KX-21N Operator's Manual N American 05.2010

OPERATOR’S MANUAL
AUTOMATED HEMATOLOGY ANALYZER
KX-21N
(North American Edition)
CHAPTER 1: INTRODUCTION
CHAPTER 2: SAMPLE ANALYSIS
CHAPTER 3: DISPLAY AND PROCESSING OF ANALYSIS RESULTS
CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT
CHAPTER 5: QUALITY CONTROL
CHAPTER 6: CALIBRATION
CHAPTER 7: TROUBLESHOOTING
CHAPTER 8: ADJUSTMENT
CHAPTER 9: FUNCTIONAL DESCRIPTION
CHAPTER 10: INSTRUMENT SETUP
APPENDIX A: INSTALLATION
APPENDIX B: TECHNICAL INFORMATION
INDEX
SYSMEX CORPORATION
KOBE, JAPAN
Copyright ©1999 - 2010 by SYSMEX CORPORATION
All rights reserved. No part of this Operator’s Manual may be Code No. 461-2264-1
reproduced in any form or by any means whatsoever without PRINTED IN JAPAN
prior written permission of SYSMEX CORPORATION. Date of Last Revision: May 2010
• Sysmex is a registered trademark of SYSMEX CORPORATION.
• CELLCLEAN, CELLPACK, EIGHTCHECK-3WP, and STROMATOLYSER-WH are
trademarks of SYSMEX CORPORATION.
• Cubitainer is a registered trademark of Hedwin Corporation.

• ESC/P is a registered trademark of Seiko Epson Corporation.
• PCL is a registered trademark of Hewlett-Packard Company.
• Teflon is a registered trademark of E.I. du Pont de Nemours & Co., Inc.
• VENOJECT is a registered trademark of Terumo Corporation.
• Other trademarks referenced are property of their respective owners.
• It is prohibited to reproduce part or all of the contents of this Manual without permission.
• The display screens carried in this Manual may in some cases differ from actual screens.
• We reserve the right to make further improvements and incorporate them in our products,
which then will have some points that differ from descriptions in this Manual.
• Patient names and doctor names are entered for information and illustration purposes
only, and do not imply real specific persons.
Sysmex KX-21N Operator’s Manual -- Revised November 2009

RECEIVING INSTRUCTIONS
The KX-21N has been thoroughly tested before shipment, and has been packaged care-
fully to prevent damage from shipping and handling. Reagents and options have also been
sent and will arrive at approximately the same time as the analyzer. Follow these guide-
lines when the system arrives:
• Check to see that the arrows on the sides of the packages are pointing up. If the
arrows do not point up, remark this information on the bill of lading.
• Visually inspect the outside of the package for rips, dents, or possible shipping dam-
age. Document any sign of damage on the bill of lading, regardless of how insignifi-
cant it may appear. This is for your protection!
• Notify your service representative that the KX-21N system and its components have
arrived.
• Wait for your service representative to unpack the system and open the packages.
• Follow the unpacking and storage instructions provided on the outside of the package.
Special requirements such as refrigeration are clearly marked on the outside of the
carton and will be included in the unpacking instructions and package inserts.
WARRANTY INFORMATION
All instruments manufactured by Sysmex® are warranted against defective materials or

workmanship for a period of one year commencing on the installation date at the cus-
tomer's required location.
This Warranty does not cover any defect, malfunction, or damage due to:
1. Accident, neglect or willful mistreatment of the product
2. Failure to use, operate, service, or maintain the product in accordance with the appli-
cable Sysmex Operator's Manual
3. Failure to use the appropriate reagents or chemicals specified for the product
Sysmex KX-21N Operator’s Manual -- Revised November 2009 I

ENSURE SAFE OPERATION OF THE INSTRUMENT
Before operating this instrument, carefully read the “Ensure Safe Operation of the Instrument”
and OPERATOR’S MANUAL, and strictly follow the instructions given in them.
This manual carries a variety of illustrations to make sure that the product can be used safely and
correctly, thus preventing you and others from suffering injuries and damage to property.
The illustrations and meaning are described in the following.

Do understand what they mean before proceeding to the text of the MANUAL.
Meaning of Signs
WARNING • If this sign is ignored and the instrument is operated incorrectly, there is a
potentially hazardous situation which could result in death or serious
injury of an operator, or grave property damage.
CAUTION • If this sign is ignored and the instrument is operated incorrectly, there is a
potentially hazardous situation which may result in injury of an operator,
adverse effect on output results, or will cause property damage.
Caution on Diagnosis
CAUTION • This product is a clinical instrument for screening of abnormalities.

Clinical judgments by physicians should take into account results from
clinical examinations and other test results besides hematology result.
II Sysmex KX-21N Operator’s Manual -- Revised November 2009

WARNING
• In the event the instrument emits abnormal odor or any smoke, turn off the power immedi-
ately and disconnect the power plug from the wall socket.
If the instrument is used continuously in that state, there is a hazard that fire, electrical shock, or
injury may result.
Contact your Sysmex service representative for inspection.
• Take care not to spill blood or reagent, or drop wire staples or paper clips into the instrument.
Those might cause short circuit or smoke emission. If such trouble should occur, turn off the power
supply immediately and pull off the power plug from the wall socket. Then contact Sysmex service
representative for inspection.
• Do not touch the electrical circuits inside the cover. Especially if your hands are wet, there is
a hazard that electrical shock may result.
• Always wear rubber gloves when performing maintenance work or inspection.

Use specified tools and parts.
After work is over, wash your hands with disinfectant.
There is a possibility that those areas of the hand which came in contact with blood could suffer
infection, electrical shock, or burn.
• Be careful when handling samples.

Always wear rubber gloves; otherwise infection by bacteria could result. If bacteria happen to enter
your eye or a cut, wash it off with plenty of water, and immediately see a doctor.
• When discarding waste liquid, or disassembling/assembling the related parts, do not touch
the waste liquid.
If it is contaminated with blood, infection of bacteria may result. If you should touch the waste liquid
inadvertently, wash it off with disinfectant first, then wash it off with soap.
When Handling Reagent

• If a reagent happens to enter your eye, wash it off immediately using plenty of water, and take
medical treatment at once.
• If you should swallow it inadvertently, call for a doctor immediately, drink plenty of water, and
throw up.
• If it happens to adhere to the hand or the skin of other area, wash it off using plenty of water.
• When discarding waste liquid, instrument consumable and instrument, take proper disposing
steps as medical, ineffective, and industrial wastes.
If they are contaminated with blood, infection of bacteria may result.
• Do not modify the instrument. (Modification is prohibited by Pharmaceutical Affairs Law in

Japan.) Check the regulations that apply to laboratories in your country.
Sysmex KX-21N Operator’s Manual -- Revised November 2009 III

WARNING
Power Supply, Connection, and Grounding

• Never put the power plug in any socket other than the specified voltage.
Otherwise, fire or electrical shock will result.
• When installing the instrument, be sure to ground it.

Otherwise, fire or electrical shock will result.
Handling Power Supply Cord

• Take care not to damage the power cord, place a heavy device on it, or pull it forcibly.
Otherwise, the wire may break causing fire or electrical shock.
• When connecting the instrument to a peripheral (host computer, printer), be sure to switch off
the power supply beforehand.
Otherwise, electrical shock or instrument failure may result.
IV Sysmex KX-21N Operator’s Manual -- Revised November 2009

CAUTION
Use of Reagents
• After unpacking, be sure not to allow dust, dirt, or bacteria to come in touch with the reagent.
• Do not use reagents which are out of the expiration date.
• Handle a reagent gently to prevent formation of bubbles.
• Take care not to spill a reagent. If it spills, wipe it off immediately using a wet cloth or the like.
• Follow other instructions described on the Package Insert on each reagent.
Use of Instrument
• When performing maintenance work or inspection, use specified tools and parts. Do not use
substitute parts, or modify the instrument. It is hazardous.
• Do not bring your body or clothes close to the instrument.
• Those who have no or only limited experience in using reagents are recommended to have
guidance or assistance of those with sufficient experience.
• If the instrument has developed a trouble by any chance, a person in charge of it should take
steps within the range specified in the OPERATOR’S MANUAL. As to troubles other than
mentioned in it, contact Sysmex service representative for repair.
• Unpacking, installation, and confirmation of initial operation must be done by Sysmex service
representative.
Environment for Use

• Install the instrument in a place which is not subject to water splash.
• Install the instrument in a place which is not subject to adverse effects of high temperature,
high humidity, dust, direct sunlight, etc.
• Do not give the instrument a strong vibration or impact.
• Do not install the instrument near a chemical storage or a place where a gas is generated.
Sysmex KX-21N Operator’s Manual -- Revised November 2009 V

STRUCTURE OF THIS MANUAL
Read this manual carefully so you will be able to use the instrument to its full extent, and operate
it correctly. This manual contains ten Chapters and APPENDICES as listed in the following:
Chapter 1: Introduction Describes overview of this instrument, including the out-

line of the instrument, operation procedure, and mes-
sages, and cautions during installation.
Chapter 2: Sample Analysis Describes procedures for start-up of the instrument,

measurement of the sample, and shut-down.
Summarizes the operation method for analyzing the
sample.
Chapter 3: Display and Processing of Describes the displayed content of the analysis data,
Analysis Results and the process of the latest sample/stored data.
Also describes the manual analysis and the external
output.
Chapter 4: Maintenance and Supplies Describes scheduled maintenance and replacement

Replacement method of supplies such as reagent.
Chapter 5: Quality Control Describes execution procedures of the X control and L-J
control for quality control.
Chapter 6: Calibration Describes procedures for automatic, manual, and cali-

brator calibration.
Chapter 7: Troubleshooting Describes error messages and troubleshooting.
Chapter 8: Adjustment Describes the method of pressure adjustment based on

the troubleshooting.
Chapter 9: Functional Description Describes the analyzing principles of this instrument

and names of the components.
Chapter 10: Instrument Setup Describes the system environment setting such as date,
time, and unit, and the data analysis setting such as
data error judgment.
Appendix A: Installation Describes the installation method of the KX-21N.
Appendix B: Technical Information Technical reference data describing the specification for
host output format.
VI Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

INTRODUCTION
Thank you for purchasing the Sysmex® Automated Hematology Analyzer KX-21N.
Carefully read the OPERATOR'S MANUAL for correct use of the unit.
Keep this MANUAL handy after reading. It will continue to be of your service in finding specific
information about this instrument.
Ordering of Supplies and Replacement Parts

If you need to order supplies or replacement parts, please contact your local Sysmex representa-
tive.
Service and Maintenance

Please contact the Service Department of your local Sysmex representative.
Training courses
For further information please contact the Sysmex representative in your country.
Sysmex KX-21N Operator’s Manual -- Revised November 2009 VII

PREMISES FOR SIGNS
Meaning of Signs
WARNING • If this sign is ignored and the instrument is operated incorrectly, there is a
potentially hazardous situation which could result in death or serious
injury of an operator, or grave property damage.
CAUTION • If this sign is ignored and the instrument is operated incorrectly, there is a
potentially hazardous situation which may result in injury of an operator,
adverse effect on output results, or will cause property damage.
CAUTION: • Indicates what we would like you to know to maintain instrument perfor-
mance and prevent its damage.
NOTE: • Indicates information which will come handy in operating the instrument.
Document Conventions
In explaining operation, this manual uses the conventions as shown below.
• The keys on the panel keyboard are expressed within square brackets.
For example: [SELECT], [ENTER], [ ]
• The display on LCD appears within quotation marks.
For example: “Stand-by,” “WB”
• The name of menu appears within quotation marks.
For example: “2: Quality Control,” “6: Settings”
NOTE: • LCD and printing described in this manual may differ from that in practice.
• Due to the improvement of the product, the content of this manual may
not conform with the product.
VIII Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

Markings on the Instrument
KX-21N Front Interior
Sysmex
1)
2)
3) *1
4)
1)
RISK OF INFECTION
1)
In principle, all parts and surfaces of the instrument
must be regarded as infective.
Sysmex KX-21N Operator’s Manual -- Revised November 2009 IX

CAUTION
2) Confirm that the metal knob is between the stoppers.
If it is not, malfunction will occur.
IMPORTANT
3) At the instrument installation, remove the Sample Rotor
Fixture by turning it counter-clockwise and remove two
spacers. Then, clean the surfaces of Fixed Values and
Rotor Valve according to the instructions. Reassemble
the Sample Rotor Value.
Since the hydraulic lines are rinsed with distilled water
before shipment, press the START switch or the AUTO
RINSE switch to wash it down. Upon completion of the
instrument sequences, verify that the background count
is within the acceptable limit.
*1: These protection sheets are removed after installation.
WBC RBC
4)
WARNING
To avoid any potential for electric shock hazard, turn off
the instrument power when opening the detector cover.
X Sysmex KX-21N Operator’s Manual -- Revised November 2009

Rear
1) BR
CELLPACK W
2)
3)
4)
1) The meanings of these signs are:

BR: Barcode Reader
(Left) Parallel Port (DP Connector)
(Right) Parallel Port (GP Connector)
(Left) RS-232C Serial Port(Service Connector)
(Right) RS-232C Serial Port (HC Connector)
2) The meaning of this abbreviation is:

W: Waste
CAUTION
3) Do not open the card slot protective cover unless neces-
sary.
Make sure to turn off the power before you open the
cover, in case required.
Sysmex KX-21N Operator’s Manual -- Revised November 2009 XI

4) Name Plate
SN Serial Number
Date of Manufacture
Name of Manufacturer
IVD For In Vitro Diagnostic Use
Right Side
1)
2)
1) The meanings of these signs are:

ON
OFF
WARNING
2) This equipment must be earthed.
WARNING
- To avoid electrical shock, disconnect supply before servicing.
- For the continued protection against risk of fire, replace only
with fuse of the specified type and current ratings.
XII Sysmex KX-21N Operator’s Manual -- Revised November 2009

KX-21N OPERATOR’S MANUAL
TABLE OF CONTENTS
CHAPTER 1: INTRODUCTION
1. INTRODUCTION ................................................................................... 1-1
2. OVERVIEW OF INSTRUMENT ............................................................ 1-2
3. OPTION UNITS ...................................................................................... 1-3
4. OUTLINE OF OPERATION................................................................... 1-4
5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT.................. 1-4
6. ANALYSIS PARAMETERS ................................................................... 1-5
7. PANEL KEYBOARD.............................................................................. 1-7
8. GRAPHIC SCREEN................................................................................ 1-8
8.1 Contents of Display ..................................................................... 1-8
8.2 Status Display Messages.............................................................. 1-9
8.3 LCD Brightness Adjustment...................................................... 1-12
9. EMERGENCY STOP PROCEDURE ................................................... 1-12
10. ALARM SOUNDS ................................................................................ 1-13
11. CONTENTS OF PACKAGE ................................................................. 1-13
12. INSTALLATION ENVIRONMENT ..................................................... 1-14
12.1 Installation and Relocation ........................................................ 1-14
12.2 Grounding .................................................................................. 1-14
12.3 Installation Space ....................................................................... 1-15
12.4 Installation Environment............................................................ 1-16
13. INSTRUMENT SPECIFICATIONS...................................................... 1-17
14. MENU TREE......................................................................................... 1-21
CHAPTER 2: SAMPLE ANALYSIS

1. INTRODUCTION ................................................................................... 2-1
1.1 Overview of Analysis Modes....................................................... 2-1
1.2 Analysis Procedure Flow Chart ................................................... 2-2
2. START-UP PROCEDURE....................................................................... 2-3
2.1 Inspection before Turning ON the Power .................................... 2-3
2.2 Turning ON the Power and Self-Check ....................................... 2-5
3. QUALITY CONTROL ............................................................................ 2-8
4. PROCEDURES IN EACH ANALYSIS MODE...................................... 2-9
4.1 Whole Blood (WB) Mode............................................................ 2-9
4.2 Pre-Diluted (PD) Mode.............................................................. 2-16
5. DISPLAY AND PRINTING OF ANALYSIS RESULT........................ 2-24
5.1 Display of Analysis Result ........................................................ 2-24
5.2 Printing of Analysis Result ........................................................ 2-25
5.3 Output of Analysis Result to Host Computer ............................ 2-27
6. LIMITATIONS....................................................................................... 2-28
6.1 Cell Count Parameters ............................................................... 2-28
6.2 Limitation of Hemoglobin ......................................................... 2-29
7. EXPECTED RESULTS ......................................................................... 2-30
8. STOPPING THE PNEUMATIC UNIT ................................................. 2-31
9. EXECUTION OF SHUTDOWN........................................................... 2-32
9.1 Shutdown Procedure .................................................................. 2-32
Sysmex KX-21N Operator’s Manual -- Revised November 2009 i

CHAPTER 3: DISPLAY AND PROCESSING OF ANALYSIS
RESULTS
1. INTRODUCTION ................................................................................... 3-1
2. PROCESSING LATEST SAMPLES....................................................... 3-2
2.1 Display of Analysis Result .......................................................... 3-2
2.2 Manual Discrimination ................................................................ 3-7
2.3 External Output.......................................................................... 3-11
3. PROCESSING STORED DATA............................................................ 3-14
3.1 Executing and Quitting Stored Data Processing Program ......... 3-14
3.2 Stored Data Screen..................................................................... 3-15
3.3 Deletion...................................................................................... 3-20
3.4 External Output.......................................................................... 3-21
3.5 Correcting a Sample Number .................................................... 3-23
CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT

1. INTRODUCTION ................................................................................... 4-1
2. KX-21N MAINTENANCE CHECKLIST .............................................. 4-2
3. DAILY MAINTENANCE AND PROCEDURE ..................................... 4-4
3.1 Clean TD Chamber and Diluted Sample Line (Shutdown) ......... 4-4
3.2 Check Trap Chamber Level and Discard ..................................... 4-6
4. WEEKLY MAINTENANCE AND PROCEDURE................................. 4-7
4.1 Clean SRV Tray ........................................................................... 4-7
5. MONTHLY MAINTENANCE AND PROCEDURE ............................. 4-9
5.1 Clean Waste Chamber (Rinse Sequence)..................................... 4-9
5.2 Clean Transducer (Rinse Sequence) .......................................... 4-12
6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE ............... 4-16
6.1 Clean Sample Rotor Valve (SRV).............................................. 4-16
6.2 Reset SRV Cycle Counter ......................................................... 4-22
7. AS-NEEDED MAINTENANCE AND PROCEDURE......................... 4-24
7.1 Auto Rinse ................................................................................. 4-24
7.2 Clean Rinse Cup ........................................................................ 4-26
7.3 Clean WBC/RBC Transducer Aperture..................................... 4-28
7.4 Replace Waste Tank ................................................................... 4-32
8. SUPPLIES REPLACEMENT................................................................ 4-33
8.1 Replenish Reagent ..................................................................... 4-33
8.2 Replace Fuse .............................................................................. 4-36
8.3 Replace Printer Paper................................................................. 4-37
8.4 Supplies List .............................................................................. 4-40
9. CONFIRMATION OF CYCLE NUMBER ........................................... 4-41
9.1 Operation Procedure .................................................................. 4-41
ii Sysmex KX-21N Operator’s Manual -- Revised November 2009

CHAPTER 5: QUALITY CONTROL
1. INTRODUCTION ................................................................................... 5-1
1.1 X Control ..................................................................................... 5-1
1.2 Levy-Jennings Control (L-J)........................................................ 5-1
1.3 QC Chart Screen .......................................................................... 5-2
2. QC ANALYSIS PROCEDURE ............................................................... 5-4
2.1 QC Analysis Procedure Flow Chart............................................. 5-4
2.2 Execute QC Program ................................................................... 5-5
2.3 Select QC File .............................................................................. 5-6
2.4 Erase All ...................................................................................... 5-7
2.5 Set TARGET/LIMIT Values ........................................................ 5-8
2.6 Execute X Control...................................................................... 5-10
2.7 Execute L-J Control ................................................................... 5-19
2.8 Exit from QC Control Program ................................................. 5-26
3. DELETION............................................................................................ 5-27
4. EXTERNAL OUTPUT.......................................................................... 5-31
4.1 Printing to Printer....................................................................... 5-31
4.2 Output to Host Computer........................................................... 5-35
CHAPTER 6: CALIBRATION
1. INTRODUCTION ................................................................................... 6-1
1.1 Calibration ................................................................................... 6-1
1.2 Calibrator Calibration Program ................................................... 6-1
2. PREPARATION FOR CALIBRATION .................................................. 6-2
2.1 Precision Check ........................................................................... 6-2
2.2 Precision Check Sample .............................................................. 6-2
2.3 HGB/HCT Calibration Samples .................................................. 6-3
2.4 Reference Values.......................................................................... 6-3
2.4.1 Calibrator Calibration .................................................... 6-3
2.4.2 HGB/HCT Calibration................................................... 6-3
2.5 Calibration Flow Chart ................................................................ 6-4
3. AUTOMATIC CALIBRATION............................................................... 6-5
3.1 Executing Automatic Calibration Program.................................. 6-5
3.2 Automatic Calibration Procedure ................................................ 6-6
4. MANUAL CALIBRATION .................................................................. 6-11
4.1 Calculating Calibration Value .................................................... 6-11
4.2 Manual Calibration Procedure ................................................... 6-12
5. CALIBRATOR CALIBRATION........................................................... 6-15
5.1 Executing Calibrator Calibration Program ................................ 6-15
5.2 Calibrator Calibration Procedure ............................................... 6-17
6. CALIBRATION HISTORY PRINT ...................................................... 6-25
Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A. iii

CHAPTER 7: TROUBLESHOOTING
1. INTRODUCTION ................................................................................... 7-1
2. WHEN YOU SUSPECT A TROUBLE................................................... 7-2
2.1 Alphabetical List of Error Messages
Displayed on Analysis Screen ..................................................... 7-3
Displayed on HELP Screen ......................................................... 7-4
2.3 Functional List of Error Messages............................................... 7-5
3. TROUBLESHOOTING GUIDE ............................................................. 7-7
3.1 Pressure/Vacuum Errors............................................................... 7-7
3.2 Chamber Errors.......................................................................... 7-10
3.3 Motor Errors .............................................................................. 7-13
3.4 Transducer Errors....................................................................... 7-15
3.5 Temperature Errors .................................................................... 7-16
3.6 Analysis Errors .......................................................................... 7-17
3.7 Memory Errors........................................................................... 7-23
3.8 Others......................................................................................... 7-25
3.9 Maintenance Errors.................................................................... 7-27
3.10 Printer Errors.............................................................................. 7-30
3.11 External Device Errors............................................................... 7-33
4. STATUS DISPLAY................................................................................ 7-34
5. ERROR HISTORY PRINT.................................................................... 7-36
6. PROGRAM VERSION.......................................................................... 7-37
CHAPTER 8: ADJUSTMENT
1. INTRODUCTION ................................................................................... 8-1
2. ADJUSTMENT OF PRESSURE AND VACUUM................................. 8-2
2.1 Location of Control Knobs .......................................................... 8-2
2.2 Pressure and Vacuum Display...................................................... 8-3
2.3 Adjusting Pressure to 0.05 MPa................................................... 8-5
2.4 Adjusting Vacuum to 0.0333 MPa ............................................... 8-6
iv Sysmex KX-21N Operator’s Manual -- Revised November 2009

CHAPTER 9: FUNCTIONAL DESCRIPTION
1. INTRODUCTION ................................................................................... 9-1
2. DETECTION PRINCIPLE...................................................................... 9-2
2.1 DC Detection Method .................................................................. 9-2
2.2 Non-Cyanide Hemoglobin Analysis Method .............................. 9-2
3. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM.... 9-4
4. CBC ANALYSIS ..................................................................................... 9-5
4.1 WBC/HGB Analysis Flow........................................................... 9-5
4.2 RBC/PLT Analysis Flow ............................................................. 9-7
4.3 Calculation of RBC Constant ...................................................... 9-9
5. BLOOD CELL DISCRIMINATION CIRCUIT .................................... 9-10
5.1 WBC Discriminator ................................................................... 9-10
5.2 RBC Discriminator .................................................................... 9-10
5.3 PLT Discriminator ..................................................................... 9-10
6. ANALYSIS OF HISTOGRAM ............................................................. 9-11
6.1 Analysis of WBC Histogram ..................................................... 9-11
6.2 Analysis of RBC/PLT Histogram .............................................. 9-20
7. ELECTRIC SYSTEM............................................................................ 9-28
8. NAMES AND FUNCTIONS OF INSTRUMENTS.............................. 9-30
8.1 Front Panel ................................................................................. 9-30
8.2 Front Interior.............................................................................. 9-31
8.3 Right Side Panel......................................................................... 9-32
8.4 Left Side Panel........................................................................... 9-33
8.5 Left Side Interior........................................................................ 9-34
8.6 Rear Panel .................................................................................. 9-35
CHAPTER 10: INSTRUMENT SETUP

1. INTRODUCTION ................................................................................. 10-1
2. SYSTEM SETUP .................................................................................. 10-3
3. DATE/TIME SETTINGS....................................................................... 10-8
4. PATIENT LIMIT.................................................................................. 10-11
5. QC SETTINGS .................................................................................... 10-14
6. HOST SETTINGS ............................................................................... 10-17
7. PRINTER SETTINGS......................................................................... 10-22
7.1 DP Output Settings .................................................................. 10-23
7.2 GP/LP Output Settings............................................................. 10-25
7.3 IP Output Settings .................................................................... 10-27
8. ID READER SETTINGS .................................................................... 10-30
9. PASSWORD SETTINGS .................................................................... 10-32
10. PRINT SET VALUES.......................................................................... 10-35
11. PERIPHERAL SETTINGS ................................................................. 10-36
12. FACTORY SETTINGS........................................................................ 10-38
Sysmex KX-21N Operator’s Manual -- Revised November 2009 v

1. INTRODUCTION .................................................................................. A-1
2. CHECK BEFORE INSTALLATION ..................................................... A-1
3. INSTALLATION SPACE ....................................................................... A-3
4. REMOVE SHIPPING CLAMPS............................................................ A-4
5. CONNECT TUBE .................................................................................. A-6
5.1 Prepare Reagent .......................................................................... A-6
5.2 Connect CELLPACK .................................................................. A-6
5.3 Connect STROMATOLYSER-WH............................................. A-8
5.4 Connect Waste Line .................................................................... A-9
6. SET PRINTER PAPER......................................................................... A-10
7. CONNECT POWER CORD AND CONNECTING CABLES............ A-12
7.1 Connect Host Computer, Printer, and
Hand Held Barcode Reader ...................................................... A-12
7.2 Connect Power Cord ................................................................. A-12
8. TURN POWER ON .............................................................................. A-13
9. REINSTALLING THE PROGRAM..................................................... A-13

1. OUTPUT FORMAT FOR HOST COMPUTER .....................................B-1
1.1 Hardware......................................................................................B-1
1.2 Software .......................................................................................B-3
2. HAND HELD BAR CODE READER SPECIFICATIONS ..................B-15
INDEX
vi Sysmex KX-21N Operator’s Manual -- Revised November 2009

CHAPTER 1 INTRODUCTION
1. INTRODUCTION ................................................................................... 1-1
2. OVERVIEW OF INSTRUMENT ............................................................ 1-2
3. OPTION UNITS ...................................................................................... 1-3
4. OUTLINE OF OPERATION................................................................... 1-4
5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT.................. 1-4
6. ANALYSIS PARAMETERS ................................................................... 1-5
7. PANEL KEYBOARD.............................................................................. 1-7

8. GRAPHIC SCREEN................................................................................ 1-8
8.1 Contents of Display ..................................................................... 1-8
8.2 Status Display Messages.............................................................. 1-9
8.3 LCD Brightness Adjustment...................................................... 1-12
9. EMERGENCY STOP PROCEDURE ................................................... 1-12
10. ALARM SOUNDS ................................................................................ 1-13
11. CONTENTS OF PACKAGE ................................................................. 1-13
12. INSTALLATION ENVIRONMENT ..................................................... 1-14

12.1 Installation and Relocation ........................................................ 1-14
12.2 Grounding .................................................................................. 1-14
12.3 Installation Space ....................................................................... 1-15
12.4 Installation Environment............................................................ 1-16
13. INSTRUMENT SPECIFICATIONS...................................................... 1-17
14. MENU TREE......................................................................................... 1-21

INTRODUCTION
1. INTRODUCTION
The Sysmex KX-21N is an automatic multi-parameter blood cell counter for in vitro
diagnostic use in clinical laboratories.
The KX-21N processes approximately 60 samples an hour and displays on the LCD
screen the particle distribution curves of WBC, RBC, and platelets, along with data of 17
parameters, as the analysis results.
Chapter 1 introduces the overview of the instrument, analysis procedure, etc. that we rec-
ommend you to read before using the KX-21N. The main contents of Chapter 1 are as fol-
lows:
Overview of Instrument
The important functions of the KX-21N and the options for efficient operation are
explained.
Main Points of Analysis Procedure

Explanation is given on the procedure for implementing each analysis mode, descriptions
and functions of the keys on panel keyboard, and the messages on the LCD screen.
Precautions at Time of Installation

Explanation is given on the matters that need to be confirmed before installation, such as
installation space, required equipment, environmental conditions.
Instrument Specifications
The instrument specifications are described.
Menu Tree
This chapter describes the KX-21N menu tree and the corresponding chapters which
explain the usage of the menus.
Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A. 1-1

INTRODUCTION
2. OVERVIEW OF INSTRUMENT
The KX-21N performs speedy and accurate analysis of 17 parameters in blood and detects
the abnormal samples. To assure easy sorting of abnormal samples in the laboratory, the
instrument displays abnormal analysis data with abnormal marks attached on the LCD
screen. Thus displayed analysis data allows detecting those samples which are outside the
tolerance and need further analysis and reconsideration.
The KX-21N employs three detector blocks and two kinds of reagents for blood analysis.
The WBC count is measured by the WBC detector block using the DC detection method.
The RBC count and platelets are taken by the RBC detector block, also using the DC
detection method. The HGB detector block measures the hemoglobin concentration using
the non-cyanide hemoglobin method.
Figure 1-2-1: Overview of KX-21N
1-2 Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

INTRODUCTION
3. OPTION UNITS
This instrument offers several option units to ensure its efficient operation. The options
that can be used with the KX-21N are:
• Graphic Printer: Prints the analysis data obtained from the KX-21N on
letter or A4-size paper.
• Data Printer: Prints the analysis data obtained from the KX-21N onto
a ticket format.
DP-510: 943-0571-9 (N.America, 117 V)
943-0581-6 (Europe, 220 V)
943-0591-3 (U.K., 240 V)
Figure 1-3-1: Data Printer
• Hand Held Barcode Reader: During analysis, reads the barcode that are affixed to the
tubes, and automatically sets the sample ID numbers.
Figure 1-3-2: Hand Held Barcode Reader
Sysmex KX-21N Operator’s Manual -- Revised November 2009 1-3

INTRODUCTION
4. OUTLINE OF OPERATION
Two analysis modes are available with the KX-21N: whole blood mode and pre-diluted
mode. Analysis procedures in these modes are listed below.
Whole blood mode Pre-diluted mode
Check before turning ON the power.
Turn ON the power.
• Self-check
• Background check
Ready
Select whole blood mode. Select pre-diluted mode.
Prepare analysis samples in pre-diluted mode
Set sample No.
(1:26 dilution).
Set sample No.
Set sample to the sample probe.
Press the start switch.
• Execute analysis.
• End analysis.
Ready
Check after analysis.
Execute shutdown.
Turn off the power.
Table 1-4-1: Outline of Operation
• The work by an operator is shown in shaded cells.

• Ready : “Ready” is displayed on the LCD screen. In this state, various operations
including analysis, settings, and data processing can be performed.
5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT

The KX-21N, when left non-operating for 15 minutes, automatically stops the pneumatic
unit. This function saves power consumption and extends component service life. In
addition, with this function, analysis-ready status can be resumed faster than by turning on
the power.
It is also possible to manually stop the pneumatic unit through the Select Menu screen.
Pressing the Start switch, the instrument will return to “Ready” status.
1-4 Sysmex KX-21N Operator’s Manual -- Revised November 2009

INTRODUCTION
6. ANALYSIS PARAMETERS
This instrument analyzes the following parameters using three detector blocks and two
kinds of reagents:
1) WBC (white blood cell) (Analysis principle: DC detection method)

WBC count in 1 µL of whole blood
2) LYM% [W-SCR] (WBC-Small Cell Ratio)

Ratio (%) of lymphocytes (small cells) to whole WBC
3) MXD% [W-MCR] (WBC-Middle Cell Ratio)

Ratio (%) of the summation of basophils, eosinophils and monocytes (middle
cells) to whole WBC
4) NEUT% [W-LCR] (WBC-Large Cell Ratio)

Ratio (%) of neutrophils (large cells) to whole WBC
5) LYM# [W-SCC] (WBC-Small Cell Count)

Absolute count of lymphocytes (small cells) in 1 µL of whole blood
6) MXD# [W-MCC] (WBC-Middle Cell Count)

Absolute count of the basophils, eosinophils and monocytes (middle cells) in 1 µL
of whole blood
7) NEUT# [W-LCC] (WBC-Large Cell Count)

Absolute count of neutrophils (large cells) in 1 µL of whole blood
8) RBC (red blood cell) (Analysis principle: DC detection method)

RBC count in 1 µL of whole blood
9) HGB (Hemoglobin) (Analysis principle: Non-Cyanide hemoglobin analysis

method)
Volume (gram) of hemoglobin in 1 dL of whole blood
10) HCT (Hematocrit value) (Analysis principle: RBC pulse height detection method)
Ratio (%) of whole RBC volume in whole blood
11) MCV (Mean RBC volume)

Mean RBC volume (fL) in whole blood, which is calculated by 10 × Hct (%)/ RBC
(× 106/µL).
12) MCH (Mean RBC hemoglobin)
Mean hemoglobin volume (pg) per RBC, which is calculated by 10 × Hgb (g/dL)/
RBC (× 106/µL).
13) MCHC (Mean RBC hemoglobin concentration)

Mean hemoglobin concentration (g/dL), which is calculated by 100 × Hgb (g/dL)/
Hct (%).

INTRODUCTION
14) RDW-CV (RBC distribution width - CV)

RBC distribution width (%) calculated from the points defining 68.26% of the
entire area spreading from the peak of the RBC particle distribution curve.
15) RDW-SD (RBC distribution width - SD)

The distribution width (fL) at the height of 20% from the bottom when the peak
RBC particle distribution curve is taken as 100%.
16) PLT (Platelet) (Analysis principle: DC detection method)

Platelet count in 1 µL of whole blood
17) MPV (Mean platelet volume)

Mean volume of platelet (fL)
NOTE: • When analyzing in the pre-diluted mode, only the CBC8 parame-
ters are output.

INTRODUCTION
7. PANEL KEYBOARD
The KX-21N is provided with the 22-key panel keyboard.
7 SAMPLE No.
8 9
4 5 6 ENTER
1 2 3 SELECT
0 -/. C MODE
HELP
SHUTDOWN
Figure 1-7-1: Panel Keyboard
Name Function
SAMPLE No. Used to set a sample No.
ENTER Used to fix a sample No., selected menu, etc.
SELECT Used to select a menu. Press this key to display the Select Menu screen. When
you press it while the Select Menu screen is displayed, the Analysis screen returns.
MODE Used to changeover analysis mode (whole blood mode/pre-diluted mode).
HELP Used when an error has occurred.
SHUTDOWN Used to execute shutdown program.
0-9 Used to enter numerics such as a sample No. and set value.
−/. Used to enter “−” (hyphen) of a sample No., the decimal point of a set value.
C Used to delete characters when entering numerics, and stop the alarm.
Used to select a menu. Each time a key is pressed, the cursor moves to the pre-
, vious or the next item.
, Used to select conditions when setting, and to select Manual Discriminator.
Table 1-7-1: Functions of Panel Keyboard
CAUTION: • When the alarm is sounding after an error, etc. occurred, press
[C] key to stop it or press [HELP] key to display the HELP screen.
By pressing [HELP] key, the alarm stops and the HELP screen
appears. While the alarm is sounding, the keys other than [C] key
and [HELP] key cannot be used.

INTRODUCTION
8. GRAPHIC SCREEN
8.1 Contents of Display
Next Sample No. Status Display Analysis Progress Status
No.1
Ready Sample Analysis Mode
No.0 WB 31/12 10:20
WBC 0.0 LYM% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
HGB 0.0 NEUT% 0.0 0.0
HCT 0.0 RDW-SD 0.0 Analysis Result
MCV 0.0 RDW-CV 0.0 Display Area
MCH 0.0 PDW 0.0
MCHC 0.0 MPV 0.0
PLT 0 P-LCR 0.0
1:M.Discri. 2:Output Menu Display Area
Figure 1-8-1: Graphic LCD
Name Contents of Display

Next Sample No. Displays the sample No. to be analyzed next.
Sample Analysis Displays the analysis mode for the sample.
Mode
: whole blood mode
: pre-diluted mode
Analysis Progress With the start-to-end analysis progress classified into six steps, the
Status present progress status is displayed.
Status Display Status of the unit is displayed.
Menu Display Area Useable menus for each screen are displayed.
Analysis Result The area for displaying analysis result
Display Area
Table 1-8-1: Contents of Display

INTRODUCTION
8.2 Status Display Messages

The KX-21N displays instrument status message on the LCD screen.
This section gives the meanings of status messages displayed on the LCD screen.
Display Message Meaning

The instrument is making self-check. When
the power is turned ON, the instrument checks
itself automatically. When the power is turned
ON, [00-01] appears briefly in the right lower
corner, which indicates the version of the unit
control program.
Sysmex KX-21N
[00-01]
Please wait.
The hydraulic system is undergoing Auto

*Auto Rinse* Rinse. When the power is turned ON, the
instrument starts self-check and motor check,
followed by auto rinse of the hydraulic system.
Auto rinse is also performed when “5: Auto
Rinse” in the Select menu is executed and
Please wait. when [SHUTDOWN] key is pressed. When an
automatic background check shows a back-
ground count exceeding the permissible back-
ground count level, rinse sequence is
automatically extended.

INTRODUCTION

The instrument is ready for analysis in the
No.1 whole blood mode. “No.” in the left upper cor-
Ready
No.0 WB 31/12 10:20 ner indicates the sample No. to be analyzed
next.
WBC 0.0 LYM% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
HGB 0.0 NEUT% 0.0 0.0
HCT 0.0 RDW-SD 0.0
MCV 0.0 RDW-CV 0.0
MCH 0.0 PDW 0.0
MCHC 0.0 MPV 0.0
PLT 0 P-LCR 0.0
1:M.Discri. 2:Output
The instrument is ready for pre-diluted mode

No.1 analysis. “No.” in the left upper corner shows
Ready
No.0 PD 31/12 10:20 the sample No. to be analyzed next.
WBC WL+000.0 LYM% WL+000.0 +000.0
RBC WL+00.00 MXD% WL+000.0 +000.0
HGB WL+000.0 NEUT% WL+000.0 +000.0
HCT WL+000.0 RDW-SD WL+000.0
MCV WL+000.0 RDW-CV WL+000.0
MCH WL+000.0 PDW WL+000.0
MCHC WL+000.0 MPV WL+000.0
PLT WL+000.0 P-LCR WL+000.0
The instrument is ready for X control. “FILE

FILE No.1 QC No. 1” in the left upper corner shows QC file
Ready
X1 X2 X Judgement No.
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
The instrument is ready for L-J control. “FILE

FILE No.1 QC No. 1” in the left upper corner shows QC file
Ready
Data Judgement No.
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT

INTRODUCTION

The whole blood mode is turning into the pre-
*Change Mode* diluted mode, or the pre-diluted mode is turn-
ing into the whole blood mode.
Please wait.
The sample is being aspirated in whole blood

No.123456789-12345 mode analysis.
Aspirating
The sample is being aspirated in pre-diluted

No.123456789-12345 mode analysis.
Aspirating
Samples are being aspirated, diluted, and

No.123456789-12345 counted.
Analyzing
Hydraulic line is being rinsed.

No.123456789-12345
Rinsing
An error occurs, making analysis impossible.

No.123456789-12345 Replenish Diluent (When an error occurs, the error message
Not Ready
appears in reversed display in the right upper
area of the LCD screen.)
When operation has been suspended over 15
No.123456789-12345 PU Sleeping minutes, the compressor power is turned OFF
Not Ready
and this message is displayed. Press the
[START] switch to get ready for analysis.
When the power is turned off without making
shutdown process or when power outage
Momentary power failure occurred. caused the instrument to stop, this message
appears when the unit is started next time.
When data is automatically output to the host
* computer, “ * ” mark lights up in the right upper
Ready corner of the screen.

INTRODUCTION
8.3 LCD Brightness Adjustment

Open the front cover of the instrument. LCD brightness can be adjusted using the bright-
ness adjustment knob under the panel keyboard. Turning to the right dims the light and
turning to the left brightens it.
Light Dark
Figure 1-8-2: Brightness adjustment knob
NOTE: • If a key input or an operation has not been performed for a fixed
time, the LCD back-light will become slightly dimmer (back-light
darkening function). To return the LCD to its original brightness,
press any key.
9. EMERGENCY STOP PROCEDURE

When there arises the need to stop the instrument urgently because of power outage, etc.,
in the laboratory, turn off the instrument power switch.

INTRODUCTION
10. ALARM SOUNDS

The KX-21N indicates different situations by five kinds of alarm sounds:
1. Key sound (single beep)

Sounds about 0.1 second when a key on the panel keyboard is pressed.
2. Input error sound (short beep)

Sounds about 1 second when a wrong key is pressed on the panel keyboard.
3. Analysis error sound (long beep)

Sounds when an error occurs in the instrument and continues until you press [C]
key or [HELP] key on the panel keyboard.
4. Sound at sample aspiration

Usually: A single “beep” when the start switch is pressed; “beep, beep” when
aspiration is finished.
Sample No. “0” or in pre-diluted mode: Beep sounds (beep, beep, ...) continue
from pressing the start switch until aspi-
ration ends.
11. CONTENTS OF PACKAGE

The instrument is fully inspected before leaving the factory and carefully packed to with-
stand shocks in transit. Upon arrival, check the package to see that there is no external
damage. Sysmex service representative will unpack, install the instrument, and make ini-
tial settings.
To confirm the contents of the package, refer to “Appendix A: INSTALLATION.”

INTRODUCTION
12. INSTALLATION ENVIRONMENT

12.1 Installation and Relocation
The KX-21N is installed by Sysmex Service representative. In case relocation becomes
necessary after installation, contact your Sysmex service representative.
Pay careful attention to this because if relocation, etc. of the instrument should be con-
ducted by the customer, resulting in any trouble, warranty would not be applied even in the
warranty period.
12.2 Grounding
The instrument power supply cord uses the 3-prong plug. When the power supply socket
is 3-prong with grounding, simply plug it to the socket.
117 VAC Spec. 220 VAC Spec. 240 VAC Spec.
Figure 1-12-1: Plugs
WARNING • Make sure to ground the instrument. Inadequate grounding could

cause electrical shocks.
NOTE: • The number of power supply sockets required is 3 including

optional Graphic Printer and optional Data Printer.

INTRODUCTION
12.3 Installation Space

To ensure that the instrument fulfills its function, it is important to install it at an appropri-
ate place:
• Choose a place that is close to the power supply and proper waterway.
• Secure a place spacious enough for maintenance and service. Giving consideration to
heat radiation by the instrument, provide at least 50 cm distance from the wall to side,
rear, and top panels. You may need some more desktop space if optional Graphic
Printer and Data Printer are provided.
• Choose a place where reagent is easy to handle.
The instrument dimensions are shown below. The power supply cord is 1.8 m long,
the waste tube up to 6 m long, and the diluent (CELLPACK) tube up to 2 m long.
Width (mm) Depth (mm) Height (mm) Weight (kg)

Main Unit 420 355 480 30
Table 1-12-1: Instrument Dimensions
480
420
355
Figure 1-12-2: Instrument Dimensions
CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long, it may
be impossible to have reagent aspirated. Avoid setting CELL-
PACK at a level higher than the instrument; otherwise, reagent
may flow into the vacuum line, possibly damaging the instrument.

INTRODUCTION
12.4 Installation Environment

• Use the instrument at an ambient temperature of 15°C - 30°C (optimum: 23°C).
• Use it at a relative humidity range of 30% - 85%.
• When air conditioning is used, the maximum cooling capacity of about 172 kcal/hour
is required to offset the heat from the instrument.
• Avoid a place that can become extremely hot or cold.
• Avoid a place that can be exposed to direct sunlight.
• Choose a well-ventilated place.
• Avoid a place close to a wireless telegraph or communication facility where high fre-
quency waves can be generated or radio interference can occur.

