Sysmex KX-21 Instruction manual

OPERATOR’S MANUAL

AUTOMATED HEMATOLOGY ANALYZER

KX-21

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  1997 - 2000 by SYSMEX CORPORATION

All rights reserved. No part of this Operator’s Manual may be Code No. 461-2261-1
reproduced in any form or by any means whatsoever without PRINTED IN JAPAN
prior written permission of SYSMEX CORPORATION. Date of Last Revision: January 2000

• Sysmex is a registered trademark of SYSMEX CORPORATION.

• CELLCLEAN, CELLPACK, EIGHTCHECK-3WP, STROMATOLYSER-WH are

trademarks of SYSMEX CORPORATION.

• Cubitainer is a registered trademark of Hedwin Corporation.

• 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-21 Operator’s Manual -- Revised October 1998

I

RECEIVING INSTRUCTIONS

The KX-21 has been thoroughly tested before shipment, and has been packaged
carefully 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 guidelines 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
damage. Document any sign of damage on the bill of lading, regardless of how

insignificant it may appear. This is for your protection!

• Notify your service representative that the KX-21 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
customer'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

applicable Sysmex Operator's Manual

3. Failure to use the appropriate reagents or chemicals specified for the product

Sysmex KX-21 Operator’s Manual -- Revised October 1998

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

CAUTION

•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.

•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.

I

Sysmex KX-21 Operator’s Manual -- Revised October 1998

I

WARNING

• In the event the instrument emits abnormal odor or any smoke, turn off the power

immediately 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 and instrument consumable, 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-21 Operator’s Manual -- Revised October 1998

II

I

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), be sure to switch off the
power supply beforehand.

Otherwise, electrical shock or instrument failure may result.

V

Sysmex KX-21 Operator’s Manual -- Revised October 1998

CAUTION

y

g

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 b
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

enerated.

Sysmex KX-21 Operator’s Manual -- Revised October 1998

Sysmex KX-21 Operator’s Manual -- Revised January 2000

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

Chapter 2: Sample Analysis

Chapter 3: Display and Processing of

Analysis Results

Chapter 4: Maintenance and Supplies

Replacement

Chapter 5: Quality Control Describes execution procedures of the X control and L-

Chapter 6: Calibration
Chapter 7: Troubleshooting

Chapter 8: Adjustment
Chapter 9: Functional Description
Chapter 10: Instrument Setup

Appendix A: Installation

Describes overview of this instrument, including the
outline of the instrument, operation procedure, and
messages, and cautions during installation.

Describes procedures for start-up of the instrument,
measurement of the sample, and shut-down.
Summarizes the operation method for analyzing the
sample.

Describes the displayed content of the analysis data,
and the process of the latest sample/stored data.
Also describes the manual analysis and the external
output.

Describes scheduled maintenance and replacement
method of supplies such as reagent.

J control for quality control.
Describes procedures for automatic/manual calibration.

Describes error messages and troubleshooting.

Describes the method of pressure adjustment based on
the troubleshooting.

Describes the analyzing principles of this instrument
and names of the components.

Describes the system environment setting such as
date, time, and unit, and the data analysis setting such
as data error judgment.

Describes the installation method of the KX-21.

Appendix B: Technical Information

VI

Technical reference data describing the specification for
host output format.
(The host output function is an option.)

Sysmex KX-21 Operator’s Manual -- Revised October 1998

INTRODUCTION

Thank you for purchasing the Sysmex® Automated Hematology Analyzer KX-21.
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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998

VII

PREMISES FOR SIGNS

Meaning of Signs

WARNING

CAUTION

CAUTION: •Indicates what we would like you to know to maintain instrument

NOTE: •Indicates information which will come handy in operating the instrument.

•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.

•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.

performance and prevent its damage.

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-21 Operator’s Manual -- Revised October 1998

KX-21 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 ....................................................1-3

5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT...............1-3

6. ANALYSIS PARAMETERS....................................................1-4

7. PANEL KEYBOARD ............................................................1-6

8. GRAPHIC SCREEN..............................................................1-7

8.1 Contents of Display ........................................................1-7

8.2 Status Display Messages...................................................1-8

8.3 LCD Brightness Adjustment.............................................1-11

9. EMERGENCY STOP PROCEDURE.........................................1-11

10. ALARM SOUNDS...............................................................1-11

11. CONTENTS OF PACKAGE ...................................................1-11

12. INSTALLATION ENVIRONMENT..........................................1-12

12.1 Installation and Relocation...............................................1-12

12.2 Grounding ..................................................................1-12

12.3 Installation Space..........................................................1-13

12.4 Installation Environment .................................................1-14

13. INSTRUMENT SPECIFICATIONS ..........................................1-15

14. MENU TREE .....................................................................1-18

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

2.2 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

6. LIMITATIONS ...................................................................2-26

6.1 Cell Count Parameters ....................................................2-26

6.2 Limitation of Hemoglobin................................................2-27

7. EXPECTED RESULTS .........................................................2-28

8. STOPPING THE PNEUMATIC UNIT .......................................2-29

9. EXECUTION OF SHUTDOWN...............................................2-30

9.1 Shutdown Procedure ......................................................2-30

Sysmex KX-21 Operator’s Manual -- Revised January 2000 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 ....................................................3-6

2.3 Printing..................................................................... 3-10

2.4 Print Paper Feed .......................................................... 3-10

3. PROCESSING STORED DATA.............................................. 3-11

3.1 Executing and Quitting Stored Data Processing Program........... 3-11

3.2 Stored Data Screen .......................................................3-12

3.3 Deletion.................................................................... 3-15

3.4 Printing..................................................................... 3-16

3.5 HC Output (Option) ...................................................... 3-16

3.6 Correcting a Sample Number ........................................... 3-17

CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT

1. INTRODUCTION.................................................................4-1

2. KX-21 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-21 Operator’s Manual -- Revised January 2000

CHAPTER 5: QUALITY CONTROL

1. INTRODUCTION.................................................................5-1

1.1

Control ...................................................................5-1

X

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............................................................... 5-5

2.4 Erase All .....................................................................5-6

2.5 Set TARGET/LIMIT Values.............................................. 5-7

2.6 Execute

Control.......................................................... 5-9

X

2.7 Execute L-J Control .......................................................5-18

2.8 Exit from QC Control Program..........................................5-24

3. DELETION........................................................................5-25

4. PRINT..............................................................................5-27

5. HC OUTPUT (OPTION) ...................................................... 5-29

CHAPTER 6: CALIBRATION

1. INTRODUCTION.................................................................6-1

1.1 Calibration Execution Timing ............................................6-1

1.2 Samples Used for Calibration.............................................6-1

1.3 Reference Values ...........................................................6-1

1.4 Calibration Flow Chart..................................................... 6-2

2. AUTOMATIC CALIBRATION ................................................6-3

2.1 Executing Automatic Calibration Program .............................6-3

2.2 Automatic Calibration Procedure.........................................6-4

3. MANUAL CALIBRATION .....................................................6-9

3.1 Calculating Calibration Value ............................................6-9

3.2 Manual Calibration Procedure ...........................................6-10

Sysmex KX-21 Operator’s Manual -- Revised January 2000 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

2.2 Alphabetical List of Error Messages 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 Built-in Printer Errors ................................................... 7-30

3.11 External Device Errors (When this option is incorporated)........ 7-33

4. STATUS DISPLAY ............................................................ 7-34

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 0.5 kg/cm

2.4 Adjusting Vacuum to 250 mmHg .......................................8-6

2

........................................ 8-5

iv Sysmex KX-21 Operator’s Manual -- Revised January 2000

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................................................................ 10-2

3. DATE/TIME SETTINGS ...................................................... 10-7

4. PATIENT LIMIT...............................................................10-10

5. QC SETTINGS ................................................................. 10-13

6. HOST SETTINGS (OPTION)................................................ 10-16

7. PRINTER SETTINGS.........................................................10-21

8. PRINT SET VALUES.........................................................10-24

9. PERIPHERAL SETTINGS ...................................................10-25

10. FACTORY SETTINGS .......................................................10-27

Sysmex KX-21 Operator’s Manual -- Revised January 2000 v

APPENDIX A: INSTALLATION

1. INTRODUCTION................................................................ A-1

2. CHECK BEFORE INSTALLATION ......................................... A-2

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................................................... A-12

