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

II Sysmex CA-500 series

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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.: [phone]
Fax: Tel.: [phone]

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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Revised January 2003 - 2.0_en

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.

Revised November 2003 - 2.0_en

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

1-4 Sysmex CA-500 series

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.

Revised November 2003 - 2.0_en

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.

Revised April 2004 - 2.0_en

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)

2-8 Sysmex CA-500 series

Revised November 2003 - 2.0_en

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.

3-2 Sysmex CA-500 series

Revised January 2003 - 2.0_en

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

Installation Environment

The dimensions of the instrument are shown below. The power cord is

1.8 m long.

Width (mm) Depth (mm) Height (mm) Weight (kg)

Main unit 540 470 487 Approx. 45

487

540

470

Caution

Be sure to place the rinse bottle and waste bottle on the
base on which the instrument is set. Do not place them
on the instrument. They may cause the instrument to
break down or to fail to produce correct results.

4-2 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Installation Environment

• Use the instrument at an ambient temperature of 15 - 35ºC.

• Use it at a relative humidity range of 30 - 85%.

• When the ambient temperature and humidity are not appropriate,

• Avoid using the instrument in a place where the temperature can

• Avoid using the instrument in a place where it may be frozen.

• Avoid using the instrument where it can be exposed to direct sun-

• Select a well-ventilated place.

• Avoid using it at a place close to a wireless telegraph, communica-

4.3 Basic Instrument Settings

Installation Environment

control by air conditioning.

become extremely high or low.

light.

tion equipment, etc. which may emit high-frequency waves or inter­fere with radio waves.

Contrast Adjustment for LCD Screen

Remove the printer cover, and adjust LCD screen contrast (shade) using
the contrast adjust dial on the left side of the printer.

Dark

Light

Turning up the dial makes the screen darker and turning down makes it
lighter.

Setup of System (Date/Time)

Set date and time.

The instrument has a built-in clock, so there is no need to set the date and
time every day. Should the power be turned off, the built-in clock is pow­ered by an internal battery.

1. Press [Special Menu] key on the Root Menu screen.

2. Press [Settings] key on the Root Menu screen.

The contents of the Root Menu will change over.

The Setting Menu screen will appear.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 4-3

Installation Environment

Ready

Sysmex

Settings

General Set Up

Date/Time
Date 12/01/2001


Time 16:35:38

Replace Rack? YES!

Auto Val/Out

Data Check

Analysis Settings

I/O Setting

General Set Up

Ready

Sysmex

Replace Rack? YES!

Date/Time

Date Format

Password Setting

Ready

Sysmex

Replace Rack? YES!

HC IP

Print Settings

HC IP

HC IP

7

4

1

0

C

Main
Menu

Return

Date

89

5

6

3

2

/

Enter

Quit

3. Press [General Set Up] key on the Setting Menu screen.

The General Set Up Menu screen will appear.

4. Press [Date/Time] key on the General Set Up Menu screen.

The Date/Time Setting screen will display current date and time.

5. Using [↑] and [↓] keys, move the cursor to select Date or Time.

6. Using the numeric keys, set Date and Time, and press [Enter] key.

The parameter in the cursor position is set and the cursor will move
to the next parameter.

Important

• When entry is made in the wrong format, the setting

is not executed.

• If the number of day or month is a single digit, enter it

with a 0 preceding it.

• Enter the time in a 24-hour clock system.

7. When setting is completed, press [Quit] key.

The Renew Confirmation screen will appear.

Sysmex

Replace Rack? YES!

HC IPReady

8. Press [FIX] key, [Continue] key, or [Cancel] key.

[FIX] key: Changes to the renewed setting and returns to the

General Set Up Menu screen.

RENEW SETTING ?

[Continue] key: Returns to the Date/Time Setting screen and allows

continued operation.

[Cancel] key: Cancels the renewed setting and returns to the Gen-

ContinueCancel FIX

4-4 Sysmex CA-500 series

eral Set Up Menu screen.

Revised January 2003 - 2.0_en

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

Revised January 2003 - 2.0_en

Sysmex CA-500 series

5. Operation

5.1 Display Screens and Operation Keys

The instrument displays all information including the instrument status,
analysis results, etc. on the LCD screen. The LCD screen is divided into
system status area, data processing area, and menu processing area. Press
a key pad, and the function indicated on the key will work.

Operation

System Status Area

(1) (2)

Ready

Sysmex

Stored

Data

Replace Rack? YES!

QC

Main Menu
1 PT 2 APTT 3 Fbg

Rack ID No.

01-01 

01-02 
01-03 
01-04 
01-05

(3)

4 TT 5 AT3

12345

Repeat

Standaed

Curve

(4)

HC IP

Group 1

ID No.

Entry

Test



Group

(5)

(6)

Start

Prev

Next

HC

Special

Menu

System Status

Data Processing

Menu Processing

The System Status Area displays [Sysmex] key, error message, analysis
status, and the status of externally connected instruments.

1. [Sysmex] key

Press this key to display Sysmex menu showing Error List, Tempera­ture, and Paper Feed. When the instrument develops an error, causing
the alarm to sound, [ALARM RESET] key appears. Press [Error
List] key to display Error History. Press [Temperature] key to dis­play temperatures of various units. Press [P. FEED] key to feed
printer paper.