INTRODUCTION
13. INSTRUMENT SPECIFICATIONS

Analysis parameters:
WBC (White Bloodcell Count), RBC (Red Bloodcell Count), HGB (hemoglobin), HCT
(hematocrit), MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin),
MCHC (mean corpuscular hemoglobin concentration), PLT (platelet), RDW-SD (RBC
distribution width-standard deviation), RDW-CV (RBC distribution width-coefficient of
variation), MPV (mean platelet volume), LYM% (W-SCR), MXD% (W-MCR), NEUT%
(W-LCR), LYM# (W-SCC), MXD# (W-MCC), NEUT# (W-LCC)
However, the parameters in pre-diluted mode are eight: WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, PLT.
Display range
WBC 0.0 - 299.9 (×103/µL)
RBC 0.00 - 19.99 (×106/µL)
HGB 0 - 25.0 (g/dL)
PLT 0 - 1999 (×103/µL)
Reagent
Diluent: CELLPACK
WBC/HGB lyse reagent: STROMATOLYSER-WH
Detergent
CELLCLEAN
Consumption of reagent (per sample)

Diluent (CELLPACK): Approx. 30 mL
WBC/HGB lyse reagent (STROMATOLYSER-WH): Approx. 1.0 mL
Throughput
Approx. 60 samples/hour
Analysis principle
WBC: DC detection method
RBC: DC detection method
HGB: Non-cyanide hemoglobin analysis method

INTRODUCTION
Reproducibility
Reproducibility is within the following range at the reliability level of 95%.
1) Whole blood mode
WBC (4.0 × 103/µL or over) 3.5% or less
RBC (4.00 × 10 /µL or over)
6
2.0% or less
HGB 1.5% or less
HCT 2.0% or less
MCV 2.0% or less
MCH 2.0% or less
MCHC 2.0% or less
PLT (100 × 103/µL or over) 6.0% or less
LYM# (W-SCC) 15.0% or less
MXD# (W-MCC) (1.0 × 103/µL or over) 30.0% or less
NEUT# (W-LCC) 15.0% or less
LYM% (W-SCR) 15.0% or less
MXD% (W-MCR) (12% or over) 30.0% or less
NEUT% (W-LCR) 15.0% or less
RDW-SD or RDW-CV 4.0% or less
MPV 5.0% or less
2) Pre-diluted mode
WBC (4.0 × 103/µL or over) 6.0% or less
RBC (4.00 × 106/µL or over) 3.0% or less
HGB 2.5% or less
HCT 3.0% or less
MCV 3.0% or less
MCH 3.0% or less
MCHC 3.0% or less
PLT (100 × 103/µL or over) 9.0% or less
Accuracy
1) Whole blood mode
WBC: ±3% or ±0.2 × 103/µL
RBC: ±2% or ±0.03 × 106/µL
PLT: ±5% or ±10 × 103/µL
2) Pre-diluted mode
WBC: ±5% or ±0.3 × 103/µL
RBC: ±3% or ±0.05 × 106/µL
PLT: ±8% or ±15 × 103/µL

INTRODUCTION
Linearity
1) Whole blood mode
WBC: 1.0 - 9.9 (× 103/µL) ±0.3 (× 103/µL)
10.0 - 99.9 (× 103/µL) ±3%
RBC: 0.30 - 0.99 (× 106/µL) ±0.03 (× 106/µL)
1.00 - 7.00 (× 106/µL) ±3%
HGB: 0.1 - 10.0 (g/dL) ±0.2 (g/dL)
10.0 - 25.0 (g/dL) ±2%
HCT: 10.0 - 33.3 (HCT%) ±1.0 (HCT%)
33.4 - 60.0 (HCT%) ±3%
PLT: 10 - 199 (× 103/µL) ±10 (× 103/µL)
200 - 999 (× 103/µL) ±5%
(However, RBC < 7.00 × 106/µL)
Carryover
WBC: 3% or less
RBC: 1.5% or less
HGB: 1.5% or less
HCT: 1.5% or less
PLT: 5% or less
Blood volume aspirated

Whole blood mode: Approx. 50 µL
Pre-diluted mode: Approx. 200 µL (Diluted blood sample)
Blood volume required for the pre-dilution is 20 µL or over.
Power supply
117/220/230/240 VAC ± 10% (50/60 Hz)
Power consumption
Approx. 230 VA or less
Heat Compensation Required

Approx. 785 BTU/h (198 kcal/h)
Dimensions
Main Unit: 420 (W) × 355 (D) × 480 (H) mm
Weight
Main Unit: Approx. 30.0 kg
Protection Type
Class I Equipment
EMC (Electro-magnetic compatibility)

This equipment is in conformity to the following IEC (EN) standard.
IEC 61326-1: 97+A1: 98 (EN 61326: 97+A1) Electrical equipment for measurement, con-
trol and laboratory use -EMC requirements-
-EMI (Class A)
-EMS (Minimum Immunity test requirements)

INTRODUCTION
Storange (Transportation) condition

Ambient temperature: -10°C to 60°C
Relative humidity: 95% or less (Non condensing / Keep dry)

INTRODUCTION
14. MENU TREE
Ana. Screen 1: M. Discri. Chapter 3, 2.2

2: Output Chapter 3, 2.3
SELECT 1: Stored Data Chapter 3 1: Delete Chapter 3, 3.3

2: Output Chapter 3, 3.4
3: Chg. Disp. Chapter 3
2: Quality Chapter 5 1: QC Analyze Chapter 5, 2

Control
2: Settings Chapter 5, 2.5
3: Erase All Chapter 5, 2.4
3: Calibration Chapter 6 1: Auto Cal. Chapter 6, 2 * 1: HGB Chapter 6, 2

2: HGB/HCT Chapter 6, 2
3: HCT Chapter 6, 2
2: Manual Cal. Chapter 6, 3 *

3: Calibrator Chapter 6
4: Print Rev. History Chapter 6, 4
4: Replace Chapter 4, 8.1
Lyse
5: Auto Rinse Chapter 4, 7.1
6: Settings Chapter 10 1: System Setup Chapter 10, 2 *

2: Date/Time Chapter 10, 3
3: Patient Limit Chapter 10, 4 *

4: QC Settings Chapter 10, 5 *
5: Host Settings Chapter 10, 6
6: Printer Settings Chapter 10, 7
7: ID Reader Settings Chapter 10, 8
8: Password Settings Chapter 10, 9 *

9: Print Set Values Chapter 10, 10
7: Maintenance Chapter 4 1: Clean W. Chamber Chapter 4, 5.1

2: Clean Transducer Chapter 4, 5.2
3: Reset SRV Counter Chapter 4, 6.2
4: Drain TD Chamber Chapter 4, 7.3
5: Status Display Chapter 7, 4
6: Error History Chapter 7, 5
7: Program Maintenance Chapter 7, 6
8: Periph.
Settings Chapter 10, 9
00: PU Sleep Chapter 2, 6
SAMPLE No. Chapter 2, 4
MODE Chapter 2, 4
HELP Chapter 7, 1
SHUTDOWN Chapter 2, 6
*: If set, password has to be entered.

INTRODUCTION
This page is intentionally left blank.

CHAPTER 2 SAMPLE ANALYSIS
1. INTRODUCTION ................................................................................... 2-1

1.1 Overview of Analysis Modes....................................................... 2-1
1.2 Analysis Procedure Flow Chart ................................................... 2-2
2. START-UP PROCEDURE....................................................................... 2-3

2.1 Inspection before Turning ON the Power .................................... 2-3
2.2 Turning ON the Power and Self-Check ....................................... 2-5
3. QUALITY CONTROL ............................................................................ 2-8
4. PROCEDURES IN EACH ANALYSIS MODE...................................... 2-9

4.1 Whole Blood (WB) Mode............................................................ 2-9
4.2 Pre-Diluted (PD) Mode.............................................................. 2-16
5. DISPLAY AND PRINTING OF ANALYSIS RESULT........................ 2-24

5.1 Display of Analysis Result ........................................................ 2-24
5.2 Printing of Analysis Result ........................................................ 2-25
5.3 Output of Analysis Result to Host Computer ............................ 2-27
6. LIMITATIONS....................................................................................... 2-28
6.1 Cell Count Parameters ............................................................... 2-28
6.2 Limitation of Hemoglobin ......................................................... 2-29
7. EXPECTED RESULTS ......................................................................... 2-30
8. STOPPING THE PNEUMATIC UNIT ................................................. 2-31
9. EXECUTION OF SHUTDOWN........................................................... 2-32

9.1 Shutdown Procedure .................................................................. 2-32

SAMPLE ANALYSIS
1. INTRODUCTION
This instrument works in two analysis modes: whole blood mode and pre-diluted mode.
This chapter describes the general operation procedures from instrument start-up to shut-
down, with the procedures in respective analysis modes.
1.1 Overview of Analysis Modes

• Whole blood mode
This is the mode of analyzing collected blood sample in the whole blood status. The
tube cap is opened and the sample is aspirated through the sample probe one after
another.
• Pre-diluted mode
This mode is used in analyzing a minute amount of child's blood, for instance, col-
lected from the earlobe or fingertip. In this mode, blood sample diluted into 1:26
before analysis is used. The sample aspiration procedure is the same as in the whole
blood mode.
NOTE: • In the pre-diluted mode, particle distribution curve and particle

distribution analysis data are not output, and the output is con-
fined to only the CBC8 parameter.

SAMPLE ANALYSIS
1.2 Analysis Procedure Flow Chart

Shown below is the Flow Chart for the operation procedure with pages to refer to.
Inspection before Turning ON Page 2-3

the Power
Turning ON the Power and

Self-Check Page 2-5
Execution of Quality Control Page 2-8
Whole Blood Mode Pre-Diluted Mode

Analysis Analysis
Page 2-9 Page 2-16
Display and Printing of Page 2-24

Analysis Result
Execution of Shutdown Page 2-32
Turning OFF the Power
Table 2-1-1: Analysis Procedure Flow Chart

SAMPLE ANALYSIS
2. START-UP PROCEDURE
2.1 Inspection before Turning ON the Power
1. Inspection of reagents
Check to see that the reagents needed for the number of the samples to be pro-
cessed for the day are available. If the number available is such as might become
short during the day, make ready the reagents for use in replenishment. When
reagents run out during analysis, the instrument will automatically come to a stop.
Replenish the reagent that gave an error. Until replenishment is completed, analy-
sis cannot be resumed. The number of samples that can be analyzed with one pack
of reagent is listed below:
• Number of the samples that can be analyzed with one pack of reagent
CELLPACK: Approx. 600 samples/20 L (cubitainer)
STROMATOLYSER-WH: Approx. 470 samples/500 mL (bottle)
(The above values are the result of continuous analyses performed in one day
in the whole blood mode. Depending on the use conditions of the instrument,
the result may differ.)
• Replenishing reagent
• Make ready a new reagent and make sure that it has not passed its expi-
ration date. (For detail, refer to Chapter 4, Section 8: SUPPLIES
REPLACEMENT.)
CAUTION • Use a reagent that has been left at room temperature (15 - 30°C)
for more than 24 hours.
• If CELLPACK that has just arrived is used, “Background Error”
may occur.
• After replenishing a reagent, make sure that its background count
is low before starting sample analysis.
• As to a reagent that may have frozen, handle it in accordance with
the precautions stated on the Package Insert. Otherwise, there is
a possibility that proper analysis cannot be performed.
• When replacing the reagent container, take care not to have dust
adhere to the cubitainer spout kit.
• After unpacking, take care to prevent entry of dust, dirt, bacteria,
etc. which could impair proper analysis.
CELLPACK 20 L 60 days
STROMATOLYSER-WH 500 mL 90 days
Table 2-2-1: Expiration After Opening the Seal

SAMPLE ANALYSIS
• We recommend preparing “Reagent Replenishment Record” in which to

enter date of replenishment, name of reagent, reagent lot No., expiration date,
name of person who replenished. Such record would come handy.
2. Inspection of the instrument

Inspect the connection of tubings and cords to see that there are no broken tubes
and the power cord is properly plugged in the outlet.
3. Inspection of waste
If waste is found to have collected in the trap chamber on the left side of the unit
and the waste tank (when provided), discard the waste.
4. Inspection of printer paper

Open the front cover and check if printer paper needed for processing the samples
for the day is available.
Figure 2-2-1: Inspection of Printer Paper (Built-in Printer)
CAUTION: • Use the printer paper specified by Sysmex. Avoid using print
paper that has its end fixed to the core. Such paper can cause
failure.

SAMPLE ANALYSIS
2.2 Turning ON the Power and Self-Check

Turn ON the power switch on the right side of the unit. Self-check, auto rinse, and back-
ground check will be automatically performed, and the “Ready” (ready for analysis) will
appear.
1. Turn ON the power switch

(1) The initial display appears on the LCD screen. The program version (Example:
[00-01]) appears at the right lower area of the screen.
Sysmex KX-21N
[00-01]
Figure 2-2-2: Initial Display
(2) Next, the instrument makes self-check of motor operation, scheduled maintenance
items, etc. The LCD screen displays “Please wait.” during this period.
Please wait.
Figure 2-2-3: LCD Screen during Self-check

SAMPLE ANALYSIS
CAUTION: • When self-check reveals any error, an error message will appear
on the LCD screen. In this case, turn OFF the power once, then
turn it ON again. If the error still occurs, contact Sysmex service
representative.
• To ensure optimum operation of the instrument, service counters
are provided for the components which require scheduled mainte-
nance. If upon the power turn-on, the counter is found exceeding
the predetermined times, the screen advising scheduled mainte-
nance is displayed. When the Scheduled Maintenance screen
appears, press [C] key to stop the alarm sound, then perform
maintenance operation by following the instructions on the
screen.
For detail, refer to Chapter 4: MAINTENANCE AND SUPPLIES
REPLACEMENT.
(3) When self-check is normally completed, auto rinse and background check are per-
formed.
*Auto Rinse*
Please wait.
Figure 2-2-4: LCD Screen during Auto Rinse
NOTE: • Auto rinse is repeated 3 - 5 times. If the background count of any

parameter exceeds tolerance after rinsing a maximum of 5 times,
the message “Background Error” is displayed and the alarm
sounds. In this case, press [HELP] key to stop the alarm and dis-
play the Action Message screen. In accordance with the Action
Message screen, take an appropriate action.
(Refer to Chapter 7: TROUBLESHOOTING.)
• Permissible background counts
WBC 0.3 [×103/µL] or less

RBC 0.02 [×106/µL] or less
HGB 0.1 [g/dL] or less
PLT 10 [×103/µL] or less

SAMPLE ANALYSIS
2. Confirming the “Ready”

When auto rinse and background check are normally completed, the buzzer (single
beep) sounds briefly and “Ready” is displayed. The LCD screen displays the
result of background check (sample No. “0”).
No.1
Ready
No.0 WB 31/12 10:20
WBC 0.0 LYM% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
HGB 0.0 NEUT% 0.0 0.0
HCT 0.0 RDW-SD 0.0
MCV 0.0 RDW-CV 0.0
MCH 0.0 PDW 0.0
MCHC 0.0 MPV 0.0
PLT 0 P-LCR 0.0
Figure 2-2-5: Ready Status
NOTE: • When the power is on, the next sample No. is displayed “1.”

SAMPLE ANALYSIS
3. QUALITY CONTROL
Quality control is of great importance for obtaining highly reliable data over a long period
of time, as is the constant monitoring of the instrument for preventing troubles or for early
detection of problems. Before starting sample analysis, analyze control blood
(EIGHTCHECK-3WP) using X control or L-J control program. The analysis mode used
in analyzing control blood is described below.
• Analysis mode to analyze a control blood

Control blood is analyzed in the QC analysis mode. For analysis procedure and
examination of analysis result, refer to Chapter 5: QUALITY CONTROL.

SAMPLE ANALYSIS
4. PROCEDURES IN EACH ANALYSIS MODE

With this instrument, sample mixing, cap removal, and tube setting are performed manu-
ally. Sample analysis can be executed when the instrument is in the Ready status.
4.1 Whole Blood (WB) Mode
Samples are processed in the following steps:

1. Collecting and preparing samples
2. Selecting whole blood mode
3. Inputting sample No.
4. Analyzing samples

A specified amount of sample, corresponding to the amount of EDTA anticoagu-
lant, is collected from the vein.
CAUTION • Some anticoagulants alter test results due to their effects on RBC
hemolysis or platelet agglutination. As anticoagulant, use EDTA-
2K, EDTA-3K, or EDTA-2Na.
• In the case of refrigerated blood, leave the blood taken from the
refrigerator for 30 minutes until it equilibrated to room tempera-
ture.
• When the reagent might have frozen, handle it according to the
precautions stated on the Package Insert of each reagent. Other-
wise, improper analysis may result.
NOTE: • All performance claims given in this manual were generated using
specimens in EDTA anticoagulant. Results may be affected by
the use of other anticoagulants. Therefore, each laboratory
should develop protocols for handling specimens collected in
these anticoagulants.
Tubes up to 80 mm in height should be used. The volume of sample that can be

aspirated is as follows:
Volume of sample aspirated Approx. 50 µL

SAMPLE ANALYSIS
2. Selecting whole blood mode

When the line on the side of the system status area on the LCD screen is “ ”,
the pre-diluted (PD) mode is in use for analysis, so change it over to the whole
blood (WB) mode by the following procedure:
(1) Confirm the Ready status.
(2) Press [MODE] key to display the Change Mode screen.
*Change Mode*
Whole Blood(WB) Pre-Diluted(PD)
Change mode with [ ]or[ ]. Press [ENTER] to Set.
Figure 2-4-1: Change Mode Screen
(3) Press [ ] or [ ] key to select “Whole Blood (WB).”
*Change Mode*
Figure 2-4-2: Selecting WB Mode
(4) Press [ENTER] key to changeover the analysis mode and return to the Analysis
screen.
NOTE: • The analysis mode selected here is maintained after completion

of analysis, until it is switched to the other analysis mode.
• At the time of turning-on the power, the system is in the whole
blood mode.

SAMPLE ANALYSIS

The sample No. can be input by the following two methods.
• Input from the panel keyboard
• Input using the hand held barcode reader (option)
NOTE: • The sample number is set by the incremented value for each
analysis. Input the sample number when changing.

(1) Press [SAMPLE No.] key in the Ready status. In the system status area on the
LCD screen, the next sample No. turns to the reverse display and the system is
waiting for Sample No. input (in the “Not Ready” status).
No.123456789012345
Not Ready
Figure 2-4-3: Waiting for Sample No. input
(2) The cursor appears under sample No. Input sample No. using the numeric keys.
[Example] Input of sample No. 5

Press [5] key on the numeric keys.
CAUTION: • Sample No. “0” (zero) is treated as a special sample number.

1) Judgment on patient limit is not made for analysis data.
2) Analysis data is not stored.
3) Data is not transferred to the host computer.
4) Sample No. is not incremented.
5) Judgment on abnormal histogram is not made.
6) When one attempts to make analysis with the sample No. of “0”
(zero), the buzzer sounds during sample aspiration.
NOTE: • When entering the sample No. (on the screen of the previous
page), press [C] key first. This will clear the entire sample No.
Then, enter a new sample No.
• In the course of entering the sample No., each time you press [C]
key, one character disappears with the cursor moving to the left.
• A sample No. of a maximum of 15 digits, comprising numerics
and a hyphen, can be used.

SAMPLE ANALYSIS
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted.
When you attempt to do so, an alarm sounds.
• In the status of waiting for sample No. input (“Not Ready”), press
[SAMPLE No.] or [SELECT] key. The screen returns to the Analy-
sis screen without updating sample No.

No.123456789012345
Not Ready
(2) Read the barcode affixed to the test tube with the hand held barcode reader.
Figure 2-4-5: Reading the Barcode
When reading has been carried out normally, the read sample number will appear.
NOTE: • In the status of waiting for sample No. input (“Not Ready”), press

SAMPLE ANALYSIS
WARNING • When analyzing samples, always wear rubber gloves. After com-
pletion of work, wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria can occur.
(1) Mix the sample sufficiently.
Figure 2-4-6: Mixing the Sample
(2) Remove the plug while taking care not to allow blood scatter.
Figure 2-4-7: Removing the Plug
(3) Set the tube to the sample probe, and in that condition, press the start switch.
Start Switch
Figure 2-4-8: Pressing the Start Switch

SAMPLE ANALYSIS
(4) The buzzer sounds two times - “beep, beep” - and when the LCD screen displays
“Analyzing,” remove the tube. After that, the unit executes automatic analysis and
displays the result on the LCD screen. Then the unit turns to the Ready status,
becoming ready for analysis of the next samples.
The screens from the start to the end of analysis are as shown in the following:
(Ready)
No.123456789-12345
Ready
(Aspirating)
No.123456789-12345
Aspirating
(Analyzing)
No.123456789-12345
Analyzing
(Rinsing)
No.123456789-12345
Rinsing
(Ready)
No.123456789-12346
Ready
Figure 2-4-9: LCD Screen (in WB Mode)
CAUTION • While the LCD screen is displaying “Aspirating,” keep holding the
tube in the aforementioned status. If the tube is removed during
its display, correct analysis result may not be obtained.
CAUTION: • Several seconds after the buzzer sounds “beep, beep” and “Aspi-
rating” appears on the LCD screen, the rinse cup lowers. By that
time, remove the tube.
• To remove the tube, lower it straight down. Take care not to bend
the sample probe.
NOTE: • The sample probe is automatically rinsed, so there is no need to

wipe it clean.

SAMPLE ANALYSIS
(5) When the LCD screen displays “Ready,” prepare the next samples and repeat the
procedure (1) to (4).
NOTE: • Sample No., if not changed, is automatically incremented by 1,

although “0” (zero) is not incremented.
[Example] 123 → 124
999999999999999 → 1
12-3 → 12-4
12-999 → 12-000

SAMPLE ANALYSIS
4.2 Pre-Diluted (PD) Mode

In this mode, a sample is diluted into 1:26 before analysis. This mode is applied in analyz-
ing a capillary blood collected from the earlobe or fingertip. Samples are processed by the
following steps:

2. Preparing analysis samples in PD mode (dilution of 1:26)
3. Selecting Pre-Diluted mode

Dilute samples to the ratio of 1:26 using CELLPACK dispensed beforehand in
containers.
[Example]
20 µL of blood is diluted in 500 µL of CELLPACK.
CAUTION • Dilute and analyze a capillary blood collected from the earlobe or
fingertip immediately to avoid possible platelet agglutination.
A correct result might not be obtained if 30 minutes are passed
after dilution.
• With a sample of blood collected from the earlobe or fingertip,
blood cell count is generally higher than normal, with lower repro-
ducibility. If possible, analyze the same diluted sample twice and
compare the results. When the blood collection tube containing a
commercial anti-coagulant is used, there is a possibility that RBC
hemolysis or platelet agglutination occurs depending on the types
of anticoagulant, with a consequent change in analysis result. As
anti-coagulant, use EDTA-2K, EDTA-3K, or EDTA-2Na.
NOTE: • All performance claims given in this manual were generated using
specimens in EDTA anticoagulant. Results may be affected by
the use of other anticoagulants. Therefore, each laboratory
should develop protocols for handling specimens collected in
these anticoagulants.
Tubes up to 80 mm in height should be used. The volume of sample is as follows:

Volume of whole blood required Approx. 20 µL or more
Volume of sample aspirated Approx. 200 µL

SAMPLE ANALYSIS
2. Preparing analysis samples in PD mode (1:26 Dilution)
(1) Clean a container such as erlenmeyer flask, beaker, etc. with CELLPACK and
remove any dirt.
(2) Using a syringe, etc., take CELLPACK into a cleaned container.
(3) Using a 500 µL transfer pipette, dispense 500 µL of CELLPACK into a micro-tube.
(4) Using a capillary tube, etc., collect 20 µL of blood and dispense it into the micro-tube.
(5) Attach the cap and mix well.
WARNING • When preparing PD-mode analysis samples, always wear rubber

gloves. After completion of work, wash hands with disinfectant. If
your hands are contaminated by blood, etc., infection of bacteria
or the like can occur.
CAUTION • A 1:26 dilution sample is prone to platelet agglutination. So, ana-

lyze the sample within 30 minutes after blood dispensing and
diluting. If diluent is dispensed in advance, evaporation and dirt
mixing will result in errors in analysis values. Therefore prepare
one sample at a time.
When preparing a 1:26 dilution sample, use the tools listed below:
• Diluent (CELLPACK)
• Micro-tube (MT-40, etc.)
• Capillary tube
• A 500 µL transfer pipette
• A container, such as erlenmeyer flask or beaker
• A syringe

SAMPLE ANALYSIS
3. Selecting Pre-Diluted mode

When the line on the side of the system status area on the LCD screen is “ ”, the
whole blood (WB) mode is in use for analysis, so change it over to the pre-diluted
(PD) mode by the following procedure:
(1) Confirm the Ready status.
(2) Press [MODE] key to display the Change Mode screen.
*Change Mode*
Figure 2-4-10: Change Mode Screen
(3) Press [ ] or [ ] key to select “Pre-Diluted (PD).”
*Change Mode*
Figure 2-4-11: Selecting PD Mode
(4) Press [ENTER] key to changeover the analysis mode and return to the Analysis
screen.
NOTE: • The analysis mode selected here is maintained after completion

of analysis, until it is switched to the other analysis mode.
• At the time of turning-on the power, the system is in the whole
blood mode.

SAMPLE ANALYSIS

The sample No. can be input by the following two methods.
NOTE: • The sample number is set by the incremented value for each
analysis. Input the sample number when changing.

(1) Press [SAMPLE No.] key in the Ready status. The next Sample No. in the system
status area on the LCD screen turns to the reverse display and the system waits for
Sample No. input (in the “Not Ready” status).
No.123456789012345
Not Ready
(2) The cursor appears under sample No. Input sample No. using the numeric keys.
[Example] Input of Sample No. 5

Press [5] key on the numeric keys.
CAUTION: • Sample No. “0” (zero) is treated as a special sample number.

1) Judgment on patient limit is not made for analysis data.
2) Analysis data is not stored.
3) Data is not transferred to the host computer.
4) Sample No. is not incremented.
5) Judgment on abnormal histogram is not made.
6) When one attempts to make analysis with the sample No. of
“0” (zero), the buzzer sounds during sample aspiration.
NOTE: • When entering the sample No. (on the screen of the previous
page), press [C] key first. This will clear the entire sample No.
Then, enter a new sample No.
• In the course of entering the sample No., each time you press [C]
key, one character disappears with the cursor moving to the left.
• A sample No. of a maximum of 15 digits, comprising numerics
and a hyphen, can be used.

SAMPLE ANALYSIS
NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted.
When you attempt to do so, an alarm sounds.
• In the status of waiting for sample No. input (“Not Ready”), press

No.123456789012345
Not Ready
(2) Read the barcode affixed to the test tube with the hand held barcode reader.
Figure 2-4-14: Reading the Barcode
When reading has been carried out normally, the read sample number will appear.
NOTE: • In the status of waiting for sample No. input (“Not Ready”), press

SAMPLE ANALYSIS
WARNING • When analyzing samples, always wear rubber gloves, and after
completion of work, wash hands with disinfectant. If your hands
are contaminated by blood, etc., infection of bacteria can occur.
(1) Mix the sample sufficiently.
Figure 2-4-15: Mixing the Sample
(2) Remove the plug while taking care not to allow blood scatter.
(3) Set the micro-tube to the sample probe, and in that condition, press the start switch.
Start Switch

SAMPLE ANALYSIS
(4) During sample aspiration, the buzzer sounds "beep, beep, beep", and when the
LCD screen displays "Analyzing," please remove the micro-tube. After that, the
unit executes automatic analysis and displays the result on the LCD screen. Then
the unit turns to the Ready status, becoming ready for analysis of the next samples.
The screens from the start to the end of analysis are as shown in the following:
(Ready)
No.123456789-12345
Ready
(Aspirating)
No.123456789-12345
Aspirating
(Analyzing)
No.123456789-12345
Analyzing
(Rinsing)
No.123456789-12345
Rinsing
(Ready)
No.123456789-12346
Ready
Figure 2-4-18: LCD Screen (in PD Mode)
CAUTION • While the LCD screen is displaying “Aspirating,” keep holding the
micro-tube in the aforementioned status. If the micro-tube is
removed during its display, correct analysis result may not be
obtained.
CAUTION: • During sample aspiration, the buzzer sounds "beep, beep, beep".
Several seconds the buzzer stops and "Aspirating" appears on
the LCD screen, the rinse cup lowers. By that time, remove the
micro-tube.
• To remove the micro-tube, lower it straight down. Take care not to
bend the sample probe.

wipe it clean.
2-22 Sysmex KX-21N Operator’s Manual -- Revised May 2010

SAMPLE ANALYSIS
(5) When the LCD screen displays “Ready,” prepare a next sample and repeat the pro-
cedure (1) to (4).
NOTE: • Sample No., if not changed, is automatically incremented by 1,

although “0” (zero) is not incremented.
[Example] 123 → 124
999999999999999 → 1
12-3 → 12-4
12-999 → 12-000

SAMPLE ANALYSIS
5. DISPLAY AND PRINTING OF ANALYSIS RESULT

5.1 Display of Analysis Result
The result of each analysis is displayed on the LCD screen.

The display screen of analysis result consists of five pages, and pages are turned over by
using [ ] or [ ] key.
For the contents of display, refer to Chapter 3, Section 2.1: Display of Analysis Result.
Examples of display (For the Whole Blood mode)
P1. All Analysis Data Display Screen P2. CBC8 Parameter & Patient Limit Graph
Display Screen
No.123456789-12346 No.123456789-12346
Ready Ready
No.123456789-12345 WB 31/12 10:59 No.123456789-12345 WB 31/12 10:59
WBC 7.1 LYM% 31.2 2.2 WBC 7.1 ×10 /µL3
RBC 3.97 MXD% 19.6 1.4 RBC 3.97 ×106/µL

HGB 14.7 NEUT% 49.2 3.5 HGB 14.7 g/dL
HCT 32.8 RDW-SD - 25.6 HCT 32.8 %
MCV - 82.6 RDW-CV 20.5 MCV - 82.6 fL
MCH 37.0 PDW - 7.9 MCH 37.0 pg
MCHC + 44.8 MPV 9.3 MCHC + 44.8 g/dL
PLT 180 P-LCR - 9.5 PLT 180 ×103/µL
1:M.Discri. 2:Output 1:M.Discri. 2:Output
P3. Calculation Parameter & Patient Limit P4. Calculation Parameter & Particle Distribution
Graph Display Screen Display Screen
No.123456789-12346 No.123456789-12346
Ready Ready
No.123456789-12345 WB 31/12 10:59 No.123456789-12345 WB 31/12 10:59
LYM% 31.2 % 2.2 LYM% 31.2 % 2.2 WBC
MXD% 19.6 % 1.4 MXD% 19.6 % 1.4
NEUT% 49.2 % 3.5 NEUT% 49.2 % 3.5
RDW-SD - 25.6 fL RDW-SD - 25.6 fL RBC
RDW-CV 20.5 % RDW-CV 20.5 %
PDW - 7.9 fL PDW - 7.9 fL
MPV 9.3 fL MPV 9.3 fL PLT
P-LCR - 9.5 % P-LCR - 9.5 %
1:M.Discri. 2:Output 1:M.Discri. 2:Output
P5. CBC8 Parameter & Particle Distribution

Display Screen
No.123456789-12346
Ready
No.123456789-12345 WB 31/12 10:59
WBC 7.1 ×10 /µL3
WBC
RBC 3.97 ×106/µL
HGB 14.7 g/dL
HCT 32.8 % RBC
MCV - 82.6 fL
MCH 37.0 pg
MCHC + 44.8 g/dL PLT
PLT 180 ×103/µL
Figure 2-5-1: Analysis Result Display Screen

SAMPLE ANALYSIS
5.2 Printing of Analysis Result

Analysis result can be printed out on the built-in or the external printer. (The external
printer is an option)
For the contents of the print and the printing procedure, refer to Chapter 3, Section 2.3:
External Output.
Examples of printing with the Built-in Printer
[Type 1] [Type 2] [Type 3]

No. 123456789-12345 No. 123456789-12345 No. 123456789-12345
Date 31/10/1999 Date 31/10/1999 Date 31/10/1999
Time 10:02 Time 10:02 Time 10:02
Mode WB [W][R][P] Mode WB [W][R][P] Mode WB [W][R][P]
WBC 7.3 ×103/µL WBC 7.3 ×103/µL WBC 7.3 ×103/µL

RBC 4.52 ×106/µL RBC 4.52 ×106/µL RBC 4.52 ×106/µL
HGB 14.8 g/dL HGB 14.8 g/dL HGB 14.8 g/dL
HCT 36.2 % HCT 36.2 % HCT 36.2 %
MCV 80.1 fL MCV 80.1 fL MCV 80.1 fL
MCH 32.7 Pg MCH 32.7 Pg MCH 32.7 Pg
MCHC 40.9 g/dL MCHC 40.9 g/dL MCHC 40.9 g/dL
PLT 206 ×103/µL PLT 206 ×103/µL PLT 206 ×103/µL
WBC LYM% 27.2 %

MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
[fL] MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
LYM% 27.2 % RDW-SD 8.3 fL
MXD% 13.4 % RDW-CV 15.0 %
NEUT% 59.4 % PDW 8.3 fL
LYM# 2.0 ×103/µL MPV 9.1 fL
MXD# 1.0 ×103/µL P-LCR 14.8 %
NEUT# 4.3 ×103/µL
RBC
[fL]
RDW-SD 8.3 fL
RDW-CV 15.0 %
PLT
[fL]
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 2-5-2: Printing of Analysis Result (Built-in Printer)
NOTE: • One print format can be selected from among Types 1, 2, and 3.
For the selecting procedure, refer to Chapter 10, Section 7.3: IP
Output Settings.

SAMPLE ANALYSIS
Examples of printing with the Graphic Printer
Sample No.:123456789-12345 31/10/1999 16:40

Mode:WB Manual Ana:[W][R][P]
[ERROR]
WBC 7.3 [×103/µL] WBC
RBC 4.52 [×106/µL]
HGB 14.8 [g/dL]
HCT 36.2 [%]
MCV 80.1 [fL]
MCH 32.7 [Pg]
MCHC 40.9 [g/dL]
PLT 206 [×103/µL] RBC
LYM% 27.2 [%]

MXD% 13.4 [%]
NEUT% 59.4 [%]
LYM# 2.0 [×103/µL]
MXD# 1.0 [×103/µL]
NEUT# 4.3 [×103/µL] PLT
RDW-SD 8.3 [fL]

RDW-CV 15.0 [%]
PDW 8.3 [fL]
MPV 9.1 [fL]
P-LCR 14.8 [%]
Figure 2-5-3: Printing of Analysis Result (Graphic Printer)

SAMPLE ANALYSIS
Examples of printing with the Data Printer
HEMATOLOGY
Carte No. Doctor
M
Name Age
F
10/12/1999 Data
123456789012345 Sample No.
5.6+ WBC 28.3 W-SCR
×10 3/µL %
3.58 RBC 18.8 W-MCR

×10 6/µL %
8.0 HGB 52.9 W-LCR

g/dL %
34.1 HCT 1.6 W-SCC

% ×10 3/µL
80.1 MCV 1.0 W-MCC

fL ×10 3/µL
32.7 MCH 3.0 W-LCC

pg ×10 3/µL
40.9 MCHC 68.5 RDW-SD

g/dL fL
206 PLT
×10 3/µL
Retic 10.0 MPV

fL
Myelo-
blast
Pro
Myelo W-SCR WBC-Small Cell Ratio
Neutro
W-MCR WBC-Middle Cell Ratio

Meta
W-LCR WBC-Large Cell Ratio
Stab
W-SCC WBC-Small Cell Count
Seg W-MCC WBC-Middle Cell Count
Eosino W-LCC WBC-Large Cell Count
RDW-CV RBC Distrib. Width-CV

Baso
PDW PLT Distrib. Width
Mono
MPV Mean Platelet Vol
Lymph P-LCR PLT-Large Cell Ratio
PRINT TICKET No.22
Figure 2-5-4: Printing of Analysis Result (Data Printer)
5.3 Output of Analysis Result to Host Computer

The analysis result can be output to the host computer.
For the output procedure to the host computer, refer to Chapter 3, Section 2.3: External
Output.

SAMPLE ANALYSIS
6. LIMITATIONS
6.1 Cell Count Parameters
Some abnormal samples may give incorrect results by automated cell counting methods.
The following table shows examples of specific specimens that could cause errors.
Parameter Specimen Error Possible Indication of Error

WBC Cold Agglutinin (+) ↑MCV, ↓HCT, red cell clumping on smear
Platelet aggregation (+) Platelet aggregates on smear
Erythroblastosis (+) Erythroblasts on smear
Nucleated RBC (+) NRBC on smear
Cryoglobulins (+)
RBC Cold Agglutinin (-) ↑MCV, ↓HCT, red cell clumping on smear
Severe Microcytosis (-)
Fragmented RBC (-)
Leukocytosis (+) Elevation of WBC
(>100,000/µL)
HGB Leukocytosis (+) Elevation of WBC
(>100,000/µL)
Lipemia (+) ↑MCHC, “milky” appearance of plasma
Abnormal Protein (+) ↑MCHC, Lysed Hgb/WBC sample turns cloudy
HCT Cold Agglutinin (-) ↑MCV, ↓HCT, red cell clumping on smear
Leukocytosis (+) Elevation of WBC
(>100,000/µL)
Abnormal Red Cell Fragility (?)
Spherocytosis (?) ↓MCV, spherocytes on smear
PLT Pseudothrombocytopenia (-) Platelet Satellitism on smear
Platelet Aggregation (-) Platelet Aggregation on smear
Increased Microcytosis (+) ↓MCV
Megalocytic Platelets (-)
(+): Instrument count is affected by an increase in the result.

(-): Instrument count is affected by a decrease in the result.
(?): Instrument count is affected by either an increase or decrease in the result which is
sample dependent.
CAUTION: • WBC results may be elevated erroneously due to unlysed red

cells in patients with hemoglobinopathies, severe liver disease or
in neonates.

SAMPLE ANALYSIS
6.2 Limitation of Hemoglobin
1. Hemoglobin measurements may be falsely elevated due to the influences of abnor-

mal samples including leukocytosis above 100,000/µL, lipemia or abnormal pro-
teins in blood plasma. The affect of lipemia and abnormal proteins may be
removed by plasma replacement or plasma blank procedures.
2. Performance specifications for hemoglobin results are assured only when instru-
ment environment and sample requirements are observed.
3. The hemoglobin method available for this analyzer cannot detect sulfhemoglobin,
verdohemoglobin choleglobin or other unusual degradation products of hemoglo-
bin.

SAMPLE ANALYSIS
7. EXPECTED RESULTS
Reference intervals (normal population reference ranges) were developed for the KX-21N
using normal individuals. The ranges for each parameter --- WBC, RBC, Hemoglobin,
Hematocrit, MCV, MCH, MCHC, RDW-CV, RDW-SD, Platelet, MPV, Lym% and #,
Mxd% and #, and Neut% and # were determined and displayed in Table 1-16-1.
Range for Range for Males
Parameter
Females n=117 n=124
WBC 3.1 - 10.3 2.6 - 8.8
RBC 3.2 - 4.6 3.6 - 5.3
Hgb 9.9 -13.6 11.3 - 15.7
Hct 30.2 - 42.3 32.6 - 47.5
MCV 78.6 - 102.2 80.3 - 103.4
MCH 25.2 - 34.7 26 - 34.4
MCHC 31.3 - 35.4 31.8 - 36.3
Plt 128 - 434 134 - 377
Lym% 15 - 45.8 17.5 - 47.9
Mxd% 1.3 - 25.9 1.9 - 24.6
Neut% 43.7 - 77.1 38.3 - 69
Lym# 0.9 - 2.8 0.8 - 2.7
Mxd# 0.1 - 1.6 0.1 - 1.5
Neut# 1.6 - 6.9 1.2 - 5.3
RDW-CV 10.6 - 15.7 10.8 - 14.9
RDW-SD 35.3 - 48.9 33.4 - 49.2
MPV 8.5 - 12.4 8.1 - 12.4
Table 2-7-1: Normal Population Reference Ranges
NOTE: • The age range for females was 17 - 66 years with a mean age of 33.4.
• The age range for males was 17 - 72 years with a mean age of 42.2.
Sysmex recommends that each laboratory establish its own expected reference intervals
based upon the laboratory’s patient population encountered during daily operation.
Expected reference intervals may vary due to differences in sex, age, diet, fluid intake,
geographic location, etc. The NCCLS Document C28A1, “How to Define and Determine
Reference Intervals in the Clinical Laboratory; Approved Guideline”. This document con-
tains guidelines for determining reference values and intervals for quantitative clinical lab-
oratory test.
1
NCCLS, 771 East Lancaster Avenue, Villanova, PA 19085, USA.

SAMPLE ANALYSIS
8. STOPPING THE PNEUMATIC UNIT

The KX-21N, when left non-operating for 15 minutes, automatically stops the pneumatic
unit. It is also possible to manually stop the pneumatic unit using the following proce-
dures:
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select “00: PU Sleep.”
*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
Figure 2-8-1: Select Menu Screen
(3) Press [ENTER] key. This stops the pneumatic unit.
NOTE: • Press the start switch to return to the ready status.

SAMPLE ANALYSIS
9. EXECUTION OF SHUTDOWN
When analyses of all samples are finished, execute shutdown before turning the power off.
By executing shutdown, the TD chamber and diluted sample line are cleaned. Execute
shutdown after the day's work is finished, and also when this instrument is used continu-
ously, shut it down at least once in 24 hours.
CAUTION: • If the power is turned OFF before executing shutdown, failures

could occur, such as fluid dripping from the rinse cup and crystals
forming around the rinse cup.
9.1 Shutdown Procedure

(1) Press [SHUTDOWN] key in the Ready status. The Shutdown screen appears.
*Shutdown*
Ready
Aspirate CELLCLEAN.
It will take approx. 5 minutes.
3:Cancel
Figure 2-9-1: Shutdown Screen
NOTE: • When [3] key is pressed, shutdown is canceled and the Analysis
screen returns.

SAMPLE ANALYSIS
(2) When executing shutdown, set CELLCLEAN to the sample probe and press the
start switch in that status. While “Aspirating” is being displayed on the screen,
keep holding CELLCLEAN in the same status.
Start Switch
WARNING • Because CELLCLEAN is a strong alkaline detergent, take care

not to have it adhere to the skin or clothes. If the skin or clothes
should come in touch with it, flush it away using plenty of water.
Otherwise, it can damage the skin or clothes.
NOTE: • Once shutdown is executed, it cannot be canceled until it is com-

pleted.
(3) When the buzzer sounds two times - beep, beep- , informing the completion of
aspiration, remove CELLCLEAN from the sample probe.
After that, shutdown is executed automatically.
*Shutdown*
Rinsing
Please wait.
Figure 2-9-3: Shutdown Execution Screen
CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to


SAMPLE ANALYSIS
(4) When shutdown is finished and the following message is displayed, turn off the
power switch on the right side of the unit.
*Shutdown*
Shut-down sequence was completed.

Turn OFF the power.
1:Re-boot
Figure 2-9-4: Shutdown Completion Message Screen
NOTE: • Shutdown will take approximately 5 minutes.

• When the [1] key is pressed, the unit will restart.

CHAPTER 3 DISPLAY AND PROCESSING OF
ANALYSIS RESULTS
1. INTRODUCTION ................................................................................... 3-1
2. PROCESSING LATEST SAMPLES....................................................... 3-2

2.1 Display of Analysis Result .......................................................... 3-2
2.2 Manual Discrimination ................................................................ 3-7
2.3 External Output.......................................................................... 3-11
3. PROCESSING STORED DATA............................................................ 3-14

3.1 Executing and Quitting Stored Data Processing Program ......... 3-14
3.2 Stored Data Screen..................................................................... 3-15
3.3 Deletion...................................................................................... 3-20
3.4 External Output.......................................................................... 3-21
3.5 Correcting a Sample Number .................................................... 3-23

DISPLAY AND PROCESSING OF ANALYSIS RESULTS
1. INTRODUCTION
This instrument displays analysis result and information that assists in breaking down
analysis result and outputs such data to external devices. This chapter describes the pro-
cessing of analysis result, such as displaying latest or stored data on the screen or output-
ting them to external devices. The gist of the contents is as follows:
Processing of Latest Samples

When analysis is finished, analysis result is displayed in three kinds of screens. The dis-
play contents of Analysis Result screen, what they mean, and how to process them are
explained here.
Processing of Stored Data

The analysis data stored in the instrument can be read at anytime. Description is made on
the display contents of stored data, what they mean, deletion by marking, and output to
external devices.

