kx-21n Sysmex
kx-21n Sysmex
kx-21n Sysmex
KX-21N
(North American Edition)
CHAPTER 1: INTRODUCTION
CHAPTER 2: SAMPLE ANALYSIS
CHAPTER 3: DISPLAY AND PROCESSING OF ANALYSIS RESULTS
CHAPTER 4: MAINTENANCE AND SUPPLIES REPLACEMENT
CHAPTER 5: QUALITY CONTROL
CHAPTER 6: CALIBRATION
CHAPTER 7: TROUBLESHOOTING
CHAPTER 8: ADJUSTMENT
CHAPTER 9: FUNCTIONAL DESCRIPTION
CHAPTER 10: INSTRUMENT SETUP
APPENDIX A: INSTALLATION
APPENDIX B: TECHNICAL INFORMATION
INDEX
SYSMEX CORPORATION
KOBE, JAPAN
All rights reserved. No part of this Operator’s Manual may be Code No. 461-2264-1
reproduced in any form or by any means whatsoever without PRINTED IN JAPAN
prior written permission of SYSMEX CORPORATION. Date of Last Revision: May 2003
• Sysmex is a registered trademark of SYSMEX CORPORATION.
• CELLCLEAN, CELLPACK, EIGHTCHECK-3WP, and STROMATOLYSER-WH are
trademarks of SYSMEX CORPORATION.
• 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.
The KX-21N 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-21N system and its components
have arrived.
• Wait for your service representative to unpack the system and open the
packages.
• Follow the unpacking and storage instructions provided on the outside of the
package. Special requirements such as refrigeration are clearly marked on the
outside of the carton and will be included in the unpacking instructions and
package inserts.
WARRANTY INFORMATION
This Warranty does not cover any defect, malfunction, or damage due to:
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
Meaning of Signs
WARNING
• If this sign is ignored and the instrument is operated incorrectly, there is
a potentially hazardous situation which could result in death or serious
injury of an operator, or grave property damage.
Caution on Diagnosis
• 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.
• 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.
Use of Reagents
• After unpacking, be sure not to allow dust, dirt, or bacteria to come in touch with
the reagent.
• Do not use reagents which are out of the expiration date.
• Handle a reagent gently to prevent formation of bubbles.
• Take care not to spill a reagent. If it spills, wipe it off immediately using a wet
cloth or the like.
• Follow other instructions described on the Package Insert on each reagent.
Use of Instrument
• When performing maintenance work or inspection, use specified tools and parts.
Do not use substitute parts, or modify the instrument. It is hazardous.
• Do not bring your body or clothes close to the instrument.
• Those who have no or only limited experience in using reagents are
recommended to have guidance or assistance of those with sufficient
experience.
• If the instrument has developed a trouble by any chance, a person in charge of it
should take steps within the range specified in the OPERATOR’S MANUAL. As to
troubles other than mentioned in it, contact Sysmex service representative for
repair.
• Unpacking, installation, and confirmation of initial operation must be done by
Sysmex service representative.
Appendix B: Technical Information Technical reference data describing the specification for
host output format.
Training courses
For further information please contact the Sysmex representative in your country.
Sysmex KX-21N
Sysmex KX-21N Operator’s
Operator’s Manual
Manual----October
Revised 1999
August 2001 VII
PREMISES FOR SIGNS
Meaning of Signs
WARNING
• If this sign is ignored and the instrument is operated incorrectly, there is
a potentially hazardous situation which could result in death or serious
injury of an operator, or grave property damage.
NOTE: • Indicates information which will come handy in operating the instrument.
Document Conventions
• 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.
CHAPTER 6: CALIBRATION
1. INTRODUCTION ................................................................ 6-1
1.1 Calibration .................................................................. 6-1
1.2 Calibrator Calibration Program .......................................... 6-1
CHAPTER 8: ADJUSTMENT
1. INTRODUCTION.......................................................................................8-1
2. ADJUSTMENT OF PRESSURE AND VACUUM ...................................8-2
2.1 Location of Control Knobs................................................................8-2
2.2 Pressure and Vacuum Display...........................................................8-3
2.3 Adjusting Pressure to 0.05 MPa........................................................8-5
2.4 Adjusting Vacuum to 0.0333 MPa....................................................8-6
INDEX
1. INTRODUCTION
The Sysmex KX-21N is an automatic multi-parameter blood cell counter for in vitro
diagnostic use in clinical laboratories.
The KX-21N processes approximately 60 samples an hour and displays on the LCD screen
the particle distribution curves of WBC, RBC, and platelets, along with data of 17
parameters, as the analysis results.
Chapter 1 introduces the overview of the instrument, analysis procedure, etc. that we
recommend you to read before using the KX-21N. The main contents of Chapter 1 are as
follows:
Overview of Instrument
The important functions of the KX-21N and the options for efficient operation are explained.
Instrument Specifications
The instrument specifications are described.
Menu Tree
This chapter describes the KX-21N menu tree and the corresponding chapters which explain
the usage of the menus.
2. OVERVIEW OF INSTRUMENT
The KX-21N performs speedy and accurate analysis of 17 parameters in blood and detects
the abnormal samples. To assure easy sorting of abnormal samples in the laboratory, the
instrument displays abnormal analysis data with abnormal marks attached on the LCD
screen. Thus displayed analysis data allows detecting those samples which are outside the
tolerance and need further analysis and reconsideration.
The KX-21N employs three detector blocks and two kinds of reagents for blood analysis.
The WBC count is measured by the WBC detector block using the DC detection method.
The RBC count and platelets are taken by the RBC detector block, also using the DC
detection method. The HGB detector block measures the hemoglobin concentration using
the non-cyanide hemoglobin method.
3. OPTION UNITS
This instrument offers several option units to ensure its efficient operation. The options that
can be used with the KX-21N are:
• Graphic Printer: Prints the analysis data obtained from the KX-21N on
letter or A4-size paper.
• Data Printer: Prints the analysis data obtained from the KX-21N onto a
ticket format.
DP-510: 943-0571-9 (N.America, 117 V)
943-0581-6 (Europe, 220 V)
943-0591-3 (U.K., 240 V)
• Hand Held Barcode Reader: During analysis, reads the barcode that are affixed to the
tubes, and automatically sets the sample ID numbers.
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 1-3
INTRODUCTION
4. OUTLINE OF OPERATION
Two analysis modes are available with the KX-21N: whole blood mode and pre-diluted
mode. Analysis procedures in these modes are listed below.
6. ANALYSIS PARAMETERS
This instrument analyzes the following parameters using three detector blocks and two kinds
of reagents:
1) WBC (white blood cell) (Analysis principle: DC detection method)
WBC count in 1 µL of whole blood
2) LYM% [W-SCR] (WBC-Small Cell Ratio)
Ratio (%) of lymphocytes (small cells) to whole WBC
3) MXD% [W-MCR] (WBC-Middle Cell Ratio)
Ratio (%) of the summation of basophils, eosinophils and monocytes (middle cells) to
whole WBC
4) NEUT% [W-LCR] (WBC-Large Cell Ratio)
Ratio (%) of neutrophils (large cells) to whole WBC
5) LYM# [W-SCC] (WBC-Small Cell Count)
Absolute count of lymphocytes (small cells) in 1 µL of whole blood
6) MXD# [W-MCC] (WBC-Middle Cell Count)
Absolute count of the basophils, eosinophils and monocytes (middle cells) in 1 µL of
whole blood
7) NEUT# [W-LCC] (WBC-Large Cell Count)
Absolute count of neutrophils (large cells) in 1 µL of whole blood
8) RBC (red blood cell) (Analysis principle: DC detection method)
RBC count in 1 µL of whole blood
9) HGB (Hemoglobin) (Analysis principle: Non-Cyanide hemoglobin analysis method)
Volume (gram) of hemoglobin in 1 dL of whole blood
10) HCT (Hematocrit value) (Analysis principle: RBC pulse height detection method)
Ratio (%) of whole RBC volume in whole blood
11) MCV (Mean RBC volume)
Mean RBC volume (fL) in whole blood, which is calculated by 10 × Hct (%)/ RBC
(× 106/µL).
12) MCH (Mean RBC hemoglobin)
Mean hemoglobin volume (pg) per RBC, which is calculated by 10 × Hgb (g/dL)/
RBC (× 106/µL).
13) MCHC (Mean RBC hemoglobin concentration)
Mean hemoglobin concentration (g/dL), which is calculated by 100 × Hgb (g/dL)/ Hct
(%).
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 1-5
INTRODUCTION
NOTE: • When analyzing in the pre-diluted mode, only the CBC8 parameters
are output.
1-6 Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual ---- October
October 1999
1999 N.A.
N.A.
INTRODUCTION
7. PANEL KEYBOARD
The KX-21N is provided with the 22-key panel keyboard.
7 8 9 SAMPLE No.
4 5 6 ENTER
1 2 3 SELECT
0 -/. C MODE
HELP
SHUTDOWN
Name Function
SAMPLE No. Used to set a sample No.
ENTER Used to fix a sample No., selected menu, etc.
SELECT Used to select a menu. Press this key to display the Select Menu screen. When
you press it while the Select Menu screen is displayed, the Analysis screen returns.
MODE Used to changeover analysis mode (whole blood mode/pre-diluted mode).
HELP Used when an error has occurred.
SHUTDOWN Used to execute shutdown program.
0-9 Used to enter numerics such as a sample No. and set value.
−/. Used to enter "−" (hyphen) of a sample No., the decimal point of a set value.
C Used to delete characters when entering numerics, and stop the alarm.
, Used to select a menu. Each time a key is pressed, the cursor moves to the
previous or the next item.
, Used to select conditions when setting, and to select Manual Discriminator.
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.
8. GRAPHIC SCREEN
8 . 1 Contents of Display
Next Sample No. Status Display Analysis Progress Status
No.1
Ready Sample Analysis Mode
No.0 WB 31/12 10:20
WBC 0.0 LYM% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
HGB 0.0 NEUT% 0.0 0.0
HCT 0.0 RDW-SD 0.0 Analysis Result
MCV 0.0 RDW-CV 0.0 Display Area
MCH 0.0 PDW 0.0
MCHC 0.0 MPV 0.0
PLT 0 P-LCR 0.0
[00-01]
Please wait.
1:M.Discri. 2:Output
1:M.Discri. 2:Output
Please wait.
No.123456789-12345
Samples are being aspirated, diluted, and
Analyzing counted.
No.123456789-12345
Hydraulic line is being rinsed.
Rinsing
Light Dark
NOTE: • If a key input or an operation has not been performed for a fixed time,
the LCD back-light will become slightly dimmer (back-light darkening
function). To return the LCD to its original brightness, press any key.
1 0 . ALARM SOUNDS
The KX-21N indicates different situations by five kinds of alarm sounds:
1 1 . 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."
1 2 . INSTALLATION ENVIRONMENT
12.1 Installation and Relocation
The KX-21N is installed by Sysmex Service representative. In case relocation becomes
necessary after installation, contact your Sysmex service representative.
Pay careful attention to this because if relocation, etc. of the instrument should be conducted
by the customer, resulting in any trouble, warranty would not be applied even in the
warranty period.
12.2 Grounding
The instrument power supply cord uses the 3-prong plug. When the power supply socket is
3-prong with grounding, simply plug it to the socket.
WARNING • Make sure to ground the instrument. Inadequate grounding could cause
electrical shocks.
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.
480
420
355
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.
1 3 . INSTRUMENT SPECIFICATIONS
Analysis parameters:
WBC (White Bloodcell Count), RBC (Red Bloodcell Count), HGB (hemoglobin), HCT
(hematocrit), MCV (mean corpuscular volume), MCH (mean corpuscular hemoglobin),
MCHC (mean corpuscular hemoglobin concentration), PLT (platelet), RDW-SD (RBC
distribution width-standard deviation), RDW-CV (RBC distribution width-coefficient of
variation), MPV (mean platelet volume), LYM% (W-SCR), MXD% (W-MCR), NEUT%
(W-LCR), LYM# (W-SCC), MXD# (W-MCC), NEUT# (W-LCC)
However, the parameters in pre-diluted mode are eight: WBC, RBC, HGB, HCT, MCV,
MCH, MCHC, PLT.
Display range
WBC 0.0 - 299.9 (×103/µL)
RBC 0.00 - 19.99 (×106/µL)
HGB 0 - 25.0 (g/dL)
PLT 0 - 1999 (×103/µL)
Reagent
Diluent: CELLPACK
WBC/HGB lyse reagent: STROMATOLYSER-WH
Detergent
CELLCLEAN
Throughput
Approx. 60 samples/hour
Analysis principle
WBC: DC detection method
RBC: DC detection method
HGB: Non-cyanide hemoglobin analysis method
Reproducibility
Reproducibility is within the following range at the reliability level of 95%.
1) Whole blood mode
WBC (4.0 × 103/µL or over) 3.5% or less
RBC (4.00 × 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
MPV 5.0% or less
2) Pre-diluted mode
WBC (4.0 × 103/µL or over) 6.0% or less
RBC (4.00 × 106/µL or over) 3.0% or less
HGB 2.5% or less
HCT 3.0% or less
MCV 3.0% or less
MCH 3.0% or less
MCHC 3.0% or less
PLT (100 × 103/µL or over) 9.0% or less
Accuracy
1) Whole blood mode
WBC: ±3% or ±0.2 × 103/µL
RBC: ±2% or ±0.03 × 106/µL
PLT: ±5% or ±10 × 103/µL
2) Pre-diluted mode
WBC: ±5% or ±0.3 × 103/µL
RBC: ±3% or ±0.05 × 106/µL
PLT: ±8% or ±15 × 103/µL
1-18 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual -- Manual
Revised -- October2000
February 1999 N.A.
N.A.
INTRODUCTION
Linearity
1) Whole blood mode
WBC: 1.0 - 9.9 (× 103/µL) ±0.3 (× 103/µL)
10.0 - 99.9 (× 103/µL) ±3%
RBC: 0.30 - 0.99 (× 106/µL) ±0.03 (× 106/µL)
1.00 - 7.00 (× 106/µL) ±3%
HGB: 0.1 - 10.0 (g/dL) ±0.2 (g/dL)
10.0 - 25.0 (g/dL) ±2%
HCT: 10.0 - 33.3 (HCT%) ±1.0 (HCT%)
33.4 - 60.0 (HCT%) ±3%
PLT: 10 - 199 (× 103/µL) ±10 (× 103/µL)
200 - 999 (× 103/µL) ±5%
(However, RBC < 7.00 × 106/µL)
Carryover
WBC: 3% or less
RBC: 1.5% or less
HGB: 1.5% or less
HCT: 1.5% or less
PLT: 5% or less
Power supply
117/220/230/240 VAC ± 10% (50/60 Hz)
Power consumption
Approx. 230 VA or less
Dimensions
Main Unit: 420 (W) × 355 (D) × 480 (H) mm
Weight
Main Unit: Approx. 30.0 kg
Protection Type
Class I Equipment
1 4 . MENU TREE
Ana. Screen 1: M. Discri. Chapter 3, 2.2
2: Output Chapter 3, 2.3
MODE Chapter 2, 4
HELP Chapter 7, 1
SHUTDOWN Chapter 2, 6
1-20 Sysmex
Sysmex
KX-21N
KX-21N
Operator’s
Operator’s
Manual
Manual
-- Revised
-- October
June1999
2001N.A.
N.A.
CHAPTER 2 SAMPLE ANALYSIS
6. LIMITATIONS................................................................. . . .2-28
6.1 Cell Count Parameters.....................................................2-28
6.2 Limitation of Hemoglobin.................................................2-29
7. EXPECTED RESULTS..........................................................2-30
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.
• 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.
2. START-UP PROCEDURE
CAUTION • Use a reagent that has been left at room temperature (15 - 30°C) for
more than 24 hours.
• If CELLPACK that has just arrived is used, "Background Error" may
occur.
• After replenishing a reagent, make sure that its background count is low
before starting sample analysis.
• As to a reagent that may have frozen, handle it in accordance with the
precautions stated on the Package Insert. Otherwise, there is a
possibility that proper analysis cannot be performed.
• When replacing the reagent container, take care not to have dust
adhere to the cubitainer spout kit.
• After unpacking, take care to prevent entry of dust, dirt, bacteria, etc.
which could impair proper analysis.
CELLPACK 20 L 60 days
STROMATOLYSER-WH 500 mL 90 days
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.
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.
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.
Sysmex KX-21N
[00-01]
(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.
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 Chapter 4: INSTRUMENT MAINTENANCE AND
SUPPLIES REPLACEMENT.
(3) When self-check is normally completed, auto rinse and background check are
performed.
*Auto Rinse*
Please wait.
No.1
Ready
No.0 WB 31/12 10:20
WBC 0.0 LYM% 0.0 0.0
RBC 0.00 MXD% 0.0 0.0
HGB 0.0 NEUT% 0.0 0.0
HCT 0.0 RDW-SD 0.0
MCV 0.0 RDW-CV 0.0
MCH 0.0 PDW 0.0
MCHC 0.0 MPV 0.0
PLT 0 P-LCR 0.0
1:M.Discri. 2:Output
NOTE: • When the power is on, the next sample No. is displayed "1."
3. QUALITY CONTROL
Quality control is of great importance for obtaining highly reliable data over a long period of
time, as is the constant monitoring of the instrument for preventing troubles or for early
detection of problems. Before starting sample analysis, analyze control blood
(EIGHTCHECK-3WP) using X control or L-J control program. The analysis mode used in
analyzing control blood is described below.
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.
*Change Mode*
*Change Mode*
(4) Press [ENTER] key to changeover the analysis mode and return to the Analysis
screen.
NOTE: • The sample number is set by the incremented value for each analysis.
Input the sample number when changing.
(2) The cursor appears under sample No. Input sample No. using the numeric keys.
NOTE: • When entering the sample No. (on the screen of the previous page),
press [C] key first. This will clear the entire sample No. Then, enter a
new sample No.
• In the course of entering the sample No., each time you press [C] key,
one character disappears with the cursor moving to the left.
• A sample No. of a maximum of 15 digits, comprising numerics and a
hyphen, can be used.
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 2-11
SAMPLE ANALYSIS
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted.
When you attempt to do so, an alarm sounds.
• In the status of waiting for sample No. input ("Not Ready"), press
[SAMPLE No.] or [SELECT] key. The screen returns to the Analysis
screen without updating sample No.
(2) Read the barcode affixed to the test tube with the hand held barcode reader.
When reading has been carried out normally, the read sample number will appear.