8. TURN POWER ON............................................................. A-12

APPENDIX B: TECHNICAL INFORMATION

1. OUTPUT FORMAT FOR HOST COMPUTER (Option)...................B-1

1.1 Hardware.....................................................................B-1

1.2 Software......................................................................B-3

INDEX

vi Sysmex KX-21 Operator’s Manual -- Revised January 2000

CHAPTER 1 INTRODUCTION

1. INTRODUCTION ................................................................. 1-1

2. OVERVIEW OF INSTRUMENT................................................ 1-2

3. OPTION UNITS...................................................................1-3

4. OUTLINE OF OPERATION..................................................... 1-3

5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT................ 1-3

6. ANALYSIS PARAMETERS.....................................................1-4

7. PANEL KEYBOARD .............................................................1-6

8. GRAPHIC SCREEN..............................................................1-7

8.1 Contents of Display......................................................... 1-7

8.2 Status Display Messages................................................... 1-8

8.3 LCD Brightness Adjustment..............................................1-11

9. EMERGENCY STOP PROCEDURE..........................................1-11

10. ALARM SOUNDS ...............................................................1-11

11. CONTENTS OF PACKAGE....................................................1-11

12. INSTALLATION ENVIRONMENT...........................................1-12

12.1 Installation and Relocation ................................................1-12

12.2 Grounding ..................................................................1-12

12.3 Installation Space...........................................................1-13

12.4 Installation Environment ..................................................1-14

13. INSTRUMENT SPECIFICATIONS...........................................1-15

14. MENU TREE......................................................................1-18

Sysmex KX-21 Operator’s Manual -- Revised October 1998

INTRODUCTION

1. INTRODUCTION

The Sysmex KX-21 is an automatic multi-parameter blood cell counter for in vitro
diagnostic use in clinical laboratories.

The KX-21 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 18 parameters,
as the analysis results.

Chapter 1 introduces the overview of the instrument, analysis procedure, etc. that we
recommend you to read before using the KX-21. The main contents of Chapter 1 are as
follows:

Overview of Instrument

The important functions of the KX-21 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-21 menu tree and the corresponding chapters which explain
the usage of the menus.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-1

INTRODUCTION

2. OVERVIEW OF INSTRUMENT

The KX-21 performs speedy and accurate analysis of 18 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-21 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 non­cyanide hemoglobin method.

Figure 1-2-1: Overview of KX-21

1-2 Sysmex KX-21 Operator’s Manual -- Revised October 1998

INTRODUCTION

y

(

y

3. OPTION UNITS

This instrument offers several option units to ensure its efficient operation. The options that
can be used with the KX-21 are:

• Serial interface: Outputs analysis data and QC data to the host computer. Ordering

Information: OUTPUT UNIT NO. 1 KX-21 (Part No. 973-4531-1)

4. OUTLINE OF OPERATION

Two analysis modes are available with the KX-21: 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

Read

Select whole blood mode. Select pre-diluted mode.

Set sample No. Prepare analysis samples in pre-diluted mode

1:26 dilution).

Set sample No.

Set sample to the sample probe.

Press the start switch.

• Execute analysis.

• End analysis.

Read

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" is displayed on the LCD screen. In this state, various operations

Ready

including analysis, settings, and data processing can be performed.

5. AUTOMATIC STOP FUNCTION OF PNEUMATIC UNIT

The KX-21, 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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-3

Sysmex KX-21 Operator’s Manual -- Revised January 2000

INTRODUCTION

6. ANALYSIS PARAMETERS

This instrument analyzes the following parameters using three detector blocks and two kinds
of reagents:

1) Whole 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 Hct/RBC.

12) MCH (Mean RBC hemoglobin)
Mean hemoglobin volume (pg) per RBC, which is calculated by Hgb/RBC.

13) MCHC (Mean RBC hemoglobin concentration)
Mean hemoglobin concentration (g/dL), which is calculated by Hgb/Hct.

1-4 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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) PDW (Platelet distribution width)*
The distribution width (fL) at the height of 20% from the bottom with the peak of
platelet particle distribution curve taken as 100%.

18) MPV (Mean platelet volume)
Mean volume of platelet (fL)

19) P-LCR (Large platelet ratio) *
Ratio (%) of large platelet volume exceeding 12 fL to the platelet volume

NOTE: • When analyzing in the pre-diluted mode, only the CBC8 parameters

are output.

• The RBC distribution width is the switchover type between RDW-SD
and RDW-CV.

* For Investigational Use Only in the United States of America.

Not a reportable parameter.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-5

INTRODUCTION

7. PANEL KEYBOARD

The KX-21 is provided with the 22-key panel keyboard.

6

C

SAMPLE No.
ENTER
SELECT
MODE

HELP

SHUTDOWN

7
4

1
0

89
5
23

-/.

Figure 1-7-1: Panel Keyboard

Name Function
SAMPLE No. Used to set a sample No. and QC File 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., QC File 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

previous 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.

1-6 Sysmex KX-21 Operator’s Manual -- Revised October 1998

8 . GRAPHIC SCREEN

8.1 Contents of Display

Next Sample

Next Sample No.

WBC 0.0
RBC 0.00×106/µL MXD% ---.-%
HGB 0.0g/dL NEUT% ---.-%
HCT 0.0% LYM# ---.-×103/µL
MCV ---.-fL MXD# ---.­MCH ---.-pg NEUT# ---.-×103/µL
MCHC ---.-g/dL RDW ---.-fL
PLT 0

Analysis Mode Status Display

No.1 WB

Ready

3

×10

/µL LYM% ---.-%

3

×10

/µL PDW ---.-fL

00/00 00:00No.0 WB

MPV ---.-fL
P-LCR ---.-%

Analysis Progress Status

3

×10

/µL

Analysis Result
Display Area

INTRODUCTION

1:M.Discri. 2:Print 3:Paper Feed

Figure 1-8-1: Graphic LCD

Name Function
Next Sample No. Displays the sample No. to be analyzed next.
Next Sample

Analysis Mode

Analysis Progress
Status

Status Display Status of the unit is displayed.
Menu Display Area Useable menus for each screen are displayed.
Analysis Result

Display Area

Displays the analysis mode for the sample to be analyzed next.
WB: whole blood mode
PD: pre-diluted mode

With the start-to-end analysis progress classified into six steps, the
present progress status is displayed.

The area for displaying analysis result

Table 1-8-1: Contents of Display

Menu Display Area

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-7

INTRODUCTION

8.2 Status Display Messages

The KX-21 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-21

[00-01]

*Auto Rinse*

Please wait.

Please wait.

The hydraulic system is undergoing Auto
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 when [SHUTDOWN] key is
pressed. When an automatic background
check shows a background count exceeding
the permissible background count level, rinse
sequence is automatically extended.

1-8 Sysmex KX-21 Operator’s Manual -- Revised October 1998

Display Message Meaning

No.1 WB

WBC 0.0×103/µL LYM% ---.-%
RBC 0.00
HGB 0.0g/dL NEUT% ---.-%
HCT 0.0% LYM# ---.-×103/µL
MCV ---.-fL MXD# ---.-×103/µL
MCH ---.-pg NEUT# ---.­MCHC ---.-g/dL RDW ---.-fL
PLT 0

1:M.Discri. 2:Print 3:Paper Feed

Ready

6

×10

/µL MXD% ---.-%

3

×10

/µL PDW ---.-fL

MPV ---.-fL
P-LCR ---.-%

00/00 00:00No.0 WB

3

×10

/µL

INTRODUCTION

The instrument is ready for analysis in the
whole blood mode. "No." in the left upper
corner indicates the sample No. to be
analyzed next.