2. PROCESSING LATEST SAMPLES

2.1 Display of Analysis Result
The analysis result is displayed in the Analysis Result Display Area on the LCD screen.
In the Analysis Result Display Area, the analysis result is displayed each time a new sam-
ple is analyzed. When the analysis result is displayed, the menu display area displays the
menu of “1: M. Discri.” and “2: Output,” which can each be executed using the numeric
keys.
The Analysis screen consists of five pages that differ from each other in “Analysis Result
Display Area.”
Use [ ] key or [ ] key to change over pages.
P2. CBC8 Parameter & Patient Limit Graph

P1. All Analysis Data Display Screen Display Screen
P3. Calculation Parameter & Patient Limit

Graph Display Screen
P5. CBC8 Parameter & Particle Distribution P4. Calculation Parameter & Particle
Display Screen Distribution Display Screen
Figure 3-2-1: Page Selection in the Analysis Screen
P1. All Analysis Data Display Screen
No.123456789-12346 System Status Display Area

Ready
Latest Sample No. No.123456789-12345 WB 31/12 10:59 Date/Time Analyzed
Mode Indication
WBC 7.1 LYM% 31.2 2.2
RBC 3.97 MXD% 19.6 1.4
HGB 14.7 NEUT% 49.2 3.5
HCT 32.8 RDW-SD - 25.6 Analysis Result Display Area
MCV - 82.6 RDW-CV 20.5
MCH 37.0 PDW - 7.9
MCHC + 44.8 MPV 9.3
PLT 180 P-LCR - 9.5
1:M.Discri. 2:Output Menu Display Area
Figure 3-2-2: All Analysis Data Display Screen

P2. CBC8 Parameter & Patient Limit Graph Display Screen
No.123456789-12346
Ready
Mode Indication
WBC 7.1 ×103/µL
RBC 3.97 ×106/µL
HGB 14.7 g/dL
HCT 32.8 % Patient Limit Graph
MCV - 82.6 fL
MCH 37.0 pg
MCHC + 44.8 g/dL
PLT 180 ×103/µL
Figure 3-2-3: CBC8 Parameter & Patient Limit Graph Display Screen
P3. Calculation Parameter & Patient Limit Graph Display Screen
NOTE: • When analysis is made in the pre-diluted mode, particle distribu-

tion analysis parameters are displayed in “- - -. -.” The particle
distribution curve is not displayed.
No.123456789-12346
Ready
Mode Indication
LYM% 31.2 % 2.2
MXD% 19.6 % 1.4
NEUT% 49.2 % 3.5
RDW-SD - 25.6 fL Patient Limit Graph
RDW-CV 20.5 %
PDW - 7.9 fL
MPV 9.3 fL
P-LCR - 9.5 %
Figure 3-2-4: Calculation Parameter & Patient Limit Graph Display Screen

P4. Calculation Parameter & Particle Distribution Display Screen
No.123456789-12346
Ready
Mode Indication
LYM% 31.2 % 2.2 WBC
MXD% 19.6 % 1.4 WBC Particle
NEUT% 49.2 % 3.5 Distribution Chart
RDW-SD - 25.6 fL RBC
RDW-CV 20.5 % RBC Particle
PDW - 7.9 fL Distribution Chart
MPV 9.3 fL PLT
P-LCR - 9.5 %
PLT Particle
Distribution Chart
Figure 3-2-5: Calculation Parameter & Particle Distribution Display Screen
P5. CBC8 Parameter & Particle Distribution Display Screen
No.123456789-12346
Ready
Mode Indication
WBC 7.1 ×103/µL WBC
RBC 3.97 ×106/µL WBC Particle
HGB 14.7 g/dL Distribution Chart
HCT 32.8 % RBC
MCV - 82.6 fL RBC Particle
MCH 37.0 pg Distribution Chart
MCHC + 44.8 g/dL PLT
PLT 180 ×103/µL
PLT Particle
Distribution Chart
Figure 3-2-6: CBC8 Parameter & Particle Distribution Display Screen

Display Contents of Analysis Data Display Screens

1) System Status Display Area
This area displays the status of the instrument. For details, refer to Chapter 1, Sec-
tion 8.1: Contents of Display.
2) Latest Sample No.

The latest sample No. is displayed.
3) Mode Indication
The latest sample's analysis mode is displayed.
The whole blood mode is displayed as “WB” and the pre-diluted mode as “PD.”
4) Date/Time Analyzed
Date and time when analysis result was obtained are displayed.
5) Analysis Data
The analysis data of the following 17 parameters or part of them are displayed
depending on the screen:
Analysis parameters (8): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT
Calculation parameters (9): LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#,
RDW-SD, RDW-CV, MPV
The marks to the left of analysis data indicate the following:

1. ! : The data is out of the linearity limit.
2. * : The data is low in reliability because of a histogram error.
3. + : The data exceeds the upper Mark Limits.
- : The data exceeds the lower Mark Limits.
NOTE: • The marks are added with the priority order of 1, 2, and 3.
• The Mark Limits with “+” and “-” can be set by the customer. For
details, refer to Chapter 10, Section 4: PATIENT LIMIT.
When an analysis error, etc. has caused errors in analysis data, the marks below are
attached to the affected data:
1. + + +. +: When data has exceeded the display range.
2. * * *. *: When data could not be calculated due to instrument failure.
3. - - -. -: When data could not be calculated due to data error.

tion analysis parameters are displayed in “- - -. -.”

When an error is found in particle distribution, a histogram error flag among the
following is displayed:
1. WL: Relative frequency of WBC-LD has exceeded the range.
2. WU: Relative frequency of WBC-UD has exceeded the range.
3. T1: T1 discriminator position cannot be determined.
4. T2: T2 discriminator position cannot be determined.
5. F1: Relative frequency of T1 has exceeded the range.
6. F2: Relative frequency of T1 or T2 has exceeded the range.
7. F3: Relative frequency of T2 has exceeded the range.
8. RL: Relative frequency of RBC-LD has exceeded the range.
9. RU: Relative frequency of RBC-UD has exceeded the range.
10. DW: Distribution width cannot be calculated.
11. MP: There are multiple peaks.
12. PL: Relative frequency of PLT-LD has exceeded the range.
13. PU: Relative frequency of PLT-UD has exceeded the range.
14. AG: The particle count equal to or less than WBC-LD has exceeded the range.
NOTE: • When analysis is made in the pre-diluted mode, no flag is dis-

played to particle distribution analysis parameters. For details,
refer to Chapter 9, Section 6: ANALYSIS OF HISTOGRAM.
6) Menu Display Area

The Menu is displayed in accordance with the screen. For details, refer to Chapter
1, Section 8.1: Contents of Display.
7) Patient Limit Graph

Synchronize with setting the Mark Limits value, and display whereabouts location
of the analysis value for a standard range.
Analysis value
Abnormal range Abnormal range
Lower Mark Limit Upper Mark Limit

Center Mark Limit
Figure 3-2-7: Patient Limit Graph
8) WBC Particle Distribution Chart

The WBC Particle distribution chart is displayed.
9) RBC Particle Distribution Chart

The RBC Particle distribution chart is displayed.
10) PLT Particle Distribution Chart

The PLT Particle distribution chart is displayed.

2.2 Manual Discrimination

This menu allows relocation of particle distribution discrimination position and re-calcula-
tion of data.
CAUTION: • Manual Discrimination can be performed only on the latest sam-

ple displayed on the Analysis screen, but not on the data with
sample number 0.
NOTE: • “1: M. Discri.” on the menu is valid only for the analysis result in
the whole blood mode.
Execution of Manual Discrimination

(1) Press [1] key on the Analysis screen displaying analysis result and select “1: M.
Discri.”
The pop-up menu to select the particle distribution for the manual discrimination
will appear.
1:WBC
2:RBC
3:PLT
Figure 3-2-8: Pop-up Menu
(2) Using [ ] key or [ ] key to select a desired particle distribution for the manual
discrimination, and press [ENTER] key.
The Manual Discrimination screen appears.
M. Discri. Screen (WBC)
*M.Discri.*
No.123456789-12345 WB 31/12 10:59
WBC WBC 7.1×103/µL
LYM% 31.2%
MXD% 19.6%
NEUT% 49.2%
LYM# - 2.0×103/µL
LD 30 fL MXD# 1.4×103/µL
T1 90 fL NEUT# 3.5×103/µL
T2 144 fL
[ ][ ] for item, [ ][ ] for cursor
Figure 3-2-9: M. Discri. Screen (WBC)

M. Discri. Screen (RBC)
*M.Discri.*
No.123456789-12345 WB 31/12 10:59
RBC RBC 3.97×106/µL
HGB 14.7g/dL
HCT 32.8%
MCV - 82.6fL
MCH 37.0pg
LD 25 fL MCHC + 44.8g/dL
UD 250 fL RDW - 25.6fL
Figure 3-2-10: M. Discri. Screen (RBC)
M. Discri. Screen (PLT)
*M.Discri.*
No.123456789-12345 WB 31/12 10:59
PLT PLT 180×103/µL
PDW - 7.9fL
MPV 9.3fL
P-LCR - 9.5%
LD 2 fL
UD 30 fL
Figure 3-2-11: M. Discri. Screen (PLT)
(3) Using [ ] key or [ ] key, move the cursor to select the discriminator for manual
discrimination.
The discriminator selected on the Particle Distribution Chart is shown with solid line.

(4) Using [ ] key or [ ] key, move the Discri. position on the Particle Distribution
Chart. The Discri. position relocated is displayed.
The range within which each Discri. position can move is shown below.
Table 3-2-1: M. Discri. Screen (WBC)

Discri. to Move Lower Limit Upper Limit
LD 6 fL (0ch) T1
T1 LD T2
T2 T1 UD
WBC particle distribution covers 50 channels of 0 to 49 (6 fL per channel), and the

channel changes by one at a time.
The relation between WBC particle distribution channel and fL display is as fol-
lows:
Discri. position (fL) = (Channel No. + 1) × 6
Table 3-2-2: M. Discri. Screen (RBC)

LD 5 fL (0ch) UD
UD LD 250 fL (49ch)
RBC particle distribution covers 50 channels of 0 to 49 (5 fL per channel), and the

The relation between RBC particle distribution channel and fL display is as fol-
lows:
Table 3-2-3: M. Discri. Screen (PLT)

LD 1 fL (0ch) UD
UD LD 40 fL (39ch)
PLT particle distribution covers 40 channels of 0 to 39 (1 fL per channel), and the

The relation between PLT particle distribution channel and fL display is as fol-
lows:
(5) After Discri. movement, press [ENTER] key.

The Discri. position is set and analysis data is re-calculated on the basis of new
Discri. position.
When [SELECT] key is pressed without pressing [ENTER] key, the Discri. posi-
tion is not changed, and the status returns to the Discri. position selection status.
(6) When you want to change another Discri., repeat the above (2) - (6) operation.

(7) When Discri. change is finished, press [SELECT] key. The Setting Change Con-
firmation Message appears.
OK to set? Cont. Set Cancel
Figure 3-2-12: Setting Change Confirmation Message
(8) Using [ ] key or [ ] key, move the cursor to select “Cont.,” “Set,” or “Cancel,”
then press [ENTER] key.
[Cont.]: Returns to the M. Discri. screen and allows M. Discri. operation.
[Set]: Updates the contents and returns to the Analysis screen.
[Cancel]: Cancels the changed contents and returns to the Analysis screen.
(9) When you update the contents, analysis values changed in M. Discri. on the Anal-
ysis screen are reverse-displayed.
No.123456789-12346
Ready
No.123456789-12345 WB 31/12 10:59
WBC 7.1 LYM% 31.2 2.2
RBC 39.7 MXD% 19.6 1.4
HGB 14.7 NEUT% 49.2 3.5
HCT 32.8 RDW-SD - 25.6
MCV - 82.6 RDW-CV 20.5
MCH 37.0 PDW - 7.9
MCHC + 44.8 MPV 9.3
PLT 180 P-LCR - 9.5
Figure 3-2-13: Analysis Screen

2.3 External Output

This menu can be used to print out the latest sample's analysis result from the built-in/
external printer or output to the host computer. (The external printer is an option)
Printing to Printer
(1) Press [2] key on the Analysis screen and select “2: Output.”
The pop-up menu to select the output destination will appear.
1:Host
2:DP
3:GP
4:LP
5:IP
6:IP Feed
7:StopOutput
(2) Using [ ] key or [ ] key to move the cursor to the desired printer, and press
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to “Output to Host
Computer” described later.
[2: DP]: The data printer starts printing the analysis result of the latest
sample.
[3: GP]: The graphic printer starts graphic printing the analysis result of
the latest sample.
[4: LP]: This cannot be selected.
[5: IP]: The built-in printer starts printing the analysis result of the latest
sample.
[6: IP Feed]: Carries out the paper feed of the built-in printer.
[7: StopOutput]: This cannot be selected.
Contents of Printing
Contents of print with built-in printer
No. 123456789-12345 Sample No.

Date 31/10/1999 Date Analyzed
Time 10:02 Time Analyzed
Mode Indication Mode WB [W][R][P] Parameter Discriminated Manually
WBC WL+ 11.3 ×103/µL

RBC 3.80 ×106/µL
Figure 3-2-15: Printing of Analysis Result (Built-in Printer)
NOTE: • For printing format of built-in printer, refer to Chapter 2, Section

5.2: Printing of Analysis Result. To change the printing format,
refer to Chapter 10, Section 7.3: IP Output Settings.

Contents of print with graphic printer
Parameter Discriminated
Mode Indication Manually Time Analyzed
Sample No. Date Analyzed
Sample No.:123456789-12345 31/10/1999 16:40

Mode:WB Manual Ana:[W][R][P]
[ERROR]
WBC 7.3 [×103/µL] WBC
RBC 4.52 [×106/µL]
HGB 14.8 [g/dL]
HCT 36.2 [%]
MCV 80.1 [fL]
MCH 32.7 [Pg]
MCHC 40.9 [g/dL]
Figure 3-2-16: Analysis Result Graphic Print (Graphic Printer)
Contents of print with data printer
HEMATOLOGY
Carte No. Doctor
M
Name Age
F
Date Analyzed 10/12/1999 Data

Sample No. 123456789012345 Sample No.
5.6+ WBC 28.3 W-SCR
×10 3/µL %
3.58 RBC 18.8 W-MCR

×10 6/µL %
8.0 HGB 52.9 W-LCR

g/dL %
34.1 HCT 1.6 W-SCC

% ×10 3/µL
80.1 MCV 1.0 W-MCC

fL ×10 3/µL
32.7 MCH 3.0 W-LCC

pg ×10 3/µL
MCHC RDW-CV
g/dL fL
Figure 3-2-17: Analysis Result List Print (Data Printer)
1) Sample No.
The latest sample No. is printed.
2) Mode Indication
The mode in which sample was analyzed is printed. The whole blood mode is
printed as “WB” and the pre-diluted mode as “PD.”

Date and time when analysis result was obtained are printed.
4) Parameter Discriminated Manually

When M. Discri is used, the parameter discriminated manually are printed.
Output to Host Computer

(1) Press [2] key on the Analysis screen and select “2: Output.”
(2) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key.
Output the analysis data of the latest sample to the host computer.

3. PROCESSING STORED DATA

This instrument is capable of storing data of up to 300 samples. The stored data is retained
after the power is turned off and can be called up unless deleted.
NOTE: • When the stored data exceeds 300, the oldest data are automati-
cally deleted.
3.1 Executing and Quitting Stored Data Processing Program

Executing the Program
(2) Using [ ] key or [ ] key, move the cursor to select “1: Stored Data.”
(3) Press [ENTER] key. The Stored Data screen [1/7] appears.
*Stored Data*
Date Time No
31/12 09:59 123456789-12341*B WB DGH
31/12 10:05 QC01 M QC DGH
31/12 10:10 123456789-12335 M WB DGH
31/12 10:25 123456789-12337 M WB DGH
31/12 10:28 123456789-12344 M PD DGH E
31/12 10:30 123456789-12345 A PD DG
31/12 10:40 123456789-12346 A WB GH
31/12 10:50 123456789-12341*M WB D
No.123456789-12345 31/12 10:59 [1/7]
[ENTER] to mark. 3:Chg.Disp.
Figure 3-3-1: Stored Data Screen
Quitting the Program

(1) Press [SELECT] key on the Stored Data screen. The Analysis screen returns.
NOTE: • The sample No. and analysis mode on the Analysis screen return
to the status before the execution of the stored data processing
program.

3.2 Stored Data Screen

The Stored Data screen lists data of up to eight samples in the order of analysis. When the
first Stored Data screen is displayed after turning on the power, the data of the last eight
samples on the list are displayed. When a new sample is analyzed, its data is automati-
cally added to the last line of the list.
As to analysis data, up to four parameters are displayed on one page, and can be switched
to the screen over seven pages with [ ] key or [ ] key. The analyzed date and informa-
tion on the analysis data such as error mark etc. will appear on the first page ([1/7]).
P1. Stored Data Screen [1/7]
P2. Stored Data Screen [2/7] P3. Stored Data Screen [3/7] P4. Stored Data Screen [4/7]
P7. Stored Data Screen [7/7] P6. Stored Data Screen [6/7] P5. Stored Data Screen [5/7]
Figure 3-3-2: Page Selection in the Stored Data Screen
*Stored Data*
Date Time No
31/12 09:59 123456789-12341*B WB DGH
31/12 10:05 QC01 M QC DGH
31/12 10:10 123456789-12335 M WB DGH
31/12 10:25 123456789-12337 M WB DGH
31/12 10:28 123456789-12344 M PD DGH E
31/12 10:30 123456789-12345 A PD DG
31/12 10:40 123456789-12346 A WB GH
31/12 10:50 123456789-12341*M WB D
No.123456789-12345 31/12 10:59 [1/7]
Figure 3-3-3: Stored Data Screen [1/7]
*Stored Data*
No. WBC RBC HGB HCT
-12341* WB 7.7+ 3.97 14.7 32.8
QC 7.5 4.51 14.1 34.7
-12346 WB 7.5+ 3.85 13.8 30.5
-12345 WB 7.1 4.30+ 12.2 29.5-
-12344 PD 7.2 3.91 14.3 32.0
-12337 PD 5.5- 3.90 15.1 40.2+
-12335 WB 7.0 4.05 18.5 31.4
-12341* WB 7.6+ 3.98 15.0 35.1
No.123456789-12341 31/12 10:50 [2/7]

Key Operation for Stored Data Screen

[ ] key: Moves up the underline cursor by one sample. When the underline
cursor is at the top, the list scrolls down.
[ ] key: Moves down the underline cursor by one sample. When the under-
line cursor is at the bottom, the list scrolls up.
[ ], [ ] key: Changes over the page.
[ENTER] key: Attaches or deletes marks.
[SAMPLE No.] key: Allows you to correct the sample number at the underline cursor.
[3] key: Displays the data at the underline cursor by the same form as Anal-
ysis screen.
*Stored Data*
No.123456789-12341 WB 31/12 10:50
WBC + 7.7 LYM% 31.2 2.2
RBC 3.97 MXD% 19.6 1.4
HGB 14.7 NEUT% 49.2 3.5
HCT 32.8 RDW-SD - 25.6
MCV - 82.6 RDW-CV 20.6
MCH 37.0 PDW - 7.9
MCHC 44.8 MPV 9.3
PLT 180 P-LCR - 9.5
1:M.Discri. 2:Output 3:Chg.Disp.
Figure 3-3-5: Stored Data Screen
The screen can be switched with [ ] key or [ ] key as well as

Analysis screen, and press [3] key to return to Stored Data screen.
For details on how to display Analysis screen, refer to Chapter 3,
Section 2.1: Display of Analysis Result.

Marking
To mark the analysis data, specify an analysis data using the underline cursor and press
[ENTER] key.
The marked analysis data has a added to its left end and the underline cursor moves to
the next analysis data. When an analysis data is marked, the Menu Display Area displays:
“1: Delete”, “2: Output”, “3: Chg. Disp.” When the mark is already attached, press
[ENTER] key to delete it.
NOTE: • When you keep pressing [ENTER] key, the marking is made con-
tinuously.
• When you return to the Analysis screen, all the marks on analysis
data are deleted.
*Stored Data*
No. WBC RBC HGB HCT
-12341* WB 7.7+ 3.97 14.7 32.8
QC 7.5 4.51 14.1 34.7
-12335 WB 7.5+ 3.85 13.8 30.5
-12337 WB 7.1 4.30+ 12.2 29.5-
-12344 PD 7.2 3.91 14.3 32.0
-12345 PD 5.5- 3.90 15.1 40.2+
-12346 WB 7.0 4.05 18.5 31.4
-12341* WB 7.6+ 3.98 15.0 35.1
No.123456789-12345 31/12 10:30 [2/7]
1:Delete 2:Output 3:Chg.Disp.
Figure 3-3-6: Marking the Data
Display Contents of Stored Data Screen
Time Analyzed Sample No. Sample No. Input Attributes

Date Analyzed Mode Indication
*Stored Data*
Not-output Mark
Date Time No
31/12 09:59 123456789-12341*B WB DGH
31/12 10:05 QC01 M QC DGH
31/12 10:10 123456789-12335 M WB DGH
31/12 10:25 123456789-12337 M WB DGH
31/12 10:28 123456789-12344 M PD DGH E Error Mark
31/12 10:30 123456789-12345 A PD DG
31/12 10:40 123456789-12346 A WB GH
31/12 10:50 123456789-12341*M WB D
Data at Underline No.123456789-12335 31/12 10:10 [1/7]

Cursor

Mode Indication Analysis Data

Sample No.
*Stored Data*
No. WBC RBC HGB HCT
-12341* WB 7.7+ 3.97 14.7 32.8
QC 7.5 4.51 14.1 34.7
-12335 WB 7.5+ 3.85 13.8 30.5
-12337 WB 7.1 4.30+ 12.2 29.5-
-12344 PD 7.2 3.91 14.3 32.0
-12345 PD 5.5- 3.90 15.1 40.2+
-12346 WB 7.0 4.05 18.5 31.4
-12341* WB 7.6+ 3.98 15.0 35.1
Data at Underline No.123456789-12335 31/12 10:10 [2/7]

Cursor
1) Data/Time Analyzed
The date and the time when analyzed the analysis data are displayed.
2) Sample No.
The sample No. of stored data is displayed.
The sample number is displayed by all of the 15 digits on [1/7] screen, but dis-
played by only 6 last digits on [2/7] to [7/7] screens.
Identical sample Nos. processed on an identical analysis date are marked with * at
the ends of the Nos. QC data are displayed in the format of “QC + File No.”
3) Sample No. Input Attributes

How to input the sample number is displayed by the marks
1. M: The sample number was input with the panel keyboard.
2. B: The sample number was input with the hand held barcode reader.
3. A: The sample number was input by automatic increment.
4) Mode Indication
The analysis mode for stored data is displayed.
“PD” is indicated for the pre-diluted mode while no indication is given for the
whole blood mode.
1. WB: Whole blood mode
2. PD: Pre-diluted mode
3. QC: QC data
5) Not-output Mark
It is displayed whether to output data to an external printer or the host computer by
the marks.
1. D : The data has not been printed to the data printer. The mark disappears
when printed.
2. G : The data has not been printed to the graphic printer. The mark disappears
when printed.
3. H : The data is not output to the host computer. The mark disappears when
output.

6) Error Mark
The E mark is displayed in data which an error occurs.
7) Analysis Data
Analysis data of 17 parameters are displayed on over six pages of [2/7] to [7/7].
Stored Data Screen [2/7]: WBC, RBC, HGB, HCT
Stored Data Screen [3/7]: MCV, MCH, MCHC, PLT
Stored Data Screen [4/7]: WBC, LYM%, MXD%, NEUT%
Stored Data Screen [5/7]: WBC, LYM#, MXD#, NEUT#
Stored Data Screen [6/7]: RDW-SD, RDW-CV
Stored Data Screen [7/7]: MPV
• Manual Discrimination Data

As to data changed through manual discrimination, analysis values are reverse-
displayed.
• Abnormal Marks
The marks on the left of analysis data indicate the following:
1. ! : The data is out of the linearity limit.
2. * : The data is low in reliability because of a histogram error.
3. + : The data exceeds the upper Mark Limits.
- : The data exceeds the lower Mark Limits.
NOTE: • The marks are added with the priority order of 1, 2, and 3.
• The Mark Limits with “+” and “-” can be set by the customer. For
details, refer to Chapter 10, Section 4: PATIENT LIMIT.
• Indication when Error

When an analysis error, etc. has caused errors in analysis data, the marks below are
attached to the affected data:
1. + + +. +: When data has exceeded the display range.
2. * * *. *: When data could not be calculated due to instrument failure.
3. - - -. -: When data could not be calculated due to data error.

tion analysis parameters are displayed in “- - -. -.”
8) Data at Underline Cursor

The sample number (15 digits), the analyzed date, and the analyzed time of the
analysis data on the underline cursor are displayed.

3.3 Deletion
This menu allows deletion of marked analysis data from stored data.
Execution of Deletion
(1) Using the underline cursor, specify the analysis data you want to delete and press
[ENTER] key. This puts the mark on the analysis data.
(2) Press [1] key to select “1: Deletion.” The Deletion Confirmation message appears.
Delete? YES NO
Figure 3-3-9: Deletion Confirmation Message
(3) Using [ ] key or [ ] key, move the cursor to select “Yes” or “NO.”
[Yes]: Deletes the marked analysis data.
[NO]: Cancels deletion.
(4) Press [ENTER] key to execute the selected process.

When you press [SELECT] key, the process is canceled.
NOTE: • Before deleting data, make sure the KX-21N completes any out-
put operation to the printer or host computer.

3.4 External Output

This menu allows the marked analysis data to be printed by the built-in/external printer, or
output to the host computer. (The external printer is an option.)
Printing to Printer
(1) Using the underline cursor, specify the analysis data you want to print and press
[ENTER] key. This puts the mark on the analysis data.
(2) Press [2] key to select “2: Output.”

1:Host
2:DP
3:GP
4:LP
5:IP
6:IP Feed
7:StopOutput
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to “Output to Host
Computer” described later.
[2: DP]: This cannot be selected.
[3: GP]: The graphic printer starts graphic printing the marked analysis
data.
[4: LP]: The graphic printer starts list printing the marked analysis data.
[5: IP]: The built-in printer starts printing the marked analysis data.
[7: StopOutput]: When two or more analysis data are output, this can be selected,
and the output will be interrupted when you select this.
When the print to the printer is completed, disappearing the not-output mark for
the printer which corresponding to the printed analysis data.
NOTE: • For print format other than the LP (list print with the graphic
printer), refer to Chapter 2, Section 5.2: Printing of Analysis
Result or Section 2.3 External Output.

List print with the graphic printer
Print Date 31/10/1999 page( 1)

Print Time 16:40
Sample No. Mode Err. WBC RBC HGB HCT MCV MCH MCHC PLT
Date RDW-SD RDW-CV PDW MPV P-LCR
Ana.Inf. LMY% MXD% NEUT% LMY# MXD# NEUT#
123456789-12344 P E 7.3 4.52 14.8 36.2 80.1 32.7 40.9 206

31/10/1999 12:15 8.3 15.0 8.3 9.1 14.8
W R P 27.2 13.4 59.4 2.0 2.0 4.3
Figure 3-3-11: Stored Data List Print
Output to Host Computer

(1) Using the underline cursor, specify the analysis data you want to output to the host
computer and press [ENTER] key. This puts the mark on the analysis data.

1:Host
2:DP
3:GP
4:LP
5:IP
6:IP Feed
7:StopOutput
The analysis data is output to the host computer in order that the mark is put.
The not-output of the output analysis data to the host computer disappears when
the output to the host computer is completed.

3.5 Correcting a Sample Number

Use the [SAMPLE No.] key to correct a sample number of analysis data.
(1) Use the underline cursor to select the desired analysis data, then press the [SAM-
PLE No.] key. The sample number on the bottom of the screen will be highlighted.
-12345 PD 5.5- 3.90 15.1 40.2+

-12346 WB 7.0 4.05 18.5 31.4
-12341* WB 7.6+ 3.98 15.0 35.1
No.123456789-12345 31/12 10:30 [2/7]
Figure 3-3-13: Correcting a Sample Number
(2) Use the numeric keypad to enter a new sample number, then press the [ENTER] key.
(3) When the confirmation message appears, select the [Set] button.
The sample number is changed, and the sample number input attribute becomes “M”.


CHAPTER 4 MAINTENANCE AND SUPPLIES
REPLACEMENT
1. INTRODUCTION ................................................................................... 4-1
2. KX-21N MAINTENANCE CHECKLIST .............................................. 4-2
3. DAILY MAINTENANCE AND PROCEDURE ..................................... 4-4

3.1 Clean TD Chamber and Diluted Sample Line (Shutdown) ......... 4-4
3.2 Check Trap Chamber Level and Discard ..................................... 4-6
4. WEEKLY MAINTENANCE AND PROCEDURE................................. 4-7

4.1 Clean SRV Tray ........................................................................... 4-7
5. MONTHLY MAINTENANCE AND PROCEDURE ............................. 4-9

5.1 Clean Waste Chamber (Rinse Sequence)..................................... 4-9
5.2 Clean Transducer (Rinse Sequence) .......................................... 4-12
6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE ............... 4-16

6.1 Clean Sample Rotor Valve (SRV).............................................. 4-16
6.2 Reset SRV Cycle Counter ......................................................... 4-22
7. AS-NEEDED MAINTENANCE AND PROCEDURE......................... 4-24

7.1 Auto Rinse ................................................................................. 4-24
7.2 Clean Rinse Cup ........................................................................ 4-26
7.3 Clean WBC/RBC Transducer Aperture..................................... 4-28
7.4 Replace Waste Tank ................................................................... 4-32
8. SUPPLIES REPLACEMENT................................................................ 4-33

8.1 Replenish Reagent ..................................................................... 4-33
8.2 Replace Fuse .............................................................................. 4-36
8.3 Replace Printer Paper................................................................. 4-37
8.4 Supplies List .............................................................................. 4-40
9. CONFIRMATION OF CYCLE NUMBER ........................................... 4-41

9.1 Operation Procedure .................................................................. 4-41

MAINTENANCE AND SUPPLIES REPLACEMENT
1. INTRODUCTION
To ensure that the instrument can function in its best state, it is necessary to give scheduled
maintenance. Perform maintenance according to the schedule below and record the result
in the Maintenance Checklist.
• Daily Maintenance
Clean the TD chamber and diluted sample line. (Execute shutdown.)
Check trap chamber level, and discard if necessary.
• Weekly Maintenance
Clean the sample rotor valve (SRV) tray.
• Monthly Maintenance (or Every 2500 Samples)

Clean the waste chamber (rinse sequence).
Clean the transducer (rinse sequence).
• Every 3-Month Maintenance (or Every 7500 Samples)

Clean the sample rotor valve (SRV).
• As-Needed Maintenance
Auto Rinse
Clean the rinse cup.
Clean WBC/RBC transducer aperture.
Replace the waste tank.
This chapter describes supplies replacement together with these maintenance items.
• Supplies Replacement
Replenish reagent.
Replace fuses.
Replace printer paper.

2.
4-2
Daily Maintenance Year: Month:
Day
Maintenance Item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 2122 23 24 25 26 27 28 29 30 31
Execute shutdown
Check trap chamber

level and drain
Signature
Weekly Maintenance As-Needed Maintenance

Week 1 2 3 4 5 Maintenance item Date, Signature Date, Signature
Maintenance Item
Clean sampling valve (SRV) tray Auto rinse
Clean rinse cup

Signature
Clean WBC/RBC transducer aperture
KX-21N MAINTENANCE CHECKLIST
Replace waste tank

Monthly Maintenance
Maintenance item Date, Signature
Supplies Replacement
Clean waste chamber (Rinse sequence)
Maintenance item Date, Signature Date, Signature
Clean transducer (Rinse sequence)
Replenish reagent
Replace fuse
Every 3-Month Maintenance
Replace printer paper
Maintenance item Date, Signature
Clean sample rotor valve (SRV)

Reagent Replenishment Record
LotNo. CELLPACK
Lot No. Date Expiry Signature Lot No. Date Expiry Signature
STROMATOLYSER-WH
Lot No. Date Expiry Signature Lot No. Date Expiry Signature

3. DAILY MAINTENANCE AND PROCEDURE

3.1 Clean TD Chamber and Diluted Sample Line (Shutdown)
By executing shutdown, the transducer chamber and diluted sample line are cleaned. Per-
form shutdown after completion of the day's work, and also at least once every 24 hours
when this instrument is used continuously.
(1) Press [SHUTDOWN] key in the Ready status. The Shutdown screen appears.
*Shutdown*
Ready
Aspirate CELLCLEAN.
3:Cancel
Figure 4-3-1: Shutdown Screen
NOTE: • When [3] key is pressed, shutdown is canceled and the Analysis
screen returns.
(2) In executing shutdown, set CELLCLEAN to the sample probe and press the start
switch in that status. While “Aspirating” is being displayed on the screen, keep
holding CELLCLEAN in the same state.
Start Switch

WARNING • Because CELLCLEAN is a strong alkaline detergent, take care

NOTE: • Once shutdown is executed, it cannot be canceled until completed.
(3) When the buzzer sounds two times - beep, beep, - informing the completion of
aspiration, remove CELLCLEAN from the sample probe. After that, shutdown is
executed automatically.
*Shutdown*
Rinsing
Please wait.
Figure 4-3-3: Shutdown Execution Screen

(4) When shutdown is completed and the following message is displayed, turn off the
power switch on the right side of the unit.
*Shutdown*
Shut-down sequence was completed.

Turn OFF the power.
1:Re-boot
Figure 4-3-4: Shutdown Completion Message Screen
NOTE: • Shutdown will take approximately 5 minutes.

• When the [1] key is pressed, the unit will restart.

3.2 Check Trap Chamber Level and Discard

After completion of analyses for the day, check trap chamber level and discard any liquid
that has collected.
(1) Turn off the power and wait approximately 30 seconds.
(2) Turn the chamber on the left side of the unit counterclockwise and remove.
Trap Chamber Float
Loosen
Figure 4-3-5: Checking the Trap Chamber
(3) After discarding the liquid, mount the chamber. Make sure the float is inside.
WARNING • When discarding the trap chamber liquid, always wear rubber
gloves. After completion of operation, wash hands with disinfec-
tant. If your hands are contaminated by the liquid, infection of
bacteria or the like can occur.
CAUTION • If liquid collects everyday, the hydraulic system may have failed.
Contact Sysmex service representative.
• Pay attention to the direction of the float in the chamber. Place it
with its pointed end facing upward.

4. WEEKLY MAINTENANCE AND PROCEDURE

4.1 Clean SRV Tray
Clean the sample rotor valve (SRV) tray once a week in the following procedure:
WARNING • When cleaning the SRV tray, always wear rubber gloves. After
completion of operation, wash hands with disinfectant. If your
hands are contaminated by blood, etc., infection of bacteria or the
like can occur.
(1) Turn off the power of the main unit and wait approximately 30 seconds.
(2) Open the front cover of the main unit.
(3) Remove the SRV tray.
Probe Fixing Screw
Tray
Figure 4-4-1: Removing the SRV Tray
CAUTION • When removing the tray, take care not to loosen the probe fixing
screw. If analysis is made with the screw loosened, air can enter
the system and affect the data.
(4) Wash the SRV tray using tap water.
Tray
Figure 4-4-2: Washing the SRV Tray

(5) Make sure no contaminants remain, then wipe off water.
(6) Re-mount the SRV tray to the original state.
CAUTION • After mounting the tray, make sure the probe fixing screw is not
loose. If analysis is made with the screw loosened, air can enter
CAUTION: • Mount the SRV tray properly as to the face/bottom and the direc-
tion.
(7) Close the front cover of the main unit.

5. MONTHLY MAINTENANCE AND PROCEDURE

5.1 Clean Waste Chamber (Rinse Sequence)
When the power is turned on, the message is displayed once a month or for every 2500
samples to instruct the scheduled maintenance.
*Scheduled Maint.*
Clean the Waste Chamber.

Cycle No. after cleaning. 2515

Date last serviced 1/12/1999
1:Exec.Clean 3:Cancel
Figure 4-5-1: Scheduled Maintenance Message Screen
When this message appears, press [1] key to select “1: Exec. Clean,” and clean the waste
chamber by the following procedure:
NOTE: • When you press [3] key and select “3: Cancel,” the start-up pro-
cess continues without cleaning the waste chamber. Until the
waste chamber is cleaned, the above message is displayed at
start-up.
• Even when the above message is not displayed, you can execute
the waste chamber cleaning by choosing “7: Maintenance” on the
Select Menu screen, then “1: Clean W. Chamber” on the Mainte-
nance Menu screen.

(1) Press [1] key to select “1: Exec. Clean” on the Scheduled Maintenance Message
screen. The Clean W. Chamber screen will display the message instructing the fol-
lowing operation:
*Clean W.Chamber*
Ready
Aspirate CELLCLEAN

3:Cancel
Figure 4-5-2: Clean W. Chamber Screen
cess continues without cleaning the waste chamber. Until the
waste chamber is cleaned, the above message is displayed at
start-up.
(2) Set CELLCLEAN to the sample probe and press the start switch in that status.
While “Aspirating” is being displayed on the screen, keep holding CELLCLEAN
in the same status.
Start Switch
WARNING • Since CELLCLEAN is a strong alkaline detergent, take care not to

have it adhere to the skin or clothes. If the skin or clothes should
come in touch with it, flush it away using plenty of water. Other-
wise, it can damage the skin or clothes.

(3) When the buzzer sounds two times - beep, beep , - informing completion of aspira-
tion, remove CELLCLEAN from the sample probe. After that, the waste chamber
cleaning is executed automatically.
*Clean W.Chamber*
Please wait.
Figure 4-5-4: Screen during Waste Chamber Cleaning

(4) When the waste chamber cleaning is completed, the auto rinse and background
check are executed, then the system turns to the Ready status.
(5) Check to see that no background error occurs. Should background error occur,
execute the auto rinse.
NOTE: • When this operation is completed, the waste chamber cycle

counter is automatically reset. For the confirmation of waste
chamber cycle number, refer to Section 9: CONFIRMATION OF
CYCLE NUMBER.

5.2 Clean Transducer (Rinse Sequence)

When the power is turned on, the message is displayed once a month or for every 2500
samples to instruct the scheduled maintenance.
*Scheduled Maint.*
Clean the Transducer.


1:Exec. Clean 3:Cancel
When this message appears, press [1] key to select “1: Exec. Clean,” and clean the trans-
ducer by the following procedure:
In addition, the error message of clogging is displayed. Even when the clogging is not
removed, clean the transducer using the same procedure.
cess continues without cleaning the transducer. Until the trans-
ducer is cleaned, the above message is displayed at start-up.
• Even when the above message is not displayed, you can execute
the transducer cleaning by choosing “7: Maintenance” on the
Select Menu screen, then “2: Clean Transducer” on the Mainte-
nance Menu screen.
• If this rinse sequence fails to remove clogging, clean with the
brush. Regarding cleaning with the brush, refer to Section 7.3:
Clean WBC/RBC Transducer Aperture.

(1) Press [1] key to select “1: Exec. Clean” on Scheduled Maintenance Message
screen. Fluid in the transducer is drained and the Clean Transducer screen appears.
*Clean Transducer*
Ready
Pour CELLCLEAN in transducer chamber

and press START switch.

3:Cancel
Figure 4-5-6: Clean Transducer Screen
cess continues without cleaning the transducer. Until the trans-
ducer is cleaned, the above message is displayed at start-up.
(3) Open the transducer cover.
Figure 4-5-7: Opening the Transducer Cover

(4) Using the filler provided with the unit, pour approximately 1 mL each of
CELLCLEAN into the WBC transducer and RBC transducer.
Filler
Figure 4-5-8: Pouring CELLCLEAN
WARNING • Since CELLCLEAN is a strong alkaline detergent, take care not to

CAUTION • Do not pour more than 1 mL of detergent (CELLCLEAN) into the

chamber. It may overflow, possibly causing electric shocks or
leakage.
CAUTION: • Take care not to have detergent (CELLCLEAN) adhere to the

chamber side wall.
(5) Close the transducer cover.

(7) Press the start switch. The transducer cleaning is executed.
*Clean Transducer*
Please wait.
Figure 4-5-9: Screen during Transducer Cleaning
(8) When the transducer cleaning is completed, the auto rinse and background check
are executed, then the system turns to the Ready status.
(9) Check to see that no background error occurs. Should background error occur,
execute the auto rinse.
NOTE: • When this operation is completed, the transducer cycle counter is

automatically reset. For the confirmation of transducer cycle number,
refer to Section 9: CONFIRMATION OF CYCLE NUMBER.

6. EVERY 3-MONTH MAINTENANCE AND PROCEDURE

6.1 Clean Sample Rotor Valve (SRV)
When the power is turned on, the message is displayed once every three months or for
every 7500 samples to instruct the scheduled maintenance.
*Scheduled Maint.*
Clean the SRV.
[1] Reset the cycle counter for SRV,

and you can turn OFF the power.
[3] Continue to start up. SRV cycle
counter will not be reset.
When this message appears, press [1] key to select “1: Exec. Clean,” and reset the cycle
counter. Then clean the sample rotor valve (SRV) by the following procedure:
WARNING • When cleaning the sample rotor valve (SRV), always wear rubber
gloves. After completion of operation, wash hands with disinfec-
tant. If your hands are contaminated by blood, etc., infection of
bacteria or the like can occur.
• Because CELLCLEAN is a strong alkaline detergent, take care
cess continues without cleaning the sample rotor valve (SRV).
Until the sample rotor valve (SRV) is cleaned, the above message
is displayed at start-up.
• When you want to clean before this message appears, or when
you selected “3: Cancel” on the Scheduled Maint. screen and exe-
cuted cleaning when the power was off, reset the cycle counter,
making reference to Section 6.2: Reset SRV Cycle Counter.

(1) Press [1] key to select “1: Exec. Clean” on the Scheduled Maintenance Message
screen. The SRV cycle counter is reset and the unit is ready to be turned off.
*Scheduled Maint.*
SRV cycle counter was reset.
Turn OFF the power.
Figure 4-6-2: Clean SRV Screen
CAUTION: • Before turning the power off, always select “1: Exec. Clean,” mak-
ing the unit ready to be turned off.
(4) Remove the sample rotor valve (SRV) tray.
Probe Fixing Screw
Tray
Figure 4-6-3: Removing the Tray
CAUTION • When removing the tray, take care not to loosen the probe fixing
screw. If analysis is made with the screw loosened, air can enter

(5) Gently push down the rinse cup using both hands. Make sure the rinse cup is
removed completely from the sample probe.
Sample Probe
Rinse Cup
Figure 4-6-4: Pushing Down the Rinse Cup
CAUTION: • If the rinse cup is not completely removed from the sample probe,
there is a possibility that the sample probe may bend when the
sample rotor valve (SRV) is removed.
(6) Remove the SRV fixing screw.
SRV Fixing Screw
Loosen
Figure 4-6-5: Removing the SRV Fixing Screw

(7) Remove the entire sample rotor valve (SRV).
Sample Rotor Valve
Figure 4-6-6: Removing the Entire SRV
CAUTION: • Take care not to pull out the valve excessively. This is to prevent
applying excess force to the tube connected to the valve.
• When removing the valve, take care not to bend the sample
probe.
(8) Remove the rotary valve.
Rotary Valve
Figure 4-6-7: Removing the Rotary Valve
CAUTION • When removing the valve, reagent could leak from the tube. If it
does, wipe it clean using cloth. If left as it is, it can cause current
leakage or electric shocks.
NOTE: • The valve components are in close contact with one another.
They can be easily removed when you gently twist and slide each
one.

(9) Clean the rotary valve using distilled water or 1:10 dilution of CELLCLEAN
detergent. After cleaned with CELLCLEAN, always clean it with distilled water.
(10) Clean the contact surfaces of the fixed and rotary valves using a gauze moistened
with distilled water. By using CELLCLEAN together with distilled water, stuck
objects, dirt, etc. can be removed easily.
Figure 4-6-8: Cleaning the Contact Faces
CAUTION • Take care not to inflict flaws or scratches on valve surfaces, since
flaws or scratches can cause blood leakage and incorrect analy-
sis results.
CAUTION: • Do not use any detergent other than CELLCLEAN. Although the
sample rotor valve (SRV) is corrosion-resistant against
CELLCLEAN, wipe it off completely to prevent troubles to the unit
or other components.
(11) Make sure the valve contact surfaces are completely free from dirt or dust.
CAUTION • If the device is used with dirt or dust attaching on valve contact
surfaces, blood leakage can occur and correct analysis results
may not be obtained.
(12) Install one each valve at a time, and assemble the sample rotor valve (SRV) in the
reverse order to disassembly.