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • 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 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual --Manual
Revised--February
October 2000
1999
SAMPLE ANALYSIS
4. Analyzing samples
(2) Remove the plug while taking care not to allow blood scatter.
(3) Set the tube to the sample probe, and in that condition, press the start switch.
Start Switch
(4) The buzzer sounds two times - "beep, beep" - and when the LCD screen displays
"Analyzing," remove the tube. After that, the unit executes automatic analysis and
displays the result on the LCD screen. Then the unit turns to the Ready status,
becoming ready for analysis of the next samples.
The screens from the start to the end of analysis are as shown in the following:
(Ready)
No.123456789-12345
Ready
(Aspirating)
No.123456789-12345
Aspirating
(Analyzing)
No.123456789-12345
Analyzing
(Rinsing)
No.123456789-12345
Rinsing
(Ready)
No.123456789-12346
Ready
• While the LCD screen is displaying "Aspirating," keep holding the tube
CAUTION in the aforementioned status. If the tube is removed during its display,
correct analysis result may not be obtained.
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"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.
(5) When the LCD screen displays "Ready," prepare the next samples and repeat the
procedure (1) to (4).
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:
2-16 Sysmex
Sysmex KX-21N KX-21N Operator’s
Operator’s Manual February
Manual -- Revised -- October2000
1999
SAMPLE ANALYSIS
(1) Clean a container such as erlenmeyer flask, beaker, etc. with CELLPACK and remove
any dirt.
(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.
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
*Change Mode*
*Change Mode*
(4) Press [ENTER] key to changeover the analysis mode and return to the Analysis
screen.
NOTE: • The sample number is set by the incremented value for each analysis.
Input the sample number when changing.
(2) The cursor appears under sample No. Input sample No. using the numeric keys.
NOTE: • When entering the sample No. (on the screen of the previous page),
press [C] key first. This will clear the entire sample No. Then, enter a
new sample No.
• In the course of entering the sample No., each time you press [C] key,
one character disappears with the cursor moving to the left.
• A sample No. of a maximum of 15 digits, comprising numerics and a
hyphen, can be used.
Sysmex KX-21N
Sysmex KX-21N Operator’s
Operator’sManual
Manual----Revised
OctoberFebruary
1999 2000 2-19
SAMPLE ANALYSIS
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • When all sample Nos. are cleared, [ENTER] key is not accepted.
When you attempt to do so, an alarm sounds.
• In the status of waiting for sample No. input ("Not Ready"), press
[SAMPLE No.] or [SELECT] key. The screen returns to the Analysis
screen without updating sample No.
(2) Read the barcode affixed to the test tube with the hand held barcode reader.
When reading has been carried out normally, the read sample number will appear.
(3) Press [ENTER] key. This will fix the sample No. and the status becomes Ready,
namely, ready for analysis.
NOTE: • 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 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual --Manual
Revised--February
October 2000
1999
SAMPLE ANALYSIS
5. Analyzing samples
(2) Remove the plug while taking care not to allow blood scatter.
(3) Set the micro-tube to the sample probe, and in that condition, press the start switch.
Start Switch
(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.123456789-12345
Ready
(Aspirating)
No.123456789-12345
Aspirating
(Analyzing)
No.123456789-12345
Analyzing
(Rinsing)
No.123456789-12345
Rinsing
(Ready)
No.123456789-12346
Ready
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"Aspirating" appears on the LCD screen, the rinse cup lowers. By that
time, remove the micro-tube.
• To remove the micro-tube, lower it straight down. Take care not to
bend the sample probe.
(5) When the LCD screen displays "Ready," prepare a next sample and repeat the
procedure (1) to (4).
P3. Calculation Parameter & Patient Limit P4. Calculation Parameter & Particle Distribution
Graph Display Screen Display Screen
No.123456789-12346 No.123456789-12346
Ready Ready
No.123456789-12345 WB 31/12 10:59 No.123456789-12345 WB 31/12 10:59
LYM% 31.2 % 2.2 LYM% 31.2 % 2.2 WBC
MXD% 19.6 % 1.4 MXD% 19.6 % 1.4
NEUT% 49.2 % 3.5 NEUT% 49.2 % 3.5
RDW-SD - 25.6 fL RDW-SD - 25.6 fL RBC
RDW-CV 20.5 % RDW-CV 20.5 %
PDW - 7.9 fL PDW - 7.9 fL
MPV 9.3 fL MPV 9.3 fL PLT
P-LCR - 9.5 % P-LCR - 9.5 %
1:M.Discri. 2:Output
RBC
[fL]
RDW-SD 8.3 fL
RDW-CV 15.0 %
PLT
[fL]
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
NOTE: • One print format can be selected from among Types 1, 2, and 3.
For the selecting procedure, refer to Chapter 10, Section 7.3: IP Output
Settings.
HEMATOLOGY
Carte No. Doctor
M
Name Age
F
10/12/1999 Data
123456789012345 Sample No.
5.6+ WBC 28.3 W-SCR
×10 3/µL %
206 PLT
×10 3/µL
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.
CAUTION: • WBC results may be elevated erroneously due to unlysed red cells in
patients with hemoglobinopathies, severe liver disease or in neonates.
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.
7. EXPECTED RESULTS
Reference intervals (normal population reference ranges) were developed for the KX-21N
using normal individuals. The ranges for each parameter --- WBC, RBC, Hemoglobin,
Hematocrit, MCV, MCH, MCHC, RDW-CV, RDW-SD, Platelet, MPV, Lym% and #,
Mxd% and #, and Neut% and # were determined and displayed in Table 1-16-1.
NOTE: • The age range for females was 17 - 66 years with a mean age of 33.4.
• The age range for males was 17 - 72 years with a mean age of 42.2.
Sysmex recommends that each laboratory establish its own expected reference intervals
based upon the laboratory’s patient population encountered during daily operation. Expected
reference intervals may vary due to differences in sex, age, diet, fluid intake, geographic
location, etc. The NCCLS Document C28A1, “How to Define and Determine Reference
Intervals in the Clinical Laboratory; Approved Guideline”. This document contains
guidelines for determining reference values and intervals for quantitative clinical laboratory
test.
1 NCCLS, 771 East Lancaster Avenue, Villanova, PA 19085, USA.
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
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
NOTE: • When [3] key is pressed, shutdown is canceled and the Analysis
screen returns.
(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
(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.
CAUTION: • To remove CELLCLEAN, lower it straight down. Take care not to bend
the sample probe.
(4) When shutdown is finished and the following message is displayed, turn off the power
switch on the right side of the unit.
*Shutdown*
1:Re-boot
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:
P5. CBC8 Parameter & Particle Distribution P4. Calculation Parameter & Particle
Display Screen Distribution Display Screen
No.123456789-12346
Ready
Latest Sample No. No.123456789-12345 WB 31/12 10:59 Date/Time Analyzed
Mode Indication
WBC 7.1 ×103/µL
RBC 3.97 ×106/µL
HGB 14.7 g/dL
HCT 32.8 % Patient Limit Graph
MCV - 82.6 fL
MCH 37.0 pg
MCHC + 44.8 g/dL
PLT 180 ×103/µL
1:M.Discri. 2:Output
Figure 3-2-3: CBC8 Parameter & Patient Limit Graph Display Screen
No.123456789-12346
Ready
Latest Sample No. No.123456789-12345 WB 31/12 10:59 Date/Time Analyzed
Mode Indication
LYM% 31.2 % 2.2
MXD% 19.6 % 1.4
NEUT% 49.2 % 3.5
RDW-SD - 25.6 fL Patient Limit Graph
RDW-CV 20.5 %
PDW - 7.9 fL
MPV 9.3 fL
P-LCR - 9.5 %
1:M.Discri. 2:Output
Figure 3-2-4: Calculation Parameter & Patient Limit Graph Display Screen
No.123456789-12346
Ready
Latest Sample No. No.123456789-12345 WB 31/12 10:59 Date/Time Analyzed
Mode Indication
LYM% 31.2 % 2.2 WBC
MXD% 19.6 % 1.4 WBC Particle
NEUT% 49.2 % 3.5 Distribution Chart
RDW-SD - 25.6 fL RBC
RDW-CV 20.5 % RBC Particle
PDW - 7.9 fL Distribution Chart
MPV 9.3 fL PLT
P-LCR - 9.5 %
PLT Particle
Distribution Chart
1:M.Discri. 2:Output
No.123456789-12346
Ready
Latest Sample No. No.123456789-12345 WB 31/12 10:59 Date/Time Analyzed
Mode Indication
WBC 7.1 ×103/µL WBC
RBC 3.97 ×106/µL WBC Particle
HGB 14.7 g/dL Distribution Chart
HCT 32.8 % RBC
MCV - 82.6 fL RBC Particle
MCH 37.0 pg Distribution Chart
MCHC + 44.8 g/dL PLT
PLT 180 ×103/µL
PLT Particle
Distribution Chart
1:M.Discri. 2:Output
3) Mode Indication
The latest sample's analysis mode is displayed.
The whole blood mode is displayed as "WB" and the pre-diluted mode as "PD."
4) Date/Time Analyzed
Date and time when analysis result was obtained are displayed.
5) Analysis Data
The analysis data of the following 17 parameters or part of them are displayed
depending on the screen:
Analysis parameters (8): WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT
Calculation parameters (9): LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#,
RDW-SD, RDW-CV, MPV
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.
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.
2 . 2 Manual Discrimination
This menu allows relocation of particle distribution discrimination position and re-calculation
of data.
NOTE: • "1: M. Discri." on the menu is valid only for the analysis result in the
whole blood mode.
(2) Using [ ] key or [ ] key to select a desired particle distribution for the manual
discrimination, and press [ENTER] key.
The Manual Discrimination screen appears.
*M.Discri.*
No.123456789-12345 WB 31/12 10:59
WBC WBC 7.1×103/µL
LYM% 31.2%
MXD% 19.6%
NEUT% 49.2%
LYM# - 2.0×103/µL
LD 30 fL MXD# 1.4×103/µL
T1 90 fL NEUT# 3.5×103/µL
T2 144 fL
*M.Discri.*
No.123456789-12345 WB 31/12 10:59
RBC RBC 3.97×106/µL
HGB 14.7g/dL
HCT 32.8%
MCV - 82.6fL
MCH 37.0pg
LD 25 fL MCHC + 44.8g/dL
UD 250 fL RDW - 25.6fL
*M.Discri.*
No.123456789-12345 WB 31/12 10:59
PLT PLT 180×103/µL
PDW - 7.9fL
MPV 9.3fL
P-LCR - 9.5%
LD 2 fL
UD 30 fL
(3) Using [ ] key or [ ] key, move the cursor to select the discriminator for manual
discrimination.
The discriminator selected on the Particle Distribution Chart is shown with solid line.
(4) Using [ ] key or [ ] key, move the Discri. position on the Particle Distribution
Chart. The Discri. position relocated is displayed.
The range within which each Discri. position can move is shown below.
(6) When you want to change another Discri., repeat the above (2) - (6) operation.
(7) When Discri. change is finished, press [SELECT] key. The Setting Change
Confirmation Message appears.
(8) Using [ ] key or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel,"
then press [ENTER] key.
[Cont.]: Returns to the M. Discri. screen and allows M. Discri. operation.
[Set]: Updates the contents and returns to the Analysis screen.
[Cancel]: Cancels the changed contents and returns to the Analysis screen.
(9) When you update the contents, analysis values changed in M. Discri. on the Analysis
screen are reverse-displayed.
No.123456789-12346
Ready
No.123456789-12345 WB 31/12 10:59
WBC 7.1 LYM% 31.2 2.2
RBC 39.7 MXD% 19.6 1.4
HGB 14.7 NEUT% 49.2 3.5
HCT 32.8 RDW-SD - 25.6
MCV - 82.6 RDW-CV 20.5
MCH 37.0 PDW - 7.9
MCHC + 44.8 MPV 9.3
PLT 180 P-LCR - 9.5
1:M.Discri. 2:Output
2 . 3 External Output
This menu can be used to print out the latest sample's analysis result from the built-
in/external printer or output to the host computer. (The external printer is an option)
Printing to Printer
(1) Press [2] key on the Analysis screen and select "2: Output."
The pop-up menu to select the output destination will appear.
1:Host
2:DP
3:GP
4:LP
5:IP
6:IP Feed
7:StopOutput
(2) Using [ ] key or [ ] key to move the cursor to the desired printer, and press
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to "Output to Host
Computer" described later.
[2: DP]: The data printer starts printing the analysis result of the latest sample.
[3: GP]: The graphic printer starts graphic printing the analysis result of the
latest sample.
[4: LP]: This cannot be selected.
[5: IP]: The built-in printer starts printing the analysis result of the latest
sample.
[6: IP Feed]: Carries out the paper feed of the built-in printer.
[7: StopOutput]: This cannot be selected.
Contents of Printing
NOTE: • For printing format of built-in printer, refer to Chapter 2, Section 5.2:
Printing of Analysis Result. To change the printing format, refer to
Chapter 10, Section 7.3: IP Output Settings.
Sysmex
SysmexKX-21N
KX-21NOperator’s
Operator’sManual
Manual----Revised
OctoberFebruary
1999 2000 3-11
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
HEMATOLOGY
Carte No. Doctor
M
Name Age
F
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."
3) Date/Time Analyzed
Date and time when analysis result was obtained are printed.
(2) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key.
Output the analysis data of the latest sample to the host computer.
NOTE: • When the stored data exceeds 300, the oldest data are automatically
deleted.
(2) Using [ ] key or [ ] key, move the cursor to select "1: Stored Data."
(3) Press [ENTER] key. The Stored Data screen [1/7] appears.
*Stored Data*
Date Time No
31/12 09:59 123456789-12341*B WB DGH
31/12 10:05 QC01 M QC DGH
31/12 10:10 123456789-12335 M WB DGH
31/12 10:25 123456789-12337 M WB DGH
31/12 10:28 123456789-12344 M PD DGH E
31/12 10:30 123456789-12345 A PD DG
31/12 10:40 123456789-12346 A WB GH
31/12 10:50 123456789-12341*M WB D
NOTE: • The sample No. and analysis mode on the Analysis screen return to
the status before the execution of the stored data processing program.
P2. Stored Data Screen [2/7] P3. Stored Data Screen [3/7] P4. Stored Data Screen [4/7]
P7. Stored Data Screen [7/7] P6. Stored Data Screen [6/7] P5. Stored Data Screen [5/7]
*Stored Data*
Date Time No
31/12 09:59 123456789-12341*B WB DGH
31/12 10:05 QC01 M QC DGH
31/12 10:10 123456789-12335 M WB DGH
31/12 10:25 123456789-12337 M WB DGH
31/12 10:28 123456789-12344 M PD DGH E
31/12 10:30 123456789-12345 A PD DG
31/12 10:40 123456789-12346 A WB GH
31/12 10:50 123456789-12341*M WB D
*Stored Data*
No. WBC RBC HGB HCT
-12341* WB 7.7+ 3.97 14.7 32.8
QC 7.5 4.51 14.1 34.7
-12346 WB 7.5+ 3.85 13.8 30.5
-12345 WB 7.1 4.30+ 12.2 29.5-
-12344 PD 7.2 3.91 14.3 32.0
-12337 PD 5.5- 3.90 15.1 40.2+
-12335 WB 7.0 4.05 18.5 31.4
-12341* WB 7.6+ 3.98 15.0 35.1
*Stored Data*
No.123456789-12341 WB 31/12 10:50
WBC + 7.7 LYM% 31.2 2.2
RBC 3.97 MXD% 19.6 1.4
HGB 14.7 NEUT% 49.2 3.5
HCT 32.8 RDW-SD - 25.6
MCV - 82.6 RDW-CV 20.6
MCH 37.0 PDW - 7.9
MCHC 44.8 MPV 9.3
PLT 180 P-LCR - 9.5
Marking
To mark the analysis data, specify an analysis data using the underline cursor and press
[ENTER] key.
The marked analysis data has a added to its left end and the underline cursor moves to the
next analysis data. When an analysis data is marked, the Menu Display Area displays:
“1: Delete”, “2: Output”, “3: Chg. Disp.” When the mark is already attached, press [ENTER]
key to delete it.
NOTE: • When you keep pressing [ENTER] key, the marking is made
continuously.
• When you return to the Analysis screen, all the marks on analysis data
are deleted.
*Stored Data*
No. WBC RBC HGB HCT
-12341* WB 7.7+ 3.97 14.7 32.8
QC 7.5 4.51 14.1 34.7
-12335 WB 7.5+ 3.85 13.8 30.5
-12337 WB 7.1 4.30+ 12.2 29.5-
-12344 PD 7.2 3.91 14.3 32.0
-12345 PD 5.5- 3.90 15.1 40.2+
-12346 WB 7.0 4.05 18.5 31.4
-12341* WB 7.6+ 3.98 15.0 35.1
1) Data/Time Analyzed
The date and the time when analyzed the analysis data are displayed.
2) Sample No.
The sample No. of stored data is displayed.
The sample number is displayed by all of the 15 digits on [1/7] screen, but displayed
by only 6 last digits on [2/7] to [7/7] screens.
Identical sample Nos. processed on an identical analysis date are marked with * at the
ends of the Nos. QC data are displayed in the format of "QC + File No."
4) Mode Indication
The analysis mode for stored data is displayed.
"PD" is indicated for the pre-diluted mode while no indication is given for the whole
blood mode.
1. WB: Whole blood mode
2. PD: Pre-diluted mode
3. QC: QC data
5) Not-output Mark
It is displayed whether to output data to an external printer or the host computer by the
marks.
1. D : The data has not been printed to the data printer. The mark disappears when
printed.
2. G : The data has not been printed to the graphic printer. The mark disappears when
printed.
3. H : The data is not output to the host computer. The mark disappears when output.
3-18 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual --Manual
Revised--February
October 2000
1999
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
6) Error Mark
The E mark is displayed in data which an error occurs.
7) Analysis Data
Analysis data of 17 parameters are displayed on over six pages of [2/7] to [7/7].
Stored Data Screen [2/7]: WBC, RBC, HGB, HCT
Stored Data Screen [3/7]: MCV, MCH, MCHC, PLT
Stored Data Screen [4/7]: WBC, LYM%, MXD%, NEUT%
Stored Data Screen [5/7]: WBC, LYM#, MXD#, NEUT#
Stored Data Screen [6/7]: RDW-SD, RDW-CV
Stored Data Screen [7/7]: MPV
• Abnormal Marks
The marks on the left of analysis data indicate the following:
1. ! : The data is out of the linearity limit.
