Sysmex CA-500 Service manual

SERVICE MANUAL

Automated Blood Coagulation Analyzer
CA-500
Section 1 Specifications
Section 2 Hydraulics and Mechanics
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: 81-78-991-1911 FAX: 81-78-992-3274 URL=http://www.sysmex.co.jp
SYSMEX AMERICA, Inc.
1 Nelson C. White Parkway, Mundelein IL 60060, U.S.A. TELEPHONE: 1-847-996-4500 FAX: 1-847-996-4505 URL=http://www.sysmex.com/
SYSMEX UK LIMITED
Sunrise Parkway, Linford Wood (East), Milton Keynes, Buckinghamshire, MK14 6QF, U.K. TELEPHONE: 44-1908-669555 FAX: 44-1908-669409
SYSMEX EUROPE GmbH
Bornbarch 1 22848, Norderstedt, Germany TELEPHONE: 49-40-527260 FAX: 49-40-52726100
SYSMEX SINGAPORE PTE LTD.
2 Woodlands Sector 1, #01-06, Woodlands Spectrum Singapore 738068 TELEPHONE: 65-221-3629 FAX: 65-221-3687
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

SECTION 1 SPECIFICATIONS

To Cover
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
CA-500 Series S/M Revised December 2001 8

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

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.
CA-500 Series S/M 1-2 Revised December 2001 8

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 (C
) or 35°C (C35) from that at 25°C (C25) lies
15
within the following ranges, when this formula is used.
C15 (or C35) - C25 x 100 C25
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
8
(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
(2) APTT
Citrated Plasma 50 Aptt 50 CaC12 50
(3) Fbg
Citrated Plasma 5 Owren’s Veronal buffer 95 Fbg 50
(4) TTO
Citrated Plasma 20 Owren’s Veronal buffer 30 CA-Series Comlex Factor TTO 125
(5) HpT
Citrated Plasma 10 Owren’s Veronal buffer 40 CA-Series Complex Factor HPT 125 Citrated Plasma 100 (6) TT Owren’s Veronal buffer 50
(7) II, V, YII, X
Citrated Plasma 5 Owren’s Veronal buffer 45 Factor Deficient Plasma 50 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 (8) VII, IX, XI, XII
Citrated Plasma 5 or 10 Owren’s Veronal buffer 45 or40 Factor Deficient Plasma 50 APTT 50 Calcium Chroride 50
(9) PC.c
Citrated Plasma 5 Protein C Deficient Plasma 35 Protein C Activator 40 APTT 40 Calcium Chloride 40 Citrated Plasma 50 (10) BXT Batroxobin 100
(11)
Citrated Plasma 100 La1 LA1 100
La2
Citrated Plasma 100 LA2 100
(12) AT3
Citrated Plasma 10 Owren’s Veronal buffer 83 Thrombin Reagent 125 Substrate Reagent 33
(13) APL
Citrated Plasma 16 Owren’s Veronal buffer 83 Plasmin 125 Plasmin Substrate 33
(14) Plg
Citrated Plasma 16 Owren’s Veronal buffer 112 Streptkinase Reagent 125 Plasmin Substrate 25
(15) BCPC
Citrated Plasma 20 Protein C Activator 125 Substrate Reagent 30
(16) Hep
Citrated Plasma 20 ATIII Reagent 20 Factor Xa Reagent 125
Heparin Substrate 40 (17) DDPI AdDD
Citrated Plasma 50
Accelerator 25
Latex 150 (18) DD
D-D Dimer Standard 16
Elpia Ace D-D Dimer Stabilizer 116
Elpia Ace D-D Dimer Latex 33
Elpia Ace D-D Dimer Diluent 112 (19) SFDP
Standard Set For Elpia FDP 10
Elpia FDP Stabilizer 122
Elpia FDP Latex 22
Owren’s Veronal buffer 97 (20) PFDP (in 800 nm analysis)
P-Fdp Standard 16
Latex Test BL-2 P-FDP Diluent 66
Latex Test BL-2 P-FDP Latex 94
P-FDP Diluent 80 (21) PFDP (in 575 nm analysis)
P-FDP Standard 16
Latex Test BL-2 P-FDP Diluent 66
Latex Test BL-2 P-FDP Latex 94
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
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) W aiting time for setting temp.: within 30 minutes
bottle adapter.)
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) W aiting time for setting temp.: within 30 minutes
(10) Pipette Rinsing Function
1) External Container: Rinse Bottle and W aste 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 PT
APTT
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
APL Plg Berichrom Plasminogen BCPC Berichrom Protein C Hep Berichrom Heparin
DDPI/AdDD D-Dimer PLUS/Advanced D-Dimer
Thromborel S Dade Innovin Dade Thromboplastin C plus Pathromtin SL Dade Actia Activated Cephanloplastin Reagent Dade Actia FS Activated FTT Reagent Dade Actia FSL Activated FTT Reagent Calcium Chroloride Solution (0.025 mol/l)
Berichrom Antithrombin (A) Berichrom α2-Antiplasmin
Latex Test BL-2 P-FDP PFDP P-FDP Diluents
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
CA CLEAN
CA-500 Series S/M 1-14 Revised December 2001 8

