Manual Usuario bs230

BS-230
Chemistry Analyzer
Operator’s Manual
© 2016 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights Reserved.
For this Operator's Manual, the issue date is 2016-03.
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.
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.
BS-230 Operator's Manual i

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.
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
ii BS-230 Operator's Manual

Preface
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. Observance of this manual is a prerequisite for proper performance and correct
operation, and it ensures patient and operator 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 actual product should prevail.
Intended audience
This manual is intended for medical laboratory professionals to do the following:
 Learn about the system hardware and software.
 Perform daily operating tasks.
 Maintain and troubleshoot the system.
Product introduction
BS-230 is a computer-controlled fully-automated chemistry analyzer, intended for quantitative
determination of clinical chemistries in serum, plasma, urine, cerebrospinal fluid (CSF), and
other human body fluids. It can fulfill auto dispensing, reaction, colorimetric measurement,
process monitoring, and result calculation. It provides measurement of multiple biochemistries
and ISE (ion-selective electrode) tests (Na+, K+ and Cl-), with maximum throughput up to 400
tests per hour. It is one of the necessary tools for laboratory automation.
Related documents
The following documents are provided for searching information about the instrument:
Operator's Manual
Contains instrument compositions, operating instructions, maintenance and troubleshooting
methods. At the beginning of this manual is a table of contents, which provides references of all
chapters for searching desired information. At the end of this manual is a glossary and index,
which provide term definitions and index to key words.
This manual is based on the maximum configuration and therefore some contents may not
apply to your product. It you have any questions, please contact us.
Operation Card
Provides daily operating procedure for quickly guiding you through basic operations of the
instrument. It includes pre-startup checks and startup, operations before test, routine test, daily
performance and powering off.
Maintenance Card
Provides regular and irregular maintenance of the instrument to help you maintain it so that it
can work normally.
 For detailed maintenance instructions, see the Operator's Manual.
Online help
Contains detailed descriptions of the software screens and parameters. It also covers the
Operator's Manual, which enables you to retrieve information related to the software screens
and operation tasks.
BS-230 Operator’s Manual 1

Preface
Conventions
Graphical symbols, formats and abbreviations are used to get better visual effects and
readability. To help you understand this manual correctly, this section provides statements of
pictures, terms and applicable models used in this manual.
Symbols and formats
The following symbols and formats are used:
Symbol and Meaning

format
A safety symbol, for alerting you to warnings about safety and
system operations.
Alerts you to biohazards.
 Item list.
 Reference content or cross reference.
Bold Headings or important information.
Italic Key points.
 Start of operating procedure.
Picture
All pictures in this manual are for illustration purpose only and must not be used for any other
purposes. The pictures of the actual product should prevail.
Terms
The analyzer has one probe for adding sample and reagent. If not specifically stated, it is
referred to as "probe". For emphasis purpose in software operations, "sample probe" is used for
adding sample, and "reagent probe" is used for adding reagent.
The analyzer has one carousel for holding sample and reagent. If not specifically stated, it is
referred to as "sample/reagent carousel". For emphasis purpose in software operations,
"sample carousel" is used for sample, and "reagent carousel " is used for reagent.
Applicable model
If no models are specifically indicated, it means the descriptions are used for all applicable
models.
Online help
The operating software provides a context-sensitive online help, which can help you better
understand the screen parameters and perform correct operations. The online help is related to
software screens, and it can display information related to menu page, maintenance item,
maintenance command, and event log.
You can open the online help window in the following ways:
 Alt+F1: press this shortcut key combination on any screen.
 : click this icon on the top-right of any screen.
 : click this button to the left of a maintenance item, a maintenance command, or an event
log.
 For more information about online help, see 1.3.5Using online help on page 1-24.
2 BS-230 Operator’s Manual

Safety information
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 silkscreens that have been
applied to the instrument and their indications.
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 warning as shown in the table below:
Symbol Text Description

WARNING Read the statement following the symbol. The statement is
alerting you to an operating hazard that can cause personal
injury.
BIOHAZARD Read the statement following the symbol. The statement is
alerting you to a potentially biohazardous condition.
CAUTION Read the statement following the symbol. The statement is
alerting you to a possibility of system damage or unreliable
results.
NOTE Read the statement following the symbol. The statement is
alerting you to information that requires your attention.
Summary of hazards
This section lists hazards of the instrument itself. The hazards of specific operation are included
in the warning information of each operation task.
Observe the following safety precautions when using the product. Ignoring any of them may
lead to personal injury or equipment damage.
BS-230 Operator's Manual 3

Safety information
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
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
WARNING
 Do not touch such moving parts as sample/reagent carousel, reaction carousel, probe, mixer, and cuvette
wash station, when the system is in operation.
 Exercise caution while using the ISE module. Prevent your hair, legs or other parts of your body from being
hurt by the driving parts.
 Do not put your fingers or hands into any open part when the system is in operation.
Photometer lamp hazards
WARNING
 Eye injury could occur from light emission from the photometer lamp. Do not stare into the lamp when the
system is in operation.
 If you want to replace the photometer lamp, first switch off the MAIN POWER and then wait at least 10
minutes for the lamp to cool down before touching it. Do not touch the lamp before it cools down, or you
may get burned.
Laser beam hazards
WARNING
Light emitted by the bar code reader may cause eye injury. Do not stare into the laser beam radiated from the
bar code reader when the system is in operation.
Sample, calibrator and control hazards
BIOHAZARD
 Inappropriately handling samples, controls and calibrators may lead to biohazardous infection. Do not touch
samples, controls, calibrators, mixtures, or waste with your bare hands. Wear gloves and lab coat and, if
necessary, goggles.
 In case your skin contacts the sample, control or calibrator, follow the standard laboratory safety procedure
and consult a doctor.
 The serum samples remaining in the electrodes may contain a great number of viruses. Wear gloves to
prevent infection while operating around the electrodes.

Safety information
Reagent and wash solution hazards
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 much water and consult an oculist.
Waste hazards
BIOHAZARD
 Some substances contained in reagent, control, calibrator, concentrated 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.
 Wear gloves and lab coat and, if necessary, goggles.
System disposal hazards
WARNING
Materials of the analyzer are subject to contamination regulations. Dispose of the waste analyzer in accordance
with your local or national rule for waste disposal.
Fire and explosion hazards
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
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(probe, mixer, etc.) and remind the person who handles the device
of the related hazards.
Summary of precautions
This section lists precautions to be understood during instrument operation. The precautions of
specific operation are included in the warning information of each operation task.
To use the product safely and efficiently, pay attention to the following operating precautions.

Safety information
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. Please consult us before you use the instrument for other purposes.
When drawing a clinical conclusion, please also refer to patients' clinical symptoms and other test results.
Environment precautions
CAUTION
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.
Electromagnetic noise precautions
CAUTION
Electromagnetic noise may interfere with operations of the system. Do not install devices generating excessive
electromagnetic noise around the system. Do not use such devices as radio transmitters in the room housing
the system. Do not use other CRT displays around the system.
Do not use other medical instruments around the system that may generate electromagnetic noise to interfere
with their operations.
Do not use this device in close proximity to sources of strong electromagnetic radiation (e.g. mobile phones or
radio transmitters), as these may interfere with the proper operation.
The electromagnetic environment should be evaluated prior to operation of the device.
This device has been designed and tested to CISPR 11 Class A, and in a domestic environment may cause
radio interference, in which case, you may need to take measures to mitigate the interference.
NOTE
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 it will perform as intended.

Safety information
Operating precautions
CAUTION
 Take the clinical symptoms or other test results of the patient into considerations when making 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, run calibrations and 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 RS-232 port on the analyzing unit is used for connection with the operation unit only. Do not use it for
other connections. Use the cables provided by our company or your local distributor for the connection.
 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 display, mouse or keyboard with wet hands or hands with chemicals.
 Do not place the MAIN POWER to ON again within 10 seconds after 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.
Chemistry 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.

Safety information
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 a long time, perform the electrode storage maintenance.
Sample precautions
CAUTION
 Use samples that are completely free of insoluble substances like fibrin or suspended matter; otherwise the
sample probe may be clogged.
 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 a sample blank,
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.
 Prepare sufficient sample volume before analysis.
 Load samples to correct positions on the sample carousel 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.
ISE calibration precautions
BIOHAZARD
The calibrators contain preservatives. In case your skin contacts calibrators, wash them off with soap and water.
In case the calibrators spill into your eyes, rinse them with water and consult an oculist. If you swallow them by
mistake, see a doctor.

Safety information
CAUTION
Use the 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 calibrators, check if they are within the expiration date.
Place them correctly; otherwise, it may cause unreliable results, or leak, or module damage.
ISE wash solution biohazards
BIOHAZARD
The ISE wash solution is sodium hypochlorite. Use the ISE wash solution carefully to prevent it from contacting
your skins or eyes. If your skins or eyes contact the ISE wash solution, rinse them off with fresh water and
consult a doctor.
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 the data loss caused by unexpected power failure, 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 authorized and 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.
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.

Safety information
Labels and silkscreen

The following non-warning and warning labels and silkscreen are used on the product for
system identification and operating instruction.
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.
Non-warning labels and silkscreen

Serial number
This symbol, contained in the product label which is attached to the rear cover of the system,
indicates the production serial number of the product.
Date of manufacture
indicates the manufacture date of the product.
In vitro diagnostic equipment

indicates that the product is in vitro diagnostic equipment.
European community representative

indicates the name and address of the authorized representative in the European Community.

Safety information
WEEE label
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.
Main power switch: ON

This symbol located on the main power switch indicates that the system power is on when the
switch is toggled rightwards to expose this symbol and ON character and the green light is
lightened.
Main power switch: OFF

This symbol located on the main power switch indicates that the system power is off when the
switch is toggled leftwards to expose this symbol and OFF character and the green light is
extinguished. All components including the reagent refrigeration system will be stopped.
Analyzer power switch

This symbol located on the analyzer power switch indicates that the analyzer power is on when
the switch is on the dotted-circle portion and off when it is on the blank-circle portion.
Network interface
This symbol located on the network interface indicates the connection between the analyzer
and the operation unit.

Safety information
Serial port
This symbol located on the serial port indicates the connection between the analyzer and the
operation unit.
Electrical ground
This symbol indicates an electrical ground.
Interfaces for fluid connection

This symbol located on the right panel of the analyzer indicates the connection of fluid tubing.

Safety information
Warning labels
Biohazard warning
This label indicating the risk of biohazardous infection is located in the following positions:
 Probe
 Waste outlet
 Waste tank
Moving parts warning

This symbol and text indicating the hazardous moving parts is located in the following positions:
 Probe
 Mixer
Laser warning
This symbol and text located near the bar code reader reminds you of not staring into the laser
beam.
Photometer lamp warning

This symbol and text located on the lamp housing reminds you of not touching the lamp before
it gets cool.
Probe collision warning

This symbol and text located near the sample/reagent carousel and reaction carousel reminds
you of not opening the cover to prevent from damaging the probe.

Safety information
Upper cover
This symbol and text located on the transparent upper cover reminds you of not wipe the upper
cover with ethanol or other organic solutions.
ISE module
This symbol and text located on the left side panel of the analyzer. Please turn off the main
power before opening the small door.
Liquid level floater

This symbol and text is located near the DI water tank liquid level floater, Please do not take out
the liquid level floater during test.
Cuvette replacement window

This symbol and text is located on the cuvette replacement window.

Table of contents
Intellectual Property Statement ...............................................................................................................................................i
Responsibility on the Manufacturer Party...........................................................................................................................i
Warranty ......................................................................................................................................................................................... ii
Exemptions ...................................................................................................................................................................... ii
Customer service department ................................................................................................................................. ii
EC - Representative ...................................................................................................................................................... ii
Preface ............................................................................................................................................................................................. 1
Intended audience ........................................................................................................................................................ 1
Product introduction .................................................................................................................................................... 1
Related documents ........................................................................................................................................................ 1
Conventions..................................................................................................................................................................... 2
Online help ....................................................................................................................................................................... 2
Safety information ····················································································································· 3
Safety symbols............................................................................................................................................................................... 3
Summary of hazards................................................................................................................................................................... 3
Summary of precautions .......................................................................................................................................................... 5
Labels and silkscreen .............................................................................................................................................................. 10
Non-warning labels and silkscreen..................................................................................................................... 10
Table of contents ····················································································································· 15
1 System description ·············································································································· 1-1
1.1 Installation requirements and procedure ............................................................................................................... 1-2
1.1.1 Installation requirements............................................................................................................................ 1-2
1.1.2 Installation Procedure .................................................................................................................................. 1-5
1.2 Hardware components .................................................................................................................................................. 1-5
1.2.1 Overview ........................................................................................................................................................... 1-5
1.2.2 Sample/Reagent handling system .......................................................................................................... 1-7
1.2.3 Mixer assembly ............................................................................................................................................ 1-12
1.2.4 Reaction system .......................................................................................................................................... 1-12
1.2.5 Photometric system ................................................................................................................................... 1-13
1.2.6 ISE unit (optional) ...................................................................................................................................... 1-13
1.2.7 Operation unit .............................................................................................................................................. 1-14
1.2.8 Output unit .................................................................................................................................................... 1-14
1.2.9 Accessories and consumables ............................................................................................................... 1-15
1.3 Software description .................................................................................................................................................... 1-16
1.3.1 Screen areas .................................................................................................................................................. 1-16
1.3.2 Screen elements ........................................................................................................................................... 1-19
1.3.3 Software hierarchy ..................................................................................................................................... 1-22
1.3.4 Using the mouse .......................................................................................................................................... 1-23
1.3.5 Using online help......................................................................................................................................... 1-24
1.4 System specifications .................................................................................................................................................. 1-25
1.4.1 Analyzing unit .............................................................................................................................................. 1-25

Table of contents
1.4.2 Power supply requirements ................................................................................................................... 1-27

1.4.3 Environment requirements .................................................................................................................... 1-27
1.4.4 Dimensions and weight ........................................................................................................................... 1-27
1.4.5 Noise and fuse .............................................................................................................................................. 1-27
1.4.6 Input device ................................................................................................................................................... 1-27
1.4.7 Output device ................................................................................................................................................ 1-28
1.4.8 Communication interfaces ...................................................................................................................... 1-28
1.4.9 Safety classification .................................................................................................................................... 1-28
1.4.10 EMC requirements ................................................................................................................................... 1-28
2 Daily operating procedure ····································································································· 2-1
2.1 Daily operating procedure ........................................................................................................................................... 2-2
2.2 Startup and daily checks ................................................................................................................................................ 2-2
2.2.1 Checks before startup................................................................................................................................... 2-2
2.2.2 Startup ................................................................................................................................................................ 2-3
2.2.3 Checking system status................................................................................................................................ 2-6
2.3 Operations before routine test ................................................................................................................................ 2-10
2.3.1 Preparing reagents ..................................................................................................................................... 2-10
2.3.2 Calibration ..................................................................................................................................................... 2-15
2.3.3 QC ...................................................................................................................................................................... 2-19
2.4 Routine test ..................................................................................................................................................................... 2-21
2.4.1 Programming and processing samples .............................................................................................. 2-22
2.4.2 Checking test results .................................................................................................................................. 2-24
2.4.3 Checking test status and performing test control ......................................................................... 2-25
2.5 Replace cuvettes............................................................................................................................................................. 2-27
2.6 Daily maintenance and powering off ................................................................................................................... 2-28
2.6.1 Daily maintenance...................................................................................................................................... 2-29
2.6.2 Powering off.................................................................................................................................................. 2-29
2.6.3 Operations after powering off ............................................................................................................... 2-29
3 Reagent ······························································································································ 3-1
3.1 ISE reagent.......................................................................................................................................................................... 3-2
3.1.1 ISE reagent/calibration screen ................................................................................................................ 3-2
3.1.2 Loading special reagents in Running status ........................................................................................ 3-2
3.1.3 Unloading special reagents......................................................................................................................... 3-3
3.1.4 Printing ISE reagent/calibration list ..................................................................................................... 3-3
3.2 Biochemistry reagent ..................................................................................................................................................... 3-3
3.2.1 Biochemistry reagent/calibration screen............................................................................................ 3-3
3.2.2 Sorting reagents.............................................................................................................................................. 3-4
3.2.3 Loading biochemistry reagents in Running status ........................................................................... 3-4
3.2.4 Unloading biochemistry reagents ............................................................................................................ 3-4
3.2.5 Customizing reagent display ..................................................................................................................... 3-5
3.2.6 Setting up reagent alarm limit .................................................................................................................. 3-6
3.2.7 Checking and auto refreshing reagent inventory ............................................................................ 3-6
4 Calibration ·························································································································· 4-1
4.1 ISE calibration ................................................................................................................................................................... 4-2
4.1.1 Calibration setup ............................................................................................................................................ 4-2
4.1.2 Calibration status and alarm ...................................................................................................................... 4-2

Table of contents
4.1.3 Results recall .................................................................................................................................................... 4-3

4.2 Biochemistry calibration ............................................................................................................................................... 4-5
4.2.1 Calibration setup ............................................................................................................................................ 4-5
4.2.2 Calibration status and alarm ................................................................................................................... 4-11
4.2.3 Reagent blank ............................................................................................................................................... 4-12
4.2.4 Recalling calibration results ................................................................................................................... 4-14
5 QC ····································································································································· 5-1
5.1 Overview ............................................................................................................................................................................. 5-2
5.1.1 QC procedure ................................................................................................................................................... 5-2
5.1.2 QC result flags .................................................................................................................................................. 5-2
5.1.3 Control status ................................................................................................................................................... 5-2
5.2 QC setup ............................................................................................................................................................................... 5-3
5.2.1 Defining/Editing a control ......................................................................................................................... 5-3
5.2.2 Setting up control concentrations ........................................................................................................... 5-4
5.2.3 Setting up QC rules ........................................................................................................................................ 5-4
5.2.4 Auto QC .............................................................................................................................................................. 5-5
5.2.5 Deleting a control ........................................................................................................................................... 5-6
5.3 Recalling control results ................................................................................................................................................ 5-6
5.3.1 Result > History screen ............................................................................................................................... 5-6
5.3.2 QC > Levey-Jennings screen ...................................................................................................................... 5-8
5.3.3 Recalling cumulative sum chart ............................................................................................................... 5-9
5.3.4 Recalling Twin-Plot chart ........................................................................................................................ 5-10
5.3.5 QC > Results screen .................................................................................................................................... 5-11
5.3.6 Recalling QC Summary ............................................................................................................................. 5-13
6 Program······························································································································ 6-1
6.1 Sample management ...................................................................................................................................................... 6-2
6.2 Sample programming and processing ..................................................................................................................... 6-3
6.2.1 Processing samples with LIS ..................................................................................................................... 6-3
6.2.2 Processing bar-coded samples ................................................................................................................. 6-4
6.2.3 Batch programming...................................................................................................................................... 6-5
6.2.4 Adding samples ............................................................................................................................................... 6-6
6.2.5 Adding/Modifying chemistries ................................................................................................................. 6-6
6.2.6 Rerunning samples........................................................................................................................................ 6-7
6.2.7 Sample blank ................................................................................................................................................. 6-12
6.3 Extended functions ....................................................................................................................................................... 6-13
6.3.1 Clearing samples .......................................................................................................................................... 6-13
6.3.2 Sample and chemistry lists ...................................................................................................................... 6-14
6.3.3 Viewing unpositioned samples ............................................................................................................. 6-16
6.3.4 Releasing sample position ....................................................................................................................... 6-17
6.3.5 View sample logs ......................................................................................................................................... 6-18
6.3.6 Customizing sample information ......................................................................................................... 6-19
6.3.7 Customizing patient demographics ..................................................................................................... 6-20
6.3.8 Optimizing result display ......................................................................................................................... 6-20
6.4 Results Recall .................................................................................................................................................................. 6-22
6.4.1 Viewing current results ............................................................................................................................ 6-22
6.4.2 Viewing history results............................................................................................................................. 6-23

Table of contents
6.4.3 Reviewing sample results ........................................................................................................................ 6-25

6.4.4 Viewing/Editing patient demographics ............................................................................................ 6-25
6.4.5 Viewing reaction curve ............................................................................................................................ 6-26
6.4.6 Sending results to LIS host ...................................................................................................................... 6-29
6.4.7 Printing results ............................................................................................................................................. 6-30
6.4.8 Editing results ............................................................................................................................................... 6-31
6.4.9 Deleting results ............................................................................................................................................. 6-33
6.4.10 Customizing result display ................................................................................................................... 6-33
6.4.11 Recalculating results ................................................................................................................................ 6-35
6.4.12 Compensating results ............................................................................................................................. 6-35
6.4.13 Recalling result trend ............................................................................................................................. 6-36
6.4.14 Archiving results ....................................................................................................................................... 6-37
6.5 Test statistics ................................................................................................................................................................... 6-37
6.6 Result statistics............................................................................................................................................................... 6-39
7 Chemistry ··························································································································· 7-1
7.1 Importing/Exporting chemistries ............................................................................................................................. 7-2
7.1.1 Importing default chemistry list .............................................................................................................. 7-2
7.1.2 Importing specified chemistry list.......................................................................................................... 7-3
7.1.3 Exporting chemistries .................................................................................................................................. 7-4
7.2 Biochemistry setup .......................................................................................................................................................... 7-4
7.2.1 User-defined chemistry setup ................................................................................................................... 7-5
7.2.2 Processing parameters................................................................................................................................ 7-6
7.2.3 Error detection limits................................................................................................................................. 7-10
7.2.4 Using qualitative result ............................................................................................................................. 7-13
7.2.5 Slope and offset adjustment ................................................................................................................... 7-13
7.2.6 Reference/Critical range setup ............................................................................................................. 7-14
7.3 ISE chemistry setup ...................................................................................................................................................... 7-16
7.3.2 Viewing ISE chemistry parameters..................................................................................................... 7-16
7.3.3 Description of ISE chemistry parameters ........................................................................................ 7-17
7.3.4 Using ISE qualitative result ..................................................................................................................... 7-17
7.4 Chemistry configuration ............................................................................................................................................ 7-18
7.4.1 Enabling chemistries ................................................................................................................................. 7-18
7.4.2 Disabling chemistries ................................................................................................................................ 7-19
7.4.3 Customizing chemistry display order ................................................................................................. 7-20
7.4.4 Adjusting test order of chemistries ..................................................................................................... 7-20
7.5 Twin chemistry .............................................................................................................................................................. 7-21
7.5.1 Chemistry definition .................................................................................................................................. 7-22
7.5.2 Removing twin relation ............................................................................................................................ 7-22
7.5.3 Reagent setup ............................................................................................................................................... 7-22
7.5.4 Setting up and requesting calibration ................................................................................................ 7-22
7.5.5 Setting up and requesting quality control ......................................................................................... 7-23
7.5.6 Sample programming and processing ............................................................................................... 7-23
7.6 Special Calculations ...................................................................................................................................................... 7-23
7.6.1 Defining/Editing a calculation ............................................................................................................... 7-23
7.6.2 Enabling/Disabling calculations ........................................................................................................... 7-24
7.6.3 Deleting user-defined calculations ........................................................................................................ 7-25

Table of contents
7.6.4 Running calculations .................................................................................................................................. 7-25

7.7 Panels ................................................................................................................................................................................. 7-25
7.7.1 Defining/Editing a panel ......................................................................................................................... 7-25
7.7.2 Adjusting display order of panels ......................................................................................................... 7-26
7.7.3 Deleting panels ............................................................................................................................................. 7-26
7.7.4 Running panels ............................................................................................................................................ 7-26
7.7.5 Setting up and running default panel ................................................................................................. 7-26
7.8 Off-system chemistry .................................................................................................................................................. 7-27
7.8.1 Defining/Editing off-system chemistry ............................................................................................. 7-27
7.8.2 Running off-system chemistry .............................................................................................................. 7-28
7.8.3 Deleting off-system chemistry ............................................................................................................... 7-28
7.9 Carryover setup ............................................................................................................................................................. 7-28
7.9.1 Defining/Editing carryover pair........................................................................................................... 7-29
7.9.2 Removing a carryover pair ..................................................................................................................... 7-29
7.10 Masking/Unmasking chemistries........................................................................................................................ 7-30
7.11 Reflex ............................................................................................................................................................................... 7-30
7.11.1 Setting up reflex relation ........................................................................................................................ 7-31
7.11.2 Editing reflex relation.............................................................................................................................. 7-31
7.11.3 Deleting reflex relation............................................................................................................................ 7-32
7.11.4 Measurement and result recall .......................................................................................................... 7-32
8 Utility·································································································································· 8-1
8.1 System commands ........................................................................................................................................................... 8-2
8.1.1 Home................................................................................................................................................................... 8-2
8.1.2 Stop print .......................................................................................................................................................... 8-2
8.2 System setup ...................................................................................................................................................................... 8-2
8.2.2 Sample test setup page ................................................................................................................................ 8-3
8.2.3 Auto rerun setup ............................................................................................................................................ 8-5
8.3 Instrument setup .............................................................................................................................................................. 8-6
8.3.1 Auto startup setup ......................................................................................................................................... 8-6
8.3.2 Masking/Unmasking Chemistries .......................................................................................................... 8-7
8.3.3 Dictionary setup ............................................................................................................................................. 8-7
8.3.4 System communication options .............................................................................................................. 8-8
8.3.5 Selecting language .......................................................................................................................................... 8-8
8.3.6 Software upgrading....................................................................................................................................... 8-9
8.3.7 Viewing software versions ........................................................................................................................ 8-9
8.3.8 Setting up system date and time ........................................................................................................... 8-10
8.3.9 Setting up QC run length and auto QC ................................................................................................ 8-11
8.3.10 Auto release of samples ......................................................................................................................... 8-11
8.3.11 Voice tone setup........................................................................................................................................ 8-11
8.3.12 Optimizing result display ...................................................................................................................... 8-12
8.3.13 Customizing sample information ...................................................................................................... 8-12
8.3.14 Customizing patient demographics .................................................................................................. 8-12
8.3.15 Reagent/Calibration setup ................................................................................................................... 8-12
8.3.16 Customizing reagent display ............................................................................................................... 8-12
8.3.17 Customizing sample position .............................................................................................................. 8-13
8.4 Print setup........................................................................................................................................................................ 8-13

Table of contents
8.4.1 General print setup options .................................................................................................................... 8-13

8.4.2 Editing print template ............................................................................................................................... 8-14
8.4.3 Importing print template......................................................................................................................... 8-14
8.4.4 Setting up default template...................................................................................................................... 8-15
8.4.5 Deleting a template ..................................................................................................................................... 8-15
8.4.6 Defining chemistry print order ............................................................................................................. 8-15
8.5 Bar code setup ................................................................................................................................................................ 8-16
8.6 LIS setup ........................................................................................................................................................................... 8-18
8.6.1 Introduction................................................................................................................................................... 8-18
8.6.2 Setting up host communication parameters ................................................................................... 8-19
8.6.3 Defining channel number of chemistries ......................................................................................... 8-21
8.7 User and Password Setup .......................................................................................................................................... 8-21
8.7.1 Defining a user ............................................................................................................................................. 8-21
8.7.2 Modifying a user ......................................................................................................................................... 8-22
8.7.3 Assigning/Modifying permissions ...................................................................................................... 8-23
8.7.4 Deleting a user.............................................................................................................................................. 8-23
9 Template modifying software ································································································· 9-1
9.1 Main screen ........................................................................................................................................................................ 9-2
9.1.1 Main screen ...................................................................................................................................................... 9-2
9.1.2 File (F) ................................................................................................................................................................ 9-2
9.1.3 Edit (E) ............................................................................................................................................................... 9-4
9.1.4 View (V)............................................................................................................................................................. 9-5
9.1.5 Insert (I) ............................................................................................................................................................ 9-6
9.1.6 Format (M) ....................................................................................................................................................... 9-7
9.1.7 Set(S) .................................................................................................................................................................. 9-8
9.1.8 Language (L) .................................................................................................................................................... 9-8
9.1.9 Help (H) ............................................................................................................................................................. 9-9
9.2 Common tools .................................................................................................................................................................... 9-9
9.3 Draw tools ........................................................................................................................................................................... 9-9
9.4 Property window ........................................................................................................................................................... 9-10
9.4.1 Page .................................................................................................................................................................. 9-10
9.4.2 Line ................................................................................................................................................................... 9-11
9.4.3 Rectangle ......................................................................................................................................................... 9-12
9.4.4 Label ................................................................................................................................................................. 9-12
9.4.5 Text ................................................................................................................................................................... 9-14
9.4.6 Title ................................................................................................................................................................... 9-15
9.4.7 Image ............................................................................................................................................................... 9-16
9.5 Report window ............................................................................................................................................................... 9-16
10 Maintenance ····················································································································· 10-1
10.1 Overview ........................................................................................................................................................................ 10-2
10.1.1 Safety information ................................................................................................................................... 10-2
10.1.2 Tools and Spare Parts .............................................................................................................................. 10-2
10.1.3 Concepts ....................................................................................................................................................... 10-3
10.1.4 Maintenance period ................................................................................................................................ 10-5
10.1.5 Maintenance execution methods ....................................................................................................... 10-5
10.1.6 Extended operations of maintenance item.................................................................................... 10-6

Table of contents
10.2 Scheduled maintenance and maintenance commands ............................................................................... 10-7

10.2.1 Scheduled maintenance ......................................................................................................................... 10-7
10.2.2 Biochemistry maintenance commands ........................................................................................... 10-8
10.2.3 ISE maintenance commands ............................................................................................................... 10-9
10.3 Maintenance log sheet ........................................................................................................................................... 10-10
10.4 Daily maintenance .................................................................................................................................................. 10-13
10.4.1 Checking probe/mixer/wash well................................................................................................. 10-13
10.4.2 Checking DI water tank and tube connection ............................................................................ 10-14
10.4.3 Checking waste connection and waste tank connection ...................................................... 10-14
10.4.4 Checking probe wash solution......................................................................................................... 10-15
10.4.5 Clean electrode tubes ............................................................................................................................ 10-16
10.4.6 Check Sample/Reagent Syringe ...................................................................................................... 10-16
10.5 Weekly maintenance.............................................................................................................................................. 10-17
10.5.1 Cleaning probe exterior ...................................................................................................................... 10-17
10.5.2 Clean the mixer ...................................................................................................................................... 10-18
10.6 Monthly maintenance ........................................................................................................................................... 10-19
10.6.1 Cleaning wash wells.............................................................................................................................. 10-19
10.6.2 Cleaning sample injection port ........................................................................................................ 10-20
10.6.3 Pump calibration ................................................................................................................................... 10-20
10.6.4 Air bubble detector calibration ........................................................................................................ 10-21
10.7 Three-month maintenance ................................................................................................................................. 10-22
10.7.1 Cleaning DI water tank ........................................................................................................................ 10-22
10.8 Six-month maintenance ....................................................................................................................................... 10-22
10.8.1 Replacing lamp ....................................................................................................................................... 10-22
10.9 As-needed/As-required maintenance ............................................................................................................ 10-23
10.9.1 Lamp background test ........................................................................................................................ 10-23
10.9.2 Cleaning analyzer panels .................................................................................................................... 10-24
10.9.3 Cleaning sample/reagent compartment ...................................................................................... 10-24
10.9.4 Cleaning probe interior ...................................................................................................................... 10-25
10.9.5 Cleaning rotor ......................................................................................................................................... 10-27
10.9.6 Replacing the probe ............................................................................................................................. 10-27
10.9.7 Removing Air Bubbles in Syringe ................................................................................................... 10-28
10.9.8 Replacing Syringe .................................................................................................................................. 10-29
10.9.9 Replacing the mixer.............................................................................................................................. 10-30
10.9.10 Special wash probe ............................................................................................................................ 10-32
10.9.11 Bar code maintenance ...................................................................................................................... 10-32
10.9.12 Replacing ISE electrode ..................................................................................................................... 10-33
10.9.13 Removing reagent pack ................................................................................................................... 10-35
10.9.14 Storing electrodes................................................................................................................................ 10-35
10.9.15 Cleaning ISE waste tube ................................................................................................................... 10-36
11 Alarms and troubleshooting ································································································ 11-1
11.1 Classification of logs................................................................................................................................................... 11-2
11.1.1 Error logs ..................................................................................................................................................... 11-2
11.1.2 Edit logs ........................................................................................................................................................ 11-3
11.2 Viewing and handling logs ..................................................................................................................................... 11-3
11.2.1 Description of Error Log screen ........................................................................................................ 11-3

Table of contents
11.2.2 Description of Edit Log screen ........................................................................................................... 11-4

11.2.3 Recalling logs.............................................................................................................................................. 11-4
11.2.4 Refreshing Logs ........................................................................................................................................ 11-5
11.2.5 Clearing logs ................................................................................................................................................ 11-5
11.2.6 Printing logs................................................................................................................................................ 11-5
11.3 Error Troubleshooting.............................................................................................................................................. 11-5
11.3.1 Error indications ...................................................................................................................................... 11-6
11.3.2 Identifying errors ..................................................................................................................................... 11-7
11.4 Data alarms.................................................................................................................................................................... 11-7
11.4.1 Data alarms and corrective actions ................................................................................................... 11-8
11.5 Error Messages and Corrective Actions ......................................................................................................... 11-20
12 Operation theories ············································································································· 12-1
12.1 Overview ........................................................................................................................................................................ 12-2
12.2 Principles of measurement .................................................................................................................................... 12-2
12.2.1 Endpoint measurements ....................................................................................................................... 12-2
12.2.2 Fixed-time measurements .................................................................................................................... 12-4
12.2.3 Calculation of Response ......................................................................................................................... 12-4
12.2.4 Kinetic measurements ........................................................................................................................... 12-4
12.3 Calibration math model and factors ................................................................................................................... 12-8
12.3.1 Linear calibrations .................................................................................................................................. 12-8
12.3.2 Non-Linear Calibrations ........................................................................................................................ 12-8
12.4 QC evaluation ............................................................................................................................................................ 12-10
12.4.1 Evaluation of single controls.............................................................................................................. 12-10
12.4.2 Two-control evaluation ....................................................................................................................... 12-11
12.5 Prozone Check .......................................................................................................................................................... 12-12
12.5.1 Introduction ............................................................................................................................................. 12-12
12.5.2 Rate check method ............................................................................................................................... 12-13
12.6 Principles of ISE measurement.......................................................................................................................... 12-13
Glossary··································································································································· 1
Index········································································································································ 1

1 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
 Introduction of software screens
 Technical specifications
BS-230 Operator’s Manual 1-1

1.1 Installation requirements and procedure 1 System description
1.1 Installation requirements and procedure

1.1.1 Installation requirements
CAUTION
Install the instrument in a place meeting the requirements presented in this section; otherwise, it will not
perform as intended.
Installation environment
The following environment requirements must be satisfied:
 The system is for indoor use only.
 The bearing platform should be level (with gradient less than 1/200).
 The bearing platform should be able to support at least 130Kg weight.
 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 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 -400-2000 m.
Power supply
The following power supply requirements must be satisfied:
 Connect the system to a power supply meeting the requirements specified in this
manual.
For more information on power supply, see 1.4.2requirements on page 1-27.
 Use the three-wire power cord provided with the system, which has good grounding
performance.
 Connect the system to a properly-grounded power socket.
 Configure the grounding voltage correctly.
WARNING
Make sure the power socket is grounded correctly. Improper grounding may lead to electric shock or equipment
damage. Check if the power sockets outputs voltage meeting the specified requirements and has a proper fuse
installed.
Temperature and humidity

The following temperature and humidity requirements must be satisfied:
 Ambient temperature: 15°C-30°C
 Relative humidity: 35%-85%, without condensation
1-2 BS-230 Operator’s Manual

1 System description 1.1 Installation requirements and procedure
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.
Water supply and drainage

The supplied water must meet the requirements of CLSI type II, with resistance more than
1MΩ.CM. and silicate lower than 0.1 mg/L.
CAUTION
The water supply must meet the requirements; otherwise insufficiently purified water may result in misleading
test results.
The probe and mixer wash waste is discharged to the provided 15 L waste tank or to a drain
outlet.
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.
CAUTION
When connecting the tubes, exercise caution to avoid folding or pressing them.
Figure 1.1 Fluidic connection diagram

Fluidic interface panel
Low conc. Low conc.
DI water Waste outlet Waste outlet
inlet 1 2
DI low
level
floater
FL03
FL01
DI water tank Low concentrated

waste tank
Space and accessibility requirements

Install the instrument according to the clearance requirements as shown in the figure below.

1.1 Installation requirements and procedure 1 System description
Figure 1.2 System clearances
Wall
Min. 500
Maximum of 3000
Min. 500
585 Operation Unit
Analyzing Unit
Front
695
Min. 500
Min. 500 Unit: mm
Recommended computer configuration

Table 1.1 Recommended computer configuration
Item Description
CPU At least P4 2.6GHz or above
Random access memory At least 2GB or above for each RAM
(RAM)
Network adapter 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 (Intel
gigabit network adapter)
Serial port The computer should provide an RS232 serial port, which is used
to connect it with the chemistry analyzer.
Parallel port or USB Used for connecting the operation unit with a printer or an
interface external storage device.
Network interface Used for communication between the analyzing unit and the
operation unit, or between the LIS and the operation unit.
Hard disk defragment At least 160GB or above for hard disk. Install the operating system
in the C drive and the operating software of the instrument in the D
drive. Make sure that the C drive is over 30G and D drives over
100G, and the disk file system is of NTFS format. Deselect the two
options at the bottom of the disk properties window: "Compress
drive to save disk space" and "Allow Indexing Service to index this
disk for fast file searching".
Operating system The operating system installed on the computer must be an
activated or free version Microsoft Windows 8(64 bit).
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.
Screen saver and system Turn off the screen saver and BS Special Power Policy power
standby scheme, and then disable the hibernation option.
Screen display Set the screen resolution as 1280*1024 pixels and color quality as
properties Highest (32 bit).

1 System description 1.2 Hardware components
Automatic Disable the Automatically synchronize with an Internet time server

synchronization with 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, perform
shutdown setup necessary settings for BIOS and network adapters while referring
to their operation manuals.
Sound card and speaker The system must be configured with sound card and speaker.
Recommended printer configuration

You are suggested to choose one of the following printers for use with the computer:
 Ink jet printer
 Laser printer (black and white)
 Stylus printer
1.1.2 Installation Procedure
WARNING
The system should be installed only by technicians of or authorized by our company.
The system should be 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.
1.2 Hardware components

1.2.1 Overview
The BS-230 consists of the following components:
 Analyzing unit (analyzer)
 Operation unit (computer)
 Output unit (printer)
 Accessories and consumables

1.2 Hardware components 1 System description
Figure 1.3 chemistry analyzer
(1) (2) (3)
(1) Analyzing unit (2) Operation unit

(3) Output unit
Analyzing unit
The analyzer, determines various clinical chemistries in samples and generates test results. It is
composed of the following components:
 Sample/Reagent handling system
 Mixer assembly
 Reaction system
 Photometric system
 ISE unit (optional)
Operation unit
A computer with the operating software installed to perform test requisition, measurement,
reaction process monitoring, result calculation, and input, storing and query of test data.
Output unit
A printer for printing out test results and other data.
Accessories and consumables
Includes cuvette, lamp, concentrated wash solution (CD80), and other accessories and
consumables required by test.

1.2.2 Sample/Reagent handling system

The sample/reagent handling system holds sample and reagent and provides them for analysis.
It consists of the following assemblies:
 Sample/Reagent carousel assembly
 Built-in bar code reader (optional) Dispenser assembly
 Probe wash assembly
Sample/Reagent carousel assembly

The sample/reagent carousel is a turntable located on the left side of the analyzer panel. It holds
sample tubes and reagent bottles and carries each of them to the aspirate position for
aspirating.
Figure 1.4 Sample/Reagent carousel assembly
(1) (2) (3)
(4)
(5)
(1) ISE sample injection port (2) Aspirate port on inner ring
(3) Aspirate port on middle ring (4) Aspirate port on outer ring
(5) Sample/Reagent carousel
Carousel positions
The carousel holds both sample and reagent, and it includes the outer ring, middle ring and
inner ring. The three rings provides the following positions:
 Outer ring: No.1-40, can hold 40 samples.
 Middle ring: No.1-40, can hold forty 20 mL reagent bottles, or 40 sample tubes with adapter.
 Inner ring: No.41-80, can hold forty 20 mL reagent bottles, or forty 40 mL reagent bottles
after merged with the middle ring.
The following fixed positions are provided for special reagents:
 W for physiological saline(40#)
 D for probe wash solution(39#)
 ISE wash solution(38#)
Reagent refrigeration
The sample/reagent carousel provides a refrigerating environment which is constant within
2°C-12°C for 24 hours a day. The reagents stored in such environment can be kept stable with
little volatilization.

CAUTION
Every day before analysis, remove the plugs on the sample/reagent carousel in order to prevent mechanical
reset failure and bending the reagent probe. Restore the plugs after finishing tests of the day.
Ensure that the sample/reagent carousel is closed while the system is running tests. Opening the carousel
cover during test could result in probe collision or other failures.
NOTE
The refrigeration unit is powered independently from the analysing unit, and it is operational once the MAIN
POWER is put to the ON position.
Installing/Removing the sample/reagent carousel
WARNING
Before installing or removing the sample/reagent carousel, make sure that the analyzer is in standby status or
is shut down, and the sample/reagent carousel has stopped.
BIOHAZARD
Wear gloves and lab coat and, if necessary, goggles.
Figure 1.5 Sample/Reagent carousel
(1)
(1) Handle
Installing the sample/reagent carousel

1 Lift the handle to make it vertical.
2 Align the hole on the hand wheel to the pin on the rotor, and then gently lay the
sample/reagent carousel.
3 Move the handle back to the horizontal position to secure the carousel to the rotor.

Removing the sample/reagent carousel

1 Lift the handle to make it vertical.
2 Hold the handle or the hand wheel to take out the sample/reagent carousel.
CAUTION
Make sure the carousel cover is closed; otherwise the refrigeration performance could be degraded and the
probe could be damaged.
Before system operation, make sure that the carousel cover is closed properly; otherwise the probe could be
damaged.
The sample/reagent compartment and the carousel could be contaminated during measurement. If sample or
reagent spills in the compartment or on the carousel, switch off the analysing unit power, and wipe them with
cloth soaked with water or disinfector.
Sample containers
Sample containers are used to hold sample.
Different sample tubes require different minimum sample volumes. Each sample tube must
contain the amount of sample 8mm higher than the unreachable sample level; otherwise, correct
aspirating cannot be ensured.
The table below shows the specifications of each type of sample container:
Table 1.2 Specification of sample containers
Sample Container Specification
Microtube Φ14×25 mm, 0.5 mL
Φ14×25 mm, 2 mL
Φ12×37 mm, 2 mL
Primary tube or plastic Φ12×68.5 mm
tube Φ12×99 mm
Φ12.7×75 mm
Φ12.7×100 mm
Φ13×75 mm
Φ13×95 mm
Φ13×100 mm
Reagent bottles
20mL and 40mL reagent bottles are used.
Loading/Unloading sample tube
WARNING
Before installing or removing a sample tube, make sure that the sample/reagent carousel and the probe have
stopped.
Do not use sample tubes other than the specified ones.
BIOHAZARD
Wear gloves and lab coat and, if necessary, goggles.
To load a sample tube, insert it into the tube holder until the tube bottom contacts the groove of
the tube rack.

To unload a sample tube, grab it and pull it upwards to remove from the tube holder.
Loading/Unloading reagent bottle
WARNING
Before installing or removing a reagent bottle, make sure that the sample/reagent carousel and the probe have
stopped.
Do not use reagent bottles other than the specified.
Some reagents may hurt human skins. Exercise caution when using the reagents. In case your skin or clothes
contact them, wash them off with clean water. In case the reagents spill into your eyes, rinse them with much
water and consult an oculist.
To load a reagent bottle, insert it into the bottle holder until the bottle bottom contacts the groove
of the holder.
To remove a reagent bottle, grab it and pull it upwards to remove from the bottle holder.
Built-in bar code reader (optional)

The bar code reader is provided for optional configuration. It is located on the upper-left corner
of the sample/reagent carousel, and used to scan the bar code on sample tube and reagent
bottle.
Figure 1.6 Bar code scanning window
(1)
(1) Bar code scanning window
WARNING
The light radiated from the sample bar code reader may hurt your eyes. Do not stare into the laser beam
coming from the bar code reader.
The table below lists the specifications of the bar code reader:
Table 1.3 Specifications of the bar code reader
Symbology Codabar, ITF, Code128, Code39, UPC/EAN, and Code93
Minimum bar code 0.19 mm - 0.50 mm
density
Length Sample bar code: 3-27 digits
Reagent bar code: 13-30 digits
Format and content User-defined
Maximum width 55mm

Minimum height Sample bar code: 10 mm

Reagent bar code: 12 mm
Maximum inclination ±5°
angle
Print quality No less than Class C according to the ANSI MH10.8M Print Quality
Specification.
Width and narrowness Sample bar code: (2.5-3.0):1
Reagent bar code: 2.5:1
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.
Dispenser assembly
The dispenser assembly located at the upper-right corner of the sample/reagent carousel is
composed of the probe, probe arm, probe rotor, syringe, wash well, and related fluidic path. It
aspirates the specified amount of sample and reagent from a sample tube and a reagent bottle
and then dispenses them into a cuvette for reaction.
Figure 1.7 Dispenser assembly
(1)
(2)
(4)
(3)
(1) Probe arm (2) Probe rotor

(3) Probe wash well (4) Probe
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.
Probe
One probe is available to add sample and reagent with the following volume range:
 Biochemistry: 2-45 μL, with increment of 0.1 μL.
 ISE test: 70 μL for serum and plasma, and 140 μL for diluted urine.
 Reagent: 10-250 μL, with increment of 0.5 μL.

Besides adding sample and reagent, the probe has the following functions:
 Vertical obstruct detection: Detects obstacles in the vertical direction. When the probe
collides with an obstacle in the vertical direction, the auto guard system is started to prevent
the probe from being damaged.
 Level detection and tracking: Detects the liquid level in sample tube and reagent bottle and
determines the depth of lowering down into the liquid based on the specified aspirate
volume.
Probe wash assembly

The probe wash assembly consists of the wash well and related fluidic path. It is responsible for
cleaning the probe interior and exterior after the probe adds sample or reagent.
1.2.3 Mixer assembly

The mixer assembly, located on the lower-left side of the reaction carousel, is composed of the
mixer, mixer arm, and drive assembly. It stirs the reaction liquid in cuvettes once sample and
reagent are added.
Figure 1.8 Mixer assembly
(4)
(1)
(3)
(2)
(1) Mixer rotor (2) Mixer wash well

(3) Mixer (4) Mixer arm
When stirring is finished, the mixer moves automatically to the wash well for cleaning.
1.2.4 Reaction system

The reaction system consists of the reaction carousel, cuvettes and drive assembly. It holds the
reaction cuvettes and carries them to the specified position for washing, adding reagent and
sample, mixing, reaction, and absorbance measuring.
Reaction carousel
The reaction carousel is a single-ring turntable, which can hold 8 cuvette segments. Each cuvette
segment includes 5 cuvettes.
The reaction carousel is heated by means of air bath to provide a constant environment at
37±0.3°C with fluctuation of ±0.1°C.