2. * : The data is low in reliability because of a histogram error.
3. + : The data exceeds the upper Mark Limits.
- : The data exceeds the lower Mark Limits.
NOTE: • The marks are added with the priority order of 1, 2, and 3.
• The Mark Limits with "+" and "-" can be set by the customer. For
details, refer to Chapter 10, Section 4: Patient Limit.
Sysmex KX-21N
Sysmex KX-21N Operator’s
Operator’s Manual
Manual -- Revised
October May
19992003
N.A. N.A. 3-19
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
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
(3) Using [ ] key or [ ] key, move the cursor to select "Yes" or "NO."
[Yes]: Deletes the marked analysis data.
[NO]: Cancels deletion.
NOTE: • Before deleting data, make sure the KX-21N completes any output
operation to the printer or host computer.
3 . 4 External Output
This menu allows the marked analysis data to be printed by the built-in/external printer, or
output to the host computer. (The external printer is an option.)
Printing to Printer
(1) Using the underline cursor, specify the analysis data you want to print and press
[ENTER] key. This puts the mark on the analysis data.
(3) Using [ ] key or [ ] key to move the cursor to the desired printer, and press
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to "Output to Host
Computer" described later.
[2: DP]: This cannot be selected.
[3: GP]: The graphic printer starts graphic printing the marked analysis data.
[4: LP]: The graphic printer starts list printing the marked analysis data.
[5: IP]: The built-in printer starts printing the marked analysis data.
[6: IP Feed]: Carries out the paper feed of the built-in printer.
[7: StopOutput]: When two or more analysis data are output, this can be selected,
and the output will be interrupted when you select this.
When the print to the printer is completed, disappearing the not-output mark for the
printer which corresponding to the printed analysis data.
NOTE: • For print format other than the LP (list print with the graphic printer),
refer to Chapter 2, Section 5.2: Printing of Analysis Result or Chapter
3, Section 2.3 External Output.
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 3-21
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
Contents of Printing
List print with the graphic printer
(3) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key.
The analysis data is output to the host computer in order that the mark is put.
The not-output of the output analysis data to the host computer disappears when the
output to the host computer is completed.
3-22 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual --Manual
Revised--February
October 2000
1999 N.A.
N.A.
DISPLAY AND PROCESSING OF ANALYSIS RESULTS
(1) Use the underline cursor to select the desired analysis data, then press the [SAMPLE
No.] key. The sample number on the bottom of the screen 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.
The sample number is changed, and the sample number input attribute becomes "M".
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.
• 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.
4-2
Daily Maintenance Year: Month:
Day
Maintenance Item 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 2122 23 24 25 26 27 28 29 30 31
Execute shutdown
Signature
Replace fuse
Every 3-Month Maintenance
Replace printer paper
Maintenance item Date, Signature
CELLPACK
Lot No. Date Expiry Signature Lot No. Date Expiry Signature
STROM ATOLYSER- W H
Lot No. Date Expiry Signature Lot No. Date Expiry Signature
(1) Press [SHUTDOWN] key in the Ready status. The Shutdown screen appears.
*Shutdown*
Ready
Aspirate CELLCLEAN.
It will take approx. 5 minutes.
3:Cancel
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
(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.
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*
1:Re-boot
(2) Turn the chamber on the left side of the unit counterclockwise and remove.
T ra p C hamber
Fl oat
Loosen
(3) After discarding the liquid, mount the chamber. Make sure the float is inside.
WARNING • When discarding the trap chamber liquid, always wear rubber gloves.
After completion of operation, wash hands with disinfectant. If your
hands are contaminated by the liquid, infection of bacteria or the like can
occur.
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.
Tray
• When removing the tray, take care not to loosen the probe fixing screw.
CAUTION If analysis is made with the screw loosened, air can enter the system
and affect the data.
Tray
• After mounting the tray, make sure the probe fixing screw is not loose.
CAUTION If analysis is made with the screw loosened, air can enter the system
and affect the data.
CAUTION: • Mount the SRV tray properly as to the face/bottom and the direction.
*Scheduled Maint.*
1:Exec.Clean 3:Cancel
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.
(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*
Ready
Aspirate CELLCLEAN
It will take approx. 15 minutes.
3:Cancel
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
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.
(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.
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 Chapter 4, Section 9: CONFIRMATION OF CYCLE
NUMBER.
*Scheduled Maint.*
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 Chapter 4, Section 7.3:
Clean WBC/RBC Transducer Aperture.
(1) Press [1] key to select "1: Exec. Clean" on Scheduled Maintenance Message screen.
Fluid in the transducer is drained and the Clean Transducer screen appears.
*Clean Transducer*
Ready
3:Cancel
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.
(4) Using the filler provided with the unit, pour approximately 1 mL each of
CELLCLEAN into the WBC transducer and RBC transducer.
Filler
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.
CAUTION: • Take care not to have detergent (CELLCLEAN) adhere to the chamber
side wall.
*Clean Transducer*
Please wait.
(8) When the transducer cleaning is completed, the auto rinse and background check are
executed, then the system turns to the Ready status.
(9) Check to see that no background error occurs. Should background error occur,
execute the auto rinse.
*Scheduled Maint.*
1:Exec.Clean 3:Cancel
When this message appears, press [1] key to select "1: Exec. Clean," and reset the cycle
counter. Then clean the sample rotor valve (SRV) by the following procedure:
WARNING • When cleaning the sample rotor valve (SRV), always wear rubber
gloves. After completion of operation, wash hands with disinfectant. If
your hands are contaminated by blood, etc., infection of bacteria or the
like can occur.
• Because CELLCLEAN is a strong alkaline detergent, take care 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: • When you press [3] key and select "3: Cancel," the start-up process
continues without cleaning the sample rotor valve (SRV). Until the
sample rotor valve (SRV) is cleaned, the above message is displayed
at start-up.
• When you want to clean before this message appears, or when you
selected "3: Cancel" on the Scheduled Maint. screen and executed
cleaning when the power was off, reset the cycle counter, making
reference to Chapter 4, Section 6.2: Reset SRV Cycle Counter.
(1) Press [1] key to select "1: Exec. Clean" on the Scheduled Maintenance Message
screen. The SRV cycle counter is reset and the unit is ready to be turned off.
*Scheduled Maint.*
CAUTION: • Before turning the power off, always select "1: Exec. Clean," making
the unit ready to be turned off.
(2) Turn off the power of the main unit and wait approximately 30 seconds.
Tray
• When removing the tray, take care not to loosen the probe fixing screw.
CAUTION If analysis is made with the screw loosened, air can enter the system
and affect the data.
(5) Gently push down the rinse cup using both hands. Make sure the rinse cup is
removed completely from the sample probe.
Sample Probe
Rinse Cup
CAUTION: • If the rinse cup is not completely removed from the sample probe, there
is a possibility that the sample probe may bend when the sample rotor
valve (SRV) is removed.
Loosen
CAUTION: • Take care not to pull out the valve excessively. This is to prevent
applying excess force to the tube connected to the valve.
• When removing the valve, take care not to bend the sample probe.
Rotary Valve
• When removing the valve, reagent could leak from the tube. If it does,
CAUTION
wipe it clean using cloth. If left as it is, it can cause current leakage or
electric shocks.
NOTE: • The valve components are in close contact with one another. They
can be easily removed when you gently twist and slide each one.
(9) Clean the rotary valve using distilled water or 1:10 dilution of CELLCLEAN detergent.
After cleaned with CELLCLEAN, always clean it with distilled water.
(10) Clean the contact surfaces of the fixed and rotary valves using a gauze moistened with
distilled water. By using CELLCLEAN together with distilled water, stuck objects,
dirt, etc. can be removed easily.
• Take care not to inflict flaws or scratches on valve surfaces, since flaws
CAUTION or scratches can cause blood leakage and incorrect analysis results.
CAUTION: • Do not use any detergent other than CELLCLEAN. Although the
sample rotor valve (SRV) is corrosion-resistant against CELLCLEAN,
wipe it off completely to prevent troubles to the unit or other
components.
(11) Make sure the valve contact surfaces are completely free from dirt or dust.
(12) Install one each valve at a time, and assemble the sample rotor valve (SRV) in the
reverse order to disassembly.
CAUTION: • Mount the rotary valve with the notch facing upward and the metal
knob coming between the stoppers.
Metal Knob
Guide Pin for Rotary Valve
Stopper
Groove
(13) Mount the SRV tray to the original position and gently push up the rinse cup to the top
using both hands.
CAUTION: • Mount the SRV tray properly as to its face/bottom and the direction.
• Make sure the rinse cup is pushed all the way up with the sample
probe inserted in the hole. If the power is turned on with the rinse cup
staying lowered, "Rinse Motor Error" will occur, making it impossible to
continue the operation.
(15) Turn on the main unit and make sure that the background error has not occurred.
(16) Perform quality control and make sure that there is no functional problem.
NOTE: • If you continue using the unit without resetting the SRV cycle counter,
the message will instruct you to perform scheduled maintenance within
three months (or before analyzing 7500 samples).
• For SRV cleaning procedure, refer to Chapter 4, Section 6.1: Clean
Sample Rotor Valve (SRV).
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Use [ ] key or [ ] key, move the cursor to select "7: Maintenance."
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
(4) Use [ ] key or [ ] key, move the cursor to select "3: Reset SRV Counter."
(5) Press [ENTER] key. The Rest SRV Counter screen appears.
*Reset SRV Counter*
1:Reset 3:Cancel
(6) Press [1] key to select "1: Reset." "Cycle No. after cleaning" is reset to "0," the date
of the present day is entered in the "Date last serviced" column, then the Analysis
screen returns.
NOTE: • Press [3] key to select "3: Cancel." The cycle counter is not reset, and
the Analysis screen returns.
• For confirmation of SRV cycle counter, refer to Chapter 4, Section 9:
CONFIRMATION OF CYCLE NUMBER.
7 . 1 Auto Rinse
Execute the Auto Rinse at background check or when the unit has been left idle without
shutdown performed. The Auto Rinse cleans all the lines in the unit and drains all waste.
Background check is also implemented to allow checking whether the unit is in normal status
or not.
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "5: Auto Rinse."
*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
*Auto Rinse*
Please wait.
NOTE: • After Auto Rinse, background check is executed. When the background
value of any parameter exceeds tolerance, background check is
repeated a maximum of twice. In case background value still exceeds
tolerance, the message "Background Error" appears while the alarm
starts sounding. Press [HELP] key. This stops the alarm and the
Action Message screen appears. Follow the Action Message screen
and take appropriate action. (Refer to Chapter 7:
TROUBLESHOOTING ).
• Background tolerance
WBC 0.3 [×103/µL] or less
RBC 0.02 [×106/µL] or less
HGB 0.1 [g/dL] or less
PLT 10 [×103/µL] or less
WARNING • When cleaning the rinse cup, 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.
(3) Gently push down the rinse cup using both hands. Make sure the rinse cup is
removed completely from the sample probe.
Sample Probe
Rinse Cup
(4) Remove the rinse cup in the order of 1, 2, and 3 as shown below.
Rinse Cup
(6) Make sure no contaminant remains on the rinse cup and wipe off water.
(7) Mount the rinse cup in the reverse order of removal. Route the thin tubes around the
rear of the rinse cup.
Rinse Cup
3
2
(8) Gently push up the rinse cup to the top using both hands.
CAUTION: • Make sure the rinse cup is pushed all the way up with the sample
probe inserted in the hole. If the power is turned on with the rinse cup
staying lowered, "Rinse Motor Error" will occur, making it impossible to
continue the operation.
WARNING • When cleaning the aperture, 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.
• 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.
1. Preparation
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Use [ ] key or [ ] key, move the cursor to select "7: Maintenance."
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
(4) Use [ ] key or [ ] key, move the cursor to select "4: Drain TD Chamber."
(5) Press [ENTER] key. Reagent in the transducer chamber is automatically drained.
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
(6) When reagent in the transducer chamber is drained, the message instructing turning-off
of the power is displayed, which indicates that it is ready for cleaning with the brush.
*Drain TD Chamber.*
3:Cancel
NOTE: • When you press [3] key, cleaning with brush is canceled and the
Analysis screen returns.
Transducer Cover
WARNING • When the power is on, never open the transducer cover. This is to
prevent possible electric shocks.
(4) Confirm that reagent in the transducer chamber has been drained.
WBC Transducer
RBC Transducer
Plug
(6) Apply CELLCLEAN on the brush provided, and dab by lightly prodding the brush
against the transducer aperture.
Aperture
Brush
(8) Close the transducer cover and main unit front cover. Then turn on the power.
WARNING • When replacing the waste tank, always wear rubber gloves. After
replacing, wash hands with disinfectant. If your hands are
contaminated by blood, etc., infection of bacteria or the like can occur.
(1) Turn off the power of the main unit and wait approximately 30 seconds.
(2) Make ready an empty waste container and remove the cap.
(4) Insert the tube in the new waste container and fix it using tape or the like.
Tube
Tape
Waste
8. SUPPLIES REPLACEMENT
8 . 1 Replenish Reagent
When reagent becomes insufficient during analysis, the instrument comes to a stop, while the
screen displays the error message. Press [HELP] key to change to the replenishment
operation.
Error
Message HELP Screen Reagent to
(Analysis Replenish
Screen)
Replenish *Help* CELLPACK
Diluent
ERR CODE:XXXXX.X.X
1:Asp. Reag. 3:Cancel
ERR CODE:12490.0.0
1:Asp.Reag. 3:Cancel
NOTE: • Press [3] key on the HELP screen and select "3: Cancel" to return to
the Analysis screen. Although Analysis screen displays the Not
Ready status, the processing, etc. of stored data can be performed.
(1) Make ready a new reagent and check to see that expiration date is not passed.
• Take care not to grasp the tube dipping into the reagent and not allow
CAUTION
dust, etc. to adhere to the tube. If dust, etc. adheres to the tube, wash
it away with reagent in use before mounting. Otherwise, correct
analysis results may not be obtained.
• Replace only fresh and fully bottled lyse reagent. Old or collected lyse
reagent will affect the analysis results.
• Take care not to spill reagent. If it spills, wipe it off immediately using
wet cloth, etc. to prevent the floor color fading.
• When replacing lyse, you do not need to disconnect the float switch. If
disconnected, connect it securely in prior to starting analysis. Starting
analysis with disconnected float switch will give you an error message
"No Lyse".
(5) When reagent replenishment is over, follow the instruction on the screen and press [1]
key to select "1: Asp. Reag." Reagent is automatically aspirated, and then background
check is performed. The check is made here to see that background error has not
occurred.
NOTE: • If you replenish lyse before error message "No Reagent" appears,
execute "4: Replace Lyse" on the Select Menu screen.
8 . 2 Replace Fuse
The main unit employs overcurrent protective fuses. When a fuse is blown, replace it by the
following procedure:
(1) Disconnect the power cord on the right side of the main unit.
WARNING • Before replacing the fuse, always turn off the power and disconnect the
power cord to prevent possible electric shocks.
(2) Pressing the notch upward with a regular screwdriver, remove the fuse cap holder.
Fuse
(3) Replace the fuse and mount the fuse cap holder.
• For continued protection against risk of fire, use the fuse of the specified
CAUTION type and rating.
*Help*
IP paper empty
[1] Restarting to print
[3] Stop printing on IP
To make IP on-line,
press [SELECT], then
[Periph. Settings]
ERR CODE:XXXXX.X.X
1:Print 2:Paper Feed 3:Stop Output
NOTE: • On the HELP screen, press [3] and select "3: Stop Output" to stop
printing on built-in printer. Analysis is executed as usual but printing is
not. When you want to use built-in printer again, select "8: Periph.
Settings" to set. (Refer to Chapter 10, Section 11: Peripheral
Settings.)
Release Lever
(3) Remove the bare paper core and mount a new printer paper.
NOTE: • When any printer paper remains, remove it together with the paper
core.
(4) Pass the printer paper as shown below, and turn the release lever down to secure.
(5) Cut off any printer paper extending from the upper part of the printer.
(7) Press [1] key and output any print data that is remaining on the memory.
8 . 4 Supplies List
1. Reagents List
2. Consumable List
NOTE: • If you need to order supplies or replacement parts, please contact your
local Sysmex representative.
Current cycle No. of each item can be checked by the following procedure:
9 . 1 Operation Procedure
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select "5: Status Display."
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
(6) Using [ ] key or [ ] key, turn over the page to display the Status Display screen 2.
*Status* WB
Ready
COUNTER 1234567 Cycle No. after cleaning waste chamber
WASTE CHAMBER 2567
DETECTOR 2567 Cycle No. after cleaning transducer
SRV 7567
Cycle No. after cleaning SRV
NOTE: • Cycle number is the number of operations after the last maintenance.
• When the power is turn-on and the counter exceeds the predetermined
cycle number (or number of days), the message instructing the
maintenance is displayed on the screen. At this time, the cycle number
and the date of the last service are displayed.
*Scheduled Maint.*
1:Exec.Clean 3:Cancel
3. DELETION ........................................................................5-27
1. INTRODUCTION
Quality Control checks are performed to monitor an instrument’s performance over time.
EIGHTCHECK-3WP is the quality control material recommended by Sysmex to monitor the
performance of the KX-21N analyzer. This product is supplied with three control levels, at
least two levels should be run every 8 hours of operation or in accordance to regulations
applicable to your laboratory. Quality control material should be run after component
replacement or after a service call. The KX-21N has two quality control methods.
1 . 1 X Control
In X control, control blood is analyzed twice and the mean of the two is used to evaluate
analyzer performance.
NOTE: • Selection of the one of the two methods can be performed using QC
method in the QC Settings program. Refer to "Chapter 10, Section 5:
QC Settings."
1 . 3 QC Chart Screen
When the QC program is executed, the QC File List screen appears first.
Six QC Files are displayed in the file list. Select the QC File used from among that, and
display the QC Chart screen.
The QC Chart can display QC data up to the latest 60 points. When a new data comes in, the
oldest data is erased.
The control parameters indicated in the QC Chart are displayed on multiple pages. [ ] key
or [ ] key can be used to change over the screen.
The Menu Display Area displays "1: QC Analyze," "2: Settings," and "3: Erase All." The
menu can be executed using the numeric keys.
P1. QC Chart Screen [1/8] P2. QC Chart Screen [2/8] P3. QC Chart Screen [3/8]
P7. QC Chart Screen [7/8] P6. QC Chart Screen [6/8] P5. QC Chart Screen [5/8]
2) Lot. No.