1.7 HOW TO OPERATE

Start Analysis
Result Output
End Analysis
Check
Instrument
Power ON
Analysis
Preparation
Shutdown
Power OFF • Rinse the pipette and turn the instrument power OFF.
• Check the rinse solution (distilled water) to make sure that the analyzer is ready for operation.
• Turn the instrument power ON 30 minutes before the analysis.
• Dissolve reagents 30 minutes before the analysis. Set the reagents to the reagent holder. Execute the quality control to check the instrument condition.
• Set the sample to the sampler. Enter sample orders to be analyzed. Press the [Start] key to start analysis.
• The analysis results will be displayed on LCD and printed out on printer paper.
• Remove the reagents and the sample.
• Execute the daily maintenance for the next analysis.
CA-500 Series S/M 1-15 Revised December 2001 8
SECTION 2 HYDRAULIC/MECHANICAL SYSTEMS
To Cover
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
SECTION 2 HYDRAULIC/MECHANICAL SYSTEMS

2.1 TUBING DIAGRAM

Probe Rinse Cup (Outside)
MAIN (PCNo.6362)
Probe Rinse Cup (Inside)
Pressure Pump
Vacuum Pump
Si2
(240)
Chamber No. 4
(160)
TA
Check Valve
TA
(520)
Si2
(240)
Si2
(240)
Si1 (620)
black redblue
Rubber Tube No. 7
SV No.14
TA
(100)
TA (250)
TA
(80)
BBSB
green
Si2
(240)
Filter
Si2
(240)
(500) (500)
TF2 (450)
Rinse Cup
Si3 (12)
Hydraulic Connector No. 23
Rear Panel
Si2
(200)
Si2Si2
LFAA 1201518H
Si2 (530)
TF1
(200)
Si4
(95)
M
TF1
Piston
Trash Box
(1600)
PipetteVolumetric
Trap Chamber
No. 7Assy
Rinse Bottle Waste Bottle
Si2
(500)
Si1: Tube Silicone 2 x 5 Si2: Tube Silicone 4 x 8 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
CA-500 Series S/M 2-1 Revised December 2001
8

2.2 HYDRAULIC SYSTEM OPERATION

2.2.1 Structure

The hydraulic system consists of the volumetric syringe for volumetric dispensing of samples or reagent, the filling line using the pressure pump and solenoid valve, and the drain line using the vacuum pump.