Figure 1.9 Reaction carousel
(1)
(2) (5)
(3)
(4)
(1) R1 dispense position (2) Sample and R2 dispense position

(3) Mixing position (4) Cuvette replacement window
(5) Reaction carousel
Reaction cuvette
Plastic reaction cuvette segments are used. Each segment includes 5 cuvettes (5 mm × 5 mm).
The light path length of the cuvette is 5 mm, and the internal dimension is 5 mm (length) × 5
mm (depth) × 29.5 mm (height).
The cuvettes used on the analyzer are disposable consumables and should be replaced manually
after each test.
1.2.5 Photometric system

The photometric system located inside the analyzing unit measures absorbance of the reaction
mixture in cuvettes. It comprises the light source, filter, lens, and other components.
1.2.6 ISE unit (optional)
WARNING
The ISE unit must be operated by skilled/trained doctors, nurses or clinical professionals.
Exercise caution while using the ISE unit Prevent your hair, legs or other parts of your body from being hurt by
the driving parts.
The ISE (Ion Selective Electrode) unit consists of the ISE module, the pump module and the
reagent module, and can measure the concentration of Na+, K+ and Cl- ions in serum, plasma
and diluted urine.
If not specifically noted, "ISE module" represents the ISE unit.

Figure 1.10 ISE system
(3)
(1)
(2)
(1) Reagent module (2) Pump module

(3) ISE module
In ISE test, 70 μL serum or plasma, or 140 μL diluted urine (diluted at the ratio of 1:10) is
required.
The following components are comprised in the ISE unit:
 ISE module: includes the spacer, Na, K, Cl, and reference electrodes.
 Reagent module: includes the calibrator A, calibrator B, waste container, and chip for
measuring reagent volume.
 Pump module: includes the calibrator A pump, calibrator B pump and waste pump.
1.2.7 Operation unit

The operation unit is a computer configured with the operating software. It consists of the
monitor, computer, keyboard, and mouse.
Figure 1.11 Operation unit
(1)
(2)
(3)
(4)
(1) Display monitor (2) Mouse

(3) Keyboard (4) Computer
 For more information on the operation unit, see its operation manual.
1.2.8 Output unit

The output unit is a printer used to print out test results and other data. The system supports
three types of printer: inkjet printer, laser printer (black and white) and stylus printer.

Figure 1.12 Output unit
(1)
(1) Printer
You should purchase an appropriate printer compatible with the analyzer.

 For more information on the printer, see its operation manual.
1.2.9 Accessories and consumables

Accessories are necessary components for the instrument to perform sample analysis, and they
should be replaced regularly. Consumables are replenishable materials to be replaced after each
use, or vulnerable materials that should be replaced on a regular basis.
Please use the accessories and consumables manufactured or recommended by our company in
order to achieve the promised system performance. The Accessories and consumables list is
subject to change;if needed, contact our customer service department or your local distributor.
Table 1.4 Accessories and consumables
No. Part Name Remarks
1 Needle .0.25+/-0.01mm*125mm round head Accessory
2 Valve Washer,10-32,18011Telfon washer Accessory
3 20ml reagent bottle brown Accessory
4 40ml reagent bottle brown Accessory
5 20ml reagent bottle Accessory
6 Reagent bottle label Accessory
7 BS200 white cap of reagent bottle Accessory
8 BS200 red cap of reagent bottle Accessory
9 Accessory kit bar code Accessory
10 Parameter list Accessory
11 Cross screwdriver 102*100 Accessory
12 Serial port cable Accessory
13 Cuvette(BA25) Accessory
14 Water tank Accessory
15 Filter Accessory
16 Tube Φ9.525XΦ15.875 PVC 55~60 degree Accessory
17 BA25 Operating Software Installation CD Accessory
18 Plug Accessory
19 Cable strap CHS-3X100mm Nylon Accessory

20 Mixer wrench Accessory
21 Reference electrode Consumable
22 K electrode Consumable
23 Na electrode Consumable
24 Spacer Consumable

1.3 Software description 1 System description
No. Part Name Remarks

25 ISE wash solution Consumable
26 Urine diluent Consumable
27 MEDICA control (Level 3) Consumable
28 Urine diluent (125ml) Consumable
29 ISE reagent pack Consumable
30 ISE Cl electrode (Turkey) Consumable
31 ISE reference electrode (Turkey) Consumable
32 ISE K electrode(Turkey) Consumable
33 ISE Na electrode (Turkey) Consumable
34 ISE spacer (Turkey) Consumable
35 ISE wash solution (Turkey) Consumable
36 ISE urine diluent(Turkey) Consumable
37 MEDICA control Level 3(Turkey) Consumable
38 ISE reagent pack (Turkey) Consumable
39 ISE reagent pack (5425)with package Consumable
40 Cl electrode 5207 Consumable
41 ISE Accessory kit with package Consumable
42 ISE Accessory kit (OEMwith package) Consumable
43 CD80(international 6 bottles) Consumable
44 CD80(international 1L*1 bottle) Consumable
45 Plastic cuvette (International,1000 pcs) Consumable
46 Three-core power cord international standard 10A 250V 1.6m Consumable
47 Power cord Europe standard (International) Consumable
48 Power cord US standard 1.5M15A Consumable
49 Power cord UK standard Consumable
50 1.8mPower cord India H05VV-F3X1.5mmVolex Consumable
51 Power cord Australia V-75 3×1.0 PVC Consumable
52 Power cord Brazil 250V 10A 3M Consumable
53 Sample tube adapter(5pcs) Consumable
1.3 Software description

1.3.1 Screen areas
The software screen is divided into the following areas:

1 System description 1.3 Software description
Figure 1.13 Screen areas

(1) (2)
(5) (3)
(4)
(1) Status display area (2) Shortcut icons area

(3) Function window (4) Prompt message area
(5) Function buttons area
Status display area

The status display area shows the system status, including: biochemistry/ISE system status, test
time left, countdown for pausing, LIS connection, printer, login user, and system date/time.
If not especially stated, "non-test status" in this manual refers to Incubation, Standby and
Stopped; while "test status" refers to other statuses.
Table 1.5 Status display area
Status indicator Description
Biochemistry/ISE This indicator appears on the left of the status display area. If an
ISE module is installed, the ISE status appears.
The status of the biochemistry system includes: Initialize,
Incubation, Standby, Running, Pause, Stopped, Maintenance,
Sample load, Reagent load, cuvette load, inventory check, restore
and Shutdown.
The status of the ISE module includes: Initialize, Standby, Running,
Stopped, Maintenance, and Shutdown.
Test time left This indicator appears in the middle of the status display area. It
indicates the minutes left that the analysis will be finished.
Countdown for pause This indicator appears on the right of the status display area. It
indicates the minutes left that the dispensing of sample or reagent
will be stopped.

LIS connection status

This indicator appears on the left of the status display area. The
following information is indicated:
 If the icon appears in blue, the LIS host is connected and

online.
 If the icon appears in grey, the LIS host is offline.

Printer connection status
This indicator appears on the left of the status display area. It
indicates the status of the printer: not printing and printing.
 If the icon appears in grey , the printer is not printing or
unconnected.
 If the icon appears in blue , the printer is printing.
Login user This indicator appears in the middle of the status display area. It
indicates the user who logs in the system.
Date and time This indicator appears on the right of the status display area. It
indicates the system date and time.
Shortcut icons area

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 testing.
 : Pause icon. Select it to stop dispensing of sample and reagent. Then you are
allowed to load new samples or reagents on the sample/reagent carousel. To resume
the test, select .
 : Emergency stop icon. Select it to stop all tests and other actions. To restore the
system into Standby status, execute the Home command.
 : STAT icon. Select it to display the STAT Sample Program window, on which you
are enabled to program emergency samples quickly.
 : Online help icon. Select it to display the online help of the current window,
where you can find description of parameters and operations.
Function window
It displays the page or window related to the selected function button or shortcut icon. It is used
to perform system operations.
Prompt message area

The prompt message area contains two lines, the upper line displaying operation prompts for
screen controls and the lower line displaying error messages.
Function buttons area

The function buttons area contains the following buttons used to access various function
windows of the system:

 : used to program patient samples and control samples, and view sample
carousel status.
 : used to recall test results of patient samples and controls and view the result
statistics and test statistics.
 : used to set reagents, define/edit calibrators, request calibrations, recall

calibration results, and view reagent carousel status.
 : used to replace the cuvette segments.
 : used to define/edit controls and QC rules, recall QC results and summary.
 : used to execute instrument commands, set up chemistry and system

parameters, perform system maintenance, and view component status.
 : used to recall and handle error logs and editing logs.
 : used to log off or shut down the system.
1.3.2 Screen elements

Page
A page appears when a tab is selected. The figure below is an example of page:
Figure 1.14 Example of page
Page
Window
A window has visible boundaries, which consists of title bar, content area and buttons.
The figure below is an example of window:

Figure 1.15 Example of window
Window
Tab
Click a tab to access the working page that it indexes.
The figure below is an example of tab:
Figure 1.16 Example of tab
Tabs
Drop-down list
Click to display a list and choose desired item in the list.

The figure below is an example of drop-down list:
Figure 1.17 Example of drop-down list
Drop-down list
Combo box
A combo box includes a field and a drop-down list, in which you can manually input characters
or select an option.
The figure below is an example of combo box:
Figure 1.18 Example of combo box
Combo box
Edit box
An edit box is a field in which you can input characters manually.
The figure below is an example of edit box:

Figure 1.19 Example of edit box

Edit box
Radio button
A radio button is a circle with text beside. It indicates a set of choices from which only one can
be selected.
The figure below is an example of radio button:
Figure 1.20 Example of radio button
Radio button
Check box
A check box is a square box with text beside. It indicates a set of choices from which one or
more can be selected.
The figure below is an example of check box:
Figure 1.21 Example of check box
Check box
Button
A button is used to open a window or to execute a defined function.
The figure below is an example of button:
Figure 1.22 Example of button
Button
Scroll bar
A scroll bar is used to display the hidden contents when they are too many to be shown on one
screen. A vertical scroll bar moves the screen up and down, and a horizontal scroll bar moves
the screen left and right.
The figure below is an example of scroll bar:

Figure 1.23 Example of scroll bar
Vertical scroll bar
Horizontal scroll bar
List
A list holds multiple chemistries or panels, or contains texts or charts in the form of table.
The figure below is an example of list:
Figure 1.24 Example of list
List
Slider
A slider is used to select a scale continuously. Click and hold the slider and drag it to the desired
scale.
The figure below is an example of slider:
Figure 1.25 Example of slider
Slider
1.3.3 Software hierarchy

The figure below shows the menu structure of the operating software. By clicking a function
button, or a shortcut icon can access the relevant window.

Figure 1.26 Software hierarchy

Sample
Program
Quality Control
Status
Current By Sample
Result
History By Chemistry
Statistics
Reagent/Calibration
Reagent
Biochemistry Calibration
ISE Calibration
Reagent Carousel Status
Cal Setup
QC Levey-Jennings
Cumulative sum
Twin-Plot
Results
Summary
QC Setup
Replace
Commands
Utility
Chemistries
System Setup Status Summary
Maintenance Count
Status Temperature
Hydro
Alarm Error Log
Edit Log
Exit
1.3.4 Using the mouse

The mouse can be used to move, click, double-click, and drag an object. It can be also used to
select an option when combined with the keyboard.
Move
The mouse is presented in the form of pointer on the screen. Place the mouse on a flat platform,
and then move it to the make the pointer lap over the object that you want to select or edit.
Click
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.
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.

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 the 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.
1.3.5 Using online help

The online help provides you information related to the software screens. If you want to
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 in any of the following ways:
 Select the icon on the upper right corner to display the help topic related to the current
screen.
Figure 1.27 Accessing the online help from the main screen
 Select the icon in front of each maintenance command or regular maintenance item to
display the relevant operating instructions.
Figure 1.28 Accessing the online help from the Maintenance window
 Select the icon in front of each error log to display the corresponding topic.

1 System description 1.4 System specifications
Figure 1.29 Accessing the online help from the Error Log screen
 Select the icon on a warning message window to display the corresponding

descriptions and solutions.
 Select the icon on an error message window to display the corresponding descriptions
and solutions.
 Press the shortcut key combination Alt+F1 to display the topic related to the current page or
window.
Viewing other information

To view other information in the online help, perform the following steps:
1 Select the icon on the upper right corner of the main screen, or press the shortcut key
combination Alt+F1.
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.
 Favourites: 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.
1.4 System specifications

This section provides technical specifications of the system. Understand them to use the system
correctly.
1.4.1 Analyzing unit

The technical specifications and performance parameters of the analyzing unit are shown in
the following tables.
Throughput and reaction type
Table 1.6 Specifications of throughput and reaction type
Throughput for Up to 200 tests/hour for single-reagent chemistries
biochemistries
Throughput for ISE tests Serum/plasma: 100 samples/hour and 300 tests/hour
(including K, Na, Cl) Diluted urine: 66 samples/hour and 198 tests/hour
Biochemistries and ISE Up to 400 tests/hour
chemistries
Maximum number of tests Without ISE module: up to 80
run simultaneously With ISE module: up to 83
Principles of analysis Colorimetry, turbidity, and ISE method
Reaction types Endpoint, fixed-time, and Kinetic
Reagent mode Supporting single-/double-reagent tests

1.4 System specifications 1 System description
Wavelength Supporting single/double-wavelength mode

Sample/Reagent handling system
Table 1.7 Specifications of the sample/reagent handling system
Sample/Reagent carousel Includes outer ring, middle ring and inner ring, with 120
positions.
 Outer ring: 40 sample positions
 Middle ring: 40 positions for sample or reagent
 Inner ring: 40 reagent positions
The middle and inner rings can be merged for holding
40 mL reagent bottle.
24 hour continuous refrigeration at 2-12 °C.
Sample volume for routine 2 μL - 45 μL, with increment of 0.1 μL
chemistry
Sample volume for ISE Serum/Plasma: 70μL; diluted urine: 140 μL
chemistry
Reagent volume 10 μL - 250 μL, with increment of 0.5 μL
Probe One probe for adding sample and reagent, featuring level
detection, vertical obstruct detection, and level tracking.
Probe washing The probe is cleaned in its wash well with water
spraying its interior and exterior
Emergent samples Emergent samples can be inserted at any time with
highest priority.
Rerunning mode Supporting auto dilution, standard volume, increment,
decrement, decrement dilution, increment dilution.
Mixer assembly
 One mixer to mix the reaction liquid after sample and R2 are added.
 Cleaned externally with deionized water.
Reaction system
Table 1.8 Specifications of the reaction system
Reaction carousel 40 positions available
Reaction temperature 37 °C ± 0.3 °C
Heating mode Air bath
Reaction cuvette Plastic cuvette segment, each including 5 cuvettes. 5 mm
× 5 mm × 29.5 mm (length × depth × height), light path
length 5 mm
disposable cuvette
Change mode (BS-230) Manually replaceable
Reaction mixture volume 100 μL - 360 μL
Photometric system
Table 1.9 Specifications of the photometric system
Light source 12V/20W tungsten-halogen lamp, 2000 hours life span
Colorimetric component Reaction cuvette
Light-splitting mode Filter wheel forward optics
Detector Photodiode

1 System description 1.4 System specifications
Measuring wavelength 8 wavelengths: 340nm, 405nm, 450nm, 510nm, 546nm,

578nm, 630nm, and 670nm
Absorbance measurement 0 - 4.0 A
range
Measuring period 18 seconds
Reaction volume 100 μL - 360 μL
Average water consumption
≤ 3 L/H
1.4.2 Power supply requirements

Choose proper power supply according to the following requirements:
Table 1.10 Power supply requirements
Power supply 110V:
110V/115V~, 60Hz
220V:
220V-240V~, 50Hz
220V/230V~, 60Hz
Rated power consumption ≤1000VA
Voltage fluctuation ±10%
Frequency fluctuation ±1Hz
1.4.3 Environment requirements

Operate and store the instrument in compliance with the following environment requirements:
Operating environment
 Temperature: 15 - 30 °C
 Relative humidity: 35% - 85%, without condensation
 Altitude height: -400 m - 2000 m (80 kPa - 106 kPa)
Storage environment
 Temperature: 0 - 40 °C
 Relative humidity: 30% - 85%, without condensation
 Altitude height: 50 kPa - 106 kPa
1.4.4 Dimensions and weight

 Dimension: ≤ 695 mm (length) × 585 mm (depth) × 600 mm (height)
 Weight: ≤ 130 Kg
1.4.5 Noise and fuse

Table 1.11 Noise and fuse
Noise ≤ 65 dBA
Fuse For 110V: 110V 10A
For 220V: 250V 10A
1.4.6 Input device

 Keyboard (prepared by user)

1.4 System specifications 1 System description
 Mouse (prepared by user)

 Display monitor (prepared by user)
 Bar code reader
 LIS: HL7 and ASTM1394 (communicating through serial port or net port of the
TCP/IP interface of static IP address)
1.4.7 Output device

 Printer (prepared by user)
 Display monitor (prepared by user)
 LIS: HL7 and ASTM1394 (communicating through serial port or net port of the
TCP/IP interface of static IP address)
1.4.8 Communication interfaces

The analyzing unit, operation unit, output unit (printer), LIS, and external storage device, can
be connected through the following interfaces. Connect them correctly according to the
descriptions below:
Table 1.12 Communication interfaces
RS232 serial port  Used for communication between the analyzing unit and
the operation unit
 Used for communication between the LIS and the
operation unit
 Used for connecting the operation unit with a printer
Network interface  Used for communication between the analyzing unit and
the operation unit
 Used for communication between the LIS and the
operation unit
Parallel port or USB interface  Used for connecting the operation unit with a printer
 Used for connecting the operation unit with an external
storage device
1.4.9 Safety classification

Table 1.13 Safety classification
Overvoltage type Class II
Pollution degree 2
Device type Fixed device
Work type Continuous
Degree of IP(Ingress Common device ,IPX0 (no protection against liquids)
Protection)
1.4.10 EMC requirements

This equipment complies with the emission and immunity requirements described in
EN61326-1:2013/IEC61326-1:2012 and EN61326-2-6:2013/IEC61326-2-6:2012.

2 Daily operating procedure
This chapter describes a typical daily operating procedure of the instrument. For instructions of
more operations, see other chapters in this book.
All operations described in this chapter are based on complete configuration of the instrument.
If you do not have certain optional module, please neglect the relevant steps or operate in
another way provided .
 To understand the detailed information of software screens, see the Online Help.

2.1 Daily operating procedure 2 Daily operating procedure
2.1 Daily operating procedure

The daily operation of the instrument includes: startup and daily checks, operations before
routine test, routine test, daily maintenance and powering off.
The following is a typical daily operating procedure:
Figure 2.1 Daily operating procedure
Startup and daily checks

1. Checks before startup
2. Startup
3. Checking system status
Operations before routine test

1. Preparing reagents
2. Calibration
3. QC
Routine test
1. Sample processing
2. Checking results
3. Checking test status and test control
Daily maintenance and powering off

1. Daily maintenance
2. Powering off
3. Operations after powering off
2.2 Startup and daily checks

Startup and daily checks can be done in following steps:
 Checks before startup
 Startup
 Checking instrument status
2.2.1 Checks before startup

Perform the following checks before starting up the instrument:
Table 2.1 Checks before startup

2 Daily operating procedure 2.2 Startup and daily checks
Check items Checking methods Comment

Water supply Check the deionized water tank or other water reservoirs, Ensure that the top of the
and make sure that water can be supplied continuously. deionized water tank is lower
than the operating platform
of the analyzer.
If you use a water unit, check if it has been powered on.
Check if the connections between the water supply and the
analyzer are correct and tight.
Check if the water tubes are free of twists and leaks.
Power supply Check if the power supply is available and can provide
correct voltage.
Check the connections among the analyzing unit, operation
unit and printer. Make sure the connections are correct
and secure. Check the power cords and make sure they are
well connected to the power sockets.
Printing Check if sufficient printing paper is prepared in the printer.
paper If not, refill the printing paper.
Waste Ensure that the top of the
connection Check if the low-concentration waste tank has been waste tank is lower than the
emptied. If not, empty it. operating platform of the
Low-concentration waste volume 2.1 L/H. analyzer, to prevent waste
from flowing back.
Ensure that the waste tubes
are above the waste tank and
smooth without bending or
twisting. Otherwise, the
waste may overflow the
analyzer panels to damage
the analyzer.
Check if the low-concentration waste tube is not bent and
the sewer opening is lower than the waste outlet of the
system.
Probe and Check the probe for dirt and bend.
mixer  If it is polluted, clean it.
 If it is bent, replace it.
Check the mixer for dirt and bend.
 If it is polluted, clean it.
 If it is bent, replace it.
Probe wash Check the probe wash solution on the sample/reagent Insufficient probe wash
solution carousel. If necessary, fill more or replace the wash solution could terminate the
solution. measurements.
2.2.2 Startup
The instrument can be started manually or automatically. For manual startup, you need to
switch on the power supply manually; for auto startup, you should set up the weekday and time
for the instrument to start up automatically.

2.2 Startup and daily checks 2 Daily operating procedure
Manual startup
You need to switch on the power supply and log on the operating software. When the
instrument is powered on, the operating software runs automatically and requires you to enter
the username and password.
To switch on the power supply
1 Turn on the main power switch on the rear panel.
Figure 2.2 Main power switch of the analyzer
(1)
(2)
(3)
(1) Main power switch (2) Power socket

(3) Serial port
Place the switch to the position to turn it on. Place the switch to the position to
turn it off.
2 Turn on the analyzing unit power switch on the left panel.
Figure 2.3 Analyzing unit power switch
(1)
(1) Analyzing unit power switch
Place the switch to the position to turn it on. Place the switch to the position to
turn it off.
3 Turn on the printer.
4 Turn on the monitor and computer of the operation unit.
To start the operating software
NOTE
If virtual reagent carousel is used, please make sure that the loaded one is the NO.1 reagent carousel before
starting the operating software each time.
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.
CAUTION
To ensure accurate test results, do not start measurement until the system status turns to Standby and
the system has been turned on for about 20 minutes, so that the light source and reaction temperature
gets steady.
Auto startup
You should specify the weekday and time for auto startup. When the set time is reached, the
system will start up automatically if it is off.
To set up auto startup timer
1 Select Utility > System Setup, and click Instrument F1.
2 Select Auto Startup Setup.
3 Select Auto Startup Setup.
Figure 2.4 Auto Startup Setup window
4 Specify the weekday and time for auto startup.

Any time within a week (from Monday to Sunday) can be defined for the system to start up
automatically.
5 Select Save.
6 Select Close.

NOTE
After setting up the auto startup time, ensure that the operation unit and the analyzer are connected to power
supply; otherwise, they cannot be started up automatically.
To start the operating software

1 When the set time is reached, the instrument starts up automatically, and the operating
software starts running.
2 Enter the username and password in the Login window, and then select OK.
2.2.3 Checking system status

After the startup procedure is finished, check the system status, such as system 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 10 Maintenance on page 10-1 and 11 Alarms and troubleshooting on page 11-1.
Checking system status

Check the system status, print status, ISE module status, and LIS connection status, according to
the table below:
Table 2.2 System status
Status name Status Meaning Action
System status Initialize The system is performing Wait until the initialization is
the startup procedure. complete.
Incubation The lamp has been turned Wait until the lamp incubation
on and is stabilizing. is complete.
Standby The system is started and You can start tests.
can perform tests.
Stopped The system experiences a Select Utility > Command >
failure during startup. Home to initialize the system.
Printer status The printer is connected You can start printing reports.
Grey icon
normally and in standby
status.
ISE module status Initialize The ISE module is Wait until the initialization is
performing the startup complete.
procedure.
Standby The ISE module is started You can start tests.
and can perform tests.
Stopped The ISE module experiences Select Utility > Command >
a failure during startup. Home to initialize the system.
LIS connection The LIS is connected You can download sample
status Blue icon normally. programs from the LIS, or send
test results to it.
LIS is not connected. Select Utility > System Setup,
Grey icon click Host F5, set up the LIS
communication status, and then
click Connect.
Checking alarm status

Check for alarms during the startup procedure and take corrective actions.

To check alarm status

1 Check the Alarm button on the left of the main screen.
2 If the button is normal, it means that no alarm occurs. Neglect the following steps.
3 If the button appears in yellow, it indicates that a warning occurs.
4 If the button appears in red, it indicates that an error occurs, or both warning and error
occur.
5 Select the Alarm button. The Error Log screen is displayed.
Figure 2.5 Error Log screen
6 Select the help button in front of the new alarm messages to view relevant descriptions and
solutions.
7 Take actions according to the recommended solutions.
Checking reagent/calibration status

Check the reagent and calibration status, and determine if the reagent volume is sufficient and if
chemistry calibration fails or is required.
To check reagent/calibration status
1 Check the Reagent button on the left of the main screen.
 If it appears in yellow, it indicates that a warning occurs.
 If it appears in red, it indicates that an error occurs, or both warning and error occur.
2 Select the Reagent button. The Reagent/Calibration screen is displayed.

Figure 2.6 Reagent/Calibration screen
3 View the reagent status. When a reagent is insufficient or exhausted, the corresponding
chemistry name and chemistries left will be indicated as follows:
 Yellow: indicates that the reagent is insufficient or expired, and the analysis will
continue. Refill or replace the reagent.
 Red: indicates that the reagent is exhausted or at least one reagent type is not loaded,
and the analysis is stopped. Refill or replace the reagent.
4 View the calibration status When the calibration is succeeded or failed, the Cal Status
column of the chemistry shows the calibration status in corresponding color.
 Yellow: indicates that the calibration factors of the chemistry have been calculated, or
extended, edited or overridden.
 Red: indicates that the calibration of the chemistry fails or expired, or the chemistry
needs to be calibrated.
5 Check the calibration time left. If it will be expired, perform calibration immediately.
For more information about calibration, refer to 2.3.2Calibration on page 2-15.
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:
 Utility button on the left of the main screen
 Maintenance tab
 Maintenance button
 Scheduled Maintenance tab
 Maintenance frequency tab
 Maintenance procedure

To check maintenance status

1 Check the Utility button on the left of the main screen. If it appears in yellow, it indicates
that a maintenance procedure is expired.
2 Select Utility > Maintenance > Maintenance.
3 Check if the Scheduled Maintenance tab and maintenance frequency tabs appear in
yellow. If they do, it indicates that at least one maintenance procedure is expired.
4 Select the maintenance frequency tab appearing in yellow, find the expired maintenance
procedure, and then perform the maintenance.
For more information of maintenance, see 10 Maintenance on page 10-1.
5 Repeat steps 3 and 4 until the maintenance frequency tabs and maintenance procedures
are displayed in normal color.
Checking subsystem status

The subsystem status indicates the current working status of each subsystem and hardware
component, which includes the status summary, cycle count, temperature, and Hydropneumatic
subsystem.
Description of subsystem status
Status summary
The status summary provides a high-level status summary of the system temperatures and
hydropneumatic subsystem.
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.
Temperatures
The actual temperature and valid range of the reaction carousel and reagent preheating are
displayed.
Hydropneumatic subsystem
Status for the Hydropneumatic subsystem shows: working status of DI water tank.
Checking subsystem status
Check the actual value of each component against the reference range and check if the status is
normal. Abnormal value or status will be indicated in red.
Follow this procedure to check the subsystem status:
1 Select Utility > Status.

2 Choose a subsystem tab.
3 Check the subsystem status. When abnormity occurs, troubleshoot errors with the
following methods:
Table 2.3 Troubleshooting errors of the subsystems
Subsystem Abnormal phenomena Corrective actions
status
Count If the cycle count of a Replace the component or
component reaches certain limit contact out customer service
and an alarm occurs, the count department or your local
appears in red. distributor for replacement of the
component.

2.3 Operations before routine test 2 Daily operating procedure
Temperature If a component’s temperature is 1. Exit the operating software

beyond the valid range or and switch off the analyzing unit
abnormal and an alarm occurs, power. After that, switch on the
the measured value appears in analyzing unit power again and
red. run the operating software.
2. If the error remains, contact
Hydropneumatics If a Hydropneumatic component out customer service department
is beyond the valid range or or your local distributor for
abnormal and an alarm occurs, replacement of the component.
the status appears in red.
2.3 Operations before routine test

Before starting routine test, you must prepare the biochemical reagents, ISE reagent and other
special reagents, to ensure that tests be performed normally. To ensure steady test performance
of the system, you are suggested to perform calibration and QC tests regularly.
2.3.1 Preparing reagents

Reagent types
After checking the system status, you need to prepare the following reagents used in routine
test:
 Biochemical reagent
 ISE reagent pack
 Probe wash solution
 ISE wash solution
 Physiological saline
You can load all these reagents in Standby or Incubation status.
Reagent channel
If the instrument has set open channels when leaving the factory, the open reagent channels can
use reagents of Mindray or of other manufacturers, and the remaining positions are closed
channels and can only use Mindray reagents. If you want to change the number of open
channels, contact our customer service department or your local distributor.

2 Daily operating procedure 2.3 Operations before routine test
Safety information
WARNING
The probe tip is sharp and may cause puncture wounds. To prevent injury, exercise caution when working
around the probes.
BIOHAZARD
Do not touch the reagent directly with your body; otherwise, skin wound or inflammation may be caused.
Loading biochemical reagents

The system supports manual and auto load of biochemical reagents. If your system is not
equipped with a bar code reader, you need to enter the reagent information manually when
loading reagents; if a bar code reader is configured, the system will scan all reagents
automatically and read reagent information from the bar code. Open reagents can be loaded
manually or via bar code scanning, while closed reagents can only be loaded via bar code
scanning.
Chemistries without reagents loaded can be requested but will not be included in measurements.
Each chemistry can have more than one bottle of reagent loaded; however the reagent of same
chemistry must be loaded on the same reagent carousel.
If an exclamation mark (!) appears near a reagent type, it indicates that one or more reagent
types of the chemistry have not been loaded yet.
NOTE
Before loading biochemistry reagent, ensure that there are no air bubbles inside the reagent bottle so as to
avoid inaccurate test results.
If a chemistry is set with sample pretreatment, ensure that the chemistry reagent and the pretreat reagent are
loaded to the same reagent carousel; otherwise, the chemistry cannot be run.
Manual load
When loading reagents manually, you need to enter the reagent information, which is the only
information source of the loaded reagents. If loaded reagents are bar-coded, the reagent
information cannot be edited; otherwise, all reagent information except for position, chemistry
and reagent type can be edited.
Manually loaded reagents have the letter “M” (Manual) appearing near them.
Figure 2.7 Flag for manually loaded reagents
(1)
(1)
(1) Flag "M" for manually loaded reagents

Manual load of biochemical reagents includes two steps:

 Setting up reagent information
 Loading reagents
To set up reagent information
1 Select Reagent > Reagent/Calibration, or select Reagent > Reagent Carousel Status.
2 Select a reagent carousel from the Reagent Carousel drop-down list.
3 Choose a position to which you want to load a reagent, and then select Load F1. The Load
Reagent window is displayed.
Figure 2.8 Load reagent window
4 Enter the following reagent information:

 Bar code
 Chemistry name
 Reagent type
 Lot number
 Serial number
 Bottle type
 Expiration date
5 Select Load F3 to save the input information.
6 Select Prev F1 and Next F2 to load reagents for other chemistries, and then repeat steps
4-5.
7 Select Print F7 to print out the biochemical reagent list.
To load reagents
1 Remove the sample/reagent carousel cover.

CAUTION
If the system is running tests, click and wait until the system status becomes Pause before
removing the reagent carousel cover. Otherwise, probe collision or other error may occur.
2 Load reagents to the set positions according to the reagent load list, and then uncap the
reagent bottles.
3 Restore the sample/reagent carousel cover.
4 Select End Load F2.
5 Select Inventory F3 to check the volume of the loaded reagents and refresh the number of
tests left on the screen.
For more information on reagent inventory check, see 3.2.7 Checking and auto refreshing
reagent inventory on page 3-6.
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 be loaded only through bar code scanning.
To load bar-coded reagents
CAUTION
If the system is running tests, click and wait until the system status becomes Pause before
removing the reagent carousel cover. Otherwise, probe collision or other error may occur.
2 Place the reagents in idle positions of the reagent carousel and then uncap the reagent
bottles.
The system scans all reagent positions and read the reagent information from the bar code.
Loading ISE reagent pack

The ISE reagent pack comprises calibrator A, calibrator B, waste container, and volume
detection chip. Before running ISE tests, load the reagent pack, perform fluidic prime and
calibration.
To load ISE reagent pack
1 Select Reagent > Reagent/Calibration > ISE Reagent, and select Load F1.
2 Remove the red caps from the reagent pack and push the wand above the top of reagent
pack.
3 Make sure that the three pipe adapters at the bottom of the wand are opposite to those on
the top of reagent pack, and then push down the wand. The wand will only fit one way.
4 Once the wand is connected to the reagent pack, place the reagent pack in the mounting
position.

NOTE
When installing ISE reagent pack, do not twist, press and squeeze the pipes of the ISE Module otherwise
the ISE pipes may be clogged.
To perform fluidic prime and calibration

1 On the Rgt Load window, enter the purge times in the Purge A/B field. The input can be
any integer within 1-50 and the default is 30.
2 Click Prime.
3 When Purge A/B is complete, select OK to perform calibration.
Loading ISE wash solution

ISE wash solution is used to wash the electrodes. Follow this procedure to load ISE wash
solution:
1 Open the ISE wash solution loading window:

a. Select Reagent > Reagent/Calibration.
b. Select ISE Wash Solution in the special reagent list.
c. Click Load F1.
Or
a. Select Reagent > Reagent Carousel Status.
b. Click position 38.
c. Click Load F1.
2 Input the following reagent information:
 Serial number
 Lot number
 Volume
 Expiration date
 Alarm limit
3 Click Load F3 to save the input information.
5 Put the ISE wash solution in position (No.38) on the sample/reagent carousel.
7 Click End Load F2.
Loading probe wash solution

Probe wash solution, also called probe special wash solution, is CD80 and used for cleaning the
probe. You should check it every day to ensure that it is sufficient for routine test.
To prepare probe wash solution
1 Find a 20 mL reagent bottle.
2 Fill the reagent bottle with CD80 concentrated wash solution.
To load probe wash solution
1 Select Reagent > Reagent/Calibration, and select Wash D.
2 Or select Reagent > Reagent Carousel Status, and then click position D.
3 Click Load F1 to display the Reagent Load window.

4 Input the following information:

 Serial number
 Lot number
 Volume
 Expiration date
 Alarm limit
5 Click Load F3, and then click Exit F5 to close the window.
7 Put the probe wash solution in position D (No.39) on the sample/reagent carousel.
NOTE
Before loading wash solution, ensure that there are no air bubbles inside the reagent bottle so as to avoid
affecting washing effects.
Loading physiological saline

Physiological saline is used for sample dilution, sample blank test, reagent blank test, and
calibration test. Follow this procedure to load physiological saline.
To prepare physiological saline
1 Find a 20 mL reagent bottle.
2 Fill the reagent bottle with physiological saline.
To load physiological saline
1 Select Reagent > Reagent/Calibration, and select Saline D.
2 Or select Reagent > Reagent Carousel Status, and then click position W.
3 Click Load F1 to display the Reagent Load window.
 Volume
 Alarm limit
5 Click Load F3, and then click Exit F5 to close the window.
7 Put the physiological saline in position W (No.40) on the sample/reagent carousel.
2.3.2 Calibration
Calibration is performed to obtain calibration factors for calculate sample test results. The
calibration test procedure is as shown below:

Figure 2.9 Calibration test procedure
Requesting calibration
 Request ISE test
 Request biochemistries
Preparing calibrators
Starting analysis
Checking calibration results
Succeeded? No Troubleshooting the error

and taking actions
Yes
Performing QC test
Calibration request includes ISE test and biochemistries.
CAUTION
After changing electrodes or other consumables, perform a calibration. You are recommended to perform
calibration at least once every day to ensure accurate results.
To request ISE calibration

1 Select Reagent > Reagent/Calibration.

Figure 2.10 ISE Reagent/Calibration screen
2 Select ISE.
3 Click Calibrate F5.
To request biochemistry calibration
3 Select the down-arrow button on the right side of the screen to display the biochemistry
reagent/calibration screen.
Figure 2.11 Biochemistry Reagent/Calibration screen

4 Select chemistries you want to calibrate.

Select the up-/down-arrow buttons to select more chemistries.
5 Select Cal F5.
6 Select Calibration, and select OK.
7 If you want to abort the calibration requests, select No Cal F6.
Calibration tests can be canceled only when they have not been started or are interrupted.
Preparing 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. 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.
To prepare calibrators
4 Select Load List F4.
The calibrator list shows all requested chemistries as well as calibrators, positions,
concentration, lot number and expiration date.
5 Select Print F7, and select Close F8.
6 Load calibrators to the sample carousel according to the calibrator list.
Starting analysis
After requesting calibrations and load calibrators to the sample carousel, you can start the
calibration test.
To start calibration test
1 Select on upper right corner of the main screen. The Start Conditions window is
displayed.
Figure 2.12 Start Conditions window

2 Select a sample carousel to which the calibrators are loaded.

3 Select a reagent carousel to which the reagents are loaded.
4 Select OK to start analysis.
Checking calibration results

After the calibration test is complete, check the test results and calibration status. If you see any
abnormity, troubleshoot the error immediately.
To check calibration results
1 Select Reagent > Biochemistry Calibration or Reagent > ISE Calibration.
2 Check for result flags in the result list.
If you see result flags, troubleshoot the error according to 11.4.1 Data alarms and corrective
actions on page 11-8.
3 Check if the Cal Status column appears in red. If it is, it means the calibration fails or
calibration is required. Perform calibration immediately.
4 After taking actions, you can start the QC test.
2.3.3 QC
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 every day.
The QC test procedure is as shown below:
Figure 2.13 QC test procedure
Programming controls
Preparing controls
Starting analysis
Checking QC results
In control? No Troubleshooting the error

and taking actions
Yes
Performing routine test
Before routine test, biochemistries, ISE test, calculations, and panels should be run with control
samples. Prior to programming controls, make sure that the QC parameters have been set
correctly; otherwise, the chemistries cannot be requested.

To program controls
1 Select Program > Quality Control
Figure 2.14 Quality Control screen
2 Select a control from the Controldrop-down list.

3 Select a position from the Pos drop-down list.
The options include all positions defined for the control. The default is the position on the
first defined sample carousel in ascending numerical order.
4 Choose a sample cup type to be used by the selected control.
5 Choose desired chemistries and panels in the chemistry list
If the chemistries included in a panel are not set up for QC parameters, they will not be
programmed for quality control.
6 If you want to run the QC test by the reagent lot number of the chemistry:
a. First select Options F2.
b. Then select reagent lot number for the chemistry.
c. Select Save.
7 Select Save F8
8 To program other controls, select Prev F4 or Next F5, and then repeat steps 3-7.

2 Daily operating procedure 2.4 Routine test
Preparing controls
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. 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.
To prepare controls
1 Select Program > Sample.
2 Select List F5.
The sample list shows all programmed patient samples, control samples and chemistries.
3 Select Print F7.
Samples and controls are printed out separately.
4 Select Exit F8.
5 Load control samples to the sample carousel according to the printed list.
Starting analysis
After programming and load the control samples, you can start the QC test.
To start QC test
displayed.
2 Select a sample carousel to which the control samples are loaded.
4 Select OK to start analysis.
Checking QC results
After the QC test is complete, check if the test results are within the normal range and the data
points on the QC chart are normal. If you see any abnormity, troubleshoot the error immediately.
To check QC results
1 Select Result > Current, and click the By Sample option button.
2 Check for result flags in the result list.
If you see result flags, troubleshoot the error according to 11.4.1 Data alarms and corrective
3 Select QC > Levey-Jennings or Twin-Plot, and check if the data points on the charts are
normal.
4 After taking actions, you can start the routine test.
2.4 Routine test

Routine test includes the following operations:
 Programming and processing samples
 Checking test results

2.4 Routine test 2 Daily operating procedure
 Checking test status and performing test control
2.4.1 Programming and processing samples

Analysis of routine and STAT samples are described in this section supposing no LIS or bar code
reader is configured. STAT sample is to be run at higher priority than routine sample.
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. 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 sample, ensure that there are no air bubbles inside the sample cup so as to avoid inaccurate
test results.
To program routine and STAT samples

Figure 2.15 Sample screen
2 Input the sample information, including: sample ID, carousel No. and position, STAT
property, sample type, comment, and patient ID.
3 Select chemistries and panels to be run.
4 To input patient information, click Demog F1.
5 To set number of replicates and dilution factors, click Options F2.
6 Click Save F8.
7 To program more samples, repeat steps 2-6.

To quickly program STAT samples
1 Select on upper right corner of the main screen. The STAT Sample Program window
is displayed.
Figure 2.16 STAT Sample Program window
2 Input the sample information, including: sample ID, carousel No. and position, sample type,
and sample cup.
3 Confirm the default chemistries.
4 To select more chemistries, perform the following steps:
a. Click Chems F3.
b. Select chemistries and panels to be run for the samples.
c. Click Save F7.
5 To input patient information, click Demog F1.
6 To set number of replicates and dilution factors, click Options F2.
7 Click Save F7.
8 To program more samples, repeat steps 2-7.
9 Click Close F8 to close the window.
To prepare samples
2 Select List F5.
The sample list shows all programmed samples, controls and chemistries.
3 Select Print F7.
Samples and controls are printed out separately.
4 Select Exit F8.
5 Load samples to the sample carousel according to the printed list.
To start sample analysis
displayed.
2 Select a sample carousel to which the samples are loaded.
4 Select a patient sample range: All or Partial. When you select Partial, you should specify a
sample position range for analysis.
5 Select OK.

Other sample test methods

Besides the manual programming of single sample described above, the system supports other
test methods.
Batch programming
With this function, you can program multiple samples at one time. For batch-programmed
samples, all program information such as sample information, chemistries and patient
demographics other than position, ID and bar code are the same.
 For details about batch programming, see 6.2.3 Batch programming on page 6-5.
Adding samples
You can add routine sample and STAT sample at any time.
 For details about adding samples, see 6.2.4 Adding samples on page 6-6.
Adding chemistries
You can add chemistries to samples of any status. Whether to change the program information
will be determined based upon the sample status.
 For details about adding chemistries, see 6.2.5 Adding/Modifying chemistries on page 6-6.
Rerunning samples
The system supports manual rerun and auto rerun. Manual rerun can be performed through
the List window and the Current or History screen. Auto rerun is based on the set critical
range of the ISE test and the rerun conditions of biochemistries. When the conditions are met,
the relevant chemistries will be rerun automatically.
 For details about rerunning samples, see 6.2.6 Rerunning samples on page 6-7.
Programming bar-coded samples with LIS

If the instrument is connected with LIS and bar code reader, you can program samples without
manually inputting the program information.
 For details about programming bar-coded samples with LIS, see 6.2.1 Processing samples with
LIS on page 6-3.
2.4.2 Checking test results

After the sample analysis is complete, you can check the test results on the Result > Current
screen. The test results beyond the set reference range will be flagged and indicated in yellow.
After checking the results, you can print them on reports.
To check test results
1 Select Result > Current > By Sample.
2 Select the desired sample in the left list. The test results of this sample are displayed in the
right list.
3 Check for flags in the result list.
4 If you see result flags, troubleshoot the error according to 11.4.1 Data alarms and corrective
5 Take corrective actions.
To print test results
1 Select Result > Current > By Sample.
2 Select the desired sample in the left list.

3 Click Print F7.

4 Select Print Sample Report.
5 Select the print range: Selected Sample(s) or All Sample(s).
6 To neglect the samples that have been printed, select the Bypass Printed Sample(s) check
box.
7 Click OK.
2.4.3 Checking test status and performing test control

During the analysis, you can check reagent inventory on the Reagent/Calibration screen, and
view test status of calibrators, controls, routine and emergent samples on the Program > Status
screen. View the reagent carousel status through Reagent > Reagent Carousel Status screen. If
needed, you can pause or stop analysis, or change the sample carousel and reagent carousel,
during test.
Checking sample carousel status

On the Program > Status screen, you can check the test status of each sample position.
To check sample carousel status
1 Select Program > Status.
Figure 2.17 Status screen
2 View the status of calibrators, controls and samples on the sample carousel graph.
Refer to the explanations of various sample statuses on the lower-right corner of the
screen.
3 To view the detailed information of certain sample, select the sample position on the sample
carousel graph.
The detailed information of the selected sample position is displayed on the right side of the
screen.
4 Choose the following buttons as needed:
 Search F1: used to search for desired calibrator, control or patient sample.

 Log F2: used to recall controls and patient samples which are not complete due to some
reasons within the recent 24 hours.
 Release F3: used to release the specified or all positions on the current sample
carousel.
 Result F4: used to display the Current Results screen, on which you can recall all
controls and patient samples that are programmed and analyzed since the system is
started up.
 Scan F5: used to scan the specified position or all positions on the selected sample
carousel.
Checking reagent carousel status

On the Reagent > Reagent Carousel Status screen, you can check the reagent volume and view
the detailed information of each reagent.
To check reagent carousel status
1 Select Reagent > Reagent Carousel Status.
2 Select a reagent carousel from the Carousel drop-down list.
Figure 2.18 Reagent carousel status
3 Check the reagent volume status according to the explanation in the middle of the carousel
graph. If a reagent is insufficient or exhausted, replace it immediately.
For instructions of loading reagent in Running status, see 3.2.3Loading biochemistry reagents in
Running status on page 3-4.
4 To view the detailed information of certain reagent, select the reagent position on the
reagent carousel graph.
The detailed information of the selected reagent position is displayed on the right side of
the screen.
5 Select the following buttons to perform respective operations:
 Load F1: select this button to load the reagent.