Lot number set in the QC File.
3) Exp. Data
Expiration date set in the QC File.
4) N
The number of control data plotted currently. In the case of X control, the average
represents a data.
5) Control parameter
Analysis parameters of control data are displayed on multiple pages:
6) LIMIT (UL)
The upper control limit. An analysis value exceeding this limit is a QC error.
7) LIMIT (LL)
The lower control limit. An analysis value exceeding this limit is a QC error.
8) Target value
QC Target value
9) DATA
The QC data of the plot specified by the vertical line cursor. In the case of X control, it
is the mean value of two consecutive analyses.
1 0 ) MEAN
The mean of QC data plotted currently
1 1 ) Line Cursor
The vertical line cursor can be moved to the right or left using [ ] key or [ ] key.
The QC data of the plot shown by the line cursor, along with analysis date, are
displayed.
2. QC ANALYSIS PROCEDURE
2.1 QC Analysis Procedure Flow Chart
2 . 2 Execute QC Program
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "2: Quality Control."
*Quality Control*
Lot.No. Exp.Date
1 : [1234567890][07.11.1999]
2 : [1234567891][14.11.1999]
3 : [1234567892][21.11.1999]
4 : [1234567893][28.11.1999]
5 : [1234567894][01.12.1999]
6 : [1234567895][06.12.1999]
2 . 3 Select QC File
This instrument stores six QC Files. To execute QC analysis, settings, file erasing, or HC
output, display the QC Chart screen for a desired file as follows.
(2) Press [ENTER] key. The QC Chart screen for the selected QC file appears.
NOTE: • The QC File can be selected directly by inputting file number of the
QC File with numeric keys.
• Press [SELECT] key to return from the QC Chart screen to the QC File
List screen.
2 . 4 Erase All
To start quality control newly, the control data in the QC File has to be erased. When a
control blood lot has changed, use the menu of "3: Erase All" to erase all control data in the
QC File.
(2) Press [3] key to select "3. Erase All." The Erase All Confirmation message appears.
(3) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Erases the plot display on the QC Chart screen and displays the second Erase
All Confirmation message.
[No]: Cancels the erasing of the plot display on the QC Chart screen and returns to
the QC Chart screen.
(4) Using [ ] key or [ ] key, move the cursor to select "Execute" or "Cancel."
[Execute]: Completely erases QC data and returns to the QC Chart screen.
[Cancel]: Cancels QC data erase and returns to the QC Chart screen.
Lot.No [ ]
Exp.Date [ ]
TARGET LIMIT
WBC 0.0 0.0 ×103/µL
RBC 0.00 0.00 ×106/µL
HGB 0.0 0.0 g/dL
HCT 0.0 0.0 %
MCV 0.0 0.0 fL
MCH 0.0 0.0 pg
MCHC 0.0 0.0 g/dL
PLT 0 0 ×103/µL
(3) Move the cursor with [ ] key or [ ] key, and select Lot.No. (lot number), Exp.Date
(expiration date) or the control parameter.
Move the cursor with [ ] key or [ ] key, and select TARGET or LIMIT in the
control parameter.
NOTE: • There are 19 control parameters, but all the control parameters cannot
be listed in one screen, so scroll the screen with [ ] key or [ ] key.
NOTE: • Each time you press [C] key in the middle of entering, one character
disappears and the cursor moves to the left.
For setting the lot number
• The Lot number can be input up to 10 digits.
• Also, the lot number can be input with the hand held barcode reader
(option).
For setting the expiration date
• The expiration date can be input up to 10 digits.
• Even if the expiration date is input, processing which judging the date
in the program is not carried out.
This is just a memo input for managing the QC File.
For setting the control parameter
• As a set value, up to five digits including decimal point can be entered.
• The decimal point position is linked to the Unit System established in
System Setup. For detail, refer to Chapter 10: INSTRUMENT
SETTING, Section 2: System Setup.
NOTE: • The contents of settings are also set when [ ] key, [ ] key, [ ] key,
or [ ] key is pressed after entering.
(6) When settings are completed, press [SELECT] key. The Setting Confirmation
message appears.
(7) Using [ ] key or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the QC File Setting screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the QC Chart screen.
[Cancel]: Cancels the changed settings and returns to the QC Chart screen.
NOTE: • QC chart will be drawn only if the TARGET and LIMIT values are both
entered appropriately.
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 5-9
QUALITY CONTROL
2 . 6 Execute X Control
The X control method for analyzing control blood is described here.
(1) Display the QC Chart screen for the QC File in which to enter QC data. For how to
select the QC File, refer to Chapter 2.3: Select QC File in this chapter.
(2) Press [1] key to select "1: QC Analyze." The X Control Analysis screen appears.
FILE No.1 QC
Ready
X1 X2 X Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
NOTE: • QC analysis is made in the whole blood mode. When the pre-diluted
mode is selected as analysis mode, the Mode Change Sequence is
activated to change over to the whole blood mode.
(5) Remove the cap while taking care not to allow blood to scatter.
(6) Set the control blood container to the sample probe and press the start switch in that
status.
Start switch
(7) When the buzzer sounds two times - beep, beep, - and "Analyzing" is displayed on the
X Control Analysis screen, remove the control blood container. Then, automatic
analysis is executed.
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 5-11
QUALITY CONTROL
The screens from the start to the end of analysis are as shown below.
(Ready)
FILE No.1 QC
Ready
(Aspirating)
FILE No.1 QC
Aspirating
(Analyzing)
FILE No.1 QC
Analyzing
(Rinsing)
FILE No.1 QC
Rinsing
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"Analyzing" appears on the screen, the rinse cup lowers. Remove the
control blood container by that time.
• To remove the container, lower it straight down. Take care not to bend
the sample probe.
(8) Under the "X1" column on the Analysis Result screen, the 1st time analysis result is
displayed.
The analysis result comprises three screens which can be changed over by pressing
[ ] key or [ ] key.
P1. CBC8 Parameter Screen P2. WBC Screen P3. RBC/PLT Screen
X1 X2 X Judgement
WBC 7.3
RBC 4.52
HGB 14.8
HCT 36.2
MCV 80.1
MCH 32.7
MCHC 40.9
PLT 206
Accept Data?
1:OK 2:NG 3:Print
If the data is acceptable, press [1] key to confirm. Press [2] key to reject.
Press [3] key and select "3: Print" to print the contents of analysis result on the built-in
printer.
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC 7.3 ×103/µL
RBC 4.52 ×106/µL
HGB 14.8 g/dL
HCT 36.2 %
MCV 80.1 fL
MCH 32.7 Pg
MCHC 40.9 g/dL
PLT 206 ×103/µL
WBC
[fl]
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RBC
[fl]
RDW-SD 27.4 fL
RDW-CV 11.4 %
PLT
[fl]
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
NOTE: • Print of analysis result is valid until the data is set. If the data is set by
pressing [1] key or [2] key, analysis result cannot be printed.
• This print format cannot be changed since it is the special format for QC
analysis.
When you press [SELECT] key before setting the 1st QC data, the QC Cancel
Confirmation message is displayed.
OK to cancel? Yes No
(10) When the 1st analysis data is accepted, the (3) - (7) procedure is repeated for the 2nd
analysis.
(11) The 2nd analysis result is displayed under "X2" on the Analysis Result screen, the
mean values of the 1st and the 2nd analyses under " X ," and the comparison result with
control limits under the "Judgment" column.
The Analysis Result screen, as in the 1st analysis, can be changed over using [ ] key
or [ ] key.
The data confirmation message is displayed and you are asked to decide whether or not
to accept the analysis result as QC data.
FILE No.1 QC
X1 X2 X Judgement
WBC 7.3 7.5 7.4
RBC 4.52 4.49 4.51
HGB 14.8 14.7 14.8
HCT 36.2 35.6 35.9
MCV 80.1 79.3 79.7
MCH 32.7 32.7 32.7
MCHC 40.9 41.3 41.1
PLT 206 209 208
Accept Data?
1:OK 2:NG 3:Print
A parameters in which the mean of the 1st and the 2nd analyses fell outside the control
limits is indicated with + or − under the "Judgment" column, while the alarm sounds
and the QC error message appears.
FILE No.1 QC QC Error
X1 X2 X Judgement
WBC 7.3 7.5 7.4
RBC 4.52 4.49 4.51
HGB 14.8 14.7 14.8
HCT 42.5 43.0 42.8 +
MCV 94.0 95.8 94.9 +
MCH 32.7 32.7 32.7
MCHC 34.8 34.1 34.5 -
PLT 106 109 108 -
Accept Data?
1:OK 2:NG 3:Print
CAUTION: • When an error occurs during QC analysis, the error message appears
in the system status area.
Press [HELP] key and perform the error recovery process. For the error
recovery process, refer to Chapter 7: TROUBLESHOOTING.
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
NOTE: • Transmission to the host is valid only when the "Host Output" is
selected. For detail, refer to Chapter 10, Section 5: QC Settings.
• As to the host output format, refer to Appendix B: Technical Information.
When you press [SELECT] key before setting the 2nd QC data, the QC Cancel
Confirmation message appears.
OK to cancel? Yes No
(1) Display the QC Chart screen for the QC File in which to enter QC data. For how to
select the QC File, refer to Chapter 2.3: Select QC File in this chapter.
(2) Press [1] key to select "1: QC Analyze." The L-J Control Analysis screen appears.
FILE No.1 QC
Ready
Data Judgement
WBC
RBC
HGB
HCT
MCV
MCH
MCHC
PLT
NOTE: • QC analysis is made in the whole blood mode. When the pre-diluted
mode is selected as analysis mode, the Mode Change Sequence is
activated to change over to the whole blood mode.
(5) Remove the cap while taking care not to allow blood to scatter.
(6) Set the control blood container to the sample probe and press the start switch in that
status.
Start switch
(7) When the buzzer sounds two times - beep, beep, - and "Analyzing" is displayed on the
L-J Control Analysis screen, remove the control blood container. Then, automatic
analysis is executed.
The screens from the start to the end of analysis are as shown below.
(Ready)
FILE No.1 QC
Ready
(Aspirating)
FILE No.1 QC
Aspirating
(Analyzing)
FILE No.1 QC
Analyzing
(Rinsing)
FILE No.1 QC
Rinsing
CAUTION: • Several seconds after the buzzer sounds "beep, beep" and
"Analyzing" appears on the screen, the rinse cup lowers. Remove the
control blood container by that time.
• To remove the container, lower it straight down. Take care not to bend
the sample probe.
(8) Analysis result is given under the "Data" column on the Analysis Result screen and
comparison result with QC limits under the "Judgment" column.
The analysis result comprises three screens which can be changed over by pressing
[ ] key or [ ] key.
P1. CBC8 Parameter Screen P2. WBC Screen P3. RBC/PLT Screen
Data Judgement
WBC 7.3
RBC 4.52
HGB 14.8
HCT 36.2
MCV 80.1
MCH 32.7
MCHC 40.9
PLT 206
Accept Data?
1:OK 2:NG 3:Print
W-SMV 56.3fL
Accept Data? W-LMV 172.4fL
1:OK 2:NG 3:Print
Data Judgement
WBC 7.5
RBC 4.49
HGB 14.7
HCT 43.0 +
MCV 95.6 +
MCH 32.7
MCHC 34.1 -
PLT 109 -
Accept Data?
1:OK 2:NG 3:Print
No. QC01-1
Date 31/10/1999
Time 10:02
Mode QC
WBC
[fl]
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RBC
[fl]
RDW-SD 27.4 fL
RDW-CV 11.4 %
PLT
[fl]
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
CAUTION: • Print of analysis result is valid until the data is set. If the data is set by
pressing [1] key or [2] key, analysis result cannot be printed.
• This print format cannot be changed since it is the special format for QC
analysis.
LYM% 27.2 %
MXD% 13.4 %
NEUT% 59.4 %
LYM# 2.0 ×103/µL
MXD# 1.0 ×103/µL
NEUT# 4.3 ×103/µL
W-SMV 56.3 fL
W-LMV 172.4 fL
RDW-SD 27.4 fL
RDW-CV 11.4 %
PDW 8.3 fL
MPV 9.1 fL
P-LCR 14.8 %
NOTE: • Transmission to the host is valid only when the "Host Output" is
selected. For detail, refer to Chapter 10, Section 5: QC Settings.
• As to the host output format, refer to Appendix B: Technical Information.
When you press [SELECT] key before setting the QC data, the QC Cancel
Confirmation message appears.
OK to cancel? Yes No
NOTE: • The sample No. and analysis mode on the Analysis screen return to
those displayed before execution of the QC program.
3. DELETION
This menu can delete one data or the range specified data of QC data in the line cursor
position.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be
deleted.
FILE No.1 [1234567890][07/11/1999]
(N=30) 31/10 LIMIT DATA
(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
1:QC Analyze 2:Settings 3:Erase All
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
• The line cursor that has changed to solid line cannot be moved.
OK to Delete? Yes No
(5) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Deletes QC data of the plot shown by the line cursor and returns the line cursor
to the dotted line.
[No]: Cancels deletion of QC data and returns the line cursor to the dotted line.
(2) Using [ ] key or [ ] key, move the line cursor to the end of the data within the
deleted range.
FILE No.1 [1234567890][07/11/1999]
(N=30) 31/10 LIMIT DATA
(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
1:QC Analyze 2:Settings 3:Erase All
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
(5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the
deleted range.
OK to Delete? Yes No
(8) Using [ ] key or [ ] key, move the cursor to select "Yes" or "No."
[Yes]: Deletes QC data of the plot shown by two line cursors and returns the line
cursor to the dotted line.
[No]: Cancels deletion of QC data and returns the line cursor to the dotted line.
4. EXTERNAL OUTPUT
Using this menu, QC data in the line cursor position can be printed out from the built-
in/external printer or output to the host computer. (The external printer is an option).
4 . 1 Printing to Printer
How to print QC Data
(1) Display the QC Chart screen of QC file that contains the data you want to print.
For how to select QC file, refer to Chapter 2.3: Select QC File in this chapter.
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data to be
printed.
FILE No.1 [1234567890][07/11/1999]
(N=30) 31/10 LIMIT DATA
(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
1:QC Analyze 2:Settings 3:Erase All
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
• The line cursor that has changed to solid line cannot be moved.
(5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the
printing range.
FILE No.1 [1234567890][07/11/1999]
(N=30) 31/10 LIMIT DATA
(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
1:Delete 2:Output 3:RangeSpec.
(8) Using [ ] key or [ ] key to move the cursor to the desired printer, and press
[ENTER] key.
[1: Host]: Output the data to the host computer. Refer to 4.2: Output to Host
Computer in this chapter.
[2: DP]: This cannot be selected.
[3: GP]: The graphic printer starts graphic printing the QC data of the plot
which the line cursor shows.
[4: LP]: The graphic printer starts list printing the QC data of the plot which
the line cursor shows.
[5: IP]: The built-in printer starts printing the QC data of the plot which the
line cursor shows.
[6: IP Feed]: Carries out the paper feed of the built-in printer.
[7: StopOutput]: When two or more analysis data are output, this can be selected, and
the output will be interrupted when you select this.
When the print to the printer is completed, the line cursor returns to the dotted line, and
the menus of the menu display area returns to "1: QC Analyze", "2: Settings" and "3:
Erase All."
Contents of Printing
Sysmex
SysmexKX-21N
KX-21NOperator’s
Operator’sManual
Manual----Revised
OctoberFebruary
1999 2000 5-33
QUALITY CONTROL
UL 4.70
PBC 4.50 4.55 4.52 0
LL 4.30
UL 15.5
HGB 15.0 15.0 14.8 0
LL 14.0
....
1) File No.
File No. of QC file is printed.
2) Analysis Mode
In the case of QC data, "QC" is printed.
3) Date/Time Analyzed
Printed is the date and time when analysis result was obtained.
5-34 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual --Manual
Revised--February
October 2000
1999
QUALITY CONTROL
(2) Using [ ] key or [ ] key, move the line cursor to the position of the data you want
to output to HC.
FILE No.1 [1234567890][07/11/1999]
(N=30) 31/10 LIMIT DATA
(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
1:QC Analyze 2:Settings 3:Erase All
NOTE: • Press [SELECT] key, and the line cursor returns to dotted line and the
menu in the Menu Display Area change to the original status.
• The line cursor that has changed to solid line cannot be moved.
(5) Using [ ] key or [ ] key, move the line cursor to the other end of the data within the
output range.
FILE No.1 [1234567890][07/11/1999]
(N=30) 31/10 LIMIT DATA
(MEAN)
UL 8.1
WBC 7.6 7.3
LL 7.1( 7.8)
UL 4.70
RBC 4.50 4.52
LL 4.30( 4.55)
UL 15.5
HGB 15.0 14.8
LL 14.5( 15.0)
1:Delete 2:Output 3:RangeSpec.
(8) Using [ ] key or [ ] key to move the cursor to [1: Host], and press [ENTER] key.
QC data of the plot shown by the line cursor is output to the host computer.
Sysmex
SysmexKX-21N
KX-21NOperator’s
Operator’sManual
Manual----Revised
OctoberFebruary
1999 2000 5-37
CHAPTER 6 CALIBRATION
1. INTRODUCTION
Upon installation of the KX-21N, the Sysmex trained service representative will perform
instrument calibration. Calibration is required at installation, and then calibration is verified
at least daily with QC material.
This chapter covers procedures necessary to calibrate the instrument for WBC (white blood
cell count), RBC (red blood cell count), HGB (hemoglobin), HCT (hematocrit) and PLT
(platelet count). WBC differential parameters are calibrated at the factory prior to shipment
and are verified by the Sysmex representative at installation. They do not need to be
calibrated at the laboratory.
1 . 1 Calibration
It is recommended that the laboratory performs calibration when any of the following occurs:
• Major preventative maintenance has been performed or critical parts replaced such as
manometers apertures or detector circuit boards.
• Controls that reflect an unusual trend or are outside of acceptable limits, and cannot be
corrected by maintenance or troubleshooting the instrument.
• The Sysmex trained service representative has advised to calibration.
(2) Calibration
Using the SCS-1000 calibrator, the instrument calibration is checked and recalibration
is performed as required.
2 . 1 Precision Check
Analyze a fresh human blood 11 times consecutively in the whole blood mode.
The system program automatically discards the first analysis and calculates the precision
(reproducibility) with the remaining 10 data.
• Transducer apertures are clog free. If not, perform the aperture cleaning procedures by
referring to Chapter 4.
• Check if the reagent volume in each reagent container is enough to complete the
calibration procedure.