CAUTION: • Mount the rotary valve with the notch facing upward and the metal
knob coming between the stoppers.
Metal Knob
Guide Pin for Rotary Valve
Stopper Groove
(View of Left Side)
Figure 4-6-9: Rotary Valve

• Confirm that the metal knob is between the stoppers. If it is not,
malfunction will occur.
(13) Mount the SRV tray to the original position and gently push up the rinse cup to the
top using both hands.
CAUTION: • Mount the SRV tray properly as to its face/bottom and the direction.
• Make sure the rinse cup is pushed all the way up with the sample
probe inserted in the hole. If the power is turned on with the rinse
cup staying lowered, “Rinse Motor Error” will occur, making it
impossible to continue the operation.
(15) Turn on the main unit and make sure that the background error has not occurred.
(16) Perform quality control and make sure that there is no functional problem.
NOTE: • When this operation is completed, the SRV cycle counter is auto-
matically reset. For confirmation of SRV cycle number, refer to
Section 9: CONFIRMATION OF CYCLE NUMBER.

6.2 Reset SRV Cycle Counter

If you have cleaned the SRV other than the time when instructed on the Scheduled Mainte-
nance screen, always reset the SRV cycle counter manually.
NOTE: • If you continue using the unit without resetting the SRV cycle
counter, the message will instruct you to perform scheduled main-
tenance within three months (or before analyzing 7500 samples).
• For SRV cleaning procedure, refer to Section 6.1: Clean Sample
Rotor Valve (SRV).
(2) Use [ ] key or [ ] key, move the cursor to select “7: Maintenance.”
(3) Press [ENTER] key. The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
Figure 4-6-10: Maintenance Menu Screen
(4) Use [ ] key or [ ] key, move the cursor to select “3: Reset SRV Counter.”

(5) Press [ENTER] key. The Rest SRV Counter screen appears.
*Reset SRV Counter*
[1] SRV cycle counter will be reset.

1:Reset 3:Cancel
Figure 4-6-11: Reset SRV Counter Screen
(6) Press [1] key to select “1: Reset.” “Cycle No. after cleaning” is reset to “0,” the
date of the present day is entered in the “Date last serviced” column, then the Anal-
ysis screen returns.
NOTE: • Press [3] key to select “3: Cancel.” The cycle counter is not reset,
and the Analysis screen returns.
• For confirmation of SRV cycle counter, refer to Section 9: CON-
FIRMATION OF CYCLE NUMBER.

7. AS-NEEDED MAINTENANCE AND PROCEDURE

When the transducer is clogged or the waste tank becomes full, perform the necessary
maintenance.
7.1 Auto Rinse

Execute the Auto Rinse at background check or when the unit has been left idle without
shutdown performed. The Auto Rinse cleans all the lines in the unit and drains all waste.
Background check is also implemented to allow checking whether the unit is in normal
status or not.
(2) Using [ ] key or [ ] key, move the cursor to select “5: Auto Rinse.”
*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
(3) Press [ENTER] key. Auto Rinse and background check are performed.
NOTE: • On the Menu screen, each menu can be selected directly by

entering a numeral from the numeric keys.
*Auto Rinse*
Please wait.
Figure 4-7-2: Auto Rinse Execution Screen

NOTE: • After Auto Rinse, background check is executed. When the back-
ground value of any parameter exceeds tolerance, background
check is repeated a maximum of twice. In case background value
still exceeds tolerance, the message “Background Error” appears
while the alarm starts sounding. Press [HELP] key. This stops
the alarm and the Action Message screen appears. Follow the
Action Message screen and take appropriate action. (Refer to
Chapter 7: TROUBLESHOOTING).
• Background tolerance
WBC 0.3 [×103/µL] or less
RBC 0.02 [×106/µL] or less
HGB 0.1 [g/dL] or less
PLT 10 [×103/µL] or less
Table 4-7-1: Background tolerance

7.2 Clean Rinse Cup

When the rinse cup has any blood on it or is clogged, clean it by the following procedure:
WARNING • When cleaning the rinse cup, always wear rubber gloves. After
like can occur.
(3) Gently push down the rinse cup using both hands. Make sure the rinse cup is
removed completely from the sample probe.
Sample Probe
Rinse Cup
Figure 4-7-3: Pushing Down the Rinse Cup
(4) Remove the rinse cup in the order of 1, 2, and 3 as shown below.
Rinse Cup
Figure 4-7-4: Removing the Rinse Cup

(5) Clean the rinse cup using tap water.
Figure 4-7-5: Cleaning the Rinse Cup
(6) Make sure no contaminant remains on the rinse cup and wipe off water.
(7) Mount the rinse cup in the reverse order of removal. Route the thin tubes around
the rear of the rinse cup.
Rinse Cup
Figure 4-7-6: Mounting the Rinse Cup
(8) Gently push up the rinse cup to the top using both hands.
CAUTION: • Make sure the rinse cup is pushed all the way up with the sample
probe inserted in the hole. If the power is turned on with the rinse
cup staying lowered, “Rinse Motor Error” will occur, making it
impossible to continue the operation.

7.3 Clean WBC/RBC Transducer Aperture

If the transducer aperture clogging persists, clean the transducer aperture using the brush
by the following procedure:
WARNING • When cleaning the aperture, always wear rubber gloves. After
like can occur.
• Since CELLCLEAN is a strong alkaline detergent, take care not to
1. Preparation
(2) Use [ ] key or [ ] key, move the cursor to select “7: Maintenance.”
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
7:Program Version
(4) Use [ ] key or [ ] key, move the cursor to select “4: Drain TD Chamber.”
(5) Press [ENTER] key. Reagent in the transducer chamber is automatically drained.


(6) When reagent in the transducer chamber is drained, the message instructing
turning-off of the power is displayed, which indicates that it is ready for cleaning
with the brush.
*Drain TD Chamber.*
Fluid in T.D.Chamber was drained.

Turn power OFF and dab the aperture
with transducer brush.
See the Operator's Manual.
3:Cancel
Figure 4-7-8: Drain TD Chamber Screen
NOTE: • When you press [3] key, cleaning with brush is canceled and the
Analysis screen returns.
2. Clean Transducer Aperture

(1) Turn off the power and wait approximately 30 seconds.
(3) Loosen the screw and open the transducer cover.
Loosen
Screw
Transducer Cover
Figure 4-7-9: Opening the Transducer Cover
WARNING • When the power is on, never open the transducer cover. This is to
prevent possible electric shocks.

(4) Confirm that reagent in the transducer chamber has been drained.
WBC Transducer
RBC Transducer
Figure 4-7-10: Checking the WBC/RBC Transducer
(5) Remove the transducer chamber plug.
Plug
CAUTION • A small volume of reagent occasionally remains. When reagent

has leaked, wipe it off immediately using wet cloth or the like. If
left as it is, it can cause current leakage or electric shocks.
(6) Apply CELLCLEAN on the brush provided, and dab by lightly prodding the brush
against the transducer aperture.
Aperture
Brush
Figure 4-7-12: Cleaning the Aperture

NOTE: • After using the brush, wash it in water thoroughly to remove

CELLCLEAN before storing it.
(7) Mount the transducer chamber plug.
CAUTION • The transducer chamber plug should be mounted securely.

Otherwise, current leakage or electric shocks can occur.
(8) Close the transducer cover and main unit front cover. Then turn on the power.
(9) Check to see that background error has not occurred.

7.4 Replace Waste Tank

When the waste tank has become full, replace it by the following procedure:
WARNING • When replacing the waste tank, always wear rubber gloves.
After replacing, wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria or the like can
occur.
(2) Make ready an empty waste container and remove the cap.
(3) Pull the tube off the waste container.
(4) Insert the tube in the new waste container and fix it using tape or the like.
Tube
Tape
Waste
Figure 4-7-13: Waste Container
CAUTION • When using a used reagent container as the waste container,

make sure to clearly mark it that it is the waste container.

8. SUPPLIES REPLACEMENT
8.1 Replenish Reagent
When reagent becomes insufficient during analysis, the instrument comes to a stop, while
the screen displays the error message. Press [HELP] key to change to the replenishment
operation.
Error
Message Reagent to
HELP Screen
(Analysis Replenish
Screen)
Replenish CELLPACK
Diluent *Help*
Replenish Diluent Container.

[1] Reaspirating Diluent
ERR CODE:XXXXX.X.X
1:Asp.Reag. 3:Cancel
Replenish STROMATOLYSER-WH
Lyse *Help*
Replenish Lyse Container.

[1] Reaspirating Lyse
ERR CODE:12490.0.0
1:Asp.Reag. 3:Cancel
NOTE: • Press [3] key on the HELP screen and select “3: Cancel” to return
to the Analysis screen. Although Analysis screen displays the Not
Ready status, the processing, etc. of stored data can be per-
formed.

(1) Make ready a new reagent and check to see that expiration date is not passed.
CAUTION • CELLPACK, if used just after delivery via transit, sometimes

develop a background error.
• In handling a reagent that may have frozen, follow the precautions
given on the Package Insert. Otherwise, correct analysis result
may not be obtained.
• Leave the reagent at room temperature (15 - 30°C) for at least 24
hours before using.
• After unpacking, take care to prevent entry of dirt, dust, and bacteria.
CELLPACK 20 L 60 days
STROMATOLYSER-WH 500 mL 90 days
Table 4-8-1: Expiration After Opening the Seal
(2) Remove the cap from the new

reagent bottle.
(3) Remove the cap from the empty

reagent bottle and pull out the
cubitainer spout set straight up.
(4) Insert the cubitainer spout set

straight down into the new reagent
bottle and tighten the cap.
Figure 4-8-1: Pulling Out the Cubitainer

Spout Set
CAUTION • Take care not to grasp the tube dipping into the reagent and not
allow dust, etc. to adhere to the tube. If dust, etc. adheres to the
tube, wash it away with reagent in use before mounting.
Otherwise, correct analysis results may not be obtained.
• Replace only fresh and fully bottled lyse reagent. Old or collected
lyse reagent will affect the analysis results.
• Take care not to spill reagent. If it spills, wipe it off immediately
using wet cloth, etc. to prevent the floor color fading.
• When replacing lyse, you do not need to disconnect the float
switch. If disconnected, connect it securely in prior to starting
analysis. Starting analysis with disconnected float switch will give
you an error message “No Lyse”.

(5) When reagent replenishment is over, follow the instruction on the screen and press
[1] key to select “1: Asp. Reag.” Reagent is automatically aspirated, and then
background check is performed. The check is made here to see that background
error has not occurred.
(6) Enter the contents of replenishment in Reagent Replenishment Record.
NOTE: • If you replenish lyse before error message “No Reagent” appears,
execute “4: Replace Lyse” on the Select Menu screen.

8.2 Replace Fuse

The main unit employs overcurrent protective fuses. When a fuse is blown, replace it by
the following procedure:
(1) Disconnect the power cord on the right side of the main unit.
WARNING • Before replacing the fuse, always turn off the power and discon-
nect the power cord to prevent possible electric shocks.
(2) Pressing the notch upward with a regular screwdriver, remove the fuse cap holder.
Fuse
Fuse Cap Holder

Notch
Figure 4-8-2: Removing the Fuse Cap Holder
(3) Replace the fuse and mount the fuse cap holder.
Specification Part No. Description Fuse Type
117 VAC 266-5109-1 Fuse 250 V 3.15 A ST4-3.15A-N1 Time Lag
220/240 VAC 266-7765-0 Fuse 250 V 2 A 50T020H Time Lag
Table 4-8-2: Fuse Rating
CAUTION • For continued protection against risk of fire, use the fuse of the
specified type and rating.

8.3 Replace Printer Paper

When the “IP paper empty” message appears on the screen, press [HELP] key and replace
printer paper of the built-in printer by the following procedure:
*Help*
IP paper empty
[1] Restarting to print
[3] Stop printing on IP
To make IP on-line,
press [SELECT], then
[Periph. Settings]
ERR CODE:XXXXX.X.X
1:Print 2:Paper Feed 3:Stop Output
Figure 4-8-3: “IP paper empty” Message Screen
NOTE: • On the HELP screen, press [3] and select “3: Stop Output” to
stop printing on built-in printer. Analysis is executed as usual but
printing is not. When you want to use built-in printer again, select
“8: Periph. Settings” to set. (Refer to Chapter 10, Section 11:
PERIPHERAL SETTINGS.)
(2) Turn the release lever up to free the paper.
Release Lever
Figure 4-8-4: Releasing the Lever

(3) Remove the bare paper core and mount a new printer paper.
New Printer Paper
Figure 4-8-5: Mounting a New Printer Paper
NOTE: • When any printer paper remains, remove it together with the
paper core.
(4) Pass the printer paper as shown below, and turn the release lever down to secure.
Figure 4-8-6: Securing the Release Lever

(5) Cut off any printer paper extending from the upper part of the printer.
Figure 4-8-7: Cutting Off Paper
(7) Press [1] key and output any print data that is remaining on the memory.

8.4 Supplies List

1. Reagents List
Product Code Product Name General Name
834-0161-8 CELLCLEAN (50 mL) Detergent
884-0871-1 CELLPACK (20 L) Diluent
974-0521-6 STROMATOLYSER-WH (500 mL × 3) WBC/HGB Lyse
Table 4-8-3: Reagents List
2. Consumable List
Product Code Product Name Chapter & Section for Reference
933-3601-9 TRANSDUCER Chapter 4, Section 7.3: Clean WBC/RBC

BLUSH NO.1 Transducer Aperture.
943-1781-1 CUBITAINER SPOUT Chapter 4, Section 8.1: Replenish Reagent

KIT NO. 1 (20 L) (Replacement of spout kit is suggested if
background count will not drop when dilu-
ent has been replaced.)
973-3041-7 FLOAT SWITCH NO. Chapter 4, Section 8.1: Replenish Reagent

23 ASSY (Replacement of float switch is suggested
if WBC/HGB background count will not
drop when lyse has been replaced.)
266-7765-0 FUSE 250 V, 2 A Chapter 4, Section 8.2: Replace Fuse

50T020H (220/240 VAC Spec.)
266-5109-1 FUSE 250 V, 3.15 A Chapter 4, Section 8.2: Replace Fuse

ST4-3.15A-N1 (117 VAC Spec.)
921-0354-9 PAPER THERMAL Chapter 4, Section 8.3: Replace Printer

F1-2 Paper
(5/BOX) (Heat-Sensitive Paper)
Table 4-8-4: Consumable List
NOTE: • If you need to order supplies or replacement parts, please contact

your local Sysmex representative.

9. CONFIRMATION OF CYCLE NUMBER

To let you know when to perform maintenance, this unit has the functions of cycle No. dis-
play and automatic reset. As to the waste chamber, transducer, and sample rotor valve
(SRV), the next maintenance period is informed in accordance with the operation cycle
No. or date, whichever comes first.
Cleaning of waste chamber Every 2500 cycles or every month
Cleaning of transducer Every 2500 cycles or every month
Cleaning of sample rotor valve (SRV) Every 7500 cycles or every 3 months
Table 4-9-1: Maintenance Timing
Current cycle No. of each item can be checked by the following procedure:
9.1 Operation Procedure

(2) Using [ ] key or [ ] key, move the cursor to select “7: Maintenance.”
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select “5: Status Display.”
(5) Press [ENTER] key. The Status Display screen 1 appears.


(6) Using [ ] key or [ ] key, turn over the page to display the Status Display screen 2.
*Status* WB
Ready
COUNTER 1234567 Cycle No. after cleaning waste chamber
WASTE CHAMBER 2567
DETECTOR 2567 Cycle No. after cleaning transducer
SRV 7567
Cycle No. after cleaning SRV
Change screen with [ ] or [ ].
Figure 4-9-2: Status Display Screen 2
NOTE: • Cycle number is the number of operations after the last mainte-
nance.
• When the power is turn-on and the counter exceeds the predeter-
mined cycle number (or number of days), the message instructing
the maintenance is displayed on the screen. At this time, the
cycle number and the date of the last service are displayed.
*Scheduled Maint.*



CHAPTER 5 QUALITY CONTROL
1. INTRODUCTION ................................................................................... 5-1

1.1 X Control ..................................................................................... 5-1
1.2 Levy-Jennings Control (L-J)........................................................ 5-1
1.3 QC Chart Screen .......................................................................... 5-2
2. QC ANALYSIS PROCEDURE ............................................................... 5-4

2.1 QC Analysis Procedure Flow Chart............................................. 5-4
2.2 Execute QC Program ................................................................... 5-5
2.3 Select QC File .............................................................................. 5-6
2.4 Erase All ...................................................................................... 5-7
2.5 Set TARGET/LIMIT Values ........................................................ 5-8
2.6 Execute X Control...................................................................... 5-10
2.7 Execute L-J Control ................................................................... 5-19
2.8 Exit from QC Control Program ................................................. 5-26
3. DELETION............................................................................................ 5-27
4. EXTERNAL OUTPUT.......................................................................... 5-31

4.1 Printing to Printer....................................................................... 5-31
4.2 Output to Host Computer........................................................... 5-35

QUALITY CONTROL
1. INTRODUCTION
Quality Control checks are performed to monitor an instrument’s performance over time.
EIGHTCHECK-3WP X-TRA is the quality control material recommended by Sysmex to
monitor the performance of the KX-21N analyzer. As the manufacturer, our recommenda-
tion is in accordance with the CLIA standard of 2 levels of control, once everyday of instru-
ment operation or as your laboratory policy dictates. It should be noted that for
troubleshooting purposes, additional control runs may be necessary.
The KX-21N has two quality control methods.
1.1 X Control
In X control, control blood is analyzed twice and the mean of the two is used to evaluate
analyzer performance.
1.2 Levy-Jennings Control (L-J)

The L-J control uses the data from a single control blood analysis to evaluated analyzer
performance.
NOTE: • Selection of the one of the two methods can be performed using
QC method in the QC Settings program. Refer to “Chapter 10,
Section 5: QC SETTINGS.”

QUALITY CONTROL
1.3 QC Chart Screen

When the QC program is executed, the QC File List screen appears first.
Six QC Files are displayed in the file list. Select the QC File used from among that, and
display the QC Chart screen.
The QC Chart can display QC data up to the latest 60 points. When a new data comes in,
the oldest data is erased.
The control parameters indicated in the QC Chart are displayed on multiple pages. [ ]
key or [ ] key can be used to change over the screen.
The Menu Display Area displays “1: QC Analyze,” “2: Settings,” and “3: Erase All.” The
menu can be executed using the numeric keys.
P1. QC Chart Screen [1/8] P2. QC Chart Screen [2/8] P3. QC Chart Screen [3/8]
P8. QC Chart Screen [8/8] P4. QC Chart Screen [4/8]
P7. QC Chart Screen [7/8] P6. QC Chart Screen [6/8] P5. QC Chart Screen [5/8]
Figure 5-1-1: Page Selection in QC Chart Screen
Lot.No. Exp.Date
FILE No.1 [1234567890][07/11/1999]
(N=30) 31/10 LIMIT DATA
(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
Line cursor
1:QC Analyze 2:Settings 3:Erase All
Figure 5-1-2: QC Chart Screen

QUALITY CONTROL
The QC Chart screen displays QC data as shown below:

1) FILE No.
FILE No. of QC Chart displayed on the screen
2) Lot. No.
Lot number set in the QC File.
3) Exp. Data
Expiration date set in the QC File.
4) N
The number of control data plotted currently. In the case of X control, the average
represents a data.
5) Control parameter
Analysis parameters of control data are displayed on multiple pages:
QC Chart screen [1/8]: WBC, RBC, HGB

QC Chart screen [2/8]: HCT, MCV, MCH
QC Chart screen [3/8]: MCHC, PLT
QC Chart screen [4/8]: LYM%, MXD%, NEUT%
QC Chart screen [5/8]: LYM#, MXD#, NEUT#
QC Chart screen [6/8]: RDW-SD, RDW-CV
QC Chart screen [7/8]: MPV
QC Chart screen [8/8]: W-SMV, W-LMV
6) LIMIT (UL)
The upper control limit. An analysis value exceeding this limit is a QC error.
7) LIMIT (LL)
The lower control limit. An analysis value exceeding this limit is a QC error.
8) Target value
QC Target value
9) DATA
The QC data of the plot specified by the vertical line cursor. In the case of X con-
trol, it is the mean value of two consecutive analyses.
10) MEAN
The mean of QC data plotted currently
11) Line Cursor

The vertical line cursor can be moved to the right or left using [ ] key or [ ] key.
The QC data of the plot shown by the line cursor, along with analysis date, are dis-
played.

QUALITY CONTROL
2. QC ANALYSIS PROCEDURE
2.1 QC Analysis Procedure Flow Chart
Execute QC program Page 5-5
Select QC File Page 5-6
YES Erase All QC Data

New QC
Page 5-7
NO
Set TARGET Values/

LIMIT Values
Page 5-8
Execute X Control Execute L-J Control

Page 5-10 Page 5-19
Delete QC Data External Output

Page 5-27 Page 5-31
Exit from QC Program Page 5-26
Figure 5-2-1: QC Analysis Procedure Flow Chart

QUALITY CONTROL
2.2 Execute QC Program

(2) Using [ ] key or [ ] key, move the cursor to select “2: Quality Control.”
(3) Press [ENTER] key. The QC File List screen appears.
*Quality Control*
Lot.No. Exp.Date
1 : [1234567890][07.11.1999]
2 : [1234567891][14.11.1999]
3 : [1234567892][21.11.1999]
4 : [1234567893][28.11.1999]
5 : [1234567894][01.12.1999]
6 : [1234567895][06.12.1999]
Figure 5-2-2: QC File List screen

QUALITY CONTROL
2.3 Select QC File

This instrument stores six QC Files. To execute QC analysis, settings, file erasing, or HC
output, display the QC Chart screen for a desired file as follows.
How to Select QC File

(1) Using [ ] key or [ ] key to move the cursor on the QC File List screen, and
select a QC file to be selected.
(2) Press [ENTER] key. The QC Chart screen for the selected QC file appears.
NOTE: • The QC File can be selected directly by inputting file number of

the QC File with numeric keys.
• Press [SELECT] key to return from the QC Chart screen to the
QC File List screen.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)

QUALITY CONTROL
2.4 Erase All

To start quality control newly, the control data in the QC File has to be erased. When a
control blood lot has changed, use the menu of “3: Erase All” to erase all control data in
the QC File.
How to Erase All QC Data

(1) Display the QC Chart screen for the QC File you want to erase.
For how to select the QC File, refer to Section 2.3: Select QC File in this chapter.
(2) Press [3] key to select “3. Erase All.” The Erase All Confirmation message appears.
OK to erase all? Yes No
Figure 5-2-4: Erase All Confirmation Message
(3) Using [ ] key or [ ] key, move the cursor to select “Yes” or “No.”
[Yes]: Erases the plot display on the QC Chart screen and displays the second
Erase All Confirmation message.
[No]: Cancels the erasing of the plot display on the QC Chart screen and
returns to the QC Chart screen.
All are erasing. Execute Cancel
Figure 5-2-5: Second Erase All Confirmation Message
(4) Using [ ] key or [ ] key, move the cursor to select “Execute” or “Cancel.”
[Execute]: Completely erases QC data and returns to the QC Chart screen.
[Cancel]: Cancels QC data erase and returns to the QC Chart screen.

QUALITY CONTROL
2.5 Set TARGET/LIMIT Values

Before executing Quality Control anew, you have to set TARGET and LIMIT values for
the QC File using “2: Settings” on the menu. Also, the lot number and the expiration date
of the control blood can be registered at the same time as setting these.
How to Set QC File

(1) Display the QC Chart screen for the QC File you want to set.
For how to select the QC File, refer to Section 2.3: Select QC File in this chapter.
(2) Press [2] key to select “2: Settings.”

The QC File Setting screen appears.
FILE No.1
Lot.No [ ]
Exp.Date [ ]
TARGET LIMIT
WBC 0.0 0.0 ×103/µL
RBC 0.00 0.00 ×106/µL
HGB 0.0 0.0 g/dL
HCT 0.0 0.0 %
MCV 0.0 0.0 fL
MCH 0.0 0.0 pg
MCHC 0.0 0.0 g/dL
PLT 0 0 ×103/µL
Press [SELECT] to exit.
Figure 5-2-6: QC File Setting Screen
(3) Move the cursor with [ ] key or [ ] key, and select Lot.No. (lot number),
Exp.Date (expiration date) or the control parameter.
Move the cursor with [ ] key or [ ] key, and select TARGET or LIMIT in the
control parameter.
NOTE: • There are 19 control parameters, but all the control parameters
cannot be listed in one screen, so scroll the screen with [ ] key
or [ ] key.

QUALITY CONTROL
(4) Enter the set values using the numeric keys.
NOTE: • Each time you press [C] key in the middle of entering, one charac-
ter disappears and the cursor moves to the left.
For setting the lot number
• The Lot number can be input up to 10 digits.
• Also, the lot number can be input with the hand held barcode
reader (option).
For setting the expiration date
• The expiration date can be input up to 10 digits.
• Even if the expiration date is input, processing which judging the
date in the program is not carried out.
This is just a memo input for managing the QC File.
For setting the control parameter
• As a set value, up to five digits including decimal point can be
entered.
• The decimal point position is linked to the Unit System estab-
lished in System Setup. For detail, refer to Chapter 10, Section 2:
SYSTEM SETUP.
(5) Press [ENTER] key.

The contents of settings are set and the cursor moves to the next item.
NOTE: • The contents of settings are also set when [ ] key, [ ] key, [ ]
key, or [ ] key is pressed after entering.
(6) When settings are completed, press [SELECT] key. The Setting Confirmation
message appears.
Figure 5-2-7: Setting Confirmation Message
(7) Using [ ] key or [ ] key, move the cursor to select “Cont.,” “Set,” or “Cancel.”
[Cont.]: Returns to the QC File Setting screen. And the setting operation can
be continued.
[Set]: Updates the settings and returns to the QC Chart screen.
[Cancel]: Cancels the changed settings and returns to the QC Chart screen.
NOTE: • QC chart will be drawn only if the TARGET and LIMIT values are
both entered appropriately.

QUALITY CONTROL
2.6 Execute X Control

The X control method for analyzing control blood is described here.
(1) Display the QC Chart screen for the QC File in which to enter QC data. For how
to select the QC File, refer to Chapter 2.3: Select QC File in this chapter.
NOTE: • QC analysis is executed by control method (X control or L-J con-

trol) set in QC Settings. For setting procedures, refer to Chapter
10, Section 5: QC SETTINGS.
• While the X Control Analysis screen is displayed, the QC File can-
not be changed.
(2) Press [1] key to select “1: QC Analyze.” The X Control Analysis screen appears.
FILE No.1 QC
Ready
X1 X2 X Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
Figure 5-2-8: X Control Analysis Screen
NOTE: • QC analysis is made in the whole blood mode. When the pre-
diluted mode is selected as analysis mode, the Mode Change
Sequence is activated to change over to the whole blood mode.
(3) Confirm that “Ready” is displayed for QC analysis.
WARNING • In analyzing control blood, always wear rubber gloves. After com-
pletion of work, wash the hands with disinfectant. If your hands
are contaminated by blood, etc., infection of pathogenic bacteria
can occur.

QUALITY CONTROL
(4) Mix control blood according to the package insert.
Figure 5-2-9: Mixing the Control Blood
(5) Remove the cap while taking care not to allow blood to scatter.
Figure 5-2-10: Removing the Cap
(6) Set the control blood container to the sample probe and press the start switch in
that status.
Start Switch
(7) When the buzzer sounds two times - beep, beep, - and “Analyzing” is displayed on
the X Control Analysis screen, remove the control blood container. Then, auto-
matic analysis is executed.

QUALITY CONTROL
The screens from the start to the end of analysis are as shown below.
(Ready)
FILE No.1 QC
Ready
(Aspirating)
FILE No.1 QC
Aspirating
(Analyzing)
FILE No.1 QC
Analyzing
(Rinsing)
FILE No.1 QC
Rinsing
Figure 5-2-12: X Control Analysis Screen
CAUTION • While the screen is displaying “Aspirating,” keep holding the con-
trol blood container in the aforementioned status. If the container
is removed during its display, correct analysis may not be
obtained.
CAUTION: • Several seconds after the buzzer sounds “beep, beep” and “Ana-
lyzing” appears on the screen, the rinse cup lowers. Remove the
control blood container by that time.
• To remove the container, lower it straight down. Take care not to

wipe it clean.

QUALITY CONTROL
(8) Under the “X1” column on the Analysis Result screen, the 1st time analysis result
is displayed.
The analysis result comprises three screens which can be changed over by pressing
[ ] key or [ ] key.
P1. CBC8 Parameter Screen P2. WBC Screen P3. RBC/PLT Screen
Figure 5-2-13: Page Selection in QC Analysis Result Screen
FILE No.1 QC
X1 X2 X Judgement
WBC 7.3
RBC 4.52
HGB 14.8
HCT 36.2
MCV 80.1
MCH 32.7
MCHC 40.9
PLT 206
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-14: P1. CBC8 Parameter Screen
FILE No.1 QC
No.QC01-1 31/12 10:02

WBC 7.3×103/µL
WBC LYM% 27.2%
MXD% 13.4%
NEUT% 59.4%
LYM# 2.0×103/µL
MXD# 1.0×103/µL
NEUT# 4.3×103/µL
W-SMV 56.3fL
Accept Data? W-LMV 172.4fL
1:OK 2:NG 3:Print
Figure 5-2-15: P2. WBC Screen
FILE No.1 QC
No.QC01-1 31/10 10:02

RBC 4.52×106/µL
RBC MCV 80.1fL
RDW-SD 27.4fL
RDW-CV 11.4%
PLT
PLT 206×103/µL
PDW 8.3fL
MPV 9.1fL
P-LCR 14.8%
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-16: P3. RBC/PLT Screen

QUALITY CONTROL
If the data is acceptable, press [1] key to confirm. Press [2] key to reject.
Press [3] key and select “3: Print” to print the contents of analysis result on the
built-in printer.
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.3 ×103/µL

RBC 4.52 ×106/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103/µL
WBC
[fl]
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RBC
[fl]
RDW-SD 27.4 fL
RDW-CV 11.4 %
PLT
[fl]
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-17: Example of Analysis Result Printing
NOTE: • Print of analysis result is valid until the data is set. If the data is
set by pressing [1] key or [2] key, analysis result cannot be
printed.
• This print format cannot be changed since it is the special format
for QC analysis.

QUALITY CONTROL
(9) Set the data using [1] key or [2] key.

[1: OK]: Accepts analysis result as the 1st time QC data. And the system turns to
be ready for the 2nd analysis.
[2: NG]: Cancels the 1st time analysis result. And the system remains to be ready
for another 1st time analysis.
CAUTION: • When an error occurs during QC analysis, error message is dis-

played in the system status area.
Press [HELP] key and perform the error recovery process. For
the error recovery process, refer to Chapter 7: TROUBLESHOOT-
ING.
When you press [SELECT] key before setting the 1st QC data, the QC Cancel
Confirmation message is displayed.
OK to cancel? Yes No
Figure 5-2-18: QC Cancel Confirmation Message
Using [ ] key or [ ] key, move the cursor to select “Yes” or “No.”

[Yes]: Rejects analysis result, exits from QC program, and returns to the Analysis
screen.
[No]: Returns to the QC Analysis screen and allows continuous QC analysis.
Press [ENTER] key to execute the selected process.
(10) When the 1st analysis data is accepted, the (3) - (7) procedure is repeated for the
2nd analysis.
(11) The 2nd analysis result is displayed under “X2” on the Analysis Result screen, the
mean values of the 1st and the 2nd analyses under “X,” and the comparison result
with control limits under the “Judgment” column.
The Analysis Result screen, as in the 1st analysis, can be changed over using [ ]
key or [ ] key.
The data confirmation message is displayed and you are asked to decide whether
or not to accept the analysis result as QC data.

QUALITY CONTROL
FILE No.1 QC
X1 X2 X Judgement
WBC 7.3 7.5 7.4
RBC 4.52 4.49 4.51
HGB 14.8 14.7 14.8
HCT 36.2 35.6 35.9
MCV 80.1 79.3 79.7
MCH 32.7 32.7 32.7
MCHC 40.9 41.3 41.1
PLT 206 209 208
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-19: Analysis Result Screen
A parameters in which the mean of the 1st and the 2nd analyses fell outside the
control limits is indicated with or - under the “Judgment” column, while the
alarm sounds and the QC error message appears.
FILE No.1 QC QC Error
X1 X2 X Judgement
WBC 7.3 7.5 7.4
RBC 4.52 4.49 4.51
HGB 14.8 14.7 14.8
HCT 42.5 43.0 42.8 +
MCV 94.0 95.8 94.9 +
MCH 32.7 32.7 32.7
MCHC 34.8 34.1 34.5 -
PLT 106 109 108 -
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-20: QC Error Message Screen

[1: OK]: QC data is accepted and the plot is entered to the QC Chart. This QC
data (mean) is kept in the stored data also.
[2: NG]: Cancels the 2nd analysis result. And the system remains to be ready for
the 2nd analysis again.
CAUTION: • When an error occurs during QC analysis, the error message

appears in the system status area.
Press [HELP] key and perform the error recovery process. For the
error recovery process, refer to Chapter 7: TROUBLESHOOTING.

QUALITY CONTROL
(13) The set data (mean) is printed on the built-in printer.
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.4 ×103/µL

RBC 4.51 ×106/µL
HGB 14.8 g/dL
HCT 35.9 %
MCV 79.7 fL
MCH 32.7 Pg
MCHC 41.1 g/dL
PLT 208 ×103/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-21: Example of Printing
NOTE: • Printing in QC settings is valid only when the “Built-in Printer” is

selected. For detail, refer to Chapter 10, Section 5: QC SETTINGS.
for QC analysis.
(14) The set data (mean) is output to the host computer.
NOTE: • Transmission to the host is valid only when the “Host Output” is
• As to the host output format, refer to Appendix B: TECHNICAL
INFORMATION.

QUALITY CONTROL
When you press [SELECT] key before setting the 2nd QC data, the QC Cancel
Confirmation message appears.

[Yes]: Rejects analysis result, exists from the QC program, and returns to the
Analysis screen.

QUALITY CONTROL
2.7 Execute L-J Control

How to analyze control blood by L-J control is described here.
(1) Display the QC Chart screen for the QC File in which to enter QC data. For how
to select the QC File, refer to Chapter 2.3: Select QC File in this chapter.
NOTE: • QC analysis is executed by control method (X control or L-J con-

trol) set in QC Settings. For setting procedures, refer to Chapter
10, Section 5: QC SETTINGS.
• While the L-J Control Analysis screen is displayed, the QC File
cannot be changed.
(2) Press [1] key to select “1: QC Analyze.” The L-J Control Analysis screen appears.
FILE No.1 QC
Ready
Data Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
Figure 5-2-23: L-J Control Analysis Screen
NOTE: • QC analysis is made in the whole blood mode. When the pre-
diluted mode is selected as analysis mode, the Mode Change
Sequence is activated to change over to the whole blood mode.
(3) Confirm that “Ready” is displayed for QC analysis.
WARNING • In analyzing control blood, always wear rubber gloves. After

completion of work, wash the hands with disinfectant. If your
hands are contaminated by blood, etc., infection of pathogenic
bacteria can occur.

QUALITY CONTROL
(4) Mix control blood according to the package insert.
Figure 5-2-24: Mixing the Control Blood
(5) Remove the cap while taking care not to allow blood to scatter.
Figure 5-2-25: Removing the Cap
(6) Set the control blood container to the sample probe and press the start switch in
that status.
Start Switch
(7) When the buzzer sounds two times - beep, beep, - and “Analyzing” is displayed on
the L-J Control Analysis screen, remove the control blood container. Then, auto-
matic analysis is executed.

QUALITY CONTROL
The screens from the start to the end of analysis are as shown below.
(Ready)
FILE No.1 QC
Ready
(Aspirating)
FILE No.1 QC
Aspirating
(Analyzing)
FILE No.1 QC
Analyzing
(Rinsing)
FILE No.1 QC
Rinsing
Figure 5-2-27: L-J Control Analysis Screen
CAUTION • While the screen is displaying “Aspirating,” keep holding the con-
trol blood container in the aforementioned status. If the container
is removed during its display, correct analysis may not be
obtained.
CAUTION: • Several seconds after the buzzer sounds “beep, beep” and “Ana-
lyzing” appears on the screen, the rinse cup lowers. Remove the
control blood container by that time.
• To remove the container, lower it straight down. Take care not to

wipe it clean.

QUALITY CONTROL
(8) Analysis result is given under the “Data” column on the Analysis Result screen
and comparison result with QC limits under the “Judgment” column.
The analysis result comprises three screens which can be changed over by pressing
[ ] key or [ ] key.
P1. CBC8 Parameter Screen P2. WBC Screen P3. RBC/PLT Screen
Figure 5-2-28: Page Selection in QC Analysis Result Screen
FILE No.1 QC
Data Judgement
WBC 7.3
RBC 4.52
HGB 14.8
HCT 36.2
MCV 80.1
MCH 32.7
MCHC 40.9
PLT 206
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-29: P1. CBC8 Parameter Screen
FILE No.1 QC
No.QC01-1 31/10 10:02

WBC 7.3×103/µL
WBC LYM% 27.2%
MXD% 13.4%
NEUT% 59.4%
LYM# 2.0×103/µL
MXD# 1.0×103/µL
NEUT# 4.3×103/µL
W-SMV 56.3fL
Accept Data? W-LMV 172.4fL
1:OK 2:NG 3:Print
Figure 5-2-30: P2. WBC Screen
FILE No.1 QC
No.QC01-1 31/10 10:02

RBC 4.52×106/µL
RBC MCV 80.1fL
RDW-SD 27.4fL
RDW-CV 11.4%
PLT
PLT 206×103/µL
PDW 8.3fL
MPV 9.1fL
P-LCR 14.8%
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-31: P3. RBC/PLT Screen

QUALITY CONTROL
As to those parameters whose analysis fell beyond control limits, or - is dis-

played under the “Judgment” column, while the alarm sounds with the QC error
message displayed.
FILE No.1 QC QC Error
Data Judgement
WBC 7.5
RBC 4.49
HGB 14.7
HCT 43.0 +
MCV 95.6 +
MCH 32.7
MCHC 34.1 -
PLT 109 -
Accept Data?
1:OK 2:NG 3:Print
Figure 5-2-32: QC Error Message Screen
If the data is acceptable, press [1] key to confirm. Press [2] key to reject.
Press [3] key and select “3: Print” to print the contents of analysis result on the
built-in printer.

QUALITY CONTROL
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.3 ×103/µL

RBC 4.52 ×106/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103/µL
WBC
[fl]
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RBC
[fl]
RDW-SD 27.4 fL
RDW-CV 11.4 %
PLT
[fl]
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-33: Example of Analysis Result Printing
CAUTION: • Print of analysis result is valid until the data is set. If the data is
set by pressing [1] key or [2] key, analysis result cannot be
printed.
for QC analysis.

[1: OK]: Sets QC data, and the plot is entered to the QC Chart. This QC data is
kept in the stored data.
[2: NG]: Cancels the analysis result, and the system remains to be ready for
another analysis.

QUALITY CONTROL
CAUTION: • When an error occurs during QC analysis, error message is dis-

played in the system status area.
Press [HELP] key and perform the error recovery process. For the
error recovery process, refer to Chapter 7: TROUBLESHOOTING.
(10) The set data is printed on the built-in printer.
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.4 ×103/µL

RBC 4.51 ×106/µL
HGB 14.8 g/dL
HCT 35.9 %
MCV 79.7 fL
MCH 32.7 Pg
MCHC 41.1 g/dL
PLT 208 ×103/µL
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
Figure 5-2-34: Example of Printing
NOTE: • Printing in QC settings is valid only when the “Built-in Printer” is

for QC analysis.
(11) The set data is output to the host computer.
NOTE: • Transmission to the host is valid only when the “Host Output” is
• As to the host output format, refer to Appendix B: TECHNICAL
INFORMATION.

QUALITY CONTROL
When you press [SELECT] key before setting the QC data, the QC Cancel Confir-
mation message appears.

[Yes]: Rejects analysis result, exist from the QC program, and returns to the
Analysis screen.
2.8 Exit from QC Control Program

(1) Press [SELECT] key on the QC Chart screen. The QC File List screen returns.
(2) Press [SELECT] key. The Analysis screen returns.
NOTE: • The sample No. and analysis mode on the Analysis screen return
to those displayed before execution of the QC program.

QUALITY CONTROL
3. DELETION
This menu can delete one data or the range specified data of QC data in the line cursor
position.
How to delete QC Data (Deletion only of one data)

(1) Display the QC Chart screen of QC file that contains the data you want to delete.
For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be
deleted.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)

The line cursor changes from dotted line to solid line, and the menu in the Menu
Display Area changes over to “1: Delete,” “2: Output,” “3: RangeSpec.”.
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and
the menu in the Menu Display Area change to the original status.
• The line cursor that has changed to solid line cannot be moved.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
1:Delete 2:Output 3:RangeSpec.
Figure 5-3-2: QC Chart Screen (At Data Selection)

QUALITY CONTROL
(4) Press [1] key to select “1: Delete.”

The Deletion confirmation message appears.
OK to Delete? Yes No
[Yes]: Deletes QC data of the plot shown by the line cursor and returns the line
cursor to the dotted line.
[No]: Cancels deletion of QC data and returns the line cursor to the dotted line.
How to delete QC Data (Deletion of range specified data)

(1) Display the QC Chart screen of QC file that contains the data you want to delete.
(2) Using [ ] key or [ ] key, move the line cursor to the end of the data within the
deleted range.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)

QUALITY CONTROL

FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
(4) Press [3] key to select “3: RangeSpec.”.

Move the line cursor of the dotted line for range specification of the other end.
(5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within
the deleted range.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
Figure 5-3-6: QC Chart Screen (At Data Range Specification)

The line cursor changes from dotted line to solid line.

QUALITY CONTROL
(7) Press [1] key to select “1: Delete.”

The Deletion confirmation message appears.
OK to Delete? Yes No
[Yes]: Deletes QC data of the plot shown by two line cursors and returns the line
cursor to the dotted line.
[No]: Cancels deletion of QC data and returns the line cursor to the dotted line.

QUALITY CONTROL
4. EXTERNAL OUTPUT
Using this menu, QC data in the line cursor position can be printed out from the built-in/
external printer or output to the host computer. (The external printer is an option).
4.1 Printing to Printer

How to print QC Data
(1) Display the QC Chart screen of QC file that contains the data you want to print.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be
printed.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)

QUALITY CONTROL

FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)

the printing range.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)


QUALITY CONTROL

1:Host
2:DP
3:GP
4:LP
5:IP
6:IP Feed
7:StopOutput
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to 4.2: Output to
Host Computer in this chapter.
[2: DP]: This cannot be selected.
[3: GP]: The graphic printer starts graphic printing the QC data of the
plot which the line cursor shows.
[4: LP]: The graphic printer starts list printing the QC data of the plot
which the line cursor shows.
[5: IP]: The built-in printer starts printing the QC data of the plot which
the line cursor shows.
[7: StopOutput]: When two or more analysis data are output, this can be selected,
and the output will be interrupted when you select this.
When the print to the printer is completed, the line cursor returns to the dotted line,
and the menus of the menu display area returns to “1: QC Analyze”, “2: Settings”
and “3: Erase All.”
Contents of print with built-in printer
No. QC01-01 File No.

Date 31/10/1999 Date Analyzed
Time 10:02 Time Analyzed
Analysis Mode Mode QC
WBC 7.3 ×103/µL

RBC 4.52 ×106/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103/µL
Figure 5-4-5: Contents of print with built-in printer

QUALITY CONTROL
Contents of graphic print with graphic printer
Print Date 31/10/1999 page( 1)

Print Time 10:26
File No.1 Lot.No.[1234567890] Exp.Date[07.11.1999]

7/10/1999 - 30/10/1999(N=60)
Target/Limit Mean SD CV%
UL 8.1
WBC 7.6 7.8 7.3 0
LL 7.1
UL 4.70
PBC 4.50 4.55 4.52 0
LL 4.30
UL 15.5
HGB 15.0 15.0 14.8 0
LL 14.0
....
Figure 5-4-6: Contents of graphic print with graphic printer
Contents of list print with graphic printer

This is printed by the same format as the stored data list print.
Refer to Chapter 3, Section 3.4: External Output.
1) File No.
File No. of QC file is printed.
2) Analysis Mode
In the case of QC data, “QC” is printed.
Printed is the date and time when analysis result was obtained.

QUALITY CONTROL
4.2 Output to Host Computer

Using this menu, QC data in the line cursor position can be output to the host computer
(option).
How to output QC Data to HC

(1) Display the QC Chart screen of QC file that contains the data you want to output to
the host computer.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data you
want to output to HC.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)

QUALITY CONTROL

FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)

the output range.
FILE No.1 [1234567890][07/11/1999]

(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)


QUALITY CONTROL

1:Host
2:DP
3:GP
4:LP
5:IP
6:IP Feed
7:StopOutput
QC data of the plot shown by the line cursor is output to the host computer.
NOTE: • For the output format, refer to Appendix B: TECHNICAL INFOR-

MATION.