For Sysmex Menu, refer to “12. Troubleshooting”.

2. Analysis Status
This indicates analysis status with the current instrument. “Ready”,

“Analyzing”, “Waiting” will appear.

3. Rack Replacement
This indicates whether the sample rack can be replaced or not.

4. HC (Host Computer)
The host computer is set to “Connected”. “HC” appears when sample

data for automatic output becomes available.

5. IP (Internal Printer)
“IP” appears when sample data for automatic output to the internal

printer becomes available.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-1

Operation

Data Processing Area

Menu Processing Area

6. [Start]/[INTERR] key

Press this key to start/stop the sampler analysis.
For STAT sample analysis, [Start STAT] key appears.

The data processing area displays analysis progress status, work list,
stored data list, reaction curve, quality control data, standard curve data,
instrument setup status, etc.

When the power supply is turned on, the work list screen (Root Menu
screen) appears.

The menu processing area always displays the menu for function selec­tion.

In selecting a menu, touch a key that shows a menu you want to see.
After power supply turn-on, when system check is completed, the Root

Menu appears. The Root Menu is the basic menu for selecting functions
of this instrument.

5-2 Sysmex CA-500 series

Revised January 2003 - 2.0_en

5.2 Menu Tree

Root Menu 5.5 ↑ 5.11

↓ 5.11

Repeat 5.11

ID No. Entry 5.11

HC 5.12

Stored Data 6.1 ← Top 6.2

QC 8.5 Settings 8.3

Operation

→ Bottom 6.2
↑ Search 6.2
↓ ID No./seq 6.3

Mark Select Display 6.4
Graph Delete 6.6
Prev Edit ID No. 6.5
Next Output 7.2
More Marked All Clear 6.6

Change Scale 8.5 (*1)

← 8.5 (*1)
→ 8.5 (*1)

Delete 8.7 (*1)
Print 8.8
Select File 8.5
Select Test 8.5

Standard Curve 9.1 Next 9.1 (*2)

Test Group 5.11 Set Reagents 5.6

Special Menu

Sysmex 12.5 Error List

Temperature
P.FEED
Main Menu

Start 5.14
INTERR 5.17

Prev 5.16
Next 5.16

Standard Analysis 9.2 (*2)
Manual Entry 9.4 (*2)
Select Param. 9.6
Select Test 9.1
Graph 9.1 (*2)
Print 9.7 (*2)
Lot No. Entry 9.5

Settings 10.1
Rinse Probe 11.2
Special Operate 12.6

: If set, password has to be entered.
*1: This item is displayed only when QC data is st ored.
*2: This item is displayed only when calculat ion

parameter is set.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-3

Operation

Root Menu Special Menu Settings Auto Val/Out 10.2

Data Check Mark Limits 10.3

Analysis Settings Set Test Name 10.6

I/O Settings 10.14 Host Comp ute r

General Set Up Date/Time 10.15

Print Settings 10.17 Auto Val/Out

Replic. Limits 10.4
Report Limits 10.5

Set Reagent Name 10 .7
Test Protocol 10.8
Set Replication 10.9
Test Group 10.10
Reagents Holder 10.11
Alarm Settings 10.12
Conversion 10.13

Barcode Scanner

Date Format 10.15
Password Setting 10.16

Data Check
Analysis Settings
I/O setting
General Set Up
All Set Data

Special Operate Rinse Prepa r e 11.11

System Tests 12.6 LCD

Cycle Counter 12.4

LED Calibration 11.6

: If set, password has to be entered.

Touch Screen
Host Computer
Printer
Barcode Scanner
Sensor Status

5-4 Sysmex CA-500 series

Revised January 2003 - 2.0_en

5.3 Types of Alarm

Operation

The instrument alarm emits 4 different sounds:

• Key entry sound (pip)

Sounds about 0.1 sec. when a touch panel key is pressed.

• Rack replacement sound (pip, pip, pip)

Sounds when sampling and dispensing of all set samples are com­pleted and the system becomes ready to add orders or replace racks.

• Analysis completion sound (pip, pip, peep)

Sounds when analysis of all registered samples is completed.

• Instrument error sound (beep)

Sounds when some error has occurred in the instrument.
This sound continues until [ALARM RESET] key is pressed.
While the alarm is sounding, the [ALARM RESET] key is dis-

played in place of [Sysmex] key.
This sound is emitted also when the sample rack has been lifted after

the system ran out of sample tubes or reagents or when they were
being replenished.

This alarm sound stops when the [Conf.] key is pressed or when the
sample rack is set correctly.

5.4 Inspection before Turning ON the Power

Inspect Rinse Bottle

When the rinse solution level is found low, replenish the rinse bottle with
distilled water. As to the procedure for replenishing rinse solution, refer
to “11.15 Replenish Rinse Solution”.

Caution

When analysis is made with the rinse bottle laid down,
there is a possibility that correct analysis result may not
be obtained. Make sure the rinse bottle is standing
upright.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-5

Operation

Inspect Waste bottle

When waste liquid has collected in the waste bottle, discard the contents.
Regarding how to dispose of waste liquid, refer to “11.4 Dispose of
Waste”.