2.2.2 Operation

(1) Outline of Hydraulic System Operation
This system's filling and draining are operated by pressure created by the pressure pump and vacuum
pump in the system. Therefore the pressure is applied to the rinse bottle and the vacuum is applied to the waste bottle.
(a) Filling line A constant pressure is applied to the rinse bottle. The valve connected to the line opens to feed rinse
solution.
(b) Drain Line The drain line is released to the atmosphere at the rinse cup. The vacuum pump operates only when
the vacuum to aspirate the waste into the waste bottle. The vacuum is not monitored. Instead, instrument checks if the liquid level becomes abnormal when the sample probe is moved to the Probe Rinse Cup (inside) (if liquid is not drained properly, the drain error occurs).
(2) Analysis Starting Operation
(a) Rinsing at Analysis Start The sample probe moves to the Probe Rinse Cup (outside) to detect the syringe home position. The
probe moves into the Probe Rinse Cup (inside) to remove remaining liquid on the probe tip. The probe moves to rinse solution position to aspirate CACLEAN I. Aspirated rinse solution is kept in the probe for a certain time to rinse the probe inside. (This can be changed in Service Program.)
The sample probe moves to the Probe Rinse Cup (inside), and the rinsing solution flows by opening
SV on Rinse Cup. At this time, the syringe piston moves to drain the rinse solution.
The probe moves into the Probe Rinse Cup (outside), and both the Probe Rinse Cup valve and the
valve on probe open to rinse the probe.
(b) Reagent Aspirating and Dispensing When aspirating sample or reagent, the probe moves to a sample to aspirate, lowers into the test
tube, detects the liquid surface, then the volumetric syringe descends and aspirates the sample. At this time, the solenoid valve does not operate (keep closed).
When draining, the probe moves to the reaction tube in the Reaction Tube Rack to dispense, the
volumetric syringe ascends and dispenses the sample. After that, the probe moves to home position, and moves to the Probe Rinse Cup (inside).
CA-500 Series S/M 2-2 Revised December 2001 8
(c) Probe Rinsing after Sample Aspiration The probe moves to the Probe Rinse Cup (inside). The Probe Rinse Cup (inside) valve opens to
empty rinse solution from the probe.
Then the probe moves to the Probe Rinse Cup (outside) to remove a drop from the probe tip.
(d) Reagent Aspiration and Dispensing The probe, which stops for cleaning after sample aspiration, moves to the reagent rack to aspirate,
descends into the reagent vial, detects the liquid surface, and then the volumetric syringe descends to aspirate the reagent. At this time, the solenoid valves does not function (closed).
When dispensing, the probe moves to the heated reaction tube, catches that reaction tube, then
moves to the dispensing position, and dispenses the heated reagent into the reaction tube.
After dispensing, the mixing motor mixes the sample and reagent in the tube, and sets it in the
detecting well.
(e) Rinsing after Reagent Dispensing and Mixing After reagent dispensing and mixing, the probe moves to the Probe Rinse Cup (inside). The Probe
Rinse Cup (inside) valve opens to flow rinse solution out of the probe.
Next, the probe moves to the Probe Rinse Cup (outside), the probe tip touches the liquid, and then a
drop adhering on its tip is removed. The probe then moves to rinse solution and aspirates CACLEAN I. After aspiration, it moves to the Probe Rinse Cup (inside), and the probe valve opens to feed out rinse solution. At this time, the syringe piston moves to dispense the rinse solution.
The probe moves to the Probe Rinse Cup (outside), and both the Probe Rinse Cup valve and the
valve on probe open to rinse the probe.
(f) Probe Rinsing The Rinse Probe key causes the probe to move to Probe Rinse Cup (outside) and detect the syringe
home position. Then the probe moves into the Probe Rinse Cup (inside), and any liquid remaining on the probe tip is removed. After that, the probe moves to rinse solution and aspirates CACLEAN I. After aspiration, the probe aspirates rinse solution 2 minutes to clean the its inside.
Now the probe moves to the Probe Rinse Cup (inside) and causes the probe valve to open and feed
out rinse solution. At this time, the syringe piston moves to dispense the rinse solution.
Next, the probe moves to the Probe Rinse Cup (outside), and both the Probe Rinse Cup (outside)
valve and the valve on probe open to rinse the probe.
After rinsing, the probe returns to the home position.
CA-500 Series S/M 2-3 Revised December 2001 8

2.3 PRESSURE CIRCUIT

2.3.1 Structure

The pressure circuit of this system consists of two circuits: the pressure circuit designed for filling solution by the pressure pump and the vacuum circuit designed for liquid draining by the vacuum pump. The pressure system comprises the pressure pump, circuit for its control, pump driving circuit, a bottle for filling, and a valve for filling line circuit. The vacuum circuit system comprises the vacuum pump, pump driving circuit, and drain line circuit with a waste bottle. For the hydraulic circuit that uses pressure to flow rinse solution.