2 Daily operating procedure 2.5 Replace cuvettes
 End Load F2: If a bar code reader is configured and the reagents have been loaded,
select this button to scan the reagent carousel; if the function of auto refreshing reagent
inventory has been enabled, the reagents with inventory 0 can be refreshed as available
when End Load F2 is selected.
 Inventory F3: select this button to check reagent inventory.
Switching carousels
Switching carousels means changing sample carousel and reagent carousel during
measurement, so that the samples and reagents on them can be tested.
Switching sample carousel
The system supports 10 virtual sample carousels, on all of which samples can be programmed in
order to improve the test efficiency.
After samples on multiple sample carousels are programmed, if those on the current sample
carousel are about to finish sample dispensing during test process, the screen shows the
countdown for sample loading and the Start Conditions window pops up. Select desired sample
carousel, load samples to it, and then select OK to resume the test.
Switching reagent carousel
The system supports 2 virtual reagent carousels, on both of which biochemistry reagents, wash
solution and physiological saline can be loaded. However, reagents of the same chemistry must
be loaded on the same carousel, and only the chemistries on the same carousel can be tested in
every batch of tests.
To run chemistries on the other reagent carousel, click to display the Start Conditions
window. Select the other reagent carousel, load reagents to it, and then select OK to resume the
test.
Pause
"Pause" means to stop addition of sample and reagent temporarily during test process, so that
you can load/unload sample and reagent on the carousel. After you click , when the started
tests finish sample/reagent dispensing, the system enters the Pause status. Then you can start
loading/unloading sample and reagent.
To cancel pausing and resume the test, select .
Emergency stop
Emergency stop will terminate all measurements on the instrument, and all tests 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 on upper right corner of the screen, and then select OK. All unfinished
actions of the system are cancelled, all pumps and valves are turned off, and the system enters
the Stopped status.
To restore system failure, select Utility > Commands, and then select Home. To resume the
analysis, select the icon.
2.5 Replace cuvettes

The cuvettes used on the BS-230 are disposable consumables and should be replaced manually
after each test.

2.6 Daily maintenance and powering off 2 Daily operating procedure
Manually replacing cuvettes
CAUTION
 Do not use reaction cuvettes other than the specified ones; otherwise, system performance will not be
achieved as promised.
 The reaction cuvettes are for single use only. If they are reused, the system performance may be degraded.
 When installing new reaction cuvettes, do not touch the light entrance of the cuvettes; otherwise accurate
measurement may not be achieved or the cuvettes will be considered unqualified.
 When installing new reaction cuvettes, place them steadily on the reaction carousel.
 Ensure the small window on the reaction carousel is always closed during measurement; otherwise, reliable
test results may not be achieved.
Manually replacing cuvettes

1 Make sure the system status is standby or cuvette load.
2 Select the button.

3 Select the cuvette segments you want to replace.
4 Push forward the handle on the small window and open the door, and then take out the old
cuvette segments.
Figure 2.19 Manually replace cuvette window
5 Align the holes on the new cuvette segment to the pins on the reaction carousel and install
the cuvette segment on the carousel.
6 Select Continue to replace other cuvettes. Click scan cuvettes to finish replacing the
cuvettes if you do not want to replace all the selected cuvette segments.
7 After installing, close the small window.
2.6 Daily maintenance and powering off

After finishing the test tasks of the day, you should perform the following operations:
 Daily maintenance

2 Daily operating procedure 2.6 Daily maintenance and powering off
 Powering off
 Operations after powering off
2.6.1 Daily maintenance

Perform the daily maintenance procedures and those maintenance procedures indicated in
yellow.
Daily maintenance procedures include:
 Check probe/mixer/wash well
 Check DI water tank and tube connection
 Check waste connection and waste tank connection
 Check probe wash solution
 Clean electrode tubes
 For detailed information of daily maintenance, see 10.4Daily maintenance on page 10-13.
2.6.2 Powering off

If you have set the auto startup timer, ignore the following powering off procedure.
To power off the system
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
 Analyzing unit power switch
When the analyzing unit power is switched off, the refrigeration system is still running. If
you are going to store the system for over 7 days, switch off the main power.
NOTE
When the analyzing unit power is switched off, the refrigeration system is still running. If you are going to
store the system for over 7 days, switch off the main power.
2.6.3 Operations after powering off

Perform the following operations after powering off the system:
1 Remove the sample/reagent carousel cover, and then remove the calibrators, controls and
patient samples.
2 Check the analyzer panel for stains and wipe them off with clean gauze if any.
3 Check the waste tank. Clear it if necessary.

2.6 Daily maintenance and powering off 2 Daily operating procedure

3 Reagent
This chapter describes reagent and calibration operations related to ISE and biochemistry tests.

3.1 ISE reagent 3 Reagent
3.1 ISE reagent

3.1.1 ISE reagent/calibration screen
Select Reagent > Reagent/Calibration. The ISE reagent/calibration is displayed by default.
Figure 3.1 ISE reagent/calibration screen
The ISE reagent/calibration screen is divided into three areas:

 ISE test calibration information area
 Special reagent list
 Function buttons area
When a reagent is insufficient or exhausted, the reagent name will be indicated as follows:
 Yellow: indicates that the reagent is insufficient or expired.
 Red: indicates that the reagent is exhausted and the volume is 0.
3.1.2 Loading special reagents in Running status

The special reagents used by the system include: ISE reagent, diluted wash solution, probe wash
solution, physiological saline, ISE wash solution, and pretreat reagent. If the software indicates
that any of them has been used up or is less than the alarm limit, replace them immediately.
The methods of loading reagent in Running status are similar with in Standby and Incubation
status, except that you need to pause the sample and reagent addition before the operation.
To load special reagents in Running status
1 Click the Load F1.
2 When the system status changes to Rgt Load, start replacing reagents in the same way as
initial loading.
For the methods of loading special reagents, see 2.3.1Preparing reagents on page 2-10
3 After finishing replacement, the system will automatically resume the previous test or to
start new test.

3 Reagent 3.2 Biochemistry reagent
3.1.3 Unloading special reagents

The system allows you to unload the ISE reagent, probe wash solution, physiological saline and
ISE wash solution.
To unload special reagents
2 Select the special reagent you want to unload.
3 Click Load F1.
4 Click Unload F3.
5 Click Exit F5.
To ensure that the routine test can go smoothly, load the special reagent immediately after
unloading.
3.1.4 Printing ISE reagent/calibration list

The ISE calibration information and special reagent information on the ISE reagent/calibration
screen can be printed on a report.
To print ISE reagent/calibration list
2 Click Print F7.
3.2 Biochemistry reagent

3.2.1 Biochemistry reagent/calibration screen
Select Reagent > Reagent/Calibration. Click the down-arrow button on the right side of the
screen to display the biochemistry reagent/calibration screen.
Figure 3.2 Biochemistry reagent/calibration screen

3.2 Biochemistry reagent 3 Reagent
All set biochemistry reagents are displayed. The reagent name is indicated by different colors
according to the reagent volume and loading status.
 Yellow: indicates that the reagent is insufficient or expired.
 Red: indicates that the reagent is exhausted or at least one reagent type is not loaded.
3.2.2 Sorting reagents

Reagents on the biochemistry reagent/calibration screen can be sorted by name, position,
chemistries left, days left, calibration time left, and calibration status, and a V-type symbol
appears to the right of the sort criteria. Prior to loading reagents or running calibrations, sort
the reagents to display the desired ones in the front.
To sort reagents
4 Choose a sorting criterion, and then click on the corresponding list head to rearrange the
reagents.
a. To view or load reagents, choose the following standards:
 Reagent position
 Chemistry name
 Chemistries left
 Tests left
 Days left
b. To view calibration status or run calibrations, choose the following standard:
 Calibration time left
 Calibration status
3.2.3 Loading biochemistry reagents in Running status

If the screen prompts that a biochemistry reagent has been used up or is less than the alarm
limit, replace it immediately.
The methods of loading reagent in Running status are similar with in Standby and Incubation
status, except that you need to pause the sample and reagent addition before the operation.
To load biochemistry reagents in Running status
1 Click Load F1.
2 When the system status changes to Rgt Load, start replacing reagents in the same way as
initial loading.
For the methods of loading biochemistry reagents, see 2.3.1reagents on page 2-10.
3 After finishing replacement, the system will automatically resume the previous test or to
start new test.
3.2.4 Unloading biochemistry reagents

If some chemistries will not be used, you are allowed to clear the chemistry parameters and
unload the relevant reagents. When a chemistry is requested for quality control, sample analysis
or calibration, all reagents of the chemistry 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.

The following procedure is 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.
To unload biochemistry reagents
1 Select Reagent > Reagent/Calibration, and select the up and down arrow buttons to
display the biochemical regent/calibration screen.
2 Or select Reagent > Reagent Carousel Status.
3 Select the desired reagent.
4 Select Load F1, and then Unload F4.
5 Remove the sample/reagent carousel cover, take out the reagent , and restore the cover.
6 Select Exit F5 to close the window.
3.2.5 Customizing reagent display

The reagent information on the biochemistry reagent/calibration screen can be tailored and
displayed in desired order.
To customize reagent display
1 Select Utility > System Setup.
2 Click Instrument F1, and select Customize Reagent Display.
Figure 3.3 Customize Reagent Display window
3 To display a header on the reagent/calibration screen, select the check box on the left.
4 To cancel displaying a header, deselect the corresponding check box.
5 Select Up and Down to adjust the display order of the reagent information.
6 Select Save to save the settings.
7 Select Exit to close the window.

3.2.6 Setting up reagent alarm limit

The system provides the function of reagent alarm limit setup. When a reagent is less than the
set alarm limit, the reagent name and the number of chemistries left on the biochemistry
reagent/calibration screen will be indicated in yellow. You should replace the reagent
immediately.
To set up reagent alarm limit
1 Select Utility > Chemistries.
2 Select the chemistry that you want to set reagent alarm limit.
3 Select Define F1. Select down arrow to get to the second page.
4 Type in the reagent alarm limit.
Enter an integer within 1-100. The default is 10.
5 Select Save F7.
6 Select Close F8.
3.2.7 Checking and auto refreshing reagent inventory

The system provides the manual and auto check of inventory of biochemical reagents. During
the test, the system automatically checks the reagent inventory and displays it on the
Reagent/Calibration screen. After the reagents are loaded, it is necessary to perform the
inventory check in order to ensure that sufficient reagents are available for analysis.
When reagent has been loaded and End Load button is selected, you can configure whether to
automatically refresh the reagent with 0 inventory as available for test.
Checking reagent inventory
Reagent inventory check is allowed only when the biochemistry system status is Incubation or
Standby, and the ISE system is Standby or Stopped or unconfigured
Checking reagent inventory
1 Select Reagent > Reagent/Calibration, or select Reagent > Reagent Carousel Status.
2 Select Inventory F3.
Figure 3.4 Check window
3 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 of the reagent carousel.

 All reagents of selected chemistry: check the inventory of all reagent types of the
selected chemistry.
4 Select Check.
 The reagent carousel graph refreshes the reagent status automatically.
 The Reagent/Calibration screen refreshes the Tests Left of the selected chemistry,
Chems Left, and the Volume of the selected wash solution.
Canceling reagent inventory check
To cancel reagent inventory check, select Close on the Check window, and then select No
Invent. F3 on the Reagent/Calibration screen, or on the Reagent Carousel Status screen.
Auto refreshing reagent inventory
2 Select Instrument F1, and then select Reagent/Calibration Setup.
3 Select the option Auto Refresh Reagent Inventory, which is unselected by default.
4 Click Save.
5 Click Exit to close the window.


4 Calibration
This chapter provides calibration setup, calibration status, and calibration result recall of ISE
test and biochemistry.

4.1 ISE calibration 4 Calibration
4.1 ISE calibration

This section describes the calibration setup, calibration status, and calibration result recall of
ISE test.
4.1.1 Calibration setup

You are allowed to set up the calibration time and auto calibration of ISE test.
When a calibrator is expired, it will be indicated in yellow and cannot be used for calibration.
When the auto calibration interval is reached, the system reminds you to perform ISE
calibration.
To set up ISE calibration options
1 Select Reagent > Setup, and then select Rules F4.
2 Select ISE from the Chemistry pull-down list.
Figure 4.1 ISE calibration setup window
3 Enter the calibration time in the Cal Time field.

The input range is 1-9999, and the default is 8 hours. If the field is left blank, it indicates
that the calibration factors can be always used.
4 Select the Auto Calibration check box and enter the auto calibration time.
The range is 1-24 hour; the default is blank.
5 Select Save F7 to save the settings.
6 Select Close F8 to close the window.
4.1.2 Calibration status and alarm

On the Reagent/Calibration screen, the chemistries are indicated with various texts and colors
for different calibration status. Chemistries in Cal Required, Cal Failed or Cal Time Out status can
be requested but will not be run.
Check the chemistries' calibration status frequently and take relevant actions according to the
following table.
Table 4.1 ISE calibration status

4 Calibration 4.1 ISE calibration
Calibration Description Severity Color

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

You can recall history calibration result and calibration trend, archive calibration result, and
extend the calibration time.
Recalling history calibration results

To recall history calibration results
1 Select Reagent > ISE Calibration.
2 Select the History option button, and then select date range that the ISE test is calibrated.
3 Select Search F1.
The ISE calibration results are displayed in the result list.
4 To print the calibration report, select Print F7.
Recalling calibration trends

To recall calibration trends
2 Search for desired calibration results.
3 Select Trend F6. The Calibration Trends window is displayed.
4 Choose desired trend type and calibration date range, and then select Search F1.
The ISE trend within the specified time period is displayed on the screen. The trend type
options will not include Reference Electrode when trends of ISE Urine are being recalled.

4.1 ISE calibration 4 Calibration
Figure 4.2 Calibration Trends window
5 Choose the Tabular Trend tab to view the trend data.

Figure 4.3 Tabular Trend window
6 To print the current graphic trend or data, select Print F7.

Archiving ISE calibration results

Both the current and early calibration factors of ISE chemistries can be archived. The archiving
file is of .csv format and named by the date and time the results are archived.
To archive ISE calibration results
3 Select Archive F5.
4 Confirm the archiving path and file name.

4 Calibration 4.2 Biochemistry calibration
5 Select OK.
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 chemistry is timed out
or succeeded. The results calculated based on extended calibration factors will be flagged.
To extend ISE calibration time
2 Choose the ISE chemistry.
3 Select Cal Options F8.
4 Select Extend Calibration Time from the Calibration Options window.
5 Select OK. The calibration factors of the ISE chemistry can be used without time limit.
6 To remove the extended status, recalibrate the ISE chemistry.
4.2 Biochemistry calibration

This section describes calibration setup, calibration status and alarm, reagent blank test,
calibration result recall of biochemistry.
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.
4.2.1 Calibration setup

Perform calibration settings in the following order:
 Define a calibrator
 Import a calibrator
 Set up calibrator concentrations
 Calibrator dilution setup
 Set up calibration rules
 Set up calibrator acceptance limits
 Auto calibration
If you change the calibration model, number of replicates, calibrator concentration, and
calibrators, you must run calibration test again.
You are allowed to remove the calibrators other than WATER.
Defining a calibrator
The system allows the definition of up to 99 calibrators. You are allowed to add, edit and delete
calibrators only when the system status is not Running.
To define a calibrator
1 Select Reagent > Cal Setup.

4.2 Biochemistry calibration 4 Calibration
2 Select Define F1.

Figure 4.4 Calibrator Definition window
3 Enter the calibrator name, lot number and expiration date.

4 Assign positions for the calibrator.
You are allowed to assign one position of each sample carousel for the calibrator.
NOTE
Calibrators of a chemistry must be placed and analyzed on the same sample carousel.
5 Select Save to save your input information.
6 To define more calibrators, click New and then repeat step 3 to 7.
7 Select Close to exit the window.
8 To edit a calibrator, select it, click Edit F2, and then change the settings as the steps above.
Importing a calibrator
Calibrator parameters such as calibrator name, lot number, expiration date, concentration of
each chemistry and dilution parameter can be imported.
To import a calibrator
2 Select Define F1.
3 Select Import and insert USB drive.
4 Select the path of .cif file.
Only .cif file can be imported; each .cif file stores information for one calibrator and each
time only one calibrator can be imported. When the system reads the calibrator
information, the following window is displayed:

Figure 4.5 Calibrator Definition window
5 Enter the lot number, select OK, and then select Close.
6 Assign position for the calibrator.
7 Select Save and then Close.
Setting up calibrator concentrations

You are required to set up calibrator concentrations for each chemistry after defining the
calibrator. Only the calibrator with positions assigned and concentrations determined can be
used for programming. The default calibrator WATER has concentration of 0 for all chemistries.
It has no lot number and expiration date and must not be edited or removed.
You are allowed to change the calibrator concentrations when the system is not running any
tests.
To set up calibrator concentrations
2 Choose a calibrator in the left list.
The chemistries configured for the calibrator are displayed in the right list.
3 Click Chems F3 to choose chemistries to which the calibrator is applicable.
4 Select the corresponding Conc column and type in the calibrator concentration for it.
The concentration must be above 0.
5 Select the Unit from the drop-down list.
6 Select Save F8 to save your input information.
A message box pops up indicating that parameters are changed and calibration is required.
Setting up calibrator dilution factors

The system supports calibrator dilution and allows one calibrator to have 9 concentrations for
the same chemistry.
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 chemistry, its original calibrator concentration will be removed.
You are allowed to edit or delete the calibrator dilution factors when the system is not running
any tests.

To set up calibrator dilution factors

2 Choose the desired calibrator and chemistry.
3 Select Dilute F5.
Figure 4.6 Calibrator Dilution Setup window
4 Set up the unit, concentration, aspirated volume, neat sample volume, and diluent volume.
 The input of aspirated volume and neat sample volume must be an integer multiple of
0.1 within 2 μL - 45 μL. The aspirated volume is required.
 The input of diluent volume must be an integer multiple of 0.5 within 100 μL - 250 μL.
This field can be left blank.
 If the neat sample volume and diluent volume are defined, ensure that the sum of the
two volumes is within 125 μL - 295 μL.
5 Select Save.
6 To edit the dilution factors, select the number button on the left, click Edit, and change the
settings.
7 To delete the dilution factors, select the number button on the left and click Delete.
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.
To set up calibration rules
2 Select Rules F4.

Figure 4.7 Calibration Setup window
3 Choose a chemistry from the Chem drop-down list.

4 Set the calibration method, K factor and number of replicates.
5 Choose calibrators in the right list for the chemistry.
The correspondence between the number of calibrators and calibration math models
shown in the table below.
Table 4.2 Correspondence between number of calibrators and calibration math model
Calibration Math Model Number of Calibrators
K Factor N=0 or 1
Two-point linear N=2
Multi-point linear 2< N≤10
Logit-Log 4P 4≤N≤10
Logit-Log 5P 5≤N≤10
Exponential 5P 5≤N≤10
Polynomial 5P 5≤N≤10
Parabola 3≤N≤10
Spline 3≤N≤10
Setting up calibrator acceptance limits

The calibration results are compared with the determined acceptance limits. If the calibration
results exceed the acceptance limits, the system will give an alarm and flag the results on
calibration reports.
To set up calibrator acceptance limits
2 Select Rules F4.
3 Enter the following acceptance limits in the Acceptance Limits area.
 Calibration time
 Slope difference

 Standard deviation (SD)

 Sensitivity
 Repeatability
 Determination coefficient
Auto calibration
Based on the auto calibration conditions, the system can determine chemistries that need to be
calibrated and remind you through calibration status and color indication.
Setting up auto calibration
2 Select Rules F4.
4 Choose auto calibration conditions:
 Bottle changed
 Lot changed: unavailable for closed chemistries of which calibration will be run
automatically when reagent lot number is changed.
 Calibration time
NOTE
If the Manage Reagents by Lot option on the System Setup screen is enabled, Bottle Changed
and Lot Changed will not appear. When a different reagent lot is used, the system will request and run
calibration automatically.
5 Select Save F7.
Auto calibration reminding
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 chemistry name and calibration status
with yellow.
Removing auto calibration
2 Select Rules F4.
4 Deselect all auto calibration conditions.
5 Select Save F7.

Deleting a calibrator
You are allowed to remove the calibrators other than WATER. When a calibrator is deleted, all
calibration settings and its position are cleared, and it cannot be used for programming. The
stored test results of the calibrator can be recalled according to the chemistry name. only
calibrators that are not requested or run can be deleted.
To delete a calibrator
2 Choose a calibrator you want to remove.
3 Select Delete F6.
4 Select OK. The selected calibrator is deleted.
4.2.2 Calibration status and alarm

On the Reagent/Calibration screen, the chemistries are indicated with various texts and colors
for different calibration status. Chemistries in Cal Required, Cal Failed or Cal Time Out status can
be requested but will not be run.
Check the chemistries' calibration status frequently and take relevant actions according to the
following table.
Table 4.3 Calibration status
Calibration Description Severity Color
Status
Cal Required Indicates that the chemistry needs to be Serious Red
calibrated.
This status appears when the chemistry is not
calibrated and auto calibration conditions are
satisfied; or calibration information or
chemistry parameters are modified.
Requested Indicates that the chemistry has been requested Normal No color
for calibration but the test has not begun. indication
Calibrated Indicates that the chemistry has been calibrated Normal No color
and has not exceeded the calibration period. indication
Cal Failed Indicates that the test has finished but cannot Serious Red
calculate 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 chemistry exceeds the Serious Red
calibration period.
Cal Time Indicates that the calibration period has been Warning Yellow
Extended extended and the current calibration factors can
be used without time limit.
Calculated Indicates that the calibration factors of the Warning Yellow
chemistry have been recalculated.
Edited Indicates that the calibration factors of the Warning Yellow
chemistry have been edited.
Cal Indicates that the test results of the chemistry Warning Yellow
Overridden are based on a failed calibration, and flagged
accordingly.
N/A Indicates the reagent has no calibration status. Normal No color
indication

4.2.3 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 Calibrated status, which means the calibration is
successfully performed.
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.
Setting up mixed blank absorbance and blank response

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.
To set up mixed blank absorbance and blank response
2 Choose a biochemical chemistry, or enter the chemistry name in the Chemistry Name field.
3 Select Define F1.
4 Enter the mixed blank absorbance range in the Mixed Blank Abs field.
Both the low and high limits must be an integer within -40000-40000. The default is
-40000-40000, and it can be left blank.
5 Enter the blank response range in the Blank Response field.
Both the low and high limits must be an integer within -40000-40000. The default is
-40000-40000, and can be left blank.
6 Select Save F7.
Running reagent blank test

Please note that reagent blank can only be run in following conditions:
 Chemistries with all calibration math models rather than two-point linear and K
factor must have the 0-concentration calibrator set up.
 K factor chemistries must have calibrators set up.
The reagent blank is allowed only in Calibrated calibration status.
Running reagent blank test
1 Select Reagent > Reagent/Calibration,
2 Select a reagent carousel from the drop-down list of Reagent Carousel.
3 Select the up and down arrow buttons to display the biochemical reagent/calibration
screen.
4 Check if the desired chemistries' calibration status is Calibrated.

5 Choose the chemistries.

6 Select Cal F5.
7 Choose Rgt Blk, and select OK.
8 Select the icon to start the analysis.
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.
To recall reagent blank response
1 Select Reagent > Biochemistry Calibration.
2 Choose the desired calibration result.
3 Select Reac Curve F3.
Figure 4.8 Reagent blank reaction curve
The response value current displayed is the updated reagent blank response.
4 Select the reaction data table to view the reagent blank reaction data.

Figure 4.9 Reagent blank reaction data

 Prev F4: to view reaction curve and data of the previous calibration test.
 Next F5: to view reaction curve and data of the next calibration test.
 Print F7: to print the current reaction curve or data.
6 Select Close F8.
To recall reagent blank trends
2 Choose the desired calibration result.
3 Select Trend F6.
4 Choose a trend type you want to recall.

The options include:
 R1 blank absorbance
 Mixed blank absorbance
 Calibrator response
 K factor (for linear calibrations only)
5 Select the calibration time range.
6 Select Search F1.
The graphical trend of the selected chemistry within the specific period is displayed.
7 Select the Tabular Trend tab to view the trend data.
 Prev F4: to view the calibration trends and data of the previous chemistry.
 Next F5: to view the calibration trends and data of the next chemistry.
 Print F7: to print the current graphic trend or data.
4.2.4 Recalling calibration results

This chapter describes the following operations related to calibration result of biochemistry.

 Recalling history calibration results

 Observing calibration curve
 Recalculating calibration factors
 Observing calibration reaction curve
 Editing calibration factors
 Archiving calibration results
 Observing calibration trends
 Extending calibration time
 Overriding calibration
 Rejecting calibration
Recalling history calibration results

2 Choose the History option button.
4 Select the date range in the Cal Date field.
5 Select Search F1.
The calibration factors used within the specified period are displayed on the screen.
 Cal Curve F2
 Reac Curve F3
 Edit F4
 Archive F5
 Trend F6
 Print F7
Observing 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.
To observe calibration curve
1 Search for desired calibration results on the Biochemistry Calibration screen.
2 Choose a chemistry in the result list.
3 Select Cal Curve F2. The Calibration Curve window is displayed.

Figure 4.10 Calibration Curve window

 Prev F4: to view the calibration curve of the previous chemistry.
 Next F5: to view the calibration curve of the next chemistry.
 Recalculate F6: to recalculate the calibration factors based on the specified math model.
 Print F7: to print the current calibration curve.
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 Biochemistry
Calibration screen.
Recalculating calibration factors is not applicable to K factor calibrations. Calibration factors
that have been recalculated cannot be calculated again.
To recalculate calibration factors
2 Search for desired calibration results to recalculate.
4 Select Cal Curve F2.
5 Select Recalculate F6. The Recalculate window shows.

Figure 4.11 Recalculate window
6 Choose a math model from the Math Model drop-down list.

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.
8 Select Save F7.
The system will recalculate the calibration factors with the selected math model and
calibrators.
 If the recalculation is succeeded, the new calibration factors will be displayed on the
Biochemistry Calibration 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.
9 To view the reaction curve of the selected calibrator, select Reac Curve F1.
Observing 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.
To observe calibration reaction curve
3 Select Reac Curve F3. The Reaction Curve window is displayed.

Figure 4.12 Reaction Curve window
4 Select a point on the curve. Relevant measuring period and absorbance are displayed on
the right of the window.
5 Select a filter condition from the following options:
 None: observe reaction curve and data in the default mode.
 Chemistry: observe reaction curve of the results for the selected test.
 Calibrator: observe reaction curve of the results for the selected calibrator.
6 Choose the Reaction Data tab to view the reaction data.
Figure 4.13 Reaction Data tab page

 Reagent F1: to view the calibrators and reagents used in calibration, and reagents for
reagent blank test.
 Sample Blank F2: to view the sample blank reaction curve and reaction data of the
calibrator.
 Adjust F3: to adjust the absorbance display range of current reaction curve.
 Prev F4: to view reaction curve and data of the previous calibration test.
 Next F5: to view reaction curve and data of the next calibration test.


To view reagent information
1 Select Reagent F1 on the Reaction Curve window.
Figure 4.14 Reagent window
The window shows the calibrators and reagents used in calibration, and reagents for
reagent blank test.
Editing calibration factors

If the calibration factors of linear calibration are higher or lower than the expected values or
than those obtained on other instruments, you are allowed to edit them to keep them consistent
with the expected ones or those on other instruments. The flag "CALE" will appear for results
calculated based on edited calibration factors, and the calibration curve and reaction curve of
edited calibration factors cannot be recalled.
Prior to editing calibration factors, ensure that you have sufficient permissions and the system
status is not Running.
To edit calibration factors
2 Search for desired calibration results to edit.
3 Choose a desired chemistry.
4 Select Edit F4. The Edit window shows.

Figure 4.15 Edit window
5 Type in slope K and offset R0.

6 Select Save.
The system will refresh the calibration results and curves with the input slope and offset,
and take the edited calibration factors as the defaults.
Archiving calibration results

The system allows you to archive all searched calibration results to a storage device, such as U
disk. Archived calibration results are displayed in the same format as on the software screen.
The archived content includes: chemistry name, flag, calibration status, R0, K factor, calibration
coefficients A/B/C/D, and calibration time. The archiving file is of .csv format and named by
date and time.
To archive calibration results
4 Confirm the archiving path and file name.
5 Select OK.
Observing calibration trends

Calibration graphical trends summarize a chemistry's calibrations during a period of time and
reflect the trends of the calibrations. The calibration graphical trends show the chemistry's R1
blank absorbance, mixed blank absorbance and calibrator response.
R1 blank absorbance and mixed blank absorbance are available only for chemistries with
0-concentration calibrators. The K factor trends can be recalled for linear chemistries.
To observe calibration trends
3 Select Trend F6. The Calibration Trends window is displayed.

Figure 4.16 Calibration Trends window
4 Choose a trend type you want to recall.

 Calibrator response
 K factor (for linear calibrations only)
5 Select the date range in the Cal Date field.
6 Select Search F1.
The trend within the specified period is displayed on the screen.
7 Choose the Tabular Trend tab to view the trend data.
Figure 4.17 Tabular Trend window

 Reac Curve F3: to view the reaction curve and data of the selected calibrator.
 Prev F4: to view the calibration trends and data of the previous chemistry among the
selected results.

 Next F5: to view the calibration trends and data of the next chemistry among the
selected results.
 Print F7: to print the current graphic trend or data.
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 chemistry 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 chemistry 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 chemistry is timed out or succeeded. The results calculated based on extended
calibration factors will be flagged with "EXT".
To extend calibration time
2 Select a reagent carousel from the drop-down list of Reagent Carousel;
3 Select the up and down arrow buttons to display the biochemical reagent/calibration
screen.
4 Choose a chemistry you want to extend.
6 Select Extend Calibration Time from the Calibration Options window.
7 Select OK. The calibration factors of the selected chemistry can be used without time limit.
To remove an extended status
Calibration extension is not absolutely definite. Recalibrate the chemistry to remove the
extended status.
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 doctor’s diagnosis. Think twice before
overriding a failed calibration.
To override a calibration
2 Choose a chemistry you want to override.
4 Select Calibration Override from the Calibration Options window.
5 Select OK. The failed calibration factors of the selected chemistry can be used for result
calculation.

Removing Cal Overridden status

Recalibrate the chemistry to remove its Cal Overridden status.
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.
Rejecting a calibration
2 Choose a chemistry you want to reject.
4 Select Reject from the Calibration Options window.
5 Select OK. Calibration factors of the selected chemistry are rejected.
Removing Reject status
Recalibrate the chemistry to remove its Reject status.


5 QC
This chapter describes QC setup and QC result processing.

5.1 Overview 5 QC
5.1 Overview
QC test is performed on samples provided with known concentration range of various analytes
by authority divisions 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.
5.1.1 QC procedure
After you define a chemistry, control, and QC rules, there is no need to edit them frequently, and
you are only required to run control samples every day to make sure that the system works well.
Run control samples according to the following procedure:
Figure 5.1 QC procedure
Define Set up two- Print monthly

Set up QC Choose QC Enable auto
Monthly control
parameters rules
control
QC QC plot and
operations samples evaluation QC summary
Program Running
Load control Recall QC Print real-time
control control
Daily operations samples results QC results
samples samples
5.1.2 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.
 1-3s
 2-2s
 R-4s
 2-2s
 4-1s
 10-x
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, see 11.4Data alarms on page 11-7.
5.1.3 Control status

When you choose a control on the Program > Quality Control screen, the current status of the
control is displayed in the Sample Status field. It is necessary to understand the control statuses.
The table below shows the various statuses of control samples.
Table 5.1 Descriptions of control status
Control Status Description
N/A Indicates that the control is not programmed for analysis.
Requested Indicates that the control sample has been programmed but not analyzed
yet.
In Progress Indicates that the control sample is being analyzed.

5 QC 5.2 QC setup
Incomplete Indicates that all chemistries of the control sample have been finished but
one or more of them have no results.
Complete Indicates that all chemistries of the control sample have been finished
with results.
5.2 QC setup
Perform QC settings in the following order:
 Define a control
 Set up control concentrations
 Set up QC rules
 Auto QC
You can delete controls while the system is in non-test status.
5.2.1 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.
To define/edit a control
1 Select QC > QC Setup.
2 Select Define F1.
Figure 5.2 Define/Edit Controls window
3 Set up the control name, No., lot number, expiration date, and sample type.
4 Assign positions for the control.
You are allowed to assign one position of each sample carousel for the control.
5 Select OK to save your input information.
6 To define more controls, select New and repeat step 3 to 5.
7 Select Exit to exit the window.

5.2 QC setup 5 QC
5.2.2 Setting up control concentrations

After defining a control, you must set the applicable chemistries and concentration parameters.
Only when both control position and concentration are specified can QC test be requested and
run.
To set up control concentrations
2 Choose a control in the left list.
3 Select Chems F2 and choose chemistries for the control.
4 Select the Mean column of a chemistry and type in the average concentration for it.
5 Select the SD column of a chemistry and type in the standard deviation for it.
6 Select a unit from the drop-down list.
The options include all units set for the chemistry. This field is uneditable for open-reagent
chemistry.
5.2.3 Setting up QC rules

You should set up the control rules after defining a control and determining concentrations for it.
The controls without QC rule can still be programmed and analyzed but will not be monitored
for error detection.
You are allowed to change the QC rules when the system is not running any tests.
To set up QC rules
2 Select Rules F3. The QC Rules Setup window is displayed.
Figure 5.3 QC Rules Setup window
3 Choose a chemistry from the Chem list.

4 Choose QC rules in the Westgard Rules area.
5 Select the control limit from cumulative sum.
6 If you assign a couple of controls for the chemistry, you are allowed to enable the
Two-Control Evaluation option.
Those controls not contained in the two-control evaluation will be monitored according the
Westgard rules.

5 QC 5.2 QC setup
7 Select the first control in the Control (X) field.

8 Select the second control in the Control (Y) field.
5.2.4 Auto QC
The system provides the auto quality control function. 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.
 When calibrated: The system will automatically run the chemistry for the selected
control(s) every time when the chemistry 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 chemistries configured for the
control samples will be run.
To set up and run auto QC
2 Select Instrument F1.
3 Choose 9 QC Evaluation.
Figure 5.4 QC Parameters window
4 Select Auto QC on carousel.

5 Set up the conditions for auto quality control:
 Number of Samples: enter the number of samples for auto QC run. The input range is
10-500, 0 means auto QC is disabled.
 When Calibrated: select the checkbox to allow the system to run controls when a
chemistry is calibrated.
6 Choose controls to be run automatically.
One or more controls can be selected.
7 Select OK.

5.3 Recalling control results 5 QC
During test, the system will insert QC runs automatically once the conditions are met.
To remove auto QC status
To remove an auto QC status, clear the auto QC settings on the QC Parameters window.
5.2.5 Deleting a control

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 programmed for
analysis cannot be deleted.
To delete a control
2 Choose a control in the left list.
3 Select Delete F6.
5.3 Recalling control results

The Recalling Control Results option allows you to view control sample results, L-J chart,
cumulative sum, twin-plot chart, analysis data and data summary.
5.3.1 Result > History screen

The History screen is used to recall results of patient sample and control sample that are
programmed and analyzed before the current day. You can observe QC reaction curve and print
QC results.
To recall history QC results
1 Select Result > History.
2 Choose a result recall mode:
 By sample
 By chemistry
3 When recalling results by sample, choose a control in the left list. The right list displays all
results of the control.
4 When recalling results by chemistry, choose a chemistry in the left list. The right list
displays all results of the chemistry.
 Search F1: to recall control results.
 Options F2: to delete or archive control samples.
 Reac Curve F4: to view reaction curve of the selected QC test.
 Print F7: to print control results.
 Host F8: to transmit the selected control results to the LIS host.
To view control reaction curve
1 Choose the desired chemistry on the History Results screen..

5 QC 5.3 Recalling control results
Figure 5.5 Reaction Curve screen

Figure 5.6 Reaction Data screen

selected control.
 Prev F4: to view the reaction curve and data of the previous test.
 Next F5: to view the reaction curve and data of the next test.
To print control results
1 Select the desired control result on the History screen.
2 Select Print F7.

4 Choose the print range:

 Selected Sample(s)
 All Sample(s)
5 If you print all samples, you are allowed to skip those that are already printed out. Mark
the Bypass Printed Sample(s) checkbox.
6 Select OK.
5.3.2 QC > Levey-Jennings screen

The Levey-Jennings (L-J) screen provides the functions of recalling L-J chart and filling
comments.
A Levey-Jennings (L-J) chart, drawn based on the QC date (X) and test results (Y), shows the QC
result trend of a chemistry 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. Each page can display
31 QC points. The query date must not be longer than 1 year.
To recall L-J chart
1 Select QC > Levey-Jennings.
2 Click Chart F3 to set the drawing mode of the L-J chart.
3 Choose a chemistry to recall in the Chem drop-down list, or select Chems F2 and then
choose a chemistry.
4 Select the date range in the QC Date field.
5 Choose controls you desire to view. Up to 3 controls can be selected.
6 Select Search F1. The L-J chart area shows the QC result trends of the selected chemistry
during the specified period.
Figure 5.7 Levey-Jennings screen

 Prev F4: to view the L-J chart of the previous chemistry.
 Next F5: to view the L-J chart of the next chemistry.

 Delete F6: 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 F7: to print the current L-J chart
 Comment F8: to add, modify and delete comments of a QC point.
To add/modify comments
1 Choose a QC point on the L-J chart.
2 Select Comment F8, and then input comments for the QC point.
3 Select OK.
4 To delete the comments of a QC point, perform the following steps:
a. Select the QC point on the chart.
b. Click Comment F8.
c. Clear the comments.
d. Click OK.
5.3.3 Recalling cumulative sum chart

1 Select QC > Cumulative sum.
choose a chemistry.
4 Choose controls you desire to view.
5 Select Search F1. The Cumulative sum chart area shows the QC result trends of the selected
chemistry during the specified period.
Figure 5.8 Cumulative sum screen

 Prev F4: to view the Cumulative sum chart of the previous chemistry.
 Next F5: to view the Cumulative sum chart of the next chemistry.

 Delete F6: to delete the selected point on the Cumulative sum chart. If you want to
display the removed points on the Cumulative sum chart, mark the Show Deleted
checkbox.
 Print F7: to print the current Cumulative sum chart
 Comment F8: to add, modify and delete comments of a QC point.
To add/modify comments
1 Choose a QC point on the cumulative sum chart.
2 Select Comment F8, and then input comments for the QC point.
3 Select OK.
4 To delete the comments of a QC point, perform the following steps:
 Select the QC point on the chart.
 Click Comment F8.
 Clear the comments.
 Click OK.
5.3.4 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 chemistry
and excludes those that have been deleted.
To recall Twin-Plot chart
1 Select QC > Twin-Plot.
choose a chemistry.
3 Select Search F1. The twin-plot chart area displays the recent 10 results of control X and
control Y for the chemistry.
Figure 5.9 Twin-Plot screen

 Prev F4: to view the twin-plot chart of the previous chemistry.

 Next F5: to view the twin-plot chart of the next chemistry.

 Print F7: to print the current twin-plot chart.
5.3.5 QC > Results screen

The QC > Results screen provides the functions of recalling QC data, viewing reaction curve and
archiving QC data.
QC data includes QC results, and the set mean and standard deviation, and can be recalled based
on control name, chemistry name and run date.
To recall QC data
1 Select QC > Results.
2 Select Chems F2.
3 Choose a chemistry to recall, and then select OK.
5 Choose a control in the Control drop-down list.
6 Select Search F1.
The result list shows all results of the control for the chemistry during the specified period,
as well as the set means and standard deviations.
Figure 5.10 Results screen

 Sort F3: to sequence the QC results by control or chemistry.
 Reac Curve F4: to view the reaction curve and data of the selected QC result.
 Comment F5: to add comments to the selected QC result.
 Archive F6: to archive the currently displayed QC results to an external storage device.
 Print F7: to print the QC results currently displayed in the result list.
To sort QC results
1 Search for desired QC results on the Results screen.

2 Select Sort F3.

3 Select a sorting criterion.
 Control: control number + chemistry + run date/time
 Chemistry: chemistry order + control + run date/time
4 Select OK.
The QC results on the Results screen are rearranged ascending based on the selected
criterion.
To view control reaction curve
2 Choose a QC result to recall.
Figure 5.11 Control reaction curve
 Control: observe reaction curve of the results for the selected control.
6 Select the Reaction Data tab to view the reaction data.
 Reagent F1: to view the reagents used for quality control, calibrators and reagents used
in calibration, and reagents for reagent blank test.
selected control.
 Prev F5: to view the reaction curve and data of the previous QC test.
 Next F6: to view the reaction curve and data of the next QC test.

To add QC comments
2 Choose a QC result in the result list.
3 Select Comment F5.
4 Type in comments for the selected QC result.
Up to 100 characters can be entered.
5 Select OK.
To archive QC data
3 Select OK.
5.3.6 Recalling QC Summary

The QC summary reports the measurements of a control for the selected chemistry 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.
To recall QC summary
1 Select QC > Summary.
2 Select Chems F2.
3 Choose a chemistry to recall, and then select OK.
5 Choose a control in the Control drop-down list.
6 Select Search F1.
The result summary of the control for the chemistry is displayed on the screen.
Figure 5.12 Summary screen

7 To print the QC summary report, select Print F7.

6 Program
This chapter describes operations related to sample analysis.

6.1 Sample management 6 Program
6.1 Sample management

Before programming samples, it is necessary to understand the sample containers and sample
volume of the system, as well as how to load and unload samples.
Sample container types
The sample carousel supports blood collecting tube, centrifugal tube, plastic tube and Microtube,
which are available in the following specifications:
 Microtube: Φ14×25 mm, 0.5 mL (Beckman); Φ14×25 mm, 2 mL (Beckman);
Φ12×37 mm, 2 mL (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.
Sample volume
The amount of sample required for a common measurement is 2-45 μL, with an increment of
0.1 μL. Analysis with insufficient samples may lead to inaccurate results.
If a sample is exhausted during the analysis, the system will automatically invalidate all
incomplete chemistry of the sample. Before running samples, make sure that they are sufficient
in volume for analysis.
Loading samples
BIOHAZARD
To load samples
1 Check if the sample inside the sample tube is sufficient for analysis and the bar code label is
applied correctly.
2 Check the system status.
 If the system status is Running, select to request for sample stop.

 If the system status is Standby or Incubation, proceed to the next step.
3 Check if the sample carousel and the sample probe have stopped moving.
4 To load samples, remove the sample carousel cover.
5 Insert the sample tube into the tube holder until the tube bottom contacts the groove of the
tube rack.
6 Repeat step 5 to load more samples.
7 Restore the sample carousel.
Unloading samples
BIOHAZARD
To unload samples
1 Check if the sample carousel and the sample probe have stopped moving.
2 If the system status is Running, select to request for sample stop.

3 Remove the sample carousel cover.
4 Grab the sample tube and pull it upward to remove it from the tube holder.

6 Program 6.2 Sample programming and processing
5 Repeat step 4 to unload more samples.

6 Restore the sample carousel.
6.2 Sample programming and processing

Except for routine sample test, the system also provides the following test functions:
 Processing samples with LIS
 Processing bar-coded samples
 Batching programming
 Adding samples
 Adding/Modifying tests
 Rerunning samples
 Running sample blank
 Processing full blood test
6.2.1 Processing samples with LIS

When connected with LIS, the system allows automatically obtaining and manually downloading
sample programs. Obtaining samples automatically
When the system status is Standby or Pause, load the samples to the sample carousel, and then
select . The system will automatically scan the samples and then query the LIS host to
download relevant program information. After matching the downloaded program information
with the samples, the system will start the analysis.
Downloading sample programs manually

Both bar-coded and non-bar-coded samples can be downloaded from LIS. Bar-coded samples can
be programmed and analyzed automatically, while non-bar-coded samples need to be
positioned before analysis.
To download bar-coded samples
1 Select Program > Sample, select List F5 and then Download F7.
2 Choose one of the following options:
 All programmed samples: to download all samples programmed on the current day.
 Latest samples: to download samples that are programmed on the current day but have
not been downloaded.
 Samples with the following IDs: to download samples with the specified program 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.
3 Select OK.
4 Confirm the sample information and selected chemistries/panels on the Sample List
screen.
5 Load the samples to idle positions of the sample carousel.
6 Select the icon, set the test conditions, select the Sample Crsl Bar Code check box,
and then click OK to start analysis.

6.2 Sample programming and processing 6 Program
To download non-bar-coded samples

1 After downloading samples from LIS, select List F5.
2 Select Unpositioned F2,and select Assign.
3 Select the date the desired samples are programmed.
4 Type in the single sample ID or ID range in the ID field.
5 Choose a sample carousel on which you will place the sample.
6 Enter the sample position.
The options include all available positions of the selected sample carousel.
 To assign position for single sample, input the position number in the first edit box.
 To assign positions for multiple samples, enter the start position number in the first edit
box, and then the end position number in the second edit box. The system will assign
positions for the samples ascending according to the sample ID.
7 Select OK.
8 Load the samples to the assigned positions on the sample carousel.
9 Select the icon, set the test conditions, and then click OK to start analysis.
6.2.2 Processing bar-coded samples

Bar-coded samples can be processed with or without LIS.
 For processing samples with LIS, see 6.2.1Processing samples with LIS on page 6-3.
If your system is not connected with a LIS host, you can program bar-coded samples with the
default panel or program them manually one by one or by batch This section describes two
methods of manually programming samples without LIS.
 For sample analysis with default panel, see 7.7.5Setting up and running default panel on page
7-26.
Before processing bar-coded samples, check if the following conditions are satisfied:
 The sample bar code reader has been configured.
 The Sample Crsl Bar Code check box on the Sample Bar Code window is selected.
 The system status is Standby or Pause.
To process bar-coded samples without LIS -- Method 1
1 Program samples manually according to "2.4.1Programming and processing samples"
(Page 2-22).
2 Place the bar-coded samples sequentially on the sample carousel.
3 Select the icon on the upper-right corner of the main screen.

5 Select the Sample Crsl Bar Code check box.
6 Specify the sample range: All or Partial. When you select Partial, you should specify a
sample position range for analysis.
7 Select OK.
The system scans the samples on the sample carousel to match the program information,
and then starts analysis.
To process bar-coded samples without LIS -- Method 2
1 Program samples manually according to "2.4.1Programming and processing samples"
(Page 2-22).

2 Place bar-coded samples sequentially on the sample carousel.

If the auto numbering feature is enabled, the system will automatically number the samples
according to the order in which they have been placed. The start number will be the next
available one since the last sample is programmed.
For auto numbering of bar-coded samples, see 8.5 Bar code setup on page 8-16.
4 Select Scan F5. The Scan window is displayed.
Figure 6.1 Scan window
5 Choose the scanning range.

 All positions: to scan all positions on the sample carousel.
 Specified positions: to scan the specified positions on the sample carousel. Input the
start and end scanning positions.
6 Select OK.
6.2.3 Batch programming

For batch-programmed samples, all program information such as sample information,
chemistries and patient demographics other than position, ID and bar code are the same.
To batch program samples
2 Enter the sample ID of the first sample.
3 Enter the start position to place the samples.
4 Set the sample information, including: STAT property, sample type, comment, and patient
ID.
5 Choose desired chemistries.
6 To set patient demographics, select Demog F1.
7 To set replicates and dilution factors, select Options F2.
8 Select Batch F3.