Risk of Infection

When disposing of waste liquid, always wear latex or
non latex examination gloves. After work is over, wash
the hands in anti-septic solution.
If hands are contaminated with blood, which could result
in infection by pathogenic organisms, give careful con­sideration to the hazards of medical or infective waste
materials.

Important

When analysis is made with the waste bottle laid down,
waste may flow back into the vacuum pump, causing the
pump to fail.
Make sure the waste bottle is standing upright.

Check Power Cord

Check Connection Cord

Check Tube Trash Drawer

Check Printer Paper

Check Light Shield Cover

Check to see the power cord is securely plugged in the socket.

When the instrument is connected with the host computer, check to see
the connection cord is securely connected.

When used reaction tubes remain in the tube trash drawer, discard them.
As to discarding, refer to “11.3 Disc ard Used Reaction Tubes”.

Check to see the internal printer has enough paper to handle the number
of samples expected that day.

Open the cover and check to see there are no obstacles for analysis.

5-6 Sysmex CA-500 series

Revised November 2003 - 2.0_en

5.5 Turn ON the Power

Turn ON the Power

Automated Blood Coagulation Analyzer

CA-500

Check in Progress

Operation

1. Turn on the power switch on the left side of the instrument.
The system automatically performs a roughly 10-second self check,

and the Root Menu screen will appear.

Ready

Sysmex

Stored

Data

Replace Rack? YES!

QC

Main Menu
1 PT 2 APTT 3 Fbg

Rack ID No.

01-01 

01-02 
01-03 
01-04 
01-05

4 TT 5 AT3

12345

Repeat

Standaed

Curve

HC IP

Group 1

ID No.

Entry

Test



Group

Special

Confirm Automatic Output

Ready

Sysmex

Stored

Data

Replace Rack? YES!

QC

Main Menu

1 PT 2 APTT 3 Fbg

Rack ID No.

01-01 

01-02 
01-03 
01-04 
01-05

4 TT 5 AT3

12345

Repeat

Standaed

Curve

HC IP

Group 1

ID No.

Entry

Test



Group

Special

Start

Prev

Next

HC

Menu

Start

Prev

Next

HC

Menu

2. When the detector and cooler reach an analysis-permitting tempera­ture, the Root Menu screen displays “Ready”.

Note

• The detector and cooler reach an analysis-permitting tem-

perature in about 5 - 30 minutes after power turn-on.

• When the system is waiting for an analysis-permitting

temperature, the message “Not Ready” is displayed and
“Start” key is not displayed.

When automatic output to the internal printer or host computer becomes
necessary, make this confirmation.

1. Confirm that the System Status area displays “HC” and “IP”.

2. Confirm the settings for automatic transfer/printout.
Refer to “10.2 Setup of Automatic Transfer/Printout”.

Note

[HC] key is displayed only when the system is set for manual
inquiry to the host computer. For detail, refer to “5.12 Manual
Inquiry”.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-7

Operation

5.6 Prepare Reagents

Prepare Reagents

Prepare coagulation reagents needed for analysis, Owren’s Veronal
Buffer, and rinse solution. Refer to the package insert of each reagent for
more information.

Parame-

ter

PT PT Reagent 100 µL
APTT APTT Reagent 50 µL

Calcium Chloride Solution (0.025 mol/L) 50 µL

Fbg Thrombin Reagent 50 µL

Owren’s Veronal Buffer 90 µL
TT Thrombin Clotting Time Reagent 100 µL
PCcl Protein C Deficient Plasma 45 µL

Protein C Activator 50 µL

PC APTT Reagent 50 µL

Calcium Chloride Solution 50 µL
BXT Batroxobin Reagent 100 µL
LA1* LA1 Screening Reagent 100 µL
LA2* LA2 Confirmation Reagent 100 µL
AT3 Berichrom° Antithrombin III (A)

Thrombin Reagent 125 µL

Substrate 33 µL

Owren’s Veronal Buffer 83 µL
BCPC Berichrom° Protein C

Protein C Activator 125 µL

Substrate 30 µL
APL* Berichrom° α2-Antiplasmin

Antiplasmin Reagent 125 µL

Substrate 25 µL

Owren’s Veronal Buffer 112 µL
Plg* Berichrom° Plasminogen

Streptokinase Reagent 125 µL

Substrate 25 µL

Owren’s Veronal Buffer 112 µL

Reagent Consumption per

Test

5-8 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Operation

Parame-

ter

Hep Berichrom° Heparin

AT3 Reagent 20 µL
FXa Reagent 125 µL
Heparin Substrate 40 µL

DDPl* D-Dimer PLUS

Accelerator 25 µL
Latex Reagent 150 µL

AdDD** Advanced D-Dimer

Accelerator 25 µL
Latex Reagent 150 µL

PFDP*** Latex Test BL-2 P-FDP

Reagent 66 µL
Latex 94 µL
P-FDP Diluents 112 µL

Rinse
Solution

Distilled Water (Rinse Bottle) Max. 24 mL per

CA CLEAN I 10 µL more than

Reagent Consumption per

Test

test

the required rea­gent volume.

(*) Not available for use in the USA.
(**) Only available for use in the USA.
(***) Only available for use in Asia.

