Sysmex CA-500 Instruction manual
INSTRUCTIONS FOR USE
Automated Blood Coagulation Analyzer
CA-500 series
CHAPTER 1: Introduction
CHAPTER 2: Safety Information
CHAPTER 3: Design and Function
CHAPTER 4: Installation Environment
CHAPTER 5: Operation
CHAPTER 6: Display and Processing of
Analysis Results
CHAPTER 7: Output
CHAPTER 8: Quality Control
CHAPTER 9: Setting Standard Curve
CHAPTER 10: Instrument Setup
CHAPTER 11: Maintenance and Supplies
Replacement
CHAPTER 12: Troubleshooting
CHAPTER 13: Functional Description
CHAPTER 14: Technical Information
CHAPTER 15: Index
CHAPTER 16: Appendix (A)
SYSMEX CORPORATION
KOBE, JAPAN
Copyright © 2001-2004 by SYSMEX CORPORATION
All rights reserved. No part of this Instruction for Use may be
reproduced in any form or by any means whatsoever without
prior written permission of SYSMEX CORPORATION.
Code No. 461-2655-0
PRINTED IN JAPAN
Date of Last Revision: April 2004
Software version 00-17 and onwards
Table of Contents
1. Introduction .........................................................1-1
1.1 Introduction ........................... ............................................. .....1-1
1.2 Explanation of Signs ...............................................................1-3
1.3 Names .................................................................................... 1-4
1.4 Serial Number..........................................................................1-4
1.5 Revision History ......................................................................1-4
2. Safety Information ...............................................2-1
2.1 Specified Conditions of Use ................................................... 2-1
2.2 General Information ................................................................2-1
2.3 Installation Location ................................................................2-3
2.4 Avoidance of Infections .......................................................... 2-3
2.5 Handling of Reagents ............................................................. 2-4
2.6 Maintenance of the Instrument ............................................... 2-5
2.7 Disposal of Materials .............................................................. 2-5
2.8 Markings on the Instrument .................................................... 2-6
2.9 Personnel ............................................................................... 2-8
2.10 Storage Condition (Transportation)......................................... 2-8
3. Design and Function ........................................... 3-1
3.1 Overview ......................... ................ ................ ................ ........ 3-1
3.2 Operation Flow ....................................................................... 3-8
4. Installation Environment ....................................4-1
4.1 Installation and Relocation ..................................................... 4-1
4.2 Installation Location ................................................................4-1
4.3 Basic Instrument Settings .......................................................4-3
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Sysmex CA-500 series I
5. Operation ..............................................................5-1
5.1 Display Screens and Operation Keys .....................................5-1
5.2 Menu Tree ............................. ... ... ... ... .....................................5-3
5.3 Types of Alarm ................................... .... ... ... ... .... ....................5-5
5.4 Inspection before Turning ON the Power ...............................5-5
5.5 Turn ON the Power .................................................................5-7
5.6 Prepare Reagents ...................................................................5-8
5.7 Set Reaction Tubes ..............................................................5-13
5.8 Confirm Standard Curve .......................................................5-14
5.9 Execute Quality Control ........................................................5-15
5.10 Prepare Samples ..................................................................5-15
5.11 Set Sample Nos. ...................................................................5-19
5.12 Manual Inquiry ...................................................................... 5-22
5.13 Automatic Inquiry ................................................... ...............5-22
5.14 Start Analysis ......................... ... ... ... ... .... ... ... ... ......................5-24
5.15 Automatic Sensitivity Adjustment of the Detector
(for CA-530, CA-540, CA-550 and CA-560 only) ..................5-26
5.16 Display Analysis Result ........................................................5-27
5.17 Interrupt Analysis ..................................................................5-28
5.18 Add Samples ........................................................................5-29
5.19 Analyze STAT Sample .......................................................... 5-30
5.20 Emergency Stop ................................................................... 5-31
5.21 Shutdown ........................................................ ...................... 5-33
6. Display and Processing of Analysis Results ....6-1
6.1 List Display/Graphic Display ...................................................6-1
6.2 Search .................................................................................... 6-6
6.3 Sort in Sequence of Sample ID Nos. and Analyses ........... ... . 6-9
6.4 Select Display ......................................................................... 6-9
6.5 Edit ID No. ............................................................................6-11
6.6 Deletion ................................................................................. 6-12
7. Output ...................................................................7-1
7.1 Automatic Printout of Analysis Data .......................................7-1
7.2 Output of Analysis Data ..........................................................7-1
7.3 Example of Printout ................................................................7-3
8. Quality Control .....................................................8-1
8.1 Quality Control Methods .........................................................8-1
8.2 QC File Setting .......................................................................8-1
8.3 Execute Quality Control ..........................................................8-5
8.4 Display QC Charts .................................................................. 8-5
8.5 Delete QC File ........................................................................8-7
8.6 Delete QC Data ......................................................................8-8
8.7 Print QC data .......................................................................... 8-9
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9. Setting Standard Curve ...................................... 9-1
9.1 Display Standard Curve ..................... ... .... ... ... ... ... .... ... ... ... .... . 9-1