2.3.2 Operation

(1) Outline of Pump Operation The filling and draining by this system are performed by the pressure and vacuum. Therefore the
pressure is applied to the rinse bottles connected to the outside of the system.
(a) Pressure System The pressure system generates pressure by the pressure pump, and utilizes the pressure sensor to
monitor and control the generated pressure to maintain a predetermined amount of rinse solution. The rinse solution in the rinse bottle is kept under a certain pressure by the pressure controlling, and it is supplied by opening the valve connected to the system.
(b) Vacuum System The vacuum circuit is released to the atmosphere at the rinse cup. The vacuum pump operates only
at the time of draining to aspirate the waste into its bottle. The vacuum circuit is not monitored. Instead, checking is made on whether or not the liquid level becomes abnormal when the sample probe moves into the Probe Rinse Cup (inside) (if waste is not drained properly, the drain error occurs).
(2) Specifications/Functions
(a) Pressure Pump Pump type: Drive power supply: AC 100 V, 50/60 Hz Pressure generation: Over 300 g/cm
(b) Vacuum Pump Pump type: Drive power supply: AC 100 V, 50/60 Hz Vacuum generation: Over -100 g/cm
2
2
CA-500 Series S/M 2-4 Revised December 2001 8

2.4 DETECTOR BLOCK

2.4.1 Outline

The CA-500 detector block is provided with 4 scattered light detecting ports, 1 transmitted light detecting port, and 6 incubation wells. The detector block is kept at 37°C by the heater and the semiconductor temperature sensor.

2.4.2 Specifications/Functions

(1) Analysis System
Scattered Light Detection Detector Unit: 4 ports Light Source: LED H-2000L (peak wavelength 660 nm) Photo Diode: S1133 silicon diode Filter: R-60 (band-pass: over 600 nm)
Transmitted Light Detection Detector Unit: 1 port Light Source: LED NLPB-500 Photo Diode: S1133 silicon diode Filter: 405 nm band-pass filter
Transmitted Light Detection (Immunoassy) Detector Unit: 1 port Light Source: LED TLGE159P Photo Diode: S1133 silicon diode Filter: 575 nm band-pass filter
(2) Other Incubation well: 6 wells Heater: 28 W film heater Overheat protection: 76°C thermal fuse

2.4.3 Assembly Diagram

CA-500 Series S/M 2-5 Revised December 2001
8

2.5 REAGENT COOLING UNIT

2.5.1 Outline

To cold-store reagents, electronic cooling element (Peltier element) cools the 4-hole reagent set.

2.5.2 Specifications/Functions

Cooling source: Peltier element (1 piece, DC 12 V applied) Cooling: 1 unit of DC fan and fin-type radiator Temperature detection: Semiconductor temperature sensor - 1 unit

2.5.3 Assembly Diagram

CA-500 Series S/M 2-6 Revised December 2001
8

2.6 VOLUMETRIC UNIT

2.6.1 Outline

The volumetric unit is used to measure a predetermined volume of sample, reagent, buffer, and rinse.

2.6.2 Specifications/Functions

(1) Drive System Drive source: Unipolar-type stepping motor (1-2 phase excitation, constant current drive) Power transmission: Timing belt type Resolving power: Approx. 0.02 mm/step Drive speed: Approx. 1300 pps (at high speed in trapezoidal control) Sensor: For drive unit home position (transmission type) - 1 unit (2) Syringe System Piston diameter: 3 mm Vertical stroke: Approx. 21 mm Syringe volume: Approx. 151 µL/21 mm Life: 300,000 cycles

2.6.3 Assembly Diagram

CA-500 Series S/M 2-7 Revised December 2001
8

2.7 X-Y DRIVE UNIT (X-AXIS MOTOR ASSEMBLY/DRIVE-AXIS ARM ASSEMBLY)

2.7.1 Outline

This unit moves the sample probe, which aspirates and dispense plasma and reagent, to the Sample Rack, Reagent Rack, and Reaction Tube Rack; and drives, in X-Y direction, the catcher which moves reaction tubes from the reaction tube rack to the heater section, detector block, and further to dispense/discard hole.

