence, in sequential mode, do not add sample rack into the
rack carrier whose indicator is flickering blue.
2-10
CCD visual recognition device

The CCD visual identification channel is located on the outermost of the storage area
on the first floor. When the rack in the rack supply unit passes the visual identification
channel, the CCD visual identification module automatically scans the barcode on the
rack and sample tube to identify the rack type and ID, sample container type and
sample information. The CCD visual identification module in the sample delivery
module is standard configuration, which can identify different sample rack types.
Sample rack bar code is the default one and cannot be set up by user.
Rack storage unit (Retrieval area)
This unit is used to store the racks on which all tests have been finished. The rack
storage units can accommodate two rack carriers.
The status of the button of the rack storage unit includes:
 On(blue): awaiting retrieval.
 Flickering(blue): Retrieving racks. Do not move the rack carrier in the rack storage
unit.
 Off: Retrieval cannot be performed. No rack carrier or rack carrier is not installed
in place.
 Flickering (orange): Rack carrier is full.
STAT Lane(STAT delivery area)
STAT lane located in the front of SDM is used to feed-in STAT racks. When the rack is
put into STAT area, press the STAT button to deliver the rack.
Other than STAT racks, other types of racks can also be admitted in this unit. For
example, when rack feeder mode is sequential mode, except for normal racks (Nxxxx),
other types of racks are available (including STAT, rerun, calibration, QC); when rack
feeder mode is rack ID mode or bar code mode, STAT rack feeder unit accepts all types
of racks.
STAT button
Located on the right side of the STAT area, it is used to insert STAT samples tests.
When the STAT button is pressed, the STAT sample is fed in, and the STAT button
flashes until the sample feeding is completed and then STAT button is off. When the
Extra urgent function is configured, when the STAT button is pressed twice, the STAT
lane starts loading samples. In the meantime, the STAT button flashes quickly. The
button flashes until sample loading is completed, and then STAT button is extinguished.
Decapping module
The decapping module is composed of decapping delivery unit, decapping upper
gripper, decapping lower gripper, waste cap disposal unit, waste cap container and
auxiliary mechanism. The decapping module automatically removes the caps of
capped sample tubes on the sample racks through sample information obtained from
the sample detection module, identifies the position of the barcode on the sample tube
and aligns the barcode with the scanning slot of the barcode reader. The removed caps
are transported to the waste cap container, which needs to be emptied manually when
filled with caps. Composed of the waste cap container and disinfection mechanism,
the waste container unit collects the discarded caps and disinfects them by ultraviolet
light.
The status of the button of the decapping module waste cap container includes:
 On (blue): The residual capacity of the waste cap container is sufficient.
 Flickering (blue): The residual capacity of the waste cap container is sufficient and
the decapping module is in operation. Do not move the waste cap container.
2-11
 On (orange): The residual capacity of the waste cap container is insufficient.

 Flickering (orange): The waste cap container is full and needs to be replaced.
 Off: The waste cap container is taken out or the container cannot be detected after
its door is closed.
Sample information detection module
This module consists of a vision camera and a barcode reader. The vision camera can
identify sample information, including sample container type and sample height. The
barcode reader can detect the sample barcode.
Rack transfer unit (Front tracks)

This unit consists of three lanes, which include passing lane, normal lane and return
lane. The sample probe aspirates samples from the passing lane and normal lane.
Racks for STAT sample, quality control, calibration and rerun are carried to the passing
lane for sample aspiration; while normal racks are only carried to the normal lane for
sample aspiration. After aspiration, the racks are carried to the rack buffer unit through
the return lane.
Rack transfer unit
(1)
(2)
(3)
(1) Passing lane (2) Normal lane

(3) Return lane
Sample racks
CAUTION
Do not disinfect the racks at high temperature (over 80°C) or by using strong acid or alkaline;
otherwise, the racks may be damaged.
There are six colors of racks, distinguished by different colors. The racks are described
as follows:
 Routine sample rack: Grey, with rack ID beginning with N
 STAT sample rack: Red, with rack ID beginning with E
 Manual rerun rack: Dark blue, with rack ID beginning with R
 Calibration rack: Orange, with rack ID beginning with S
 QC rack: Light blue, with rack ID beginning with C
 Maintenance rack: Pink, with rack ID beginning with M
Rack Carrier
The Rack Carrier is used to store multiple sample racks and transfer them to the supply
unit of the SDM. It can hold a maximum of 15 sample racks every time, that is, 150
samples in total.
2-12
This carrier boasts rack anti-slippery and anti-tilt feature. When the carrier is lifted, the
two anti-slippery helical locking devices on the interior of the carrier will automatically
protrude to press tightly two sides of the rack in the carrier to avoid racks slipping along
the carrier. When the carrier is placed on the table or flat surface, the two anti-slippery
helical locking devices on the interior carrier will retrieve automatically to ensure that
sample racks are put into the carrier easily.
The carrier features anti-falling. In normal conditions, the anti-falling stopper of the
carrier is in protruding position, preventing samples in the carrier from falling over the
carrier. Only when the carrier is put on the device, will the anti-falling stopper
automatically retrieve so that racks in the carrier can be normally delivered.
Orange and black markings has been labeled in the carrier to show the racks’ direction.
The orange trapezoid symbol indicates the front of the rack (The head of the rack is
printed orange as the indication color). The black rectangle symbol indicates the tail
of the rack. When putting sample racks, please ensure the direction of racks is
consistent with indications. If sample rack is put in a reversed direction, the rack bar
code and ID will not be identified and will be delivered to the rack storage unit directly.
The carrier itself has installation direction. When the carrier is installed on the
instrument, please place the opening side of the carrier towards the track so that the
rack can move from the carrier to corresponding track. To identify it easily, the arrow
indicating rack’s installation direction is labeled on the surface of the carrier. When
installing the carrier, make the arrow point at the back of sample processing system.
Rack Carrier
Carrying samples:
1 Put multiple sample racks successively into the Rack Carrier by hanging their two
ends on the two wide edges.
2 Carry the Rack Carrier to near the instrument.
CAUTION
When carrying the Rack Carrier, keep it upwards to prevent sample spilling.
If loading less than 10 sample racks, prevent the Rack Carrier from tilting for more
than 30° to avoid rack falling down.
3 Place the Rack Carrier into rack supply unit.

Maintaining the Rack Carrier:
If sample or other liquid is spilled on the Rack Carrier, use cotton swabs dipped with
ethanol to clean it and leave it dry in air.
2-13
Sample dispenser assembly

The sample dispenser assembly is composed of the sample probe, probe arm, probe
rotor, syringe, wash well and related tubing. It aspirates the specified amount of sample
from a sample tube and then dispenses it into a cuvette for reaction and analysis.
Sample dispenser assembly
(1)
(2)
(3)
(4)
1. Sample probe arm 3. Sample probe

2. Sample probe rotor 4. Sample probe wash well
Sample probe
There are two sample probes:
S1 probe: on the right side responsible for dispensing sample in the cuvette on the
inner ring of the reaction carousel and dispensing sample for the ISE module.
S2 probe: on the left side responsible for dispensing sample in the cuvette on the outer
ring of the reaction carousel and dispensing sample for Hemoglobin A1c Test.
They aspirate the specified amount of sample for different type of tests:
 Biochemical tests: 1.5μL-25μL, with increment of 0.1μL.
 ISE tests: 22μL.
The sample probe is capable not only of aspirating sample but also of the following
functions:
 Clog detection: checks the sample probe for blockage. When detecting blockage,
the system produces a warning and prompts you with the next step.
 Horizontal obstruct detection: detects obstacles in the horizontal direction. When
the sample probe collides with an obstacle in the horizontal direction, the auto
guard system is started to prevent the sample probe from being damaged.
 Vertical obstruct detection: detects obstacles in the vertical direction. When the
sample probe collides with an obstacle in the vertical direction, the auto guard
system is started to prevent the sample probe from being damaged.
 Bubble detection: detects air bubbles in sample. When bubble exists, the system
will give an alarm to avoid inaccurate dispensing.
 Level detection and tracking: detects the sample level and determines the depth
of lowering down into the sample based on the specified aspirate volume.
2-14
WARNING
When the system is in operation, do not place any part of your body or any obstacle in the
route where the sample probe arm moves; otherwise, personal injury or equipment damage
may be caused.
Sample probe washing

The sample probe is cleaned in its wash well with preheated water spraying its interior
and exterior from an oblique direction.
Sample probe cleanser (DC), alkaline detergent(DB) and acid detergent(DA) are used
to special wash sample probes.
Sample syringe
The sample syringes are located behind the left door of the analyzer. When you open
the left door, you will see six syringes. The two syringes on the right are intended for
sample aspirating and dispensing.
Sample syringes
(1) (2)
1. Sample syringe 1 2. Sample syringe 2
Sample containers
Sample containers used on racks include:
 Microtube: Φ14×25mm, 0.5ml (Beckman); Φ14×25mm, 2ml (Beckman);
Φ12×37mm, 2ml (Hitachi).
 Blood collecting tube or plastic tube: Φ12×68.5 mm, Φ12×99 mm, Φ12.7×75 mm,
Φ12.7×100 mm, Φ13×75 mm, Φ13×95 mm, Φ13×100 mm, Φ16×75mm, and
Φ16×100mm.
Sample tubes varying in specification requires different minimum sample volumes.
Each sample tube must contain the minimum amount of sample; otherwise, correct
aspirating cannot be ensured. The minimum sample volume is the sum of the sample
volume for analysis (sum of defined sample volume for test and the excessive
aspiration 5μL) and the dead volume of the sample container.
Note
If the tested sample is whole blood, the centrifuged whole blood sample must be held in
the sample tube. Whole blood samples cannot be analyzed with microtubes.
To ensure accurate whole blood analysis, make sure that the blood cell height of the whole
blood sample is at least 10 mm.
2-15
The table below shows the dead volume of each type of sample container.
Specification and dead volume of sample containers
Sample Container Specification Dead Volume
Sample Cup 0.5 mL-L Φ14×25mm, 50μL
0.5ml(Beckman)
Sample Cup 2mL-L Φ14×25mm, 2ml(Beckman) 150μL
Sample Cup 2mL-H Φ12×37mm, 2ml(Hitachi). 100μL
Primary tube or Φ12×68.5 mm 8mm more over the
plastic tube Φ12×99 mm unacceptable sample
level height
Φ12.7×75 mm
Φ12.7×100 mm
Φ13×75 mm
Φ13×95 mm
Φ13×100 mm
Φ16.5×92mm
Φ16×75mm
Φ16×100mm
2.2.3 Reagent Handling System

The reagent handling system is used to hold reagents and provides them for reacting
with samples. It consists of the following assemblies:
 Reagent carousel assembly
 Reagent load button
 Reagent bar code reader
 Reagent dispenser assembly
 Reagent bottle
Reagent carousel assembly

The reagent carousel is a turntable located on left side of the analyzer panel. It holds
reagent bottles and carries each of them to the reagent aspirate position for aspirating.
There are two reagent carousels, the first reagent carousel in the front of the panel and
the second reagent carousel in the back. Each carousel contains 72 positions, and 144
positions in total, all of which support bar code scanning. Each carousel is composed
of the outer ring and the inner ring, which are coaxial but driven separately. The four
rings are numbered below:
 First reagent carousel outer ring: R11
 First reagent carousel inner ring: R12
 Second reagent carousel outer ring: R21
 Second reagent carousel inner ring: R22
The outer ring has 40 positions and inner ring has 32 position for each reagent carousel.
The first carousel is used for holding R1 and R3. The second carousel is used for
holding R2 and R4.
The positions for detergents and DI water are specified as follows:
2-16
Detergent Position
DA for R11 71DA
DB for R11 72DB
DI water for R11 70W
DA for R12 31 DA
DB for R12 32 DB
DI water for R12 30 W
DA for R21 71 DA
DB for R21 72 DB
DA for R22 31 DA
DB for R22 32 DB
The reagent carousel provides a refrigerating environment, which is constant within

2°C-8°C for 24 hours a day. The reagents stored in such environment can be kept stable
with little volatilization. The reagent carousel cover must be installed when the reagent
compartment is used for refrigeration.
Reagent carousel
(1)
(2)
1. Second reagent carousel 2. First reagent carousel
Reagent pad
This pad is located on the left corner of R1 reagent carousel used to display the
reagents and consumables, reset and load them.
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Reagent PAD
CAUTION
Every day before analysis, remove the plugs on the reagent carousels in order to prevent
mechanical reset failure and bending reagent probes. Restore the plugs after finishing tests
of the day.
Ensure that the reagent carousel is closed while the system is analyzing. Opening the
reagent carousel cover during analyzing will abort the analysis and invalidate the tests that
are running.
If reagent is sprayed on the position numbers of the reagent carousel outer ring, clean it
immediately with ethanol-dipped gauze.
Reagent load button

The reagent load buttons located on the lower-left corner of the first reagent carousel
is used to rotate the reagent carousel. There are two reagent load buttons available,
the lower one for the first reagent carousel and the upper one for the second one. When
a reagent load button is pressed and held, the corresponding carousel starts rotating;
when the button is released, the carousel stops rotating.
The buttons work only when the reagent carousels are opened.
Reagent load button
(1)
(2)
2-18
1. Reagent load button for second reagent carousel

2. Reagent load button for first reagent carousel
Reagent bar code reader

The reagent bar code reader located on the Lower-left inside the reagent carousel
consists of the following components:
 Reagent bar code reader
 Bar code label
 Hardware and software to control bar code scanning
When the reagent carousel cover is closed after reagent bottles are loaded, the system
scans automatically all reagents positions to reader reagent information and then
displays it on the screen.
WARNING
The light radiated from the reagent bar code reader may hurt your eyes. Do not stare into
the laser beam coming from the reagent bar code reader.
Reagent dispenser assembly

The reagent dispenser assembly located on the right side of the two reagent carousels
consists of the reagent probe, probe arm, probe rotor, syringes and related tubing. It
aspirates the specified amount of reagent from a reagent bottle and then dispenses it
into a cuvette for reaction and analysis.
Reagent dispenser assembly
(3)
(4)
(5)
(1)
(7)
(6)
(2)
1. Second reagent carousel 5. Probe R11

2. First reagent carousel 6. Probe R12
3. Probe R22 7. Wash well
4. Probe R21
Reagent probe
The system has four reagent probes: probe R11, probe R12, probe R21 and probe R22.
The first two are used to aspirate/dispense R1 and R3 reagents, and the last two to
aspirate/dispense R2 and R4 reagents. The four probes aspirate reagent within the
following range:
 R1: 80μL-200μL, with increment of 0.5μL
2-19
 R2-R4: 10μL-200μL, with increment of 0.5μL

The reagent probes are capable not only of aspirating reagent but also of the following
functions:
 Horizontal obstruct detection: detects obstacles in the horizontal direction. When
the reagent probe collides with an obstacle in the horizontal direction, the auto
guard system is started to prevent the reagent probe from being damaged.
 Vertical obstruct detection: detects obstacles in the vertical direction. When the
reagent probe collides with an obstacle in the vertical direction, the auto guard
system is started to prevent the reagent probe from being damaged.
 Bubble detection: detects air bubbles in reagent. When bubble exists, the system
will give an alarm to avoid inaccurate dispensing.
 Empty aspirate detection: monitor the reagent probe’s reagent aspiration. If no
reagent is aspirated, the system will give an alarm to prevent affecting the
measurement.
 Level detection: detects the reagent level inside reagent bottle.
WARNING
When the system is in operation, do not place any part of your body or any obstacle in the
route where the reagent probe arm moves; otherwise, personal injury or equipment damage
may be caused.
Reagent probe washing

Probe reagent adopts the waterfall exterior wash and high-pressure interior wash, in
which the preheated cleaning fluid is used to clean the interior and exterior of the probe.
Reagent syringe
The reagent syringe is located behind the right door of the analyzer. When you open
the right door, you will see six syringes. The four syringes on the left are related to
probes R11, R12, R21, and R22.
Reagent syringe
(1)
1. Reagent syringes
R11 and R12 syringes are used to aspirate/dispense R1 and R3, and R21 and R22
syringes to aspirate/dispense R2 and R4.
2-20
Reagent bottle
The reagent carousel is compatible with 20ml, 40ml, 62ml and 70ml reagent bottles.
Only one reagent bottle can be held in each reagent position. The table below shows
the dead volume of each type of reagent bottle.
Specification and dead volume of reagent bottle
Reagent Bottle Type Dead Volume
20ml 2ml
40ml 3ml
62ml 3.5ml
70ml 6ml
Prior to measurement, prepare sufficient reagent according to the dead volume above
to ensure smooth going of the test.
2.2.4 Reaction System

The reaction system is composed of the reaction carousel and cuvettes. It holds
reaction cuvettes and provides an appropriate and steady environment for reaction
mixture, which is transmitted to the photometric position for signal detecting and
absorbance calculation.
Reaction carousel
The reaction carousel is a two-ring turntable located in the middle of the analyzer panel
and provides 412 positions for cuvettes, 206 each on inner ring and outer ring. It holds
reaction cuvettes and transmits each of them to the photometric position for signal
detecting and absorbance calculation.
The reaction carousel is capable of temperature control and provides a constant
environment at 37±0.3°C with fluctuation of ±0.1°C.
Reaction carousel
(3)
(4)
(1) (2)
1. Reaction carousel 3. Cuvette wash station

2. Sample probe 4. Reagent mixer
2-21
Reaction cuvette
The reaction cuvette is reusable and used to hold reaction mixture for photometric
measuring. The light path length of the cuvette is 5mm, and its inside dimension is
5mm (length)*4mm (depth)*29mm (height). The total volume of reaction mixture
should be within 80μL-280μL.
When finishing a test, the system washes and dries the cuvette automatically for later
use.
2.2.5 Cuvette Wash Station

The system provides auto wash function, through which the cuvettes on two rings of
the reaction carousel are washed via nine-phase wash probes of the wash station
when a test is finished. The cuvette wash station consists of the wash probes,
elevating motor and related tubing. The wash probes driven by the elevating motor to
go up and down during each wash phase dispense and aspirate wash solution in the
cuvette to finish washing and drying.
Cuvette wash station
(1) (2) (3) (4) (5)
1. Wash probe 4. Cuvette wash station for reaction carousel

outer ring
2. Wipe block 5. Reagent mixer
3. Cuvette wash station for reaction carousel
inner ring
The cuvette wash station cleans the cuvettes with wash solution and Deionized water,
which are divided as follows:
 Phase 1 and 2: the cuvette is washed with diluted wash solution
 Phase 3 to 6: the cuvette is rinsed with deionized water
 Phase 7 and 9: the cuvette is dried and wiped
The cuvette is washed and rinsed with preheated diluted wash solution and deionized
water in phase 1 to 6. After the washing, the waste fluid is discharged in two flows:
high-concentration waste and low-concentration waste. The system is capable of
detecting the waste fluid level and produces an alarm when detecting excessive waste.
2-22
2.2.6 Photometric System

The photometric system located inside of the analyzer measures the absorbance of
the reaction mixture in the cuvette. The photometric system, composed of the
photometer assembly and the signal detection assembly, measures the light
transmitted through the reaction mixture and then converts the light change signal into
electrical signal, which reflects the change of the light intensity.
The photometer assembly, which consists of the light source, colorimetric component
and optical component, provides sufficient monochromatic light and reliable
colorimetric structure.
The signal detection assembly consists of the AD conversion component and the AD
signal collection component. It converts the monochromatic light transmitted through
the reaction mixture into an electrical signal, which is amplified and output as
photometric data and then sent to the corresponding control unit for absorbance
calculating.
The table below shows the main technical parameters of the photometric system.
Specifications of photometric system
Name Value
Light source Tungsten-halogen lamp, 12V/50W
Lamp service life 2400 hours
Colorimetric component Reaction cuvette
Light transmission component Holographic concave flat-field gratings
Light transmission mode Reversed optics
Signal detector Photodiode array
Measuring wavelength 16 wavelengths:
340nm,380nm,412nm,450nm,480nm,505nm,5
46nm,570nm,605nm,630nm,660nm,700nm,74
0nm,770nm,800nm and 850nm
Wavelength accuracy ±2nm
Measurement range 0-3.5A
Full width at half maximum (FWHM) ≤10nm
Absorbance resolution 0.0001A
2.2.7 Mixer Assembly

The mixer assembly, consisting of the sample mixer assembly and the reagent mixer
assembly, is used to stir the reaction mixture when sample/R3 and R2/R4 are
dispensed into the cuvette.
2-23
Sample mixer assembly

Sample mixer assembly
(1) (2) (3) (4)
1. Mixer arm 3. Sample mixer

2. Sample mixer 4. Sample mixer
The sample mixer assembly located at the upper-left corner of the reaction carousel
stirs the reaction mixture when sample and R3 are dispensed. There are six sample
mixers in total, two for each set. Each set works in three phases:
 Phase 1 and 2: The mixers are washed.
 Phase 3: The mixers stir the reaction mixture.
Sample mixer washing:
There are four wash wells to clean sample mixers in two phases.
After stirring, the sample mixer moves to the two wash wells for cleaning.
Stirring sample:
The sample mixer stirs the reaction mixture in horizontal and vertical directions and is
able to detect the rotation speed while stirring.
2-24
Reagent mixer assembly

Reagent mixer assembly
(1) (2) (3) (4)
1. Reagent mixer 3. Mixer arm

2. Reagent mixer 4. Reagent mixer
The reagent mixer assembly located at the upper-right corner of the reaction carousel
stirs the reaction mixture when R2 and R4 are dispensed. There are six reagent mixers
in total, two for each set. Each set works in three phases:
 Phase 3: The mixers stir the reaction mixture.
Reagent mixer washing:
There are four wash wells to clean reagent mixers in two phases.
After stirring, the reagent mixer moves to the two wash wells for cleaning.
Stirring reagent:
The reagent mixer stirs the reaction mixture in horizontal and vertical directions and is
able to detect the rotation speed while stirring.
2.2.8 Operation Unit

The operation unit is a computer configured with the operating software. It consists of
the touchscreen, computer, keyboard and mouse.
2.2.9 Output Unit

The output unit is a displayer and printer used to display test information and print out
test results and other data. The system supports two types of printer, which include
inkjet printer and laser printer.
2-25
2.2.10 Accessories and Consumables

Accessories and consumables are replenishable components required to run tests and
should be checked regularly for refilling and replacement including cuvettes and
Na/K/Cl/ reference electrode.
CAUTION
Use the accessories, power cords and consumables manufactured or recommended by
our company in order to achieve the promised system performance and safety. If needed,
contact our customer service department or your local distributor.
For more information about accessories and consumables, refer to 11.1.2 Accessory
Information (page 11-2).
2.2.11 Data Management Software

The Data Management Software is used to deal with test data of chemistry analyzers
and can meet the demands of data processing in clinical laboratories. The Data
Management Software is allowed to connect with multiple chemistry analyzers. As a
data management center, it possesses an independent database to provide data
support for user ends, such as clinical professionals, instruments, administrators, etc,
and is capable of managing and printing test results.
The data management software is provided together with the instrument. If you already
have a LIS system and do not need the data management software, contact our
customer service department or your local distributor.
The “LIS” in this manual can indicate either the data management software developed
by our company or a Laboratory Information System (LIS) that you have possessed.
All LIS functions of the instrument are applicable for bother the data management
software and LIS.
2-26
2.3 Optional Modules

2.3.1 Introduction
Optional modules are not provided as standard configuration accompanying the
instrument when it is delivered. They can be configured according to your requirements.
The following modules are supplied:
 ISE module
 Built-in sample bar code reader
 HbA1c Sample Probe
 Water supply module
 External vacuum pump
 Displayer Arm
 Ultrasonic cleaning unit
2.3.2 ISE Module

The Ion-Selective Electrode (ISE) module consists of the sampling and measuring
channel, syringe, heat stabilizer, degassing unit and waste discharger, used in
combination with Na+ electrode, K+ electrode, Cl- electrode, reference electrode to
measures the concentration of Na, K and Cl in serum, plasma and diluted urine. The
sample volume for measuring is 22μL. The theory of measurement is indirect ion-
selective electrode method.
ISE Module
(5)
(1) (2) (3) (4)
1. Degassing unit 4. Diluent syringes

2. Heat stabilizer 5. Electrodes and measuring channel
3. Waste discharger
2.3.3 Water Supply Module

The water supply module provides deionized water for the chemistry analyzer. When
water is required during the measuring process, the water supply module turns on the
internal inlet valve and transmits water while driven by the pneumatic pump. When
water is not needed, the water supply module turns off the internal inlet valve and cuts
off the power supply of the pneumatic pressure pump to stop supplying water.
Before starting test every day, you should switch on the power of the water supply
module. After finishing test of the day, you should switch off the power.
2-27
Water supply module
(1) (5)
(4)
(2) (3)
1. Inlet 4. Pressure gauge

2. Air vent 5. Outlet
3. Ball valve
Rotate the handle clockwise to the vertical position to turn on the ball valve and release
the residual pressure inside the module; rotate the handle counterclockwise to the
horizontal position to turn off the ball valve. Please make sure the ball valve is turned
off when the system is analyzing.
Connecting instrument with water supply module
Chemistry analyzer
DI water tank
Fixed by tube
clamps
1 2
Water supply
3 4 inlet filter
5 6 7: Water inlet
DI water inlet 7 8 9 8: Air vent

Inlet filter
9: Water outlet
Water supply module
Make sure that there is sufficient space between the water supply module and the wall
(no less than 0.5m in front and back and no less 0.2m on left and right) so that it is
convenient to install or operate the module. Use the provided three-wire power cord to
connect the module to a properly-grounded power socket.
Sufficient deionized water should be prepared in the water tank when using the water
supply module. Make sure the water supply module is powered on before running. The
module should be powered off if not used for a long time.
If there is something wrong with the water supply module, please consult our customer
service department or your local distributor.
2-28
2.3.4 External Vacuum Pump

When operated in a place with the altitude above 2,000m, the system may be degraded
in its liquid aspirating performance due to the decreased atmospheric pressure. In this
situation, an external vacuum pump is required to assist the system with liquid
aspiration.
Front view of the external vacuum pump
(1)
(2)
1. Pressure gauge
2. Dust screen
Rear view of the external vacuum pump
(1)
(3)
(2)
(4)
(5)
1. Gas connector 4. Power switch

2. Control interface 5. Power jack
3. Cooling fans
Make sure that there is sufficient space between the external vacuum pump and the
wall (no less than 0.5m in front and back and no less 0.2m on left and right) so that it
is convenient to install or operate the module. Before using the vacuum pump, connect
the gas connector and control interface with the counterpart connectors on the rear
panel of the analyzer; connect the vacuum pump to a properly-grounded power socket
with the three-wire power cord. The external vacuum pump will be controlled by the
analyzer when powered on and requires no manual operations.
When finishing all tests everyday, you are recommended to power off the external
vacuum pump. Before starting the tests every day, please make sure the external
vacuum pump is powered on.
2-29
The pointer of the pressure gauge is deviated from the 0 point when the vacuum pump
works normally. If the pointer stops at the 0 point while the vacuum pump is running,
there must be something wrong with the vacuum pump. Consult our customer service
The external vacuum pump should be installed and adjusted only by the technicians of
or authorized by our company.
2.3.5 HbA1c Sample Probe

S2 probe can choose HbA1c Sample Probe, which can be used for dispensing whole
blood samples for Hemoglobin A1c Test.
2.3.6 Displayer Arm

It is used to hold the displayer, wireless keyboard and mouse and handheld barcode
reader.
2.3.7 Handheld Barcode Reader

It is used to scan the barcode of the samples, reagents, calibrators and controls.
2.3.8 Other Optional Modules

For more information about other optional modules, contact our customer service
2-30
2.4 Software Description

2.4.1 Main Screen
Main screen
(1)
(2) (3)
1. Status display area 3. Function window

2. Function buttons area
Status display area

The status display area shows the status of the entire system, including
biochemistry/ISE system status, estimated completion time, remaining time, system
date/time, LIS connection, printer, login user, and module status.
2-31
Status display area

Status Description
Biochemistry - ISE / SDM This indicator appears on the left of the status display
status area and shows general status of the consisting
modules. If an ISE module is installed, the ISE status
appears.
The biochemistry status of both analyzing module
includes: Initialize, Wakeup, Incubation, Standby,
Running, Reagent Load, Inventory, Stopped, Restore,
Sleep, Maintenance,Alignment,SPT Diagnosis and
Shutdown.
The status of the ISE module includes: Initialize,
Restoring, Stopped, Shutdown, Sleep, Wake Up, Standby,
Running, and Sampling Stop.
Estimated Completion This is displayed in the middle of status display area,
Time indicating the estimated completion time for the test.
Remaining Time This is displayed in the middle of status display area,

indicating the remaining time for the maintenance.
Date and time This indicator appears on the upper right corner of the
main screen. It indicates the system date and time.
LIS status
This indicator appears on the upper right corner of the
main screen. The following information is indicated:
 If the icon appears in green, the LIS host is connected
and online.
 If the icon appears in red or grey, the LIS host is

not connected successfully or not used.
Printer status
This indicator appears on the upper right corner of the
main screen. It indicates the status of the printer: not
printing and printing.
 If the icon appears in red, the printer is not
performing print tasks or unconnected.
 If the icon appears in green , the printer is

printing.
When printing reports, click this icon to stop the printing.
Login user This indicator appears on the right of the status display
area. It indicates the user who logs in the system.
2-32
Status Description
Module Status This icon shows the configured analyzing unit and its
status. Click this icon to display the System Status
screen, on which the detailed status of the analyzer and
sample delivery module are provided.
The module status includes:
 Error-red: An error occurs. The analyzer icon appears
in red.
 Warning - yellow: A warning occurs. The analyzer icon
appears in yellow.
 Normal: The system is running normally.
Function buttons
The function buttons area contains the following buttons used to access various
function windows of the system:
: used to order sample tests and control samples, and view samples
and tests, sample results and rack status.
: used to load reagents, view reagent and consumable statuses and

inventory check.
: used to define/edit controls and rules, request QC tests and recall QC

results and summary.
: Calibration: Used to define calibrators, request calibration tests and

view calibration results and data.
: used to perform maintenance, view system statuses and view edit

log and error log.
: used to set up test and system parameters.
Function window
The function window contains options, buttons and other controls used to perform
various functions of the system.
Shortcut icons
The shortcut icons area contains the following icons used to quickly access certain
function window or perform an operation:
 : Start icon. Select it to display the Start Conditions window, on

which you are allowed to start new analysis or resume early testing.
2-33
 : Sampling Stop icon. After sampling stop, the SDM stops

delivering racks from the rack supply unit to the instrument. When rack feeding
from the rack supply unit is finished, the system status changes to Sampling Stop.
At this time, you can add new racks to the rack supply unit or replenish the samples
that are insufficient in the test.
 : Emergency stop icon. Select it to stop all tests and other actions.
To restore the system into Standby status, execute the Home command.
 : exit the system.
 : Online help icon. Select it to display the online help of the current window,
where you will find description of parameters and operations.
2.4.2 Using a Mouse

Move
The mouse is presented on the screen in the form of pointer. Place the mouse on a flat
platform, and then move it to make the pointer lap over the object that you want to
select or edit.
Select
Move the mouse to make the pointer lap over the object that you want to select or edit,
and then press the left mouse button and release it quickly. Pressing the left mouse
button is functionally equivalent to touching the screen.
Double-click
Move the mouse to make the pointer lap over the object that you want to select or edit,
and then quickly press the left mouse button twice and release it. Pressing the left
mouse button twice is functionally equivalent to touching the screen twice.
Drag
Dragging is used to move the slider on a screen in order to choose a scale. Move the
mouse to make it stop over the slider, press and hold the left mouse button, move the
mouse left and right to adjust the slider to the desired scale.
Using a mouse in conjunction with a keyboard

Some lists on the screen allow you to select more than one object at one time, and you
can achieve this by using a mouse in conjunction with a keyboard. When selected, the
objects will be highlighted for easy identification.
Perform the following operations to select more than one object:
 To select discontinuous objects, press the left mouse button to select the first
object, press and hold the Ctrl key, use the mouse to select other desired objects,
and then release the Ctrl key.
 To select continuous objects, press the left mouse button to select the first object,
press and hold the Shift key, use the mouse to select the last object, and then
release the Shift key.
2-34
2.4.3 Using a Touchscreen

The system supports a touchscreen, by using which you are allowed to perform various
operations of measurement. The touchscreen can be operated in the following ways:
Move
Put your finger above the mouse pointer, and then move your finger to make the pointer
stop at the object that you want to select or edit.
Select
Move your finger to make the pointer lap over the object that you want to select or edit,
touch the screen and then release it quickly. Touching the screen is functionally
equivalent to pressing the left mouse button.
Double-click
Move your finger to make the pointer lap over the object that you want to select or edit,
quickly touch the screen twice and then release it. Quickly touching the screen twice is
functionally equivalent to pressing the left mouse button twice.
Drag
Dragging is used to move the slider on a screen in order to choose a scale. Move the
mouse pointer to make it stop over the slider, press and hold the screen, and then move
the pointer left and right to adjust the slider to the desired scale.
Using a touchscreen in conjunction with a keyboard

Some lists on the screen allow you to select more than one object at one time, and you
can achieve this by using a touchscreen in conjunction with a keyboard. When selected,
the objects will be highlighted for easy identification.
Perform the following operations to select more than one object:
 To select discontinuous objects, touch the screen to select the first object, press
and hold the Ctrl key, touch the screen again to select other desired objects, and
then release the Ctrl key.
 To select continuous objects, touch the screen to select the first object, press and
hold the Shift key, touch the screen again to select the last object you desire, and
then release the Shift key.
2.4.4 Using Online Help

The system provides you with help information about the screens. If you do not
understand a parameter or an operation on a screen, you can go to the online help for
relevant information.
Accessing the online help

Access the online help from the following screens:
 Select the icon on the upper right corner to display the help topic related
to the current screen.
2-35
Accessing the online help from the main screen
Viewing information
To view information in the online help,
1 Select the icon on the upper right corner of the main screen,.
2 Select the following tabs to view relevant information:
 Contents: to navigate through all topics of the online help.
 Index: to view topics related to the input keywords.
 Search: to view topics containing the input keywords.
 Favorites: to view your favorite topics.
3 Read the help topics. Move the scroll bar on the right side of the help window to
view more information.
4 Select to close the help window.
2-36
2.5 System Specifications

2.5.1 Technical Parameters
Throughput and reaction type
Throughput and reaction type
Parameter Description
Throughput for biochemical Configuration 1 and 3(including one analyzing
tests module): 2000 tests/hour for single-/double-reagent
tests, 2400 tests/hour when ISE module is configured.
Configuration 2(including two analyzing modules):
4000 tests/hour for single-/double-reagent tests,
4800 tests/hour when ISE module is configured.
Throughput for ISE tests 1 ISE module: serum/plasma 600 tests/hour
(including K, Na, Cl) 1 ISE module: urine 400 tests/hour
Maximum number of tests Configuration 1 and 3(including one analyzing
run simultaneously module): Maximum 72 tests
Configuration 2(including two analyzing modules):
Maximum 138 tests
Principles of analysis Colorimetry, turbidity, and ion-selective electrode
method
Reaction types Endpoint, fixed-time, and Kinetic
Reagent mode Supporting single-/double-/triple-/quadruple-reagent
tests
Wavelength Supporting double-wavelength mode
Reaction time The maximum reaction time is equal to or less than
20 minutes 42 seconds and can be set up.
Sample handling system

Specifications of the sample handling system
Sample volume for routine 1.5μL-25μL, with increment of 0.1μL
test
Sample volume for ISE test 22μL
Sample probe Two sample probes, featuring level detection,
horizontal/vertical obstruct detection, clog detection,
bubble detection, and level tracking.
Sample probe washing The sample probe adopts the waterfall exterior wash
and high pressure interior wash, and the preheated
cleaning fluid is used to clean the interior and exterior
of the probes.
Emergent samples Emergent samples can be analyzed at any time with
highest priority.
Rerunning mode Supporting auto dilution and rerunning of samples,
and manual rerun.
Extra Urgent mode Support extra urgent sample test. Extra urgent sample
shall be delivered and handled first.
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Rack feeder system

Specifications of the rack feeder system
Composition Composed of the sample delivery module and rack
transfer unit. Multiple analyzers are interconnected
through the sample delivery module.
Sample delivery module Located to the right of the analyzers and used to load
and unload sample racks.
The sample can be delivered continuously.
Independent STAT lane provided.
Rack transfer unit Located in front of the analyzers and level to the
analyzer front panel. The rack transfer unit is
responsible for carrying racks to the relevant aspirate
position and then carrying them back to the sample
delivery module.
Sample rack Provides 10 sample positions. Sample racks are
distinguished through bar code and color.
Sample capacity Each rack provides 10 sample positions.
Up to 60 sample racks (600 samples) can be loaded
simultaneously when four carriers are configured.
Up to 58 sample racks (58 samples) can be loaded
simultaneously when four carriers and decapping
module are configured.
One STAT lane is provided for 10 STAT samples.
Sample container Supports micro-cup, primary collection tube or plastic
tube.
Sample load Racks can be loaded or unloaded conveniently, and
batch load/unload is supported. Samples and tests
can be added during analysis. Priority of emergency
samples, priority of outpatient samples and auto rerun
are supported.
Bar code scanning CCD visual identification module is provided together
with the instrument and used to scan bar code of
racks and samples. The rack bar code is defined by
the manufacturer, and the sample bar code can be set
up by users.
Interconnection of analyzers Up to 2 analyzers of the same model can be
interconnected and they share the same sample
delivery module, operation unit, and operating
software.
Decapping speed (if the ≥ 550 tubes/hour at peak
analyzer is configured with
the decapping module)
Capacity of the waste cap ≥1200 caps
container (if the analyzer is
configured with the
decapping module)
2-38
Reagent handling system

Specifications of the reagent handling system
Reagent carousel Configuration 1&3: two reagent carousels. 72
positions for each carousel, 144 positions in total.
Configuration 2: each analyzing unit has two reagent
carousels. 72 positions for each carousel, 288
positions in total.
The reagent carousel provides a refrigerating
environment which is constant within 2°C -8°C for 24
hours a day.
Reagent volume 10μL-200μL, with increment of 0.5μL
Reagent probe Four reagent probes available: R11, R12, R21, and
R22. The first two are for R1/R3 and the last two for
R2/R4. The four probes feature level detection,
horizontal/vertical obstruct detection, bubble
detection, and empty aspirate detection.
Reagent probe washing Waterfall exterior wash and interior high pressure
wash are used to clean the interior and exterior of the
probe with preheated cleaning fluid.
Mixer assembly
Specifications of the mixer assembly
Mixer assembly Composed of the sample mixer assembly and reagent
mixer assembly, each providing 6 mixers.
Mixer 12 mixers in total, capable of detecting the rotation
speed while stirring.
Mixer washing Washed with preheated wash solution and deionized
water in two phases.
Reaction system
Specifications of the reaction system
Reaction carousel Dual-ring, providing 206 positions on each ring, and
412 in total.
Reaction temperature 37°C±0.3°C with a fluctuation no more than ±0.1°C
Reaction cuvette Reusable glass cuvettes. 5mm*4mm*29mm (length *
depth * height), light path length of 5mm, and volume
of 580μL.
Reaction mixture volume 80μL-280μL
Cuvette washing Washed automatically by the dual-layer wash station
in 9 phases.
2-39
Photometric system
Specifications of the photometric system
Light transmission mode Holographic concave flat-field gratings
Light source 12V/50W tungsten-halogen lamp
Measuring wavelength 16 wavelengths:
340nm,380nm,412nm,450nm,480nm,505nm,546nm,570
nm,605nm,630nm,660nm,700nm,740nm,770nm,800nm
and 850nm
Measuring period 18 seconds
Absorbance resolution 0.0001A
Water consumption
number of analyzers * 70L/H
Water supply module

Specifications of water supply module
Power supply 100V-240V~, 50Hz/60Hz
Voltage fluctuation ±10%
Rated input power 100VA
Flow 4LPM
Tube length and 12*18mm PU tubes
connecting method INLET to water supply
OUTLET to filter inlet, and filter outlet to analyzer’s water
inlet
All tubes for above connections in total should be no
longer than 10m.
4*6mm PU tube
VENT to sewer, with tube less than 10m
Weight 18Kg±1Kg
Size(length*width* 540mm×485mm×345mm (±5mm)
height)
Maintenance No need to perform the maintenance procedure
requirement
External vacuum pump

Specifications of the external vacuum pump
Power supply 110V:
110V/115V~, 60Hz
220V:
220V-240V~, 50Hz
220V/230V~, 60Hz
2-40
Rated input power 500VA
No-load flow 100LPM (50Hz) or 110LPM (60Hz)
Tube PU tube,7×10mm,<3m
Weight 29.7Kg±1.2Kg
Size 478mm×425mm×466mm
Maintenance requirement Clean the dust screen monthly according to the
operation guide
2.5.2 Power Supply

Power supply
Power supply 220V:
220V-240V~, 50Hz
220V/230V~, 60Hz
Frequency fluctuation ±1Hz
Rated power consumption Configuration 1: 5300VA
Configuration 2: 9800VA
Configuration 3: 5300VA
Power cord for analyzer M1/M2:
European standard three-core power cord
Certified requirement: certified with regional
certification
Insulation material:EPDM(rubber)
Rated temperature: 70°C
Max working current: 48A
Rated voltage:220V
Withstand voltage: 450V
Power cord for water supply Using the power cord in accessory kit.
module and external vacuum
pump
2.5.3 Environmental Requirements

Operating environment
 Temperature: 15°C-30°C (The fluctuation of temperature must be no more than
2°C per hour.)
 Humidity: 35%RH-85%RH, without condensation
 Altitude height: -400m-4000m (106kPa-61.6kPa) (An external vacuum pump is
required for areas with altitude height above 2000m.)
Storage and transportation environment

 Temperature: 0°C-40°C
 Humidity: 30%RH-85%RH, without condensation
2-41
 Atmospheric pressure: 106kPa-50kPa (-400m-5500m)
2.5.4 Dimensions and Weight

Analyzer
 Dimension: 1600mm(length)×1170mm(depth)×1300mm(height)
 Weight: ≤600Kg

 Weight: ≤300Kg
Rack transfer unit

 Weight: ≤50Kg
Sample rack
 Weight: ≤100g
2.5.5 Input Device

 Keyboard (prepared by user)
 Mouse (prepared by user)
 Displayer (prepared by user)
 Bar code reader
 LIS: HL7 and ASTM1394 (communicating through the TCP/IP interface of static
IP address)
2.5.6 Output Device

 Printer (prepared by user)
 Displayer (prepared by user)
 LIS: HL7 and ASTM1394 (communicating through the TCP/IP interface of static
IP address)
2.5.7 Noise Level

Noise Level
Noise M1-M2: No greater than 65dBA
2.5.8 Communication Interfaces

Communication interfaces
Communication Interfaces Description
PC Network interface 1  Used for communication between the analyzing unit
and the operation unit
2-42
Communication Interfaces Description

PC Network interface 2  Used for communication between LIS or data
management software and operation unit.
Network interface of  Used for communication between the analyzing unit
analyzing unit and the operation unit
USB interface  Used for connecting the operation unit with a printer
 Used for connecting the operation unit with an
external storage device
2.5.9 Safety Classification

Safety classification
Overvoltage type Class II
Pollution degree 2
Device type Fixed device
Work type Continuous
Degree of ingress protection Common device
2.5.10 Major Performance Indexes

Stray Light
Absorbance should be no less than 4.9.
Absorbance Linearity Range

The maximum absorbance with relative bias within ±5% should be no less than 3.5.
Absorbance Accuracy
The absorbance accuracy meets the requirements in Table 2.20
Absorbance Accuracy
Absorbance Absorbance Accuracy
0.5 ±0.025
1.0 ±0.07
Absorbance Stability
Absorbance change should not be greater than 0.01.
Absorbance Repeatability
Expressed by coefficient of variation (CV), which should not be greater than 0.5%.
Temperature accuracy and fluctuation

The temperature accuracy of the constant temperature chamber is within 37°C±0.3°C
and the temperature fluctuation range is not greater than ±0.1°C.
2-43
Sample Carryover Rate

The sample carryover rate should not be greater than 0.05%.
Sampling Accuracy and Repeatability

The accuracy and repeatability of sampling shall meet the requirements in Table 2.21
Accuracy and Repeatability of
Accuracy and Repeatability of Sampling
Type Volume(ML) Allowable Error Coefficient of

Variation
Sample 1. 5 ±5% ≤2%
dispensing
5 ±5% ≤2%
25 ±3% ≤1%
First reagent 10 ±5% ≤2%
probe Dispensing
200 ±2% ≤1%
Second reagent 10 ±5% ≤2%
probe Dispensing
200 ±2% ≤1%
Carryover Rate of ISE Module

The carryover of ISE module should meet the requirements in Table 2.22 .
Stability of ISE Module

The stability of the ISE module should meet the requirements in Table 2.22 .
Accuracy of ISE Module

The accuracy of the ISE module should meet the requirements in Table 2.22 .
Precision of ISE Module

The precision of the ISE module should meet the requirements in Table 2.22 .
Linearity of ISE Module

The linearity of the ISE module should meet the requirements in Table 2.22 .
2-44
Performance Requirements of ISE Module
Paramet Carryove Stability( Accuracy Precision Linearity(D)

er r(△§) △D) (CV)
Interval Deviation Related
(mmol/ Coefficie
L) nt(R)
K+ ≤1.5% ≤2.0% Not greater than ≤1.5% 1.5-7.5 ≤3.0% ≥0.995
±3.0%
Na+ ≤1.5% ≤2.0% Not greater than ≤1.0% 100.0- ≤3.0% ≥0.995
±3.0% 180.0
Cl- ≤1.5% ≤2.0% Not greater than ≤1.5% 80.0- ≤3.0% ≥0.995
±3.0% 160.0
Within-run precision of clinical chemistries

The coefficient of variation (CV) shall meet the requirements in Table 2.23
Within-Lot Precision of Clinical Chemistries
Test Concentration Coefficient of
range Variation
ALT(Alanine 30-50 U/L CV≤5%
aminotransferase)
UREA(Urea) 7.0 -11.0 mmol/L CV≤2.5%
TP(Total protein) 50.0-70.0 g/L CV≤2.5%
2.5.11 Contraindication
None
2.5.12 EMC Requirements

The IVD device complies with the EMC standard IEC 61326-1/EN 61326-1 and IEC
61326-2-6/EN 61326-2-6. For EMISSIONS and IMMUNITY specific requirements, see
the two tables below.
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC EMISSIONS
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
EMISSIONS TEST COMPLIANCE
RF emissions
CISPR 11
RF emissions Group 1 Class A
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage Fluctuations/ Flicker Emissions N/A
IEC 61000-3-3
2-45
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY
GUIDANCE AND MINDRAY DECLARATION-ELECTROMAGNETIC IMMUNITY

The system is intended for use in the electromagnetic environment specified below. The
customer or the user of system should assure that it is used in such an environment.
TEST VALUE PERFORMAN
BASIC
IMMUNITY TEST CE
STANDARD
CRITERION
Electrostatic ± 4 kV contact B
IEC 61000-4-2
Discharge (ESD) ± 2 kV, ± 4 kV, ± 8 kV air B
Electromagnetic field IEC 61000-4-3 3 V/m (80 MHz to 6 GHz) A
Electrical fast
IEC 61000-4-4 ± 1 kV (5 kHz or 100 kHz) B
Transient / burst
± 0,5 kV line-to-line B
Surge IEC 61000-4-5
± 1 kV line-to-ground B
Conducted RF IEC 61000-4-6 3 V (150 kHz to 80 MHz) A
Voltage dips, Short 0 % during 0,5 cycles B
interruptions and 0 % during 1 cycle B
voltage variation on IEC 61000-4-11
70 % during 25/30 cycles C
power supply input
voltage 0 % during 250/300 cycles C
Power frequency
IEC 61000-4-8 3 A/m (50 Hz, 60 Hz) A
magnetic field
NOTE: “25/30 cycles" means "25 cycles for 50 Hz test" or "30 cycles for 60 Hz test”.
Performance criterion:
A. The equipment shall continue to operate as intended during and after the test.
B. The equipment shall continue to operate as intended after the test.
C. LOSS OF FUNCTION is allowed, provided the function is self-recoverable or can be
restored by the operation of the controls.
2-46
3 General Operating Procedure
 This chapter illustrates the methods of using the instrument and the routine
operating procedure in clinical laboratories. The common steps include:
 Powering on
 Checking system status
 Loading reagents
 Calibration
 Quality control
 Ordering routine samples
 Ordering STAT samples
 Test status and test control
 Daily maintenance
 Powering off
 Check after powering off
3-1
3.1 General Operating Procedure

General operating procedure
Procedures Description Page
1. Check before powering on Check if the following components are Page 3-3
ready for analysis: water supply, power
supply, printing paper, low-/high-
concentration waste connection,
probes/mixers, rack feeder system,
concentrated wash solution inventory.
2. Powering on Turn on the water inlet valve, switch on Page 3-5
the water supply module, vacuum pump
and analyzer, and run the operating
software.
3. Checking system status Check the status of the system, alarms, Page 3-7
reagent/calibration, maintenance and
subsystems.
4. Preparing reagents Prepare the biochemical reagents, ISE Page 3-11
reagents and wash solutions.
5. Calibration Request calibrations, prepare calibrators Page 3-30
and run calibration tests.
6. Quality Control Request, prepare and run control Page 3-34
samples.
7. Ordering routine samples Request, prepare and run routine Page 3-37
samples.
8. Ordering STAT samples Request, prepare and run emergent and Page 3-43
STAT samples
9. Test status and analysis View reagent status, as well as the Page 3-48
control running status of calibrators, control
samples, routine samples and STAT
samples; view rack status and reagent
carousel status; pause sample and
reagent dispensing, stop the analysis, and
switching carousels.
10. Daily maintenance Perform daily maintenance procedures. Page 3-55
11. Powering off Switch off the water supply and power Page 3-56
supply.
12. Check after powering off Restore the reagent carousel cover, take Page 3-57
out the calibrators, controls and samples
and store them properly, clean the
analyzer panels, and empty the waste
tank.
3-2
3.2 Check before Powering On

3.2.1 Checking Water Supply
1 Check the deionized water tank or other water reservoirs, and make sure that
water can be supplied continuously.
2 Check if the connections between the water supply, water supply module, and
analyzer are correct and tight, and the length of the inlet tubing does not exceed
10m.
3 Check if the water tubes are free of twists and leaks.
3.2.2 Checking Power Supply

1 Check if the power supply is available and can provide correct voltage:
2 Check the connections among the sample delivery module, operation unit and
printer. Make sure the connections are correct and secure. Check the power cords
of the sample delivery module, operation unit and printer and make sure they are
well connected to the power sockets.
3.2.3 Checking Printing Paper

Check if sufficient printing paper is prepared in the printer. If not, refill the printing paper.
3.2.4 Checking Waste Tanks and Tubing

The waste fluid of the system is discharged in two flows: high-concentration waste
and low-concentration waste. The former is drained through the waste tank and then
disposed according to relevant regulations, or drained to the sewer; the latter is directly
drained to the sewer.
BIOHAZARD
While checking the waste tanks and tubing, wear gloves, lab coat, goggles and a mask.
Keep a safe distance away from the tubing and waste tank in case the liquid splashes or
spatters.
1 Check if the high-concentration waste tank has been emptied. If not, empty it.
High-concentration waste output: Number of analyzers × 2.23L/H (including ISE
waste), or Number of analyzers × 2.08L/H (exclusive of ISE waste).
2 Check if the low-concentration waste tubing is not bent and the sewer opening is
lower than the waste outlet of the system.
3.2.5 Checking Probes and Mixers

The sample probes, reagent probes and mixers are easy to be polluted or damaged.
Check them carefully for dirt and bend before powering on the system.
1 Check the sample probe for dirt and bend.
 If they are polluted, clean them.
 If they are bent, replace them.
2 Check the reagent probes for dirt and bend.
 If they are bent, replace them.
3-3
CAUTION
Every day before analysis, remove the plugs on the reagent carousels in order to
prevent mechanical reset failure and bending reagent probes. Restore the plugs after
finishing tests of the day.
3 Check the sample mixers for dirt and bend.

 If they are bent or scratched, replace them.
4 Check the reagent mixers for dirt and bend.
 If they are bent or scratched, replace them.
3.2.6 Checking Rack Feeder System

Check the rack placement areas and sample track to ensure they are normal.
1 Check the rack supply unit and rack storage unit for racks and dirt.
2 Check the passing lane, normal lane and return lane for racks and other obstacles.
3.2.7 Checking CD80 Detergent and Probe Wash solutions

Insufficient concentrated wash solution or probe cleanser may terminate the
measurements. Check the wash solution according to the following steps:
1 Check the wash solution placed on the sample and reagent carousels. If
necessary, fill more or replace the wash solution.
2 Check the DA, DB, DC wash solutions on the panel.
3 Open the front door of the analyzer and check the CD80 detergent. If necessary,
fill more or replace the wash solution.
3-4
3.3 Powering On
3.3.1 Turning On Water Supply, Water Supply Module and External Vacuum
Pump
Turn on the water supply switch and ensure that the water supply pressure is within
100kPa-392kPa. If the pressure does not meet the requirements, use an external water
supply module. Turn on the water supply module.
3.3.2 Powering On the System

After connecting correctly the system to the power sockets, switch on the power in the
sequence presented below:
1 Turn on the main power switch (located at the bottom of the sample delivery
module’s rear panel and marked with “MAIN”) of the instrument.
 Toggle the switch upwards to turn it on.
 Toggle the switch downwards to turn it off.
2 Turn on the power switch (located at the bottom of the sample delivery module’s
rear panel and marked with “SDM”) of the sample delivery module.
3 Turn on the main power switch (located at the bottom of the sample delivery
module’s rear panel and marked with “ANL1” or ”ANL2”) of analyzer.
4 Turn on the printer.
5 Turn on the monitor of the operation unit.
6 Turn on the display monitor of the computer installed with the Data Management
Software (optional).
7 Turn on the computer of operation unit.
8 Turn on the computer installed with the Data Management Software (optional).
3.3.3 Starting the Operating Software

1 When the operation unit (computer) is turned on, the operating software will run
automatically.
2 Enter the username and password in the Login window, and then select OK.
NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when
logging on the system for the first time in order to prevent others from abusing the
privileges of the administrator.
If an operator forgets his password, he may ask the administrator to log on the system
and delete the username and then redefine a username; or he may contact our
customer service department or your local distributor. If the administrator forgets his
password, contact our customer service department or your local distributor.
3 When the startup check is passed, the main screen shows. The startup procedure
is finished.
3-5
The system will display prompt message when detecting unsatisfied environment
during the startup process. Please take actions according to the instructions in
the message box.
3-6
3.4 Checking System Status

After the startup procedure is finished, check the system status, such as analyzer
status, alarm status, reagent/calibration status, maintenance status and sub system
status. If the status is not satisfied for measurement, troubleshoot and maintain the
system as instructed by 12 Alarms and Troubleshooting (page 12-1) and 11
Maintenance (page 11-1).
Printer status
Check the printer status indication in the system status area of the main screen:
 If the icon appears in green, the printer is connected normally.
 If the icon appears in red, the printer is not normally connected.
ISE module status

Check the ISE module status indication in the system status area of the main screen:
 If Standby is displayed, it indicates that an ISE module is steady and ready for
measurement.
 If other statuses are displayed, it indicates that the ISE module is performing a
task or goes wrong, wait until the task is finished or troubleshoot the error, and
then take relevant corrective solutions.
LIS status
Check the LIS status indication in the system status area of the main screen:
 If the Icon appears in green, the LIS host is connected and online.
 If the Icon appears in red , the LIS host is offline.
3.4.1 Checking Analyzer Status

1 Click the module status icon at the top of the screen or System. The System
Status screen is displayed.
3-7
System Status screen
The screen shows the system status and alarm status of the sample delivery
module, configured analyzers, and rack transfer lanes.
 SDM: indicates system status of the sample delivery module.

Status Description
Standby The sample delivery module is standby and waiting for
delivery of racks.
Running The sample delivery module is delivering racks.
Stopped
The sample delivery module fails, or the button
is pressed.
Sampling Stop The sample delivery module stops delivering new racks,
while those on the track are still being delivered. When
Sampling stop is finished, the SDM continues the rack
delivery.
Restore The sample delivery module is being restored.
Diagnosis The sample delivery module is being diagnosed.
 M1-M2: shows status of biochemical system and ISE module, measurement
time left, and countdown for sample load or reagent load.
 Alarm status: shows status of the configured analyzers, sample delivery
module, SDM and rack transfer lanes. Alarm levels are indicated by different
colors, red for error and yellow for warning.
2 To mask certain analyzers, select Mask Module.
3 To unmask an analyzer, select Unmask.
4 If you want to restore an analyzer, select Home.
5 If you want to put an analyzer to sleep, select Sleep.
6 If you want to wake up an analyzer, select Wake up.
7 If you want to stop an analyzer, select Stop.
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8 If you want to shut down an analyzer, select Shut Down.

9 To enable the decapping function, select Enable Decapping; to disable the
function, select Disable Decapping.
3.4.2 Checking Alarm Status

View Alarm List and Prompt List
Click , and the warning list and prompt list pops up.
View Error log

1 Select System.
2 Select Error Log.
3 Select Error Details.
4 Troubleshoot according to the recommended method.
Error Log screen
3.4.3 Checking Maintenance Status

When the system is started up, it is necessary to check the maintenance status. If a
maintenance procedure is expired, perform it immediately to make sure that the
system will run normally. When a maintenance procedure is expired, the following
buttons and options will be indicated by corresponding color:
 Maintenance tab
 Maintenance procedure
1 Select System ˃ Maintenance ˃ Maintenance Procedures.
2 Check if the maintenance procedures tabs appear in yellow. If they do, it indicates
that at least one maintenance procedure is expired.
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3 Select perform manually or auto perform to find the expired maintenance

procedure, and then perform the maintenance.
4 Repeat steps 2 and 3 until the maintenance frequency tabs and maintenance
procedures are displayed in normal color.
3.4.4 Checking Subsystems

The subsystem status indicates the current working status of each subsystem and
hardware component, which includes the status summary, cycle count, temperature,
power supply, Hydropneumatic subsystem, and control modules.
Checking subsystems
1 Select System ˃ System Status.
2 Choose a subsystem tab.
3 Check the subsystem status. When abnormity occurs, troubleshoot errors with the
following methods:
 If the cycle count of a component reaches certain limit and an alarm occurs,
replace the component or contact out customer service department or your
local distributor for replacement of the component.
 If a component’s temperature is beyond the valid range or abnormal and an
alarm occurs (indicating the overheat protection system works normally), exit
the operating software and switch off the analyzer power. After that, switch
on the analyzer power again and run the operating software. If the error
remains, contact out customer service department or your local distributor
for replacement of the component.
 If a component’s voltage is beyond the valid range or abnormal and an alarm
occurs, exit the operating software and switch off the analyzer power. After
that, switch on the analyzer power again and run the operating software. If the
error remains, contact out customer service department or your local
distributor for replacement of the component.
 If a Hydropneumatic container is beyond the valid range or abnormal and an
alarm occurs, exit the operating software and switch off the analyzer power.
After that, switch on the analyzer power again and run the operating software.
If the error remains, contact out customer service department or your local
distributor for replacement of the component.
 If a smart module is abnormal and an alarm occurs, exit the operating
software and switch off the analyzer power. After that, switch on the analyzer
power again and run the operating software. If the error remains, contact out
customer service department or your local distributor for replacement of the
component.
Description of subsystem status

Status summary
The status summary provides a high-level summary of the status of the system
temperatures, power supply, Hydropneumatic, and control modules.
Cycle count
The cycle count provides an approximation of a component’s usage, which can be
useful for estimating the maintenance frequencies or anticipating component failure.
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Ambient information
The actual temperature and valid range of the deionized water, wash solution, reagent
carousel, reaction carousel, instrument interior, and wash station are displayed.
Power supply
Status for the power supply module shows:
 The actual voltage and valid range for the main board, carousel drive board, probe
drive board, and reagent refrigeration board.
 The actual voltage and valid range for the radiator.
 The working status of the fans and mixers.
Hydropneumatic containers
Status for the Hydropneumatic subsystem shows:
 Working status of various tanks
 The actual air pressure and valid range for air pressure equipment
Control Unit
Smart module status monitors the working status of each smart module, which
includes probes, mixers, carousels, cuvette wash station, ISE unit, etc.
3.4.5 Checking Reagent/Consumable Status

1 Select Reagents ˃ Reagent Overview. Choose a module.
The displayed information for the reagent includes Test Name, carousel, module,
tests available, tests required, tests left.
Take R0 400 |R1 400 | R2 450 for instance. Here R0 can support 400 tests, R1 400
tests and R2 450 tests.
The reagent has the following four statuses:
 Sufficient: No color is marked for the background.
 Insufficient for daily requirement: The background is purple.
 Low inventory: The background is orange.
 Exhausted: The background is red.
The Consumable has the following three statuses:
 Sufficient: blueish green
 Insufficient for inventory alarm limit: orange.
 Exhausted: red.
When abnormal information exists for the reagent, it is flagged. Click the flag and an
air bubble pops up to display the abnormal information.
The abnormal information includes:
 Reagent prompt: Masked reagent
 Reagent warning: Disabled reagent
 Calibration prompt: Calibration extension, edited calibration factor,
recalculated calibration result, calibration timeout, calibration overridden.
 Calibration warning: Calibration failure, calibration expired, calibration required
and calibration unfinished.
 Reagent Expiration: Reagent expired.
Intelligent Sort is enabled by default. When it is enabled, the order is sorted as follows:
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Reagent exhausted → Insufficient for inventory alarm limit → Insufficient for daily
requirement→ Sufficient.
View via Reagent List

Select Reagent ˃ R List ˃ Reagent/ Consumable.
View via Reagent Carousel

Reagent Carousel
2 Select Reagent ˃ Carousel. Select a module and view the reagent carousel. View
reagent information of each position.
The consumable status is as follows:
Color Graphic Meaning actions

indication
Red exhausted Load consumable
Orange Below inventory Refill

alarm limit
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Color Graphic Meaning actions

indication
Blueish green Sufficient No action needed
3 Refer to 3.5 Preparing Reagents for loading consumables.
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3.5 Preparing Reagents

After confirming the system status and performing the daily checks, prepare the
reagents for measurement. Tests without reagents loaded can be requested but will
not be included in measurements. Loading reagents is allowed when the system status
is Standby, Incubation or Sleep. In Running status, you should request reagent load
before loading reagents. After assigning reagent positions, print out the reagent list
and then manually load reagents according to it. When all reagents are loaded, the
system will check the reagent inventory during measurement and then display it on the
Reagent List screen. You are recommended to perform inventory check manually after
loading reagents; otherwise, the tests left will not be displayed on the Reagent List
screen.
If the instrument has set open channels when leaving the factory, the open reagent
channels can be used to hold reagents of Mindray or of other manufacturers, and the
remaining positions are closed channels and can only hold Mindray reagents. If you
want to change the number of open channels, contact our customer service
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution
when working around the probes.
BIOHAZARD
Wear gloves, a mask and lab coat, if necessary, goggles.
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation
may be caused.
CAUTION
Do not drop any liquid on the reagent load buttons to avoid damage.
NOTE
Prepare sufficient reagent to avoid test interruption due to reagent running out.
3.5.1 Loading Biochemical Reagents

The system supports manual and auto load of biochemical reagents. Each test can
have more than one bottle of reagent loaded, and reagents of the same test can be
loaded to the same carousel. If your system is not equipped with a reagent bar code
reader, you need to enter the reagent information manually when loading reagents; if a
reagent bar code reader is configured, the system will scan all reagents automatically
and read reagent information from the bar code.
All reagent types of a multi-reagent-type test must be loaded simultaneously to inner
ring or outer ring of the reagent carousels. When one or more reagents of a multi-
reagent test are not loaded, the “!” sign will appear near the test’s reagent types that
have been loaded.
Open reagents can be loaded manually or via bar code scanning, while closed reagents
can only be loaded via bar code scanning. For more information about loading bar-
coded reagents, refer to 5.3.3 Loading Bar-Coded Reagents (page 5-8).
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NOTE
Before loading biochemistry reagent, ensure that there are no air bubbles inside the reagent
bottle so as to avoid inaccurate test results.
Manual load
When loading reagents manually, you need to enter the reagent information, which is
the only information source of the loaded reagents. You are allowed to input reagent
information before, during or after loading reagents to the reagent carousel. If loaded
reagents are bar-coded, the reagent information cannot be edited; otherwise, all
reagent information except for position, test and reagent type can be edited.
Reagent/Consumable List
1 Check the system status and operate accordingly.

 Standby, Incubation or Sleep: Proceed to the next step.
 Running: Select Reagent ˃ R List. Select Reagent Stop to request reagent load.
When the countdown for reagent load becomes 0 and the system status is
Reagent Load, a message box pops up. Select OK, and then proceed to the
next step.
2 Select Reagent ˃ R List ˃ Reagent.
3 Choose a module to load reagent.
“ALL” means all configured analyzers.
4 Choose a position to which you want to load a reagent.