No.1 PD

WBC 0.0×103/µL LYM% ---.-%
RBC 0.00
HGB 0.0g/dL NEUT% ---.-%
HCT 0.0% LYM# ---.-×103/µL
MCV ---.-fL MXD# ---.-×103/µL
MCH ---.-pg NEUT# ---.­MCHC ---.-g/dL RDW ---.-fL
PLT 0

1:M.Discri. 2:Print 3:Paper Feed

FILE No.1 QC

X1 X2 X Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT

FILE No.1 QC

Data Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT

Ready

6

×10

/µL MXD% ---.-%

3

×10

/µL PDW ---.-fL

MPV ---.-fL
P-LCR ---.-%

Ready

Ready

00/00 00:00No.0 PD

3

×10

/µL

The instrument is ready for pre-diluted mode
analysis. "No." in the left upper corner shows
the sample No. to be analyzed next.

The instrument is ready for X control. "FILE
No. 1" in the left upper corner shows QC file
No.

The instrument is ready for L-J control. "FILE
No. 1" in the left upper corner shows QC file
No.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-9

INTRODUCTION

Change Mode

*

Display Message Meaning

*

The whole blood mode is turning into the pre­diluted mode, or the pre-diluted mode is
turning into the whole blood mode.

Please wait.

No.123457 WB

No.123457 PD

No.123457 WB

No.123457 WB

No.123457 WB

No.123457 WB

Aspirating

Aspirating

Analyzing

Rinsing

Replenish Diluent

Not Ready

PU Sleeping

Not Ready

Momentary power failure occurred.

WB

Ready

The sample is being aspirated in whole blood
mode analysis.

The sample is being aspirated in pre-diluted
mode analysis.

Samples are being aspirated, diluted, and
counted in whole blood mode (or pre-diluted
mode).

Hydraulic line in the whole blood mode (or
pre-diluted mode) is being rinsed.

An error occurs, making analysis impossible.
(When an error occurs, the error message
appears in reversed display in the right upper
area of the LCD screen.)

When operation has been suspended over
15 minutes, the compressor power is turned
OFF 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
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 corner of the screen. This applies only
when an optional serial interface is
incorporated.

1-10 Sysmex KX-21 Operator’s Manual -- Revised October 1998

INTRODUCTION

8.3 LCD Brightness Adjustment

Open the front cover of the instrument. LCD
brightness can be adjusted using the brightness
adjustment knob under the panel keyboard.
Turning to the right brightens the light and turning
to the left dims it.

Light

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.

10. ALARM SOUNDS

Dark

The KX-21 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 aspiration ends.

11. CONTENTS OF PACKAGE

The instrument is fully inspected before leaving the factory and carefully packed to withstand
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 initial settings.
To confirm the contents of the package, refer to "Appendix A: Installation."

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-11

INTRODUCTION

12. INSTALLATION ENVIRONMENT

12.1 Installation and Relocation

The KX-21 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 conducted
by the customer, resulting in any trouble, warranty would not be applied even in the
warranty period.

1 2 .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

NOTE: • The number of power supply sockets required is one.

• Make sure to ground the instrument. Inadequate grounding could cause
electrical shocks.

1-12 Sysmex KX-21 Operator’s Manual -- Revised October 1998

INTRODUCTION

12.3 Installation Space

To ensure that the instrument fulfills its function, it is important to install it at an appropriate
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.

• 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 28

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 CELLPACK at a
level higher than the instrument; otherwise, reagent may flow into the
vacuum line, possibly damaging the instrument.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-13

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

frequency waves can be generated or radio interference can occur.

1-14 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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), PDW (platelet distribution width)*, MPV (mean platelet volume), P-LCR (platelet
large cell ratio)*, LYM% (W-SCR), MXD% (W-MCR), NEUT% (W-LCR), LYM# (W­SCC), MXD# (W-MCC), NEUT# (W-LCC) (RDW-SD or RDW-CV: Switch over type)
However, the parameters in pre-diluted mode are eight: WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, PLT.

* For Investigational Use Only in the United States of America.

Not a reportable parameter.

Display range

WBC 0.0 - 299.9 (×10

3

/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

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-15

INTRODUCTION

Reproducibility

Reproducibility is within the following range at the reliability level of 95%.

1) Whole blood mode

WBC (4.0 × 10

3

/µL or over) 3.5% or less

RBC (4.00 × 106/µL or over) 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
PDW 12.0% or less
MPV 5.0% or less
P-LCR 20.0% 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 or less
RBC: ±2% or ±0.03 × 106/µL or less
PLT: ±5% or ±10 × 103/µL or less

2) Pre-diluted mode

WBC: ±5% or ±0.3 × 103/µL or less
RBC: ±3% or ±0.05 × 106/µL or less
PLT: ±8% or ±15 × 103/µL or less

1-16 Sysmex KX-21 Operator’s Manual -- Revised October 1998

Linearity

1) Whole blood mode

WBC: 1.0 - 9.9 (× 10

3

/µL) ±0.3 (× 103/µL) or less

10.0 - 99.9 (× 103/µL) ±3% or less

RBC: 0.30 - 0.99 (× 106/µL) ±0.03 (× 106/µL) or less

1.00 - 7.00 (× 106/µL) ±3% or less

HGB: 0.1 - 10.0 (g/dL) ±0.2 (g/dL) or less

10.0 - 25.0 (g/dL) ±2% or less

HCT: 10.0 - 33.3 (HCT%) ±1.0 (HCT%) or less

33.4 - 60.0 (HCT%) ±3% or less

PLT: 10 - 199 (× 103/µL) ±10 (× 103/µL) or less

200 - 999 (× 103/µL) ±5% or less
(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

INTRODUCTION

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% or less (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. 28.0 kg

Classification

According to the type of protection against electric shock: Class I Equipment
According to the degree of protection against electric shock: Type B Equipment

Sysmex KX-21 Operator’s Manual -- Revised October 1998 1-17

Sysmex KX-21 Operator’s Manual -- Revised January 2000

INTRODUCTION

14. MENU TREE

Ana. Screen

SELECT

1: M. Discri.
2: Print

3: Paper Feed

1: Stored Data

2: Quality
Control

3: Calibration

4: Replace
Lyse

5: Auto Rinse

6: Settings

Chapter 3, 2.2
Chapter 3, 2.3
Chapter 3, 2.4

Chapter 3

Chapter 5

Chapter 6

Chapter 4, 8.1

Chapter 4, 7.1

Chapter 10

1: Delete

2: Print

3: HC Output

1: QC Analyze
2: Settings

3: Erase All

1: Auto Cal.

2: Manual Cal.

1: System Setup
2: Date/Time
3: Patient Limit
4: QC Settings
5: Host Settings
6: Printer Settings
7: Print Set Values

Chapter 3, 3.3
Chapter 3, 3.4

Chapter 3, 3.5

Chapter 5, 2
Chapter 5, 2.5

Chapter 5, 2.4

Chapter 6, 2

Chapter 6, 3

Chapter 10, 2
Chapter 10, 3
Chapter 10, 4
Chapter 10, 5
Chapter 10, 6
Chapter 10, 7
Chapter 10, 8

1: HGB
2: HGB/HCT
3: HCT

Chapter 6, 2
Chapter 6, 2

Chapter 6, 2

7: Maintenance

8: Periph.
Settings

00: PU Sleep

SAMPLE No.

MODE

HELP

SHUTDOWN

Chapter 2, 4

Chapter 2, 4

Chapter 7, 1

Chapter 2, 6

: Applicable when the option is provided.

Chapter 4

Chapter 10, 9

Chapter 2, 8

1-18 Sysmex KX-21 Operator’s Manual -- Revised October 1998

1: Clean W. Chamber
2: Clean Transducer
3: Reset SRV Counter
4: Drain TD Chamber
5: Status Display

Chapter 4, 5.1
Chapter 4, 5.2
Chapter 4, 6.2
Chapter 4, 7.3
Chapter 7, 4

Sysmex KX-21 Operator’s Manual -- Revised January 2000

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

2.2 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

6. LIMITATIONS....................................................................2-26

6.1 Cell Count Parameters.....................................................2-26

6.2 Limitation of Hemoglobin.................................................2-27

7. EXPECTED RESULTS..........................................................2-28

8. STOPPING THE PNEUMATIC UNIT .......................................2-29

9. EXECUTION OF SHUTDOWN ...............................................2-30

9.1 Shutdown Procedure ......................................................2-30

Sysmex KX-21 Operator’s Manual -- Revised January 2000

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
shutdown, 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, collected
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 confined to
only the CBC8 parameter.