2.7.2 Specifications/Functions

(1) X-Direction System Drive Source: Unipolar type stepping motor (1-2 phase excitation, constant current drive) Drive transmission: Timing belt type Resolving power: Approx. 0.08 mm/step Drive speed: Approx. 4500 pps (at high speed in trapezoidal control) Sensor: For drive unit home position (transmission type) - 1 unit (2) Y-Direction System Drive Source: Unipolar type stepping motor (1-2 phase excitation, constant current drive) Drive transmission: Timing belt type Resolving power: Approx. 0.08 mm/step Drive speed: Approx. 4000 pps (at high speed in trapezoidal control) Sensor: For drive unit home position (transmission type) - 1 unit

2.7.3 Assembly Diagram

CA-500 Series S/M 2-8 Revised December 2001
8

2.8 Z-AXIS DRIVE UNIT (Z-AXIS BASE ASSEMBLY)

2.8.1 Outline

To use the sample probe for aspiration or draining and to move reaction tubes, this unit grips the catcher and drives it in Z direction. The Z-axis base assembly incorporates a mechanism for mixing plasma and reagent in reaction tubes.

2.8.2 Specifications/Functions

(1) Z-Direction System Drive Source: Unipolar type stepping motor (1-2 phase excitation, constant current drive) Drive transmission: Timing belt type Resolving power: Approx. 0.08 mm/step Drive speed: Approx. 3100 pps (at high speed in trapezoidal control) Sensor: For drive unit home position (transmission type) - 1 unit (2) Stirring Function Power source: DC motor (Driving voltage: 1.05 V) (3) Reaction tube Presence Detection Sensor: Detects presence of reaction tubes (modulation-reflection type) - 1 unit (4) Sample Probe ShapeMaterial: ID 0.50 mm/OD 0.85 mm, SUS316 Heater: Sensor: Glass chip thermistor Overheat protection: Thermal fuse 76°C

2.8.3 Assembly Diagram

CA-500 Series S/M 2-9 Revised December 2001
8

2.9 BAR CODE READER UNIT (ID COMPLETED PARTS)

2.9.1 Outline

This unit drives the bar code reader, which reads ID labels affixed on the sampler set on the sample table.

2.9.2 Specifications/Functions

(1) Drive System Drive Source: Unipolar-type stepping motor (2-phase excitation, constant current drive) Drive Transmission: Timing belt type Resolving Power: Approx. mm/step Drive Speed: Approx. pps (at high speed in constant control) Sensor: For drive unit home position (transmission type) - 1 unit (2) ID Specifications Light Source/Receptor Element: LED/CCD image sensor Read Width: 80 mm Scan Cycles: 500 scans/500 decodes per second Interface: Conforms to RS-232C Power Source: DC 5 V, 300 mA Corresponding Code: CODE39, NW-7, Industrial 2 of 5, CODE 128, etc.
CA-500 Series S/M 2-10 Revised December 2001 8

2.10 PUMP UNIT (PRESSURE PUMP/VACUUM PUMP COMPLETED PARTS)

2.10.1 Outline

The pump unit comprises the pressure pump that applies positive pressure into the bottle to feed rinse solution from the rinse bottle into the system and the vacuum pump that applies vacuum into the bottle to feed out waste from the system into waste bottle.

2.10.2 Specifications/Functions

(1) Pressure Pump Structure: Pressure: 250 mmHg as adjusted 19 (2) Vacuum Pump Structure: Vacuum: Approx. 180 mmHg as not adjusted 19

2.10.3 Assembly Diagram

CA-500 Series S/M 2-11 Revised February 2004 19 TB200408
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