9.2 Standard Curve Analysis ................ ...... .... ... ... ... ... .... ... ... ... .... . 9-3
9.3 INR Manual Dilution Analysis ................................................ . 9-6
9.4 Manual Entry ..........................................................................9-8
9.5 Set Reagent Information ........................... ................ .............. 9-9
9.6 Set Calculation Parameters .................................................. 9-10
9.7 Print Standard Curve ............................................................ 9-13
10. Instrument Setup ...............................................10-1
10.1 General Information ..............................................................10-1
10.2 Setup of Automatic Transfer/Printout ................................... 10-2
10.3 Judgment on Analysis Result ............................................... 10-4
10.4 Replication Range .......... ... ... ... .... ... ... ... .... ... ... ... ... .... ...... ... ... 10-6
10.5 Report Limit ....... ... ... .... ... ... ................................................... 10-7
10.6 Setup of Test Name ..............................................................10-8
10.7 Reagent Name ..................................................................... 10-9
10.8 Test Protocol ............................................... ... ... ... .... ...... ... . 10-10
10.9 Replication ............................................................ ..............10-19
10.10 Setup of Test Group ........................................................... 10-20
10.11 Reagent Holder ..................................................................10-21
10.12 Setup of Reagent Volume Monitoring ................ ................. 10-23
10.13 Setting of Conversion Formula ........................................... 10-23
10.14 Devices to be Connected ...................................................10-24
10.15 Setup of System ................................................................. 10-26
10.16 Password Settings .............................................................. 10-28
10.17 Printout of Settings ............................... .... ... ... ... ... .... ... ... ... . 10-29
10.18 Addition of New Analysis Parameters ................................10-30
10.19 Reagent Name/Holder List ................................................. 10-31
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Sysmex CA-500 series III
11. Maintenance and Supplies Replacement ........11-1
11.1 Maintenance Schedule ...................... .... ... ... ....... ... ... ... ... .... .. 11-1
11.2 Clean Sample Probe .............................................................11-2
11.3 Discard Used Reaction Tubes .............................................. 11-3
11.4 Dispose of Waste ......................................................... ... ......11-4
11.5 Remove Dew from Reagent Rack
(for CA-530, CA-540, CA-550 and CA-560 only) ..................11-5
11.6 LED Calibration .....................................................................11-6
11.7 Replace Rinse Filter .............................................................11-9
11.8 Supply Printer Paper ............................................................. 11-9
11.9 Replace Fuse ......................................................................11-11
11.10 Check and Drain Trap Chamber ..... .................................... 11-11
11.11 Prime Rinse Solution to Hydraulic Line ..............................11-12
11.12 Clean Instrument ................................................................11-13
11.13 Replenish Reagent ...................................... ... .... ... ...... ... .... 11-14
11.14 Replenish Reaction Tubes .................................................. 11-16
11.15 Replenish Rinse Solution .................................................... 11-18
11.16 Supply Parts List .................................................................11-19
12. Troubleshooting ................................................12-1
12.1 Introduction ..................................................... ...................... 12-1
12.2 Error Corrective Procedure ...................................................12-2
12.3 Analysis Data Error ............................................................. 12-13
12.4 Cycle Counter .....................................................................12-14
12.5 Sysmex Menu .....................................................................12-15
12.6 Special Operation ...............................................................12-16
13. Functional Description ......................................13-1
13.1 Detection Principle of Coagulation Method (PT, APTT,
Fbg, TT, PCcl, BXT, LA1*, LA2*, Factor Deficiency) ............13-1
13.2 Detection Principle of Chromogenic Method (AT3, APL*, Plg*,
PC, Hep: CA-530, CA-540, CA-550 and CA-560 only) .........13-4
13.3 Detection Principle of Immunology Method
(D-Dimer, P-FDP*: CA-550 and CA-560 only) ......................13-5
13.4 Analysis Mechanism .............................................................13-7
13.5 Analysis Flow ........................................................................ 13-7
13.6 Reference Procedures ........................................................13-16
14. Technical Information .......................................14-1
14.1 Instrument Specifications ...................................................... 14-1
14.2 Installation ....................................................... .... ... ... ... ... ......14-8
14.3 Serial Interface for Host Computer ..................................... 14-17
14.4 Text Format ........................................................................14-24
14.5 ID Barcode ............................. ... ... ... ... .... ... ..........................14-34
15. Index ...................................................................15-1
16. Appendix (A) ......................................................16-1
16.1 Maintenance CheckList ........................................................ 16-1
16.2 Reagents .............................................................................. 16-3
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IV Sysmex CA-500 series
1. Introduction ..............................................................1-1
1.1 Introduction .................................................................................1-1
1.2 Explanation of Signs ...................................................................1-3
1.3 Names ................................ .................................... ..................... 1-4
1.4 Serial Number..............................................................................1-4
1.5 Revision History ..........................................................................1-4
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Sysmex CA-500 series
1. Introduction
1.1 Introduction
Introduction
The Sysmex® Automated Blood Coagulation Analyzer CA-500 series is
a compact fully-automated instrument capable of 5-parameter random
analysis for In Vitro Diagnostic use.