Sysmex KX-21 Operator’s Manual -- Revised October 2-1

Sysmex KX-21 Operator’s Manual -- Revised December 1999

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
the Power

Turning ON the Power and
Self-Check

Execution of Quality Control

Whole Blood Mode
Analysis

Page 2-9

Pre-Diluted Mode
Analysis

Page 2-16

Page 2-3

Page 2-5

Page 2-8

Display and Printing of
Analysis Result

Execution of Shutdown

Turning OFF the Power

Table 2-1-1: Analysis Procedure Flow Chart

Page 2-24

Page 2-26

2-2 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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 processed
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, analysis 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.)

SAMPLE ANALYSIS

• Replenishing reagent

• Make ready a new reagent and make sure that it has not passed its expiration

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
STROMATOLYSER-WH 500 mL

Table 2-2-1: Expiration After Opening the Seal

60 days
90 days

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-3

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

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.

2-4 Sysmex KX-21 Operator’s Manual -- Revised October 1998

Sysmex KX-21 Operator’s Manual -- Revised January 2000

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
background 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-21

[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

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-5

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 maintenance. If
upon the power turn-on, the counter is found exceeding the
predetermined times, the screen advising scheduled maintenance 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

SUPPLIES REPLACEMENT

Chapter 4: INSTRUMENT MAINTENANCE AND

.

(3) When self-check is normally completed, auto rinse and background check are

performed.

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 display 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 [×10

RBC 0.02 [×106/µL] or less

HGB 0.1 [g/dL] or less

PLT 10 [×103/µL] or less

3

/µL] or less

2-6 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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 WB

WBC 0.0×103/µL LYM% ---.-%
RBC 0.00×106/µL MXD% ---.-%
HGB 0.0g/dL NEUT% ---.-%
HCT 0.0% LYM# ---.-×103/µL
MCV ---.-fL MXD# ---.-×103/µL
MCH ---.-pg NEUT# ---.-×103/µL
MCHC ---.-g/dL RDW ---.-fL
PLT 0

1:M.Discri. 2:Print 3:Paper Feed

Ready

3

×10

/µL PDW ---.-fL

MPV ---.-fL
P-LCR ---.-%

00/00 00:00No.0 WB

Figure 2-2-5: Ready Status

NOTE: • When the power is on, the next sample No. is displayed "1."

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-7

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
analyzing control blood is described below.

control or L-J control program. The analysis mode used in

X

• 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.

2-8 Sysmex KX-21 Operator’s Manual -- Revised October 1998

SAMPLE ANALYSIS

4 . PROCEDURES IN EACH ANALYSIS MODE

With this instrument, sample mixing, cap removal, and tube setting are performed manually.
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

1. Collecting and preparing samples

A specified amount of sample, corresponding to the amount of EDTA anticoagulant, 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 temperature.

• When the reagent might have frozen, handle it according to the
precautions stated on the Package Insert of each reagent. Otherwise,
improper analysis may result.

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

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-9

SAMPLE ANALYSIS

)

2. Selecting whole blood mode

When "PD" is indicated in the system status area on the LCD screen, 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)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

*

Whole Blood(WB) Pre-Diluted(PD)

Change mode with [ ]or[ ]. Press [ENTER] to Set.

*

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.

2-10 Sysmex KX-21 Operator’s Manual -- Revised October 1998

SAMPLE ANALYSIS

3. Inputting sample No.

• Input from the panel keyboard

(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.1 WB

WBC 0.0×103/µL LYM% ---.-%
RBC 0.00×106/µL MXD% ---.-%
HGB 0.0g/dL NEUT% ---.-%
HCT 0.0% LYM# ---.-×103/µL
MCV ---.-fL MXD# ---.-×103/µL
MCH ---.-pg NEUT# ---.-×103/µL
MCHC ---.-g/dL RDW ---.-fL
PLT 0

1:M.Discri. 2:Print 3:Paper Feed

Not Ready

3

×10

/µL PDW ---.-fL

MPV ---.-fL
P-LCR ---.-%

00/00 00:00No.0 WB

Figure 2-4-3: Inputting Sample No.

(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) Judgement 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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-11

SAMPLE ANALYSIS

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 six digits, comprising numerics and a
hyphen, can be used.

• The hyphen cannot be used at the first or last digit of a number, and
two or more hyphens cannot be entered in succession.
[Example] NG -123

NG 123­ NG 1--23

• Any number beginning with "0" (zero) cannot be entered.
[Example] NG 0123

(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 Analysis
screen without updating sample No.

2-12 Sysmex KX-21 Operator’s Manual -- Revised October 1998

4. Analyzing samples

• When analyzing samples, always wear rubber gloves. After

WARNING

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 2-4-4: Mixing the Sample

(2) Remove the plug while taking care not to allow blood scatter.

SAMPLE ANALYSIS

Figure 2-4-5: Removing the Plug

(3) Set the tube to the sample probe, and in that condition, press the start switch.

Start Switch

Figure 2-4-6: Pressing the Start Switch

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-13

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.123457 WB

Ready

(Aspirating)

No.123457 WB

Aspirating

(Analyzing)

No.123457 WB

Analyzing

(Rinsing)

No.123457 WB

Rinsing

(Ready)

No.123458 WB

Ready

Figure 2-4-7: LCD Screen (in WB Mode)

CAUTION

CAUTION: • Several seconds after the buzzer sounds "beep, beep" and

NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it

• 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.

"Aspirating" 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.

clean.

2-14 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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

999999 → 1
12-3 → 12-4
12-999 → 12-000

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-15

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 analyzing
a capillary blood collected from the earlobe or fingertip. Samples are processed by the
following steps:

1. Collecting and preparing samples

2. Preparing analysis samples in PD mode (dilution of 1:26)

3. Selecting Pre-Diluted mode

4. Inputting sample No.

5. Analyzing samples

1. Collecting and preparing samples

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

• A capillary blood collected from the earlobe or fingertip is prone to
platelet agglutination, so dilute and analyze it within 30 minutes.
Otherwise, correct analysis result may not be obtained.

• With a sample of blood collected from the earlobe or fingertip, blood cell
count is generally higher than normal, with lower reproducibility. If
possible, analyze the same diluted sample twice and compare the
results. When the blood collection tube containing a commercial anti­coagulant 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 EDTA­2K, EDTA-3K, or EDTA-2Na.

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

2-16 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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.

• When preparing PD-mode analysis samples, always wear rubber

WARNING

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, analyze
the sample within 30minntes 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

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-17

SAMPLE ANALYSIS

)

3. Selecting Pre-Diluted mode

When "WB" is displayed in the system status area on the LCD screen, 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

*

Whole Blood(WB) Pre-Diluted(PD)

Change mode with [ ]or[ ]. Press [ENTER] to Set.

*

Figure 2-4-8: Change Mode Screen

(3) Press [ ] or [ ] key to select "Pre-Diluted (PD)."

Change Mode

*

Whole Blood(WB) Pre-Diluted(PD)Pre-Diluted(PD

Change mode with [ ]or[ ]. Press [ENTER] to Set.

*

Figure 2-4-9: 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.

2-18 Sysmex KX-21 Operator’s Manual -- Revised October 1998

SAMPLE ANALYSIS

4. Inputting sample No.

• Input from the panel keyboard

(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.1 PD

WBC 0.0×103/µL LYM% ---.-%
RBC 0.00×106/µL MXD% ---.-%
HGB 0.0g/dL NEUT% ---.-%
HCT 0.0% LYM# ---.-×103/µL
MCV ---.-fL MXD# ---.-×103/µL
MCH ---.-pg NEUT# ---.-×103/µL
MCHC ---.-g/dL RDW ---.-fL
PLT 0

1:M.Discri. 2:Print 3:Paper Feed

Not Ready

3

×10

/µL PDW ---.-fL

MPV ---.-fL
P-LCR ---.-%

00/00 00:00No.0 PD

Figure 2-4-10: Inputting Sample No.

(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) Judgement 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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-19

SAMPLE ANALYSIS

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 six digits, comprising numerics and a
hyphen, can be used.

