SYSMEX CA-500 Manual de usuario

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: 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

First Edition November 1999

Second Edition December 2001

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 [ – ]

(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

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

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