The amount of Owren’s Veronal Buffer per test includes the amount
used in dilution for each analysis parameter.

When analyzing the parameters that require two reagents, a rinse opera­tion is performed three times in total after dispensing samples and rea­gents.

Thus the amount used per test is approximately 24 mL. However, the
number of rinse operations can be changed. (Refer to “10.8 Test Proto­col”.)

CA CLEAN I is used after the reagent is dispensed. The amount used for
one rinse is the amount of the reagent + 10 µL.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-9

Operation

Caution

• Prepare each reagent taking into consideration the
analysis parameters and the number of the samples
to be analyzed. Prepare extra volumes as shown
below, in addition to the required volumes for analy­sis:

Each coagulation reagent: Approx. 0.6 mL
Distilled water: Approx. 500 mL
Owren’s Veronal Buffer: Approx. 0.9 mL
CA CLEAN I: Approx. 0.9 mL

• The amount of reagent used in the initial operation
(rinse operation) after analysis starts is as follows:

Distilled water: Approx. 20 mL
CA CLEAN I: Approx. 125 µL
Owren’s Veronal Buffer: Approx. 200 µL (*)
(*)only when parameters are analyzed for the Chro-

mogenic Method or Immunology Method

The amount of extra reagents required vary according to the containe r
used.

Sample cup conical (4 mL): Approx. 0.2 mL

®

Behring 4 mL vial: Approx. 1.0 mL

Dade

®

Dade

Behring 5 mL vial (GW5): Approx. 0.8 mL

TTO, NT 3 mL vial: Approx. 0.4 mL
Push Vial PV-10 (22 mm OD × 40 mm high): Approx. 0.9 mL
SLD Vial: Approx. 0.4 mL

The extra volumes shown are the maximum which may be required.
There may be variation due to differences in fluid viscosity and slight
vial to vial variation.

Caution

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.

5-10 Sysmex CA-500 series

Revised April 2004 - 2.0_en

Operation

Dade Behring

Thromboplastin•C Plus

[ ]

[ ]

[ ]

Holder No. 11

1. Prepare Reagents.
Prepare reagents as per the document supplied with each reagent.

Caution

Strictly follow the instructions as given in the package

[ ]

insert supplied with each reagent. Otherwise, you will fail
to obtain correct analysis result.

2. Set the reagents on the rack.
Reagent bottles (each measuring 22 mm OD and 40 mm height), or

optional reagent holders and sample cups can be set in the reagent
rack. (Refer to “10.19 Reagent Name/Holder List”.)

Caution

• Always set the reagents at the specified positions to
obtain correct results.

• Confirm that reagents contain no bubbles. Other­wise, correct analysis results cannot be obtained.

• Be sure to set CA CLEAN I in Holder No. 11 (inner
right side).

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-11

Operation

Register Reagent Volume

7

CaCl2

0.0mL

0.0mL

8

HC IP

9



10 12

11

CleanI

OVB

Ready

Sysmex

PT

5.0mL

4.8mL

2

Fbg

AT3Thro

Replace Rack? YES!

3

APTT

0.0mL

0.0mL

4

AT3Subs

0.0mL

0.0mL

Enter Reagent Volume

51

0.0mL

0.0mL

6

0.0mL

0.0mL

0.0mL

0.0mL

0.0mL

0.0mL

Main

Menu

1. Press [Special Menu] key on the Root Menu screen.

The contents of the Root Menu will change over.

2. Press [Set Reagents] key in the Root Menu.

The Reagent Volume screen will display reagent level for each rea­gent holder.

3. Press the key of the reagent holder to be registered.
The Reagent Volume Entry Screen will display the numeric keys to

enter reagent volume.

Ready

Sysmex

Sysmex

1

PT

5. 0 m L

5. 0 m L

Replace Rack? YES!

Ready
Replace Rack? YES!

RENEW SETTING ?

Enter Reagent Volume

Enter Reagent Volume

IP HC

7

4

1

0

C

HC IP

89

5

6

3

2

Enter

.

Quit

4. Enter the reagent volume set on the reagent holder and press
[ENTER] key.

The value entered at the cursor position will be displayed. The sec­ond line will automatically display the available reagent volume to
be used for the analyses.

By pressing [↑] and [↓] keys, movement can be effected to the pre­ceding or following reagent holder No.

Note

• If the Reagent Volume Monitoring is set to “Valid”, each

time the reagent is dispensed, the volume for the test will
be subtracted from the entered value.

• Refer to “10.12 Setup of Reagent Volume Monitoring” for

the setting procedures.

• Refer to “10.11 Reagent Holder” for confirmation of vial

type.

5. Press [Quit] key on the numeric keys.
The Reagent Volume Screen will reappear.
Confirm the entered value.

6. Press [Main Menu] key on the Reagent Volume screen.
The Renew Check screen is displayed. Press [Cancel] key, [FIX]

key, or [Continue] key to return to the Root Menu screen.

Important

The reagent amount which was input is erased when the

FIX ContinueCancel

5-12 Sysmex CA-500 series

power is turned OFF.

Revised January 2003 - 2.0_en

5.7 Set Reaction Tubes

Operation

Reaction tube

30

Reaction tube rack

1

Set the reaction tubes for analysis on the reaction tube rack.
Set the reaction tube rack on the specified location on the analysis table.