• The hyphen cannot be used at the first or last digit of a number, and
two or more hyphens cannot be entered in succession.
[Example] NG -123

NG 123­ NG 1--23

• Any number beginning with "0" (zero) cannot be entered.
[Example] NG 0123

(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 Analysis
screen without updating sample No.

2-20 Sysmex KX-21 Operator’s Manual -- Revised October 1998

5. Analyzing samples

• When analyzing samples, always wear rubber gloves, and after

WARNING

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 2-4-11: Mixing the Sample

(2) Remove the plug while taking care not to allow blood scatter.

SAMPLE ANALYSIS

Figure 2-4-12: Removing the Plug

(3) Set the micro-tube to the sample probe, and in that condition, press the start switch.

Start Switch

Figure 2-4-13: Pressing the Start Switch

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-21

SAMPLE ANALYSIS

(4) The buzzer sounds two times - "beep, beep" - and when the LCD screen displays

"Analyzing," 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.123457 PD

Ready

(Aspirating)

No.123457 PD

Aspirating

(Analyzing)

No.123457 PD

Analyzing

(Rinsing)

No.123457 PD

Rinsing

(Ready)

No.123458 PD

Ready

Figure 2-4-14: LCD Screen (in PD Mode)

CAUTION

CAUTION: • Several seconds after the buzzer sounds "beep, beep" and

NOTE: • The sample probe is automatically rinsed, so there is no need to wipe it

• 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.

"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.

clean.

2-22 Sysmex KX-21 Operator’s Manual -- Revised October 1998

SAMPLE ANALYSIS

(5) When the LCD screen displays "Ready," prepare a next sample 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

999999 → 1
12-3 → 12-4
12-999 → 12-000

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-23

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 three pages, and pages are turned over by
using [

] or [ ] key.

No.123458 WB

WBC 7.1×103/µL LYM% 31.2%
RBC 3.97×106/µL MXD% 19.6%
HGB 14.7g/dL NEUT% 49.2%
HCT 32.8% LYM# 2.2×103/µL
MCV - 82.6fL MXD# 1.4×103/µL
MCH 37.0pg NEUT# 3.5
MCHC + 44.8g/dL RDW - 25.6fL
PLT 180

1:M.Discri. 2:Print 3:Paper Feed

No.123458 WB

WBC

RBC

PLT

1:M.Discri. 2:Print 3:Paper Feed

No.123458 WB

WBC 7.1×103/µL
RBC 3.97
HGB 14.7g/dL
HCT 32.8%
MCV - 82.6fL
MCH 37.0pg
MCHC + 44.8g/dL
PLT 180

Ready

×

103/µL PDW - 7.9fL

MPV 9.3fL
P-LCR - 9.5%

Ready

LYM% 31.2%
MXD% 19.6%
NEUT% 49.2%
LYM# 2.2×103/µL
MXD# 1.4×103/µL
NEUT# 3.5
RDW - 25.6fL
PDW - 7.9fL
MPV 9.3fL
P-LCR - 9.5%

Ready

×

106/µL

×

103/µL

31/12 23:59No.123457 WB

31/12 23:59No.123457 WB

31/12 23:59No.123457 WB

×

103/µL

×

103/µL

No.123459 PD

WBC 7.1×103/µL LYM% ---.-%
RBC 3.97×106/µL MXD% ---.-%
HGB 14.7g/dL NEUT% ---.-%
HCT 32.8% LYM# ---.-×103/µL
MCV - 82.6fL MXD# ---.-×103/µL
MCH 37.0pg NEUT# ---.­MCHC + 44.8g/dL RDW ---.-fL
PLT 180

1:M.Discri. 2:Print 3:Paper Feed

No.123459 PD

WBC

RBC

PLT

1:M.Discri. 2:Print 3:Paper Feed

No.123459 PD

WBC 7.1×103/µL
RBC 3.97
HGB 14.7g/dL
HCT 32.8%
MCV - 82.6fL
MCH 37.0pg
MCHC + 44.8g/dL
PLT 180

Ready

×

103/µL PDW ---.-fL

MPV ---.-fL
P-LCR ---.-%

Ready

LYM% ---.-%
MXD% ---.-%
NEUT% ---.-%
LYM# ---.-×103/µL
MXD# ---.-×103/µL
NEUT# ---.­RDW ---.-fL
PDW ---.-fL
MPV ---.-fL
P-LCR ---.-%

Ready

×

106/µL

×

103/µL

31/12 23:59No.123458 PD

31/12 23:59No.123458 PD

31/12 23:59No.123458 PD

×

103/µL

×

103/µL

1:M.Discri. 2:Print 3:Paper Feed

1:M.Discri. 2:Print 3:Paper Feed

(Whole Blood Mode) (Pre-diluted Mode)

Figure 2-5-1: Analysis Result Display Screen

2-24 Sysmex KX-21 Operator’s Manual -- Revised October 1998

SAMPLE ANALYSIS

5.2 Printing of Analysis Result

Analysis result can be printed out on the built-in printer.

NOTE: • One print format can be selected from among Types 1, 2, and 3. For

the selecting procedure, refer to

Setting.

Chapter 10, Section 7: Printer Output

[Type 1]

No. 123457
Date 31/12/97 10:02
Mode WB

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

×10

3

/µL

MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL

RBC

[fL]

[Type 2]

No. 123457
Date 31/12/97 10:02
Mode WB

WBC 7.3

×10

3

/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

LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
RDW 98.3 fL
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %

[Type 3]

No. 123457
Date 31/12/97 10:02
Mode WB

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

RDW 98.3 fL

PLT

[fL]

PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %

Figure 2-5-2: Printing of Analysis Result

Sysmex KX-21 Operator’s Manual -- Revised October 2-25

Sysmex KX-21 Operator’s Manual -- Revised January 2000

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

Platelet aggregation
Erythroblastosis
Nucleated RBC
Cryoglobulins

RBC Cold Agglutinin

Severe Microcytosis
Fragmented RBC
Leukocytosis
(>100,000/µL)

HGB Leukocytosis

(>100,000/µL)
Lipemia
Abnormal Protein

HCT Cold Agglutinin

Leukocytosis
(>100,000/µL)
Abnormal Red Cell Fragility
Spherocytosis

PLT Pseudothrombocytopenia

Platelet Aggregation
Increased Microcytosis
Megalocytic Platelets

(+)
(+)
(+)
(+)
(+)

(-)
(-)
(-)

(+)

(+)
(+)

(+)

(-)

(+)

(?)
(?)

(-)
(-)

(+)

(-)

↑MCV, ↓HCT, red cell clumping on smear
Platelet aggregates on smear
Erythroblasts on smear
NRBC on smear

↑MCV, ↓HCT, red cell clumping on smear

Elevation of WBC

Elevation of WBC

↑MCHC, “milky” appearance of plasma
↑MCHC, Lysed Hgb/WBC sample turns

cloudy
↑MCV, ↓HCT, red cell clumping on smear

Elevation of WBC

↓MCV, spherocytes on smear
Platelet Satellitism on smear

Platelet Aggregation on smear
↓MCV

(+): 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.

2-26 Sysmex KX-21 Operator’s Manual -- Revised October 1998

SAMPLE ANALYSIS

6.2 Limitation of Hemoglobin

1. Hemoglobin measurements may be falsely elevated due to the influences of abnormal

samples including leukocytosis above 100,000/µL, lipemia or abnormal proteins 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 instrument
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 hemoglobin.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-27

SAMPLE ANALYSIS

7. EXPECTED RESULTS

Reference intervals (normal population reference ranges) were developed for the KX-21 using
normal individuals. The ranges for each parameter --- WBC, RBC, Hemoglobin, Hematocrit,
MCV, MCH, MCHC, RDW-CV, RDW-SD, Platelet, PDW*, MPV, P-LCR*, Lym% and #,
Mxd% and #, and Neut% and # were determined and displayed in Table 1-16-1.

* For Investigational Use Only in the United States of America.

Not a reportable parameter.

Parameter Range for

Females n=117

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
PDW 9.4 - 18.1 9.8 - 18.0
MPV 8.5 - 12.4 8.1 - 12.4
P-LCR 14.3 - 44 10.7 - 45.0

Range for Males

n=124

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

1

location, etc. The NCCLS Document C28A

, “How to Define and Determine Reference
Intervals in the Clinical Laboratory; Approved Guideline”. This document contains
guidelines for determining reference values and intervals for quantitative clinical laboratory
test.