This instrument incorporates latest technologies as represented by microcomputers, thus enabling analysis of multiple parameters with increased
flexibility. Of PT, APTT, Fbg, Thrombin Time (Coagulation Method),
and Antithrombin III (Chromogenic Method: Can be analyzed only with
CA-530, CA-540, CA-550 and CA-560), D-Dimer (Immunology
Method: Can be analyzed only with CA-550 and CA-560), etc., this
instrument is able to analyze 5 parameters simultaneously. In addition, it
has a number of functions including preferential processing of STAT
samples and a built-in quality control function. Moreover, it allows
analyzed data to be displayed and printed out together with reaction
curves, thus making it possible to obtain highly reliable analysis results.
Analysis Parameters and Detection Principles
Parameter Test name Applied
Prothrombin Time PT Coagulation Method
Activated Partial Thromboplastin Time APTT Coagulation Method
Fibrinogen Fbg Coagulation Method
Thrombin Time TT Coagulation Method
Protein C coagulometric PCcl Coagulation Method
Batroxobin BXT Coagulation Method
LA1 Screening* LA1 Coagulation Method
LA2 Confirmation* LA2 Coagulation Method
Factor Assay** II, V, VII, VIII, IX,
Antithrombin III AT3 Chromogenic Method
α2-Antiplasmin* APL Chromogenic Method
Plasminogen* Plg Chromogenic Method
Protein C chromogenic BCPC Chromogenic Method
Heparin Hep Chromogenic Method
D-Dimer Plus*, Advanced D-Dimer*** DDPl, AdDD Immunoassay Method
P-FDP**** PFDP Immunoassay Method
Coagulation Method
X, XI, XII
(*) Not available in the USA.
(**) Data evaluated for factors VII and VIII only.
(***) Only available for use in the USA.
(****) Only available for use in Asia.
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Sysmex CA-500 series 1-1
Introduction
Manufacturer
SYSMEX CORPORATION
1-5-1 Wakinohama-Kaigandori
Chuo-ku, Kobe 651-0073
Japan
European Representative
SYSMEX EUROPE GmbH
Bornbarch 1
D – 22848 Norderstedt
Tel.: +49 40 5 27 26-0
Fax: Tel.: +49 40 5 27 26-100
Ordering of Supplies and Replacement Parts
If you need to order supplies or replacement parts, please contact your
local Sysmex representative.
Service and Maintenance
Training Courses
CE-Mark
Please contact the Service Department of your local Sysmex representative.
For further information please contact the Sysmex representative in your
country.
The IVD system described in this manual is marked with a CE mark
which confirms the observance of the essential requirements of the following European directives:
-98/79/EC in-Vitro Diagnostics Directive.
CA-500 series instruments with serial numbers shown below or smaller
numbers only conform to the 89/336/EEC electromagnetic compatibility.
CA-510 A1342
CA-520 A1017
CA-530 A1902
CA-540 A3883
CA-550 A1051
CA-560 A1110
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1.2 Explanation of Signs
Introduction
This manual carries a variety of illustrations to make sure that the product can be used safely and correctly, thus preventing users and others
from suffering injuries and damage to property.
The illustrations and meaning are described in the following.
Do understand what they mean before proceeding to the text of the
MANUAL.
Risk of Infection
Indicates the presence of a biohazardous material or
condition.
Warning
If this sign is ignored and the instrument is operated
incorrectly, there is a potentially hazardous situation
which could result in death or serious injury of operator,
or grave property damage.
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Caution
If this sign is ignored and the instrument is operated
incorrectly, there is a potentially hazardous situation
which may result in injury of operator, adverse effect on
results, or may cause property damage.
Important
Indicates what we would like you to know to maintain
instrument performance and prevent its damage.