Figure 6.2 Program Batch window
8 Enter the sample ID of the last sample.

9 Select OK.
6.2.4 Adding samples

You can add routine samples and STAT samples at any time, and test them in the same way as
routine test. You can also add and analyze calibrators and controls in the same way.
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. 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.
To add samples in Running status

1 Add samples according to "2.4.1Programming and processing samples" (Page 2-22).

4 When the system status becomes Pause, place the added samples on the assigned positions
of the sample carousel, and then select .

 If the samples are on the current sample carousel, click OK to start the test.
 Otherwise, you should specify the sample carousel and position to start the analysis.
To add samples in other system statuses
1 Add samples according to "2.4.1Programming and processing samples" (Page 2-22).
2 Place the added samples on the assigned positions of the sample carousel.
6.2.5 Adding/Modifying chemistries

No matter in which status a sample is, chemistries can be added or removed.
To add/modify chemistries
2 Type in the sample ID and press Enter.

The programming information of the sample is displayed on the screen.

3 Deselect chemistries you won't run, and then select chemistries you desire to run.
4 Deselect panels you won't run, and then select panels you desire to run.
5 Select Save F8.
 If the system is running tests, it will analyze the added chemistries and panels
automatically.
 If the system is in Standby status, select the icon, set the test conditions, and then
click OK to start analysis.
6.2.6 Rerunning samples

The system provides the manual rerun and auto rerun functions, for rerunning samples that
have abnormal results or have results beyond the set linearity range or critical range.
Perform manual rerun on the following screens:
 Program > Sample > List window: rerun single or batch samples
 Result > Current or History screen: rerun by sample or by chemistry
Perform auto rerun on the following screens:
 Utility > Chemistries > Reference/Critical Range window: rerun ISE test
 Utility > System Setup > Auto Rerun Setup screen: rerun biochemistry
Manual rerun on List window

The List > Rerun window allows you to manually rerun single or multiple samples that are in
Complete, Incomplete, Rerun or In Progress status.
When rerunning samples, you are allowed to edit the sample cup type, sample position, STAT
feature and chemistries. If a chemistry is finished, it can be rerun with edited sample volume,
replicates and predilution factor. Sample ID, bar code, sample type and collection time of
rerunning samples must not be edited.
To rerun single sample
1 Select Program > Sample, and select List F5.
2 Select Rerun F4.
Figure 6.3 Rerun window
3 Type in the ID or bar code of the sample you desire to rerun or enter the barcode of the
sample.
4 Click Select.

Figure 6.4 Rerun Samples window
5 Edit the following information:

 Position: change the carousel number and position of the sample.
 STAT: select or deselect the STAT checkbox.
 Comment: choose or enter a sample comment.
 Chemistry and panel: change chemistries and panels.
 Options: edit the number of replicates and predilution factors for the sample or for a
chemistry, and then modify the sample cup type.
6 Select Save F8.
7 Select Exit F7.
8 After confirming all rerun information, load samples to the assigned positions, and select
to start the analysis.
 If the sample is on the current sample carousel, it is analyzed automatically.
To rerun batch samples
1 Select Program > Sample, and select List F5.
2 Select Rerun F4.
3 Type in the sample ID or range you desire to rerun.
Separate single samples with comma, e.g. 5, 7, 9; and connect multiple continuous samples
with a dash, e.g. 1-3.
4 Select Batch.

Figure 6.5 Rerun Batch window
5 Choose chemistries for rerunning the samples.

The list includes all chemistries that have been enabled and configured. The selected
chemistries will be requested for rerunning the samples.
6 Select OK.
7 After confirming all rerun information, load samples to the assigned positions, and select
to start the analysis.
 If the samples are on the current sample carousel, they are analyzed automatically.
Manual rerun on Current or History screen

With the Rerun F5 button on the Current or History screen, you can rerun samples in Complete
or Incomplete status that have finished tests. You can rerun multiple chemistries by sample or
rerun multiple samples by chemistry.
To rerun chemistries by sample
1 Select Result > Current or History, and choose the By Sample option.
2 Search for desired sample results.
3 Select the sample and chemistries you desire to rerun.
4 Select Rerun F5.
5 Modify the following sample information for all chemistries:

 Carousel No. and position

 Sample volume (2-45)
 Sample cup
 Off-line dilution factor (2-9999)
 Predilution factor (4-126)
 Sample blank
6 Modify the following information for single chemistry:
 Sample blank
7 Select Save.
8 Load samples to the assigned positions, and select to start the analysis.
 If the sample is on the current sample carousel, it is analyzed automatically.
To rerun samples by chemistry
1 Select Result > Current Results or History Results, and choose the By Chemistry option.
3 Choose the chemistry and samples you desire to rerun.
4 Select Rerun F5.
5 To run sample blank for all samples, select the Sample Blank check box.
6 Modify the following information for single sample:
 Off-line dilution factor (2-9999)
 Sample blank
7 Select OK.
8 Load samples to the original positions, and select to start the analysis.
 If the samples are on the current sample carousel, they will be analyzed automatically.

Auto rerun of ISE chemistry based on critical range

The auto rerun function can be enabled on the Reference/Critical Range window. Once the
auto rerun is enabled, the system will check if the ISE result is beyond the critical range, and if it
is, will rerun the sample.
To auto rerun ISE test
1 Select Utility > Chemistries, and select Ref Range F4.
2 Select ISE from the Chemistry drop-down list.
3 Set up the critical range as well as sample type, patient gender and age range
4 Mark the Auto Rerun checkbox with a tick.
The system will rerun samples if the ISE test result is beyond the critical range.
Rerunning biochemistries when meeting auto rerun conditions

The auto rerun function can be also enabled on the Define/Edit Chemistries 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.
To enable auto rerun and set up error detection parameters
2 Choose a chemistry, and select Define F1.
3 Mark the Auto Rerun checkbox with a tick.
4 Select the down-arrow button to show the error detection parameters setup page.
5 Set up the following parameters:
 Linearity range (for standard, decreased and increased volumes)
 Linearity limit
 Substrate depletion limit
 Blank response
 Prozone check parameters (Q1-Q4, PC, ABS)
To set up critical range
1 Select Utility > Chemistries, and select Ref Range F4.
2 Select the desired biochemistry from the Chemistry drop-down list.
3 Set up the critical range as well as sample type, patient gender and age range.
To set up the auto rerun conditions
2 Click the arrow buttons to display the auto rerun setup screen.

3 Select the check box in front of desired conditions, and choose a sample volume for rerun
from the drop-down list.
4 Click Save F8.
The system will rerun samples with the set volume type if the test result satisfies the
conditions.
Recalling rerun results

The rerun results of a sample are presented on the Recall Rerun Results window, through
which you are allowed to recall all rerun results. You can set the result of any rerun as the
default of a chemistry.
To recall rerun results
1 Select Result > Current or History.
3 Choose a sample and then a chemistry you desire to recall.
4 Select Options F2, and select Recall Rerun Results. The Recall Rerun Results window is
displayed.
The window shows the sample information and all reruns results of the chemistry.
Figure 6.8 Recall Rerun Results window
5 The latest rerun result is the default one. To change the default result, choose a result, and
then select Set Defaults.
The Default column of the result shows Y, which stands for Yes.
6.2.7 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. Sample blank is
only effective for single-reagent endpoint chemistries.
To run sample blank
2 Choose a chemistry.

6 Program 6.3 Extended functions
3 Select Define F1.

4 Mark the Sample Blank checkbox with a tick.
5 Select Save F7.
6 Select Close F8.
The system will run a sample blank when running calibrators, controls and samples for the
chemistry.
To recall sample blank reaction curve
3 Choose a sample and then a chemistry you desire to recall.
4 Select Reac Curve F4.
5 Select Sample Blank F2.
7 To print the reaction curve or reaction data, select Print F7.
6.3 Extended functions

This section describes other functions related to sample analysis.
6.3.1 Clearing samples

The Clear Samples function is used to delete programmed 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
programming other samples. The action of clearing samples will be recorded in the edit logs.
To clear samples
2 Select Clear F4. The Clear Samples window appears.
Figure 6.9 Clear Samples window
3 Select samples you desire to clear.

 Current sample: type in the sample ID on the Sample screen.
 Sample(s) with following ID(s): type in the sample ID range in the Sample ID field. Single
sample ID and sample range are acceptable.
4 Select OK.
The selected samples are cleared along with their programming information.

6.3 Extended functions 6 Program
6.3.2 Sample and chemistry lists

The List option allows you to view, inquire and print all unfinished samples, and assign
positions for unpositioned samples. You are also allowed to view the requested chemistries’
calibration status, reagent status, tests left, and number of requests.
The List window includes two tab pages: Sample List and Chemistry List.
Sample list
The sample list shows all patient and controls samples that have been programmed but not
analyzed yet. On the Sample List screen, you can search samples, assign position for
unpositioned samples, download program information from LIS, rerun tests, and print the
sample list.
 For assigning position for unpositioned samples, see 6.3.3 Viewing unpositioned samples on
page 6-16.
 For downloading program information from LIS, see 6.2.1 Processing samples with LIS on page
6-3.
 For manual rerun, see Manual rerun on List window on page 6-7.
To view programmed samples

2 Select List F5.
Figure 6.10 Sample List tab page
3 Move the scroll bar to view more samples.

4 To print the sample list, select Print F7.
To inquire samples by program date, sample status or ID
1 Select Search F1 on the Sample List tab page.

Figure 6.11 Search window
2 Enter the conditions:

 Select the program date of samples you desire to inquire; and/or
 Select a sample status, which is available in All, Programmed, In Progress, Incomplete,
Complete, and Rerun; and/or
 Type in the single sample ID or ID range in the Sample ID field.
3 Select OK. All samples that satisfy the conditions are displayed on the screen.
To inquire a bar-coded sample
1 Select Search F1 on the Sample List tab page.
2 Type in the sample bar code you desire to inquire.
3 Select OK. The corresponding sample is displayed on the screen.
Chemistry list
The chemistry list shows the summary of chemistries that are requested on the current day or
requested before but not finished yet. On the Chemistry List screen, you can download
program information from LIS and rerun tests.
 For downloading program information from LIS, see 6.2.1 Processing samples with LIS on page
6-3.
 For manual rerun, see Manual rerun on List window on page 6-7.
To view chemistry list

2 Select List F5.
3 Select the Chemistry List tab.

Figure 6.12 Chemistry List tab page
4 Move the scroll bar to view more chemistries.

5 To print the chemistry list, select Print F7.
6.3.3 Viewing unpositioned samples

Unpositioned samples are those:
 downloaded from the LIS host and not positioned yet. Such samples cannot be
programmed for analysis until they have positions assigned. If your system is
equipped with a sample bar code reader, the samples can be analyzed immediately
without assigning positions for them.
 that are in Incomplete status when their positions are used for programming new
samples.
 that are incomplete when their positions are released.
Once positioned, the samples will be removed from the unpositioned samples list.
To view unpositioned samples
2 Select List F5.
3 Select Unpositioned F2.

Figure 6.13 Unpositioned Samples window
4 Move the scroll bar to view more samples.

To assign positions and perform test
1 Select Assign on the Unpositioned Samples window.
Figure 6.14 Assign positions
2 Select the program date of sample(s) to assign position.

3 Type in the sample ID or range in the ID field.
4 Choose a sample carousel on which you will place the sample.
5 Enter the positions in the Pos field.
 To assign position for single sample, input the position number in the first edit box.
 To assign positions for multiple samples, enter the start position number in the first edit
box, and then the end position number in the second edit box. The system will assign
positions for the samples ascending according to the sample ID.
6 Select OK.
6.3.4 Releasing sample position

When a sample is analyzed, the position cannot be used for programming new sample until it is
released. The system provides the function of manual and auto releasing samples.
The Program > Status screen provides the Release Sample Position function, which allows you
to release the selected position or all positions on the current sample carousel that are not
running any tests. Only patient samples rather than controls, calibrators, ISE wash solution and
physiological saline can be released.

Sample positions can be released automatically at specified time every day.

When a sample is released, its results and programming information can be still recalled.
To manually release sample positions
2 Choose a sample carousel to release samples.
3 Select Release F3.
Figure 6.15 Release Positions window
4 Choose the sample range:

 Following position(s): type in single sample position or position range in the edit box.
 All positions: to release all positions of the selected sample carousel.
5 Select OK.
To automatically release samples
3 Select Auto Release Sample.
4 Select the auto release time of patient samples in the Auto Release Time field.
Select an integer between 00 and 23. The default is 00.
5 Select OK.
When the time is reached, the system will release automatically all sample positions in the
status of Complete.
6.3.5 View sample logs

The Sample Logs screen provides the controls and patient samples that are not complete within
the recent 24 hours due to certain reasons. You are to rerun the samples or take other actions
for the controls and samples.
To view sample logs
2 Select Log F2.

Figure 6.16 Sample Logs window
3 To print the sample logs, select Print F7.

6.3.6 Customizing sample information

The system provides the Cust. Sample Info. option for specifying sample information to be
displayed on the Sample screen.
To customize sample information
3 Select Cust. Sample Info.
Figure 6.17 Customize Sample Information window

4 Find desired sample information and mark the corresponding Customize checkbox.
Click the checkbox again to deselect it.
5 Select Save.
6.3.7 Customizing patient demographics

You can specify patient demographics to be displayed, its default and its display order on the
Patient Demographics screen.
To customize patient demographics
3 Select Patient Demographics.
Figure 6.18 Patient Demographics
4 Select the desired information and the default value and then click Add.
5 Select the desired information and click Delete to delete it from the demographics list.
6 Select Up, Down, Home and End button to adjust the displayed order of patient
demographics.
7 Select OK to save the settings.
6.3.8 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.
Table 6.1 Optimizing result display
When test result.. Displayed as...
Less than the low limit of linearity range < Low limit of linearity range

greater than the high limit of linearity > High limit of linearity range
range
less than concentration of the < Concentration of the lowest-concentration
lowest-concentration calibrator calibrator
greater than concentration of the > Concentration of the highest-concentration
highest-concentration calibrator calibrator
less than both the low limit of linearity < Maximum of the two values
range and concentration of the
lowest-concentration calibrator
greater than the high limit of linearity > Minimum of the two values
range and concentration of the
highest-concentration calibrator
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.
To optimize result display
3 Select Optimize Result Display.
Figure 6.19 Optimize Result Display window
4 Find desired chemistry, and mark the corresponding Low and High checkboxes.
5 To optimize result display of all chemistries, select Select All.
6 To cancel all settings, select Clear.
7 Select Save.
8 Select Cancel to close the window.

6.4 Results Recall 6 Program
6.4 Results Recall

The Results Recall option allows routine samples, STAT samples and controls to be recalled and
handled on the Current Results or History Results screen. The Current Results include those
that are programmed and analyzed on the current day; the History Results are those
programmed and analyzed before the current day. All results can be recalled by sample or by
chemistry.
Except the Recalculate option for current results, other operations are applicable to both
current and history results.
6.4.1 Viewing current results

The Current screen shows all samples and controls that are programmed and analyzed on the
current day. You can search current results by sample information and patient demographics,
and can sort samples by sample category, sample ID, status, position, completion time, program
date/time, host, print and review statuses.
To view current results
1 Select Result > Current.
Figure 6.20 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.
 When certain test of a control sample or patient sample triggers a data alarm, the sample
will appear in yellow.
 By sample
 By chemistry

6 Program 6.4 Results Recall
3 When recalling results by sample, choose a sample in the left list. The right list displays all
results of the sample.
 Search F1: to inquire sample results.
 Options F2: to delete, edit and print samples, recall rerun results, customize result
display options, recalculate results, compensate results, archive results, and observe
result trend.
 Demog F3: to view patient demographics of the sample.
 Reac Curve F4: to view the reaction curve and data of the selected test.
 Rerun F5: to rerun a finished sample.
 Review F6 to review the sample result.
 Print F7: to print sample results.
 Host F8: to transmit the selected sample results to the LIS host.
To recall current results
2 Select Search F1.
Figure 6.21 Recall results window
3 Enter one or more search conditions.

4 Select OK. The samples matching the condition are displayed on the screen.
5 Select a function button to perform relevant operations.
6.4.2 Viewing history results

The History screen shows all samples and controls that are programmed and analyzed before
the current day. You can search history samples by sample type, patient name, patient ID, sample
ID or sample bar code, along with the program date. To quickly search for desired results from
the tremendous amount of data, you are recommended to enter both the program date and any
of the conditions.
To view history results
1 Select Result > History.

Figure 6.22 History Results 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.
 By sample
 By chemistry
3 Select Search F1 to search for desired results.
4 When recalling results by sample, choose a sample in the left list. The right list displays all
results of the sample.
 Options F2: to delete, edit and print samples, recall rerun results, customize result
display options, compensate results, archive results, and observe result trend.
 Demog F3: to view patient demographics of the sample.
 Reac Curve F4: to view the reaction curve and data of the selected test.
 Rerun F5: to rerun a finished sample.
 Review F6 to review the sample results.
 Print F7: to print sample results.
 Host F8: to transmit the selected sample results to the LIS host.
To recall history results
1 Select Result > History Results.
2 Select Search F1.

Figure 6.23 Recall Results window
3 Select the program date range you want to recall. Select the start date in the first box and
the end date in the second box.
4 Enter one or more search conditions.
5 Select OK. The samples matching the condition are displayed on the screen.
6 Select a function button to perform relevant operations.
6.4.3 Reviewing sample results

Only when the sample status is complete, can the sample results be reviewed.
To review sample results
2 Choose the By Sample option.
3 Choose a sample or more samples in the sample list
4 Select Review F6.
The review status in the sample list turns from N to Y.
5 Select No Review to cancel the review operation.
6.4.4 Viewing/Editing patient demographics

Patient demographics can be viewed or edited in any system status.
To view/edit patient demographics
3 Choose a sample in the sample list.
4 Select Demog F3.

Figure 6.24 Demographics window
Patient demographics can be customized. For more information, see 6.3.7Customizing patient
demographics on page 6-20.
5 Edit the related patient information:
6 Select Save F7 to save your input.
7 To obtain the default values, select Restore F3.
6.4.5 Viewing reaction curve

A reaction curve reflects the relationship of the absorbance measured at the primary
absorbance of the sample-reagent mixture measured within the reaction period.
Observing reaction curve and data is not applicable to ISE chemistry, off-system chemistry, and
special calculation.
Viewing reaction curve
1 Search for desired samples on the Current or History screen.
 By sample
 By chemistry
3 Choose desired result in the result list.

Figure 6.25 Sample reaction curve
 Sample: observe reaction curve of the results for the selected sample.
Figure 6.26 Sample reaction data

 Reagent F1: to view the reagents used for sample analysis, calibrators and reagents
used in calibration, and reagents for reagent blank test.
selected sample.
 Adjust F3: to adjust the absorbance display range of current reaction curve. Refer to
the following page for details.

 Prev F4: to view the reaction curve and data of the previous test.
 Next F5: to view the reaction curve and data of the next test.
Viewing reagent 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.
To view reagent information
1 Select Reagent F1 on the Reaction Curve window.
Figure 6.27 Reagent window
The window shows the calibration date and time; sample measurement date and time;
calibrators, reagents for reagent blank test; and reagents for sample analysis.
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.
To adjust display range
1 Select Adjust F3 on the Reaction Curve window.

Figure 6.28 Adjust window
2 Choose an adjustment mode:

 Auto: The system automatically determines the display range of X axis (measuring
period) and Y axis (absorbance) according to the reaction data.
 Manual: The system displays the reaction curve according to the specified absorbance
range. Input the absorbance range (-40000-40000).
3 Select OK. The current reaction curve is refreshed accordingly.
6.4.6 Sending 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.
To send results to LIS host
3 To transmit single or multiple samples, select them in the sample list
4 To transmit all samples, do not select any samples.
5 Select Host F8.
Figure 6.29 Transmit Results window
6 Select the sample range you want to transmit:

 Selected sample(s)
 All samples
7 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.
8 Select OK.

6.4.7 Printing results

Samples can be printed manually on the Current Results and History Results 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, or all samples to be printed out.
Printing results by sample

You can print test results of one or more samples when they are recalled by sample.
To print results by sample

3 To print single or multiple samples, select them in the sample list.
4 To print all samples, do not select any samples.
5 Select Print F7.
Figure 6.30 Print window

 Selected Sample(s)
 All Sample(s)
8 If you print all samples, you are allowed to skip those that are already printed out. Mark
the Bypass Printed Sample(s) checkbox.
9 Select OK.
Printing results by chemistry

You can print test results of one or more chemistries when they are recalled by chemistries.
To print results by chemistry
2 Choose the By Chemistry option.
3 To print single chemistry in the chemistry list, select it; to print all chemistries, there is no
need to select them.

4 Select Print F7.

Figure 6.31 Print window

 Selected chemistry
 All chemistries
6 Select OK.
6.4.8 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 while results of off-system chemistry can 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.
To edit results
 By sample
 By chemistry
4 Choose a sample or chemistry in the sample list which includes the off-system chemistries
as well.
5 Select Options F2, and select Edit Results.
The screen shows the samples or chemistry and all measured results.

Figure 6.32 Edit Results window – By sample (Current results)
Figure 6.33 Edit Results window – By sample(History results)
Figure 6.34 Edit Results window – By chemistry
6 Choose a chemistry to edit, and then input result in the Final Result column.
 For normal runs, only Complete chemistries can be edited.

 For reruns, only the default result can be edited.

7 Select Save to save your editing.
6.4.9 Deleting results

The system has a limited storage capacity, and when it is exceeded, the results with the earliest
date will be overridden. 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.
To delete results
 By sample
 By chemistry
4 When recalling results by sample, choose samples in the sample list. When recalling results
by chemistry, choose a chemistry in the left list.
5 Select Options F2, and select Delete Results.
Figure 6.35 Delete Results window
6 Choose the sample range:

 Selected result(s): to delete the results of the selected samples or chemistries.
 All results: to delete all results on the screen.
7 Select OK.
6.4.10 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 chemistry, only the result list can be tailored.
To customize result display
 By sample

 By chemistry
3 Select Options F2, and select Customize Result Display.
Figure 6.36 Customize Result Display window – By sample
Figure 6.37 Customize Result Display window – By chemistry
4 If recalling results by sample,

a. To forbid display of a header name in the sample list, deselect the corresponding
checkbox.
b. 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.
c. Choose desired header names 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.
5 If recalling results by chemistry,
a. To forbid display of a header name in the result list, deselect the corresponding checkbox.
b. Choose desired header names in the Result List Setup area. Use the Up and Down
buttons to adjust the display order of the header names.
6 Select Save to save the settings and close the window.

6.4.11 Recalculating results

The Recalculate Results option is used to recalculate current sample results with the latest valid
calibration factors of relevant chemistry. This option is often used when test result cannot be
calculated due to incomplete or failed calibration.
Recalculate Results is only applicable to biochemistries. Result of samples in In Progress status
cannot be recalculated. The recalculation will be automatically recorded in event logs.
To recalculate results
2 Select Options F2, and select Recalculate.
Figure 6.38 Recalculate window

4 Select Calculate.
Results of the selected chemistry for the specified samples are recalculated automatically
with the latest calibration factors and then displayed in the list at the bottom.
6.4.12 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 chemistry, special calculations and off-system chemistries.
A calculation will be recalculated automatically once its constituent chemistries are compensated.
Only users that have sufficient permissions are allowed to compensate results. The
compensation will be automatically recorded in event logs.
To compensate results
1 Select Result > Current or History
2 Choose the By Chemistry option.
3 Choose the chemistry that you want to compensate in the left list.

4 Select Options F2, and select Compensate Results.

All results of the chemistry are displayed in the list at the bottom.
Figure 6.39 Compensate window
5 Input the slope K and offset B.

6 Select Save.
The system recalculates all results of the chemistry with the specified slope and offset. The
final results are displayed in the list of the window.
6.4.13 Recalling result trend

Result trend allows you to observe the result trend of the selected chemistry.
To recall result trend
2 Choose the result recall mode - By chemistry.
4 Choose a chemistry in the left list.
5 Select Options F2, and select Recall Result Trend.

6 Program 6.5 Test statistics
Figure 6.40 Result Trend window
6 Move the cursor to certain point on the graphic trend. The actual result, final result,
completion time, reagent lot number, serial number, and calibration time are displayed on
7 To show all results of repeated analysis or rerun tests, select the Include Replicate Results
checkbox.
8 To observe result trend of other sample tests, select Prev F1 or Next F2.
6.4.14 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.
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 Options F2.
3 Select Archive.
4 Select OK.
6.5 Test statistics

On the Tests screen, you can view test requests and reagent application for each chemistry
during a period, and you can sample requests and the quantity of its chemistries as well.
Calibration test and QC test are not included in the statistics.
To view test statistics
1 Select Result > Statistics > Tests.
2 Select By Sample or By Test.

6.5 Test statistics 6 Program
Figure 6.41 Tests screen - By sample
Figure 6.42 Tests screen - By test
 By Sample: To view all requested samples and the quantity of its requested chemistries.
 By Test: To view test requisitions and reagent volume for the chemistries.
3 Select or enter the start date and end date in the Date field. the start date cannot be later
than the end date.
4 Select Search F1.
All samples or tests requested during the period are displayed in the middle list of the Tests
screen.
5 Select Print to print out the currently displayed statistic information of measurements.

6 Program 6.6 Result statistics
6.6 Result statistics

Result statistics option can summarize the total chemistries and the distribution trend of its
results and provide the test data and graph. Calibration and control tests are not included in the
statistics.
1 Select Result > Statistics.

2 Select the Results.
3 Select Statistic Graph or Statistic Data.
4 Click Search F1. The Recall results box pops up.
Figure 6.43 Recall results window
5 Input one or more search conditions.

6 Click OK.
The statistic results matching the search conditions are displayed.
Figure 6.44 Result statistics screen -statistic graph

6.6 Result statistics 6 Program
Figure 6.45 Result statistics screen -statistic data
7 Select Print F7 to print out the statistic graph and statistic data.

7 Chemistry
This chapter describes the setup methods of closed-/open-reagent chemistries and special
chemistries, as well as the extended chemistry functions.

7.1 Importing/Exporting chemistries 7 Chemistry
7.1 Importing/Exporting chemistries

The system supports specified and default chemistries to be imported from an external file, and
open-reagent chemistries to be exported to an external storage device.
A maximum of 300 open-/closed-reagent chemistries can be imported. When chemistries are
imported, they are enabled by default if set up correctly. If the number of open-reagent
chemistries imported exceeds the maximum limit, the excessive open-reagent chemistries will
be disabled.
Only users with sufficient permission are allowed to import or export chemistries. Importing
and exporting chemistries can be performed only when the system status is Standby, Incubation
and Stopped.
CAUTION
While importing chemistries, do not switch off the analyzing unit main power or exit the operating software.
If an imported chemistry is no longer needed, it can be deleted with the Delete F2 button on the
Chemistries screen.
7.1.1 Importing default chemistry list

Closed-reagent chemistries can be imported from an .item file. They include biochemistries, ISE
test 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.
Only the full name, print name result unit, decimal places, and error detection limits can be
edited, while others can only be browsed.
To import default chemistry list
1 Select Utility > Chemistries, select Config F3.
2 Select Options, and then select Import.
Figure 7.1 Import window
3 Select Load Default.

7 Chemistry 7.1 Importing/Exporting chemistries
All chemistries contained in the default parameter form are displayed in the Available
Chemistries list.
4 Use the following buttons to import desired chemistries:
 Add All>>: add all chemistries in the Available Chemistries list to the Imported
Chemistries list.
 Add ->: add the selected chemistries in the Available Chemistries list to the Imported
Chemistries list.
 <-Remove: remove the selected chemistries from the Imported Chemistries list.
 <<Remove All: remove all chemistries from the Imported Chemistries list.
5 Select Import.
All imported chemistries are enabled by default and can be used for measurement. If the
result unit is changed, the corresponding chemistry must be recalibrated.
6 Select Exit.
7.1.2 Importing specified chemistry list

Open-reagent chemistries can be imported from a .csv file. The open-reagent chemistries
include biochemistries, as well as the processing parameters, error detection limits, slope and
offset.
To import specified chemistry list
1 Select Utility > Chemistries, select Config F3, and then Options.
2 Select Import.
3 Select Load.
4 Locate the path of the parameter form, select a .csv file, and then select Open.
All chemistries contained in the parameter form are displayed in the Available
Chemistries list.
5 Use the following buttons to import desired chemistries:
 Add All>>: add all chemistries in the Available Chemistries list to the Imported
Chemistries list.
 Add ->: add the selected chemistries in the Available Chemistries list to the Imported
Chemistries list.
 <-Remove: remove the selected chemistries from the Imported Chemistries list.
 <<Remove All: remove all chemistries from the Imported Chemistries list.
6 Select Import.
All imported chemistries with correct parameters are enabled by default and can be used
for measurement. If you change any of the following parameters of an imported chemistry,
recalibrate the chemistry:
 Reaction type
 Primary wavelength
 Secondary wavelength
 Reaction direction
 Reaction time
 Blank time
 Result unit
 Standard sample volume, diluting sample volume and diluent volume
 Reagent volume (R1 and R2)
 Sample blank

7.2 Biochemistry setup 7 Chemistry
 Twin chemistries
 Pretreatment parameters
7 Select Exit.
7.1.3 Exporting chemistries

Open-reagent chemistries, as well as the processing parameters error detection limits and slope
and offset, can be exported to a storage device.
To export chemistries
1 Select Utility > Chemistries, select Config F3 and then Options.
2 Select Export.
Figure 7.2 Export window
3 Use the following buttons to export desired chemistries:

 Add All>>: add all chemistries in the Available Chemistries list to the Exported
Chemistries list.
 Add ->: add the selected chemistries in the Available Chemistries list to the Exported
Chemistries list.
 <-Remove: remove the selected chemistries from the Exported Chemistries list.
 <<Remove All: remove all chemistries from the Exported Chemistries list.
4 Select Export.
5 Select the path to export and input the file name.
The default file name is composed of the current date and time, such as 20140827_0951.
The file format is .csv.
6 Select Save.
7 Select Exit.
7.2 Biochemistry setup

This section describes the setup of open-reagent chemistry and closed-reagent chemistry.

7 Chemistry 7.2 Biochemistry setup
7.2.1 User-defined chemistry setup

User-defined chemistry, also called open-reagent chemistry, can be defined, edited and deleted.
Only when the system status is Standby, Incubation or Stopped, can be operations be done.
Defining a chemistry
Up to 200 chemistries can be defined.
To define a chemistry
2 Choose a blank frame in the chemistry list, and select Define F1.
Figure 7.3 Chemistry Type window
Biochemistry is selected by default.

3 Select OK.
4 Set the processing parameters and error detection limits of the chemistry.
 For more information on setup of processing parameters and error detection limits, see
7.2.2Processing parameters on page 7-6 and 7.2.3Error detection limits on page 7-10.

6 Select Close F8 to exit the window.
7 To set up the reference range, select Ref Range F4.
8 To set up slope and offset, select Slop/Offset F5.
Editing user-defined chemistry

You are allowed to edit user-defined chemistries if:
 You have sufficient permissions, and
 The system is not running tests.
Editing user-defined chemistries is similar to defining a chemistry Refer to other sections in this
chapter for details.
If any of the following chemistry parameters are changed, a calibration is required:
 Primary wavelength
 Secondary wavelength
 Blank time
 Reaction time
 Reagent volume (R1/R2)
 Standard sample volume, diluting sample volume and diluent volume
 Reaction type
 Reaction direction Sample blank and result unit

 Twin chemistries
Deleting a user-defined chemistry

Make sure that you have sufficient permission to delete a chemistry you have defined. When a
chemistry is deleted, all relevant test results, data and parameters are cleared.
To delete a user-defined chemistry
1 Remove the reagent from the reagent carousel.
3 Select the chemistry in the chemistry list.
4 Check if the following conditions are satisfied:
 The selected chemistry is not requested or run for samples, calibrators and controls.
 The selected chemistry is disabled.
 The corresponding reagent has been unloaded from the reagent carousel.
5 Select Delete F2.
7.2.2 Processing parameters

This section describes the setup of processing parameters. The processing parameters setup
window is as shown below:
Figure 7.4 Processing parameters setup window
Chem
Chemistry name is the only identity of a chemistry and must not be duplicate. A chemistry name
can be composed of up to 10 characters.
No.
No. is a unique number for chemistry. It can be left blank but must not be duplicate. Chemistry
number is composed of numbers, and it ranges from 1-400 for open-reagent chemistries.
Sample type
Sample type refers to the samples to which the chemistry is applicable. The options include
serum, plasma, urine, CSF and other. The options available in the Sample Type drop-down list
are those supported by the chemistry, and the default is the default sample type.

The system allows definition of chemistry parameters for more than one sample type, including
the processing parameters and error detection limits. During definition of chemistries, the
parameters should be firstly defined for serum sample, and then other sample types. Such
chemistries will be calibrated with serum sample parameters by default.
Chemistry
Chemistry is the complete form of chemistry name. It can be composed of up to 50 characters.
The input is not case sensitive. The Chemistry field can be left blank or duplicate.
A chemistry is only represented by its print name on patient reports and appears on other
reports in the form of short name.
Print Name
Print name is displayed on patient reports representing a chemistry. 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 chemistry name will appear on reports. A chemistry is represented by its
short name on all reports other than patient reports.
Reaction Type
Reaction type is a measurement theory based on which chemistries are run for samples and
then calculated. The system supports three reaction types, which are Endpoint, Fixed-time and
Kinetic.
Table 7.1 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.
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, 405nm, 450nm, 510nm, 546nm, 578nm,
630nm, and 670nm.

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, 405nm, 450nm, 510nm, 546nm,
578nm, 630nm, and 670nm.
Unit
Changing the result units of the chemistries are allowed.
 For closed-reagent chemistries, 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 chemistries, 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.
Decimal
Decimal specifies the number of decimal places for test results. The decimal is allowed to be
edited. Up to 3 decimal places can be set up and respectively correspond to 0, 0.1, 0.01 and
0.001.
Incubation Time, Blank Time and Reaction Time
Incubation time refers to the period between sample addition and R2 addition. It is applicable to
double-reagent chemistry.
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.
Incubation time, blank time and reaction time are counted in measuring points. Suppose the
incubation time is F, the blank time range is N-P and the reaction time range is L-M.
For single-reagent chemistry, 0 point is the measuring point at which sample is added; for
double-reagent chemistry, 0 point is the measuring point at which R2 is added.
Table 7.2 Input range of incubation time, blank time and reaction time for endpoint analysis
Endpoint Incubation Blank time Reaction time K
time
When the blank absorbance is read before the reaction begins,
Single-reagent / -9≤N≤P≤-1 1≤L≤M≤68 K1
Double-reagent 0≤F≤34 -F≤N≤P≤-1 1≤L≤M≤34 K2
When the blank absorbance is read after the reaction begins,
Single-reagent / 1≤N≤P P＜L≤M≤68 1
Double-reagent 0≤F≤34 1≤N≤P P＜L≤M≤34 1
When the blank absorbance is not subtracted,
Single-reagent N/A N and P are 1＜L≤M≤68 0
blank.

Double-reagent 0≤F≤34 N and P are 1＜L≤M≤34 0

blank.
Table 7.3 Input range of incubation time, blank time and reaction time for fixed-time and Kinetic analysis
Fixed-time and Incubation Blank time Reaction time K
Kinetic time
When the blank absorbance is read before the reaction begins,
Single-reagent N/A -9≤N≤P≤-1 1≤L≤M≤68 K1
Double-reagent 0≤F≤34 -F≤N≤P≤-1 1≤L≤M≤34 K2
When the blank absorbance is not subtracted,
Single-reagent N/A N and P are 1≤L≤M≤68 0
blank.
Double-reagent 0≤F≤34 N and P are 1≤L≤M≤34 0
blank.
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 2 μL to 45μL with an increment of 0.1 μL. The default is 2 μL. 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 2 μL to 45 μL with an increment of 0.1 μL. The default is blank. A maximum of one
decimal is allowed.
Diluent volume refers to the amount of diluent used for sample dilution. It ranges from 100 μL
to 250 μL with an increment of 0.5 μL. 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 125μL -
295 μL; 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. It ranges
from 2 μL to 45μL with an increment of 0.1 μL. The default is blank. A maximum of one decimal
is allowed.
Increased sample volume indicates the sample amount required for an increment test. It ranges
from 2 μL to 45μL with an increment of 0.1 μL. The default is blank. A maximum of one decimal
is allowed.
Sample Blank
sample interference (Hemolysis, icterus and lipemia) on absorbance readings. Sample blank is
only effective for single-reagent endpoint chemistries.
Mark the Sample Blank checkbox with a tick. The chemistry will be sample blanked before the
reaction begins, and the Sample Blank checkbox on the Options and Rerun windows will be
selected automatically and cannot be modified.

Auto Rerun
The Auto Rerun option is used to rerun the chemistries when the auto rerun conditions are
satisfied.
Mark the Auto Rerun checkbox means enabling the auto rerun option.
 For more information about auto rerun, see 6.2.6Rerunning samples on page 6-7.
Reagent Volume
Reagent volume specifies the reagent amount, which should be dispensed for measurement.
 R1: 100 μL to 250 μL with an increment of 0.5 μL.
 R2: 10 μL to 250 μL with an increment of 0.5 μL.
NOTE
The combined volume of all reagents and sample must be within 100 μL and 360 μL.
7.2.3 Error detection limits

This section describes the setup of error detection limits. The error detection limits setup
window is as shown below:
Figure 7.5 Error detection limits setup window
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 linearity range for standard, increased and decreased sample volume test should be set
separately. The input should be no more than 12 digits, and the default is blank.
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 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. The
default is blank, which means not performing this check.
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,
 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 -40000-40000. The default is blank,
which means not performing this check.
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 -40000-40000, 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".
The default is -40000-40000; the field can be left blank.
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 -40000-40000, 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
-40000-40000, 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".
On-board Stability
It 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.
Twin Chemistry
Twin Chemistry is associated with the current chemistry, and the two chemistries are run with
the same reagent. Results of two twin chemistries are calculated in the same test.
The chemistry whose result will be firstly calculated should be defined prior to the associated
chemistry. Volume of the shared reagent and sample volume must be the same for the two
chemistries. Only the two chemistries that have had no reagents loaded can be configured as
twins.
 For more information about twin chemistries, see 7.5 Twin chemistr on page 7-21.
Reagent Alarm Limit

Set up the reagent alarm limit for the chemistry. The input range is 1-100, and the default is 10.
It can be left blank. When the number of chemistries left is lower than the limit, an alarm will
occur; if no alarm limit is defined, the system will not give an alarm.
Only when sample type is Serum can reagent alarm limit be defined.
Enzyme Linear Extension
Linearity limit is only applicable to Kinetic analysis. Select this option to enable enzyme linear
extension function.
 For more details of enzyme linear extension, see Enzyme linearity range extension on page
12-7.
Prozone Check
The Prozone check can be performed by means of rate check
You are required to set up the following six parameters for the rate check method, which are Q1,
Q2, Q3, Q4, PC and ABS. The unit is the same as the reaction time and blank time.
Enter the six parameters as follows:
 Single-reagent chemistries: 1≤q1<q2<q3<q4≤68, "1" is the first measuring point
after the sample is dispensed and stirred.
 Double-reagent chemistries: 1≤q1<q2<q3<q4≤34, "1" is the first measuring point
after R2 is dispensed and stirred.
 PC: any integer between -99999999 and 99999999.
 ABS: any integer between -99999999 and 99999999.

7.2.4 Using qualitative result

When the analyzer is in the status of standby, incubation, or stopped, you can flag the result of
the chemistries qualitatively and the results will be represented by a qualitative flag.
To use qualitative result
2 Select the desired chemistry.
3 Select Define F1.
4 Select Qualitative F3.
Figure 7.6 Qualitative result window
5 Select Use Qualitative Result.

6 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 chemistry 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 chemistry 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.
7 Select OK to save the setup.
7.2.5 Slope and offset adjustment

The slope and offset are calculation factors that are used to compensate the test results of a
chemistry when the QC result of the chemistry 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.
Before setting up the calculating factors, make sure that you have sufficient permissions and the
system is not running tests.

To set up slope and offset

2 Select Slope/Offset F5.
Figure 7.7 Slope/Offset Adjustment window
3 Choose a chemistry.
4 Double click the Slope field and then input the slope.
5 Double click the Offset field and then input the offset.
7 To restore the factory settings of slope and offset, select Restore Defaults.
8 Select Close the exit the window.
7.2.6 Reference/Critical range setup

The system allows the setup of reference/critical ranges for each chemistry.
 Reference range indicates the allowable concentration range of a normal sample.
 Critical range is the allowable result range from the perspective of clinical diagnosis.
If the calculated sample concentration is beyond the defined reference range or critical range,
the following flags will be given:
Table 7.4 Flags for test result beyond reference range and critical range
Condition Flag
Greater than the high limit of the reference range ^
Less than the low limit of the reference range v
Greater than the high limit of the critical range ^!
Less than the low limit of the critical range v!
The system provides auto rerun of ISE test. When ISE test result is beyond the set critical range,
the ISE test will be rerun automatically.
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

To define/edit reference/critical range
2 Select Ref Range F4.
Figure 7.8 Reference/Critical Range Setup window
3 Choose a chemistry from the Chemistry drop-down list.

4 Set the applicable sample type, patient gender and age range
5 Set the reference range and critical range.
6 To rerun the ISE chemistry when its test result is beyond the critical range, mark the Auto
Rerun check box with a tick.
 For more information about auto rerun, see 6.2.6samples on page 6-7
7 Select Save F7. The reference/critical range are displayed in the middle list.
8 Select Prev F4 or Next F5 to set up reference/critical range for more chemistries.
Setting up default reference/critical range

You are allowed to select a default reference/critical range for a sample type and gender. The
default range appears in red. Only one default reference/critical range is allowed for the same
sample type and gender of each chemistry.
To set up default reference/critical range
3 Choose the chemistry, sample type, gender and age range.
4 Choose a reference/critical range in the middle list.
5 Select Set Defaults F1.
The selected reference/critical range is set as the default of the chemistry. The system will
check the test result, and if necessary, flag and rerun the chemistry.

7.3 ISE chemistry setup 7 Chemistry
Deleting a reference/critical range

You are allowed to delete the set reference range and critical range.

3 Choose the chemistry name, sample type, gender and age range.
4 Choose a reference/critical range you want to remove.
5 Select Delete F2, and then select OK.
6 To clear all ranges of the chemistry, select Del All F3, and then select OK.
7.3 ISE chemistry setup

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 chemistries 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 chemistry
parameters for serum.
ISE chemistry parameters can be viewed but cannot be modified and reconfigured. ISE test
results can be expressed by qualitative flags.
Figure 7.9 Define/Edit ISE Chemistries window
7.3.2 Viewing ISE chemistry parameters

The ISE chemistry parameters are open to all users for viewing in any system status.

2 Choose the ISE box.
3 Select Define F1.
4 View the parameters.
5 Click Exit to close the window.

7 Chemistry 7.3 ISE chemistry setup
7.3.3 Description of ISE chemistry parameters

ISE chemistry parameters and measurement range are displayed on the Define/Edit ISE
chemistries screen. ISE chemistry has two test mode: serum and urine. For urine, it has to be
diluted manually before test.
In the following table, U stands for urine and S for serum.
Table 7.5 ISE chemistry parameters(cannot be edited)
Parameter/Chemistry K+ Na+ Cl-
Unit (S) mmol/L mmol/L mmol/L
Unit (U) mmol/L mmol/L mmol/L
Decimal (S) 0.01 0.1 0.1
Decimal (U) 0 0 0
Measurement Range 1.00–8.00 100.0–200.0 50.0–150.0
(S)
Measurement Range 5–200 10–500 15–400
(U)
Unit
The unit of K, Na and Cl is mmol/L which can be viewed but cannot be edited.
Decimal
The decimal of the result can be viewed but cannot be edited.
Measurement range
The measurement range can be viewed but cannot be edited.
7.3.4 Using ISE qualitative result

To use ISE qualitative result
2 Choose the ISE box, select Define F1, and then click the down arrow button.

7.4 Chemistry configuration 7 Chemistry
Figure 7.10 Define/Edit ISE Chemistries window
3 Select Use Qualitative Result under Na.

4 Enter the qualitative range and flag.
For instance, type in "10" in the first edit box of the Range field under Na, and then enter
"+" in the Flag field of the same row. If the Na concentration (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 Na concentration (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 steps 5-6 to flag the qualitative result for K and Cl.
6 Click OK to save the setup.
7.4 Chemistry configuration

The Chemistry Configuration function is used to enable/disable chemistries that have been
defined correctly and customize their display order on the Sample, STAT Sample Program and
Quality Control screens.
7.4.1 Enabling chemistries

Only the enabled chemistries can be requested for measurements and recalled on results
screens. The closed-reagent chemistries are enabled by default after being imported from a
chemistry file; while the open-reagent chemistries will be enabled only if the parameters are set
up correctly. If an ISE module is configured, the ISE chemistries will always be enabled.
The system allows up to 200 chemistries to be enabled. The number of open-reagent
chemistries can be adjusted according to the practical situations in your laboratory.
To enable chemistries
2 Select Config F3.

7 Chemistry 7.4 Chemistry configuration
Figure 7.11 Chemistry Configuration window
3 Choose one or more chemistries in the Available Chemistries list.

4 Select Add->.
The selected chemistries are enabled and appear in the Configured Chemistries list.
5 To enable all available chemistries, select Add All>>.
All chemistries in the Available Chemistries list are enabled and displayed in the
Configured Chemistries list.
6 Select OK.
7.4.2 Disabling chemistries

Some chemistries that will not be used for the moment can be disabled, and will no longer
appear on request screens. ISE chemistries and SI are always available and cannot be disabled.
Results of disabled chemistries cannot be recalled until the chemistries are enabled again.
A chemistry can be disabled only if:
 It is not an ISE chemistry.
 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 Programmed, Incomplete or
Rerun status.
To disable chemistries
2 Select Config F3.
3 Choose a chemistry in the Configured Chemistries list.
4 Select <-Remove.
The selected chemistry is disabled and removed from the Configured Chemistries list.
5 To disable all chemistries, select <<Remove All.
All chemistries in the Configured Chemistries list that meet the requirements are disabled.
The disabled open-reagent chemistries are indicated in red.