5 Select Load. The Load Reagent window is displayed.
6 Enter the following reagent information:
 Bar code
 Test name
 Reagent type (required)
 Lot number
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 Serial number
 Bottle type (required)
 Expiration date
7 Select Load to save the input information.
8 Select Prev or Next to load reagents for other tests on the module.
9 Select Print to print out the biochemical reagent list.
10 Remove the reagent carousel cover.
CAUTION
If the system is running tests, after requesting reagent load, do not remove the reagent
carousel cover until the countdown for reagent load is 0, the system status is Reagent
Load, and the popup message is confirmed; otherwise, the tests currently run will be
invalidated.
11 Load reagents according to the reagent load list. Place R1 and R3 on the first
reagent carousel and R2 and R4 on the second. Then uncap the reagent bottles.
NOTE
While loading reagents, press the load buttons to rotate the two carousels for
convenient loading. When the reagent load button is pressed, the corresponding
carousel starts rotating; when the button is released, the carousel stops rotating.
12 Restore the reagent carousel cover.
Auto load
Auto load is to load bar-coded reagents to the reagent carousel, which are identified
by bar code scanning.
The closed reagents can only be loaded through bar code scanning.
 Running: Select Reagent ˃ Overview/R List. Select Reagent Stop to request
reagent load. When the countdown for reagent load becomes 0 and the
system status is Reagent Load, a message box pops up. Select OK, and then
proceed to the next step.
CAUTION
invalidated.
3 Place R1 and R3 on the first reagent carousel and R2 and R4 on the second, and
then uncap the reagent bottles.
NOTE
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The system scans all reagent positions automatically and read the following
reagent information from the bar code.
3.5.2 Loading Concentrated Wash Solution

CD80 detergent, a kind of alkaline concentrated wash solution, is used to clean
reaction cuvettes and can only be loaded manually. The lot number, serial number,
expiration date, volume, alarm limit and other information of the loaded wash solution
must be entered.
A tank of concentrated wash solution is 2L and can be used for 2 days on condition
that 200 samples with 15 tests each are analyzed every day. Before loading
concentrated wash solution, ensure that the diluted wash solution is enough for the
tests in progress.
1 Select Reagent ˃ R List ˃ Consumable.
2 Choose a module to load concentrated wash solution.
3 If the wash solution is less than 1 bottle or not sufficient for the current day, load
CD80 detergent.
4 Open the front door of the analyzer.
5 Load CD80 detergent. And then lay down the CD80 aspirate tube assembly. When
the system detects that CD80 aspirate assembly is placed in the tank, the volume
refreshes to 100% automatically.
Positions for CD80 detergent
(1) (2)
(1)CD80-1 (2)CD80-2
6 Close the front door of the analyzer.
7 Select Load Consumable.
8 Enter the following information:
 Volume %
 Serial number
 Expiration date
 Lot number
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9 Select Load.
3.5.3 Loading Reagent Probe Wash Solution

Reagent probe wash solution including CD80 alkaline concentrated wash solution and
acid wash solution poured into a reagent bottle are used to clean the reagent probes,
sample probe, sample mixer, reagent mixer, and reaction cuvettes in a special wash
procedure. It can only be loaded manually. The volume, lot number, serial number,
expiration date, bottle type and other information of the loaded wash solution must be
entered.
You are recommended to check the reagent probe wash solution every day to ensure
its sufficiency.
The number for the reagent carousels are defined as follows:
 First reagent carousel outer ring: R11
 First reagent carousel inner ring: R12
 Second reagent carousel outer ring: R21
 Second reagent carousel inner ring: R22
The positions for detergents and DI water are specified as follows:
Detergent Position
DA for R11 71DA
DB for R11 72DB
DI water for R11 70W
DA for R12 31 DA
DB for R12 32 DB
DI water for R12 30 W
DA for R21 71 DA
DB for R21 72 DB
DA for R22 31 DA
DB for R22 32 DB
DB is alkaline wash solution (CD80 detergent); DA is acid wash solution. The DI water
for R21 and R22 are optional and no fixed positions are assigned for them. If you want
to place the DI water on the R21 and R22 reagent carousel, place them in number 30
and 70 positions.
NOTE
Before loading wash solution, ensure that there are no air bubbles inside the reagent bottle
so as to avoid affecting washing effects.

 Running: Select Reagent ˃ R List ˃ Consumable Select Reagent Stop to
request reagent load. When the countdown for reagent load becomes 0 and
the system status is Reagent Load, a message box pops up. Select OK, and
then proceed to the next step.
3 Choose a module to load reagent probe wash solution.
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4 Select DA/DB/DI water you want to load.

5 Select Load. The Load Consumable window is displayed.
7 Place the consumables in the designated positions.
NOTE
Click the sector of reagent carousel graph, rotate the carousel to the location
convenient for loading.

If a reagent bar code reader has been configured, the system will scan the reagent
carousel automatically and refresh the displayed reagent information.

 Volume (100% by default)
 Serial number
 Expiration date
 Lot number
 Bottle type (required)
10 Select Load.
3.5.4 Loading Sample Probe Wash Solution

Sample probe wash solutions including CD80 detergent, acid wash solution and probe
cleanser poured into a reagent bottle, are used to clean the sample probe, sample mixer,
reagent mixer, and reaction cuvettes in a special wash procedure. It can only be loaded
manually. The volume, lot number, serial number, expiration date and other information
of the loaded wash solution must be entered. When the sample probe wash solution
is expired or exhausted, the system will give an alarm, which will not influence the
analysis. Fill more sample probe wash solution.
You are recommended to check and replace the sample probe wash solution every day
to ensure its sufficiency.
NOTE
Before loading wash solution, ensure that there are no air bubbles inside the reagent bottle
so as to avoid affecting washing effects.

 Running: Click Sampling Stop . Select an instrument to load wash

solution, select OK to request for sample load, and then proceed to the next
step.
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3 Choose a module to load.

4 Select DA/DB/DC of S1 and S2 on the panel.

5 Select Load.
6 Place CD80 detergent in the DB position, acid wash solution in the DA position and
probe cleanser in the DC position .
 Volume (100% by default)
 Serial number
 Expiration date
 Lot number
8 Select Load.
3.5.5 Loading Physiological Saline

Physiological saline is used to run sample blanks, reagent blanks and calibrations, and
dilute samples, and it can only be loaded manually. The bottle type and volume of the
loaded saline must be entered. Physiological saline used for running sample blanks
and diluting samples should be loaded to the position 30W/70W on the reagent
carousel.
Loading physiological saline to reagent carousel

 Standby: Proceed to the next step.
 Running: Select Reagent ˃ R List ˃ Consumable. Select Reagent Stop to
request reagent load. When the countdown for reagent load becomes 0 and
the system status is Reagent Load, a message box pops up. Select OK, and
then proceed to the next step.
 Incubation: Proceed to the next step.
 Sleep: Proceed to the next step.
3 Choose a module to load physiological saline.
4 Select Physiological Saline in 30W or 70W position that you want to load.
5 Select Load.
CAUTION
invalidated.
7 Place the physiological saline in position 70W or 30W.
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NOTE

If a reagent bar code reader has been configured, the system will scan the reagent
carousel automatically and refresh the displayed reagent information.
9 Enter the following information of physiological saline for sample blanks and
sample dilution:
 Volume (100 % be default)
 Bottle type
10 Select Load.
3.5.6 Emptying Waste Cap Container (when decapping module configured)

The waste cap container indicator is located in the position shown in the figure below.
The indicator status of the waste cap container of the decapping module is as follows:
 on (blue): The capacity of waste cap container is sufficient.
 flashing (blue): The remaining capacity of waste cap container is sufficient and
the decapping module is running.
 on (orange): The remaining space of waste cap container is insufficient.
 flashing (orange): Waste cap container is full. Empty it.
 off: When the waste cap container is removed, the indicator is off, or the waste
cap container is not detected after the door is closed.
When the waste cap container is full, the indicator flashes yellow to remind the user of
clearing the waste caps.
1 Open the door of waste cap container.
2 Take out the waste cap container that you want to empty or the waste cap
container of which corresponding indicator is flashing, and empty it.
3 Install the waste cap container back and press its button to confirm that the waste
cap container has been installed back.
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The remaining capacity of the waste cap container is automatically refreshed on the
consumables screen.
3.5.7 Pad Overview

Overview
Pad overview consists of two modules: Reagent and Consumables. On the screen,
green indicates sufficient inventory, yellow indicates low inventory (lower than the
alarm limit or daily consumption threshold), and red indicates empty inventory.
Sufficient inventory
Inventory Low or Empty
View Consumables
1 Tap Consumables on the overview screen to go to the corresponding screen of
consumables.
2 The consumables with low or insufficient inventory are selected by default. Select
Confirm Reset to refresh the inventory of the selected consumables to 100%.
3 Select Select All. All consumables are selected.
4 Select Clear to deselect all consumables.
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Consumables resetting screen
View Reagents
1 When you tap reagent on the overview screen, the corresponding screen of
reagent appears.
2 After the screen is displayed, the tests left and consumables inventory of all on-
board tests are displayed. The red box indicates that the reagent inventory is blank,
the yellow box indicates that the reagent inventory is low, and the purple box
indicates that the tests left of reagent does not meet the today's test threshold.
3 Select Smart Sort, and the screen will display in the order of "Inventory empty" -
"Inventory low" - "Inventory does not meet the test threshold”.
4 Select To Overview.
5 If reagent or consumables are insufficient during measurement, select Reagent
Stop and select the reagent/consumable to be replaced, and open the carousel
cover to replenish the reagents /consumables.
6 Select Consumable Reset.
7 Select To overview to return to Overview screen.
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Reagent overview screen
Intelligent sort
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Reagent Stop
Reagent Stop countdown
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After the countdown ends, the upper shielding cover and carousel cover can be
opened.
3.5.8 Reagent Loading Via Pad

1 When the system status is standby, opening the reagent carousel cover will
automatically switch to the reagent loading status screen.
2 Each reagent positions has the following statuses:
 Empty bottle: Reagent inventory is 0.
 Empty position: Reagent bottles are not loaded in this position.
 To be refreshed: After a closed reagent bottle is unloaded, a new reagent bottle
is loaded. The reagent bottle is displayed as to-be-refreshed.
 Third party: Manually registered third party reagent
3 Tap the A, B, C, and D sectors and tap Rotate. The reagent carousel rotates to the
opening.
4 Tap a reagent, all its positions and inventory will be displayed.
5 If the cover of another reagent carousel is open, tap the R2/R1 reagent carousel
area, and the reagent loading status will be switched to that of the other reagent
carousel.
6 If reagent requirements have been calculated on the PC, slide reagent Load List
on the right side of the screen.
7 Select To overview to return to Overview screen.
8 After loading all reagents, select Reagent Refresh to allow the reagent carousel to
scan bar code quickly when the carousel cover is open.
Warning
Do not perform reagent loading and unloading operations when the reagent carousel is
rotating.
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Reagent Loading Status
View the inventory of the same test on the instrument
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Switch to R2 carousel
View the loading list
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Reagent refreshing
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3.6 Calibration
Running calibration is to calculate calibration factors for sample result calculation.
Generally, calibration is recommended when one of the following conditions occurs:
 A new test is configured.
 QC alarms are given while the reagent, calibrator and control sample are within the
expiration date.
 Reagent lot or bottle is changed.
 The calibration factors of a test are expired.
 The ISE electrodes are adjusted or the ISE module is maintained.
 The calibration rules are changed, such as calibration method, replicates,
concentration and calibrator.
 The test parameters are changed, such as primary wavelength, secondary
wavelength, blank time, reaction time, reagent volume (R1/R2/R3/R4), sample
volume, sample dilution parameters, reaction type, reaction direction, sample
blank and result unit.
 The lamp, syringe or sample probe is replaced.
If any of the following test parameters are changed, a calibration is required:
 Primary wavelength
 Secondary wavelength
 Blank time
 Reaction time
 Reagent volume(R1/R2/R3/R4)
 Standard sample volume, diluting sample volume and diluent volume
 Reaction type
 Sample type
 Reaction direction
 Sample blank and result unit
 Twin test
For more information about calibration setup, refer to 6.2 Calibration Setup (Page 6-3).
3.6.1 Requesting Calibrations

Calibration request via Cal Status screen
When one of the above-mentioned conditions is happened, request a calibration
according to the steps stated below.
Before requesting a calibration, make sure that the calibrator has been loaded to
correct position.
1 Select Calibration > Overview.
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Cal Overview
2 Choose a module to request calibration.

“ALL” means all configured analyzers, and M1-M2 means relevant analyzer.
3 Select tests you want to calibrate.

4 Select Request Calibration.
5 Select Calibration Request Options.
 Full
 Reagent blank
6 Select OK.
You can select Bottl Cal to request calibration by bottle or select Request Cal Panel
to request calibration by calibrator panel.
7 If you want to abort the calibration requests, select No Cal.

Calibration tests can be canceled only when they have not been started or are
interrupted.
Calibration request via Reagent List screen

1 Select Reagent > R List > Reagent.
3 Choose the test you want to request calibration.

 Full
 Reagent blank
6 Select OK.
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interrupted.
3.6.2 Loading Calibrators
BIOHAZARD
Inappropriate handling of calibrators may lead to biohazardous infection. Do not touch the
calibrators directly with your hands. Wear gloves and lab coat, if necessary, goggles and a
mask. In case your skin contacts the calibrators, follow standard laboratory safety
procedure and consult a doctor.
CAUTION
Do not use expired calibrators; otherwise, unreliable test results may be caused.
1 Select Calibration > Overview.

2 Choose a module to run calibration.
3 Select Load List.
The calibrator list shows all requested tests as well as calibrators, positions,
concentration, lot number, calibrator aliquot volume and expiration date.
4 Select Print.
5 Select Exit.
6 Load calibrators according to the calibrator list.
 Load calibrators to an orange rack, and then put the rack in the rack supply
unit. Ensure that calibrators are loaded to the correct positions.
3.6.3 Running Calibrations

After requesting calibrations and load calibrators to the sample rack you can start the
calibration test.
1 Select . The Start Conditions window is displayed.

Start Conditions window - Rack ID mode or bar code mode
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Start Conditions window - Sequential mode
2 Select OK to start analysis.
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3.7 Quality Control

QC results are tools used to monitor the system performance. To check if the system
is running normally and steadily, you are recommended to run control samples
everyday. The system provides two modes to run control samples, auto and manual.
New tests can be added no matter in which status the control samples are. The control
orders can be edited when the control status is ordered rather than In Progress.
3.7.1 Requesting Control Test

QC runs are requested by ordering control samples. You are allowed to choose a
control, control position and sample cup type as well as tests and panels for
measurement. At least one test must be selected for control ordering.
1 Select QC > Order QC.
Quality Control screen
2 Select a control.
3 Input sample ID and Rack ID and Position.
4 Choose a sample cup type to be used by the selected control.
5 Choose desired tests and panels in the test list.
If the tests included in a panel are set up for QC parameters, they will not be
ordered for quality control.
6 If you want to perform QC on certain reagent, select Assign Reagent.

Select a reagent and click OK on the popup window.
7 Select Submit.
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3.7.2 Loading Control Samples
BIOHAZARD
Inappropriate handling of control samples may lead to biohazardous infection. Do not
touch the control samples directly with your hands. Wear gloves and lab coat, if necessary,
goggles and a mask. In case your skin contacts the control samples, follow standard
laboratory safety procedure and consult a doctor.
CAUTION
Do not use expired control samples; otherwise, unreliable test results may be caused.
1 Select QC > Ctrl Setup.

The control list shows all requested controls and tests, including the following
information:
 Sample ID or control name

 Bar code or lot number
 Position
 Sample cup type
 Control volume
The test list shows the following information:
 Test name
 Concentration
 SD
 Unit
2 Load control samples according to the list.
 If running control with rack, load controls to a light blue rack, and then put the
rack in the rack supply unit. Ensure that controls are loaded to the correct
positions.
3.7.3 Running Control Samples
NOTE
Do not start measurement after starting up the system until the status becomes Standby.
After ordering and load the control samples, you can start the QC test.

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3.7.4 Auto quality control

Controls can be run automatically based on specified samples and calibration. When
auto QC is enabled, the system will automatically run all tests of the selected controls
once the conditions are met. When conditions for auto quality control on racks are
satisfied, a message pops up, reminding you to order controls for the relevant tests.
For more information about auto quality control, refer to “7.5 Auto Quality Control”
(Page 7-12).
1 Select QC ˃ Ctrl Setup.
2 Select QC Setup.
3 Set Auto Request Daily QC: QC Interval(Hour).
4 Set up the conditions for auto quality control:
 Number of samples
 QC after calibration
For more information about auto QC setup, refer to 7.5 Auto Quality Control (page
7-12).
5 Select OK.
When conditions for auto quality control are satisfied, a message pops up,
reminding you to order controls for the relevant tests.
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3.8 Ordering Routine Samples

After running quality controls, if the test results indicate that the system is in control,
you can start ordering patient samples. This section describes how to order and run
routine samples.
3.8.1 Routine Sample Orders

You are allowed to order samples one by one or in batch. Batch order is not allowed
when the sample status is In Progress, Incomplete, Rerun or Complete. If the sample
status is ordered, the new order information will overwrite the previous order
information.
Ordering a sample/ordering batch

1 Select Sample ˃ S orders.
2 Select Routine.
Sample orders
3 Enter the sample ID and barcode.

4 Enter the sample position.
5 Select a sample type from the Sample Type pull-down list.
The options include serum, plasma, urine, CSF, whole blood, pleural effusion and
others.
6 Select Sample Cup.

7 Enter comments.
8 If you want to auto-dilute sample, select Increased or decreased. If you want to
manual-dilute the sample, input the Offline Dilution factor.
9 Choose desired tests and panels.
Tests in various statuses are indicated by symbols and color.
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Description of test statuses
Symbol or Color Test Description

▲ Test for increment The test will be run with sample
measurement volume increased.
▼ Test for decrement The test will be run with sample
measurement volume decreased.
Masked test The test is masked. It can be
requested but cannot be run.
Reagent Unavailable Reagent is not loaded or inventory
is 0.
Calibration The current calibration status does
Unavailable not satisfy test conditions.
Test name in Test Available The test can be requested for
black analysis.
Test name in Test selected The test is selected.

blueish green
10 Select Options.
Options window
11 Enter Replicates. The input range is 1-90.

12 If you want to run a test with different parameters, enter the values in the test
option area:
 Sample Vol: sample volume required to run the test. The sample volume is
the same as that defined for the test. If increased and decreased volumes are
defined for the test, Increased and Decreased are available here for selection.
 Replicates: number of times the test is to be run.
 Predilution: ratio at which samples containing the test will be prediluted
before being analyzed. When standard, increased and decreased sample
volume parameters are defined, the product between the maximum dilution
factor of the three and the auto dilution factor must not be greater than 134.
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 Sample Blank: set up sample blank for tests.

 Pretreatment: Set if pretreatment is needed.
13 Select OK.
14 Select Assign Reagent to assign reagent for the sample test.
15 Select Submit.
 If you want to batch order the samples, select Batch Order and input Number
of samples and End Sample ID and then click Submit.
Editing patient information

You can enter the patient information at any time. When sample analysis is finished,
you can view and edit the sample information on the Current and History screens.
1 Access the Demographics window.
 Select Sample > S orders, enter the sample ID in the ID field, and then select
Demog.
 Select Sample > Current or History, choose desired sample, and select
Demog.
Demographics window
2 To change the priority of the sample, select Routine under sample class.
3 Enter the patient information.
4 Select Submit to save your input.
5 To edit demographics of other patients, select .
6 Select to close the window.
Editing and confirming order information

If the ordered sample is not in progress, you are allowed to edit the order information
and add more tests. Samples that are being analyzed, rerun, incomplete or complete
must not be edited. New tests can be added to samples of any status.
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1 Select Sample ˃ S Orders.

2 Enter the sample ID/barcode or other information to search for sample.
The order information of the sample is displayed.
3 Edit the following information:

 STAT property
 Sample type
 Comment
 Module
 Tests
 Panels
 Sample options and test options
4 Confirm the order information.
5 Select Submit.
6 You can select Delete Order to delete sample order.
3.8.2 Loading Routine Samples
BIOHAZARD
Inappropriate handling of samples may lead to biohazardous infection. Do not touch the
samples directly with your hands. Wear gloves and lab coat, if necessary, goggles and a
mask. In case your skin contacts the samples, follow standard laboratory safety procedure
and consult a doctor.
CAUTION
Do not use expired samples; otherwise, unreliable test results may be caused.
NOTE
Before loading samples, ensure that the sample cups are free of air bubble so as to avoid
inaccurate results.
CAUTION
Prepare the sample according to the procedure recommended by the tube manufacturer.
For collection and preparation of samples, please see the reagent Instructions for Use. Use
clean tubes, microcups and other disposable materials specified by the manufacturer. Do
not reuse disposables.
When using vacuum collection tube for sample collection, make sure that the cap of the
vacuum collection tube is clean.
When using an EP tube as a sample container, cut the cap of the EP tube otherwise the
position of the EP tube may deviate and vertical collision may occur.
1 Select Sample > S Orders > Order List.

The sample list shows all ordered samples and tests, including the following
information:
 Order date and time
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 Sample ID
 Sample bar code or control lot number
 Position
 Patient name
 Test
2 Select Print.
Samples are printed out.
3 Load samples according to the printed list.

Load samples to a grey rack based on the ordering mode, and then put the rack
into the rack carrier and place the carrier in the rack supply unit.
3.8.3 Running Routine Samples (Sequential mode)
NOTE
Do not start measurement after starting up the system until the status becomes Standby.
NOTE
Make sure the start ID and start position you enter on this window match the actual start
ID and the actual position in which the start sample is placed.
In sequential mode, to ensure correct sample ID, do not put routine sample into STAT
delivery channel.
Caution
For how to collect and prepare samples, see the instructions for Use of reagent.
Use clean tubes, microcups and other disposable materials specified by the manufacturer.
Do not reuse disposables.
After ordering and loading the samples, you can start the analysis. To view sample
results, refer to 8.8 Results Recall (8-25).

2 Input the start ID and start position of routine sample.
Before starting the test, place the sample racks in sequence into the priority rack
carrier as shown on the start conditions window.
When system status becomes running, it means test is successfully started.
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3.8.4 Running Routine Samples (Bar code mode and Rack ID mode)
1 Select .
Note: When you select , the samples in all rack supply units will be
analyzed. When you press the button of the rack supply unit, only the samples in
corresponding rack supply unit will be tested.

Before starting test, make sure the racks are placed into the priority rack carrier
as shown on the start conditions window.
When system status becomes running, it means test is successfully started.
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3.9 Ordering STAT Samples

STAT sample order allows emergent samples to be ordered and analyzed with high
priority. The system provides common STAT and Extra urgent order. Common STAT
order is used to run emergent samples with higher priority than routine samples. Extra
urgent order is mainly used to order emergent samples quickly with higher priority than
routine and common STAT samples.
The system supports three sample analysis modes for racks: sequential mode, rack ID
mode and bar code mode, and any one of they can be chosen. For sample ordering in
the three modes, refer to “8.2 Sample Ordering and Processing” (Page 8-5).
Quick STAT samples can be only ordered and processed through sample rack.
3.9.1 Ordering STAT Samples

1 Select Sample > S Orders.
2 Select STAT under sample priority.
3 Enter the sample ID and barcode.
Sample ID is composed of numbers, or letters and numbers. Up to 10 digits can
be entered. The first sample on each day is numbered as 1. Duplicate sample IDs
are not allowed before the next time the samples are released.
4 Enter the sample position.

 If ordering samples with rack, input the rack ID and position number based on
the analysis mode. The rack ID for STAT sample ranges from E0001 to E9999.
6 Select sample cup.
7 Enter sample comment or select one in the Comment field.
8 If auto dilution is needed, select increased or decreased sample volume for
prediluton. If manual dilution is needed, input manual dilution factor. The input
range is 2-9999.
9 Choose desired tests and panels.
Tests in various statuses are indicated by symbols and color.
Description of test statuses
▲ Test for increment The test will be run with sample
measurement volume increased.
▼ Test for decrement The test will be run with sample
measurement volume decreased.
Masked test The test is masked. It can be
requested but cannot be run.
Reagent Unavailable Reagent is not loaded or inventory
is 0.
Calibration The current calibration status does
Unavailable not satisfy test conditions.
Test name in Test Available The test can be requested for
black analysis.
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Test name in Test selected The test is selected.
blueish green
10 Select Options.
Options window
11 Enter replicates. The input range is 1-90.

12 If you want to run a test with different parameters, enter the values in the test
option area:
 Replicates: number of times the test is to be run.
 Pretreatment: Set if pretreatment is needed
13 Select OK.
14 Select Assign reagent to assign reagent for the sample test.
15 Select Submit.
 If you want to batch order the samples, select Batch Order and input Number
of samples and End Sample ID and then click Submit.
Ordering Extra Urgent Samples

If an extra urgent sample needs to be processed, the function of extra urgent can be
enabled, and the extra urgent racks will be first delivered for measured. If there are
tests or maintenance in progress, the current process will be interrupted and the extra
emergent tests will be preferentially performed.
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If the sample to be expedited is not placed in the system, you can directly place the
sample on the sample rack and send it to the STAT channel. Press the STAT button
twice to start the test.
When the sample to be expedited is in the system, it can be processed quickly via the
Current screen, History screen and Rack screen.
1 Select Sample > Current /History or Rack Status.
Extra urgent Sample window
2 Choose sample(s) or sample rack.

3 Select Extra Urgent.
4 Select OK.
3.9.2 Loading STAT Samples
BIOHAZARD
CAUTION
NOTE
Before loading samples, ensure that the sample cups are free of air bubble so as to avoid
inaccurate results.
CAUTION
For collection and preparation of samples, please see the reagent instructions. Use clean
tubes, microcups and other disposable materials specified by the manufacturer. Do not
reuse disposables. When using vacuum collection tube for sample collection, make sure
that the cap of the vacuum collection tube is clean.
Loading common STAT samples

3-45
2 Select List.
The sample list shows all ordered samples and tests, including the following
information:
 Order date and time

 Sample ID
 Bar code
 Position
 Patient name
 Test
3 Load samples according to the printed list.
 Load samples to a red rack based on the ordering mode. Place the sample rack
into STAT delivery area or into a rack carrier and put the carrier into the rack
supply unit.
Loading extra urgent samples

Load samples to a red rack based on the ordering mode and place it into STAT lane
and press the STAT button twice. Note: If the test mode is sequential mode, gray
normal sample racks cannot be placed in the STAT lane.
3.9.3 Starting Analysis

After ordering and loading the samples, you can start the analysis. To view sample
results, refer to 8.8 Results Recall (8-25).
1 Select .The Start Conditions window is displayed.

Start Conditions window –Sequential mode
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Start Conditions window – Rack ID mode or bar code mode
 In sequential mode, input the start ID and start position of STAT samples.
 In rack ID or bar code mode, the start ID and start position of STAT samples
are not required.
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3.10 Test Status and Test Control

During the analysis, you can check reagent inventory on the Reagent Overview screen,
view test status of calibrators, controls, routine and emergent samples on the Sample
-Rack Status screens, and view reagent carousel status on the reagent carousel screen.
3.10.1 Checking Reagent/Consumable Status

Refer to 3.4.5 Checking Reagent/Consumable Status(page3-11).
3.10.2 Viewing Status of Racks

The Rack Status screen shows the status of the rack storage unit and buffer unit.
Follow this procedure to view rack status:
1 Select Sample > Rack Status.
Sample status on rack
Icon Color Sample status Description
Red circle Extra Urgent Extra urgent sample
White idle No sample in this position

background
Light blue ordered The sample is ordered but not
measured.
Sky blue Aspirated Sample dispensing has been
finished.
Dark blue Running Running test
Green Complete All tests of the sample are

finished with results calculated.
Red Test abnormal Test is incomplete or test is
abnormal.
Red abnormal The sample probe aspirates
exclamatory nothing, is clogged, or collides
mark on white with an obstacle.
background
Red barcode Barcode reading Invalid bar code, duplicate bar
on white error code, or failed to analyze.
background
Red LIS LIS Down failed Downloading from LIS failed.
White question No Test The sample has no ordered

mark on tests.
purple
background
Red square Rack Abnormal The rack is duplicate, the rack
type cannot be identified, the
rack type conflicts with the rack
bar code, or the rack bar code
scanning fails.
2 Select a rack and view the detailed information on the right side of the screen.
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3 Choose the following buttons as needed:

 Extra Urgent: Perform urgent tests on the selected sample or sample rack.
 Remove rack: Select the rack and click this button to retrieve it.
 Locate Result: Locate the result to certain position on the rack.
Searching sample
On rack status screen, you can search sample by entering sample ID or bar code
/Patient ID/Patient Name (supporting fuzzy inquiry by entering the last digits of the bar
code).
1 Select Sample > Rack Status.
2 Choose search conditions.
Retrieving designated rack

On rack status screen, you can retrieve designated rack to rack storage unit.
1 Select a rack in the buffer area or search a rack through sample ID or Bar code.
2 Click Remove Rack.
If the rack is in the buffer area, it will be delivered into rack storage unit. For the rack
on which sample is being aspirated, the rack will be delivered into rack storage unit
after all sampling is completed.
3.10.3 Sampling Stop

Sampling stop means pausing transmission of sample racks during test process, so
that you can load or replenish samples in the rack supply unit. Click to request
sampling stop. The sample delivery module stops delivering racks to the passing lane
or normal lane. Those racks that have been carried to the inside of the SDM will
continue with the analysis.
When sample supply units finish delivering current sample racks, the two blue
indicators of the sample supply units are off and the indicator of the sample supply
unit that was feeding the racks just ago turns orange and starts flickering to indicate
the system is entering Sampling Stop. When Sampling Stop is achieved, the indicator
of the rack supply unit is off and you can add racks in the sample supply unit.
To cancel Sampling stop and resume the test, select .
 In sequential mode, click to start test.
 In rack ID mode or bar code mode, click or press the corresponding button
of the rack supply unit to start test.
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Note:
When you select on the screen of the operating software, all racks in the two
rack supply units will be stopped. If you want to resume the test of one rack supply unit,
you can select or press its corresponding button to start test. After you select
to start analyses, sample racks in the supply unit with yellow indicator flickering
will be delivered first.
3.10.4 Reagent Stop

Reagent Stop means to pause dispensing reagent during the test, and then load and
unload reagent on the reagent carousel. When Reagent Stop is selected, the
countdown for loading reagent is displayed in the status prompt area at the top of the
screen. When the started tests finish dispensing reagent, the system status changes
to Reagent Load, and you are allowed to load and unload reagent.
To cancel the reagent stop and resume the test, select or No Load button.
3.10.5 Emergency Stop

The system allows emergently stopping single or all analyzer modules. Emergency
stop will terminate all measurements on the relevant module, and all tests on the
module that are not finished yet will be invalidated. Do not use emergent stop unless
it is really needed, for example, system failure. Emergency stop can be performed in
any system status.
Select the icon, select desired modules, and then select OK; or, click the module
status icon at the top of the screen to access the System Status screen, select desired
modules, and then select Stop. All unfinished actions of the modules are cancelled, all
pumps and valves are turned off, and the modules enter the Stopped status.
To restore system failure, access the System Status screen, select the desired
modules to restore, and then select Home. To resume the analysis, select the
icon.
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3.11 Home the System

The Home command is used to initialize the analyzing unit and the rack feeder system,
and to recover them from failures, making all components return to the home positions.
You are allowed to restore the analyzing unit or rack feeder system separately. When
the Home command is executed, the system status changes to Standby.
Make sure that the racks on the track are cleared before restoring the system.
1 Select system overview icon or System > System Status.
2 Select the desired module and select Home.
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3.12 Sleep and Wake Up

Select Sleep to put the system into Sleep status. The Wake Up command is executed
to wake up the system. You are allowed to sleep or wake up one analyzer or all
configured analyzers. In addition to waking up the system by performing the Wake Up
command, the system can also be waken up automatically by performing the Auto
Wake Up command. When the set conditions are reached, the system will wake up
automatically and then enter the Standby status.
3.12.1 Sleep
2 Select a module and select Sleep.
3.12.2 Wake Up
2 Select a module and select Wake Up or click Start button.
The system automatically executes the wake-up instruction and then enters the
Standby status.
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3.13 Masking/Unmasking Module

Users are allowed to mask or unmask analyzers. When an analyzer is masked, it will
stop running tests, and the rack feeder system will stop delivering racks to it; other
operations other than running tests, however, can still be performed normally.
NOTE
Masking/Unmasking module can be performed only when the system status is Standby,
Stopped, and Sleep.
Once a module is masked, operations other than running tests can still be performed.
When a masked module is unmasked, tests can be run and the system status prior to
masking can still remain.
3.13.1 Masking/Unmasking Module

1 Click the module status icon on the main screen. The System Status screen is
displayed.
2 Select Mask Module.
 Mask Sample: This module is not used to measure sample.
 Mask Test: This module is not used to measure sample, run QC and calibration.
Once a module is masked, the “ ” symbol appears on the upper-right corner

of the module icon, and the system will stop delivering racks to the module.
3 To unmask a module, select Unmask.
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3.14 View Software Version

1 Click the upper right corner and click About.
2 View the version number and upgrade record. You can select More to view the
open source statement.
3-54
3.15 Daily Maintenance

After finishing all tests everyday, you are required to perform the daily maintenance
procedures and those maintenance procedures indicated in yellow.
Daily maintenance procedures include:
 Check DI Water Connection
 Check Waste Connection
 Check inventory of CD80 detergent and probe wash
 Check Sample/reagent Syringe
 Check Sample Probe Wash Solution
 Check mixer installation position
 Clean ISE electrodes
 Special Wash Probes/Mixers
3-55
3.16 Shutdown and Log off

3.16.1 Log off
You can log off the operating software and use a new user name and password to log
on it.
1 Make sure that the system is in "Standby” status.
2 Select Exit on the left of the main screen and select Log Off.
3 Select OK.
4 Log on again or use a new name and password to log on.
3.16.2 Shut down

1 Make sure that the system is in Standby status.
2 Select Exit > Shut Down on the left of the main screen. The Windows operating
system will quit automatically.
3 Switch off the power in the following order:
 Printer
 Monitor display of the operation unit
 Monitor display of the computer installed with the Data Management
Software (optional)
 Water supply module (optional)
 External vacuum pump (optional)
When the analyzer is shut down, the refrigeration system is still running. If you are
going to store the system for over 7 days, switch off the main power switch of
analyzers.
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3.17 Check after Powering Off

1 Check the analyzer panel for stains and wipe them off with clean gauze if any.
2 Check the high-concentration waste tank. Clear it if necessary.
3 Check the sample track for racks. If any, take out the racks and store them properly.
4 Take out racks from the rack storage unit and store them properly.
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3-58
4 Setup
This chapter introduces the basic setup options of the system, which include:
 Test Settings
 Analysis Settings
 System Setup
4-1
4 Setup
4.1 Tests Setup

4.1.1 Introduction
The system supports both closed-reagent and open-reagent tests. The same test on
all configured analyzers uses the same parameters. Definition, modification, and
deletion of user-defined tests are valid for the entire system. Closed-reagent tests can
only be run with the reagents provided by our company, and must not be edited for
parameters other than print name, result unit, decimal places, error detection limits,
and slope/offset. If you are not going to use certain closed-reagent tests, you are
allowed to mask them, and if needed some day, unmask them. The Tests screen is as
shown below:
Tests screen
Definition and setup of user-defined tests will be described in detail in the following
sections.
4.1.2 Import Tests

The system supports specified and default tests to be imported from an external file,
and open-reagent tests to be exported to an external storage device.
When tests are imported, they are enabled by default if set up correctly. If the number
of open-reagent tests imported exceeds the maximum limit, the excessive open-
reagent tests will be disabled.
Only users with sufficient permission are allowed to import or export tests. Importing
and exporting tests can be performed only when the system status is Standby,
Incubation, Stop and Sleep.
If an imported closed-reagent test is no longer needed, it can be deleted with the Delete
button on the Tests screen.
Import default test list

Closed-reagent tests can be imported from an .item file. They include biochemical
tests, ISE tests, SI and special calculations, as well as carryover pairs, reagent type,
biochemistry calibration settings, ISE calibration settings, unit conversion rules,
processing parameters, error detection limits, carryover settings and slope and offset.
4-2
4 Setup
Only the print name, result unit, decimal places, error detection limits, and slope/offset
can be modified and deleted, while the others can only be browsed.
1 Select Setup > Tests.
2 Select Import.
Import window
3 Select Default.
All tests contained in the default parameter form are displayed in the Tests list.
4 Select OK.
All imported tests are enabled by default and can be used for measurement. If the
result unit is changed, the corresponding test must be recalibrated.
Import specified test list

Open-reagent tests can be imported from a .csv or .dat file. The open-reagent tests
include biochemical tests, as well as the processing parameters, error detection limits,
slop and offset, and sample type.
2 Select Import.
3 Select Open File.
4 Locate the path of the parameter form, and then select a .csv or .dat file.
5 Select Open.
6 Select Import.
7 Select OK.
4-3
4 Setup
4.1.3 View the Version of Tests

2 Select Version.
View the version of tests, parameters list and generating tool.
4.1.4 Open Tests Setup

Defining a test
2 Select Define.
3 Enter the test, number, test name, print name and select decimal and unit of the
result.
4 Set up the analysis parameters, check parameters and calibration parameters.
5 Select Submit.
Editing open tests

You are allowed to edit user-defined tests if:
 You have sufficient permissions, and
 The analyzers on which the tests are configured are not running tests.
Editing user-defined tests is similar to defining a test. Refer to other sections in this
chapter for details.
Viewing open tests

You are allowed to view the following information in any system status:
 Processing parameters
 Error detection limits
 Slope and offset
 Reference/Critical range
 Carryover
Perform the following steps to view tests you have defined:
2 Choose a test from the test list.
3 Select View and Edit to view the processing parameters, error detection limits,
reflex testing, and qualitative result flags.
Refer to 4.1.10 Analysis Parameters, 4.1.11 Check Parameters and 4.1.12 Calibration
Parameters for parameter settings.
Exporting open tests

1 Select Setup > Tests > Test View&Setup.
2 Click and select the open-reagent tests you want to export.

3 Select export path and click OK.
4-4
4 Setup
4.1.5 Test Configuration

The Test Configuration function is used to enable/disable tests that have been defined
correctly and customize their display order on the Sample, STAT Sample Order and
Quality Control screens. When disabled, tests will no longer appear on the Sample,
Reagent/Calibration, Quality Control, Define/Edit Panels, Special Calculations,
Current Result and History Result screens. Only the enabled tests can be requested
for measurements and recalled on results screens.
Enabling Tests
All tests other than ISE tests and SI can be enabled or disabled. The closed-reagent
tests are enabled by default after being imported from a test file; while the open-
reagent tests will be enabled only if the parameters are set up correctly. The SI is
always enabled and cannot be disabled. If an ISE module is configured, the ISE tests
will always be enabled.
Tests can be enabled for single analyzer or for all analyzers. When one of a twin tests
is configured, the other twin is configured automatically.
To enable tests, perform the following steps:
1 Select Setup > Tests > Test Configuration.
Test Configuration screen
2 Choose a module.
3 Select reagent carousel.
4 Select the test(s) you want to configure.
Configured tests are selected by default and unconfigured ones are not.
5 Select OK.
Disabling Tests
Some tests that will not be used for the moment can be disabled, and will no longer
appear on request screens. ISE tests and SI are always available and cannot be
disabled. Results of disabled tests cannot be recalled until the tests are enabled again.
4-5
4 Setup
A test can be disabled only if:

 It is not an ISE test.
 It is not SI.
 It has no reagent position.
 It has no calibrator position and has not been requested for calibration.
 It has no control position.
 It is not contained in samples and controls that are in ordered, Incomplete or Rerun
status.
Tests can be disabled for single analyzer or for all analyzers. When one of a twin tests
is deconfigured, the other twin is deconfigured automatically.
Perform the following procedure to disable tests:
1 Select Setup > Tests > Test Configuration.
2 Choose a module.
3 Select reagent carousel.
4 Deselect the tests that you desire to deconfigure.
5 Select OK.
4.1.6 Masking/Unmasking Tests

The test masking function is used when a test needs to be disabled temporarily due to
abnormal result or reagent exhaustion. Masked tests are flagged with and can be
requested but cannot be run until they are unmasked. Tests on reagent carousel inner
ring or outer ring can be masked or unmasked simultaneously.
In any system status tests on each analyzer (M1-M2) can be masked or unmasked.
Any users are allowed to mask or unmask tests.
If a sample contains masked tests, it will enter the Incomplete status when finished; if
tests are unmasked while the sample status is ordered, the they will be run along with
other tests; if tests are unmasked while the sample is being analyzed, they will be
added automatically to the analysis; if tests are unmasked after the sample is analyzed,
they will be run automatically when analysis begins next time.
Masking/Unmasking Tests
2 Select Mask/Unmask Test.
3 Choose a module to mask tests.
The default is M1.
4 Choose mask type.

 Test mask：once masked, the sample analysis, QC and calibration cannot be
performed for this test. The test which is not started yet will be invalidated and
flagged as Mask.
 Sample mask：once masked, the sample analysis is unavailable, but the QC
and calibration can be performed. The sample analysis which is not started yet
will be invalidated and flagged as Mask.
5 Select the tests you want to mask and click OK.
4-6
4 Setup
6 To unmask tests, select them and then select OK.

7 Select Return.
4.1.7 Deleting Tests

Make sure that you have sufficient permission to delete a test you have defined.
1 Remove the reagent from the reagent carousel.
3 Select the test in the test list.
4 Check if the following conditions are satisfied:
 The system is not running tests.
 The selected test is not requested or run for samples, calibrators and controls.
 The selected test on all configured analyzers is disabled.
 The corresponding reagent has been unloaded from the reagent carousel.
5 Select Delete.
All test results, data and parameters related to the test are cleared.
4.1.8 Display Settings

It is used to set up unit, decimal, print name, result optimization, test order, etc.
Customizing Test Display Order

1 Select Setup > Tests > Display Settings.
Display setup
2 Select a test.
3 Use the following buttons to adjust the test’s display order:
 Home: to move the test to the first position.
 Up: to move the test to the previous position.
4-7
4 Setup
 Down: to move the test to the next position.

 End: to move the test to the last position.
4 Select OK.
The test list on the request screens are refreshed automatically.
5 Select Return.
Flag Qualitative Result

When the analyzer is in the status of standby, incubation, hibernation or stop, you can
flag the result of the tests qualitatively and the results will be represented by a
qualitative flag.
2 Select the desired test.
3 Select Flag Qualitative Results.
4 Select Flag Qualitative Results and enter the qualitative range and flag.
For instance, type in “10” in the first edit box of the Range field, and then enter “+”
in the Flag field of the same row. If the test result (L1) contained in a sample is
less than or equal to 10, the “+” sign will be added to the result in the patient report.
Type in “20” in the second edit box below the Range icon and “+-” in the second
edit box below the Flag icon. If the test result (L2) is greater than 10 and less than
or equal to 20, the result will be flagged with the “+-” sign. The cycle continues. If
the result is greater than L5, the six flag will appear on the patient report.
5 You can also Semi-quantitative.

6 Select OK to save the settings.
4.1.9 Adjusting Measurement Order of Tests

Test order of configured biochemical tests can be adjusted manually. During sample
analysis, the tests are run in the order of ISE tests, SI, and then biochemical tests. If
multiple biochemical tests are requested, they will be run in the default order. If the test
order is adjusted manually, the biochemical tests will be run in the updated order.
1 Select Setup > Tests > Test View and Settings.
2 Select Test Orders.
3 Use the following buttons to adjust the test’s test order:
4 Select OK.
5 Select Restore Default to restore the previous order.
4.1.10 Analysis Parameters

This section introduces the analysis parameters for the tests.
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4 Setup
The analysis parameters setup window is as shown below:

Analysis parameters
Test
Test name is the only identity of a test and must not be duplicate. A test name can be
composed of up to 10 characters, and is not case sensitive.
No.
No. is a unique number for test. It can be left blank but must not be duplicate. Test
number is composed of numbers and ranges from 0-9999.
The number of open-reagent test ranges from 0 to 400.
Sample type
Sample type refers to the samples to which the test is applicable. The options include
serum, plasma, urine, CSF, whole blood, pleural effusion and other. The options
available in the Sample Type pull-down list are those supported by the test, and the
default is the default sample type.
The system allows definition of test parameters for more than one sample type,
including the processing parameters and error detection limits. Sample types of a
closed-reagent test are imported through the test list; and sample types of an open-
reagent test can be defined by the user.
During definition of open-reagent tests, the parameters should be firstly defined for
serum sample, and then for other sample types. Such tests will be calibrated with
serum sample parameters by default.
Test Name
This field is the complete form of test name. It can be composed of up to 36 characters.
The input is not case sensitive. The Test field can be left blank or duplicate.
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4 Setup
Print Name
Print name is displayed on patient reports representing a test. It can be composed of
up to 15 characters. The print name can be edited and duplicate. When this field is left
blank, the short form of the test name will appear on reports.
A test is only represented by its print name on patient reports and appears on other
reports in the form of short name.
Unit
Changing the result units of both closed-reagent and open-reagent tests are allowed.
 For closed-reagent tests, only the unit options provided by the manufacturer can
be selected. When the result unit is changed, the system will automatically refresh
the finished sample results, calibrator concentrations, control concentrations,
reference ranges and offsets in light of the conversion rate between units.
 For open-reagent tests, the result unit is blank by default. After changing the unit,
you are required to update calibrator concentrations, control concentrations and
standard deviations (SDs), reference ranges and offsets. Those test results
calculated with the old unit will remain unchanged.
Run calibration again after changing the result unit of open-reagent test.
Decimal
Decimal specifies the number of decimal places for test results. The decimal is
allowed to be edited for both open and closed reagent tests. The number of decimal
places is 0 for open test and same as that defined in the database for closed test.
Up to 3 decimal places can be set up and respectively correspond to 0, 0.1, 0.01 and
0.001.
Reaction Type
Reaction type is a measurement theory based on which tests are run for samples and
then calculated. The system supports three reaction types, which are Endpoint, Fixed-
time and Kinetic.
Reaction types
Reaction Type Description

Endpoint Qualitative analysis is performed based on the absorption
spectrum and absorbed light intensity of the reactant when the
reaction becomes equilibrious.
Fixed-time For this reaction type, the reaction velocity is directly proportional
to the substrate concentration. As the substrate is consumed
continuously, the reaction velocity is decreasing gradually, and so
is the absorbance change rate. It will take a long time for such
reaction to become equilibrium, and the reaction can get steady
only after a delay.
Kinetic Kinetic, also called continuous monitoring method, is used to
continuously measure the multiple change points of a reactant or
substrate’s concentration which varies with the enzymatic
reaction, thus calculating the initial velocity of the enzymatic
reaction and then the enzyme activity. This reaction type is mainly
used for measurement of enzyme activity.
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4 Setup
Reaction Direction
Reaction direction refers to the change trend of absorbance during the reaction
process, and includes two options:
 Positive: indicates increasing absorbance with time.
 Negative: indicates decreasing absorbance with time.
Primary Wavelength
The primary wavelength is chosen based on the light absorption features of the
reactant and used to measure the absorbed light intensity.
Options for primary wavelength include 340nm, 380nm, 412nm, 450nm,
480nm,505nm,546nm,570nm,605nm,630nm,660nm,700nm,740nm,770nm,800nm
and 850nm.
Secondary Wavelength
The secondary wavelength is used to correct the absorbance measured at the primary
wavelength and eliminate the influence of noise, such as light flash and drift, and
scratches on cuvettes, etc. The two wavelengths cannot be equal.
Options for secondary wavelength include blank, 340nm, 380nm,412nm, 450nm,
480nm,505nm,546nm,570nm,605nm,630nm,660nm,700nm,740nm,770nm,800nm
and 850nm.
On-board Stability Time(days)

The On-board Stability Time refers to the number of days that the reagent can be kept
valid since uncapped at the first time.
The input range must be within 1-999 days. The default is blank.
Blank Time and Reaction Time

Blank time refers to the period between dispensing of the second reactant (reagent or
sample) in reversed order and of the last reactant (reagent or sample).
For endpoint analysis, the reaction time refers to the time span from the start point of
the reaction to the end point; for fixed-time and Kinetic analysis, it refers to the period
from reaction equilibrium to the end of monitoring.
The blank time and reaction time are counted in measuring points.
Suppose the blank time range is N-P and the reaction time range is L-M. The start point
is the first measuring point after dispensing of R1.
Blank time and reaction time input ranges for endpoint analysis
Endpoint Blank Time Reaction Time

When the blank absorbance is read before the reaction begins,
Single-reagent 2≤N≤P≤3 5≤L≤M≤33
Double-reagent 5≤N≤P≤16 17≤L≤M≤33
Triple-reagent 17≤N≤P≤36 41≤L≤M≤69
Quadruple-reagent 41≤N≤P≤52 53≤L≤M≤69
When the blank absorbance is read after the reaction begins,
Single-reagent 5≤N≤P P<L≤M≤33
Double-reagent 17≤N≤P P<L≤M≤33
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4 Setup
Endpoint Blank Time Reaction Time

Triple-reagent 41≤N≤P P<L≤M≤69
Quadruple-reagent 53≤N≤P P<L≤M≤69
When the blank absorbance is not subtracted,
Single-reagent N=P=0 5≤L≤M≤33
Double-reagent N=P=0 17≤L≤M≤33
Triple-reagent N=P=0 41≤L≤M≤69
Quadruple-reagent N=P=0 53≤L≤M≤69
Blank time and reaction time input ranges for fixed-time and Kinetic analysis
Fixed-time and Kinetic Blank Time Reaction Time
Single-reagent 2≤N<P≤3 5≤L<M≤33
Double-reagent 5≤N<P≤16 17≤L<M≤33
Triple-reagent 17≤N<P≤36 41≤L<M≤69
Quadruple-reagent 41≤N<P≤52 53≤L<M≤69
Single-reagent N=P=0 5≤L<M≤33
Double-reagent N=P=0 17≤L<M≤33
Triple-reagent N=P=0 41≤L<M≤69
Quadruple-reagent N=P=0 53≤L<M≤69
The blank time and reaction time are almost the same for both fixed-time and Kinetic
analysis, except that M-L≥2 is required for Kinetic analysis, that is, the reaction time
should include at least 3 measuring points.
Sample Volume, Standard, Aspirated, Diluent, Increased, and Decreased

Sample volume is the standard sample amount, which should be dispensed in a normal
test. It ranges from 1.5μL to 25μL with an increment of 0.1μL. The default is 1.5μL. A
maximum of one decimal is allowed.
Aspirated volume refers to the amount of sample used for dilution at the specified ratio.
It ranges from 1.5μL to 25μL with an increment of 0.1μL. The default is blank. A
Diluent volume refers to the amount of diluent used for sample dilution. It ranges from
75μL to 200μL with an increment of 0.5μL. The default is blank. A maximum of one
decimal is allowed.
NOTE
If aspirated volume for dilution and diluent volume are defined, ensure the total sum of
them is within 100μL-280μL; otherwise, the settings cannot be saved.
The diluent volume for standard, increased and decreased analysis can be defined in the
same way.
Decreased sample volume indicates the sample amount required for a decrement test.
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4 Setup
Increased sample volume indicates the sample amount required for an increment test.
NOTE
If aspirated volume for dilution and diluent volume are defined, standard, decreased and
increased analysis will be performed with diluted sampled; otherwise, it will be done based
on standard, decreased or increased sample volume.
Sample Blank
Sample blank is similar to sample analysis except for use of equivalent amount of
physiological saline. Sample blank is used for removal of non-chromogenesis reaction,
such as influence of sample interference (Hemolysis, icterus and lipemia) on
absorbance readings.
Mark the Sample Blank checkbox with a tick. The test will be sample blanked before
the reaction begins; the Sample Blank checkbox on the Options and Rerun windows
will be selected automatically and cannot be modified.
Reagent Volume and Diluent

Reagent volume specifies the reagent amount, which should be dispensed for
measurement. The system allows the dispensing of four reagents:
 R1: 80μL-200μL for normal reagent, 10μL-200μL for concentrated reagent, with an
increment of 0.5μL. The default is 120μL.
 R2-R4: 10μL-200μL, with an increment of 0.5μL. The default is blank.
The second, third and fourth reagents are allowed only when the reagent(s) prior to
them are configured. For example, R2 can be set up with the prerequisite of R1; R3 with
R1and R2; R4 with R1, R2 and R3. If one of R2, R3 and R4 is removed, the remaining
reagents behind it will also be removed and appear in grey.
Diluent volume refers to the amount of diluent used for reagent dilution. It ranges from
10μL to 200μL with an increment of 0.5μL. The default is blank. If aspirated reagent
volume for dilution and diluent volume are defined, ensure the total sum of R1 and
diluent is within 80μL-200μL and that of R2/R3/R4 and diluent is within 10μL-200μL.
The combined volume of all reagents, reagent diluent and sample must be within 80μL
and 280μL. If your input does not satisfy the requirements of reaction mixture volume,
the system will display an error message. Check the sample volume and reagent
volumes you have entered, and change them if necessary.
Sample Pretreatment
Enable the sample pretreatment function to pretreat patient samples with
pretreatment reagent for the test. Sample pretreatment includes common
pretreatment and blood cell pretreatment.
Only when the Pretreatment checkbox is selected, common pretreatment, blood cell
pretreatment, pretreatment of calibrator and control can be enabled, and the pretreat
sample volume and pretreatment reagent volume can be set.
Pretreatment tests cannot be set with predilution factor. Setting pretreatment
parameters for the twin of a former test is not allowed.
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4 Setup
Common Pretreatment
Select this option to pretreat the samples other than whole blood samples. Probe
aspirates the sample from the top of the sample tube and then the sample is pretreated
with pretreatment reagent.
Blood Cell Pretreatment
Select this option to pretreat the whole blood samples. Probe aspirates the sample
from the bottom of the sample tube and then the sample is pretreatment with
pretreatment reagent.
Calibrator Pretreatment
When this option is enabled, the calibrators of the test will be pretreated with the
pretreatment reagent during calibration test according to the set pretreat sample
volume and pretreatment reagent volume. If a multi-point pretreatment solution is
adopted, the calibrator must be pretreated with pretreatment reagent with the sample
volume and diluent volume set for calibration dilution.
Control Pretreatment
When this option is enabled, the controls of the test will be pretreated with the
pretreatment reagent during QC test according to the set pretreat sample volume and
pretreatment reagent volume.
Pretreat sample volume

Enter the pretreat sample volume within 1.5 μL - 25 μL, with an increment of 0.1 μL.
The default is 4 μL.
Pretreatment reagent volume

Enter the pretreatment reagent volume within 75 μL - 200 μL, with an increment of 0.5
μL. The default is 200 μL.
The sum of pretreat sample volume and pretreatment reagent volume must be within
100 μL - 225 μL.
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4 Setup
4.1.11 Check Parameters

Check Parameters
Linearity Range
The linearity range indicates the measurable range of the system, during which the test
result is linear to the response R. Determine the linearity range according to the reagent
package insert. The high limit can be any number greater than or equal to 0, and the
low limit is lower than or equal to the high limit.
The system compares the calculated sample concentration with the linearity range.
When the high limit is exceeded, the > sign will appear near the result; when the low
limit is exceeded, the < sign will appear.
The input range for standard/increased/decreased linearity Range is -99999-999999.
The default is blank, which means not performing this check.
Linearity Limit
Linearity limit is only applicable to Kinetic analysis, in which the absorbance change is
linear to the reaction time. If the reagent undergoes substrate depletion, or the
photometer fluctuates, or the reaction mixture is not stirred evenly, the test results may
be unreliable. Therefore, the linearity of the measuring period is calculated and then
compared with the set linearity limit.
If the reaction data within the linearity range does not satisfy the linearity limit, the
system will flag the test result with “LIN” on the patient report.
The linearity limit can be any number between 0 and 1 with a maximum of 2 decimals.
Substrate Depletion
The Substrate Depletion option is only applicable to Kinetic and fixed-time analysis. It
can be obtained through the following formula:
Substrate depletion limit = Input substrate depletion limit + K(L1-Lb)
Where,
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4 Setup
 L1: refers to the absorbance of primary wavelength measured at the first

measuring point when sample is dispensed and stirred in sample analysis.
 Lb: refers to the absorbance of primary wavelength measured at the first
measuring point when sample is dispensed and stirred in a reagent blank test or
calibration with 0-concentration calibrator.
 K: correction factor of liquid volume
Results will not be adjusted when L1-Lb≤0 or the measurement is not a reagent blank
or 0-concentration calibration. Substrate depletion is not applicable for calibrations.
We deem that substrate depletion occurs if the primary wavelength absorbance of the
first measuring point is greater than the substrate depletion limit in ascending
reactions or lower than the substrate depletion limit in descending reactions. When
substrate depletion occurs, the system will flag the test result with “BOE” in the patient
report.
The substrate depletion limit can be any number within -35,000-35,000. The default is
blank, which means not performing this check.
Enzyme Linearity Extension

If this option is selected, when the number of measuring points without substrate
depletion is N=0 or N=1 within the linearity range, the enzyme linearity range extension
function is enabled. If the result can be calculated within the lag time, the result is
displayed and marked with "EXP" and "NLN." If the number (N) of valid measuring
points within the lag time is less than two, the system shall not display the results but
flag ENC (no calculation interval) and give an alarm. If this option is not selected, when
the number of measuring points within the linearity range without substrate depletion
is N=0 or N=1, the result will not be displayed, and the flag "NLN" will be given.
R1 Blank Absorbance Range

The R1 Blank Abs indicates the allowable range of the maximum absorbance in the
previous period prior to sample dispensing. The input range must be within -35,000-
35,000, and the low limit lower than the high limit.
If the maximum absorbance in the previous period prior to sample dispensing is
beyond the set range, the system will flag the test result with “RBK”.
Mixed Blank Absorbance Range

The Mixed Blank Abs indicates the allowable range of the absorbance measured at the
end point of a zero-concentration calibrator reaction or a reagent blank reaction. The
input range must be within -35,000-35,000, and the low limit lower than the high limit.
If the absorbance measured at the reaction end point is beyond the set range, the
system will flag the test result with “MBK”.
Blank Response
The Blank Response specifies the allowable range of the response in a zero-
concentration calibrator analysis or a reagent blank test. The input range can be any
number within -35,000-35,000, and the low limit lower than the high limit.
If the response is beyond the set range, the system will flag the test result with “BLK”.
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4 Setup
Twin Test
Twin Test is associated with the current test, and the two tests are run with the same
reagent. Results of two twin tests are calculated in the same test.
The test whose result will be firstly calculated should be defined prior to the associated
test. Volume of the shared reagent and sample volume must be the same for the two
tests. Only the two tests that have had no reagents loaded can be configured as twins.
Prozone Check
Prozone check can be performed in two ways: Antigen addition and rate check. Antigen
addition is determined by two formulas: Formular 1 and Formular 2. Rate check is
based on both rate check formula 1 and formula 2.
Prozone check is applicable to Kinetic, fixed-time and endpoint measurements. When
the conditions for triggering an alarm are met, the system shall flag the test result with
"PRO" for prozone check error, "BOE" for Kinetic analysis, and give an alarm.
Formula 1 for antigen addition:
PC1≤Aq2-k×Aq1≤PC2
Where,
Aq1 is the absorbance of the Q1 measuring point, and Aq2 is the absorbance of the Q2
measuring point. Q1 and Q2 are the number of the measuring point on the reaction
curve.
Single reagent test k＝(VR1+VS)/(VR1+VR3+VS)
Double reagent test k＝(VR1+VS+VR2)/( VR1+VS+VR2+VR3)

VR1, VR2 and VR3 are the volumes of the R1, R2 and R3 reagent, and Vs is the actual
volume of sample dispensed. If reagent is concentrated, then VR1, VR2 and VR3 are
the sum of reagent volume and diluent volume.
Formula 1 of rate check method:
A q 4  A q3
q 4  q3
PC1   PC 2
A q 2  A q1
q 2  q1
Where,
Aq1 - Q4 are the absorbance of measuring point Q1, Q2, Q3 and Q4. Where Q1, Q2, Q3
and Q4 are the number of the measuring point on the reaction curve.
Formula 2:
1) Aq6- Aq5≥V3 at Q5≠Q6
2) Q5= Q6: Same point, Aq5≥V3
Where,
curve.
Prozone check parameters for rate check
[Q1] [Q2] [V1] [Y/N] [Q3] [Q4] [V2] [Y/N]
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4 Setup
[Q5] [Q6] [V3] [Y/N] [PC1] [PC2] [Y/N] [A/O]

Prozone check parameters for antigen addition:
[Q1] [Q2]
[Q5] [Q6] [V3] [Y/N] [PC1] [PC2] [Y/N] [A/O]
Antigen Additon reagent Volume and Diluent Volume.
For both single-reagent and double-reagent tests, set up the reagent volume of antigen
addition of R3: Reagent volume for R3 and diluent volume for R3.
Factor Description Value Range
1St entry field (Q1) Measuring point on reaction curve Single and double reagent
test of rate check:
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
Antigen addition and rate
check R3, R4 reagent test
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
≠Q 4 are required and Q
5= Q 6 are allowed. At
least one of Q1, Q2, Q 5
and Q 6 is greater than or
equal to 41.
2nd entry field (Q2) Measuring point on reaction curve Single and double reagent
test of rate check:
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
equal to 41.
3rd entry field (V1) Aq2- Aq1 threshold [-35000, 35000]
4th entry field(Y/N) Y indicates that condition Aq2- Y/N
Aq1< V1 is met. N indicates that
condition Aq2- Aq1≥V1 is met.
If the conditions are met, the
system will not perform prozone
check.
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4 Setup
5th entry field (Q3) Measuring point on reaction curve Single and double reagent
test of rate check:
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
equal to 41.
test of rate check:
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
equal to 41.
7th entry field (V2) Aq4- Aq3 threshold [-35000, 35000]
8th entry field(Y/N) Y indicates condition Aq4- Aq3< Y/N
V2 is met. N indicates that
check.
test of rate check:
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
equal to 41.
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4 Setup
test of rate check:
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
equal to 41.
11th entry field (V3) Threshold of formula 2 [-35000, 35000]
12th entry Define the range to trigger Y/N
field(Y/N) judgment formula 2. Y indicates
that the value of formula 2 is
within the defined range, and N
indicates that the value of formula
2 is outside the defined range.
13th entry field Lower threshold of formula 1. [-35000, 35000]
(PC1) PC1<PC2 is required.
14th entry field Upper threshold of formula 1. [-35000, 35000]
15th entry Defines the range of formula 1 to Y/N
field(Y/N) trigger judgment. Y means the
value of PC is within the range of
formula 1; N means the value of
PC is outside the range of formula
1.
16th entry This sets the logical triggering A/O
field(A/O) relationship between formula 1
and formula 2. If A is selected,
when both formula 1 and formula
2 are satisfied, the logic relation is
triggered ("and" logic). If O is
selected, either formula 1 or
formula 2 triggers the logic
relation (“Or” logic).
Serum Index Check

Serum index refers to the degree of hemolysis, icterus and lipemia in serum samples.
1 Select appropriate test methods as needed: "Blank," "Semi-quantitative" and
"Qualitative." "Blank" indicates that the serum index check is disabled.
2 Set the alarm threshold for each test: An alarm will be triggered when the L/H/I
test result is greater than the threshold.
3 Three levels of alarm thresholds can be set. Threshold 1 must be set, otherwise
the alarm function will be disabled. Thresholds 2 and 3 can be null. Based on
different threshold settings, alarms can be classified into three categories.
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4 Setup
 When Threshold 1≤L/H/I < Threshold 2, the result flag is L.In, indicating slight
interference. It has a small impact on the test result.
 When Threshold 2 ≤ L/H/I< Threshold value 3, result flag is L. +/L. -/L,
indicating severe interference, which has a great impact on the test result.
 When Threshold 3≤L/H/I, result flag is L.OUT indicating an abnormal sample
and the test result is unreliable.
4.1.12 Calibration Parameters

This section is to introduce the settings of calibration parameters.
Calibration Parameters
Setting up Calibration Rules

You should set up the calibration rules after defining a calibrator and determining
concentrations for it. You are allowed to set up or edit the calibration rules, replicates,
K factor and auto calibration only when the system is not running any tests.
2 Choose a calibration method in the Math Model field.
The options include:
 K factor
 Two-point linear
 Multi-point linear
 Logit-Log 4P
 Logit-Log 5P
 Exponential 5P
 Polynomial 5P
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4 Setup
 Parabola
 Spline
 Logit-Log 3P
 Polyline
3 If you choose K Factor, type in the K factor in the Factor field.
This field is activated only when the one-point linear math model is chosen. When
the K factor is determined, the calibration results will be calculated with the
equation Y=K*X. Where, Y is the calibration result, K is the factor, and X is the
response.
4 Choose the number of replicates.