QUALITY CONTROL

CHAPTER 6 CALIBRATION
1. INTRODUCTION ................................................................................... 6-1

1.1 Calibration ................................................................................... 6-1
1.2 Calibrator Calibration Program ................................................... 6-1
2. PREPARATION FOR CALIBRATION .................................................. 6-2

2.1 Precision Check ........................................................................... 6-2
2.2 Precision Check Sample .............................................................. 6-2
2.3 HGB/HCT Calibration Samples .................................................. 6-3
2.4 Reference Values.......................................................................... 6-3
2.4.1 Calibrator Calibration ...................................................... 6-3
2.4.2 HGB/HCT Calibration..................................................... 6-3
2.5 Calibration Flow Chart ................................................................ 6-4
3. AUTOMATIC CALIBRATION............................................................... 6-5

3.1 Executing Automatic Calibration Program.................................. 6-5
3.2 Automatic Calibration Procedure ................................................ 6-6
4. MANUAL CALIBRATION .................................................................. 6-11

4.1 Calculating Calibration Value .................................................... 6-11
4.2 Manual Calibration Procedure ................................................... 6-12
5. CALIBRATOR CALIBRATION........................................................... 6-15

5.1 Executing Calibrator Calibration Program ................................ 6-15
5.2 Calibrator Calibration Procedure ............................................... 6-17
6. CALIBRATION HISTORY PRINT ...................................................... 6-25
Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.
CALIBRATION
1. INTRODUCTION
Upon installation of the KX-21N, the Sysmex trained service representative will perform
instrument calibration. Calibration is required at installation, and then calibration is veri-
fied at least daily with QC material.
This chapter covers procedures necessary to calibrate the instrument for WBC (white
blood cell count), RBC (red blood cell count), HGB (hemoglobin), HCT (hematocrit) and
PLT (platelet count). WBC differential parameters are calibrated at the factory prior to
shipment and are verified by the Sysmex representative at installation. They do not need
to be calibrated at the laboratory.
1.1 Calibration
It is recommended that the laboratory performs calibration when any of the following
occurs:
• Major preventative maintenance has been performed or critical parts replaced such as
manometers apertures or detector circuit boards.
• Controls that reflect an unusual trend or are outside of acceptable limits, and cannot
be corrected by maintenance or troubleshooting the instrument.
• The Sysmex trained service representative has advised to calibration.
1.2 Calibrator Calibration Program

Calibrate the WBC, RBC, HGB, HCT and PLT of the KX-21N using the SCS-1000 cali-
brator. The calibration program consists of the following two functions.
(1) Precision Check

Using fresh human blood, the instrument reproducibility is checked against manu-
facturer's specifications for precision.
(2) Calibration
Using the SCS-1000 calibrator, the instrument calibration is checked and recalibra-
tion is performed as required.
NOTE: • Do not use EIGHTCHECK-3WP for calibration. It is used for qual-

ity control. Calibration should be performed at the room tempera-
ture within 25±5°C.

CALIBRATION
2. PREPARATION FOR CALIBRATION

2.1 Precision Check
Analyze a fresh human blood 11 times consecutively in the whole blood mode.
The system program automatically discards the first analysis and calculates the precision
(reproducibility) with the remaining 10 data.
The following has to be verified prior to starting the precision check:
• Transducer apertures are clog free. If not, perform the aperture cleaning procedures
by referring to Chapter 4.
• Check if the reagent volume in each reagent container is enough to complete the cali-
bration procedure.
• Check if the reagent is within the expiration date.
• If a waste container is used, check if the waste container has enough room to complete
the calibration procedure.
• Check if the background values fall within the following ranges;
WBC ≤ 0.3 × 103/µL
RBC ≤ 0.02 × 106/µL
HGB ≤ 0.1 g/dL
PLT ≤ 10 × 103/µL
2.2 Precision Check Sample

One sample of fresh normal whole blood should be used for the precision check. The
sample should be analyzed within six hours of collection and stored at room temperature.
Observe the following recommendations when selecting blood for precision check pur-
poses.
• The sample should be collected from a person who is not on medication.

• The sample should be morphologically and numerically normal, as;
WBC ≥ 4.00 × 103/µL
RBC ≥ 4.00 × 106/µL
PLT ≥ 100 × 103/µL
• Lipemic, icteric, and hemolyzed specimens must be avoided.
• The anticoagulant should be the proper type and in proportion with the sample.
• The volume of whole blood per sample should be greater than 2 mL (smaller volumes
may indicate poor sample collection and increase the risk of hemolysis or have incor-
rect anticoagulant proportions).
NOTE: • Do not use the control blood for precision check. System program
for the precision check is designed to analyze human blood.

CALIBRATION
2.3 HGB/HCT Calibration Samples

Five to ten samples of fresh normal whole blood should be used for the HGB/HCT calibra-
tion. The samples should be analyzed within six hours of collection and kept at room tem-
perature. Observe the following recommendations when selecting blood for HGB/HCT
calibration purposes.
• Blood of a healthy person who is not taking any medicine

• Blood added with appropriate anticoagulant
• Per-sample whole blood volume to exceed 2 mL
• HGB value to exceed 10.0 g/dL
• HCT value to be within 35.5% - 55.5%
NOTE: • For calibration, do not use EIGHTCHECK-3WP, which was not

prepared for calibration but for the use as control blood.
2.4 Reference Values

2.4.1 Calibrator Calibration
The Assay Target values provided for each calibrator will be the reference values for Cali-
brator calibration samples.
2.4.2 HGB/HCT Calibration

Five or more normal blood samples prepared for calibration of HGB and HCT should be
accurately analyzed three times each in accordance with the reference method. The mea-
surements thus obtained are used as reference values.
HGB values: Cyanmethemoglobin method
HCT values: Microhematocrit method
(Five samples are used for automatic calibration.)
NOTE: • HGB reference value will be influenced by WBC count, diluent,

lyse reagent, HGB light source, temperature, and etc.
• HCT reference value decreases significantly due to excessive
anticoagulant.

CALIBRATION
2.5 Calibration Flow Chart
HGB/HCT calibration start Calibrator calibration start
Analyze samples by the reference method to determine

reference value (target value).
Automatic calibration: 5 samples
Manual calibration: Over 5 samples
Page 6-3
Automatic Manual
calibration calibration
Select automatic Select calibrator

calibration Analyze in whole calibration
program. Page 6-5 blood mode. Page 6-11 program. Page 6-15
Select calibration parameter. Calculate calibration

1: HGB value. Precision check
2: HGB and HCT Page 6-11 Page 6-17
3: HCT
Page 6-6
Select manual
calibration Enter assay target
Page 6-12 value.
Enter target value. program. Page 6-19
Page 6-7
Analyze in
Enter calibration
Analyze in whole calibrator
value. Page 6-13 analysis mode. Page 6-22
blood mode.
Page 6-8
Update calibration Update calibration Update calibration

value. Page 6-10 value. Page 6-14 value. Page 6-24
Completion of HGB/HCT calibration Completion of calibrator calibration

CALIBRATION
3. AUTOMATIC CALIBRATION
In automatic calibration, five or more fresh, normal blood samples are used for automatic
calibration of HGB and HCT values.
3.1 Executing Automatic Calibration Program

(2) Using [ ] or [ ] key, move the cursor to select “3: Calibration.”
(3) Press [ENTER] key. The Calibration Menu screen appears.
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
Figure 6-3-1: Calibration Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select “1: Auto Cal.”
(5) Press [ENTER] key. The Automatic Calibration Menu screen appears.
*Auto Cal.*
1:HGB
2:HGB/HCT
3:HCT
Figure 6-3-2: Automatic Calibration Menu Screen
On the Automatic Calibration Menu screen, an automatic calibration parameter can be

selected from among “1: HGB,” “2: HGB/HCT,” and “3: HCT.”
NOTE: • Each menu can be selected directly by entering a numeral from

the numeric keys.

CALIBRATION
3.2 Automatic Calibration Procedure
1. Selecting Automatic Calibration Parameter

(1) Using [ ] or [ ] key, move the cursor to select an automatic calibration parame-
ter on the Automatic Calibration Menu Screen:
[1: HGB]: Calibrates HGB alone.
[2: HGB/HCT]: Calibrates two parameters of HGB and HCT at the same time.
[3: HCT]: Calibrates HCT alone.

the numeric keys.

The Automatic Calibration screen for the selected parameter appears.
*Auto Cal.*
Target Data Compensation
HGB HGB HGB
1
2
3
4
5
Current Cal.(%)100.0
New Cal.(%)
Press [SELECT] to Set.
Figure 6-3-3: HGB Automatic Calibration Screen
*Auto Cal.*
HGB HCT HGB HCT HGB HCT
1
2
3
4
5
Current Cal.(%)100.0 100.0

New Cal.(%)
Figure 6-3-4: HGB/HCT Automatic Calibration Screen

CALIBRATION
*Auto Cal.*
HCT HCT HCT
1
2
3
4
5
Current Cal.(%)100.0
New Cal.(%)
Figure 6-3-5: HCT Automatic Calibration Screen
2. Entering Target Values

(1) Using the numeric keys, enter the HGB or HCT reference values obtained by the
reference method in the target column.
NOTE: • Press [C] key to delete one letter at a time.
(2) Press [ENTER] key to fix the entered value and move the reverse display to the
next target column.
*Auto Cal.*
1 12.5
2
3
4
5
Current Cal.(%)100.0 100.0

New Cal.(%)
Figure 6-3-6: Entering Target Values
NOTE: • After entering the 5th target value, pressing [ENTER] key does
not move the reverse display to the next target column.
• An entered value can be set also by pressing [ ] or [ ] key after
entering the target value.

CALIBRATION
(3) When all target values have been entered, press [SELECT] key.
The Target Value Setting Confirmation message appears.
Figure 6-3-7: Target Value Setting Confirmation Message
(4) Using [ ] or [ ] key, move the cursor to select “Cont.,” “Set,” or “Cancel.”
[Cont.]: Returns to the status for entering target values. And the setting opera-
tion can be continued.
[Set]: Sets target values and charges to the Sample Analysis Waiting status.
[Cancel]: Cancels automatic calibration and returns to the Analysis screen.
3. Analysis for Automatic Calibration

(1) When the target values are set, the system turns to the Ready status for automatic
calibration analysis.
NOTE: • Automatic calibration analysis is performed in the whole blood

mode. When the analysis mode is set in the pre-diluted mode,
the mode changeover sequence is activated to switch to the
whole blood mode.
*Auto Cal.* WB
Ready
1 12.5 50.0
2 13.0 45.2
3 13.5 51.5
4 11.0 40.8
5 15.0 52.5
Current Cal.(%)100.0 100.0

New Cal.(%)
Figure 6-3-8: Automatic Calibration Screen (Before Analysis)
(2) Analyze the samples used for determining the standard value.
The sample being analyzed is indicated by the underline cursor.

CALIBRATION
(3) After completion of analysis, analysis result appears in the data column and com-
pensation rate in the compensation column, then the underline cursor moves to the
next sample. Upon completion of more than one sample, average compensation
rate is automatically calculated and displayed at the bottom of the compensation
column.
*Auto Cal.* WB
Ready
1 12.5 50.0 13.0 48.0 96.2 104.2
2 13.0 45.2 13.7 43.9 94.9 103.0
3 13.5 51.5 14.1 50.0 95.7 103.0
4 11.0 40.8
5 15.0 52.5
95.6 103.4
Current Cal.(%)100.0 100.0
New Cal.(%)
Figure 6-3-9: Automatic Calibration Screen (After Analysis)
CAUTION: • When an error occurs during automatic calibration analysis, the

error message appears in the system status display area. The
result of analysis in which an error has occurred is masked with
“---.-,” which is not calculated for compensation rate and not used
for average compensation rate calculation, either.
• If “0” is input to the target value, compensation rate for the sample
is not calculated and the analysis result is not used for average
compensation rate calculation, either.

CALIBRATION
4. Updating Calibration Value

(1) When all analyses are finished, press [SELECT] key.
New compensation values will be calculated and the Calibration Value Change
Confirmation message will appear.
Change? Yes No
Figure 6-3-10: Calibration Value Change Confirmation Message
NOTE: • The new compensation value is calculated as follows:
New compensation Current compensation value (%) × Average compensation rate (%)
=
value (%) 100
• When the compensation rate exceeds the following range, “Cali-
bration Error” is displayed and the Calibration Value Change Con-
firmation message does not appear.
Average compensation rate > 105%
Average compensation rate < 95%
New compensation value > 120%
New compensation value < 80%
*Auto Cal.* Calibration Error
Figure 6-3-11: Calibration Error Message
About calibration errors, refer to Chapter 7: TROUBLESHOOTING.
(2) Using [ ] or [ ], move the cursor to select “YES” or “NO.”

[YES] : Updates the calibration value and returns to the Analysis screen.
[NO] : Does not update the calibration value and returns to the Analysis screen.

CALIBRATION
4. MANUAL CALIBRATION
In manual calibration, calculated calibration value can be entered using the numeric keys.
4.1 Calculating Calibration Value

(1) Analyze more than five samples, each three times, by the reference method and
average HGB, HCT, WBC, RBC and PLT values.
(2) Gently mix the same samples sufficiently and analyze them in the whole blood
mode.
(3) When there is a difference between data gained by analysis with this instrument
and the reference value gained by the reference method, use the following formula
to calculate the new calibration value:
Average of values gained

by reference method
New calibration value = Previous calibration value ×
Average of values gained
by this instrument
[Example]
Average of HGB values gained by the reference method = 15.6 g/dL
Average of HGB values gained by this instrument = 15.5 g/dL
Previous calibration value of HGB = 100.0%
15.6 = 100.65 .= 100.7%

100.0 × .
15.5
Therefore, the new calibration value of HGB needs to be set at 100.7%. This
means that the calibration value increased 0.7%.

CALIBRATION
4.2 Manual Calibration Procedure

*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
(4) Using [ ] or [ ] key, move the cursor to select “2: Manual Cal.”
(5) Press [ENTER] key. The Manual Calibration screen appears.
*Manual Cal.*
HGB 100.0
HCT 100.0
WBC 100.0
RBC 100.0
PLT 100.0
Figure 6-4-2: Manual Calibration Screen

the numeric keys.

CALIBRATION
1. Entering Calibration Value

(1) Using [ ] or [ ] key, move the cursor to select “HGB” or “HCT.”
(2) Using the numeric keys, enter the calibration value obtained by calculation.
NOTE: • Press [C] key to delete one letter at a time.
(3) Press [ENTER] key to set the entered value and move the reverse display to the
next parameter.
*Manual Cal.*
HGB 100.7
HCT 100.0
WBC 100.0
RBC 100.0
PLT 100.0
Figure 6-4-3: Entering Calibration Value
NOTE: • An entered value can be set also by pressing [ ] or [ ] key after

entering the calibration value.
• If no input is made or a space is input, it cannot be set.

CALIBRATION

(1) When all calibration values are entered, press [SELECT] key.
The Calibration Value Change Confirmation message appears.
Change? Yes No
NOTE: • When there is no calibration value changed, the Calibration Value

Change Confirmation message is not displayed and the system
returns to the Analysis screen.
• When the compensation rate exceeds the following range, “Cali-
bration Error” is displayed and the Calibration Value Change Con-
firmation message does not appear.
Average of values gained by reference method

Compensation rate = × 100
Average of values gained by this instrument
Compensation rate > 105%
Compensation rate < 95%
New compensation value > 120%
New compensation value < 80%
*Manual Cal.* Calibration Error
Figure 6-4-5: Calibration Error Message
About calibration errors, refer to Chapter 7: TROUBLESHOOTING.
(2) Using [ ] or [ ], move the cursor to select “YES” or “NO.”

[YES]: Updates the calibration value and returns to the Analysis screen.
[NO]: Does not update the calibration value and returns to the Analysis screen.

CALIBRATION
5. CALIBRATOR CALIBRATION
Calibrate the WBC, RBC, HGB, HCT and PLT using the SCS-1000 calibrator.
5.1 Executing Calibrator Calibration Program

(2) Using [ ] or [ ] key, move the cursor to select “3: CALIBRATION.”
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
(4) Using [ ] or [ ] key, move the cursor to select “3: Calibrator.”
(5) Press [ENTER] key. The Precision Check screen appears.
The Precision Check screen consists of 2 pages. Use the [ ] and [ ] keys to
switch pages.
Precision Check Screen 1: Displays analysis data.

Precision Check Screen 2: Displays statistical values.
The upper limits of the acceptable precision (repro-
ducibility) values are displayed in the LMT(%) col-
umn for each parameter.

the numeric keys.

CALIBRATION
*Preci.Check* WB
Ready
WBC RBC HGB HCT PLT
1
2
3
4
5
6
7
8
9
10
Figure 6-5-2: Precision Check Screen 1
*Preci.Check* WB
Ready
WBC RBC HGB HCT PLT
Mean
SD
CV(%)
LMT(%) 3.5 2.0 1.5 2.0 6.0
Figure 6-5-3: Precision Check Screen 2

CALIBRATION
5.2 Calibrator Calibration Procedure
1. Precision Check
(1) Analyze the sample in the whole blood mode.
The sample being analyzed is indicated by the underline cursor.
After the analysis is completed, the results will be displayed and the underline cur-
sor will move to the next line.
NOTE: • Precision check analysis is performed in the whole blood mode.

When the analysis mode is set in the pre-diluted mode, the mode
changeover sequence is activated to switch to the whole blood
mode.
*Preci.Check* WB
Analyzing
WBC RBC HGB HCT PLT
1 7.0 4.79 15.5 41.2 220
2
3
4
5
6
7
8
9
10
Figure 6-5-4: Precision Check Screen 1 (Analyzing)
(2) When at least three analyses are complete, the average, the standard deviation (SD)
and coefficient of variation (CV%) will be automatically calculated and displayed
in the “Mean”, “SD” and “CV(%)” columns, respectively.
NOTE: • The first analysis data is not included in the calculation.

The first analysis data is overwritten by the second analysis data.
• When an error occurs during precision check analysis, the error
message appears in the system status display area. The analysis
result with an error is masked with “---.-.” At this time, the under-
line cursor will not move to the next line and the next sample is
analyzed using the same number.

CALIBRATION
(3) Analyze the sample a total of 11 times.

If the obtained CV(%) values for all five parameters are within the Precision Limit
(CV%) values, the menu will be displayed in the menu display area.
*Preci.Check* WB
WBC RBC HGB HCT PLT
Mean 6.9 4.82 14.0 40.9 212
SD 0.048 0.043 0.056 0.532 1.69
CV(%) 0.7 0.9 0.4 1.3 0.8
LMT(%) 3.5 2.0 1.5 2.0 6.0
1:Calibration 3:Cancel
Figure 6-5-5: Precision Check Passed Screen
(4) Using the numeric keys, select “1: Calibrate” or “3: Cancel.”
[1: Calibrate]: The SCS-1000 Analyzing Calibrator screen appears.
[3: Cancel]: Returns to the Analysis screen.
If any of the obtained CV(%) values exceed the LMT (%) value, the CV (%) value
will be reverse display and the “1: Calibrate” menu will not be displayed.
Refer to Chapter 7 “Troubleshooting” and take corrective action. If assistance is
required, contact a Sysmex service representative.
*Preci.Check* WB
WBC RBC HGB HCT PLT
Mean 6.90 4.82 15.1 40.9 212
SD 0.255 0.043 0.056 0.532 1.69
CV(%) 3.7 0.9 0.4 1.3 0.8
LMT(%) 3.5 2.0 1.5 2.0 6.0
3:Cancel
Figure 6-5-6: Precision Check Failed Screen

CALIBRATION
2. Entering Target Values
To perform calibrator calibration, you must enter the Assay Target values exactly as pro-
vided with the Sysmex SCS-1000 Calibrator product. Verify that the assay sheet matches
the Lot # of calibrator.
(1) When the precision check is completed and “1: Calibration” is selected, the Ana-
lyzing Calibrator screen appears.
The Analyzing Calibrator screen consists of 2 pages. Use the [ ] and [ ] keys to
switch pages.
Analyzing Calibrator Screen 1: Displays the Target values and analysis data.
Analyzing Calibrator Screen 2: Displays statistical values.
When the Analyzing Calibrator screen 1 is displayed, the area to input the WBC
Target value is reverse display.
*Calibrator*
WBC RBC HGB HCT PLT

Target
0
1
2
3
4
5
Figure 6-5-7: Analyzing Calibrator Screen 1
*Calibrator*
WBC RBC HGB HCT PLT

Range V.
MaxRange 0.7 0.20 0.5 1.8 35
Mean V.
Delta%
ACPT LMT 3.95 1.54 0.76 2.21 3.53
SERV LMT 14.00 5.00 5.00 5.00 15.00
Current 102.1 99.9 101.6 98.4 100.4
New

CALIBRATION
Explanation of Displayed Items
Target : Assay Target values provided with calibrator are entered.

Range V. : The highest value minus the lowest value within five consecutive
analyses is displayed.
MaxRange : The maximum Range Value allowed is automatically calculated
from the Assay Target and displayed.
Mean V. : Mean value of five consecutive analysis results.
Delta% : Assay Target - Mean Value
× 100 (%) is automatically calculated
Mean Value
ACPT LMT : Maximum Upper Limit of Delta Percent (%). Calibration is not
necessary when the Delta Percent is within this limit.
SERV LMT : If the Delta Percent exceeds this limit, technical assistance may be
necessary and your instrument system needs service. Calibration
will not be allowed.
Current : Current calibration value, which was obtained in the previous cali-
bration procedure.
New : New calibration value calculated from the calibrator analysis.
(2) Using the numerical keys, enter the assay target value exactly for the WBC param-
eter. Press [Enter] key, and the input value is displayed in the “Target” column.
The reverse display then moves to the next parameter.
Enter the assay target values for all 5 parameters.
*Calibrator*
WBC RBC HGB HCT PLT

Target 7.0
0
1
2
3
4
5
Figure 6-5-9: Entering Target Value
NOTE: • Press [C] key to delete entirely.

CALIBRATION
(3) When the assay target values for all five parameters are entered, make sure once
again the entered values are correct with the Assay Sheet. If correction is required,
select the parameter using the [ ] and [ ] keys, and enter the correct value.
*Calibrator*
WBC RBC HGB HCT PLT

Target 7.0 4.80 15.0 40.8 220
0
1
2
3
4
5
Figure 6-5-10: Verifying Target Value Screen
(4) When all assay target values have been entered, press [SELECT] key.
The Target values setting confirmation message appears.
Figure 6-5-11: Target Value Setting Confirmation Message
(5) Using [ ] and [ ] key, move the cursor to select “Cont.”, “Set” or “Cancel.”
[Cont.]: Returns to the status for entering assay target values. And the setting
operation can be continued.
[Set]: Sets assay target values and charges to the calibrator analysis waiting
status.
[Cancel]: Cancels calibrator calibration and returns to the Analysis screen.

CALIBRATION
3. Analysis for Calibrator Calibration
(1) When the target values are set, the system turns to the Ready status for calibrator
analysis.
NOTE: • Calibrator analysis is performed in the whole blood mode. When

the analysis mode is set in the pre-diluted mode, the mode
changeover sequence is activated to switch to the whole blood
mode.
In the whole blood mode, “CL” in the calibrator analysis mode is
displayed in the system status display area.
*Calibrator* CL
Ready
WBC RBC HGB HCT PLT

Target 7.0 4.80 15.0 40.8 220
0
1
2
3
4
5
Figure 6-5-12: Analyzing Calibrator Screen 1 (1)
*Calibrator* CL
Analyzing
WBC RBC HGB HCT PLT

Target 7.0 4.80 15.0 40.8 220
0 6.9 4.77 15.3 40.8 214

1
2
3
4
5
Figure 6-5-13: Analyzing Calibrator Screen 1 (2)
(2) When an analysis is complete, the results will be displayed and the underline cur-
sor will move to the next line.
(3) When the six analysis data are completed, “Range V.”, “Mean V.”, “Delta%” and
“New” will begin to be automatically calculated and displayed in their respective
columns.

CALIBRATION
NOTE: • The first analysis data is not included in the calculation.

• When an error occurs during calibrator analysis, the error mes-
sage appears in the system status display area. The analysis
result with an error is masked with “---.-” or “***.*”. At this time, the
underline cursor will not move to the next line and the next sample
is analyzed using the same number.
*Calibrator*
WBC RBC HGB HCT PLT

Target 7.0 4.80 15.0 40.8 220
0 6.9 4.77 15.3 40.8 214

1 6.9 4.82 15.1 40.2 210
2 7.0 4.79 14.9 41.3 213
3 7.0 4.89 15.1 41.4 212
4 7.0 4.88 15.0 41.5 211
5 7.0 4.78 15.1 41.4 213
*Calibrator*
WBC RBC HGB HCT PLT

Range V. 0.1 0.12 0.4 1.3 4
MaxRange 0.7 0.20 0.5 1.8 35
Mean V. 6.9 4.83 15.0 41.2 212
Delta% 0.03 0.66 0.27 0.87 3.87
ACPT LMT 3.95 1.54 0.76 2.21 3.53
SERV LMT 14.00 5.00 5.00 5.00 15.00
Current 102.1 99.9 101.6 98.4 100.4
New 102.1 99.9 101.6 98.4 104.2

CALIBRATION
If the Range values exceed the MaxRange values, the Range value will be reverse
display.
If the Delta% values exceed SERV LMT values, the Delta% value will be reverse
display.
Calibration will not be allowed.
*Calibrator*
WBC RBC HGB HCT PLT

Range V. 0.1 0.12 0.6 1.3 4
MaxRange 0.7 0.20 0.5 1.8 35
Mean V. 6.9 4.83 15.0 41.2 212
Delta% 0.03 4.66 0.27 0.87 3.87
ACPT LMT 3.95 1.54 0.76 2.21 3.53
SERV LMT 14.00 5.00 5.00 5.00 15.00
Current 102.1 99.9 101.6 98.4 100.4
New 102.1 99.9 101.6 98.4 104.2
Figure 6-5-16: Rang V. > MaxRange or Delta% > SERV LMT Screen
1) When there are:

Range V. > MaxRange
or Delta% > SERV LMT
or Delta% ≤ ACPT LMT,
New = Current
2) Other than above,

New = (Target/Mean V.) × Current

(1) After the statistical values are calculated, press [SELECT] key.
New compensation values will be calculated and the Calibration Value Change
Confirmation message will appear.
Change? Yes No
(2) Using [ ] or [ ], move the cursor to select “Yes” or “No.”

[Yes] : Updates the calibration value and returns to the Analysis screen.
[No] : Does not update the calibration value and returns to the Analysis screen.

CALIBRATION
6. CALIBRATION HISTORY PRINT

Using this menu, a recent five times calibration history can be printed from the built-in
printer.
Execution of Calibration History Print

*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
(4) Using [ ] or [ ] key, move the cursor to select “4: Print Rev. History.”

The built-in printer prints the calibration history.
Print Example
Date 31/10/1999
Time 10:23
*Cal.History*
Date 29/10/1999
Time 08:23
HGB 95.6
HCT 103.4
Date 30/10/1999
Time 08:23
HGB 99.3
HCT 101.2
..
..
Figure 6-6-2: Calibration History Print

CALIBRATION

CHAPTER 7 TROUBLESHOOTING
1. INTRODUCTION ................................................................................... 7-1
2. WHEN YOU SUSPECT A TROUBLE................................................... 7-2

Displayed on Analysis Screen ..................................................... 7-3
Displayed on HELP Screen ......................................................... 7-4
2.3 Functional List of Error Messages............................................... 7-5
3. TROUBLESHOOTING GUIDE ............................................................. 7-7

3.1 Pressure/Vacuum Errors............................................................... 7-7
3.2 Chamber Errors.......................................................................... 7-10
3.3 Motor Errors .............................................................................. 7-13
3.4 Transducer Errors....................................................................... 7-15
3.5 Temperature Errors .................................................................... 7-16
3.6 Analysis Errors .......................................................................... 7-17
3.7 Memory Errors........................................................................... 7-23
3.8 Others......................................................................................... 7-25
3.9 Maintenance Errors.................................................................... 7-27
3.10 Printer Errors.............................................................................. 7-30
3.11 External Device Errors............................................................... 7-33
4. STATUS DISPLAY................................................................................ 7-34
5. ERROR HISTORY PRINT.................................................................... 7-36
6. PROGRAM VERSION.......................................................................... 7-37

TROUBLESHOOTING
1. INTRODUCTION
If the running instrument develops any symptom that you suspect to be a trouble, check it
making reference to “2. WHEN YOU SUSPECT A TROUBLE” which begins from the next
page. When there is not any item that confirms to the trouble in question or if “Action”
fails to eliminate the symptom, contact your Sysmex service representative for assistance.
When a trouble occurs, the instrument displays an error message on the LCD screen.
When there occurs an error unique to a sample analyzed, analysis data is displayed with a
flag.
This chapter describes the cause of a trouble on which an error message is displayed,
along with actions that the customer can take in checking and repairing.
HELP Function
When a trouble has occurred, the warning alarm sounds and an error message is displayed
on the screen. By pressing [HELP] key on the panel keyboard, you can stop the alarm and
change over to the HELP screen that shows what action to take against the error. Supple-
mentary explanation for that function is given here.
In the event multiple errors occur at the same time, press [HELP] key. The errors that have
occurred are listed in the order from higher priority.
*Help*
Multiple errors occurred.
Pressure/Vac Error
Rinse Motor Error
Waste Not Draining
Sampling Error
Room Temp. High
Press[HELP] for more information.
Figure 7-1-1: Help Screen (Error List)
Press [HELP] key again. The screen changes to the HELP screen for the error listed at top.
NOTE: • When you contact your Sysmex service representative, inform him
of “ERR CODE” given on the HELP screen. By doing so, you can
inform him of the instrument's status easier and more correctly.
WARNING • When you repair in accordance with TROUBLESHOOTING, be

sure to turn the power OFF except when you have to confirm dis-
plays and instructions on the screen.
If you repair with the power turned ON, you have a risk of electric
shock hazard and you may give a permanent damage to electric
parts.

TROUBLESHOOTING
2. WHEN YOU SUSPECT A TROUBLE
1. Turning the power ON does not start the • Is the power cord connected securely?
unit. • Isn't the fuse blown?
Refer to Chapter 4, Section 8.2: Replace Fuse.
• Is the power supplied to AC outlet?
2. When the power is ON, nothing is dis- • There is a possibility that memory error has
played and “beep” keeps sounding. occurred. Turn OFF the power, and turn it ON again
1 - 2 minutes later.
3. The screen displays nothing. • Isn't LCD brightness properly adjusted?

Refer to Chapter 1, Section 8.3: LCD Brightness
Adjustment.
4. The screen displays “PU Sleeping” mes- • Timer mode turned OFF the pneumatic unit power.
sage and no key entry is accepted. To return the instrument to the ready status, press
the [SELECT] key to return to the analysis result
screen, and then the [Start] switch.
5. Fluid leaks from the unit. • Turn OFF the power and wipe off leaking fluid. If
fluid leakage persists after turning ON the power,
contact your Sysmex service representative.
WARNING • When operating, always wear rubber gloves. After completion of

work, wash hands with disinfectant. If your hands are contaminated
by blood, etc., infection of bacteria can result.
6. Data has error. • Check QC data of control blood.

• Referring to Chapter 4: MAINTENANCE AND SUP-
PLIES REPLACEMENT, conduct the maintenance
below:
Chapter 4, Section 5.2: Clean Transducer (Rinse
Sequence)
Chapter 4, Section 6.1: Clean Sample Rotor Valve
(SRV)
7. An error occurs. Search the following message lists for an error in ques-
tion and refer to the corresponding pages in TROU-
BLESHOOTING:
1) Message List
To search the pages, the error messages are
listed in “Alphabetical” and “Functional” orders.
2) TROUBLESHOOTING
Cause and action for each trouble are described
for respective error message.

TROUBLESHOOTING
2.1 Alphabetical List of Error Messages Displayed on Analysis Screen
[A]
Abnormal DP (when data printer is incorporated)......................................................... 7-31
Abnormal GP (when graphic printer is incorporated) .......................................... 7-31, 7-32
Abnormal IP.......................................................................................................... 7-30, 7-32
Analysis Error ....................................................................................................... 7-21, 7-22
[B]
Background Error .......................................................................................................... 7-17
[C]
Calibration Error ............................................................................................................ 7-26
Clean SRV. ..................................................................................................................... 7-27
Clean Transducer ........................................................................................................... 7-29
Clean Waste Chamber. ................................................................................................... 7-28
[H]
HGB Error...................................................................................................................... 7-20
Host Comm. Error.......................................................................................................... 7-33
[M]
Momentary Power Failure ............................................................................................. 7-24
Memory Error ................................................................................................................ 7-23
[P]
Pressure/Vac Error .............................................................................................7-7, 7-8, 7-9
[Q]
QC Error ........................................................................................................................ 7-25
[R]
RBC Aperture Clog ....................................................................................................... 7-15
Replenish Diluent .......................................................................................................... 7-11
Replenish Lyse ............................................................................................................... 7-12
Rinse Motor Error ................................................................................................. 7-13, 7-14
Room Temp. High.......................................................................................................... 7-16
Room Temp. Low .......................................................................................................... 7-16
[S]
Sampling Error...................................................................................................... 7-18, 7-19
Set Value Error...................................................................................................... 7-23, 7-24
[W]
Waste Not Draining........................................................................................................ 7-10
WBC Aperture Clog ...................................................................................................... 7-15

TROUBLESHOOTING
2.2 Alphabetical List of Error Messages Displayed on HELP Screen
0.05 MPa Pressure Error .................................................................................................. 7-7

0.05 MPa Pressure Error at count .................................................................................... 7-9
0.0333 MPa Vacuum Error .............................................................................................. 7-8
[A]
Abnormal detection sensitivity ...................................................................................... 7-22
[B]
Background count exceeds tolerance............................................................................. 7-17
[C]
Calibration value is out of range. .................................................................................. 7-26
Clean the SRV. ............................................................................................................... 7-27
Clean the Transducer. ................................................................................................... 7-29
Clean the Waste Chamber. ............................................................................................ 7-28
Clog in the aperture (RBC) ............................................................................................ 7-15
Clog in the aperture (WBC)........................................................................................... 7-15
[D]
DP printout error (when data printer is incorporated) ................................................... 7-31
[E]
Error has occurred during counting (PLT). ................................................................... 7-18
Error has occurred during counting (RBC).................................................................... 7-18
Error has occurred during counting (WBC). ................................................................. 7-18
Error occurred during HGB analysis. ............................................................................ 7-20
Error on IP ..................................................................................................................... 7-30
Error on Rinse Cup ............................................................................................... 7-13, 7-14
[G]
GP paper empty (when graphic printer is incorporated)................................................ 7-32
GP printout error (when graphic printer is incorporated) .............................................. 7-31
[H]
Host Output Error .......................................................................................................... 7-33
[I]
IP paper empty ............................................................................................................... 7-32
[M]
Memory error occurred. (Repairing)............................................................................. 7-23
Memory error occurred. (Turn OFF then ON the power.) ...................................7-23, 7-24
Momentary power failure occurred................................................................................ 7-24
[Q]
QC data falls out of control limits. ................................................................................ 7-25
[R]
Replenish Diluent Container. ........................................................................................ 7-11
Replenish Lyse Container. ............................................................................................ 7-12
Room Temp. Error ........................................................................................................ 7-16
[S]
Sampling Error has occurred. ....................................................................................... 7-19
[W]
Waste Not Drained ......................................................................................................... 7-10
WBC/HGB Analysis Error ............................................................................................ 7-21

TROUBLESHOOTING
2.3 Functional List of Error Messages
NOTE: • [ ] indicates error naming that is displayed on the Analysis screen.
1. Pressure/Vacuum Errors
0.05 MPa Pressure Error [Pressure/Vac Error] ................................................... 7-7
0.0333 MPa Vacuum Error [Pressure/Vac Error]................................................ 7-8
0.05 MPa Pressure Error at count [Pressure/Vac Error] ...................................... 7-9
2. Chamber Errors
Waste Not Drained [Waste Not Draining] ........................................................ 7-10
Replenish Diluent Container. [Replenish Diluent] ........................................... 7-11
Replenish Lyse Container. [Replenish Lyse] .................................................... 7-12
3. Motor Errors
Error on Rinse Cup [Rinse Motor Error] .................................................7-13, 7-14
4. Transducer Errors
Clog in the aperture (WBC) [WBC Aperture Clog] ......................................... 7-15
Clog in the aperture (RBC) [RBC Aperture Clog] ........................................... 7-15
5. Temperature Errors
Room Temp. Error [Room Temp. High]........................................................... 7-16
Room Temp. Error [Room Temp. Low] ........................................................... 7-16
6. Analysis Errors
Background count exceeds tolerance. [Background Error] .............................. 7-17
Error has occurred during counting. (PLT) [Sampling Error] .......................... 7-18
Error has occurred during counting. (RBC) [Sampling Error] ......................... 7-18
Error has occurred during counting. (WBC) [Sampling Error] ........................ 7-18
Sampling Error has occurred. [Sampling Error] ............................................... 7-19
Error occurred during HGB analysis. [HGB Error].......................................... 7-20
WBC/HGB Analysis Error [Analysis Error] .................................................... 7-21
Abnormal detection sensitivity [Analysis Error] .............................................. 7-22
7. Memory Errors
Memory error occurred. (Turn OFF then ON the power.) [Memory Error] .... 7-23
Memory error occurred. (Repairing) [Set Value Error] .................................... 7-23
Memory error occurred. (Turn OFF then ON the power.) [Set Value Error]... 7-24
Momentary power failure occurred. [-]............................................................. 7-24
8. Others
QC data falls out of control limits. [QC Error]................................................. 7-25
Calibration value is out of range. [Calibration Error]....................................... 7-26

TROUBLESHOOTING
9. Maintenance Errors
Clean the SRV. [-] ............................................................................................. 7-27
Clean the Waste Chamber. [-] ........................................................................... 7-28
Clean the Transducer. [-]................................................................................... 7-29
10. Printer Errors

Error on IP [Abnormal IP] ................................................................................. 7-30
GP printout error [Abnormal GP] ...................................................................... 7-31
DP printout error [Abnormal DP] ...................................................................... 7-31
IP paper empty [Abnormal IP]........................................................................... 7-32
GP paper empty [Abnormal GP] ....................................................................... 7-32
11. External Option Errors

Host Output Error [Host Comm. Error]............................................................ 7-33

TROUBLESHOOTING
3. TROUBLESHOOTING GUIDE
3.1 Pressure/Vacuum Errors
Error Message Meaning of Message

“Pressure/Vac Error” 0.05 MPa is out of the monitor range in Ready
status.
*Help*
Monitor range: 0.039 - 0.059 MPa
0.05 MPa Pressure Error
0.034 [0.039 - 0.059]

Adjust 0.05 MPa Pressure.
[1] Restarting to monitor the pressure
ERR CODE:XXXXX.X.X
1:End of Adj
Cause 1) 0.05 MPa pressure adjustment error

2) Pneumatic unit pressure error
3) Air leakage from pressure line
Action 1) Adjust Pressure to 0.05 MPa.
The HELP screen displays pressure value in real time.
Adjust pressure referring to Chapter 8, Section 2.3: Adjusting
Pressure to 0.05 MPa.
2) Check Pressure Line
Check the pressure line for loosened nipple or tube, or breakage.
If any abnormality is noted, reconnect or replace.
After adjustment or check, press [1] key to return to the original
screen.
Analysis after error Not Ready until the error is resolved.
occurrence

TROUBLESHOOTING

“Pressure/Vac Error” 0.0333 MPa vacuum is out of the monitor
range in Ready status.
*Help*
0.0333 MPa Vacuum Error
0.0287 [0.0307 - 0.0360]

Adjust 0.0333 MPa Vacuum.
[1] Restarting to monitor the vacuum
ERR CODE:XXXXX.X.X
1:End of Adj
Cause 1) 0.0333 MPa vacuum adjustment error

2) Fluid back-flows into the trap chamber.
3) Pneumatic unit vacuum error
4) Air leakage from vacuum line
Action 1) Adjust Vacuum to 0.0333 MPa
The HELP screen displays vacuum value in real time.
Adjust vacuum referring to Chapter 8, Section 2.4: Adjusting
Vacuum to 0.0333 MPa.
2) Discard fluid in Trap Chamber
Discard fluid if collected. Refer to Chapter 4, Section 3.2: Check
Trap Chamber Level and Discard.
3) Check Vacuum Line
Check the vacuum line for loosened nipple or tube, or breakage.
If any abnormality is noted, reconnect or replace.
screen.
occurrence

TROUBLESHOOTING

“Pressure/Vac Error” 0.05 MPa pressure is out of the monitor range
during analysis.
*Help*
0.05 MPa Pressure Error at count
Turn OFF then ON the power.
ERR CODE:XXXXX.X.X
3:Ana.Screen
Cause 1) 0.05 MPa pressure adjustment error

Action 1) Adjust Pressure to 0.05 MPa
Turn the power OFF, and turned it ON again. Then adjust pres-
sure referring to Chapter 8, Section 2.3: Adjusting Pressure to
0.05 MPa.
Check the pressure line for loosened nipple or tubing, or break-
age. If any abnormality is noted, reconnect or replace.
screen.
Analysis after error The power needs to be turned OFF then ON again.
occurrence
NOTE: • Press [3] key to return to the Analysis screen. The status is not ready for
analysis, but the processing, etc. of stored data in Select Menu can be per-
formed.

TROUBLESHOOTING
3.2 Chamber Errors

“Waste Not Draining” Waste in the waste chamber can not be
drained within the prescribed draining time.
*Help*
Waste Not Drained
Check kinked or blocked tubings.
[1] Retrying to drain the waste
ERR CODE:XXXXX.X.X
1:Draining 3:Cancel
Cause 1) Breakage or clogging of waste chamber or waste line tube

4) Float switch malfunction
5) Faulty operation of solenoid or master valve
Action 1) Check Waste Line Tube
Check the waste drain line for breakage, clogging, etc. If any
abnormality is present, clean or replace the tube. Specially
check for contaminant or clogging near the drain outlet nipple.
Check the pressure line for loosened nipple or tubing, or break-
age. If any abnormality is noted, reconnect or replace.
screen.
occurrence
formed.

TROUBLESHOOTING

“Replenish Diluent” Diluent (CELLPACK) can not be aspirated
within the prescribed diluent aspiration time.
*Help*
Replenish Diluent Container.
[1] Reaspirating Diluent
ERR CODE:XXXXX.X.X
1:Asp. Reag. 3:Cancel
Cause 1) Lack of diluent (CELLPACK)

2) Diluent aspiration line error
3) Air leakage from vacuum line
5) Faulty operation of solenoid valve or master valve
Action 1) Replenish Diluent (CELLPACK)
If there is no diluent, replenish with a new diluent container.
2) Check Tube
Check the diluent line tubing for breakage and the nipple for
looseness. If any abnormality is noted, reconnect or replace.
After replenishment or check, press [1] to return to the original
screen.
3) Check Vacuum Line
Check the vacuum line for breakage and loosened nipple or tub-
ing.
occurrence
formed.

TROUBLESHOOTING

“Replenish Lyse” No lyse remains.
*Help*
Replenish Lyse Container.
[1] Reaspirating Lyse
ERR CODE:XXXXX.X.X
1:Asp. Reag. 3:Cancel
Cause 1) Lack of lyse (STROMATOLYSER-WH)

Action 1) Replenish Lyse (STROMATOLYSER-WH)
When no lyse is left, replenish with a new lyse container.
After replenishment or check, press [1] key to return to the original
screen.
occurrence
formed.

TROUBLESHOOTING
3.3 Motor Errors

“Rinse Motor Error” The rinse cup is at lower position at start-up
(This happens only when the power is ON.)
*Help*
Error on Rinse Cup
If Rinse Cup is out of position,
Turn power OFF and correct manually.
ERR CODE:XXXXX.X.X
3:Ana.Screen
Cause 1) Rinse cup drive motor malfunction

2) The power was turned ON with the rinse cup remaining lowered.
Action 1) Turn OFF the power, manually raise the rinse cup with both
hands to the original top position, then turn ON the power.
occurrence
formed.

TROUBLESHOOTING

“Rinse Motor Error” The rinse cup is not operating normally.
*Help*
Error on Rinse Cup
ERR CODE:XXXXX.X.X
3:Ana.Screen
Cause 1) Rinse cup drive motor malfunction

2) Error of the rinse cup drive motor controller
Faulty operation of CPU due to sudden noise interference, etc.
Action 1) Turn OFF the power and check to see that tubing, etc. are not in
contact with the top or bottom of rinse cup.
2) Turn OFF the power and clean the rinse cup.
Refer to Chapter 4, Section 7.2: Clean Rinse Cup.
occurrence
formed.