7.4 Chemistry configuration 7 Chemistry
If one of the chemistries does not satisfy the requirements, the operation will be aborted
and all the chemistries cannot be disabled.
6 Select OK.
7.4.3 Customizing chemistry display order

Chemistries can be customized to match the test order of your laboratory and will be refreshed
on the request screens.
Chemistries on the Chemistry Configuration window are displayed alphabetically. In case an
ISE module is configured, Na, K and Cl will appear on the first three positions in the Configured
Chemistries list. In the Available Chemistries and Configured Chemistries lists, click the
Chemistry or Module header line to sort the chemistries by name or by module.
To customize chemistry display order
2 Select Config F3.
4 Use the following buttons to adjust the chemistry's display order:
 Home: to move the chemistry to the first position.
 Up: to move the chemistry to the previous position.
 Down: to move the chemistry to the next position.
 End: to move the chemistry to the last position.
5 Select OK.
The chemistry list on the request screens are refreshed automatically.
7.4.4 Adjusting test order of chemistries

Test order of configured biochemistries can be adjusted manually. During sample analysis, the
chemistries are run in the order of ISE chemistries, SI, and then biochemistries. If multiple
biochemistries are requested, they will be run in the default order. If the test order is adjusted
manually, the biochemistries will be run in the updated order.
Only users with corresponding permission are allowed to adjust the test order of
biochemistries.
To adjust test order of chemistries
2 Select Config F3.
3 Select Options, and then select Test Order.

7 Chemistry 7.5 Twin chemistry
Figure 7.12 Test Order window

5 Use the following buttons to adjust the chemistry’s test order:
6 Select OK.
7 To restore the default test order, select Restore Defaults.
7.5 Twin chemistry

Twin chemistries are run and calculated based on the same reagent. Results of the two twin
chemistries are calculated through the same test. Take the reagent HBA1C as an example. It can
be used for running two chemistries in the same test. The chemistry HB is measured during the
former reaction period, while the chemistry HbA1c measured during the latter one. Finally,
HbA1C (%) can be calculated based on results of the two chemistries.
Similar to normal chemistries, twin chemistries can be run only when the following settings are
finished:
 defining chemistries
 assigning reagent position
 setting up calibrator and calibration rule
 setting up control and QC rule

7.5 Twin chemistry 7 Chemistry
7.5.1 Chemistry definition

Twin chemistries can be defined in the same way as normal chemistries. The following
parameters, however, must be set up differently for two twin chemistries:
 Sample type
 Normal sample volume, increased sample volume, and decreased sample volume
 Volume of the same reagent type
 Prozone check
For setup of chemistry parameters, see 7.2 Biochemistry setup on page 7-4.
A chemistry that has been set as the twin of another chemistry must not have another twin.
When twin chemistries are defined, both chemistries must be calibrated.
7.5.2 Removing twin relation

To remove the twin relation between two chemistries, cancel the selection of a twin chemistry.
Only when reagents of the two chemistries are unloaded can the twin relation between them be
removed.
7.5.3 Reagent setup

Twin chemistries are run with the same reagent in the same position. The reagent can be loaded
manually or through bar code scanning.
Manual load
You are only required to manually set up reagents for one of the twin chemistries. The reagent
of the same type for the other twin chemistry will be automatically set up with the same
position.
Automatic load
Place the bar-coded reagents of twin chemistries on the reagent carousel, the system will scan
the reagent bar code and automatically assign the same position for the same reagent of the
twin chemistries.
If reagent loading fails for either of the twin chemistries, both chemistries cannot be run.
For details of reagent loading, see 2.3.1reagents on page 2-10.
7.5.4 Setting up and requesting calibration

Calibration setup
The calibrator, number of replicates and auto calibration conditions must be the same for two
twin chemistries.
 For calibration settings, see 4.2.1 Calibration setup on page 4-5.
Twin chemistries can be requested for calibration in the same way as normal chemistries.
When either of the twin chemistries is requested, the other twin will be requested automatically,
and finally both chemistries will be calibrated. You are allowed to recall the calibration results,
calibration curves and reaction curves of the two chemistries.

7 Chemistry 7.6 Special Calculations
7.5.5 Setting up and requesting quality control

QC setup
Twin chemistries must be defined with the same control, and the QC setup of twin chemistries is
the same as that of normal chemistries.
For QC settings, see 5.2 QC setup on page 5-3.
Twin chemistries can be requested for quality control in the same way as normal chemistries.
and finally both chemistries will be run for quality control. You are allowed to recall the QC
results and QC reaction curves of the two chemistries.
7.5.6 Sample programming and processing

Twin chemistries can be requested for sample analysis in the same way as normal chemistries.
and finally both chemistries will be run for sample analysis. You are allowed to recall the sample
results and sample reaction curves of the two chemistries.
7.6 Special Calculations

Calculation of certain chemistries can derive new chemistries of clinical purposes, such as A/G
(ALB/ (TP-ALB)), I-BIL (T-Bil - D-Bil), etc.
A calculation is composed of chemistries, calculation operators and algorithm. Only users with
sufficient permissions are allowed to define, modify and delete calculations.
7.6.1 Defining/Editing a calculation

Importing and defining calculations is supported. The system allows a maximum of 50
calculations to be defined.
 For importing methods of closed calculations, see 7.1.1 Importing default chemistry list on Page
7-2.
To define/edit a calculation
2 Select Calculations F6, and then elect Define F1.

7.6 Special Calculations 7 Chemistry
Figure 7.13 Special Calculations window

 Abbreviation name and full name
 Sample type
 Print name
 Result unit and decimal place
4 If you are going to use the calculation for analysis, mark the Enable checkbox. Select Flag to
flag the result of the calculation.
5 Edit the calculation formula:
 Choose chemistries in the Chemistries list. The chemistries are then displayed in the
Formula field.
 Choose numbers and operators in the Mathematical Symbols area to constitute the
calculation formula along with the chemistries.
 To remove a chemistry, number or operator, move the cursor behind them and select
BS.
 To clear the entire formula, select AC.
6 Select Flag qualitative results if you want to flag the qualitative results.
For more information on using qualitative results, see 7.2.4 Using qualitative result on page
7-13.
7.6.2 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.
To enable/disable calculations
2 Select Calculations F6.
3 To activate a calculation, mark the Enable checkbox.

7 Chemistry 7.7 Panels
4 To inactivate a calculation, deselect the Enable checkbox.
7.6.3 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.
To delete user-defined calculations
2 Select Calculations F6.
3 Choose calculations to delete.
4 Select Delete F2.
7.6.4 Running calculations

Calculations will not be run for calibration, but for quality control and sample analysis along
with other chemistries.
If a chemistry contained in a calculation is run for more than one replicates, the final result of
the chemistry will be used to calculate the result of the special calculation.
7.7 Panels
A couple of chemistries combined together for certain clinical purposes can constitute a panel,
such as liver function, kidney function, etc. Panels can help fast programming of samples.
Panels can be composed of biochemistries and ISE chemistries. The system allows a maximum
of 100 panels to be defined. Only users with sufficient permissions are allowed to define, modify
and delete panels.
7.7.1 Defining/Editing a panel

To define/edit a panel
2 Select Panels F7, and then select Define F1.
Figure 7.14 Define/Edit Panels window
3 Type in the panel number and name.

7.7 Panels 7 Chemistry
4 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.
5 Choose chemistries for the panel.
At least one biochemistry should be selected.
6 Select Save F7.
7.7.2 Adjusting display order of panels

Display order of panels on the Sample and Quality Control screens can be adjusted manually
for convenient test requisition.
To adjust display order of panels
2 Select Panels F7.
3 Select the panel you want to move.
4 Select Up F3 to move the current panel to the previous position, or select Down F4 to
move it to the next position.
7.7.3 Deleting panels

Panels can be deleted by users with sufficient permissions while the system status is not
Running. When a panel is removed, the chemistries contained in it will still remain and can
constitute panels with other chemistries.
To delete panels
2 Select Panels F7.
3 Choose panels to delete.
4 Select Delete F2.
7.7.4 Running panels

Panels will not be run for calibration, but for sample and control analysis along with other
chemistries.
7.7.5 Setting up and running default panel

The system allows a maximum of one default panel to be defined. When a bar-coded sample has
no relevant programming information on the LIS host or has not been programmed 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 chemistries.
Only a sample panel rather than control panel can be set as the default.
To define the default panel
1 Select Utility > Chemistries, and then select Panels F7.
2 Choose the desired panel in the panel list.

7 Chemistry 7.8 Off-system chemistry
3 Mark the Default check box in the same row as the selected panel.
To running the default panel for patient sample
1 Load bar-coded samples to the sample carousel.

4 Select OK.
7.8 Off-system chemistry

All the chemistries that are not run by the analyzer are referred to as the off-system chemistries.
You can manually enter the off-system chemistry results into the system to print out them in
the patient report
There are two types of off-system test: qualitative and quantitative.
 Qualitative chemistries: No numeric results are obtained but the flags you defined on
the system. Reference value can be set for the qualitative chemistries
 Quantitative chemistries: Numeric results and defined flags are displayed and printed.
Reference range can be set for the quantitative chemistries
7.8.1 Defining/Editing off-system chemistry

To define/edit off-system chemistry
2 Select a blank chemistry box, and select Define F1.
3 Select Off-system, and select OK.
Figure 7.15 Define/Edit chemistries
4 Enter the following chemistry parameters:

 Abbreviation name and full name
 ID number
 Print name

7.9 Carryover setup 7 Chemistry
 Attribute and reference value

 Result unit and decimal place
5 To set up result flags for quantitative result, perform the following steps:
a. Select the Use Qualitative Result check box.
b. 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 chemistry 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 chemistry 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.
6 Select Save F7.
7 Select Exit F8.
7.8.2 Running off-system chemistry

After the off-system chemistries are programmed, you can edit their results on the Result
screen. The results of the off-system chemistries can be edited in any status of the sample.
To run off-system chemistry
1 Program off-system chemistries on the Program > Sample screen.
For more information on sample programming, see 2.4.1samples on page 2-22.
3 Select the desired sample in the sample list.
4 Select Option F2, and select Edit Results.
5 Select the requested off-system chemistries, and input the results.
6 Click Save.
7.8.3 Deleting off-system chemistry

When the system status is not running, the off-system chemistries can be deleted.
To delete off-system chemistry
2 Select the off-system chemistry you want to delete.
3 Select Delete F2.
7.9 Carryover setup

The Carryover Setup option is used to set up the carryover relations between open-reagent
chemistries and between cuvettes. The system will insert a cleaning to reagent probe and
cuvettes based on the carryover settings. The closed-reagent chemistries have been set up by
the manufacturer and cannot be viewed or edited, while the open-reagent chemistries need to
be set up on the Carryover window.
When carryover settings are performed for a twin chemistry, the other twin will update
synchronously.
Carryover setup can only be performed by users with sufficient permissions when the system
status is not Running.

7 Chemistry 7.9 Carryover setup
7.9.1 Defining/Editing carryover pair

To define/edit carryover pair
1 Select Utility > Chemistries, and select Carryover F8.
Figure 7.16 Carryover window
2 Choose one or all contaminator chemistries that may contaminate other chemistries.
"ALL" means all chemistries may contaminate others.
3 Choose one or all contaminated chemistries in the Contaminated list.
"ALL" means all chemistries may be contaminated. All (the entire contaminator) to All (the
contaminated) is not permitted to set up.
4 Choose contaminator reagent that may contaminate other reagent.
5 Choose the contaminated reagent.
6 Choose a wash type.

The options include special wash and routine wash.
7 Define the wash cycle.
Only when either of the contaminator or contaminated is ALL, you are enabled to define
wash cycle (1-5).
8 Select Save F7.
The defined carryover pair appears in the Carryover Pairs list. To abort the carryover
settings, select Discard F6.
9 Select Define F1 and follow the above steps to set up other carryover pairs.
7.9.2 Removing a carryover pair

To remove a carryover pair
1 Select Utility > Chemistries, and select Carryover F8.
2 Choose desired carryover pair.
3 Select Delete F5.

7.10 Masking/Unmasking chemistries 7 Chemistry
4 Select OK to confirm the deletion.

7.10 Masking/Unmasking chemistries

The chemistry masking function is used when a chemistry needs to be disabled temporarily due
to abnormal result or reagent exhaustion. Masked chemistries can be requested but cannot be
run until they are unmasked.
In any system status chemistries can be masked or unmasked. Any users are allowed to mask or
unmask chemistries.
If a sample contains masked chemistries, it will enter the Incomplete status when finished; if
chemistries are unmasked while the sample status is Programmed, the they will be run along
with other chemistries; if chemistries are unmasked while the sample is being analyzed, they
will be added automatically to the analysis; if chemistries are unmasked after the sample is
analyzed, they will be run automatically when analysis begins next time.
To mask/unmask chemistries
3 Select Mask/Unmask Chem.
Figure 7.17 Mask/Unmask Chemistries window
4 Choose chemistries to mask, select OK.

The marked chemistry will have a symbol appearing on its upper-left corner, and will
still be displayed on the Sample, Quality Control and Reagent/Calibration screens.
5 To unmask chemistries, select them and then select OK.
7.11 Reflex
The Reflex option allows related chemistries to be requested and run automatically when the
deciding biochemistry's result is within specified range. Each biochemistry may embrace
multiple reflex conditions, and each condition may contain a maximum of 20 related chemistries.

7 Chemistry 7.11 Reflex
Reflex conditions and related chemistries are open for observation, but only users with
corresponding permission are allowed to set, modify or delete reflex relation.
7.11.1 Setting up reflex relation

Before using the reflex function, it must be enabled with reflex conditions and related
chemistries configured. Please note that the chemistries in a reflex condition must have existed.
When the system status is running, the reflex function cannot be set up.
To set up reflex relation
2 Choose a chemistry for which you desire to configure reflex settings, and then select Define
F1.
3 Select Reflex F2.
Figure 7.18 Reflex window
4 Mark the Enable Reflex Function checkbox to activate this option.

5 Set up reflex conditions.
Two conditions are available: "or" and "and":
 or: When the test result (concentration) is greater than certain value OR less than
certain value, the related chemistries will be requested and run automatically.
 and: When the test result (concentration) is greater than certain value AND less than
certain value, the related chemistries will be requested and run automatically.
Select an option and input the concentration range.
6 Choose related chemistries in the chemistry list.
The options include all configured biochemistries.
7 Select OK.
The defined reflex relation is shown in the left list.
7.11.2 Editing reflex relation

Only users with corresponding permission are allowed to edit reflex relation.

7.11 Reflex 7 Chemistry
To edit reflex relation

1 Select the desired reflex relation on the Reflex window.
2 Modify the condition and related chemistries.
3 Select OK.
7.11.3 Deleting reflex relation

Only users with corresponding permission are allowed to delete reflex relation. If a chemistry is
deleted, the corresponding reflex relation to which it is related will be removed automatically.
To delete reflex relation
1 Select the desired reflex relation on the Reflex window.
2 Select Delete.
3 Select OK.
7.11.4 Measurement and result recall

Chemistries with reflex settings are run in the same way as routine biochemistries. When the
test result meets the set condition, the related chemistries will be requested and run
automatically while those that have been requested for the sample will be excluded. To view the
results, select Result > Current or History.

8 Utility
This chapter provides descriptions of system commands, system setup, instrument setup, print
setup, bar code setup, LIS setup, and user setup.

8.1 System commands 8 Utility
8.1 System commands

The system provides two commands: Home and Stop Print, which are respectively used to
restore the system into standby status and stop the printing.
8.1.1 Home
The Home command is used to initialize the biochemistry system and the ISE module, and to
recover them from failures, making all components return to the home positions. When the
Home command is executed, the system status becomes Standby.
To home the system
1 Select Utility > Commands.
2 Select Home.
8.1.2 Stop print

The Stop Print command will stop all print requests in the print queue and prevent them from
being sent to the printer. This feature is used for stopping print requests of many pages, such as
error logs, QC reports, multi-sample reports, etc. The print tasks that are Printing, Deleted,
Canceling or Canceled in the print task window will not be deleted.
To stop printing
1 Select Utility > Commands.
2 Select Stop Print. All print requests in the print queue will be removed.
8.2 System setup

This section describes the setup options on the System Setup screen, which includes the
following pages:
 Sample test setup page
 Auto rerun setup page
Click the arrow buttons on the right to switch between the two pages.
Select Utility > System Setup to display the following screen:

8 Utility 8.2 System setup
Figure 8.1 System Setup screen
8.2.2 Sample test setup page

The following setup options are provided on the sample test setup page.
Default sample type
The system supports a couple of sample types, which include serum, plasma, urine,
cerebrospinal fluid samples (CSF) and other. The default is serum. When the default sample type
is set up, it will be selected by default for programmed samples on the Sample screen.
Default sample cup type
The system supports the standard sample cup and Microtube. The default is the standard sample
cup. When the default sample cup type is set up, it will be selected by default for programmed
samples on the Sample screen.
Valid period of samples
Valid period of samples refers to the time interval that a patient sample is first loaded to the
sample carousel and then expired. When the valid period of samples is set up, only samples
within this period are allowed for analysis. If the valid period is not set up, the samples are valid
all the time.
The valid period ranges from 1 to 99 in hour or day. The default is day.
Valid period is applicable to patient samples rather than calibrators and controls. Once the
collection time is entered, the system will calculate the valid period from the time when the
sample is collected; otherwise, the time when the sample is programmed will be used for
calculating the valid period.
Reaction temperature monitoring
The reaction temperature can be monitored before analysis begins.

8.2 System setup 8 Utility
 When the Start Analysis When Temperature is Steady checkbox is selected, the
system will check before analysis begins if the reaction temperature is normal. If the
temperature is normal, you are allowed to select to start analysis; otherwise, 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 reaction temperature is
normal and within 37±2.0°C. If the temperature is normal, you are allowed to select
to start analysis; otherwise, the system will remind you that the results may be
influenced if you continue to start analysis. You may continue or abort the analysis.
Alarm when reagent exhausted
Each chemistry can have more than one bottle of reagent loaded. You can set up alarms for the
case that the reagent is running out.
Select the Alarm when reagent exhausted option. When the reagent is exhausted, the system
will give an alarm. If the option is not selected, the system will not give an alarm.
Manage reagents by lot
This option is used to monitor the calibration status and time of each reagent lot, supports
reagent lot calibration, and displays calibration results of each reagent lot.
When this option is enabled, special attentions should be paid for the following operations:
 Loading reagents: You are required to input the lot number when loading reagents
manually. The lot number of bar-coded reagents cannot be left blank; otherwise,
reagent load will fail.
 Viewing calibration status and requesting calibration: You can view calibration status
and time of each reagent lot, and request calibration accordingly.
 Recalling calibration results: You can recall calibration results of each reagent lot on
the Biochemistry Calibration screen.
 Auto calibration: Auto calibration by reagent bottle or lot is forbidden. When a
different reagent lot is used, the system will request and run calibration
automatically. Reagent lots with valid calibration factors will not be calibrated again
when used for measurement.
Special wash before test
Select this option to execute a special wash with wash solution for the sample probe, reagent
probes and mixers before a batch of tests. If it is unselected, no special wash will be performed
before a batch of tests.
Pause Immediately
If this option is selected, when you click the pause button on the right corner of the main screen ,
the system will pause immediately after one test cycle about 18 seconds.
Result display settings
This option is used to set up 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.
Click the relevant color setup button, choose desired color, and then select OK. The system will
display flags in the Flag column of the Current Results and History Results screens and on
patient reports if the test result is less than or greater than the reference range. 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 set color.

8 Utility 8.2 System setup
Reagent alarm limit

Reagent alarm limit is only applicable to ISE reagent. The input range is 1-50, and the default is
5. If the inventory alarm limit is set up, the system will give an alarm and mark the reagent with
colors when the reagent inventory is less than the alarm limit.
Alarm Sound volume
This option is to adjust the volume of alarm tone and beep. Alarm tone is the sound of a system
alarm and beep is given when mis-input or mis-operation occurs. Volume of both sounds can be
adjusted manually according to the practical conditions of the environment. Drag the slider in
the Alarm Volume and Beep Volume fields horizontally. The scale is ascending from left to right.
When the slider is moved to the leftmost position, the alarm buzzer is silenced.
Since the Windows 8 does not support alarming through buzzer, you should install an audio card
on your computer in order to ensure the alarm and beep sound can be adjusted and given.
ISE prime cycle
Set up the ISE prime cycle. The input range is 1-50, and the default is 30.
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.
Only administrators are allowed to define or modify the startup prime times.
8.2.3 Auto rerun setup

The system provides a couple of conditions for auto rerun. When selected conditions are
satisfied, chemistries for which auto rerun has been enabled will be rerun automatically with
the specified sample volume type.
Only users who have the permissions of system setup are allowed to set up auto rerun
conditions.
Above Critical High
Select a rerun mode from the drop-down list. It means that the system will rerun the tests with
the selected mode when the test result exceeds the critical range high limit.
Unselection means this item will not be checked.
Below Critical Low
the selected mode when the test result is lower than the critical range low limit.
Above Linearity High
the selected mode when the test result exceeds the linearity high limit.
Below Linearity Low
the selected mode when the test result is lower than the linearity low limit.

8.3 Instrument setup 8 Utility
Above Highest Calib.

Select a rerun mode from the drop-down list. When selected, it means the analyzer will rerun
the sample with the selected mode automatically if its response is beyond that of the
highest-concentration calibrator.
Below Lowest Calib.
the sample with the selected mode automatically if its response is beyond that of the
lowest-concentration calibrator.
Substrate Depletion
the tests with the selected mode automatically if the substrate ran out during running.
Prozone Check Error
the selected mode when prozone occurs during reaction process.
Nonlinear
Select a rerun mode from the drop-down list. If the calculated linearity is greater than the
defined linearity limit, the system will rerun the tests with the selected mode.
No Linear Interval
the selected mode when the number of measuring points within substrate limit is less than or
equal to 3. This option applies to Kinetic method only.
No Calculation Interval
Select a rerun mode from the drop-down list. If the number of measuring points within linearity
range is less than 2 during high-activity enzyme measurement, the linearity range will be
expanded. If the number of measuring points is less than 2 even when the lag time is included,
the system will rerun the tests with the selected mode. This option applies to Kinetic method
only.
8.3 Instrument setup

On the Instrument Setup window, you are allowed to perform the following settings.
8.3.1 Auto startup setup

The Auto Startup Setup option allows you to define date and time of starting up the system.
The system allows you to choose a weekday and specific time that the system will be started up
automatically. When the time is reached, the system will be started up if it is off.

8 Utility 8.3 Instrument setup
NOTE
After setting up the auto startup time, ensure that the operation unit and the analyzer are connected to power
supply; otherwise, they cannot be started up automatically.
 For details of Auto startup setup, see Auto startup on page 2-5.
8.3.2 Masking/Unmasking Chemistries

The Masking/Unmasking Chemistries option is used to disable chemistries, which will still be
displayed on the Sample, Quality Control and Reagent/Calibration screens. Masked
chemistries can be requested but will not be run for sample analysis.
 For details of chemistry masking/unmasking, see 7.10Masking/Unmasking chemistries on page
7-30.
8.3.3 Dictionary setup

The Dictionary option is provided for setting up and managing frequent data information, such
as: result unit, sample type, sample comment, and QC comment. Sample comment can be
entered manually or selected from the Comment drop-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.
To define, edit and delete data options
1 Select Utility > System Setup, and select Instrument F1.
2 Select Dictionary.
Figure 8.2 Dictionary window
3 Choose desired dictionary in the Data list.

4 To add a data option:
a. Select New.
b. Input the data description in the Data field.
c. Select Save.

5 To modify a data option:

a. Select desired data option in the data list.
b. Modify the data description in the Data field.
c. Select Save.
6 To delete a data option:
a. Select desired data option in the data list.
b. Select Delete.
7 Select Close.
8.3.4 System communication options

The Com Setup option is used to set up the IP address for connections between the PC and
LIS/RMS .
To set up communication parameters
2 Select Com Setup. The System Communication window is displayed.
Figure 8.3 System communication setup
3 Select PC and LIS (selected by default) and PC and RMS.

4 Choose a network connection in the Network Adaptor area.
5 Set up the connection between operation unit and LIS/RMS.
 Auto Obtain IP Address(selected by default)
 Or set using Following IP Address: type in the IP Address, Subnet Mask and Default
Gateway for connecting the operation unit PC with the LIS host and RMS.
6 Select Apply.
A dialog box pops up: Check the network cable connection prior to applying new settings.
Please check the connection of the network cable and then click OK to save the settings.
8.3.5 Selecting language

The operating software is displayed by default in the same language as the current operating
software. You are allowed to change the language of the operating software.
Select System Setup > Instrument F1 > Language, and then choose a language. Select OK to
save the settings. The language you select will take effect only when you reboot the operating
software.

8.3.6 Software upgrading

Software Upgrade is used to upgrade the operating software and ISE module software. When
software versions is upgraded, the original data, including those in the database and saved in
files, will not be destroyed and can be compatible with the new versions.
To upgrade the software
3 Select Version Upgrade.
4 Insert the U disk containing the software into the USB interface of the computer.
5 Select OK, and then operate according to the screen prompts.
8.3.7 Viewing software versions

You are allowed to view the version number of the operating software and control software in
any system status.
To view the software version
2 Select Version Info.
Figure 8.4 Software Version window
3 View the version number of the operating software, model, number of open channels.
4 To view the version numbers of the smart module software, select Details.

Figure 8.5 Smart module software version window
5 Move the scroll bar to view more versions.

6 Select OK.
8.3.8 Setting up system 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 Results screen or QC evaluation and Twin-Plot chart.
To set up the system date and time
2 Select Date/Time.
Figure 8.6 Date/Time window
3 Set the current date and time.

4 Choose a date format from the Order drop-down list.

 yyyy-mm-dd: e.g. 2014-08-27

 dd-mm-yyyy: e.g. 27-08-2014
 mm-dd-yyyy: e.g. 08-27-2014
5 Choose a time format from the Time Format drop-down list.
 24-hour: e.g. 14:33:27
 12-hour: e.g. 02:33:27
6 To restore the date and time defaults, select Restore Defaults.
8.3.9 Setting up QC run length and auto QC

By choosing the QC Evaluation, you are allowed to set up the QC run length and auto QC
conditions.
 For setup of QC run, see Setting up QC run on page 12-11.
 For auto QC setup, see 5.2.4 Auto QC on page 5-5.
8.3.10 Auto release of samples

The system allows setting of daily release time of samples. When the set time is reached, samples
that are currently in Complete status will be released automatically.
 For more information on auto releasing samples, see 6.3.4 Releasing sample positionon page
6-17.
8.3.11 Voice tone setup

This option is used to customize the alarm sound and beep sound.
The Voice Tone Setup option provides voice tone choices for system failures or user’s mis-input
or mis-operation. You are allowed to import audio files from an external storage device and set
them as voice tone.
To import audio files
2 Select Voice Tone Setup.
3 Select Import.
4 Select the path and one or more favorite audio files.
5 Select Open.
The imported audio files are displayed in the Alarm and Message Tip drop-down lists.
To set up voice tone
2 Select Voice Tone Setup.

Figure 8.7 Voice Tone Setup window
3 Choose a voice tone from the drop-down list, and then select the corresponding Test
button to test the voice effect until the proper one is found.
8.3.12 Optimizing result display

This option is used to set up display mode of sample results that are beyond the linearity range.
 For more information on optimizing result display, see 6.3.8Optimizing result display on page
6-20.
8.3.13 Customizing sample information

Customizing sample information allows you to specify sample information to be displayed on
the Sample screen.
 For more information on customizing sample information, see 6.3.6Customizing sample
information on page 6-19.
8.3.14 Customizing patient demographics

You can specify patient demographics to be displayed, its default and its display order on the
Patient Demographics screen.
 For more information on customizing patient demographics, see 6.3.7Customizing patient
demographics on page 6-20.
8.3.15 Reagent/Calibration setup

Via Reagent/Calibration option on instrument setup screen, you can configure whether to
automatically refresh the reagent with 0 inventory as available for test, when reagent has been
loaded and End Load F2 button is selected.
 For more information on auto refreshing reagent volume, see 3.2.7 Checking and auto
refreshing reagent inventory on page 3-6.
8.3.16 Customizing reagent display

This option is used to set up reagent information displayed on the biochemistry
 For more information on customizing reagent display, see 3.2.5Customizing reagent display on
page 3-5.

8 Utility 8.4 Print setup
8.3.17 Customizing sample position

On the middle ring of the sample/reagent carousel, 40 sample tubes can be placed with adapters.
Before placing sample tubes on the middle ring, you should specify the sample position range so
that the samples can be identified correctly.
To customize sample position
2 Select Customize Sample Position.
3 Specify the sample position range (40-80).
For example: When 50 is input, it means that the positions from No.1 on the outer ring to
No.50 on the middle ring are used to hold samples.
4 Select Save.
5 Select Exit.
After customizing sample positions, the positions on the sample carousel and reagent carousel
are indicated as follows:
 The set positions of the inner ring on the Program > Status screen are indicated in white,
which means available for sample.
 The positions indicated with two crosses"××"on the sample carousel graph can be only used
for reagents.
 The positions indicated with a red cross " " on the Reagent > Reagent Carousel Status
screen means unavailable for reagents.
8.4 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, default printer and printed hospital name, import
print report, but also define the print order of chemistries, edit print template and preview print
template.
8.4.1 General print setup options

You can enable auto printing of patient report, calibration report and QC report, and specify a
printer and print mode.
To perform general print setup
1 Select Utility > System Setup, and select Print F3.

8.4 Print setup 8 Utility
Figure 8.8 Print setup screen
2 Enable the following auto print functions:

 Auto print patient reports
 Print after reviewal
 Auto print QC reports
 Auto print calibration reports
3 Choose a printer type.
The system supports three types of printer, which include laser printer, inkjet printer and
stylus printer.
4 Choose a default printer to print reports.
5 Choose a print mode between Paginal and Serial.
6 Select OK.
8.4.2 Editing print template

To edit print template
2 Select a report type from the Report list on the left of the window.
3 Select a template from the template list.
4 Click Edit to open the template modifying software. You can edit the report templates as
needed.
For details of the template modifying software, see 9 Template modifying software on page 9-1.
8.4.3 Importing print template

To import print template
2 Click Import to import the print template.

8 Utility 8.4 Print setup
Figure 8.9 Import print template window
3 Select a report type from the Factory drop-down list.

4 Select one or more templates in the template list to be imported, and click Import.
The selected template(s) can be imported.
5 Click Customize to import the template you edited from a tmplt file.
The legal directory should be a portable storage device. The templates can be imported in
batch.
6 Click Import
The imported templates will be displayed in the template list.
7 Click Exit to exit the window.
8.4.4 Setting up default template

To set up default template
4 Click Set Defaults to set the selected template in the template list as the default one.
8.4.5 Deleting a template

To delete a template
4 Click Delete to delete the selected template.
If it is the default one or it has the print duty, it cannot be deleted.
8.4.6 Defining chemistry print order

To define chemistry print order
2 Select Print Order.

8.5 Bar code setup 8 Utility
Figure 8.10 Print Order window
3 Use the following buttons to adjust the chemistry print order:

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.
6 To restore the factory settings, select Restore Defaults.
8.5 Bar code setup

On the Bar Code Setup window, you can set up sample and reagent bar code parameters. Only
when a bar code reader is installed, can the settings be performed.
To perform sample bar code setup
1 Select Utility > System Setup, and select Bar Code F4.
2 Choose Sample Bar Code.
3 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

8 Utility 8.5 Bar code setup
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.
4 Set up sample bar code applications.
 Enable/Disable sample carousel bar code
When this option is selected, the system scans the entire sample carousel to locate samples
at the beginning of test.
 Enable or disable auto numbering of bar-coded samples
When this option is enabled, the system will automatically number the bar-coded samples
during bar code scanning. The start number will be the next available one since the last
sample is programmed. The default start number for every day is 1.
 Extract sample information
° When this option is selected, the system will automatically extract the sample
information according to the barcode.
° Only when LIS communication mode is unidirectional, can the option be enabled.
 Define STAT sample positions on sample carousel
Input the start and end positions within the range of 1~40. The set positions will be
indicated by E (Emergent) on the sample carousel status screen. Samples placed in the
specified STAT positions will be taken automatically as emergent samples.
The Sample Crsl Bar Code and Auto Number Scanned Samples options are selected by
default.
5 Select OK to save the setup.
6 Select Format
7 Define the bar code digits.
The system can scan a sample bar code of fixed length or within 3-27 digits. The Interleaved
2 of 5 only supports bar code of even number length and the digits of the barcode must be
defined.
 To use a fixed-length bar code,
° Mark the Fixed Digits checkbox of relevant symbology.
° Type in the number of digits in the edit box to the right of the Fixed Digits field.
 To use a sample bar code within 3-27 digits, you have no need to define the fixed digits.
To perform reagent bar code setup
1 Select Utility > System Setup, and select Bar Code F4.
2 Choose Reagent Bar Code.
3 Select or deselect Analyze barcode of open reagent.
 If Reagent barcode system is configured, the option Analyze barcode of open reagent
is not selected by default
 When Analyze barcode of open reagent is selected, once the barcode of the open
reagent is identified, its information is analyzed according to its setup.
 While loading the reagent manually, you can enter the barcode of the open reagent on
the condition that Analyze barcode of open reagent is not selected.
4 Choose a bar code symbology and set up the check digit status.
The following symbologies are provided:

8.6 LIS setup 8 Utility
 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 T 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 S field.
 Type in the end digit of the reagent bar code in the E 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 S field.
 Type in the end digit of the reagent information in the E field.
Table 8.1 Reagent bar code compositions
Reagent Information Number of Digits
Chemistry number 0-4 digits
Chemistry name 0-10 digits
Reagent type 1 digit ("1" stands for R1 and "2" stands for R2)
Serial number 0-5 digits
Bottle type 1-3 digits
Lot number 0-18 digits
Expiration date 0, 4, 6 or 8 digits (4 digits: yymm; 6 digits:
yyyymm; 8 digits: yyyymmdd)
7 Select OK.
8.6 LIS setup

8.6.1 Introduction
The analyzer is connected with LIS (Laboratory Information System) through a fixed interface,
to download sample program information, send test results after test, review and print the test
results.

8 Utility 8.6 LIS setup
Figure 8.11 Connection between the analyzer and LIS
Sample program
LIS Chemistry Analyzer
Result transfer
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 program information from or sent
results to the host, you need to set up the chemistry code used for identification of chemistries
on both the LIS host and the analyzer, which, otherwise, cannot identify the chemistries
simultaneously.
8.6.2 Setting up host communication parameters

To set up host communication parameters
2 Select Host F5. The Host Communication Parameters window shows.
Figure 8.12 Host communication Parameters window
3 Set up the following parameters:

Table 8.2 Host communication parameters
Parameter Description
Transport Choose a transport mode from the Transport Mode drop-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.
Serial If you choose Serial as the transport mode, set up the following parameters:
communication  Serial port: The default is COM1.
parameters  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.

8.6 LIS setup 8 Utility
 Baud rate: 300, 1200, 2400, 4800, 9600, or 19200. The default is 9600.
Protocol Choose a protocol for connection between the analyzer and the LIS host from the
Protocol drop-down list. The options include HL7 and ASTM 1394.
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 programs from it.
 Bidirectional: You are allowed to send results and patient demographics to the
host and downloading sample programs from it.
Timeout Enter the time out limit for querying the LIS host. The input range is 30s-60s, and
the default is 30s.
If the time out limit is exceeded when you attempt to download sample programs
from, or send results to, or connect the analyzer with the LIS host, the system will
give an alarm indicating communication timed out.
Auto Connect to LIS When the checkbox is selected, the system will connect to the LIS host
automatically when started up.
Retry after When the checkbox is selected, the system will try to reconnect the LIS host for
Disconnection every set interval once the connection is interrupted.
Interval Input the time interval for which the system will try to reconnect the LIS host for
every set interval once the connection is interrupted. The default is 30 seconds.
Send Complete When the checkbox is selected, the system will automatically send results to the LIS
Samples 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 Incomplete When the checkbox is selected, the system will automatically send results to the LIS
Samples host after a sample changes from In Progress to Incomplete. This function is only
applicable to samples analyzed on the current day rather than those analyzed
before.
Advanced options Select Advanced. The Advanced window appears, providing the following options:
 Send Programmed Samples: When the checkbox is selected, the system will
automatically send the program information to the LIS host once a single or
batch routine and STAT samples are programmed.
 Rerun Finished Chemistries When Downloaded: When the checkbox is
selected, chemistries that have been finished will be rerun if downloaded again.
If this option is not selected, they will be neglected.
 Send Actual Results and Rerun Results: When the checkbox is selected, all
actual results and rerun results of each chemistry will be sent to the LIS. If this
option is not selected, only the default result will be sent.
 Bypass Results Beyond Linearity Range: When the checkbox is selected, those
results that are beyond the linearity range will not be sent to the LIS. If this
option is not selected, they will be sent.
 Ignore Alarms for Unknown Chemistries: When the checkbox is selected, the
system will not give an alarm if the samples downloaded from the LIS host
contain unknown chemistries without identification code. If this option is not
selected, an alarm will be given indicating sample programming failure.
5 Select Connect to connect the analyzer with the LIS host.

8 Utility 8.7 User and Password Setup
8.6.3 Defining channel number of chemistries

Chemistries are identified by channel number on the analyzer and LIS host. Make sure that the
channel numbers assigned to chemistries on the analyzer are consistent with those on the LIS
host; otherwise, correct information transfer cannot be done.
To define channel number of chemistries
2 Select Host F5. The Host Communication Parameters window shows.
3 View the chemistry channel number list on the right of the window.
The screen shows the chemistries and code in two columns. The left column provides all
chemistries that have been defined and set up correctly; the right column shows the code
for identifying a chemistry on the LIS host.
4 Click on the Channel No. column of a chemistry, and then type in a code for it.
5 Repeat step 4 to define a code for other chemistries.
6 Select Save.
8.7 User and Password Setup

Users can be defined, deleted or modified on the User and Password window. 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.
8.7.1 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.
To define a user
1 Select Utility > System Setup, and select User F6.

8.7 User and Password Setup 8 Utility
Figure 8.13 User and Password window
2 Enter the username.

3 Enter the password.
A maximum of 20 characters can be entered.
4 Enter the password again in the Confirm field.
5 Choose a user group in the User Group drop-down list.
 Administrator
 Operator
6 Select a doctor from Associated Physician drop-down list.
When the user and the associated physician have been set up, the default tester in the
patient demographics is the associated physician of the current login user.
7 Select New. The defined user appears in the user list.
8.7.2 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.
To modify a user
2 Choose a user to edit in the user list.
3 Enter the new username.
4 Enter the new password.
5 Enter the new password again in the Confirm Password field.
6 Choose a user group in the User Group drop-down list.
 Administrator
 Operator
7 Select Modify.

8 Utility 8.7 User and Password Setup
8.7.3 Assigning/Modifying permissions

Permissions are assigned to user groups, which include administrator and operator.
Administrators are allowed to use, assign and modify all permissions that are assigned for
operators; while operators are only allowed to use common functions, such as assigning
reagent position; programming samples, controls and calibrators; recalling
sample/QC/calibration results; and those assigned by the administrators.
To assign/modify permissions
2 Choose a user you desire to setup permissions in the user list, and then select Permission.
Figure 8.14 Permission assignment
3 Assign permissions for the selected user.

 To assign new permissions, select the box in front of the relevant operation. The select
button changes to Yes.
 To cancel permissions, deselect the box in front of the relevant operation. The select
button changes to No.
8.7.4 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.
To delete a user
2 Choose a username in the user list.
3 Select Delete.
4 Select OK.

8.7 User and Password Setup 8 Utility

9 Template modifying software
The Template Modifying Software is affiliated with the Operating Software and used to create or
edit print templates, which illustrate the contents and format of patient reports.
The Template Modifying Software can be started separately or together with the Operating
Software. To start the Template Modifying Software, select the Edit button on the Print page of
the operating software.
The following sections introduce the Template Modifying Software by menus and toolbars.

9.1 Main screen 9 Template modifying software
9.1 Main screen

9.1.1 Main screen
The following figure shows the main screen of the Template Modifying Software.
Figure 9.1 Main screen
9.1.2 File (F)

The File menu is used to create, save, import/export and print out the templates. Select File on
upper-left corner of the main screen. The File menu is displayed.
Figure 9.2 File menu
The following table explains the menu in detail.

Table 9.1 Options of the File menu
Option Description

9 Template modifying software 9.1 Main screen
New Select New to create a template. The type of the template is determined by the
report that is currently selected on the report window.
You can also use the shortcut key Ctrl+N instead.
After changing the currently-displayed template, select New to display the
following dialog box.
 Select Yes to save the changes and create a template.

 Select No to cancel the changes and create a template.
 Select Cancel to abort creating and return to the previous screen.
Save Select Save to save the newly-created template or the changes to a template.
You can also use the shortcut key Ctrl+S instead.
To save a new template, you should define the template name:
 Enter the name in the edit box.

 Select OK to save the template and add the name to the template list on the
report window.
 Select Cancel to abort saving and return to the previous screen.
If a template with the same name already exists, a dialog box pops up.
 Select Yes to overwrite the template.
 Select No to cancel saving and return to the previous screen.
Save As Save the current template with another name.
If a template with the same name already exists, a dialog box appears to ask for
your confirmation.
Delete Delete a template. Not available.
Import Import a template. Not available.
Template
Export Export a template. Not available.
Template
Import Import BMP, GIF, JPEG, PNG, TIFF, and EMF images from a storage device to the
Image picture folder.
Print Print the current template. Not available.

Preview Select this option to view the template exactly as it will be printed out.
The main screen will be hidden when you preview a template.
The tool bar on the Preview window is as follows.
 If the template has more than one page, and are available.
 : Go to the first page.
 : Go to the previous page.
 : Go to the specified page.
 : Go to the next page.
 : Go to the last page.
 : Select to expand the template view among 25%, 50%, 75% and 100%.
The default is 100%.
 : Select to shrink the template view.
 : Print out the template. It is equivalent to the Print option in the File
menu.
 : Select to exit the preview window and return to the template.
Exit Select this option to close the Template Modifying Software.
You can use the shortcut key Alt+F4 instead.
If the template is changed, the following dialog box pops up.
 Select Yes to save the changes and exit the software.

 Select No to exit the software without saving the changes.
 Select Cancel to abort exiting and return to the previous screen.
9.1.3 Edit (E)

The Edit menu provides the functions like cut, copy, paste and delete. Select Edit on the menu
bar of the main screen. The Edit menu is displayed.

Figure 9.3 Edit menu
NOTE
The control(s) you have cut or copied can only be pasted on the current Template Modifying Software rather
than another one or other software.

Table 9.2 Options of the Edit menu
Option Description
Cut Select this option to copy and delete single or multiple controls.
You can use the shortcut key Ctrl+X instead.
This option is available only when a control(s) is selected.
Copy Select this option to copy single or multiple controls.
You can use the shortcut key Ctrl+C instead.
Paste Select this option to paste the controls that are previously cut or copied at the
same place as where the controls are from.
You can use the shortcut key Ctrl+P instead.
This option is available only when a control(s) is cut or copied.
Delete Select this option to delete single or multiple controls
You can use the shortcut key Ctrl+D instead.
9.1.4 View (V)

The View menu is used to enable or disable the toolbars and to set up the displaying proportion.
Select View on the menu bar of the main screen. The View menu is displayed.
Figure 9.4 View menu

Table 9.3 Options of the View menu

Option Description
Common Enable or disable the common toolbar.
Tool
Draw Tool Enable or disable the draw toolbar.
Property Enable or disable the property window.
Window
Report Enable or disable the report window.
Window
Status Bar Enable or disable the status bar.
25%-200 Select a proportion to display the template. The default is 100%.
%
NOTE
You are recommended to select 100% when saving a template.
9.1.5 Insert (I)

The Insert menu is used to create controls in the editing page. Select Insert on the menu bar of
the main screen. The Insert menu is displayed.
Figure 9.5 Insert menu
Only one option on the Insert menu can be selected simultaneously.

Table 9.4 Options of the Insert menu
Option Description
Select
Select this option to change the mouse pointer to a .
When the mouse pointer changes to a , you can select single or multiple
controls in the editing area.
NOTE
Selecting a control while holding the Ctrl key copies the control.
Line Select this option to insert a line in the editing area. The mouse pointer changes
into a +. Click once in the editing area and drag the mouse to draw a line.
Rectangle Select this option to insert a rectangle in the editing area. The mouse pointer
changes into a +. Click once in the editing area and drag the mouse to draw a
rectangle.

Label Select this option to insert a label in the editing area. The mouse pointer
changes into a +. Click once in the editing area and drag the mouse to draw a
label.
Label is a type of text control and the contents on a label will not change when
printed.
Text Select this option to insert a text control in the editing area. The mouse pointer
changes into a +. Click once in the editing area and drag the mouse to create a
text.
The contents in a text control will be replaced by the actual test data when
printed.
Title Select this option to insert a title in the editing area. The mouse pointer changes
into a +. Click once in the editing area and drag the mouse to create a title.
Title is a type of text control. The “%s” will be replaced by a hospital name
when printed. Please note “%s” is added by user and not produced
automatically.
Image Select this option to insert an image in the editing area. The mouse pointer
changes into a +. Click once in the editing area and drag the mouse to create an
image.
The image on the template is for illustration only and will be replaced by
corresponding curve graph when printed.
9.1.6 Format (M)

The Format menu is used to arrange the controls on a template. Select Format on the menu bar
of the main screen. The Format menu is displayed.
Figure 9.6 Format menu

Table 9.5 Options of the Format menu
Option Description
Left Align the specified controls with the left of the lastly-selected control.
Right Align the specified controls with the right of the lastly-selected control.
Top Align the specified controls with the top side of the lastly-selected control.
Bottom Align the specified controls with the bottom side of the lastly-selected control.
Center H Align one or multiple controls to the horizontal center of current template.

Center V Align one or multiple controls to the vertical center of current template.
Even Space Arrange three or more controls with same space horizontally.
H
Even Space Arrange three or more controls with same space vertically.
V
Same Width Adjust the specified controls to the same width as the lastly-selected control.
Same Height Adjust the specified controls to the same height as the lastly-selected control.
Same Size Adjust the specified controls to the same width and height as the
lastly-selected control.
9.1.7 Set(S)
The Set menu only includes an option, Print ID. See the figure below.
Figure 9.7 Set menu
Select Print ID. The Set Print ID dialog box is displayed. You can enable or disable the print
fields and view the corresponding ID of each field.
Figure 9.8 Set Print ID window
9.1.8 Language (L)

Select Language on the menu bar of the main screen. The Language menu is displayed.
Figure 9.9 Language menu

9 Template modifying software 9.2 Common tools
Table 9.6 Options of the Language menu

Option Description
Chinese Switch the screen language to Chinese. Not available.
English Switch the screen language to English. Not available.
9.1.9 Help (H)

Select Help on the menu bar of the main screen. The Help menu is displayed.
Figure 9.10 Help menu

Table 9.7 Options of the Help menu
Option Description
Version Select this option to view the version information of the template
modifying software.
9.2 Common tools

The common toolbar provides the shortcut buttons that enables you to perform an operation
quickly.
Figure 9.11 Common toolbar
The following table shows the correspondence between the shortcut buttons and menu options.
Table 9.8 Common tools
Button Menu Option Button Menu Option
New File/New Cut Edit/Cut
Save File/Save (not enabled) Copy Edit/Copy
Save As File/Save As Paste Edit/Paste
Import File/Import Delete Edit/Delete
Export File/Export Zoom View/25%-200%
Delete File/Delete Property View/Property Window
Print File/Print Rpt List View/Report Window
Preview File/Preview Print ID Set/Print ID
9.3 Draw tools

The draw toolbar provides the shortcut buttons that enables you to create and draw controls
quickly.