• Check if the reagent is within the expiration date.
• If a waste container is used, check if the waste container has enough room to complete
the calibration procedure.
• Check if the background values fall within the following ranges;
WBC ≤ 0.3 x 103/µL
RBC ≤ 0.02 x 106/µL
HGB ≤ 0.1 g/dL
PLT ≤ 10 x 103/µL
NOTE: • Do not use the control blood for precision check. System program for
the precision check is designed to analyze human blood.
2 . 4 Reference Values
NOTE: • HGB reference value will be influenced by WBC count, diluent, lyse
reagent, HGB light source, temperature, and etc.
• HCT reference value decreases significantly due to excessive
anticoagulant.
Automatic Manual
calibration calibration
Select manual
calibration Enter assay target
Page 6-12 value.
Enter target value. program. Page 6-19
Page 6-7
Analyze in
Enter calibration
Analyze in whole calibrator
value. Page 6-13 analysis mode. Page 6-22
blood mode.
Page 6-8
3. AUTOMATIC CALIBRATION
In automatic calibration, five or more fresh, normal blood samples are used for automatic
calibration of HGB and HCT values.
3 . 1 Executing Automatic Calibration Program
(1) Press [SELECT] key in the Ready status. The Select Menu screen appears.
(2) Using [ ] or [ ] key, move the cursor to select "3: Calibration."
(3) Press [ENTER] key. The Calibration Menu screen appears.
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
1:HGB
2:HGB/HCT
3:HCT
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
(1) Using [ ] or [ ] key, move the cursor to select an automatic calibration parameter on
the Automatic Calibration Menu Screen:
[1: HGB]: Calibrates HGB alone.
[2: HGB/HCT]: Calibrates two parameters of HGB and HCT at the same time.
[3: HCT]: Calibrates HCT alone.
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
Current Cal.(%)100.0
New Cal.(%)
Press [SELECT] to Set.
*Auto Cal.*
Target Data Compensation
HCT HCT HCT
1
2
3
4
5
Current Cal.(%)100.0
New Cal.(%)
Press [SELECT] to Set.
(2) Press [ENTER] key to fix the entered value and move the reverse display to the next
target column.
*Auto Cal.*
Target Data Compensation
HGB HCT HGB HCT HGB HCT
1 12.5
2
3
4
5
NOTE: • After entering the 5th target value, pressing [ENTER] key does not
move the reverse display to the next target column.
• An entered value can be set also by pressing [ ] or [ ] key after
entering the target value.
(3) When all target values have been entered, press [SELECT] key.
The Target Value Setting Confirmation message appears.
(4) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the status for entering target values. And the setting operation
can be continued.
[Set]: Sets target values and charges to the Sample Analysis Waiting status.
[Cancel]: Cancels automatic calibration and returns to the Analysis screen.
(1) When the target values are set, the system turns to the Ready status for automatic
calibration analysis.
*Auto Cal.* WB
Ready
Target Data Compensation
HGB HCT HGB HCT HGB HCT
1 12.5 50.0
2 13.0 45.2
3 13.5 51.5
4 11.0 40.8
5 15.0 52.5
(2) Analyze the samples used for determining the standard value.
The sample being analyzed is indicated by the underline cursor.
(3) After completion of analysis, analysis result appears in the data column and
compensation rate in the compensation column, then the underline cursor moves to the
next sample. Upon completion of more than one sample, average compensation rate is
automatically calculated and displayed at the bottom of the compensation column.
*Auto Cal.* WB
Ready
Target Data Compensation
HGB HCT HGB HCT HGB HCT
1 12.5 50.0 13.0 48.0 96.2 104.2
2 13.0 45.2 13.7 43.9 94.9 103.0
3 13.5 51.5 14.1 50.0 95.7 103.0
4 11.0 40.8
5 15.0 52.5
95.6 103.4
Current Cal.(%)100.0 100.0
New Cal.(%)
CAUTION: • When an error occurs during automatic calibration analysis, the error
message appears in the system status display area. The result of
analysis in which an error has occurred is masked with "---.-," which is
not calculated for compensation rate and not used for average
compensation rate calculation, either.
• If "0" is input to the target value, compensation rate for the sample is
not calculated and the analysis result is not used for average
compensation rate calculation, either.
Change? Yes No
New compensation = Current compensation value (%) × Average compensation rate (%)
value (%) 100
4. MANUAL CALIBRATION
In manual calibration, calculated calibration value can be entered using the numeric keys.
(2) Gently mix the same samples sufficiently and analyze them in the whole blood mode.
(3) When there is a difference between data gained by analysis with this instrument and the
reference value gained by the reference method, use the following formula to calculate
the new calibration value:
Average of values gained
New calibration = Previous by reference method
×
value calibration value Average of values gained
by this instrument
[Example]
Average of HGB values gained by the reference method = 15.6 g/dL
Average of HGB values gained by this instrument = 15.5 g/dL
Previous calibration value of HGB = 100.0%
Therefore, the new calibration value of HGB needs to be set at 100.7%. This means
that the calibration value increased 0.7%.
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
(4) Using [ ] or [ ] key, move the cursor to select "2: Manual Cal."
*Manual Cal.*
HGB 100.0
HCT 100.0
WBC 100.0
RBC 100.0
PLT 100.0
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
(2) Using the numeric keys, enter the calibration value obtained by calculation.
(3) Press [ENTER] key to set the entered value and move the reverse display to the next
parameter.
*Manual Cal.*
HGB 100.7
HCT 100.0
WBC 100.0
RBC 100.0
PLT 100.0
(1) When all calibration values are entered, press [SELECT] key.
The Calibration Value Change Confirmation message appears.
Change? Yes No
NOTE: • When there is no calibration value changed, the Calibration Value Change
Confirmation message is not displayed and the system returns to the
Analysis screen.
• When the compensation rate exceeds the following range, "Calibration
Error" is displayed and the Calibration Value Change Confirmation
message does not appear.
Average of values gained by reference method
Compensation rate = X 100
Average of values gained by this instrument
Compensation rate > 105%
Compensation rate < 95%
New compensation value > 120%
New compensation value < 80%
5. CALIBRATOR CALIBRATION
Calibrate the WBC, RBC, HGB, HCT and PLT using the SCS-1000 calibrator.
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
The Precision Check screen consists of 2 pages. Use the [ ] and [ ] keys to switch
pages.
NOTE: • Each menu can be selected directly by entering a numeral from the
numeric keys.
*Preci.Check* WB
Ready
WBC RBC HGB HCT PLT
1
2
3
4
5
6
7
8
9
10
*Preci.Check* WB
Ready
WBC RBC HGB HCT PLT
Mean
SD
CV(%)
LMT(%) 3.5 2.0 1.5 2.0 6.0
NOTE: • Precision check analysis is performed in the whole blood mode. When
the analysis mode is set in the pre-diluted mode, the mode changeover
sequence is activated to switch to the whole blood mode.
*Preci.Check* WB
Analyzing
WBC RBC HGB HCT PLT
1 7.0 4.79 15.5 41.2 220
2
3
4
5
6
7
8
9
10
*Preci.Check* WB
WBC RBC HGB HCT PLT
Mean 6.9 4.82 14.0 40.9 212
SD 0.048 0.043 0.056 0.532 1.69
CV(%) 0.7 0.9 0.4 1.3 0.8
LMT(%) 3.5 2.0 1.5 2.0 6.0
1:Calibration 3:Cancel
If any of the obtained CV(%) values exceed the LMT (%) value, the CV (%) value will
be reverse display and the "1: Calibrate" menu will not be displayed.
Refer to Chapter 7 "Troubleshooting" and take corrective action. If assistance is
required, contact a Sysmex service representative.
*Preci.Check* WB
WBC RBC HGB HCT PLT
Mean 6.90 4.82 15.1 40.9 212
SD 0.255 0.043 0.056 0.532 1.69
CV(%) 3.7 0.9 0.4 1.3 0.8
3:Cancel
To perform calibrator calibration, you must enter the Assay Target values exactly as provided
with the Sysmex SCS-1000 Calibrator product. Verify that the assay sheet matches the
Lot # of calibrator.
(1) When the precision check is completed and "1: Calibration" is selected, the Analyzing
Calibrator screen appears.
The Analyzing Calibrator screen consists of 2 pages. Use the [ ] and [ ] keys to
switch pages.
Analyzing Calibrator Screen 1: Displays the Target values and analysis data.
Analyzing Calibrator Screen 2: Displays statistical values.
When the Analyzing Calibrator screen 1 is displayed, the area to input the WBC Target
value is reverse display.
*Calibrator*
*Calibrator*
(2) Using the numerical keys, enter the assay target value exactly for the WBC parameter.
Press [Enter] key, and the input value is displayed in the "Target" column.
The reverse display then moves to the next parameter.
*Calibrator*
(3) When the assay target values for all five parameters are entered, make sure once again
the entered values are correct with the Assay Sheet. If correction is required, select the
parameter using the [ ] and [ ] keys, and enter the correct value.
*Calibrator*
(1) When the target values are set, the system turns to the Ready status for calibrator
analysis.
NOTE: • Calibrator analysis is performed in the whole blood mode. When the
analysis mode is set in the pre-diluted mode, the mode changeover
sequence is activated to switch to the whole blood mode.
In the whole blood mode, "CL" in the calibrator analysis mode is
displayed in the system status display area.
*Calibrator* CL
Ready
*Calibrator* CL
Analyzing
(3) When the six analysis data are completed, "Range V.", "Mean V.", "Delta%" and
"New" will begin to be automatically calculated and displayed in their respective
columns.
*Calibrator*
*Calibrator*
If the Range values exceed the MaxRange values, the Range value will be reverse
display.
If the Delta% values exceed SERV LMT values, the Delta% value will be reverse
display.
Calibration will not be allowed.
*Calibrator*
Figure 6-5-16: Rang V. > MaxRange or Delta% > SERV LMT Screen
1) When there are:
Range V. > MaxRange
or Delta% > SERV LMT
or Delta% ACPT LMT,
New = Current
(1) After the statistical values are calculated, press [SELECT] key.
New compensation values will be calculated and the Calibration Value Change
Confirmation message will appear.
Change? Yes No
*Calibration*
1:Auto Cal.
2:Manual Cal.
3:Calibrator
4:Print Rev. History
(4) Using [ ] or [ ] key, move the cursor to select "4: Print Rev. History."
Print Example
Date 31/10/1999
Time 10:23
*Cal.History*
Date 29/10/1999
Time 08:23
HGB 95.6
HCT 103.4
Date 30/10/1999
Time 08:23
HGB 99.3
HCT 101.2
..
..
Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual --
-- Revised
OctoberFebruary
1999 N.A.2000 N.A. 6-25
CHAPTER 7 TROUBLESHOOTING
1. INTRODUCTION................................................................. 7-1
1. INTRODUCTION
If the running instrument develops any symptom that you suspect to be a trouble, check it
making reference to "2. WHEN YOU SUSPECT A TROUBLE" which begins from the next
page. When there is not any item that confirms to the trouble in question or if "Action" fails
to eliminate the symptom, contact your Sysmex service representative for assistance.
When a trouble occurs, the instrument displays an error message on the LCD screen. When
there occurs an error unique to a sample analyzed, analysis data is displayed with a flag.
This chapter describes the cause of a trouble on which an error message is displayed, along
with actions that the customer can take in checking and repairing.
HELP Function
When a trouble has occurred, the warning alarm sounds and an error message is displayed
on the screen. By pressing [HELP] key on the panel keyboard, you can stop the alarm and
change over to the HELP screen that shows what action to take against the error.
Supplementary explanation for that function is given here.
In the event multiple errors occur at the same time, press [HELP] key. The errors that have
occurred are listed in the order from higher priority.
*Help*
Multiple errors occurred.
Pressure/Vac Error
Rinse Motor Error
Waste Not Draining
Sampling Error
Room Temp. High
Press [HELP] key again. The screen changes to the HELP screen for the error listed at top.
NOTE: • When you contact your Sysmex service representative, inform him of
"ERR CODE" given on the HELP screen. By doing so, you can inform
him of the instrument's status easier and more correctly.
1. Turning the power ON does not start the • Is the power cord connected securely?
unit. • Isn't the fuse blown?
Refer to Chapter 4, Section 8.2: Replace Fuse.
• Is the power supplied to AC outlet?
2. When the power is ON, nothing is • There is a possibility that memory error has occurred.
displayed and "beep" keeps sounding. Turn OFF the power, and turn it ON again 1 - 2
minutes later.
3. The screen displays nothing. • Isn't LCD brightness properly adjusted?
Refer to Chapter 1, Section 8.3: LCD Brightness
Adjustment.
4. The screen displays "PU Sleeping" • Timer mode turned OFF the pneumatic unit power.
message and no key entry is accepted. To return the instrument to the ready status, press
the [SELECT] key to return to the analysis result
screen, and then the [Start] switch.
5. Fluid leaks from the unit. • Turn OFF the power and wipe off leaking fluid. If fluid
leakage persists after turning ON the power, contact
your Sysmex service representative.
WARNING • When operating, always wear rubber gloves. After completion of work,
wash hands with disinfectant. If your hands are contaminated by
blood, etc., infection of bacteria can result.
7-4 Sysmex
Sysmex KX-21N KX-21N Operator’s
Operator’s ManualFebruary
Manual -- Revised -- October 1999
2000
TROUBLESHOOTING
1. Pressure/Vacuum Errors
0.05 MPa Pressure Error [Pressure/Vac Error]-------------------------------------------7-7
0.0333 MPa Vacuum Error [Pressure/Vac Error] ----------------------------------------7-8
0.05 MPa Pressure Error at count [Pressure/Vac Error] ---------------------------------7-9
2. Chamber Errors
Waste Not Drained [Waste Not Draining]----------------------------------------------- 7-10
Replenish Diluent Container. [Replenish Diluent]-------------------------------------- 7-11
Replenish Lyse Container. [Replenish Lyse] ------------------------------------------- 7-12
3. Motor Errors
Error on Rinse Cup [Rinse Motor Error]-----------------------------------------7-13, 7-14
4. Aperture Errors
Clog in the aperture (WBC) [WBC Aperture Clog]------------------------------------ 7-15
Clog in the aperture (RBC) [RBC Aperture Clog] ------------------------------------- 7-15
5. Temperature Errors
Room Temp. Error [Room Temp. High]------------------------------------------------ 7-16
Room Temp. Error [Room Temp. Low] ------------------------------------------------ 7-16
6. Analysis Errors
Background count exceeds tolerance. [Background Error] --------------------------- 7-17
Error has occurred during counting. (PLT) [Sampling Error] ------------------------ 7-18
Error has occurred during counting. (RBC) [Sampling Error] ----------------------- 7-18
Error has occurred during counting. (WBC) [Sampling Error]----------------------- 7-18
Sampling Error has occurred. [Sampling Error]---------------------------------------- 7-19
Error occurred during HGB analysis. [HGB Error] ----------------------------------- 7-20
WBC/HGB Analysis Error [Analysis Error]-------------------------------------------- 7-21
Abnormal detection sensitivity [Analysis Error]---------------------------------------- 7-22
7. Memory Errors
Memory error occurred. (Turn OFF then ON the power.) [Memory Error]-------- 7-23
Memory error occurred. (Repairing) [Set Value Error]-------------------------------- 7-23
Memory error occurred. (Turn OFF then ON the power.) [Set Value Error] ------ 7-24
Momentary power failure occurred. [-]-------------------------------------------------- 7-24
8. Others
QC data falls out of control limits. [QC Error]------------------------------------------ 7-25
Calibration value is out of range. [Calibration Error] ---------------------------------- 7-26
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 7-5
TROUBLESHOOTING
9. Maintenance Errors
Clean the SRV. [Clean SRV.] ------------------------------------------------------------ 7-27
Clean the Waste Chamber. [Clean Waste Chamber.] ---------------------------------- 7-28
Clean the Transducer. [Clean Transducer.] --------------------------------------------- 7-29
1 0 . Printer Errors
Error on IP [Abnormal IP]----------------------------------------------------------------- 7-30
GP printout error [Abnormal GP]--------------------------------------------------------- 7-31
DP printout error [Abnormal DP] --------------------------------------------------------- 7-31
IP paper empty [Abnormal IP] ------------------------------------------------------------ 7-32
GP paper empty [Abnormal GP]---------------------------------------------------------- 7-32
3. TROUBLESHOOTING GUIDE
3 . 1 Pressure/Vacuum Errors
Error Message Meaning of Message
"Pressure/Vac Error" 0.05 MPa is out of the monitor range in Ready
*Help* status.
0.05 MPa Pressure Error Monitor range: 0.039 - 0.059 MPa
0.034 [0.039 - 0.059]
Adjust 0.05 MPa Pressure.
ERR CODE:XXXXX.X.X
1:End of Adj
Sysmex KX-21N
Sysmex KX-21N Operator’s
Operator’s Manual
Manual --
-- October
Revised February
1999 2000 7-7
TROUBLESHOOTING
ERR CODE:XXXXX.X.X
1:End of Adj
7-8 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual --Manual
Revised--February
October 2000
1999
TROUBLESHOOTING
ERR CODE:XXXXX.X.X
3:Ana.Screen
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 7-9
TROUBLESHOOTING
3 . 2 Chamber Errors
ERR CODE:XXXXX.X.X
1:Draining 3:Cancel
ERR CODE:XXXXX.X.X
1:Asp. Reag. 3:Cancel
ERR CODE:XXXXX.X.X
1:Asp. Reag. 3:Cancel
3 . 3 Motor Errors
ERR CODE:XXXXX.X.X
3:Ana.Screen
ERR CODE:XXXXX.X.X
3:Ana.Screen
3 . 4 Transducer Errors
ERR CODE:XXXXX.X.X
1:Clog Remove 3:Cancel
3 . 5 Temperature Errors
ERR CODE:XXXXX.X.X
3:Return
3 . 6 Analysis Errors
ERR CODE:XXXXX.X.X
3:Retuen
ERR CODE:XXXXX.X.X
1:Exec. Clean 3:Cancel
ERR CODE:XXXXX.X.X
3:Return
ERR CODE:XXXXX.X.X
3:Return
3 . 7 Memory Errors
ERR CODE:XXXXX.X.X
ERR CODE:XXXXX.X.X
1:Continue
Cause 1) Momentary power failure, etc. caused the unit to stop temporarily.
2) Shutdown had not been performed the last time the unit was
turned OFF.
Action Press [1] key to start up the unit. Perform SHUTDOWN before turning
OFF the power.