Caution

• When setting reaction tubes on the reaction tube
rack, be careful not to drop sweat or the saliva into
the reaction tube. This will alter the analysis result.

• Reaction tubes are for single use only or incorrect
results may occur.

Important

• Set the reaction tube rack securely to prevent the
tubes from unseating and rising; otherwise, the probe
might be damaged.

• The reaction tubes are set successively from the first
position (top on extreme right-hand column). There­fore, make sure no position is left empty.

• Make ready some extra reaction tubes in addition to
the quantity needed for analysis.

• Be sure to use the supplied reaction tubes (SU-40).
The reaction tubes (SUA-400A) for CA-6000, etc. or
those manufactured by other companies cannot be
used.

Note

A maximum of 30 reaction tubes can be mounted on a reaction
tube rack. Since two reaction tube racks can be used, the max­imum number of reaction tubes that can be set is 60.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-13

Operation

5.8 Confirm Standard Curve

Ready

Sysmex

%

50.0

25.0

12.5

6.3

3.1




sec

11.4

17.4

27.9

52.6

11.4

1.73

Replace Rack? YES!

Cal Date 12/01/2001

PT Apc.63

Ref.

0.0

0.0

Standard

Analysis

Standard Curve PT
PT%

100.0

Normal

ISI

HC IP

Lot No.EXP.

Manual

Entry

12/31/2001

12/31/2001

Select

Param.

Confirm before performing analysis that the standard curve is correctly
set.

Caution

Unless the standard curve is properly set, percent activ­ity, concentration, and other calculation parameters can­not be reported.

1. Press [Standard Curve] key on the Root Menu screen.

The Standard Curve screen will be displayed.

2. Press [Select Test] key on the Standard Curve screen.

The Select Test screen will appear.

Select

Sysmex

Standard Curve

PT

VIII

Sysmex

Standard Curve PT
PT%

%

100.0

50.0

25.0

12.5

Normal

ISI

Select

Graph

Test

Ready
Replace Rack? YES!

APTT Fbg TT

AT3 BCPC Hep

Ready
Replace Rack? YES!

sec

PT Apc.63

11.4

17.4

27.9

52.6

0.0

6.3

0.0

3.1


11.4



1.73



Graph

Test

Print

Cal Date 12/01/2001

Ref.

Standard

Analysis

Print

Lot No.

Entry

HC IP

II

DDPl

HC IP

Lot No.EXP.

Manual

Entry

Lot No.

Entry

12/31/2001

12/31/2001

Main

Menu

Cancel

Select

Param.

Main

Menu

3. Press the analysis parameter key to be confirmed.
The standard curve data of the parameter selected will appear on the

standard curve screen.

4. Press [Graph] key.
Check the standard curve.

5. Press [Main Menu] key.
The standard curve setting program is now completed.

Repeat the above Step-(2 - 3) to confirm the standard curve of each anal­ysis parameter. For detail, refer to “9.2 Standard Curve Analysis”.

5-14 Sysmex CA-500 series

Revised January 2003 - 2.0_en

5.9 Execute Quality Control

5.10 Prepare Samples

Operation

To maintain the reliability of analyzed data, quality control has to be per­formed.
With the instrument, when QC File No. (QC01 - QC06) is registered for
ID No., and QC sample (control plasma, pooled plasma, etc.) is ana­lyzed, then analysis data is kept in the QC File. It is by processing this
analysis data with the QC Program that instrument stability that varies
from-time- to-time is monitored.

For detail of the QC Program, refer to “8. Quality Control”.

Set sample tubes or dispensed sample cups on the sampler rack.

Caution

If samples are left at room temperature for a long time,
they may deteriorate. Set samples to the sampler just
before analysis starts.

A

75mm18mm

1. Prepare plasma.

1) Add 1 part of 3.8%, 3.2% or 3.13%* sodium citrate solution as
anticoagulant to 9 parts of venous blood, and mix the contents
thoroughly.

2) Centrifuge the mixture at 3000 rpm for 15 minutes to separate

plasma components from blood components.

*Not for use in the USA.

3) Affix Barcode Label (Option).

To ensure correct reading of a barcode, a barcode label has to be

affixed at the proper position.

4) Set, in the supplied sample rack, the centrifuged blood tube itself

or the plasma which has been removed and put into another test
tube.
Insert the test tube securely to the bottom of the rack.
When an optional sample barcode scanner is used, set barcode
labels so as to face the scanner.

Warning

• Affix the barcode label so that the bars on the label
would become horizontal when the rack is placed on
the sampler. If the barcode label is affixed slanted,
the potential of the incorrect reading of the barcode
label will be increased.

Revised September 2003 - 2.0_en

Sysmex CA-500 series 5-15

Operation

Anticoagulant 3.8% sodium citrate solution

3.2% sodium citrate solution

3.13% sodium citrate solution*

Useable OD: 10 - 15 mm

HT: 65 -100 mm
(Tubes less than 8 mm in ID cannot be used)

*Not for use in the USA.

Caution

Cautions about handling plasma:

• As its container, use a plastic or silicone-coated
glass tube.

