SYSMEX CA-500 User manual

SERVICE MANUAL
Automated Blood Coagulation Analyzer
CA-500
Section 1 Specifications
Section 2 Hydraulics and Mechanics
Section 3 Electronics
Section 4 Adjustment
Section 5 Service Program
Section 6 Error Messages and Troubleshooting
Section 7 Schematics
Appendix A Parts List
Appendix B Installation
Appendix C Disassembly
SYSMEX CORPORATION
KOBE, JAPAN

SYSMEX CORPORATION, TECHNO CENTER
4-4-4 Takatsukadai, Nishi-ku, Kobe 651-2271, Japan
TELEPHONE: [phone]
FAX: [phone]
URL=http://www.sysmex.co.jp
SYSMEX AMERICA, Inc.
1 Nelson C. White Parkway, Mundelein IL 60060, U.S.A.
TELEPHONE: [phone]
FAX: [phone]
URL=http://www.sysmex.com/
SYSMEX UK LIMITED
Sunrise Parkway, Linford Wood (East), Milton Keynes, Buckinghamshire, MK14 6QF, U.K.
TELEPHONE: [phone]
FAX: [phone]
SYSMEX EUROPE GmbH
Bornbarch 1 22848, Norderstedt, Germany
TELEPHONE: [phone]
FAX: [phone]
SYSMEX SINGAPORE PTE LTD.
2 Woodlands Sector 1, #01-06, Woodlands Spectrum Singapore 738068
TELEPHONE: [phone]
FAX: [phone]
Copyright © 1999 through 2001 by SYSMEX CORPORATION
First Edition November 1999
Second Edition December 2001
All right reserved. No part of this book may be reproduced in any form or by
any electronic or mechanical means, including information storage and
retrieval systems, without written permission from the publisher.
Printed in Japan
Part Code Number
Printed Manual: 601-8244-3
CD-ROM Manual: 601-8268-2

CA-500 Series S/M Revised December 2001 8
SECTION 1 SPECIFICATIONS
1.1 Outline ..................................................................................................................................................1-1
1.2 Name and Model ..................................................................................................................................1-1
1.3 Configuration and Dimensions .............................................................................................................1-1
1.3.1 Configuration and Expandability of the System.......................................................................1-1
1.3.2 Power Source..........................................................................................................................1-2
1.3.3 Dimensions and Weight ..........................................................................................................1-2
1.3.4 Each Unit Function and Operation ..........................................................................................1-2
1.3.5 Principles of Measurement......................................................................................................1-3
1.4 Performance, Intended Use and Effectiveness ....................................................................................1-3
1.4.1 Intended Use...........................................................................................................................1-3
1.4.2 Performance............................................................................................................................1-3
1.4.3 Functions.................................................................................................................................1-9
1.5 Acoustic Noise Level ..........................................................................................................................1-13
1.6 Environmental Conditions...................................................................................................................1-14
1.6.1 Operating Environment .........................................................................................................1-14
1.6.2 Reagents to be used .............................................................................................................1-14
1.7 How to Operate ..................................................................................................................................1-15
To Cover

SECTION 1 SPECIFICATIONS
1.1 OUTLINE
The Sysmex CA-500 Automated Blood Coagulation Analyzer obtains clotting times by detecting changes in
scattered light intensity reflected from a diluted sample with buffer reagent which are illuminated by red light of
LED.
Incubated plasma taken from the centrifuged sample blood is rapidly mixed with warmed reagent and
coagulation is performed and analyzed. Its result can be automatically displayed and printed. In accordance
with the way of coagulation the chromogenics substrate method and the method of immunoassay are optionally
available on this unit .
1.2 NAME AND MODEL
Name: AUTOMATED BLOOD COAGULATION ANALYZER
Model: CA-510, CA-520, CA-530, CA-540, CA-550, CA-560
1.3 CONFIGURATION AND DIMENSIONS
1.3.1 Configuration and Expandability of the System
(1) Configuration
1) Main Unit (including Sampler Unit, Pneumatic Unit and Built-in Printer)
2) Chromogenic Unit and Bar Code Reader can be connected according to the following combinations
as the factory option.
Reagent Cooler Unit Chromogenic Unit Immunoassay Bar Code Reader
CA-510 – – – Option
CA-520 – – – O
CA-530 O O – Option
CA-540 O O – O
CA-550 O O O* Option
CA-560 O O O* O
* 575 nm is used for Immunoassy.
(2) Factory Option
1) ID Bar Code Reader (optional supply is available for CA-510 and CA-530)
Sample ID numbers can be automatically read by Built-in Type Bar Code Reader (built in the
sampler unit), which can scan the samples in one rack and the STAT sample. (CA-520, CA-540)
2) Chromogenic Unit
The chromogenic analysis is available on Chromogenic Unit built in Main Unit. (CA-530, CA-540)
3) Immunoassay Unit
The immunoassay is available on Immunoassay Unit built in Main Unit. (CA-550, CA-560)
4) Reagent Cooler Unit
Cooling reagent (for four parameters) is available on Reagent Cooler Unit built in Main Unit.
(CA-530, CA-540)
(3) Interface with Other Instruments
1) RS-232C
2) PC-DPS(C), CA-DPS, SIS, or Host Computer can be connected.
CA-500 Series S/M 1-1 Revised December 2001 8