9.4 Property window 9 Template modifying software
Figure 9.12 Draw tool bar
The following table shows the correspondence between the shortcut buttons and menu options.
Table 9.9 Draw tools
Button Menu Option Button Menu Option
Insert/Select Format/Top
Insert/Line Format/Bottom
Insert/Rectangle Format/Center H
Insert/Label Format/Center V
Insert/Text Format/Even Space H
Insert/Title Format/Even Space V
Insert/Image Format/Same Width
Format/Left Format/Same Height
Format/Right Format/Same Size
9.4 Property window

The property window enables you to view and edit the properties of the selected control. If no
control is selected in the window, the properties of the current template are displayed.
9.4.1 Page
When no control is selected, the property window shows the properties of the current template,
such as paper, print type, etc.
Figure 9.13 Page property area
The following table explains the template properties in detail.

9 Template modifying software 9.4 Property window
Table 9.10 Page properties

Paper Define the paper type of the template. There are 9 common types available.
If the paper width and height you defined are beyond the specified range,
Custom is displayed in the Paper field.
Paper Width Define the width of the template.
Paper Define the height of the template.
Height
Grid Point Enable or disable grid points on the template.
Print Type Includes Paginal and Serial. Not available.
Combination Whether to print two reports on one piece of paper. Merging reports is now
Type not permitted. Not available.
9.4.2 Line
When a line control is selected, the property window shows the properties of the line.
Figure 9.14 Line property area
The following table explains the line properties in detail.

Table 9.11 Line properties
ID Print ID of the line. The ID is 2.
Start X Set the X-coordinate value of the start point.
NOTE
The control coordinate originates from the upper-left corner of the editing area, from
which the X axis (positive) is extended horizontally to the right and the Y axis (positive)
vertically to the bottom. The unit is mm.
Start Y Set the Y-coordinate value of the start point.
End X Set the X-coordinate value of the end point.
End Y Set the Y-coordinate value of the end point.
Line Width Set the width of the line. The unit is mm.

Group No. A group gathers multiple controls that will be used frequently on the
template. e.g. a line of controls constitutes a group. The group No. is 0 if not
defined.
Line Color Set the color of the line.
Print Enable or disable printing the line on actual reports.
9.4.3 Rectangle
When a rectangle control is selected, the property window shows the properties of the rectangle.
Figure 9.15 Rectangle property area
The following table explains the rectangle properties in detail.

Table 9.12 Rectangle properties
ID Print ID of the line. The ID is 1.
Start X Set the X-coordinate value of the start point (upper-left corner).
Start Y Set the Y-coordinate value of the start point (upper-left corner).
Width Set the width of the rectangle.
Height Set the height of the rectangle.
Frame Width Set the frame width of the rectangle.
Group No. A group gathers multiple controls that will be used frequently on the template.
e.g. a line of controls constitutes a group. The group No. is 0 if not defined.
Frame Color Set the color of the frame.
Print Enable or disable printing the rectangle on actual reports.
9.4.4 Label
When a label control is selected, the property window shows the properties of the label.

Figure 9.16 Label property area
The following table explains the label properties in detail.

Table 9.13 Label properties
ID Print ID of the label. The ID is 4.
Text Set the text on the label. It will be printed unchanged on actual reports.
Width Set the width of the label.
Height Set the height of the label.
Bk Color Set the background color of the label.
Font Set the font of the label text.
Text Place Set the aligning mode of label text. It includes Left, Center and Right.
Print Frame Enable and disable printing frame.
Frame Width Set the width of the label frame.
Frame Color Set the color of the label frame.
Print Enable or disable printing the label on actual reports.
Text ID Set text ID for the control. When it is edited, the template is refreshed.
Replace text Choose whether to use the defined text ID to replace the text of the control.

9.4.5 Text
When a text control is selected, the property window shows the properties of the text.
Figure 9.17 Text property area
The following table explains the text properties in detail.

Table 9.14 Text properties
ID Print ID of the text. The default is 0 and means unknown ID.
Print ID indicates the meaning of the text. Correct printout can be ensured
only when print ID is set properly.
Name Set the contents to be displayed on the text control. It varies from different
IDs.
Text Set the contents displayed on the text control. It will be replaced by actual data
when printed.
Show Detail Enable or disable printing the control in group.
Width Set the width of the text.
Height Set the height of the text.
Text Type Reserved parameter. The default is 0.
Bk Color Set the background color of the text.
Font Set the font of the text.
Text Place Set the aligning mode of the text. It includes Left, Center and Right.


Frame Width Set the width of the text frame.
Frame Color Set the color of the label frame.
Print Enable or disable printing the text on actual reports.
9.4.6 Title
When a title control is selected, the property window shows the properties of the title.
Figure 9.18 Title property area
The following table explains the title properties in detail.

Table 9.15 Title properties
ID Print ID of the title. The ID is 5.
Text Set the contents to be displayed on the title. “%s” will be
replaced by a hospital name and can be displayed in any place
of the title.
Start X Set the X-coordinate value of the start point (upper-left
corner).
Width Set the width of the title.
Height Set the height of the title.
Bk Color Set the background color of the title.
Font Set the font of the title text.
Text Place Set the aligning mode of title text. It includes Left, Center and
Right.

9.5 Report window 9 Template modifying software

Frame Width Set the width of the title frame.
Frame Color Set the color of the title frame.
Print Enable or disable printing the title on actual reports.
Text ID Set text ID for the control. When it is edited, the template is
refreshed.
Replace text Choose whether to use the defined text ID to replace the text of
the control.
9.4.7 Image
When an image control is selected, the property window shows the properties of the image.
Figure 9.19 Image property area
The following table explains the image properties in detail.

Table 9.16 Image properties
ID Print ID of the image. The ID is 3.
Width Set the width of the image.
Height Set the height of the image.
Group No. A group gathers multiple controls that will be used frequently
on the template. e.g. a line of controls constitutes a group. The
group No. is 0 if not defined.
Print Enable or disable printing the image on actual reports.
File Name Name of image file. Specify it in the picture folder and draw it
on the image control.
9.5 Report window

The report window locates on the lower-right corner of the main screen and shows all the
templates of a selected report type.

9 Template modifying software 9.5 Report window
Figure 9.20 Report window
(1)
(2)
(1) Report type (2) Template list

9.5 Report window 9 Template modifying software

10 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.

10.1 Overview 10 Maintenance
10.1 Overview
Maintenance of the system should be performed regularly by trained personnel to ensure
reliable performance and reduce unnecessary service calls. Even you are only an operator, it is
important for you to read this chapter. Your thorough understanding will help you obtain the
best performance of the system.
In the case of maintenance that is beyond your capability or not covered in this chapter, contact
our customer service department or your local distributor.
Maintenance frequency
The maintenance frequencies stated in this manual are based on 300 tests/day, and
300×25=7,500tests/month.
10.1.1 Safety information
WARNING
 Maintain the system strictly as instructed by this manual. Inappropriate maintenance may lead to unreliable
results, equipment damage or personal injury.
 Do not touch the components other than those specified in this chapter.
 Performing unauthorized maintenance procedures can damage the instrument and cause personal injury, or
invalidate the applicable warranty provisions in the service contract.
 Do not spill water or reagent on mechanical or electrical components of the system.
 Shut down and turn off analyzer 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 the photometer lamp should be done when the system power has been switched off for at
least 10 minutes.
 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.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
CAUTION
 To wipe off dust from the system surface, use a soft, clean and moistened cloth soaked with soap water
rather than organic solvents such as ethanol. After cleaning, wipe the surface dry with dry cloth.
 Replacement of major parts as photometer lamp, probe and mixer must be followed by re-calibration.
 After performing maintenance, make verification to ensure that the system runs normally.
 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 following use.
10.1.2 Tools and Spare Parts

Please use the accessories and spare parts manufactured or recommended by our company in
order to achieve the promised system performance. If needed, contact our customer service
department or your local distributor.

10 Maintenance 10.1 Overview
Accessories
 Cross screwdriver (φ4.7×100): for install and removing the probe
 Round-head needle, 0.25+/-0.01mm×125mm: for unclogging the probe
Spare parts
Table 10.1 Spare parts
Part name Related maintenance Comment
Lamp Replacing lamp Regularly-replaced part.
Replace it when it serves for over
2000 hours or in every 6 months.
Syringe Replacing syringe Replace it when it serves for over
100,000 times.
Reaction cuvette Replacing cuvette Consumable. Replace it when needed.
Probe Replacing probe Regularly-replaced part.
Replace it when needed.
ISE electrode Replacing ISE electrode Regularly-replaced part.
Replace it when needed.
Electrode case Storing ISE electrode Use it when store the ISE electrodes.
ISE wash solution Cleaning electrode tubes Consumable. Use it when cleaning the
electrode tubes every day.
Tools to be prepared by user
Before maintenance, prepare the following tools:
Table 10.2 Tools to be prepared by user
Item Applicable maintenance
Clean gauze Checking syringe; cleaning rotors, probe/mixer
exterior and cuvette wash station
Cotton swabs Cleaning wash well and sample/reagent
compartment
Suction cleaner Cleaning fans and dust screens
Hair brush Cleaning dust screen
Tweezers Removing/Installing probe and syringe washer
Thread syringe Unclogging the probe
Tube brush or ultrasound cleaner Cleaning filter core
Beaker Unclogging and cleaning the probe
Ethanol Cleaning the photometer lens, probe, mixer and
wash station
NaClO (0.5% sodium hypochlorite Cleaning wash wells
solution)
Fiber-free gloves Cleaning and replacing reaction cuvettes
Large water container Cleaning deionized water tank
Screen and keyboard wash solution Cleaning screen and keyboard
Sample tube Cleaning ISE electrodes
10.1.3 Concepts
The Maint window includes the following tab pages:

 Scheduled Maintenance: Provides maintenance reminding and maintenance record

tracking.
 Biochemistry Maintenance: Provides maintenance commands of the biochemistry system,
which can be performed through the screen wizards.
 ISE Maintenance: Provides maintenance commands of the ISE module, which can be
performed through the screen wizards.
The scheduled maintenance items can be performed manually or automatically through a
wizard. The biochemistry and ISE maintenance commands can be executed by specified
frequency or according to the instrument condition.
Scheduled maintenance item
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. The maintenance item can be performed
manually, or by executing one or more maintenance commands.
The scheduled maintenance item list provides the functions of maintenance confirmation, auto
maintenance reminding, filling maintenance logs, recalling maintenance history, and
customizing maintenance items.
Maintenance confirmation
After maintenance confirmation, the system updates the Date Performed of relevant
maintenance item as the current date, and uses it to calculate the next maintenance time.
Auto maintenance reminding
When a maintenance procedure is expired, the system displays the following buttons and
options in yellow. You should perform relevant maintenance immediately.
 Utility button on the left of the main screen
 Maintenance tab
Filling maintenance logs
Recording the abnormal conditions and other information about the maintenance.
Recalling maintenance history
Viewing all execution records of each maintenance item, including date, log and operator. Each
maintenance record can be edited or deleted.
Customizing maintenance item
Defining and customizing maintenance items according to the actual use. You are allowed to add
and delete self-defined maintenance items.
Biochemistry maintenance command
Maintenance item of the biochemistry system, which can be performed through wizard. The
commands may be included in certain scheduled maintenance procedure, or may be executed
independently when needed.

10 Maintenance 10.1 Overview
ISE maintenance command

Maintenance item of the ISE module, which can be performed through wizard. The commands
may be included in certain scheduled maintenance procedure, or may be executed independently
when needed.
10.1.4 Maintenance period

The scheduled maintenance procedures are divided into the following periods:
 Daily: 1 day
 Weekly: 8 days
 Two-week: 15 days(No maintenance item for this model)
 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:
 Utility button on the main screen
 Maintenance tab
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.
10.1.5 Maintenance execution methods

Follow these steps to perform scheduled maintenance and maintenance commands.
To perform scheduled maintenance
1 Determine the maintenance items you are going to perform.
 Check for maintenance items indicated in yellow on the Scheduled Maintenance tab
page.
 Determine maintenance items according to using conditions of the system components.
 Select Utility > Status > Count, check the use count of each component, and determine
maintenance items.
2 Find the maintenance items in this chapter and perform the described steps.
3 After maintenance, select Utility > Maintenance > Maintenance > Scheduled
Maintenance, and then click the relevant frequency tab.
4 Select the corresponding Select check box and click OK. The system updates the current
date as the date performed.
5 Click Log to record comments and other important information of the maintenance, and
then click OK.

To execute biochemistry maintenance command

1 Select Utility > Maintenance > Maintenance > Biochemistry Maintenance.
2 Click the maintenance command you are going to execute.
3 Perform the maintenance according to the wizard.
To execute ISE maintenance command
1 Select Utility > Maintenance > Maintenance > ISE Maintenance.
2 Click the maintenance command you are going to execute.
3 Perform the maintenance according to the wizard.
10.1.6 Extended operations of maintenance item

You can view execution records of each maintenance item, customize and delete self-defined
maintenance items.
Viewing maintenance history
This feature provides a stored history record of maintenance performance with date and
operator for the procedure selected. You are allowed to edit or delete a maintenance record.
To view maintenance history
1 Choose a maintenance procedure on the Scheduled Maintenance screen.
2 Select History. The Maintenance Log window is displayed.
3 View all performance records of the selected maintenance procedure.
4 To edit a maintenance record:
a. Mark the checkbox of the desired maintenance record.
b. Select Edit.
c. Modify the maintenance record.
d. Select OK.
Only one maintenance record can be edited at one time.
5 To delete maintenance records:
a. Mark the checkbox of one or more desired maintenance records.
b. Select Delete.
c. Select OK. The selected maintenance records are removed.
Customizing maintenance item
Based on the actual use condition of the instrument, you can define and delete maintenance
items.
To access the Customize Maintenance Procedure window
Select Customize on the Scheduled Maintenance screen. You can add, define and delete
maintenance items for the selected frequency.
To define a maintenance procedure
1 Select New.
2 Enter the name of the new maintenance procedure.
3 Select OK. The maintenance procedure is displayed in the Available Procedures list.
4 Use >> and << to configure or cancel user-defined maintenance procedures. The property
of a user-defined maintenance procedure is User.
5 Select OK to save the configuration, or select Cancel to abort it.

10 Maintenance 10.2 Scheduled maintenance and maintenance commands
To configure a maintenance procedure

1 Choose a maintenance frequency in the Frequency drop-down list.
2 Choose a maintenance procedure in the Available Procedures list. Move the vertical scroll
bar to view more maintenance procedures.
3 Select >>. The selected maintenance procedure appears in the Enabled Procedures list,
and the relevant maintenance schedule screen will be refreshed automatically.
To remove a maintenance procedure
1 Choose a maintenance procedure in the Enabled Procedures list.
2 Select <<. The selected maintenance procedure is removed from the Enabled Procedures
list and appears in the Available Procedures list. The relevant maintenance schedule
screen will be refreshed automatically.
3 Select OK to save the configuration, or select Cancel to abort it.
Deleting self-defined maintenance procedure
The system allows deleting of maintenance procedures that will no longer be used. Only
user-defined rather than manufacturer-defined maintenance procedures can be deleted.
To delete self-defined maintenance procedure
1 Choose a maintenance procedure on the Scheduled Maintenance screen.
2 Select Delete.
3 Select OK. The selected maintenance procedure is deleted. The Available Procedures list
on the Customize Maintenance Procedure window is refreshed automatically.
10.2 Scheduled maintenance and maintenance commands

This section provides a summary of all scheduled maintenance items, biochemistry and ISE
maintenance commands. Execute them when needed.
10.2.1 Scheduled maintenance

The following table lists all scheduled maintenance items and their execution frequency.
CAUTION
"Cleaning ISE waste tube" is not provided on the software. To avoid clogged waste tube after long-term use,
when you see alarm “No fluid in tube” or “Air in calibrator A” or “Air in calibrator B”, and check that the waste
tube is clogged, perform this maintenance item.
Table 10.3 Scheduled maintenance items

Frequency Maintenance item
Daily Check probe/mixer/wash well
Check DI water tank and tube connection
Check waste connection and waste tank connection
Check probe wash solution

Check sample/reagent syringe
Clean electrode tubes
Weekly Clean probe exterior

10.2 Scheduled maintenance and maintenance commands 10 Maintenance
Frequency Maintenance item

Clean mixer
Monthly Clean wash wells
Clean sample injection port

Pump calibration
Air bubble detector calibration
3-month Clean DI water tank
6-month Replace lamp
As-needed/As-required Lamp background test
Clean analyzer panels
Bar code maintenance
Clean sample/reagent compartment
Clean probe interior
Clean rotors
Replace probe
Replace mixer
Replace syringe
Remove air bubbles in syringe
Special wash probe
Replace ISE electrode
Store electrodes
Remove reagent pack
Clean ISE waste tube
10.2.2 Biochemistry maintenance commands

The following table lists all maintenance commands of the biochemistry system, as well as their
usage and execution time. You can execute them according to the descriptions in this chapter or
through the wizard on the software.
Table 10.4 Biochemistry maintenance commands
Biochemistry Usage Execution time
maintenance command
Home Reset the probe, mixer and wash  Check probe/mixer/wash well
station, and clean the probe and mixer.  Clean probe interior
 Replace probe
 Replace mixer
 Clean wash wells
 Special wash probe
Clean probe/mixer/wash Reset the probe and mixer Check probe/mixer/wash well
wells mechanically to return them to the
wash position.
Clean probes interior Remove air bubbles possibly existing After maintenance of probe and
in the tubes, and clean the probe and wash wells
wash well.

10 Maintenance 10.2 Scheduled maintenance and maintenance commands
Biochemistry Usage Execution time

maintenance command
Special wash probes Use concentrated wash solution to Special wash probe
clean the probe in order to eliminate
cross contamination.
Clean probes/mixers Remove air bubbles possibly existing After maintenance of probe and
exterior in the tubes, and clean the probe and wash wells
wash well.
Replace lamp Replace the lamp. Replace lamp
Background test Check the light intensity of the lamp Lamp error or if needed
Lamp Background and Inquire current background AD value If needed
Dark Current Query and dark current AD value
10.2.3 ISE maintenance commands

The following table lists all maintenance commands of the ISE module, as well as their usage and
execution time. You can execute them according to the descriptions in this chapter or through
the wizard on the software.
Table 10.5 ISE maintenance commands
ISE maintenance command Usage Execution time
Two-point calibration Calibrate the ISE module with When needed
calibrators A and B.
Clean electrode tubes Clean the electrode tubes with ISE wash Clean electrode tubes
solution to remove the materials on
the electrode surface.
Pump calibration Calibrate the peristaltic pump to Pump calibration
ensure accurate test result.
Maintenance Discharge the calibrator from the When needed
electrode inside before electrode Or automatically executed during
replacement. “Clean sample injection port” and
“Replace electrode”
Air bubble detector Calibrate the air bubble detector to Air bubble detector calibration
calibration ensure good sensitivity.
Purge A Dispense 100 μL calibrator A to the When needed
inside of the electrodes through the Or automatically executed during
sample injection port. “ Clean sample injection port”,
“Replace electrode” and “Unload
reagent pack”
Purge B Dispense 100 μL calibrator B to the When needed
inside of the electrodes through the Or automatically executed during
sample injection port. “ Clean sample injection port”,
“Replace electrode” and “Unload
reagent pack”
Replace electrode Replace the ISE electrodes. Replace electrode
Replace tubes of pump and Replace the aging tubes of the Used by service engineers to
calibrator peristaltic pump and calibrator. replace the tubes of pump and
calibrator
Unload reagent pack Remove the reagent pack and empty Remove reagent pack
the tubes.

10.3 Maintenance log sheet 10 Maintenance
ISE maintenance command Usage Execution time

Program check View the software version of the ISE When needed
module.
Air bubble detector View the result of air bubble detector After performance of “Air bubble
calibration result calibration. detector calibration”
Pump calibration result View the result of pump calibration. After performance of “Pump
calibration”
Write dallas chip Write information on the Dallas chip. When needed
Read dallas chip Read the information on the Dallas When needed
chip.
Store Electrodes Remove the electrodes and store them When needed
Clean Sample Injection Port Clean the sample injection port When needed
10.3 Maintenance log sheet

Refer to the following table for scheduled maintenance procedures you are supposed to perform.
Please copy it every month and place a check mark in relevant day column every time after you
performing maintenance.

10 Maintenance 10.3 Maintenance
log sheet
Table 10.6 Maintenance log sheet

Maintenance log sheet
Month Year
Daily maintenance 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 probe/mixer/wash well
Check DI water tank and tube
2
connection
Check waste connection and
3
waste tank connection
4 Check probe wash solution
5 Clean electrode tubes
6 Check sample/reagent syringe
Weekly maintenance 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 probe exterior
2 Clean mixer
Monthly maintenance 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 wash wells
2 Clean sample injection port
3 Pump calibration
4 Air bubble detector calibration
Three-month maintenance 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 DI water tank
Six-month maintenance 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
As-required/As-needed maintenance 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 Lamp background test
2 Clean analyzer panels
3 Bar code maintenance
Clean sample/reagent
4
compartment
5 Clean probe interior
6 Clean rotors
7 Replace probe
8 Replace mixer
9 Special wash probe

10 Replace ISE electrode

10.3 Maintenance log sheet 10 Maintenance
Maintenance log sheet

Month Year
11 Store electrodes
12 Remove reagent pack
13 Clean ISE waste tube
14 Replace syringe
15 Remove air bubbles in syringe

10 Maintenance 10.4 Daily maintenance
10.4 Daily maintenance

10.4.1 Checking probe/mixer/wash well
Abnormal probe, wash well or mixer may influence the measurement performance and lead to
inaccurate results. Prior to measurements every day, check the probe and mixer for stains and
crystals, and check if the water flow in the wash wells is abnormal. If the above-mentioned
abnormities exist, clean or adjust the probe and mixer immediately.
Purpose
To check the probe for water dripping, stains and liquid flow abnormities, and check if the
mixer can rotate normally and the water flow in the wash wells is abnormal.
When to do
You are recommended to do this maintenance procedure every day before starting the analysis.
System status
Make sure that the system status is Standby
Precautions
Warning
The probe and mixer are sharp and vulnerable. To prevent injury and equipment damage, exercise caution
when working around the probe and mixer. Keep away from the probe and mixer to avoid collision with them.
BIOHAZARD
Wear gloves and lab coat, and if necessary, goggles.
How to do
1 Open the protective shield of the analyzer.
3 Select Clean Probes/Mixers/Wash Wells.
4 Check the exterior of the probe and mixer for stains. If stains exist, perform the "Cleaning
probe exterior" and "Cleaning the mixer" procedures.
5 Select Continue to clean the probe interior.
6 Check the liquid flow of the probe.
 If the liquid flow is sprayed out or does not come out vertically, the probe may be
clogged. Perform the "Special wash probe" procedure, and then check it again.
 If the abnormity remains, perform the "Cleaning probe interior" procedure.
 If the abnormity still remains, perform the "Replacing the probe" procedure, or contact
a service engineer.

10.4 Daily maintenance 10 Maintenance
Figure 10.1 Normal and abnormal liquid flows of the probe

OK Error
7 Select Second Wash. The probe interior wash can be performed again.
8 Select Continue.
9 Observe the water flow of the probe/mixer wash wells, and check if the water reaches to
about 5 mm of the probe/mixer from the tip.
10 If the water flow is abnormal, contact a service engineer.
11 Select Continue and Done.
12 Restore the protective shield.
10.4.2 Checking DI water tank and tube connection

If the deionized water tank is empty or the tubes are not connected properly, the deionized
water cannot be supplied normally or leak may be caused, influencing the measurements.
Perform this check every day.
Purpose
To check the deionized water tank and the tube connection to ensure normal supply of DI water.
When to do
System status
Make sure that the system is powered off, or the system status is Incubation or Standby.
How to do
1 Check that the water tank or other water containers have sufficient deionized water.
2 Check that the tubes are not bent or folded or leaking.
10.4.3 Checking waste connection and waste tank connection

If the waste tube is not connected properly or the waste tank is full, overflow may be caused,
resulted in environmental contamination or cross contamination, or even damaging the
equipment. It is necessary to regularly check the waste tube connection and the waste tank.
Refer to the following waste amount when checking the waste tanks:
 BS-230: low-concentration waste no more than 2.1 L/H.

10 Maintenance 10.4 Daily maintenance
Purpose
To check the waste tube connection and the waste tank to prevent overflow.
When to do
System status
Precautions
BIOHAZARD
Dispose of the waste in accordance with your local or national guidelines for biohazard waste disposal.
How to do
1 Check the waste tubes, and ensure that they are not leaking or bent.
2 Check if the waste tank is full. If yes, empty it.
10.4.4 Checking probe wash solution

Insufficient probe wash solution (CD80 alkaline concentrated wash solution) may cause probe
clogging and cross contamination. You are recommended to check and replace the probe wash
solution every day to ensure its sufficiency.
Three special washes will be conducted for the probe when every batch of tests is finished, and
about 295 μL wash solution is consumed each time. The amount of concentrated wash solution
for weekly cleaning of reaction cuvettes is 15 mL.
Purpose
To check the sample probe wash solution volume to prevent measurements from being
terminated.
When to do
System status
Precautions
CAUTION
You are recommended to replace the probe wash solution every day in order to prevent probe clogging and
cross contamination.
While the system is running tests, do not try to fill probe wash solution until the system status becomes
Standby.
How to do
1 Check the volume of the probe wash solution on the sample/reagent carousel position D.
2 If necessary, fill more or replace the wash solution. To ensure wash effects, you are
recommended to replace it.

10.4 Daily maintenance 10 Maintenance
10.4.5 Clean electrode tubes

When the ISE module finishes a great number of measurements, the proteins and lipid
contained in samples may remain on surfaces of the electrodes, influencing their measurement
performance. You should clean the electrodes regularly to ensure system performance.
Purpose
To remove the proteins and lipid remaining on the electrode surfaces.
When to do
You are recommended to perform this procedure after finishing all ISE tests of the day, or before
shutting down the system, or 50 samples are analyzed.
Materials required
ISE wash solution, 20 mL or 40 mL reagent bottle
System status
Make sure that the status of both the biochemistry system and ISE modules Standby.
Precautions
BIOHAZARD
The wash solution may hurt your eyes and skins. Exercise caution while using the wash solution. If your eyes
contact the wash solution, rinse them off with fresh water and consult a doctor.
CAUTION
Please use consumables recommended by our company. Use of other consumables may degrade the system
performance.
NOTE
After performing this procedure, recalibrate the ISE electrodes prior to starting analysis.
How to do
2 Choose Clean Electrode Tubes. The maintenance guide window shows.
3 Open the upper protective shield of the analyzer.
4 Fill a reagent bottle with at least 2.5 mL ISE wash solution, and then load it to ISE wash
solution position (Position 38#) on the reagent carousel.
5 Select Continue. The system starts cleaning the ISE electrode tubes.
6 Select Done.
After finishing the maintenance, run ISE calibration.
 For more information on ISE calibration, see Requesting calibration on page 2-16.
10.4.6 Check Sample/Reagent Syringe

The sample syringe /reagent syringe is precise devices used to aspirate/dispense small amount
of sample and reagent. If the syringe leaks, it cannot aspirate/dispense the correct amount of
sample or reagent, and may even be damaged. Prior to measurements every day, check the
sample/reagent syringes for leak.
Purpose

10 Maintenance 10.5 Weekly maintenance
To check the sample/reagent syringe for leak and air bubbles.

When to do
Materials required
Clean gauze
System status
Make sure that the system status is Incubation or Standby.
Precautions
BIOHAZARD
How to do
1 Open the upper shield. You will see one syringe.

2 Check the T piece assembly and plunger guide cap for leak.
3 Use dry gauze to wipe the T piece, and then check if the gauze is moistened.
 If it is not, proceed to the next step.
 If it is, tighten the T piece.
 Check the T piece and plunger guide cap again. If the leak remains, check if the
washer inside the syringe connector is intact.
 If the washer is damaged, replace it with a new one; otherwise, replace the
syringe.
4 Check the syringe interior for air bubbles. If yes, remove the air bubbles.
5 Check if the retaining screws at the bottom of the syringe are tightened.
 If not, tighten them and proceed to the next step.
 If yes, proceed to the next step.
6 Close the front door of the analyzer.
10.5 Weekly maintenance

10.5.1 Cleaning probe exterior
The probe is often dirty on its surface, causing carryover between samples or reagents and
resulting in inaccurate results. You are recommended to perform this procedure every week.
Purpose
To clean the exterior of the probe to prevent cross contamination.
When to do
This procedure should be performed on weekly basis.
Materials required
2 pieces of clean gauze, ethanol, deionized water, tweezers

10.5 Weekly maintenance 10 Maintenance
System status
Make sure that the system status is not Running.
Precautions
Warning
around the probes. If the probe is bent or damaged, replace it immediately; otherwise, unreliable results may be
obtained.
BIOHAZARD
How to do
1 Switch off the analyzing unit power.
2 Pull the probe arm to the highest point and then rotate it to move the probe to a position
convenient for cleaning.
3 Use gauze soaked with ethanol to gently wipe the probe exterior. Clean the probe tip until
it becomes clear without stain.
4 Use gauze moistened with deionized water to clear the ethanol on the probe.
CAUTION
Do not pull the probe horizontally to prevent probe damage.
5 After finishing the cleaning, close the shielding cover, and turn on the analyzing unit power
switch.
6 Select Utility > Commands > Home to reset the system.
10.5.2 Clean the mixer

The mixer is often dirty on its surface, causing carryover between samples or reagents and
resulting in inaccurate results. You are recommended to perform this procedure every week.
Purpose
To clean the mixer to prevent cross contamination.
When to do
This procedure should be performed on weekly bases.
Materials required
2 pieces of clean gauze, ethanol, deionized water, tweezers
System status

10 Maintenance 10.6 Monthly maintenance
Precautions
BIOHAZARD
CAUTION
Exercise caution while working around the mixer. If it is bent or damaged, replace it immediately; otherwise,
unreliable results may be obtained.
How to do
2 Pull the mixer arm to the highest point and then rotate it to move the mixer to a position
convenient for cleaning.
3 Use gauze soaked with ethanol to gently wipe the mixer exterior until it becomes clear
without stain.
4 Use gauze moistened with deionized water to clear the ethanol on the mixer.
CAUTION
Do not pull the mixer horizontally to prevent damage.
5 After finishing the cleaning, close the shielding cover, and turn on the analyzing unit power
switch.
6 Select Utility > Commands > Home to reset the system.
10.6 Monthly maintenance

10.6.1 Cleaning wash wells
When the system is used for a long time, waste and dust may accumulate in the wash wells and
block them. Clean the wash wells every month to keep them clean and smooth.
Purpose
To remove the waste and dust from the wash wells (of the probe and mixer).
When to do
This procedure should be performed on monthly basis.
Materials required
Cotton swabs and sodium hypochlorite solution (NaClO, with 0.5% chlorite)
System status
Precautions
BIOHAZARD
How to do

10.6 Monthly maintenance 10 Maintenance
2 Rotate the probe and mixer to keep them away from the wash wells.
3 Use clean cotton swabs moistened with NaClO to clean the wash wells.
4 After finishing the cleaning, turn on the analyzing unit power switch.
5 Select Utility > Commands > Home or execute the Clean Probes/Mixers/Wash Wells
command, and check if the wash wells have a normal water flow.
10.6.2 Cleaning sample injection port

When the ISE module is used for a period, stains may build up in the sample injection port and
influence the measurement performance. Clean the sample injection port regularly to keep it
clear.
Purpose
To remove the stains accumulating in the sample injection port.
When to do
You are recommended to perform this procedure every month.
Materials required
Deionized water, cotton swabs, and ethanol
Precautions
BIOHAZARD
System status
Make sure that the status of the ISE module is Standby or Stopped.
How to do
1 Select Utility > Maintenance > Maintenance > ISE Maintenance, and choose the Clean
Sample Injection Port option.
2 Select Continue.
3 Use clean cotton swab soaked with ethanol to wipe the sample injection port (interior of
the sample injection cup of the ISE module ) until it is clean.
4 Use a clean cotton swab soaked with DI water to wipe the interior and periphery of the
sample injection port.
5 Select Done.
6 Select Purge A and Purge B to prime the ISE module, each for 3 times.
7 Restore the cover of the ISE module.
10.6.3 Pump calibration

The peristaltic pump may get aging when used for a long time. It is necessary to calibrate it
regularly.
Purpose
To calibrate the peristaltic pump to ensure accurate test result.
When to do

10 Maintenance 10.6 Monthly maintenance
Materials required
Deionized water, sample tube
System status
Make sure that the status of the biochemistry system and the ISE module is Standby.
Precautions
BIOHAZARD
How to do
2 Choose Pump Calibration.
3 Fill the sample tube with at least 1000 μL deionized water and then place it in No.40
position of the sample/reagent carousel.
4 Select Start.
When the calibration is complete, the calibration results are displayed on the screen.
5 Select Done.
6 To view the detailed results, select Pump Calibration Result. The detailed results are
displayed in the data list.
10.6.4 Air bubble detector calibration

The air bubble detector may get aging when used for a long time. It is necessary to calibrate it
regularly.
Purpose
To calibrate the air bubble detector to ensure accurate test result.
When to do
System status
Make sure that the status of the biochemistry system and the ISE module is Standby.
Precautions
BIOHAZARD
How to do
2 Choose Air Bubble Detector Calibration.
3 Select Start.
When the calibration is complete, the calibration results are displayed on the screen.
4 Select Done.
5 To view the detailed results, select Air Bubble Detector Calibration Result. The detailed
results are displayed in the data list.

10.7 Three-month maintenance 10 Maintenance
10.7 Three-month maintenance

10.7.1 Cleaning DI water tank
Stains will remain in the deionized water tank when it is used for a long time and may influence
the cleaning effects of the system.
Purpose
To clean the deionized water tank to ensure good cleaning performance of the system.
When to do
You are recommended to perform this procedure every 3 months.
Materials required
Water container
System status
Make sure that the system status is Standby.
How to do
1 Remove the quick connector from the outlet of the water tank.
2 Clean the water tank repeatedly with deionized water.
3 Connect the outlet tube of the water tank.
10.8 Six-month maintenance

10.8.1 Replacing lamp
An aged lamp will has 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.
Purpose
To ensure that the lamp works normally.
When to do
You are recommended to perform this procedure every 6 months or when you find that the
lamp does not satisfy the requirements after performing the Photometer Check.
Materials required
New lamp
System status
Make sure that the system status is Standby or Stopped.

10 Maintenance 10.9 As-needed/As-required maintenance
Precautions
CAUTION
 Too hot lamp may burn you. Do not replace the lamp until it gets cool.
 Please use consumables recommended by our company. Use of other consumables may degrade the
system performance.
 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
2 Choose Replace Lamp. The maintenance guide window pops up. Select Continue.
3 Make sure that the lamp has cooled down for 10 minutes, and then select Continue.
4 Remove the cover plate of the lamp.
5 Loosen the nuts on the cable terminals, and then remove the O-ring connectors from the
terminals.
6 Loosen the retaining screw on the left side of the lamp.
7 Remove the lamp from the lamp housing.
CAUTION
Do not hold the lamp by its bulb to prevent contamination and damage.
8 Install the new lamp, and the retaining screw, O-ring connectors, cable terminal nuts and
lamp cover plate in the reversed order.
9 Select Done.
10.9 As-needed/As-required maintenance

10.9.1 Lamp background test
Purpose
If the light intensity is too large or the lamp is aged, the test precision will be affected. To ensure
the best performance of the analyzer, lamp background test should be performed to check the
light intensity.
When to do
When the lamp goes wrong or necessary.
Materials required
/
System status
Make sure that the system status is Standby or Stopped.
How to do
2 Choose Lamp background test.
3 Make sure that the lamp has been turned on for 5 minutes and then click OK. Do not open
the cuvette replacement window.

10.9 As-needed/As-required maintenance 10 Maintenance
4 If the lamp intensity is too strong or weak, please contact our customer service department
or local distributor.
5 If the lamp background is within 12000-63000, it means the light intensity is normal.
6 Click Finish.
10.9.2 Cleaning analyzer panels

The analyzer and computer are often accessed and easily get dirty. To keep a good operating
environment and minimize the biohazards, clean the components that are often accessed, such
as analyzer panel, carousel cover, screen, keyboard, etc.
Purpose
To clean the analyzer panels, carousel covers, screen, and keyboard.
When to do
Perform this procedure when dust or other stains are found on the components.
Materials required
Clean gauze, screen wash solution, and deionized water
System status
Precautions
BIOHAZARD
 Wear gloves and lab coat, and if necessary, goggles during the maintenance process.
 Dispose of the used gauze in accordance with your local or national guidelines for biohazard waste
disposal.
CAUTION
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.
How to do
1 Use clean gauze moistened with ethanol to clean the analyzer panels and carousel covers.
2 Use wash solution to clean the screen and keyboard.
10.9.3 Cleaning sample/reagent compartment

When sample or reagent is sprayed into the compartment, or dusts accumulate inside the
compartment, clean them immediately in order to minimize the risks of cross contamination.
Purpose
To clean the sample/reagent carousel assembly to ensure clear operating environment and
eliminate the risks of cross contamination.
When to do
Perform this procedure when sample or reagent is spilled into the compartment or dust is found
inside of it.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs

System status
Make sure that the system is not running any tests
Precautions
BIOHAZARD
disposal.
CAUTION
Do not spill water or ethanol into the sample compartment to prevent equipment damage.
How to do
1 Remove the sample/reagent carousel cover and the carousel, and then store them
properly.
2 Use clean gauze soaked with deionized water or ethanol to clean the interior of the
compartment. If necessary, use gauze moistened with neutral wash solution.
3 Use clean gauze soaked with deionized water or ethanol to clean the carousel, and then use
cotton swabs dipped with ethanol to clean the sample and reagent positions.
4 Install the sample/reagent carousel and the carousel cover.
10.9.4 Cleaning probe interior

The probe, once blocked, cannot aspirate or dispense sample and reagent correctly. Clean the
probe interior regularly to ensure normal test performance of the instrument.
Purpose
To clean the interior of the probe and avoid clogging.
When to do
Perform this procedure when you find that the probe is clogged and cannot aspirate or
dispense sample and reagent, or when the probe is detected with abnormal liquid flow during
the "Checking probe/mixer/wash well" maintenance.
Materials required
Unclogging device (or needle), small slot-head screwdriver, small Philips-head screwdriver,
beaker, tweezers, deionized water, and thread syringe
System status
Make sure that the system status is not running any tests.
Precautions
BIOHAZARD
How to do
 To remove the probe
1 Recall the maintenance logs and check if the probe has been removed and reinstalled for 3
times. If it has, replace the washer with a new one.
a. Prepare a new washer.

b. Moisten it with deionized water.

Store the washer properly to avoid being lost.
3 Loosen the screws on the arm cover and remove the cover from the arm base.
4 Press the circuit board with one hand and unplug the tube connector with the other hand.
5 Remove the retaining screw from the probe and take out the spring.
6 While holding the connector on the probe with one hand, unscrew the tube connector
counterclockwise with the other hand until the tube connector is disconnected. Remove
the tube from the probe.
Exercise caution to prevent the washer from dropping out. If the washer drops out, store it
in a clear place for later installation. To replace the washer, take it out from the tube
connector.
7 To replace the washer, remove it.
8 Remove the sample probe.
 To clean the probe
1 Connect the unclogging device to the probe.
2 Fill the syringe with deionized water and then connect it to the unclogging device.
3 Put the probe inside the beaker while keeping the probe tip not contacting the beaker.
4 Push the syringe to rinse the interior of the probe. Repeat this step for 10 times.
5 If the syringe plunger leaks and the probe cannot be unclogged due to serious blockage,
replace the probe.
6 Check if continuous water flow comes out of the probe in the same direction with the
probe. If it does, it indicates the cleaning procedure is finished successfully.
7 If water flow is still abnormal after unclogging, replace the probe with a new one.
8 Remove the unclogging device.
 To install the probe
1 Insert the probe downwards into the hole on the probe arm while aligning the screw hole
on the probe plate to the rod inside the arm.
2 If you have removed the old washer from the tube connector, install a new one.
3 Connect the tube connector to the probe and then tighten it.
4 Fix the earthing wire of the probe to the earthing terminal inside the arm; connect the
probe connector to the liquid level detection board.
5 Sleeve the spring on the rod and tighten the retaining screw.
Pay attention to the spring direction and make the thread opening face downwards.
6 Pinch the probe by the part near the probe arm. Push the probe upwards and then release
it to check if the spring works well.
7 If the spring cannot restore, check if it is clamped or fixed too tightly.
 To check the probe
1 Switch on the analyzing unit power, and then check if the No.D2 LED indicator on the
circuit board inside the probe arm is lit.
2 If it is not, the liquid level detection system is abnormal. Contact our customer service
3 Install the probe arm cover properly, and then tighten the screws on it.
4 Pinch the probe by the part near the probe arm. Push the probe upwards and then release
it to check if the spring works well.

5 If the spring cannot restore, it indicates that the arm cover is not installed correctly.
Reinstall the arm cover and check the spring until it can move freely.
6 Execute the Home maintenance command or the Home system command. Check if the
water flow coming out of the probe is continuous and in the same direction as the probe.
7 If it is not, perform the "Checking probe/mixer/wash well" procedure to troubleshoot the
problems.
10.9.5 Cleaning rotor

Clean the rotor of the probe and mixer to eliminate noise and fraying.
Purpose
Clean the rotors of the probe and mixer to minimize noise and fraying due to movement in
order to extend the service life.
When to do
This procedure should be performed when there are dirty substances or dust on the rotors.
Materials required
Clean gauze
System status
Make sure that the system status is Standby
Precautions
Warning
The probe and mixer tip are sharp and may cause puncture wounds. To prevent injury, exercise caution when
working around the probe and mixer.
BIOHAZARD
disposal.
How to do
2 Pull the probe/mixer arm to the highest point, and then rotate the arm to move the
probe/mixer to a position convenient to operate.
3 Wipe the rotor with clean gauze.
4 After finishing the cleaning, turn on the analyzing unit power switch.
5 Select Utility > Commands > Home to reset the probe and mixer.
10.9.6 Replacing the probe

Replace the probe when it is damaged and cannot be repaired, or blocked seriously, or bent.
Purpose
To replace the probe.

When to do
Perform this procedure when the probe is damaged and cannot be repaired due to the following
causes, such as serious blockage, or bending.
Materials required
Small slot-head screwdriver, small Philips-head screwdriver, tweezers, and new probe
System status
Make sure that the system is not running any tests.
Precautions
Warning
around the probes.
BIOHAZARD
How to do
 To remove the old probe
Remove the old probe.
 For more information on removing probe, see 10.9.4 Cleaning probe interior on page 10-25.
 To install the new probe

Install the new probe.
 For more information on installing probe, see 10.9.4 Cleaning probe interior on page 10-25.
 To check the new probe

Check the new probe.
 For more information on checking probe, see 10.9.4 Cleaning probe interior on page 10-25.
10.9.7 Removing Air Bubbles in Syringe

Purpose
To remove the air bubbles possibly existing inside the syringe tubes.
When to do
Perform this procedure when you find air bubbles inside the sample syringe.
Materials required
Deionized water, beaker
System status
Precautions

BIOHAZARD
How to do
1 Switch off the analyzing unit power, and open the upper shield of the analyzer.
2 Loosen counterclockwise the four retaining screws on top of the syringe, and then remove
the screws and the fixing blocks.
3 Loosen counterclockwise the retaining screw at the bottom of the syringe and then remove
it.
4 Hold the T piece with one hand and the syringe connector with the other hand. Loosen the
syringe counterclockwise and then remove the washer.
5 Soak the syringe connector in the deionized water beaker, pull the plunger head to aspirate
half syringe of deionized water, and then push the plunger head to remove the air. Repeat
this pull-push operation until the air bubbles are removed from the syringe. Fill the syringe
with half cylinder of deionized water to prevent new bubbles.
6 Put the washer in the T piece. Hold the T piece with one hand and the syringe connector
with the other hand, and then screw the T piece clockwise.
7 Install the syringe on the bracket.
8 Install the fixing blocks and 4 retaining screws while having the retaining screws not
tightened.
9 Align the plunger head to the retaining screw at the bottom of the syringe, and then tighten
clockwise the retaining screw.
10 Pinch the plunger guide cap to adjust the syringe height to make the syringe head over the
upper fixing block for 7.5 scales.
11 Tighten the four retaining screws on the fixing blocks.
12 Turn on the analyzing unit power switch.
13 Perform the Home maintenance procedure. Check the new syringe for leak and bubbles,
and if there is, perform the Check Sample/Reagent Syringe procedure.
10.9.8 Replacing Syringe

The syringe has a limited life span, and when due, may have leak or other phenomena causing
inaccurate aspirating/dispensing and resulting in unreliable results.
Purpose
To replace the syringe plunger assembly to ensure optimal measuring performance.
When to do
Perform this procedure when the syringe is used for 100,000 times.
Materials required
Deionized water, beaker, and syringe plunger assembly
System status
Precautions

BIOHAZARD
How to do
1 Prepare a new syringe plunger assembly and washer, put the plunger head in the deionized
water beaker to remove air from the syringe, and then moisten the washer in the
deionized water.
3 Open the upper shield of the analyzer. You will see one syringe. They are, from left to right,
sample syringe, reagent syringe 1 and reagent syringe 2.
4 Loosen counterclockwise the four retaining screws on top of the syringe, and then remove
the screws and the fixing blocks.
5 Loosen counterclockwise the retaining screw at the bottom of the syringe and then remove
it.
6 Hold the T piece with one hand and the syringe connector with the other hand. Loosen the
syringe counterclockwise and then remove the washer.
7 Loosen the plunger guide cap counterclockwise, hold the plunger head and pull it slightly to
remove the plunger assembly from the syringe.
8 Insert the plunger head of the new plunger assembly into the bottom of the syringe, and
then tighten the retaining screw to fix the plunger head.
9 Soak the new syringe connector in the deionized water beaker, pull the plunger head to
aspirate half syringe of deionized water, and then push the plunger head to remove the air.
10 If there is no washer inside the T piece, put the new washer in the T piece. Hold the T piece
with one hand and the syringe connector with the other hand, and then screw the T piece
clockwise.
11 Install the syringe on the bracket.
12 Install the fixing blocks and 4 retaining screws while having the retaining screws not
tightened.
13 Align the plunger head to the retaining screw at the bottom of the syringe, and then tighten
clockwise the retaining screw.
14 Pinch the plunger guide cap to adjust the syringe height to make the syringe head over the
upper fixing block for 7.5 scales.
15 Tighten the four retaining screws on the fixing blocks.
17 Perform the Home maintenance procedure. Check if the new syringe has leak. If it does,
perform the Check Sample/Reagent Syringe procedure to check the syringe.
18 Close the front door of the analyzer.
10.9.9 Replacing the mixer

Replace the mixer when it is bent or damaged and cannot be repaired.
Purpose
Replace the mixer.
When to do
Perform this procedure when the mixer is damaged and cannot be repaired.