1

NCCLS, 771 East Lancaster Avenue, Villanova, PA 19085, USA.

2-28 Sysmex KX-21 Operator’s Manual -- Revised October 1998

SAMPLE ANALYSIS

8. STOPPING THE PNEUMATIC UNIT

The KX-21, 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 procedures:

(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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-29

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
continuously, 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.

2-30 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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

Figure 2-9-2: Pressing the Start Switch

• Because CELLCLEAN is a strong alkaline detergent, take care not to

WARNING

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 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 2-9-3: Shutdown Execution Screen

CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend

the sample probe.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 2-31

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.

*

Figure 2-9-4: Shutdown Completion Message Screen

NOTE: • Shutdown will take approximately 5 minutes.

2-32 Sysmex KX-21 Operator’s Manual -- Revised October 1998

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...................................................... 3-6

2.3 Printing..................................................................... 3-10

2.4 Print Paper Feed........................................................... 3-10

3. PROCESSING STORED DATA .............................................. 3-11

3.1 Executing and Quitting Stored Data Processing Program ............ 3-11

3.2 Stored Data Screen........................................................ 3-12

3.3 Deletion..................................................................... 3-15

3.4 Printing..................................................................... 3-16

3.5 HC Output (Option)....................................................... 3-16

3.6 Correcting a Sample Number............................................ 3-17

Sysmex KX-21 Operator’s Manual -- Revised January 2000

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
processing of analysis result, such as displaying latest or stored data on the screen or
outputting 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 display
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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-1

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

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 sample is
analyzed. When the analysis result is displayed, the menu display area displays the menu of
"1: M. Discri.," "2: Print," and "3: Paper Feed," which can each be executed using the
numeric keys.
The Analysis screen consists of three pages that differ from each other in "Analysis Result
Display Area."
Use [ ] key or [ ] key to change over pages.

P1. All Analysis Data
Display Screen

P2. Particle Distribution
Display Screen

Figure 3-2-1: Page Selection in the Analysis Screen

P3. CBC8 Parameter
Display Screen

3-2 Sysmex KX-21 Operator’s Manual -- Revised October 1998

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

Latest Sample No.

Mode Indication

No.123457 WB

Ready

31/12 23:59No.123458 WB

WBC 7.1×103/µL LYM% 31.2%
RBC 3.97×106/µL MXD% 19.6%

System Status Display Area
Date/Time Analyzed

HGB 14.7g/dL NEUT% 49.2%
HCT 32.8% LYM# 2.2×103/µL
MCV - 82.6fL MXD# 1.4×103/µL
MCH 37.0pg NEUT# 3.5×103/µL
MCHC + 44.8g/dL RDW - 25.6fL
PLT 180

3

×10

/µL PDW - 7.9fL

Analysis Result Display Area

MPV 9.3fL
P-LCR - 9.5%

1:M.Discri. 2:Print 3:Paper Feed

Menu Display Area

Figure 3-2-2: All Analysis Data Display Screen

NOTE: • When analysis is made in the pre-diluted mode, particle distribution

analysis parameters are displayed in "- - -. -." The particle distribution
curve is not displayed.

No.123457 WB

Latest Sample No.

Mode Indication

WBC

RBC

PLT

Ready

31/12 23:59No.123458 WB
LYM% 31.2%
MXD% 19.6%
NEUT% 49.2%
LYM# 2.2×103/µL
MXD# 1.4×103/µL
NEUT# 3.5
RDW - 25.6fL
PDW - 7.9fL
MPV 9.3fL
P-LCR - 9.5%

×10

Date/Time Analyzed

3

/µL

1:M.Discri. 2:Print 3:Paper Feed

Figure 3-2-3: Particle Distribution Display Screen

No.123457 WB

Ready

Date/Time AnalyzedLatest Sample No.

Mode Indication

31/12 23:59No.123458 WB

WBC 7.1×103/µL
RBC 3.97×106/µL
HGB 14.7g/dL
HCT 32.8%
MCV - 82.6fL
MCH 37.0pg
MCHC + 44.8g/dL
PLT 180

×10

3

/µL

1:M.Discri. 2:Print 3:Paper Feed

Figure 3-2-4: CBC8 Parameter Display Screen

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-3

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

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, Section

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 18 parameters or part of them are displayed
depending on the screen:
Analysis parameters (8): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT
Calculation parameters (10): LYM%, MXD%, NEUT%,

LYM#, MXD#, NEUT#, RDW, PDW, MPV, P-LCR

NOTE: • As for RDW, either RDW-CV or RDW-SD is output.

When shipped from factory, it is set at RDW-SD
When you want to display RDW-CV, refer to

System Setup

• The instrument can be set to block out PDW and P-LCR. Contact
Sysmex service representative for assistance.

.

Chapter 10, Section 2:

The marks to the left of analysis data indicate the following:

1. ! : The data is out of the linearity limit.

2. + : The data exceeds the upper Mark Limits.

- : The data exceeds the lower Mark Limits.

3. * : The data is low in reliability.

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

.

3-4 Sysmex KX-21 Operator’s Manual -- Revised October 1998

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

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.

NOTE: • When analysis is made in the pre-diluted mode, particle distribution

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 displayed to

particle distribution analysis parameters. For details, refer to

Section 6: Particle Distribution Analysis

.

Chapter 9,

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) WBC Particle Distribution Chart

The WBC Particle distribution chart is displayed.

8) RBC Particle Distribution Chart

The RBC Particle distribution chart is displayed.

9) PLT Particle Distribution Chart

The PLT Particle distribution chart is displayed.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-5

Sysmex KX-21 Operator’s Manual -- Revised December 1998

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

2.2 Manual Discrimination

This menu allows relocation of particle distribution discrimination position and re-calculation
of data.

CAUTION: • Manual Discrimination can be performed only on the latest sample

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 Manual Discrimination screen (WBC) appears.

M.Discri.

*

WBC

LD 43 fL

T1 93 fL
T2 123 fL

Select item/cursor by [ ][ ]/[ ][ ].

Figure 3-2-5: P1. M. Discri. Screen (WBC)

(2) Using [

] key or [ ] key, select a desired page of the M. Discri. screen. The M.

Discri. screen consists of three pages.

P1. M. Discri. Screen (WBC) P2. M. Discri. Screen (RBC) P3. M. Discri. Screen (PLT)

Figure 3-2-6: Page Selection in the M. Discri. Screen

*

31/12 23:59No.123458 WB

WBC 7.1
LYM% 31.2%
MXD% 19.6%
NEUT% 49.2%
LYM# - 2.0×103/µL
MXD# 1.4×103/µL
NEUT# 3.5

×10

×10

3

/µL

3

/µL

3-6 Sysmex KX-21 Operator’s Manual -- Revised October 1998

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

M.Discri.

*

RBC

LD 30 fL

UD 250 fL

Select item/cursor by [ ][ ]/[ ][ ].

*

31/12 23:59No.123458 WB

RBC 3.97
HGB 14.7g/dL
HCT 32.8%
MCV - 82.6fL
MCH 37.0pg
MCHC + 44.8g/dL
RDW - 25.6fL

×10

6

/µL

Figure 3-2-7: P2. M. Discri. Screen (RBC)

M.Discri.

*

PLT

*

31/12 23:59No.123458 WB

PLT 180
PDW - 7.9fL
MPV 9.3fL
P-LCR - 9.5%

×10

3

/µL

LD 3 fL

UD 30 fL

Select item/cursor by [ ][ ]/[ ][ ].

Figure 3-2-8: P3. M. Discri. Screen (PLT)

(3) Using [ ] key or [ ] key, move the cursor to select the discriminator for manual

discrimination.

(4) Press [ENTER] key.

The discriminator for manual discrimination is set and the discriminator selected on the
Particle Distribution Chart is shown with solid line.