Analysis after error Ready for analysis (This error occurs at starting.)
occurrence
3 . 8 Others
ERR CODE:XXXXX.X.X
3:Return
ERR CODE:XXXXX.X.X
3:Return
3 . 9 Maintenance Errors
1:Exec.Clean 3:Cancel
Cause
Action Press [1] key. Following the instructions on the screen, turn OFF the
power and clean the sample rotor valve (SRV). (Refer to Chapter 4:
Section 6.1: Clean Sample Rotor Valve (SRV) ).
If you perform cleaning later, press [3] key. This activates the usual
startup sequence and makes the system Ready.
∗ The same message will appear the next time you start the unit; it will
be displayed at each startup until the cleaning is performed.
Analysis after error Ready for analysis
occurrence
N O T E : • When you clean SRV without pressing [1] key, execute "7:
Maintenance," and then "3: Reset Counter" in the Select Menu.
1:Exec.Clean 3:Cancel
Cause
Action Press [1] key. Following the instructions on the screen, clean the
waste chamber. (Refer to Chapter 4, Section 5.1: Clean Waste
Chamber ).
If you perform cleaning later, press [3] key. This activates the usual
startup sequence and makes the system Ready.
∗ The same message will appear the next time you start the unit; it will
be displayed at each startup until the cleaning is performed.
Analysis after error Ready for analysis
occurrence
N O T E : • When the waste chamber rinse sequence has been completed, the
cycle counter is automatically reset.
1:Exec.Clean 3:Cancel
Cause
Action Press [1] key. Following the instructions on the screen, clean the
transducer (Refer to Chapter 4, Section 5.2: Clean Transducer).
If you perform cleaning later, press [3] key. This activates the usual
startup sequence and makes the system Ready.
∗ The same message will appear the next time you start the unit; it will
be displayed at each startup until the cleaning is performed.
Analysis after error Ready for analysis
occurrence
N O T E : • When the transducer rinse sequence has been completed, the
cycle counter is automatically reset.
3 . 1 0 Printer Errors
ERR CODE:XXXXX.X.X
1:Printing 2:Paper Feed 3:Stop Output
4. STATUS DISPLAY
The unit has the Status Display screen by which you can confirm the status of the instrument.
The Status Display screen displays in real time a currently-running sequence,
pressure/vacuum readings, sensor status, and solenoid valve operating status. You can also
confirm on the screen HGB Converted value, cycle Nos. after performing the last
maintenance, and currently-registered cycle No.
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select "5: Status Display."
NOTE: • On the Menu screen, each menu can be selected directly by entering a
numeral from the numeric keys.
The Status Display screen comprises two pages; you can turn over the pages using
[ ] key or [ ] key.
Page Selection in Status Dislay Screen
*Status* WB
Ready Sequence No.
SEQ.No. 12
PRESSURE 0.051 0.05 MPa Pressure
VACUUM 0.0320 0.0333 MPa Vacuum
HGB CONVERT 550 HGB Converted Value
SENSOR 1 2 3 4 5 6 7 Sensor status
SV 1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0 Solenoid valve operating status
1 2 3 4
*Status* WB
Ready Cycle No.
COUNTER 1234567
WASTE CHAMBER 2567 Cycle No. after cleaning waste chamber
DETECTOR 2567 Cycle No. after cleaning transducer
SRV 7567 Cycle No. after cleaning SRV
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 7-35
TROUBLESHOOTING
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select "6: Print Error History."
(5) Press [ENTER] key. The built-in printer prints the error history.
Print Example
Date 31/12/2000
Time 23:59
*Error History*
Date 31/12/2000
Time 13:00
Pressure/Vac Error
XXXXXX.XXXXXX.XXXXXX
Date 24/12/2000
Time 09:15
Waste Not Draining
XXXXXX.XXXXXX.XXXXXX
Date 24/12/2099
Time 12:30
Host Comm. Error
XXXXXX.XXXXXX.XXXXXX
..
..
6. PROGRAM VERSION
This menu can be used to display the program version.
(1) Press [SELECT] key on the Analysis screen. The Select Menu screen appears.
(2) Using [ ] key or [ ] key, move the cursor to select "7: Maintenance."
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
(4) Using [ ] key or [ ] key, move the cursor to select "7: Program Version."
*Program Version*
1. INTRODUCTION................................................................. 8-1
1. INTRODUCTION
The adjustment procedures described here are important in maintaining accuracy of this
instrument. Your Sysmex service representative will perform initial adjustment. Should it
require any adjustment subsequently, follow the procedures given below.
NOTE: • When an error has occurred, press [HELP] key to check pressure or
vacuum value on the Help screen.
(Refer to Chapter 7: TROUBLESHOOTING.)
*Help*
0.05 MPa Pressure Error
0.034 [0.039 - 0.059]
(2) Move the cursor using [ ] key or [ ] key, and select "7: Maintenance."
*Maintenance*
1:Clean W.Chamber
2:Clean Transducer
3:Reset SRV Counter
4:Drain TD Chamber
5:Status Display
6:Print Error History
7:Program Version
(4) Move the cursor using [ ] key or [ ] key, and select "5: Status Display."
*Status* WB
Ready
SEQ.No. 12
PRESSURE 0.051
VACUUM 0.0320
HGB CONVERT 550
SENSOR 1 2 3 4 5 6 7
SV 1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4
NOTE: • Each menu can be selected directly on the Menu screen by entering a
numeral from the numeric keys.
NOTE: • The Status Display screen shows current pressure and vacuum.
*Status* WB
Ready
SEQ.No. 12 Pressure: 0.05 MPa
PRESSURE 0.051 (displaying 0.051 MPa)
VACUUM 0.0320
HGB CONVERT 550 Vacuum: 0.0333 MPa
(displaying 0.0320 MPa)
SENSOR 1 2 3 4 5 6 7
SV 1 2 3 4 5 6 7 8 9 0
1 2 3 4 5 6 7 8 9 0
1 2 3 4
(6) Adjust the pressure and vacuum by following the procedures given on the next page
and later.
(2) Loosen the 0.05 MPa regulator locking nut on the left side of the unit.
(3) While watching the pressure and vacuum indication on the Status Display screen, turn
the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob
clockwise to increase pressure and vacuum.
Low
Loosen
High
Locking nut
Adjusting knob
(4) When adjustment is finished, tighten the locking nut while taking care not to allow the
adjusting knob to rotate.
(2) By turning counterclockwise, loosen the locking nut for the bellows unit on the left
side of the unit.
(3) While watching the pressure and vacuum indication on the Status Display screen, turn
the adjusting knob to regulate pressure and vacuum. Turn the adjusting knob
clockwise to increase pressure and vacuum.
Low High
Loosen
Adjusting knob
Locking nut
(4) When adjustment is finished, tighten the locking nut while taking care not to allow the
adjusting knob to rotate.
1. INTRODUCTION
This chapter describes blood cell count detection principle and analysis method used in this
instrument, and flow of individual analysis. Also the hardware elements are explained.
2. DETECTION PRINCIPLE
This instrument performs blood cell count by DC detection method.
2 . 1 DC Detection Method
Blood sample is aspirated, measured to a predetermined volume, diluted at the specified
ratio, then fed into each transducer. The transducer chamber has a minute hole called the
aperture. On both side of the aperture, there are the electrodes between which flows direct
current. Blood cells suspended in the diluted sample pass through the aperture, causing
direct current resistance to change between the electrodes. As direct current resistance
changes, the blood cell size is detected as electric pulses.
Blood cell count is calculated by counting the pulses, and a histogram of blood cell sizes is
plotted by determining the pulse sizes. Also, analyzing a histogram makes it possible to
obtain various analysis data.
DC
DC Supply
Transducer Chamber
Resistance
External Electrode +
The Oxyhemoglobin method, on the other hand, is faster in hemoglobin conversion rate; in
fact, blood hemoglobin is converted instantaneously into oxyhemoglobin. Also, it does not
contain poisonous substance as cyanmethemoglobin method, making the method suitable for
automation. This method, however, is unable to convert methemoglobin into
oxyhemoglobin. Consequently, when a great amount of methemoglobin is contained as in
control blood, lower-than-real values result, although usual human blood poses no
problems.
Non-cyanide hemoglobin analysis method utilizes the advantages of both of the above
methods. Non-cyanide hemoglobin analysis method rapidly converts blood hemoglobin as
the Oxyhemoglobin method and contains no poisonous substance, making it suitable for
automated method.
Being capable of analyzing methemoglobin, this method can accurately analyze control
blood, etc. which contain methemoglobin.
4.0 µL (1:500)
1.994 mL
1.0 mL WBC
WBC/HGB Lyse TD Chamber
Sample Rotor Valve 6 µL (1:500)
(SRV)
(1:500)
<Pre-diluted Mode>
1.99792 mL
Diluent RBC
TD Chamber
Mixing Chamber 2.08 µL
(1:25000)
1.922 mL
1.0 mL WBC
WBC/HGB Lyse TD Chamber
78 µL
Sample Rotor Valve
(1:1000)
(SRV)
(1:1000)
4. CBC ANALYSIS
WBC Transducer
Tube or Microtube
Whole Blood Mode: 50 µL
Pre-diluted Mode: 1:26 Diluted Sample 200 µL
(2) 6 µL of blood measured by the sample rotor valve is transferred to the WBC
transducer chamber along with 1.994 mL of diluent. At the same time, 1.0 mL of
WBC/HGB lyse is added to prepare 1:500 dilution sample.
When the solution is made to react in this status for approximately 10 seconds, RBC is
hemolyzed and platelets shrink, with WBC membrane held as they are. At the same
time, hemoglobin is converted into red colored methemoglobin.
(4) 500 µL of sample in the WBC transducer is aspirated through the aperture. The pulses
of the blood cells when passing through the aperture are counted by the DC detection
method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting
diode (LED) is applied to the sample in the HGB flow cell. Concentration of this
sample is measured as absorbance. This absorbance is compared with that of the
diluent alone that was measured before addition of the sample, thereby calculating
HGB (hemoglobin value).
• Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This
sample is aspirated from the sample probe into the sample rotor valve.
(2) 78 µL of diluted blood measured by the sample rotor valve is transferred to the WBC
transducer chamber along with 1.922 mL of diluent. At this time, 1.0 mL of
WBC/HGB lyse is added to prepare 1:1000 dilution sample.
When the solution is made to react in this status for approximately 10 seconds, RBC is
hemolyzed and platelets shrink, with WBC membrane held as they are. At the same
time, hemoglobin is converted into red colored methemoglobin.
(4) 500 µL of sample in the WBC transducer chamber is aspirated through the aperture.
The pulses of the blood cells when passing through the aperture are counted by the DC
detection method.
(5) In the HGB flow cell, 555 nm wavelength beam irradiated from the light emitting
diode (LED) is applied to the sample in the HGB flow cell. Concentration of this
sample is measured as absorbance. This absorbance is compared with that of the
diluent alone that was measured before addition of the sample, thereby calculating
HGB (hemoglobin value).
RBC/PLT Transducer
(1) Blood is aspirated from the sample probe into the sample rotor valve.
(2) 4.0 µL of blood measured by the sample rotor valve is diluted into 1:500 with 1.996
mL of diluent and brought to the mixing chamber as diluted sample. (1st step dilution)
(3) Out of the 1:500 dilution sample, 40 µL is measured by the sample rotor valve, diluted
into 1:25000 with 1.960 mL of diluent, then transferred to the RBC/PLT transducer
chamber. (2nd step dilution)
(4) 250 µL of the sample in the RBC/PLT transducer chamber is aspirated through the
aperture. At this time, RBC and PLT are counted by the DC detection method.
At the same time, HCT (hematocrit value) is calculated by RBC pulse height detection
method.
• Pre-diluted Mode
(1) Blood sample that was diluted beforehand to 1:26 dilution using CELLPACK. This
sample is aspirated from the sample probe into the sample rotor valve.
(2) 2.08 µL of diluted blood measured by the sample rotor valve is transferred in 1.99792
mL of diluent to the RBC/PLT transducer chamber, and is made into 1:25000 dilution
sample.
(3) Of the sample in the RBC/PLT transducer chamber, 250 µL is aspirated through the
aperture. At this time, RBC and PLT are calculated by the DC detection method. At
the same time, HCT (hematocrit value) is calculated by RBC pulse height detection
method.
5 . 1 WBC Discriminator
As to WBC LOWER discriminator, the optimum position in 30 - 60 fL is automatically
determined by the microcomputer. WBC is calculated from the particle counts more than this
LOWER discriminator.
5 . 2 RBC Discriminator
As to RBC LOWER discriminator and UPPER discriminator, the optimum position in 25 -
75 fL and 200 - 250 fL, respectively, are automatically determined by the microcomputer.
RBC is calculated from the particle counts between this LOWER discriminator and UPPER
discriminator.
5 . 3 PLT Discriminator
As to PLT LOWER discriminator and UPPER discriminator, the optimum position in 2 - 6
fL and 12 - 30 fL, respectively, are automatically determined by the microcomputer. PLT
count is calculated from the particle counts between this LOWER discriminator and UPPER
discriminator.
6. ANALYSIS OF HISTOGRAM
Analysis of histogram allows use of the flagging system that suggests sample error or
instrument error.
Histograms of WBC, RBC, and PLT can be calculated respectively within the ranges given
below.
• WBC Histogram
LD T1 T2 UD
WBC
LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% 28.3 [%]
MXD% 17.4 [%]
NEUT% 54.3 [%]
LYM# 1.9 [×103/µL]
100 200 300 [fL] MXD# 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]
When TROUGH Discriminator (T1) or (T2) cannot be set or when frequency for a set
discriminator position is higher than the range, it is flagged as WBC histogram error.
Those histogram error flags are listed below in the order of higher priority. If more
than one flag are applied, the flag of the highest priority is taken.
WL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable
cause is inclusion of numerous platelet agglutinations, large platelets, and etc.
T1: Lower TROUGH Discriminator, that distinguishes lymphocytes and mixed cells,
cannot be not determined.
T2: Higher TROUGH Discriminator, that distinguishes mixed cells and neutrophils,
cannot be not determined.
F1: Small cell histogram error. Relative frequency for T1 exceeds the range.
F2: Middle cell histogram error. Relative frequency for T1 or T2 exceeds the range.
F3: Large cell histogram error. Relative frequency for T2 exceeds the range.
WU: Relative frequency for UPPER discriminator (UD) exceeds the range.
Applicable cases are those in which hemolysis is insufficient (for instance,
samples whose RBC membrane has extremely strong resistance against lyse) or
in which numerous abnormal blood cells are present.
AG: The particle count equal to or less than the LD exceeds a prescribed range.
Probable cause is platelet agglutination, which does not alter WBC count but
may result in decreased platelet count. Therefore, this flag is added to the PLT
parameter.
NOTE: • When analyzing in the pre-diluted mode, since CBC8 parameters only
are output, flagging is limited to a WBC parameter.
LD T1 UD
WBC WL 2.8 [×103/µL]
WBC
LYM% WL 45.9 [%]
MXD% WL ---.- [%]
NEUT% WL ---.- [%]
LYM# WL 1.3 [×103/µL]
100 200 300 [fL] MXD# WL ---.- [×103/µL]
NEUT# WL ---.- [×103/µL]
Figure 9-6-4: WBC Histogram Error-WL (1B)
3) 1C Histogram with high LD but without T1
WL flag is added to WBC and other parameters are not output. Note [+] on
WBC numeric data in the example below. This WBC value exceeds the upper
Patient Mark Limits mentioned earlier.
4) 2A Histogram without T1
Although the histogram error flag is not added to WBC, all other parameters are
flagged with T1 and their data are not output. Note that WBC in the graph
exceeds the upper Patient Mark Limits.
LD T1 T2 UD
WBC 6.7 [×103/µL]
WBC
LYM% F1 28.3 [%]
MXD% F2 17.4 [%]
NEUT% 54.3 [%]
LYM# F1 1.9 [×103/µL]
100 200 300 [fL] MXD# F2 1.2 [×103/µL]
NEUT# 3.6 [×103/µL]
Figure 9-6-9: WBC Histogram Error - F1 (4A)
LD T1 T2 UD
WBC +18.5 [×103/µL]
WBC
LYM% 9.5 [%]
MXD% F2 +23.7 [%]
NEUT% F3 66.8 [%]
LYM# 1.1 [×103/µL]
100 200 300 [fL] MXD# F2 2.7 [×103/µL]
NEUT# F3 7.7 [×103/µL]
Figure 9-6-11: WBC Histogram Error - F2 (5A)
• Calculation of RDW-CV
L2 - L1
RDW-CV (%) = ×100
L2 + L1
L1 L2
• Definition of RDW-SD
100%
20%
RDW-SD
9-20 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual -- Manual
Revised -- October2000
February 1999
FUNCTIONAL DESCRIPTION
2. PLT Histogram
Platelet histogram is analyzed using three discriminators: two discriminators (LD) and
(UD) - determined automatically between 2 - 6 fL and between 12 - 30 fL, respectively
-and the fixed discriminator at 12 fL. Regarding PLT histogram, check is made to see
that there are no relative frequency errors at discriminators (LD) and (UD), distribution
width error, and there is a single peak.
PCT (%)
MPV (fL) = 3 ×1000
PLT (×10 /µL)
Where PCT (%) represents the value weighted with PLT frequency and is called
platelet-crit or platelet volume ratio. The analysis method used is the same as
mentioned in HCT analysis principle 4.2 RBC/PLT Analysis Flow in this chapter.
RL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable
cause is the effect of noise, RBC morphological change, platelet coagulation, or
the like.
RU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable
cause is the effect of noise.
DW: Particle distribution width error for 20% frequency with the peak taken as 100%.
When the 20% frequency does not cross the histogram two times, this flag is
attached.
NOTE: • Since CBC8 parameters only are output in the pre-diluted mode, a flag
is not output to RDW-SD or RDW-CV.
When two or more flags are applicable to a parameter, the highest priority flag is used.
PL: Relative frequency for LOWER discriminator (LD) exceeds the range. Probable
cause is the effect of noise and etc.
PU: Relative frequency for UPPER discriminator (UD) exceeds the range. Probable
cause is the effect of platelet agglutination, noise interference, and etc.
DW: Particle distribution width error for 20% frequency with the peak taken as 100%.
When the 20% frequency does not cross the histogram two times, this flag is
attached.
NOTE: • Since CBC8 parameters only are output in the pre-diluted mode, flag
output is limited to a PLT parameter.