• As anticoagulant, use 3.8%, 3.2% or 3.13%* sodium
citrate solution. When any other anticoagulant than
this solution is used, it will cause a white precipitation
and lead to incorrect analysis results.

• Mix blood and sodium citrate solution in an accurate
ratio of 9 parts to 1 part, respectively. As the mixing
ratio varies, coagulation time also varies, occasion­ally leading to incorrect analysis results.

• Samples must be analyzed within 4 hours of collect­ing if stored cool.

• Those samples that had more than 4 hours pass
after collecting and those kept in improper storage
condition will not give correct analysis results.

*Not for use in the USA.

Dead volume of plasma-only sample

Plasma

ID

12

0.3 mL
or more

ID
13

0.4 mL
or more

0.2 mL
or more

ID

8.0 - 10.6

ID
11

0.3 mL
or more

Height between tube bottom and plasma surface: Approx. 7 mm

Dead volume of centrifuged sample

Plasma
layer

ID
13

0.6 mL
or more

0.3 mL
or more

Blood
layer

ID

8.0 - 10.6

11

ID

0.5 mL
or more

ID
12

0.5 mL
or more

Height of plasma layer: Approx. 4.5 mm

ID
14

ID

14

0.5 mL
or more

0.7 mL
or more

Revised September 2003 - 2.0_en

5-16 Sysmex CA-500 series

Operation

OD x Length Blood Volume

13 mm x 75 mm 1.8*, 2.4, 2.7**, 3.0**, 3.5**, 4.5 mL

13.2 mm x 78 mm 1.8, 2.7, 4.5 mL

12.8 mm x 75 mm 1.8, 2.7, 3.6 mL

12.7 mm x 75 mm 2, 3 mL

* Does not include VACUTAINER Plus Plastic Citrate Tube 1.8

mL (Becton Dickinson).

** Except for the following tubes with a double wall structure any

other tubes with a double wall structure which are not applica­ble:

- VACUTAINER Plus Plastic Citrate Tube, 2.7 mL

- VACUETTE Sandwich Coagulation Tube, 3.0 mL/3.5 mL

Caution

• The blood volumes shown above are the dead vol­umes. (Prepare an extra volume for the parameter to
be analyzed.)

• If there is plasma only in the test tubes and the sam­ple volume is lower than the dead volume, air may
get aspirated and/or a “Probe Crash” or “Sampling
Error” may occur, preventing correct analysis results
from being obtained.

• If there is plasma only in the tubes, it is not recom­mended to use the following tubes with a double wall
structure because their narrow inner diameters and
higher bottom positions cause a higher possibility of
a short sample error.

- VACUTAINER Plus Plastic Citrate Tube,
13 mm × 75 mm, 2.7 mL

- VACUETTE Sandwich Coagulation Tube,
13 mm × 75 mm, 3.0 mL/3.5 mL

• If the sample volume of centrifuged samples is lower
than the dead volume, blood cells may get aspirated,
preventing correct analysis results from being
obtained.

Revised April 2004 - 2.0_en

Sysmex CA-500 series 5-17

Operation

Caution

• When using test tubes with an outside diameter of 15
mm, remove the 13 mm tube adapters from the sam­ple rack beforehand.
When using test tubes with an outside diameter of 10
mm, remove the adapters from the sample rack and
mount the optional holder No. 113 (φ10 mm test tube
adapter) beforehand.

• When using sample cups, set the optional holder No.
70 beforehand.

• When using sample cups, avoid setting samples
which are low in plasma volume. Such samples will
cause the error of “Sample Probe Crash”.
For samples, prepare the required volume plus 100
µL.

Sampler

Sampler Rack Sensor

2. Pull out the sampler.

3. Set the sample rack in the sampler.
Only one rack (10 s amples) can be set.

Important

Unless the sample rack is correctly set, instrument fail­ure will result.
Press in the sample rack sensor (lower left) so that the
sample rack is level.

5-18 Sysmex CA-500 series

Revised September 2003 - 2.0_en

5.11 Set Sample Nos.

Set Sample Nos. and Analysis Parameters

With the instrument, all samples are analyzed according to the analysis
order.

Analysis information for 10 samples (1 rack filled) can be set at a time.
There are four procedures for setting sample ID Nos. and analysis

parameters:

• Manual setting with the numeric keys and analysis parameter

• Receiving sample ID Nos. and analysis parameters collectively

• Manually entering sample ID Nos. so that analysis orders will be

• Using sample ID Nos. that have been read with the optional bar-

Operation

keys.

from the host computer (Refer to “5.12 Manual Inquiry”.)

automatically received from the host computer (Refer to
“5.13 Automatic Inquiry”.)

code scanner so that analysis information will be automatically
received from the host computer. (Refer to “5.13 Automatic
Inquiry”.)

Setting of Sample ID Nos.

Ready

Sysmex

Main Menu

1 PT 2 APTT 3 Fbg

-01

01-01 123-456-78901

01-02



01-03
01-04
01-05

Replace Rack? YES!

ID No.
123-456-78901
123-456-78902
123-456-78903
123-456-78904
123-456-78905

Repeat

4 TT 5 AT3

12345

HC IP

Group 1

7

4

1

0 −



C

ID No.