Note
Indicates information which will come handy in operating the
instrument.
Sysmex CA-500 series 1-3
Introduction
1.3 Names
• Sysmex is a registered trademark of SYSMEX CORPORATION in
the USA, in Germany and other countries.
• CA CLEAN I and CA CLEAN II are trademarks of SYSMEX COR-
PORATION in the USA, in Germany and other countries.
• Actin, Ci-Trol, Data-Fi and Innovin are registered trademarks of
Dade Behring Inc in the USA, in Germany and other countries.
• Dade is a registered trademark of Dade Behring Inc.
• Pathromtin and Thromborel are registered trademarks of Dade
Behring Marburg GmbH in Germany and other countries and are
trademarks of Dade Behring Marburg GmbH in the USA.
• VACUTAINER is a registered trademark of Becton, Dickinson and
Company.
• VACUETTE is a registered trademark of Greiner Bio-One GmbH.
1.4 Serial Number
1.5 Revision History
• Other trademarks referenced are property of their respective owners.
CA-500 series instruments with serial numbers below or smaller
CA-510 A1300
CA-520 A1018
CA-530 A1805
CA-540 A3405
will not have the capability to manage more than 7 Assays/Standard
curves and they are limited to use 7 × 6 QC files.
Version Date Changes
Manual Software
1.0 00-13 October 2001 Launch Version
2.0 00-15 January 2003 Second Edition
2.0 00-15 May 2003 Minor Correction
2.0 00-15 September 2003 Minor Correction
2.0 00-15 November 2003 To conform with IVD
Directive
2.0 00-17 April 2004 Minor Correction
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Revised April 2004 - 2.0_en
2. Safety Information ...................................................2-1
2.1 Specified Conditions of Use ........................................................2-1
2.2 General Information ....................................................................2-1
2.3 Installation Location ..................... ... ... .... .....................................2-3
2.4 Avoidance of Infections ...............................................................2-3
2.5 Handling of Reagents ............................. ... ... ... ... .... .....................2-4
2.6 Maintenance of the Instrument ....................................................2-5
2.7 Disposal of Materials ...................................................................2-5
2.8 Markings on the Instrument .........................................................2-6
2.9 Personnel .................................. .................................................. 2-8
2.10 Storage Condition (Transportation) .. ... .... ... ... ... ... .... ... ... ....... ... ... ..2-8
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Sysmex CA-500 series
2. Safety Information
Before operating this instrument, carefully read this manual, and strictly
follow the instructions given in them.
2.1 Specified Conditions of Use
The instrument shall only be used for in vitro analysis of human blood or
artificial control blood. It may not be used for any other purpose.
Only reagents and cleaning solutions mentioned in this manual are permitted for use.
By observing the specified conditions of use, the frequency of cleaning
and maintenance work can be reduced.
2.2 General Information
Safety Information
Warning
• Keep long hair, fingers and clothing away from rotating parts of the instrument.
• During analysis, do not open the light shield cover
and put in hands or fingers.
This could cause injury. When the light shield cover
is opened during analysis, the alarm sounds and the
operation stops.
• In the event that the instrument emits an abnormal
odor or any smoke, turn off its power supply immediately and pull out the power plug from the wall
socket.
If the instrument is used continuously in that state,
there is a hazard that fire, electrical shock, or injury
may result. Contact your local service representative
for inspection.
• Take care not to spill blood or reagent, or drop wire
staples or paper clips into the instrument.
These might cause short circuit or smoke emission. If
such problem should occur, turn off the power supply
immediately and pull out the power plug from the wall
socket. Then contact your local service representative for inspection.
Revised January 2003 - 2.0_en
Sysmex CA-500 series 2-1
Safety Information
Warning
• Do not touch the electric circuits inside the instrument. Especially with wet hands there is a risk of
electric shock.
• Never put the power plug in any socket other than
that specified. When installing the instrument, be
sure to ground it. Otherwise, fire or electrical shock
will result.
• Take care not to damage the power cord, put a
heavy thing on it, or pull it forcibly. Otherwise, the
wire may become shorted or break, causing fire or
electrical shock.
• When connecting the instrument to a peripheral (host
computer, etc.), be sure to switch off the power supply beforehand. Otherwise, fire or electrical shock
may result.
• Use the check-digit as much as possible. If the
check-digit cannot be used, the potential of the incorrect reading of the barcode label may be increased.
Caution
• Read this manual carefully to operate the instrument
by the proper method. Keep it securely in a specified
location for future reference.
• This instrument must only be operated as instructed
in this manual.
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Revised January 2003 - 2.0_en
2.3 Installation Location
Safety Information
Caution
• Install in a place which is not subject to water splash.