The input range is 1-5, and the default is 1.
Calibration Check
The system checks the calibration results against the set detection limit. If the set limit
is exceeded, the system will give an alarm and add a flag to the calibration result report.
Set the parameters as follows and click Submit. Click Undo to undo the settings that
have not been submitted. Select Return to the upper-level screen.
Calibration Check
Acceptance Criteria Description

Calibration time(hour) The validity period indicates the number of days that the
calibration factors can be used. If the validity period is
exceeded, the system will give an alarm.
The input range must be within 1-9999 hours. The default is
blank.
Lot Calibration Calibration factors can be used within the specified period. If
Expiration(Day) the set limit is exceeded, the system will give an alarm.
Slope difference The slope difference is applicable to linear calibration only. It is
the K factor (slope) difference between two adjacent
calibrations. The system will give the flag “FAC” and an alarm
when the slope difference is exceeded.
Type in the percentage within 0-100. The default is blank,
which means not performing this check.
Standard deviation The standard deviation is used for multi-point linear and non-
(SD) linear calibrations. The system will give the flag “CSD” and an
alarm when the SD value is exceeded.
The input range must be within 0-999. The default is blank,
which means not performing this check.
Determination The determination coefficient is used for multi-point linear and
coefficient non-linear calibrations. It is the fit degree of the calibration
curve. The system will give the flag “DET” and an alarm when
the calibration fit degree is exceeded.
The input range must be within 0-1. The default is blank, which
means not performing this check.
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4 Setup
Acceptance Criteria Description

Repeatability The repeatability means the difference of the maximum and
minimum response of each calibrator within valid test times
exceeds the threshold. If the calculated calibrator response
difference is greater than the set absolute and relative
threshold, the system will give the flag “DUP” and an alarm.
 The input range of absolute threshold must be within 0-
35,000.
 The input range of relative threshold ABS.x% must be within
0-500.
Sensitivity The sensitivity is ratio between the response difference and
concentration difference of the two calibrators with the
maximum and minimum concentration. The system will give
the flag “SEN” and an alarm when the sensitivity exceeds the
defined threshold.
 The input range must be within 0-99,999.
 The default is blank, which means not performing this
check.
Calibration Reminder When the auto calibration conditions are satisfied, the system
will remind you through the calibration status, prompt
message and color indication.
• If you choose the Bottle Changed option, the system will
display a message indicating calibration is required when you
use a different bottle of reagents.
• If you choose the Lot Changed option, the system will
display a message indicating calibration is required when you
use reagents of a different lot.
• If you choose the Cal Time option, the system will remind
you in 30 minutes before the calibration is timed out and
display the test name and calibration status with yellow.
4.1.13 Editing Closed-Reagent Tests

You are allowed to edit closed-reagent tests if:
 You have sufficient permissions, and
 The system is not running tests.
After importing closed-reagent tests, you are enabled to set up the following
parameters:
 Print name
 Result unit
 Decimal
 Increased and decreased sample volumes and dilution parameters
 Sample blank
 Linearity range
 Linearity limit
 Auto rerun
 Substrate depletion limit
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4 Setup
 R1 blank absorbance
 Mixed blank absorbance
 Blank response
 Reagent on-board stability time
 Twin test
 Reagent alarm limit
 Prozone check
Refer to 4.1.10 Analysis Parameters, 4.1.11 Check Parameters and 4.1.12 Calibration
Parameters for parameter settings.
4.1.14 Slope and Offset Adjustment

The slope and offset are calculation factors that are used to compensate the test
results of a test when the QC result of the test is slightly deviating.
When the measurement is finished, the system adjusts the test result with the
following equation:
y=kx+b
Where, x is the test result before adjustment, y is the result after adjustment, k is the
slope, and b is the offset.
Slope and offset can be set up for each configured analyzer. Reagents of a test on
inner ring or outer ring of reagent carousels can be set up respectively. Before setting
up the calculating factors, make sure that you have sufficient permissions and the
system is not running tests.
2 Select Slope/Offset.
Slope/Offset Adjustment window
3 Choose a module from the Mdl pull-down list.

4 Select a reagent carousel ring on which reagents of the test locate.
5 Choose a test.
6 Double click the Slope field and then input the slope.
Positive, negative and decimal numbers (-9999999-99999999) can be entered.
The maximum input length is 8 digits.
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4 Setup
7 Double click the Offset field and then input the offset.
Positive, negative and decimal numbers (-9999999-99999999) can be entered.
The maximum input length is 8 digits.
8 Repeat step 3 to 7 to set up the slope and offset for other tests.
9 Select OK to save your input information.
10 To restore the factory settings of slope and offset, select Restore Defaults.
4.1.15 Reagent Management Mode

1 Select Setup > Tests > Management Mode.
2 Select Manage by test/lot/bottle.
Calibration by bottle can be selected only when Manage by Bottle is selected.
4.1.16 Carryover Setup

The Carryover Setup option is used to set up the carryover relations between open-
reagent tests, between samples and between cuvettes. The system will insert a
cleaning to reagent probes and cuvettes based on the carryover settings. The closed-
reagent tests have been set up by the manufacturer and cannot be viewed or edited,
while the open-reagent tests need to be set up on the Carryover window. The setup
option is only applied to biochemical tests, rather than SI, ISE test, special calculation,
and panel.
When carryover settings are performed for a twin test, the other twin will update
synchronously.
Carryover setup can only be performed by users with sufficient permissions when the
system status is not Running.
Defining/Editing Reagent Carryover

2 Select a test and select Carryover.
Carryover window
3 Select Edit and Reagent Carryover.
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4 Setup
4 Choose one or all contaminator tests that may contaminate other tests.
"ALL" means all tests may contaminate others.
5 Choose one contaminator reagent type that may contaminate other tests.
The options include R0, R1, R2, R3 and R4.
6 Choose one or all contaminated tests in the Contaminated list.

"ALL" means all tests may be contaminated. All (the entire contaminator) to All
(the contaminated) is not permitted to set up. If the Contaminator is DB/DA, then
the wash type cannot be same as it. E.g. If the contaminator is DB, then the wash
type must be DA. DA is short for detergent acid and DB for detergent base.
7 Choose a wash type.

The options include alkaline wash(DB), acid wash(DA), DC wash and routine wash.
8 Define the wash cycle.

9 Select if Compulsory Special Wash is needed. If selected, the designated wash
cycles must be completed, then the tests are allowed.
10 Select OK.
The defined carryover pair appears in the Carryover Pairs list.
Defining/Editing Sample Carryover

3 Select Edit and Sample Carryover.
4 Choose a Contaminator sample type that may contaminate other sample types.
The options include serum, plasma, urine, CSF and other.
5 Choose a Contaminated sample type.

The options include serum, plasma, urine, CSF and other.
6 Choose one contaminated test in the Contaminated list.

The options include alkaline special wash, acid special wash and routine wash.
If the Contaminator is DB/DA, then the wash type cannot be same as it. E.g. If the
contaminator is DB, then the wash type must be DA.

9 Select if Compulsory Special Wash is needed.
10 Select OK.
Defining/Editing Cuvette Carryover

3 Select Edit and Cuvette Carryover.
4 Choose one or all contaminator tests that may contaminate other tests.
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4 Setup
"ALL" means all tests may contaminate others.
5 Choose one or all contaminated tests in the Contaminated list.

"ALL" means all tests may be contaminated. All (the entire contaminator) to All
(the contaminated) is not permitted to set up. If the Contaminator is DB/DA, then
the wash type cannot be same as it. E.g. If the contaminator is DB, then the wash
type must be DA.

The options include alkaline wash(DB), acid wash(DA), DC wash and routine wash.

8 Select if Compulsory Special Wash is needed.
9 Select OK.
Removing a Carryover Pair

2 Select Carryover.
3 Choose desired carryover pair.
4 Select Delete.
5 Select OK to confirm the deletion.
4.1.17 Panels
A couple of tests combined together for certain clinical purposes can constitute a
panel, such as liver function, kidney function, etc. Panels can help fast ordering of
samples.
Panels can be composed of biochemical tests and ISE tests. Only users with sufficient
permissions are allowed to define, modify and delete panels.
Defining/Editing a Panel
2 Select Panels.
3 Select Define.
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4 Setup
Define/Edit Panels window
4 Type in the panel number.

5 Type in the panel name.
6 Choose panel types.
 Sample: indicates that the panel can be used for sample analysis.
 QC: indicates that the panel can be used for quality control.
At least one panel type must be selected. A panel can be applied to both sample
and control analysis.
7 Choose tests for the panel.

At least one biochemistry should be selected. The three ISE tests (Na, K and Cl)
can be selected alone.
8 To remove a test, click it again.

9 Select OK.
10 Select or to define or edit other panels.
Defining the Default Panel

The system allows a maximum of one default panel to be defined. When a bar-coded
sample has no relevant ordering information on the LIS host or has not been ordered
manually, it can be analyzed with the default panel. The default panel is only applicable
to routine and emergent samples, and often used for a tremendous amount of samples
that are analyzed with the same tests. The default panel is often used at nighttime or
weekends to avoid complicated test requisition.
Only a sample panel rather than control panel can be set as the default.
2 Select Panels.
3 Select a panel.
4 Mark the Default checkbox in the same row as the selected panel.
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4 Setup
Adjusting Display Order of Panels

Display order of panels on the Sample and Quality Control screens can be adjusted
manually for convenient test requisition.
2 Select Panels.
3 Select Up to move the current panel to the previous position, or select Down to
move it to the next position.
4 Select Save to save the settings.
Deleting Panels
Panels can be deleted by users with sufficient permissions while the system status is
not Running. When a panel is removed, the tests contained in it will still remain and can
constitute panels with other tests.
2 Select Panels.
3 Choose panels to delete.
4 Select Delete.
4.1.18 Special Calculations

Calculation of certain tests can derive new tests of clinical purposes, such as
A/G(ALB/(TP-ALB)), I-BIL (T-Bil - D-Bil), etc.
A calculation is composed of tests, calculation operators and algorithm. Only users
with sufficient permissions are allowed to define, modify and delete calculations.
Defining/Editing a Calculation
Importing and defining calculations is supported. For importing methods of closed
calculations, see Import default test list (Page 4-2). The system allows a maximum of
50 calculations to be defined.
2 Select Calculations.
3 Select Define. Or select Edit to modify the calculations.
Special Calculations window
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4 Setup
4 Type in the calculation’s short name in the Test field.

5 If you are going to use the calculation for analysis, mark the Enable checkbox.
6 Choose a sample type to which the calculation will be applied.
 Serum
 Plasma
 Urine
 CSF
 Other
7 Type in the calculation’s full name in the Test field.
8 Choose a result unit from the Unit pull-down list.
9 Choose a result precision, that is, the number of decimal places.
 0
 0.1
 0.01
 0.001
10 Select Flag.
When this option is selected, if the result of certain test included in the calculation
is beyond the linearity range, the system will flag the calculation with "CalcE."
11 Edit the calculation formula:

 Choose tests in the Tests list. The tests are then displayed in the Formula field.
 Choose numbers and operators in the Mathematical Symbols area to
constitute the calculation formula along with the tests.
 To remove a test, number or operator, move the cursor behind them and select
BS.
 To clear the entire formula, select AC.
Enabling/Disabling Calculations
When a special calculation is defined, it is enabled by default and will be calculated for
sample analysis. If a calculation is disabled, it will not be calculated for sample
measurements. Before enabling or disabling a calculation, make sure that the system
status is not Running.
Perform the following steps to enable or disable calculations:
 The calculation list shows all calculations and formulas.
 When the Enable checkbox is marked, it indicates that the calculation will be
included for result calculating.
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4 Setup
 When the Enable checkbox is not marked, it indicates that the calculation will
not be included for result calculating.
3 To activate a calculation, mark the Enable checkbox.
4 To inactivate a calculation, deselect the Enable checkbox.
Deleting User-Defined Calculations

Calculations can be deleted by users with sufficient permissions while the system
status is not Running. Only user-defined calculations rather than closed calculations
can be deleted.
3 Choose calculations to delete.
4 Select Delete.
4.1.19 Reference/Critical Range Setup

The system allows the setup of reference range, critical range, and custom range, as
well as rerun type and priority for each test.
 Reference range indicates the allowable concentration range of a normal sample.
 Critical range is the allowable result range from the perspective of clinical
diagnosis.
 Custom range is the allowable result range defined by the user.
If a result is greater than the high limit of the reference range,” ^” will appear near the
result; if a result is less than the low limit of the reference range, “v” will appear near
the result. If a result is greater than the high limit of the critical range, “^!” will appear
near the result; if a result is less than the low limit of the critical range, “v!” will appear
near the result.
Test can be rerun with specified rerun type and priority based on its measurement
range, which is imported from the parameter file.
Prior to defining the reference/critical range, ensure that you have sufficient
permissions and the system status is not Running.
Defining/Editing reference/critical range/user-defined range

For each test, reference range, critical range and user-defined range, as well as rerun
type and priority can be set according to sample type, sex and age.
1 Select Setup > Tests > Reference Range.
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Reference/Critical Range Setup window
2 Choose a test from the Tests list.

3 Choose a sample type for the reference and critical range.
4 Choose patient sex for the reference and critical range.
5 Enter the age range in the Age Range field.
 Enter the age low limit in the first edit box.
 Enter the age high limit in the second edit box.
 Choose an age unit from year, month, day and hour.
6 Enter the reference range.
 Enter the reference range low limit in the first edit box.
 Enter the reference range high limit in the second edit box.
 The maximum input length is 8 digits.
7 Enter the critical range.
 Enter the critical range low limit in the first edit box.
 Enter the critical range high limit in the second edit box.
 The maximum input length is 8 digits
8 Enter the user defined range.
 Enter the user defined range low limit in the first edit box.
 Enter the user defined range high limit in the second edit box.
 The maximum input length is 8 digits.
9 Select OK.
To abort the input information, select Cancel.
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4 Setup
Setting up multi-line reference range

The multi-line reference range setup function allows multiple special reference ranges
to be set besides the measurement range. Tests with multi-line reference ranges
cannot be rerun automatically or flagged for abnormal results.
2 Choose a test from the Test list.
3 Choose a sample type for the multi-line reference range.
4 Choose patient sex for the multi-line reference range.
5 Enter the age range in the Age Range field.
6 Select Multi-Line Ref Range.
7 Enter the interval, Reference Range Upper Limit and Reference Range Lower Limit.
8 Select OK.
Deleting a reference/critical range/user defined range

2 Choose the test name, sample type, sex and age range.
3 Choose a reference/critical range you want to remove.
4 Select Delete.
5 Select Delete Selected Record or Delete All Records.
6 Select OK.
Import reference range

2 Click Import Ref Range.
3 Select Open File. Select a file in format of rf and click Open.
4 Choose tests from the list. You are allowed to select all tests.
5 Select OK.
Export reference range

2 Click .
3 Choose tests from the list. You are allowed to select all tests.
4 Select export path.
5 Select OK.
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4 Setup
Out of Range Result Flag

Define flags and color for results less than or greater than the reference range, as well
as color for results less than or greater than the critical range.
2 Select Out of Range Result Flag.
3 Set the flag and color.
The flags can be composed of numbers, letters and symbols for no more than 10 digits.
The default flags for reference range are "^" and "v". If a result is greater than the high
limit, "^" will appear near the result; if a result is less than the low limit, "v" will appear
near the result.
If test results are beyond the critical range, they will appear in the defined color.
4.1.20 Auto Rerun Setup

The system provides a couple of conditions for auto rerun. When selected conditions
are satisfied, tests for which auto rerun has been enabled will be rerun automatically
with the specified sample volume type.
Auto Rerun Setup-Abnormal Alarm Check

1 Select Setup > Tests > Auto Rerun or select Setup > Tests > Reference Range >
Auto Rerun Setup.
Auto rerun>Abnormal Alarm Check
2 Select Abnormal Alarm Check. Select biochemistry or ISE.

3 Define the rerun type for each alarm flag.
The rerun types include:
 Immediate rerun: After conditions are met, the test is rerun immediately. If the
rerun fails, the test is invalidated.
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4 Setup
 Immediate retrieval: Once the rack to be rerun reaches the buffer unit, it is
retrieved.
 Wait for a fixed time: Count the time when the sample rack returns to the buffer
unit, and try every 6s to see if the test conditions are satisfied. If yes, rerun the
sample. If the conditions are not satisfied, wait in the buffer unit and try
according to the period. If the requirement is not met after the defined waiting
time is reached, the test is invalidated. Set the fixed waiting time here.
 No rerun: Rerun is not executed
4 Select Enable. You can select Enable at the header to enable all rerun rules.
5 Select OK.
You can select Restore Defaults to restore the settings to the defaults.
Auto Rerun Setup-Result Alarm Check-Batch Setup

Auto Rerun Setup.
2 Select Result Alarm Check. Select a test and set the rerun rule and rerun type for
each result flag.
3 Select Reflex Test to set the test which will be rerun with the current test.
4 Select Auto Order or Auto Execute.
 Auto request: When the rerun conditions are satisfied, the rerun is requested
automatically.
 Auto Execution: When the rerun conditions are satisfied, the sample will be
rerun.
You can select the auto request and auto execution at the header to apply to all
results flags.
5 Select OK.
6 Select Enable Rerun Rules.
Auto Rerun Setup-Sample characteristic Check-Batch Setup

Auto Rerun Setup.
2 Select Sample Characteristic Check. Select a test and set the rerun rule and rerun
module for each result flag.
3 Select Auto Order or Auto Execute.
 Auto Request: When the rerun conditions are satisfied, the rerun is requested
automatically.
rerun.
results flags.
4 Select OK.
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4 Setup
Auto Rerun Setup-Range Check

It is used to set the rerun rules when results exceed the defined reference range, critical
range or user-defined range.
Auto Rerun Setup.
2 Select Range Check.
3 Select Biochemistry or ISE.
4 Select a test.
5 Set the rerun type and rerun module.
6 Select Reflex Test to choose a test to run together.
 Auto Request: When the rerun conditions are satisfied, the rerun is requested
automatically.
rerun.
results flags.
7 Select OK.
Auto Rerun Setup-Logic Relation Check

In clinical application, the results of different tests will be compared in certain way. The
comparison result should meet the logic requirement (e.g. the total bilirubin TBil should
not be smaller than the direct bilirubin DBil). Therefore, you can set whether to enable
and execute auto rerun rules according to the logic relationship.
1 Select Setup > Tests > Auto Rerun. Or choose Setup > Tests > Range Setup > Auto
Rerun.
2 Select logical relation check.
3 On the Logic Relationship Setup screen, set whether to enable and execute rerun
rules.
4 Select OK.
4.1.21 Serum Index

Serum index is the degree of lipemia, hemolysis and icterus contained in samples, and
used to check if these interferents will influence the sample results.
For more information about serum index, refer to 8.3 Serum Index (page 8-18).
4.1.22 Research Result Setup

This window is used to recall interference analysis of tests and to disable research
results.
1 Select Setup > Tests > Research Result Setup.
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4 Setup
Research Result Setup window
2 Choose a test in the list. The right part shows the number and percentage of
interference samples for each test.
3 Click Disable Research to disable research results. The test will not generate the
research results that optimized interference samples.
4.1.23 LIS Result Interception

This window is used to set whether to enable LIS result interception and define
interception rules. When the intercept function is enabled, the intercepted sample
results will not be sent to the LIS. Only Administrators and above can modify
interception rules.
1 Select Setup > Tests > LIS Result Interception.
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4 Setup
LIS Result Interception
2 Click Enable Interception. When the intercept function is enabled, the intercepted
sample results will not be sent to LIS.
3 Select the checkbox on the right of a test to enable the rule for the test.
Adding Interception Rules

Adding Interception Rules
1 Select Setup > Tests > LIS Result Interception > New.
2 Select the sample type to which the interception rule applies in pull-down list.
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4 Setup
3 Select the corresponding result flag in pull-down list and click Add to automatically
generate the interception formula.
Or edit formula directly. The supported relationship operators include: >, <, =, <>,
Contains, Excludes, AND, OR.
Interception rules support interception of result values and result flags.
 Result flag interception formula: For example, [result flag] Contains {PRO}
 [result flag]: Rule variable, enclosed by []
 Contains: Operator (The result flag interception formula only supports
Contains and Excludes.)
 {PRO}: Variable content, enclosed by { }
 Result value interception formula: For example, [result value] <0
 [result value]: Rule variable, enclosed by []
 <: Operator
 0: value
 Relationship operators can be used between formulas to support more
complex interception scenarios.
4 Select OK.
Editing Interception Rules

2 Select the interception rule to be edited and click Edit.
3 Select OK.
Deleting Interception Rules

2 Select the interception rule to be deleted and click Delete.
3 Select OK.
Importing Interception Rules

2 Click Import to import interception rules from the file.
3 Select OK.
Exporting Interception Rules

2 Click Export to export interception rules in .csv format.
3 Select OK.
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4 Setup
4.2 Sample Analysis Setup

4.2.1 Sample Order Settings
1 Select Setup > Analysis > Sample Order Settings.
2 Select the following parameters.
Default sample type
The system supports a couple of sample types: Serum, plasma, urine, CSF, whole blood,
pleural effusion and others. The default is serum. When the default sample type is set
up, it will be selected by default for ordering samples on the sample order screen.
Default sample cup type
The system supports the routine sample tube, EP tube 1.5mL, sample cup 0.5 mL-L,
sample cup 2.0 mL-L, sample cup 2 mL-H. The default is the Routine sample tube.
When the default sample cup type is set up, it will be selected by default for ordering
samples on the sample orders screen.
Sample Expiration Date
Sample Expiration Date refers to the time interval that a patient sample is first loaded
to the sample rack and then expired. When it is set, the system will allow analysis but
will check the valid period of the sample when the sample is tested. If Sample
Expiration Date is not set, the default is long-term validity.
The input range is 1-99, which can be hour or day. The default is day.
Sample Analysis Mode
Supports three sample analysis modes: Sequential mode, rack ID mode, and bar code
mode. Routine samples and STAT samples share the same analysis mode.
Before changing the analysis mode, make sure that the system status is Standby or
Stopped.
Set sample blank for each sample
When the function is enabled, the user is allowed to set up sample blank separately for
each sample during sample order and rerun; otherwise, the system shall decide
whether to apply the sample blank based on the test parameter settings.
Default STAT Sample ID
Set the default ID for STAT samples. The system default is 9001.
3 Select OK.
4.2.2 Rack Supply and Retrieval Settings

1 Select Setup > Analysis > Rack Supply and Retrieval Settings.
2 Select Priority for Outpatients. The outpatient samples will be handled first.
3 Select Rack Carrier for Outpatients. The outpatient samples will be placed into
this rack carrier to analyze.
4 Set Reserved STAT Grids.
5 Set Priority Retrieval Area.
6 Set Retrieve Abnormal sample.
7 Set Clear rack status of the retrieval area automatically.
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4 Setup
8 Select OK.
4.2.3 SI Index Settings

1 Select Setup > Analysis > SI Index Setup.
2 Select the following options.
Auto Serum Index
When the auto serum index function is enabled, the SI tests will be requested
automatically for serum or plasma samples or samples downloaded from the LIS. The
system will measure the concentration of hemolysis, icterus and lipemia contained in
the samples. If qualitative result flag is enabled on the serum index screen, the system
will flag the test result on the patient report.
Serum index is only used to check the integrity of a sample and not to make a diagnosis.
Smart Serum Index
When smart serum index is enabled and serum and plasma samples are ordered on
the sample screen or when samples are downloaded from the LIS host, smart request
of SI test without lowering analyzing speed will be enabled. The system determines
whether to request serum index based on the test parameters and reduces the
consumption of physiological saline, thereby increasing the throughput of SI tests.
3 Select OK.
4.2.4 Auto Release Sample

For details, please refer to 8.5 Release Sample Position(Page 8-22).
4.2.5 Inventory Alarm Limit Settings

When the reagent/consumable inventory is below the alarm limit, the system will give
an alarm.
1 Select Setup > Analysis >Inventory Alarm Limit Settings.
2 Select a module and then select reagent/consumable.
3 Enter Inventory Alarm Limit.
4 Select OK.
4.2.6 Customizing Patient Demographics

You can specify patient demographics to be displayed, its default and its display order
through the Patient Demographics screen.
Customizing Patient Demographics

1 Select Setup > Analysis > Patient Demographics.
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4 Setup
Patient Demographics window
2 Select the desired information and you can select at the header to select all.
3 Select Up, Down, Home and End button to adjust the displayed order of patient
demographics.
4 Select OK to save the settings or select Cancel to restore the previous settings.
5 Select Restore Default to restore to default settings.
4.2.7 Auto Backup

You can export sample data to external storage device.
1 Select Setup > Analysis > Auto Backup.
2 Select Auto backup to external storage device.
3 Select OK.
4.2.8 Sample Position Traceability Settings

This function is to facilitate the search of samples whose tests are completed.
1 Select Setup > Analysis > Sample traceability settings.
2 Select Display Sample Traceability.
3 Select OK.
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4 Setup
4.3 System Setup

This section summarizes the setup options on the System Setup screen as shown in
the figure below.
System Setup screen
4.3.1 Instrument Setup Options

1 Select Setup > System > Instrument Setup.
Instrument Configuration window
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4 Setup
Start Analysis When Temperature is Steady

The analyzer temperature can be monitored before analysis begins.
 When the Start Analysis When Temperature is Steady checkbox is selected, the
system will check before analysis begins if the temperature of the reaction
carousel, dispersion carousel and substrate is normal. If the temperature is normal,
you are allowed to select to start analysis; if the temperature is abnormal,

a message will appear indicating analysis is forbidden in current condition.
 When the Start Analysis When Temperature is Steady checkbox is not selected,
the system will still check before analysis begins if the temperature of the reaction
carousel, dispersion carousel and substrate is normal. If the temperature is normal,
you are allowed to select to start analysis; if the temperature is abnormal,

the system will prompt you that the results may be influenced if you continue to
start analysis. You may continue or abort the analysis.
Auto Sleep
Select sleep interval. The default is 60 minutes. You are allowed to enable/disable auto
sleep and set up the time interval for auto sleep. Select "No Sleep" and set the time
range.
Auto Awake
The Auto Awake option allows you to set up the auto awake date and time within one
week. Choose the weekday for auto awake, and then set up the auto awake time.
You are allowed to wake up the system any time within the week (from Monday to
Sunday). When the week and time is reached, the system will be woken up
automatically if it is sleeping.
Number of tests
Select this option to perform the special wash of sample probe during analysis. After
this option is selected, input the number of tests when the special wash of sample
probe is performed. The default is 500 tests.
ISE Periodic Prime
To ensure the activity of the ISE module, periodic prime is needed.
ISE prime cycle
For details of ISE primes setup, refer to 9.8 ISE Prime (page 9-20).
Optional Modules
Click this button to configure optional modules. You can configure an ISE module,
reagent barcode scanning, and set position for physiological saline. If Reagent
Barcode Scanning is not selected, when reagent carousel cover is closed, reagent
barcodes will not be scanned. If Set physiological saline for R2 Rgt Crsl is selected,
one position is reserved for physiological saline on R2 reagent carousel; otherwise, it
is used as a normal reagent position.
Ultrasonic cleaning within a batch of tests
If this option is selected, the ultrasonic cleaning will be started according to the number
of tests set for ultrasonic cleaning.
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4 Setup
4.3.2 LIS Settings

Refer to 10.2 LIS Communication(Page 10-3).
4.3.3 Sample Bar Code Reader

Refer to 8.1.2 Sample Bar Code Setup (Page 8-3).
4.3.4 Sample Rack Settings

Set the number of calibration racks, QC racks and rerun racks.
1 Select Setup > System > Sample Rack Settings.
2 Set the number of calibration racks, QC racks and rerun racks.
3 Select OK.
4.3.5 User Administration

Users can be defined, deleted or modified. The system allows up to 100 users to be
defined and belonged to two user groups: administrator and operator. Administrators
are allowed to assign permissions for operators.
NOTE
The default username and password for administrator is Admin. Please note that the
password is case sensitive. You are recommended to change the password when logging
on the system for the first time in order to prevent others from abusing the privileges of the
administrator.
If an operator forgets his password, he may ask the administrator to log on the system and
delete the username and then redefine a username; or he may contact our customer
service department or your local distributor. If the administrator forgets his password,
contact our customer service department or your local distributor.
Defining a User
Only administrators are allowed to define users. Up to 100 users are allowed, including
administrators. You should enter the username, password, confirm password and user
group when defining a user.
1 Select Setup > System > User Administration.
2 Select New.
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4 Setup
User and Password window
3 Enter the username.

4 Enter the password.
A maximum of 20 characters can be entered.
5 Enter the password again in the Confirm field.

6 Choose a user group in the User Group pull-down list.
 Administrator
 Operator
7 Select a doctor from Associated Doctor pull-down list.
When the user and the associated doctor have been set up, the default tester in
the patient demographics is the associated doctor of the current login user.
8 Select OK. The defined user appears in the user list.
Modifying a User
Only administrators are allowed to edit the user group of themselves and other users.
Username and password can only be modified by the user himself rather than anyone
else.
2 Choose a user to edit in the user list.
3 Select Modify.
4 Choose a user group in the User Group pull-down list.
 Administrator
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4 Setup
 Operator
5 Choose a doctor associated with the current login user.
6 Select OK.
Deleting a User
The username that has been used to log on the system currently cannot be deleted.
Only the administrators are allowed to delete users.
2 Choose a username in the user list.
3 Select Delete.
4 Select OK.
Resetting Password
2 Select current log-on user.
3 Select Reset Password. Enter the old password and reset a new one.
4 Select OK.
4.3.6 Auto Startup Settings

It is used to set the date and time when the analyzer will be started automatically.
1 Select Setup > System > Auto Startup Settings.
2 Set the date and time for auto startup.
3 Select OK.
4.3.7 Dictionary Setup

The Dictionary option is provided for setting up and managing frequent data
information. Sample comment can be entered manually or selected from the Comment
pull-down list on the Sample screen, Levey-Jennings screen, and (QC) Results screen.
Data options can be defined, edited or deleted in any system status. The default data
options cannot be deleted or edited.
Defining, Editing and Deleting Data Option

1 Select Setup > System > Dictionary.
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4 Setup
Dictionary window
2 Choose desired dictionary in the Data list.

To add a data option:
 Select New.
 Input the data name in the Data field.
 Input the symbolic character for the data.
 Input the data description.
 Select OK.
To modify a data option:
 Select desired data option in the data list.

 Modify the data name in the Data field.
 Input the symbolic character and data description.
 Select OK.
To delete a data option:
 Select desired data option in the data list.

 Select Delete.
3 Select Return.
4.3.8 Screen Saver Settings

1 Select Setup > System > Screen Saver Settings.
2 Set the time when the software displays screen saver.
3 Select OK.
4-48
4 Setup
4.3.9 Reagent Barcode Settings

Please refer to 5.3.2 Reagent Bar Code Setup(Page 5-7).
4.3.10 Print Setup

Results and data can be printed out with the specified template through the printer.
You are allowed not only to set up the printer type and auto print, but also define the
print order of tests.
General Print Setup Options

1 Select Setup > System > Print Setup.
Print setup screen
2 Select a report type from the report list on the left of the window.
3 Select a template from the template list.
4 Set up auto print options:
 Auto print patient reports
 Auto print QC reports
 Auto print calibration reports
 Print patient report after review
5 Choose a default printer to print reports.
6 Select OK.
Setting Up Default Template

2 Select a report type from the Report list on the left of the window.
4-49
4 Setup
4 Select Set Defaults to set the selected template in the template list as the default
one.
Deleting Template
4 Select Delete.
The selected template cannot be deleted if it is the default one or the print task exists.
Importing Template
2 Select Import.
Editing Template
4 Select Edit.
Defining Test Print Order

2 Select Print Order.
Print Order window
3 Use the following buttons to adjust the test print order:

4-50
4 Setup
4 Set up result print mode.

 To print results on patient report, select the corresponding Print checkbox.
 To forbid printing results on patient report, deselect the corresponding Print
checkbox or leave it unselected.
5 Select OK to save your settings.
4.3.11 Date and time

The Date and Time option allows you to set the current date and time, select the
date/time formats to be displayed on software screens and printed reports, and restore
default date and time formats.
When adjusted, the date and time will influence the time left of reagents and calibration,
shelf life of samples, and run length of two-control evaluation. The date and time
cannot be edited when the system status is Running. Modification of the date and time
will not affect samples on the Current screen or QC evaluation and Twin-Plot chart.
Follow this procedure to change system date and time:
1 Select Setup > System > Date/Time.
Date/Time window
2 Choose a date format from the Date Format pull-down list.

 yyyy-mm-dd: e.g. 2010-07-28
 dd-mm-yyyy: e.g. 28-07-2010
 mm-dd-yyyy: e.g. 07-28-2010
3 Choose a time format from the Time Format pull-down list.
 24-hour: e.g. 14:33:27
 12-hour: e.g. 02:33:27
4.3.12 Select Language

1 Select Setup > System > Select Language.
2 Select a language.
4-51
4 Setup
4.3.13 Remote Download Settings

1 Select Setup > System > Remote Download Settings.
2 Select the options according to your requirements.
3 Select OK.
4.3.14 Scanner Model Setup

1 Select Setup > System > Scanner Model Setup.
2 Select the model of the scanner.
3 Select OK.
4.3.15 Decapping Module Settings

1 Select Setup > System > Decapping Module Setting.
2 Select Enable Decapping, Enable serum image capture, Barcode Rotary
Alignment or Enable UV Lamp.
3 Select OK.
4.3.16 Test Alias

1 Select Setup > Tests > Test View and Setup.
2 Select a close a test.
3 Select Test Alias.
4 Set the alias for the test and click OK.
4-52
5 Reagents&Consumables
This chapter provides you with functions and operating instructions associated with
reagent.
5-1
5.1 View Reagents/Consumables

You can view reagent/consumable status via reagent overview/reagent
list/consumable status screen.
5.1.1 Reagent Overview

Select Reagent in the function button area of the main screen. The Reagent Overview
screen is displayed.
Reagent Overview
The screen displays reagent information of all on-board tests, including: test name,
module, tests available, and test requirements.
The reagents are displayed in four statuses.
 Sufficient: The background color of the test is not marked.
 Not sufficient for the day: The background of the test is marked purple.
 Low inventory: The background of the test is marked orange.
 Used up: The background of the test is marked red.
The consumables are displayed in three statuses.
 Sufficient: Turquoise.
 Below Inventory Alarm Limit: Orange.
 Used up: Red.
When a test has abnormal information, abnormal icon will be marked. Select the icon
on the test card to display the details of the abnormal information in a bubble.
Abnormal information includes prompts and warnings.
 Reagent prompt: Reagent mask
 Reagent warning: Reagent Disabled
 Calibration prompts: Calibration extended, calibration edited, calibration
recalculated, calibration about to expire, and calibration overridden.
5-2
 Calibration warnings: Calibration failed, calibration expired, calibration required,

or calibration not completed.
 Reagent Expiration Prompt: expired.
Smart sorting is enabled by default, and it is sorted in the following order:
Reagent used up → below inventory alarm limit → not sufficient for daily test →
sufficient.
The statuses are sequenced by test and then by module.
5.1.2 Reagent List

Select Reagent in the function button area of the main screen and then select Reagent
List.
The screen shows module options and all configured biochemistry reagents, including
the following information:
 Carousel: inner ring or outer ring of reagent carousels.
 Position: position of the reagent on the reagent carousel.
 Test: name of the test.
 Tests Available: It refers to the minimum tests left of R1, R2, R3 and R4. When the
number of tests left is 0, the test is still allowed for ordering and measurement.
 Reagent type: reagent type of a multi-reagent test. It includes R1, R2, R3 and R4.
 Tests left: It refers to the remaining tests of each reagent bottle.
 Exp Date: the difference of reagent expiration date and current date and the on-
board stability time, whichever the less. When a negative value is displayed, it
indicates that the reagent is expired and should be replaced immediately.
 Lot number: lot number of the reagent. It can be input manually during reagent
load.
 Serial number: serial number of reagent bottle.
 Calibration status: calibration status of the test, including, Cal Required,
Requested, Calibrated, Cal Failed, Cal Time Out, Cal Time Extended, Calculated,
Edited, Cal Overridden and N/A.
 Calibration Expiration: the time left when the calibration factors are expired. It will
be displayed only when the calibration status is Calibrated, Cal Time Out or Cal
Time Extended. When the time left is less than 30 minutes, the system displays a
message indicating calibration time out; when the calibration time is exceeded,
the calibration factors can no longer be used, and you are allowed to recalibrate
the test or extend the calibration time.
 Load date: the loading date of the reagent.
5.1.3 Consumable List

Select Reagent > R List > Consumables.
The screen displays all consumables information, load date, volume, status, days left,
and expiration date.
The screen is divided into two areas. The upper list displays consumable name, area,
inventory, load date, days left, expiration date, lot number, and serial number. The
function buttons area at the bottom is used to perform various operations.
5-3
5.1.4 Reagent Carousel

Select Reagent > Carousel. The screen displays the reagent status of each position of
the reagent carousel and the status of the consumables with the legend.
The status of each reagent position of the reagent carousel is displayed on the screen.
When a certain reagent position is selected, the reagent information, including the
tests left, test name, the reagent type and bottle type, is displayed on the right side of
the reagent carousel.
In the meantime, consumables on both the panel and the cabinet can be viewed
through the carousel screen.
Reagent Carousel
5-4
5.2 Reagent Requirements

5.2.1 Requirements Settings
Requirements setup is used to set the daily consumption of reagent. It can be set
based on the working day.
1 Select Reagent ˃ Overview or R List ˃ Requirement Calculation ˃ Requirement
Setting.
2 Enter the daily consumption amount for each test.
3 Tap + or – to batch adjust daily consumption limit.
4 Select Smart Statistics.
The system automatically refreshes the daily consumption of selected tests.
5.2.2 Reagent Requirement Forecast

You can forecast the reagent replenishing requirements on the reagent overview and
reagent list screen.
1 Select Reagent ˃ Overview or R List ˃ Requirement Calculation.
2 Select Requirements of current day or Requirements of next day to view the
required amount of reagent.
3 Select + or - to adjust the required reagent amount and the number of bottles to
be replaced.
4 Select Batch Adjust to enable batch adjustment of reagent requirements for the
current day or tomorrow.
5 Tab to print Requirement, and prepare reagents according to the printed

requirement table.
5-5
5.3 Reagent Bar Code Reader

The reagent bar code reader obtains reagent information from the bar code label.
When bar-coded reagents are loaded to the reagent carousel, the system will make a
full scan and obtain reagent information from the bar code labels.
Reagent bar code specifications

The reagent bar code reader is compatible with various application environments. The
code128 is selected by default with total bar code length of 13 digits. Users are allowed
to set up the symbology and bar code compositions for open reagents. Open reagents
are identified based on the symbology and bar code compositions defined by the user;
while closed reagents are identified based on those defined by the manufacturer.
Reagent bar code specifications
Name Description
Symbology Codabar, ITF, Code128, Code39, UPC/EAN, and
Code93
Minimum bar code density 0.25mm
Length 13-30 digits
Format and content User-defined
Maximum width 80mm (within the flat area of the reagent bottle's
back)
Minimum height 10mm
Maximum inclination angle ±5°
Print quality No less than Class C according to the ANSI MH10.8M
Print Quality Specification.
Width and narrowness 2.5-3.0:1
Print paper Coated paper or matte paper. Printing bar code on
common paper may result in vague bar code or
degraded bar code label. You are not suggested to
print bar code on common print paper.
Characters Numbers 0-9 are recommended. Use 1, 2, 3, and 4 for
reagent types R1, R2, R3, and R4; use 1, 3, 4 and 5 for
reagent bottle types 20ml, 40ml, 62ml and 70ml; use
4, 6 and 8 digits for expire date formats YYMM,
YYYYMM, and YYYYMMDD.
Information contained in a reagent bar code

The system will obtain the following information from a reagent bar code:
 Test number
 Test name
 Reagent type
 Bottle type
 Lot number
 Serial number
 Expiration date (YYMM)
The reagent information obtained from a bar code label cannot be modified.
5-6
5.3.2 Reagent Bar Code Setup

It is necessary to set up the reagent bar code symbologies, check digit and bar code
information before using the reagent bar code scanning. Only open-reagent bar code
needs to be set up.
1 Select Setup > System.
2 Choose Reagent Bar Code.
3 Select the Analyze Bar Code of Open Reagent checkbox to enable obtaining
reagent information from bar code.
4 Choose a bar code symbology and set up the check digit status.
The following symbologies are provided:
 Codabar
 Interleaved 2 of 5
 Code128
 Code39
 UPC/EAN
 Code93
Code 128, Code 93 and UPC/EAN requires a check digit by default, and other
symbologies are not compulsive. The Code 128 is selected by default and cannot
be modified.
CAUTION
You are recommended to enable the check function for all symbologies in order to
prevent misreading of bar code.
5 Define the total length of reagent bar code.

 Type in the total length of the reagent bar code in the Total field. The input
range is 13-30 digits. The Interleaved 2 of 5 only supports bar code of even
number length.
 Type in the start digit of the reagent bar code in the Start Digit field.
 Type in the end digit of the reagent bar code in the End Digit field.
6 Determine reagent bar code compositions.
 Type in the number of digits for reagent information in the Digits field.
 Type in the start digit of the reagent information in the Start Digit field.
 Type in the end digit of the reagent information in the End Digit field.
Reagent bar code compositions
Reagent Information Number of Digits

Test number 0-4 digits
Test name 0-10 digits
Reagent type 1 digit (“1” stands for R1, “2” for R2, “3” for R3,
and “4” for R4)
Serial number 0-5 digits
Bottle type 1-3 digits
5-7
Reagent Information Number of Digits

Lot number 0-18 digits
Expiration date 0, 4, 6 or 8 digits
7 Select OK.
5.3.3 Loading Bar-Coded Reagents

Both open reagents and closed reagents can be loaded through bar code scanning.
When loading bar-coded reagents, put them on the reagent carousel. The system will
scan all reagent positions automatically and obtain reagent information from the bar
code label. The information obtained from a reagent bar code can only be viewed and
cannot be edited.
The bar code scanning is only applied to biochemical reagents.
Refer to Auto load (page 3-16) for details.
5-8
5.4 Customizing Reagent Display

You are allowed to customize the reagent information on the reagent list screen.
2 Select the icon on the right.

3 Select checkbox of reagent information to display it on the reagent screen,
deselect checkbox to cancel the display.
4 Click Up, Down, Home and End to adjust the display order of reagent information
on the Biochemistry reagent screen.
5 You can select Restore Defaults to restore the settings.
5-9
5.5 Sorting Reagents

Reagents on the biochemistry reagent screen can be sorted by position, test, tests
available, type, tests left, reagent state, calibration expiration, calibration status and
expiration date. Click to sort reagents. Prior to loading reagents or running

calibrations, sort the reagents to display the desired ones in the front.
5.5.1 Smart Sort on Reagent Overview Screen

Reagent smart sort is enabled by default.
The rules of smart sort are as follows:
Reagent used up → below inventory alarm limit → not sufficient for daily test →
sufficient
The statuses are sequenced by test name and then by module.
5.5.2 Sorting Reagents on Reagent List Screen

2 Choose a sorting criterion, and then click on the corresponding list head to
rearrange the reagents.
To view or load reagents, choose the following standards:
 Reagent carousel
 Reagent position
 Test name
 Tests available
 Tests left
 Exp Date
To view calibration status or run calibrations, choose the following standard:
 Calibration expiration
 Calibration status
5-10
5.6 Masking/Unmasking Reagent

1 Select Reagent > R List.
2 Select a reagent you want to mask.
3 Select Mask.
4 Select Mask Sample or Mask Test.
 Mask Sample: The masked reagent cannot be used for sample analysis.
 Mask Reagent: The masked reagent cannot be used for sample, QC and
calibration test.
To unmask the reagent, select it and then select Unmask. The masked reagent is
displayed with icon .
5-11
5.7 Reagent Inventory Check

5.7.1 Introduction
The system provides the manual and auto check of inventory of biochemical reagents.
After reagents are loaded, it is necessary to perform the inventory check in order to
ensure that sufficient reagents are available for analysis. During the test, the system
automatically checks the reagent inventory and displays it on the Reagent screen.
Reagent inventory check is allowed only when the system status is Incubation or
Standby. While the system is checking reagent inventory, loading or unloading reagents
on the current module is not permitted, and the Utility button is disabled.
5.7.2 Checking Reagent Inventory

2 Choose a module to check reagent inventory.
3 Select Inv’t Check.
Inventory Check window
4 Choose reagent positions:

 Following position(s): check the reagents on specified positions. Enter
reagent positions and separate them with a comma. Enter single reagent
positions like 1, 2, 3, or position range like 2-15, 20-25.
 All positions: check all reagent positions on the two reagent carousels.
 All reagents of selected test: check the inventory of all reagent types of the
selected test.
5 Select Check.
5-12
5.8 Printing Reagent Information

When viewing reagent/calibration information or the reagent carousel status, you are
allowed to print by test or by position all reagents or those with remaining tests less
than the alarm limit or equal to 0.
1 Select Reagent > Overview, or select Reagent > R List.
2 Choose a module to view reagent/calibration information or reagent carousel
status.
3 Select Requirements Calculation.
4 Click the print button .

5 Select OK.
5.8.1 Printing Reagent list and Reagent Use Record

2 Click the print button .

3 Select Reagent list or Reagent Enabled Record Table.
4 Select OK.
5-13
5.9 On-line Load of Reagents

5.9.1 Introduction
The on-line load of reagents is performed while the system is running tests. Before
starting an on-line load, request for reagent load, do not load reagents until all started
tests are finished for reagent dispensing. If the system is running calibrations, STAT
samples or diluted samples, you are not allowed to start loading reagents unless all
tests finish reagents dispensing.
WARNING
BIOHAZARD
may be caused.
5.9.2 On-line Load of Reagents

2 Choose a module to load reagents.
3 Select Reagent Stop to request for reagent load.
Rack transfer is stopped automatically, the system status area shows a
countdown for reagent load, and a message box will be displayed when the
countdown is finished.
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise,
the tests currently run will be invalidated.
4 To load non-bar-coded reagents, select OK and then Load, and remove the reagent
carousel cover; to load bar-coded reagents, just remove the reagent carousel cover.
5 Place R1 and R3 on the first reagent carousel, and R2 and R4 on the second.
 For load of non-bar-coded reagents, enter the reagent information on the Load
Reagent window.
 For load of bar-coded reagents, the system scans all reagent positions
automatically and read reagent information from the bar code.
Select the icon to resume the test or start new test.
5-14
5.10 Off-line Load of Reagents

5.10.1 Introduction
The off-line load of reagents is performed while the system is not running any tests.
You are allowed to directly place the reagents on the reagent carousels.
WARNING
BIOHAZARD
may be caused.
5.10.2 Off-line Load of Reagents

2 Place R1 and R3 on the first reagent carousel, and R2 and R4 on the second.
Reagent window.
 For load of bar-coded reagents, when the measurement is started next time,
the system scans all reagent positions automatically and read reagent
information from the bar code.
5-15
5.11 On-Line Replacement of Reagents

5.11.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while the system is
running tests, you should request for reagent stop and replace the reagent immediately
to ensure that the following measurements will be done smoothly.
5.11.2 On-Line Replacement of Reagents

1 Select Reagent > Overview or R List.
2 Choose a module to replace reagents.
3 Confirm the reagent to be replaced and select the reagent position.
4 Select Reagent Stop to request for reagent load.
Rack transfer is stopped automatically, the system status area shows a
countdown for reagent load, and a message box will be displayed when the
countdown is finished.
CAUTION
Do not open the reagent carousel cover before the countdown is finished; otherwise,
the tests currently run will be invalidated.
5 To load non-bar-coded reagents, select OK and then Load, and remove the reagent
carousel cover; to load bar-coded reagents, just remove the reagent carousel cover.
6 Remove the reagent.
7 Place the new reagent.
NOTE

Reagent window.
 For load of bar-coded reagents, the system scans all reagent positions
automatically and read reagent information from the bar code.
Select the icon to resume the test or start new test.
5-16
5.12 Off-Line Replacement of Reagents

5.12.1 Introduction
When a reagent is insufficient or exhausted or going to be expired while the system is
not running any tests, you should replace the reagent immediately to ensure that the
following measurements will be done smoothly.
5.12.2 Off-line Replacement of Reagents

2 Remove the reagent.
3 Place the new reagent.
NOTE

Reagent window.
 For load of bar-coded reagents, when the measurement is started next time,
the system scans all reagent positions automatically and read reagent
information from the bar code.
5-17
5.13 Unloading Reagents

5.13.1 Introduction
If some tests will not be used, you are allowed to clear the test parameters and unload
the relevant reagents. The Unload option is also used to remove reagents that are going
to be exchanged. Only biochemical reagents can be unloaded.
When a test is requested for quality control, sample analysis or calibration, all reagents
of the test still can be unloaded.
When a reagent is unloaded, all relevant information and its position are cleared. The
reagents that are being used for analysis cannot be unloaded.
5.13.2 Unloading Biochemical Reagents

The following procedures are only applicable to unloading the reagents without bar
code; for those reagents with barcode, when the reagents are taken away from the
reagent carousel, they are unloaded automatically.
1 Make sure that the reagent to be unloaded is not being used for analysis.
3 Choose a module to unload reagents.
4 Select the reagent position to unload reagent.
5 Select Load.
6 Select Unload.
8 Take out the reagent from the reagent carousel.
5-18
6 Calibration
This chapter describes functions and operation instructions associated with

calibration, which include:
 Calibration status and alarm indication
 Calibration Settings
 Calibrator dilution setup
 Reagent blank
 Auto calibration
 Extending calibration time
 Overriding a calibration
 Rejecting a calibration
 Calibration results recall
6-1
6 Calibration
6.1 Overview
In a calibration, the system measures the response of the calibrator with given
concentration, and then calculates the factors in the concentration-response equation.
In this way, a math equation about concentration and response is determined. The
concentration of a patient sample can be calculated based on the math equation and
the measured sample response.
When the calibration status is abnormal, the system will give an alarm and display the
calibration status with specific color. The system allows multiple concentrations of a
calibrator for multi-point calibration. The calibration factors can be adjusted through a
reagent blank test. When you set up the auto calibration conditions, the system will
automatically remind you of calibrating tests. Expired calibration factors can be used
again by extending the calibration time. You are allowed to override a failed calibration
and obtain results based on the failed calibration factors. Current calibration factors
can be rejected and the latest valid ones are used to calculate sample results.
6-2
6 Calibration
6.2 Calibration Setup

Perform calibration settings in the following order:
 Define/Edit a calibrator
 Set up calibrator concentrations
 Set up calibration rules
 Set up calibrator acceptance limits
You are allowed to add, edit and delete calibrators only when the system status is not
Running.
6.2.1 Defining a Calibrator

The system allows the definition of up to 99 calibrators. You are required to input the
name and position for each defined calibrator.
1 Select Cal > Cal Setup.
2 Select Add Calibrator.
Calibrator Definition window
3 Select Scan Barcode or Add Manually. The calibrator information can be imported
automatically through scanning barcode.
4 If you select manual, enter the expiration date of the calibrator. The default is the
current day in the next year.
Calibrators beyond the expiration date cannot be used.
5 Enter the lot number.

The input range is 0-18 and accepts numbers and letters. Calibrators with the
same name must not have the same lot number.
6 Select Number of Concentrations and then select tests.

7 Select Submit.
6-3
6 Calibration
6.2.2 Editing a Calibrator

You are allowed to edit calibrators only when the system is not running any tests. It is
used for reagent blank measurement and cannot be edited or deleted. WATER can be
also placed on any position on a rack, and the WATER on a rack can be modified or
deleted.
2 Choose a calibrator to edit.
3 Edit the following calibrator information in the popup dialog box:
 Calibrator name
 Expiration date
 Lot number
 Rack number and positon
 Barcode
 Concentration
4 Select Submit to save your input information.
6.2.3 Setting up Calibrator Concentrations

You are required to set up calibrator concentrations for each test after defining the
calibrator. A calibrator should be defined with the same concentration for a test on
each analyzer. Only the calibrator with positions assigned and concentrations
determined can be used for ordering. You are allowed to change the calibrator
concentrations when the system is not running any tests.
The default calibrator WATER has concentration of 0 for all tests. It has no lot number
and expiration date and must not be edited or removed.
2 Choose a calibrator.
3 Set up the rack number and position for the calibrator.
Calibrator concentration setup screen
6-4
6 Calibration
4 Choose tests in the right list to which the calibrator is applicable, and then select
the corresponding Conc column and type in the calibrator concentration for it.
The concentration must be above 0.
5 Select Submit to save your input information.

A message box pops up indicating that parameters are changed and calibration is
required.
6.2.4 Setting up Calibration Rules

After setting up calibrator and concentration, you need to set up the calibration rules
for the test. You are allowed to set up or modify the calibration rules, replicates, K factor
and auto calibration conditions only when the system is not running any tests.
2 Select Test View and Setup.
3 Select New or select a test and click View and Edit.
4 Select Calibration Parameters > Calibration Rules.
 K factor
 Two-point linear
 multi-point linear
 Logistic-Log 4P
 Logistic-Log 5P
 Exponential 5P
 Polynomial 5P
 Parabola
 Spline
 Logistic-Log 3P
 Polygon
5 If K factor is selected, enter the factor.
This field is activated only when the one-point linear calibration rule is selected.
When the K factor is input, the calibration results will be calculated with Y=K*X.
Where, Y is calibration result, K is factor, and X is response.
6 Select replicates from the Replicates pull-down list.

The options include 1-5, and the default is 1.
7 Click Submit to save the settings.
6-5
6 Calibration
6.2.5 Calibrator Management

Deleting a Calibrator
You are allowed to remove the calibrators other than WATER. If a calibrator is
configured on more than one analyzer, only that on the selected analyzer will be deleted.
When a calibrator is deleted, all calibration settings and its position are cleared, and it
cannot be used for ordering. The stored test results of the calibrator can be recalled
according to the test name. only calibrators that are not requested or run can be
deleted.
2 Select Manage Cal.
3 Choose a calibrator you want to remove.
4 Select Delete. The selected calibrator is deleted.
Activate and Deactivate Calibrator

The newly imported calibrators are enabled by default. When the old lot of calibrators
is not used up, a new lot of calibrators are entered in advance, and the old lot of
calibrators can be used again by activating them. You are allowed not to display the
disabled or used-up calibrators on the calibrator setup screen.
2 Select Manage Cal.
3 Select a calibrator from the calibrator list.
4 Select Activate or Deactivate.
5 Select OK.
6-6
6 Calibration
6.3 Calibrator Dilution Setup

6.3.1 Introduction
The system supports calibrator dilution and allows one calibrator to have 9
concentrations for the same test. You are only required to enter the final concentration
of the diluted calibrator and the diluted calibrator volume aspirated by the sample
probe during calibration. The system will automatically calculate the diluent volume
and the sample volume for diluting. When you set up the dilution factors for a test, its
original calibrator concentration will be removed.
Diluted calibrator is only applied to Biochemical tests rather than ISE tests.
You are allowed to edit or delete the calibrator dilution factors when the system is not
running any tests.
6.3.2 Setting up Calibrator Dilution Factors

2 Choose a calibrator and a test.
3 Select Dil. Setup.
Calibrator Dilution Setup window
4 Enter the final concentration of the diluted calibrator in the Conc field.
5 Enter the calibrator volume used for diluting in the Neat Vol field.
The input must be an integer multiple of 0.1 within 1.5μL-25μL. This field can be
left blank.
6 Enter the diluent volume used for diluting in the Diluent Vol field.
The input must be an integer multiple of 0.5 within 75μL-200μL. This field can be
left blank.
NOTE
If the neat sample volume and diluent volume are defined, ensure that the sum of the
two volumes is within 100μL-280μL.
The two volumes must be defined or left blank simultaneously.
6-7
6 Calibration
7 Enter the calibrator volume dispensed by the sample probe during calibration in
the Aspirated Vol field.
The input must be an integer multiple of 0.1 within 1.5μL-25μL. This field is
required.
8 Select OK.
6.3.3 Editing Calibrator Dilution Factors

2 Choose a calibrator and a test.
3 Select Dil. Setup.
4 Change the concentration, sample volume, neat sample volume and diluent
volume.
NOTE
If the neat sample volume and diluent volume are defined, ensure that the sum of the
two volumes is within 100μL-280μL.
The two volumes must be defined or left blank simultaneously.
5 Select OK.
6-8
6 Calibration
6.4 Calibration Status

On the calibration Overview screen, the calibration statuses are displayed on small
cards and indicated with various texts and colors e.g. Tests in Cal Required, Cal Failed
or Cal Time Out status can be requested but will not be run.
Smart Sort is enabled by default for calibration statuses. The sorting rules are as
follows:
Calibration Failed - > Cal Time Out - > About to expire - > Cal Required - > Requested - >
In Progress - > Overwritten - > Extended - > Edit - > Recalculate - > Calculated.
When smart sorting is not enabled, the sorting rules are as follows:
1. Test display order. 2. Module. 3. Reagent carousels sorted from outer to inner 4.
Reagent groups sorted in ascending order of priority.
The calibration status of each test is indicated by different texts and colors. Tests in
Cal Required, Cal Failed or Cal Timed Out status can be requested but will not be run.
Check the tests’ calibration status frequently and take relevant actions according to
the following table.
Calibration statuses
Calibration Description Color

Status
Cal Required Indicates that the test needs to be calibrated. Red
This status appears when the test is not calibrated; or
auto calibration conditions are satisfied; or calibration
information or test parameters are modified.
Requested Indicates that the test has been requested for No color
calibration but the test has not begun. The calibration indication
completion time will be displayed, accurate to minute.
Calibrated Indicates that the test has been calibrated and has not No color
exceeded the calibration period. indication
If successful calibration by lot is performed, Calibrated
(lot) is displayed. If Successful calibration by bottle is
performed, Calibrated (bottle) is displayed.
The calibration time left is displayed. For instance "1d"
is displayed, it indicates "1 day left"before expiration.
Cal Failed Indicates that the test has finished but cannot calculate Red
the final result, or the calculated result exceeds the
acceptance limits, or calibration is requested but
without results due to test error.
Cal Time Out Appears when the test exceeds the calibration period. Red
The calibration time left is displayed. For instance "-1d"
is displayed, it indicates that "1 day "exceeds the
expiration date.
Cal Time Indicates that the calibration period has been extended Orange
Extended and the current calibration factors can be used without
time limit.
About to Indicates calibration factors are about to expire. Orange
Expire
Cal Indicates that the test results of the test are based on a orange
Overridden failed calibration, and flagged accordingly.
6-9
6 Calibration
6.5 Calibration
Running calibration is to calculate calibration factors for sample result calculation.
Generally, calibration is recommended when one of the following conditions occurs:
 A new test is configured.
 QC alarms are given while the reagent, calibrator and control sample are within the
expiration date.
 Reagent lot or bottle is changed.
 The calibration factors of a test are expired.
 The ISE electrodes are adjusted or the ISE module is maintained.
 The calibration rules are changed, such as calibration method, replicates,
concentration and calibrator.
 The test parameters are changed, such as primary wavelength, secondary
wavelength, blank time, reaction time, reagent volume (R1/R2/R3/R4), sample
volume, sample dilution parameters, reaction type, reaction direction, sample
blank and result unit.
 The lamp, syringe or sample probe is replaced.
If any of the following test parameters are changed, a calibration is required:
 Primary wavelength
 Secondary wavelength
 Blank time
 Reaction time
 Reagent volume(R1/R2/R3/R4)
 Standard sample volume, diluting sample volume and diluent volume
 Reaction type
 Sample type
 Reaction direction
 Sample blank and result unit
 Twin test
6.5.1 Requesting Calibrations

Calibration request via Cal Status screen
When one of the above-mentioned conditions is happened, request a calibration
according to the steps stated below.
Before requesting a calibration, make sure that the calibrator has been loaded to
correct position.
1 Select Cal > Overview.
6-10
6 Calibration
Calibration Overview

“ALL” means all configured analyzers, and M1~M2 means relevant analyzer.
3 Select tests you want to calibrate.

4 Select Order Cal.
 Full
 Reagent blank
6 Select OK.
interrupted.
If you want to calibrate by bottle, select Bottle Cal.
Calibration Request via Reagent List Screen

3 Choose the test you want to request calibration.

 Full
 Reagent blank
6 Select OK.
6-11
6 Calibration

interrupted.
If you want to calibrate by bottle, select Bottle Cal.
Cancelling Calibration
If you do not want to start a calibration after requesting a calibration, you are allowed
to cancel the calibration request. If the calibration test has started, but the sample rack
for which the calibration is requested has not entered the track, or the calibration test
is stopped in the midway (after the emergency stop button is clicked or the instrument
is stopped due to an error), you are allowed to cancel the calibration request. The
calibration status is restored to the status before the request.
6.5.2 Loading Calibrators
BIOHAZARD
Inappropriate handling of calibrators may lead to biohazardous infection. Do not touch the
calibrators directly with your hands. Wear gloves and lab coat, if necessary, goggles and a
mask. In case your skin contacts the calibrators, follow standard laboratory safety
procedure and consult a doctor.
CAUTION
Do not use expired calibrators; otherwise, unreliable test results may be caused.

3 Select Load List.
The calibrator list shows all requested tests as well as calibrators, positions,
concentration, lot number and expiration date.
4 Select Print button.

5 Load calibrators according to the calibrator list.
 Load calibrators to an orange rack, and then put the rack in the rack supply
unit. Ensure that calibrators are loaded to the correct positions.
6-12
6 Calibration
6.5.3 Running Calibrations

After requesting calibrations and load calibrators to the sample rack you can start the
calibration test.

Start Conditions window – Rack ID mode or bar code mode
Start Conditions window – Sequential mode
6-13
6 Calibration
6.6 Reagent Blank

In a reagent blank test, the reagents react with the physiological saline or a calibrator
with concentration of 0, and then the blank absorbance is calculated. When a reagent
is uncapped for a long period, the reagent absorbance may be changed. At this time,
you are allowed to run a reagent blank instead of calibration to calculate the reagent
blank absorbance, which will be used to adjust the calibration factors of the reagent in
order to ensure reliable sample results.
The reagent blank is allowed only in the following calibration status: Calibrated which
means the calibration is successfully performed. Reagent blank is applied to
Biochemical tests only.
If the reagent blank results, including the mixed blank absorbance and blank response,
are within the acceptance range, the system will update the calibration factors and the
remaining calibration time based on the results. If the results exceed the acceptant
limits, the system will give an alarm and remind you to rerun the reagent blank. The
Biochemistry Calibration screen shows the calculated reagent blank response,
absorbance and run date.
6.6.1 Mixed Blank Absorbance and Blank Response

When defining a test, you need to set up the mixed blank absorbance and blank
response to check the reagent blank results.
The mixed blank absorbance indicates the allowable range of the absorbance
measured at the end point of a zero-concentration calibrator reaction or a reagent
blank reaction. If the absorbance measured at the reaction end point is beyond the set
range, the system will flag the test result.
The blank response specifies the allowable range of the response in a zero-
concentration calibrator analysis or a reagent blank test. If the response is beyond the
set range, the system will flag the test result.
2 Choose a biochemical test, or enter the test name in the Test Name field.
3 Select View.
4 Select Check Parameters and then click Edit.
5 Enter the mixed blank absorbance range in the Mixed Blank Abs field.
6 Enter the blank response range in the Blank Response field.
7 Select Submit.
6.6.2 Requesting a Reagent Blank

Please note that reagent blank can only be run in following conditions:
 Tests with all calibration math models rather than two-point linear and K factor
must have the 0-concentration calibrator set up.
 K factor tests must have calibrators set up.
The reagent blank is allowed only in Calibrated calibration status.
1 Select Reagent > R List, and select Reagent.
2 Choose a module to request reagent blank test.
3 Check if the desired tests’ calibration status is Calibrated.
4 Choose the tests.
6-14
6 Calibration
5 Select Request Cal.

6 Choose Rgt Blk.
7 Select OK.
8 Select the icon to start the analysis.
6.6.3 Recalling Reagent Blank Results

If the reagent blank results are within the acceptance limit range, they will be used to
update the current calibration parameters. You are allowed to recall the reagent blank
response, absorbance and run date on the Biochemistry Calibration screen.
Calibration curve of reagent blank cannot be recalled.
Recalling reagent blank response

1 Select Reagent > Cal Result.
2 Select a module.
3 Choose a test.
4 Select View Details.
The calibration results and reagent blank results of the test are displayed in the
result list.
5 Choose a calibration result.

6 Click Cal Curve or click Trend , select the data tab, and then highlight a calibration
data record.
7 Select Reac Curve.
The response value current displayed is the updated reagent blank response.
8 Select the reaction data table to view the reagent blank reaction data.
 Print: to print the current reaction curve or data.
Recalling reagent blank trends

1 Select Cal > Cal Result.
2 Choose a module.
3 Choose a test.
4 Select View Details.
result list.
5 Choose a calibration result.

6 Select Trend.
7 Choose a trend type you want to recall.
 R1 blank absorbance
 Mixed blank absorbance
 Response of WATER
6-15
6 Calibration
 Calibrator response
 K factor (for linear calibrations only)
8 Click icon and select the calibration time range.

9 Select OK.
The graphical trend of the selected test within the specific period is displayed.
10 Click or to zoom in or out the trend plot.