Q C

Start

89

5

6

3

2

Enter

Quit

Important

The instrument does not store analysis information. The
information is erased when power is turned off.

1. Specify the rack to be set on the Root Menu screen.

Press [↑] and [↓] keys to move the cursor to the desired rack posi­tion.

2. Press [ID No. Entry] key.

The numeric keys screen will be displayed.

3. Enter sample ID No. and press [Enter] key.
By pressing [C] key, you can erase one letter entered (back space

function).
When entering a sample ID No. for QC, press [QC] key following a

numeral between 01 - 06.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-19

Operation

Important

• When an ID No. is not registered, this instrument
automatically assigns it. After power turn-on, it
begins with 000000000000001 (15 digits), which is
incremented by 1 at a time.

• Analysis results will not be stored in a QC File if a
Standard Curve is not set and QC parameters are set
as calculation parameters.

Note

To completely erase a registered sample ID No., position the
cursor over the number and press first [C] key then [Enter]
key.

Group Selection

4. Press [Quit] key on the numeric keys.

The screen returns to the Root Menu.

A combination of analysis parameters, selected from three menus, can be
set. The analysis parameters that can be set are limited to those in the
selected group.

1. Press [Test Group] key on the Root Menu.

The Group Setting screen will be displayed.

Note

When the cursor is on a rack which has been or is being
analyzed, [Test Group] key is not displayed if an analysis
parameter is already set.

2. Press [Group] key.
Select a group from among three groups ([Group 1] - [Group 3]) by

using [↑] key, or [↓] key. For the group setting program, refer to
“10.10 Setup of Test Group”.

5-20 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Setting of Analysis Parameters

Operation

3. Press [Return] key.

The Root Menu will return and the analysis parameter will change to
the parameter selected with the group setting program .

Note

Using this [Test Group] function, Fbg with alternative dilu­tion ratios can be displayed.

• + Fbg is a parameter that is analyzed with Fbg diluted to

1:20 (a half of the usual concentration).

• - Fbg is a parameter that is analyzed with Fbg diluted to

1:5 (2 times of the usual concentration).

Ready

Sysmex

Stored

Data

Replace Rack? YES!

12345

Repeat

Standaed

QC

Curve

Main Menu
1 PT 2 APTT 3 Fbg4 TT 5 AT3

Rack ID No.

02-01 123-456-78901

01-01 123-456-78901


01-02 123-456-78902
01-03 123-456-78903
01-04 123-456-78904
01-05 123-456-78905

Repeat

Ready

Sysmex

Stored

Data

Replace Rack? YES!

12345

Repeat

Standaed

QC

Curve

Main Menu
1 PT 2 APTT 3 Fbg4 TT 5 AT3

Rack ID No.

02-01 123-456-78901

01-01 123-456-78901


01-02 123-456-78902
01-03 123-456-78903
01-04 123-456-78904
01-05 123-456-78905

HC IP

Group 1

ID No.

Entry

Test

Group

HC IP

Group 1

ID No.

Entry

Test

Group

Start

Prev

Next

HC

Special

Menu

Start

Prev

Next

HC

Special

Menu

1. Specify the samples to be set on the Root Menu screen

Press [↑] and [↓] keys to move the cursor to a sample to be set.

2. Set an analysis parameter by pressing analysis parameter keys.

Each time an analysis parameter key ([PT], [APTT], [Fbg], [TT],
[AT3]) is pressed, signs “- (Not analyze)” and “O (Analyze)” change
alternately.

Assigns consecutive sample ID Nos. for one rack (10 samples), with the
cursor positioned at the top, and copies analysis parameter setting for all
subsequent samples.

1. Using [↑] and [↓] keys, specify a sample you want to repeat.

2. In the Root Menu screen or ID No. Entry screen, press [Repeat] key.

Important

When sample ID No. is “0” or it is for QC or Standard
Curve, [Repeat] cannot be executed.

Note

Sample ID No. cannot be carried beyond “-”.
For example, the number following 1-99 will be 1-00.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-21

Operation

5.12 Manual Inquiry

5.13 Automatic Inquiry

When the instrument is bidirectionally connected with the host compu­ter, analysis information for one rack (10 samples), ba sed on rack Nos.,
can be received prior to analysis. For this purpose, the host computer
needs to be set in the conditions shown below. For detail, refer to
“10.14 Devices to be connected”.

Connection: Connected
Class: Class B
Inquiry: Manual

1. Press [HC] key on the Root Menu.
The instrument makes inquiries to the host computer for a specified

rack No. and receives analysis information. Each time analysis infor­mation is received for one sample, it is displayed on the screen.

2. Analysis information received is confirmed on the screen.

The following automatic inquiry process is performed depending on bar­code scanner connection status and order entry status.

Sample ID No. With manually entered order Without manually entered order

Without barcode scanner • No inquiry to host computer

• Analysis with automatically-

assigned sample ID No. and manu­ally entered order

With
barcode
scanner

Reading normal • No inquiry to host computer

• Analysis with sample ID No. from

barcode and manually entered order
of barcode

Reading error • No inquiry to host computer

• Analysis with error No. and manu-

ally entered order

Automatic Inquiry (without barcode scanner)

When the instrument is bidirectionally connected with the host compu­ter, the instrument can receive, in advance, analysis information for one
rack (10 samples) based on manually entered sample ID Nos.