• Install in a place which is not subject to adverse
effects of high temperature, high humidity, dust,
direct sunlight, etc.
• Do not give the instrument a strong vibration or
impact.
• Install at a place which is well ventilated.
• Do not install near devices that cause signal noise,
such as radios and centrifugal machines.
• Do not install near chemicals storage or in a place
where gas is generated.
2.4 Avoidance of Infections
Risk of Infection
• In principle, all parts and surfaces of the instrument
must be regarded as infective.
• Never touch waste, or parts having been in contact
with waste, with bare hands.
• Should you inadvertently come in contact with potentially infective materials or surfaces, immediately
rinse skin thoroughly with plenty of water, then follow
the antiseptic regulations of your laboratory.
• Be careful when handling samples. Always wear
latex or non latex examination gloves; otherwise contamination could result. If a sample happens to enter
your eye or a cut, wash it off with plenty of water, and
immediately visit a physician.
• Control plasma may also be infective. Wear latex or
non latex examination gloves during QC process. If
plasma happens to enter your eye or a cut, wash it
off with plenty of water, and immediately visit a physician.
• Use care when handling waste liquid. If it adheres to
the skin or clothing, wash it off using an antiseptic
solution.
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Sysmex CA-500 series 2-3
Safety Information
2.5 Handling of Reagents
Warning
• Avoid direct contact with reagents. Reagents can
cause irritation of the eyes, skin and mucous membranes.
• If a reagent happens to adhere to the hand or the
skin of another area, wash it off immediately using
plenty of water.
• If a reagent happens to enter your eye, wash it off
immediately using plenty of water, and take medical
treatment at once.
• If you should swallow it inadvertently, call for a physician immediately, drink a large volume of water, and
then induce vomiting.
• CA CLEAN I is a strong alkaline cleaning material. It
should not come in contact with skin or clothing. If it
happens nevertheless, rinse skin or clothing with
plenty of water to avoid injury or damage.
Caution
• Read the instructions described on the reagent containers.
• After unpacking, be sure not to allow dust, dirt, or
bacteria into the reagents.
• Do not use reagents that have passed the expiration
period.
• Handle a reagent gently to prevent formation of bubbles. Shake carefully if necessary.
Do not use directly after transportation.
• Take care not to spill a reagent. If it has spilled, wipe
it off immediately using a wet cloth or something.
• Prepare a sufficient volume of reagent which takes
into consideration the minimum sample volume
required. When the volume of the reagent is insufficient, sample may not be analyzed accurately.
• The CA CLEAN I rinse solution contains sodium
hypochlorite. If the material makes contact with the
instrument's surfaces, it will affect the surface finish.
There is a danger of corrosion. Immediately wipe up
CA CLEAN I with a damp cloth.
• A reagent is a chemical substance employed for
external diagnosis and cannot be used for any medical treatment.
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2-4 Sysmex CA-500 series
2.6 Maintenance of the Instrument
Always wear latex or non latex examination gloves when
performing maintenance work or inspection. Also use the
specified tools and parts. After work is over, wash the
hands in an antiseptic solution. There is a possibility that
those areas of the hand which came in contact with
blood could suffer infection.
When carrying out inspection and maintenance of the
instrument, use only the specified tools and parts. Never
use substitute parts or modify parts. Such actions are
dangerous and prohibited by the Pharmaceutical Affairs
Law.
Safety Information
Risk of Infection
Warning
2.7 Disposal of Materials
Risk of Infection
When discarding waste liquid, instrument consumables
and instrument, take proper steps to dispose of them as
medical, infective and industrial wastes.
If they are contaminated with blood, there is a possibility
of bacterial infection occurring.
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Sysmex CA-500 series 2-5
Safety Information
2.8 Markings on the Instrument
Warning
DO NOT place your fingers and hands inside while analyzing. Pipette can move in any direction.
Fast Stop (Mechanical Stop)
Warning
DO NOT press on the sampler unit to prevent damage.
Risk of Infection
In principle, all parts and surfaces of the instrument must
be regarded as infective.
Warning
When the arm is to be moved while the pipette is in the
down position, pull up the pipette to the same height as
catcher, and move the arm.
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2-6 Sysmex CA-500 series
Safety Information
Warning
To avoid risk of electrical shock, disconnect the power
cord before replacing the fuse.
Warning
Proper use of the appropriate power cord assures adequate grounding for the system. Failure to properly
ground the instrument bypasses important safety features and may result in an electrical hazard.
RS-232C Serial Port (HC Connector)
Risk of Infection
To avoid contact with biohazardous materials, gloves
must be worn when handling the tube trash and used
reaction tubes.
