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

(Continued from the previous page.)
Parameter Sample/Reagent Quantity
Citrated Plasma 5 or 10
Owren’s Veronal buffer 45 or40
Factor Deficient Plasma 50
APTT 50
(8) VII, IX, XI, XII
Calcium Chroride 50
Citrated Plasma 5
Protein C Deficient Plasma 35
Protein C Activator 40
APTT 40
(9) PC.c
Calcium Chloride 40
Citrated Plasma 50(10) BXT
Batroxobin 100
Citrated Plasma 100La1
LA1 100
Citrated Plasma 100
(11)
La2
LA2 100
Citrated Plasma 10
Owren’s Veronal buffer 83
Thrombin Reagent 125
(12) AT3
Substrate Reagent 33
Citrated Plasma 16
Owren’s Veronal buffer 83
Plasmin 125
(13) APL
Plasmin Substrate 33
Citrated Plasma 16
Owren’s Veronal buffer 112
Streptkinase Reagent 125
(14) Plg
Plasmin Substrate 25
Citrated Plasma 20
Protein C Activator 125
(15) BCPC
Substrate Reagent 30
Citrated Plasma 20
ATIII Reagent 20
Factor Xa Reagent 125
(16) Hep
Heparin Substrate 40
Citrated Plasma 50
Accelerator 25
(17) DDPI
AdDD
Latex 150
D-D Dimer Standard 16
Elpia Ace D-D Dimer Stabilizer 116
Elpia Ace D-D Dimer Latex 33
(18) DD
Elpia Ace D-D Dimer Diluent 112
Standard Set For Elpia FDP 10
Elpia FDP Stabilizer 122
Elpia FDP Latex 22
(19) SFDP
Owren’s Veronal buffer 97
P-Fdp Standard 16
Latex Test BL-2 P-FDP Diluent 66
Latex Test BL-2 P-FDP Latex 94
(20) PFDP (in 800 nm analysis)
P-FDP Diluent 80
P-FDP Standard 16
Latex Test BL-2 P-FDP Diluent 66
Latex Test BL-2 P-FDP Latex 94
(21) PFDP (in 575 nm analysis)
P-FDP Diluent 112
Additionally, approximately 6 mL of distilled water and approximately 212 µL (at the maximum) of rinsing
solution (CA CLEAN I) are required for rinsing per test.
CA-500 Series S/M 1-8 Revised December 2001 8

1.4.3 Functions
(1) Sample Tube Transportation Function
Sample tube is transported from the sample tube rack to the sample incubation unit by the Slide Catcher
Method.
(2) Reaction Tube Feeding Function
1) Reaction Tube Feeding Method: Fed manually to Reaction Tube Rack
2) Number of Reaction Tube: 2 racks containing 30 tubes each (maximum 60 reaction tubes)
3) Kinds of Reaction Tube: Tube SU-40 for CA-1000
4) Detecting Reaction Tube: Detected by Reaction Tube Detective Sensor
(3) Sample Plasma and Reagent Dispensing Function
One dispensing pipette with the heating function moves up and down, traverses, and dispenses the
sample and the reagent.
1) Temperature Control Accuracy: 37.0 ± 1.0°C (with ambient temperature of 15 ~ 30°C)
2) Waiting Time for Setting Temp.: within 30 minutes
3) Volumetric Method: Sample and reagent are aspirated, dispensed and rinsed by the
syringe.
4) Volumetric Syringe: 1
5) Pipette: 1
(4) Liquid Surface Detection Function
The pipette has the liquid surface detection function, so that it senses the meniscus automatically and
then stops at a certain depth of the sample or the reagent.
(5) Sampler Function
1) Sample Storing Method: Sysmex Rack
2) Maximum Sample Storage: 1 rack (10 samples)
3) Usable Collection Tubes:
The following types with inside diameter of 8 mm or more.
(i) 15 (OD) X 75 ~ 100 mm length
(ii) 12 (OD) X 75 ~ 100 mm length
(iii) 10 (OD) X 65 mm length (The optional spacer is required.)
(iv) Sample cup of 2 mL or 4 mL
4) Sample Cooling Function: None
5) Sample ID Reading Function: Sample ID No. can be read by the Bar Code Reader.
(6) STAT Sample Measurement Function
1) The specified sample in the STAT Sample Rack can be analyzed, interrupting the usual analysis.
Within 10 minutes from the interruption by the STAT sample analysis, the analysis result can be
output (when the single parameter is analyzed).
2) Number of STAT sample
One sample only.
(7) Measurement Interrupt/Restart Function (CA-550 and CA-560 only)
The analyzer has the function to allow setting additional samples to the rack in process after starting a
measurement and measuring them. The registration of the additional samples can be made on the left
side from the left-end tube position for the samples already set in rack and registered for measurement.
CA-500 Series S/M 1-9 Revised December 2001 8