Materials required
Ethanol, clean gauze, new mixer
System status
Precautions
Warning
The mixer tip is sharp and may cause puncture wounds. To prevent injury, exercise caution when working
around the mixer.
BIOHAZARD
CAUTION
 When trying to pull out the mixer, concentrate your force in the direction of the axis on the mixer arm Biased
force may damage the mixer and/or the axis.
 Ensure the mixer is all the way pushed to the end.
How to do
Replacing the mixer includes the following steps:
 Removing the mixer
 Installing and checking the mixer
 To remove the mixer
2 Gently pull the mixer to its highest point and rotate it to a position convenient to operate.
3 Pinch the mixer by the knurled part with one hand and unscrew (counterclockwise) the
retaining nut with the other hand until the mixer loosened.
Figure 10.2 Mixer
Knurled part
Mixer
4 Pull the bar downward to remove it and remove the nut.

 To install and check the new mixer
1 Align the new mixer to the bigger hole of the retaining nut and gently screw it into the nut
until the end of the mixer is in line with the smaller hole of the nut.

Figure 10.3 Mixer and lock nut

Lock nut
Mixer
2 Pinch the mixer by the flat part and align the hole of the nut to the axis on the mixer and
push the nut onto the mixer until it reaches the end of the mixer.
3 Screw the lock nut clockwise to tighten the mixer.
4 Visually check whether the mixer is vertical to the bar arm.
5 If it is not, remove the mixer and reinstall it.
6 Pull the mixer arm to its highest point and rotate it back to a position above its wash well.
8 Select Utility > Commands, and execute the Home command.
10.9.10 Special wash probe

Purpose
To eliminate cross contamination of the probe, and prevent waste from leaving in the waste
tubes.
When to do
Perform this procedure when the probe is clogged or the carryover result exceeds the limit.
Materials required
Concentrated wash solution manufactured by our company, or sodium hypochlorite solution
(NaClO, with 0.5% chlorite)
System status
How to do
1 Place more than 20 mL concentrated wash solution in position D of the reagent carousel.
3 Choose Special Wash Probe.
4 Set replicates and wash volume, and then select Continue.
5 When the cleaning is finished, select Done.
10.9.11 Bar code maintenance

This maintenance procedure is used to clean the bar code scanning windows in order to avoid
influencing bar code scanning.
Purpose
To clean the glass of the bar code scanning windows in order to avoid influencing bar code
scanning.

When to do
This maintenance should be performed if the glass of the bar code scanning window is
contaminated and causes bar code scanning failure.
Materials required
Clean gauze, deionized water, ethanol, and cotton swabs
System status
Precautions
BIOHAZARD
CAUTION
Exercise caution not to spray water or ethanol or other liquids on the glass of the bar code scanning window.
How to do
1 Remove the sample/reagent carousel cover and the carousel.
2 Use clean gauze to clean the bar code scanning window inside the compartment.
3 If necessary, use gauze soaked with ethanol or deionized water. Make sure that there is no
trace or dust left on the glass.
4 Install the carousel and the carousel cover.
10.9.12 Replacing ISE electrode

ISE electrodes are consumables and have a limited life span. When used for a long period or
after measuring a large number of samples, the ISE electrodes may have their performance
degraded and should be replaced immediately.
Purpose
To replace the ISE electrodes to ensure the optimal measurement performance.
When to do
 Reference electrode: Every 6 months
 Other electrodes:
° When 10,000 ISE tests are performed.
° When the ISE electrodes are used for 6 months since installation.
° When calibration fails or quality control is abnormal as the result of degraded electrode
performance.
Materials required
Reference electrode, ISE electrode
System status

Precautions
BIOHAZARD
NOTE
After performing this procedure, recalibrate the ISE electrodes prior to starting analysis.
How to do
 To remove the electrodes
2 Choose Replace Electrode.
3 Select desired electrodes, and enter the lot number and expiration date.
4 Select Add and then select OK.
5 Select Continue.
6 Open the ISE side door and remove the cover of the shielding box.
7 Open the electrode case, take out the electrode, remove the tapes around its inside, and then
use clean tissue to wipe it.
NOTE
Take out the insert from the reference electrode, and ensure no crystallized salt exists in and around it. If
needed, clean the electrode with warm water.
Make sure the red ball of the reference electrode floats on the internal fluid. Make sure the O rings of all
electrodes remain intact.
8 Remove all electrodes from the ISE module.
 To install the new electrodes
1 To install a new reference electrode:
a. Place the reference electrode at the bottom of the ISE module and make the rear part of
the electrode contact closely with the internal wall of the ISE module.
b. Loosen the compressor and ensure the electrodes are fixed tightly.
2 Install other electrodes in the order of Cl, K, Na, and spacer from bottom to top.
3 If the O ring is lost, install a new one.
There are two more O rings in each electrode case.
4 Check if the electrode positions are correct:
 The Na, K and Cl electrodes are of the same size and shape. Ensure that the electrodes
are inserted in the correct order.
 If one of the electrodes cannot be easily pushed into the housing, check the electrode
first and then repeat the installation process.
 Check if the 5 electrodes are relatively on the same straight line; otherwise, liquid
cannot flow through the electrode tubes smoothly.
5 Select Continue. The system primes the tubes with calibrators A and B.
6 Select Done.
7 Restore the cover of the shielding box and close the side door of the ISE module.
8 Run ISE calibration.

NOTE
The new electrode can be calibrated successfully only after certain time period.
9 If the calibration fails, perform the following operations:
 Run ISE calibration for multiple times so that the electrodes can get steady quickly.
 Or, drip little serum sample in the electrode channel, and leave it for 10-30 minutes, and
then run calibration again.
10.9.13 Removing reagent pack

When powering off the analyzer for a long time, or storing the electrodes, or replacing the
electrode tubes, remove the reagent pack first.
When to do
Perform this maintenance procedure when powering off the analyzer for a long time (over 3
days), or storing the electrodes, or replacing the electrode tubes.
System status
How to do
1 Select Utility > Maintenance > Maintenance > ISE Maintenance, and choose Remove
Reagent Pack.
2 Remove the tube of pump A and then reinstall the tube by switching the connectors of the
tube.
3 Handle pump B in the same way.
4 Select Continue.
The system executes purge A and B each for 30 times.
5 Restore the reversed pump tubes.
6 Install the three red caps on the tube connectors of the reagent pack, and keep the reagent
pack at room temperature away from sunshine.
7 Select Done.
10.9.14 Storing electrodes

Before the analyzer is powered off for a long time or after the reagent pack is removed, the ISE
electrodes cannot be moistened by regular prime, and may be damaged due to lack of water. It is
necessary to store the electrodes properly before powering off the analyzer for a long period.
Purpose
To store the electrodes separately to prevent them from being damaged due to lack of water
while the analyzer is powered off.
Materials required
Electrode cases and tapes
When to do
Perform this procedure when the analyzer is going to be powered off for over 3 days. If it will
be powered off for no more than 3 days, prime the ISE electrodes to protect them from being
damaged.

System status
Make sure that the status of the ISE modules Standby or Stopped.
Precautions
BIOHAZARD
NOTE
Make sure that the storage temperature is below 40℃.
How to do
1 Remove the reagent pack according to 10.9.13 Removing reagent pack on page 10-35.
2 Open the ISE side door and remove the cover of the shielding box.
3 Remove all electrodes from the ISE module.
4 To save the reference electrode:
a. Put back the insert to the cell of the reference electrode and prevent the crystallized salt
from clogging the cell.
b. Store the electrode in an electrode case at the room temperature in a sun-shielding place.
5 To save the Na, K and Cl electrodes:
a. Take out a little calibrator A from the reagent pack, inject it into the cell of the electrode
and seal it with tape. Make sure proper amount of calibrator is injected into the cell of the
electrode.
b. Store the capped electrodes in an electrode case at the room temperature in a
sun-shielding place.
6 Restore the cover of the shielding box and close the side door of the ISE module.
10.9.15 Cleaning ISE waste tube

Samples containing insoluble substance like fibrin may accumulate in the ISE wand waste outlet
after extended usage and clog the waste tube.
Purpose
Clean the waste tube of ISE module to prevent the sediment inside from clogging the tube.
When to do
When the alarm "No fluid in tube" or "Air in calibrator A" or "Air in calibrator B" occurs and the
waste tube is clogged.
Materials required
Unclogging tool for the ISE waste tube, bleaching agent(Dilution Ratio 1:1) or 50% sodium
hypochlorite, and deionized water
System status
Make sure that the system is not running test.

Precautions
BIOHAZARD
Note
Excessive bleach and DI water flushed into the ISE reagent pack waste bag may cause waste bag over
expansion and clog the Cal A & Cal B reagent flow.
Do not spill liquid on the analyzer. Liquid ingression may cause equipment damage.
How to do
1 Ensure the analyzer is in Standby status. Open the ISE cover on the left panel.
Figure 10.4 Open ISE cover
(1)
(1) ISE module cover

2 Remove the electrode housing cover. Remove the waste tube fitting from the bottom of the
right angle adapter. Remove waste peri-pump tube from the pump bracket. Refer to
pictures below.
Figure 10.5 Removing the right angle adapter and waste pump
(2)
(1)
(1) Waste pump tube (2) Right angle adapter

3 Connect the waste tube fitting to a syringe and unclogging tool with 5 mL of undiluted
household bleach. Refer to pictures below.

Figure 10.6 Connect the unclogging tool and the right angle adapter
(3)
(2)
(1)
(1) and (2) Unclogging tool (3) Tube fitting for right angle adaptor
4 Press the wand release button to remove the wand from the current in use ISE reagent
pack and keep it in a save place. Engage the wand to an old used-up reagent pack.
5 Inject bleach into the ISE waste tube and soak the tube for 5 minutes. Discharge the waste
into the reagent pack.
6 If the bleach cannot be injected into the ISE pack, remove the wand and push down to open
the waste valve manually with a sharp object, and then inject again.
 If bleach can go through this time, the waste bag was clogged and cannot be used.
 If bleach still cannot be injected, replacing the ISE wand is recommended.
Figure 10.7 Waste valve
(1)
(1) Waste valve

7 Repeat steps 5-6, and clean the tubes with the syringe by aspirating 5 mL deionized water.
8 Remove the wand from the old use-up pack and re-install it back to the current in use ISE
pack. Re-install the waste tube fitting back to the ISE electrode housing right angle adaptor
and waste peri-pump tube back to the pump bracket. Re-install the housing cover.
9 Calibrate ISE pump to ensure it passes, all reagents and waste flow are normal.
10 Calibrate all electrodes and run QC test to ensure they all pass within their given range.

11 Alarms and troubleshooting
This chapter describes 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.

11.1 Classification of logs 11 Alarms and troubleshooting
11.1 Classification of logs

The logs provided by the system are divided into:
 Error log
 Edit log
11.1.1 Error logs

Error logs record all types of failures occurring on the system components. Error code
Each error has a unit code used for identification and locating probable causes and solutions. An
error code consists of 6 letters and numbers, such as "C01001", in which "C" indicates that the
error occurs on the operation unit, "01" is the error description of instrument connection, and
"001" is the serial number of the error. Therefore, "C01001" is described as "the first error of
instrument connection on the operation unit".
The following tables provide a summary of error codes for the operation unit and analyzing unit.
Table 11.1 Error code of the operation unit
Error Code Description
C Indicates that the error occurs on the operation unit.
00-99 Indicates the specific component on which the error occurs.
 00-Operating system
 01- System communication
 02-Database
 03-Result calculation
 04-Sample bar code
 05-Reagent bar code
 06-LIS host communication
 07-Other
000-999 Serial number of the error.
Table 11.2 Error code of the analyzing unit

Error Code Description
A Indicates that the error occurs on the analyzing unit.
00-99 Indicates the specific component on which the error occurs.
 00-Command execution
 01/02-Probe unit
 05-Mixer
 06-Reaction carousel unit
 07-Sample /reagent carousel unit
 11-Wash unit
 12-Temperature unit
 21-Probe interior wash unit
 22-Home process or ISE unit
000-999 Serial number of the error.

11 Alarms and troubleshooting 11.2 Viewing and handling logs
Help
Every error log is provided with online help information. Select the icon in front of an error
log. The descriptions, possible causes and solutions of the error are displayed.
11.1.2 Edit logs

Edit logs record all deletions and part of editing actions performed by the user.
 The deleting logs record all deleting actions other than the error deletion.
 The editing logs include editing of sample results and calibration factors.
11.2 Viewing and handling logs

All error logs and edit logs can be recalled, searched, refreshed, deleted and printed.
11.2.1 Description of Error Log screen

Select Alarm in the function buttons area of the main screen. The Error Log screen is displayed
by default and shows all errors occurring on the current day.
Figure 11.1 Error Log screen
Every error log contains the event ID, date/time, error description (by processing method),
event class (by subsystem) and symptom.
Choose the following buttons as needed:
 Search F1: to search for error logs by date, event ID, symptom, or event class.
 Refresh F2: to refresh the error logs based on the current search conditions.
 Delete F3: to remove specified error logs on the screen.
 Print F7: to print all error logs currently displayed on the screen.

11.2 Viewing and handling logs 11 Alarms and troubleshooting
11.2.2 Description of Edit Log screen

Select Alarm > Edit Log. The Edit Log screen is displayed and shows all editing actions
occurring on the current day.
Figure 11.2 Edit Log screen
Every edit log contains the serial number, date/time, operator, event type and description.
Choose the following buttons as needed:
 Search F1: to search for edit logs based on the occurring date.
 Refresh F2: to refresh the edit logs based on the current search conditions.
 Delete F3: to remove specified edit logs on the screen.
 Print F7: to print all edit logs currently displayed on the screen.
11.2.3 Recalling logs

Error logs and edit logs can be recalled by all users in any system status. Error logs can be
recalled by date, event ID, symptom and event class, while edit logs can only be recalled by
occurring date.
Perform the following steps to recall desired event logs:
1 Select Alarm > Error Log or Edit Log.

2 Select Search F1.
3 Enter one or more of the following conditions:
 Date
 Event ID (available for error logs only)
 Symptom (available for error logs only)
 Event class (available for error logs only)
4 Select OK. The event logs satisfying the conditions are displayed on the screen.

11 Alarms and troubleshooting 11.3 Error Troubleshooting
 Refresh F2: to refresh the logs based on the current search conditions.
 Delete F3: to remove specified logs on the screen.
 Print F7: to print all logs currently displayed on the screen.
11.2.4 Refreshing Logs

To refresh the event logs, perform the following procedure:

2 Select Refresh F2.
3 The system refreshes the logs based on the previous search conditions.
 New error logs are displayed chronologically and highlighted by different colors. Yellow
indicates a warning, and red indicates a serious error.
 New edit logs are displayed chronologically on the front-most of the log list.
 Delete F3: to remove specified logs on the screen.
 Print F7: to print all logs currently displayed on the screen.
11.2.5 Clearing logs

Since the system has a limited storage capacity, you should clear and manage the event logs
regularly to ensure that the most-recent and important logs are kept. Only users with sufficient
permissions are allowed to delete event logs.
 For more information about user permissions, refer to8.7.3Assigning/Modifying permissions
on page 8-23.
Perform the following steps to clear event logs:

2 Select event logs you desire to delete.
3 Select Delete F3.
4 Select OK. To abort the deleting, select Cancel.
When you confirm the deleting, the system removes the selected event logs from the
screen.
11.2.6 Printing logs

After searching for desired logs on the Error Log or Edit Log screen, select Print F7. The event
logs currently displayed are printed out in the same format as shown on the screen.
Printing logs will take a long time and requires a great number of papers. Think twice before
printing logs.
To terminate the printing, select Utility > Commands > Stop Print.
11.3 Error Troubleshooting

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.

11.3 Error Troubleshooting 11 Alarms and troubleshooting
 Identify the error and determine relevant solutions.

 Implement the solutions.
 Check and evaluate the implementation of the solutions.
11.3.1 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:

2 Adjust the alarm tone in the Alarm Volume field.
3 Test the alarm tone until it is satisfied.
4 To silence the alarm tone, drag the slider to the leftmost position of the scale.
5 Select Save F8 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.
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.

11 Alarms and troubleshooting 11.4 Data alarms
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.
11.3.2 Identifying errors

To identify errors, understand the error indication thoroughly, check the error logs and system
status, and then determine relevant solutions.
The table below shows the error types that may occur on the system. Find relevant corrective
actions according to the description.
Table 11.3 Error types
Error Type Description
Instrument failure and Instrument failure and error may be detected on all subsystems
error and processed in different ways. Such errors are shown in the
Error messages and corrective actions table, and can be identified
through the event ID.
Data alarm Data alarm is a flag indicating biochemistry or ISE chemistry result
error. The flags are included in the Result flags table, and can be
identified through the flag symbol.
11.4 Data alarms

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 chemistry 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.

11.4 Data alarms 11 Alarms and troubleshooting
11.4.1 Data alarms and corrective actions

Table 11.4 Data alarms and corrective actions
Flag Alarm Type Description Probable Causes Corrective Actions
< Result related Exceeds linearity range The result exceeds the low limit of the linearity Take no actions, or rerun the test
low range. for confirmation.
< ISE result Exceeds measurement Sample or control result exceeds the low limit Take no actions, or rerun the test
related range low of the measurement range for confirmation.
> Result related Exceeds linearity range The result exceeds the high limit of the Rerun the test with sample diluted
high linearity range. or decreased.
> ISE result Exceeds measurement Sample or control result exceeds the high limit Rerun the test with sample diluted
related range high of the measurement range. or decreased.
▲ Result related Sample volume is Sample volume is Increased one No actions are required.
Increased one
▼ Result related Sample volume is Sample volume is decreased one No actions are required.
decreased one
^ Result related Exceeds reference range The result exceeds the high limit of the No actions are required.
high reference range.
^! Result related Exceeds critical range The result exceeds the high limit of the critical No actions are required.
high range.
v Result related Exceeds reference range The result exceeds the low limit of the No actions are required.
low reference range.
v! Result related Exceeds critical range low The result exceeds the low limit of the critical No actions are required.
range.
10-x Result related 10-x Results of five runs (10 results), or 10 Check if the reagent is qualified,
continuous results of a control are on the same control sample is normal, and the
side. instrument is working correctly.
1-2s Result related 1-2s The current QC result is between ±2 and ± No actions are required.
3 standard deviations from the assigned mean
concentration.

1-3s Result related 1-3s The current QC result is greater than ±3 Check if the reagent is qualified,
standard deviations from the assigned mean control sample is normal, and the
concentration. instrument is working correctly.
2-2s Result related 2-2s Results of two controls in the same run or two Check if the reagent is qualified,
continuous results of a control are on the same control sample is normal, and the
side and greater than ±2 standard deviations instrument is working correctly.
from the assigned mean concentration.
4-1s Result related 4-1s Results of two runs (4 results), or 4 continuous Check if the reagent is qualified,
results of a control are on the same side and control sample is normal, and the
greater than ±1 standard deviation from the instrument is working correctly.
assigned mean concentration.
ABS Result related Absorbance out of range The absorbance of primary or secondary Check the sample for foreign
wavelength used for calculating results is matters or interferents; check if the
greater than 3.4A. reagent is qualified and placed in
the correct position; check the
cuvette is clean; check if the
photometric system is working
normally.
BLK Calibration Blank response out of The reagent goes wrong; insufficient reagent Check if the cuvette is not
related range is dispensed; the cuvette contains air bubbles; overflowed, the reagent is sufficient
the light drifts; or the cuvette is overflowed. without air bubbles, the light does
not drift and the chemistry
parameters are reasonable. If yes,
replace the reagent and then rerun
the test.
BOE Result related Substrate depletion The sample concentration is too high, and Check the reaction curve and the
substrate depletion occurs during fixed-time substrate depletion limit. Rerun the
measurements. test with diluted sample.
CALE Result related Edited calibration factor The calibration factors are edited. No actions are required.
CALF Result related Calibration failed.(for The calibration fails. Recalibrate.
biochemistries)

CALF Result related No fluid in tubing 1. Waste pump tube is aging, blocked, or 1. Replace the reagent pack with
broken； a new one
2. Sample injection port and fluidic path are 2. Perform purge B to remove
blocked or leaking. bubbles
3. Air bubble detector failed. 3. /4. Replace the pump tube
5. Clean the sample injection port
and reinstall electrodes.
6. Replace the bubble detector.
1. Place sufficient ISE wash

solution.
2. Replace the pump tube
CALF Calibration No fluid in tubing 1. Waste pump tube is aging, blocked, or 1. Replace the reagent pack with
related broken； a new one
2. Sample injection port and fluidic path are 2. Perform purge B to remove
blocked or leaking. bubbles
3. Air bubble detector failed. 3. /4. Replace the pump tube
1. Place sufficient ISE wash

solution.
2. Replace the pump tube
CALJ Calibration Rejected calibration The calibration factors are rejected. No actions are required.
related factor

CALM Result related Air in segment 1. Waste pump tube is aging, blocked, or 1. Replace the pump tube
broken； 2. Clean the sample injection port
2. Sample injection port and fluidic path are and reinstall electrodes.
blocked or leaking. 3. Replace the bubble detector.
3. Air bubble detector failed.
CALM Calibration Air in segment 1. Waste pump tube is aging, blocked, or 1. Replace the pump tube
related broken； 2. Clean the sample injection port
blocked or leaking. 3. Replace the bubble detector.
3. Air bubble detector failed.
CALR Result related Recalculated calibration The calibration factors are recalculated. No actions are required.
factor
COV Calibration Calibration curve not For nonlinear calibration, a satisfying base Check that the reagent and
related convergent cannot be calculated and no calibration curve calibrator are normal, and then
is drawn. recalibrate. If the error remains,
contact our customer service
department.
CSD Calibration Calibration curve The calculated standard deviation of the Check if the acceptance limit is
related standard deviation out of calibration curve exceeds the specified limit. reasonable and the reagent and
range calibrator are normal, and then
recalibrate.
DEL Calibration Deleted QC result The QC result has been deleted. No actions are required.
related
DET Calibration Calibration determination The calculated determination coefficient of the Check if the acceptance limit is
related coefficient out of range calibration curve exceeds the specified limit. reasonable and the reagent and
calibrator are normal, and then
recalibrate.

DEP Calibration Saving calibration result 1. ISE communication cable failure. 1. Replace the ISE communication
related error 2. Communication interface or pins failure cable.
3. Main control board of the ISE module goes 2. Replace the interface or pins.
wrong. 3. Replace the main control board
4. Software error. of the ISE module.
4. Upgrade the operating software
or reinstall it.
DTGL Result related Insufficient probe wash The probe wash solution is insufficient during Fill more probe wash solution.
solution measurement.
DUP Calibration Calibration repeatability The difference between the maximum and Check if the acceptance limit is
related error minimum response of the calibrator exceeds reasonable, troubleshoot the error,
the specified limit. and then recalibrate.
EDT Result related Edited result The result has been edited. No actions are required.
EDT Calibration Edited calibration factor The calibration factors have been edited. No actions are required.
related
ENC Result related No calculation interval The sample concentration is too high, and Check the reaction curve and the
substrate depletion occurs within the lag time substrate depletion limit. Rerun the
of rate check measurements. test with diluted sample.
EXP Result related Enzyme linearity range The high-concentration sample leads to Rerun the test with diluted sample.
extension substrate depletion during the reaction time,
and the result is calculated by using measuring
points within the lag time.
EXT Result related Extended calibration The result is obtained by extending the Take no actions, or recalibrate.
factor calibration time.
FAC Calibration Calibration slope The slope difference is applicable to linear Check if the acceptance limit is
related difference out of range calibration only and refers to the K factor reasonable and the reagent and
(slope) difference between two adjacent calibrator are normal, and then
calibrations. It exceeds the specified limit. recalibrate.
ICA Result related The response is normal, The chemistry has not been calibrated. Rerun it after calibration.
but results cannot be
calculated.

L! Result related Water blank fluctuation is 1. The cuvette is overflowing. 1. Check if the cuvette is
out of range. 2. The lamp has been replaced incorrectly. overflowing.
3. Cuvette check is not performed after 2. Check if the Replace Lamp
maintenance. command is executed during lamp
4. The cable connectors are not tightened. replacement.
5. The retaining screw is not tightened. 3. Check if the cable connectors and
retaining screw of the lamp have
6. Cleaning liquid inside the cuvette is little.
been tightened.
7. The lamp is aged.
4. Check if the cleaning liquid inside
8. The photometer goes wrong. the cuvette is no less than half of
the cuvette.
5. Check if the reaction curve
fluctuates irregularly. If yes, replace
the lamp.
6. If the error remains, contact our
customer service department.
LIN Result related Non-linear The measuring points for result calculation are Check the reaction curve and the
nonlinear, because the sample concentration is substrate depletion limit. Rerun the
too high, or the substrate depletion limit is not test with diluted sample. If the
specified or unreasonable. The lamp is aged. alarm occurs for more than one
chemistry, and the reaction curve
fluctuates irregularly, replace the
lamp.
LOW Result related Response less than that of The sample concentration is lower than the For ascending calibration curve,
the sensitivity indicated on the reagent pack, rerun the test with standard or
minimum-concentration making response less than that of the increased sample volume; for
calibrator lowest-concentration calibrator. descending calibration curve, rerun
the test with diluted sample.
MBK Calibration Mixed blank absorbance The reagent goes wrong; the cuvette is not Check if the cuvette is clear and not
related out of range clear; the reaction cuvette is overflowed; or overflowed, the reagent is sufficient
insufficient reagent is dispensed. without air bubbles, and the
chemistry parameters are
reasonable. If yes, replace the
reagent and then rerun the test.

MON Calibration Calibration curve not The calibration data and calibration curve are Check if the calibrator is defined
related monotonic not monotonic. and placed correctly, and then
recalibrate.
NLN Result related No linear interval The high-concentration sample leads to less Rerun the test with diluted sample.
than 3 valid measuring points within the
reaction time of rate check measurements.
NOIS Result related Electrode voltage noise 1. Electrode failure. 1. Replace the electrode.
2. Environment interference. 2. Relocate the instrument.
3. ISE main control board failure. 3. Replace the main control board
4. Salt buildup around electrodes or tubes due of the ISE module.
to fluidic leaks. 4. Clean the tubes and electrodes.
NOIS Calibration Electrode voltage noise 1. Electrode failure. 1. Replace the electrode.
related 2. Environment interference. 2. Relocate the instrument.
3. ISE main control board failure. 3. Replace the main control board
4. Salt buildup around electrodes or tubes due of the ISE module.
OVE Result related Overridden calibration The result is obtained by overriding a failed Take no actions, or recalibrate.
factor calibration.
PUGA Result related Air in calibrator A 1. Calibrator A is exhausted. 1. Replace the reagent pack with
2. Bubbles exist in calibrator tube A a new one
3. Pump tube A is aging, blocked, or broken. 2. Perform purge B to remove
4. Waste pump tube is aging, blocked, or bubbles
broken； 3. /4. Replace the pump tube
5. Sample injection port and fluidic path are 5. Clean the sample injection port
blocked or leaking. and reinstall electrodes.
6. Air bubble detector failed. 6. Replace the bubble detector.

PUGA Calibration Air in calibrator A 1. Calibrator A is exhausted. 1. Replace the reagent pack with
related 2. Bubbles exist in calibrator tube A a new one
PUGB Result related Air in calibrator B 1. Calibrator B is exhausted. 1. Replace the reagent pack with
2. Bubbles exist in calibrator tube B a new one
PUGB Calibration Air in calibrator B 1. Calibrator B is exhausted. 1. Replace the reagent pack with
related 2. Bubbles exist in calibrator tube B a new one
PRO Result related Prozone check error Antibody excess occurs due to too high sample Check the reaction curve and the
concentration. prozone check parameters. Rerun
the test with diluted sample.
R Result related Rerun result The result is obtained by rerunning the test. No actions are required.
R4S Result related R4S One result of a run is greater than +2 standard Check if the reagent is qualified,
deviations from the assigned mean and the control sample is normal, and the
other greater than -2SDs. instrument is working correctly.

RBK Result related R1 blank absorbance out The reagent goes wrong; the cuvette is not Check if the cuvette is clear and not
of range clear; the reaction cuvette is overflowed; or overflowed, the reagent is sufficient
insufficient reagent is dispensed. without air bubbles, and the
chemistry parameters are
reasonable. If yes, replace the
reagent and then rerun the test.
RCE Result related Response calculation Absorbance data for calculation is incomplete, Rerun the test. If the error remains,
error or the dividend is 0. contact our customer service
department.
REC Result related Recalculated result The sample result is recalculated manually /
with the latest calibration factors.
RESP Result related ISE response check code 1. ISE communication cable failure. 1. Replace the ISE communication
error 2. Communication interface or pins failure cable
Command format or 3. Main control board of the ISE module goes 2. Replace the interface or pins.
execution error wrong. 3. Replace the main control board
or reinstall it.
RESP Calibration ISE response check code 1. ISE communication cable failure. 1. Replace the ISE communication
related error 2. Communication interface or pins failure cable.
Command format or 3. Main control board of the ISE module goes 2. Replace the interface or pins.
execution error wrong. 3. Replace the main control board
or reinstall it
RGTE Result related Expired reagent The result is based on an expired reagent. Replace the reagent.
RGTL Result related Insufficient reagent The result is based on insufficient reagent. Replace the reagent.
RGTL Calibration Insufficient reagent The calibration result is based on insufficient Replace the reagent.
related reagent.
RRN Result related Response greater than The sample concentration exceeds the high Rerun the test with diluted sample.
that of the limit of the calibrator concentration.
maximum-concentration
calibrator

SEN Calibration Calibration sensitivity The difference of final response of the Check if the acceptance limit is
related error maximum and minimum concentration reasonable and the reagent and
calibrators exceeds the specified limit. calibrator are normal, and then
recalibrate.
SJAM Result related Sample probe is clogged Probe clogging is detected during sampling or Sample treatment.
the sample probe is clogged during sampling.
SLDR Calibration Electrode slope drift 1. Electrode or reagent pack fails. 1. Replace the problematic electrode
related 2. Electrode is unsteady. and reagent pack.
3. New reagent pack is unsteady. 2. New electrode will become
4. Reference electrode has been used for over steady after 15 minutes since
66 months. installed.
5. ISE main control board failure. 3. Run a couple of calibrations after
installing new reagent pack.
6. Ambient temperature fluctuates drastically
4. Replace the reference electrode.
5. Replace the ISE main control
board.
6. Control the ambient temperature
to make the fluctuation within
+/-4℃.
SLEX Calibration Slope out of range 1. Electrode is not installed correctly. 1. Reinstall the electrode
related 2. Calibrator expired. 2. Replace the calibrator.
3. Electrode degenerated 3. Replace the problematic electrode
4. Bubbles in reference electrode and rerun.
5. Reference electrode has been used for a long 4. Remove the electrode and clap on
time it to eliminate bubbles. Reinstall the
6. Electrodes interfered. electrode and run calibration.
7. Module or tubing temperature above 32℃. 5. Replace reference electrode and
rerun.
6. Troubleshoot the electrodes by
replacing them in different groups.
7. Monitor temperature, if too high,
relocate equipment.
SLP Result related Corrected result The result is adjusted with calculation factors. No actions are required.

SLP Result related The results are produced Calibration factors instead of the default ones No actions are required.
when the calibration are configured for the second time calibration.
factors instead of the
default ones are
configured for the second
time calibration.
SMPA Result related Air in sample 1. Sample is insufficient or contains many 1. Increase the sample volume. At
bubbles after dispensing. least 90μl sample should be
2. No or insufficient sample has been prepared.
dispensed into the sample injection port. 2. Electrode is not installed
3. The electrodes are not properly installed, correctly. Reinstall it.
causing leakage. 3. Check the waste tube, and if
4. The waste pump tube is aging or broken. necessary, replace it.
SMPE Result related Expired sample The sample is expired. Replace the sample.
SMPL Result related Insufficient sample The sample is insufficient during analysis. Refill the sample.
SMPL Calibration Insufficient sample The sample is insufficient during analysis. Refill the sample.
related
VDRF Result related Electrode voltage drift 1. Electrode or reagent pack fails. 1. Replace the problematic electrode
2. Electrode is unsteady. and reagent pack.
6. Ambient temperature fluctuates drastically.
board.
+/-4℃

VOUT Result related Electrode Voltage 1. Electrode or reagent pack fails. 1. Replace the problematic electrode
Overflow 2. Electrode is unsteady. and reagent pack.
board.
VOUT Calibration Electrode Voltage 1. Electrode or reagent pack fails. 1. Replace the problematic electrode
related Overflow 2. Electrode is unsteady. and reagent pack.
board.
T1 Result related Reaction disk 1. The ambient temperature is out of range. 1. Check if the error is accidental.
temperature error 2. The temperature sensor goes wrong. 2. If not, contact our customer
(component error and cable error) service department.
3. The temperature protection switch goes
wrong. (component error and cable error)
4. The heater goes wrong. (component error
and cable error)
5. PCB error
6. Parameters are lost.
7. Electromagnetic interference exists.

11.5 Error Messages and Corrective Actions 11 Alarms and troubleshooting
11.5 Error Messages and Corrective Actions

Table 11.5 Error messages and corrective actions
Event Component Event Error Message and Flag Probable Causes Corrective Actions
ID class Event Log
A00006 Middle layer unit Error Equipment / E2PROM read/write error Switch off the analyzing unit power
configuration cannot and switch on it again. Recover
be read or saved failure by performing the Home
Error: maintenance procedure. If this
message appears for 3 times, contact
our customer service department or
A00007 Middle layer unit Error Instruction execution / Instrument instructions cannot be executed. Switch off the analyzing unit power
error and switch on it again. Recover
failure by performing the Home
maintenance procedure. If this
A01006 Sample probe unit Error Sample probe vertical / Sample probe vertical movement error Recover failure by performing the
movement error 1. Sensor status error: Home maintenance procedure. If this
Position: The sample probe assembly is probably message appears for 3 times, contact
Error: forced to move vertically. our customer service department or
2. Failed to find the zero position:
Or The sample probe assembly is probably
jammed.
Sample probe 3. Collision occurs during operation other
horizontal movement than aspirating:
error The sample probe collides with other object.
Position: 4. Collision error:
Error: The collision remains.
5. Moving vertically is not allowed in current
Or position:

11 Alarms and troubleshooting 11.5 Error Messages and Corrective Actions
ID class Event Log
The sample probe moves vertically in an
Sample syringe unknown position.
movement error. Sample probe horizontal movement error
Position: 1. Sensor status error:
Error: The sample probe assembly is probably
forced to move horizontally.
The sample probe assembly is obstructed
when rotating.
3. Collision occurs during horizontal
movement:
The sample probe assembly is obstructed
when rotating.
4. Moving horizontally is not allowed in
current position:
The sample probe assembly is probably
forced to move vertically.
Sample syringe movement error.
1. Sensor status error:
The syringe assembly is probably forced to
move.
The syringe assembly is probably jammed.
A01007 Sample probe unit Warning Sample probe collides / 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
with an obstacle when The sample probe collides with other object. Remove the obstacle, and then
aspirating recover failure by performing the
Sample position: Home maintenance procedure.
Sample ID/bar code:
Specific position:
A01024 Sample probe unit Warning Insufficient sample / There is no sample or insufficient sample on 1. Check if the sample is sufficient,
the designated position. and then try again.

ID class Event Log
or 2. If the error remains, contact our
Sample probe level customer service department or your
detection failed. local distributor.
A01028 Sample probe unit Error Sample probe fails to / There is no deionized water, or the deionized 1. Check if the water supply is
detect liquid level water is not supplied normally. normal.
during cleaning 2. Recover the failure for 3 times. If
the error remains, contact our
Customer Service Department or
A01033 Sample probe unit Warning Sample probe fails to / There is no reagent or insufficient reagent 1. Check if R1 volume is sufficient
detect liquid level on in the reaction cuvette. and the reagent bottle is free of air
reaction carousel bubbles, and then try again.
when dispensing. 2. If the problem remains, contact the
Cuvette No.: manufacturer.
Sample ID/bar code:
Chemistry:
or
Sample probe level
detection failed.
Cuvette No.:
Sample ID/bar code:
Chemistry:
A01039 Probe unit Error Instruction execution / Instrument instructions cannot be executed. Switch off the analyzing unit power
A02007 Probe unit Warning Probe R2 collides with / 1. Collision occurs during aspirating: 1. Collision occurs during aspirating:
an obstacle when The probe R2 collides with other object. Remove the obstacle and then

ID class Event Log
aspirating recover the failure.
Reagent position:
Specific position:
A02023 Probe unit Warning Insufficient reagent / There is no reagent or insufficient reagent 1. Check if the reagent is sufficient,
Or on the designated position. and then try again.
Probe R2 level 2. If the error remains, contact our
detection failed. customer service department or your
local distributor.
A02025 Probe unit Warning Probe dispenses / 1. The probe aspirates nothing. 1. Check if the reagent satisfies the
insufficient reagent requirement and is sufficient in
volume, and then try again.
2. Recover the failure. If this message
appears for 3 times, contact our
customer service department or your
local distributor.
A02027 Probe unit Warning Water residues exist / DI water residual exists in cuvette. Recover the failure. If this message
in the cuvette or appears for 3 times, contact our
Probe level detection customer service department or your
failed local distributor.
A05006 Mixer unit Error Mixer vertical / 1.Sensor status error. the assembly is Recover failure by performing the
movement error probably forced to move vertically. Home maintenance procedure. If this
Mixer horizontal 2.Failed to find the zero position. The mixer message appears for 3 times,
movement error assembly is probably jammed contact our customer service
3.Vertical movement is not allowed in department or your local distributor.
current horizontal position.
The reagent mixer moves vertically in an
unknown position.
1.Sensor status error. the assembly is
probably forced to move vertically.
2. Failed to find the zero position The mixer
assembly is obstructed when rotating

ID class Event Log
3. Horizontal movement is not allowed in
current vertical position.
A05007 Mixer unit Error Instruction execution / Instrument instructions cannot be executed. Switch off the analyzing unit power
A06006 Reaction carousel Error Reaction carousel / Reaction carousel movement error Switch off the analyzing unit power
unit movement error 1. Failed to find the home position and switch on it again. Recover
Error: The reaction carousel is obstructed or failure by performing the Home
blocked. maintenance procedure. If this
2. The coder missed steps
The reaction carousel is obstructed or your local distributor.
blocked.
3. The reaction carousel missed steps when
moving to the home position.
The reaction carousel is obstructed or
blocked.
A06007 Reaction carousel Error Filter wheel / 1. Instrument instructions cannot be Switch off the analyzing unit power
unit movement error executed. and switch on it again. Recover
2. Filter wheel motor error failure by performing the Home
3. The home position sensor of Filter maintenance procedure. If this
wheel is abnormal. message appears for 3 times, contact
A06008 Reaction carousel Error Instruction execution / Instrument instructions cannot be executed. Switch off the analyzing unit power
unit error and switch on it again. Recover

ID class Event Log
A07006 Sample/reagent Error Sample carousel / Sample carousel movement error Recover the failure. If this message
carousel unit movement error 1. Failed to find the home position appears for 3 times, contact our
Error: The sample carousel is obstructed or customer service department or your
blocked. local distributor.
2. The coder missed steps
The sample carousel is obstructed or
blocked.
3. The sample carousel missed steps when
moving to the home position.
The sample carousel is obstructed or
blocked.
A07009 Sample/reagent Error Sample bar code / The sample bar coder reader goes wrong due Recover the failure. If the error still
carousel unit reader error to system failure. remains, contact our Customer
Service Department or your local
distributor.
A07010 Sample/reagent Warning Sample bar code error / Sample bar coder reader does not work Try again. If your attempt fails,
carousel unit Position: normally due to communication error. contact our customer service
A07011 Sample/reagent Error Sample bar code / Sample bar coder sending buffer is full due Recover the failure or reboot the
carousel unit sending buffer is full to communication error. analyzing unit.
A09011 Sample/reagent Error Reagent bar code / The reagent bar coder reader goes wrong Recover the failure. If the error still
carouse unit reader does not work due to system failure. remains, contact our Customer
normally Service Department or your local
distributor.
A09012 Sample/reagent Warning Reagent bar code / Reagent bar coder sending buffer is full due Try again. If your attempt fails,
carousel unit error to communication error. contact our customer service
Position: department or your local distributor.
A09014 Sample/reagent Error Reagent bar code / Reagent bar coder reader does not work Recover the failure or reboot the
carousel unit sending buffer is full normally due to communication error. analyzing unit.

ID class Event Log
Position:
A11005 Wash station Error Wash station / Wash station movement error Switch off the analyzing unit power
movement error 1. Sensor status error and switch on it again. Recover
Error: The wash station assembly is probably failure by performing the Home
forced to move. maintenance procedure. If this
2. Failed to find the home position
The wash station assembly is obstructed by your local distributor.
other object.
3. The wash station collides with an obstacle
when moving.
The wash station collides with other object,
or the wash probes then collide with the
reaction carousel.
A11013 Wash station Error Water tank is empty / 1. The water tank is empty. 1. Check if the water level inside the
2. The low-level floater of the water tank water tank is low.
goes wrong. 2. Check if the error is accidental.
3. If the error is not accidental,
A11015 Wash station Error Insufficient diluted / 1. The low-level floater of the diluted wash 1. Check the floater of the diluted
wash solution solution tank goes wrong. wash solution tank.
2. The diluted wash solution tank is empty. 2.Fill the diluted wash solution tank.
3. Check if the error is accidental.
A11020 Wash station Error High concentration / 1. The high concentration waste tank is full 1. Check the high-concentration
waste tank is full 2. The floater of the high concentration waste tank. If it is full, replace the
waste tank goes wrong. waste tank, close the full tank and
dispose of the waste properly.
2. Check if the error is accidental.

ID class Event Log
A11034 Wash station Error Cuvette wash syringe / 1.Sensor status error. The syringe assembly Switch off the analyzing unit power
movement error. is probably forced to move.2.Failed to find and switch on it again. Recover
the mechanical zero position. The syringe failure by performing the Home
assembly is probably jammed. maintenance procedure. If this
A11038 Wash station Error Instruction execution / Instruction execution error Switch off the analyzing unit power
A12005 Temperature unit Warning Reaction carousel T1 1. The ambient temperature is out of range. 1. Check if the error is accidental.
temperature is out of 2. The temperature sensor goes wrong. 2. If the error is not accidental,
range (component error and cable error) contact our customer service
3. The temperature protection switch goes department or your local distributor.
wrong. (component error and cable error)
4. The heater goes wrong. (component error
and cable error)
5. Temperature control fan error.
6 PCB error
7. Parameters are lost.
A12006 Temperature unit Warning Temperature of wash / 1. The ambient temperature is out of range. 1. Check the temperature of the
solution for cleaning 2. The temperature sensor goes wrong. deionized water for cleaning the
cuvettes is out of (component error and cable error) whole unit.
range 2. Check if the water supply is

ID class Event Log
Temperature: 3. The temperature protection switch goes normal and has the temperature
wrong. (component error and cable error) between 15°C-30°C.
4. The heater goes wrong. (component error 3. Check if the error is accidental.
and cable error) 4. If the error is not accidental,
5. PCB error contact our customer service
6. Parameters are lost. department or your local distributor.
A12007 Temperature unit Warning Temperature of / 1. The ambient temperature is out of range. 1. Check the temperature of the
deionized water for 2. The temperature sensor goes wrong. deionized water for cleaning the
cleaning cuvettes is (component error and cable error) whole unit.
out of range 3. The temperature protection switch goes 2. Check if the water supply is
wrong. (component error and cable error) normal and has the temperature
4. The heater goes wrong. (component error between 15°C-30°C.
and cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental,
6. Parameters are lost. contact our customer service
7. Electromagnetic interference exists. department or your local distributor.
A12010 Temperature unit Warning Reagent preheating / 1. The ambient temperature is out of range. 1. Check the temperature of the
temperature is out of 2. The temperature sensor goes wrong. deionized water for cleaning the
range. (component error and cable error) whole unit.
3. The temperature protection switch goes 2. Check if the water supply is
wrong. (component error and cable error) normal and has the temperature
4. The heater goes wrong. (component error between 15°C-30°C.
and cable error) 3. Check if the error is accidental.
5. PCB error 4. If the error is not accidental,
6. Parameters are lost. contact our customer service
7. Electromagnetic interference exists. department or your local distributor.
A21001 Probe Interior Error Probe interior wash / 1.Sensor status error. The syringe assembly Switch off the analyzing unit power
Wash Unit syringe movement is probably forced to move.2.Failed to find and switch on it again. Recover
error. the mechanical zero position. The syringe failure by performing the Home

ID class Event Log
Error: assembly is probably jammed. message appears for 3 times, contact
A22001 ISE unit Error Slope out of range, SLEX 1. Electrode installation incorrect. 1. Reinstall the electrode.
electrode: 2. Calibrator expired. 2. Replace the calibrator.
3. Electrode degenerated. 3. Replace the problematic electrode
4. Bubbles in reference electrode. and rerun.
5. Reference electrode has been used for a 4. Remove the electrode and clap on it
long time. to eliminate bubbles. Reinstall the
6. Electrodes interfered. electrode and run calibration.
7. Module or tubing temperature above 32°C. 5. Replace reference electrode and
rerun.
6. Troubleshoot the electrodes by
replacing them in different groups.
7. Monitor temperature, if too high,
relocate equipment.
A22002 ISE unit Error Air in sample. SMPA 1. Sample is insufficient or contain much 1.&2. Increase the sample volume. At
Position: bubbles after dispensing. least 90μl sample should be
2. No or insufficient sample has been prepared.
dispensed into the sample injection port. 3. Electrode is not installed correctly.
3. Liquid leakage due to that the electrodes Reinstall it.
are not properly installed. 4. Check the waste tube, and if
4. The waste pump tube is aging or broken. necessary, replace it.
A22004 ISE unit Error ISE unit cannot be / 1. ISE power supply failure. 1. Replace the 24V power supply
connected. 2. ISE communication cable failure. board.
3. Communication interface or pins failure. 2. Replace the ISE communication
4. ISE main control board failure. cable.
3. Replace the interface or pins.
board.
A22005 ISE unit Error ISE unit response / 1. ISE communication cable failure. 1. Replace the ISE communication
error 2. Communication interface or pins failure. cable.
3. ISE main control board failure. 2. Replace the interface or pins.