11 Select Return.
6-16
6 Calibration
6.7 Auto Calibration

Based on the auto calibration conditions, the system can determine tests that need to
be calibrated and remind you through calibration status and color indication. Auto
calibration conditions include:
 Calibration factors’ validity period
 Reagent lot changed
 Reagent bottle changed
For open tests, when the lot number or serial number of R1, R2, R3 or R4 is changed,
calibration is required. If no lot number or serial number is set for open reagents, the
tests will not be calibrated automatically even though the conditions are met. When
the calibration time is exceeded, the system will remind you of running calibrations.
For closed tests, calibration will be run automatically when reagent lot number is
changed.
6.7.1 Auto Calibration Setup

2 Select a test.
3 Select View. Select Calibration Parameters and then select Edit.
4 Choose auto calibration conditions:
 Bottle changed: The system will remind you to run a calibration when you use
a different bottle of reagents.
 Lot changed: The system will remind you to run a calibration when you use
reagents of a different lot.
 Calibration time: The system will remind you in 30 minutes before the
calibration is timed out and display the test’s calibration status with yellow.
5 Select Submit.
6.7.2 Auto Calibration Reminder

When the auto calibration conditions are satisfied, the system will remind you through
the calibration status, prompt message and alarm color.
 If you choose the Calibration Time option, the system will remind you in 30 min
before the calibration is timed out and mark the test name with yellow.
 If you choose the option of Lot Changed, the system will prompt you to run a
calibration if you use reagent of a different lot.
 If you choose Bottle Changed and use a reagent without the current calibration
factors, the system will prompt you to run a calibration for it.
6.7.3 Removing Auto Calibration

To disable the auto calibration, perform the following steps:
1 Deselect all auto calibration conditions on the Calibration Parameters window.
2 Select Submit.
6-17
6 Calibration
6.8 Extending Calibration Time

Calibration factors that exceed the calibration period cannot be used for result
calculation. The calibration status becomes Cal Time Out and the test can no longer
be run. The system will display a warning message in 30 minutes before the calibration
is timed out, and you are allowed to recalibrate the test or extend its calibration time.
If you are certain that the calibration factors are correct and valid, you may prolong
their validity period by using the calibration time extension function. A calibration time
can be extended only if the current calibration of the test is timed out or succeeded.
The results calculated based on extended calibration factors will be flagged with "EXT".
6.8.1 Extending Calibration Time

2 Choose a test you want to extend.
3 Select Extended.
4 Select OK. The calibration factors of the selected test can be used without time
limit.
6.8.2 Removing an Extended Status

Calibration extension is not absolutely definite. Recalibrate the test to remove the
extended status.
6-18
6 Calibration
6.9 Calibration Override

The Calibration Override option allows the system to override a failed calibration and
calculate results based on the failed calibration factors. Calibration override is only
applied to failed calibrations. Results that are obtained based on failed calibration
factors will be flagged with "OVE".
CAUTION
Before overriding a calibration, make sure that the calibration factors are within the
acceptance limits of your laboratory. The magnitude of the error should be totally under the
control of your laboratory. Use of overridden calibration factors may lead to unreliable
results and influence the clinical diagnosis. Think twice before overriding a failed
calibration.
6.9.1 Overriding a Calibration

2 Choose a test you want to override.
3 Select Override.
4 Select OK. The failed calibration factors of the selected test can be used for result
calculation.
6.9.2 Removing Cal Overridden Status

Recalibrate the test to remove its Cal Overridden status.
6-19
6 Calibration
6.10 Reject
If the current calibration fails but sample analysis needs to be performed immediately,
you may use the Reject function to reject the current calibration factors, and use the
latest valid ones for calculating sample results, which will be flagged with "CALJ".
Calibration factors of status other than Requested and Cal Required can be rejected.
Rejected calibration factors cannot be rejected again.
6.10.1 Rejecting a Calibration

2 Choose a test you want to reject.
3 Select Reject.
4 Select OK. Calibration factors of the selected test are rejected.
6.10.2 Removing Reject Status

Recalibrate the test to remove its Reject status.
6-20
6 Calibration
6.11 Recalling Calibration Results

On the Calibration Results screen you are enabled to recall the current and stored
calibration factors of a test. Click View Details to recall the calibration curve, calibration
reaction curve and calibration trends during the specified period, and edit or
recalculate the calibration factors.
6.11.1 Recalling Calibration Results

2 Choose a module. You can click the filter icon to search for results within a
certain period.
The screen shows all the calibrations requested on the day, including the following
information:
 Reagent carousel
 Test name
 Result flag
 Calibration status
 Calibration date and time
 Calibrator Lot No.
 Reagent Lot No.
 Reagent Serial No.
 Math model
 M/T (M and T flags are used to indicate which parameter type the calibration
results are based on; M stands for ml and T stands for test.)
6.11.2 Calibration Curve

A calibration curve reflects the mathematical relation between calibrator concentration
and response. It is drawn based on the obtained response and the multiple values
between the minimum and maximum concentrations of the calibrator. The calibration
curve is a straight line in linear calibrations and a curve in nonlinear calibrations.
K-factor, edited or reagent-blanked calibration factors have no calibration curve to
recall.
1 Search for desired calibration results on the Calibration Results screen.
2 Choose a test in the result list.
3 Select View Details. The Calibration Result/Calibration Data window is displayed.
4 Select Calibration Curve.
6-21
6 Calibration
Calibration Curve window

 Reaction Curve : to view the calibration curve and data of the test.
 : to view the calibration curve of the previous test.
 : to view the calibration curve of the next test.

 Recalculate : to recalculate the calibration factors based on the specified
math model.
 : to print the current calibration curve.

6 Select Return.
Recalculating calibration factors

Calibration results in Calibrated, Cal Failed, Cal Time Out, Extended, or Overridden
status can be recalculated based on the existing factors, a new math model and
calibrators. The flag "CALR" indicating that the calibration result is recalculated will
appear on the Calibration Result screen.
Recalculating calibration factors is not applicable to K factor calibrations. Calibration
factors that have been recalculated cannot be calculated again.
1 Enter Calibration Results screen.
4 Select Calibration Curve.
5 Select Recalculate. The Recalculate window shows.
6-22
6 Calibration
Recalculate window
6 Choose a math model.

The corresponding calculation formula is displayed in the text box to the right of
the Math Model field.
7 Choose calibrators to recalculate in the left list. Move the scroll bar to view more
calibrators.
Choose the correct number of calibrators corresponding to the math model. For
more information, refer to 0Setting up Calibration Rules (page 6-5).
8 Select Confirm.
The system will recalculate the calibration factors with the selected math model
and calibrators.
 If the recalculation succeeds, the new calibration factors will be displayed on

the Calibration Results screen with the calibration status shown as
Recalculated, and “CALR” will appear in the corresponding Flag column.
 If the recalculation fails, the system will show a message box indicating the
old calibration factors will remain to be used.
6.11.3 Calibration Reaction Curve

A calibration reaction curve reflects the relationship of the absorbance measured at
the primary wavelength, secondary wavelength and primary-secondary wavelength. It
is drawn based on the absorbance of the calibrator-reagent mixture measured within
the reaction period.
Observing reaction curve:
1 Search for desired calibration results on the Calibration Results screen.
6-23
6 Calibration
Reaction Curve window
4 Select Reaction Curve.

5 Select a calibrator to view from calibrator drop-down box.
6 Select a point on the curve. Relevant measuring period and absorbance are
displayed on the right of the window.
7 The following options allow you to view the reaction curve in different ways:
 "All Curves" checkbox: Select this checkbox to display the calibration curves of
multiple replicates. If this option is not selected, only one calibration reaction
curve will be displayed.
 The Pri Wave, Sec Wave, and Pri-Sec checkboxes are selected by default, and
the reaction curves of Pri-Sec, Sec, and Pri-Sec wavelengths are all displayed.
When the checkbox of a certain wavelength is deselected, the curve of that
wavelength is not displayed.
8 Choose the Reaction Data tab to view the reaction data.
 Sample Blank : Turn on the switch to view the sample blank

reaction curve and reaction data of the calibrator.
 Adjust : Turn on the switch to adjust the absorbance display range

of current reaction curve. Refer to 8.8.6 Reaction Curve (Page 8-28) for details.
 : to view reaction curve and data of the previous calibration test.
 : to view reaction curve and data of the next calibration test.

6-24
6 Calibration
6.11.4 Archiving Calibration Results

The system allows you to archive all searched calibration results to a storage device,
such as U disk, floppy disk, etc. Archived calibration results are displayed in the same
format as on the software screen. The archiving file is of .csv format and named by
date and time.
2 Search for desired calibration results.
3 Select Archive button .

4 Confirm the archiving path and file name.
5 Select OK.
6.11.5 Calibration Trends

Calibration graphical trends summarize a test’s calibrations during a period of time
and reflect the trends of the calibrations. The calibration graphical trends show the
test’s R1 blank absorbance, mixed blank absorbance, and calibrator response.
R1 blank absorbance and mixed blank absorbance are available only for tests with 0-
concentration calibrators. The K factor trends can be recalled for linear tests.
Follow this procedure to observe calibration trends:
2 Choose a module.
3 Choose a test.
4 Select Calibration Data.
result list.
5 Select Trend.
6 Choose a trend type you want to recall.
 R1 blank absorbance
 Mixed blank absorbance
 Response of WATER
 Calibrator response
 K factor (for linear calibrations only)
7 Click icon and select the calibration time range.

8 Select OK.
The graphical trend of the selected test within the specific period is displayed. You
can view the calibration data on the right side of the screen.
9 Click or to zoom in or out the trend plot. Click Zoom button to

view calibration details such as calibration date, calibrator name, and
concentration.
6-25
6 Calibration
Calibration Trends window
10 Select Return to close the window.
6-26
Operator’s Manual
Contents
Intellectual Property Statement ............................................................................................................ ii

Responsibility on the Manufacturer Party ........................................................................................... iii
Warranty ................................................................................................................................................ iv
Exemptions ................................................................................................................................ iv
Customer service department .................................................................................................. iv
EC - Representative ................................................................................................................... iv
Preface ········································································································································ I
Contents ······································································································································ I
1 Safety Information ················································································································· 1-1
Safety Symbols .................................................................................................................................. 1-2

1.1 Summary of Hazards................................................................................................................... 1-3
Introduction ............................................................................................................................. 1-3
Electric Shock Hazards .......................................................................................................... 1-3
Moving Parts Hazards ............................................................................................................ 1-3
Photometer Lamp Hazards .................................................................................................... 1-4
Laser Beam Hazards .............................................................................................................. 1-4
Sample, Calibrator and Control Hazards ............................................................................... 1-4
Reagent and Wash Solution Hazards .................................................................................... 1-4
Waste Hazards........................................................................................................................ 1-5
System Disposal Hazards ...................................................................................................... 1-5
Fire and Explosion Hazards ................................................................................................... 1-5
Removal of Analyzer from Use for Repair or Disposal ......................................................... 1-5
Cleaning and Decontamination ............................................................................................. 1-6
Software and Cybersecurity ................................................................................................... 1-6
Notification of Adverse Events .............................................................................................. 1-7
Introduction ............................................................................................................................. 1-8
Intended Use ........................................................................................................................... 1-8
Environment Precautions ....................................................................................................... 1-8
Installation Precautions ......................................................................................................... 1-8
Electromagnetic Noise Precautions ...................................................................................... 1-9
Operating Precautions.......................................................................................................... 1-10
Maintenance and Servicing Precautions ............................................................................ 1-11
I
Contents-Volume II
Test Parameter Configuration Precautions ........................................................................ 1-11

ISE Module Precautions ....................................................................................................... 1-11
Sample Precautions ............................................................................................................. 1-12
Reagent, Calibrator and Control Precautions ..................................................................... 1-12
Rack Feeder System Precautions........................................................................................ 1-13
Data Archiving Precautions ................................................................................................. 1-13
External Equipment Precautions ......................................................................................... 1-13
External Vacuum Pump Precautions................................................................................... 1-13
Tube and Liquid Container Precautions .............................................................................. 1-14
Shielding Cover ..................................................................................................................... 1-14
1.3 Labels and Silkscreen ................................................................................................................ 1-15
Introduction ........................................................................................................................... 1-15
1.3.1 Labels and Silkscreen ................................................................................................. 1-15
1.3.2 Warning Labels ............................................................................................................ 1-22
1.4 Abbreviations ............................................................................................................................. 1-27
2 System Description ················································································································ 2-1
2.1 Installation Requirements and Procedure .................................................................................. 2-2

2.1.1 Installation Requirements............................................................................................. 2-2
2.1.2 Installation Procedure ................................................................................................... 2-6
2.2 System Overview ......................................................................................................................... 2-7
2.2.1 System Structure ........................................................................................................... 2-7
2.2.2 Sample Handling System ............................................................................................. 2-9
2.2.3 Reagent Handling System .......................................................................................... 2-16
2.2.4 Reaction System ......................................................................................................... 2-21
2.2.5 Cuvette Wash Station.................................................................................................. 2-22
2.2.6 Photometric System ................................................................................................... 2-23
2.2.7 Mixer Assembly ........................................................................................................... 2-23
2.2.8 Operation Unit .............................................................................................................. 2-25
2.2.9 Output Unit ................................................................................................................... 2-25
2.2.10 Accessories and Consumables ............................................................................... 2-26
2.2.11 Data Management Software .................................................................................... 2-26
2.3 Optional Modules....................................................................................................................... 2-27
2.3.1 Introduction ................................................................................................................. 2-27
2.3.2 ISE Module ................................................................................................................... 2-27
2.3.3 Water Supply Module .................................................................................................. 2-27
2.3.4 External Vacuum Pump .............................................................................................. 2-29
2.3.5 HbA1c Sample Probe .................................................................................................. 2-30
2.3.6 Displayer Arm .............................................................................................................. 2-30
2.3.7 Handheld Barcode Reader .......................................................................................... 2-30
2.3.8 Other Optional Modules .............................................................................................. 2-30
2.4 Software Description ................................................................................................................. 2-31
2.4.1 Main Screen ................................................................................................................. 2-31
2.4.2 Using a Mouse ............................................................................................................. 2-34
2.4.3 Using a Touchscreen................................................................................................... 2-35
II
Contents-Volume II
2.4.4 Using Online Help ........................................................................................................ 2-35

2.5 System Specifications ............................................................................................................... 2-37
2.5.1 Technical Parameters ................................................................................................. 2-37
2.5.2 Power Supply ............................................................................................................... 2-41
2.5.3 Environmental Requirements ..................................................................................... 2-41
2.5.4 Dimensions and Weight .............................................................................................. 2-42
2.5.5 Input Device ................................................................................................................. 2-42
2.5.6 Output Device .............................................................................................................. 2-42
2.5.7 Noise Level .................................................................................................................. 2-42
2.5.8 Communication Interfaces ......................................................................................... 2-42
2.5.9 Safety Classification ................................................................................................... 2-43
2.5.10 Major Performance Indexes ..................................................................................... 2-43
2.5.11 Contraindication ........................................................................................................ 2-45
2.5.12 EMC Requirements ................................................................................................... 2-45
3 General Operating Procedure ·································································································· 3-1
3.1 General Operating Procedure ...................................................................................................... 3-2

3.2 Check before Powering On.......................................................................................................... 3-3
3.2.1 Checking Water Supply ................................................................................................. 3-3
3.2.2 Checking Power Supply ................................................................................................ 3-3
3.2.3 Checking Printing Paper ............................................................................................... 3-3
3.2.4 Checking Waste Tanks and Tubing .............................................................................. 3-3
3.2.5 Checking Probes and Mixers ........................................................................................ 3-3
3.2.6 Checking Rack Feeder System ..................................................................................... 3-4
3.2.7 Checking CD80 Detergent and Probe Wash solutions ............................................... 3-4
3.3 Powering On ................................................................................................................................. 3-5
3.3.1 Turning On Water Supply, Water Supply Module and External Vacuum Pump ......... 3-5
3.3.2 Powering On the System .............................................................................................. 3-5
3.3.3 Starting the Operating Software ................................................................................... 3-5
3.4 Checking System Status ............................................................................................................. 3-7
3.4.1 Checking Analyzer Status ............................................................................................. 3-7
3.4.2 Checking Alarm Status ................................................................................................. 3-9
3.4.3 Checking Maintenance Status ..................................................................................... 3-9
3.4.4 Checking Subsystems ................................................................................................ 3-10
3.4.5 Checking Reagent/Consumable Status ..................................................................... 3-11
3.5 Preparing Reagents ................................................................................................................... 3-14
3.5.1 Loading Biochemical Reagents.................................................................................. 3-14
3.5.2 Loading Concentrated Wash Solution ....................................................................... 3-17
3.5.3 Loading Reagent Probe Wash Solution ..................................................................... 3-18
3.5.4 Loading Sample Probe Wash Solution ...................................................................... 3-19
3.5.5 Loading Physiological Saline...................................................................................... 3-20
3.5.6 Emptying Waste Cap Container (when decapping module configured).................. 3-21
3.5.7 Pad Overview ............................................................................................................... 3-22
3.5.8 Reagent Loading Via Pad ........................................................................................... 3-26
3.6 Calibration .................................................................................................................................. 3-30
III
Contents-Volume II

3.7 Quality Control ........................................................................................................................... 3-34
3.7.1 Requesting Control Test ............................................................................................. 3-34
3.7.2 Loading Control Samples ........................................................................................... 3-35
3.7.3 Running Control Samples ........................................................................................... 3-35
3.7.4 Auto quality control ..................................................................................................... 3-36
3.8 Ordering Routine Samples ........................................................................................................ 3-37
3.8.1 Routine Sample Orders ............................................................................................... 3-37
3.8.2 Loading Routine Samples ........................................................................................... 3-40
3.8.3 Running Routine Samples (Sequential mode)........................................................... 3-41
3.8.4 Running Routine Samples (Bar code mode and Rack ID mode) .............................. 3-42
3.9 Ordering STAT Samples ............................................................................................................ 3-43
3.9.1 Ordering STAT Samples .............................................................................................. 3-43
3.9.2 Loading STAT Samples ............................................................................................... 3-45
3.10 Test Status and Test Control .................................................................................................. 3-48
3.10.1 Checking Reagent/Consumable Status................................................................... 3-48
3.10.2 Viewing Status of Racks ........................................................................................... 3-48
3.10.3 Sampling Stop ........................................................................................................... 3-49
3.10.4 Reagent Stop ............................................................................................................. 3-50
3.10.5 Emergency Stop ........................................................................................................ 3-50
3.11 Home the System .................................................................................................................... 3-51
3.12 Sleep and Wake Up .................................................................................................................. 3-52
3.12.1 Sleep .......................................................................................................................... 3-52
3.12.2 Wake Up ..................................................................................................................... 3-52
3.13 Masking/Unmasking Module.................................................................................................. 3-53
3.13.1 Masking/Unmasking Module ................................................................................... 3-53
3.14 View Software Version ............................................................................................................ 3-54
3.15 Daily Maintenance ................................................................................................................... 3-55
3.16 Shutdown and Log off ............................................................................................................. 3-56
3.16.1 Log off........................................................................................................................ 3-56
3.16.2 Shut down .................................................................................................................. 3-56
3.17 Check after Powering Off ........................................................................................................ 3-57
4 Setup ···································································································································· 4-1
4.1 Tests Setup .................................................................................................................................. 4-2

4.1.1 Introduction ................................................................................................................... 4-2
4.1.2 Import Tests .................................................................................................................. 4-2
4.1.3 View the Version of Tests ............................................................................................. 4-4
4.1.4 Open Tests Setup .......................................................................................................... 4-4
4.1.5 Test Configuration ......................................................................................................... 4-5
4.1.6 Masking/Unmasking Tests ........................................................................................... 4-6
4.1.7 Deleting Tests ................................................................................................................ 4-7
IV
Contents-Volume II
4.1.8 Display Settings ............................................................................................................. 4-7

4.1.9 Adjusting Measurement Order of Tests ....................................................................... 4-8
4.1.10 Analysis Parameters ................................................................................................... 4-8
4.1.11 Check Parameters..................................................................................................... 4-15
4.1.12 Calibration Parameters ............................................................................................. 4-21
4.1.13 Editing Closed-Reagent Tests .................................................................................. 4-23
4.1.14 Slope and Offset Adjustment ................................................................................... 4-24
4.1.15 Reagent Management Mode .................................................................................... 4-25
4.1.16 Carryover Setup ......................................................................................................... 4-25
4.1.17 Panels ........................................................................................................................ 4-27
4.1.18 Special Calculations ................................................................................................. 4-29
4.1.19 Reference/Critical Range Setup ............................................................................... 4-31
4.1.20 Auto Rerun Setup ...................................................................................................... 4-34
4.1.21 Serum Index............................................................................................................... 4-36
4.1.22 Research Result Setup .............................................................................................. 4-36
4.1.23 LIS Result Interception .............................................................................................. 4-37
4.2 Sample Analysis Setup .............................................................................................................. 4-40
4.2.1 Sample Order Settings ................................................................................................ 4-40
4.2.2 Rack Supply and Retrieval Settings............................................................................ 4-40
4.2.3 SI Index Settings.......................................................................................................... 4-41
4.2.5 Inventory Alarm Limit Settings ................................................................................... 4-41
4.2.6 Customizing Patient Demographics .......................................................................... 4-41
4.2.7 Auto Backup ................................................................................................................ 4-42
4.2.8 Sample Position Traceability Settings ....................................................................... 4-42
4.3 System Setup ............................................................................................................................. 4-43
4.3.1 Instrument Setup Options........................................................................................... 4-43
4.3.2 LIS Settings.................................................................................................................. 4-45
4.3.3 Sample Bar Code Reader ............................................................................................ 4-45
4.3.4 Sample Rack Settings ................................................................................................. 4-45
4.3.5 User Administration .................................................................................................... 4-45
4.3.6 Auto Startup Settings .................................................................................................. 4-47
4.3.7 Dictionary Setup .......................................................................................................... 4-47
4.3.8 Screen Saver Settings ................................................................................................. 4-48
4.3.9 Reagent Barcode Settings .......................................................................................... 4-49
4.3.10 Print Setup ................................................................................................................. 4-49
4.3.11 Date and time ............................................................................................................ 4-51
4.3.12 Select Language........................................................................................................ 4-51
4.3.13 Remote Download Settings ...................................................................................... 4-52
4.3.14 Scanner Model Setup................................................................................................ 4-52
4.3.15 Decapping Module Settings ..................................................................................... 4-52
4.3.16 Test Alias ................................................................................................................... 4-52
5 Reagents&Consumables ········································································································· 5-1
5.1 View Reagents/Consumables .................................................................................................... 5-2
V
Contents-Volume II
5.1.1 Reagent Overview.......................................................................................................... 5-2

5.1.2 Reagent List ................................................................................................................... 5-3
5.1.3 Consumable List ........................................................................................................... 5-3
5.1.4 Reagent Carousel .......................................................................................................... 5-4
5.2 Reagent Requirements ................................................................................................................ 5-5
5.2.1 Requirements Settings.................................................................................................. 5-5
5.2.2 Reagent Requirement Forecast .................................................................................... 5-5
5.3 Reagent Bar Code Reader ........................................................................................................... 5-6
5.3.2 Reagent Bar Code Setup ............................................................................................... 5-7
5.3.3 Loading Bar-Coded Reagents ....................................................................................... 5-8
5.4 Customizing Reagent Display ..................................................................................................... 5-9
5.5 Sorting Reagents ....................................................................................................................... 5-10
5.5.1 Smart Sort on Reagent Overview Screen................................................................... 5-10
5.5.2 Sorting Reagents on Reagent List Screen ................................................................. 5-10
5.6 Masking/Unmasking Reagent .................................................................................................. 5-11
5.7 Reagent Inventory Check .......................................................................................................... 5-12
5.7.1 Introduction ................................................................................................................. 5-12
5.7.2 Checking Reagent Inventory ....................................................................................... 5-12
5.8 Printing Reagent Information .................................................................................................... 5-13
5.8.1 Printing Reagent list and Reagent Use Record ......................................................... 5-13
5.9 On-line Load of Reagents .......................................................................................................... 5-14
5.9.1 Introduction ................................................................................................................. 5-14
5.9.2 On-line Load of Reagents ........................................................................................... 5-14
5.10 Off-line Load of Reagents ....................................................................................................... 5-15
5.10.1 Introduction ............................................................................................................... 5-15
5.10.2 Off-line Load of Reagents ......................................................................................... 5-15
5.11 On-Line Replacement of Reagents ......................................................................................... 5-16
5.11.1 Introduction ............................................................................................................... 5-16
5.11.2 On-Line Replacement of Reagents .......................................................................... 5-16
5.12 Off-Line Replacement of Reagents ........................................................................................ 5-17
5.12.1 Introduction ............................................................................................................... 5-17
5.12.2 Off-line Replacement of Reagents ........................................................................... 5-17
5.13 Unloading Reagents ................................................................................................................ 5-18
5.13.1 Introduction ............................................................................................................... 5-18
5.13.2 Unloading Biochemical Reagents ............................................................................ 5-18
6 Calibration ···························································································································· 6-1
6.1 Overview ....................................................................................................................................... 6-2

6.2 Calibration Setup ......................................................................................................................... 6-3
6.2.1 Defining a Calibrator ..................................................................................................... 6-3
6.2.2 Editing a Calibrator ........................................................................................................ 6-4
6.2.3 Setting up Calibrator Concentrations........................................................................... 6-4
6.2.4 Setting up Calibration Rules ......................................................................................... 6-5
6.2.5 Calibrator Management ................................................................................................ 6-6
6.3 Calibrator Dilution Setup ............................................................................................................. 6-7
VI
Contents-Volume II
6.3.1 Introduction ................................................................................................................... 6-7

6.3.2 Setting up Calibrator Dilution Factors .......................................................................... 6-7
6.3.3 Editing Calibrator Dilution Factors ............................................................................... 6-8
6.4 Calibration Status ........................................................................................................................ 6-9
6.5 Calibration .................................................................................................................................. 6-10
6.6 Reagent Blank ............................................................................................................................ 6-14
6.6.1 Mixed Blank Absorbance and Blank Response ......................................................... 6-14
6.6.2 Requesting a Reagent Blank ....................................................................................... 6-14
6.6.3 Recalling Reagent Blank Results ................................................................................ 6-15
6.7 Auto Calibration ......................................................................................................................... 6-17
6.7.1 Auto Calibration Setup ................................................................................................ 6-17
6.7.2 Auto Calibration Reminder.......................................................................................... 6-17
6.7.3 Removing Auto Calibration ......................................................................................... 6-17
6.8 Extending Calibration Time ....................................................................................................... 6-18
6.8.1 Extending Calibration Time......................................................................................... 6-18
6.8.2 Removing an Extended Status ................................................................................... 6-18
6.9 Calibration Override ................................................................................................................... 6-19
6.9.1 Overriding a Calibration .............................................................................................. 6-19
6.9.2 Removing Cal Overridden Status ............................................................................... 6-19
6.10 Reject ........................................................................................................................................ 6-20
6.10.1 Rejecting a Calibration .............................................................................................. 6-20
6.10.2 Removing Reject Status............................................................................................ 6-20
6.11 Recalling Calibration Results .................................................................................................. 6-21
6.11.1 Recalling Calibration Results.................................................................................... 6-21
6.11.2 Calibration Curve ....................................................................................................... 6-21
6.11.3 Calibration Reaction Curve ....................................................................................... 6-23
6.11.4 Archiving Calibration Results ................................................................................... 6-25
6.11.5 Calibration Trends ..................................................................................................... 6-25
Contents ······································································································································ I
7 Quality Control······················································································································· 7-1
7.1 Overview ....................................................................................................................................... 7-2

7.1.1 Introduction ................................................................................................................... 7-2
7.1.2 Quality Control Operating Procedure ........................................................................... 7-2
7.1.3 QC Alarms ...................................................................................................................... 7-2
7.1.4 QC Result Flags ............................................................................................................. 7-2
7.1.5 Control Status ................................................................................................................ 7-3
7.1.6 Control Analysis Mode .................................................................................................. 7-3
7.2 QC Evaluation ............................................................................................................................... 7-4
7.2.1 Introduction ................................................................................................................... 7-4
7.2.2 Evaluation of Single Controls ....................................................................................... 7-4
VII
Contents-Volume II
7.2.3 Two-Control Evaluation ................................................................................................. 7-5

7.3 QC Setup....................................................................................................................................... 7-7
7.3.1 Defining/Editing a Control ............................................................................................ 7-7
7.3.2 Selection of Tests.......................................................................................................... 7-8
7.3.3 Setting up Control Positions and Concentrations ....................................................... 7-8
7.3.4 Setting up QC Rules ...................................................................................................... 7-9
7.3.5 Managing Controls ........................................................................................................ 7-9
7.4 Quality Control ........................................................................................................................... 7-11
7.4.1 QC Setup ...................................................................................................................... 7-11
7.5 Auto Quality Control................................................................................................................... 7-12
7.5.1 Auto QC Setup ............................................................................................................. 7-12
7.5.2 Auto Quality Control .................................................................................................... 7-13
7.5.3 Removing Auto QC Status .......................................................................................... 7-13
7.6 Recalling Control Results .......................................................................................................... 7-14
7.6.1 QC Overview ................................................................................................................ 7-14
7.6.2 Control Sample Results .............................................................................................. 7-14
7.6.3 Recalling L-J Chart ...................................................................................................... 7-15
7.6.4 Recalling Twin-Plot Chart ........................................................................................... 7-17
7.6.5 Recalling QC Data........................................................................................................ 7-19
7.6.6 Recalling QC Summary ............................................................................................... 7-21
8 Sample Ordering and Processing ····························································································· 8-1
8.1 Sample Bar Code ......................................................................................................................... 8-2

8.1.2 Sample Bar Code Setup ................................................................................................ 8-3
8.2 Sample Ordering and Processing ............................................................................................... 8-5
8.2.1 Adding Samples ............................................................................................................ 8-5
8.2.2 Adding/Modifying Tests ............................................................................................... 8-6
8.2.3 Rerunning Samples ....................................................................................................... 8-6
8.2.4 Ordering Samples with Increased or Decreased Volume ......................................... 8-10
8.2.5 Ordering Diluted Samples ........................................................................................... 8-11
8.2.6 Sample Analysis Mode ............................................................................................... 8-12
8.2.7 Sample Blank ............................................................................................................... 8-15
8.2.8 Sample Management .................................................................................................. 8-16
8.3 Serum Index ............................................................................................................................... 8-18
8.3.1 Theory of Serum Index ................................................................................................ 8-18
8.3.2 Serum Index Setup ...................................................................................................... 8-19
8.3.3 Auto Serum Index ........................................................................................................ 8-20
8.3.4 Running SI Test............................................................................................................ 8-20
8.4 Clear Sample Orders .................................................................................................................. 8-21
8.4.1 Clearing Sample Orders .............................................................................................. 8-21
8.5 Release Sample Position........................................................................................................... 8-22
8.6 Sample and Test Lists ............................................................................................................... 8-23
8.6.1 Sample List and Test List ........................................................................................... 8-23
8.7 Optimizing Result Display ......................................................................................................... 8-24
VIII
Contents-Volume II
8.7.1 Optimizing Result Display ........................................................................................... 8-24

8.8 Results Recall............................................................................................................................. 8-25
8.8.1 Displaying Current Results ......................................................................................... 8-25
8.8.2 Recalling Results ......................................................................................................... 8-26
8.8.3 Viewing Abnormal Sample ......................................................................................... 8-27
8.8.4 Review Sample Results ............................................................................................... 8-27
8.8.5 Viewing/Editing Patient Demographics ..................................................................... 8-28
8.8.6 Reaction Curve ............................................................................................................ 8-28
8.8.7 Transmitting Results to LIS Host ............................................................................... 8-30
8.8.8 Printing Results ........................................................................................................... 8-31
8.8.9 Editing Results ............................................................................................................. 8-33
8.8.10 Deleting Results ........................................................................................................ 8-34
8.8.11 Customizing Result Display ...................................................................................... 8-34
8.8.12 Recalculating Results ............................................................................................... 8-36
8.8.13 Compensating Results.............................................................................................. 8-37
8.8.14 Archiving Results ...................................................................................................... 8-37
8.9 Test Statistics ............................................................................................................................ 8-38
8.10 Result Statistics ....................................................................................................................... 8-40
8.11 Charge Statistics ..................................................................................................................... 8-42
8.11.1 Charge setup ............................................................................................................. 8-42
8.11.2 Search charges.......................................................................................................... 8-42
9 Use of ISE Module ·················································································································· 9-1

9.1.1 Introduction ................................................................................................................... 9-2
9.1.2 Precautions on Use ....................................................................................................... 9-2
9.2 Principles of Measurement ......................................................................................................... 9-4
9.3 ISE Test Parameters .................................................................................................................... 9-5
9.3.1 Introduction ................................................................................................................... 9-5
9.3.2 Viewing ISE Test Parameters ....................................................................................... 9-6
9.3.3 Defining Print Name ...................................................................................................... 9-7
9.3.4 Modifying/Configuring ISE Test Parameters ............................................................... 9-7
9.3.5 Summary of ISE Test Parameters ................................................................................ 9-7
9.4 Preparing ISE Reagents for Measurement ............................................................................... 9-12
9.4.1 Introduction ................................................................................................................. 9-12
9.4.2 Loading Buffer Solution .............................................................................................. 9-12
9.4.3 Loading ISE Detergent ................................................................................................ 9-12
9.5 Calibration and Results Recall .................................................................................................. 9-13
9.5.1 Introduction ................................................................................................................. 9-13
9.5.2 Calibration Setup ......................................................................................................... 9-13
9.5.3 Calibration Status and Alarm ..................................................................................... 9-13
9.5.4 Requesting a Calibration............................................................................................. 9-14
9.5.6 Results Recall .............................................................................................................. 9-15
9.5.7 Extending ISE Calibration Time .................................................................................. 9-16
IX
Contents-Volume II
9.6 Quality Control and Results Recall ........................................................................................... 9-17

9.6.1 Quality Control and Results Recall ............................................................................. 9-17
9.7 Sample Ordering and Results Recall ........................................................................................ 9-18
9.7.1 Sample Ordering and Results Recall .......................................................................... 9-18
9.7.2 Recalling Reaction Data .............................................................................................. 9-19
9.8 ISE Prime Cycle .......................................................................................................................... 9-20
9.8.1 Introduction ................................................................................................................. 9-20
9.8.2 Defining/Modifying ISE Prime Times ......................................................................... 9-20
9.9 Daily Maintenance ..................................................................................................................... 9-21
9.9.1 Daily Maintenance ....................................................................................................... 9-21
9.10 Troubleshooting ISE Module ................................................................................................... 9-22
9.10.1 Troubleshooting ISE Module .................................................................................... 9-22
10 LIS ···································································································································· 10-1
10.1 Overview ................................................................................................................................... 10-2

10.2 LIS Communication ................................................................................................................. 10-3
10.2.1 Introduction ............................................................................................................... 10-3
10.2.2 Host Communication Parameters ........................................................................... 10-3
10.2.3 Defining Channel Number of Tests .......................................................................... 10-6
10.3 Ordering Samples with LIS Host ............................................................................................. 10-7
10.3.1 Ordering Functions.................................................................................................... 10-7
10.4 Result Transmission ................................................................................................................ 10-9
10.4.1 Result Transmission Setup ....................................................................................... 10-9
10.4.2 Manually Sending Results to LIS Host ..................................................................... 10-9
10.5 Troubleshooting LIS .............................................................................................................. 10-10
11 Maintenance ······················································································································ 11-1
11.1 Overview ................................................................................................................................... 11-2

11.1.1 Introduction ............................................................................................................... 11-2
11.1.2 Accessory Information ............................................................................................. 11-2
11.1.3 Materials required and tools .................................................................................... 11-4
11.2 Maintenance Screen ................................................................................................................ 11-6
11.2.1 Maintenance Screen Overview ................................................................................. 11-6
11.2.2 Maintenance Setup ................................................................................................... 11-8
11.2.3 Maintenance History ................................................................................................. 11-8
11.3 Scheduled Maintenance .......................................................................................................... 11-9
11.3.1 Introduction ............................................................................................................... 11-9
11.3.2 Maintenance Schedule ............................................................................................. 11-9
11.3.3 Scheduled Maintenance Procedures ....................................................................... 11-9
11.3.4 Maintenance Log ...................................................................................................... 11-9
11.4 Daily maintenance ................................................................................................................. 11-13
11.4.1 Check DI Water Connection.................................................................................... 11-13
11.4.2 Check Waste Connection ....................................................................................... 11-13
11.4.3 Check Inventory of CD80 Detergent and Probe Wash Solution ........................... 11-14
11.4.4 Check Sample/Reagent Syringe............................................................................. 11-15
X
Contents-Volume II
11.4.5 Check Sample Probe Wash Solution ..................................................................... 11-16

11.4.6 Check Mixer Installation Position .......................................................................... 11-17
11.4.7 Clean ISE Electrodes ............................................................................................... 11-18
11.4.8 Special Wash Probes/Mixers ................................................................................. 11-19
11.5 Weekly Maintenance ............................................................................................................. 11-20
11.5.1 Weekly Special Wash and Cuvette Check ............................................................. 11-20
11.5.2 Ultrasonic Cleaning of Sample Probe .................................................................... 11-21
11.6 Two-Week Maintenance ........................................................................................................ 11-22
11.6.1 Clean ISE Tubes....................................................................................................... 11-22
11.7 Monthly Maintenance ............................................................................................................ 11-24
11.7.1 Clean Cuvette Wash Station ................................................................................... 11-24
11.7.2 Clean Wash Wells.................................................................................................... 11-24
11.7.3 Clean ISE SIC/Drain Outlet...................................................................................... 11-25
11.7.4 Wash R1/R2 Physiological Saline Bottle ............................................................... 11-27
11.8 Three-Month Maintenance .................................................................................................... 11-28
11.8.1 Dilution Ratio Self-calibration of Diluted Wash Solution ...................................... 11-28
11.8.2 Probe Interior Wash Pressure Adjustment ............................................................ 11-28
11.8.3 Whole Unit Circulating Water Wash Pressure Adjustment ................................... 11-29
11.8.4 Clean DI Water Tank ................................................................................................ 11-29
11.8.5 Clean Dust Screens of External Vacuum Pump .................................................... 11-31
11.8.6 Clean Dust Screens ................................................................................................. 11-33
11.9 Six-Month Maintenance ........................................................................................................ 11-35
11.9.1 Replace Lamp.......................................................................................................... 11-35
11.10 When Appropriate Maintenance ......................................................................................... 11-37
11.10.1 Check Probes/Mixers/Wash Wells ...................................................................... 11-37
11.10.2 Clean Probes/Mixers Exterior .............................................................................. 11-38
11.10.3 Replace Cuvettes .................................................................................................. 11-39
11.10.4 Cuvette Check ....................................................................................................... 11-41
11.10.5 Lamp Hour Inquiry ................................................................................................ 11-42
11.10.6 Clean Analyzer Panels .......................................................................................... 11-43
11.10.7 Reagent Barcode Maintenance ............................................................................ 11-43
11.10.8 Rack Barcode Maintenance ................................................................................. 11-44
11.10.9 Clean Sample Probe Interior ................................................................................ 11-46
11.10.10 Clean Reagent Probe Interior ............................................................................. 11-48
11.10.11 Replace Sample Probe ....................................................................................... 11-49
11.10.12 Replace Reagent probe ...................................................................................... 11-51
11.10.13 Replace Sample Mixer ........................................................................................ 11-51
11.10.14 Replace Reagent Mixer ....................................................................................... 11-52
11.10.15 Remove Air Bubbles in Syringe .......................................................................... 11-53
11.10.16 Water Prime......................................................................................................... 11-54
11.10.17 Replace ISE electrodes ....................................................................................... 11-54
11.10.18 Storing Electrodes............................................................................................... 11-57
11.10.19 Prime Buffer Solution ......................................................................................... 11-59
11.10.20 Waste Discharge ................................................................................................. 11-60
11.10.21 Service Life Query of Wearing Parts .................................................................. 11-61
XI
Contents-Volume II
11.10.22 Generate Daily Maintenance Report .................................................................. 11-61

11.11 Shutdown Maintenance ...................................................................................................... 11-62
12 Alarms and Troubleshooting ······························································································· 12-1
12.1 Classification of Logs ............................................................................................................. 12-2

12.1.1 Introduction ............................................................................................................... 12-2
12.1.2 Edit Logs .................................................................................................................... 12-2
12.2 Viewing and Handling Logs .................................................................................................... 12-3
12.2.1 Description of Error Log Screen ............................................................................... 12-3
12.2.2 Description of Edit Log Screen ................................................................................. 12-4
12.3 Error Troubleshooting .............................................................................................................. 12-5
12.3.1 Introduction ............................................................................................................... 12-5
12.3.2 Error Indications ........................................................................................................ 12-5
12.4 Data Alarm ............................................................................................................................... 12-7
12.4.1 Result Flags ............................................................................................................... 12-7
12.5 Troubleshooting Procedure .................................................................................................. 12-24
12.5.1 Error Alerts and View .............................................................................................. 12-24
12.5.2 Software Screen Prompt ........................................................................................ 12-26
12.5.3 Troubleshooting ...................................................................................................... 12-27
12.5.4 Clear Errors .............................................................................................................. 12-29
12.6 Troubleshooting ..................................................................................................................... 12-30
12.6.1 No Alarm Troubleshooting ..................................................................................... 12-30
12.6.2 Troubleshooting Alarms ......................................................................................... 12-30
13 Operation Theories ············································································································· 13-1
13.1 Overview ................................................................................................................................... 13-2

13.2 Principles of Measurement ..................................................................................................... 13-3
13.2.1 Introduction ............................................................................................................... 13-3
13.3 Endpoint Measurements ......................................................................................................... 13-4
13.3.1 Introduction ............................................................................................................... 13-4
13.3.2 Calculation of Reaction Absorbance ....................................................................... 13-4
13.3.3 Calculation of Blank Absorbance ............................................................................. 13-4
13.3.4 Calculation of K Factor ............................................................................................. 13-4
13.3.6 Sample Blanked Response ....................................................................................... 13-5
13.4 Fixed-time Measurements ...................................................................................................... 13-6
13.4.1 Introduction ............................................................................................................... 13-6
13.5 Kinetic Measurements ............................................................................................................ 13-8
13.5.1 Introduction ............................................................................................................... 13-8
13.5.2 Data Calculation in Kinetic Measurements ............................................................. 13-8
13.5.3 Determination of Linearity Range ............................................................................ 13-8
13.5.5 Evaluation for Linearity ........................................................................................... 13-10
13.5.6 Enzyme Linearity Range Extension ........................................................................ 13-11
XII
Contents-Volume II
13.6 Calibration Math Model and Factors .................................................................................... 13-12

13.6.1 Linear Calibrations .................................................................................................. 13-12
13.6.2 Non-Linear Calibrations .......................................................................................... 13-13
13.7 Prozone Check ....................................................................................................................... 13-15
13.7.1 Introduction ............................................................................................................. 13-15
13.7.2 Prozone Check Parameters .................................................................................... 13-15
Vocabulary ·································································································································· 1
Index ········································································································································ 11
Electronic Interface ···················································································································· 13
Bibliography ······························································································································ 14
XIII
Contents-Volume II
XIV
7 Quality Control
This chapter describes applications of quality control, which include:

 Daily and monthly QC procedure
 QC alarm indications
 QC result flags
 Control status
 QC evaluation
 Auto QC
 Control results recall
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7 Quality Control
7.1 Overview
7.1.1 Introduction
QC test is performed on samples provided with known concentration range of various
analytes by authorities or reagent suppliers. By comparing with the given range, the
test results obtained on this instrument can be used to judge if the instrument is in
normal status and the sample results are reliable.
To ensure the system performance, run control samples every time after you perform
a calibration, or change the reagent lot, or maintain and troubleshoot the instrument.
7.1.2 Quality Control Operating Procedure

After you define a test, control, and QC rules, there is no need to edit them frequently,
and you are only required to run control samples everyday to make sure that the system
works well. Run control samples according to the following procedure:
Quality control operating procedure
Define Set up two-

Set up QC Choose QC Enable auto Print monthly QC
Monthly control
parameters rules
control
QC
plot and QC
operations samples evaluation summary
Program Running Print real-

Load control Recall QC time QC
control control
Daily operations samples results results
samples samples
7.1.3 QC Alarms
The system provides the real-time monitoring of quality controls, and check if the QC
results are under control when a QC run is finished. If the results exceed the reference
range, the system will give an audible alarm and shows an alarm message indicating
the test name, control name and control rules. For instance, “Test: , control: , 1-3s out
of control!”. In this situation, you should stop the analysis and find the causes of the
failure, and resume the analysis after solving the problem.
7.1.4 QC Result Flags

When a QC result fails, the system will give an audible alarm and show alarm message
to remind you of the failure. Moreover, the following flags will appear for failed results
in the Flag column of the QC reports.
 13s
 12s
 R4s
 22s
 41s
 10x
The system checks the failed QC results for system error or random error and then flag
them accordingly. A “#” sign indicates a systematic error, and an asterisk “*” indicates
a random error. For more information about QC result flags, refer to 12.4 Data
Alarm(page 12-7).
7-2
7 Quality Control
7.1.5 Control Status

When you choose a control on the Quality Control screen, the current status of the
control is displayed in the QC Status field. It is necessary to understand the control
statuses. The table below shows the various statuses of control samples.
Descriptions of control status
Control Status Description
N/A Indicates that the control is not ordered for analysis.
Requested Indicates that the control sample has been ordered but not
analyzed yet.
In Progress Indicates that the control sample is being analyzed.
Incomplete Indicates that all tests of the control sample have been finished
but one or more of them have no results.
Complete Indicates that all tests of the control sample have been finished
with results.
7.1.6 Control Analysis Mode

If ordering controls with racks, assign rack positions for controls and specify the rack
ID and position number. After ordering controls, load controls to assigned light blue
racks, put the racks into the rack supply unit, and then start analysis.
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7 Quality Control
7.2 QC Evaluation
7.2.1 Introduction
The system provides the Westgard rules for evaluating QC results of the tests, and give
alarms and flags when the obtained QC results are beyond the reference range. Since
every test may have one or more control samples, the QC results can be evaluated with
different rules accordingly. Those controls that are not included in any lots will be
evaluated as single controls.
7.2.2 Evaluation of Single Controls

The Westgard rules for evaluation of single controls are listed in the table below:
Westgard rules for single controls
Rules Description Flag Error Type

12s One result is between ±2 and ±3 N/A N/A
standard deviations from the
assigned mean concentration.
13s One result is greater than ±3 13s *(1)
standard deviations from the
assigned mean concentration.
22s Two continuous results are greater 22s #(2)
than +2 or -2 standard deviations
from the assigned mean
concentration, e.g. (Xn, Xn-1)
41s Four continuous results are greater 41s #
than +1 or -1 standard deviation
from the assigned mean
concentration, e.g. (Xn, Xn-1, Xn-2,
Xn-3)
10x Ten results being compared are on 10x #
the same side, e.g. (Xn, Xn-1, Xn-2,
Xn-3...Xn-9)
(1) An asterisk “*” indicates a random error, which requires no special action but must
not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special consideration.
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7 Quality Control
The evaluation procedure of single controls is shown in the figure below:

Evaluation procedure of single controls
Control data
No
>2S In-control
Yes No
Yes
12S Warning
No
No No No
13S 22S 41S 10X
Yes Yes Yes Yes
Out of control
7.2.3 Two-Control Evaluation

What is a run
A QC run is based on two control samples: C1 and C2, and at most one QC run is
performed for each test. The system allows the definition of QC run interval on the
System Setup screen. The maximum QC run interval is 24 hours.
1 Select QC > Ctrl Setup > QC Setup.
2 Type in the QC run length in the Run Length field.
Enter an integer between 1 and 24. The default is 24.
3 Select OK.
Two-control evaluation rules

In every QC run, two results are obtained: Xn and Yn, which are used to define a point
on the Twin-plot chart. In this way, a complete twin-plot chart is drawn based on all the
QC results and used for detecting systematic errors and random errors.
The Westgard rules for two-control evaluation are listed in the table below:
Two-control evaluation rules

12s One result is between ±2 and ±3 N/A N/A
standard deviations from the assigned
mean concentration.
13s One result is greater than ±3 standard 13s *(1)
deviations from the assigned mean
concentration.
22SA Two results (Xn, Yn) of a run are 22s #(2)
simultaneously greater than +2 or -2
mean.
R4s One result of a run is greater than +2 R4s *
mean and the other greater than -2SDs.
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7 Quality Control

22SW Two continuous results of a control are 22s #
greater than +2 or -2 standard deviations
from the assigned mean concentration,
e.g. (Xn, Xn-1), (Yn, Yn-1).
41SA Results of two continuous runs are 41s #
greater than +1 or -1 standard deviation
from the assigned mean, e.g. (Xn, Yn, Xn-
1, Yn-1).
41SW Four continuous results of a control are 41s #
greater than +1 or -1 standard deviations
from the assigned mean concentration,
e.g. (Xn, Xn-1, Xn-2, Xn-3), (Yn, Yn-1, Yn-2,
Yn-3).
10XA Results of five continuous runs (10 10x #
results) compared are on the same side,
e.g. (Xn, Yn, Xn-1, Yn-1, Xn-2, Yn-2, Xn-3,
Yn-3, Xn-4, Yn-4).
10XW Ten continuous results (10 results) of a 10x #
control are on the same side, e.g. (Xn,
Xn-1, Xn-2, Xn-3...Xn-9), (Yn, Yn-1, Yn-2,
Yn-3...Yn-9).
(1) An asterisk “*” indicates a random error, which requires no special action but must
not be ignored.
(2) A “#” symbol indicates a systematic error, which requires special consideration.
The systematic errors in two-control evaluation correspond to those in single-control
evaluation as follows:
 22SA\22SW corresponding to 22s.
 41SA\41SW corresponding to 41s.
 10XA\10XW corresponding to 10x.
The procedure of two-control evaluation is shown in the figure below:
Two-control evaluation workflow
Measured values of X
and Y controls
No
12S In control
Yes
No
No No No No No No No
13S 22SA R4S 22SW 41SA 41SW 10XA 10XW
Yes Yes Yes Yes Yes Yes Yes Yes
Out of control (occurrence of alarm)
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7 Quality Control
7.3 QC Setup
Perform QC settings in the following order:
 Define/Edit a control
 Select tests
 Set up control concentrations
 Set up QC rules
7.3.1 Defining/Editing a Control

The system allows the definition of up to 99 controls. You are required to enter the
control name and sample type. The combination of control name and lot number must
not be duplicate and should be unique. If a control has no lot number, you are not
allowed to define another control with the same name. Adding or editing controls is
allowed only when the system status is Incubation, Standby or Sleep.
2 Select Add Control. You can scan the bar code to import the control or add control
manually.
Define/Edit Controls window
3 When defining the control manually, type in the control name.

4 Enter the control number.
The lot number can be composed of characters or numbers. The combination of
control name and lot number must not be duplicate.

The options include serum, plasma, urine, CSF, whole blood, pleural effusion and
other. The default is serum.
7 Select expiration date for the control.

When the expiration date is exceeded, the control can still be ordered and analyzed,
while the system flags the test result in the Flag column to remind you of replacing
the expired control.
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7 Quality Control
8 Input the manufacturer of the control.

9 Select tests for the control.
10 Select Submit.
7.3.2 Selection of Tests

After defining a control, you need to select tests for which the control will be used.
When selecting tests, make sure that the system status is Incubation, Standby,
Stopped or Sleep, and the control status is not ordered or Incomplete.
2 Choose a control in the left list.
3 Select Tests Selection.
4 Choose tests for the control.
5 To choose all tests in the list, select Select All.
6 To deselect the tests, select Clear.
7 Select OK.
7.3.3 Setting up Control Positions and Concentrations

You are required to set up the average concentrations and SDs of a control for each
test after defining the control and choosing tests. Only the control with positions
assigned and concentrations determined can be used for ordering.
To run quality control for special calibrations, you must define the mean value and SD;
otherwise, no control results will be calculated. If the sub tests of a special calculation
have no mean value and SD, QC evaluation will not be done and QC plot cannot be
recalled.
Setup screen
2 Choose a module from the Mdl pull-down list.
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7 Quality Control
3 Choose a control in the left list.

4 Input Rack ID, Position, Barcode and Sample ID.
5 Select the Mean column of a test and type in the average concentration for it.
The concentration must be above 0 with no more than 8 digits.
6 Select the SD column of a test and type in the standard deviation for it.
The SD must be above 0 with no more than 8 digits.
7.3.4 Setting up QC Rules

After defining a control and determining concentrations for it, you should set up the
QC rules for it. Controls without QC rule can still be requested but will not be checked
for error. You are allowed to edit the QC rules when the system is not running any tests.
2 Select QC Rules.
3 Choose a test you want to define.
4 Choose rules in the Westgard multi-rule setup menu.
You can enable the Westgard multi-rule batch setup switch for batch
setup.
5 Set up out-of-control warning rules.

6 If you assign a couple of controls for the test, you are allowed to enable the Two-
Control Evaluation option.
Those controls that are not included in the two-control evaluation will be evaluated
according to the evaluation rules for single controls.

8 Repeat step 3 to 8 to set up quality control rules for other chemistries.
9 Select the icon to close the window.
7.3.5 Managing Controls

Deleting a Control
You are allowed to delete controls when the system is not running any tests. When a
control is deleted, the control information, concentration parameters and QC results as
well as the control position are cleared. If the deleted control is included in the two-
control evaluation, the relevant two-control evaluation will be disabled. Those controls
ordered for analysis cannot be deleted.
1 Select QC > Ctrl Setup > QC Setup.
2 Choose a control in the list.
3 Select Delete.
Activate and Deactivate Control

1 Select QC > Ctrl Setup > Ctrl Manag.
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7 Quality Control
2 Choose control(s) in the list.

3 Select Activate or Deactivate.
If you want to disuse certain control, deactivate it then this control will not be displayed
in the list of controls on the screen.
7-10
7 Quality Control
7.4 Quality Control

QC results are tools used to monitor the system performance. To check if the system
is running normally and steadily, you are recommended to run control samples
everyday. The system provides two modes to run control samples, auto and manual.
New tests can be added no matter in which status the control samples are. The control
orders can be edited when the control status is ordered rather than In Progress.
For requesting and running QC test, please refer to 3.7 Quality Control(Page 3-34).
7.4.1 QC Setup
2 Click QC Setup.
3 Set up the interval for auto requesting of daily control.
4 Set up auto QC. The options include:
 QC interval: Set up the number of samples
 QC after calibration
5 Set up Inherit QC precision.
Inherit QC precision: If this option is selected, the CV value of the control in the
previous lot will still be used when new controls are imported via barcode or file.
If this option is disabled, the CV value of the newly imported control will use that
imported from QC target value list.
6 Set up QC Batch Time Limit(Hour).

Interval for requesting two batches of QC. The default is 4 hours.
7 Select OK.
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7 Quality Control
7.5 Auto Quality Control

The system provides the auto quality control function. When the conditions for auto
quality control on racks are satisfied, a message will pop up reminding you to order
controls; The control samples automatically run can be selected on the QC Settings
window.
The conditions for auto quality control include:
 Number of samples: indicates the number of patient samples. After the given
number of samples is finished, the system will run the selected control(s)
automatically.
 QC after Calibration: The system will automatically run the test for the selected
control(s) every time when the test is calibrated. Auto QC is not applicable to non-
measurement calibrations, such as recalculation and editing.
When the control samples automatically run are selected, all tests configured for the
control samples will be run.
7.5.1 Auto QC Setup

2 Select QC Setup.
QC setup
3 Set up the conditions for auto request quality control:

 QC Interval: set the auto QC interval between two requests .
4 Select OK.
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7 Quality Control
7.5.2 Auto Quality Control

When the conditions for auto quality control on racks are satisfied, a message will pop
up reminding you to order controls.
7.5.3 Removing Auto QC Status

To remove an auto QC status, deselect Interval QC, and deselect the QC after
Calibration option on QC Settings screen.
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7 Quality Control
7.6 Recalling Control Results

The Recalling Control Results option allows you to view control sample results, L-J
chart, twin-plot chart, analysis data and data summary.
7.6.1 QC Overview
You can view the QC status on the QC - > QC Overview screen.
Display rules of QC status:
 QC out of control: Red background
 QC warning: Orange background
 In-control: White background
The QC status of each level is determined by the last test point at the level.
The screen is displayed via smart sort. Smart sorting rule is QC out of control - QC
warning - QC normal - QC not performed.
Click the chemistry card to link to the L-J chart of the chemistry.
The dots below the test indicate the replicates of QC run. One dot means one replicate
and a maximum of 5 dots can be displaye. If more than 5 replicates occur, the last 5
replicates are displayed. If there is no QC test, no dot will be displayed. The color of the
dot indicates the QC status:
 Green: Under control
 Yellow: QC warning
 Red: QC out of control
7.6.2 Control Sample Results

1 Select Sample > Current or History.
 The Current screen displays all incomplete patient samples and control
samples, as well as those ordered on the current day.
 The History screen displays all patient samples and control samples ordered
before the current day.
2 Choose a result recall mode:
 View samples
 View tests
3 Click filter icon to filter the QC results. Enter the date range and select QC
from sample type.
4 When recalling results by sample, choose a control in the left list. The right list
displays all results of the control. When recalling results by test, choose a test in
the left list. The right list displays all results of the test.
5 Select Details to view result flags, alarm information, reaction curve and data.
Select Return to return to previous screen.
 Delete: to delete the QC results of the selected QC test.
 Print : to print control results.
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7 Quality Control
 Host : to transmit the selected control results to the LIS host.
Viewing control reaction curve

1 Search for desired control results on the Current or History screen.
3 Select Result Details.
Reaction Curve screen
4 Choose the Reaction Curve or Reaction Data tab to view the reaction data.
 Enable Sample Blank : to view the sample blank reaction curve and reaction
data of the selected control.
 Adjust : to adjust the absorbance display range of current reaction curve.
7.6.3 Recalling L-J Chart

A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test results (Y),
shows the QC result trend of a test during the specified period. The graphical trends of
up to 3 controls can be displayed on one L-J chart and distinguished with different
colors. The query date must not be longer than 1 year.
Recalling L-J chart

1 Select QC > QC Plot > Levey-Jennings.
2 Choose a module.
3 Choose a test to recall.
4 Click filter icon and select date range.

5 Choose controls you desire to view. Up to 3 controls can be selected.
7-15
7 Quality Control
Levey-Jennings screen
 : to view the L-J chart of the previous test.
 : to view the L-J chart of the next test.

 Delete : to delete the selected point on the L-J chart. If you want to display the
removed points on the L-J chart, mark the Show Deleted checkbox.
 Print : to print the current L-J chart.

 Comment : to add, modify and delete comments of a QC point.
 Rerun: to rerun QC test for a QC point.
Adding/Modifying comments
2 Select a module, test, QC date and controls.
3 Choose a QC point on the chart.
4 Select Comment , and then choose a comment for the QC point.
QC comment can be defined on the Dictionary window.
5 Select OK.
Select the QC point on the chart. The comments of this QC point are displayed in
the Comment area at the upper-right corner of the screen.
To delete the comments of a QC point, select the QC point on the chart, clear the
comments, and then select OK.
7-16
7 Quality Control
Selecting chart option

The L-J chart can be drawn by QC date or QC time. Either of the two options can be
selected to display the L-J chart. The default standard is QC time.
2 Select Chart.
Chart Options window
3 Choose an option to draw the L-J chart:

 QC Time: The X coordinate of the L-J chart is displayed in the format of
“YYMMDDHHMMSS”.
 QC Date: The X coordinate of the L-J chart is displayed in the format of
“MMDD”.
4 Select OK. The L-J chart is refreshed automatically and displayed in the selected
format.
7.6.4 Recalling Twin-Plot Chart

A twin-plot chart, drawn based on the results of control X and control Y in the same
run, is used to detect systematic errors and random errors. It shows the recent 10 QC
results of a test and excludes those that have been deleted.
1 Select QC > QC Plot > Twin-Plot.
2 Choose a module.
3 Choose a test to recall.
The twin-plot chart area displays the recent 10 results of control X and control Y
for the test.
7-17
7 Quality Control
Twin-Plot screen
 : to view the twin-plot chart of the previous test.
 : to view the twin-plot chart of the next test.
 : to print the current twin-plot chart.
7-18
7 Quality Control
7.6.5 Recalling QC Data

QC data includes QC results, and the set mean and standard deviation, and can be
recalled based on control name, test name and run date.
1 Select QC > Results.
2 Choose a module
3 Click Filter button to search the results according to time, test and control.
The result list shows all results of the control for the test during the specified
period, as well as the set means and standard deviations.
Results screen

 Reac Curve: to view the reaction curve and data of the selected QC result.
 Comment: to add comments to the selected QC result.
 Archive : to archive the currently displayed QC results to an external

storage device.
 Print : to print the QC results currently displayed in the result list.
Viewing control reaction curve

1 Search for desired QC results on the Results screen.
2 Choose a QC result to recall.
3 Select Reac Data. The Reaction Curve window is displayed.
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7 Quality Control
Control reaction curve
5 Select a filter condition from the following options:
 None: observe reaction curve and data in the default mode.
 Test: observe reaction curve of the results for the selected test.
 Control: observe reaction curve of the results for the selected control.
6 Select the Reaction Data tab to view the reaction data.
 Reagent: to view the reagents used for quality control, calibrators and
reagents used in calibration, and reagents for reagent blank test. Refer to
8.8.6 Reaction Curve (Page 8-28) for details.
 Sample Blank: to view the sample blank reaction curve and reaction data of
the selected control.
 Adjust: to adjust the absorbance display range of current reaction curve. Refer
to 8.8.6 Reaction Curve (Page 8-28) for details.
 Prev: to view the reaction curve and data of the previous QC test.
 Next: to view the reaction curve and data of the next QC test.
7-20
7 Quality Control
Archive QC data
The system allows archiving of QC results to a storage device. The file format is CSV
and the default file name is QCData.csv. which cannot be edited.
Perform the following steps to archive QC results and data:
1 Search for desired QC results on the Results screen.
2 Select Archive .
3 Select OK.
7.6.6 Recalling QC Summary

The QC summary reports the measurements of a control for the selected test during
the specified period. It presents you the means, standard deviations and coefficients
of variation in this period, and compares them with the set mean and SD, enabling you
to check if the system is working normally.
1 Select QC > Summary.
2 Choose a module.
3 Click Filter button to search the results according to time, test and control.
The result list shows all results of the control for the test during the specified
period, as well as the set means and standard deviations.
4 Select OK.
The result summary of the control for the test is displayed on the screen.
Summary screen
5 To print the QC summary report, select Print .
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7 Quality Control
7-22
8 Sample Ordering and Processing
This chapter provides description of functions and operating instructions about

sample analysis, which include:
 Modifying/Adding samples and tests
 Rerunning samples
 Ordering samples with increased or decreased volume
 Ordering diluted samples
 Sample analysis mode
 Sample blank
 Loading/Unloading samples
 Viewing unpositioned samples and assign positions for them
 Releasing finished samples
 Viewing sample logs
 Customizing sample information
 Customizing patient information
 Viewing sample and test lists
 Optimizing result display
 Sample results recall
 Viewing test statistics
 Viewing result statistics
8-1
8.1 Sample Bar Code

The sample bar code system consists of the sample rack bar code system and sample
tube bar code system. The bar code on sample racks is scanned by the bar code reader
in the rack feeder system to obtain rack type and rack ID. Sample tube bar code is
applied to sample tubes on rack. By scanning sample bar code on sample tubes,
sample information can be obtained. The bar code reader in the rack feeder system is
standard configuration. When bar-coded samples are loaded to rack, the system will
make a full scan and locate samples through the bar code.
Sample rack bar code

Sample rack bar code has been applied on racks when the racks leave the factory.
When sample rack bar code label is damaged and cannot be read normally, it should
be replaced immediately.
Sample rack bar code specifications
Name Description
Bar code The bar code consists of 5 characters: XXXXX. The first
character indicates rack type, and the remaining characters
indicate rack ID. For example, N0001 refers to No.1 normal
sample rack. Letter N means normal sample rack; letter E
means emergent sample rack, letter C means control sample
rack, letter S means calibrator rack, and letter R means rerun
sample rack. M means maintenance rack.
Application Sample rack bar code label should be applied on the front
requirements side of rack, facing the sample bar code reader and level to
the top of rack. Make sure that the rack ID label is oriented
towards the heading direction of rack.
Sample racks can be identified through both bar code and rack ID. The rack ID label is
located in the front of rack.
Sample tube bar code specifications

The sample tube bar code reader is in compliance with the Clinical and Laboratory
Standards Institute (CLSI) and compatible with various application environments.
8-2
Sample tube bar code specifications

Name Description
Symbology Codabar, ITF, Code128, Code39, UPC/EAN, and Code93
Minimum bar code 0.19mm
density
Length 3-27 digits
Format and content User-defined
Maximum width 55mm
Minimum height 10mm
Maximum inclination ±5º
angle
Print quality No less than Class C according to the ANSI MH10.8M
Print Quality Specification.
Width and narrowness 2.5-3.0:1
Print paper Coated paper or matte paper. Printing bar code on
common paper may result in vague bar code or degraded
bar code label. You are not suggested to print bar code on
common print paper.
Characters Meaningful characters, such as numbers (0-9) and upper-
case letters (A-Z). You are recommended to print the
check digit in order to check that a bar code is read
accurately.
Information contained in a sample tube bar code

The system will obtain the following information from the LIS host based on sample
tube bar code:
 Sample category
 Test date/time
 Sample ID
 Sample type
 Panel No.
8.1.2 Sample Bar Code Setup

Before performing the setup procedure, check if your system is equipped with a sample
bar code reader. If needed, contact our customer service department or your local
distributor.
Perform the following steps to set up sample bar code:
1 Select Setup > System > Sample Bar Code.
2 Choose a bar code symbology and set up the check digit status.
The following symbologies are provided:
 Codabar
 Interleaved 2 of 5
 Code128
 Code39
8-3
 UPC/EAN
 Code93
Code 128, Code 93 and UPC/EAN requires a check digit by default, and other
symbologies are not compulsive. The Code 128 is selected by default and cannot
be modified.
CAUTION
You are recommended to enable the check function for all symbologies in order to
prevent misreading of bar code.
8-4
8.2 Sample Ordering and Processing

Except for analysis of routine samples, you often need to add samples or tests to the
order or rerun an abnormal sample. Samples can be diluted manually or prediluted
automatically before being analyzed.
8.2.1 Adding Samples
BIOHAZARD
CAUTION
Adding samples to rack
NOTE
When the rack in STAT area is being delivered, STAT sample cannot be added i.e. when the
STAT indicator is blue flickering, adding STAT samples is not allowed. When the STAT
indicator is off, put STAT sample rack into this area and request the test.
In sequential mode, when you add samples during test running, it is recommended to fill
full of the last rack of the previous batch of samples so that the new sample ID succeeds
the previous one. Place the racks that you newly add to the last of the last working rack
carrier or place them in order in the non-working rack carrier. To ensure correct sampling
sequence, do not add racks in the rack carrier whose indicator is flickering blue.
In bar code mode or rack ID mode, there are no requirements about sampler rack order or
whether the last rack is full, you can place the rack behind the pusher dog of the current
working rack carrier as long as there is rack to be tested in this carrier.
Adding samples to rack is different in different analysis modes. This section describes
sample adding in details.
Sequential mode
When adding samples in the sequential mode, you should consider if the new sample
ID succeeds the previous one in order to avoid ID and invalid results.
1 Order new samples according to “3.8.1 Routine Sample”(Page 3-37).
2 Check that the sample order information is correct.
3 Load added samples to a new sample rack and put the rack into rack carrier and
place it into the rack supply unit.
4 Select , enter the start sample ID and start sample position, and select OK
to start analysis.
Note: in sequential mode, when inputting the start sample ID and start sample position,
you must make them match the actual ID and position otherwise correct sample ID
and position relation cannot be established and wrong test results may be produced.
After you select OK, the indicator of corresponding areas turns blue flickering or
constantly lit, adding sample is successful.
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Rack ID mode or bar code mode:

New samples can be added at any time in the rack ID mode. Make sure that the added
samples are loaded to the assigned racks and positions.
Before adding samples in the bar code mode, ensure that the sample bar code
scanning and LIS bidirectional communication functions have been enabled, and the
bar code on the sample cups has been applied correctly.
1 Order new samples according to “3.8.1 Routine Sample”.
2 Check that the sample order information is correct.
3 Load added samples to a new sample rack and put the rack into the rack carrier
and place the tray into sample supply unit.
4 Press the control button of corresponding rack carrier to start analysis; or select
, and select to OK start analysis.
Note
When you click on the operating software, the sample test of all rack carriers will be
initiated. If you press the control button of rack supply unit, only the sample test of
corresponding rack carrier is started.
8.2.2 Adding/Modifying Tests

No matter in which status a sample is, new tests can be added, and dilution factors
and replicates can be defined for them. For samples that are ordered but not analyzed
yet, editing the sample information, patient demographics and tests is allowed; for
samples in the status of In Progress, Incomplete or Complete, the sample information
and tests must not be edited, while patient demographics can be edited and new tests
can be added.
2 Type in sample ID, bar code, Position, name or patient ID and then press Enter to
search for desired sample.
The ordering information of the sample is displayed on the screen.
3 Deselect tests you won’t run, and then select tests you desire to run.
4 Deselect panels you won’t run, and then select panels you desire to run.
5 Choose tests and panels to add to the sample.
6 Select Submit.
 If the system is in Standby status, select the icon on the upper-right

corner of the main screen.
8.2.3 Rerunning Samples

Finished samples can be rerun in manual or auto mode. Only tests that have been
finished can be rerun. If a test is run for more than one replicate, it cannot be rerun only
when all replicates are finished. Manual rerun is performed on the Abnormal Results
screen, Current screen and History screen; auto rerun is performed when a result is
beyond the set range.
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Manual rerun on Current or History screen

2 Choose the View Samples option.
3 Search for desired sample results.
4 Check the Flag column for flags indicating abnormities.
5 Choose results you desire to rerun.
6 Select Rerun.
Rerun window
7 Change the rack ID and position of the sample.
NOTE
In sequential mode and rack ID mode, samples can be rerun in the original positions
or on a rerun rack; in bar code mode, they can be rerun in any idle positions of a routine
or STAT sample rack or on a rerun rack. To assign positions in bar code mode, only
the original positions can be selected.
8 Select a sample volume type to rerun the sample.