CA-500 Series S/M 1-2 Revised December 2001 8
1.3.2 Power Source
(1) Rated voltage
AC 100 V/117 V ± 10%
AC 230 V ± 15%
(2) Type of Current
Direct Current
(3) Frequency
50 or 60 Hz
(4) Maximum power consumption
Unit CA-510 CA-520 CA-530 CA-540 CA-550 CA-560
Main Unit 310 VA or less 320 VA or less 380 VA or less 400 VA or less 380 VA or less 400 VA or less
(5) Class and Type of Electrical Protection
Class-I electrical apparatus, Type-B electrical apparatus
1.3.3 Dimensions and Weight
(1) Dimensions (excluding projections)
540 mm (width) X 487 mm (height) X 470 mm (depth) ± 3% respectively
(2) Weight
Unit CA-510 CA-520 CA-530 CA-540 CA-550 CA-560
Main Unit 43 kg 44 kg 44 kg 45 kg 44 kg 45 kg
1.3.4 Each Unit Function and Operation
(1) Main Unit Power Switch
Turns the power ON/OFF
(2) Display Unit
Displays the analysis registrations, analysis results, stored information and operation contents on the
LCD.
(3) Control Unit
Using LCD and Touch Panel, controls the operation in dialog.
(4) XYZ Drive Mechanism
Dispenses sample and reagent. Transfers the reaction tubes.
(5) Mechanical Stop Switch
Stops the operation temporary.
(6) Detector Block
Determines the coagulation time by measuring changes in the intensity of light scattered by increasing
turbidity.
(7) Chromogenic Unit
Detects the changes in the light absorbance by the transmitted light.
(8) Immunoassay Unit
Detects the changes in the light absorbance by the transmitted light.
(9) Temperature Control Unit
Controls temperatures for Detector Block, Reagent Heater Section and Cooling Section.
(10) System Control Unit
Controls Main Unit system.
(11) Drive Circuit Unit
Controls each motor ‘s driving.
(12) Pneumatic Unit
(13) Sampler Unit
Enables the continuous automatic operations by the sampler. One sampler rack can contain 10 sample
tubes.

1.3.5 Principles of Measurement
1.3.5.1 Biological Activation Method
(1) Coagulation Reaction Detection Method (Scattered Light Measuring Method):
Red light (660 nm) is irradiated onto the mixture of plasma and reagent and the change of the scattered
light is detected, corresponding to the turbidity change when the fibrinogen is converted to fibrin.
(2) Coagulation End-Point Detection Method (Percent Detection Method):
Let the scattered light intensity at the time when the coagulation reagent is added to be 0% and that when
the coagulation reaction is completed to 100. The coagulation time is obtained from the time to reach the
presumed percent of the coagulation curve.
1.3.5.2 Chromogenic Substrate Method
(1) Calorimetric Method
Rate Method
1.4 PERFORMANCE, INTENDED USE AND EFFECTIVENESS
1.4.1 Intended Use
This unit measures the coagulation of the plasma or serum component of anti-coagulant (sodium citrate) added
human blood.
1.4.2 Performance
(1) Measurement Parameters and Display Parameters (Default Unit is shown in [ ]).
1) Prothrombin Time (PT) [second]
Calculated Parameters:
(a) Prothrombin Activation Percent [%]
(b) Prothrombin Ratio [ – ]
(c) International Normalized Ratio (INR) [ INR ]
(d) Derived Fbg (for export specification only) [mg/dL]
2) Activated Partial Thromboplastin Time (APTT) [second]
Calculated Parameters:
(a) APTT Ratio [ – ]
(b) Activation Percent (for European and UK specifications only) [% ]
3) Fibrinogen (Fbg) [second]
Calculated Parameters:
(a) Fibrinogen Concentration [mg/dL]
4) Thrombo Test (Plasma Method) [second]
Calculated Parameters:
(a) Activation Percent [%]
(b) INR (for European and UK specification only) [ – ]
CA-500 Series S/M 1-3 Revised December 2001 8