ID class Event Log
4. Software failure. 3. Replace the ISE main control
board.
4. Upgrade the operating software or
reinstall it.
A22006 ISE unit Error Purge A and B failed. / 1. Leaks exist due to improperly-installed 1. Reinstall the electrode and check
electrode or missing O ring. for O ring.
2. Sample injection port or electrode inside is 2. Use warm water to clean and
clogged. unclog the sample injection port with
3. Calibrator is exhausted. fresh water and unclog the electrode
4. Prime combinations are not enough. tube. Check the reference electrode
5. Pump tube is aging, blocked, or broken. for crystallized salt.
6. Calibrator cannot be dispensed normally 3. Replace the reagent pack.
due to clogged reagent pack tube. 4. Increase the prime cycle.
5. Replace the pump tube.
6. Unclog the reagent pack tube with
warm water.
A22007 ISE unit Warning ISE reagent is going to / Calibrator is exhausted. Replace the reagent pack with a new
be exhausted. one.
A22008 ISE unit Error Voltage overflow, VOUT 1. Electrode or reagent pack failed. 1. Replace the problematic electrode
electrode: 2. Electrode is unsteady. and reagent pack.
3. New reagent pack is unsteady. 2. New electrode will become steady
4. Reference electrode has been used for over after 15 minutes since installed.
6 months. 3. Run a couple of calibrations after
5. ISE main control board failure. installing new reagent pack.
board.
A22009 ISE unit Error Electrode slope drift. VDRF/ 1. Electrode or reagent pack failed. 1. Replace the problematic electrode
(during calibration) SLDR 2. Electrode is unsteady. and reagent pack.
Or 3. New reagent pack is unsteady. 2. New electrode will become steady
Electrode voltage drift. 4. Reference electrode has been used for over after 15 minutes since installed.
(during sample 6 months. 3. Run a couple of calibrations after
5. ISE main control board failure. installing new reagent pack.

ID class Event Log
analysis) 6. Ambient temperature fluctuates 4. Replace the reference electrode.
Electrode: drastically. 5. Replace the ISE main control
board.
+/-4℃.
A22010 ISE unit Error Voltage noise, NOIS 1. Electrode failure. 1. Replace the electrode.
electrode: 2. Environment interference. 2. Relocate the instrument.
3. ISE main control board failure. 3. Replace the ISE main control
4. Salt buildup around electrodes or tubes due board.
A22011 ISE unit Error Air in calibrator B PUGB 1. Calibrator B is exhausted. 1. Replace the reagent pack with a
2. Bubbles exist in calibrator tube B. new one.
3. Pump tube B is aging, blocked, or broken. 2. Perform purge B to remove
4. Waste pump tube B is aging, blocked, or bubbles.
broken. 3.&4. Replace the pump tube.
6. Air bubble detector fails. 6. Replace the air bubble detector.
A22012 ISE unit Error Air in calibrator A PUGA 1. Calibrator A is exhausted. 1. Replace the reagent pack with a
2. Bubbles exist in calibrator tube A. new one.
3. Pump tube B is aging, blocked, or broken. 2. Perform purge A to remove
4. Waste pump tube B is aging, blocked, or bubbles.
broken. 3.&4. Replace the pump tube.
A22013 ISE unit Error ISE pump calibrating / 1. Pump tube is aging. 1. Replace the pump tube.
failed! 2. Sample probe aspiration/dispensing 2. Replace the sample probe.
failure.
A22014 ISE unit Error Air bubble detector / 1. Air bubble detector board is eroded due to Replace the bubble detector.
failure the leaks at the joint of sample injection port

ID class Event Log
and bubble detector.
2. Air bubble detector fails.
A22015 ISE unit Error Reading reagent pack / 1. Reagent pack is not installed. 1. Install reagent pack.
chip error 2. Reagent pack wand fails. 2. Replace the wand.
A22016 ISE unit Error Reagent pack chip / 1. Reagent pack is not installed. 1. Install reagent pack.
writing error. Unload 3. Reagent pack wand fails. 3. Replace the wand.
the reagent pack and
load it again.
A22017 ISE unit Error Air in ISE wash / 1. ISE wash solution is insufficient. 1. Place sufficient ISE wash solution.
solution 2. Waste pump tube B is aging, blocked, or 2. Replace the pump tube.
broken. 3. Clean the sample injection port
blocked or leaking. 4. Replace the air bubble detector.
4. Air bubble detector fails.
A22018 ISE unit Error No fluid in tubing CALF 1. Waste pump tube B is aging, blocked, or 1. Place sufficient ISE wash solution.
broken. 2. Replace the pump tube.
A22019 ISE unit Error Saving calibration DEP 1. ISE communication cable failure. 1. Replace the ISE communication
result error 2. Communication interface or pins failure. cable.
board.
reinstall it.
A22021 ISE unit Error Command format or RESP 1. ISE communication cable failure. 1. Replace the ISE communication
execution error 2. Communication interface or pins failure. cable.
board.

ID class Event Log
reinstall it.
A22022 ISE unit Error No fluid in tubing / 1. Waste pump tube B is aging, blocked, or 1. Place sufficient ISE wash solution.
broken. 2. Replace the pump tube.
A22023 ISE unit Error No reagent module / 1. Reagent pack is not installed. 1. Install reagent pack.
has been loaded. 2. Reagent pack wand fails. 2. Replace the wand.
A22024 ISE unit Error ISE response check RESP 1. The communication wire between ISE and 1.Replace the communication wire
code error the middle-layer unit goes wrong. 2.Change the interface or the pin.
2. Communication interface or pin error. 3.Change the main control board.
3.Main control board does not function.
4.Upgrade the software or reinstall
4.Software error the software.
A22027 / Error Fluidic prime failed. / Fluidic is not primed. 1. Turn off the analyzing unit power
and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
customer service or your local
distributor.
A22036 / Error Initializing sample bar / Sample bar code reader failed due to system 1. Recover failure by performing the
code reader failed. error. Home maintenance procedure.
2. If this error remains
A22038 / Error Scanning reagent bar / Scanning reagent bar code failed. 1. Turn off the analyzing unit power
code failed. and reswitch it on.
2. If the error occurs for continuous
three times, please contact our
distributor.

ID class Event Log
A22039 / Error Unmatched software / 1.Version inquiry instruction failed. 1. Turn off the analyzing unit power
version. and reswitch it on.
2. The version information of the control
software does not match the one stored in 2. If the error occurs for continuous
the operating software. three times, please contact our
distributor.
C00007 Operating system Error CPU performance low / The CPU is too busy. Reboot the computer and operating
software. If this message appears for
3 times, contact our customer
service department or your local
distributor.
C00011 Operating system Error The last abnormal exit / The operating software is abnormal, or the Restart the operating software, and
may cause carryover instrument power is cut off unexpectedly. execute the Special Wash
not handled. Execute maintenance command before
the Special Wash starting analysis.
maintenance
command before
starting analysis to
ensure accurate
results.
C00012 Operating system Warning Sound card failure / No sound card is installed. Sound card Reinstall the sound card or the
failure. Incorrect sound card driver. sound card driver.
C00013 Operating system Error The cuvette status / The operating software is not exited Take out and check the standby
may not be refreshed normally due to some reasons.(BS-230) cuvettes. If they are used, replace
due to the last them. When you are uncertain if they
abnormal exit of the are used, replace them.
system. To ensure the
correct test results,
please check the
cuvettes and replace
them.

ID class Event Log
C01001 Instrument Error Equipment cannot be / The serial cable is not connected; or the Check the serial port connection.
connection connected analyzing unit power is switched off. Replug the cable. Check if the
analyzing unit is powered on. Start
the initialization again. Restart the
computer and analyzing unit. If three
continuous attempts are failed,
C02001 Database Error Database initialing / The database file is damaged or lost. Reboot the computer and analyzing
failed unit. If three continuous attempts are
failed, contact our customer service
C02002 Database Error Database upgrade / The database file is damaged or lost. Reboot the computer and analyzing
C02004 Database Warning Database backup / The database file is damaged or lost. Reboot the computer and analyzing
C02005 Database Warning Reading/Writing / The database does not work normally. Reboot the computer and analyzing
database failed unit. If three continuous attempts are
C03001 Result calculation Warning Result cannot be RCE Absorbance data for calculation is Rerun the test. If the error remains,
calculated incomplete, or the dividend is 0. contact our customer service
Sample ID/bar code: department or your local distributor.
Position:
Chemistry:
C03002 Result calculation Warning Absorbance out of ABS 1. Probe R1 dispenses insufficient reagent, 1. Observe the reaction curve. If the
range or air bubbles exist in the reagent. absorbance of R1 is too high, check
the reagent for air bubbles and the

ID class Event Log
Sample ID/bar code: 2. The reagent is placed in an incorrect syringe for leaking.
Position: position or is abnormal. 2. Check if the reagent has been
Chemistry: 3. The sample concentration is too high, placed in the correct position.
resulting in great response. 3. Rerun the test after dilution.
4. The absorbance data used for calculation is 4. Contact our customer service
incomplete (due to photoelectric data loss), department or your local distributor.
or the error of division by zero occurs.
C03003 Result calculation Warning R1 blank absorbance RBK The reagent goes wrong; the cuvette is not Check if the reagent is sufficient
out of range clear; the reaction cuvette is overflowed; or without air bubbles and the
insufficient reagent is dispensed. (BS-240) chemistry parameters are
The reagent goes wrong; or insufficient reasonable. If yes, replace the reagent
reagent is dispensed.(BS-230) and then rerun the test. Check if the
cuvette is normal. If the error
remains, contact our customer
distributor.
C03004 Result calculation Warning Substrate depletion BOE The sample concentration is too high, and Check the reaction curve and the
Sample ID/bar code: substrate depletion occurs during fixed-time substrate depletion limit. Rerun the
Position: measurements. test with diluted sample.
Chemistry:
C03005 Result calculation Warning Result cannot be ENC The sample concentration is too high, and Check the reaction curve and the
calculated substrate depletion occurs within the lag substrate depletion limit. Rerun the
Sample ID/bar code: time of rate check measurements. test with diluted sample.
Position:
Chemistry:
C03006 Result calculation Warning Linearity limit out of LIN The measuring points for result calculation Check the reaction curve and the
range are nonlinear, because the sample substrate depletion limit. Rerun the
Sample ID/bar code: concentration is too high, or the substrate test with diluted sample.
Position: depletion limit is not specified or
unreasonable.
Chemistry:
C03007 Result calculation Warning Prozone check error PRO Antibody excess occurs due to too high Check the reaction curve and the

ID class Event Log
Sample ID/bar code: sample concentration. prozone check parameters. Rerun
Position: the test with diluted sample.
Chemistry:
C03008 Result calculation Warning Sample concentration RRN The sample concentration exceeds the high Rerun the test with diluted sample.
is higher than that of limit of the calibrator concentration.
the highest-level
calibrator
Sample ID/bar code:
Position:
Chemistry:
C03009 Result calculation Warning Mixed blank MBK The reagent goes wrong; the cuvette is not Check if the reagent is sufficient
absorbance out of clear; the reaction cuvette is overflowed; or without air bubbles and the
range insufficient reagent is dispensed. chemistry parameters are
Chemistry: reasonable. Check if the cuvette is
normal. Replace the reagent and then
rerun the test. If the error remains,
C03010 Result calculation Warning Blank response out of BLK The reagent goes wrong; insufficient Check if the reagent is sufficient
range reagent is dispensed; the cuvette contains without air bubbles and the
Chemistry: air bubbles; the light drifts; or the cuvette is chemistry parameters are
overflowed. (BS-240) reasonable. Check if the cuvette is
The reagent goes wrong; insufficient normal. Replace the reagent and then
reagent is dispensed; the cuvette contains rerun the test. If the error remains,
air bubbles; the light drifts;(BS-230) contact our customer service
C03011 Result calculation Warning Calibration DUP The difference between the maximum and Check if the acceptance limit is
repeatability exceeds minimum response of the calibrator exceeds reasonable, troubleshoot the error,
limit. Chem: the specified limit. and then recalibrate.
C03012 Result calculation Warning Calibration sensitivity SEN The difference of final response of the Check if the acceptance limit is
exceeds limit. Chem: maximum and minimum concentration reasonable and the reagent and
calibrators exceeds the specified limit. calibrator are normal, and then

ID class Event Log
recalibrate.
C03013 Result calculation Warning Calibration curve SD CSD The calculated standard deviation of the Check if the acceptance limit is
exceeds limit, Chem: calibration curve exceeds the specified limit. reasonable and the reagent and
calibrator are normal, and then
recalibrate.
C03014 Result calculation Warning Calibration DET The calculated determination coefficient of Check if the acceptance limit is
determination the calibration curve exceeds the specified reasonable and the reagent and
coefficient exceeds limit. calibrator are normal, and then
limit, Chem: recalibrate.
C03015 Result calculation Warning Calibration slope FAC The slope difference is applicable to linear Check if the acceptance limit is
difference out of calibration only and refers to the K factor reasonable and the reagent and
range. Chem: (slope) difference between two adjacent calibrator are normal, and then
calibrations. It exceeds the specified limit. recalibrate.
C03016 Result calculation Warning Calibration curve is MON The calibration data and calibration curve Check if the calibrator is defined and
not monotonic, Chem: are not monotonic. placed correctly, and then
recalibrate.
C03017 Result calculation Warning Calibration curve is COV For nonlinear calibration, a satisfying base Check that the reagent and
not convergent, cannot be calculated and no calibration calibrator are normal, and then
Chem: curve is drawn. recalibrate. If the error remains,
C03018 Result calculation Warning Chemistry: 1-2s The QC result is between ±2 and ±3 No actions are required.
Control: 1-2s warning standard deviations from the assigned mean
concentration.
C03019 Result calculation Warning Chemistry: 1-3s The QC result is greater than ±3 standard Check if the reagent is qualified and
Control: 1-3s out of deviations from the assigned mean control is normal. If the error
control concentration. remains, contact our customer
distributor.
C03020 Result calculation Warning Chemistry: 2-2s Results of two controls or two results of one Check if the reagent is qualified and
Control: 2-2s out of control within a run are simultaneously control is normal. If the error

ID class Event Log
control greater than +2 or -2 standard deviations remains, contact our customer
from the assigned mean. service department or your local
distributor.
C03021 Result calculation Warning Chemistry: R-4s One result of a run is greater than +2 Check if the reagent is qualified and
Control: R-4s out of standard deviations from the assigned mean control is normal. If the error
control and the other greater than -2SDs. remains, contact our customer
distributor.
C03022 Result calculation Warning Chemistry: 4-1s Results of two runs in two-control evaluation Check if the reagent is qualified and
Control: 4-1s out of or four continuous results of a control are control is normal. If the error
control greater than +1 or -1 standard deviation remains, contact our customer
from the assigned mean concentration. service department or your local
distributor.
C03023 Result calculation Warning Chemistry: 10-x Results of five runs in two-control evaluation Check if the reagent is qualified and
Control: 10-x out of or ten continuous results of a control that control is normal. If the error
control are being compared are on the same side. remains, contact our customer
distributor.
C03024 Result calculation Error Biochemistry test / 1. Software error Rerun the test. Reboot the operating
period time out. 2. Operating system error software, analyzing unit and
Cannot continue computer. If the error remains,
C03026 Result calculation Warning Photoelectric data is / Communication error. If the error persists, contact our
lost customer service department or your
local distributor.
C03027 Result calculation Warning Chemistry: 2.7s Multiple QC data and threshold values or Check if the reagent is qualified and
Control: 1.0-2.7 out of cumulative sum exceed ±2.7SD. control is normal. If the error
control remains, contact our customer
distributor.

ID class Event Log
distributor.
distributor.
C03030 Result calculation Error Photoelectric / 1. Software error 1. Rerun the operating software.
measurement period 2. Reboot the operation unit.
is out of range 3. If the error remains, contact our
Sample ID/bar code: customer service department or your
Position: local distributor.
Chemistry:
C03031 Result calculation Error Multiple consecutive / 1. Software error 1. Rerun the operating software.
photoelectric 2. Reboot the operation unit.
measurements are 3. If the error remains, contact our
time out customer service department or your
Sample ID/bar code: local distributor.
Position:
Chemistry:
C04001 Sample bar code Warning Duplicate sample bar / Duplicate bar code is used. Replace the duplicate sample bar
code. code label.
Sample ID/bar code:
Position 1:
Position 2:
C04002 Sample bar code Warning Bar code has no / The sample of the bar code has not been Program the sample of the bar code.
corresponding programmed.
programming.
Sample ID/bar code:

ID class Event Log
Position:
C04006 Sample bar code Warning Sample is expired / The sample is loaded after its shelf life is The sample is expired. Replace the
Sample ID/bar code: exceeded. sample and program it again. Reject
Position: the expired sample. If the sample
shelf life is too short, change it to a
reasonable one.
C04008 Sample bar code Warning Sample bar code too / The bar code length is greater than the Redefine the bar code with no more
long. Position: maximum value of 27 digits. than 27 digits.
C04009 Sample bar code Warning Sample bar code is less / The sample bar code is too short, less than Reprint the bar code and ensure it is
than 3 digits. the minimum range of 3 digits. no less than 3 digits.
position:
C04012 Sample bar code Warning Sample bar code / Barcode information does not conform with Reset the barcode format or reprint
analysis error the barcode format the barcode and scan it.
Sample bar code:
Position:
C05001 Reagent bar code Warning Duplicate reagent bar / Incorrect reagent or reagent bar code is Reprint the reagent bar code, or
code being used, or an invalid reagent bar code is replace the reagent bottle with an
Reagent: being used. Bar code is aligned with invalid bar code.
Position 1: reagents, and cannot be used again for new
reagent when a reagent is exhausted.
Position 2:
C05002 Reagent bar code Warning Reagent bar code / Incorrect reagent bar code is being used, or Print the new reagent bar code with
information error. reagent bar code is not configured correct settings and check the bar
Position: reasonably. The reagent bar code contains code against the settings. Replace the
incomplete or incorrect reagent information, reagent bottle, or contact the reagent
such as expiration date, reagent volume, etc. supplier.
C05003 Reagent bar code Warning Reagent bar code / Incorrect reagent bar code is being used, or Check the reagent bar code settings,
analysis error reagent bar code settings are incorrect. The or reprint the reagent bar code
Position: system fails to extract reagent information against the settings. Contact the
from the bar code. reagent supplier.
C05006 Reagent bar code Error Wash solution / Reagent rather than wash solution is placed Reposition the reagent, or remove it
position on reagent in the fixed wash solution position (D) on from the fixed reagent position.

ID class Event Log
carousel is occupied reagent carousel.
by another reagent
Position:
C05008 Reagent bar code Error Physiological saline / Reagent rather than physiological saline is Reposition the reagent, or remove it
position on reagent placed in the fixed physiological saline from the fixed wash solution
carousel is occupied position (W) on reagent carousel. position.
by another reagent
Position:
C05010 Reagent bar code Error The pretreatment / Reagent rather than pretreatment reagent is Reposition the reagent, or remove it
reagent position is placed in the pretreatment reagent position from the pretreatment reagent
occupied by other on reagent carousel. position.
reagent. Position:
C05011 Reagent bar code Error The ISE wash solution / Reagent rather than ISE wash solution is Reposition the reagent, or remove it
position is occupied placed in the pretreatment reagent position from the ISE wash solution position.
by another reagent. on reagent carousel.
C06001 Host Error LIS initialization error / Host file is damaged or does not exist. Reinstall the operating software.
communication
C06002 Host Error LIS communication / Host parameters error Re-set or modify the host
communication parameter error communication parameters.
C06003 Host Error LIS communication / Communication error If the error occurs accidentally, send
communication error or receive the instruction again. If
the error still remains, contact our
local distributor.
C06004 Host Error LIS host cannot be / Abnormal network connection or the LIS Check LIS connection and network
communication connected host is not started. cable. Check if LIS host and LIS
station can start normally.
C06005 Host Warning Sending sample / Communication error If the error occurs accidentally, send
communication results failed. or receive the instruction again. If
Sample ID/bar code: the error still remains, contact our
Position: customer service department or your

ID class Event Log
local distributor.
C06006 Host Warning Sending sample / Communication error If the error occurs accidentally, send
communication information failed. or receive the instruction again. If
Sample ID/bar code: the error still remains, contact our
Position: customer service department or your
local distributor.
C06007 Host Warning Inquiring sample / LIS host failure. If the error occurs accidentally,
communication information failed. neglect it. If the error occurs
Sample ID/bar code: frequently, contact the manufacturer
Position: of LIS or contact our customer
distributor.
C06008 Host Warning Downloading sample / Incorrect channel settings or insufficient or Check and re-set the chemistry
communication failed. redundant chemistries on the LIS host. correspondence between the
Sample ID/bar code: operating software and the LIS host.
Position:
C07003 Light source Error Light intensity is too / 1. The lamp is not installed correctly. 1. Check if the lamp is installed
weak 2. The cuvette is contaminated. correctly.
3. The lamp is aging. 2. Perform the diluted wash
4. The wash station dispenses liquid procedure and then the lamp check
incorrectly. procedure.
5. The photoelectric collection board goes 3. Replace the lamp.
wrong. 4. Check if the wash station
dispenses liquid with correct volume
to reaction cuvettes.
5. If your attempt fails, contact our
local distributor.
C07004 Light source Warning Cuvette blank out of / 1. The cuvette is contaminated. 1. Open the reaction carousel and
range 2. The lamp is aging. check if the lamp is turned on. If it is
Cuvette No.: 3. The lamp is not installed correctly. not, rerun the operating software.

ID class Event Log
4. The wash station dispenses liquid 2. Check if the lamp is installed
incorrectly. correctly.
5. The photoelectric collection board goes 3. Perform the diluted wash
wrong. procedure and then the cuvette
check procedure.
4. Replace or clean the failed cuvette.
5. Replace the lamp.
6. Check if the wash station
dispenses liquid with correct volume
to reaction cuvettes.
7. If your attempt fails, contact our
local distributor.
C07005 Light source Error Lamp is not turned on / 1. The lamp is damaged. 1. Open the reaction carousel and
2. The lamp cable is not connected properly. check if the lamp is turned on. If it is
3. The power board of the lamp is not not, rerun the operating software.
connected properly. 2. Check if the lamp cable is
4. The power supply of the analyzing unit is tightened.
disconnected. 3. Replace the lamp.
5. The photoelectric collection board goes 4. If your attempt fails, contact our
wrong. customer service department or your
local distributor.
C07006 Light source Error Light intensity is too / 1. A cuvette position has no cuvette installed. 1. Check if all cuvette positions have
strong 2. The circuit gain is too high and beyond cuvettes installed.
the measurement range. 2. Contact our customer service
department or your local distributor
to adjust the gain.
C07007 Light source Error Dark current is too / 1. The circuit gain is too high and beyond If three continuous attempts are
high the measurement range. failed, contact our customer service
Channel: 2. The photoelectric collection board goes department or your local distributor.
AD: wrong.

ID class Event Log
C07009 Light source Error Water blank out of L! 1. The cuvette wash station is overflowing. 1. Check if the cuvette is overflowing.
range (10X) 2. The lamp has been replaced incorrectly. 2. Check if the Replace Lamp
3. Cuvette check is not performed after command is executed during lamp
maintenance. replacement.
4. The cable connectors are not tightened. 3. Check if the Cuvette Check
5. The retaining screw is not tightened. command is executed after
maintenance.
6. The wash station dispenses insufficient
fluid. 4. Check if the cleaning liquid inside
the cuvette is no less than half of the
7. The lamp is aged.
cuvette.
5. Check if the cable connectors and
retaining screw of the lamp have
been tightened.
6. Check if the reaction curve
fluctuates irregularly. If yes, replace
the lamp.
7. If the error remains, contact our
customer service department.
C07012 Other error of Warning Storage device error. / No U disk is inserted. No file is found in the U Check if a U disk is inserted or full.
operation unit Cannot import data disk, or file error, or file is damaged. The U Check if the storage device is
disk is locked or damaged. damaged.
C07013 Other error of Warning Storage device error. / No U disk is inserted. Insufficient disk space. Check if a U disk is inserted or full.
operation unit Cannot export data The U disk is locked or damaged. Check if the storage device is
damaged.
C07014 Other error of Warning Reagent exhausted / All reagents of the reagent type for the Refill or replace the reagent.
operation unit Chemistry: chemistry are less than the minimum limit.
Position: All reagents of the type are too little to be
detected.
C07016 Other error of Warning Insufficient wash / Insufficient wash solution on the reagent Refill the wash solution on the
operation unit solution carousel. reagent carousel.
Position:

ID class Event Log
C07017 Other error of Warning Wash solution is / The wash solution on the reagent carousel is Refill the wash solution on the
operation unit exhausted exhausted. reagent carousel.
Position:
C07022 Other error of Warning Less than X tests are / All reagents of the reagent type for the Refill or replace the reagent.
operation unit left in biochemistry chemistry are less than the minimum limit.
reagent. Chemistry: All reagents of the type are too little to be
detected.
C07023 Other error of Warning Chemistry: %s, 30 / The calibration factors will be expired. Recalibrate the chemistries.
operation unit minutes left for next
calibration.
C07027 Other error of Warning Calibrator %s has / The calibrator is expired. Replace the calibrator.
operation unit been expired
C07028 Other error of Warning Chemistry: %s, lot / The reagent is expired. Replace the reagent.
operation unit No.: %s, position: %s,
has been expired
C07029 Other error of Warning Chemistry: %s, lot / The on-board stability time of the reagent Replace the reagent.
operation unit No.: %s, pack is too long.
position: %s, has
exceeded the
on-board stability
time
C07034 Other error of Warning Insufficient / Insufficient physiological saline. Refill the physiological saline on the
operation unit physiological saline reagent carousel.
Position:
C07035 Other error of Warning Physiological saline is / Physiological saline is exhausted. Refill the physiological saline on the
operation unit exhausted reagent carousel.
Position:
C07036 Other Warning Chemistry: %s. / The calibration factors have been expired. Recalibrate the chemistry.
Calibration factors are
expired

ID class Event Log
C07037 Other Warning Reagent bottle / Serial number of the reagent is changed. Recalibrate the chemistry.
number of %s
chemistry is changed.
Please recalibrate
C07038 Other Warning Reagent lot number / Lot number of the reagent is changed. Recalibrate the chemistry.
of %s chemistry is
changed. Please
recalibrate
C07039 Other Warning Calibration factors / The calibration factors are expired. Recalibrate the chemistry.
of %s chemistry are
expired. Recalibrate
C07040 Other Warning Reagent exhausted / 1. The reagent is running out. Refill or replace the reagent.
Chemistry: 2. The reagent is too little to be detected.
C07041 Other Error ISE reagent is less / ISE reagent inventory is below the alarm Check the inventory. If the reagent is
than %s limit insufficient, load the reagent.
C07042 Other Warning %s, lot number: %s, / One or more special reagents have been Replace them with new reagents.
position: %s, has been expired.
expired
C07043 Other Warning Pretreatment reagent / The pretreatment reagent is running out. Add more pretreatment reagent
is exhausted.
Position:
C07044 Other Warning Pretreatment reagent / The pretreatment reagent is insufficient. Add more pretreatment reagent
is insufficient.
Position:
C07045 Other Warning ISE wash solution is / ISE wash solution is exhausted. Add the ISE wash solution.
exhausted.
C07046 Other Warning ISE wash solution is / ISE wash solution is insufficient. Add the ISE wash solution.
insufficient.


12 Operation theories
This chapter gives brief introduction of the operation theories of the instrument, which include:
 Principles of biochemistry measurement
 Calibration math model and calculation of factors
 QC determination methods
 Prozone check
 Principles of ISE measurement

12.1 Overview 12 Operation theories
12.1 Overview
The system is a fully automated computer-controlled clinical chemistry analyzer allowing
random selection of chemistries. It is capable of running a variety of chemistries based on the
operation theories and measurement principles.
The system performs measurement and generates the test results in the following procedure:
Figure 12.1 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.
12.2 Principles of measurement

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, and F indicates the incubation time. 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.
12.2.1 Endpoint 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. 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.

12 Operation theories 12.2 Principles of measurement
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.
AM  AM 1
Ai= .
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.
Calculation of blank absorbance

The blank absorbance Ab is calculated in the same way as the reaction absorbance Ai.
When N and P are not specified, the blank absorbance Ab will not be calculated.
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
Where, VR1 and VR2 are the volumes of R1 and R2; Vs is the actual sample volume dispensed for
reaction.
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 chemistry parameters.
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

12.2 Principles of measurement 12 Operation theories
12.2.2 Fixed-time measurements

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 can, however, 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 (Tl-Tm). 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.
12.2.3 Calculation of Response

The response in fixed-time measurements is calculated as follows:
AM  AL A  AN
R  60*( k P )
tM  t L tP  tN
12.2.4 Kinetic measurements

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.
Data calculation in Kinetic measurements

Figure 12.2 Data calculation flow of Kinetic measurements
Determination of linearity
range
Calculate response with the

least square method
Evaluation for linearity
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.
Figure 12.3 Determination of linearity range for Kinetic measurements
Enter [L-M]
Enter substrate
No
depletion limit?
Yes
Yes Find M′ without substrate

Substrate
depletion within M and the
depleted at M?
reaction start reading point
Number (N)
of measuring points without No
No
substrate depletion between L
and M′ is greater than
or equal to 3.
Yes
Linearity range [L- Linearity range [L-

Alarm of "NLN"
M] 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;
 If N=2, the system will give the flag "NLN" while using two measuring points for
calculating the response.

12.2 Principles of measurement 12 Operation theories
 If N=0 or 1, when Enzyme Linear Extension option is selected on the chemistry

parameter screen, enzyme linear extension will be enabled and the system gives the
flag "NLN"; when Enzyme Linear Extension option is not selected on the chemistry
parameter screen, enzyme linear extension will not be enabled and the system gives
the flag "NLN" too.
Absorbance change rate⊿ALM' within the reaction time
The response ⊿ALM' within L-M' is calculated with the least square method.
M'
 (T  T )  ( A  A)
i i
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
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.
The response in Kinetic measurements is calculated as follows:
R  ALM'  K  A NP
Evaluation for linearity
A f  Ab
Linearity= 100  Linearity Limit
Au ,v
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.
 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 chemistry, and will
flag the test result with “LIN” and given an alarm if the configured linearity is exceeded.
Enzyme linearity range extension

Figure 12.4 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" and "NLN".

12.3 Calibration math model and factors 12 Operation theories
12.3 Calibration math model and factors

The system provides linear and non-linear math models. The former is used for Colorimetry
chemistries and the later for turbidity chemistries.
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
12.3.1 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 chemistry 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
12.3.2 Non-Linear Calibrations

Logit–Log 4P
1
Calculation formula: R  R0  K
1  exp[ (a  b ln C )]

12 Operation theories 12.3 Calibration math model and factors
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 chemistries which have a calibration curve with the
response reversely proportional to the concentration.
Logit–Log 5P
1
R  R0  K
Calculation formula: 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 chemistries 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  dx
2 3
can be calculated with the least square method for polynomial
expressions.
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 is n,
R a b ci
then the calculation formula contains 4(n-1) factors, which are 0 i , i , i , and . Due to the
subsection fitting, this math model has be best fit curves than other math models.

12.4 QC evaluation 12 Operation theories
12.4 QC evaluation
The system provides the Westgard rules for evaluating QC results of the chemistries, and give
alarms and flags when the obtained QC results are beyond the reference range. Since every
chemistry 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.
12.4.1 Evaluation of single controls

The Westgard rules for evaluation of single controls are listed in the table below:
Table 12.1 Westgard rules for single controls
Rules Description Flag Error Type
1-2s One result is between ±2 and ±3 standard N/A N/A
deviations from the assigned mean
concentration.
1-3s One result is greater than ±3 standard 1-3s *(1)
concentration.
2-2s Two continuous results are greater than +2 or 2-2s #(2)
-2 standard deviations from the assigned
mean concentration, e.g. (Xn, Xn-1)
4-1s Four continuous results are greater than +1 or 4-1s #
-1 standard deviation from the assigned mean
concentration, e.g. (Xn, Xn-1, Xn-2, Xn-3)
10-x Ten results being compared are on the same 10-x #
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.
The evaluation procedure of single controls is shown in the figure below:
Figure 12.5 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

12 Operation theories 12.4 QC evaluation
12.4.2 Two-control evaluation

Setting up QC run
A QC run is based on two control samples: C1 and C2, and at most one QC run is performed for
each chemistry. The system allows the definition of QC run interval on the System Setup screen.
The maximum QC run interval is 24 hours.
To set up QC run
3 Choose 9 QC Evaluation.
4 Type in the QC run length in the Run Length field.
Enter an integer between 1 and 24. The default is 24.
5 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:
Table 12.2 Two-control evaluation rules
Rules Description Flag Error Type
1-2s One result is between ±2 and ±3 standard N/A N/A
concentration.
1-3s One result is greater than ±3 standard 1-3s *(1)
concentration.
2-2SA Two results (Xn, Yn) of a run are simultaneously 2-2s #(2)
greater than +2 or -2 standard deviations from
the assigned mean.
R-4s One result of a run is greater than +2 standard R-4s *
deviations from the assigned mean and the other
greater than -2SDs.
2-2SW Two continuous results of a control are greater 2-2s #
than +2 or -2 standard deviations from the
assigned mean concentration, e.g. (Xn, Xn-1),
(Yn, Yn-1).
4-1SA Results of two continuous runs are greater than 4-1s #
+1 or -1 standard deviation from the assigned
mean, e.g. (Xn, Yn, Xn-1, Yn-1).
4-1SW Four continuous results of a control are greater 4-1s #
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).
10-XA Results of five continuous runs (10 results) 10-x #
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).

12.5 Prozone Check 12 Operation theories
10-XW Ten continuous results (10 results) of a control 10-x #

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 random 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:
Figure 12.6 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)
12.5 Prozone Check

12.5.1 Introduction
Figure 12.7 Reaction curve of antigen and antibody
Prozone Equivalent Postzone
Response R
(antibody excess) zone (antigen excess)
Concentration C

12 Operation theories 12.6 Principles of ISE measurement
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.
The system supports the rate check method.
12.5.2 Rate check method

The rate check method is based on the condition that the antibody excess reaction rather than
the antigen excess reaction can reach equilibrium within the same specified period. Enter the
Prozone check factors as follows:
 PCM (Prozone check limit), q1, q2, q3 and q4.
 Absorbance low limit: ABS
Aq 4  Aq 3
q 4  q3
 Sample PC: PC  . If PC>PCM, the system will flag the test result with
Aq 2  Aq1
q 2  q1
"PRO" and give an alarm.
Enter the measuring points as follows:
 Single-reagent chemistries: 1≤q1<q2<q3<q4≤68, "1" is the first measuring point
after the sample is dispensed and stirred.
 Double-reagent chemistries: 1≤q1<q2<q3<q4≤34. "1" is the first measuring point
after R2 is dispensed and stirred.
If one of PCM, q1, q2, q3 and q4 is not input, the system will not check the reaction rate.
Prozone check will be disabled if:
 (Reaction end point absorbance - Reaction start point absorbance) <ABS
 The sample response is not within the calibrator response range for sample and
control analysis of non-linear chemistries.
12.6 Principles of ISE 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. Serum is
tested without dilution while urine should be diluted manually before test with buffer solution
at the ratio of 1:9.
A single measurement of the ISE unit is conducted in the following order:
 Drainage: The calibrator in the ISE pipe is drained
 Sample analysis: The sample probe dispenses the sample (70 μL for serum
sample,140 μL for diluted urine) into the sample injection port of the ISE module and
then the sample is absorbed into the flow cell for measurement. When the
measurement is finished, the waste is drained from it.
 Cleaning pipework: 100 μL calibrator A is dispensed into the ISE module for cleaning
the ISE flow cell.

12.6 Principles of ISE measurement 12 Operation theories
 Single point calibration: 80 μL calibrator is dispensed into the ISE module to perform
single point calibration.

Glossary
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.
Analyzing unit
The analyzing unit, the analyzer, determines various clinical chemistries in samples and displays
the test results. It consists of the sample/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 chemistry will
be run again.
Bar code reader
Fixed laser beam scanner. It scans the bar code label on sample tube and reagent bottle to
identify the sample and reagent.
Batch program
Batch program is to program a group of samples with identical programming 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.
Calibration factor
Calibration factor is obtained based on the equation of calibrator concentration (known) and
response (calibration math model).
BS-230 Operator’s Manual Glossary-1

Glossary
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 chemistry’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 chemistry or the reaction of other mixture, resulting in inaccurate
results.
Chemistry configuration
Chemistry configuration is applicable to all chemistries other than ISE chemistry and SI, and
used to enable or disable chemistries that have been defined correctly.
Closed-reagent chemistry
Closed-reagent chemistry is run by using the reagents provided by the analyzer manufacturer.
Closed-reagent chemistries cannot be modified or deleted.
Concentrated wash solution
CD80 alkaline concentrated wash solution, used to clean the reaction cuvettes during 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 chemistry, 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 programmed 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 four 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 Chemistries window.
Diluent
Liquid used to dilute other liquids.
Dilution factor
User-defined dilution ratio, to be multiplied with sample result to obtain the final result.
Glossary-2 BS-230 Operator’s Manual

Glossary
Download
To obtain sample programming information from the LIS host and match it with the scanned
samples. The system supports real-time and manual downloading of sample programming
information.
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 the phase 1 cuvette wash. It can be drained to the
provided high-concentration waste tank and then disposed of according to your local or national
regulations.
History results
Stored results are those programmed and analyzed before the current day.
Increased
Increased indicates the sample volume required for analysis and can be defined on the
Define/Edit Chemistries 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.
ISE
ISE is the abbreviation of Ion Selective Electrode. It consists of the ISE module, pump module and
reagent module, and is used to measure the concentration of Na, K and Cl ions 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.
BS-230 Operator's Manual Glossary-3

Glossary
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 chemistry 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 phase 2-4 cuvette wash and probe/mixer cleaning.
It can be drained to the provided low-concentration waste tank or the sewer of your laboratory.
Mask/Unmask chemistries
Used when a chemistry needs to be disabled temporarily due to abnormal result or reagent
exhaustion. The masked chemistry 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 chemistries cannot be requested until they are
unmasked.
Mixer
The system provides one mixer for stirring the mixture inside a reaction cuvette when sample
and R2 are respectively dispensed.
Multi-sample report
Containing the results of multiple samples, and can be printed out on the Current Results and
History Results screens.
Off-line dilution
Prior to analysis, samples are diluted manually based on specific ratio.
Offset
Offset is a value added or subtracted to compensate a result. It is often used along with the slope
in the equation y=kx+b, in which k is the slope and b is the offset.
Off-system chemistry
All the chemistries that are not run by the analyzer are referred to as the off-system
chemistries.

Glossary
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 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+F1 to display the topics related to the
current screen or window.
Open-reagent chemistry
Open-reagent chemistry, an opposite of the closed-reagent chemistry 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 chemistries combined together for certain clinical purposes, such as liver
function, kidney function, etc. Panels can help fast programming of samples.
Patient demographics
Patient demographics contain information related to the patient and sample, such as patient
name, age, gender, 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: 340 nm,
405 nm, 450 nm, 510 nm, 546 nm, 578 nm, 630 nm, and 670 nm.
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.

Glossary
Print name
Print name appears on a patient report representing a chemistry, and if left blank, will be
replaced by the short name of the chemistry.
Probe
The probe aspirates the specified amount of sample and reagent and then dispenses it into a
cuvette for reaction and analysis.
Probe wash solution
CD80 alkaline concentrated wash solution. It is placed in position D of the sample/reagent
carousel, and used for special cleaning the probe, in order to prevent cross contamination.
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 rate check method is supported.
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.
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
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.

Glossary
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 status can be requested for reagent blank.
Reagent carryover
Cross contamination between the reagent probe and the mixers. When the number of tests
between the contaminating chemistry and the contaminated is less than or equal to the defined
number (N), and no concentrated wash is inserted between the two chemistries, 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.
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.
Release
Used to clear the specified sample position or all positions on the current sample carousel.
When a sample is released, its results and programming information can be still recalled. The
released position can be used for programming of new samples.
Replicates
Number of times to run a test, to ensure accurate results.
Result statistics
Result statistics option can summarize the total chemistries and the distribution trend of its
results and provide the test data and graph.
Sample blank
sample interference (Hemolysis, icterus and lipemia) on absorbance readings.
Sample/Reagent carousel
The sample/reagent carousel is located on left side of the analyzer panel. It holds sample tubes
and reagent bottles and carries each of them to the aspirate position for aspirating.

Glossary
Sample comments
Remarks for some special samples, such as, ** sample has hemolysis; ** sample needs to be
analyzed immediately, etc.
Sample log
Contains the controls and patient samples that are not complete within the recent 24 hours due
to certain reasons. Based on the sample log you are allowed to rerun the samples or take other
actions for the controls and samples.
Sample panel
Used for analysis of patient samples.
Sample type
Type of sample. The sample type options include serum, plasma, urine, CSF and other.
Page
Page 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.
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 chemistries and has specific clinical
purposes, such as A/G, TBil-DBil, etc.
Special wash
Special wash is to clean the probe, mixer and reaction cuvettes by using the probe wash solution
with the aim of eliminating carryover and preventing waste from leaving 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.

Glossary
STAT
STAT means emergent, including common STAT and quick STAT program. STAT sample program
allows emergent samples to be programmed and analyzed with high priority. Common STAT
program is used in daytime to run emergent samples with higher priority than routine samples.
Quick STAT program is mainly used in nighttime and weekends to program 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.
Systematic error
An alarm of quality control monitoring. A systematic error may occur when both the lowest
value and highest value of a QC result are on the same side.
Transmit
Transmit is an action sending specified sample results or QC results to the LIS host.
Twin chemistries
Twin chemistries are run with the same reagents and calculated through the same test. For two
twin chemistries, the sample volume, volume of shared reagent, calibration replicates, and auto
calibration conditions should be the same. When either of the two chemistries is requested for
calibration, quality control or sample analysis, the other chemistry will be automatically
requested, and finally results of both chemistries 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 chemistry
and excludes those that have been deleted.
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.
Wash solution
All wash solution used by the instrument is CD80 alkaline concentrated wash solution. It is used
to clean the probe, mixer and reaction cuvettes.
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.

Glossary
Test statistics
On the Tests screen, you can view test requests and reagent application for each chemistry
during a period, and sample requests and the quantity of its chemistries.

Index
Index
LIS, 1-28, 6-23, 8-20, 11-42, 11-43
Ａ Lot number, 2-12
Absorbance, 11-16, 11-35

Auto calibration, 4-10 Ｍ
Main screen, 9-2
Ｂ Measuring point, 8-6, 12-6
Mouse, 1-23
Background, 9-13, 9-14, 9-15
Bottle type, 2-12
Ｐ
Ｃ Panels, 7-26
physiological saline, 11-42, 11-46
calibration curve, 12-9 Primary tube, 1-9
Calibration factors, 4-22
calibration status, 4-5, 4-20, 4-22
calibrator, 12-8 Ｑ
calibrator dilution, 4-7
Concentrated wash solution, 5 QC rules, 5-2
Control, 4, 5-12, 4
Ｒ
Ｄ Reaction carousel, 11-24
daily maintenance, 2-29 Reaction curve, 12-12
Delete/edit logs, 11-4 Reaction cuvette, 2-28
Demographics, 6-26 Reaction time, 12-3
Reagent blank, 4-14, 7-11
Reagent volume, 7, 11-41
Ｅ response, 12-9
Endpoint, 1-25
Error logs, 11-4 Ｓ
Sample blank, 8, 5-7
Ｈ Sample carousel, 1-26, 11-25
Sample carousel outer ring, 11-25
Host, 8-19, 11-42 Sample probe, 11-22
host communication, 11-2, 11-42 sample status, 7-30
Sample syringe, 11-21
Serial number, 10, 2-12, 11-2
Ｉ Software version, 10-5
Standby, 2-5, 7-2, 10-14, 10-15, 10-17, 10-28, 10-29
ISE module, 4, 8, 8-5 STAT, 2-23
Syringe plunger assembly, 10-29, 10-30
Ｋ System relocation, 1-5
K factor, 4-20, 11-38

Ｔ
Ｌ Template Modifying Software, 9-2, 9-4
Two-control evaluation, 5-6
Light source, 11-43, 11-44
BS-230 Operator's Manual Index-1

Index
Index-2 BS-230 Operator’s Manual

P/N: 046-008979-00(2.0)

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BS-230

Intellectual Property Statement

Responsibility on the Manufacturer Party

BS-230 Operator's Manual i

Customer service department

ii BS-230 Operator's Manual

BS-230 Operator’s Manual 1

Symbol and Meaning

2 BS-230 Operator’s Manual

Symbol Text Description

BS-230 Operator's Manual 3

4 BS-230 Operator’s Manual

Reagent and wash solution hazards

BS-230 Operator's Manual 5

6 BS-230 Operator’s Manual

BS-230 Operator's Manual 7

ISE module precautions

8 BS-230 Operator’s Manual

BS-230 Operator's Manual 9

Labels and silkscreen

Non-warning labels and silkscreen

In vitro diagnostic equipment

European community representative

10 BS-230 Operator’s Manual

Main power switch: ON

Main power switch: OFF

Analyzer power switch

BS-230 Operator's Manual 11

Interfaces for fluid connection

12 BS-230 Operator’s Manual

Moving parts warning

Photometer lamp warning

Probe collision warning

BS-230 Operator's Manual 13

Liquid level floater

Cuvette replacement window

14 BS-230 Operator’s Manual

BS-230 Operator's Manual 15

1.4.2 Power supply requirements ................................................................................................................... 1-27

16 BS-230 Operator’s Manual

4.1.3 Results recall .................................................................................................................................................... 4-3

BS-230 Operator's Manual 17

6.4.3 Reviewing sample results ........................................................................................................................ 6-25

18 BS-230 Operator’s Manual

7.6.4 Running calculations .................................................................................................................................. 7-25

BS-230 Operator's Manual 19

8.4.1 General print setup options .................................................................................................................... 8-13

20 BS-230 Operator’s Manual

10.2 Scheduled maintenance and maintenance commands ............................................................................... 10-7

BS-230 Operator's Manual 21

11.2.2 Description of Edit Log screen ........................................................................................................... 11-4

22 BS-230 Operator’s Manual

BS-230 Operator’s Manual 1-1

1.1 Installation requirements and procedure

Temperature and humidity

1-2 BS-230 Operator’s Manual

Water supply and drainage

Figure 1.1 Fluidic connection diagram

DI water tank Low concentrated