(8) Reagent Storage Function
1) Reagent Storage Method: Stored in the reagent rack
2) Reagent holder capacity: Maximum 10 kinds of reagent bottles can be set in the reagent
rack. Buffer and rinsing solution can also be set.
3) Usable container: Dade Bering’s old DADE for 5 mL, a sample cup, can be set, and
also GW5, a new type of reagent bottles only for
CA-550/CA-560, can be set.
(The outer diameter of the reagent bottle should be less than
22.5 mm, and also, if the inner diameter is too small, use the
bottle adapter.)
4) Reagent Cooling Function: Four reagents can be cooled. (CA-530, CA-540)
5) Temperature Control Accuracy: within 15 ± 2°C (Room temperature: 15°C - 30°C)
6) Waiting time for setting temp.: within 30 minutes
7) Reagent Mixing Function: None
Type of reagent Number of
accommodation
Cooling function Container which can be
accommodated
PT 1 Yes
APTT 2 No
Fbg 1 Yes DADE 5 mL Reagent Bottle
TTO 1 No (with outer diameter of
NT 1 No 22.3 mm)
TT 1 Yes
AT-III 2 Yes (only one)
Buffer 1 No
CA CLEAN I 1 No
(9) Detection Function
1) Principle of Measurement
[Coagulation Method]: Scattered Light Measuring Method (wave length 660 nm)
[Chromogenic Method]: Calorimetric method (wave length 405 nm)
[Immunoassay]: Colorimetric method (wave length 575 nm)
2) Number of Detectors
[Coagulation Method]: 4 detection wells (High and Low sensitivity automatic switching)
[Chromogenic Method]: 1 detection well
[Immunoassay]: 1 detection well
3) No. of Incubation wells: 6 wells
4) Temperature Control Accuracy: within 37.0 ± 0.5°C (ambient temperature: 15°C-30°C)
within 37.0 ± 1.0°C for Incubation Well
5) Waiting time for setting temp.: within 30 minutes
(10) Pipette Rinsing Function
1) External Container: Rinse Bottle and Waste Bottle
2) Rinse Cup: Probe Rinse Cup (Outside) and Probe Rinse Cup (Inside)
3) Rinsing Function: Pipette is rinsed by controlling the syringe and the solenoid valve, with
applying the pressure on the Rinse Bottle.
4) Waste Draining: The waste is aspirated by controlling the solenoid valve, with applying
vacuum on the waste bottle.
CA-500 Series S/M 1-10 Revised December 2001 8

(11) XYZ Driving Function
Pipette and sample catcher mechanism on the head unit (Z axis) is driven by the XY-axis mechanism to
dispense sample and reagent and transfer and discard the reaction tubes.
1) XY-axis Mechanism: Linear Slider driven by stepper motor
2) Z-axis Mechanism: Pipette and sample tube catcher are driven by one motor.
(12) Mixing Function
After dispensing the reagent, the reaction tube is vibrated and mixed by the miniature motor.
(13) Sample Data Storage Function
1) Contents of Data
(i) Measurement data
(ii) Setting values
(iii) Quality control data
(iv) Date (year, month, day, hour, minute)
2) Memory Capacity
(i) Data of 300 samples (maximum 1500 tests = 300 samples X 5 parameters). The analysis
print data is not stored once the power is OFF. As for the reaction curve, the latest 600 tests
are stored.
(ii) Quality control data: 12 kinds X 7 parameters X 180 plots (CA-510 to CA-540)
6 kinds X 14 parameters X 180 plots. To the Quality Control file, the
parameters of dilution magnification such as -Fbg, +Fbg, +DD, +DDPl, +SFD, and +PFD are
also included. (CA-550 and CA-560 only)
(14) Display and Input Function
1) Display Type
Graphic panel display + touch panel using a 3.2 X 4 inch liquid crystal display (white and black back
light)
2) Displayed Data
(i) Date
(ii) Measurement condition, Analysis status, Results
(iii) Stored sample: Stored sample list: Date, Time, Sample ID number, Parameter name,
Measured data, Reaction curves (CA-550 and CA-560 allow zooming in to view), Rack
number. (CA-550 and CA-560 only).
(iv) Quality control (QC data, QC chart)
(Only CA-550 and CA-560 can carry markings on screen display about the data beyond the
upper and lower limits of quality control. In addition, the CA-550 and CA-560 analyzers stores
the data of slight coagulation errors.)
(v) Standard curve (SC data, SC chart)
(vi) Operation messages
(vii) Error messages
(viii) Maintenance information and various setting values
(ix) Temperatures at incubation well, heater pipette, reagent cooler unit
3) Input Method
Change, select, and set functions on each screen by LCD touch panel method.
CA-500 Series S/M 1-11 Revised December 2001 8

