SYSMEX KX-21 User 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

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

•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

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

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

•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

•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.

WARNING

CAUTION

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

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

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.

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

CAUTION

Use of Rea

ents

•After un

ackin

, be sure not to allow dust, dirt, or bacteria to come in touch with

the rea

ent.

•Do not use rea

ents which are out of the ex

iration date.

•Handle a rea

ent

entl

revent formation of bubbles.

•Take care not to s

ill a rea

ent. If it s

ills, wi

e it off immediatel

usin

a wet

cloth or the like.

•Follow other instructions described on the Packa

e Insert on each rea

ent.

Use of Instrument

•When

erformin

maintenance work or ins

ection, use s

ecified tools and

arts.

Do not use substitute

arts, or modif

the instrument. It is hazardous.

•Do not brin

our bod

or clothes close to the instrument.

•Those who have no or onl

limited ex

erience in usin

rea

ents are

recommended to have

uidance or assistance of those with sufficient

erience.

•If the instrument has develo

ed a trouble b

chance, a

erson in char

e of it

should take ste

s within the ran

e s

ecified in the OPERATOR’S MANUAL. As to

troubles other than mentioned in it, contact S

smex service re

resentative for

air.

•Un

ackin

, installation, and confirmation of initial o

eration must be done b

smex service re

resentative.

Environment for Use

•Install the instrument in a

lace which is not sub

ect to water s

lash.

•Install the instrument in a

lace which is not sub

ect to adverse effects of hi

tem

erature, hi

h humidit

, dust, direct sunli

ht, etc.

•Do not

ive the instrument a stron

vibration or im

act.

•Do not install the instrument near a chemical stora

e or a

lace where a

as is

enerated.

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

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

STRUCTURE OF THIS MANUAL

Read this manual carefully so you will be able to use the instrument to its full extent, and

operate it correctly. This manual contains ten Chapters and APPENDICES as listed in the

following:

Chapter 1: Introduction Describes overview of this instrument, including the

outline of the instrument, operation procedure, and

messages, and cautions during installation.

Chapter 2: Sample Analysis Describes procedures for start-up of the instrument,

measurement of the sample, and shut-down.

Summarizes the operation method for analyzing the

sample.

Chapter 3: Display and Processing of

Analysis Results 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.

Chapter 4: Maintenance and Supplies

Replacement Describes scheduled maintenance and replacement

method of supplies such as reagent.

Chapter 5: Quality Control Describes execution procedures of the

control and L-

J control for quality control.

Chapter 6: Calibration Describes procedures for automatic/manual calibration.

Chapter 7: Troubleshooting Describes error messages and troubleshooting.

Chapter 8: Adjustment Describes the method of pressure adjustment based on

the troubleshooting.

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

and names of the components.

Chapter 10: Instrument Setup Describes the system environment setting such as

date, time, and unit, and the data analysis setting such

as data error judgment.

Appendix A: Installation Describes the installation method of the KX-21.

Appendix B: Technical Information 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 VII

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

VIII

PREMISES FOR SIGNS

Meaning of Signs

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

performance and prevent its damage.

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

Document Conventions

In explaining operation, this manual uses the conventions as shown below.

•The keys on the panel keyboard are expressed within square brackets.

For example: [SELECT], [ENTER], [ ]

•The display on LCD appears within quotation marks.

For example: "Stand-by," "WB"

•The name of menu appears within quotation marks.

For example: "2: Quality Control," "6: Settings"

NOTE: • LCD and printing described in this manual may differ from that in

practice.

• Due to the improvement of the product, the content of this manual may

not conform with the product.

WARNING

CAUTION

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