The sample volume is the same as that defined for the test. If increased and
decreased volumes are defined for the test, Increased and Decreased are
available here for selection.
9 Enable or disable sample blank for the sample.

Only when the Set Sample Blank Individually checkbox is selected on the Setup >
Analysis > Sample Ordering Setup screen, the Sample Blank option will appear. If
you need the settings, contact our customer service department or your local
distributor.
10 Choose a sample tube type. The options include micro and standard.
11 Enter the off-line dilution factor.
The input range is 2-9999, and the default is blank.
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12 Enter the predilution factor.

The input range is 4-134, and the default is blank.
13 If you want to run a test with different sample volume, replicates and predilution
factor, enter the values in the test option area:
14 Select Rerun Module.
15 Select OK.
16 Load the samples.
 Put the original routine or STAT sample rack to the rack supply unit, or load
samples to the assigned rerun rack and put the rack into the rack supply unit.
NOTE
If rerunning tests in sequential mode, you should load samples in the original order.
No matter having rerunning samples or not, racks within the rerunning range must be
loaded.
17 Select to start the analysis.
Batch rerun on Current or History screen

When recalling results by test on the Current or History screen, you are allowed to rerun
multiple samples of a test that are Complete or Incomplete.
2 Choose the View Tests option.
4 Choose a test and samples you desire to rerun.
5 Select Rerun.
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Rerun window
The window shows the selected test and samples, as well as sample ID, bar code,
sample volume in previous test, predilution factor, off-line dilution factor, and
sample blank.
6 Enable or disable sample blank for the test.

7 Modify the sample volume, predilution factor, off-line dilution factor and sample
blank for each sample.
 Predilution factor: The input range is 4-134, and the default is blank.
 Off-line dilution factor: The input range is 2-9999, and the default is blank.
 Sample blank: set up sample blank for samples.
 Rerun Module: Assign rerun module.
8 Select OK.
9 Load the samples.
 Put the original routine or STAT sample rack to the rack supply unit, or load
samples to the assigned rerun rack and put the rack into the rack supply unit.
NOTE
If rerunning tests in sequential mode, you should load samples in the original order.
No matter having rerunning samples or not, racks within the rerunning range must be
loaded.
10 Select OK to start the analysis.
Rerun tests via Abnormal Results screen

1 Select Sample > Abnorm.
2 Choose a test and samples you desire to rerun.
3 Select Rerun.
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Rerun tests when meeting auto rerun conditions

The auto rerun function can be also enabled on the Auto rerun Setup window. Once
the auto rerun is enabled, the system will check if the rerun conditions are met, and if
they are, will rerun the sample.
Auto Rerun Setup.
2 Set up auto rerun rules, rerun type and reflex tests.
The system will rerun the sample if the rerun conditions are met.

4 Select Return.
8.2.4 Ordering Samples with Increased or Decreased Volume

In common tests, tests are run with standard sample volume. Owing to the specificity
of certain sample, the result may be high or low. To ensure accurate results, the system
allows the processing of samples with increased or decreased volume. When a sample
is analyzed with standard volume and a result is beyond the reference range or deemed
abnormal, you are allowed to rerun the corresponding test manually with the increased
or decreased sample volume.
2 Choose a test.
3 Select View then select Edit .
4 Type in the decreased and increased sample volume.
5 Select OK.
6 Select Return.
 ID
 Sample position (rack ID and position number)
 STAT status
 Sample type
 Comment
 Tests and panels
9 Set the test options:
 Sample volume
 Sample cup
 Number of replicates
 Off-line dilution factor
 Predilution factor
 Sample blank
10 Select Submit.
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8.2.5 Ordering Diluted Samples

Due to patient specificity, certain results of a sample may be relatively high. In this
condition, you are allowed to rerun the corresponding tests by manually or
automatically diluting the sample at certain ratio for part or all of the tests. When a
sample is analyzed and a result is beyond the reference range or deemed abnormal,
you are allowed to rerun the corresponding test manually with the sample diluted.
You are allowed to set the sample dilution factors when defining a test or requesting
the test for sample analysis. When you set both the off-line dilution factor and
predilution factor when requesting a test, the result will be multiplied automatically by
the two dilution factors. For tests with dilution factors,
 If the dilution factors are not set, the result will be directly multiplied by the
predilution factor.
 If the dilution factors are set, the result will be directly multiplied by the product
between the predilution factor and the ratio calculated based on the set dilution
factors.
If the sample volume, replicates and predilution factor are set for both the sample and
the test, the test will be run based on its own settings instead of those of the sample.
Perform the following steps to run diluted samples.
2 Choose a test.
3 Select View then select Edit.
4 Type in the aspirated sample volume and diluent volume for standard sample
volume analysis.
5 Select OK.
6 Select Return.
 ID
 Sample position
 STAT status
 Sample type
 Comment
9 Set the test options:
 Sample volume
 Sample cup
 Number of replicates
 Off-line dilution factor
 Predilution factor
 Sample blank
10 Select Submit.
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8.2.6 Sample Analysis Mode

Sample ordering through rack supports three modes: sequential mode, rack ID mode,
and bar code mode, and only one of the three modes can be used simultaneously.
Sequential mode
In sequential mode, the system aligns sample order information with the orderly-
loaded samples according to the input sample ID, and then analyzes the samples. Load
samples to racks in the order they are ordered, and put the racks into the rack supply
unit successively.
NOTE
In sequential mode, make sure the start ID and start position you enter on this window
match the actual start ID and the actual position in which the start sample is placed.
NOTE
In sequential mode, routine sample racks are not allowed to be inserted into STAT lane.
In sequential mode, STAT racks are not allowed to be placed in rack supply unit.
Perform the following steps to order single or multiple samples.

Ordering a single sample:
2 Enter sample ID in the Sample ID field.
 Routine or STAT
 Sample type
 Bar code
 Comment
4 Repeat steps 2 to 4 to order more samples.
5 Load samples to racks in the sample ID order.
If the sample ID is discontinuous, the samples loaded to the racks should be
discontinuous accordingly, and no samples should be placed in spacing positions.
6 Put the racks successively into the rack supply unit.
7 Select , enter the start sample ID and start sample position, and then select
OK to start analysis.
When system status turns to running from standby, sample request and starting
test are successful.
Batch ordering:
2 Enter sample ID of the first sample in the Sample ID field.
 Routine or STAT
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 Sample type
 Bar code
 Comment
4 Select Batch, enter the sample ID of the last sample, and then select OK.
5 Load samples to racks in the sample ID order.
6 Put the racks successively into the rack supply unit.
7 Select , enter the start sample ID and start sample position, and then select
OK to start analysis.
NOTE
In sequential mode, the corresponding control button of rack carrier does not function
to start test. Select on the operating software to start sample analysis on all
rack carriers. (The left rack carrier is delivered first by default). The indicator of the
currently working rack carrier is flickering blue. The other one is blue and constantly
lit.
During test running, do not add racks in the currently working rack carrier to avoid
affecting test sequence. Do not remove the rack carrier in rack supply unit when its
indicator is flickering blue in case the rack will topple over.
Rack ID mode
In rack ID mode, the system aligns sample order information with the loaded samples
according to the input rack ID and position number, and then analyzes the samples.
When loading samples to racks, make sure the rack ID and position number of the
actually-loaded samples is the same with the input one. Racks can be put in any order
into the rack supply unit, because the system can identify samples through the rack ID
and sample position.
Perform the following steps to order single or multiple samples.
Ordering a single sample:
2 Enter the rack ID and position number.
 STAT or Routine
 Sample type
 Bar code
 Comment
4 Select OK.
5 Repeat steps 2 to 5 to order more samples.
6 Load samples to the assigned positions of the assigned racks.
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7 Put the racks into the rack supply unit.
8 Select , and then select OK to start analysis.

Or Press the control button of corresponding rack carrier to start the test. The
control button of corresponding turns blue flickering or constantly lit, sample
request and starting test are successful.
The indicator of currently working rack carrier is flickering blue. Constantly lit blue
indicator indicates the rack carrier is waiting for rack delivery.
NOTE
Do not remove the rack carrier in rack supply unit when its indicator is flickering blue in
case the rack will topple over.
NOTE
On-line racks are not allowed in rack ID mode.
9 To add samples during analysis, repeat steps 2 to 9.

Batch ordering:
2 Enter the rack ID and position number of the first sample.
 STAT or Routine
 Sample type
 Bar code
 Comment
4 Select Batch , enter the position number of the last sample, and then select OK.
5 Load samples to the assigned positions of the assigned racks.
7 Select ,and then select OK to start analysis.

8 To add samples during analysis, repeat steps 2 to 7.
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Bar code mode

Prior to choosing the bar code mode, ensure that the sample bar code scanning and
LIS bidirectional communication functions have been enabled on your system. The
system scans bar code on sample cups, obtains sample order information from the
LIS host, and then finishes sample ordering and processing automatically.
Perform the following steps to analyze samples in bar code mode:
1 Load bar-coded samples to racks.
3 Select , and then select OK to start analysis. The system starts scanning the
sample bar code, obtaining relevant order information from the LIS host, and then
analyzing the samples.
Note: in rack ID mode or bar code mode, after you click , only the samples
in the rack carriers currently on board are tested. If you want to start the test of
the carrier which is placed on board later, you should order the samples and add
them to the test sequence.
When the control button of the rack carrier is pressed, only samples in the
corresponding tray are analyzed and samples in other area are not analyzed.
The indicator of currently working rack carrier is flickering blue. Constantly lit blue
indicator indicates the rack carrier is waiting for rack delivery.
Do not remove the rack carrier in rack supply unit when its indicator is flickering
blue in case the rack will topple over.
8.2.7 Sample Blank

Running a sample blank

2 Choose a test.
3 Select View and then Edit.
4 Mark the Sample Blank checkbox with a tick on Analysis parameters screen.
5 Select Submit.
6 Select Return.
The system will run a sample blank when running calibrators, controls and
samples for the test.
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Recalling sample blank results

3 Choose a sample and then a test you desire to recall.
4 Select Details.
5 Enable Sample Blank Switch.
6 Choose the Reaction Data tab to view the reaction data.
7 To print the reaction curve or reaction data, select Print.
8 Select Return.
8.2.8 Sample Management

Before ordering samples, it is necessary to understand the sample cups, and sample
volume of the system, as well as how to load and unload samples.
CAUTION
For collection and preparation of samples, please see the reagent Instructions for Use. Use
clean tubes, microcups and other disposable materials specified by the manufacturer. Do
not reuse disposables.
Sample cup types

The sample rack supports blood collecting tube, centrifugal tube, plastic tube and
Microtube, which are available in the following specifications:
 Microtube: Φ14×25mm, 0.5ml (Beckman); Φ14×25mm, 2mL (Beckman);
Φ12×37mm, 2mL (Hitachi).
 Blood collecting tube or plastic tube: Φ12×68.5 mm, Φ12×99 mm, Φ12.7×75 mm,
Φ12.7×100 mm, Φ13×75 mm, Φ13×95 mm, Φ13×100 mm, Φ16.5×92mm,
Φ16×75mm, and Φ16×100mm.
Sample volume
The amount of sample required for a common measurement is 1.5-25μL, with an
increment of 0.1μL.
If a sample is exhausted during the analysis, the system will automatically invalidate
all incomplete test of the sample. Before running samples, make sure that they are
sufficient in volume for analysis.
Loading samples to rack
BIOHAZARD
1 Check if the sample inside the sample tube is sufficient for analysis and the bar
code label is applied correctly.
2 Load sample tubes to the racks according to the applied analysis mode.
 Sequential mode: load samples to racks in the order they are ordered.
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 Rack ID mode: load samples to the assigned positions of assigned racks.

 Bar code mode: load bar-coded samples randomly to racks.
3 Check the system status.
 If the system status is Running, press the STAT button or select to

request for Sampling stop.
 If the system status is Standby, proceed to the next step.
 If the system status is Incubation, wait until the system gets steady, and then
proceed to the next step.
4 Check if the sample track and the sample probe have stopped moving, and the
control buttons of rack carrier stop flickering.
5 Put the racks into the rack carrier and place the rack carrier into rack supply unit
according to the applied analysis mode.
 Sequential mode: put the sample rack successively into the rack carrier in the
order the samples are ordered and place the rack carrier into rack supply unit
 Rack ID mode and bar code mode: put the racks randomly into the rack carrier
and place the tray into rack supply unit.
Unloading samples from rack

When the rack storage unit is full, take out the racks immediately to prevent rack
damage, and then take out sample tubes from the racks.
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8.3 Serum Index

Serum index is the degree of hemolysis, icterus and lipemia contained in serum sample.
They are usually seen in serums and can influence the test results in physical or
chemical way.
The serum index function is used to analyze the interferents in samples, helping clinical
professionals to evaluate the test results.
8.3.1 Theory of Serum Index

Absorption spectrum of interferents in serum samples
(1)
(2)
(3)
The figure above shows the absorption spectrum of interferents in serum samples. (1)
refers to lipemia, (2) refers to hemolysis, and (3) refers to icterus.
The three interferents are selective to wavelength and have complex absorption
spectrums. They cannot be removed completely by means of double-wavelength
measurements. The serum index option can be used to analyze the interferents
contained in samples, helping clinical professionals to evaluate the test results,
determining if the sample is usable or if a sample blank test is needed.
Serum index test is single-reagent endpoint measurement, in which serum sample of
10μL and physiological saline of 200μL are used. Six wavelengths are chosen to
determine the serum index. The equations of serum index are as follows:
 Lipemia: primary wavelength of 660, secondary wavelength of 700.
AL  A660  A700 , lipemia index: L  1 / C  AL
 Hemolysis: primary wavelength of 570, secondary wavelength of 605.
AH  A570  A605 , hemolysis index: H  1 / A  ( AH  B  AL )
 Icterus: primary wavelength of 450, secondary wavelength of 505.
AI  A450  A505 , icterus index: I  1 / D  [ AI  E  ( AH  B  AL )  F  AL ]
Where,
 B and F: determined by the absorption spectrum of lipemia and not adjustable.
 E: determined by the absorption spectrum of hemolysis and not adjustable.
 C: determined by single lipemia, and not adjustable.
 A: determined by single hemolysis, and not adjustable.
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 D: determined by single icterus, and not adjustable.
8.3.2 Serum Index Setup

The serum index includes lipemia (L), hemolysis (H) and icterus (I), and has the
common name of SI. The test name, sample volume and reagent volume of SI are
defined by the manufacturer and cannot be modified by users. The SI test cannot be
deleted. You are allowed to define the print names and qualitative result flags for the
test.
Defining print name

2 Choose the SI test.
3 Select View and then Edit.
4 Type in the print name of lipemia in the Print Name of the Lipemia area. Up to 15
characters can be entered.
The lipemia index will appear as the print name on patient reports and as “SI” on
other reports.
5 Repeat step 4 to define print names for hemolysis and icterus.

6 Select Submit.
Defining qualitative result flags

The Qualitative Analysis option, when enabled, analyzes every sample for the detection
of lipemia, hemolysis and icterus and calculates the numeric values of the index. If the
volume of the interferents contained in a sample is beyond the set range, a flag will be
added to the patient report.
The system allows 6 ranges and flags for each interferent.
2 Choose the L, H or I of SI test.
3 Select Flag Qualitative Results and mark Use Qualitative Result.
The Range and Flag fields below are activated for editing.
4 Type in the detection range in the first edit box of the Range field, and then enter
a flag in the first edit box of the Flag field.
For instance, type in “10” in the first edit box of the Range field in the Lipemia area,
and then enter “+” in the Flag field of the same row. If the lipemia volume (L1)
contained in a sample is less than or equal to 10, the “+” sign will be added to the
result in the patient report. Type in “20” in the second edit box below the Range
icon and “+-” in the second edit box below the Flag icon. If the lipemia volume (L2)
is greater than 10 and less than or equal to 20, the result will be flagged with the
“+-” sign. The cycle continues. If the result is greater than L5, the six flag will
appear on the patient report.
5 Repeat step 4-5 to define ranges and flags for hemolysis and icterus.
6 Select OK.
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8.3.3 Auto Serum Index

When the Auto Serum Index function is enabled, the system will select the SI test
automatically for serum or plasma samples. The SI test will also be requested
automatically when you order routine samples manually or by using the LIS host, or
order STAT samples, or order routine samples with the default panels.
When ordering samples with auto serum index, you are required to select at least one
test other than SI.
1 Select Setup > Analysis Settings > SI Settings.
2 Mark the Auto Serum Index checkbox with a tick.
3 Select OK.
8.3.4 Running SI Test

The SI test is not applicable to controls and calibrators.
To run the SI test, choose the SI test while ordering samples. It will be analyzed along
with other tests.
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8.4 Clear Sample Orders

The Clear Samples function is used to delete ordered samples that have not been
analyzed. One or more samples can be cleared at one time. When samples are cleared,
the sample information will be removed completely; the sample ID, position and bar
code can be used for ordering other samples. The action of clearing samples will be
recorded in the edit logs.
8.4.1 Clearing Sample Orders

2 Enter the sample ID/bar code, position, patient name or patient ID to inquire the
samples.
3 Select Delete Order.
4 Select OK.
The selected samples are cleared along with their ordering information.
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8.5 Release Sample Position

8.5.1 Auto Release Sample
When a sample is analyzed, the position cannot be used for ordering new sample until
it is released.
1 Select Setup > Analysis Settings > Auto Release Sample.
2 Select auto release time of patient samples in the Auto Release Time field.
3 Enter the Shift Transition Interval.
4 Select OK.
When the time is reached, the system will automatically release all samples of the
current day when system status is standby or Stopped.
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8.6 Sample and Test Lists

The List option allows you to view, inquire and print all unfinished samples, and assign
positions for unpositioned samples.
8.6.1 Sample List and Test List

Viewing ordered samples
The sample list shows all samples that have been ordered but not analyzed yet.
Samples can be inquired by order date, sample status, ID, or bar code.
2 Select List.
Sample List tab page
3 Select Sample List or Test List.

4 Set the position for unpositioned samples.
Please first look for the samples without positon then set the positon for them.
The positions are assigned automatically according to the start position and the
sequence of sample ID.
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8.7 Optimizing Result Display

Due to low sensitivity of certain reagents, samples with low concentration may have 0
or negative results, or cannot be represented accurately by results out of linearity range.
To express sample concentration accurately, the system provides the Optimize Result
Display option to customize such results. When less than the low limit of linearity range,
results will show as “< Low limit of linearity range”; when greater than the high limit of
linearity range, they will show as “> High limit of linearity range”.
Result optimizing will not affect storage, transmission and archiving of results. Only
users who have the permissions of system setup are allowed to optimize result display.
8.7.1 Optimizing Result Display

Display window
2 Find desired test, and mark Optimize low results and Optimize high results.
Click the checkbox again to deselect it.
 Select Optimize Low results. When a result is less than the low limit of
linearity range or concentration of the lowest-concentration calibrator, it will
show as “< X” or “X”.
 Select Optimize high results. When a result is greater than the high limit of
linearity range or concentration of the highest-concentration calibrator, it will
show as “> X”.
 Select batch low value optimization and batch high value optimization to
optimize the high value and low value results of all tests. Batch optimization
can be cleared by selecting the blank value in the drop-down list.
3 Select OK.
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8.8 Results Recall

The Results Recall option allows routine samples, STAT samples and controls to be
recalled and handled on the Current or History screen. The Current include those that
are ordered and analyzed on the current day; the History Results are those ordered and
analyzed before the current day. All results can be recalled by sample or by test.
After sample analysis, results can be printed out automatically. For setup methods,
refer to 0General Print Setup Options (Page 4-49).
8.8.1 Displaying Current Results

Current screen
The sample type includes R, E and C. R stands for routine sample, E for STAT
sample, and C for control.
The Host column indicates the transmission status of the sample. Y means that
the sample has been sent to the LIS host, and N means the opposite.
The Print column indicates the print status of the sample. Y means that the
sample has been printed, and N means the opposite.
Samples displayed in the sample list can be sorted by the type, ID, status, position,
completion time, order date/time, host and print fields.

 View Samples
 View Tests
3 When recalling results by sample, choose a sample in the left list. The right list
displays all results of the sample. When recalling results by test, choose a test in
the left list. The right list displays all results of the test.
4 Select Details to view Flags, alarms, reaction curve, result trace, plots and data list.
Click Return.
 Extra Urgent: to run the sample with top priority.
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 Delete: to delete sample results.

 Details: to view the reaction curve and data of the selected test.
 Rerun: to rerun a finished sample.
 Edit: to edit results
 Demog: to view patient demographics of the sample.
 Manual Release: to release the select sample(s).
 Review: to review the test results.
 Print : to print sample results.
 Host : to transmit the selected sample results to the LIS host.
 Export :to export results.
8.8.2 Recalling Results

Current results can be inquired by sample information and patient demographics,
along with the current date. Whichever status the system is, only one condition is
required for inquiring desired results.
Search sample via Sample ID/Position/Patient Name/Patient ID

Recall results window
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2 Enter the sample ID, bar code, position, patient name or patient ID to search for
samples. The system supports fuzzy query.
The retrieved sample information is automatically displayed on the screen.
3 Select OK. The samples matching the condition are displayed on the screen.
4 Select a function button to perform relevant operations.
Search sample via Date/Status/Sample ID

2 Select Filter button on the upper right of the screen.

3 Enter Search Conditions.
 Select the order date range from the pull-down list.
 The options include yesterday, within 1h, 3h and 5h.
 Enter the single sample ID or ID range in the ID/bar code field.
4 Select STAT, routine or control in the Sample Type field.
5 Select OK. Click Reset to clear the filter condition before confirmation.
The searched results are automatically displayed on the screen. Click of Search
Conditions to clear the search conditions and display all sample results.
8.8.3 Viewing Abnormal Sample

When the tests of a sample have been completed, but no test result is produced, the
sample and its test will be displayed on the abnormal status screen.
Viewing abnormal samples

1 Select Sample > Abnormal Results.
Sample ID, bar code, position, test, and error code of abnormal samples are
displayed in the list. The list can be sorted by sample ID, test or error code.

 Rerun: Select this button to rerun the abnormal sample.
 Result Details: View result details.
Rerunning abnormal samples

1 Select Sample > Abnormal Results.
2 Select a sample that you desire to rerun.
3 Click Rerun.
4 Click Delete delete abnormal sample.
8.8.4 Review Sample Results

Only when the sample status is complete, can the sample results be reviewed.
2 Choose the View Sample option.
3 Choose a sample or more samples in the sample list.
8-27
4 Select Review.
The review status in the sample list turns from N to Y.
8.8.5 Viewing/Editing Patient Demographics

Patient demographics can be viewed or edited in any system status.
2 Choose the By Sample option.
3 Choose a sample in the sample list. Move the scroll bar to view more samples.
4 Select Demog.
Demographics window
Patient demographics can be customized. For more information, refer to 4.2.6

Customizing Patient Demographics (Page 4-41).
5 Edit the patient information.

6 Select Submit to save your input.
7 Select or to view demographics of the previous or next sample.
8.8.6 Reaction Curve

A reaction curve reflects the relationship of the absorbance measured at the primary
wavelength, secondary wavelength and primary-secondary wavelength. It is drawn
based on the absorbance of the sample-reagent mixture measured within the reaction
period.
Observing reaction curve:
1 Search for desired samples on the Current or History screen.
8-28
 View sample
 View test
3 Choose desired result in the result list and select Result Details.
4 Select Reac Curve. The Reaction Curve window is displayed.
Sample reaction curve
6 Select a filter condition from the following options:
 None: observe reaction curve and data in the default mode.
 Test: observe reaction curve of the results for the selected test.
 Sample: observe reaction curve of the results for the selected sample.
7 Choose the R Data tab to view the reaction data and 3D Display to view 3D graph
for the AD value.
 Sample Blank : Enable Sample Blank to view the sample blank

reaction curve and reaction data of the selected sample.
 Adjust : Enable to adjust the absorbance display range of current

reaction curve. Refer to the following page for details.
Viewing result trace information:
On the reaction curve window, you are allowed to view the reagents in sample
measurement, the calibrators and reagents used in calibration, and reagents for
reagent blank test. For ISE test, only calibrators and reagents used in the test are
displayed.
1 Search for desired samples on the Current Results or History Results screen.
8-29

 View sample
 View test
3 Choose a test or sample in the result list.
5 Click to fold the reaction curve.
6 View Result Trace.
7 Select Return.
Adjusting display range:
The maximum absorbance display range of reaction curve can be adjusted
automatically or manually. The adjustment is only applicable to the currently-displayed
curve, which will restore the default display when opened next time.
1 Search for desired samples on the Current Results or History Results screen.
 View sample
 View test
3 Choose a test or sample in the result list.
4 Select Result Details. The Reaction Curve is displayed.
5 Enable Curve Adjust .

Adjust window
6 Select Input the absorbance range (-40000~40000).
8.8.7 Transmitting Results to LIS Host

Sample results and QC results can be sent to the LIS host in any system status if the
LIS host is connected correctly. The Host option allows the transmission of single or
multiple samples, or all samples to the LIS host.
2 Choose View Sample.
3 To transmit single or multiple sample results, select them in the left list.
4 Select Host .
8-30
Transmit Results window
5 Select the sample range you want to transmit:

 Selected sample(s)
 All samples
6 If you transmit all samples, you are allowed to skip those results that are already
transmitted to the LIS host. Mark the Bypass Transmitted Results checkbox.
7 Select OK.
8.8.8 Printing Results

Samples can be printed manually on the Current Result and History Result screens.
The system allows multiple samples to be printed on one report or one sample on one
report. Before printing the recalled results, you should select a report template on the
System Setup screen.
The Print option allows single or multiple samples, EQA(External Quality Sample)or all
samples to be printed out.
Print by sample
The print by sample option allows you to print the test results of one or more samples
when results are recalled by sample.
2 Choose View Sample.
3 To print single or multiple samples, select them in the sample list.
4 Select .
8-31
Print window
5 Select Sample Report.

6 Choose the print range:
 Selected Sample(s)
 All Sample(s)
7 If you print all samples, you are allowed to skip those that are already printed out.
Mark the Bypass Printed Sample(s) checkbox.
8 Select OK.
Print by test
The Print by test option allows you to print the test results of one or more tests when
results are recalled by test.
Laboratory Version
2 Choose the View Test option.
3 To print single test in the test list, select one; to print all tests, there is no need to
select them.
4 Select .
5 Choose the print range:
 Selected test
 All tests
6 Select OK.
8-32
8.8.9 Editing Results

The Edit Results option allows editing of results that slightly exceed the reference
range or the linearity range but will not lead to mis-diagnosis of patients, or of results
that are all on the high side or low side. This option is used for sample results only,
exclusive of control results. Results of special calculations cannot be edited. Edited
results will be flagged for distinguishing from others.
Only the samples that have been analyzed and have results can be edited. For those
tests that are run for over one time, result of each run can be edited. For rerun tests,
only the default result can be edited.
CAUTION
Edit Results function gives doctors with freedom to modify the results, and therefore, must
be used with cautions. Only users that have sufficient permissions are allowed to edit
results.

 View samples
 View tests
4 Choose a sample or test in the left list.

5 Select Edit Results.
The screen shows the sample or test and all measured results.
Edit Results window – By sample
6 Choose a result to edit, and then input result in the Result column.
 For normal runs, only Complete tests can be edited.
 For reruns, only the default result can be edited.
7 Repeat step 7 to edit other results.
8-33
8 Select OK to save your editing.
8.8.10 Deleting Results

The system has a limited storage capacity and can store a maximum of 50,000
samples. The results with the earliest date will be overridden when the capacity is
exceeded. The system allows deleting of routine samples, emergent samples and
controls, while they are sent to the LIS host or printed out. When the system status is
Running, samples in the status of Running cannot be deleted; when the system status
is but Running, samples in any status can be removed. Deleted results cannot be
restored. Make sure that you have archived them by sending them to the LIS host or
printed out or in other ways.
Before deleting a result, check if you have sufficient permissions. Only users that have
sufficient permissions are allowed to delete results. The deleting operation will be
automatically recorded in event logs.
 View samples
 View tests
4 Choose a sample or test in the left list.

5 Select Delete.
All results of the samples are displayed on the screen.
Delete Results window
6 Select OK.
8.8.11 Customizing Result Display

The Customize Result Display option allows tailoring of sample and result display
options on the Current and History screens.
When recalling results by sample, the sample list and result list can be customized.
When recalling results by test, only the result list can be tailored.
8-34

 View samples
 View tests
3 Select .
4 Select the fields you want to display on the screen.
Customize Result Display window – By sample
Customize Result Display window – By test
5 If recalling results by sample,

 Choose desired header names in the Sample List Setup area and screens
where they are going to be displayed. Use the Up and Down buttons to adjust
the display order of the header names.
8-35
To forbid display of a header name in the sample list, deselect the corresponding
checkbox. Please note that the Type option for the History screen cannot be
forbidden.
 Choose desired header names and screen in the Result List Setup area. Use
the Up and Down buttons to adjust the display order of the header names.
To forbid display of a header name in the result list, deselect the corresponding
checkbox.
6 If recalling results by test,

Choose desired header names and screen in the Result List Setup area. Use the
Up and Down buttons to adjust the display order of the header names.
To forbid display of a header name in the result list, deselect the corresponding
checkbox.
8.8.12 Recalculating Results

The Recalculate Results option is used to recalculate current sample results with the
latest valid calibration factors of relevant test. This option is often used when test
result cannot be calculated due to incomplete or failed calibration.
Recalculate Results is only applicable to biochemical tests. Result of samples in In
Progress status cannot be recalculated. The recalculation will be automatically
recorded in event logs.
1 Select Sample > Current.
2 Select a test.
3 Select Recalculate Results.
Recalculate Results window
Results of the selected test for the specified samples are recalculated
automatically with the latest calibration factors and then displayed in the list at
the bottom.
4 Select OK.
8-36
8.8.13 Compensating Results

The Compensate Results option is used to recalculate multiple results of certain
biochemistry through the linear formula Y=K*X+B with specified slope K and offset B.
Compensate Results is invalid for ISE test and special calculations. A calculation will
be recalculated automatically once its constituent tests are compensated. Only users
that have sufficient permissions are allowed to compensate results. The
compensation will be automatically recorded in event logs.
2 Choose View Test.
3 Choose the test that you want to compensate in the left list.
4 Select Compensate Results.
All results of the test are displayed in the list at the bottom.
“Compensate” window
5 Select desired tests to compensate.

6 Input the slope K and offset B.
7 Select Ok.
The system recalculates all results of the test with the specified slope and offset.
The final results are displayed in the list of the window.
8.8.14 Archiving Results

The system allows archiving of sample results to a storage device. The file format is
CSV and the default file name is SampleResultYYYYMMDD.csv. which cannot be
edited.
Perform the following steps to archive sample results and data:
1 Search for desired sample results on the Current or History screen.
NOTE
It may take a long time to archive a large amount of results. You are recommended
not to archive results over one week each time.
2 Select Archive .
3 Select OK.
8-37
8.9 Test Statistics

On the Tests screen, you can view test requests and reagent application for each test
during a period, and you can sample requests and the quantity of its tests as well.
Calibration test and QC test are not included in the statistics.
1 Select Sample > Statistic.
2 Select By Sample or By Test.
Tests screen-by sample
Tests screen-by test
8-38
 By Sample: To view all requested samples and the quantity of their requested
tests.
 By Test: To view test requisitions and reagent volume for the tests.
3 Select Filter to select the date range.
4 Select OK.
All samples or tests requested during the period are displayed in the middle list of
the Tests screen.
8-39
8.10 Result Statistics

Result statistics option can summarize the total tests and the distribution trend of its
results, and provide the test data and graph. Calibration and control tests are not
included in the statistics.
2 Select the Statistic Graph or Statistic Data tab.
Result statistics screen -statistic graph
Result statistics screen -statistic data
3 Click Filter to select the date range.
8-40
4 Click OK.
The relevant statistic results are displayed on the screen.
5 Select to print out the statistic graph and statistic data.
8-41
8.11 Charge Statistics

On Charge statistics screen, you can view the charge information in a period of time.
8.11.1 Charge setup

2 Select Charge.
3 Select Charge setup.
4 Set the charge for each test.
5 Select OK.
6 Select Cancel to exit the window.
8.11.2 Search charges

2 Select Charge.
3 Click Filter to select the date range.
4 Select OK.
The number of tests and charges for each patient and the total quantity of tests and
the sum of charges are displayed on the screen.
8-42
9 Use of ISE Module
This chapter introduces the ISE module in the following aspects:

 Precautions on use
 Principles of measurement
 Test parameters setup
 Preparing reagents for analysis
 Running ISE tests
 Results recall
 Prime cycle and calibration factor expiration date
 Maintenance and troubleshooting
9-1
9 Use of ISE Module
9.1 Precautions on Use

9.1.1 Introduction
Read the following precautions thoroughly prior to using the ISE module.
9.1.2 Precautions on Use

Operator Precautions
Warning
The ISE module must be operated by skilled/trained doctors, nurses or clinical
professionals.
Driver parts precautions
Warning
Exercise caution while using the ISE module. Prevent your hair, legs or other parts of your
body from being hurt by the driver parts.
Serum sample biohazards
BIOHAZARD
The serum samples remaining in the electrodes may contain a great number of viruses.
Wear gloves to prevent infection while operating around the electrodes. If the sample
contacts skin, wash it immediately with soap and water.
Contact with the waste tube of ISE waste liquid may lead to infection. Follow the standard
laboratory specifications. Wear gloves and mask when handling ISE waste and ISE waste
tube.
Electrode precautions
CAUTION
The inner solution inside the electrodes will run off as the electrodes are used. If you find
that the inner solution inside an electrode decreases, weigh the electrode. If the electrode
weighs less than 9g, stop using it; otherwise, the measuring performance will be influenced.
The Cl electrode is vulnerable to vibrations. Use the Cl electrode carefully to prevent
damage.
The Na+/K+/Cl- electrodes can be used after activation. After unpacking the electrodes,
clean them with sufficient water. Before use, wipe them dry. A small amount of salt on the
electrodes may rust the conductive interfaces and affect the test results.
The service life of an electrode is 30,000 samples, three months on-board or until the
expiration date on the electrode package, whichever occurs first.
If electrodes are stored in refrigerated environment, allow them to equilibrate in room
temperature for a period of time before use.
9-2
9 Use of ISE Module
Calibration precautions
CAUTION
Calibrate the ISE tests for serum and urine before starting the measurement. If the result
of a test is based on the calibration factors of another test, it may not be accurate enough.
For ISE serum and urine calibration, when setting the calibration position on the calibration
rack, place the high-value calibrator (H-STD) in front of the low-value calibrator (L-STD),
otherwise the calibration will fail.
Perform ISE calibration under one of the following conditions: ISE buffer changes its batch;
the quality control is out of control; the ambient temperature is violently fluctuating; the
Na+/K+/Cl-/Ref electrode, the sample probe S1, the solenoid valve, the tubing, the sample
injection cup or other consumables are replaced. The calibration validity period of ISE is 24
hours. The calibration should be performed once a day to ensure accurate test results.
For ISE calibration, make sure to use the calibrator immediately after it is taken out and
avoid repeated use. Repeated use may volatilize or dilute the calibrator, increase or
decrease the ion concentration, and possibly result in inaccurate calibration results and
measurement results.
Buffer solution and calibrator biohazards
BIOHAZARD
The buffer solution and calibrators contain preservatives. In case your skin contacts the
buffer solution or calibrators, wash them off with soap and water. In case the buffer
solution and calibrators spill into your eyes, rinse them with water and consult an oculist.
If you swallow them by mistake, see a doctor.
CAUTION
Use the buffer solution and calibrators specified by our company. Use of other reagents or
calibrators may result in unreliable results, or damage the Hydropneumatic system, or even
shorten the electrodes life span.
Prior to using the buffer solution and calibrators, check if they are within the expiration date.
Do not use uncapped calibrators or ISE diluent that exceeds the expiration date; otherwise,
inaccurate results may be obtained.
When on-board stability time of ISE buffer is expired or ISE buffer is expired or insufficient,
replace it. Do not add the used buffer solution to a new buffer solution bottle. Otherwise,
the results may be inaccurate.
Place them correctly; otherwise, it may cause unreliable results, or leak, or module damage.
ISE detergent biohazards
BIOHAZARD
The ISE detergent is sodium hypochlorite. Use the ISE detergent carefully to prevent it from
contacting your skins or eyes. If your skins or eyes contact the ISE detergent, rinse them
off with fresh water and consult a doctor.
Do not use the uncapped detergent that is beyond the validity period; otherwise, the
cleaning effect may be affected and the accuracy of the test results may be affected.
9-3
9 Use of ISE Module
9.2 Principles of Measurement

The ISE unit measures the concentration of Na+, K+ and Cl- ions contained in serum
and urine samples with the ion-selective electrode method. The relation between the
electromotive force of ion-selective electrodes and the ion concentration is expressed
in a Nernst formula. Samples are diluted with buffer solution at the ratio of 1:33 and
then measured for ion concentration.
A single measurement of the ISE unit is conducted in the following order:
 Prime: When the measurement begins, buffer solution is pumped into the sample
cup.
 Measurement of buffer: The buffer solution in the sample cup is absorbed into the
flow cell for measurement.
 Sample analysis: 726μL buffer is pumped into the sample cup, and then mixed
with the 22μL sample dispensed by the sample probe. The sample-buffer mixture
is absorbed into the flow cell for measurement. When the measurement is finished,
the waste fluid is discharged from the outlet.
 Prime and buffer measurement: Buffer is pumped into the sample cup to prime it.
When the priming is finished, new buffer is pumped again into the sample cup and
then absorbed into the flow cell for measurement.
The table below lists the measurement range of the ISE module:
Measurement range of ISE module
Test Serum Urine

Na+ 100~200mmol/L 10~400mmol/L
K+ 1~10mmol/L 2~300mmol/L
Cl- 50~200mmol/L 15~400mmol/L
9-4
9 Use of ISE Module
9.3 ISE Test Parameters

9.3.1 Introduction
The ISE module measures the concentration of K+, Na+ and Cl- ions contained in
human body fluid by means of electrodes, helping diagnosis of electrolyte disturbance,
body fluid equilibrium, and other relevant diseases.
The ISE tests are applicable to serum and urine, and the default sample type is serum.
If the sample is of a type other than serum and urine, it will be analyzed with the test
parameters for serum.
The system allows the ISE test parameters to be viewed, modified and reconfigured.
Only administrators are allowed to modify ISE test parameters.
Define/Edit ISE tests window (1/2)
9-5
9 Use of ISE Module
Define/Edit ISE tests window (2/2)
9.3.2 Viewing ISE Test Parameters

The ISE test parameters are opened to all users for viewing in any system status.
2 Choose the ISE test.
3 Select Define and Edit.
4 View the following parameters:
 Calibrate replicates
 Dilution coefficient
 Temperature correction coefficient
 Ion concentration of H-STD
 Ion concentration of L-STD
 EMF of H-STD
 EMF of L-STD
 Slope range
 Concentration of buffer
 Gain
 Calibration tolerance
 Decimal
 Result unit
 Reagent on-board stability time
5 Select the down-arrow button to view the qualitative range and flag settings.
6 To modify the ISE parameters, refer to 9.3.4 Modifying/Configuring ISE Test
Parameters (page 9-7).
7 Select Rerun to close the window.
9-6
9 Use of ISE Module
9.3.3 Defining Print Name

The ISE tests are only represented by their print names on patient reports and appear
on other reports in the form of short name, i.e. Na, K, Cl. The print names can be defined
and modified, and if left blank, will be replaced by the short names on patient reports.
3 Select View and Edit.
4 Choose a sample type from the Sample Type pull-down list.
 Serum
 Urine
5 Enter the print names for Na, K and Cl in the Print Name field.
6 Select Submit.
7 Select Return.
9.3.4 Modifying/Configuring ISE Test Parameters

You are allowed to edit ISE tests if:
 You have sufficient permissions, and
 The ISE module status is Incubation, Standby, Stop or Sleep.
When modified, the test parameters should be configured, and then will be used for
sample measurement.
Perform the following procedure to modify and configure ISE test parameters:
3 Select View and Edit.
4 Choose a sample type from the Sample Type pull-down list.
 Serum
 Urine
5 Modify the test parameters.
6 Select Submit to save your modification and configure it for the ISE module.
7 To cancel the modification or restore the default values, select:
 Discard
 Restore Def
9.3.5 Summary of ISE Test Parameters

Calibrate replicates
Calibrate replicates refer to the maximum number of replicates that the high-/low-
concentration calibrator should be run.
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9 Use of ISE Module
Dilution coefficient
The Dilution Coefficient indicates the allowable range of dilution factor obtained in
calibration. If the dilution factor is beyond the range, a flag will appear on patient
reports. For more information about result flags, refer to 12.4 Data Alarm (page 12-7).
 The low limit of the range must be within 1-100, and the default is 25.0.
 The high limit of the range must be within 1-100, and the default is 60.0.
 Make sure that the high limit is greater than the low limit; otherwise, the system
will display a message indicating input range error.
Na test parameters
Configure the following parameters for the Na test:
 Concentration of H-STD: Na concentration of high-concentration calibrator
 Concentration of L-STD: Na concentration of low-concentration calibrator
 EMF of H-STD: electromotive force of Na ion in high-concentration calibrator
 EMF of L-STD: electromotive force of Na ion in low-concentration calibrator
 Slope range
 Concentration of buffer: Na concentration of buffer solution
 Gain
Na test parameters
Parameter Type Parameters Default Reference

Value Range
Na concentration of calibrator H-STD serum 160.0 100.0-200.0
L-STD serum 120.0 100.0-200.0
H-STD urine 200.0 10.0-400.0
L-STD urine 50.0 10.0-400.0
Slope range Low limit 38.0 0-100
High limit 65.0 0-100
Gain / 10 1-100
Na concentration of buffer / 2.00 0-5.00
Temperature correction Temperature correction 1.33 -10.0-10.0
coefficient coefficient of Na (serum)
Temperature correction 0.78 -10.0-10.0
coefficient of Na (urine)
Na EMF of calibrator Low limit of Na EMF in H- 250 -2450-2450
STD (serum)
High limit of Na EMF in H- 350 -2450-2450
STD (serum)
Low limit of Na EMF in L- 160 -2450-2450
STD (serum)
High limit of Na EMF in L- 270 -2450-2450
STD (serum)
9-8
9 Use of ISE Module

Value Range
Low limit of Na EMF in H- 190 -2450-2450
STD (urine)
High limit of Na EMF in H- 480 -2450-2450
STD (urine)
Low limit of Na EMF in L- -10 -2450-2450
STD (urine)
High limit of Na EMF in L- 230 -2450-2450
STD (urine)
K test parameters
Configure the following parameters for the K test:
 Concentration of H-STD: K concentration of high-concentration calibrator
 Concentration of L-STD: K concentration of low-concentration calibrator
 EMF of H-STD: electromotive force of K ion in high-concentration calibrator
 EMF of L-STD: electromotive force of K ion in low-concentration calibrator
 Slope range
 Concentration of buffer: K concentration of buffer solution
 Gain
K test parameters

Value Range
K concentration of H-STD serum 6.0 1.0-10.0
calibrator L-STD serum 3.5 1.0-10.0
H-STD urine 100.0 2.0-300.0
L-STD urine 10.0 2.0-300.0
Slope range Low limit 38.0 0-100
High limit 65.0 0-100
Gain / 10 1-100
K concentration of / 0.075 0-5.00
buffer
Temperature Temperature correction 1.02 -10.0-10.0
correction coefficient of K (serum)
coefficient Temperature correction 1.76 -10.0-10.0
coefficient of K (urine)
K EMF of calibrator Low limit of K EMF in H- 220 -2450-2450
STD (serum)
High limit of K EMF in H- 360 -2450-2450
STD (serum)
Low limit of K EMF in L- 110 -2450-2450
STD (serum)
High limit of K EMF in L- 250 -2450-2450
STD (serum)
9-9
9 Use of ISE Module

Value Range
Low limit of K EMF in H- 540 -2450-2450
STD (urine)
High limit of K EMF in H- 1160 -2450-2450
STD (urine)
Low limit of K EMF in L- 60 -2450-2450
STD (urine)
High limit of K EMF in L- 660 -2450-2450
STD (urine)
Cl test parameters
Configure the following parameters for the Cl test:
 Concentration of H-CAL: Cl concentration of high-concentration calibrator
 Concentration of L-CAL: Cl concentration of low-concentration calibrator
 EMF of H-CAL: electromotive force of Cl ion in high-concentration calibrator
 EMF of L-CAL: electromotive force of Cl ion in low-concentration calibrator
 Slope range
 Concentration of buffer: Cl concentration of buffer solution
 Gain
Cl test parameters

Value Range
Cl concentration of H- STD serum 120.0 50-200.0
calibrator L- STD serum 85.0 50-200.0
H- STD urine 180.0 15.0-400.0
L- STD urine 50.0 15.0-400.0
Slope range Low limit -65.0 -100-0
High limit -38.0 -100-0
Gain / 5.0 1-100
Cl concentration of / 2.00 0-5.00
buffer
Temperature Temperature correction -0.15 -10.0-10.0
correction coefficient of Cl (serum)
coefficient Temperature correction -0.20 -10.0-10.0
coefficient of Cl (urine)
Cl EMF of calibrator Low limit of Cl EMF in H- -180 -2450-2450
STD (serum)
High limit of Cl EMF in H- -95 -2450-2450
STD (serum)
Low limit of Cl EMF in L- -100 -2450-2450
STD (serum)
High limit of Cl EMF in L- -20 -2450-2450
STD (serum)
9-10
9 Use of ISE Module

Value Range
Low limit of Cl EMF in H- -260 -2450-2450
STD (urine)
High limit of Cl EMF in H- -90 -2450-2450
STD (urine)
Low limit of Cl EMF in L- -110 -2450-2450
STD (urine)
High limit of Cl EMF in L- 40 -2450-2450
STD (urine)
Calibration tolerance
Calibration Tolerance is the difference of replicate results of a calibrator and used to
check the accuracy of ISE test calibration. If the obtained difference is beyond the
calibration tolerance range, a flag will appear on patient reports. For more information
about result flags, refer to 12.4 Data Alarm (page 12-7).
The table below shows the calibration tolerance range of each ISE test: (The high and
low tolerances are the same for each test.)
Calibration tolerance of ISE tests
Parameter Default Value Reference Range

Na (serum) 3.0 0-9.9
Na (urine) 5.0 0-9.9
K (serum) 3.0 0-9.9
K (urine) 5.0 0-9.9
Cl (serum) 3.0 0-9.9
Cl (urine) 5.0 0-9.9
Decimal
Decimal specifies the number of decimal places for test results. It can be defined for
each of K, Na and Cl tests of serum and urine samples.
The range is 0-6 decimal places. The default K+ in serum and plasma is 0.01 with two
decimal places. The range for Na+, Cl - in serum and Na+, K+, Cl – in urine is 0.1 with
one decimal place.
Unit
The result unit for K, Na and Cl is mmol/L, and can only be viewed rather than modified.
The result unit has nothing to do with the sample type and is the same(mmol/L) for all
sample types.
On-board Stability time

The on-board stability time is the number of days that the reagent can be kept valid
since uncapped at the first time.
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9 Use of ISE Module
9.4 Preparing ISE Reagents for Measurement

9.4.1 Introduction
When the ISE module is removed from the system, the ISE buffer solution and wash
solution that have been loaded will be deleted automatically. Install and replace ISE
reagents as instructed below.
9.4.2 Loading Buffer Solution

The buffer solution is used for measurement of ISE tests and can only be loaded
manually. The lot number, serial number, expiration date and volume must be entered
when ISE buffer solution is loaded.
1 Select Reagent > R List > Consumable.
2 Choose a module from M1 to M2 to load ISE buffer solution.
If more than one analyzer has been configured with an ISE module, the ISE buffer
solution should be loaded separately. If ALL is selected, loading buffer solution
cannot be done.
3 Select ISE Buffer.

4 Select Load. The Load Reagent window is displayed.
5 Open the front door of the analyzer.
6 Uncap the new ISE buffer tank.
7 Push upward the ISE slide, take out the empty ISE buffer tank. Put the buffer level
sensor into the new buffer tank, and then cap the new buffer tank.
NOTE
After taking out the buffer level sensor from the empty buffer tank, directly put it into
the new buffer tank rather than on the bracket or ground in order to avoid
contaminating the ISE buffer.
8 Place the ISE buffer into the cabinet.

 Volume (required)
 Number of primes (required)
 Serial number
 Expiration date (required)
 Lot number
11 Select Load. The system will prime the ISE module for the specified times.
12 Select Exit to close the window.
9.4.3 Loading ISE Detergent

ISE detergent is loaded in position 1 on the maintenance rack.
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9 Use of ISE Module
9.5 Calibration and Results Recall

9.5.1 Introduction
You should define the ISE calibrators and assign positions for them prior to running a
calibration. Current calibration factors and all intermediate data are provided on the
ISE Calibration screen. Calibration results can be printed out or archived to an external
storage device. The Trend option is provided to enable you to view the calibration
trends of ISE tests during a period of time. When the calibration factors are expired,
the Extend Calibration Time can help prolonging their validity period for measurement.
9.5.2 Calibration Setup

Set up ISE calibrators and the calibration time. When a calibrator is expired, it will be
indicated in yellow and cannot be used for calibration.
Setting up ISE calibrator

1 Select Reagent > Cal Setup.
2 Choose an ISE calibrator from the calibrator list.
The ISE calibrators provided by the system include:
 HSTD Serum
 LSTD Serum
 HSTD Urine
 LSTD Urine
3 Select expiration date for the calibrator.
The input range is 0-18 and accepts numbers and letters.
5 Assign rack number and position.

6 Select Submit.
9.5.3 Calibration Status and Alarm

On the Calibration Status screen, the tests are indicated with various texts and colors
for different calibration status. Tests in Cal Required, Cal Failed or Cal Time Out status
can be requested but will not be run.
Check the tests’ calibration status frequently and take relevant actions according to
the following table.
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9 Use of ISE Module
ISE calibration status

Calibration Description Severity Color
Status
Cal Required Indicates that the test needs to be Serious Red
calibrated.
This status appears when the test is
not calibrated or the ISE
reagent/electrode is replaced.
Requested Indicates that the test has been Normal No color
requested for calibration but not indication
finished yet.
Calibrated Indicates that the test has been Normal No color
calibrated successfully and has not indication
exceeded the calibration time.
Cal Failed Indicates that the test has Serious Red
calibration factors calculated but
they exceed the acceptance limits,
or has no calibration factors
calculated.
Cal Time Out Appears when the test exceeds the Serious Red
calibration period or the reagent of
different serial number and lot
number is used. Appears when the
test exceeds the calibration time.
Cal Time Indicates that the calibration period Warning Yellow
Extended has been extended and the current
calibration factors can be used
without time limit.
9.5.4 Requesting a Calibration

ISE tests are divided into serum and urine, each of which includes three tests. The
serum tests include Na (serum), K (serum) and Cl (serum), which are calibrated with
ISE Serum L-CAL and ISE Serum H-CAL; the urine tests include Na (urine), K (urine) and
Cl (urine), which are calibrated with ISE Urine L-CAL and ISE Urine H-CAL.
2 Choose an analyzer or All to run calibration.
3 Choose ISE Serum or ISE Urine, or choose both of them.
4 Select Cal.
5 To cancel the calibration requisition, select No Cal.
Only calibrations in Requested status can be cancelled.
9.5.5 Starting Analysis

3 Select Load List.
The calibrator list shows all requested ISE tests as well as calibrators, positions,
concentration, lot number and expiration date.
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9 Use of ISE Module
4 load calibrators to the relevant rack according to the calibrator list.
5 Select on upper right corner of the main screen. The Start Conditions
window is displayed.
9.5.6 Results Recall

The calibration data and trends of ISE tests are provided on the ISE Calibration screen.
The system allows you to recall the current ISE calibration factors and results of recent
540 calibrations. If a calibration result is abnormal, a flag will be added on patient
reports and on the ISE Calibration screen.
For more information about result flags, refer to 12.4 Data Alarm (page 12-7).
Recalling calibration results

2 Select a module.
3 Select Filter button and input date range.
4 Select OK.
The calibration results of the test are displayed in the result list.
Recalling calibration data

All intermediate data during the ISE calibration can be recalled through the ISE
Calibration Data window.
1 Search for desired calibration results on the Calibration Result screen.
2 Select Cal Data.
3 Choose an ISE test in the result list.
Recalling calibration trends

1 Search for desired calibration results on the Calibration Result screen.
2 Click View Details.
3 Select Trend. The Calibration Trends window is displayed.
4 Select Filter button and input date range.
5 Choose the Tabular Trend tab to view the trend data.
Archiving ISE calibration results

Both the current and early calibration factors of ISE tests can be archived. The
archiving file is of .csv format and named by the date and time the results are archived.
1 Select Calibration > Cal Result.
2 Search for desired calibration results.
3 Select Archive button .

4 Specify archiving path and file name.
5 Select Save.
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9 Use of ISE Module
9.5.7 Extending ISE Calibration Time

When ISE calibration factors exceed the validity period, they cannot be used for
measurement, and the calibration status changes to Cal Time Out. If you are certain
that the calibration factors are correct and valid, you may prolong their validity period
by using the calibration time extension function. A calibration time can be extended
only if the current calibration of the test is timed out or succeeded. The results
calculated based on extended calibration factors will be flagged.
3 Select Extended.
4 Select OK. The calibration factors of the ISE test can be used without time limit.
5 To remove the extended status, recalibrate the ISE test.
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9 Use of ISE Module
9.6 Quality Control and Results Recall

9.6.1 Quality Control and Results Recall
Control samples can be defined, run and recalled for the ISE tests in the same way as
for biochemical tests. The ISE tests are divided into the following based on the sample
types:
 Na (serum)
 K (serum)
 Cl (serum)
 Na (urine)
 K (urine)
 Cl (urine)
For the operating procedure of quality control, refer to 3.7 Quality Control (page 3-34).
For details of QC evaluation and results recall, refer to 7 Quality Control (page 7-1).
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9 Use of ISE Module
9.7 Sample Ordering and Results Recall

9.7.1 Sample Ordering and Results Recall
The ISE tests, like biochemical tests, can be also used for analyzing routine samples,
emergent samples, added samples and reruns, and requested along with the
biochemical tests. They are requested in the form of Na, K and Cl, and applicable to
serum, plasma and urine. The four sample types other than urine are ordered with the
serum parameters, while urine sample is with the urine parameters.
Follow the clinical laboratory test method to collect samples for ISE test. Use newly
collected serum, plasma (anti-coagulated with lithium heparin) or urine as samples.
Avoid using hemolysis and lipemia samples. After centrifugation, do not leave the
serum on the cells. The concentration of potassium ions in the red blood cells will be
much higher than that in the serum or plasma, which will be released into the serum or
plasma, resulting in falsely high K results. In the coagulation process, potassium ions
are released from the platelets in the patient with thrombocytosis. Generally, the higher
the platelet count, the greater the error, resulting in pseudohyperkalemia. For this type
of patients, it is recommended to use lithium heparin anticoagulant tubes to collect
plasma samples for testing.
Serious lipemia samples may affect the accuracy of test results. Samples containing
visible lipemia can be removed by ultracentrifugation. Urine turbidity samples must be
removed by centrifugation.
Some anticoagulants, preservatives, drugs, and organic compounds may affect the
measurement of Na+, K+, and Cl-. Note that unknown interference from drugs or
endogenous materials may affect the measurement results.
In order to prevent the volatilization of the sample and the fluctuation of the test results
caused by the change of the activity of the ions when the sample is placed too long,
the sample should be stored in a refrigerator and sealed. In addition, the samples
stored in a refrigerator should be tested after being restored to the normal temperature.
Nevertheless, the ISE tests are slightly different from biochemical tests for that they
do not support the measurement with increased, decreased, or prediluted samples.
Only when ISE tests are Calibrated or Extended can they be requested for sample
analysis.
For the operating procedure of sample analysis, refer to 3.8 Ordering Routine Samples
(page 3-37).
ISE test results have no reaction curves and can be recalled in the same way as other
tests. Refer to 8 Sample Ordering and Processing (page 8-1) for details.
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9 Use of ISE Module
9.7.2 Recalling Reaction Data

ISE tests have no reaction curves but reaction data, which includes the primary data
and calculated parameters. The primary data include Sample (mV), Buffer (mV), Buffer
1 (mV), Buffer 2 (mV), Sample Th1, Buffer Th1, Sample Th2 and Buffer Th2; the
calculated parameter is S-B (Sample-Buffer).
Primary data and calculated parameter of ISE tests
Data Item Description
S-B (sample - buffer) Difference of sample and buffer, indicating the response
of ISE test.
Sample Electromotive force for sample analysis.
Buffer Average electromotive force of buffer 1 and buffer 2.
Buffer1 Electromotive force of the buffer when it is measured at
the first time, that is, prior to sample analysis.
Buffer2 Electromotive force of the buffer when it is measured at
the second time, that is, after sample analysis.
Sample Th1 Output of the temperature sensor during sample
analysis.
Buffer Th1 Output of the temperature sensor during buffer
measurement.
Sample Th2 Output of the temperature sensor during sample
analysis.
Buffer Th2 Output of the temperature sensor during buffer
measurement.
Perform the following steps to recall ISE reaction data:

1 Search for desired samples on the Current screen.
2 Choose an ISE test in the result list.
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9 Use of ISE Module
9.8 ISE Prime Cycle

9.8.1 Introduction
While the analyzer is started up and new reagent pack is identified, the ISE module will
prime automatically to replace the reagents inside of it with fresh reagents. The
number of primes can be defined on the System Setup screen.
Only administrators are allowed to define or modify the prime times.
9.8.2 Defining/Modifying ISE Prime Times

1 Select Setup > System > Instrument Configuration.
2 Type in the number of primes in the ISE Prime Cycle field.
3 Select OK.
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9 Use of ISE Module
9.9 Daily Maintenance

9.9.1 Daily Maintenance
To ensure the ISE module’s life span and measurement performance, maintain it
regularly as instructed in this manual. The system provides scheduled maintenance
and maintenance instructions, in which the latter contains all of the scheduled
maintenance procedures and some maintenance instructions that can be performed
independently.
The table below is a summary of the scheduled maintenance procedures and
maintenance instructions for the ISE module.
Scheduled maintenance and instructions for ISE module
Schedule Maintenance Procedures

Daily Clean ISE electrodes
Weekly Clean ISE tubes
Monthly Clean sample injection cup and drain outlet
Other Replace ISE electrodes
Water prime
Store electrodes
Maintenance instructions Clean electrodes
Clean tubes
Clean sample injection cup and drain outlet
Water prime
Replace electrode
Buffer prime
Drain waste
Home
Store electrodes
For more information about ISE module maintenance, refer to 11 Maintenance (page
11-1).
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9 Use of ISE Module
9.10 Troubleshooting ISE Module

9.10.1 Troubleshooting ISE Module
The failures occurring on the ISE module may be related to the sample probe unit, rack
feeder unit, Hydropneumatic unit, ISE module, reagent inventory, reference electrode
and communication.
For troubleshooting of the ISE module, refer to 12 Alarms and Troubleshooting (page
12-1).
9-22
10 LIS
This chapter contains communication parameter setup of LIS, sample analysis and
result transmission when an LIS is connected.
10-1
10 LIS
10.1 Overview
The chapter provides detailed description of the LIS.
Laboratory Information System (LIS) is an external host computer connected with the
chemistry analyzer through a fixed interface. The LIS is used to download sample order
information to the analyzer and receives results sent from the analyzer.
You should set up the communication parameters and results transmission methods
prior to using the LIS host.
Check that your analyzer is equipped with a LIS. If needed, contact our customer
10-2
10 LIS
10.2 LIS Communication

10.2.1 Introduction
The host communication parameters, such as transmission mode, IP address and port,
should be set up prior to use of the LIS host. To download sample order information
from or sent results to the host, you need to set up the test code used for identification
of tests on both the LIS host and the analyzer, which, otherwise, cannot identify the
tests simultaneously.
10.2.2 Host Communication Parameters

2 Select LIS. The Host Communication Parameters window shows.
Host communication Parameters window
3 Set up the following parameters:

Host communication parameters
Transport Choose a transport mode from the Transport Mode pull-down
list. The options include Serial and TCP/IP. The default is Serial.
IP address Enter the IP address of the LIS host. The connection between
the analyzer and the LIS host is based on the network, i.e.
TCP/IP protocol.
Port Enter the interface number of the LIS host.
Timeout Enter the timeout limit for querying the LIS host. The input
range is 30s-60s, and the default is 30s.
10-3
10 LIS
If the timeout limit is exceeded when you attempt to download
sample orders from, or send results to, or connect the analyzer
with the LIS host, the system will give an alarm indicating
communication timed out.
Serial If you choose Serial as the transport mode, set up the following
communication parameters:
parameters  Serial port: The default is COM1.
 Data bits: 7 or 8. The default is 8.
 Stop bits: 1 or 2. The default is 1.
 Parity: None, Odd, or Even. The default is None.
 Baud rate: 300, 1200, 2400, 4800, 9600, or 19200. The
default is 9600.
Mode Choose a data transmission mode for the analyzer and LIS
host. The available options are Unidirectional and Bidirectional.
 Unidirectional: You are only allowed to send results and
patient demographics to the host rather than downloading
sample orders from it.
Bidirectional: You are allowed to send results and patient
demographics to the host and downloading sample orders
from it.
Protocol Choose a protocol for connection between the analyzer and the
LIS host from the Protocol pull-down list. The options include
HL7 and ASTM 1394.
Protocol LIS protocol version. When version 2.0 is selected, LIS Flag
Version Custom is enabled. You can set which flags are sent to LIS.
4 Set up upload and download parameters:
Send Complete When the checkbox is selected, the system will automatically
Samples send results to the LIS host after a sample changes from In
Progress to Complete. This function is only applicable to
samples analyzed on the current day rather than those
analyzed before.
Send When the checkbox is selected, the system will automatically
Incomplete send results to the LIS host after a sample changes from In
Samples Progress to Incomplete. This function is only applicable to
samples analyzed on the current day rather than those
analyzed before.
Send Actual When the checkbox is selected, all actual results and rerun
Results and results of each test will be sent to the LIS. If this option is not
Rerun Results: selected, only the default result will be sent.
Bypass Results When the checkbox is selected, those results that are beyond
Beyond the linearity upper limit will not be sent to the LIS. If this option
Linearity Upper is not selected, they will be sent.
Limit
Bypass Results When the checkbox is selected, those results that are beyond
Beyond the linearity lower limit will not be sent to the LIS. If this option
Linearity Lower is not selected, they will be sent.
Limit
10-4
10 LIS
Send the QC When the checkbox is selected, the system will send the QC
result as that of test results as those of routine samples when QC sample is
routine sample ordered as a routine sample.
Resend result Sample results are sent to LIS after SI check is performed for
after SI Check the sample.
STAT Sample includes Sample, ISE/Biochemistry and Test. Selecting sample
Setting means when all the test results of the sample are completed,
the results will be sent to LIS. Selecting Test means when the
result of a test is produced, its result will be sent to LIS.
Selecting ISE/Biochemistry means when all tests of ISE or all
tests of biochemistry are completed, the results are sent to LIS.
Routine Sample includes Sample, Test and ISE Test. Selecting sample means
Setting when all the test results of the sample are completed, the
results will be sent to LIS. Selecting ISE/Biochemistry means
when all tests of ISE or all tests of biochemistry are completed,
the results are sent to LIS. Selecting Test means once its test is
completed, the result is sent to LIS.
Download Settings
Rerun Finished When the checkbox is selected, tests that have been finished
Tests When will be rerun if downloaded again. If this option is not selected,
Downloaded: they will be neglected.
Auto Number The system automatically numbers the samples which have
Scanned been scanned.
Samples:
Fuzzy match if this option is selected, system matches the sample type after
sample type sample information is downloaded from LIS. If the downloaded
information contains sample type then this sample type is
used. If not, the sample type is other type.
Merge Samples If sample information downloaded from LIS includes both bar
by Sample ID code and sample ID, but matching sample in the analyzer
cannot be found through barcode, then sample ID is used to
find the sample. When the barcode of the found sample is
blank if merge samples by sample ID is selected, then the
sample information downloaded from LIS will be merged with
that of the found sample. if “merge samples by sample ID” is
not selected, then a new sample is established with the bar
code of the obtained sample and a blank sample ID.
Send barcode Disabled by default. When it is selected, enter the barcode that
failed to read failed to read. The barcode length is within 3-27digits.
Ignore Alarms When the checkbox is selected, the system will not give an
for Unknown alarm if the samples downloaded from the LIS host contain
Tests unknown tests without identification code. If this option is not
selected, an alarm will be given indicating sample order failure.
5 Select OK.
10-5
10 LIS
10.2.3 Defining Channel Number of Tests

Tests are identified by channel number on the analyzer and LIS host. Make sure that
the channel numbers assigned to tests on the analyzer are consistent with those on
the LIS host; otherwise, correct information transfer cannot be done.
1 Select Setup > System > LIS Settings.
2 Select Channel No.
3 View Channel No. List.
The list shows test abbreviation and channel number. The left column provides all
tests that have been defined and set up correctly; the right column shows the code
for identifying a test on the LIS host.
4 Click on the Channel No. column of a test, and then type in a code for it.
5 Repeat step 4 to define a code for other tests.
6 Select OK.
10-6
10 LIS
10.3 Ordering Samples with LIS Host

Sample ordering information can be sent by or downloaded from the LIS host, and then
the measured results are sent to it manually or in real-time mode.
Both bar-coded and non-bar-coded samples can be ordered with the LIS host. When a
sample bar code module is configured, the system will automatically identify samples
and match them with the ordering information downloaded from the host. If there is
no sample bar code module, you should manually assign positions for the downloaded
samples.
10.3.1 Ordering Functions

Samples can be downloaded manually or automatically from the LIS host. If the system
status is Standby, you are allowed to download samples manually from LIS.
Sample orders downloaded from the LIS host can be edited. When orders are
downloaded for samples that are in ordered status, the requested tests in the orders
will be used to overwrite the original tests; if the samples are in a status other than
ordered, the requested tests will be added to the original ones.
Sending sample orders from LIS

Sending bar-coded samples:
1 When samples are sent from the LIS host to the analyzer, select Sample > S Orders.
2 Select Order List to view the received samples.
3 On the Sample Orders screen, type in the sample bar code, and then confirm the
order information.
4 Select OK.
5 Load the samples to idle positions of rack.
6 Select the icon.