10 20 30 [fL]
4) 2A High UD
PLT and MPV parameters are flagged with PU.
PLT
PLT PU 171 [×103/µL]
PDW DW ---.- [fL]
MPV PU ---.- [fL]
P-LCR PU ---.- [%]
10 20 30 [fL]
PLT
PLT 91 [×103/µL]
PDW DW ---.- [fL]
MPV DW ---.- [fL]
P-LCR DW ---.- [%]
10 20 30 [fL]
PLT
PLT 155 [×103/µL]
PDW MP ---.- [fL]
MPV MP ---.- [fL]
P-LCR MP ---.- [%]
10 20 30 [fL]
7. ELECTRIC SYSTEM
The microprocessor in the main unit controls the hydraulic system's solenoid valves and
master valves, thus regulating the flow of samples, reagents, and waste in the hydraulic
system.
Electric signals received from various transducers go through the analogue circuit for
electrical waveform-processing, and to the microcomputer. The microcomputer converts the
analogue signals into digital signals for the calculation.
The WBC, RBC, and PLT cell signals are sent to the respective waveform-processing
circuits in the analogue circuit, where the noise in signals is eliminated to acquire the required
cell signals only. The microcomputer converts the A/D-converted cell signals into particle
distribution data, and outputs them to the printer or to the host computer.
To calculate HGB, absorbance of only the diluent (background) is deducted from samples'
absorbance. The beam that has passed through the fluid is detected by the photo diode. And
the signals is photoelectrically converted, A/D converted, and then sent to the HGB counting
circuit for the calculation of the absorbance.
Memory
KX-21N Operator’s
RBC Counting Circuit
WBC
Electric Diagram
Interface
Waveform PLT Counting Circuit
Transducer Circuit Processor
Processing
Operator’sManual
Circuit HGB Counting Circuit
Manual----Revised
RBC Interface Graphic Printer
Amplification WBC A-D (Option)
1999
Waveform Conversion
Processing
OctoberFebruary
Circuit Interface Data Printer
RBC, PLT
Interface
RBC, PLT Circuit
Bus
WBC Calculator
Transducer Detection Circuit (Option)
PLT
2000
Amplification Serial Interface
Waveform RBC A-D (Computer)
Processing Conversion
Circuit Circuit
PLT A-D
Conversion
Interface
Circuit
RBC Calculator
9-29
FUNCTIONAL DESCRIPTION
FUNCTIONAL DESCRIPTION
Sysmex
1) Front Cover
5) Panel Keyboard
2) Sample Probe
3) START switch
1) Front Cover
The front cover can be opened to the right by your hands. It is opened to replace lyse
containers, check or clean the interior of measuring unit.
2) Sample Probe
The sample probe is used to aspirate sample in the whole blood and pre-diluted modes.
3) START Switch
This switch starts whole blood mode analysis and pre-diluted mode analysis.
4) Graphic Screen
This displays Sample Nos., analysis results, instrument status, error messages, etc.
For detail, refer to Chapter 1, Section 8: GRAPHIC SCREEN.
5) Panel Keyboard
This keyboard allows basic operations such as entry of Sample No. and selection of
analysis parameters. For detail, refer to Chapter 1, Section 7: PANEL KEYBOARD.
8 . 2 Front Interior
1) Detector Block
3) Rinse Cup
5) Built-in Printer
4) WBC/HGB Lyse
(STROMATOLYSER-WH)
1) Detector Block
Incorporates RBC transducer, WBC transducer, and HGB flow cell.
3) Rinse Cup
Cleans the sample probe.
5) Built-in Printer
Prints analysis data, error messages, etc.
1) Fuse
1) Fuse
Replace with provided time-lag type fuse. The rating will be different depending on
the instrument specification.
WARNING • To avoid risk of electrical shock, disconnect the power cord before
replacing the fuses.
• For continued protection against risk of fire, use the fuse of specified
CAUTION type and rating.
CAUTION: • Avoid turning this switch ON and OFF continuously in short duration.
This will overload the fuse and may cause fuse blown.
1) Trap Chamber
Prevents reagent, etc. from flowing into the vacuum pump of the compressor when an
error occurs with the instrument.
4) Air Filter
Prevents dirt and dust from entering the bellows.
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FUNCTIONAL DESCRIPTION
2) Pneumatic Unit
1) Waste Chamber
Collects wastes from transducers and mixing chambers.
2) Pneumatic Unit
Supplies pressure and vacuum.
CAUTION: • Do no open the left face unless your Sysmex service representative
asks you to.
8 . 6 Rear Panel
1) ID Reader Connector
2) GP Connector
5) Drain Outlet Nipple
3) DP Connector
1) ID Reader Connector
Connects an optional hand held barcode reader.
2) GP Connector
Connects an optional graphic printer.
3) DP Connector
Connects an optional data printer.
4) Serial Interface
Connector for communicating with the host computer.
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May 2003 9-35
CHAPTER 10 INSTRUMENT SETUP
6. HOST SETTINGS..............................................................10-17
7. PRINTER SETTINGS.........................................................10-22
7.1 DP Output Settings.......................................................10-23
7.2 GP/LP Output Settings ..................................................10-25
7.3 IP Output Settings........................................................10-27
1. INTRODUCTION
Your Sysmex service representative performs the settings of the instrument at time of
installation. The settings can be changed by using this program.
This chapter describes how to use this setting program.
System Setup
Sets up the instrument system status.
Date/Time
Sets date/time of the built-in clock.
Patient Limit
Sets upper and lower Patient Mark Limits to check for error in analysis data.
QC Settings
Selects between X control and L-J control as the QC method, and sets the output method of
QC data.
Host Settings
Sets the interface conditions for transferring data to the host computer.
Printer Settings
Sets the output selection and output conditions of the built-in printer or the external printers
(Data Printer, Graphic Printer: option).
ID Reader Settings
Sets whether to Use or Not Use of the hand held barcode reader (option).
Password Settings
Sets and changes the password.
Print Set Values
Prints all the contents of the settings by the built-in printer.
Peripheral Setting
Sets whether to Use or Not Use of the printer, hand held barcode reader (option), or the host
computer output.
CAUTION: • The setting program can be run only when the instrument is ready.
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February 2000 10-1
INSTRUMENT SETUP
2. SYSTEM SETUP
This program is used to set unit system, display language, and WBC analysis parameters.
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select "1: System Setup."
(5) Press [ENTER] key. The current setting status is displayed on the System Setup
screen.
*System Setup*
Units Type2
Language English
Parameter Naming LYM%
NOTE: • When the password is set, the Password Input screen appears, and
input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
For System Setup, three parameters can be set.
(7) Using [ ] or [ ] key, select the content of settings. Each time you press the key, the
content of settings changes.
(8) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1) Unit Setting
Sets the unit system for displaying analysis data. The unit can be selected from
the following six kinds:
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-- October
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INSTRUMENT SETUP
2) Language Setting
Set the language for displaying on the screen. The language can be selected from
the eight kinds listed below:
NOTE: • The settings of language become valid from the next time you turn ON
the instrument power.
(9) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
(10) Using[ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the System Setup screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
3. DATE/TIME SETTINGS
This instrument displays date/time on analysis data, using the built-in clock.
This program is used to set the date/time for the built-in clock and date format.
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(5) Press [ENTER] key. The current setting status is displayed on the Date/Time screen.
*Date/Time*
Date Format dd/mm/yyyy
yy 1999
mm 12
dd 31
hh 23
mm 59
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
(8) Press [ENTER] key. The content of the settings is set and the cursor moves to the
next set parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
2) Year Setting
Enter in the dominical year using the numeric keys.
3) Month Setting
Enter the numerical value of 1 - 12 using the numeric keys.
4) Day Setting
Enter the numerical value of 1 - 31 using the numeric keys.
5) Hour Setting
Enter the numerical value of 0 - 23 by 24-hour system with using the numeric
keys
6) Minute Setting
Enter the numerical value of 0 - 59 using the numeric keys
(9) When the setting of each parameter is completed, press [SELECT] key.
The date entered is checked and when there is no setting error, the Setting Change
Confirmation message is displayed.
If there is any setting error, the alarm sounds and the Setting Change Confirmation
message is not displayed.
NOTE: • About the date setting, the following items are checked:
Leap year check: whether 2/29 is set in non-leap year
Month/day check: whether 4/31, e.g., is set
(10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Date/Time screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
4. PATIENT LIMIT
For Patient Limit, you can set Mark Limits.
The Mark Limits are the values set to determine whether analysis values are within the
normal range or not. This program can be used to set the upper and lower Mark Limits for
each analysis parameter.
When analysis data exceeds the upper Mark Limit, it is flagged with [+] mark, and when it
exceeds the lower Mark Limit, it is flagged with [-] mark. Analysis data output to the built-in
printer or the host computer is also attached with either marks.
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select "3: Patient Limit."
(5) Press [ENTER] key. The current setting status is displayed on the Patient Limit
screen.
*Patient Limit*
LL UL
WBC 3.0 15.0 ×103/µL
RBC 2.50 5.50 ×106/µL
HGB 8.0 17.0 g/dL
HCT 26.0 50.0 %
MCV 86.0 110.0 fL
MCH 26.0 38.0 pg
MCHC 31.0 37.0 g/dL
PLT 50 400 ×103/µL
LYM% 5.0 55.0 %
MXD% 1.0 20.0 %
Press [SELECT] to exit.
NOTE: • When the password is set, the Password Input screen appears, and
input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter.
NOTE: • Total 17 setting parameters of Patient Limit are displayed. But not all of
them can be displayed in one screen at a time. Therefore, scroll the
screen using [ ] or [ ] key.
*Patient Limit*
LL UL
MXD% 1.0 20.0 %
NEUT% 45.0 95.0 %
LYM# 0 0 ×103/µL
MXD# 0 0 ×103/µL
NEUT# 0 0 ×103/µL
RDW-SD 37.0 54.0 fL
RDW-CV 11.0 16.0 %
PDW 9.0 17.0 %
MPV 9.0 13.0 fL
P-LCR 13.0 43.0 %
Press [SELECT] to exit.
(7) Using [ ] or [ ] key, move the cursor to select LL (Lower Limit) or UL (Upper
Limit).
(9) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
(10) When the setting of each parameter is completed, press [SELECT] key.
When the set values are checked and there is no setting error, the Setting Change
Confirmation message is displayed.
In case Upper Limit < Lower Limit is set, the alarm sounds and the Setting Change
Confirmation message is not displayed.
(11) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Patient Limit screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
5. QC SETTINGS
This program is used to set QC method and output method of QC data. Two kinds of QC
methods are available with this instrument: X control and L-J control. Select either of them
that suits your purpose.
X Control: Control blood is subjected to two consecutive analyses and the mean of
them is used as the QC data. This method causes little influence on
reproducibility in analysis.
L-J Control: This control uses the data from a single analysis of control blood as QC
data. The control width in the L-J control is prone to influence in
reproducibility in analysis, so that the control width is wider than in the
case of X control.
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(5) Press [ENTER] key. The current setting status is displayed on the QC Settings screen.
*QC Settings*
QC Method X
Data Output Print
NOTE: • When the password is set, the Password Input screen appears, and
input the password, and then press [ENTER] key
(6) Using [ ] or [ ] key, move the cursor to select the set parameter. QC settings can be
made on three parameters.
(8) Press [ENTER] key. The content of setting is set and the cursor moves to the next
analysis parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1) QC Method Setting
Set the QC method. The QC method can be selected from the following two
kinds: 17
Settings QC Method
X X Control
L-J L-J Control
NOTE: • For print format to the built-in printer, refer to Chapter 5, Section 2.6:
Execute X Control or Chapter 5, Section 2.7: Execute L-J Control.
• For output format to the host computer, refer to Appendix B: Technical
Information.
• The data output format for quality control differs from the format for usual
analysis.
(9) When the setting for each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
(10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the QC Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
6. HOST SETTINGS
This program is used to set the interface conditions for transferring data to the host computer.
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select "5: Host Settings."
(5) Press [ENTER] key. The current setting status is displayed on the Host Settings
screen.
*Host Settings*
(6) Using [ ] or [ ] key, move the cursor to select the desired set parameter. For Host
Settings, twelve parameters can be set.
NOTE: • There are 12 setting parameters for Host Settings, but all the setting
parameters cannot be listed in one screen, so scroll the screen with [ ]
key or [ ] key.
*Host Settings*
(7) Using [ ] or [ ] key, select the condition. The condition changes each time you
press the key.
(8) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1) Connect Settings
Set whether to connect the host computer or not.
Settings Connection
Use Connect
Not Use Not Connect
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INSTRUMENT SETUP
8) Protocol Settings
Set the protocol. This can be set selected from the following two kinds:
Settings Protocol
Class A Class A
Class B Class B
Settings Interval
0 0 second
2 2 seconds
3 3 seconds
5 5 seconds
7 7 seconds
10 10 seconds
15 15 seconds
1 2 ) ID Padding
The sample ID can be set whether to make padding by selecting from following
two types.
Settings Padding
0 Padding Allowed 0 padding
None Not allowed 0 padding
NOTE: • ID Padding will set how to pad the most significant digits output to the
host computer, if the number of the sample ID digits is 14 or less.
ex) When the Sample ID No. is “12345”
0 Padding “000000000012345”
None “∆∆∆∆∆∆∆∆∆∆12345” “∆” means “a space”.
(9) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
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INSTRUMENT SETUP
(10) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Host Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
7. PRINTER SETTINGS
This program is used to set the output selection and output conditions for the built-in printer
or the external printers (Data Printer, Graphic Printer).
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select "6: Printer Settings."
(5) Press [ENTER] key. The Printer Settings Menu screen appears.
*Settings*
1 : DP
2 : GP/LP
3 : IP
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INSTRUMENT SETUP
NOTE: • When you press [ENTER] key on this screen, the screen returns to the
Analysis screen.
(6) Using [ ] or [ ] key, move the cursor and select the printer to be set.
7 . 1 DP Output Settings
Select "1: DP" on Printer Settings Menu screen and press [ENTER] key. The DP Settings
screen for Data Printer appears.
*DP*
Connect Use
DP Auto Output On
(1) Using [[ ] or [ ] key, move the cursor to select the desired setting parameter.
In the output setting for the data printer, you can set two parameters.
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Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 10-23
INSTRUMENT SETUP
(3) Press [ENTER] key. The content of setting is set and the cursor moves to the next
analysis parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1) Connect Settings
Set whether to use the data printer or not.
Settings Connection
Use Connect
Not Use Not Connect
(4) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
(5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the DP Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
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INSTRUMENT SETUP
Select "2: GP/LP" on Printer Settings Menu screen and press [ENTER] key. The GP/LP
Settings screen for Graphics Printer appears.
*GP/LP*
Connect Use
Printer type Type1
GP Auto Output On
(1) Using [[ ] or [ ] key, move the cursor to select the desired setting parameter.
In the output setting for the data printer, you can set three parameters.
(3) Press [ENTER] key. The content of setting is set and the cursor moves to the next
analysis parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1) Connect Settings
Set whether to use the graphic printer or not.
Settings Connection
Use Connect
Not Use Not Connect
(4) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
(5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the GP/LP Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
7 . 3 IP Output Settings
Select "3: IP" on Printer Settings Menu screen and press [ENTER] key. The IP Settings
screen for Built-in Printer appears.
*IP*
Connect Use
Print Condition All Data
Print Format Type1
(1) Using [ ] or [ ] key, move the cursor to select the set parameter. Printer settings can
be made on three parameters.
(3) Press [ENTER] key. The content of settings is set and the cursor moves to the next set
parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
1) Connect Settings
Set whether to use the built-in printer or not.
Settings Connection
Use Connect
Not Use Not Connect
NOTE: • For print format, refer to Chapter 2, Section 5.2 Printing of Analysis
Result.
• For print format for quality control, refer to Chapter 5, Section 2.6:
Execute X Control or Chapter 5, Section 2.7: Execute L-J Control.
(4) When the setting of each parameter is completed, press [SELECT] key. The Setting
Change Confirmation message appears.
(5) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Printer Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
8. ID READER SETTINGS
This program can set whether to Use or Not Use of the hand held barcode reader (option)
which is for reading the sample IDs.
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select "7: ID Reader Settings."
(5) Press [ENTER] key. The current setting status appears on ID Reader Settings screen.
*IP Reader*
Connect Use
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(8) Press [SELECT] key. The Setting Change Confirmation message appears.
(9) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Printer Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
9. PASSWORD SETTINGS
This program can set and change the password.
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select "8: Password Settings."
*Password*
New Password [ ]
Enter Again [ ]
NOTE: • When you have already set the password, the Password Input screen
is displayed, and then input a correct password.
*Password*
Password [ ]
(6) Input the set password to the New Password column with numeric keys, and press
[ENTER] key.
Set the password up to 10 digits by using the figure (0-9) or the hyphen (-).
If [ENTER] key is pressed, the status becomes the input waiting for the Enter Again
column.
NOTE: • When you do not set the password, the password can be deleted by
the following operating.
• Press [ENTER] key at the status of no password input.
(7) Again, input the set password to the Enter Again column with numeric keys, and press
[ENTER] key.
If the password input to the New Password column and the password input to the
Enter Again are different, set over again from the input of the New Password column.
If they are the same, the Setting Change Confirmation message appears.
(8) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Printer Settings screen. And the setting operation can be
continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
NOTE: • When the password has been forgotten, contact Sysmex service
representative.
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INSTRUMENT SETUP
1:System Setup
2:Date/Time
3:Patient Limit
4:QC Settings
5:Host Settings
6:Printer Settings
7:ID Reader Settings
8:Password Settings
9:Print Set Values
(4) Using [ ] or [ ] key, move the cursor to select "9: Print Set Values."
(5) Press [ENTER] key. The built-in printer starts printing all the set values.
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Sysmex KX-21N Operator’s Manual -- October 1999
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INSTRUMENT SETUP
1 1 . PERIPHERAL SETTINGS
When you want to temporarily cancel external output due to error occurrence, use this
program to set "Use" or "Not use" of the built-in/external printer, host computer output or
the hand held barcode reader.
NOTE: • For peripheral settings, refer to "5: "Host Settings" and "6: Printer
Settings" which carry description of similar settings.
*SELECT*
1:Stored Data
2:Quality Control
3:Calibration
4:Replace Lyse
5:Auto Rinse
6:Settings
7:Maintenance
8:Periph. Settings
00:PU Sleep
(2) Using [ ] or [ ] key, move the cursor to select "8: Periph. Settings."