Sysmex KX-21 Operator’s Manual -- Revised December 1999

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-7

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

(5) 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 follows:

Discri. position (fL) = (Channel No. + 1) × 6

Table 3-2-2: M. Discri. Screen (RBC)

Discri. to Move Lower Limit Upper Limit

LD 5 fL (0ch) UD

UD L D 250 fL (49ch)

RBC particle distribution covers 50 channels of 0 to 49 (5 fL per channel), and the
channel changes by one at a time.
The relation between RBC particle distribution channel and fL display is as follows:

Discri. position (fL) = (Channel No. + 1) × 5

Table 3-2-3: M. Discri. Screen (PLT)

Discri. to Move Lower Limit Upper Limit

LD 1 fL (0ch) UD

UD L D 40 fL (39ch)

PLT particle distribution covers 40 channels of 0 to 39 (1 fL per channel), and the
channel changes by one at a time.
The relation between PLT particle distribution channel and fL display is as follows:

Discri. position (fL) = (Channel No. + 1) × 1

(6) 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. position is
not changed, and the status returns to the Discri. position selection status.

(7) When you want to change another Discri., repeat the above (2) - (6) operation.

3-8 Sysmex KX-21 Operator’s Manual -- Revised October 1998

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

(8) When Discri. change is finished, press [SELECT] key. The Setting Change

Confirmation Message appears.

OK to set? Cont. Set Cancel

Figure 3-2-9: Setting Change Confirmation Message

(9) 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.

(10) When you update the contents, analysis values changed in M. Discri. on the Analysis

screen are reverse-displayed.

No.123457 WB

WBC

RBC

PLT

Ready

LYM% 31.2%
MXD% 19.6%
NEUT% 49.2%
LYM# 2.2×103/µL
MXD# 1.4×103/µL
NEUT# 3.5
RDW - 25.6fL
PDW - 7.9fL
MPV 9.3fL
P-LCR - 9.5%

31/12 23:59No.123458 WB

3

×10

/µL

1:M.Discri. 2:Print 3:Paper Feed

Figure 3-2-10: Analysis Screen

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-9

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

g

2 . 3 Printing

This menu can be used to output the latest sample's analysis result from the built-in printer.

Printing of Latest Sample

(1) Press [2] key on the Analysis screen and select "2: Print."

The built-in printer starts printing analysis result.

NOTE: • For printing format, refer to

Result

. To change the printing format, refer to

Printer Settin

s

.

Contents of Printing

No. 123456
Date 31/12/97 23:59

Mode Indication

Mode WB [W][R][P]
WBC WL+11.3 ×103/µL

RBC +3.80 ×106/µL
HGB +11.5 g/dL

• • • •

Figure 3-2-11: Example of Printing

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."

Chapter 2, Section 5.2: Printing of Analysis

Chapter 10, Section 7:

Sample No.
Date/Time Analyzed

Parameter Discriminated Manually

3) Date/Time Analyzed

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.

2.4 Printer Paper Feed

(1) Press [3] key on the Analysis screen and select "3: Paper Feed." While the key is

being held in, paper feed continues.

3-10 Sysmex KX-21 Operator’s Manual -- Revised October 1998

Sysmex KX-21 Operator’s Manual -- Revised January 2000

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

3. PROCESSING STORED DATA

This instrument is capable of storing data of up to 240 samples. The stored data is retained
after the power is turned off and can be called up unless deleted.

NOTE: • The particle distribution chart is not stored.

• When the stored data exceeds 240, the oldest data are automatically
deleted.

3.1 Executing and Quitting Stored Data Processing Program

Executing the Program

(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "1: Stored Data."
(3) Press [ENTER] key. The Stored Data screen [1/5] appears.

Stored Data

*

No.
123451*
QC01
123453
123454 PD
123455* PD
123456 PD
123457
123451*

Date 31/12/97 12:59

[ENTER] to mark, [SELECT] to exit.

*

WBC

7.7+

7.5

7.5+

7.1

7.2

5.5-

7.0

7.6+

RBC

3.97

4.51

3.85

4.30+

3.91

3.90

4.05

3.98

HGB

14.7

14.1

13.8

12.2

14.3

15.1

18.5

15.0

HCT

32.8

34.7

30.5

29.5-

32.0

40.2+

31.4

35.1
[1/5]

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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-11

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

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 automatically
added to the last line of the list.
As to analysis data, four parameters are displayed on one page. And there are five pages in
total. Using [ ] key or [ ] key, a page with four parameters can be changed over to the
next page.

P1. Stored Data

Screen [1/5]

WBC, RBC, HGB, HCT

Figure 3-3-2: Page Selection in the Stored Data Screen

P2. Stored Data

Screen [2/5]

MCV, MCH, MCHC, PLT

P5. Stored Data

Screen [5/5]

RDW, PDW, MPV, P-LCR

Stored Data

*

No.
123451*
QC01
123453
123454 PD
123455* PD
123456 PD
123457
123451*

Date 31/12/97 12:59

[ENTER] to mark, [SELECT] to exit.

*

WBC

7.7+

7.5

7.5+

7.1

7.2

5.5-

7.0

7.6+

RBC

3.97

4.51

3.85

4.30+

3.91

3.90

4.05

3.98

WBC, LYM%, MXD%, NEUT%

WBC, LYM#, MXD#, NEUT#

HGB

14.7

14.1

13.8

12.2

14.3

15.1

18.5

15.0

Figure 3-3-3: Stored Data Screen

P3. Stored Data

Screen [3/5]

P4. Stored Data

Screen [4/5]

HCT

32.8

34.7

30.5

29.5-

32.0

40.2+

31.4

35.1
[1/5]

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

underline 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.

3-12 Sysmex KX-21 Operator’s Manual -- Revised October 1998

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

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:
Deletion," "2: Print," "3: HC Output." When the mark is already attached, press [ENTER]
key to delete it.

NOTE: • When you keep pressing [ENTER] key, the marking is made

continuously.

• When you return to the Analysis screen, all the marks on analysis data
are deleted.

• "3. HC Output" on the Menu is displayed only when the optional Serial
Interface is incorporated.

Stored Data

*

No.
123451*
QC01
123453
123454 PD
123455* PD
123456 PD
123457
123451*

Date 31/12/97 12:41

*

WBC

7.7+

7.5

7.5+

7.1

7.2

5.5-

7.0

7.6+

RBC

3.97

4.51

3.85

4.30+

3.91

3.90

4.05

3.98

HGB

14.7

14.1

13.8

12.2

14.3

15.1

18.5

15.0

HCT

32.8

34.7

30.5

29.5-

32.0

40.2+

31.4

35.1
[1/5]

1:Delete 2:Print 3:HC Output

Figure 3-3-4: Marking the Data

Display Contents of Stored Data Screen

1) Sample No.

The sample No. of stored data is displayed.
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."

2) 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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-13

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

3) Analysis Data

Analysis data of 18 parameters are displayed in a group of four parameters on five
pages:
Stored Data Screen [1/5]: WBC, RBC, HGB, HCT
Stored Data Screen [2/5]: MCV, MCH, MCHC, PLT
Stored Data Screen [3/5]: WBC, LYM%, MXD%, NEUT%
Stored Data Screen [4/5]: WBC, LYM#, MXD#, NEUT#
Stored Data Screen [5/5]: RDW, PDW, MPV, P-LCR

The marks on the left of analysis data indicate the following:

1. ! : The data is out of the linearity limit.

2. + : The data exceeds the upper Mark Limits.

- : The data exceeds the lower Mark Limits.

3. * : The data is low in reliability.

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.

NOTE: • When analysis is made in the pre-diluted mode, particle distribution

analysis parameters are displayed in "- - -. -."

4) Date Analyzed

The date when the analysis data in the underline cursor position was analyzed is
displayed.

5) Manual Discrimination Data

As to data changed through manual discrimination, analysis values are reverse­displayed.

3-14 Sysmex KX-21 Operator’s Manual -- Revised October 1998

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

6) Not-output Data

If the optional serial interface has been mounted, the mark will appear next to the
data which has not been output to the host computer. This mark disappears when the
data output is completed.

Stored Data

*

No.
123451* PD
QC01 PD
123453 PD
123454*HPD
123455*HPD
123456*HPD
123457*HPD
123451*HPD

Date 31/12/99 12:59

[ENTER] to mark, [SELECT] to exit.