Obtaining samples automatically

When the system status is Standby or Sample Load, load the samples to rack and then
select . The system will automatically scan the samples and then query the LIS
host to download relevant order information. After matching the downloaded order
information with the samples, the system will start the analysis.
The obtained sample order information includes:
 Patient demographics: patient name and sex.
 Requested tests: sample bar code, sample ID, sample type, test code.
Downloading samples manually

Downloading bar-coded samples:
2 Select Download Test Information.
3 Choose one of the following options:
 All ordered samples: to download all samples ordered on the current day.
10-7
10 LIS
 Latest samples: to download samples that are ordered on the current day but
have not been downloaded.
 Samples with the following IDs: to download samples with the specified order
date and ID. Enter the sample IDs or ID range to download.
 Sample with the following bar code: to download the sample with the
specified bar code. Enter the bar code of the desired sample.
4 Select OK.
5 Confirm the sample information and selected tests/panels on the Sample List
screen.
6 Load the samples to idle positions of rack.
7 Select the icon on the upper-right corner of the main screen, set the
analysis conditions, and then select OK to start analysis.
10-8
10 LIS
10.4 Result Transmission

Sample results and QC results can be sent manually or in real-time mode to the LIS
host for reviewing and storage. When a sample is analyzed with its all tests finished,
the system can automatically send the test results to the LIS host; also you are allowed
to search for desired results and then manually send them to LIS.
Patient demographics, sample results and QC results can be sent to the LIS host.
10.4.1 Result Transmission Setup

When all tests of a sample are finished and at least one of them has calculated a result,
the result can be sent to the LIS host automatically. The results of all replicates of a
sample or test will sent to the LIS host.
2 Select LIS. The Host Communication Parameters window shows.
3 Mark the Send Complete Samples or Send Incomplete Samples checkbox with a
tick.
A sample will be sent to the LIS host automatically when it changes from In
Progress to Complete or Incomplete. If you won’t send results, deselect the
checkbox.
4 Select OK.
10.4.2 Manually Sending Results to LIS Host

2 Search for control results or sample results to transmit.
3 Select desired samples in the sample list.
4 Select .
5 Select the sample range you want to transmit:
 Selected sample(s)
 All samples
6 If you transmit all results, you are allowed to skip those that are already
transmitted to the LIS host. Mark the Bypass Transmitted Results checkbox.
7 Select OK.
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10 LIS
10.5 Troubleshooting LIS

For troubleshooting methods of the LIS host, refer to 12 Alarms and Troubleshooting
(page 12-1).
10-10
11 Maintenance
This chapter provides you with maintenance of the instrument, including frequently-
used maintenance commands and scheduled maintenance procedures. The purpose,
time, system status, precautions and steps of each maintenance procedure are
described here.
11-1
11 Maintenance
11.1 Overview
11.1.1 Introduction
To ensure the reliable performance, good working condition and service life of the
system, operate and maintain the system regularly in strict accordance with the
requirements of this manual. Even if you are only an operator, it is very important for
you to understand the maintenance and overhaul knowledge in this chapter. In-depth
learning will help you achieve the best operation status and performance during use.
For problems that cannot be solved during use and those that are not covered in this
chapter, contact our customer service department or your local distributor.
Warning
 Do not perform any maintenance that is not described in this chapter. Otherwise, system
damage and personal injury may be caused.
 Do not touch components that are not intended to be operated and maintained by the
user.
 Unauthorized service of the system may damage the system and cause personal injury,
and invalidate the promised terms in the service contract.
 When the maintenance is complete, check if the system works normally.
 Do not spill water, reagent or other liquid on the mechanical or electrical parts of the
system.
 If the system is to be stored for a long time (over 1 week) or transported, contact our
customer service department or your local distributor to perform necessary
maintenance in order to ensure the system's optimal performance in next startup.
Biohazard
Wear gloves and lab coat, if necessary, goggles.
11.1.2 Accessory Information

Use accessories manufactured or recommended by our company to ensure personal
safety and system performance. If necessary, contact our customer service
11-2
11 Maintenance
Accessory Information
Component Name Position Remarks

Tungsten-halogen lamp 12 Lamp housing Replace the parts
V 50 W lamp regularly. Replace the
lamp when it has been
used for 2400 hours or the
system prompts that the
lamp intensity is
insufficient.
It is recommended that
each lamp has been used
for no more than 6
months.
Reagent probe assembly Reagent probe arm Replace parts from time
to time. Replace it when it
is damaged or bent.
Sample probe assembly Sample probe arm Replace parts from time
is damaged or bent.
Mixer Mixer arm Replace parts from time
is damaged.
Water inlet filter Water supply to the Replaced every 6 months
analyzer
CD80 detergent / Consumables
Detergent A acid wash / Consumables
solution
Detergent B alkaline wash / Consumables
solution
Mindray inner ring bottle Reagent disk Consumables
(62 ml)
MR Serum Standard H&L ISE module(Optional) Consumables
set (ISE serum calibrator)
MR Urine Standard H&L set ISE module(Optional) Consumables
(ISE urine calibrator)
MR Buffer Solution(ISE ISE module(Optional) Consumables
buffer)
MR Detergent Solution(ISE ISE module(Optional) Consumables
wash solution)
MR Na electrode(Sodium ISE module(Optional) Consumables
electrode)
MR K electrode(Potassium ISE module(Optional) Consumables
electrode)
MR Cl electrode(Chlorine ISE module(Optional) Consumables
electrode)
MR Ref ISE module(Optional) Consumables
electrode(Reference
electrode)
11-3
11 Maintenance
Component Name Position Remarks

MR Na/K Check ISE module(Optional) Consumables
Solution(Sodium and
potassium electrode test
solution)
Urine Quality Control(Urine ISE module(Optional) Consumables
Control)
11.1.3 Materials required and tools

The following tools are required for maintenance of the system.
Accompanying Supplies and Tools
Accompanying Supplies and Tools
Supplies and Tools Applicable Maintenance

Cross-head screwdriver φ3.3× 100 Removing the Enclosure and Cooling Fan
Cross-head screwdriver φ4.7× 100 Installing probes and lamps
Flathead screwdriver φ4.7× 100 Install/remove the probe and install the tube
clamp
CD80 Detergent Special Wash
Detergent A acid wash solution Special Wash
Detergent B alkaline wash solution Special Wash
Detergent C probe detergent cleanser Special Wash
Needle, 0.25+/-0.01 mm*125 mm Unclogging
round head
Unclogging device for reagent probe Unclogging reagent probe
Unclogging device for sample probe Unclogging sample probe
Tools prepared by the user

Tools prepared by the user

Tube brush Clean Filter Core
Clean gauze Check the syringe, wipe the rotor,
probe/mixer exterior
Cotton swabs Clean wash wells and sample compartments
Vacuum cleaner Clean fans and dust screens
Hair brush Clean dust screens
Forceps Removing/Installing Probe and Syringe
Washer
Screw syringe Unclogging the sample probe and reagent
probe
Tube brush or ultrasound cleaner Clean Filter Core
Beaker Unclogging
Ethanol Clean the photometer lens, probes, mixers
and wash station.
Fiber-free gloves Clean and replace cuvettes
11-4
11 Maintenance

Large water container Clean DI Water Tank
On-screen keyboard wash solution Clean the touch screen and keyboard
Sample cup Clean ISE Electrodes
Pipette Clean ISE tubes, sample injection cup and
drain outlet
11-5
11 Maintenance
11.2 Maintenance Screen

11.2.1 Maintenance Screen Overview
1 Select System > Maintenance to access the Maintenance screen, which is used
to perform common maintenance procedures.
2 Select a module to display the Scheduled Maintenance screen. The screen shows
the biochemistry maintenance procedures that are frequently used. (ISE
maintenance procedures are displayed on the screen only when an ISE module is
configured in Setup > System > Instrument Setup > Optional Modules.
3 The Scheduled Maintenance window consists of the maintenance frequency tabs,
maintenance list, scroll bar, and function buttons. Select a tab to view relevant
maintenance procedures. Choose a maintenance procedure, and then select the
function buttons to perform relevant operations.
You are allowed to sort maintenance items by clicking the on the Scheduled
Maintenance tab. The Procedures are sorted in alphabetical order, the Date
Performed is sorted by time, and the Maintenance Status is sorted in the order of
Failed, Expired, and Successful. The module filter function is available on the
upper right corner of the maintenance screen. You can select a module to view
maintenance information.
Scheduled Maintenance screen
The fields and buttons on the screen are described in detail below.
Maintenance List
This window shows all preset maintenance procedures and user-defined shutdown
maintenance procedures. Select an instruction and click Execute to start. On the
maintenance setup screen, you are allowed to set up the maintenance procedures
automatically performed by the system as shutdown procedures. When the tests are
finished, the system will automatically perform the maintenance procedures and then
shut down the system.
11-6
11 Maintenance
Manual Confirm
When Manual Confirm is selected, the maintenance procedures list shows all manual
maintenance procedures of the current frequency. Choose a maintenance procedure
and click OK. The system records the maintenance time and changes the maintenance
status to Successful.
Semi-auto Perform
When Semi-Auto is selected, the maintenance procedures list shows all semi-auto
Perform maintenance procedures in the current frequency. Select a maintenance
procedure and click Execute. When maintenance is started, manual interaction is
required during system maintenance.
Auto
When Auto is selected, the maintenance procedures list shows all automatically
performed maintenance procedures in the current frequency. Choose a maintenance
procedure and click Execute. The system starts to execute the procedure automatically.
Module
Displays the module that executes maintenance instructions.
Frequency
Displays the frequency of maintenance commands, which can be divided into daily,
weekly, biweekly, monthly, 6 months and when appropriate.
Maintenance Procedures
Displays the maintenance procedure name.
Maintenance Conditions
Displays the conditions to execute the maintenance command.
Date Performed
Displays the last time the maintenance procedure is performed. After performing
maintenance operations, choose a maintenance procedure and click OK. The date is
refreshed as the current date. The system will recount down the maintenance period
from the current time.
Maintenance Status
The maintenance status is Successful or Failed.
Maintenance Log
Abnormalities or other important events that occur during maintenance are recorded
in logs.
Scroll bar
If all maintenance procedures of a period are not displayed on the current screen, use
the scroll bar to view more maintenance procedures.
Maintenance History
You are allowed to recall the maintenance procedures of a period of time.
Maintenance Setup
The user shall be able to set up maintenance periods and set up maintenance
procedures that will be run automatically before system shutdown.
11-7
11 Maintenance
11.2.2 Maintenance Setup

On the maintenance setup screen, you are allowed to set up daily maintenance
frequency and auto maintenance.
1 Click Maintenance Setup on the Scheduled Maintenance screen.
2 Select a maintenance procedure on the daily maintenance screen, and then select
a maintenance frequency on the right side. You are allowed to choose a frequency
for all scheduled maintenance procedures except those defined.
3 If the maintenance procedure is performed automatically, select Auto
Maintenance Setup. By selecting a maintenance procedure, you are allowed to
define the date/time, shutdown procedure and cycles for the maintenance. This
option is selected by default. You can set idle period for the daily, weekly and
quarterly auto maintenance procedures. When the system status is satisfied, it
will automatically execute the maintenance. If the maintenance is performed
when the analyzer is shut down before the idle period, the maintenance is not
performed during the idle period.
Maintenance setup – Scheduled maintenance setup screen
11.2.3 Maintenance History

1 Click Maintenance History on the Scheduled Maintenance screen.
2 Select to export history record.
3 Select to print history record

4 Select Maintenance Data to view maintenance data.
After Cuvette Check or Weekly Special Wash and Cuvette Check, select Maintenance
Data to view and print the cuvette blank value.
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11 Maintenance
11.3 Scheduled Maintenance

11.3.1 Introduction
Scheduled maintenance procedures are determined by use of the components and
frequency of performance, and should be performed regularly by trained personnel to
ensure reliable performance and reduce unnecessary service calls. Read this section
carefully prior to doing the maintenance.
Most of the scheduled maintenance procedures are performed by executing
maintenance instructions, while the remaining part by manual operations. Perform the
maintenance strictly as instructed in this manual.
11.3.2 Maintenance Schedule

The scheduled maintenance procedures are divided into the following periods:
 Daily: 1 day
 Weekly: 8 days
 Two-week: 15 days
 Monthly: 31 days
 Three-month: 91 days
 Six-month: 181 days
 Other (As-needed/As-required)
The maintenance frequency is counted down from the date of performing. When the
countdown becomes 0, the corresponding maintenance procedure is highlighted in
yellow. To determine that a due maintenance procedure is due, check if the following
items are displayed in yellow background:
 Maintenance button
 Maintenance frequency tab
 Maintenance procedure
The maintenance information will not be lost when the operating software version is
upgraded. When new version software is installed to remove the system failure or fix
the system, the maintenance counter returns to 0 and restarts a countdown.
11.3.3 Scheduled Maintenance Procedures

Maintenance procedures vary from different maintenance frequencies.
11.3.4 Maintenance Log

The following table lists the components to be maintained and the recommended
maintenance schedule. Please copy this form on a monthly basis, and mark the record
in the column corresponding to the maintenance date after the maintenance.
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11 Maintenance
11-10
11 Maintenance
Maintenance Record
Year Month
Maintenance (Daily) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Check DI Water Connection
2 Check Waste Connection
Check inventory of CD80
3 detergent and probe wash
solution
4 Check Sample/reagent Syringe
Check Sample Probe Wash
5
Solution
6 Check mixer installation position
7 Clean ISE electrodes
8 Special Wash Probes/Mixers
Maintenance (Weekly) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Weekly special wash and cuvette
1
check
Ultrasonic cleaning of sample
2
probe
Maintenance procedures(Every two
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
weeks)
1 Clean ISE Tubes
Maintenance procedures(Monthly) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Clean Cuvette Wash Station
2 Clean wash wells
3 Clean SIC and drain outlet
Wash R1\R2 physiological saline
4
bottle
Maintenance (Every three months) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Diluted Wash Solution Dilution
1
Ratio Self-calibration
Probe Interior Wash Pressure
2
Adjustment
Whole Unit Circulating Water
3
Wash Pressure Adjustment
4 Clean dust screens
Clean dust screens of external
5
vacuum pump
11-11
11 Maintenance
Maintenance Record
Year Month
6 Clean DI Water Tank
Maintenance (Every six months) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
1 Replace Lamp
Maintenance procedures(Timely) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Check Probes/Mixers/Wash
1
Wells
Clean Samples/reagent
2
Probes/Mixers Exterior
3 Replace Cuvettes
4 Cuvette Check
5 Lamp Hour Inquiry
6 Clean Analyzer Panels
7 Reagent Barcode Maintenance
8 Clean Sample Probe Interior
9 Clean reagent Probe Interior
10 Replace Sample Probe
11 Replace Reagent probe
12 Replace Sample Mixer
13 Remove Air Bubbles in Syringe
14 Water Prime
15 Replace Electrode
16 Storage of ISE Electrodes
17 Prime ISE Buffer
18 ISE module reset
19 Pretreatment of reagent probe
20 Service life query of wearing parts
Generate daily maintenance
21
report
22 Rack barcode maintenance
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11 Maintenance
11.4 Daily maintenance

11.4.1 Check DI Water Connection
If the deionized water is not connected properly, the water supply may be insufficient
or water leakage may occur, causing measurement failure.
Purpose
Check the deionized water connection to make sure the water supply is normal.
When to do
You are recommended to perform this procedure every day before starting analysis.
Analyzer Status
Make sure that the system status is Stopped, Incubation or Standby.
Procedure
1 Check if the water inlet on the rear panel of the analyzer is well connected to the
water supply tube.
2 Check if the water tank or other water containers have sufficient deionized water.
3 Check that the tubes are not bent or folded or leaking.
4 Check if the water supply module is powered on.
5 Select System > Maintenance, and select Manual Confirm.
6 Select the check deionized water connection procedure of the corresponding
module and click OK.
7 The current maintenance time and status are updated after maintenance.
11.4.2 Check Waste Connection

Improper connection of the waste tube or failure to empty the high-concentration
waste tank in time will result in waste overflow, environmental contamination and
cross infection, and even damage the instrument. Therefore, it is necessary to check
the waste connection frequently.
Purpose
Check the waste tube connection and the high-concentration waste tank to avoid
overflow.
When to do
Analyzer Status
Make sure that the system is Stopped, or the system status is Incubation or Standby.
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11 Maintenance
Precautions
Biohazard
Wear gloves and lab coat, if necessary, goggles and mask.
Keep a distance from the check object in case the waste is sprayed or damaged.
Dispose of the waste in accordance with your local or national guidelines for biohazard
waste disposal.
Procedure
1 Check if the waste drainage system is normal, make sure that the waste tubes are
not bent, the waste is drained smoothly, and the high-/low-concentration waste is
handled properly. (Refer to local regulations for waste disposal methods.)
2 Make sure the waste tube is clear and not bent or folded. Otherwise, the waste
may overflow from the analyzer panel due to poor drainage, which may cause
damage to the analyzer.
3 If leak remains after performing the above-stated steps, contact our customer
4 Empty the high-concentration waste tank.
 High-concentration waste volume: × 2.23 L/H High-concentration waste
volume (exclusive of ISE waste): ×2.08 L/H The water consumption of the
whole unit is not more than ×70 liters/hour.
6 Select the check waste connection maintenance procedure of the corresponding
module on the maintenance list, and click OK.
11.4.3 Check Inventory of CD80 Detergent and Probe Wash Solution

If CD80 detergent or probe wash solution is insufficient, the system may not be able to
run tests continuously. Prior to measurements everyday, check the inventory of CD80
detergent and probe wash solution, and if necessary, fill more.
Purpose
To check the inventory of CD80 detergent and probe wash solution, and prevent them
from being insufficient.
When to do
Analyzer Status
Make sure that the system is powered off, or the system status is Incubation or
Standby.
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11 Maintenance
Precautions
Warning
CD80 detergent may hurt your skin. Wear gloves and goggles while checking the
concentrated wash solution. If your hands or clothes contact them, wash them with soap
and water. In case of eye contact, flush with plenty of water immediately and consult an
ophthalmologist.
Caution
When the system status is not Standby (during initialization), auto dilution may be in
progress. Do not add concentrated wash solution.
The instrument has two CD80 loading positions. When the corresponding indicator of CD80
is flashing, the detergent is being used. Do not load detergent that is being used.
Procedure
1 Open the front door of the analyzer and check the inventory of CD80 detergent. If
the volume is insufficient, fill more or replace the wash solution.
3 Power on the analyzer and run the operating software.
4 Check the inventory of reagent probe wash solution on the Reagent > Overview
screen.
5 Make sure that the system status is Incubation or Standby.
7 Choose the Check CD80 detergent/Probe Wash Solution maintenance procedure
for the corresponding module on the maintenance list, and then click OK.
11.4.4 Check Sample/Reagent Syringe

The sample syringe and reagent syringe are precise devices used to aspirate/dispense
small amounts of sample and reagent. If the syringe leaks, the aspirated and
dispensed volume may be inaccurate or even damaged. Prior to measurements
everyday, check the sample syringe and reagent syringe for leak.
Purpose
Check the sample syringe and reagent syringe for leak and air bubbles.
When to do
Materials required
Clean gauze
Analyzer Status
Make sure that the system status is Incubation or Standby.
Precautions
Biohazard
11-15
11 Maintenance
Procedure
1 Open the front door of the analyzer. You will see six syringes on the right of the
analyzer.
2 Use dry gauze to wipe the connector at the inlet and outlet of the syringe, and then
check if the gauze is moistened.
 If leak occurs, tighten the connector on the inlet and outlet of the syringe.
3 Check the syringe interior for air bubbles. If yes, take actions according to
11.10.15 Remove Air Bubbles in Syringe.
4 Check the plunger at the bottom of the syringe for leak.
5 Use dry gauze to wipe the plunger and check if the gauze is moistened.
 If leak occurs, contact the service engineer to replace the syringe.
8 Select the check sample/reagent syringe maintenance procedure of the
corresponding module.
9 Select OK to refresh the current date as the performance date.
11.4.5 Check Sample Probe Wash Solution

If the sample probe wash solution is insufficient, sample probe clog and carryover may
occur.
Purpose
To check the sample probe wash solution volume in case the tests cannot be
continued due to insufficient wash solution.
When to do
Analyzer Status
The system is powered off, or the system status is Incubation or Standby.
Precautions
Caution
To ensure the wash effect, you are recommended to update the sample probe wash
solution every day to avoid probe clogging and serious cross contamination.
Do not load sample probe wash solution during measurement.
Procedure
1 Remove the sample probe wash solution and the detergent from the DB, DA, DC
position next to the sample probe wash well, and then check their volume.
2 If the volume is insufficient, fill more or replace it. To ensure the wash effect,
replace the wash solution.
3 Select System > Maintenance and select the corresponding module.
4 Select Manual Confirm.
5 Select Check Sample Probe Wash Solution of corresponding module on the
maintenance list, and click OK.
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11 Maintenance
11.4.6 Check Mixer Installation Position

Procedure
1 Check if the mixers are installed in correct positions.
2 If it is not, install it in a proper position, as shown in Figure below.
4 Choose the check mixer installation position maintenance procedure for the
corresponding module on the maintenance list, and then click OK.
Mixer installation check
1. The flat part is well matched The upper 1. The flat part is not properly
with the inner side of the sleeve. surface of the matched with the inner side of the
2. Press the mixer and feel the flat part is not sleeve.
lower flat end surface of the flush with the 2. Press the mixer. The lower
mixer should contact closely sleeve. surface of the flat part is not close
with the bottom surface of the to the bottom of the mixer sleeve,
sleeve while the upper flat end and the upper surface of the flat
surface should align with the part is not level with the bottom of
upper surface of the sleeve. the mixer sleeve.
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11 Maintenance
11.4.7 Clean ISE Electrodes

After the ISE module finishes a lot of tests, the proteins and lipids in the samples may
adhere to the electrode surface and affect the measurement performance. Clean the
electrodes to ensure the system performance. It will take about 3 minutes to perform
this procedure.
Purpose
Remove the proteins and lipids attached to the electrodes to ensure their proper
performance.
When to do
You are recommended to perform this procedure after finishing all ISE tests of the day
or before shutting down the system.
Materials required
ISE wash solution, 2 mL sample cup
Analyzer Status
Make sure that the biochemistry system and ISE module are in Standby status.
Precautions
Biohazard
The wash solution will irritate the eyes and skin. Prevent the wash solution from splashing
on the eyes or skin. If you spill it on your eyes, wash your eyes with plenty of water and
consult a doctor.
Caution
Please use consumables recommended by our company. Use of other consumables may
degrade the system performance.
Note
After finishing this procedure, calibrate the ISE module before starting measurements.
Procedure
1 Choose System > Maintenance > Semi-Auto, select the relevant ISE electrode
cleaning procedure, and then click Execute.
2 Place a sample tube or microtube with at least 200 μ L ISE electrode wash
solution in position # 1 of the pink maintenance sample rack (M0001).
3 Place a sample tube or microtube with at least 200 μL ISE of activating solution
(serum or control sample) in position # 2 of the rack.
4 Place the maintenance rack into the loading area of the SDM and start the test.
Select OK. The system starts cleaning the ISE electrodes.
5 The current maintenance time and status are updated automatically.
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11 Maintenance
11.4.8 Special Wash Probes/Mixers

Purpose
To eliminate carryover among sample probe, reagent probe and mixers and prevent
waste from leaving in the waste tubes.
When to do
Perform this command when the probes or mixers are clogged or the carryover result
exceeds the limit.
Materials required
Concentrated wash solution
Analyzer Status
Make sure that the system status is Standby.
Procedure
Special wash probes/mixers can be set to Auto or Manual Perform.
Manual operation steps
1 Select System > Maintenance, and select Semi-Auto.
2 Select Probe/Mixer Special Wash of relevant module and select Execute.
3 Load wash solution in positions 72DB, 32DB, 71DA and 31DA of R1 carousel. Load
wash solution in positions 72DB, 32DB, 71DA and 31DA of R2 carousel. Check the
consumables for inventory. The inventory of wash solution in position DA and DB
of the R1 reagent carousel should be greater than 35%. The inventory of wash
solution in position DA and DB of the R2 reagent carousel should be greater than
35%. The inventory of wash solution in position DA, DB and probe-detergent
should be greater than 25%.
4 Click OK. Set up special wash parameters. Enter the cycles (1~81) under the probe
unit. The default is 9. Enter the maintenance cycles (1-27) below the mixer unit.
The default one is 3. When Start is clicked, the maintenance procedure starts and
the maintenance countdown is displayed on the screen.
5 When Stop is clicked, the selected units are put into Stop. When the exit button is
clicked, exit the procedure.
Auto Operation Procedure
Same as the Auto Maintenance Setup in 11.2.2 Maintenance Setup.
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11 Maintenance
11.5 Weekly Maintenance

11.5.1 Weekly Special Wash and Cuvette Check
Special wash is used to clean the sample probe, reagent probe, mixers, cuvettes and
wash station with wash solution, in order to reduce carryover and prevent waste from
remaining in the waste tubes. After washing, the system checks the energy of
photometer, and verifies the working status of cuvettes, attenuation of lamp radiation,
and stability of the lamp.
Purpose
To eliminate carryover among electrodes, sample probe, reagent probe, mixers,
cuvettes and wash station, in order to prevent waste from remaining in the waste tubes.
Check the energy and cuvette status after the wash.
When to do
You are recommended to perform this procedure every week or when the system is
going to be idle for a long time.
Materials required
CD80, acid wash solution and probe detergent produced by our company.
Analyzer Status
Procedure
Weekly special wash and cuvette check can be performed automatically or manually.
1 Open the upper protective shield of the analyzer.
2 Load wash solution in positions 72DB, 32DB, 71DA and 31DA of R1carousel. Load
wash solution in positions 72DB, 32DB, 71DA and 31DA of R2 carousel. Fill wash
solution in S1-DB/S1-DA/S1-DC and S2-DB/S2-DA/S2-DC on the desk panel.
3 Select System > Maintenance, select Auto, select the weekly special wash and
cuvette check procedure of the relevant module, and then click Execute.
4 After maintenance, select the maintenance data button on the Maintenance
History window to view cuvette check results.
5 Close the upper protective shield of the analyzer.
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11 Maintenance
11.5.2 Ultrasonic Cleaning of Sample Probe

The sample probe is cleaned in its wash well by using preheated water to clean its
interior and exterior and further cleaned with ultrasound.
Purpose
Use ultrasound to further clean sample probe S1 and S2.
When to do
You are recommended to perform this procedure every week.
Materials required
Ultrasonic wash well
Analyzer Status
Ultrasonic cleaning of the sample probe can be performed automatically or by clicking
"Execute" on the maintenance screen.
The manual operation steps are as follows:
1 Choose System > Maintenance, and then select Auto.
2 Select the sample probe ultrasonic cleaning maintenance procedure of the
relevant module and then click "Execute."
3 Ultrasonic cleaning of M1 (or M2) sample probe is shown in the middle of the
status bar on the main screen. During maintenance, click Cancel and OK to stop
the maintenance.
4 After maintenance, the software automatically updates the current maintenance
time and status.
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11 Maintenance
11.6 Two-Week Maintenance

11.6.1 Clean ISE Tubes
Clean the ISE tubes with ISE detergent solution to remove the stains inside of them. It
will take about 25 minutes to perform this procedure.
Purpose
To remove the stains from the tubes and keep them unobstructed.
When to do
To clean the ISE tubes regularly based on the number of tests performed on dialysis
patients every month:
 If less than 100 dialysis patient samples are analyzed every month and less than
routine 100 samples are analyzed every day, perform the procedure every month.
 If less than 100 dialysis patient samples are analyzed every month and no less
than 100 samples are analyzed every day, perform the procedure every two weeks.
 If no less than 100 dialysis patient samples are analyzed every month, perform the
procedure every week.
 If no less than 500 dialysis patient samples are analyzed every month, perform the
procedure every 3 days.
Materials required
ISE detergent solution, 2mL serum, pipette, and spacer
Analyzer Status
Make sure that the ISE module status is Incubation or Standby.
Precautions
Biohazard
The detergent solution will irritate the eyes and skin. Prevent the wash solution from
splashing on the eyes or skin. If you spill it on your eyes, wash your eyes with plenty of
water and consult a doctor.
Caution
Note
Tighten the retaining screws on the ISE electrodes and the stainless steel plate by hand.
Do not tighten them with a screwdriver.
Procedure
1 Select System > Maintenance, and then select Semi-Auto. Choose an ISE tube
wash for the relevant module.
2 Click Execute.
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11 Maintenance
4 Open the cover of the ISE module on the analyzer's front panel.
5 Remove the stainless steel plate on the ISE module.
6 Use the spacer to replace the Na, K, Cl and reference electrodes.
Note: Exercise caution to avoid missing the O rings between electrodes and
between electrodes and the module.
7 Remove the spacer cap and use the pipette to dispense 5 ml wash solution into
the spacer.
8 Tighten the electrode cover.
9 Select Continue. The system starts cleaning the tubes.
10 Wait for about 14 minutes. When the screen shows, open the spacer cap, use a
pipette to add 5 ml deionized water into it, and then tighten the cap.
11 Select Continue.
12 After cleaning, remove the spacer and reinstall the Na, K, Cl and reference
electrodes.
Note: Exercise caution to avoid missing the O rings between electrodes and
between electrodes and the module.
13 Select Continue to prime the tubes.

14 After the priming, restore the stainless steel plate and cover of the ISE module,
and restore the upper protective shield of the analyzer.
15 Select Done to exit.
16 Activation is recommended: Prepare 2mL serum sample, and run ISE (Na, K, Cl)
serum for 20 replicates.
17 Before starting analysis, calibrate the ISE module.
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11 Maintenance
11.7 Monthly Maintenance

11.7.1 Clean Cuvette Wash Station
Clean the cuvette wash station every month to prevent waste from accumulating on it
and causing cross contamination.
Purpose
To clean the wash station in order to avoid waste accumulation and cross
contamination.
When to do
You are recommended to perform this procedure every month.
Materials required
Gauze, ethanol, deionized water, and waste containers(Large beaker)
Analyzer Status
Precautions
Biohazard
Do not discard the gauze. Dispose of the gauze properly in accordance with relevant
regulations.
Procedure
1 Open the back cover of the analyzer.
2 Remove the wash station, and use ethanol-moistened gauze to wipe the wash
probes and wipe blocks.
Note: Wipe the wipe blocks gently from bottom to top to avoid damaging the them.
3 Use gauze moistened with deionized water to clear the ethanol on the wash
probes and wipe blocks.
4 Restore the cuvette wash station.
5 Select System > Maintenance, and then select Semi-Auto. Choose Clean Cuvette
wash station of relevant module. Click Execute.
6 This software updates the current maintenance time and status after
maintenance.
7 Close the back cover of the analyzer.
11.7.2 Clean Wash Wells

When the instrument is used for a long time, the waste and dust may accumulate in
the wash well and block the wash well. It is recommended to clean the wash wells
every month to keep them clean and unblocked.
Purpose
To remove the waste and dust from the six wash wells (reagent probe, sample probe,
sample mixer and reagent mixer).
11-24
11 Maintenance
When to do
You are recommended to perform this procedure every month.
Materials required
Cotton swabs and sodium hypochlorite(NaClO)
Analyzer Status
Precautions
Biohazard
Procedure
1 Select System > Maintenance, and then select Semi-Auto.
2 Select Clean Wash Wells of relevant module.
3 Click Execute.
4 After the probes/mixers finish moving, open the upper protective shield and back
cover of the analyzer.
5 Move the sample probe, reagent probe and mixer arm away from the wash well.
6 Use clean cotton swabs moistened with NaClO to clean the wash wells, and then
use clean cotton swabs to clear the residual NaClO solution.
7 Select Continue. The system starts cleaning the mixer exterior.
8 Observe the water flow of the sample mixer wash well and the reagent mixer wash
well. Check if the water flows out of the wash well. If not, contact the service
engineer.
9 Select Done. The system resets automatically.
10 The software automatically updates the current maintenance time and status.
11 Close the upper protective shield and back cover of the analyzer.
11.7.3 Clean ISE SIC/Drain Outlet

When the ISE module is used for a period of time, stains may accumulate in the sample
injection cup and drain outlet and affect the measurement result. Therefore, it is
necessary to clean it regularly. It will take about 10 minutes to perform this procedure.
Purpose
To remove the stains accumulated on the ISE sample injection cup and drain outlet
due to long term use.
When to do
You are recommended to clean the ISE sample injection cup and drain outlet every
month.
Materials required
Deionized water, pipette, cotton swab, and Philips-head screwdriver
Analyzer Status
Make sure that the ISE module status is Standby.
11-25
11 Maintenance
Precautions
Biohazard
The detergent solution will irritate the eyes and skin. Prevent the wash solution from
splashing on the eyes or skin. If you spill it on your eyes, wash your eyes with plenty of
water and consult a doctor.
Caution
Procedure
2 Select Clean SIC/Drain Outlet of corresponding module.
3 Select OK to start the procedure.
6 Loosen the screws on the sample injection cup and remove the sample probe
guide block. Use clean gauze soaked with ethanol to wipe the exterior of the buffer
nozzle until it is clean.
Note: Loosen the screws carefully to prevent them from falling off the instrument.
7 Use a pipette to fill about 1 ml deionized water in the sample injection cup while
keeping the deionized water level over the sample injection port.
8 Wait for 5 minutes to ensure that the crystals on the sample injection port are
dissolved. During the waiting process, proceed to the next step to clean the drain
outlet.
9 Use cotton swabs to wipe away the dirt from the drain outlet.
Note: Do not damage the drain outlet.
10 Check that the crystals on the sample injection port are dissolved or the
countdown is finished, and click Continue. The system starts to empty the sample
injection cup.
11 Use cotton swabs to dry the sample injection port.
12 Restore the sample probe guide block.
13 Select Continue. The system starts priming the ISE module with buffer solution.
14 When the priming is finished, restore the cover of the ISE module on the analyzer's
front panel.
15 Close the upper protective shield of the analyzer.
16 Select Done.
Note
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11 Maintenance
11.7.4 Wash R1/R2 Physiological Saline Bottle

If the reagent bottles of physiological saline are not cleaned regularly after being used
for a period of time, bacterial contamination may occur. Therefore, it is necessary to
clean them regularly. It will take about 5 minutes to perform this procedure.
Purpose
Remove the bacterial impurities from the reagent bottle of physiological saline.
When to do
It is recommended to clean the reagent bottles of physiological saline every month.
Materials required
0.5% chlorine sodium hypochlorite solution, deionized water
Analyzer Status
Non-running status.
Precautions
Biohazard
Dispose of the gauze properly in accordance with relevant regulations.
Procedure
1 Open the R1 and R2 reagent carousels' covers and rotate the reagent carousel to
remove the reagent bottles on both rings.
2 Clean the reagent bottles with 0.5% sodium hypochlorite.
3 Rinse the reagent bottles with deionized water to remove the residual sodium
hypochlorite solution.
4 After cleaning, fill the reagent bottles with physiological saline and put them back
to physiological saline positions on the inner ring and outer ring.
5 Restore the reagent carousel covers.
6 Select System > Maintenance, and then select Manual Confirm. Choose the Wash
R1\R2 physiological saline bottles of relevant module.
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11 Maintenance
11.8 Three-Month Maintenance

11.8.1 Dilution Ratio Self-calibration of Diluted Wash Solution
This function is used to perform calibration every three month. Each calibration is
performed when the instrument is idle and can be performed manually.
Purpose
After the diluted wash solution tube is used for a long time, the dilution ratio is incorrect
due to various reasons, which affects the cleaning effect.
When to do
You are recommended to perform this procedure every 3 months or as needed.
Materials required
None
Analyzer Status
This procedure can be performed automatically or manually.
1 Select System > Maintenance, and then select Auto.
2 Select Dilution Ratio Self-Calibration of relevant module and click Execute.
3 Select Execute and then OK to start the procedure.
4 When the maintenance procedure is finished, the current maintenance time and
status are refreshed automatically.
11.8.2 Probe Interior Wash Pressure Adjustment

Adjust the sample probe interior wash pressure to prevent clogging.
Purpose
The probe interior wash pressure is adjusted to maintain the cleaning capability. Or
adjust the pressure after replacing the interior pump, degasser and other components
to keep the cleaning capability.
When to do
Materials required
None
Analyzer Status
2 Select Probe Interior Wash Pressure Adjustment of relevant module.
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11 Maintenance

4 When the maintenance procedure is finished, the current date and time and status
will be refreshed automatically.
11.8.3 Whole Unit Circulating Water Wash Pressure Adjustment

Adjust the whole unit wash pressure.
Purpose
Adjust the wash pressure of the whole unit to maintain the wash capability. Or adjust
the pressure after replacing the circulating pump, preheating tank and other
components to maintain the cleaning capability.
When to do
Materials required
None
Analyzer Status
2 Select Whole Unit Wash Pressure Adjustment of relevant module.
4 When the maintenance procedure is finished, the current date and time and status
will be refreshed automatically.
11.8.4 Clean DI Water Tank

If the deionized water tank is used for a long time, stains may accumulate and affect
the cleaning effect.
Purpose
Clean the deionized water tank regularly to ensure the cleaning effect.
When to do
You are recommended to clean the deionized water tank once every three months.
Materials required
Water container
Analyzer Status
Make sure that the system status is Standby or Shutdown.
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11 Maintenance
Precautions
Biohazard
Procedure
2 Choose the Clean DI Water Tank procedure of relevant module, and then click
Execute. A dialog box pops up. Click Continue.
3 Open the front door of the analyzer as shown in the figure below.
Deionized water tank
Deionized water
tank
4 Unplug the quick connector from the outlet of the water tank, and pull the water
tank forward with both hands to expose the opening above the front end of the
water tank.
5 Use a water container to hold the water tank connector, and insert another
normally open quick connector to the water tank connector. The water will flow
out through the quick connector and wait for the water tank to empty before
proceeding to the next step. You can also place a hard object against the outlet
joint of the water tank to drain the water or take out the water tank and then pour
out the water from the upper opening. This method is applicable when the water
volume in the water tank is small.
6 Remove the tube from the inlet of the water tank, remove the floater signal cable
from the right side panel, pull out the water tank completely, and then remove the
floater. The steps of the water tank are shown in the figure below.
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11 Maintenance
Removing DI water tank
7 Use DI water to wash the water tank several times.

8 Insert the floater into the opening of the water tank, install the water tank back,
and insert the reflux tube in a proper position before the water tank is pushed into
the analyzer. Connect the floater signal cable and the water outlet tube in front of
the water tank according to the label on the vertical plate on the right side of the
water tank.
9 Select Continue. The system starts priming the tubes with deionized water. When
the procedure is completed, the maintenance is finished.
10 Restore the container and close the front door of the analyzer.
If you perform this procedure while the system is shut down, install the water tank
and restart the system. After initialization, the system status changes to preheat.
On the Scheduled Maintenance window, select Clean DI Water Tank and select
Execute. Prime the DI water tube to remove the air from it.
11 The maintenance is completed. The corresponding current maintenance time and

status are refreshed.
11.8.5 Clean Dust Screens of External Vacuum Pump

The dust screen of the external vacuum pump should be cleaned every month to
prevent the dust from reducing the heat dissipation efficiency of the vacuum pump.
1 Remove the dust screen in the front of the air pump.
 Push the dust screen upwards gently and make it move upwards along the
slot with the lower end of the screen away from the slot.
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11 Maintenance
 Pull the dust screen out of the slot.
2 Replace the dust screens.

 Insert the upper end of the dust screen into the slot and push the screen
upwards.
 Press the dust screen gently to make it closely pressed to the slot.
 Push the dust screen downward gently until its lower end is also inserted into
the slot.
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11 Maintenance
3 Rinse the old dust screens with tap water and dry them for future use.
4 Select System > Maintenance, and select the corresponding module.
6 Choose the dust screen maintenance procedure for the external vacuum pump.
11.8.6 Clean Dust Screens

After the analyzer runs for a long time, the dust on the dust screen will block the gap,
which will make the air inlet of the analyzer insufficient and reduce the heat dissipation
capability. It is necessary to clean the dust screens regularly.
Purpose
Clean the dust screens to ensure sufficient air intake.
When to do
You are recommended to perform this procedure every 3 months.
Materials required
Suction cleaner, hair brush and clean water
Analyzer Status
Make sure that the main power of the analyzer is switched off.
Precautions
Note
 Do not remove the dust screens when cleaning them with a suction cleaner. Remove
the dust screens when they are cleaned with brush and water.
 Do not install the dust screens back to the instrument when they are wet, and they must
be dry completely before use.
 When installing the dust screens back to the system, do not leave any gaps.
 If you hit the dust screen manually, go to a proper place to avoid dust pollution. In
addition, knock your thumb against the reinforcing rib of the dust screen to prevent its
deformation. See the figure below:
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11 Maintenance
Procedure
1 Make sure the analyzer main power is off.
2 Open the front door of the analyzer and remove the dust screens.
There is a dust screen in the front of the analyzer, in the front of the left panel of
the middle door, and at the lower side of the analyzer. Hold the dust screen
inwards with both hands, and then pull it upwards. Lift the dust screen at the lower
side and push it outward to remove it.
Dust screens
3 Use a suction cleaner, a hair brush or clear water to clean the dust screens, and
then dry them in air.
4 Reinstall the dust screens when they are dry.
6 Power on the analyzer and run the operating software.
7 Make sure that the system status is Incubation or Standby.
8 Select System > Maintenance.
10 Choose a cleaning procedure for the relevant module.
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11 Maintenance
11.9 Six-Month Maintenance

11.9.1 Replace Lamp
An aged lamp will have its energy decreased and influence the measurement accuracy.
Failed lamp will make measurements impossible. To ensure the optimal performance
of the system, replace the lamp regularly. Every time after you replacing the lamp, if the
light intensity is insufficient, replace the lamp immediately. It will take about 10
minutes to perform this procedure.
Purpose
To ensure that the lamp works normally.
When to do
You are recommended to perform this procedure in following conditions: in every 6
months, or in every 2400 hours, or the alarm indicating unsteady lamp happens
frequently, or when you find that the lamp does not satisfy the requirements after
performing the Photometer Check.
Materials required
New lamp, Philips-head screwdriver, cotton or antistatic gloves
System status
Make sure that the system status is Standby or Failure.
Precautions
CAUTION
Too hot lamp may burn you. Do not replace the lamp until it gets cool.
Do not touch the light entrance on the lamp housing or the lens in front of the lamp. In case
the light entrance is dirty, use cotton swabs moistened with absolute ethanol to clean it.
How to do
1 Select System>Maintenance.
2 Choose Replace Lamp of relevant module. Select Execute.
3 Make sure that the lamp has cooled down for 5 minutes, and then select Continue.
4 Remove the lamp replacement door on the rear panel of the analyzer.
Lamp housing
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11 Maintenance
5 Wear a pair of cotton or antistatic gloves, loosen the nuts on the cable terminals,
and then remove the O-ring connectors from the terminals.
Remove lamp cables
6 Loosen the retaining screw on the left side of the lamp.

Remove retaining screw
7 Remove the lamp from the lamp housing.

8 Hold the new lamp on its handle with its slot facing the reaction carousel and
insert the lamp into the lamp housing. Make sure that the slot on the lamp base is
aligned to the counterparts on the lamp housing.
NOTE
After inserting the lamp into the lamp housing and tightening the retaining screws,
check if there is space between the lamp base and the lamp housing. If there is,
reinstall the lamp according to step 6 to 8.
9 Install the retaining screw, O-ring connectors, cable terminal nuts and lamp
replacement door in the reversed order.
10 Select Continue.
11 When the lamp is incubated, select Done.
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11 Maintenance
11.10 When Appropriate Maintenance

11.10.1 Check Probes/Mixers/Wash Wells
Abnormal sample probe, reagent probe or mixers may influence the measurement
performance and result in inaccurate results. Prior to measurements everyday, check
the sample probe and reagent probe for stains and crystals, check if the mixers are
working abnormally, and check if the wash wells have a normal water flow. If the above-
mentioned abnormities exist, clean or adjust them immediately.
Purpose
Check the sample probe and reagent probe for water dripping, stains and liquid flow
abnormities. Check if the mixer works normally. Check if the water flows out of the
wash well normally.
When to do
You are recommended to perform this procedure when water flow from the wash well
is abnormal.
Analyzer Status
Precautions
Warning
Exercise caution to avoid being hurt by the probes or bending of the sample probe, reagent
probe or mixers. Do not approach the sample probe, reagent probe, mixers or other moving
parts.
Biohazard
Procedure
1 Open the upper protective shield and back cover of the analyzer.
3 Choose the Check Probes/Mixers/Wash Wells procedure of relevant module.
4 Select Execute to enter probe interior/exterior wash well maintenance command
screen.
5 Choose all items for interior and exterior wash.
6 Select Clean Interior and Exterior.
7 Observe the liquid flow of probe S1, probe S2, probe R11 and R12, and probe R21
and R22. If cleaning fluid is sprayed out or not discharged vertically from the probe
tip, the probe may be clogged. Perform the Special Wash Probes/Mixers
procedure, and then check them again. If the error remains, perform the Clean
Sample Probe Interior or Clean reagent Probe Interior procedure. If the error
remains, perform the Replace Sample Probe or Replace reagent Probe
maintenance procedure, or contact a service engineer.
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11 Maintenance
Normal and abnormal water flow direction of sample probe and Reagent
probe
Normal Abnormal
8 Check if water flows out normally from probe and mixer wash wells (sample probe
S1 probe R21 and R22, reagent mixers and sample mixers, probe S2, probes R11
and R12), water supply is proper, and check if the water reaches to about 5 mm of
the probe tip. Check if the water flow from the mixer wash well is normal. Under
normal circumstances, the cleaning fluid should flow out of the inner hole of the
wash well. If the water flow is normal, go to the next step; otherwise, contact our
customer service department.
9 If you still need to observe the probe interior wash button, repeat step 7 and 8.
10 After the test, click Exit.
12 This system updates the current maintenance time and status after maintenance.
11.10.2 Clean Probes/Mixers Exterior

The exterior of the sample probes, reagent probes and mixers is easy to be dirty, which
may cause carryover between samples or reagent and result in incorrect test results.
Purpose
To clean the exterior of the sample probe, reagent probe and mixers to prevent
carryover.
When to do
You are recommended to perform this procedure as needed.
Materials required
Clean gauze (two pieces), ethanol, deionized water
Analyzer Status
Make sure that the system status is Incubation or Standby.
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11 Maintenance
Precautions
Warning
Exercise caution to avoid scratching your hand. Exercise caution while working around the
sample probe. If it is bent or damaged, replace it immediately; otherwise, unreliable results
may be obtained.
Biohazard
Procedure
2 Choose the Clean Probes /Mixers Exterior maintenance procedure of relevant
module.
3 Click Execute.
4 After the probes/mixers finish moving, open the upper protective shield and back
cover of the analyzer.
5 Rotate the probe arm to move the probe to a position convenient for cleaning, and
then use gauze moistened with ethanol to gently wipe the probe exterior. Clean
the probe tip until it is clean.
6 Use gauze moistened with deionized water to clear the ethanol on the probe.
When wiping the sample probe, do not push or pull it horizontally to avoid bending
the probe or mixer.
7 Take out the 12 mixers from the mixer unit. Use clean gauze moistened with
ethanol to wipe the surface of each mixer, and then use gauze moistened with
deionized water to clear the ethanol on the mixers.
8 Install the mixer from the top of the arm. Rotate each mixer to make it better
contact the hole on the arm.
9 Select Continue. The system starts cleaning the mixer exterior.
10 Select Done. The system resets automatically.
11.10.3 Replace Cuvettes

If a cuvette is contaminated by serum or other stains or scratches or cracks occur, the
absorbance accuracy will be affected. It is necessary to check the reaction cuvettes. If
they are abnormal, replace them immediately. It will take about half a minute to replace
a cuvette.
Purpose
Make sure the cuvettes are normal and not contaminated, scratched or broken.
When to do
Replacing cuvettes is not scheduled for maintenance. Replace it in time when:
 Abnormal cuvette is found after cuvette check.
 The cuvettes are still unusable after washing.
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11 Maintenance
 Scratches or cracks are found on the optical surface of the cuvette.

Materials required
Fiber-free gloves, dry cloth or gauze, reaction cuvettes, and concentrated wash solution
manufactured by our company
Analyzer Status
Precautions
Warning
Exercise caution to avoid scratching the reaction cuvettes. Do not touch the optical surface
of the reaction cuvettes. If the optical surface is contaminated, the absorbance data may
be inaccurate.
While installing the reaction cuvettes, make sure that the optical surface is radially along
the reaction carousel.
Wear gloves free of fiber and powder to avoid polluting the optical surface of the reaction
cuvettes.
Biohazard
Caution
Note
If a cuvette cannot be removed from the reaction carousel, first remove the 1~2 cuvettes
to the right of the cuvette. Use a blade to remove the spring plate of the cuvette. Finally,
take out the cuvette with your hand or tweezers.
In case of large-scale maintenance of reaction cuvettes due to overflow, contact our
customer service department or your local distributor.
Procedure
2 Choose Replace Cuvettes of relevant module.
3 Select Execute to start the maintenance procedure.
4 Remove the four mixers and cuvette wash station close to the reaction carousel,
rotate the suction device to the dodging position, and gently remove the reaction
carousel cover.
5 Enter the cuvette number.
The input range is 1~ 412. Only one position number can be entered each time.
6 Select Replace. Rotate the cuvette to the groove in the front of the analyzer.
7 Use your forefinger and thumb to take out cuvettes in radial direction of the
reaction carousel, and then search for corresponding positions according to the
silkscreen.
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11 Maintenance
8 Load the new cuvettes or the cleaned cuvettes into the reaction carousel, and
press the cuvettes until they stop moving forward.
9 Repeat step 5-8 to replace all reaction cuvettes.
10 Select Exit.
11 This system updates the current maintenance time and status.
12 Restore the reaction carousel cover, install the removed mixers and wash station,
and turn the suction device back to the working position.
Suggestion: Perform the Cuvette Check procedure to check if the new cuvettes
meet the requirements.
For more information, refer to. 11.10.4 Cuvette Check
11.10.4 Cuvette Check

If the reaction cuvettes are used for a long time, proteins or debris may remain on their
surfaces, which may affect the light transmittance of the cuvettes. In addition, if the
interior or exterior of the cuvette is contaminated or there are scratches or cracks on
the cuvette, the transmittance or uniformity of the cuvette will be affected, and the
accuracy and stability of the absorbance test results will be affected. Check the use
status of the cuvettes.
Purpose
To check if the cuvettes are contaminated and the transmittance is decreased in order
to avoid affecting test results.
When to do
You are recommended to perform this procedure after replacing or cleaning the
reaction cuvettes.
Analyzer Status
Before performing the maintenance, make sure that the system has been powered on
for over 20 minutes and the system status is Standby. Check if all cuvette positions
have cuvettes. If not, load cuvettes.
Precautions
Note
To ensure the photometer's performance, replace or handle the reaction cuvettes as soon
as they are judged to be dirty. After replacement, perform Cuvette Check again.
Since residual substances inside the cuvettes may affect the cuvette check results, you are
recommended to perform the Cuvette Check after finishing the Special Wash procedure.
Procedure
2 Select Cuvette Check on the Scheduled Maintenance window, and click Execute
and then OK. The Cuvette Check window pops up.
3 Select cuvettes to be tested: Select all cuvettes, or select 3 cuvettes in the
specified position.
4 After selecting cuvettes, select Start to start cuvette check. To stop the check,
select Stop. ).
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11 Maintenance
5 When finishing the check, the system refreshes the cuvette status based on the
check results.
6 The screen shows all cuvette positions on both inner and outer rings with dirty
cuvettes indicated by colors.
 No flag: The cuvette is normal.
 Red: Incorrect homogeneity
 Orange: Contamination error
 Yellow: Consistency error
Check the cuvette status and record the cuvettes indicated in yellow. Clean or
replace the cuvettes according to 11.5.1 Weekly Special Wash and Cuvette
Check(Page11-20).
7 Click Select All, that is, select all cuvettes at the same time. Click Blank or
Uniformity to view the latest test results of the 412 cuvettes at all wavelengths.
Description of cuvette water blank absorbance:
 Less than 3700: Indicates that the energy of the optical system is too strong.
 Greater than 19500: Indicates that the energy of the optical system does not
meet the test requirements.
8 After cuvette check, select Exit.
9 This interface updates the current maintenance time and status.
11.10.5 Lamp Hour Inquiry

Purpose
The customer prepares for the lamp through inquiry. Remind the user to replace the
lamp in time.
When to do
Record the using time of the lamp.
Materials required
None
Analyzer Status
You are allowed to perform this maintenance procedure in any system status.
Procedure
1 Select System > Maintenance, and then select Manual Confirm.
2 Select Lamp Hour Inquiry of the corresponding module on the maintenance list,
and click Execute.
3 The screen shows the time of replacing the lamp.
 The service life progress bar of the lamp is displayed on the screen. The
progress bar is the proportion of the total usage time and the claimed service
life. The progress bar is displayed in green when the total time is <2000 h. If
2000 h≤ total time <2400 h, yellow is displayed. If the total time is ≥2400 h,
orange is displayed.
 The software shows the total using time, normal turn-on time and sleeping
time of the lamp. After the lamp is replaced, they are all cleared.
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11 Maintenance
4 Select Exit to return to the maintenance screen and refresh the current date and
time.
11.10.6 Clean Analyzer Panels

The analyzer and computer are often accessed and easily get dirty. To keep a clean
working environment and minimize the biohazards, clean the components that are
often accessed, such as analyzer panel, carousel cover, touchscreen, keyboard, etc.
Purpose
Clean the analyzer panels, carousel covers, touchscreen and keyboard.
When to do
Perform this procedure when dust or other stains are found on the panels.
Materials required
Clean gauze, neutral wash solution and deionized water
Analyzer Status
Make sure that the system status is not Running.
Precautions
Warning
Do not spill liquid on the analyzer. Liquid ingression may damage the analyzer.
Biohazard
Dispose of the gauze properly in accordance with relevant regulations.
Procedure
1 Make sure that the system is not running tests, and then open the upper protective
shield of the analyzer.
2 Use ethanol-moistened gauze to wipe the panels and carousel covers.
3 Use special cleaning agent to to clean the touchscreen and keyboard.
4 Restore the protective shield.
5 Select System > Maintenance and then select Manual Confirm.
6 Choose a clean analyzer panel maintenance procedure of relevant module.
11.10.7 Reagent Barcode Maintenance

This function is used to clean the reagent bar code scanning window.
Purpose
Clean the glass of the reagent bar code scanning window to avoid influencing bar code
scanning.
When to do
Perform this procedure when the glass of the reagent bar code scanning window is
contaminated and causes bar code scanning failure.
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11 Maintenance
Materials required
Clean gauze, deionized water, ethanol and cotton swabs
Analyzer Status
Make sure that the system status is not Running.
Precautions
Biohazard
Caution
Do not spill water or ethanol on the glass or drop it on the sample.
Procedure
2 Select reagent bar code maintenance of relevant module on the maintenance list.
3 Click Execute, click OK, and then click Start to start the maintenance procedure.
4 Open the first reagent carousel cover after you see the screen prompts "Wipe the
reagent carousel bar code window with ethanol and a cloth."
5 Use clean gauze to clean the bar code scanning window inside the reagent
compartment. If necessary, wipe the glass with little ethanol or deionized water.
Make sure that no traces or dusts remain.
6 Restore carousel reagent cover.
7 Open the second reagent carousel cover.
8 Use clean gauze to clean the bar code scanning window inside the reagent
compartment. If necessary, wipe the glass with little ethanol or deionized water.
Make sure that no traces or dusts remain.
9 Restore the second reagent carousel cover.
10 Select Done to exit the maintenance screen.
11 The system automatically updates the current maintenance time and status.
11.10.8 Rack Barcode Maintenance

When sample rack bar code label is damaged and cannot be read normally, replace it
immediately.
Purpose
Make sure the rack bar code is correctly identified.
When to do
Replace the rack bar code label when it cannot be read normally by the bar code reader
or falls off due to glue glue failure.
Materials required
Rack barcode
System status
Make sure that the system is not running any tests.
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11 Maintenance
Precautions
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles and a mask during the maintenance
process.
1 Remove the old rack bar code label and rack ID label.
Removing old rack bar code label
2 Apply a new rack bar code label on the front concave side of the rack, and then
find the corresponding rack ID label and apply it on the end of the rack.
NOTE
Please apply rack bar code label to the rack’s front side on the round end, and ensure
the label is aligned with the protruded edge in order to avoid bar code scanning failure.
Applying new rack bar code label
Applying relevant rack ID label
3 Check that the new bar code label is consistent with the rack ID label.
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11 Maintenance
11.10.9 Clean Sample Probe Interior

The sample probe, once blocked, cannot aspirate or dispense sample correctly. When
you find that the sample probe is clogged and cannot aspirate or dispense sample, or
when the sample probe is detected with abnormal liquid flow, clean it immediately.
Purpose
To clean the interior of the sample probe and avoid clogging.
When to do
Perform this procedure when you find that the sample probe is clogged and cannot
aspirate or dispense sample, or when the sample probe is detected with abnormal
liquid flow through the Check Probes/Mixers maintenance.
Materials required
Unclogging device, small slot-head screwdriver, small Philips-head screwdriver, beaker,
deionized water, and screw syringe
Analyzer Status
Precautions
Biohazard
Procedure
1 Recall the maintenance logs and check if the sample probe has been removed and
reinstalled for 3 times. Prepare a new washer and moisten it with deionized water.
Use tweezers to remove the washer and store it properly to prevent it from being
lost.
2 Switch off the analyzing unit power and open the upper protective shield of the
analyzer.
3 Loosen the screws on the probe cover, and remove the arm cover from the arm
base.
4 Hold the circuit board with one hand and unplug the connector with the other hand.
Use a small cross screwdriver to loosen the earthing wire on the sample probe.
5 Use a small screwdriver to remove the retaining screw from the sample probe and
take out the spring.
6 While holding the connector on the sample probe with one hand, unscrew the tube
connector counterclockwise with the other hand until the tube connector is
disconnected. Remove the tube from the sample probe.
Take necessary measures to prevent the washer from dropping out. If the washer
drops out, store it in a clean place for later installation. To replace the washer, take
it out.
7 Remove the sample probe from the arm according to the figure below.
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11 Maintenance
Remove Sample Probe Washer
washer
Prevent washer
from dropping
Level sense
Tube joint
connector
8 Connect the unclogging device to the sample probe, fill the syringe with deionized
water and then connect it to the unclogging device. Put the sample probe inside
the beaker while keeping the probe tip not contacting the beaker. Push the syringe
to rinse the interior of the sample probe. Repeat this step for 10 times.
If the syringe plunger leaks and the sample probe cannot be unclogged due to
serious blockage, replace the sample probe.
9 When continuous water flow comes out of the sample probe in the same direction
with the probe, it indicates the cleaning procedure is finished successfully.
Remove the sample probe from the unclogging device.
10 Insert the sample probe downwards into the hole on the probe arm while aligning
the screw hole on the probe plate to the rod inside the arm.
11 To replace the washer, remove the old one from the tube connector and install the
new one. Connect the tube connector to the sample probe and then tighten it.
12 Fix the earthing wire of the sample probe to the earthing screw on the probe arm,
and insert the plug on the end of the sample probe into the connector of the level
sense board.
13 Sleeve the spring on the rod and tighten the retaining screw. Pay attention to the
spring direction and make the thread opening face downwards.
14 Pinch the sample probe by the part near the probe arm. Push the sample probe
upwards and then release it to check if the spring works well.
 If the spring works freely, proceed to the next step.
 If not, check if the spring is stuck or the screw is too tightened, rule out error.
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11 Maintenance
15 After the maintenance, power on the analyzer, and check if the No.D2 LED
indicator on the circuit board inside the probe arm is lit.
 If it is, it indicates that the level detection system works normally.
 If not, contact our customer service department or your local distributor.
16 Install the arm cover until you hear a click, and then tighten the screws on it.
 If the spring works well, proceed to the next step.
 If the spring cannot stretch, the arm cover is not installed correctly. Reinstall
the arm cover and check the spring until it can move freely.
19 Choose the Clean Sample Probe Interior maintenance procedure for the relevant
module.
20 Select Execute to enter probe interior/exterior wash well maintenance command
screen.
21 Select Clean Sample Probe Interior.
22 Select Execute button.
23 Check if the water flow coming out of the sample probe is continuous and in the
same direction as the probe. If not, perform the Replace Sample Probe or Replace
Reagent probe maintenance procedure, or contact a service engineer.
24 Select Exit to refresh the current date and time as the performance date.
11.10.10 Clean Reagent Probe Interior

