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
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 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
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
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
•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
CAUTION

Sysmex KX-21 Operator’s Manual -- Revised October 1998
I
II
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
I
V
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
g
ents
•After un
p
ackin
g
, be sure not to allow dust, dirt, or bacteria to come in touch with
the rea
g
ent.
•Do not use rea
g
ents which are out of the ex
p
iration date.
•Handle a rea
g
ent
g
entl
y
to
p
revent formation of bubbles.
•Take care not to s
p
ill a rea
g
ent. If it s
p
ills, wi
p
e it off immediatel
y
usin
g
a wet
cloth or the like.
•Follow other instructions described on the Packa
g
e Insert on each rea
g
ent.
Use of Instrument
•When
p
erformin
g
maintenance work or ins
p
ection, use s
p
ecified tools and
p
arts.
Do not use substitute
p
arts, or modif
y
the instrument. It is hazardous.
•Do not brin
g
y
our bod
y
or clothes close to the instrument.
•Those who have no or onl
y
limited ex
p
erience in usin
g
rea
g
ents are
recommended to have
g
uidance or assistance of those with sufficient
ex
p
erience.
•If the instrument has develo
p
ed a trouble b
y
an
y
chance, a
p
erson in char
g
e of it
should take ste
p
s within the ran
g
e s
p
ecified in the OPERATOR’S MANUAL. As to
troubles other than mentioned in it, contact S
y
smex service re
p
resentative for
re
p
air.
•Un
p
ackin
g
, installation, and confirmation of initial o
p
eration must be done b
y
S
y
smex service re
p
resentative.
Environment for Use
•Install the instrument in a
p
lace which is not sub
j
ect to water s
p
lash.
•Install the instrument in a
p
lace which is not sub
j
ect to adverse effects of hi
g
h
tem
p
erature, hi
g
h humidit
y
, dust, direct sunli
g
ht, etc.
•Do not
g
ive the instrument a stron
g
vibration or im
p
act.
•Do not install the instrument near a chemical stora
g
e or a
p
lace where a
g
as is
g
enerated.
Sysmex KX-21 Operator’s Manual -- Revised January 2000

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