TROUBLESHOOTING
3.4 Transducer Errors

“WBC Aperture Clog” The monitor value for aperture clog is out of
“RBC Aperture Clog” the prescribed range.
*Help*
Clog in the aperture
Parameter: WBC RBC
1 Execute clog removal sequence.
If clog persists,
press[SELECT],then
[Maintenance]->[Clean Transducer]
or dab with brush after [SELECT],
[Maintenance]->[Drain TD Chamber]
ERR CODE:XXXXX.X.X
1:Clog Remove 3:Cancel
Cause 1) Transducer aperture clogging

Action 1) Remove Aperture Clogging.
Press [1] key to execute automatic clog removal sequence.
2) Transducer Rinse Sequence
Pour 1 mL each of CELLCLEAN in the transducer chamber to
perform auto rinse sequence.
Refer to Chapter 4, Section 5.2: Clean Transducer (Rinse
Sequence).
3) Clean the Transducer with Brush
Clean the aperture with brush.
Refer to Chapter 4, Section 7.3: Clean WBC/RBC Transducer
Aperture.
Analysis after error Ready for analysis (although the next sample could be affected)
occurrence
NOTE: • Press [3] key to return to the Analysis screen. Although the system is ready
for analysis, the error may occur in the next analysis.

TROUBLESHOOTING
3.5 Temperature Errors

“Room Temp. High” Temperature in the unit (around the trans-
“Room Temp. Low” ducer) is out of the monitor range.
Monitor range: 10.0 - 40.0°C
*Help*
Room Temp.Error
41.5˚C [10.0 - 40.0]
Analysis data has lower reliability.

Check the room temperature.
ERR CODE:XXXXX.X.X
3:Return
Cause 1) Temperature in the transducer is high (or low.)

Action 1) Check the Ambient Temperature
Check to see that the ambient temperature is between 15°C -
30°C.
occurrence

TROUBLESHOOTING
3.6 Analysis Errors

“Background Error” In Auto Rinse, background check reveals that
the background count of any parameter
*Help* exceeds the tolerance.
Background count exceeds tolerance.
WBC 0.1 [<=0.3] (×103/µL)
Tolerance: WBC 0.3×103/µL or less
RBC 0.05 [<=0.02](×106/µL)
HGB 0.0 [<=0.1] (g/dL) RBC 0.02×106/µL or less
PLT 12 [<=10] (×103/µL) HGB 0.1g/dL or less
Suspected a dirty aperture or SRV.
PLT 10×103/µL or less
[1] Execute an Auto Rinse.
ERR CODE:XXXXX.X.X
1:Auto Rinse 3:Cancel
Cause 1) Dirty aperture

2) Dirty HGB flow cell
3) Bubbles mixing
4) Faulty reagent
Action 1) Auto Rinse
Press [1] key to perform Auto Rinse.
2) Clean Transducer
Sequence) or Chapter 4, Section 7.3: Clean WBC/RBC Trans-
ducer Aperture.
3) Clean SRV
Refer to Chapter 4, Section 6.1: Clean Sample Rotor Valve (SRV).
4) Replenish Reagent
Faulty lyse will affect background for WBC or HGB. In case dilu-
ent is faulty, it will affect all parameters, notably PLT background
count.
occurrence

TROUBLESHOOTING

“Sampling Error” Sampling data falls into disorder.
*Help*
Sampling data refers to the count taken every
0.5 seconds during counting. The system
Error has occurred during counting. monitors the counts.
Parameter: WBC RBC PLT
Suspected a clogged aperture.
[1] Execute clog removal sequence.

If clog persists,
press[SELECT], then
[Maintenance]->[Clean Transducer]
or dab with brush after [SELECT]
[Maintenance]->[Drain T.D.Chamber]
ERR CODE:XXXXX.X.X
1:Clog Remove 3:Cancel
Cause 1) Dirty aperture

2) Effect of external noise interference
Action 1) Clean Transducer
1. Remove Aperture Clogging
Press [1] key to execute automatic clog removal sequence.
2. Transducer Rinse Sequence
Pour 1 mL each of CELLCLEAN in the transducer chamber
to perform auto rinse sequence. Refer to Chapter 4, Section
5.2: Clean Transducer (Rinse Sequence).
3. Clean the Transducer with Brush
Clean the aperture using brush. Refer to Chapter 4, Section
7.3: Clean WBC/RBC Transducer Aperture.
2) Remove Source of External Noise
Move the noise source away from the unit.
occurrence

TROUBLESHOOTING

“Sampling Error” Sampling data falls into disorder.
*Help*
Sampling data refers to the count taken every
0.5 seconds during counting. The system
Sampling Error has occurred. monitors the counts taken.
ERR CODE:XXXXX.X.X
3:Retuen
Cause 1) CPU malfunction due to sudden noise interference, etc.

Action 1) Turn OFF then ON the power again.
If the error persists after turning ON the power again, contact
your Sysmex service representative.
occurrence

TROUBLESHOOTING

“HGB Error” HGB converted value is out of the prescribed
range.
*Help*
1. Blank value is out of the range.
Error occurred during HGB analysis.
2. Blank value exceeds sample value.
Flow Cell may be dirty.
[1] Clean TD Chamber will be performed.

(It will take approx. 7 minutes.)
ERR CODE:XXXXX.X.X
1:Exec. Clean 3:Cancel
Cause 1) Dirty HGB flow cell

2) Bubbles mixed in HGB sample line
3) Dirty WBC TD chamber
Action 1) Clean Transducer
Press [1] key to execute the transducer rinse sequence.
Sequence).
occurrence

TROUBLESHOOTING

“Analysis Error” WBC (including HGB) analysis error is con-
tinuing.
*Help*
WBC/HGB Analysis Error
ERR CODE:XXXXX.X.X
3:Return
Cause 1) Faulty lyse (STROMATOLYSER-WH)

Action 1) Replenish Lyse
After replenishing lyse, always execute “4: Replace Reagent” in
the Select Menu, making reference to Chapter 4, Section 8.1:
Replenish Reagent. After replenishment and checking, analyze
the control blood and confirm that there is no abnormality.
occurrence

TROUBLESHOOTING

“Analysis Error” Sensitivity in the transducer exceeds the pre-
scribed range.
*Help*
Abnormal detection sensitivity
ERR CODE:XXXXX.X.X
3:Return
Cause 1) Faulty diluent (CELLPACK)

Action 1) Replenish Diluent
After replenishing diluent, execute “5: Auto Rinse” in the Select
Menu, and perform background check. In addition, analyze the
control blood to see that there is no abnormality.
occurrence

TROUBLESHOOTING
3.7 Memory Errors

“Memory Error” Error occurs on the Read Only Memory
(ROM) or Random Access Memory (RAM).
*Help* The alarm keeps sounding.
Memory error occurred.
ERR CODE:XXXXX.X.X
Cause 1) Momentary power failure, sudden noise interference, etc. causes

CPU malfunction.
Analysis after error Inoperative (The power could be turned OFF.)
occurrence

“Set Value Error” Errors occur in the set values of the following:
*Help*
• Stored data
• Quality Control data
Stored data,and • Customer-set values
QC data
[1] will be repaired.

Repairing may end incomplete.
[2]
2 Deleting files and initializing.
ERR CODE:XXXXX.X.X
1:Repairing 2:Initialize
Cause 1) Momentary power failure, sudden noise interference, etc. causes

analysis value errors.
Action 1) Repair
Press [1] key to execute repairing.
2) Initializing
If execution of “1: Repairing” fails to correct the error, initialize
using [2] key. Initializing deletes all stored data and QC data,
and set values return to initial values.
After completion of initializing, perform all settings referring to Chap-
ter 10: INSTRUMENT SETUP.
occurrence

TROUBLESHOOTING

“Set Value Error” Errors occur in the set values of the following:
*Help* • Stored data
• Quality Control data
• Customer-set values
• Factory-set values
ERR CODE:XXXXX.X.X
Cause 1) Momentary power failure or sudden noise interference causes

set value errors.
If the error persists even after the power is turned OFF then ON,
contact your Sysmex service representative for assistance.
Analysis after error Inoperative (The power could be turned OFF.)
occurrence

Momentary Power Failure The program had not been normally quitted
the last time the power was turned off.
Momentary power failure occurred, or

[SHUT DOWN]has not been performed
in the last time.
Perform[SHUT DOWN]in prior to
turning OFF the power.
[1] Continue to start up.
1:Continue
Cause 1) Momentary power failure, etc. caused the unit to stop tempo-
rarily.
2) Shutdown had not been performed the last time the unit was
turned OFF.
Action Press [1] key to start up the unit. Perform SHUTDOWN before turn-
ing OFF the power.
Analysis after error Ready for analysis (This error occurs at starting.)
occurrence

TROUBLESHOOTING
3.8 Others

“QC Error” This error occurs only when executing Quality
Control.
*Help*
Analysis data is out of QC limits.
QC data falls out of control limits.
ERR CODE:XXXXX.X.X
3:Return
Cause 1) Control blood aspiration error

2) Control blood insufficient mixing
3) Faulty control blood
4) Instrument failure
Action 1) Reanalyze Control Blood
Press [3] key to return to the QC screen and perform reanalysis.
2) Analyze using New Vial.
3) Maintenance Service of Unit
When the above 1) and 2) steps fail to resolve the error, a hard-
ware problem may be suspected. Refer to Chapter 4: MAINTE-
NANCE AND SUPPLIES REPLACEMENT and clean the
transducer, SRV, etc.
Analysis after error Ready for analysis
occurrence

TROUBLESHOOTING

“Calibration Error” The set calibration value does not meet the
conditions:
*Help*
• Difference from the last calibration must
Calibration value is out of range. not exceed 5%.
If error persists, • Calibration value must be in the range of
>=5% difference from the last calib. 80% - 120%.
Calib. factor is out of 80%-120%.
ERR CODE:XXXXX.X.X
3:Return
Cause 1) Input error of target or calibration values

2) Instrument failure caused data to shift.
Action 1) Checking Entered Values
Press [3] key to return to the Calibration screen and check the
target or calibration value.
• In case of input error of target value in automatic calibration
Select “No” on the Update screen for calibration value and
execute Auto Calibration again from the beginning.
• In case of input error of calibration value in manual calibration
Select “No” on the Update screen for calibration value and
enter calibration value again.
2) Maintenance of Instrument
Check QC data, and if data is found to have shifted, a hardware
problem is conceivable. Referring to Chapter 4: MAINTENANCE
AND SUPPLIES REPLACEMENT, clean the transducer, SRV,
etc.
Analysis after error Not Ready until calibration value is fixed.
occurrence

TROUBLESHOOTING
3.9 Maintenance Errors

It is time to clean the SRV.
*Scheduled Maint.*
Three months have passed from the previous
cleaning.
Clean the SRV.
7500 samples have been analyzed from the
[1] Reset the cycle counter for SRV, previous cleaning.
and you can turn OFF the power.
[3] Continue to start up. SRV cycle
counter will not be reset.
Cause
Action Press [1] key. Following the instructions on the screen, turn OFF the
power and clean the sample rotor valve (SRV). (Refer to Chapter 4:
Section 6.1: Clean Sample Rotor Valve (SRV) ).
If you perform cleaning later, press [3] key. This activates the usual
startup sequence and makes the system Ready.
∗ The same message will appear the next time you start the unit; it
will be displayed at each startup until the cleaning is performed.
occurrence
NOTE: • When you clean SRV without pressing [1] key, execute “7: Maintenance,” and
then “3: Reset Counter” in the Select Menu.

TROUBLESHOOTING

It is time to clean the waste chamber.
*Scheduled Maint*
One month has passed from the previous
cleaning.
previous cleaning.

Cause
Action Press [1] key. Following the instructions on the screen, clean the
waste chamber. (Refer to Chapter 4, Section 5.1: Clean Waste
Chamber (Rinse Sequence)).
occurrence
NOTE: • When the waste chamber rinse sequence has been completed, the cycle
counter is automatically reset.

TROUBLESHOOTING

It is time to clean the transducer.
*Scheduled Maint*
One month has passed from the previous
cleaning.
Clean the Transducer.
previous cleaning.

Cause
Action Press [1] key. Following the instructions on the screen, clean the
transducer (Refer to Chapter 4, Section 5.2: Clean Transducer
(Rinse Sequence)).
occurrence
NOTE: • When the transducer rinse sequence has been completed, the cycle counter
is automatically reset.

TROUBLESHOOTING
3.10 Printer Errors

“Abnormal IP ” The printer has an error.
*Help*
Error on IP
Press the paper guide lever down.

[3] Stop printing on IP
To make IP on-line,
press[SELECT], then
[Periph.Settings]
ERR CODE:XXXXX.X.X
1:Printing 2:Paper Feed 3:Stop Output
Cause 1) The paper release lever is not in the secured position.

Action 1) Confirming the Printer
Check the printer, and make it to a normal status.
After checking, press [1] key to print the not completed data.
2) Make the Built-in Printer Off-line
Press [3] key to make the printer off-line. The main unit becomes
Ready but cannot print. When you want to try printing again,
refer to Chapter 10: INSTRUMENT SETUP and make settings
for connecting the printer.
occurrence For the built-in printer (IP), paper-feed can be performed by pressing
[2] key.

TROUBLESHOOTING

“Abnormal GP, Abnormal DP ” The printer has an error.
*Help*
(“GP” (graphic printer) or “DP” (data printer) is
displayed in “##” of the screen.)
## printout error
Check ##
[1] Restart printing

[3] Stop printing on ##
To make ## on-line
press[SELECT], then
[Periph.Settings]
ERR CODE:XXXXX.X.X
Cause 1) The printer is not connected.

2) There is no power to the printer.
3) Abnormality of connected cable
Action 1) Confirming the Printer
Check the printer, and make it to a normal status.
After checking, press [1] key to print the not completed data
2) Make the Printer Off-line
Press [3] key to make the printer off-line. The main unit becomes
Ready but cannot print. When you want to try printing again,
occurrence

TROUBLESHOOTING

“Abnormal IP, Abnormal GP” Paper found empty.
*Help*
(“IP” (built-in printer) or “GP” (graphic printer)
is displayed in “##” of the screen.)
## paper empty

[3] Stop printing on ##
To make ## on-line,
press[SELECT], then
[Periph.Settings]
ERR CODE:XXXXX.X.X
Cause 1) No printer paper in the printer

Action 1) Replace Print Paper
Refer to Chapter 4, Section 8.3: Replace Printer Paper. After
replacing, press [1] key to print the data that has not yet printed.
2) Make the Printer Off-line
When you press [3], the printer is made off-line. The main unit
becomes Ready but cannot print. When you want to try printing,
occurrence
NOTE: • For the built-in printer (IP), paper-feed can be performed by pressing [2] key.

TROUBLESHOOTING
3.11 External Device Errors

“Host Comm. Error” Communications cannot be made with the
host computer. There are four cases:
*Help*
• Host Off-line
Host Output Error
*Host ACK Time Out Error*
• Host ACK Time Out Error
Check Host Condition • Host NAK Retry Error
[1] Retries to transmit to Host • Host Transmission Time Out Error
[3] Stop transmitting to Host
To make Host Computer on-line,
press[SELECT], then
[Periph.Settings]
ERR CODE:XXXXX.X.X
1:Re-sending 3:Stop Output
Cause 1) Computer connecting cable failure

2) Computer is not turned ON or not ready for communication.
3) Host computer serial interface error
Action 1) Inspect Host Computer Cable
2) Inspect Connection Cable
When you press [1] key after inspection, data transmission is
resumed.
3) Disconnecting Host Computer
When you press [3] key, transmission to the host computer is
canceled and the host is off-lined in the main unit. The main unit
is now Ready but cannot output to the host computer.
To resume transmission to the host computer, refer to Chapter
10: INSTRUMENT SETUP and make settings for connecting the
host computer.
occurrence

TROUBLESHOOTING
4. STATUS DISPLAY
The unit has the Status Display screen by which you can confirm the status of the instru-
ment. The Status Display screen displays in real time a currently-running sequence, pres-
sure/vacuum readings, sensor status, and solenoid valve operating status. You can also
confirm on the screen HGB Converted value, cycle Nos. after performing the last mainte-
nance, and currently-registered cycle No.
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select “5: Status Display.”
(5) Press [ENTER] key. The Status Display screen appears.

The Status Display screen comprises two pages; you can turn over the pages using
[ ] key or [ ] key.
Page Selection in Status Dislay Screen
P1. Status Display Screen 1 P2. Status Display Screen 2
Figure 7-4-2: Page Selection in Status Display Screen

TROUBLESHOOTING
*Status* WB
Ready Sequence No.
SEQ.No. 12
PRESSURE 0.051 0.05 MPa Pressure
VACUUM 0.0320 0.0333 MPa Vacuum
HGB CONVERT 550 HGB Converted Value
SENSOR 1 2 3 4 5 6 7 Sensor status
SV 1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0 Solenoid valve operating status
1 2 3 4
Change screen with [ ] or [ ]
Figure 7-4-3: P1. Status Display Screen 1
*Status* WB
Ready Cycle No.
COUNTER 1234567
WASTE CHAMBER 2567 Cycle No. after cleaning waste chamber
DETECTOR 2567 Cycle No. after cleaning transducer
SRV 7567 Cycle No. after cleaning SRV
Figure 7-4-4: P2. Status Display Screen 2

TROUBLESHOOTING
5. ERROR HISTORY PRINT

Recent occurred ten times error history can be printed from the built-in printer.
Execution of Error History Print

*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select “6: Print Error History.”
(5) Press [ENTER] key. The built-in printer prints the error history.
Print Example
Date 31/12/2000
Time 23:59
*Error History*
Date 31/12/2000
Time 13:00
Pressure/Vac Error
XXXXXX.XXXXXX.XXXXXX
Date 24/12/2000
Time 09:15
Waste Not Draining
Date 24/12/2099
Time 12:30
Host Comm. Error
..
..
Figure 7-5-2: Error History Print

TROUBLESHOOTING
6. PROGRAM VERSION
This menu can be used to display the program version.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select “7: Program Version.”
(5) Press [ENTER] key. The Program Version screen appears.
*Program Version*
Program Version [1KXNF ##-##]
Figure 7-6-2: Program Version Screen

TROUBLESHOOTING

CHAPTER 8 ADJUSTMENT
1. INTRODUCTION ................................................................................... 8-1
2. ADJUSTMENT OF PRESSURE AND VACUUM................................. 8-2

2.1 Location of Control Knobs .......................................................... 8-2
2.2 Pressure and Vacuum Display...................................................... 8-3
2.3 Adjusting Pressure to 0.05 MPa................................................... 8-5
2.4 Adjusting Vacuum to 0.0333 MPa ............................................... 8-6

ADJUSTMENT
1. INTRODUCTION
The adjustment procedures described here are important in maintaining accuracy of this
instrument. Your Sysmex service representative will perform initial adjustment. Should it
require any adjustment subsequently, follow the procedures given below.
The following adjustment procedures are explained in this chapter.
• Pressure: 0.05 MPa

• Vacuum: 0.0333 MPa

ADJUSTMENT
2. ADJUSTMENT OF PRESSURE AND VACUUM

Pressure and vacuum from the built-in Pneumatic Unit are regulated to 0.05 MPa and
0.0333 MPa. The pressure and vacuum are always monitored by pressure sensors. When
an error occurs, an error message is displayed.
If the pressure or vacuum error message is displayed, check tubing connections or the like
for any air leakage. If there is no such error, display the Status Display screen and adjust
pressure or vacuum as required.
2.1 Location of Control Knobs
0.0333 MPa Bellows Unit
0.05 MPa Regulator
Figure 8-2-1: Location of Control Knobs
NOTE: • When an error has occurred, press [HELP] key to check pressure
or vacuum value on the Help screen.
(Refer to Chapter 7: TROUBLESHOOTING.)
*Help*
0.05 MPa Pressure Error
0.034 [0.039 - 0.059]
Adjust 0.05 MPa Pressure
1 Restarting to monitor the pressure
ERR CODE: XXXX.X.X

1:End of Adj
Figure 8-2-2: Help Screen

ADJUSTMENT
2.2 Pressure and Vacuum Display

(1) Press [SELECT] key when the status is “Ready.” The Select Menu screen appears.
(2) Move the cursor using [ ] key or [ ] key, and select “7: Maintenance.”

The Maintenance Menu screen appears.
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
7:Program Version
(4) Move the cursor using [ ] key or [ ] key, and select “5: Status Display.”

The Status Display screen appears.
*Status* WB
Ready
SEQ.No. 12
PRESSURE 0.051
VACUUM 0.0320
HGB CONVERT 550
SENSOR 1 2 3 4 5 6 7
SV 1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4
Figure 8-2-4: Status Display Screen
NOTE: • Each menu can be selected directly on the Menu screen by enter-
ing a numeral from the numeric keys.

ADJUSTMENT
NOTE: • The Status Display screen shows current pressure and vacuum.
*Status* WB
Ready
SEQ.No. 12 Pressure: 0.05 MPa
PRESSURE 0.051 (displaying 0.051 MPa)
VACUUM 0.0320
HGB CONVERT 550 Vacuum: 0.0333 MPa
(displaying 0.0320 MPa)
SENSOR 1 2 3 4 5 6 7
SV 1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4
Figure 8-2-5: Status Display Screen
(6) Adjust the pressure and vacuum by following the procedures given on the next
page and later.

ADJUSTMENT
2.3 Adjusting Pressure to 0.05 MPa

(1) Using the procedure of “2.2 Pressure and Vacuum Display,” display the Status Dis-
play screen.
(2) Loosen the 0.05 MPa regulator locking nut on the left side of the unit.
(3) While watching the pressure and vacuum indication on the Status Display screen,
turn the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob
clockwise to increase pressure and vacuum.
Adjustment range: 0.05±0.01 MPa
Low
Loosen
High
Locking nut
Adjusting knob
Figure 8-2-6: Adjusting the Pressure
CAUTION: • Always adjust pressure and vacuum so as to increase to the prede-

termined levels. Should any of them be too high, lower it to below
that level once, then raise it to the set level. Unless adjustment is
properly conducted, accurate adjustment may not be possible.
(4) When adjustment is finished, tighten the locking nut while taking care not to allow
the adjusting knob to rotate.
(5) Press [SELECT] key to return to the Ready status.

ADJUSTMENT
2.4 Adjusting Vacuum to 0.0333 MPa

(1) Using the procedure of “2.2 Pressure and Vacuum Display,” display the Status
Display screen.
(2) By turning counterclockwise, loosen the locking nut for the bellows unit on the left
side of the unit.
(3) While watching the pressure and vacuum indication on the Status Display screen,
turn the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob
clockwise to increase pressure and vacuum.
Adjustment range: 0.0333±0.0013 MPa
Low High
Loosen
Adjusting knob
Locking nut
Figure 8-2-7: Adjusting the Vacuum
CAUTION: • Always adjust pressure and vacuum so as to increase to the prede-

termined levels. Should any of them be too high, lower it to below
that level once, then raise it to the set level. Unless adjustment is
properly conducted, accurate adjustment may not be possible.
(4) When adjustment is finished, tighten the locking nut while taking care not to allow
the adjusting knob to rotate.
(5) Press [SELECT] key to return to the Ready status.

CHAPTER 9 FUNCTIONAL DESCRIPTION
1. INTRODUCTION ................................................................................... 9-1
2. DETECTION PRINCIPLE...................................................................... 9-2

2.1 DC Detection Method .................................................................. 9-2
2.2 Non-Cyanide Hemoglobin Analysis Method .............................. 9-2
3. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM ......9-4
4. CBC ANALYSIS ..................................................................................... 9-5

4.1 WBC/HGB Analysis Flow........................................................... 9-5
4.2 RBC/PLT Analysis Flow ............................................................. 9-7
4.3 Calculation of RBC Constant ...................................................... 9-9
5. BLOOD CELL DISCRIMINATION CIRCUIT .................................... 9-10

5.1 WBC Discriminator ................................................................... 9-10
5.2 RBC Discriminator .................................................................... 9-10
5.3 PLT Discriminator ..................................................................... 9-10
6. ANALYSIS OF HISTOGRAM ............................................................. 9-11

6.1 Analysis of WBC Histogram ..................................................... 9-11
6.2 Analysis of RBC/PLT Histogram .............................................. 9-20
7. ELECTRIC SYSTEM............................................................................ 9-28
8. NAMES AND FUNCTIONS OF INSTRUMENTS.............................. 9-30

8.1 Front Panel ................................................................................. 9-30
8.2 Front Interior.............................................................................. 9-31
8.3 Right Side Panel......................................................................... 9-32
8.4 Left Side Panel........................................................................... 9-33
8.5 Left Side Interior........................................................................ 9-34
8.6 Rear Panel .................................................................................. 9-35

FUNCTIONAL DESCRIPTION
1. INTRODUCTION
This chapter describes blood cell count detection principle and analysis method used in
this instrument, and flow of individual analysis. Also the hardware elements are
explained.
• Detection Principle: Principle each of DC detection method and non-cya-

nide hemoglobin analysis method is described.
• Flow of Analysis: Flow of each analysis parameter on the main unit
and analysis method for particle distribution are
described.
• Function of Measuring Unit: Names and functions of the measuring unit's ele-
ments are briefly described.

2. DETECTION PRINCIPLE
This instrument performs blood cell count by DC detection method.
2.1 DC Detection Method

Blood sample is aspirated, measured to a predetermined volume, diluted at the specified
ratio, then fed into each transducer. The transducer chamber has a minute hole called the
aperture. On both side of the aperture, there are the electrodes between which flows direct
current. Blood cells suspended in the diluted sample pass through the aperture, causing
direct current resistance to change between the electrodes. As direct current resistance
changes, the blood cell size is detected as electric pulses.
Blood cell count is calculated by counting the pulses, and a histogram of blood cell sizes is
plotted by determining the pulse sizes. Also, analyzing a histogram makes it possible to
obtain various analysis data.
DC
DC Supply
Transducer Chamber
Resistance
External Electrode +
Blood Cell Suspension
Aperture Internal Electrode -
Figure 9-2-1: DC Detection Method
2.2 Non-Cyanide Hemoglobin Analysis Method

To analyze hemoglobin by automated methods, the Cyanmethemoglobin method or
Oxyhemoglobin method have so far been the main stream.
Cyanmethemoglobin method was recommended as the international standard method in
1966 by ICSH (International Committee for Standardization in Hematology). This
method, however, is so low in hemoglobin conversion rate that it cannot be said an
appropriate method in the automated process in which multi-sample processing is the
pre-condition. In addition, this method uses the reagent of cyanide compound which is a
poisonous substance and requires waste processing; thus, it can hardly be called an
environmentally favorable method.
At present, this method cannot be said suitable for a fully-automated instrument which is
required to handle a large amount of waste.

The Oxyhemoglobin method, on the other hand, is faster in hemoglobin conversion rate;
in fact, blood hemoglobin is converted instantaneously into oxyhemoglobin. Also, it does
not contain poisonous substance as cyanmethemoglobin method, making the method suit-
able for automation. This method, however, is unable to convert methemoglobin into
oxyhemoglobin. Consequently, when a great amount of methemoglobin is contained as in
control blood, lower-than-real values result, although usual human blood poses no prob-
lems.
Non-cyanide hemoglobin analysis method utilizes the advantages of both of the above
methods. Non-cyanide hemoglobin analysis method rapidly converts blood hemoglobin
as the Oxyhemoglobin method and contains no poisonous substance, making it suitable
for automated method.
Being capable of analyzing methemoglobin, this method can accurately analyze control
blood, etc. which contain methemoglobin.

3. MEASURING UNIT HYDRAULIC SYSTEM BLOCK DIAGRAM

<Whole Blood Mode>
1.960 mL
RBC
Diluent 1.996 mL TD Chamber
Mixing Chamber 40 µL (1:25000)
4.0 µL (1:500)
1.994 mL
1.0 mL WBC
WBC/HGB Lyse TD Chamber
6 µL
Sample Rotor Valve

(1:500)
(SRV)
HGB Flow Cell
(1:500)
Whole Blood Sample (50 µL)
Figure 9-3-1: Hydraulic System in Whole Blood Mode
<Pre-diluted Mode>
1.99792 mL
Diluent RBC
TD Chamber
Mixing Chamber 2.08 µL
(1:25000)
1.922 mL
1.0 mL WBC
WBC/HGB Lyse TD Chamber
78 µL
Sample Rotor Valve
(1:1000)
(SRV)
HGB Flow Cell
(1:1000)
1:26 Diluted Sample (200 µL)
Figure 9-3-2: Hydraulic System in Pre-diluted Mode

4. CBC ANALYSIS
4.1 WBC/HGB Analysis Flow
In WBC and HGB analysis, the volume of WBC and hemoglobin in the blood are mea-
sured. The flow of WBC/HGB analysis is described below:
Diluent: 2.0 mL WBC/HGB Lyse:

Whole Blood Mode 1.0 mL
Pre-diluted Mode 1.0 mL
Sample Rotor Valve
Whole Blood Mode 1 mL

Pre-diluted Mode 1 mL
HGB Flow Cell

Whole Blood Mode : Diluent 1.994 mL
Whole Blood 6 µL
Pre-diluted Mode : Diluent 1.922 mL
1:26 Diluted Sample 78 µL
WBC Transducer
Tube or Microtube
Whole Blood Mode: 50 µL
Pre-diluted Mode: 1:26 Diluted Sample 200 µL
Figure 9-4-1: WBC/HGB Analysis Flow
• Whole Blood Mode

(1) Blood is aspirated from the sample probe into the sample rotor valve.
(2) 6 µL of blood measured by the sample rotor valve is transferred to the WBC
transducer chamber along with 1.994 mL of diluent. At the same time, 1.0 mL of
WBC/HGB lyse is added to prepare 1:500 dilution sample.
When the solution is made to react in this status for approximately 10 seconds,
RBC is hemolyzed and platelets shrink, with WBC membrane held as they are. At
the same time, hemoglobin is converted into red colored methemoglobin.
(3) Of the diluted/hemolyzed sample in the WBC transducer chamber, approximately

1 mL is transferred to the HGB flow cell.

(4) 500 µL of sample in the WBC transducer is aspirated through the aperture. The
pulses of the blood cells when passing through the aperture are counted by the DC
detection method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting
diode (LED) is applied to the sample in the HGB flow cell. Concentration of this
sample is measured as absorbance. This absorbance is compared with that of the
diluent alone that was measured before addition of the sample, thereby calculating
HGB (hemoglobin value).
• Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK.
This sample is aspirated from the sample probe into the sample rotor valve.
(2) 78 µL of diluted blood measured by the sample rotor valve is transferred to the
WBC transducer chamber along with 1.922 mL of diluent. At this time, 1.0 mL of
WBC/HGB lyse is added to prepare 1:1000 dilution sample.
When the solution is made to react in this status for approximately 10 seconds,
RBC is hemolyzed and platelets shrink, with WBC membrane held as they are. At
the same time, hemoglobin is converted into red colored methemoglobin.
(3) Of the diluted/hemolyzed sample in the WBC transducer chamber, approximately

1 mL is transferred to the HGB flow cell.
(4) 500 µL of sample in the WBC transducer chamber is aspirated through the aper-
ture. The pulses of the blood cells when passing through the aperture are counted
by the DC detection method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting
diode (LED) is applied to the sample in the HGB flow cell. Concentration of this
sample is measured as absorbance. This absorbance is compared with that of the
diluent alone that was measured before addition of the sample, thereby calculating
HGB (hemoglobin value).

4.2 RBC/PLT Analysis Flow

In RBC/PLT analysis, RBC and platelet count in the blood are measured. The flow of
RBC/PLT analysis is described below:
• Whole Blood Mode
Diluent: 2.0 mL Diluent 1.996 mL

Whole Blood 4 µL
Sample Rotor Valve Diluent 1.960 mL

1:500 Diluted Sample 40 µL
RBC/PLT Transducer
(1:500 Diluted Sample: 40 µL)

Tube
(Whole Blood: 50 µL) Mixing Chamber
Figure 9-4-2: RBC/PLT Analysis Flow in Whole Blood Mode
(1) Blood is aspirated from the sample probe into the sample rotor valve.
(2) 4.0 µL of blood measured by the sample rotor valve is diluted into 1:500 with
1.996 mL of diluent and brought to the mixing chamber as diluted sample. (1st
step dilution)
(3) Out of the 1:500 dilution sample, 40 µL is measured by the sample rotor valve,
diluted into 1:25000 with 1.960 mL of diluent, then transferred to the RBC/PLT
transducer chamber. (2nd step dilution)
(4) 250 µL of the sample in the RBC/PLT transducer chamber is aspirated through the
aperture. At this time, RBC and PLT are counted by the DC detection method.
At the same time, HCT (hematocrit value) is calculated by RBC pulse height
detection method.

• Pre-diluted Mode
Diluent : 2.0 mL Diluent 1.99792 mL

1:26 Diluted Sample 2.08 µL
Sample Rotor Valve
Microtube RBC/PLT Transducer

(1:26 Diluted Sample: 200 µL)
Figure 9-4-3: RBC/PLT Analysis Flow in Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK.
This sample is aspirated from the sample probe into the sample rotor valve.
(2) 2.08 µL of diluted blood measured by the sample rotor valve is transferred in
1.99792 mL of diluent to the RBC/PLT transducer chamber, and is made into
1:25000 dilution sample.
(3) Of the sample in the RBC/PLT transducer chamber, 250 µL is aspirated through
the aperture. At this time, RBC and PLT are calculated by the DC detection
method. At the same time, HCT (hematocrit value) is calculated by RBC pulse
height detection method.

4.3 Calculation of RBC Constant

RBC constant (mean RBC volume, mean RBC hemoglobin, mean RBC hemoglobin con-
centration) is calculated from RBC, HGB, and HCT.
1. Mean RBC Volume (MCV)

Calculation is made from RBC and HCT by the formula below:
HCT (%)
MCV (fL) = 6 ×10
RBC (×10 /µL)
2. Mean RBC Hemoglobin (MCH)

Calculation is made from RBC and HGB by the formula below:
HGB (g/dL)
MCH (pg) = 6 ×10
RBC (×10 /µL)
3. Mean RBC Hemoglobin Concentration (MCHC)

Calculation is made from HCT and HGB by the formula below:
HGB (g/dL)
MCHC (g/dL) = ×100
HCT (%)

5. BLOOD CELL DISCRIMINATION CIRCUIT

WBC, RBC, and PLT are discriminated and calculated by the following blood cell dis-
criminator.
5.1 WBC Discriminator

As to WBC LOWER discriminator, the optimum position in 30 - 60 fL is automatically
determined by the microcomputer. WBC is calculated from the particle counts more than
this LOWER discriminator.
5.2 RBC Discriminator

As to RBC LOWER discriminator and UPPER discriminator, the optimum position in 25 -
75 fL and 200 - 250 fL, respectively, are automatically determined by the microcomputer.
RBC is calculated from the particle counts between this LOWER discriminator and
UPPER discriminator.
5.3 PLT Discriminator

As to PLT LOWER discriminator and UPPER discriminator, the optimum position in 2 - 6
fL and 12 - 30 fL, respectively, are automatically determined by the microcomputer. PLT
count is calculated from the particle counts between this LOWER discriminator and
UPPER discriminator.

6. ANALYSIS OF HISTOGRAM
Analysis of histogram allows use of the flagging system that suggests sample error or
instrument error.
Histograms of WBC, RBC, and PLT can be calculated respectively within the ranges
given below.
WBC: Approx. 30 - 300 fL (particle after lyse dripping)

RBC: Approx. 25 - 250 fL
PLT: Approx. 2 - 30 fL
6.1 Analysis of WBC Histogram

1. WBC Histogram
The WBC histogram is discriminated into small, middle, and large WBC by 3-part
differential method using 4 discriminators. The LOWER discriminator (LD) is
automatically determined at an optimum position between 30 and 60 fL. The
UPPER discriminator (UD) is fixed at 300 fL, which is used as the monitor for his-
togram error. The WBC histogram troughs in the (LD)-to-(UD) range are deter-
mined; the 1st one is defined TROUGH Discriminator 1 (T1) and the 2nd one
TROUGH Discriminator 2 (T2).
• WBC Histogram
LD T1 T2 UD
WBC
100 200 300 [fL]

Lymphocytes Mixed cells Neutrophils
Figure 9-6-1: WBC Histogram
1) LYM# [W-SCC (WBC-Small Cell Count) ]

Lymphocytes between discriminator (LD) and (T1), which is considered
highly correlated with lymphocyte count.
2) MXD# [W-MCC (WBC-Middle Cell Count) ]

Mixed cells between discriminator (T1) and (T2), which is considered highly
correlated with the sum of monocytes, basophils, and eosinophils.
3) NEUT# [W-LCC (WBC-Large Cell Count)]

Neutrophils more than discriminator (T2), which is considered highly corre-
lated with neutrophils.

4) LYM% [W-SCR (WBC-Small Cell Ratio) ]

Ratio of lymphocytes to whole WBC
5) MXD% [W-MCR (WBC-Middle Cell Ratio) ]

Ratio of mixed cells to whole WBC
6) NEUT% [W-LCR (WBC-Large Cell Ratio) ]

Ratio of neutrophils to whole WBC

2. WBC Histogram Error Flag

When the WBC histogram is normal with three peaks, there are a lower trough
(T1) and a higher trough (T2) between LOWER discriminator (LD) and UPPER
discriminator (UD).
• Output Example of Normal WBC Three-Peak Histogram
LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% 28.3 [%]
MXD% 17.4 [%]
NEUT% 54.3 [%]
LYM# 1.9 [×103/µL]
100 200 300 [fL] MXD# 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]
Figure 9-6-2: Normal WBC Three-Peak Histogram
When TROUGH Discriminator (T1) or (T2) cannot be set or when frequency for a
set discriminator position is higher than the range, it is flagged as WBC histogram
error. Those histogram error flags are listed below in the order of higher priority.
If more than one flag are applied, the flag of the highest priority is taken.
WL: Relative frequency for LOWER discriminator (LD) exceeds the range.
Probable cause is inclusion of numerous platelet agglutinations, large
platelets, and etc.
T1: Lower TROUGH Discriminator, that distinguishes lymphocytes and mixed

cells, cannot be not determined.
T2: Higher TROUGH Discriminator, that distinguishes mixed cells and neutro-
phils, cannot be not determined.
F1: Small cell histogram error. Relative frequency for T1 exceeds the range.
F2: Middle cell histogram error. Relative frequency for T1 or T2 exceeds the
range.
F3: Large cell histogram error. Relative frequency for T2 exceeds the range.
WU: Relative frequency for UPPER discriminator (UD) exceeds the range.
Applicable cases are those in which hemolysis is insufficient (for instance,
samples whose RBC membrane has extremely strong resistance against
lyse) or in which numerous abnormal blood cells are present.
AG: The particle count equal to or less than the LD exceeds a prescribed range.
Probable cause is platelet agglutination, which does not alter WBC count
but may result in decreased platelet count. Therefore, this flag is added to
the PLT parameter.

• WBC and Calculation Parameters versus Analysis Value Error Flags
WBC Histogram Error Flag Output

[1] [2]
Case
No. LD T1 T2 UD WBC LYM% MXD% NEUT% LYM# MXD# NEUT# HOST
1 High WL WL WL WL WL WL WL 1
2A O × O T1 T1 T1 T1 T1 T1 5
2B O × High WU T1 T1 T1 T1 T1 T1 5
3A O High × O F1 T2 T2 F1 T2 T2 6
3B O High × High WU F1 T2 T2 F1 T2 T2 6
3C O O × O T2 T2 T2 T2 6
3D O O × High WU T2 T2 T2 T2 6
4A O High O O F1 F2 F1 F2 7
4B O High O High WU F1 F2 F1 F2 7
4C O High High O F1 F2 F3 F1 F2 F3 7
4D O High High High WU F1 F2 F3 F1 F2 F3 7
5A O O High O F2 F3 F2 F3 8
5B O O High High WU F2 F3 F2 F3 8
6 O O O High WU 2
7 (The particle count equal to PLT parameter is flagged with AG. 2
or less than LD is higher than
the range)
[1] : Output flag to LCD screen, printer.

[2] : Output flag to host computer.
O : Analysis result of each discriminator is normal
High : Frequency for each discriminator is higher than the range.
× : A trough is not clear and cannot be detected.
: Any of “O ,” “×,” and “High” is applicable.
Table 9-6-1: WBC Histogram Error Flags
NOTE: • When analyzing in the pre-diluted mode, since CBC8 parameters

only are output, flagging is limited to a WBC parameter.

1) 1A Histogram having high LD frequency with troughs T1 and T2

WL flag is added to all WBC parameters (WBC, LYM%, MXD%, NEUT%,
LYM#, MXD#, NEUT#).
• WBC Histogram Error-WL (1A)
LD T1 T2 UD
WBC WL 8.5 [×103/µL]
WBC
LYM% WL 39.3 [%]
MXD% WL 17.6 [%]
NEUT% WL 43.1 [%]
LYM# WL 3.4 [×103/µL]
100 200 300 [fL] MXD# WL 1.5 [×103/µL]
NEUT# WL 3.6 [×103/µL]
Figure 9-6-3: WBC Histogram Error-WL (1A)

2) 1B Histogram with high LD and trough T1 but without T2
WL flag is added to all analysis results for WBC, LYM% and LYM#. WL
flag is added to mixed cell and neutrophil parameters (MXD%, NEUT%,
MXD#, NEUT#) and their data are not output. ([---.-])
• WBC Histogram Error-WL (1B)
LD T1 UD
WBC WL 2.8 [×103/µL]
WBC
LYM% WL 45.9 [%]
MXD% WL ---.- [%]
NEUT% WL ---.- [%]
LYM# WL 1.3 [×103/µL]
100 200 300 [fL] MXD# WL ---.- [×103/µL]
NEUT# WL ---.- [×103/µL]
Figure 9-6-4: WBC Histogram Error-WL (1B)

3) 1C Histogram with high LD but without T1
WL flag is added to WBC and other parameters are not output. Note [+] on
WBC numeric data in the example below. This WBC value exceeds the
upper Patient Mark Limits mentioned earlier.
• WBC Histogram Error-WL (1C)
LD UD
WBC WL +16.4. [×103/µL]
WBC
LYM% WL ---.- [%]
MXD% WL ---.- [%]
NEUT% WL ---.- [%]
LYM# WL ---.- [×103/µL]
100 200 300 [fL] MXD# WL ---.- [×103/µL]
NEUT# WL ---.- [×103/µL]
Figure 9-6-5: WBC Histogram Error-WL (1C)

4) 2A Histogram without T1
Although the histogram error flag is not added to WBC, all other parameters
are flagged with T1 and their data are not output. Note that WBC in the
graph exceeds the upper Patient Mark Limits.
• WBC Histogram Error-T1 (2A)
LD UD WBC +15.4 [×103/µL]

WBC
LYM% T1 ---.- [%]
MXD% T1 ---.- [%]
NEUT% T1 ---.- [%]
LYM# T1 ---.- [×103/µL]
100 200 300 [fL] MXD# T1 ---.- [×103/µL]
NEUT# T1 ---.- [×103/µL]
Figure 9-6-6: WBC Histogram Error-T1 (2A)
5) 2B Histogram having high UD but without T1

WBC is flagged with WU. All other parameters are flagged with T1 and
their data are not output.
6) 3A Histogram with high T1 but without T2

WBC is not flagged. F1 flag is added to lymphocyte parameters (LYM%,
LYM#). Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#,
NEUT#) are flagged with T2 and their data are not output.
• WBC Histogram Error-T2 (3A)
LD T1 UD WBC 5.2 [×103/µL]

WBC
LYM% F1 29.7 [%]
MXD% T2 ---.- [%]
NEUT% T2 ---.- [%]
LYM# F1 1.5 [×103/µL]
100 200 300 [fL] MXD# T2 ---.- [×103/µL]
NEUT# T2 ---.- [×103/µL]
Figure 9-6-7: WBC Histogram Error-T2 (3A)
7) 3B Histogram with high T1 but without T2, and high in UD frequency

WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are
flagged with F1. Mixed cell and neutrophil parameters (MXD%, NEUT%,
MXD#, NEUT#) are flagged with T2 and their data are not output.

8) 3C Histogram with T1 but without T2

WBC and lymphocyte parameters (LYM%, LYM#) are not flagged as the
histogram error. Mixed cell and neutrophil parameters (MXD%, NEUT%,
MXD#, NEUT#) are flagged with T2 and data are not output.
WBC shown below exceeds the upper Patient Mark Limits.
• WBC Histogram Error-T2 (3C)
LD T1 UD
WBC +15.2 [×103/µL]
WBC
LYM% 12.9 [%]
MXD% T2 ---.- [%]
NEUT% T2 ---.- [%]
LYM# 1.6 [×103/µL]
100 200 300 [fL] MXD# T2 ---.- [×103/µL]
NEUT# T2 ---.- [×103/µL]
Figure 9-6-8: WBC Histogram Error-T2 (3C)
9) 3D Histogram with high T1 but no T2, and with high UD

WBC is flagged with WU. Lymphocyte parameters (LYM%, LYM#) are not
flagged. Mixed cell and neutrophil parameters (MXD%, NEUT%, MXD#,
NEUT#) are flagged with T2 and their data are not output.
10) 4A Histogram with high T1

WBC and neutrophil parameters (NEUT%, NEUT#) are not flagged.
Lymphocyte parameters (LYM%, LYM#) are flagged with F1 and mixed cell
parameters (MXD%, MXD#) are flagged with F2.
• WBC Histogram Error - F1 (4A)
LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% F1 28.3 [%]
MXD% F2 17.4 [%]
NEUT% 54.3 [%]
LYM# F1 1.9 [×103/µL]
100 200 300 [fL] MXD# F2 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]
Figure 9-6-9: WBC Histogram Error - F1 (4A)
11) 4B Histogram with high T1 and UD

WBC is flagged with WU, lymphocyte parameters (LYM%, LYM#) are
flagged with F1, and mixed cell parameters (MXD%, MXD#) with F2.
Neutrophil parameters (NEUT%, NEUT#) are not flagged.