Reagent probe is clogged and cannot aspirate or dispense sample according to the
normal test procedure. It is necessary to clean the interior of the Reagent probe from
time to time.
Purpose
To clean the interior of Reagent probe in case the test can not be performed due to
clogging.
When to do
Perform this procedure when you find that the reagent probe is clogged and cannot
aspirate or dispense reagent, or when the reagent probe is detected with abnormal
liquid flow through the Check Probes/Mixers maintenance.
Materials required
Unclogging device, small slot-head screwdriver, small Philips-head screwdriver, beaker,
deionized water, and screw syringe
Analyzer Status
Precautions
Biohazard
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11 Maintenance
Procedure
1 Recall the maintenance logs and check if the reagent probe has been removed
and reinstalled for three times. Prepare a new washer, moisten it with deionized
water, and store the washer properly to avoid being lost.
analyzer.
11.10.11 Replace Sample Probe

If the sample probe is damaged or scrapped or cannot be repaired or if it is severely
blocked and cannot be unclogged, it should be replaced in time to avoid affecting the
test.
Purpose
Replace the sample probe.
When to do
Perform this procedure when the sample probe is damaged or cannot be repaired. For
example, the sample probe is clogged and cannot be unclogged, or the sample probe
is bent or discarded.
Materials required
Small slot-head screwdriver, small Philips-head screwdriver, and new sample probe
Analyzer Status
Precautions
Warning
Exercise caution to avoid being scratched by the probe tip.
Biohazard
Procedure
1 Prepare the new sample probe. Recall the maintenance logs and check if the
sample probe has been removed and reinstalled for 3 times. If it has, prepare a
new washer and moisten it with deionized water. Store the washer properly to
avoid being lost.
analyzer.
3 Loosen the screws on the probe cover, and remove the arm cover from the arm
base.
4 Hold the circuit board with one hand and unplug the connector with the other hand.
Use a small cross screwdriver to loosen the earthing wire on the sample probe.
5 Use a small screwdriver to remove the retaining screw from the sample probe and
take out the spring.
6 While holding the connector on the sample probe with one hand, unscrew the tube
connector counterclockwise with the other hand until the tube connector is
disconnected. Remove the tube from the sample probe.
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11 Maintenance
Take necessary measures to prevent the washer from dropping out. If the washer
drops out, store it in a clean place for later installation. To replace the washer, take
it out.
7 Remove the sample probe from the arm according to the figure below.
Remove Sample Probe Washer
washer
Prevent washer
from dropping
Level sense Tube joint

connector
8 Insert the sample probe downwards into the hole on the probe arm while aligning
the screw hole on the probe plate to the rod inside the arm.
9 To replace the washer, remove the old one from the tube connector and install the
new one. Connect the tube joint to the sample probe and then tighten it.
10 Fix the earthing wire of the sample probe to the earthing screw on the probe arm,
and insert the plug on the end of the sample probe into the connector of the level
sense board.
11 Sleeve the spring on the rod and tighten the retaining screw. Pay attention to the
spring direction and make the thread opening face downwards.
 If the spring works freely, proceed to the next step.
 If not, check if the spring is stuck or the screw is too tightened, troubleshoot
it.
13 After the maintenance, power on the analyzer, and check if the No.D2 LED
indicator on the circuit board inside the probe arm is lit.
 If it is, it indicates that the level detection system works normally.
 If not, contact our customer service department or your local distributor.
14 Install the arm cover until you hear a click, and then tighten the screws on it.
11-50
11 Maintenance

16 Choose the Replace Sample Probe procedure for the corresponding module.
17 Select Execute to enter probe interior/exterior and wash well maintenance
command screen.
18 Select Sample Probe Interior Wash.
19 Select Execute button.
20 Check if the water flow coming out of the sample probe is continuous and in the
same direction as the probe. If not, perform the Clean Sample Probe Interior or
contact a service engineer.
21 Select Exit to refresh the current date and time as the performance date.
11.10.12 Replace Reagent probe

If the reagent probe is damaged or scrapped or cannot be repaired or if it is severely
blocked and cannot be unclogged, it should be replaced in time to avoid affecting the
test.
Purpose
Replace probes R11/R12/R21/R22.
Materials required
Small slot-head screwdriver, small Philips-head screwdriver, and new reagent probe
Analyzer Status
Precautions
Warning
Exercise caution to avoid being scratched by the probe tip.
Biohazard
Procedure
2 For the maintenance procedures, refer to 11.10.11 Replace Sample Probe(Page
11-49), where the maintenance object is Reagent probe .
11.10.13 Replace Sample Mixer

If the sample mixer is damaged or scrapped or cannot be repaired, it should be
replaced in time to avoid affecting the test.
Purpose
Replace the sample mixer.
When to do
Perform this procedure when the sample mixer is damaged or cannot be repaired.
11-51
11 Maintenance
Materials required
Ethanol, clean gauze, new sample mixers
Analyzer Status
Precautions
Warning
Exercise caution to avoid scratching the mixers.
Biohazard
Procedure
2 Take out the sample mixer from the mixer unit.
3 Prepare new mixers, and then use clean gauze moistened with ethanol to wipe the
surface of each mixer.
4 Install the new mixer from the top of the arm. Rotate each mixer to make it better
7 Choose a Replace Sample Mixer procedure for each maintenance module.
8 Click OK, the current maintenance time and status are refreshed automatically.
11.10.14 Replace Reagent Mixer

If the reagent mixer is damaged or scrapped or cannot be repaired, it should be
replaced in time to avoid affecting the test.
Purpose
Replace reagent mixer.
When to do
If the reagent mixer is damaged or cannot be repaired, perform this procedure.
Materials required
Ethanol, clean gauze, new reagent mixer
Analyzer Status
Precautions
Warning
Exercise caution to avoid scratching the mixers.
11-52
11 Maintenance
Biohazard
Procedure
2 Take out the reagent mixer from the mixer unit.
3 Prepare new mixers, and then use clean gauze moistened with ethanol to wipe the
surface of each mixer.
4 Install the new mixer from the top of the arm. Rotate each mixer to make it better
7 Select the Replace Reagent Mixer maintenance procedure of the corresponding
module.
8 Click OK, and the current maintenance time and status are refreshed automatically.
11.10.15 Remove Air Bubbles in Syringe

Purpose
Remove the air bubbles in the tubes and prime the probe wash well. It will take about
5 minutes to execute this command.
When to do
When the syringe contains air bubbles.
Materials required
None
Analyzer Status
Procedure
1 Open the front door of the analyzer and check the reagent and sample syringes
for air bubbles. If air bubbles exist, perform the maintenance procedure.
2 Choose System > Maintenance, and select Manual Confirm.
3 Select Remove Air Bubbles in Syringe maintenance procedure of the
corresponding module click Execute and then click Start.
4 Select the syringe that needs to remove bubbles check box. By default, all syringes
are selected.
5 Select the number of primes, which is 10 by default.
6 Select Continue to start the procedure.
7 After the operation, check the reagent and sample syringe again for air bubbles,
and if there are still air bubbles, repeat step 4~6.
8 Select Done.
This interface updates the current maintenance time and status.
11-53
11 Maintenance
11.10.16 Water Prime

If the main power of the analyzer will be switched off for 1 to 2 days, you should
perform the Water Prime procedure to prime the ISE module with deionized water and
make the electrodes moistened. It will take about 3 minutes to perform this procedure.
Purpose
To prime the ISE electrodes to make them moistened while the analyzer's main power
is switched off.
When to do
If the analyzer will be powered off for 1 to 2 days, you are recommended to perform
this procedure before powering off the analyzer.
Materials required
Deionized water
Analyzer Status
Precautions
Warning
Keep away from the sample probe moving area during cleaning to avoid collision or
scratching.
Procedure
1 Select System > Maintenance and click Semi-Auto.
2 Select Water Prime on the maintenance list and click Execute. When the
maintenance dialog box pops up, click start.
5 Use a pipette to fill 750 μL DI water to the sample injection port.
6 Select Continue. The system starts priming the ISE electrodes.
7 After the priming, restore the cover of the ISE module and the upper protective
shield of the analyzer.
8 Click OK and the current maintenance time and status are refreshed automatically.
11.10.17 Replace ISE electrodes

Due to the limited life span of the electrodes, when the number of tests reaches 30,000,
the reference electrode has been used for three months, or the system gives the alarm
that the voltage of the reference electrode is out of range, the electrodes should be
replaced to ensure the test performance. It will take about 10 minutes to perform this
procedure.
Purpose
To replace the ISE electrodes to ensure the optimal measurement performance.
11-54
11 Maintenance
When to do
If the number of tests reaches 30,000 or three months (whichever comes first), replace
the electrode. That is to say, if the number of tests reaches 30,000 but service time is
not longer than three months, or the number of tests does not reach 30,000 but service
time is longer than three months, replace the electrode. Replace electrodes when
calibration fails due to degenerated electrodes or QC error occurs.
Materials required
10 mL serum, 30 mL buffer solution, 2 mL or 3 mL disposable pipette, pretreated ISE
electrode, and Philips-head screwdriver
Analyzer Status
Precautions
Biohazard
Caution
 Install the electrodes in correct order to avoid influencing the test.
 While placing the electrodes into the electrode case, do not remove the cap on the
electrode connector to prevent liquid from entering the connector.
 The electrodes contain liquid which decreases with time. If you find no liquid in the
electrodes by shaking them, weigh them. If the electrode weighs less than 9g, it cannot
be used.
 The Cl electrode is sensitive to vibrations and should be handled with caution.
Note
Pretreatment of Na, K and Cl electrodes

On the day before the current day that the Na, K and Cl electrodes are to be replaced,
prepare them by performing the following steps.
1 Take out the ISE electrodes from the package. If the electrodes are wet, wipe off
the water and dry them.
2 Remove the sponge from the electrode case and put the electrodes into it for
pretreatment.
3 Dispense 0.5 ml serum into the flow cell of the electrodes. Make sure the serum
penetrates through the flow cell of the electrodes.
4 Add about 25 ml buffer solution to soak the electrodes and keep the electrodes
soaked overnight.
5 Use deionized water to clean the electrodes and dry them.
Reference Electrode Pretreatment
1 Take out the reference electrode from the reference electrode case.
2 Use water to remove the high-concentration salt solution on the surface, and then
dry it.
11-55
11 Maintenance
If the pretreatment time is too long and the test data is unstable after installation,
please clean the electrodes. For more information, refer to 11.4.7 Clean ISE Electrodes.
Replace Electrode
1 Select System > Maintenance, and click Semi-Auto.
2 Select Replace ISE Electrodes of the relevant module and click Execute. The
maintenance window pops up. Click Continue.
5 Loosen the screws on the stainless steel plate and remove the plate by moving it
rightwards.
6 Disconnect the electrode connector.
7 Remove the thumbscrew, loosen the mounting plate and remove the electrode.
8 Install the new electrodes in the correct order.
The electrodes should be arranged from left to right in this order: Reference, Na, K
and Cl.
9 Check that an O-shape washer exists between each electrode, between the
reference electrode and the module, and between the Cl electrode and the module.
10 Restore the mounting plate and tighten the screws.
11 Remove the cap from the electrode connector.
Keep away the electrode cap properly for use of electrode storage.
12 Connect the sensors according to the color indication.

The mapping between electrode and connector color is as follows:
 Na electrode - Yellow
 K electrode - Red
 CL electrode - Blue
 Reference - Black
13 Loosen the thumbscrew on the mounting plate, press and then tighten the screws.
14 Shake the electrodes gently to make sure they are connected properly.
15 Select Continue to display the Buffer Prime window.
16 Enter the prime cycle and select Start.
17 Observe the priming carefully and perform the following operations:
 If air bubbles enter continuously, check the connecting parts for leakage and
looseness.
 Check if the liquid is drained smoothly from the sample injection cup. If the
waste is not drained but increases, it indicates that the waste tube is
incorrectly connected or the drain tube is clogged. Stop the priming.
 Take out the Na and K electrodes and check their flow cell for blockage.
 If no problem is found, the replaced electrodes are in normal status.
18 After the priming, install the stainless steel plate, tighten the screws and restore
the cover of the ISE module.
19 Restore the upper protective shield of the analyzer.
11-56
11 Maintenance
20 Select Done.
11.10.18 Storing Electrodes

When the analyzer is powered off for a long time, the ISE electrodes cannot be
moistened by regular prime. The electrodes may be damaged by drying up. Therefore,
it is necessary to store the electrodes.
Purpose
While the analyzer is powered off, store the electrodes separately to prevent them from
being damaged due to drying up.
Materials required
Electrode packing box and spacer
When to do
The instrument will be powered off for a long time (more than 3 days). If it has been
powered off for no more than 3 days, prime the ISE electrodes to protect them from
being damaged.
Analyzer Status
Make sure that the system is powered off.
Precautions
Biohazard
Procedure
1 Select System > Maintenance.
2 Select Store Electrodes of relevant module and click Execute. The maintenance
guide window pops up. Click Continue.
5 Loosen the screws fixing the stainless steel plate and remove the plate.
6 Disconnect the electrodes and take them out.
7 Install the spacer on the ISE module.
8 Restore the stainless steel plate and tighten the thumbscrew.
9 Restore ISE module cover on the analyzer's front panel.
10 Process the Na and K electrodes.
 Install the cap on the Na and K electrodes.
 Store the electrodes in an electrode case.
11 Click Continue and complete the following operations according to the screen
prompt.
12 Process the Cl and reference electrodes.
11-57
11 Maintenance
Note: The Na, K and Cl electrodes can be soaked in buffer solution. With its level
over the flow cell of the electrodes. Do not store the reference electrode in buffer
solution; otherwise, the inner solution inside the electrode will diffuse.
Method 1:
 Install the cap on the electrodes.

 Place a sponge in the electrode case and then fill the electrode case with 2
mL buffer solution.
Place the sponge and dispense diluent into the electrode case.
 Place the electrodes on the sponge.

Place the electrodes in the electrode case.
 Restore the electrode case seamlessly. The electrodes are moistened by the
vapor of the diluent. Therefore, the airtightness of the electrode case is very
important.
Restore the electrode case cover.
11-58
11 Maintenance
Method 2:
 Install the cap on the electrodes.

 Moisten the gauze with ISE buffer and then dry it. Wrap the electrodes with
gauze and put them in the electrode packaging box.
Wrap electrodes with gauze moistened with buffer solution
 Cover the electrode case seamlessly to ensure that the buffer solution in the
gauze will not be vaporized.
Restore the electrode case cover.
13 Select Continue.
14 When Done is clicked, the current maintenance time and status are refreshed.
11.10.19 Prime Buffer Solution

Purpose
Perform this procedure to ensure that the tubes connecting the ISE buffer solution and
the sample probe are filled with liquid without interference from gas after repairing or
replacing ISE components.
When to do
Perform this procedure when you have replaced the degassing module, solenoid valve,
syringe or other ISE components or air bubbles exist in the tubes.
Materials required
None
Analyzer Status
11-59
11 Maintenance
Precautions
Warning
scratching.
Procedure
2 Select Prime Buffer Solution of relevant module and select Execute. When the
maintenance dialog box pops up, click start.
3 On the Buffer Prime window, enter the prime cycle or set the default value, and
then select Continue to start priming.
4 Select Done after the priming.
5 The current maintenance time and status are updated.
11.10.20 Waste Discharge

Purpose
Residual buffer in the sample injection cup may affect the next ISE test or prime. In
order to prevent the buffer from overflowing the sample injection cup during the next
ISE test or prime, it is necessary to perform the Waste Discharge Maintenance
procedure.
When to do
You are recommended to perform this procedure when an alarm is given indicating
sample probe level too high or maintenance is required.
Materials required
None
Analyzer Status
Precautions
Warning
scratching.
Procedure
2 Select Waste Discharge on the maintenance list and click Execute. When the
maintenance dialog box pops up, click Start.
3 On the Waste Discharge window, enter the drain cycle or set the default value, and
then select Continue to start discharging the waste.
4 Select Done after draining.
5 The current maintenance time and status are updated.
11-60
11 Maintenance
11.10.21 Service Life Query of Wearing Parts

If the wearing parts are replaced, re-set the life count of the wearing parts.
Purpose
Check the service life of the wearing parts and prepare for replacement.
When to do
Replace the wearing parts or check as required.
Materials required
None
Analyzer Status
Non-running status.
Procedure
2 Select the Service Life Query of Wearing Parts of the corresponding module.
3 Click Execute. A dialog box pops up. Click OK.
4 Select Clear to set the using time to 0.
5 If the parameters on the parameter setup window are modified, click Save to save
the usage of the wearing parts.
6 Select Exit. The current maintenance time and status are refreshed automatically.
11.10.22 Generate Daily Maintenance Report

To print daily maintenance reports, perform this procedure.
Purpose
Generate daily maintenance reports.
When to do
As required.
Materials required
None
Analyzer Status
Non-running status.
Procedure
2 Select the corresponding module to generate daily maintenance report
maintenance procedures.
3 Click Execute. A dialog box pops up. Click OK.
4 Select the period for maintenance.
5 Click Export. The export path selection dialog box is displayed.
6 Select the export path and click OK to generate a daily maintenance report.
7 Click Exit and the current maintenance time and status are refreshed
automatically.
11-61
11 Maintenance
11.11 Shutdown Maintenance

The shutdown maintenance procedure is used to automatically execute the
maintenance procedure during the shutdown process. (For details about shutdown
maintenance procedure, refer to11.2.2 Maintenance Setup(Page 11-8).
1 Select Exit on the lower left corner of the main screen.

2 Click Shutdown. The shutdown maintenance dialog box pops up. Click OK.
If the consumables for the shutdown maintenance procedures are insufficient, the
corresponding dialog box pops up prompting which consumables are insufficient.
Select OK to return to the main screen of the operating software. After
replenishing the consumables, repeat step 1.
When the shutdown maintenance procedures are finished, the system continues to
follow the shutdown procedure. During the shutdown procedure, if the maintenance
fails, the system still follows the shutdown procedure. Please check the shutdown
maintenance procedures in the maintenance history.
11-62
12 Alarms and Troubleshooting
The following pages describe how to view and edit error logs and edit logs, and how to
locate failure and determine relevant corrective actions. Read this chapter thoroughly
to achieve the best performance of the instrument.
12-1
12 Alarm and Troubleshooting
12.1 Classification of Logs

12.1.1 Introduction
The logs provided by the system are divided into:
 Error log
 Edit log
12.1.2 Edit Logs

Edit logs record all deletions and part of editing actions performed by the user.
The delete logs record all deleting actions other than the error deletion. The edit logs
include editing of sample results and calibration factors.
12-2
12.2 Viewing and Handling Logs

All error logs and edit logs can be recalled, searched, refreshed, deleted and printed.
12.2.1 Description of Error Log Screen

Select System and enter the Error Log screen.
Error Log screen
Every error log contains the event ID, date/time, error description (by processing
method), event class (by subsystem) and symptom.
12-3
12.2.2 Description of Edit Log Screen

Select System and enter the Edit Log screen.
Edit Log screen
Every edit log contains the serial number, date/time, operator, event type and
description.
12-4
12.3 Error Troubleshooting

12.3.1 Introduction
When an error occurs, it will be indicated in many ways. The following pages describe
how to troubleshoot errors and help you determine solutions to such errors.
Generally, troubleshooting is divided into the following steps:
 An error occurs and is indicated in various ways.
 Check the error logs and component status.
 Identify the error and determine relevant solutions.
 Implement the solutions.
 Check and evaluate the implementation of the solutions.
12.3.2 Error Indications

Errors may occur on hardware, software and the entire system. When an error occurs,
it will be indicated in many ways to help identify it and determine the possible causes
and solutions. Errors can be indicated by alarm tone, alarm message, color, alarm
message box, result flag and error log, through which you will obtain detailed
information about errors and find the relevant solutions.
Alarm tone
When an error occurs, the buzzer gives alarm tone reminding you to notice the error
and take corrective actions. Alarm tone can be adjusted manually or silenced.
Perform the following steps to adjust the alarm tone:
1 Select System > Error Log > Alarm Setup.
2 Select Enable Audio and Visual Alarm.
3 Select Enable Sound Alarm and Adjust the alarm tone in the Alarm Volume field.
4 Test the alarm tone until it is satisfied.
5 To silence the alarm tone, deselect Enable Sound Alarm.
6 Set the Repeat times of alarm sound.
7 Select OK to save the adjustment.
Alarm message
When an error occurs, the system gives an alarm and displays the alarm message in
the second line of the prompt message area.
Color highlight
An error will be indicated by highlighting relevant buttons and screen texts with
different colors. Yellow indicates a warning, and red indicates a serious warning or
error.
 Reagent button
 Utility button
 Alarm button
Select a button to access relevant function page, check for abnormities and take
corrective actions. When the problem is solved, the alarm indication disappears.
12-5
Alarm message box

An error can also be shown in an alarm message box, which contains the date/time,
event ID, time(s) and help icon.
Errors that are indicated through an alarm message box are divided into the following
types:
 Common error: including those that are indicated by warning the user, and by
invalidating tests, reagents and samples. When such error occurs, the alarm
message box shows with the title bar highlighted in yellow.
 Serious error: including those except for the common error. When such error
occurs, the alarm message box shows with the title bar highlighted in red, and you
are only allowed to reboot or exit the system.
When an alarm message box appears, select the Alarm button to view the new error
logs, analyze the possible causes and determine relevant corrective actions.
Flag
Flag is also called data alarm. When calibration error or failure, or sample result error
occurs due to the sample, reagent or system failure, a flag will appear near the
corresponding calibration result or sample results.
Error log
All alarms are recorded in the error logs. By recalling the error logs you are enabled to
master the current status of the system and troubleshoot errors.
12-6
12.4 Data Alarm

Data alarm is a result flag indicating that an error or abnormity occurs to a result. By
identifying results flags can evaluate if the results are reliable and acceptable. Data
alarm is not necessarily an error but will definitely influence the result and should be
considered carefully.
The system provides monitoring of biochemistry results and ISE test results. When
calibration error or failure, or sample result error occurs due to the sample, reagent or
system failure, a flag will appear near the corresponding calibration result or sample
results. The following pages summary the result flags of the system.
12.4.1 Result Flags

General Result Flags
Flag Alarm Type Description Probable Cause Corrective Actions

< Result-related Exceeds linearity Sample or control result Take no actions, or
range low exceeds the low limit of rerun the test for
the linearity range. confirmation.
< ISE Result Related Exceeds low limit of Sample or control result Take no actions, or
measurement range exceeds the low limit of rerun the test for
the measurement range. confirmation.
<Def Result-related Exceeds the lower Sample result exceeds No actions are
limit of custom range the lower limit of custom required.
range
> Biochemistry Exceeds linearity Sample or control result Rerun the test with
Result Related range high exceeds the high limit of sample diluted or
the linearity range. decreased.
> ISE Result Related Exceeds high limit of Sample or control result Rerun the test with
measurement range exceeds the high limit of sample diluted or
the measurement range. decreased.
>Def Result-related Exceeds the higher Sample result exceeds No actions are
limit of custom range the higher limit of required.
custom range
∧ Result-related Exceeds reference Sample result exceeds No actions are
range high the high limit of the required.
reference range.
∧! Result-related Exceeds critical range The result exceeds the No actions are
high high limit of the critical required.
range.
∨ Result-related Exceeds reference The result exceeds the No actions are
range low low limit of the reference required.
range.
∨! Result-related Exceeds critical range The sample result is No actions are
low lower than the low limit required.
of the critical range.
& Result-related Research result This is a research result. No actions are
required.
12-7

10-x Result-related 10-x The results of controls of Check if reagent is
latest 5 batches of tests qualified, control is
in Two-Control normal and the
Evaluation or the latest instrument is in
10 continuous results of normal status.
one control fall on the
same side of the mean.
1-2s Result-related 1-2s The current QC result is No actions are
less than ±3SD but required.
exceeds ±2SD
1-3s Result-related 1-3s Current QC value Check if reagent is
exceeds ±3SD qualified, control is
normal and the
instrument is in
normal status.
2-2s Result-related 2-2s The continuous two Check if reagent is
results of two controls or qualified, control is
one control of same normal and the
batch of tests exceed instrument is in
mean ±2SD on the normal status.
same side.
4-1s Result-related 4-1s The results of controls of Check if reagent is
latest two batches of qualified, control is
tests in Two-Control normal and the
Evaluation or the latest instrument is in
four continuous results normal status.
of one control exceed
mean ±1SD on the
same side.
ABS Result-related Absorbance out of The absorbance of Check the sample
range primary and secondary for impurities or
wavelength used for interferents. Check
calculating results is the reagent
greater than 3.5 A. placement and
reagent quality.
Check if the
cuvettes are clean.
Check if the
photometric system
is normal.
BIAS Calibration related Cl bias out of range The Cl electrode is dirty. 1. Clean the
The Cl electrode is electrode
degenerated. repeatedly and then
recalibrate.
2. Replace the Cl
electrode.
12-8

BLK Calibration related Blank response out of Reagent goes wrong; Check if the cuvette
range reagent is placed in the is not overflowed,
wrong position; reagent the position of
dispensing is reagent is correct,
insufficient; air bubbles the volume of
exist in cuvette; light reagent is sufficient
drifts. Cuvette overflow (without air
bubbles), the test
parameters are
reasonable, and the
light drifts. If yes,
replace the reagent
and then rerun the
test.
BOE Result-related Substrate depletion The sample Check the reaction
concentration is too high, curve and the
and substrate depletion substrate depletion
occurs during fixed-time limit. Rerun the test
measurements. with diluted sample.
BRRW Result-related Factors reset to Use the default Recalibrate
default calibration factors to
calculate sample and QC
results
Buf.NA Result-related ISE buffer solution is ISE buffer solution is Replace and rerun.
exhausted. exhausted.
CAL.EXP Calibration related Calibration check Calibration factors or Replace and
failed: Calibration calibrators are expired recalibrate
factors or calibrators
are expired
CAL.EXT Result-related Calibration time Use extended calibration Take no actions, or
extended factors to calculate recalibrate.
results
CAL.NA Calibration related Test not calibrated Test not calibrated Rerun the test after
calibration.
CalcE Result-related Sub test is out of Sample and control Manually dilute the
linearity range results of special sample or use
calculation are beyond increased or
the linearity range. decreased volume
method to rerun the
test.
CALE Result-related Recalculate results Use the edited No actions are
calibration curve to required.
calculate results.
CALF Result-related Recalculate results The result is calculated No actions are
based on the failed required.
calibration curve.
CALJ Result-related Recalculate results The result is calculated No actions are
based on the specified required.
calibration curve.
CALR Result-related Recalculate results Use the recalculated No actions are
calibration curve to required.
calculate results.
12-9

CarOvr Result-related Carryover The test may be Carryover has not
contaminated by the been cleared.
previous test. Please rerun
CCP.ERR Result-related Instrument error: The reaction carousel Please contact our
Reaction carousel assembly goes wrong. customer service
department.
CD80.NA Result-related CD80 detergent is CD80 detergent is Please add and
exhausted. exhausted. rerun.
CO2.ERR Result-related Ambient CO2 Ambient CO2 Please turn on the
concentration out of concentration out of indoor ventilation
range range device.
COV Calibration related Calibration curve is For nonlinear calibration, Check if reagent
not convergent. the root meeting the and calibrator are
accuracy requirement normal, and then
cannot be found, and the recalibrate. If the
calibration curve cannot error remains,
be fit. contact our
customer service
department.
COV.NA Result-related The shielding cover is The shielding cover is Close the window
opened. opened during and rerun the test.
measurement.
COV.R1 Result-related R1 reagent carousel R1 reagent carousel Close the window
cover is opened. cover is opened. and rerun the test.
COV.R2 Result-related R2 reagent carousel R2 reagent carousel Close the window
cover is opened. cover is opened. and rerun the test.
CSD Calibration related Calibration curve SD The calculated standard Check if the
out of range deviation of the parameters are
calibration curve reasonable, reagent
exceeds the specified and calibrators are
limit. normal, and then
recalibrate.
Cuv.ERR Result-related The cuvette is The cuvette is Cuvettes are
contaminated or contaminated or contaminated or
scratched. scratched. scratched. Perform
weekly special
wash.
CW.ERR Result-related Instrument error: The cuvette wash Please contact our
Cuvette wash assembly goes wrong. customer service
department.
DEL Result-related Deleted QC result The QC result has been No actions are
deleted. required.
DET Calibration related Calibration curve The calculated fit of the Check if the
determination calibration curve parameters are
coefficient out of exceeds the specified reasonable, reagent
range limit. and calibrators are
normal, and then
recalibrate.
12-10

Dil.NA Result-related Physiological saline Physiological saline W is Check the adding
W insufficient/Empty insufficient or contains and then rerun the
aspiration/Collision air bubbles, causing test.
empty aspiration or
collision.
DILE Calibration related Dilution ratio Calibrator is stored for 1. Replace the
calculation error too long or electrodes calibrator. Perform
are degenerated. calibration again.
The electrode is not 2. Reinstall the
installed correctly. electrode and check
The calibrator is if the O ring
contaminated or between electrodes
misplaced. is correctly installed
and there should be
only one O ring
between electrode
and module.
3. Replace the
electrode.
DILO Calibration related Dilution ratio out of Calibrator is stored for 1. Replace the
range too long or electrodes calibrator. Perform
The electrode is not 2. Reinstall the
installed correctly. electrode and check
if the O ring
between electrodes
is correctly installed
and there should be
only one O ring
between electrode
and module.
3. Replace the
electrode.
DTGL Result-related Insufficient special The diluted wash Fill more diluted
wash solution solution is insufficient wash solution.
during measurement.
DUP Calibration related Calibration The difference between Check if the
repeatability out of the maximum and parameters are
range minimum response of reasonable and the
the calibrator exceeds repeatability is
the specified limit. poor. Check if the
electrodes are
installed correctly
and then
recalibrate.
EDT Result-related Manually editing Manually editing results No actions are
results required.
EDT Calibration related Manually editing Manually editing No actions are
calibration factors calibration factors required.
12-11

ENC Result-related The reaction curve The sample Check the reaction
has no calculation concentration is too high, curve and the
interval. and substrate depletion substrate depletion
occurs within the lag limit. Rerun the test
time of rate check with diluted sample.
measurements.
ERR Result-related The results are Invalidate the analyzer Perform
invalidated due to due to component failure troubleshooting
instrument failure. or emergency stop. based on specific
alarms.
EXP Result-related Enzyme linearity Sample concentration is No actions are
range extension too high. Start the required.
enzyme linear extension
algorithm.
FAC Calibration related Calibration slope Only applicable for linear Check if the
difference out of calibration. It refers to parameters are
range the difference between reasonable, reagent
current k and last k in and calibrators are
slope. It exceeds the normal, and then
specified limit. recalibrate.
FAN.ERR Result-related Instrument error: The light source fan Please contact our
Light source fan error assembly goes wrong. customer service
department.
H Result-related Obvious hemolysis Hemolysis is found in Please check the
interference serum index test sample.
H.- Result-related Obvious hemolysis The serum index test Negative
interference; negative found that the sample interference. Please
interference had significant check the sample.
hemolysis interference
and the result was
negatively interfered.
H. In Result-related Slight hemolysis Slight hemolysis No actions are
interference interference found in required.
serum index test
H. Out Result-related Serious hemolysis Serum index test found Please check the
interference that the sample had sample.
serious hemolysis
interference
H.+ Result-related Obvious hemolysis The serum index test Positive
interference; positive found that the sample interference. Please
interference had significant check the sample.
hemolysis interference
and the result was
positively interfered.
HI Result-related Hemolysis and Hemolysis and icterus Please check the
icterus exist are detected sample.
simultaneously simultaneously
I Result-related Obvious icterus Serum index test shows Please check the
interference that the sample has sample.
obvious icterus
interference.
12-12

I.- Result-related The measurement is Serum index test shows Result Negative
obviously interfered that the sample has interference. Please
by icterus and the obvious icterus check the sample.
result is negative. interference.
I. In Result-related Slight icterus e Serum index indicates No actions are
interference that the sample has required.
slight icterus.
I. Out Result-related Severe icterus Serum index test shows Please check the
severe icterus
interference.
I.+ Result-related Obviously interfered Serum index test shows Result Positive
by icterus. Result that the sample has interference. Please
positive interference obvious icterus check the sample.
interference.
ILLOG Result-related Logic check error Logic check error Rerun the test
ICA Result-related The response is Result cannot be The test is
normal, but results calculated due to no completed but the
cannot be calculated. valid calibration factors. valid calibration
curve is missing. It
will be recalculated
automatically after
calibration.
ISE.ERR Result-related Instrument error: ISE The ISE assembly goes Please contact our
module wrong. customer service
department.
ISE.NA Result-related ISE buffer solution ISE buffer solution Check the electrode
dispensing deviation dispensing deviation is installation.
is too large too large Perform ISE wash
and then rerun the
test.
ISET.ERR Result-related Instrument error: ISE The ISE fan assembly Please contact our
cooling fan goes wrong. customer service
department.
Result-related ISE communication ISE communication error Home the system.
ISEC.ERR
error
Result-related ISE communication ISE communication Home the system.
ISEC.NA
timeout timeout
Result-related Electrode response Electrode response Replace the
voltage low voltage low reference electrode
ISEE.ERR
and then rerun the
test.
Result-related ISE electrode has ISE electrode has Please check and
ISEE.Exp exceeded the limit of exceeded the limit of replace it in time.
using time/times. using time/times.
Result-related Electrode response Electrode response Rerun the test.
ISEE.NA
voltage low voltage low
Result-related ISE reagent packet ISE reagent packet Please replace with
status is abnormal. status is abnormal. a new reagent
ISER.ERR
packet and rerun
the test.
12-13

Result-related Please check and Please check and Please check and
ISER.Exp
replace it in time. replace it in time. replace it in time.
Result-related ISE reagent is ISE reagent is exhausted. Replace it and rerun
ISER.NA
exhausted. the test.
Result-related ISE test sample is ISE test sample is Please contact
ISES.ERR
abnormal. abnormal. service engineer.
Result-related ISE test sample is ISE test sample is Please contact
ISES.NA
abnormal. abnormal. service engineer.
Result-related Instrument error: ISE The ISE fan assembly Please contact
ISET.ERR
fan goes wrong. service engineer.
IW.ERR Result-related Instrument error: Probe interior wash Please contact our
Probe interior wash syringe error customer service
syringe department.
L Result-related Obvious lipemia Lipemia is found in Please check the
interference serum index test sample.
L! Result-related Water blank 1. Overflow Check if the
fluctuation out of 2. The lamp has been cuvettes are
range replaced incorrectly. overflowing. Check
3. Cuvette check is not if the Replace Lamp
performed after cuvette command is
maintenance. executed when the
lamp is replaced.
4. The lamp cable is not
Check if the cable
connected properly.
connectors and
5. The retaining screw of retaining screws
the lamp has not been are tightened.
tightened. Check if the wash
6. Cuvette wash solution solution inside the
is insufficient. cuvette is no less
7. Lamp is aging. than half of the
8. Photometer error wash solution. If
the reaction curve
fluctuates
irregularly, replace
the lamp. If the
error remains,
contact our
customer service
department.
L.- Result-related Lipemia is interfered Lipemia is found in Negative
obviously. Negative serum index test interference. Please
interference check the sample.
L. In Result-related Slight lipemia Slight lipemia is found in No actions are
the serum index test. required.
L. Out Result-related Severe lipemia Serum index test shows Please check the
serious lipemia
interference.
L.+ Result-related Lipemia is interfered Lipemia is found in Positive
obviously. Positive serum index test interference. Please
interference. check the sample.
12-14

LACK.ERR Result-related Instrument error: The front track of the Please contact our
Front track instrument goes wrong. customer service
department.
LH Result-related Lipemia and Serum index test found Please check the
hemolysis that the sample had sample.
interference lipemia and hemolysis at
the same time.
LHI Result-related Lipemia, hemolysis Serum index test shows Please check the
and icterus that the sample is sample.
interference interfered by lipemia,
hemolysis and icterus at
the same time.
LHI.NA Result-related Serum index test is The serum index test is No actions are
not finished or still in progress. required.
abnormal.
LI Result-related Lipemia or icterus Serum index test shows Please check the
that the sample is sample.
interfered by lipemia and
icterus at the same time.
LIN Result-related Linearity limit out of Sample concentration is Check the reaction
range too high. The measuring curve and the
points for result substrate depletion
calculation are nonlinear limit. Rerun the test
or the substrate with diluted sample.
depletion limit is not If the error occurs
specified or for multiple
unreasonable. The lamp chemistries
is aging. simultaneously, if
the reaction curve
fluctuates
irregularly, replace
the lamp.
LOW Result-related Response less than The sample For ascending
that of the lowest- concentration is lower calibration curve,
level calibrator than the sensitivity rerun the test with
indicated on the reagent normal or increased
pack, making response volume; for
less than that of the descending
lowest-concentration calibration curve,
calibrator. rerun the test with
diluted sample.
M.MASK Result-related Module masked Module masked No actions
required.
MASK Result-related Masking tests or Masking tests or Unmask the
instruments instruments instrument or test,
and then rerun the
test.
12-15

MBK Calibration related Mixed blank The reagent goes wrong. Check if the cuvette
absorbance out of Cuvettes are not clean. is clear and not
range Cuvettes are overflowed; overflowed, the
reagent addition is not reagent is sufficient
sufficient. without air bubbles,
and the test
parameters are
reasonable. If yes,
replace the reagent
and then rerun the
test.
MON Calibration related Calibration curve is The calibration data and Check if the
not monotonic. calibration curve are not calibrator is defined
monotonic. and placed
correctly, and then
recalibrate.
MX.ERR Result-related Instrument error: Mixer drive assembly Contact our
Mixer drive assembly error customer service
department
NLN Result-related No linear interval The high-concentration Rerun the test with
sample leads to less diluted sample.
than 3 valid measuring
points within the reaction
time of rate check
measurements.
NOID Result-related Instrument error: Instrument software If the error remains,
Software error error. Sample ID is lost. contact our
customer service
department.
OVE Result-related Calibration factor Use the sample and Take no actions, or
overridden control result gained by recalibrate.
the overridden
calibration factor
Overflow! Result-related Cuvette overflow 1.Weekly special wash Check if the
solution and optical unit cuvettes are
check are not performed overflowing. If not,
on time. execute the weekly
2.Overflow special wash and
optical unit check
commands. If the
error remains,
contact our
customer service
department.
Para.NA Result-related Parameter is not Parameter is not correct. Set correct
correct. parameters.
PRO Result-related Prozone check error Antigen excess occurs Check the reaction
due to too high sample curve and the
concentration. prozone check
parameters. Rerun
the test with diluted
sample.
12-16

QC.EXP Result-related Control is expired Control is expired Replace and rerun
R Result-related Rerun result Rerun the finished tests. No actions are
required.
R. Exp Result-related Reagent expired Reagent expired Please check the
reagent and replace
it in time.
R.MASK Result-related Reagent is masked. Reagent is masked. No actions are
required.
R0.NA Result-related R0 reagent R0 reagent Please check the
insufficient/aspiration insufficient/aspiration corresponding
empty/collision/too empty/collision/too Full. reagent volume.
Full. Please check.
empty/collision/too empty/collision/too Full. reagent volume.
Full. Please check.
R11.ERR Result-related Instrument error: Probe R11 goes wrong. Contact our
Probe R11 customer service
department.
department.
R1DA.NA Result-related Acid wash for Probe Acid wash for Probe R1 Please check the
R1 is insufficient. is insufficient. Reagent corresponding acid
Reagent probe probe aspirates nothing wash volume.
aspirates nothing or or collides.
collides.
R1DB.NA Result-related Probe R1 alkaline Probe R1 alkaline wash Please check the
wash is insufficient. is insufficient. Probe R1 corresponding
Probe R1 aspirates aspirates nothing or alkaline wash
nothing or collides. collides. Please check. volume.
Please check.
R1W.ERR Result-related Instrument error: Probe R1 washing failed. Perform the test
Probe R1 washing again after
failed. resetting.
R1W.NA Result-related Probe R1 reagent Probe R1 reagent Please rerun
washing failed. washing failed.
empty/collision/over empty/collision/over reagent volume.
Full. Full. Please check.
department.
department.
12-17

R2DA.NA Result-related Acid wash for R2 Acid wash for R2 probe Please check the
probe is insufficient. is insufficient. R2 probe corresponding Acid
R2 probe aspirates aspirates nothing or wash volume.
nothing or collides. collides.
R2DB.NA Result-related Alkaline wash for R2 Alkaline wash for R2 Please check the
probe is insufficient probe is insufficient or corresponding
or R2 reagent probe R2 reagent probe Alkaline wash
aspirates nothing or aspirates nothing or volume.
collides. Please collides. Please check.
check.
R2W.ERR Result-related Instrument error: Probe R2 cleaning failed. Perform the test
Probe R2 washing again after
resetting.
R2W.NA Result-related Probe R2 reagent Probe R2 reagent Wash Please rerun.
Wash failed. failed.
R3.NA Result-related R3 Reagent is R3 Reagent is Please check the
insufficient. Reagent insufficient. Reagent corresponding
probe aspirates probe aspirates reagent volume.
nothing/collides with nothing/collides with an
an obstacle. R3 is too obstacle. R3 is too Full.
Full.
R4.NA Result-related R4 Reagent is R4 Reagent is Please check the
insufficient. Reagent insufficient. Reagent corresponding
probe aspirates probe aspirates reagent volume.
nothing/collides with nothing/collides with an
an obstacle. R4 is too obstacle. R4 is too Full.
Full.
R-4S Result-related R-4S out of control For the test results of Check if reagent is
controls in Two-Control qualified, control is
Evaluation, one exceeds normal and the
mean +2SD, the other - instrument is in
2SD. normal status.
RACK.NA Result-related Sample is not in the Sample is not in the Place the right
system. system. sample.
RBK Result-related R1 blank absorbance The absorbance of Check if the cuvette
out of range primary and secondary is clear and not
wavelengths of the test overflowed, the
is not within [-35000 or reagent is sufficient
35000] at the 1-4 without air bubbles,
measuring point. and the test
The reagent goes wrong. parameters are
Cuvettes are not clean. reasonable. If yes,
Cuvettes are overflowed; replace the reagent
reagent addition is not and then rerun the
sufficient. test.
RCE Result-related Result cannot be The absorbance data for Rerun the test. If
calculated calculation is the error remains,
incomplete, or the contact our
dividend is 0. customer service
department.
12-18

RDA.NA Result-related Acid wash for reagent Acid wash for reagent Please check.
probe is insufficient probe is insufficient or
or reagent probe reagent probe aspirates
aspirates nothing or nothing or collides.
collides.
RDB.NA Result-related The alkaline wash for The alkaline wash for Please check.
reagent probe is reagent probe is
insufficient or reagent insufficient or reagent
probe aspirates probe aspirates nothing
nothing or collides. or collides.
RE Result-related Abnormal reaction Abnormal reaction curve Please check and
curve rerun the test.
REC Result-related Sample manually Recalculate sample /
recalculated results with new
calibration factors
REE Result-related Compensated Result Proceed No actions are
required.
REF Calibration related Output of reference The reference electrode Replace the
electrode lower than is degenerated. calibrator and
100 mv recalibrate. If the
error remains,
replace the
reference electrode.
REPL Calibration related More than calibration The calibration 1. Replace the
times repeatability of the ISE calibrator. Perform
module is poor. calibration again.
2. If the electrodes
are new, activate
them and then
recalibrate.
3. Check the
connection of the
ISE buffer tank and
then recalibrate.
RG! Result-related Reagent blank error Fluctuation of reagent 1.Check if the
blank exceeds 0.2Abs in cuvettes are
ten consecutive tests. overflowed
2.Check whether
the temperature
and humidity of the
test environment
are too high.
3.Check if reagent
is expired or
contains air
bubbles.
RM.ERR Result-related Instrument error: The reagent mixer goes Contact our
Reagent mixing wrong. customer service
department.
RP.ERR Result-related Instrument error: The reagent carousel Contact our
reagent carousel assembly goes wrong. customer service
department.
12-19

RRN Result-related Sample concentration The sample Rerun the test with
is higher than that of concentration exceeds diluted sample.
the highest-level the high limit of the
calibrator calibrator concentration.
RT.ERR Result-related Instrument error: The reagent refrigeration Contact our
Reagent refrigeration assembly goes wrong. customer service
department.
S. CarOvr Result-related The sample may be The sample may be Check if the wash
contaminated by the contaminated by the solution is
previous test. previous test. sufficient.
S. Clot Result-related Sample is insufficient Sample contains fibrins Check the sample,
or contains fibrins or clogs and use a bamboo
and clots. Sample probe is clogged. tab to remove the
Insufficient sample fiber or clot from
the sample.
Prepare the tested
sample again
Use the unclogging
device to unclog the
sample probe
S. Delay Result-related Sample arrives late Sample Delay Please rerun
S. Exp Result-related Expired sample Expired sample Collect new sample
or replace the
control.
S. NA Result Insufficient Sample is Check the
related/calibration sample/empty insufficient/aspirated corresponding
related aspiration/collision nothing/collision sample
S1.ERR Result-related Instrument error: Probe S1 assembly goes Please contact our
Probe S1 wrong. customer service
department.
S2.ERR Result-related Instrument error: Probe S2 assembly goes Please contact our
Probe S2 wrong. customer service
department.
SDA.NA Result-related Sample probe acid Sample probe acid wash Check
wash is insufficient. is insufficient. Sample corresponding acid
Sample probe probe aspirates nothing wash
aspirates nothing or or collides.
collides.
SDB.NA Result-related Sample probe alkaline Sample probe alkaline Check
wash is insufficient. wash is insufficient. corresponding
Sample probe Sample probe aspirates alkaline wash
aspirates nothing or nothing or collides.
collides.
SDC.NA Result-related Insufficient sample Insufficient sample Check
probe probe wash corresponding
detergent/sample solution/sample probe detergent.
probe aspirates aspirates nothing or
nothing or collides collides
SDM.ERR Result-related Instrument error: SDM running error Please contact our
SDM customer service
department.
12-20

SEN Calibration related Calibration sensitivity The difference of final Check if the
out of range response of the parameters are
maximum and minimum reasonable, reagent
concentration calibrators and calibrators are
exceeds the specified normal, and then
limit. recalibrate.
SEN Calibration related EMF out of range 1. The calibrator is 1. Check the
during ISE module placed in an incorrect calibrator's position
calibration position. and replace the
2. The electrode is calibrator; check if
degenerated. the electrodes are
correctly installed,
and then
recalibrate.
2. If the electrodes
are new, activate
them and then
recalibrate.
3. Replace the
electrode.
SLE Calibration related Slope calculation Calibrator is stored for 1. Replace the
error too long or electrodes calibrator. Perform
The electrode is not 2. If the electrodes
installed correctly. are new, activate
them and then
recalibrate.
3. Reinstall the
electrode and check
if the O-shape
washer between
electrodes and the
module is installed
correctly.
4. Replace the
electrode.
12-21

SLO Calibration related Slope out of range Calibrator is stored for 1. Replace the
too long or electrodes calibrator. Perform
The electrode is not 2. If the electrodes
installed correctly. are new, activate
them and then
recalibrate.
3. Reinstall the
electrode and check
if the O-shape
washer between
electrodes and the
module is installed
correctly.
4. Replace the
electrode.
5. Check if the
calibration status of
the test is Cal
Failed.
SLP Result-related Calibration factor set Calibration factor set for No actions are
for the test. the test. required.
SM.ERR Result-related Instrument error: The sample mixer Please contact our
Mixing sample assembly goes wrong. customer service
department.
SW.ERR Result-related Instrument error: Sample probe cleaning Perform the test
Sample probe failed again after
washing resetting.
SW.NA Result-related Sample probe Sample probe cleaning Please rerun
cleaning failed. failed
SYS.ERR Result-related Instrument error: Instrument operation Please contact our
Instrument does not abnormal customer service
work normally department.
T. ERR Result-related Instrument error: The temperature control Please contact our
Temperature control system goes wrong or customer service
system the ambient temperature department.
is abnormal.
TD Result-related Photoelectric Photoelectric 1. Rerun the
measurement is time measurement is time operating software.
out. out. 2. Restart the
analyzing unit.
3. If the error
remains, contact
our customer
service department.
VAC.ERR Result-related Instrument error: Cuvette wash is Please contact our
Cuvette wash error abnormal. customer service
department.
W.ERR Result-related Instrument error: Fluidic unit error Please contact our
Fluidic unit error customer service
department.
12-22

WST.ERR Result-related Instrument error: Waste drainage system Please contact our
Waste discharge error abnormal customer service
department.
WST.F Result-related Waste tank is full Waste tank is full Please empty or
replace the waste
tank.
12-23
12.5 Troubleshooting Procedure

When the analyzer is running, some problems may occur. When the analyzer detects
these problems, it will give an audible and visual alarm to remind you of the problem.
You can see the current problem on the software screen. Meanwhile, you can clear the
alarm through the prompt on the software screen. When the problem is solved, the
analyzer will go back to normal. If the troubleshooting measures prompted by the
analyzer cannot solve your problem, please give feedback to Mindray customer service
department in time.
12.5.1 Error Alerts and View

The analyzer provides alerts in multiple ways. For abnormal situations that require
immediate intervention, the instrument will remind the user through audible and visual
alarms. When the consumables of the cabinet need to be replenished, the
consumables indicator of the instrument will prompt the user to add the consumables.
If the error is not serious and does not need immediate handling you can see the alarm
message on the software screen, and then choose your handling method according to
the software prompts and actual conditions.
The analyzer classifies alarms into three levels, and different levels of alarms will be
indicated in different ways.
Alarm level
The analyzer classifies alarms into three categories: Severe alarm, warning alarm and
prompt alarm.
 For alarms that cause stop or are about to cause stop, you need to handle them
immediately.
 Warning alarms are alarms that may pause the analysis, or stop the system if not
handled properly, and affect the TAT time of the sample. You should also handle
them as soon as possible after a warning alarm occurs.
 For prompt-level alarms, generally you need not to take actions, which has little
impact on the test. If you are beside the analyzer, you can check the prompt
messages on the software screen.
Analyzer status indicator

The status indicators above the shielding cover indicate the status of the analyzer with
different colors. When you are far away from the analyzer, you can determine whether
the analyzer is working or not according to the color of the analyzer status indicator.
When the analyzer is in the sleep or shutdown status, all the analyzer status indicators
are not on.
There are three colors when the analyzer status indicator is working. Different colors
indicate different statuses of the analyzer.
12-24
Red:
When the status indicator of the analyzer is red, the analyzer may have a serious error,
which triggers a serious alarm that the analyzer has stopped or is about to stop. Check
the instrument as soon as possible to check for errors.
Yellow:
When the status indicator of the analyzer is yellow, the analyzer triggers a warning
alarm. Problems will not lead to the stop of the analyzer, but may affect the current
test, for example, the reagent of a test is used up or consumables are used up. If the
analyzer status indicator is yellow, you should also go to the analyzer as soon as
possible to avoid delaying the completion of tests and report output.
Blue:
When the status indicator of the analyzer is blue, the analyzer is in normal working
status and does not require much intervention. If you are in front of the analyzer, tap
the alarm button on the analyzer screen to access the alarm screen. On the Alarm
screen, you can see the abnormal information of the analyzer.
Consumables Indicator
The consumables status of the analyzer cabinet will be indicated by the consumables
indicator. The consumable indicators are on the left cover of the front track. If you see
consumables flashing, replenish consumables as instructed by the indicators.
Consumables indicators consists of four parts
The CD80 detergent indicator is on the left of the consumables indicator. There are
three indicators, digital "1," digital "2" and silkscreen on the CD80 detergent tank.
ISE buffer solution is on the right of the consumable indicator, corresponding to the
ISE silkscreen.
12-25
The relationship between consumable lamp status and consumables is shown in the
following table.
Consumables Purpose Status

Indicator On Flashing Off
CD80 CD80 status CD80 in CD80 is -
normal use insufficient
and needs to
be
replenished.
Number CD80-1 In use Replace the CD80-1 is
"1" Status CD80-1 CD80-1 when not used
it is currently
insufficient.
Number CD80-2 In use Replace the Not using
"2" Status CD80-2 CD80-2 when CD80-2
it is currently
insufficient.
ISE ISE buffer ISE buffer ISE buffer No ISE
solution solution is solution is module is
status being used insufficient configured.
normally. and needs to
be
replenished.
12.5.2 Software Screen Prompt

When detecting an abnormity, the analyzer will remind you in the following two ways:
Display of severe alarms

When the analyzer is in serious failure and may stop. An alarm box pops up on the
software screen. You can view the error information in the pop-up alarm box and
determine the solution according to the prompt.
In the pop-up window, if you are prompted to recover the failure, you can select a failed
module and then click the "Home" button to start the process.
If you have closed the error dialog box but need to check the error information or the
solutions, click the analyzer status icon in the upper left corner of the software screen
or the system icon in the middle left corner of the software.
In this window, you can view the alarms that have not been recovered, select a faulty
module and click the "Home" button to recover the failure.
12-26
Display of warning and prompt alarms

There is an icon in the upper right corner of the screen.
You can click the icon to enter the screen for warnings and prompts.
On the warning and tip screens, all warning errors are displayed by default.
You can also view the prompts by clicking the "Tip" tab.
On the warning and tip screens, you are also allowed to view the errors of the
corresponding categories through the "Sample," "QC," "Calibration" and "reagent" tabs.
12.5.3 Troubleshooting
You can see cards with error messages in the pop-up window for severe alarms and
warning and prompt alarms.
12-27
Alarm time Alarm Alarm No. Clear button

Time Name
Alarm Solution hyperlink button

Description
The alarm card contains the following information:
 Alarm Name
 Alarm time
 Alarm No.
 Alarm Description
 Solution
 Clear button: If you do not care about the alarm or you can confirm that the alarm
is resolved, you can click the Clear button. When the button is clicked, the screen
will display and delete the corresponding alarms.
 Hyperlink button: You can click this button to enter other screens related to this
alarm. After entering the corresponding screen, you can perform relevant software
operations to solve the problem.
You can try to solve the problem according to the prompt on the alarm card.
See the table for the causes and solutions of common errors.
If the error still remains, contact our customer service department or your local
distributor.
To contact Mindray customer service personnel, prepare the following information:
 Account/User ID
 Analyzer SN
 Module Type and SN
 Software version
 Alarm and Alarm Code
If biochemistry test results are involved
You should also provide the following information:
 Reagent Ref No., Lot No., and Expiration Date
 Lot number of ISE electrode (If ISE test is involved)
 Recent calibration results
 Latest QC results
 Abnormal test results and test-related information (If specific tests are involved)
12-28
12.5.4 Clear Errors

Errors can be cleared automatically by the instrument or manually by the user.
Auto Clear
If the analyzer detects that the previous alarms or condition no longer meets the alarm
conditions, the corresponding alarm will be cleared automatically. Clearing alarms in
such cases is the active operation of the analyzer. For example, if an alarm indicates
that a reagent has been used up, the analyzer will clear the alarm after detecting that
the reagent has been added.
Manual Clear
Some alarms are used to record abnormal conditions that have occurred and may not
be cleared automatically. In this case, the corresponding alarm can also be cleared
manually.
On the warning and prompt screens, if you know all alarms and you do not need to pay
attention to them, you can click the one-click clear button on the lower right corner of
the warning and prompt screens. After you click this button, the software clears the
alarms on the corresponding alarm screen and clears the corresponding alarm count.
Note that the above alarm clearing function is only used to clear the prompt
information on the alarm screen. If you do not actively clear the alarms on the screen,
no extra impact will be incurred.
12-29
12.6 Troubleshooting
12.6.1 No Alarm Troubleshooting
The following table lists conditions that may affect the startup of the analyzer. If the
analyzer cannot be turned on or is not connected or offline without any alarm, it is
recommended to perform the following checks. If the problem is not solved through
all measures, please contact technical support.
Cause Description Corrective Actions

Instrument is not powered on Connect the power cord to the socket or
the air switch.
The instrument switch is turned off. Turn on the main switch and module
switch.
Network cable is not connected Connect the computer network cable to
the network interface on the back of the
SDM.
Network cable connection error Possible cause: Incorrectly plug the
communication network cable into the
LIS communication port. Adjust the
network cable connection.
The instrument is set to Turn off the computer software and
offline/disconnected status. power switch of the module, wait for 10
seconds, then turn on the module power
in turn, and then run the operating
software again.
12.6.2 Troubleshooting Alarms

Reagent /Consumable Problems
Reagent/consumable problems
No. Description Cause Corrective Actions

Reagent is Use the reagent within the
216320201 Expired reagent is used.
expired. validity period.
Reagent exceeds
Reagent is uncapped too Use the reagent within the
216320301 the on-board
long. validity period.
stability time
Check whether the reagent is
Reagent is about Close to the expiration date
216320101 expired. If yes, replace the
to expire. of reagent.
reagent.
Insufficient
Reagent is insufficient and
216320503 biochemical Please replenish reagent.
about to be used up.
reagent
Biochemistry
216320603 reagent Reagent is exhausted. Please replenish reagent.
exhausted
210540201 There is no reagent or
R1 reagent
insufficient reagent in the Please replenish reagent.
210640201 insufficient
position.
210740201 Please replenish reagent.
12-30

There is no reagent or
R2 reagent
210840201 insufficient reagent in the
insufficient
position.
Insufficient CD80 CD80 detergent is about to
216340303 Refill CD80 detergent.
detergent be used up.
CD80 detergent is
216340503 CD80 detergent is exhausted. Refill CD80 detergent.
exhausted.
Buffer tank of
The diluted CD80 in the
215030602 CD80 is Refill CD80 detergent.
instrument is exhausted.
exhausted.
Wash solution is
216330203 Wash solution is exhausted. Please refill the wash solution.
exhausted.
Insufficient
Physiological saline is about
216330401 physiological Refill physiological saline.
to be exhausted.
saline
Physiological Physiological saline is
216330503 Refill physiological saline.
saline exhausted exhausted.
Physiological
saline position on Reposition the reagent and
Reagent is placed in the
216310503 reagent carousel remove it from the saline
wrong position.
is occupied by position.
another reagent.
ISE buffer
ISE buffer solution is about to
216340101 solution is Please refill ISE buffer solution.
be used up.
insufficient.
ISE buffer
ISE buffer solution is
216340203 solution is Please refill ISE buffer solution.
exhausted.
exhausted.
If CD80 detergent is exhausted,
Diluted wash Concentrated wash solution
fill more.
215030202 solution tank is is exhausted.
empty. If the water tank is empty, turn
Water tank level error.
on the water supply switch.
If CD80 detergent is exhausted,
Filling diluted Concentrated wash solution
fill more.
215030102 wash solution is exhausted.
tank timeout If the water tank is empty, turn
Water tank level error.
on the water supply switch.
Check the reagent filling volume
R1 reagent to ensure that the reagent liquid
210540401 The reagent volume is too
Excessive filling level does not exceed 7 mm
210640401 much.
volume above the bottle shoulder. Rerun
the test.
210740401 Check the reagent filling volume
R2 reagent to ensure that the reagent liquid
The reagent volume is too
Excessive filling level does not exceed 7 mm
210840401 much.
volume above the bottle shoulder. Rerun
the test.
Biochemistry
216320403 reagent is Reagent is exhausted. Please replenish reagent.
exhausted.
210510601
12-31

R1 reagent bottle The reagent cap is not Open the reagent cap before
210610601
cap is not opened opened. starting the test.
210710601 R2 reagent bottle The reagent cap is not Open the reagent cap before
210810601 cap is not opened opened. starting the test.
212010402 Check if the reagent at the alarm

R1 reagent R1 reagent carousel has
position is open and inserted in
carousel reagent uncapped or not
212020402 place. Place the reagent properly
movement error inserted in place.
and rerun the test.
212110402 Check if the reagent at the alarm
Reagent R2 R2 reagent carousel has
position is open and inserted in
carousel reagent uncapped or not
212120402 place. Place the reagent properly
movement error inserted in place.
and rerun the test.
R1 reagent
carousel cover is Reagent The carousel cover Close the carousel cover and
212030103
not installed is not installed correctly. rerun the test.
correctly.
Carousel reagent
Reagent The carousel cover Close the carousel cover and
212130103 cover not
is not installed correctly. rerun the test.
installed properly
210540301
210640301 Air bubbles exist Remove the air bubbles from the
Reagent has air bubbles.
210740301 during aspiration reagent bottle and rerun the test.
210840301
Incorrect reagent bar code is
Check the reagent bar code
used, or reagent bar code
against its decoding rules, or
settings are incorrect. Non-
Reagent barcode reprint the bar code according to
closed reagent barcode is
216310203 cannot be the decoding rules. If you are
used in the closed-reagent
analyzed using a closed reagent system,
reagent system. The system
contact the reagent vendor for
cannot analyze any reagent
replacement.
information.
210140501 R1 reagent has air
Remove the air bubbles from the
bubbles during Reagent has air bubbles.
210240501 reagent bottle and rerun the test.
dispensing.
1. Overflow or water Check if overflow or water
ingression on reaction ingression on reaction carousel
carousel is not cleared. has occurred. If yes, remove the
Reagent blank Bubbles exist when reagent reaction carousel and dry the
213130702 fluctuation is dispensed. temperature bath and reaction
abnormal R1 Reagent Dispense volume carousel.
is insufficient. Check if there are air bubbles in
reagent;
Check if probe R1 is clogged.
12-32
Sample Problems
Sample problems

210140301 Please check the sample.
Sample contains air Sample contains air
Remove the bubbles and rerun
210240301 bubbles. bubbles.
the test.
210140201
210150301 Check the sample to see if it is
Insufficient sample Insufficient sample.
210240201 sufficient, and then try again.
210250301
210110601 Sample probe collides
Check the sample to see if it is
with an obstacle when Insufficient sample.
210210601 sufficient, and rerun the test.
aspirating
210150201 Check the samples to make
The sample contains The sample contains sure they have been pre-
210250201 fibrins and clogs. fibrins and clogs. treated correctly and then
rerun the tests.
Check the samples on the
A sample has been
rack, confirm the order
606020401 No order information loaded but not ordered
information and run the test
for analysis.
again.
The alarm position has
no sample placed, but
At least one sample is rack, confirm the order
606030203 the corresponding
lost on sample rack information and run the test
sample has been
again.
ordered.
Sample barcode has no Sample barcode has no
606020703 Order the sample.
order information. order information.
All samples on the rack
All sample racks have current rack, confirm the order
606020803 have no order
no order information. information and run the test
information.
again.
1. Use clear and complete
1. Sample bar code is
sample bar code.
too poor to be identified.
2. Adjust the sample bar code
2. Sample bar code label
label to make it face the rack
Sample bar code cannot is not applied correctly.
606020501 bar code scanning window.
be identified 3. Symbology, digits and
3. Check if the symbology,
check digit of sample
digits and check digit of
bar code are not set
sample bar code are set
correctly.
correctly.
1) Rack is loaded in an
1) Load the rack in the correct
incorrect direction.
direction. 2) Clean the rack bar
The rack is placed 2) Rack bar code label is
code label or replace it with a
606030103 reversely or the rack bar damaged or dirty.
new one. 3) If the error occurs
code is dirty. 3) The lens of the
for multiple racks, contact our
barcode scanning
customer service department.
camera is dirty.
12-33

Check if two or more racks
Sample racks with the
with the same rack ID are
Duplicate rack ID in the same bar code are used
606030403 included in the same batch of
system in the same batch of
tests. Use different racks for
tests.
analysis.
Test Problems
Test problems

Check the sample for
The sample contains impurities or interferents;
impurities or reagent is Check the reagent placement
216011001 Absorbance out of range
expired, resulting in and reagent quality. Check if
excessive reaction. the cuvette is clean. Check if
the optical path is normal.
Instrument Problems
Instrument problems