*

WBC

7.7+

7.5

7.5+

7.1

7.2

5.5-

7.0

7.6+

RBC

3.97

4.51

3.85

4.30+

3.91

3.90

4.05

3.98

HGB

14.7

14.1

13.8

12.2

14.3

15.1

18.5

15.0

HCT

32.8

34.7

30.5

29.5-

32.0

40.2+

31.4

35.1
[1/5]

Figure 3-3-5: Not-Output Data

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 3-3-6: Deletion Confirmation Message

(3) Using [

[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-21 completes any output

] key or [ ] key, move the cursor to select "Yes" or "NO."

operation to the printer or host computer.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-15

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

g

(

)

3 . 4 Printing

This menu allows the marked analysis data to be printed by the built-in printer.

Execution of Printing

(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: Print." The built-in printer starts printing the marked

analysis data.

NOTE: • For print format, refer to

Result

• In printin
print format is selected.

.

stored data, Type 2 print is performed even when Type 1

Chapter 2, Section 5.2: Printing of Analysis

Particle distribution is not printed.

3.5 HC Output (Option)

This menu allows outputting the marked analysis data to the host computer, if an optional
serial interface is incorporated.

NOTE: • "3: HC Output" on the Menu is displayed only when the optional serial

interface is incorporated.

Execution of HC Output

(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.

(2) Press [3] key to select "3: HC Output."

Analysis data is output to the host computer in the order of marking.
During output to the host computer, the * mark blinks at the right top edge of the
system status display area.

Stored Data

*

*

*

Figure 3-3-7: Screen during Output to Host

NOTE: • Output to the host computer cannot be interrupted.

3-16 Sysmex KX-21 Operator’s Manual -- Revised October 1998

Sysmex KX-21 Operator’s Manual -- Revised January 2000

DISPLAY AND PROCESSING OF ANALYSIS RESULTS

3.6 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 [SAMPLE

No.] key. The selected sample number will be highlighted.
(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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 3-17

CHAPTER 4 MAINTENANCE AND

SUPPL IES REPL A CEMENT

1. INTRODUCTION .................................................................4-1

2. KX-21 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

Sysmex KX-21 Operator’s Manual -- Revised January 2000

MAINTENANC E AND SUPPLIES REPLAC EMENT

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.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 4-1

Sysmex KX-21 Operator’s Manual -- Revised January 2000

MAINTENANCE AND SUPPLIES REPLACEMENT

2. KX-21 MAINTENANCE CHECKLIST

Year: Month:

Date, Signature

Date, Signature

Replace waste tank

Clean WBC/RBC transducer aperture

Clean rinse cup

Auto rinse

Maintenance item

As-Needed Maintenance

Date, Signature

Date, Signature

Replenish reagent

Maintenance item

Supplies Replacement

Replace printer paper

Replace fuse

10111213141516171819202122232425262728293031

Date, Signature

Date, Signature

12345

Week

123456789

Day

Signature

level and drain

Check trap chamber

Execute shutdown

Maintenance Item

Daily Maintenance

Signature

Clean sampling valve (SRV) tray

Maintenance Item

Weekly Maintenance

Maintenance item

Monthly Maintenance

Clean transducer (Rinse sequence)

Clean waste chamber (Rinse sequence)

Every 3-Month Maintenance

Clean sample rotor valve (SRV)

Maintenance item

4-2 Sysmex KX-21 Operator’s Manual -- Revised October 1998

Reagent Replenishment Record

MAINTENANC E AND SUPPLIES REPLAC EMENT

Lot No.

Lot No.

Date

Date

Month

CELLPACK

Expiry

Signature

Lot No.

Date

Expiry

STROMATOLYSER-WH

Expiry Expiry

Signature

Lot No.

Date

Year

Signature

Signature

Sysmex KX-21 Operator’s Manual -- Revised October 1998 4-3

Sysmex KX-21 Operator’s Manual -- Revised January 2000

MAINTENANCE AND SUPPLIES REPLACEMENT

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.
Perform 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

*

Aspirate CELLCLEAN.
It will take approx. 5 minutes.

*

Ready

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

Figure 4-3-2: Pressing the Start Switch

4-4 Sysmex KX-21 Operator’s Manual -- Revised October 1998

MAINTENANCE AND SUPPLIES REPLACEMENT

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 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

CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend

the sample probe.

(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.

Figure 4-3-4: Shutdown Completion Message Screen

NOTE: • Shutdown will take approximately 5 minutes.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 4-5

MAINTENANCE AND SUPPLIES REPLACEMENT

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

CAUTION

• When discarding the trap chamber liquid, always wear rubber gloves.
After completion of operation, wash hands with disinfectant. If your
hands are contaminated by the liquid, infection of bacteria or the like can
occur.

• 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.

4-6 Sysmex KX-21 Operator’s Manual -- Revised October 1998

MAINTENANCE AND SUPPLIES REPLACEMENT

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

Sysmex KX-21 Operator’s Manual -- Revised October 1998 4-7

MAINTENANCE AND SUPPLIES REPLACEMENT

(5) Make sure no contaminants remain, then wipe off water.
(6) Re-mount the SRV tray to the original state.

CAUTION

CAUTION: • Mount the SRV tray properly as to the face/bottom and the direction.

• After mounting the tray, make sure the probe fixing screw is not loose.
If analysis is made with the screw loosened, air can enter the system
and affect the data.

(7) Close the front cover of the main unit.

4-8 Sysmex KX-21 Operator’s Manual -- Revised October 1998

MAINTENANCE AND SUPPLIES REPLACEMENT

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.
It will take approx. 15 minutes.

Cycle No. after cleaning. 2567
Date last serviced 31/12/97

*

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 process

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 Maintenance Menu
screen.

Sysmex KX-21 Operator’s Manual -- Revised October 1998 4-9

MAINTENANCE AND SUPPLIES REPLACEMENT

(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
following operation:

Clean W.Chamber

*

Aspirate CELLCLEAN
It will take approx. 15 minutes.

Cycle No. after cleaning. 2567
Date last serviced 31/12/97

*

Ready

3:Cancel

Figure 4-5-2: Clean W. Chamber Screen

NOTE: • When you press [3] key and select "3: Cancel," the start-up process

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

Figure 4-5-3: Pressing the 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. Otherwise, it can
damage the skin or clothes.

4-10 Sysmex KX-21 Operator’s Manual -- Revised October 1998

MAINTENANCE AND SUPPLIES REPLACEMENT

(3) When the buzzer sounds two times - beep, beep , - informing completion of aspiration,

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

CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend

the sample probe.

(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

NUMBER

.

Chapter 4, Section 9: CONFIRMATION OF CYCLE

Sysmex KX-21 Operator’s Manual -- Revised October 1998 4-11

MAINTENANCE AND SUPPLIES REPLACEMENT

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.
It will take approx. 7 minutes.

Cycle No. after cleaning. 2567
Date last serviced 31/12/97

*

1:Exec. Clean

3:Cancel

Figure 4-5-5: Scheduled Maintenance Message Screen

When this message appears, press [1] key to select "1: Exec. Clean," and clean the
transducer 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.

NOTE: • When you press [3] key and select "3: Cancel," the start-up process

continues without cleaning the transducer. Until the transducer 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 Maintenance Menu screen.

• If this rinse sequence fails to remove clogging, clean with the brush.
Regarding cleaning with the brush, refer to

Clean WBC/RBC Transducer Aperture.

Chapter 4, Section 7.3:

4-12 Sysmex KX-21 Operator’s Manual -- Revised October 1998

MAINTENANCE AND SUPPLIES REPLACEMENT

(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

*

Pour CELLCLEAN in transducer chamber
and press START switch.
It will take approx. 7 minutes.

Cycle No. after cleaning. 2567
Date last serviced 31/12/97

*

Ready

3:Cancel

Figure 4-5-6: Clean Transducer Screen

NOTE: • When you press [3] key and select "3: Cancel," the start-up process

continues without cleaning the transducer. Until the transducer is
cleaned, the above message is displayed at start-up.

(2) Open the front cover of the main unit.
(3) Open the transducer cover.

Figure 4-5-7: Opening the Transducer Cover

Sysmex KX-21 Operator’s Manual -- Revised October 1998 4-13