(15) Printing Function
1) Printing Method
Graphic print by a built-in thermal printer
2) Printed Data
(i) Stored sample data (the same as the measured data)
(ii) Quality control (QC data, QC chart)
(iii) Measured data (Date, Time, Sample ID number, Parameter name, Measured data, Reaction
curve, Analysis print data, Rack number (CA-550 and CA-560 only))
(iv) Standard curve (SC data, SC chart)
(v) Confirmation messages, Error messages
(vi) Maintenance information and various setting values (CA-550 and CA-560 can print at each
parameter.)
(16) Quality Control Function
1) L-J control or X control is possible using control material.
2) Applicable parameters: PT, APTT, Fbg, TTO, NT, TT, AT III
14 parameters (CA-550 and CA-560 only)
-Fbg, +Fbg, +DD, +DDPl, +SFD, and +PFD are also treated as
parameters and QC analysis can be performed on each parameter.
(CA-550 and CA-560 only)
3) Number of stored files: 12 files for each parameter
67 files (CA-550 and CA-560 only)
4) Number of data points: 180 for each parameter
(17) Select Function
1) Measurement Mode
(i) Random access measurement mode
5 parameters are selected out of 7 parameters (14 parameters in CA-550 and CA-560) and the
five parameters are measured at random.
(ii) Programmable measurement mode
All parameters are measured with changing the measurement order.
(iii) Replication mode
The same sample is measured twice (or more) and the mean value is determined to be the
measurement result. However, the throughput is less than half number of that of ordinary
measurement.
2) Settings
(i) Sample ID number
(ii) Date/Time
(iii) Setting function for APTT heating time
2, 3, 4 or 5 (minutes) of heating time can be set. (Standard setting is 3 minutes and the
throughput changes if other time is set.)
3) Output
Automatic transfer or Manual transfer can be set.
Raw data output is available in Service mode. (CA-550 and CA-560 only)
4) Stored data processing
Displaying and printing the stored data is possible.
5) Service Function
For the Customer: Displaying of standard curve data and setting of abnormal values
(range)
For the Servicing Personnel: Service mode, System tests, Memory Initialization, and
adjustment/setting (of X-Y axis position)
CA-500 Series S/M 1-12 Revised December 2001 8