If the life span of the lamp has
1. The lamp service life
expired, replace it.
The lamp goes wrong. expires.
213120102 If the lamp cable is not
The lamp is damaged. 2. The lamp cable is not
connected properly, tighten the
connected properly.
cable.
1. Open the reaction carousel
and check for overflow.
2. Check if the dispense
volume of the wash station is
half more than the cuvette
height.
1. Overflow or cuvette
3. Perform the diluted wash
contaminated.
213130502 Cuvette contamination procedure and then the lamp
or overflow 2. Wash station check procedure.
213130602
dispenses liquid
4. Check if the lamp is
incorrectly.
installed correctly.
5. Replace the lamp.
6. If the error remains, contact
our customer service
department or your local
distributor.
Start Analysis When
Select Start Analysis When
The lamp goes wrong. Temperature is Steady is
213120801 Temperature is Steady. If the
The lamp is unstable. not selected
lamp is expired, replace it.
Lamp Life Expired
12-34
Fluidic Problems
Fluidic problems

Check if the water unit is
The water unit is not turned on and the water
215040602 Water tank is empty turned on or its flow pressure and flow are normal.
is low. Check if the water unit works
properly, and then try again.
Check if the water unit is
The water unit is not turned on and the water
Water inlet of water tank is
215040502 turned on or its flow pressure and flow are normal.
time out.
is low. Check if the water unit works
properly, and then try again.
210150801 Clean the sample probe with
Sample probe washing diluted wash solution.
Sample probe is
failed. Sample probe is
210250801 clogged. Remove the sample probe and
clogged during washing.
unclog it.
210140701 Sample probe fails to There is no or
Check if the water supply is
detect liquid level during insufficient deionized
210240701 normal.
cleaning water.
210540701
210640701 Reagent probe fails to There is no or
Check if the water supply is
detect liquid level during insufficient deionized
210740701 normal.
cleaning. water.
210840701
210540802
210640802 Reagent probe dispensing Contact our customer service
There is residual
position deviation is too department or your local
210740502 water in the cuvette.
large distributor.
210840502
The tube from the Check the inventory of the
buffer solution bottle buffer solution, prime the ISE
213040201 Insufficient ISE buffer
to the dilution cup is module with buffer for about
leaking or clogged. 20 times, Rerun the test.
210540501 Contact our customer service
Probe R1 detects residual There is residual
210640501 water in the cuvette. water in the cuvette.
distributor.
1. Liquid level sensor Recover failure by performing

the Home procedure. If this
Concentrated wash of the buffer solution
tank is abnormal. message appears for 3 times,
215030902 solution is consumed
contact our customer service
abnormally. 2. Filling wash department or your local
solution failed. distributor.
12-35
Environmental Problems
Environmental issues

Water supply
Inlet water temperature is Take measures to ensure the
215160201 temperature is too
too low. water supply part is insulated.
low.
Inlet water
Inlet water temperature is
215160302 temperature is too Cool down water supply unit.
too high.
high.
Operation Problems
Operation problems

Sample rack is Take out the sample rack from
Sample rack is found in
600510902 detected in the track the track, and then reset the
normal lane
during resetting. delivery system.
Sample rack is Take out the sample rack from
Sample rack is found in
600610902 detected in the track the track, and then reset the
passing lane
during resetting. delivery system.
Sample racks are
Take out sample racks from
detected on the
Sample rack is found on the the rack delivery system, and
600360902 delivery carriage
carriage then clean the rack in the rack
during buffer rack
buffer unit.
clearing process.
609910802 Do not take out racks while the
Sample racks are
Rack movement of front system is delivering them.
taken out during rack
600610102 track is time out Recover the failure and then
delivery.
rerun the test.
600180203 The carrier is not Please place the carrier and
Carrier not properly placed
600190203 properly placed. restart the test.
600280103 Carrier not properly placed The carrier is not Please place the carrier and
600290103 in retrieval area properly placed. restart the test.
1.Racks are not Take away the full carrier or
taken away in the full the sample rack on the carrier,
carrier or the carrier place an empty carrier, or
No carrier available in is not taken away. place the carrier properly,
600230203
retrieval area 2. The empty carrier observe the system alarm
is not placed in time; status. If the alarm persists,
3. The carrier is not contact Mindray customer
properly placed. service department.
600280201 The test can be resumed after
Carrier full Rack carrier is full.
600290201 the full carrier is cleared.
12-36

When the rack is transported
to the rack storage unit, the
racks are loaded to the
specified area according to the
A routine sample sample priority (STAT or
Routine rack is detected in
rack is placed in the routine). Then the racks are
606030503 STAT area under sequential
STAT sample area by loaded to the specified area
mode
mistake for testing. and rerun (follow the rule that
STAT racks are not allowed in
the loading area and routine
racks are not allowed in the
STAT area).
Take out a sample rack from
the rack storage unit, load it to
In sequential mode, the corresponding rack
STAT rack detected in
the STAT rack is put according to the sample
606030603 loading area in sequential
into the loading area priority (STAT or normal), and
mode
by mistake. then load the rack to the
correct area. Run the test
again.
The upper cover of the SDM The upper cover of
Restore the upper cover of the
buffer is opened and the the buffer is opened
609920502 buffer unit, reset the delivery
SDM status changes to during delivery or
system and rerun the test.
Stopped. reset.
Instrument shielding cover Instrument shielding Close the shielding cover
219960303
not closed cover is opened before starting the test.
210520402 Check if the reagent probe is
210620402 The reagent probe obstructed around the track. If
Reagent probe collides with
collides with an not, remove the obstacle and
210720402 an obstacle when moving
obstacle when perform the resetting
horizontally
moving horizontally. procedure and then rerun the
210820402
test.
Check if the sample probe is
210120402
The sample probe obstructed around the track. If
Sample probe collides with
collides with an it is, remove the obstacle and
an obstacle when moving
obstacle when perform the resetting
210220402 horizontally
moving horizontally. procedure and then rerun the
test.
The wash station
Wash station vertical Check if the reaction carousel
collides with an
212610602 movement error Vertical cover is closed, and then try
obstacle when
collision again.
moving vertically.
The suction device
Suction device vertical
collides with an Check if the suction device is
212620602 movement error Vertical
obstacle when in position, and then try again.
collision
moving vertically.
Contact our customer service
Software version does not Software version
999930302 department to install the
match does not match.
correct software version.
219930402 Parameter out of range
12-37

Incorrect parameter Contact our customer service
version or alignment department to import the
609910402
parameters out of correct parameters or readjust
range. the relevant units.
Decapping Module Alarms

Alarm No. Alarm Title Alarm Causes Corrective Actions
Descriptions
620720102 The decapping Sensor No. The zero-position sensor of Home the system. If the
delivery Z axis decapping delivery Z axis error remains, contact our
sensor goes and the working position in- customer service
wrong. position sensor are blocked department or your local
at the same time. The distributor.
sensor is blocked by debris
or dust.
620720302 Movement is / 1. Sensor is blocked by Check if there are debris
not allowed in debris or dust. or dust on the two Z-axis
the current 2. Hardware circuit goes sensors. If so, reset the
position of the wrong. sensor after cleaning. If
decapping 3. The wire or sensor is not, contact our customer
delivery damaged. service department or
mechanism. your local distributor after
reset fails.
620720402 Decapping Cause: Sensor The assembly is probably Home the system. If the
delivery Z axis status error moved manually. error remains, contact our
movement customer service
error department or your local
distributor.
620720502 Decapping Cause: Finding The assembly may be Home the system. If the
delivery Z axis the zero jammed. error remains, contact our
movement position failed. customer service
distributor.
620720602 Decapping Cause: The Target sensor is not Home the system. If the
delivery Z axis target position detected within the extreme error remains, contact our
movement exceeds the stroke. customer service
error limit. department or your local
distributor.
620720702 Decapping Cause: Not System initialization is not Click the operating
delivery Z axis calibrated performed. software to start the
movement initialization.
error
620720802 Decapping Cause: Losing The assembly is probably 1. Belt or belt pulley is
delivery Z axis steps when moved manually. loose.
movement passing the 2. The stopper is loose.
error zero position 3. The cable or the sensor
is damaged.
12-38

Descriptions
620730902 Decapping X Cause: Sensor The assembly is probably 1) Sensor is blocked by
axis movement status error moved manually. debris or dust.
error 2) Hardware circuit goes
wrong.
3) The wire or sensor is
damaged.
620731002 Decapping X Cause: Finding The mechanism assembly Home the system. If the
axis movement the zero may be jammed. error remains, contact our
error position failed. customer service
distributor.
620731102 Decapping X Cause: The Target sensor is not Home the system. If the
axis movement target position detected within the extreme error remains, contact our
error exceeds the stroke. customer service
limit. department or your local
distributor.
620731202 Decapping X Cause: Not System initialization is not Home the system. If the
axis movement calibrated performed. error remains, contact our
error customer service
distributor.
620731302 Decapping X Cause: Losing The assembly is probably Click the operating
axis movement steps when moved manually. software to start
error passing the initialization.
zero position
upper gripper Z status error moved manually. error remains, contact our
axis movement customer service
distributor.
620740302 Decapping Cause: Finding The assembly is probably Check if there is debris or
upper gripper Z the zero jammed. dust on the two Z-axis
axis movement position failed. sensors. If so, reset the
error sensor after cleaning. If
not, contact our customer
service department or
your local distributor after
reset fails.
upper gripper Z target position detected when the probe error remains, contact our
axis movement exceeds the reaches the extreme stroke. customer service
distributor.
620740502 Decapping Cause: Not System initialization is not Home the system. If the
upper gripper Z calibrated performed. error remains, contact our
distributor.
12-39

Descriptions
620740602 Decapping Cause: Losing The assembly is probably Home the system. If the
upper gripper Z steps when moved manually. error remains, contact our
axis movement passing the customer service
error zero position department or your local
distributor.
upper gripper status error moved manually. error remains, contact our
rotation customer service
mechanism department or your local
movement distributor.
error
620740902 Decapping Cause: Finding The assembly is probably Check if there is debris or
upper gripper the zero jammed. dust on the two Z-axis
rotation position failed. sensors. If so, reset the
mechanism sensor after cleaning. If
movement not, contact our customer
error service department or
reset fails.
upper gripper target position detected when the probe error remains, contact our
rotation exceeds the reaches the extreme stroke. customer service
mechanism limit. department or your local
error
upper gripper calibrated performed. error remains, contact our
rotation customer service
mechanism department or your local
error
upper gripper steps when moved manually. error remains, contact our
rotation passing the customer service
mechanism zero position department or your local
error
upper clamper status error moved manually. error remains, contact our
distributor.
620741502 Decapping Cause: Finding The assembly is probably Home the system. If the
upper clamper the zero jammed. error remains, contact our
distributor.
12-40

Descriptions
620741602 Decapping Cause: The Target sensor is not Check if there is debris or
upper clamper target position detected within the extreme dust on the two Z-axis
movement exceeds the stroke. sensors. If so, reset the
error limit. sensor after cleaning. If
reset fails.
upper clamper calibrated performed. error remains, contact our
distributor.
upper clamper steps when moved manually. error remains, contact our
movement passing the customer service
distributor.
lower gripper Z- status error moved manually. error remains, contact our
distributor.
620750302 Decapping Cause: Finding The mechanism assembly Check if there is debris or
lower gripper Z- the zero may be jammed. dust on the two Z-axis
axis movement position failed. sensors. If so, reset the
reset fails.
lower gripper Z- target position detected within the extreme error remains, contact our
axis movement exceeds the stroke. customer service
distributor.
lower gripper Z- calibrated performed. error remains, contact our
distributor.
lower gripper Z- steps when moved manually. error remains, contact our
distributor.
lower clamper status error moved manually. error remains, contact our
distributor.
12-41

Descriptions
620750902 Decapping Cause: Finding The assembly may be Home the system. If the
lower clamper the zero jammed. error remains, contact our
distributor.
lower clamper target position detected within the extreme error remains, contact our
movement exceeds the stroke. customer service
distributor.
620751102 Decapping Cause: Not System initialization is not Check if there is debris or
lower clamper calibrated performed. dust on the two Z-axis
movement sensors. If so, reset the
reset fails.
lower clamper steps when moved manually. error remains, contact our
movement passing the customer service
distributor.
620760202 Receiving cap Cause: Sensor The assembly is probably Home the system. If the
mechanism Y- status error moved manually. error remains, contact our
distributor.
620760302 Receiving cap Cause: Finding The mechanism assembly Home the system. If the
mechanism Y- the zero may be jammed. error remains, contact our
axis movement position failed. customer service
distributor.
620760402 Receiving cap Cause: The Target sensor is not Home the system. If the
mechanism Y- target position detected within the extreme error remains, contact our
distributor.
620760502 Receiving cap Cause: Not System initialization is not Check if there is debris or
mechanism Y- calibrated performed. dust on the two sensors.
axis movement If so, take out and put in
error the waste cap container
again after cleaning. If the
indicator of the waste cap
container does not
change, contact our
customer service
distributor after reset
fails.
12-42

Descriptions
620760602 Receiving cap Cause: Losing The assembly is probably Home the system. If the
mechanism Y- steps when moved manually. error remains, contact our
distributor.
620760802 Discarding Cause: Sensor The assembly is probably Power on the analyzer
mechanism Z- status error moved manually. and home the system. If
axis movement the error remains, contact
error our customer service
department.
620760902 Discarding Cause: Finding The mechanism assembly Click the Initialize button
mechanism Z- the zero may be jammed. on the Diagnosis screen.
axis movement position failed. If problem remains,
error contact our customer
service department.
620761002 Discarding Cause: The Target sensor is not Home the system. If the
mechanism Z- target position detected within the extreme error remains, contact our
distributor.
620761102 Discarding Cause: Not System initialization is not Home the system. If the
mechanism Z- calibrated performed. error remains, contact our
distributor.
620761202 Discarding Cause: Losing The assembly is probably Home the system. If the
mechanism Z- steps when moved manually. error remains, contact our
distributor.
620761302 Decapping Cause: Sensor Sensor status error Home the system. If the
sensor error status error error remains, contact our
customer service
distributor.
620761402 Waste cap not Cause: The The waste cap sticks to the Home the system. If the
discarded waste cap discarding mechanism. error remains, contact our
sticks to the customer service
hopper and department or your local
cannot be distributor.
discarded.
620761502 Decapping Cause: Sensor Sensor status error Home the system. If the
sensor error status error error remains, contact our
customer service
distributor.
620770102 Cap container / The waste cap container is Put the waste cap
not loaded not placed in place. container in place.
12-43

Descriptions
620770202 The decapping The decapping User does not close the Close the door.
compartment compartment compartment door.
door not closed door is open,
and the
decapping
action stops.
620770302 The decapping Cause: Sensor Decapping compartment Close the door. If the
compartment status error door stroke switch error prompt still reminds that
door stroke the door is not closed,
switch error contact our customer
service department.
620770402 Waste Cause: Sensor Waste container stroke Close the waste container
container status error switch error door. If the prompt still
stroke switch reminds that the
error decapping compartment
door is not closed,
contact our customer
service department.
620770502 Waste cap Cause: Sensor Waste cap container sensor Put the waste cap
container status error error container in place. If the
sensor error system still does not work
after the waste cap
container is put in place,
please contact Mindray
customer service
personnel.
620770602 Waste cap Cause: Sensor The sensor status is Put the waste cap
container status error mistakenly ON because the container in place. If the
sensor error sensor is blocked by debris system still does not work
or dust. after the waste cap
container is put in place,
please contact Mindray
customer service
personnel.
620780101 Visual camera Reason: The The user has loaded the Take out the wrong
identifies that sample type sample of which the image sample container from
the sample identified by cannot be identified the current rack and load
type is out of the visual effectively. it again.
the known camera is not
range. within the
known range.
620780001 Camera serial Camera serial The camera cables are Home the system. If the
port port loose or the camera is error remains, contact our
communication communication abnormal. customer service
abnormal cannot be department or your local
connected or distributor.
return is time
out.
12-44

Descriptions
return is time
out.
return is time
out.
return is time
out.
620780005 FTP Image file is FTP environment Home the system. If the
transmission not detected. configuration goes wrong or error remains, contact our
abnormal the camera is abnormal. customer service
distributor.
620780006 Camera serial Serial port data The camera cables are Home the system. If the
port abnormal loose or the camera is error remains, contact our
communication abnormal. customer service
abnormal department or your local
distributor.
abnormal abnormal department or your local
distributor.
620780008 Camera Camera The camera position Home the system. If the
position position changes. error remains, contact our
abnormal abnormal customer service
distributor.
620780009 Light source Light source The light source is Home the system. If the
brightness is brightness is damaged or its wires are error remains, contact our
abnormal. abnormal. loose; the lens or light customer service
source is dirty or damaged. department or your local
distributor.
620780010 Light source Light source The light source is Home the system. If the
brightness is brightness is damaged or its wires are error remains, contact our
abnormal. abnormal. loose; the lens or light customer service
distributor.
12-45

Descriptions
620780011 Abnormal Abnormal The light source is Home the system. If the
image quality image quality damaged or its wires are error remains, contact our
loose; the lens or light customer service
distributor.
620780012 Image storage The D:\Image The D:\Image folder does Home the system. If the
directory does folder does not not exist. error remains, contact our
not exist. exist. customer service
distributor.
620780013 Abnormal Image file is FTP setting error Home the system. If the
image reading not detected. error remains, contact our
customer service
distributor.
620780014 Abnormal Reading image Camera cable is loose or Home the system. If the
image reading file failed. FTP setting is abnormal. error remains, contact our
customer service
distributor.
620780015 Image Algorithm Camera cable is loose or Home the system. If the
identification identification is FTP setting is abnormal error remains, contact our
error timeout. customer service
distributor.
620780016 Image Image The software goes wrong. Home the system. If the
identification identification error remains, contact our
error error customer service
distributor.
620780017 Image Image The background is polluted Home the system. If the
identification identification or damaged or the camera error remains, contact our
error error position is deviated. customer service
distributor.
12-46
13 Operation Theories
This chapter gives brief introduction of the operation theories of the instrument, which
include:
 Principles of measurement
 Calibration math model and calculation of factors
 Prozone check
13-1
13.1 Overview
The system is a fully automated computer-controlled clinical chemistry analyzer
allowing the random selection of tests. It is capable of running a variety of tests based
on the operation theories and measurement principles.
The system performs measurement and generates the test results in the following
procedure:
Measurement workflow
AD value
Absorbance
Response
Calibration factors
Sample result QC result
QC conclusion
The system measures the light intensity through photoelectric conversion, linear
amplification and AD conversion, and then calculates the reaction mixture’s
absorbance and the absorbance change rate, that is, the response, based on which the
calibration factors are obtained. The system performance is evaluated according to
the test results of the control samples. If the system is working normally, you may start
the analysis of patient samples and the system will calculate the sample results with
the calibration factors.
13-2
13.2 Principles of Measurement

13.2.1 Introduction
The system performs measurement with the following principles:
 Endpoint
 Fixed-time
 Kinetic
In the description of the following sections, N and P indicate the blank read time range,
L and M indicate the reaction read time range. In double-wavelength measurements,
absorbance A is the absorbance difference between the primary and secondary
wavelengths; in single-wavelength measurements, absorbance A is the absorbance
measured at the primary wavelength.
13-3
13.3 Endpoint Measurements

13.3.1 Introduction
In endpoint measurements, the reaction reaches equilibrium after a period of time.
Since the equilibrium constant is quite high, it can be considered that all substrates
(analytes) have changed into products, and the absorbance of the reactant will not
change any more. The absorbance change is directly proportional to the analytes’
concentration. The endpoint method, also called equilibrium method, is most ideal for
measurements.
The endpoint reaction is insensitive to minor changes in such conditions as the
enzyme volume, pH value and temperature, provided the changes are not significant
enough to affect the reaction time.
13.3.2 Calculation of Reaction Absorbance

Set up the reaction time range by understanding the following instructions:
 If L=M, that is, [M] and [M] are entered for the reaction time range, one measuring
point will be used for absorbance calculation, and the reaction absorbance will be
the absorbance measured at point M, i.e. Ai=AM.
 If L=M-1, that is, [M-1] and [M] are entered for the reaction time range, two
measuring points will be used for absorbance calculation, and the reaction
absorbance will be the average of the absorbance measured at the two points, i.e.
A  AM 1
Ai= M .
2
 If L=M-2, that is, [M-2] and [M] are entered for the reaction time range, three
measuring points will be used for absorbance calculation, and the reaction
absorbance will be the mediate absorbance measured at the three points, while
the maximum and minimum absorbance is removed.
 If M>L+2, the reaction absorbance will be the average of the remaining
absorbance when the maximum and minimum absorbance is removed.
13.3.3 Calculation of Blank Absorbance

The blank absorbance Ab is calculated in the same way as the reaction absorbance Ai.
When N=P=0, the blank absorbance Ab will not be calculated.
13.3.4 Calculation of K Factor

The system provides four K factors for result calculation, which are expressed through
the following equations:
VR1
 k1 
VR1  VS
VR1  VS
 k2 
VR1  VS  VR 2
VR1  VS  VR 2
 k3 
VR1  VS  VR 2  VR3
VR1  VS  VR 2  VR3
 k4 
VR1  VS  VR 2  VR3  VR 4
13-4
Where, VR1, VR2, VR3 and VR4 are the volumes of R1, R2, R3 and R4; Vs is the actual
volume of sample dispensed for reaction.
13.3.5 Calculation of Response

The response in endpoint measurements is calculated as follows:
R  Ai  k  Ab
k is the calculation factor and varies with the test parameters.
Calculation of response for endpoint measurements
Endpoint Blank Time Reaction Time K Factor
Single-reagent 2≤N≤P≤3 5≤L≤M≤33 K1
Double-reagent 5≤N≤P≤16 17≤L≤M≤33 K2
Triple-reagent 17≤N≤P≤36 41≤L≤M≤69 K3
Quadruple-reagent 41≤N≤P≤52 53≤L≤M≤69 K4
When the blank absorbance is read after the reaction begins,
Single-reagent 5≤N≤P P<L≤M≤33 1
Double-reagent 17≤N≤P P<L≤M≤33 1
Triple-reagent 41≤N≤P P<L≤M≤69 1
Quadruple-reagent 53≤N≤P P<L≤M≤69 1
Single-reagent N=P=0 5≤L≤M≤33 0
Double-reagent N=P=0 17≤L≤M≤33 0
Triple-reagent N=P=0 41≤L≤M≤69 0
Quadruple-reagent N=P=0 53≤L≤M≤69 0
13.3.6 Sample Blanked Response

Sample blank is used for removal of non-chromogenesis reaction, such as influence of
sample interference (Hemolysis, icterus and lipemia) on absorbance readings. The
sample blank reaction curve is almost a straight line with slope of 0 during the reaction
period, and therefore means nothing for fixed-time and Kinetic analysis.
In single-reagent endpoint measurements, the response of the sample blank test is
Rsb  Ai  k  Ab R '  R  RSb
, and the sample blanked response is .
13-5
13.4 Fixed-time Measurements

13.4.1 Introduction
In fixed-time measurements, namely, rate measurements, the reaction velocity (v) is
directly proportional to the substrate concentration [S] within a specific period, that is,
v=k[S]. As the substrate is consumed continuously, the reaction velocity is decreasing
gradually, and so is the absorbance change rate. It takes a long time for the reaction to
reach equilibrium. Theoretically, the absorbance reading can be taken at any time. The
reaction, however, can become steady only after a lag because it is complicated at the
beginning and there are miscellaneous reactions due to complex serum compositions.
For any rate measurements, the substrate concentration [S] at a given point t since the
reaction begins is obtained through the following formula:
S   S 0  e  kt
Where,
 S0: the initial substrate concentration
 e: base of the natural log
 k: velocity constant
The change of substrate concentration Δ[S] over a fixed time interval, t1 to t 2 , is
related to [S0] by the following equation:
 [ S ]
[ S 0]   kt1  kt 2
e e
That is, the change in substrate concentration is directly proportional to its initial
concentration within a fixed time interval. This is the common feature of rate
measurements. Within this interval, the absorbance change is directly proportional to
the analytes concentration. The fixed-time reaction is also called, rate reaction, first-
order Kinetic reaction and two-point Kinetic reaction.
It is available in single-interval and double-interval according to the input mode of
measuring points. In the double-interval reaction, the sample blank, which is the
absorbance change at two points within the incubation time, is subtracted from the
reaction absorbance.
The fixed-time measurements allow the check of substrate depletion at the two
measuring points. When detecting substrate depletion, the system will flag the test
result with “BOE” and give an alarm.

The response in fixed-time measurements is calculated as follows:
AM  AL A  AN
R  60*( k P )
tM  t L tP  t N
13-6
Calculation of response for fixed-time measurements

Fixed-time Blank Time Reaction Time K Factor
Single-reagent 2≤N<P≤3 5≤L<M≤33 K1
Double-reagent 5≤N<P≤16 17≤L<M≤33 K2
Triple-reagent 17≤N<P≤36 41≤L<M≤69 K3
Quadruple-reagent 41≤N<P≤52 53≤L<M≤69 K4
Single-reagent N=P=0 5≤L<M≤33 0
Double-reagent N=P=0 17≤L<M≤33 0
Triple-reagent N=P=0 41≤L<M≤69 0
Quadruple-reagent N=P=0 53≤L<M≤69 0
13-7
13.5 Kinetic Measurements

13.5.1 Introduction
In Kinetic measurements, namely, zero-order Kinetic measurements or continuous-
monitoring measurements, the reaction velocity is not related to substrate
concentration and remains constant during the reaction process. As a result, the
analytes absorbance changes evenly at a given wavelength, and the change rate
(A/min) is directly proportional to the activity or concentration of the analytes. The
Kinetic method is usually used to measure enzyme activity.
In fact, it is impossible for the substrate concentration to be absolutely high, and the
reaction will be no longer a zero-order reaction when the substrate is consumed to
certain degree. Therefore, the reaction type only stands within certain reaction period.
In addition, the reaction can become steady only after a period of time, because the
reaction is complicated at the beginning and there are miscellaneous reactions due to
complex serum compositions.
In Kinetic reaction, the concentration or activity is obtained according to the
absorbance change among specified measuring points.
13.5.2 Data Calculation in Kinetic Measurements

Data calculation flow of Kinetic measurements
Determination of linearity range
Calculate response with the

least square method
Evaluation for linearity
13.5.3 Determination of Linearity Range

The absorbance linearity range is determined based on the substrate depletion limit,
and checked within the reaction time rather than the blank time.
13-8
Determination of linearity range for Kinetic measurements
Enter L and M
Enter substrate
depletion limit?
No
Yes
Substrate Yes
Alarm of "NLN"
depleted at L+1
No
Find M without substrate

Yes
Substrate depletion within M and the
depleted at M reaction start reading point
No
Linearity range is L-
M Linearity range is L-M
The number (N) of measuring points within the substrate depletion limit is monitored
for different operations:
 If N≥3, the linearity range includes all measuring points from the reaction start
point to the substrate depletion limit; otherwise, the test result will be flagged with
“NLN”.
 If N=0 or 1, the enzyme linear extension will be enabled.
 If N=2, the system will give an alarm while using two measuring points for
calculating the response.
Absorbance change rate ⊿ALM’ within the reaction time
The response ⊿ALM’ within L-M’ is calculated with the least square method.
M'
 (T i  T )  ( Ai  A)
A LM'  60 * iL
M'
 (T  T )
iL
i
2
Where,
 L: start point of the linearity range
 M’: end point of the linearity range
 Ai: absorbance measured at measuring point i
 A : average absorbance within L-M’
 Ti: actual measuring time (second) at measuring point i
 T : average measuring time within L-M
13-9
If there are less than two measuring points without substrate depletion within the
reaction time, the system will calculate the absorbance change rate by extending the
enzyme linearity range.
Absorbance change rate ⊿ANP within the blank time
The absorbance change rate ⊿ANP within the blank time is calculated with the same
equation as ⊿ALM’.
If N=P=0, the absorbance change rate within the blank time is 0.
Calculation of Response
The response in Kinetic measurements is calculated as follows:
R  A LM'  K  A NP
Calculation of response for Kinetic measurements
Kinetic Blank Time Reaction Time K

Single-reagent 2≤N<P≤3 5≤L<M≤33 K1
Double-reagent 5≤N<P≤16 17≤L<M≤33 K2
Triple-reagent 17≤N<P≤36 41≤L<M≤69 K3
Quadruple-reagent 41≤N<P≤52 53≤L<M≤69 K4
Single-reagent N=P=0 5≤L<M≤33 0
Double-reagent N=P=0 17≤L<M≤33 0
Triple-reagent N=P=0 41≤L<M≤69 0
Quadruple-reagent N=P=0 53≤L<M≤69 0
Note: M-L≥2 indicates that at least 3 measuring points should be included within the
reaction time.
13.5.5 Evaluation for Linearity

Af  Ab
100  Linearity Limit
Au ,v
Linearity=
Where, A f , Ab and Au ,v are the absorbance change rates in the front part,
back part and at all measuring points of the reaction. These three values are calculated
based on the number of measuring points within the linearity range.
 When N>8, A f is the absorbance change rate of the first 6 measuring points,
Ab of the last 6 measuring points, and Au ,v of all measuring points.
 When 4  N  8 , A f is the absorbance change rate of the first 3 measuring
points, Ab of the last 3 measuring points, and Au ,v of all measuring points.
13-10
 When N  3, the system will not check the test results for linearity.
A  A b  A
u ,v 
 When f
60 or 60 (unit: A/10000/minute), the system will not
check the test results for linearity.
The system will compare the calculated linearity with that defined for the test, and will
flag the test result with “LIN” and given an alarm if the configured linearity is exceeded.
13.5.6 Enzyme Linearity Range Extension

Reaction curve with extended enzyme linearity range
Lag time
Reaction Time
Absorbance
Substrate depletion mark
Substrate depleted
Absorbance read time
In high-activity enzyme measurements, the substrate may be depleted quickly and the
reaction curve will appear obviously nonlinear (as a smooth curve). If the measurement
is performed based on the general procedure, the system will flag the test result with
“NLN” (no linearity interval), reminding the user to rerun the test after diluting the
sample. This will more or less bring troubles to the user.
Extending enzyme linearity range:
Suppose the reaction start time is t1 and the reaction time is tL-tM, then t1-tL is the lag
time.
If the number (N) of valid measuring points within tL-tM is less than 2 and too few to
calculate the response, the sample response can be obtained by extending the enzyme
linearity range.
Calculation of ⊿Amax:
The linearity range t1-tL’ without substrate depletion is found within the lag time t1-tL.
If the number (N) of valid measuring points within tL-tM is less than 2, the system will
not calculate the response but flag the test result with “ENC” (no calculation interval)
and give an alarm; or the system calculates the reaction rate ⊿A=60*(Ai+1-Ai)/(ti+1-
ti), i=1, 2…L’ with the lag time t1-tL’. The maximum ⊿A is taken as the response of the
sample. Therefore, the enzyme linearity range is extended via the lag time. The results
calculated by extending the enzyme linearity range will be flagged with “EXP”.
13-11
13.6 Calibration Math Model and Factors

The system provides linear and non-linear math models. The former is used for
Colorimetry tests and the later for turbidity tests.
In this section,
 R: calibrator response
 C: calibrator concentration (or internal converting concentration in non-linear
calibrations)
 K, R0, a, b, c and d: calibration factors
13.6.1 Linear Calibrations

Single-point linear calibration
The single-point linear calibration is also called the K factor method. Calculation
formula: C  K  ( R  R0 )
Where, K is the user-defined K factor, R0 is the reagent blank response of the first
calibrator. If the test is not reagent blanked, R0=0.
Please note that the R and R0 must be divided by 10,000.
Two-point linear calibration
Calculation formula: C  K  (R R 0 )
C 2  C1 C1
The formula contains two factors, K and R0, where K  , and R0  R1  .
R2  R1 K
The calibration math model requires two calibrators. C1 and C2 are the concentrations
of calibrator 1 and 2; R1 and R2 are the responses of calibrator 1 and 2.
Multi-point linear calibration

C  K  (R R 0 )
Calculation formula:
The formula contains two factors, K and R0. The calibration math model requires n(n≥3)
calibrators. Ci is the concentration of calibrator i. Ri is the response of calibrator i. K
and R0 can be calculated with the least square method:
n n n
 CiRi  ( Ci )( Ri ) / n
K i 1
n
i 1
n
i 1
 Ri
i 1
2
 ( Ri ) 2 / n
i 1
n
( Ci ) / n
R0  ( Ri ) / n  i 1
i 1 K
13-12
13.6.2 Non-Linear Calibrations

Logit–Log 4P
1
Calculation formula: R  R0  K
1  exp[ (a  b ln C )]
The formula contains four factors, which are R0, K, a and b.
The calibration math model requires at least four calibrators. The four factors can be
calculated with the L-M method.
This calibration type is applied to the tests which have a calibration curve with the
response reversely proportional to the concentration.
Logit–Log 5P
1
R  R0  K
1  exp[ (a  b ln C  cC )]
The formula contains five factors, which are R0, K, a, b and c. The calibration math
model requires at least five calibrators, and calculates the five factors with the L-M
method.
This math model has the same application with the Logit-Log 4P except for a higher
fitting.
Exponential 5P
R  R0  K exp[ a ln C  b(ln C ) 2  c(ln C ) 3 ]
The formula contains five factors, which are R0, K, a, b and c. The calibration math
model requires at least five calibrators, and calculates the five factors with the L-M
method.
This calibration type is applied to the tests which have a calibration curve with the
response directly proportional to the concentration.
Polynomial 5P
R  R0 R  R0 2 R  R0 3
ln C  a  b( )  c( )  d( )
Calculation formula: 100 100 100
The formula contains five factors, which are R0, a, b, c and d. The calibration math
model requires at least five calibrators. The response (R) of the first calibrator (with
internal converting concentration of 0) is R0, which is given.
R  R0
x
Suppose, y  ln C and 100 .
Then,
y  a  bx  cx 2  dx 3 can be calculated with the least square method for
polynomial expressions.
13-13
Parabola
R  aC 2  bC  R0
The formula contains three factors, which are a, b and R0. The calibration math model
requires at least three calibrators. The three factors can be calculated with the least
square method.
Spline
R  R0i  ai (C  Ci )  bi (C  Ci ) 2  ci (C  Ci ) 3
The calibration math model requires 2-9 calibrators. Suppose the number of calibrators
R0i ai bi
is n, then the calculation formula contains 4(n-1) factors, which are , , , and
ci
. Due to the subsection fitting, this math model has be best fit curves than other
math models.
Logistic-Log3P
1
R  R0  K
Calculation formula: 1  aC
The formula contains three factors, which are R0, K and a. At least 3 calibrators
(including blank solution) shall be provided. Use L-M method to solve the parameters
R0, K and a.
Polyline
Ci  K i  ( R  R 0i )
The calibration math model requires 2-10 calibrators. Suppose the number of
calibrators is n, then the calculation formula contains 2( n －1) factors, that is,
K i , R0 i
( i =2…,n.)
Ci  Ci 1 Ci 1 Ri  Ci Ri 1
Ki  R 
Where,
Ri  Ri 1 , 0i Ci 1  Ci and Ci and Ri are the concentration
and response of the n th calibrator, and Ci-1 and Ri-1 are the concentration and
response of the (n-1 )th calibrator.
13-14
13.7 Prozone Check

13.7.1 Introduction
Reaction curve of antigen and antibody
Response Prozone Equivalent Postzone

(antibody excess) zone (antigen excess)
R
Concentration C
In the reaction of antigen and antibody, the amount of generated insoluble compound
is closely related to the proportion of antigen and antibody. The maximum amount of
compound will be generated at a proper proportion of antigen and antibody, at this
point least light is passed and the greatest absorbance is obtained. For other
proportions, the amount of insoluble compound will decrease with more light passed
and lower absorbance calculated. Therefore, samples with quite different
concentrations may generate the equivalent amount of insoluble antigen/antibody
compound, and can have the same test results without a Prozone check. The Prozone
check, therefore, is necessary for antigen-antibody reactions.
13.7.2 Prozone Check Parameters

Prozone check can be performed in two ways: Antigen addition and rate check. Antigen
addition is determined by two formulas: Formular 1 and Formular 2. Rate check is
based on both rate check formula 1 and formula 2.
Prozone check is applicable to Kinetic, fixed-time and endpoint measurements. When
the conditions for triggering an alarm are met, the system shall flag the test result with
"PRO" for prozone check error, "BOE" for Kinetic analysis, and give an alarm.
Formula 1 for antigen addition:
PC1≤Aq2-k×Aq1≤PC2
Where,
curve.
Single reagent test k＝(VR1+VS)/(VR1+VR3+VS)
Double reagent test k＝(VR1+VS+VR2)/( VR1+VS+VR2+VR3)
13-15
VR1, VR2 and VR3 are the volumes of the R1, R2 and R3 reagent, and Vs is the actual
volume of sample dispensed. If reagent is concentrated, then VR1, VR2 and VR3 are
the sum of reagent volume and diluent volume.
Formula 1 of rate check method:
A q 4  A q3
q 4  q3
PC1   PC 2
A q 2  A q1
q 2  q1
Where,
Aq1 ~ Q4 are the absorbance of measuring point Q1, Q2, Q3 and Q4. Where Q1, Q2, Q3
and Q4 are the number of the measuring point on the reaction curve.
Formula 2:
1) Aq6- Aq5≥V3 at Q5≠Q6
2) Q5= Q6: Same point, Aq5≥V3
Where,
curve.
Prozone check parameters for rate check
[Q1] [Q2] [V1] [Y/N] [Q3] [Q4] [V2] [Y/N]
[Q5] [Q6] [V3] [Y/N] [PC1] [PC2] [Y/N] [A/O]
Prozone check parameters for antigen addition:
[Q1] [Q2]
[Q5] [Q6] [V3] [Y/N] [PC1] [PC2] [Y/N] [A/O]
Antigen Additon reagent Volume and Diluent Volume.
For both single-reagent and double-reagent tests, set up the reagent volume of antigen
addition of R3: Reagent volume for R3 and diluent volume for R3.

1St entry field (Q1) Measuring point on reaction Single and double reagent
curve test of rate check:
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
check R3,R4 reagent test
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
≠Q 4 are required and Q 5=
Q 6 are allowed. At least
one of Q1, Q2, Q 5 and Q 6
is greater than or equal to
41.
13-16

2nd entry field (Q2) Measuring point on reaction Single and double reagent
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
41.
3rd entry field (V1) Aq2- Aq1 threshold [-35000, 35000]
4th entry field(Y/N) Y indicates that condition Aq2- Y/N
Aq1< V1 is met. N indicates that
check.
5th entry field (Q3) Measuring point on reaction Single and double reagent
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
41.
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
41.
7th entry field (V2) Aq4- Aq3 threshold [-35000, 35000]
13-17

8th entry field(Y/N) Y indicates condition Aq4- Aq3< Y/N
V2 is met. N indicates that
check.
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
41.
1≤Q1, Q 2, Q 3, Q 4, Q 5, Q
6≤33
1≤Q 1, Q 2, Q 3, Q 4, Q 5,
and Q 6≤69. Q1≠Q2, Q 3
41.
11th entry field (V3) Threshold of formula 2 [-35000, 35000]
12th entry Define the range to trigger Y/N
field(Y/N) judgment formula 2. Y indicates
that the value of formula 2 is
within the defined range, and N
indicates that the value of
formula 2 is outside the defined
range.
13th entry field Lower threshold of formula 1. [-35000, 35000]
14th entry field Upper threshold of formula 1. [-35000, 35000]
15th entry Defines the range of formula 1 to Y/N
field(Y/N) trigger judgment. Y means the
value of PC is within the range of
formula 1; N means the value of
PC is outside the range of
formula 1.
13-18

16th entry This sets the logical triggering A/O
field(A/O) relationship between formula 1
and formula 2. If A is selected,
when both formula 1 and formula
2 are satisfied, the logic relation
is triggered ("and" logic). If O is
selected, either formula 1 or
formula 2 triggers the logic
relation (“Or” logic).
13-19
13-20
Vocabulary
Absorbance
The difference between the amount of light entering a solution (incident light) and the
amount of light passing through the solution (transmitted light) without being
absorbed, to determine the concentration of the substance in the solution.
Analyzer
The analyzer, determines various clinical tests in samples and displays the test results.
It consists of the sample handling system, reagent handling system, reaction system,
cuvette wash station, photometric system, and mixer assembly.
Auto rerun
When a result is beyond the defined range or satisfies the defined conditions, the test
will be run again.
Auto serum index
When the Auto Serum Index function is enabled, the system will select the SI test
automatically for serum or plasma samples. The SI test will also be requested
automatically when you order routine samples manually or by using the LIS host, or
order STAT samples, or order routine samples with the default panels.
Bar code reader
Fixed laser beam scanner. It scans the bar code label on sample tubes to identify
samples and match the obtained ordering information with the scanned samples.
Batch order
Batch order is to order a group of samples with identical ordering information, with the
exception of the sample ID.
Blank time
Blank time refers to the period between dispensing of the second reactant (reagent or
sample) in reversed order and of the last reactant (reagent or sample).
Bottle type
Volume of the reagent bottle.
Calibration curve
A calibration curve reflects the mathematical relation between calibrator concentration
and response. It is drawn based on the obtained response and the multiple values
between the minimum and maximum concentrations of the calibrator.
1
Vocabulary
Calibration factor
Calibration factor is obtained based on the equation of calibrator concentration (known)
and response (calibration math model).
Calibration math model
Calibration math model is used to calculate calibration factors and create calibration
curves. It includes single-point K factor, two-point linear, multi-point linear, Logit-Log4P,
Logit-Log5P, Exponential5P, Polynomial5P, Parabola and Spline.
Calibration trend
Calibration trend summarizes a test’s calibrations during a period of time and reflect
the trends of the calibrations.
Carryover
Carryover is the interference of certain substance contained in a reagent. It can
influence measurement of another test or the reaction of other mixture, resulting in
inaccurate results.
Test configuration
Test configuration is applicable to all tests other than ISE test and SI, and used to
enable or disable tests that have been defined correctly.
Closed-reagent test
Closed-reagent test is run by using the reagents provided by the analyzer manufacturer.
Closed-reagent tests cannot be modified or deleted.
Concentrated wash solution
Concentrated wash solution is CD80 alkaline concentrated wash solution. It is placed
in the front cabinet of the analyzer and used to clean the reaction cuvettes during the
8 phases.
Critical range
An allowable result range from the perspective of clinical diagnosis. If the test result is
beyond the critical range, the patient may need immediate treatment. You may enable
the auto rerun function for a test, which will be rerun automatically once the test result
is beyond the critical range.
Current results
Current results include those that are in Incomplete status until the current system
time and those ordered and analyzed on the current day.
Cuvette wash station
The cuvette wash station consists of the wash probes, elevating motor and related
tubing, and is used to clean the reaction cuvettes with the eight wash probes when a
test is finished.
Database
A collection of data arranged for quick search and retrieval.
Decreased
Decreased indicates the sample volume required for analysis and can be defined on
the Define/Edit Tests window.
Diluent
Liquid used to dilute other liquids.
2
Vocabulary
Dilution factor
User-defined dilution ratio, to be multiplied with sample result to obtain the final result.
Download
To obtain sample ordering information from the LIS host and match it with the scanned
samples. The system supports real-time and manual downloading of sample ordering
information.
EMF
EMF stands for Electromotive Force. The ISE module determines the concentration of
ion by measuring the electromotive force of ion with ion selective electrodes. A
calibrator with constant concentration should have electromotive force within certain
range.
Endpoint
The endpoint method, also called equilibrium method, is most ideal for measurements.
In endpoint measurements, the reaction reaches equilibrium after a period of time.
Since the equilibrium constant is quite high, it can be considered that all substrates
(analytes) have changed into products, and the absorbance of the reactant will not
change any more. The absorbance change is directly proportional to the analytes’
concentration.
Fixed-time
In fixed-time measurements, namely, rate measurements, the reaction velocity (v) is
directly proportional to the substrate concentration [S] within a specific period, that is,
v=k[S].
Flag
Flag is a manufacturer-defined symbol, which appears on patient reports or result list
when a result is beyond the user-defined reference range or exceeds the defined limits.
High-concentration waste
High-concentration waste is produced during phase 1 and phase 8 of cuvette cleaning
and includes the ISE waste. It can be drained in a waste tank or to the sewer according
to your local or national regulations on waste liquid disposal.
History results
Stored results are those ordered and analyzed before the current day.
Increased
Increased indicates the sample volume required for analysis and can be defined on the
Define/Edit Tests window.
Initialization
Initialization is a series of operations automatically performed by the system during
the startup procedure. It includes parameters check, reset, testing, cleaning and
priming.
Inventory check
Used to check the remaining volume of the biochemistry reagents, sample probe wash
solution and reagent probe wash solution and refresh the tests left and wash solution
volume on the Reagent/Calibration screen.
3
Vocabulary
ISE
ISE is the abbreviation of Ion Selective Electrode. It consists of the Na electrode, K
electrode, Cl electrode, reference electrode, sampling and measuring channel, syringe,
heat stabilizer, degassing unit and waste discharger. The ISE module measures the
concentration of Na, K and Cl in serum, plasma and diluted urine.
K factor
C  K  ( R  R0 )
K factor is manually input for single-point linear calibration formula
and used to calculate results.
Lamp
Lamp is located on the photometer assembly and used to measure the absorbance of
mixture in a reaction cuvette. It should be replaced regularly.
Linearity
Degree of linearity for a reaction curve or calibration curve. Reaction curve linearity is
available in fixed-time measurements, while calibration curve linearity specifies the
allowable concentration range for result calculation.
LIS
LIS stands for Laboratory Information System. It is a host computer and
communicates with chemistry analyzers through the internet interface.
L-J chart
A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test results (Y),
shows the QC result trend of a test during the specified period. The graphical trends of
up to 3 controls can be displayed on one L-J chart and distinguished with different
colors.
Lot number
Lot number is assigned to controls, calibrators or wash solutions of the same lot for
identifying manufacture date, quality, expiration date and other related information.
Low-concentration waste
Low-concentration waste is produced during the 2nd-7th phase of cuvette cleaning. It
can be drained to the sewer of your laboratory.
Mask/Unmask tests
Used when a test needs to be disabled temporarily due to abnormal result or reagent
exhaustion. The masked test will have a symbol appearing on its upper-left corner,
and will still be displayed on the Sample, Quality Control and Reagent/Calibration
screens but not run for sample analysis. Masked tests cannot be requested until they
are unmasked.
Mixer
The system provides sample mixers and reagent mixers, which stir the mixture inside
a reaction cuvette when sample/R3 and R2/R4 are respectively dispensed.
Multi-sample report
Containing the results of multiple samples, and can be printed out on the Current and
History screens.
Off-line dilution
Prior to analysis, samples are diluted manually based on specific ratio.
4
Vocabulary
Offset
Offset is a value added or subtracted to compensate a result. It is often used along
with the slop in the equation y=kx+b, in which k is the slope and b is the offset.
Online help
Online help provides you with help information about the screens. If you do not
understand a parameter or an operation on a screen, you can go to the online help for
relevant information. Access the online help from the following screens:
 Select the icon on the upper right corner to display the help topic related to
the current screen.
 Select the button in front of each maintenance instruction or item to display
the relevant operating instructions.
 Select the icon in front of each diagnostic test to display the corresponding
topic.
 Select the button in front of each error log to display the corresponding topic.
 Click the button on a warning message window to display the

corresponding descriptions and solutions.
 Press the shortcut combination key Alt+ to display the topics related to the current
screen or window.
Open-reagent test
Open-reagent test, an opposite of the closed-reagent test, can be measured by using
the reagents provided by other manufacturers. It can be user-defined, edited and
deleted.
Operation unit
The operation unit, a computer configured with the operating software, controls the
analyzing unit to finish tests and produce test results.
Output unit
A printer used to print out test results and other data.
Panel
Consists of a couple of tests combined together for certain clinical purposes, such as
liver function, kidney function, etc. Panels can help fast ordering of samples.
Patient demographics
Patient demographics contain information related to the patient and sample, such as
patient name, age, sex, collection date/time, etc.
Physiological saline
0.9% sodium chloride solution, used for reagent blank and sample dilution.
Predilution
Prior to analysis, samples are diluted automatically based on the defined dilution factor.
Primary wavelength
The primary wavelength is chosen based on the light absorption features of the
reactant and used to measure the absorbed light intensity. Options for primary
wavelength include: 340nm, 380nm, 412nm, 450nm, 505nm, 546nm, 570nm, 605nm,
660nm, 700nm, 740nm, 800nm, and 850nm.
5
Vocabulary
Prime
Prime is an action to replace the reagents in tubing of the ISE module. A prime is
required to replace the reagents in tubing with new ones during the startup procedure
or when a reagent is changed.
Print name
Print name appears on a patient report representing a test, and if left blank, will be
replaced by the short name of the test.
Prozone check
Prozone check is intended to checking samples with quite different concentrations,
which may generate the equivalent amount of insoluble antigen/antibody compound
and can have the same test results. The Prozone check can be performed in two ways:
rate check and antigen addition.
Pull-down list
A control of the software screen or window. Select the down-triangle button on the
right of a pull-down list to show multiple options.
QC panel
Used for analysis of control samples.
QC rule
A set of rules to evaluate if the QC results are under control and the analyzing system
is stable. Examples of QC rule are 1-2s, 1-3s, etc.
QC summary
Contains the mean values and standard deviations of controls analyzed within the
specified period, as well as the set mean and SD value. The obtained results are
compared with the set values to judge if the system is working normally.
Qualitative analysis
Qualitative analysis is used to analyze every sample for the detection of lipemia,
hemolysis and icterus and calculate the numeric values of the index. If the volume of
the interferents contained in a sample is beyond the set range, a flag will be added to
the patient report.
Rack feeder system
The Rack Feeder System is responsible for carrying samples to the aspiration aspirate
position on each analyzer and retrieving the racks when the aspiration is done. Multiple
analyzers can be interconnected through this system.
Rack supply unit
This unit is used to load racks to be tested. The system delivers the racks automatically
from this unit to the rack transfer unit when analysis starts. This unit can
accommodate up to 30 racks, and 10 sample positions are available on each rack,
indicating that at most 300 samples can be accepted at one time. Users are allowed
to add new samples without stopping the analysis.
6
Vocabulary
Rack transfer unit

This unit consists of three lanes, which include: passing lane, normal lane and return
lane. The sample probe aspirates samples from the passing lane and normal lane.
Racks for STAT sample, quality control, calibration and rerun are carried to the passing
lane for sample aspiration; while normal racks are only carried to the normal lane for
sample aspiration. After aspiration, the racks are carried to the rack buffer unit through
the return lane.
Random error
An alarm of quality control monitoring. A random error may occur when the lowest and
highest values of QC results respectively exceed -2SD/-3SD and +2SD/+3SD.
Reaction carousel
Reaction carousel is a turntable, and used to hold reaction cuvettes and transmit each
of them to the photometric position for signal detecting and absorbance calculation.
Reaction curve
A reaction curve reflects the relationship of the absorbance measured at the primary
wavelength, secondary wavelength and primary-secondary wavelength. It is drawn
based on the absorbance of the sample-reagent mixture measured within the reaction
period. The system provides 4 types of reaction curves: calibration reaction curve, QC
reaction curve, sample blank reaction curve, and sample reaction curve.
Reaction cuvette
Reaction cuvette is a carrier in which reagents and samples react with each other and
then carried to the photoelectric position for signal detecting and response calculation.
Reaction direction
Reaction direction refers to the change trend of absorbance during the reaction
process. It includes positive and negative.
Reaction time
For endpoint analysis, the reaction time refers to the time span from the start point of
the reaction to the end point; for fixed-time and Kinetic analysis, it refers to the period
from reaction equilibrium to the end of monitoring.
Reagent blank
In the reagent blank test, the reagents react with the physiological saline, and the blank
absorbance is calculated to correct the calibration factors. Only the reagents that are
in Calibrated or Cal Time Out status can be requested for reagent blank.
Reagent carousel
The reagent carousel is located on left side of the analyzer panel. It holds reagent
bottles and carries each of them to the reagent aspirate position for aspirating.
Reagent carryover
Cross contamination between the reagent probes and the mixers. When the number of
tests between the contaminating test and the contaminated is less than or equal to the
defined number (N), and no concentrated wash is inserted between the two tests, it
indicates that the reagents underlie the risk of carryover.
Reagent inventory alarm limit
Alarm limit of reagents and wash solutions. When the reagent inventory is lower than
the alarm limits during or before the analysis, the system will give an alarm and display
the reagent or wash solution name in yellow on the Reagent/Calibration screen.
7
Vocabulary
Reagent load button

The reagent load button located on the lower-right corner of the reagent carousel is
used to rotate the reagent carousel. There are two reagent load buttons available, the
left one for the first reagent carousel and the right one for the second one. When a
reagent load button is pressed and held, the corresponding carousel starts rotating;
when the button is released, the carousel stops rotating.
Reagent probe
The reagent probe aspirates the specified amount of reagent from a reagent bottle and
then dispenses it into a cuvette for reaction and analysis. The system has four reagent
probes: probe R11, probe R12, probe R21 and probe R22. The first two are used to
aspirate/dispense R1 and R3 reagents, and the last two to aspirate/dispense R2 and
R4 reagents. The four probes aspirate reagent within the following range:
Reference range
Reference range is a user-defined range consisting of low limit and high limit. When a
result is beyond the reference range, a flag will appear near the result.
Replicates
Number of times to run a test, to ensure accurate results.
Sample blank
Sample comments
Remarks for some special samples, such as, ** sample has hemolysis; ** sample
needs to be analyzed immediately, etc.
The sample delivery module is responsible for storing racks to be tested, retrieving the
racks when tests are complete, and preparing the racks for repeated analysis.
Sample panel
Used for analysis of patient samples.
Sample probe
The sample probe aspirates the specified amount of sample from a sample tube and
then dispenses it into a cuvette for reaction and analysis.
Sample type
Type of sample. The sample type options include serum, plasma, urine, CSF and other.
Screen
Screen is a part of the software interface. It is rectangular and contains various
controls, such as edit box, function button, etc.
Secondary wavelength
The secondary wavelength is used to remove the interference in primary wavelength
values and eliminate the influence of noise, such as light flash and drift, and scratches
on cuvettes, etc. It cannot be the same as the primary wavelength.
8
Vocabulary
Serial number
Sequence number of the reagent bottle.
Slope
Multiplied with the test result to make it consistent with that obtained on other
instruments. It is often used along with the offset in the equation y=kx+b, in which k is
the slope and b is the offset.
Special calculation
Special calculation is derived from calculation of certain tests and has specific clinical
purposes, such as A/G, TBil-DBil, etc.
Special wash
Special wash is to clean the sample probe, reagent probes, mixers and reaction
cuvettes by using the probe wash solution, with the aim of eliminating carryover and
preventing waste from remaining in the waste tubes.
Standard deviation (SD)
Standard deviation is the mean of deviations from the mean value. It is an index to
judge the measurement accuracy under specific conditions. In this manual, SD refers
to the standard deviation of control concentration.
Standby
Standby is one of the system statuses. When the system status is Standby, it indicates
that all tests are finished and all actions of the system have stopped.
STAT
STAT means emergent, including common STAT and quick STAT order. STAT sample
order allows emergent samples to be ordered and analyzed with high priority. Common
STAT order is used in daytime to run emergent samples with higher priority than routine
samples. Quick STAT order is mainly used in nighttime and weekends to order
emergent samples quickly with higher priority than routine and common STAT samples.
Symbology
Symbology is a set of rules for encoding and decoding information contained in a bar
code label. The system provides a couple of symbologies, such as Codabar, ITF,
code128, code39, UPC/EAN, and Code93.
Transmit
Transmit is an action sending specified sample results or QC results to the LIS host.
Twin tests
Twin tests are run with the same reagents and calculated through the same test. For
two twin tests, the sample volume, volume of shared reagent, calibration replicates,
and auto calibration conditions should be the same. When either of the two tests is
requested for calibration, quality control or sample analysis, the other test will be
automatically requested, and finally results of both tests will be calculated.
Twin-Plot chart
A twin-plot chart, drawn based on the results of control X and control Y in the same
run, is used to detect systematic errors and random errors. It shows the recent 10 QC
results of a test and excludes those that have been deleted.
9
Vocabulary
Two-control evaluation
In two-control evaluation, two results are obtained: Xn and Yn, which are used to define
a point on the Twin-plot chart. In this way, a complete twin-plot chart is drawn based
on all the QC results and used for detecting systematic errors and random errors.
Unpositioned samples
Samples without positions assigned or with positions not assigned successfully,
including those:
 downloaded from the LIS host and not positioned yet.
 that are in Incomplete status when their positions are assigned for new samples.
 that are incomplete when their positions are released.
Westgard rule
Westgard rule is used for monitoring of quality control. In the Westgard rule, single
rules such as 12S, 13S, 22S and 41S are combined to evaluate results of single or
multiple controls.
10
Index
A K
Accessories and Consumables, 2-26
Kinetic Measurements, 13-8
Alarms and Troubleshooting, 12-1
B L
BIOHAZARD, 1-2, 1-4, 1-5, 1-13, 2-3, 3-3, 3-14, 3-32, 3-35, LIS, 8-3
3-40, 3-45, 5-14, 5-15, 6-12, 8-5, 8-16, 9-2, 9-3 LIS Communication, 10-3
LIS status, 3-7
C
M
Calibration, 2-12, 2-33, 3-1, 3-2, 3-11, 3-30, 3-31, 3-32, 3-
38, 3-43, 4-4, 4-20, 4-21, 4-22, 4-23, 4-24, 4-25, 5-2, 5- Maintenance, 1-4, 1-11, 2-12, 2-32, 2-40, 2-41, 3-9, 3-55,
3, 5-10, 6-1, 6-3, 6-4, 6-5, 6-6, 6-7, 6-8, 6-9, 6-10, 6-11, 9-1, 9-21, 11-1, 11-9, 11-35, 11-37
6-12, 6-14, 6-15, 6-17, 6-18, 6-19, 6-20, 6-21, 6-22, 6- Masking/Unmasking Reagent, 5-11
23, 6-25, 6-26, 7-12, 7-13, 8-38, 8-40, 9-3, 9-6, 9-11, 9-
13, 9-14, 9-15, 9-16, 12-9, 12-10, 12-11, 12-12, 12-16, O
12-19, 12-20, 12-21, 12-22, 13-1, 13-12, 13-13, 2, 4, 5,
8, 9 On-line Load of Reagents, 5-14
CAUTION, 1-2, 1-8, 1-9, 1-11, 1-12, 1-13, 2-2, 2-3, 2-12, 2- Operation Unit, 2-25
13, 2-18, 2-26, 3-4, 3-14, 3-16, 3-20, 3-32, 3-35, 3-40, 3- Ordering Routine Samples, 3-37
Ordering STAT Samples, 3-43
45, 5-7, 5-14, 5-16, 6-12, 6-19, 8-4, 8-5, 8-16, 8-33, 9-
2, 9-3, 11-35
CD80 detergent, 3-18 P
Charge Statistics, 8-42
Physiological Saline, 3-20
Powering On, 3-5
D Preparing Reagents, 3-14
Principles of Measurement, 13-3
Data Alarm, 12-7
Printer status, 3-7
Displayer Arm, 2-30
Prozone Check, 13-15
E Q
Endpoint Measurements, 13-4
Quality Control, 1-28, 3-2, 3-34, 4-4, 4-28, 7-1, 7-2, 7-3, 7-
External Vacuum Pump, 2-29
11, 7-12, 9-17, 5
F R
Fixed-time Measurements, 13-6
Rack Carrier, 2-12
Reaction carousel, 2-21
H Reagent Bar Code Reader, 5-6
Reagent Blank, 6-14
Home the System, 3-51
Reagent Inventory Check, 5-12
Reagent probe, 2-19
I Reagent Requirement Forecast, 5-5
Requirements Settings, 5-5
Installation Requirements, 2-2
Result Statistics, 8-40
ISE, 11-17, 11-25, 11-26, 11-54, 11-55, 11-56, 11-57
Result Transmission, 10-9
ISE Module, 2-27
ISE Test Parameters, 9-5
S
11
Index
Sample Analysis Setup, 4-37 T

Sample Bar Code, 8-2
Sample containers, 2-15 Temperature and humidity, 2-2
Sample Handling System, 2-9 Test Statistics, 8-38
Sample mixer assembly, 2-24 Tests Setup, 4-2
Sample Order Settings, 4-37
Sample probe, 2-14 U
Sample syringe, 2-15
Sample type, 8-3 Unloading Reagents, 5-18
Serum Index, 8-18
Sleep and Wake Up, 3-52 W
STAT Lane, 2-11
symbology, 8-3 WARNING, 1-2, 1-3, 1-4, 1-5, 1-6, 1-8, 1-13, 1-14, 2-2, 2-4,
Symbology, 8-3 2-5, 2-6, 2-15, 2-19, 2-20, 3-14, 5-14, 5-15
System Setup, 4-40 Water Supply Module, 2-27
12
Electronic Interface
Description Network interface

Interface Standard The interface standard of RJ45 is met.
Interface The communication rate is 100 Mbps

Specifications
Interface Purpose The host receives and executes
instructions from the PC through this
interface, and returns the execution results
to the PC through this interface.
13
Bibliography
1. Burtis C.A., Ashwood E.R. and Bruns D.E. Tietz Fundamentals of Clinical Chemistry.
6th Ed. Saunders/Elseviser, St. Louis, Missouri, 2008, 63-262.
2. Burtis C.A., Ashwood E.R. and Bruns D.E. Tietz Textbook of Clinical Chemistry and
Molecular Diagnostics. 5th Ed., Saunders/Elseviser, St. Louis, Missouri, 2012, 7-59.
3. Gauglitz G. and Vo-Dinh T. Handbook of Spectroscopy. WILEY-VCH Verlag GmbH &
Co. KGaA, Weinheim, 2003, 37-162.
4. Gottschalk P.G. and Dunn J.R. The five-parameter logistic: A characterization and
comparison with the four-parameter logistic. Analytical Biochemistry, 2005; 343: 54–
65.
5. Levey S. and Jennings E.R. The use of control charts in the clinical laboratory. Am J
Clin Pathol, 1950; 20: 1059-1066.
6. Madsen K., Nielsen H.B. and Tingleff O. Methods for Non-Linear Least Squares
Problems. 2nd Ed., Informatics and Mathematical Modelling, Technical University
of Denmark, Lyngby, Denmark, 2004.
7. Westgard J.O. and Barry P.L. Cost-Effective Quality Control: Managing the quality
and productivity of analytical processes. AACC Press, Washington DC, 1986.
8. Westgard J.O., Barry P.L., Hunt M.R. and Groth T. A multi-rule Shewhart chart for
quality control in clinical chemistry. Clin Chem 1981; 27: 493-501.
14
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Operator’s Manual

Intellectual Property Statement

Responsibility on the Manufacturer Party

Customer service department

Observance of this manual is a prerequisite for proper performance and correct

Intellectual Property Statement ............................................................................................................ ii

1 Safety Information ················································································································· 1-1

Safety Symbols .................................................................................................................................. 1-2

Reagent, Calibrator and Control Precautions ..................................................................... 1-12

2 System Description ················································································································ 2-1

2.1 Installation Requirements and Procedure .................................................................................. 2-2

2.5.2 Power Supply ............................................................................................................... 2-41

3 General Operating Procedure ·································································································· 3-1

3.1 General Operating Procedure ...................................................................................................... 3-2

3.7 Quality Control ........................................................................................................................... 3-34

4 Setup ···································································································································· 4-1

4.1 Tests Setup .................................................................................................................................. 4-2

4.1.11 Check Parameters..................................................................................................... 4-15

5 Reagents&Consumables ········································································································· 5-1

5.1 View Reagents/Consumables .................................................................................................... 5-2

5.1.4 Reagent Carousel .......................................................................................................... 5-4

6 Calibration ···························································································································· 6-1

6.1 Overview ....................................................................................................................................... 6-2

6.4 Calibration Status ........................................................................................................................ 6-9

7 Quality Control······················································································································· 7-1

7.1 Overview ....................................................................................................................................... 7-2

7.3.2 Selection of Tests.......................................................................................................... 7-8

8 Sample Ordering and Processing ····························································································· 8-1

8.1 Sample Bar Code ......................................................................................................................... 8-2

8.8.2 Recalling Results ......................................................................................................... 8-26

9 Use of ISE Module ·················································································································· 9-1

9.1 Precautions on Use...................................................................................................................... 9-2

9.7.1 Sample Ordering and Results Recall .......................................................................... 9-18

10 LIS ···································································································································· 10-1

10.1 Overview ................................................................................................................................... 10-2

11 Maintenance ······················································································································ 11-1

11.1 Overview ................................................................................................................................... 11-2

11.4.8 Special Wash Probes/Mixers ................................................................................. 11-19

12 Alarms and Troubleshooting ······························································································· 12-1

12.1 Classification of Logs ............................................................................................................. 12-2

13 Operation Theories ············································································································· 13-1

13.1 Overview ................................................................................................................................... 13-2

13.6.2 Non-Linear Calibrations .......................................................................................... 13-13

Electronic Interface ···················································································································· 13

1.1 Summary of Hazards

Electric Shock Hazards

Moving Parts Hazards

Photometer Lamp Hazards

Laser Beam Hazards

Sample, Calibrator and Control Hazards

Reagent and Wash Solution Hazards

System Disposal Hazards

Fire and Explosion Hazards

Removal of Analyzer from Use for Repair or Disposal

Cleaning and Decontamination

Software and Cybersecurity

Notification of Adverse Events

1.2 Precautions on Use

Electromagnetic Noise Precautions