(3) Press [ENTER] key. This displays connection status of external devices on the
Peripheral Settings screen.
*Periph.Settings*
(Data Printer)
DP Use
(Graphic Printer)
GP/ LP Use
(Built-in Printer)
IP Use
Host Output Use
ID Reader Use
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October 2000
1999
INSTRUMENT SETUP
(4) Using [ ] or [ ] key, move the cursor to select the desired external device.
(5) Using [ ] or [ ] key, select "Use" or "Not Use". "Use" and "Not Use" change over
each time you press the key.
(6) Press [ENTER] key. The content of the settings is set and moves the cursor to the
next set parameter.
NOTE: • The settings can also be set when you press [ ] or [ ] key after
changing the content of settings.
(7) Press [SELECT] key. The Setting Change Confirmation message appears.
(8) Using [ ] or [ ] key, move the cursor to select "Cont.," "Set," or "Cancel."
[Cont.]: Returns to the Peripheral Settings screen. And the setting operation can
be continued.
[Set]: Updates the settings and returns to the Analysis screen.
[Cancel]: Cancels the changed settings and returns to the Analysis screen.
1 2 . FACTORY SETTINGS
The settings made at the factory are listed below:
• System Settings
Units Type 2
Language English
Parameter Naming LYM%
• Date/Time
Date Format dd/mm/yyyy
• Patient Limits LL UL
WBC 3.0 15.0
RBC 2.50 5.50
HGB 8.0 17.0
HCT 26.0 50.0
MCV 86.0 110.0
MCH 26.0 38.0
MCHC 31.0 37.0
PLT 50 400
LYM% 5.0 55.0
MXD% 1.0 20.0
NEUT% 45.0 95.0
LYM# 0.0 0.0
MXD# 0.0 0.0
NEUT# 0.0 0.0
RDW-SD 37.0 54.0
RDW-CV 11.0 16.0
MPV 9.0 13.0
• QC Settings
QC Method L-J
Data Output Print
• Host Settings
Connect Not use
Output format KX-21N
Auto Output Off
Baud Rate 2400 bps
Data Length 7 bits
Stop Bit 2 bits
Parity Check Even
Protocol Class A
Interval 2
RTS/CTS Ignore
RDW Output RDW-CV
ID Padding 0 Padding
10-38 SysmexOperator’s
Sysmex KX-21N KX-21N Operator’s
Manual --Manual
Revised--February
October 2000
1999 N.A.
N.A.
INSTRUMENT SETUP
APPENDIX A: INSTALLATION
1. INTRODUCTION ........................................................................A-1
1. INTRODUCTION
This product is a clinical test instrument. Sysmex representative is responsible for
unpacking, installing, and initial setup of the product to ensure its proper and safe operation.
The next several pages will give some essential information on this instrument.
NOTE: • When the optional external printers (Data Printer and Graphic Printer) or
Hand Held Barcode Reader is intended to incorporate to this instrument,
contact your Sysmex service representative.
Sysmex
Sysmex KX-21N Operator’s Manual -- October 1999
Revised February 2000 A -1
INSTALLATION
Quantity
No. Part No. Description 117 V 220 V 240 V
1 461-2264-1 OPERATOR'S MANUAL KX-21N (N.A.) 1 0 0
1 461-2265-5 OPERATOR'S MANUAL KX-21N (ENGLISH) 0 1 1
2 923-8092-8 POWER CORD NO. 15 (C-2/N. AMERICA) 1 - -
2 265-4731-5 POWER CORD 4622-007-0092 (EUROPE) - 1 -
2 265-4728-3 POWER CORD NO. 7650 - - 1
3 943-1781-1 CUBITAINER SPOUT KIT NO. 1 (20 L) 1 1 1
4 973-3041-7 FLOAT SWITCH NO. 23 ASSY 1 1 1
5 367-1051-9 TRAY NO. 20 1 1 1
6 442-5338-7 TUBE POLYURETHANE 4 MM ID × 6 MM OD 3M 3M 3M
7 442-5340-5 TUBE POLYURETHANE 6 MM ID × 9 MM OD 6M 6M 6M
8 423-1776-2 MINI-PET NO. 10 (1 ML) 2 2 2
9 933-3601-9 TRANSDUCER BRUSH NO. 1 1 1 1
10 266-5109-1 FUSE 250V 3.15A ST4-3.15A-N1 2 - -
10 266-5292-6 FUSE 250V 2A NO. 19195 (EUROPE) - 2 2
11 266-6743-4 CLAMP LWS-8S-2.5W 1 1 1
12 369-8234-6 CAUTION MARK NO.170 1 1 1
13 462-4842-7 PAPER THERMAL F1-2 (5/BOX) 1 1 1
14 993-2811-6 PROGRAM CARD 1KXNH ASSY 1 1 1
A -2 Sysmex Sysmex
KX-21NKX-21N Operator’s
Operator’s ManualManual -- October
-- Revised 1999
August 2001
INSTALLATION
3. INSTALLATION SPACE
To ensure that the instrument performs to its full extent, it should be installed at an
appropriate place.
• Select a place where the power supply is located close.
• Secure a space for maintenance and service. Giving consideration to heat radiation by the
instrument, provide at least 50 cm clearance between the wall and the instrument's side
rear, and top panels. You may need some more desktop space if optional Data Printer and
Graphic Printer are provided.
Each dimension of the instrument is shown below. The power cord is 1.8 m long.
480
420
355
Tray No. 20
Protection Sheets
(4) Remove the pneumatic unit fixing screws (2 pcs). Keep these screws for future use.
Fixing Screws
(5) Remove the rubber caps of the reagent connection nipples. Keep these rubber caps for
future use.
Rubber Caps
5. CONNECT TUBE
5 . 1 Prepare Reagent
Prepare the reagents and connection kits shown below.
5 . 2 Connect CELLPACK
(1) Prepare the following reagent tube.
Tube Polyurethane 4 mmID × 6 mmOD : 1 pc
(2) Connect the diluent (CELLPACK) inlet aspiration nipple behind the unit and the nipple
of the cubitainer spout kit No. 1 with the tube polyurethane 4 mmID × 6 mmOD.
(3) Set the cubitainer spout kit No. 1 to the CELLPACK container.
Cap
CE
LL
PA
CK
CELLPACK
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.
CAUTION: • After connecting the tube, do not pull it by force for reagent
replacement.
Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual ----October
Revised 1999
May 2003 A -7
INSTALLATION
5 . 3 Connect STROMATOLYSER-WH
(1) Gently remove the provided float switch No. 23 from the dust-protection bag.
(2) Install the float switch No. 23 to STROMATOLYSER-WH. Then, set it to the table.
STROMATOLYSER-WH
(2) Connect an end of the tube polyurethane 6 mmID × 9 mmOD to the drain outlet nipple
behind the unit. Connect the other end of the tube to the waste sewer in the lab.
If the waste sewer is not available, connect it to a waste tank.
The maximum waste line length is 6 m.
(3) Arrange and tie the diluent and waste line tubings as shown in the figure using the
provided clamp.
Waste Sewer
or
Waste Tank
Clamp
Sysmex KX-21N
Sysmex KX-21N Operator’s
Operator’s Manual
Manual --
-- October
Revised 1999
May 2003 A -9
INSTALLATION
Release Lever
Printer Paper
A -10 Sysmex
Sysmex KX-21N KX-21N Manual
Operator’s Operator’s ManualFebruary
-- Revised -- October 1999
2000
INSTALLATION
(4) Pass the printer paper as shown below, and turn the release lever down to secure.
(5) Cut off any printer paper extending from the upper part of the printer.
ID Reader Connector
GP Connector
DP Connector
Serial Interface
Power Cord
A -12 Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual -- October
-- Revised 1999
May 2003
INSTALLATION
8. TURN POWER ON
It is necessary to run the service sequence at the initial start-up.
Your Sysmex service representative is responsible for the operation.
(2) Loosen the screws of the card slot protective cover on the rear panel, and open the card
slot protective cover.
(4) Close the card slot protective cover, and turn ON the power.
(5) When "*Program Upgrade*" is displayed on the screen, press [1] key, and then install
the program.
When the installation is completed, the message "Installation was successful" will be
displayed.
(6) Turn OFF the power, and extract the program card.
(7) Close the card slot protective cover, and turn ON the power.
1 . 1 Hardware
1. Connector
• The connector for the output to the host computer is located on the rear panel.
• Use a 9-pin D-SUB, female connector.
• Fixing screws for this connector are in inch-specification.
2. Connector Signals
3. Communication Format
The data is communicated in the asynchronous, full duplex mode.
4. Signal Level
Signal level conforms to JIS C6361.
5. Interface Circuit
• Output circuit
VDD
OUT
300 Ω EMI filter
Vss
MC145407 Driver
• Input circuit
VDD
15 kΩ
IN
EMI filter
5.4 kΩ
Vss
MC145407 Receiver
1 . 2 Software
1. Communication Format
1) Code
ASCII codes are used for output.
(Except for K-DPS output)
2) Structure of text
"STX" (02 H) is sent prior to data and "ETX" (03 H) is sent at the end of data.
(Except for K-DPS output)
S E
T T
X X
Order of transmission
Figure B-1-3: Order of Transmission
3) Communication protocol
The following 2 protocols are provided in the system, and can be selected according to
the system status.
• Class A
One-way transmission to the host computer without requiring ACK nor NAK from
host computer.
• Class B
The KX-21N transmits data and then waits for ACK or NAK to complete the data
transmission.
Communication error
occurs. When an error occurs, NAK
Analysis data is sent NAK (15H) is sent.
automatically (retrying up
to 3 times). If the reply is
still NAK after 3 retries,
instruction is made whether
the same data is sent again
or the transmission is
canceled by key input.
4) Transmission errors
If the KX-21N detects a transmission error, the data transmission is canceled and an
error message is displayed. Re-transmission of the data ([1] key) or cancellation of the
transmission ([3] key) can be selected. Transmission errors occur in the following
situations.
Serial interface
↓
Host computer
Normal analysis Analysis data (A)
Quality control QC data (A)
• Analysis data includes the date, sample ID No., parameter data, and the flag.
• QC data is X or L-J data.
• The setting of the connecting device is changed in the setting program.
2. Text Format
The following three types of formats are used for computer output.
• KX-21N: Format for connecting to the host computer
• K-1000: Format for connecting to the host computer
• K-DPS: Special format for connecting to K-DPS
NOTE: • KX-21N format is selected at the time of shipping from the factory.
B-4 Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual -- October
-- Revised 1999
June 2001
TECHNICAL INFORMATION
B-6 Sysmex
Sysmex
KX-21N
KX-21N
Operator’s
Operator’s
Manual
Manual
-- Revised
-- October
June 1999 N.A.
2001 N.A.
TECHNICAL INFORMATION
1) The order of output is from the top parameter to the bottom. The data is sent
from the upper line without performing zero suppression.
2) Because the decimal point is not sent, the decimal point specified in each
parameter has to be added and represented by numeric value at the host
computer.
Code Description
"0" Histogram is normal.
"1" Histogram is abnormal.
"2 " Manually discriminated
Code Description
"0" Normal
WBC/RBC/PLT
"1" (L) discriminator degree is high.
WBC/RBC/PLT
"2" (U) discriminator degree is high.
WBC/RBC/PLT
"3" Analysis is impossible because there is no pair of intersection on the 20%
degree level for calculation of DW.
RBC/PLT
"4" Two peaks are recognized in the particle distribution.
RBC/PLT
"5" (T1) discriminator cannot be determined.
WBC
"6" (T2) discriminator cannot be determined.
WBC
"7" (T1) discriminator level is high, and the data is not reliable.
WBC
"8" (T1) or (T2) discriminator level is high, and the data is not reliable.
WBC
"9" (T2) discriminator level is high, and the data is not reliable.
WBC
"A" The particle count equal to or less than (L) discriminator exceeds the range.
WBC
B-8 Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual -- October
-- Revised 1999
June 2002
TECHNICAL INFORMATION
Data Flag
Code Description
"0" Normal
"1" Abnormality judgment is "+."
"2" Abnormality judgment is "-."
"3" Out of linearity limit
"4" Reliability is low.
6) In case of analysis error, or if the data lacks some data such as the calculation
parameter in pre-diluted mode, the data is transmitted as follows:
*0000
• K-1000 format
K-1000 format has two formats; one is "analysis data format" for output of the
sample data, and the other is "QC data format" for output of the QC data. They
differ in length and content of the text. (They are distinguished by the sample
distinction code.)
The text distinction code II is fixed at "1".
However, when the text exceeds 256 bytes in a future modification, the text is
divided into 2 or more blocks. The number in text distinction code II shows the
order of the blocks. The ETB (17 H) is not used.
B-10 Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual -- October
-- Revised 1999 N.A.
June 2001
TECHNICAL INFORMATION
1) The order of output is from the top parameter to the bottom. The data is sent
from the upper line without performing zero suppression.
2) Because the decimal point is not sent, the decimal point specified in each
parameter has to be added and represented by numeric value at the host
computer.
4) The sample ID No. is 15-digit numerals, but 12 digits are output in this format.
The upper 3 digits are deleted. Depending on the usage, "-" (2D H) may be
inserted in the numeral column. In this case, "-" is included in the 12 digits.
Code Description
"0" Histogram is normal.
"1" Histogram is abnormal.
"2 " Manually discriminated
B-12 Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual -- October
-- Revised 1999
June 2001
TECHNICAL INFORMATION
Code Description
"0" Normal
WBC/RBC/PLT
"1" (L) discriminator degree is high.
WBC/RBC/PLT
"2" (U) discriminator degree is high.
WBC/RBC/PLT
"3" Analysis is impossible because there is no pair of intersection on the 20%
degree level for calculation of DW.
RBC/PLT
"4" Two peaks are recognized in the particle distribution.
RBC/PLT
"5" (T1) discriminator cannot be determined.
WBC
"6" (T2) discriminator cannot be determined.
WBC
"7" (T1) discriminator level is high, and the data is not reliable.
WBC
"8" (T1) or (T2) discriminator level is high, and the data is not reliable.
WBC
"9" (T2) discriminator level is high, and the data is not reliable.
WBC
"A" The particle count equal to or less than (L) discriminator exceeds the range.
WBC
Data Flag
Code Description
"0" Normal
"1" Abnormality judgment is "+."
"2" Abnormality judgment is "-."
"3" Out of linearity limit
"4" Reliability is low.
8) In case of analysis error, or if the data lacks some data such as the calculation
parameter in pre-diluted mode, the data is transmitted as follows:
*0000
B-14 Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual -- October
-- Revised 1999
June 2002
TECHNICAL INFORMATION
1) Specification
(1) The kind of Bar Code: UPC-A, UPC-E, CODE39, CODE128, ITF, NW-7
(2) Decoder: Built-in a reading head.
(3) Interface: RS-232C
(4) Connector: DIN 8P
(5) Power Supply: DC5V+/-5%
2. Software Specifications
1) Communication Protocol
Sysmex KX-21N
Sysmex KX-21N Operator’s
Operator’s Manual
Manual ----October
Revised 1999
November 2000 B-15
TECHNICAL INFORMATION
2) Protocol
RTS/CTS Effective
Non Protocol
3) Format
STX DATA ETX
(1) CODE39
Data can be transmitted without Check Digits, since Check Digits (MOD-43) is judged within
Bar Code Reader.
All data may be transmitted with Check Digits, but with no-effect.
(3) NW-7
Data can be transmitted without Check Digits, since Check Digits (MOD-16) is judged within
Bar Code Reader.
All data except Start/Stop Code may be transmitted by the setup of the Check Digits, but with
no-effect.
(4) ITF
Data can be transmitted without Check Digits, since Check Digits (MOD-10) is judged within
Bar Code Reader.
All data may be transmitted with Check Digits, but with no-effect.
(5) CODE128
Data can be transmitted without Check Digits, since Check Digits (MOD-103) is judged
within Bar Code Reader.
Set the optional manual ID Bar Code Reader, as specified for each bar code symbology.
1) Code39
Check Digit=Use
Check Digit=Not transmit
ST/SP=Not transmit
Full ASCII=Non
Multi-read=No
ID Character=Not transmit
2) NW-7
Check Digit=Not transmit
ST/SP=Not transmit
ST/SP Character=a, b, c, d
Hex Format=No
ID Character=Not transmit
4) ITF
Check Digit=Not transmit
ID Character=Not transmit
5) Code128
Check Digit=Use
Check Digit=Not transmit
ID Character=Not transmit
Sysmex KX-21N
Sysmex KX-21N Operator’s
Operator’s Manual
Manual ----October
Revised 1999
November 2000 B-17
INDEX
ii Sysmex
Sysmex KX-21N
KX-21N Operator’s
Operator’s Manual
Manual -- October
-- Revised June1999
2001N.A.
N.A.
R T
RBC Discriminator--------------------------- 9-10 Temperature Errors-------------------------- 7-16
RBC/PLT Analysis Flow -----------------------9-7 Transducer Errors---------------------------- 7-15
Rear Panel ------------------------------------ 9-35 Troubleshooting Guide------------------------7-7
Reference Values-------------------------------6-3 Turn Power ON ------------------------------A-13
Reinstalling the Program --------------------A-13 Turning ON the Power and Self-Check------2-5
Remove Shipping Clamps-------------------- A-4
Replace Fuse---------------------------------- 4-36 W
Replace Printer Paper------------------------ 4-37 WBC Discriminator -------------------------- 9-10
Replace Waste Tank-------------------------- 4-32 WBC/HGB Analysis Flow----------------------9-5
Replenish Reagent --------------------------- 4-33 Weekly Maintenance and Procedure ---------4-7
Reset SRV Cycle Counter ------------------- 4-22 When You Suspect a Trouble -----------------7-2
Right Side Panel------------------------------ 9-32 Whole Blood (WB) Mode---------------------2-9
S X
Select QC File ----------------------------------5-6
X Control---------------------------------------5-1
Set Printer Paper -----------------------------A-10
Set TARGET/LIMIT Values ------------------5-8
Shutdown Procedure------------------------- 2-32
Software---------------------------------------- B-3
Start-up Procedure-----------------------------2-3
Status Display -------------------------------- 7-34
Status Display Messages ----------------------1-9
Stopping the Pneumatic Unit --------------- 2-31
Stored Data Screen--------------------------- 3-15
Supplies List---------------------------------- 4-40
Supplies Replacement ----------------------- 4-33
System Setup --------------------------------- 10-3
Sysmex
Sysmex KX-21N Operator’s Manual -- October
Revised February
1999 N.A.2000 N.A. iii