12) 4C Histogram with high T1 and high T2

WBC is not flagged. Lymphocyte parameters (LYM%, LYM#) are flagged
with F1, mixed cell parameters (MXD%, MXD#) with F2, and neutrophil
parameters (NEUT%, NEUT#) with F3.
• WBC Histogram Error - F1 (4C)
LD T1 T2 UD WBC 10.7 [×103/µL]

WBC
LYM% F1 20.8 [%]
MXD% F2 11.2 [%]
NEUT% F3 68.0 [%]
LYM# F1 2.2 [×103/µL]
100 200 300 [fL] MXD# F2 1.2 [×103/µL]
NEUT# F3 7.3 [×103/µL]
Figure 9-6-10: WBC Histogram Error - F1 (4C)
13) 4D Histogram high in all T1, T2, and UD

WBC data are output with WU flag, lymphocyte parameters (LYM%,
LYM#) with F1 flag, mixed cell parameters (MXD%, MXD#) with F2 flag,
and neutrophil parameters (NEUT%, NEUT#) with F3 flag.
14) 5A Histogram with high T2

Histogram error flag is not added to WBC and lymphocyte parameters
(LYM%, LYM#). Mixed cell parameters (MXD%, MXD#) are flagged with
F2, and neutrophil parameters (NEUT%, NEUT#) with F3 flag. WBC and
MXD% exceed the upper Patient Mark Limits.
• WBC Histogram Error - F2 (5A)
LD T1 T2 UD
WBC +18.5 [×103/µL]
WBC
LYM% 9.5 [%]
MXD% F2 +23.7 [%]
NEUT% F3 66.8 [%]
LYM# 1.1 [×103/µL]
100 200 300 [fL] MXD# F2 2.7 [×103/µL]
NEUT# F3 7.7 [×103/µL]
Figure 9-6-11: WBC Histogram Error - F2 (5A)
15) 5B Histogram with high T2 and high UD

WBC is flagged with WU and lymphocyte parameters (LYM%, LYM#) are
not flagged. Mixed cell parameters (MXD%, MXD#) are flagged with F2,
and neutrophil parameters (NEUT%, NEUT#) with F3.

16) 6 Histogram with high UD

WBC is flagged with WU and other parameters are not flagged. WBC in
this instance exceeds the upper Patient Mark Limits.
• WBC Histogram Error - WU (6)
LD T1 T2 UD
WBC WU+ 15.4 [×103/µL]
WBC
LYM% 24.5 [%]
MXD% 7.5 [%]
NEUT% 68 [%]
LYM# 3.3 [×103/µL]
100 200 300 [fL] MXD# 1.0 [×103/µL]
NEUT# 8.1 [×103/µL]
Figure 9-6-12: WBC Histogram Error - WU (6)
17) 7 The particle count equal to or less than LD is higher than the range.
PLT is flagged with AG and other parameters are not flagged.

6.2 Analysis of RBC/PLT Histogram

1. RBC Histogram
As mentioned earlier, RBC are determined as particle counts between two discrim-
inators (LD) and (UD) which are automatically counted in the ranges of 25 - 75 fL
and 200 - 250 fL, respectively.
As to histogram, check is made for relative frequency errors on respective discrim-
inator levels, for more than one peak, and for distribution width error.
In addition, this instrument is capable of expressing RBC distribution width

(RDW) by two methods below:
RDW-CV (RBC Distribution Width - Coefficient of Variation) is calculated by the

formula below, after determining points L1 and L2 for 68.26% of the entire parti-
cle area. The unit applied is %.
• Calculation of RDW-CV
L2 - L1
RDW-CV (%) = ×100
L2 + L1
68.26% of Entire Distribution Area
L1 L2
Figure 9-6-13: Calculation of RDW-CV
RDW-SD (RBC Distribution Width - Standard Deviation) is set on 20% frequency

level with the peak taken as 100%. The unit applied is fL (femto-liter = 10-15L).
• Definition of RDW-SD
100%
20%
RDW-SD
Figure 9-6-14: Definition of RDW-SD

2. PLT Histogram
Platelet histogram is analyzed using three discriminators: two discriminators (LD)
and (UD) - determined automatically between 2 - 6 fL and between 12 - 30 fL,
respectively -and the fixed discriminator at 12 fL. Regarding PLT histogram,
check is made to see that there are no relative frequency errors at discriminators
(LD) and (UD), distribution width error, and there is a single peak.
1) MPV (Mean Platelet Volume)

MPV is calculated by the following formula:
PCT (%)
MPV (fL) = 3 ×10000
PLT (×10 /µL)
Where PCT (%) represents the value weighted with PLT frequency and is called
platelet-crit or platelet volume ratio. The analysis method used is the same as
mentioned in HCT analysis principle 4.2 RBC/PLT Analysis Flow in this chapter.

3. RBC Histogram Error Flag

When RBC histogram is not normal, a histogram error flag is added to the corre-
sponding parameter of the analysis value. Those histogram error flags are listed in
the order of higher priority. When two or more flags are applicable to a parameter,
the highest-priority flag is used.
RL: Relative frequency for LOWER discriminator (LD) exceeds the range.
Probable cause is the effect of noise, RBC morphological change, platelet
coagulation, or the like.
RU: Relative frequency for UPPER discriminator (UD) exceeds the range.
Probable cause is the effect of noise.
MP: Two or more peaks in histogram.
DW: Particle distribution width error for 20% frequency with the peak taken as
100%. When the 20% frequency does not cross the histogram two times,
this flag is attached.
• Matching of eight kinds of RBC histogram error flags
RBC Histogram Error Flag Output

[1] [2]
Case RDW RDW
No. LD UD DW MP RBC HCT MCV MCH MCHC PLT HOST
-SD -CV
1A High O O RL RL RL RL RL RL RL RL 1
1B High × O RL RL RL RL RL RL DW RL 1
1C High × RL RL RL RL RL RL MP MP 1
2A O High O O RU RU RU RU RU RU RU RU 2
2B O High × O RU RU RU RU RU RU DW RU 2
2C O High × RU RU RU RU RU RU MP MP 2
3 O O × O DW 3
4 O O × MP MP 4
[1]: Output flag to LCD screen, printer.

[2]: Output flag to host computer.
O: • When analysis results of LD and UD are normal
• In the case of DW, when RDW-SD could be analyzed
• In the case of MP, when RBC histogram has a single peak
High: Frequencies of LD and UD are higher than the range
×: • In the case of DW, when RDW-SD could not be analyzed
• In the case of MP, when RBC histogram has two or more peaks
Table 9-6-2: RBC Histogram Error Flags
NOTE: • Since CBC8 parameters only are output in the pre-diluted mode,
a flag is not output to RDW-SD or RDW-CV.

1) 1A Histogram with high frequency for LD

RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data
parameters are flagged with RL. MCV and RDW-SD exceed the upper
Patient Mark Limits, and MCHC falls below the lower Patient Mark Limits.
• RBC Histogram Error - RL (1A)
RBC
RBC RL 3.57 [×106/µL]
HGB 11.5 [g/dL]
HCT RL 41.8 [%]
MCV RL +117.1 [fL]
MCH RL 32.2 [pg]
MCHC RL -27.5 [g/dL]
100 200 250 [fL]
RDW-SD RL +91.7 [fL]
PLT RL 185 [×103/µL]
Figure 9-6-15: RBC Histogram Error - RL (1A)
2) 1B High frequency for LD with 20% particle distribution width error

RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL.
Of the particle distribution width data, RDW-CV is flagged with RL and its
data are output. RDW-SD parameter is flagged with DW and its data are not
output.
3) 1C High LD with two or more peaks

RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RL.
RDW-CV is flagged with MP and its data are output, while RDW-SD is
flagged with MP but its data are not output.
4) 2A Frequency high for UD

RBC, HCT, MCV, MCH, MCHC, PLT, and particle distribution width data
parameters are flagged with RU. In this instance, flags to indicate that their
data are out of Patient Mark Limits are added to MCV, MCHC, and RDW-SD.
• RBC Histogram Error - RU (2A)
RBC RU 3.57 [×106/µL]

RBC
HGB 11.5 [g/dL]
HCT RU 41.8 [%]
MCV RU +117.1 [fL]
MCH RU 32.2 [pg]
MCHC RU -27.5 [g/dL]
100 200 250 [fL]
RDW-SD RU +91.7 [fL]
PLT RU 185 [×103/µL]
Figure 9-6-16: RBC Histogram Error - RU (2A)

5) 2B High UD with 20%-frequency distribution width error

RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged. Out of
the particle distribution width data, RDW-CV is flagged with RU and its data
are output.
RDW-SD is flagged with DW and its data are not output. In this instance,
MCV and MCHC are out of Patient Mark Limits.
• RBC Histogram Error - RU, DW (2B)
RBC RU 3.57 [×106/µL]

RBC HGB 11.5 [g/dL]
HCT RU 52.9 [%]
MCV RU +148.2 [fL]
MCH RU 32.2 [pg]
MCHC RU -21.7 [g/dL]
100 200 250 [fL]
RDW-SD DW ---.- [fL]
PLT RU 185 [×103/µL]
Figure 9-6-17: RBC Histogram Error - RU, DW (2B)
6) 2C High UD with two or more peaks

RBC, HCT, MCV, MCH, MCHC, and PLT parameters are flagged with RU.
As to particle distribution width data, RDW-CV is flagged with MP and its
data are output, while RDW-SD is also flagged with MP but its data are not
output.
7) 3 20%-frequency particle distribution width error

RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As
to the particle distribution width data, RDW-CV data are output without flag-
ging, while RDW-SD data are flagged with DW and their data are not output.
8) 4 Two or more peaks

RBC, HCT, MCV, MCH, MCHC, and PLT parameters are not flagged. As
to the particle distribution width data, RDW-CV data are output with MP
flag. RDW-SD is flagged with MP and its data are not output. In this
instance, RDW-CV is out of Patient Mark Limits.
• RBC Histogram Error - MP (4)
RBC 4.80 [×106/µL]

RBC
HGB 14.2 [g/dL]
HCT 41.5 [%]
MCV 86.5 [fL]
MCH 29.6 [pg]
MCHC -34.2 [g/dL]
100 200 250 [fL]
RDW- CV MP +33.3 [%]
PLT 216 [×103/µL]
Figure 9-6-18: RBC Histogram Error - MP (4)

4. Platelet Histogram Error Flag

When the platelet histogram is not normal, a histogram error flag is added to the
corresponding parameter of the analysis value. Those histogram error flags - used
with the particle distribution analysis unit mounted, are listed in the order of higher
priority.
When two or more flags are applicable to a parameter, the highest priority flag is used.
PL: Relative frequency for LOWER discriminator (LD) exceeds the range.
Probable cause is the effect of noise and etc.
PU: Relative frequency for UPPER discriminator (UD) exceeds the range.
Probable cause is the effect of platelet agglutination, noise interference,
and etc.
MP: Two or more peaks in histogram
DW: Particle distribution width error for 20% frequency with the peak taken as
100%. When the 20% frequency does not cross the histogram two times,
this flag is attached.
• Matching of eight kinds of platelet histogram error flags
Platelet Histogram Error Flag Output

[1] [2]
Case
No. LD UD DW MP PLT MPV HOST
1A High O O PL PL 1
1B High × O PL PL 1
1C High × PL PL 1
2A O High O O PU PU 2
2B O High × O PU PU 2
2C O High × PU PU 2
3 O O × O DW 3
4 O O × MP 4
[1]: Output flag to LCD screen, printer.

[2]: Output flag to host computer.
O: • When analysis results of LD and UD are normal
• In the case of MP, when PLT histogram has a single peak
High: Frequencies of LD and UD are higher than the range.
×: • In the case of MP, when PLT histogram has two or more peaks
Table 9-6-3: Platelet Histogram Error Flags
NOTE: • Since CBC8 parameters only are output in the pre-diluted mode,
flag output is limited to a PLT parameter.

1) 1A High frequency for LD

PLTM and MPV parameters are flagged with PL.
• Platelet Histogram Error - PL (1A)

PLT
PLT PL 211 [×103/µL]
PDW PL 12.5 [fL]
MPV PL 9.3 [fL]
P-LCR PL -22.6 [%]
10 20 30 [fL]
Figure 9-6-19: Platelet Histogram Error - PL (1A)
2) 1B High LD with 20%-frequency distribution width error

PLT parameter is flagged with PL.
MPV is flagged with PL and its data is not output.
3) 1C High LD with two or more peaks

PLT parameter is flagged with PL.
MPV is flagged with PL and its data is not output.
4) 2A High UD
PLT and MPV parameters are flagged with PU.
5) 2B High UD with 20%-frequency particle distribution width error

PLT parameter is flagged with PU.
MPV is flagged with PU and its data is not output.
• Platelet Histogram Error - PU (2B)

PLT
PLT PU 171 [×103/µL]
PDW DW ---.- [fL]
MPV PU ---.- [fL]
P-LCR PU ---.- [%]
10 20 30 [fL]
Figure 9-6-20: Platelet Histogram Error - PU (2B)

6) 2C High UD with two or more peaks

PLT parameter is flagged with PU.
MPV is flagged with PU and its data is not output.
7) 3 20%-frequency particle distribution width error

PLT is not flagged. MPV is flagged with DW and its data is not output.
• Platelet Histogram Error - DW (3)

PLT
PLT 91 [×103/µL]
PDW DW ---.- [fL]
MPV DW ---.- [fL]
P-LCR DW ---.- [%]
10 20 30 [fL]
Figure 9-6-21: Platelet Histogram Error - DW (3)
8) 4 Two or more peaks

PLT is not flagged. Other parameters are flagged with MP and their data are
not output.
• Platelet Histogram Error - MP (4)

PLT
PLT 155 [×103/µL]
PDW MP ---.- [fL]
MPV MP ---.- [fL]
P-LCR MP ---.- [%]
10 20 30 [fL]
Figure 9-6-22: Platelet Histogram Error - MP (4)

7. ELECTRIC SYSTEM
The microprocessor in the main unit controls the hydraulic system's solenoid valves and
master valves, thus regulating the flow of samples, reagents, and waste in the hydraulic
system.
Electric signals received from various transducers go through the analogue circuit for elec-
trical waveform-processing, and to the microcomputer. The microcomputer converts the
analogue signals into digital signals for the calculation.
The WBC, RBC, and PLT cell signals are sent to the respective waveform-processing cir-
cuits in the analogue circuit, where the noise in signals is eliminated to acquire the
required cell signals only. The microcomputer converts the A/D-converted cell signals
into particle distribution data, and outputs them to the printer or to the host computer.
To calculate HGB, absorbance of only the diluent (background) is deducted from samples'
absorbance. The beam that has passed through the fluid is detected by the photo diode.
And the signals is photoelectrically converted, A/D converted, and then sent to the HGB
counting circuit for the calculation of the absorbance.

Main Unit Microcomputer Circuit
Transducer Analogue Circuit WBC Counting Circuit
Memory
RBC Counting Circuit
WBC
WBC WBC Detection Amplification
Interface
PLT Counting Circuit
Electric Diagram
Transducer Circuit Waveform

Processor
Processing
Circuit HGB Counting Circuit
Interface Hand Held Barcode Reader

(Option)
RBC Interface Graphic Printer

Amplification WBC A-D (Option)
Waveform Conversion
Processing Circuit
RBC, PLT Interface Data Printer
Interface
RBC, PLT Circuit
Bus
WBC Calculator
Transducer Detection Circuit (Option)
PLT

Amplification Serial Interface
Waveform RBC A-D (Computer)
Processing Conversion
Circuit Circuit
PLT A-D
Conversion
Interface
Circuit
Figure 9-7-1: Electric Diagram

RBC Calculator
LCD Display Unit

LCD screen
Interface
HGB HGB
HGB PDA Unit
Amplification Conversion
Transducer Operation
Circuit Circuit
Pressure Interface Unit
Panel Switch
Monitoring
Unit Input-
Output Built-in
Driver Interface Printer
Printer
Solenoid Built-in Printer
Interface
Motor
9-29
8. NAMES AND FUNCTIONS OF INSTRUMENTS

8.1 Front Panel
4) Graphic Screen
Sysmex
1) Front Cover
5) Panel Keyboard
2) Sample Probe
3) START switch
Figure 9-8-1: Front Panel
1) Front Cover
The front cover can be opened to the right by your hands. It is opened to replace
lyse containers, check or clean the interior of measuring unit.
2) Sample Probe
The sample probe is used to aspirate sample in the whole blood and pre-diluted
modes.
3) START Switch
This switch starts whole blood mode analysis and pre-diluted mode analysis.
4) Graphic Screen
This displays Sample Nos., analysis results, instrument status, error messages, etc.
For detail, refer to Chapter 1, Section 8: GRAPHIC SCREEN.
5) Panel Keyboard
This keyboard allows basic operations such as entry of Sample No. and selection
of analysis parameters. For detail, refer to Chapter 1, Section 7: PANEL KEY-
BOARD.

8.2 Front Interior
1) Detector Block
2) Sample Rotor Valve (SRV)
3) Rinse Cup
5) Built-in Printer
4) WBC/HGB Lyse
(STROMATOLYSER-WH)
Figure 9-8-2: Front Interior
1) Detector Block
Incorporates RBC transducer, WBC transducer, and HGB flow cell.
2) Sample Rotor Valve (SRV)

Makes volumetric measurement of aspirated blood.
3) Rinse Cup
Cleans the sample probe.
4) WBC/HGB Lyse (STROMATOLYSER-WH)

Reagent to measure WBC/HGB
5) Built-in Printer
Prints analysis data, error messages, etc.

8.3 Right Side Panel
1) Fuse
2) Power Supply Switch
3) Power Supply Connector
Figure 9-8-3: Right Side Panel
1) Fuse
Replace with provided time-lag type fuse. The rating will be different depending
on the instrument specification.
Specification Part No. Description Fuse Type
117 VAC 266-5109-1 Fuse 250 V 3.15 A ST4-3.15A-N1 Time Lag
220/240 VAC 266-7765-0 Fuse 250 V 2 A 50T020H Time Lag
WARNING • To avoid risk of electrical shock, disconnect the power cord before
replacing the fuses.
CAUTION • For continued protection against risk of fire, use the fuse of speci-
fied type and rating.
2) Power Supply Switch

Turns on and off the main unit power supply.
CAUTION: • Avoid turning this switch ON and OFF continuously in short dura-
tion. This will overload the fuse and may cause fuse blown.
3) Power Supply Connector

Using the furnished power supply cord, this connector supplies power from the
outlet.

8.4 Left Side Panel
3) 0.0333 MPa Bellows Unit

1) Trap Chamber
4) Air filter
2) 0.05 MPa Regulator
Figure 9-8-4: Left Side Panel
1) Trap Chamber
Prevents reagent, etc. from flowing into the vacuum pump of the compressor when
an error occurs with the instrument.
2) 0.05 MPa Regulator

Regulates pressure to 0.05 MPa.
3) 0.0333 MPa Bellows Unit

Regulates vacuum to 0.0333 MPa vacuum.
4) Air Filter
Prevents dirt and dust from entering the bellows.

8.5 Left Side Interior
1) Waste Chamber
2) Pneumatic Unit
Figure 9-8-5: Left Side Interior
1) Waste Chamber
Collects wastes from transducers and mixing chambers.
2) Pneumatic Unit
Supplies pressure and vacuum.
CAUTION: • Do no open the left face unless your Sysmex service representa-
tive asks you to.

8.6 Rear Panel
1) ID Reader Connector
2) GP Connector
5) Drain Outlet Nipple
3) DP Connector
4) Serial Interface 6) Diluent Inlet Nipple

(CELLPACK)
7) Card Slot Protective Cover
Figure 9-8-6: Rear Panel
1) ID Reader Connector
Connects an optional hand held barcode reader.
2) GP Connector
Connects an optional graphic printer.
3) DP Connector
Connects an optional data printer.
4) Serial Interface
Connector for communicating with the host computer.
5) Drain Outlet Nipple

This nipple drains waste. It connects with the drain sewer or waste tank.
6) Diluent Inlet Nipple (CELLPACK)

This nipple aspirates diluent. It connects with the diluent container.
7) Card Slot Protective Cover

This is a protective cover for the slot to insert the program card.


CHAPTER 10 INSTRUMENT SETUP
1. INTRODUCTION ................................................................................. 10-1
2. SYSTEM SETUP .................................................................................. 10-3
3. DATE/TIME SETTINGS....................................................................... 10-8
4. PATIENT LIMIT.................................................................................. 10-11
5. QC SETTINGS .................................................................................... 10-14
6. HOST SETTINGS ............................................................................... 10-17
7. PRINTER SETTINGS......................................................................... 10-22

7.1 DP Output Settings .................................................................. 10-23
7.2 GP/LP Output Settings............................................................. 10-25
7.3 IP Output Settings .................................................................... 10-27
8. ID READER SETTINGS .................................................................... 10-30
9. PASSWORD SETTINGS .................................................................... 10-32
10. PRINT SET VALUES.......................................................................... 10-35
11. PERIPHERAL SETTINGS ................................................................. 10-36
12. FACTORY SETTINGS........................................................................ 10-38

INSTRUMENT SETUP
1. INTRODUCTION
Your Sysmex service representative performs the settings of the instrument at time of
installation. The settings can be changed by using this program.
This chapter describes how to use this setting program.
System Setup
Sets up the instrument system status.
Date/Time
Sets date/time of the built-in clock.
Patient Limit
Sets upper and lower Patient Mark Limits to check for error in analysis data.
QC Settings
Selects between X control and L-J control as the QC method, and sets the output method
of QC data.
Host Settings
Sets the interface conditions for transferring data to the host computer.
Printer Settings
Sets the output selection and output conditions of the built-in printer or the external print-
ers (Data Printer, Graphic Printer: option).
ID Reader Settings
Sets whether to Use or Not Use of the hand held barcode reader (option).
Password Settings
Sets and changes the password.
Print Set Values

Prints all the contents of the settings by the built-in printer.
Peripheral Setting
Sets whether to Use or Not Use of the printer, hand held barcode reader (option), or the
host computer output.
CAUTION: • The setting program can be run only when the instrument is ready.

INSTRUMENT SETUP
NOTE: • Menu selection method

(1) Cursor selection (explained in this Manual)
Using [ ] or [ ] key, move the cursor to a desired program
and press [ENTER] key to set.
(2) Direct key selection
Using the numeric keys, enter a menu number of the program
you want to set, thus selecting the menu.
The menu number is displayed on the Menu screen.
• Change set values and move the cursor to the next parameter
using [ ] or [ ] key ([ ] or [ ] key also can be used in Patient
Limit setting) or press [ENTER] key. This sets the settings.
• When the password is set, the following programs cannot be used
if the password is not input.
• System Setup
• Patient Limit
• QC Settings
• Password Settings

INSTRUMENT SETUP
2. SYSTEM SETUP
This program is used to set unit system, display language, and WBC analysis parameters.
How to Setup System Status

(2) Using [ ] or [ ] key, move the cursor to select “6: Settings.”
(3) Press [ENTER] key. The Setting Menu screen appears.
*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
Figure 10-2-1: Setting Menu Screen
(4) Using [ ] or [ ] key, move the cursor to select “1: System Setup.”

INSTRUMENT SETUP
(5) Press [ENTER] key. The current setting status is displayed on the System Setup
screen.
*System Setup*
Units Type2
Language English
Parameter Naming LYM%
Figure 10-2-2: System Setup Screen
NOTE: • When the password is set, the Password Input screen appears,
and input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
For System Setup, three parameters can be set.
(7) Using [ ] or [ ] key, select the content of settings. Each time you press the key,
the content of settings changes.
(8) Press [ENTER] key. The content of settings is set and the cursor moves to the next
set parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1) Unit Setting
Sets the unit system for displaying analysis data. The unit can be selected
from the following six kinds:
Settings Unit System Settings Unit System

Type 1 For Japan Type 4 Dutch SI
Type 2 For General Export Type 5 Standard SI
Type 3 Canada SI Type 6 Hong Kong SI
Table 10-2-1: Unit Setting

INSTRUMENT SETUP
For the detail of unit system, refer to the following table:

For Japan For General Export Canada SI
Item Decimal Unit Decimal Unit Decimal Unit
point point point
WBC #### ×102/µL ###.# ×103/µL ###.# ×109/L
RBC #### ×104/µL ##.## ×106/µL ##.## ×1012/L
HGB ###.# g/dL ###.# g/dL #### g/L
HCT ###.# % ###.# % #.### L/L
MCV ###.# fL ###.# fL ###.# fL
MCH ###.# pg ###.# pg ###.# pg
MCHC ###.# g/dL ###.# g/dL #### g/L
PLT ###.# ×104/µL #### ×103/µL #### ×109/L
LYM% ###.# % ###.# % #.###
MXD% ###.# % ###.# % #.###
NEUT% ###.# % ###.# % #.###
LYM# #### ×102/µL ###.# ×103/µL ###.# ×109/L
MXD# #### ×102/µL ###.# ×103/µL ###.# ×109/L
NEUT# #### ×102/µL ###.# ×103/µL ###.# ×109/L
RDW-SD ###.# fL ###.# fL ###.# fL
RDW-CV ###.# % ###.# % #.###
MPV ###.# fL ###.# fL ###.# fL
Dutch SI Standard SI Hong Kong SI

Item Decimal Unit Decimal Unit Decimal Unit
point point point
WBC ###.# ×109/L ###.# ×109/L ###.# ×109/L
RBC ##.## ×1012/L ##.## ×1012/L ##.## ×1012/L
HGB ###.# mmol/L #### g/L ###.# g/dL
HCT #.### L/L #.### #.###
MCV ###.# fL ###.# fL ###.# fL
MCH #### amol ###.# pg ###.# pg
MCHC ###.# mmol/L #### g/L ###.# g/dL
PLT #### ×109/L #### ×109/L #### ×109/L
LYM% #.### #.### ###.# %
MXD% #.### #.### ###.# %
NEUT% #.### #.### ###.# %
LYM# ###.# ×109/L ###.# ×109/L ###.# ×109/L
MXD# ###.# ×109/L ###.# ×109/L ###.# ×109/L
NEUT# ###.# ×109/L ###.# ×109/L ###.# ×109/L
RDW-SD ###.# fL ###.# fL ###.# fL
RDW-CV #.### #.### ###.# %
MPV ###.# fL ###.# fL ###.# fL
Table 10-2-2: Details of Unit System

INSTRUMENT SETUP
2) Language Setting
Set the language for displaying on the screen. The language can be selected
from the eight kinds listed below:
Settings Display language

Japanese Japanese
English English
Chinese Chinese
French French
German German
Spanish Spanish
Italian Italian
Portuguese Portuguese
Table 10-2-3: Language Setting
3) Parameter Name Setting

Set WBC analysis parameter names. The parameter can be selected from the
following two kinds:
Settings Analysis Parameter Name

W-SCR W-SCR
W-MCR
W-LCR
W-SCC
W-MCC
W-LCC
LYM% LYM%
MXD%
NEUT%
LYM#
MXD#
NEUT#
Table 10-2-4: Parameter Name Setting
NOTE: • The settings of language become valid from the next time you turn
ON the instrument power.

INSTRUMENT SETUP
(9) When the setting of each parameter is completed, press [SELECT] key. The Set-
ting Change Confirmation message appears.
Change? Cont. Set Cancel
(10) Using[ ] or [ ] key, move the cursor to select “Cont.,” “Set,” or “Cancel.”
[Cont.]: Returns to the System Setup screen. And the setting operation can
be continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
(11) Press [ENTER] to execute the selected process.

INSTRUMENT SETUP
3. DATE/TIME SETTINGS
This instrument displays date/time on analysis data, using the built-in clock.
This program is used to set the date/time for the built-in clock and date format.
How to Set Date/Time

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “2: Date/Time.”
(5) Press [ENTER] key. The current setting status is displayed on the Date/Time screen.
*Date/Time*
Date Format dd/mm/yyyy
yy 1999
mm 12
dd 31
hh 23
mm 59
Figure 10-3-2: Date/Time Screen

INSTRUMENT SETUP
(7) Using [ ], [ ], or the numeric keys, set each parameter.

In setting the date format, use [ ] or [ ] key. Year, month, day, hour, and minute
are entered using the numeric keys.
(8) Press [ENTER] key. The content of the settings is set and the cursor moves to the
next set parameter.
1) Date Format Setting

Using [ ] or [ ] key, select the date format.
The date format can be selected from the following three types. It changes
each time you press the key.
Settings Example of display

yyyy/mm/dd 1999/12/31
mm/dd/yyyy 12/31/1999
dd/mm/yyyy 31/12/1999
Table 10-3-1: Date Format Setting
2) Year Setting
Enter in the dominical year using the numeric keys.
3) Month Setting
Enter the numerical value of 1 - 12 using the numeric keys.
4) Day Setting
5) Hour Setting
Enter the numerical value of 0 - 23 by 24-hour system with using the
numeric keys.
6) Minute Setting

INSTRUMENT SETUP
(9) When the setting of each parameter is completed, press [SELECT] key.
The date entered is checked and when there is no setting error, the Setting Change
If there is any setting error, the alarm sounds and the Setting Change Confirmation
message is not displayed.
NOTE: • About the date setting, the following items are checked:
Leap year check: whether 2/29 is set in non-leap year
Month/day check: whether 4/31, e.g., is set
[Cont.]: Returns to the Date/Time screen. And the setting operation can be
continued.

INSTRUMENT SETUP
4. PATIENT LIMIT
For Patient Limit, you can set Mark Limits.
The Mark Limits are the values set to determine whether analysis values are within the
normal range or not. This program can be used to set the upper and lower Mark Limits for
each analysis parameter.
When analysis data exceeds the upper Mark Limit, it is flagged with [+] mark, and when it
exceeds the lower Mark Limit, it is flagged with [-] mark. Analysis data output to the
built-in printer or the host computer is also attached with either marks.
How to Set Mark Limits

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “3: Patient Limit.”

INSTRUMENT SETUP
(5) Press [ENTER] key. The current setting status is displayed on the Patient Limit
screen.
*Patient Limit*
LL UL
WBC 3.0 15.0 ×103/µL
RBC 2.50 5.50 ×106/µL
HGB 8.0 17.0 g/dL
HCT 26.0 50.0 %
MCV 86.0 110.0 fL
MCH 26.0 38.0 pg
MCHC 31.0 37.0 g/dL
PLT 50 400 ×103/µL
LYM% 5.0 55.0 %
MXD% 1.0 20.0 %
Figure 10-4-2: Patient Limit Screen
and input the password, and then press [ENTER] key.
NOTE: • Total 17 setting parameters of Patient Limit are displayed. But not
all of them can be displayed in one screen at a time. Therefore,
scroll the screen using [ ] or [ ] key.
*Patient Limit*
LL UL
MXD% 1.0 20.0 %
NEUT% 45.0 95.0 %
LYM# 0 0 ×103/µL
MXD# 0 0 ×103/µL
NEUT# 0 0 ×103/µL
RDW-SD 37.0 54.0 fL
RDW-CV 11.0 16.0 %
PDW 9.0 17.0 %
MPV 9.0 13.0 fL
P-LCR 13.0 43.0 %
Figure 10-4-3: Scrolling the Screen
(7) Using [ ] or [ ] key, move the cursor to select LL (Lower Limit) or UL (Upper
Limit).

INSTRUMENT SETUP
(8) Enter the settings using the numeric keys.
set parameter.
NOTE: • When [ ], [ ], [ ], or [ ] key is pressed after entering, the

contents of settings are also set.
• When both the upper and lower limits are set at “0,” the judgment
on patient limit is not executed.
(10) When the setting of each parameter is completed, press [SELECT] key.
When the set values are checked and there is no setting error, the Setting Change
In case Upper Limit ≤ Lower Limit is set, the alarm sounds and the Setting Change
Confirmation message is not displayed.
[Cont.]: Returns to the Patient Limit screen. And the setting operation can
be continued.

INSTRUMENT SETUP
5. QC SETTINGS
This program is used to set QC method and output method of QC data. Two kinds of QC
methods are available with this instrument: X control and L-J control. Select either of
them that suits your purpose.
X Control: Control blood is subjected to two consecutive analyses and the mean of
them is used as the QC data. This method causes little influence on repro-
ducibility in analysis.
L-J Control: This control uses the data from a single analysis of control blood as QC
data. The control width in the L-J control is prone to influence in reproduc-
ibility in analysis, so that the control width is wider than in the case of X
control.
How to Set QC Settings

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “4: QC Settings.”

INSTRUMENT SETUP
(5) Press [ENTER] key. The current setting status is displayed on the QC Settings
screen.
*QC Settings*
QC Method X
Data Output Print
Figure 10-5-2: QC Settings Screen
and input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the set parameter. QC settings
can be made on three parameters.
(7) Using [ ] or [ ] key, select the content of settings.

The content of settings changes each time you press the key.
(8) Press [ENTER] key. The content of setting is set and the cursor moves to the next
analysis parameter.
1) QC Method Setting
Set the QC method. The QC method can be selected from the following two
kinds: 17
Settings QC Method
X X Control
L-J L-J Control
Table 10-5-1: QC Method Setting

INSTRUMENT SETUP
2) Data Output Setting

Set the QC data output method. The QC data output can be selected from
the following four kinds:
Settings QC data output

None Not output
Print Print on built-in printer
Host Output to host computer
Print, Host Print on built-in printer and output to host computer
Table 10-5-2: Data Output Setting
NOTE: • For print format to the built-in printer, refer to Chapter 5, Section
2.6: Execute X Control or Chapter 5, Section 2.7: Execute L-J
Control.
• For output format to the host computer, refer to Appendix B:
TECHNICAL INFORMATION.
• The data output format for quality control differs from the format
for usual analysis.
(9) When the setting for each parameter is completed, press [SELECT] key. The Set-
[Cont.]: Returns to the QC Settings screen. And the setting operation can be
continued.

INSTRUMENT SETUP
6. HOST SETTINGS
This program is used to set the interface conditions for transferring data to the host com-
puter.
How to Set Host Output

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “5: Host Settings.”
(5) Press [ENTER] key. The current setting status is displayed on the Host Settings
screen.
*Host Settings*
Connect Not Use

Output Format K-1000
Auto Output On
Baud Rate 2400
Data Length 7bits
Stop Bit 2bits
Parity Check Even
Protocol Class A
Interval 2
RTS/CTS Ignore
Figure 10-6-2: Host Settings Screen

INSTRUMENT SETUP
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter. For
Host Settings, twelve parameters can be set.
NOTE: • There are 12 setting parameters for Host Settings, but all the set-
ting parameters cannot be listed in one screen, so scroll the
screen with [ ] key or [ ] key.
*Host Settings*
RDW Output RDW-CV

ID Padding 0 Padding
Figure 10-6-3: Host Settings Screen
(7) Using [ ] or [ ] key, select the condition. The condition changes each time you
press the key.
set parameter.
1) Connect Settings
Set whether to connect the host computer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-6-1: Host Output Settings

INSTRUMENT SETUP
2) Output Format Settings

Set output format of analysis data to the host computer. This can be selected
from the following three kinds:
Settings Output Format

KX-21N Standard output format of KX-21N
Refer to Appendix B: TECHNICAL INFORMATION.
K-1000 ASCII data is output in the published format.
Refer to Appendix B: TECHNICAL INFORMATION.
K-DPS Binary data is output for connecting with K-DPS.
Data format is not published.
Table 10-6-2: Output Format Settings
3) Auto Output Settings

Set whether to make auto output to the host computer or not.
Settings Auto Output

On Auto Output
Off Not Auto Output
Table 10-6-3: Auto Output Settings
4) Baud Rate Settings

Set the baud rate. This can be selected from the following four kinds:
Settings Baud Rate

1200 1200 bps
2400 2400 bps
4800 4800 bps
9600 9600 bps
Table 10-6-4: Baud Rate Settings
5) Data Length Settings

Set the data length. This can be selected from the following two kinds:
Settings Data Length

7 bits 7 bits
8 bits 8 bits
Table 10-6-5: Data Length Settings

INSTRUMENT SETUP
6) Stop Bit Settings

Set the stop bit. This can be set selected from the following two kinds:
Settings Stop Bit

1 bit 1 bit
2 bits 2 bits
Table 10-6-6: Stop Bit Settings
7) Parity Check Settings

Set the parity check method. This can be set selected from the following
three kinds:
Settings Parity Check

None None
Odd Odd
Even Even
Table 10-6-7: Parity Check Settings
8) Protocol Settings
Set the protocol. This can be set selected from the following two kinds:
Settings Protocol
Class A Class A
Class B Class B
Table 10-6-8: Protocol Settings
9) Transmission interval Settings

Select a transmission interval from the following:
Settings Interval
0 0 second
2 2 seconds
3 3 seconds
5 5 seconds
7 7 seconds
10 10 seconds
15 15 seconds
Table 10-6-9: Transmission Interval

INSTRUMENT SETUP
10) RTS/CTS control Settings

Specify whether or not the RTS/CTS flow control takes place.
Settings RTS/CTS control

Refer Allowed
Ignore Not allowed
Table 10-6-10: RTS/CTS control
11) RDW Output

When the K-1000 format is selected, RDW Output can be set by selecting
from following two types.
Settings RDW Output

RDW-SD Outputs RDW-SD
RDW-CV Outputs RDW-CV
Table 10-6-11: RDW Output
12) ID Padding
The sample ID can be set whether to make padding by selecting from follow-
ing two types.
Settings Padding
0 Padding Allowed 0 padding
None Not allowed 0 padding
Table 10-6-12: ID Padding
NOTE: • ID Padding will set how to pad the most significant digits output to
the host computer, if the number of the sample ID digits is 14 or
less.
ex) When the Sample ID No. is “12345”
0 Padding “000000000012345”
None “∆∆∆∆∆∆∆∆∆∆12345” “∆” means “a space”.

INSTRUMENT SETUP
[Cont.]: Returns to the Host Settings screen. And the setting operation can
be continued.
7. PRINTER SETTINGS
This program is used to set the output selection and output conditions for the built-in
printer or the external printers (Data Printer, Graphic Printer).
How to Set Printer Output

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “6: Printer Settings.”
(5) Press [ENTER] key. The Printer Settings Menu screen appears.
*Settings*
1 : DP
2 : GP/LP
3 : IP
Figure 10-7-2: Printer Settings Menu Screen

INSTRUMENT SETUP
NOTE: • When you press [ENTER] key on this screen, the screen returns
to the Analysis screen.
(6) Using [ ] or [ ] key, move the cursor and select the printer to be set.

The Printer Settings screen for the selected printer appears.
For how to set the printer output of DP (Data Printer), refer to Section 7.1: DP Out-
put Settings in this chapter.
For how to set the printer output of GP/LP (Graphic Printer), refer to Section 7.2:
GP/LP Output Settings in this chapter.
For how to set the printer output of IP (Built-in Printer), refer to Section 7.3: IP
Output Settings in this chapter.
7.1 DP Output Settings

Select “1: DP” on Printer Settings Menu screen and press [ENTER] key. The DP Settings
screen for Data Printer appears.
*DP*
Connect Use
DP Auto Output On
Figure 10-7-3: DP Settings Screen
(1) Using [ ] or [ ] key, move the cursor to select the desired setting parameter.
In the output setting for the data printer, you can set two parameters.
(2) Using [ ] or [ ] key, select the content of settings.

The content of settings changes each time you press the key.

INSTRUMENT SETUP
analysis parameter.
1) Connect Settings
Set whether to use the data printer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-7-1: Data Printer Settings
2) DP Auto Output Settings

Whether the analysis data is output to the data printer by the automatic oper-
ation can be set.

On Auto Output
Off Not Auto Output
[Cont.]: Returns to the DP Settings screen. And the setting operation can be
continued.

INSTRUMENT SETUP
7.2 GP/LP Output Settings

Select “2: GP/LP” on Printer Settings Menu screen and press [ENTER] key. The GP/LP
Settings screen for Graphics Printer appears.
*GP/LP*
Connect Use
Printer type Type1
GP Auto Output On
Figure 10-7-5: GP/LP Settings Screen
(1) Using [ ] or [ ] key, move the cursor to select the desired setting parameter.
In the output setting for the data printer, you can set three parameters.
(2) Using [ ] or [ ] key, select the condition.

The condition changes each time you press the key.
analysis parameter.
1) Connect Settings
Set whether to use the graphic printer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-7-3: Graphic Printer Settings

INSTRUMENT SETUP
2) Printer type Settings

The type of graphic printer to be connected can be set by selecting from fol-
lowing two types.
Settings Printer type

Type 1 Printer of ESC/P system
Type 2 Printer of PCL5 system
Type 3 Printer of LX-300+ system
Table 10-7-4: Printer type Settings
3) GP Auto Output Settings

Whether the analysis data is output to the graphic printer by the automatic
operation can be set.

On Auto Output
Off Not Auto Output
[Cont.]: Returns to the GP/LP Settings screen. And the setting operation
can be continued.

INSTRUMENT SETUP
7.3 IP Output Settings

Select “3: IP” on Printer Settings Menu screen and press [ENTER] key. The IP Settings
screen for Built-in Printer appears.
*IP*
Connect Use
Print Condition All Data
Print Format Type1
Figure 10-7-7: IP Settings Screen
(1) Using [ ] or [ ] key, move the cursor to select the set parameter. Printer settings
can be made on three parameters.
(2) Using [ ] or [ ] key, select the condition.

The condition changes each time you press the key.
set parameter.
1) Connect Settings
Set whether to use the built-in printer or not.
Settings Connection
Use Connect
Not Use Not Connect
Table 10-7-6: Built-in Printer Settings

INSTRUMENT SETUP
2) Print Condition Settings

Set the auto print condition for the built-in printer. This can be selected from
the following three kinds:
Settings Auto Print Conditions

All Data Print All Samples
Abnormal Data Print Abnormal Data Only
None Not Auto Print
Table 10-7-7: Print Condition Settings
NOTE: • Data printed as abnormal data:

• Data in which analysis error occurred
• Data in which noise error occurred
• Data with flags other than Mark Limits
• Data with histogram flag
• Data out of the linearity limit
• For print conditions of QC data, refer to Chapter 10, Section 5:
QC SETTINGS.
3) Print Format Settings

Set the print format for the built-in printer. This can be selected from the fol-
lowing three kinds:
Settings Print Format

Type 1 Print 17 parameters + histograms.
Type 2 Print 17 parameters.
Type 3 Print 8 parameters.
Table 10-7-8: Print Format Settings
NOTE: • For print format, refer to Chapter 2, Section 5.2 Printing of Analy-
sis Result.
• For print format for quality control, refer to Chapter 5, Section 2.6:
Execute X Control or Chapter 5, Section 2.7: Execute L-J Control.

INSTRUMENT SETUP
[Cont.]: Returns to the Printer Settings screen. And the setting operation
can be continued.

INSTRUMENT SETUP
8. ID READER SETTINGS
This program can set whether to Use or Not Use of the hand held barcode reader (option)
which is for reading the sample IDs.
How to Set ID Reader

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “7: ID Reader Settings.”
(5) Press [ENTER] key. The current setting status appears on ID Reader Settings
screen.
*IP Reader*
Connect Use
Figure 10-8-2: ID Reader Settings Screen

INSTRUMENT SETUP
(6) Using [ ] or [ ] key, select “Use” or “Not Use.”

The display of “Use” and “Not Use” changes whenever the key is pressed.
(7) Press [ENTER] key. The setting contents can be confirmed.
(8) Press [SELECT] key. The Setting Change Confirmation message appears.
can be continued.

INSTRUMENT SETUP
9. PASSWORD SETTINGS
This program can set and change the password.
NOTE: • In order to execute under the control of the instrument manager,

an important program is protected by the password.
• For the programs protected by the password, refer to Chapter 1,
Section 14: MENU TREE.
• When the program protected by the password is executed, the
Password Input window appears. When the set password is
input, and [ENTER] key is pressed, the program is executed.
How to Set Password

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “8: Password Settings.”