5) Normotest (NT) [second]
Calculated Parameters:
(a) Activation Percent [%]
(b) INR (for European and UK specification only) [ – ]
6) Thrombin Time (for export specifications only) [second]
7) Factor (II, V, VII, VIII, IX, X, XI, XII) [second]
Calculated Parameters:
(a) Activation Percent [%]
8) Protein C Coagulum (PCc) [second]
Calculated Parameters:
(a) Activation Percent [%]
(9) Batroxithonbin (BXT) [second]
(10) LA1, LA2 [second]
[Options]
(11) Anti-thrombin III (AT-III) [%]
(12) α2 Anti-plasmin (APL) [%]
(13) Anti-plasminogen (Plg) [%]
(14) Protein C (PC) [%]
(15) Heparin (Hep) [%]
International Unit [IU/mL]
(16) FDP (SFDP) [µg/mL]
(17) Plasma FDP (PFDP) [µg/mL]
(18) D-Dimer (DPI/DD) [g/mL] [µg/mL]
(2) Measurement Ranges
1) Fbg
Measuring is possible from 25 mg/dL to 1000 mg/dL of the fibrinogen concentration.
(In case of 450 mg/dL or above, measurement is performed with automatic re-dilution in high Fbg
concentration mode, and in case of 50 mg/dL or less, in low Fbg concentration mode. In CA-550 and
CA-560, measurement for 900 mg/dL or above is performed in high Fbg concentration mode, and for
100 mg/dL or less, in low Fbg concentration mode. )
2) D-Dimer (CA-550 and CA-560 only)
With applicable reagents, measuring is possible from 50 to 9999 µ/gL. However, the concentration of
2000 µ/gL or above is measureed in 8-hold dilution mode (+D-Dimer).
3) Serum FDP(CA-550 and CA-560 only)
With applicable reagents, measuring is possible from 2.5 to 320 µg/mL . However, the concentration
of 40 µg/mL or above is measureed in 8-hold dilution mode (+PFC).
4) Plasma FDP (CA-550 and CA-560 only)
With applicable reagents, measuring is possible from 2.5 to 480 µg/mL. However, in the concentration
of 60 µg/mL or above, measurement is performed in 8-hold dilution mode (+PFC).
CA-500 Series S/M 1-4 Revised December 2001 8

(3) Measurement Time
1) Maximum Measurement Time in Standard Mode
PT 100 seconds (120 seconds in CA-550 and CA-560)
Fbg 100 seconds
Others 190 seconds
ATIII 30 seconds
2) Maximum Measurement Time in Automatic Extended Mode
All Parameters 600 seconds
(4) Accuracy
When control plasma N is measured consecutively 10 times, measurement error of the average time
(second) should lie within the following ranges. (The ambient temperature must be 25 ± 10°C.)
PT ± 8% or less
APTT ± 8% or less
(5) Reproducibility
Coefficient of variation, when control plasma N is measured consecutively 10 times, should lie within the
following ranges with 95 % confidence if specified reagents are used. The ranges should be observed
when measuring was performed on 10 to 30 µg/mL of diluent sample with SFDP and PFDP, and on 500
to 1000 µg/mL of diluent sample with D-Dimer.
PT, APTT [second] CV within 2%
TTO, NT [second] CV within 4%
Fbg [second] CV within 4%
Factor (II, V, VII, VIII, IX, X, XI, XII)
[second] CV within 5%
TT [second] CV within 10%
BXT [second] CV within 4%
LA1/LA2 [second] CV within 4%
PCc [second] CV within 5%
AT-III [%] CV within 5%
APL [%] CV within 5%
Plg [%] CV within 5%
BCPC [%] CV within 5%
Hep [IU/mL] CV within 5%
SFDP [µg/mL] CV within 10%
PFDP [µg/mL] CV within 10%
D-Dimmer [µg/L] [µg/mL] CV within 10%
CA-500 Series S/M 1-5 Revised December 2001 8