Wash your hands with an antimicrobial solution after
completing the procedure.
Warning
To avoid dusts or contaminants entering the rinse bottle,
ensure the float switch does not touch any surfaces
when replenishing distilled water. Dusts or contaminants
will cause malfunction of the solenoid value.
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Sysmex CA-500 series 2-7
Safety Information
2.9 Personnel
Risk of Infection
The waste container and contents should be considered
potentially biohazardous. Do not handle the waste container without proper protective equipment. Wear gloves
when handling. Wash your hands with an antiseptic solution after completing the procedure.
Caution
• Those who have no or only limited experience in
using the instrument are recommended to have guidance or assistance from those with sufficient experience.
• If the instrument has developed a problem by any
chance, a person in charge of it should take steps
within the range specified in Instructions For Use. As
to problems other than those mentioned, contact
your local service representative for repair.
• Instrument unpacking, installation, and confirmation
of initial operation must be done by your local service
representative.
Warning
This instrument is clinical laboratory equipment for
screening.
When making clinical judgment based on analysis
results, the doctor must also consider clinical conditions
and other inspection results for an overall judgment.
2.10 Storage Condition (Transportation)
• Ambient Temperature: -10ºC to +60ºC
• Relative humidity: 95% or less
(Non condensing / Keep dry)
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3. Design and Function ...............................................3-1
3.1 Overview ..................................................................................... 3-1
3.2 Operation Flow ....................................................... .....................3-8
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Sysmex CA-500 series
3. Design and Function
3.1 Overview
Front
Design and Function
1. Light Shield Cover
2. LCD (Liquid Crystal Display)
3. LCD Contrast Adjustment Knob
4. Mechanical Stop Switch
5. Built-in Printer
6. Sampler
1. Light Shield Cover
Prevents photoelectric detection from being affected by scattered light from external sources.
Ensure this cover is shut before proceeding to analyze any samples. Analysis cannot be started
if this cover remains open.
Important
Do not open the Light Shield Cover while analysing. Opening the cover will suspend analysis and beep the alarm. Also, opening the cover and inserting your hand
may cause injury.
2. Liquid Crystal Display (LCD)
Displays analysis results, reaction curves, sample numbers, test conditions, etc.
The LCD functions as a touch-sensitive control panel. The operator can execute various opera-
tions and enter settings by lightly touching keys displayed on the LCD.
3. LCD Contrast Adjustment Knob
Controls LCD contrast. This knob is located inside the printer cover.
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Sysmex CA-500 series 3-1
Design and Function
4. Mechanical Stop Switch
Used to immediately stop the mechanical unit in the instrument in the event of an emergency.
Note that the power of the instrument is not turned off even when this switch is turned on. If
emergency stop of the instrument is required due to power failure of the laboratory, immediately turn off the power of the instrument.
If there is a sample that has been already dispensed, this sample has to be reanalyzed from the start.
5. Built-in Printer
Setting conditions, error messages and analysis results are printed out on the thermal paper of
the graphic printer. The LCD contrast adjustment knob is located inside the built-in printer.
6. Sampler
The sampler has a load capacity of one sampler rack with 10 sample tubes. The sampler racks
are specific for Sysmex instruments. One rack can be set on the sampler at a time.
Pull out the Sampler toward you to load a rack. Once the rack is loaded, the sampler will oper-
ate without the need for intervention by the operator.
Important
Note
• The sampler unit is locked while sampling and dispensing. Once the status has become
ready to set samples, the sampler lock is released. You can pull out the sampler to set
samples on available positions on the rack in use, or to place a next rack to allow continuous analyses.
• The sampler unit can also be pulled out by the STAT sample analysis procedure to
allow an analysis of a STAT sample.
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Front Interior (When Opening Light Shield Cover)
888
10
10 10
8
10
97
88
1. Reaction Tube Rack
2. Reagent Cooler Holder
3. Reagent Rack
Design and Function
7. Detection Well (For Immunology
Method)
8. Sample Incubation Wells
9. Detection Well (For Chromogenic
Method)
10. Detection Well (For Coagulation
Method)
11. Probe
12. Reaction Tube Trash
13. Probe Rinse Cup (Outside)
14. Probe Rinse Cup (Inside)
15. CA CLEAN I Holder (default)
16. Buffer Holder (default)
4. Sampler
5. ID Barcode Reader
6. STAT Sample Rack
1. Reaction Tube Rack
Two reaction tube racks can be set. One rack holds up to 30 reaction tubes (SU-40). Tube posi-
tion numbers are assigned from the right rear position of the right rack (No. 1) and count
upwards moving toward the front.