(18) Standard Curve Setting Function
Standard curve of seven parameters (14 parameters in CA-550 and CA-560) can be set at six points or
less within the measurable range. Setting Standard Curve is performed by the Auto dilution or Manual
Entry. (Manual dilution analysis is available only in CA-550 and CA-560.) Two kinds of standard curves
can be set to one parameter (only in CA-550 and CA-560). Settings should be given to each parameter
individually.
(19) Analytical Algorithm corresponding to V-Lin-Integral (CA-550 and CA-560 only)
As a new analysis method, analytical algorithm equivalent to V-Lin-Integral is provided.
(20) APTT Initial Reaction Check Algorithm (CA-550 and CA-560 only)
An algorithm to check APTT’s initial reactions is newly provided.
(21) Detector Block Self-Checking Function (CA-550 and CA-560 only)
Besides the already-provided functions to adjust the detector block, a function is newly provided that the
analyzer self-monitors the state of the detector block and carry out auto calibration.
(22) Error Alert Function
1) Unit Error monitoring function
(i) Temperature of heater section
(ii) Shortage of reagent
(iii) Presence or absence of sample rack
(iv) Shortage of rinse solution
(v) Overflow from the waste bottle
(vi) Operation of mechanical parts
(vii) Operation of printer
(viii) Shortage of printer paper
(ix) Serial output
(x) Other self-diagnosis by service mode
2) Sample Abnormality monitoring function
(i) Upper and lower limit judgment (PT, APTT, Fbg, TTO, NT, TT, AT-III)
Display when the measured data exceeds the preset range.
(23) External Input/Output Function
The I/O terminal in accordance with RS-232C is provided as bit serial voltage I/O.
(24) Protection Function
1) Over-heat protection thermal fuse (Pipette Unit and Detector Block)
2) Mechanical stop switch
3) Light Shield cover open/close switch
4) Sampler position sensor
(25) Display Languages
Capable of displaying six languages such as Japanese, English, French, Italian, German, and Spanish.
Screen displays and messages should be consistent with those of existing models.
1.5 ACOUSTIC NOISE LEVEL
Noise level should be within the following values. (The measuring position is 1 meter from the front of the
product.
(1) Stand-by status: 58 dB or less
(2) Measuring operation status: 60 dB or less
Temporary noises (less than 65 dB continued within 5 seconds) are produced on occasions, such as home
positioning of X-Y table or syringe drive mechanism are not included.
CA-500 Series S/M 1-13 Revised December 2001 8

1.6 ENVIRONMENTAL CONDITIONS
1.6.1 Operating Environment
(1) Ambient temperature: 15 ~ 35°C
(2) Relative humidity: 30 ~ 85% (non-condensing)
(3) Atmospheric pressure: 70 ~ 106 kPa
(4) Place to be installed: avoid direct sunlight, dust, vibration and acid vapors
1.6.2 Reagents to be used
Parameter Reagent
Thromborel S
Dade Innovin
PT
Dade Thromboplastin C plus
Pathromtin SL
Dade Actia Activated Cephanloplastin Reagent
Dade Actia FS Activated FTT Reagent
Dade Actia FSL Activated FTT Reagent
APTT
Calcium Chroloride Solution (0.025 mol/l)
Fbg Dade Thrombin Reagent
TT Thrombin Clotting Time Reagent
II Clotting Factor-II Deficient Plasma
V Clotting Factor-V Deficient Plasma
YII Clotting Factor-VII Deficient Plasma
X Clotting Factor-X Deficient Plasma
VIII Clotting Factor-VIII Deficient Plasma
IX Clotting Factor-IX Deficient Plasma
XI Clotting Factor-XI Deficient Plasma
XII Clotting Factor-XII Deficient Plasma
LA1/LA2 LA1 Screening Reagent/LA2 Confirmation Reagent
PC.c Protein C reagent
BXT Batroxobin reagent
AT3 Berichrom Antithrombin Ⅲ(A)
APL Berichrom α2-Antiplasmin
Plg Berichrom Plasminogen
BCPC Berichrom Protein C
Hep Berichrom Heparin
Latex Test BL-2 P-FDPPFDP
P-FDP Diluents
DDPI/AdDD D-Dimer PLUS/Advanced D-Dimer
Control Plasma N(Human)
Control Plasma P(Human)
DadeCi-Trol Coagulation Control,Level 1
DadeCi-Trol Coagulation Control,Level 2
DadeCi-Trol Coagulation Control,Level 3
Standard Human Plasma
P-FDP Standard
D-Dimer PLUS Standard Plasma
PT Calibration Plasma Kit
CA CLEAN Ⅰ
CA CLEAN Ⅱ
CA-500 Series S/M 1-14 Revised December 2001 8

1.7 HOW TO OPERATE
Check
Instrument
• Check the rinse solution (distilled water) to make sure that the analyzer is ready
for operation.
Power ON
• Turn the instrument power ON 30 minutes before the analysis.
Analysis
Preparation
• Dissolve reagents 30 minutes before the analysis.
Set the reagents to the reagent holder.
Execute the quality control to check the instrument condition.
Start Analysis
• Set the sample to the sampler.
Enter sample orders to be analyzed.
Press the [Start] key to start analysis.
Result Output
• The analysis results will be displayed on LCD and printed out on printer paper.
End Analysis
• Remove the reagents and the sample.
Shutdown
• Execute the daily maintenance for the next analysis.
Power OFF • Rinse the pipette and turn the instrument power OFF.
CA-500 Series S/M 1-15 Revised December 2001 8