(6) Stability
1) Temperature Stability
Variation of measurement (Activation % for AT III) at 15°C (C15) or 35°C (C35) from that at 25°C (C25) lies
within the following ranges, when this formula is used.
C15 (or C35) - C25
x 100
C25
8
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
2) Stability within-a-day
Variation of measurement (Activation % for AT III) at the time of 2, 4 and 8 hours from that at 30 minutes
after the power is turned on (initial value) lies within the following ranges. The ambient temperature at the
time of measurement should be within the specified range. Temperature variation must be within 5°C.
( Measurement after 2, 4 or 8 hours ) - ( Measurement at 30 minutes )
x 100
( Measurement at 30 minutes )
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
3) Long-term Stability (daily variation)
Variations in measurement values (Activation % for AT III) during the continuous 10 days lie within the
following ranges. The ambient temperature at the time of measurement should be within the specified
range. Temperature variation must be within 5°C.
( Measurement after second day ) - ( Mean Measurement )
x 100
( Mean Measurement )
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
4) Stability against Power Source Variation
Variation of measurement (Activation % for AT III) lies within the following ranges when the rated voltage
changes at ±10%.
( Measurement at +10% or -10% ) - ( Measurement at rated voltage )
x 100
( Measurement at rated voltage )
PT, APTT (second) ± 8% or less
Fbg, TTO, HpT (second) ± 10% or less
AT III (%) ± 10% or less
D-Dimmer (µg/L) ± 10% or less
CA-500 Series S/M 1-6 Revised December 2001

(7) Analysis Mode and Sample Throughput
1) Analysis Mode
5 parameters are selected out of 7 parameters (14 parameters in CA-550 and CA-560) to perform
random analysis.
2) Sample Throughput
Maximum Throughput: approx. 54 tests/hour (when PT single parameter is measured)
Mean Throughput (PT, APTT, Fbg): approx. 40 tests/hour (when three parameters are measured at
the same time)
Mean throughput in this case means the mean throughput at the point of which an hour has passed from
a Start-key entry.
(8) Time Resolution
1) Coagulation
Time resolution is as follows depending on the elapsed time from the start of measurement.
0.1 second 2 through 120 seconds
0.2 second 120 through 240 seconds
1.0 second 240 through 600 seconds
2) Chromogenics Substrate Method and Immunoassay Method
The unit can continue performing sampling every second up to 600 seconds at maximum.
(9) Compensation functions
1) Setting of Coagulation Detection End Point
The coagulation detection point can be set every 1% within the range of 2 to 80%, enabling the data
calibration.
2) External compensation Function
The measured data is corrected with the linear equation.
(10) Required Volume of Plasma and Reagent
The required sample amount for each parameter and the required volume of reagent for the
measurement of one sample are shown below. (Unit in µL)
Parameter Sample/Reagent Quantity
Citrated Plasma 50(1) PT
Pt 100
Citrated Plasma 50
Aptt 50
(2) APTT
CaC12 50
Citrated Plasma 5
Owren’s Veronal buffer 95
(3) Fbg
Fbg 50
Citrated Plasma 20
Owren’s Veronal buffer 30
(4) TTO
CA-Series Comlex Factor TTO 125
Citrated Plasma 10
Owren’s Veronal buffer 40
(5) HpT
CA-Series Complex Factor HPT 125
Citrated Plasma 100(6) TT
Owren’s Veronal buffer 50
Citrated Plasma 5
Owren’s Veronal buffer 45
Factor Deficient Plasma 50
(7) II, V, YII, X
PT 100
(Continues to the next page.)
CA-500 Series S/M 1-7 Revised December 2001 8