2. Reagent Cooler Holders (For CA-530, CA-540, CA-550 and CA-560 only)
Can hold up to 4 vials with cooler function.
3. Reagent Rack
Reagent vials, whose outer diameter is 22 mm and he ight is 40 mm , can be set directly. Use
sample cups or optional holders to place any vial with other outer diameters.
Caution
If any vial higher than 40 mm is used, the Probe will be damaged permanently.
4. Sampler
Can hold one sample rack.
5. ID Barcode Reader (Optional on CA-510, CA-530 and CA-550)
ID Barcode Reader moves in front of the rack and reads the barcoded label automatically.
6. STAT Sample Rack
Place a STAT sample collection tube or sample cup here. If a sample collection tube is placed,
use optional holders to make the tube diameter fit the rack.
7. Detection well (For Immunology Method: CA-550 and CA-560 only)
Detection well for the immunologic sample. The number of wells is one. The detector is always
kept at 37.0ºC ± 1.0ºC.
Revised September 2003 - 2.0_en
Sysmex CA-500 series 3-3
Design and Function
8. Sample Incubation Wells
Six incubation wells are provided, and these wells are kept at 37.0ºC ± 1.0ºC.
9. Detection Well (For Chromogenic Method: CA-530, CA-540, CA-550 and CA-560 only)
Detection well for the chromogenic sample. The number of wells is one. The detector is always
kept at 37.0ºC ± 1.0ºC.
10. Detection Wells (For Coagulation Method)
Four scattered light detection wells are provided, and these wells are kept at 37.0ºC ± 1.0ºC.
11. Probe
This pipette is used to aspirate samples and reagents. It is kept at 37.0ºC ± 1.0ºC.
12. Reaction Tube Trash
Used reaction tubes are disposed into this trash.
13. Probe Rinse Cup (Outside)
The outside of the probe is rinsed with the rinse fluid kept in this rinse cup.
14. Probe Rinse Cup (Inside)
The inside of the probe is rinsed in this rinse cup.
15. CA CLEAN I Holder
CA CLEAN I detergent is set in the vial, whose outer diameter is 22 mm or less, and height is
50 mm or less.
Caution
Use the provided vials to hold the CA CLEAN I detergent. If any vial higher than
50 mm is used, the Probe will be damaged permanently.
16. Buffer Holder
Buffer diluent used for sample dilution is set in the vial, whose outer diameter is 22 mm or less,
and height is 50 mm or less.
Caution
Use the provided vials for the container to keep the Buffer. If any vial higher than
50 mm is used, the Probe will be damaged permanently.
3-4 Sysmex CA-500 series
Revised April 2004 - 2.0_en
Left Side
Design and Function
2. Cover Sensor Switch
1. Power Switch
3. Cooler Unit
1. Power Switch
Turns the power ON or OFF.
Caution
Please allow at least 5 seconds between turning the instrument OFF and back ON,
or the fuse may be blown.
Right Side
2. Cover Sensor Switch
This monitors if the Light Shield Cover is closed.
3. Cooler Unit
This keeps the reagent cool.
8. Solenoid Valve
for Sample Aspiration
9. Reaction Tube Trash
Drawer
1. X-Y Drive Motor
This motor drives the Probe unit in the X-axis and Y-axis directions.
1. X-Y Drive Motor
2. Host Computer Serial Port
3. Memory Card Cover
4. Pressure Pump
5. DIP Switch
6. Vacuum Pump
7. Solenoid Valve
for Probe Rinse
2. Host Computer Serial Port
For connecting to an external host computer.
Revised January 2003 - 2.0_en
Sysmex CA-500 series 3-5
Design and Function
3. Memory Card Cover
This card has PROM chips to load the CA-500 program in to RAM memory. (In tended for your
local service representative use only)
4. Pressure Pump
Supplies the pressure. The instrument cannot function properly at lower pressures.
5. DIP Switch
Changes the system settings.
(Intended for your local service representative use only)
6. Vacuum Pump
Supplies vacuum. The instrument cannot function properly if the vacuum level is lower.
7. Solenoid Valve for Probe Rinse
This valve controls the supply of the rinse solution to the rinse cup unit.
8. Solenoid Valve for Sample Aspiration
This valve controls the aspiration of sample plasma with high accuracy.
9. Reaction Tube Trash Drawer
Rear
Used for storing used reaction tubes.
1. Trap Chamber
6. Fuse Holder
2. Float Switch Connector
for Waste Bottle
3. Float Switch Connector
for Rinse Bottle
4. Pressure Supply Nipple
for Rinse Bottle
5. Rinse Aspiration Nipple
8. Vacuum Nipple for Waste Bottle
9. Waste Outlet Nipple
7. Power Connector
1. Trap Chamber
Prevents the waste fluid from flowing back to affect the vacuum pump, in the event of an
abnormality with the instrument.