SECTION 2 HYDRAULIC/MECHANICAL SYSTEMS
2.1 TUBING DIAGRAM..............................................................................................................................2-1
2.2 HYDRAULIC SYSTEM OPERATION ..................................................................................................2-2
2.2.1 Structure ................................................................................................................................2-2
2.2.2 Operation...............................................................................................................................2-2
2.3 PRESSURE CIRCUIT..........................................................................................................................2-4
2.3.1 Structure ................................................................................................................................2-4
2.3.2 Operation...............................................................................................................................2-4
2.4 DETECTOR BLOCK ............................................................................................................................2-5
2.4.1 Outline ...................................................................................................................................2-5
2.4.2 Specifications/Functions........................................................................................................2-5
2.4.3 Assembly Diagram ................................................................................................................2-5
2.5 REAGENT COOLING UNIT ................................................................................................................2-6
2.5.1 Outline ...................................................................................................................................2-6
2.5.2 Specifications/Functions........................................................................................................2-6
2.5.3 Assembly Diagram ................................................................................................................2-6
2.6 VOLUMETRIC UNIT ............................................................................................................................2-7
2.6.1 Outline ...................................................................................................................................2-7
2.6.2 Specifications/Functions........................................................................................................2-7
2.6.3 Assembly Diagram ................................................................................................................2-7
2.7 X-Y DRIVE UNIT (X-AXIS MOTOR ASSEMBLY/DRIVE-AXIS ARM ASSEMBLY).............................2-8
2.7.1 Outline ...................................................................................................................................2-8
2.7.2 Specifications/Functions........................................................................................................2-8
2.7.3 Assembly Diagram ................................................................................................................2-8
2.8 Z-AXIS DRIVE UNIT (Z-AXIS BASE ASSEMBLY) ..............................................................................2-9
2.8.1 Outline ...................................................................................................................................2-9
2.8.2 Specifications/Functions........................................................................................................2-9
2.8.3 Assembly Diagram ................................................................................................................2-9
2.9 BAR CODE READER UNIT (ID COMPLETED PARTS) ...................................................................2-10
2.9.1 Outline .................................................................................................................................2-10
2.9.2 Specifications/Functions......................................................................................................2-10
2.10 PUMP UNIT (PRESSURE PUMP/VACUUM PUMP COMPLETED PARTS) ....................................2-11
2.10.1 Outline .................................................................................................................................2-11
2.10.2 Specifications/Functions......................................................................................................2-11
2.10.3 Assembly Diagram ..............................................................................................................2-11
CA-500 Series S/M Revised December 2001 8
To Cover

CA-500 Series S/M 2-1 Revised December 2001
SECTION 2 HYDRAULIC/MECHANICAL SYSTEMS
2.1 TUBING DIAGRAM
Trap Chamber
BBSB
M
TF1 (1600)
Si3
(12)
Si2
(530)
LFAA
1201518H
TF2 (450)
SV No.14
TA (250) TF1
(200)
Si2 (200)
Si2Si2
Si2
Si2
Si2 (240)
Si1
(620)
TA (160)
TA
(520)
TA
(100)
TA
(80)
MAIN (PCNo.6362)
Si4 (95)
Pressure
Pump
Vacuum
Pump
Rinse Bottle Waste Bottle
No. 7Assy
black redblue green
Hydraulic Connector
No. 23
Rear Panel
PipetteVolumetric
Piston
Si1: Tube Silicone 2 x 5
Si3: Tube Silicone 1/32 x 3/32 inches
Si4: Tube Silicone 6 x 10
TF1: Tube Teflon 1.2 x 2.0
TF2: Tube Teflon 1.5 x 2.5
TA: Tube Toalone 3 x 6
B: Connecting Tube No. 50
C: Connecting Tube No. 3
S: Nipple No. 123
Trash Box
Rinse Cup
Rubber Tube No. 7
Probe Rinse Cup (Outside)
Probe Rinse Cup (Inside)
Si2
Si2
(240)
Si2
(240)
Check Valve
Filter
Chamber No. 4
(240)
(240)
(500)
(500) (500)
Si2: Tube Silicone 4 x 8
8