INSTRUMENT SETUP
(5) Press [ENTER] key. The Password Settings screen appears.
*Password*
New Password [ ]
Enter Again [ ]
Figure 10-9-2: Password Settings Screen
NOTE: • When you have already set the password, the Password Input
screen is displayed, and then input a correct password.
*Password*
Password [ ]
Figure 10-9-3: Password Input Screen
In the input of a correct password, and pressing [ENTER] key, the

Password Settings screen appears.
• On the screen, all the values of the password display part are dis-
played by “*”. The purpose of this is to make other people not
seen the password when setting it.
• Press [SELECT] key to discontinue the password setting, and to
return to Analysis screen.

INSTRUMENT SETUP
(6) Input the set password to the New Password column with numeric keys, and press
[ENTER] key.
Set the password up to 10 digits by using the figure (0-9) or the hyphen (-).
If [ENTER] key is pressed, the status becomes the input waiting for the Enter
Again column.
NOTE: • When you do not set the password, the password can be deleted
by the following operating.
• Press [ENTER] key at the status of no password input.
(7) Again, input the set password to the Enter Again column with numeric keys, and
press [ENTER] key.
If the password input to the New Password column and the password input to the
Enter Again are different, set over again from the input of the New Password column.
If they are the same, the Setting Change Confirmation message appears.
can be continued.
NOTE: • When the password has been forgotten, contact Sysmex service
representative.

INSTRUMENT SETUP
10. PRINT SET VALUES

To backup the set values, all the contents of the settings can be printed by the built-in
printer.
How to Print Set Values

*Settings*
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select “9: Print Set Values.”
(5) Press [ENTER] key. The built-in printer starts printing all the set values.
NOTE: • If any faulty operation occurs, contact your Sysmex service repre-
sentative. Keep the printed contents of the settings in good condi-
tion because the service representative may have to confirm the
contents of settings.
• When the QC method of the QC Setting is “X”, it is printed as “X”.

INSTRUMENT SETUP
11. PERIPHERAL SETTINGS

When you want to temporarily cancel external output due to error occurrence, use this pro-
gram to set “Use” or “Not use” of the built-in/external printer, host computer output or the
hand held barcode reader.
NOTE: • For peripheral settings, refer to “5: Host Settings” and “6: Printer
Settings” which carry description of similar settings.
How to Set Peripheral Connection

*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
(2) Using [ ] or [ ] key, move the cursor to select “8: Periph. Settings.”
(3) Press [ENTER] key. This displays connection status of external devices on the
Peripheral Settings screen.
*Periph.Settings*
(Data Printer)
DP Use
(Graphic Printer)
GP/ LP Use
(Built-in Printer)
IP Use
Host Output Use
ID Reader Use
Figure 10-11-2: Peripheral Settings Screen

INSTRUMENT SETUP
(4) Using [ ] or [ ] key, move the cursor to select the desired external device.
(5) Using [ ] or [ ] key, select “Use” or “Not Use”. “Use” and “Not Use” change
over each time you press the key.
(6) Press [ENTER] key. The content of the settings is set and moves the cursor to the
next set parameter.
(7) Press [SELECT] key. The Setting Change Confirmation message appears.
[Cont.]: Returns to the Peripheral Settings screen. And the setting operation
can be continued.

INSTRUMENT SETUP
12. FACTORY SETTINGS

The settings made at the factory are listed below:
• System Settings
Units Type 2
Language English
Parameter Naming LYM%
• Date/Time
Date Format dd/mm/yyyy
• Patient Limits LL UL
WBC 3.0 15.0
RBC 2.50 5.50
HGB 8.0 17.0
HCT 26.0 50.0
MCV 86.0 110.0
MCH 26.0 38.0
MCHC 31.0 37.0
PLT 50 400
LYM% 5.0 55.0
MXD% 1.0 20.0
NEUT% 45.0 95.0
LYM# 0.0 0.0
MXD# 0.0 0.0
NEUT# 0.0 0.0
RDW-SD 37.0 54.0
RDW-CV 11.0 16.0
MPV 9.0 13.0
• QC Settings
QC Method L-J
Data Output Print
• Host Settings
Connect Not use
Output format KX-21N
Auto Output Off
Baud Rate 2400 bps
Data Length 7 bits
Stop Bit 2 bits
Parity Check Even
Protocol Class A
Interval 2
RTS/CTS Ignore
RDW Output RDW-CV
ID Padding 0 Padding

INSTRUMENT SETUP
• Printer Settings (DP)

Connect Not use
DP Auto Output Off
• Printer Settings (GP/LP)
Connect Not use
Printer type Type 1
GP Auto Output Off
• Printer Settings (IP)
Connect Use
Print Condition All Data
Print Format Type 1
• ID Reader
Connect Not Use

INSTRUMENT SETUP

1. INTRODUCTION .................................................................................. A-1
2. CHECK BEFORE INSTALLATION ..................................................... A-1
3. INSTALLATION SPACE ....................................................................... A-3
4. REMOVE SHIPPING CLAMPS............................................................ A-4
5. CONNECT TUBE .................................................................................. A-6

5.1 Prepare Reagent .......................................................................... A-6
5.2 Connect CELLPACK .................................................................. A-6
5.3 Connect STROMATOLYSER-WH............................................. A-8
5.4 Connect Waste Line .................................................................... A-9
6. SET PRINTER PAPER......................................................................... A-10
7. CONNECT POWER CORD AND CONNECTING CABLES............ A-12

7.1 Connect Host Computer, Printer, and
Hand Held Barcode Reader ...................................................... A-12
7.2 Connect Power Cord ................................................................. A-12
8. TURN POWER ON .............................................................................. A-13
9. REINSTALLING THE PROGRAM..................................................... A-13

INSTALLATION
1. INTRODUCTION
This product is a clinical test instrument. Sysmex representative is responsible for
unpacking, installing, and initial setup of the product to ensure its proper and safe opera-
tion. The next several pages will give some essential information on this instrument.
NOTE: • When the optional external printers (Data Printer and Graphic
Printer) or Hand Held Barcode Reader is intended to incorporate
to this instrument, contact your Sysmex service representative.
2. CHECK BEFORE INSTALLATION

Make sure the KX-21N is free from external damages and check the quantities of the pro-
vided supply parts.
No. Part No. Description Quantity

117V 220V 240V
1 461-2264-1 OPERATOR'S MANUAL 1 0 0
KX-21N (N.A.)
1 461-2265-5 OPERATOR'S MANUAL 0 1 1

KX-21N (ENGLISH)
2 923-8092-8 POWER CORD 1 - -

NO. 15 (C-2/N. AMERICA)
2 265-7153-5 TA-6P(A)+TA-5(A) H05VV-F - 1 -
2 265-4733-2 POWER CORD - - 1

NO. 7687
3 943-1781-1 CUBITAINER SPOUT KIT 1 1 1

NO. 1 (20 L)
4 973-3041-7 FLOAT SWITCH NO. 23 ASSY 1 1 1
5 367-1051-9 TRAY NO. 20 1 1 1
(CONTINUED ON NEXT PAGE)
Sysmex KX-21N Operator’s Manual -- Revised November 2009 A-1

INSTALLATION
No. Part No. Description Quantity

117V 220V 240V
6 442-5338-7 TUBE POLYURETHANE 3M 3M 3M
4 MM ID × 6 MM OD
7 442-5340-5 TUBE POLYURETHANE 6M 6M 6M

6 MM ID × 9 MM OD
8 423-1776-2 MINI-PET NO. 10 (1 ML) 2 2 2
9 933-3601-9 TRANSDUCER BRUSH NO. 1 1 1 1
10 266-5109-1 FUSE 2 - -
250V 3.15A ST4-3.15A-N1
10 266-7765-0 FUSE - 2 2
250V 2A 50T020H (EUROPE)
11 266-6743-4 CLAMP LWS-8S-2.5W 1 1 1
12 369-8234-6 CAUTION MARK NO. 170 1 1 1
13 462-4842-7 PAPER THERMAL F1-2 1 1 1
Table A-2-1: KX-21N Unpacking Checklist
NOTE: • Item No. 4 (973-3041-7 Float Switch No. 23 Assy) is pre-installed

in the Main Unit Front Interior at the factory.
• Affix the Caution Mark No.170 to some place on the front panel
that is easily visible.
• If you need to order supplies or replacement parts, please contact
your local Sysmex representative.
A-2 Sysmex KX-21N Operator’s Manual -- Revised November 2009

INSTALLATION
3. INSTALLATION SPACE
To ensure that the instrument performs to its full extent, it should be installed at an appro-
priate place.
• Select a place where the power supply is located close.
• Secure a space for maintenance and service. Giving consideration to heat radiation by
the instrument, provide at least 50 cm clearance between the wall and the instrument's
side rear, and top panels. You may need some more desktop space if optional Data
Printer and Graphic Printer are provided.
Each dimension of the instrument is shown below. The power cord is 1.8 m long.
Width (mm) Depth (mm) Height (mm) Weight (kg)

Main Unit 420 355 480 30
Table A-3-1: Instrument Dimensions
480
420
355
Figure A-3-1: Instrument Dimensions

INSTALLATION
4. REMOVE SHIPPING CLAMPS

(1) Peel off the fixing tape of the outer cover gently.
Figure A-4-1: Removing the Tape
(3) Remove the protection sheets of the sampling valve.

1) Remove the SRV fixing screw.
2) With the fixed and rotary valves separated sufficiently, remove the protection
sheets.
3) Return the valves and the SRV fixing screw to their original positions.
4) Set the provided sample rotor valve tray.
SRV Fixing Screw
Tray No. 20
Protection Sheets
Figure A-4-2: Removing the Protection Sheets
A-4 Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

INSTALLATION
(4) Remove the pneumatic unit fixing screws (2 pcs). Keep these screws for future use.
Fixing Screws
Figure A-4-3: Removing the Screws
(5) Remove the rubber caps of the reagent connection nipples. Keep these rubber caps
for future use.
(6) Remove the factory-installed protective plate.
Rubber Caps
Figure A-4-4: Removing the Rubber Caps and the Protective Plate

INSTALLATION
5. CONNECT TUBE
5.1 Prepare Reagent
Prepare the reagents and connection kits shown below.
Reagent Part No. Type Part Name Connection Kit

884-0871-1 PK-30L CELLPACK Cubitainer spout kit No. 1 (for 20L)
974-0521-6 SWH-200A STROMATOLYSER-WH Float switch No. 23
5.2 Connect CELLPACK

(1) Prepare the following reagent tube.
Tube Polyurethane 4 mmID × 6 mmOD : 1 pc
NOTE: • Cut the tube to an appropriate length, and connect it.
(2) Connect the diluent (CELLPACK) inlet aspiration nipple behind the unit and the
nipple of the cubitainer spout kit No. 1 with the tube polyurethane 4 mmID × 6
mmOD.
(3) Set the cubitainer spout kit No. 1 to the CELLPACK container.
Cap
Cubitainer Spout Kit No. 1
CE
LL
PA
CK
Figure A-5-1: Setting the Cubitainer Spout Kit

INSTALLATION
Diluent Inlet Nipple
Tube Polyurethane 4 mmID × 6 mmOD

Cubitainer Spout Kit No. 1
CELLPACK
Figure A-5-2: Connecting the CELLPACK
CAUTION • Take care not to spill a reagent on to the instrument. If it spills,

wipe it off immediately using a wet cloth or the like.
• If it happens to adhere to your skin, wash it off using plenty of
water.
• If a reagent happens to enter your eye, wash it off immediately
using plenty of water, and take medical treatment at once.
• After unpacking, be sure not to allow dust or dirt to come into the
instrument. Use up CELLPACK within 60 days from the unpack-
ing date, and STROMATOLYSER-WH within 90 days.
CAUTION: • When the diluent (CELLPACK) tube is more than 2 m long, it may
be impossible to have reagent aspirated. Avoid setting CELL-
PACK at a level higher than the instrument; otherwise, reagent
may flow into the vacuum line, possibly damaging the instrument.
• After connecting the tube, do not pull it by force for reagent
replacement.

INSTALLATION
5.3 Connect STROMATOLYSER-WH

(1) Gently remove the provided float switch No. 23 from the dust-protection bag.
(2) Install the float switch No. 23 to STROMATOLYSER-WH. Then, set it to the table.
Float switch No. 23
STROMATOLYSER-WH
Figure A-5-3: Installing the STROMATOLYSER-WH

INSTALLATION
5.4 Connect Waste Line

(1) Prepare the following waste line tube.
Tube Polyurethane 6 mmID × 9 mmOD : 1 pc
(2) Connect an end of the tube polyurethane 6 mmID × 9 mmOD to the drain outlet
nipple behind the unit. Connect the other end of the tube to the waste sewer in the
lab.
If the waste sewer is not available, connect it to a waste tank.
The maximum waste line length is 6 m.
NOTE: • Cut the tube to an appropriate length, and connect it.

• Since waste is removed from the system by pressurized air, the
waste tank may be located at the same height as, or lower than,
the drain outlet nipple. Otherwise the waste may be flown back
into the system, which will result of a malfunction.
(3) Arrange and tie the diluent and waste line tubings as shown in the figure using the
provided clamp.
Diluent Inlet Nipple

Drain Outlet Nipple
Tube Polyurethane 6 mmID × 9 mmOD
Waste Sewer
or
Waste Tank
Clamp
Figure A-5-4: Connecting the Waste Line and Clamping Tubings

INSTALLATION
6. SET PRINTER PAPER

(2) Turn the release lever up to free the paper.
Release Lever
Figure A-6-1: Releasing the Lever
(3) Mount a printer paper.
Printer Paper
Figure A-6-2: Mounting a Printer Paper

INSTALLATION
(4) Pass the printer paper as shown below, and turn the release lever down to secure.
Figure A-6-3: Securing the Release Lever
(5) Cut off any printer paper extending from the upper part of the printer.
Figure A-6-4: Cutting Off Paper

INSTALLATION
7. CONNECT POWER CORD AND CONNECTING CABLES

7.1 Connect Host Computer, Printer, and Hand Held Barcode Reader
Connect to each instrument with connecting cables.
ID Reader Connector
GP Connector
DP Connector
Serial Interface
Figure A-7-1: Connecting the Connecting Cables
NOTE: • Perform setting concerning the output referring to Chapter 10,

Section 6: HOST SETTINGS, Chapter 10, Section 7: PRINTER
SETTINGS or Chapter 10, Section 8: ID READER SETTINGS to
use the connected external instruments.
7.2 Connect Power Cord

Connect the provided power cord to the power supply outlet.
Power Cord
Connect to the Power Supply Outlet
Figure A-7-2: Connecting the Power Cord

INSTALLATION
8. TURN POWER ON
It is necessary to run the service sequence at the initial start-up.
Your Sysmex service representative is responsible for the operation.
9. REINSTALLING THE PROGRAM

The program is installed in the KX-21N in the factory, but when there is a necessity for
reinstalling the program by a problem or any other reason, reinstall the program according
to the following procedures.
(1) Turn OFF the power of the main unit.
(2) Loosen the screws of the card slot protective cover on the rear panel, and open the
card slot protective cover.
(3) Insert the program card in the card slot.
Figure A-8-1: Insert the Program Card
(4) Close the card slot protective cover, and turn ON the power.
(5) When “*Program Upgrade*” is displayed on the screen, press [1] key, and then
install the program.
When the installation is completed, the message “Installation was successful” will
be displayed.
(6) Turn OFF the power, and extract the program card.
(7) Close the card slot protective cover, and turn ON the power.

INSTALLATION

1. OUTPUT FORMAT FOR HOST COMPUTER .....................................B-1

1.1 Hardware......................................................................................B-1
1.2 Software .......................................................................................B-3
2. HAND HELD BAR CODE READER SPECIFICATIONS ..................B-15

TECHNICAL INFORMATION
1. OUTPUT FORMAT FOR HOST COMPUTER

The bit serial voltage type, which conforms to the RS-232C interface, is used for host
computer output of the KX-21N. The serial interface port for the connection with the host
computer is on the rear panel of the main unit.
1.1 Hardware
1. Connector
• The connector for the output to the host computer is located on the rear panel.
• Use a 9-pin D-SUB, female connector.
• Fixing screws for this connector are in inch-specification.
2. Connector Signals
Pin No. Signal Name Signal Direction

1
2 Receive data (R×D) From Host to KX-21N
3 Transmit Data (T×D) To Host from KX-21N
4 Data Terminal Ready (DTR) To Host from KX-21N
5 Signal Ground (SG)
6 Data Set Ready (DSR) From Host to KX-21N
7 Request to Send (RTS) To Host from KX-21N
8 Clear to Send (CTS) From Host to KX-21N
9
Table B-1-1: Pin Assignment
3. Communication Format
The data is communicated in the asynchronous, full duplex mode.
4. Signal Level
Signal level conforms to JIS C6361.
Level Data signal Control signal

+3V or higher Logic “1”, Start bit ON
-3V or lower Logic “0”, Stop bit OFF
Table B-1-2: Signal Level
Sysmex KX-21N Operator’s Manual -- Revised November 2009 B-1

5. Interface Circuit
• Output circuit
VDD
OUT
300 Ω EMI filter
Vss
MC145407 Driver
Figure B-1-1: Interface Output Circuit
• Input circuit
VDD
15 kΩ
IN
EMI filter
5.4 kΩ
Vss
MC145407 Receiver
Figure B-1-2: Interface Input Circuit
B-2 Sysmex KX-21N Operator’s Manual -- Revised November 2009

1.2 Software
1. Communication Format
1) Code
ASCII codes are used for output.
(Except for K-DPS output)
2) Structure of text
“STX” (02 H) is sent prior to data and “ETX” (03 H) is sent at the end of data.
(Except for K-DPS output)
S E
T T
X X
Order of transmission
Figure B-1-3: Order of Transmission
3) Communication protocol
The following 2 protocols are provided in the system, and can be selected accord-
ing to the system status.
• Class A
One-way transmission to the host computer without requiring ACK nor NAK
from host computer.
• Class B
The KX-21N transmits data and then waits for ACK or NAK to complete the
data transmission.
KX-21N Host computer
Analysis data is sent. Analysis data is received.
Analysis data transmission When an error does not

is completed correctly. occur, ACK (06H) is sent.
ACK
Communication error
occurs. When an error occurs, NAK
Analysis data is sent NAK (15H) is sent.
automatically (retrying up
to 3 times). If the reply is
still NAK after 3 retries,
instruction is made whether
the same data is sent again
or the transmission is
canceled by key input.
Figure B-1-4: Data Transmission

4) Transmission errors
If the KX-21N detects a transmission error, the data transmission is canceled and
an error message is displayed. Re-transmission of the data ([1] key) or cancella-
tion of the transmission ([3] key) can be selected. Transmission errors occur in the
following situations.
• The computer is off line.

• The control signal DSR is off.
• After the data is transmitted, there is no response from the computer in 15
seconds. (Class B only)
• After the data is transmitted, other than ACK or NAK is sent from the com-
puter. (Class B only)
• After the data is transmitted, the fourth NAK is sent. (Class B only. The
KX-21N resends the data automatically up to 3 times when NAK is sent.)
5) Timing, subject, and content of transmission
Serial interface
↓
Host computer
Normal analysis Analysis data (A)
Quality control QC data (A)
Table B-1-3: Content of Transmission
• Analysis data includes the date, sample ID No., parameter data, and the flag.
• QC data is X or L-J data.
• The setting of the connecting device is changed in the setting program.
2. Text Format
The following three types of formats are used for computer output.
• KX-21N: Format for connecting to the host computer
• K-1000: Format for connecting to the host computer
• K-DPS: Special format for connecting to K-DPS
NOTE: • KX-21N format is selected at the time of shipping from the factory.
The details of KX-21N and K-1000 format are as follows.

• KX-21N format
KX-21N format has two formats; one is “analysis data format” for output of
the sample data, and the other is “QC data format” for output of the QC data.
They differ in length and content of the text. (They are distinguished by the
sample distinction code.)
The text distinction code II is fixed at “1”.
However, when the text exceeds 256 bytes in a future modification, the text is
divided into 2 or more blocks. The number in text distinction code II shows
the order of the blocks. The ETB (17 H) is not used.

(1) Analysis data format
Parameter No. of Characters Example

STX 1 (02 H)
Text distinction code I 1 “D”
Text distinction code II 1 “1”
Sample distinction code 1 “U”
Year 4 “1999”
Month 2 “09”
Day 2 “30”
Analysis information 1 (O)
Sample ID No. 15 (OOOOOOOOOOOOOOO)
PDA information 6 (OOOOOO)
Reserve 1 “O”
WBC [×103/µL] 5 XXX.XF
RBC [×106/µL] 5 XX.XXF
HGB [g/dL] 5 XXX.XF
HCT [%] 5 XXX.XF
MCV [fL] 5 XXX.XF
MCH [pg] 5 XXX.XF
MCHC [g/dL] 5 XXX.XF
PLT [×103/µL] 5 XXXXF
LYM% (W-SCR) [%] 5 XXX.XF
MXD% (W-MCR) [%] 5 XXX.XF
NEUT% (W-LCR) [%] 5 XXX.XF
LYM# (W-SCC) [×103/µL] 5 XXX.XF
MXD# (W-MCC) [×103/µL] 5 XXX.XF
NEUT# (W-LCC) [×103/µL] 5 XXX.XF
RDW-SD [fL] 5 XXX.XF
RDW-CV [%] 5 XXX.XF
(Dummy) 5 XXX.XF
MPV [fL] 5 XXX.XF
(Dummy) 5 XXX.XF
ETX 1 (03 H)
Total 131
Table B-1-4: Analysis Data Format
Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A. B-5

(2) QC data format

STX 1 (02 H)
Sample distinction code 1 “C”
Data distinction code 1 “X” or “L”
Year 4 “1999”
Month 2 “09”
Day 2 “30”
Hour 2 “09”
Minute 2 “59”
QC File Number 1 “5”
Not used 1 “0”
Reserve 1 “0”
WBC [×103/µL] 4 XXX.X
LYM% (W-SCR) [%] 4 XXX.X
MXD% (W-MCR) [%] 4 XXX.X
NEUT% (W-LCR) [%] 4 XXX.X
LYM# (W-SCC) [×103/µL] 4 XXX.X
MXD# (W-MCC) [×103/µL] 4 XXX.X
NEUT# (W-LCC) [×103/µL] 4 XXX.X
RBC [×106/µL] 4 XX.XX
HGB [g/dL] 4 XXX.X
HCT [%] 4 XXX.X
MCV [fL] 4 XXX.X
MCH [pg] 4 XXX.X
MCHC [g/dL] 4 XXX.X
RDW- SD [fL] 4 XXX.X
RDW- CV [%] 4 XXX.X
PLT [×103/µL] 4 XXXX
(Dummy) 4 XXX.X
MPV [fL] 4 XXX.X
(Dummy) 4 XXX.X
W-SMV [fL] 4 XXX.X
W-LMV [fL] 4 XXX.X
ETX 1 (03 H)
Total 105
Table B-1-5: QC data format
B-6 Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

(3) Details of the analysis data output in KX-21N format
1) The order of output is from the top parameter to the bottom. The data is sent from
the upper line without performing zero suppression.
2) Because the decimal point is not sent, the decimal point specified in each parame-
ter has to be added and represented by numeric value at the host computer.
3) Analysis information shows the following content of the analysis.
Manual No. input

WB mode analysis “0”
Pre-diluted mode analysis “5”
Table B-1-6: Analysis Information
4) PDA information consists of the following 6 items.
Item No. of Characters

WBC histogram information 1
WBC histogram flag 1
RBC histogram information 1
RBC histogram flag 1
PLT histogram information 1
PLT histogram flag 1
Table B-1-7: PDA Information
Code Description
“0” Histogram is normal.
“1” Histogram is abnormal.
“2” Manually discriminated
Table B-1-8: Histogram Information

Code Description
“0” Normal
WBC/RBC/PLT
“1” (L) discriminator degree is high.
WBC/RBC/PLT
“2” (U) discriminator degree is high.
WBC/RBC/PLT
“3” Analysis is impossible because there is no pair of intersection on the 20%
degree level for calculation of DW.
RBC/PLT
“4” Two peaks are recognized in the particle distribution.
RBC/PLT
“5” (T1) discriminator cannot be determined.
WBC
WBC
“7” (T1) discriminator level is high, and the data is not reliable.
WBC
“8” (T1) or (T2) discriminator level is high, and the data is not reliable.
WBC
WBC
“A” The particle count equal to or less than (L) discriminator exceeds the range.
WBC
Table B-1-9: Histogram Flag
The histogram flag corresponds to the flagging characters of the LCD and the
printer as follows.
Particle distribution Flagging characters of LCD and printer

FLAG WBC RBC PLT
“0”
“1” WL RL PL
“2” WU RU PU
“3” DW DW
“4” MP MP
“5” T1
“6” T2
“7” F1
“8” F2
“9” F3
“A” AG
Table B-1-10: Flagging Character

5) The numerical data configuration in the Analysis Data Format is as follows.
Upper digit Lower digit
Data Flag
Figure B-1-5: Numerical Data Configuration
Code Description
“0” Normal
“1” Abnormality judgment is “+.”
“2” Abnormality judgment is “-.”
“3” Out of linearity limit
“4” Reliability is low.
Table B-1-11: Details of Flag
6) In case of analysis error, or if the data lacks some data such as the calculation
parameter in pre-diluted mode, the data is transmitted as follows:
*0000
• K-1000 format
K-1000 format has two formats; one is “analysis data format” for output of the sample
data, and the other is “QC data format” for output of the QC data. They differ in
length and content of the text. (They are distinguished by the sample distinction
code.)
The text distinction code II is fixed at “1”.
However, when the text exceeds 256 bytes in a future modification, the text is divided
into 2 or more blocks. The number in text distinction code II shows the order of the
blocks. The ETB (17 H) is not used.

(1) Analysis data format

STX 1 (02 H)
Sample distinction code 1 “U”
Year 2 “99”
Month 2 “09”
Day 2 “30”
Analysis information 1 (O)
Sample ID No. 12 (OOOOOOOOOOOO)
PDA information 6 (OOOOOO)
RDW select information 1 “S” or “C”
WBC [×103/µL] 5 XXX.XF
RBC [×106/µL] 5 XX.XXF
HGB [g/dL] 5 XXX.XF
HCT [%] 5 XXX.XF
MCV [fL] 5 XXX.XF
MCH [pg] 5 XXX.XF
MCHC [g/dL] 5 XXX.XF
PLT [×103/µL] 5 XXXXF
LYM% (W-SCR) [%] 5 XXX.XF
MXD% (W-MCR) [%] 5 XXX.XF
NEUT% (W-LCR) [%] 5 XXX.XF
LYM# (W-SCC) [×103/µL] 5 XXX.XF
MXD# (W-MCC) [×103/µL] 5 XXX.XF
NEUT# (W-LCC) [×103/µL] 5 XXX.XF
RDW-SD/CV [fL/%] 5 XXX.XF
(Dummy) 5 XXX.XF
MPV [fL] 5 XXX.XF
(Dummy) 5 XXX.XF
ETX 1 (03 H)
Total 121
Table B-1-12: Analysis Data Format
B-10 Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

(2) QC data format

STX 1 (02 H)
Sample distinction code 1 “C”
Data distinction code 1 “X” or “L”
Year 2 “97”
Month 2 “09”
Day 2 “30”
Hour 2 “09”
Minute 2 “59”
QC File Number 1 “5”
Not used 1 “0”
RDW select information 1 “C”
WBC [×103/µL] 4 XXX.X
LYM% (W-SCR) [%] 4 XXX.X
MXD% (W-MCR) [%] 4 XXX.X
NEUT% (W-LCR) [%] 4 XXX.X
LYM# (W-SCC) [×103/µL] 4 XXX.X
3/µL] 4 XXX.X
MXD# (W-MCC) [×10
NEUT# (W-LCC) [×103/µL] 4 XXX.X
RBC [×106/µL] 4 XX.XX
HGB [g/dL] 4 XXX.X
HCT [%] 4 XXX.X
MCV [fL] 4 XXX.X
MCH [pg] 4 XXX.X
MCHC [g/dL] 4 XXX.X
RDW-(CV/SD) [%/fL] 4 XXX.X
PLT [×103/µL] 4 XXXX
(Dummy) 4 XXX.X
MPV [fL] 4 XXX.X
(Dummy) 4 XXX.X
W-SMV [fL] 4 XXX.X
W-LMV [fL] 4 XXX.X
ETX 1 (03 H)
Total 99
Table B-1-13: QC data format
Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A. B-11

(3) Details of the analysis data output in K-1000 format
1) The order of output is from the top parameter to the bottom. The data is sent from
the upper line without performing zero suppression.
2) Because the decimal point is not sent, the decimal point specified in each parame-
ter has to be added and represented by numeric value at the host computer.
3) Analysis information shows the following content of the analysis.
Manual No. input

WB mode analysis “0”
Pre-diluted mode analysis “5”
Table B-1-14 Analysis Information
4) The sample ID No. is 15-digit numerals, but 12 digits are output in this format. The
upper 3 digits are deleted. Depending on the usage, “-” (2D H) may be inserted in
the numeral column. In this case, “-” is included in the 12 digits.
5) PDA information consists of the following 6 items.
Item No. of Characters

WBC histogram information 1
WBC histogram flag 1
RBC histogram information 1
RBC histogram flag 1
PLT histogram information 1
PLT histogram flag 1
Table B-1-15: PDA Information
Code Description
“0” Histogram is normal.
“1” Histogram is abnormal.
“2” Manually discriminated
Table B-1-16: Histogram Information

Code Description
“0” Normal
WBC/RBC/PLT
“1” (L) discriminator degree is high.
WBC/RBC/PLT
“2” (U) discriminator degree is high.
WBC/RBC/PLT
“3” Analysis is impossible because there is no pair of intersection on the 20%
degree level for calculation of DW.
RBC/PLT
“4” Two peaks are recognized in the particle distribution.
RBC/PLT
WBC
WBC
WBC
“8” (T1) or (T2) discriminator level is high, and the data is not reliable.
WBC
WBC
“A” The particle count equal to or less than (L) discriminator exceeds the range.
WBC
Table B-1-17: Histogram Flag
The histogram flag corresponds to the flagging characters of the LCD and the
printer as follows.
Particle distribution Flagging characters of LCD and printer

FLAG WBC RBC PLT
“0”
“1” WL RL PL
“2” WU RU PU
“3” DW DW
“4” MP MP
“5” T1
“6” T2
“7” F1
“8” F2
“9” F3
“A” AG
Table B-1-18: Flagging Character

6) RDW select information

It shows whether RDW-CV or RDW-SD is output.
“C”: RDW-CV
“S”: RDW-SD
NOTE: • RDW-SD is selected at the initial setting of K-1000.

• To output RDW-CV, refer to Chapter 10, Section 6: HOST SET-
TINGS.
7) The numerical data configuration in the Analysis Data Format is as follows.
Upper digit Lower digit
Data Flag
Figure B-1-6: Numerical Data Configuration
Code Description
“0” Normal
“1” Abnormality judgment is “+.”
“2” Abnormality judgment is “-.”
“3” Out of linearity limit
“4” Reliability is low.
Table B-1-19: Details of Flag
8) In case of analysis error, or if the data lacks some data such as the calculation
parameter in pre-diluted mode, the data is transmitted as follows:
*0000

2. HAND HELD BAR CODE READER SPECIFICATIONS

1. Hardware Specifications
1) Specification
(1) The kind of Bar Code: UPC-A, UPC-E, CODE39, CODE128, ITF, NW-7
(2) Decoder: Built-in a reading head.
(3) Interface: RS-232C
(4) Connector: DIN 8P
(5) Power Supply: DC5V+/-5%
2) Pin Arrangement of Connector (DIN 8P)
Pin No. Signal name Direction of signal

1 TXD Transmitting Data to HOST
2 RXD Receiving Data from HOST
3 RTS Request to Send to HOST
4 CTS Clear to Send from HOST
5 NC
6 DTR Data Terminal ready to HOST
7 SG Signal Ground
8 +5V from HOST
3) Data Transmission Procedure
PRE (ID) DATA POST

PRE: STX
POST: ETX
2. Software Specifications
1) Communication Protocol
Baud Rate 2400

Code 7-bit
Stop Bit 2-bit
Parity Even
RTS/CTS Use
Protocol None
Preamble Transmit STX
Postamble Transmit ETX

2) Protocol
RTS/CTS Effective
Non Protocol
3) Format
STX DATA ETX
4) The Kind of Bar Code
(1) CODE39
Data can be transmitted without Check Digits, since Check Digits (MOD-43) is judged
within Bar Code Reader.
All data may be transmitted with Check Digits, but with no-effect.
(2) JAN, UPC-A, UPC-E, EAN13, EAN8

(3) NW-7
All data except Start/Stop Code may be transmitted by the setup of the Check Digits, but
with no-effect.
(4) ITF
All data may be transmitted with Check Digits, but with no-effect.
(5) CODE128
3. Setting for Each Bar Code Symbology
Set the optional manual ID Bar Code Reader, as specified for each bar code symbology.
1) Code39
Check Digit=Use
Check Digit=Not transmit
ST/SP=Not transmit
Full ASCII=Non
Multi-read=No
ID Character=Not transmit

2) NW-7
ST/SP=Not transmit
ST/SP Character=a, b, c, d
Hex Format=No
3) UPC-A, UPC-E, EAN13, EAN8

Add-On=No
4) ITF
5) Code128
Check Digit=Use


INDEX
A Confirmation of Cycle Number........................4-41

Adjusting Pressure to 0.05 MPa ........................ 8-5 Connect Cables................................................A-12
Adjusting Vacuum to 0.0333 MPa..................... 8-6 Connect CELLPACK ........................................A-6
Adjustment of Pressure and Vacuum................. 8-2 Connect Host Computer ..................................A-12
Alarm Sounds .................................................. 1-13 Connect Hand Held Barcode Reader ..............A-12
Alphabetical List of Error Messages Connect Power Cord .......................................A-12
Displayed on Analysis Screen..................... 7-3 Connect Printer................................................A-12
Alphabetical List of Error Messages Connect STROMATOLYSER-WH...................A-8
Displayed on HELP Screen......................... 7-4 Connect Tube ....................................................A-6
Analysis Errors ................................................ 7-17 Connect Waste Line ..........................................A-9
Analysis of Histogram ..................................... 9-11 Contents of Display............................................1-8
Analysis of RBC/PLT Histogram ................... 9-20 Contents of Package .........................................1-13
Analysis of WBC Histogram ........................... 9-11 Correcting a Sample Number...........................3-23
Analysis Parameters........................................... 1-5
Analysis Procedure Flow Chart ........................ 2-2 D
As-Needed Maintenance and Procedure.......... 4-24 Daily Maintenance and Procedure .....................4-4
Auto Rinse ....................................................... 4-24 Date/Time Settings ...........................................10-8
Automatic Calibration ....................................... 6-5 DC Detection Method ........................................9-2
Automatic Calibration Procedure ...................... 6-6 Deletion ............................................................5-27
Automatic Stop Function of Pneumatic Unit..... 1-4 Deletion (Stored Data) .....................................3-20
Detection Principle.............................................9-2
B Display and Printing of Analysis Result ..........2-24
Blood Cell Discrimination Circuit................... 9-10 Display of Analysis Result....................... 2-24, 3-2
C DP Output Settings.........................................10-23
Calculating Calibration Value.......................... 6-11 E
Calculation of RBC Constant ........................... 9-9 Electric System.................................................9-28
Calibration ......................................................... 6-1 Emergency Stop Procedure ..............................1-12
Calibration Flow Chart ..................................... 6-4 Erase All.............................................................5-7
Calibration History Print.................................. 6-25 Error History Print ...........................................7-36
Calibrator Calibration ............................... 6-3, 6-15 Every 3-Month Maintenance and
Calibrator Calibration Procedure..................... 6-17 Procedure ..................................................4-16
Calibrator Calibration Program ......................... 6-1 Execute X Control............................................5-10
CBC Analysis .................................................... 9-5 Execute L-J Control .........................................5-19
Cell Count Parameters ..................................... 2-28 Execute QC Program..........................................5-5
Chamber Errors................................................ 7-10 Executing and Quitting Stored Data
Check before Installation.................................. A-1 Processing Program ...................................3-14
Check Trap Chamber Level and Discard........... 4-6 Executing Automatic Calibration Program ....... 6-5
Clean Rinse Cup .............................................. 4-26 Executing Calibrator Calibration Program.......6-15
Clean Sample Rotor Valve (SRV).................... 4-16 Execution of Shutdown ....................................2-32
Clean SRV Tray ................................................. 4-7 Exit from QC Control Program........................5-26
Clean TD Chamber and Diluted Sample Expected Results ..............................................2-30
Line (Shutdown).......................................... 4-4 External Device Errors .....................................7-33
Clean Transducer (Rinse Sequence) ................ 4-12 External Output .............................. 3-11,3-21,5-31
Clean Waste Chamber (Rinse Sequence)........... 4-9
Clean WBC/RBC Transducer Aperture........... 4-28
Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A. i

F N
Factory Settings ............................................. 10-38 Names and Functions of Instruments ...............9-30
Front Interior.................................................... 9-31 Non-Cyanide Hemoglobin Analysis
Front Panel....................................................... 9-30 Method ........................................................9-2
Functional List of Error Messages..................... 7-5 O
G Operation Procedure.........................................4-41
GP/LP Output Settings .................................. 10-25 Option Units .......................................................1-3
Graphic Screen................................................... 1-8 Others ...............................................................7-25
Grounding ........................................................ 1-14 Outline of Operation ..........................................1-4
Output Format for Host Computer .................... B-1
H Output of Analysis Result to Host
Hand Held Bar Code Computer ...................................................2-27
Reader Specifications................................B-15
Output to Host Computer .................................5-35
Hardware............................................................B-1
Overview of Analysis Modes .............................2-1
HGB/HCT Calibration....................................... 6-3
Overview of Instrument......................................1-2
HGB/HCT Calibration Samples ........................ 6-3
Host Settings.................................................. 10-17 P
Panel Keyboard ..................................................1-7
I Password Settings...........................................10-32
ID Reader Settings......................................... 10-30
Patient Limit...................................................10-11
Inspection before Turning ON the Power .......... 2-3
Peripheral Settings .........................................10-36
Installation and Relocation .............................. 1-14
PLT Discriminator............................................9-10
Installation Environment......................... 1-14, 1-16
Pre-Diluted (PD) Mode ....................................2-16
Installation Space..................................... 1-15, A-3
Precision Check..................................................6-2
Instrument Specifications ................................ 1-17
Precision Check Sample.....................................6-2
IP Output Settings.......................................... 10-27
Preparation for Calibration.................................6-2
K Prepare Reagent ................................................A-6
KX-21N Maintenance Checklist........................ 4-2 Pressure and Vacuum Display ...........................8-3
L Pressure/Vacuum Errors .....................................7-7
LCD Brightness Adjustment............................ 1-12 Print Set Values ..............................................10-35
Left Side Interior.............................................. 9-34 Printer Errors ...................................................7-30
Left Side Panel................................................. 9-33 Printer Settings ...............................................10-22
Levy-Jennings Control (L-J).............................. 5-1 Printing of Analysis Result ..............................2-25
Limitation of Hemoglobin ............................... 2-29 Printing to Printer .............................................5-31
Limitations....................................................... 2-28 Procedures in each Analysis Mode ....................2-9
Location of Control Knobs ................................ 8-2 Processing Latest Samples .................................3-2
Processing Stored Data ....................................3-14
M Program Version...............................................7-37
Maintenance Errors.......................................... 7-27
Manual Calibration ......................................... 6-11 Q
Manual Calibration Procedure......................... 6-12 QC Analysis Procedure ......................................5-4
Manual Discrimination ...................................... 3-7 QC Analysis Procedure Flow Chart ...................5-4
Measuring Unit Hydraulic System QC Chart Screen ................................................5-2
Block Diagram ............................................ 9-4 QC Settings ....................................................10-14
Memory Errors................................................. 7-23 Quality Control...................................................2-8
Menu Tree........................................................ 1-21
Monthly Maintenance and Procedure................ 4-9
Motor Errors .................................................... 7-13
ii Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

R T
RBC Discriminator .......................................... 9-10 Temperature Errors...........................................7-16
RBC/PLT Analysis Flow ................................... 9-7 Transducer Errors .............................................7-15
Rear Panel........................................................ 9-35 Troubleshooting Guide.......................................7-7
Reference Values ............................................... 6-3 Turn Power ON ...............................................A-13
Reinstalling the Program ................................ A-13 Turning ON the Power and Self-Check..............2-5
Remove Shipping Clamps ................................ A-4
W
Replace Fuse.................................................... 4-36 WBC Discriminator .........................................9-10
Replace Printer Paper ...................................... 4-37 WBC/HGB Analysis Flow .................................9-5
Replace Waste Tank......................................... 4-32 Weekly Maintenance and Procedure ..................4-7
Replenish Reagent ........................................... 4-33 When You Suspect a Trouble .............................7-2
Reset SRV Cycle Counter................................ 4-22 Whole Blood (WB) Mode .................................2-9
Right Side Panel .............................................. 9-32
X
S X Control............................................................5-1
Select QC File.................................................... 5-6
Set Printer Paper ............................................. A-10
Set TARGET/LIMIT Values.............................. 5-8
Shutdown Procedure ........................................ 2-32
Software.............................................................B-3
Start-up Procedure ............................................. 2-3
Status Display .................................................. 7-34
Status Display Messages ................................... 1-9
Stopping the Pneumatic Unit ........................... 2-31
Stored Data Screen .......................................... 3-15
Supplies List .................................................... 4-40
Supplies Replacement...................................... 4-33
System Setup ................................................... 10-3
Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A. iii

iv Sysmex KX-21N Operator’s Manual -- Revised November 2009

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OPERATOR’S MANUAL

AUTOMATED HEMATOLOGY ANALYZER

• Cubitainer is a registered trademark of Hedwin Corporation.

• Other trademarks referenced are property of their respective owners.

Sysmex KX-21N Operator’s Manual -- Revised November 2009

All instruments manufactured by Sysmex® are warranted against defective materials or

1. Accident, neglect or willful mistreatment of the product

Sysmex KX-21N Operator’s Manual -- Revised November 2009 I

The illustrations and meaning are described in the following.

CAUTION • This product is a clinical instrument for screening of abnormalities.

II Sysmex KX-21N Operator’s Manual -- Revised November 2009

• Always wear rubber gloves when performing maintenance work or inspection.

• Be careful when handling samples.

When Handling Reagent

• Do not modify the instrument. (Modification is prohibited by Pharmaceutical Affairs Law in

Sysmex KX-21N Operator’s Manual -- Revised November 2009 III

Power Supply, Connection, and Grounding

• When installing the instrument, be sure to ground it.

Handling Power Supply Cord

IV Sysmex KX-21N Operator’s Manual -- Revised November 2009

Environment for Use

Sysmex KX-21N Operator’s Manual -- Revised November 2009 V

Chapter 1: Introduction Describes overview of this instrument, including the out-

Chapter 2: Sample Analysis Describes procedures for start-up of the instrument,

Chapter 4: Maintenance and Supplies Describes scheduled maintenance and replacement

Chapter 6: Calibration Describes procedures for automatic, manual, and cali-

Chapter 7: Troubleshooting Describes error messages and troubleshooting.

Chapter 8: Adjustment Describes the method of pressure adjustment based on

Chapter 9: Functional Description Describes the analyzing principles of this instrument

Appendix A: Installation Describes the installation method of the KX-21N.

VI Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

Ordering of Supplies and Replacement Parts

Service and Maintenance

Sysmex KX-21N Operator’s Manual -- Revised November 2009 VII

VIII Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A.

Sysmex KX-21N Operator’s Manual -- Revised November 2009 IX

X Sysmex KX-21N Operator’s Manual -- Revised November 2009

1) The meanings of these signs are:

(Left) Parallel Port (DP Connector)

(Right) Parallel Port (GP Connector)

(Left) RS-232C Serial Port(Service Connector)

(Right) RS-232C Serial Port (HC Connector)

2) The meaning of this abbreviation is:

Sysmex KX-21N Operator’s Manual -- Revised November 2009 XI

IVD For In Vitro Diagnostic Use

1) The meanings of these signs are:

XII Sysmex KX-21N Operator’s Manual -- Revised November 2009

CHAPTER 2: SAMPLE ANALYSIS

Sysmex KX-21N Operator’s Manual -- Revised November 2009 i

CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT

ii Sysmex KX-21N Operator’s Manual -- Revised November 2009

Sysmex KX-21N Operator’s Manual -- Revised November 2009 N.A. iii

iv Sysmex KX-21N Operator’s Manual -- Revised November 2009

CHAPTER 10: INSTRUMENT SETUP

Sysmex KX-21N Operator’s Manual -- Revised November 2009 v

APPENDIX B: TECHNICAL INFORMATION

vi Sysmex KX-21N Operator’s Manual -- Revised November 2009

1. INTRODUCTION ................................................................................... 1-1

2. OVERVIEW OF INSTRUMENT ............................................................ 1-2

3. OPTION UNITS ...................................................................................... 1-3