2. Float Sensor Connector for Waste Bottle (“WASTE”)
For connecting the float sensor switch, located on the waste container, for detecting the waste
fluid level.
3-6 Sysmex CA-500 series
Revised January 2003 - 2.0_en
Design and Function
3. Float Sensor Connector for Rinse Bottle (“RINSE”)
For connecting the float sensor switch, located on the rinse container, for detecting rinse water
level.
4. Pressure Supply Nipple for Rinse Bottle (Colored Black)
To be connected via a tube with the Rinse Bottle.
Important
When the Rinse Bottle is to be opened, disconnect this tubing first to release the
pressure accumulated inside the Rinse Bottle. Failing to do this will splash the pressurized rinse fluid.
5. Rinse Aspiration Nipple (Colored Blue)
For aspirating the rinse water from the Rinse Bottle. To be connected via a tube to the Rinse
Bottle.
Important
When the Rinse Bottle is to be opened, disc onnecting this tubing first will splash the
pressurized rinse fluid. Disconnect the black tubing first.
6. Fuse Holder
Two time-lag type fuses are installed in this Fuse Holder. Replace with the correct type of fuse
(supplied). The rating will be different depending on the instrument specification as below.
Specification Part No. Description Fuse Type Location
117 VAC 266-5106-0 Fuse 250V 6.3A ST4-6.3A-N1
Time Lag Rear Panel
(N.Amer)
220-240 VAC 266-5293-0 Fuse 250V 3.15A No. 19195
(Europe)
Time Lag Rear Panel
Warning
• To avoid risk of electrical shock, disconnect the power cord before replacing the
fuses.
• For continued protection against risk of fire, replace only with a fuse of the specified type and current ratings.
7. Power Connector
For connecting the main power supply (via the supplied power cable).
8. Vacuum Nipple for Waste Bottle (Colored Green)
To be connected via a tube with the Trap Chamber.
9. Waste Outlet Nipple (Colored Red)
For draining waste fluids. Must be connected via a tube to the Waste Bottle.
Revised January 2003 - 2.0_en
Sysmex CA-500 series 3-7
Design and Function
3.2 Operation Flow
Manual Order Registration On-Line Order Registration
(Manual Inquiry)
Inspection Before Turning On Power
Turn On Power
• Self Check
Ready
Prepare Reagents
Register Analysis
(Manual Registration)
Prepare Samples
Operation After Completion of Analysis
: Indicates actions performed by the operator.
Prepare Samples
Register Analysis
Press [HC] key
Press [Start] key
• Execution of Analysis
• Completion of Analysis
Ready
Turn Off Power
On-Line Order Registration
(Auto Inquiry)
Prepare Samples
: The message "Ready" will appear on the LCD screen, indicating that analysis, setting, dat a
processing and other operations can be executed.
Revised January 2003 - 2.0_en
3-8 Sysmex CA-500 series
4. Installation Environment .........................................4-1
4.1 Installation and Relocation ........................ ... ... ... .... ... ... ... .... ... ... ..4-1
4.2 Installation Location ..................... ... ... .... ... ... ... ... .... ... ... ... .... ........4-1
4.3 Basic Instrument Settings ...................... ... ... ... ... .... ... ... ... .... ... .....4-3
Revised January 2003 - 2.0_en
Sysmex CA-500 series
4. Installation Environment
4.1 Installation and Relocation
Installation of the instrument must be conducted by your local service
representative. If it is necessary to relocate the instrument, contact your
local service representative.
It is to be noted that if problems should develop as a result of relocation
conducted by a customer, it will void the warranty even if the instrument
is in the warranty period.
4.2 Installation Location
Grounding
The power cord of each instrument uses the 3P plug. When the power
supply socket is 3P (with ground) type, simply plug it to the socket. The
type of cord and plug supplied depends on the source voltage for the system.
Installation Environment
Installation Space
Warning
Proper use of the appropriate power cord assures adequate grounding for the system. Failure to properly
ground the instrument bypasses important safety features and may result in an electric hazard.
Note
The number of power supply sockets required is one.
To ensure optional instrument performance properly, install it at an
appropriate location.
• Select a place where the power supply is located close.
• Be sure to use the supplied bottles to collect rinse solution and waste.
• Keep a space for maintenance and service. Giving consideration to
heat radiation by the instrument, provide at least 50 cm distance from
the wall to sides, rear, and top panels.
Revised January 2003 - 2.0_en
Sysmex CA-500 series 4-1
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