The host computer must be set in the conditions given below. For detail,
refer to “10.14 Devices to be connected”.

Host Computer Status: Connected

Barcode scanner: Not connected

• No inquiry to host computer

• No analysis

• Inquiry made to host computer

using sample ID No. from barcode

• Analysis with sample ID No. and

order from host computer

• No inquiry to host computer

• No analysis

Class: Class B
Inquiry: Auto

1. Manually set sample ID Nos.
Refer to “5.11 Set Sample Nos.”.

5-22 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Operation

Ready

Sysmex

Main Menu
1 PT 2 APTT 3 Fbg

Rack ID No.

01-01 123-456-78901

01-02 123-456-78902
01-03 123-456-78903
01-04 123-456-78904
01-05 123-456-78905

Replace Rack? NO!

HC Inquiry
Please wait.

4 TT 5 AT3

12345

HC IP

Group 1

Start

Prev

Next

2. Press [Start] key.

Instrument makes inquiries to the host computer using the manually
entered ID No. for one sample at a time. It then displays the analysis
information on the screen, and starts analysis when the inquiries for
10 samples are completed.

Automatic Inquiry (with barcode scanner)

When the instrument is bidirectionally connected with the host compu­ter, and the optional barcode scanner is fitted, the instrument can receive
analysis information for one rack (10 samples), based on the ID Nos.
read with the barcode scanner.

The host computer must be set in the conditions shown below. For detail,
refer to “10.14 Devices to be connected”.

Host Computer Status: Connected

Barcode scanner: Connected

1. Set the samples in the sample rack.

Important

• Inquiry is not performed for those samples on which

both ID Nos. and analysis parameters have been set.

• Inquiry is not performed either for those samples on

which ID Nos. have not yet been set.

Class: Class B
Inquiry: Auto

Revised January 2003 - 2.0_en

Set the samples with the barcode labels facing toward you for read­ing.

2. Pull out the sampler, set the sample rack, and push it in.

3. Press [Start] key.

The sample ID Nos. for one rack are read from the barcode labels,
and inquiries are made to the host computer for those ID Nos. When
the analysis information is received, it is displayed on the screen and
analysis is started.

Caution

Remove any foreign matters, if exists, on barcode drive
mechanism.

Note

• Should any error occur in reading barcode labels, the sam-

ple ID Nos. become “ERR0000000001” and increase in
sequence. Inquiry is not performed.

Sysmex CA-500 series 5-23

Operation

5.14 Start Analysis

Note

• Regarding the rack positions for those ID Nos. that have

been manually set, you can make inquiries to the host
computer using the manually set ID Nos, without reading
barcodes.

• Inquiries are not made for samples with registered analysis

parameters.

With completion of analysis preparation and registration of analysis
information, the instrument is now ready to start analysis.

1. Check the system status display of the instrument.
Make sure that the Root Menu screen displays “Ready”.

2. Press [Start] key.

Ready

Sysmex

Sysmex

Stored

Data

Replace Rack? NO!

Continue

Analyzing
Replace Rack? NO!

12345

Repeat

Group 1

Select Tube Position

Main Menu
1 PT 2 APTT 3 Fbg 4 TT 5 AT3

Rack ID No.

02-01 123-456-78901

02-02 123-456-78902
02-03 123-456-78903
02-04 123-456-78904
02-05 123-456-78905

HC IP

First
Tube

HC IP

ID No.

Entry

INTERR

Prev

Next

HC

The screen confirming the first tube's initial position will appear.

3. Press [Continue] key or [First Tube] key.
[Continue] key: Starts with the reaction tube that follows the last

used tube in the previous analysis.

[First Tube] key: Starts with the upper extreme-right tube in the

right-hand reaction tube rack.

Important

When you have pressed [First Tube] key inadvertently,
causing the instrument to stop by error, then Continue
information for the reaction tubes is lost. In this case, set
the reaction tubes again from the first position, and press
[Start] key.

Note

• The first time the analysis is started after power switch on,

[Continue] key is not displayed.

5-24 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Ready

Sysmex

Select Tube Position

Replace Rack? NO!

Rinsing Probe program was
forced to run due to long
interval.

HC IP

Operation

Note

• When analysis begins, if 24 hours have been passed from

the previous run, following will be displayed and rinsing
program will run automatically to replace rinse and buffer
solutions in the hydraulic lines. It will take approximately
3 minutes.

• Automatic sensitivity adjustment of the detector is per-

formed when the first analysis starts after power-ON, or
when analysis starts after each interval of 24 hours. (Refer
to “5.15 Automatic Sensitivity Adjustment of the Detector
(for CA-530, CA-540, CA-550 and CA-560 only)”.)

4. When all analyses are over, the alarm sounds “pip, pip, peep”.
If you want to continue analysis, when the message “Replace Rack?

No!” changes to “Replace Rack? YES!”, then samples can be set to
the next sample rack or the same sample rack. (Refer to “5.18 Add
Samples” for sample addition.)

Even during analysis, when the [INTERR] key changes to the
[Start] key, it will be possible to analyze samples in the next rack.

Warning

During analysis, do not insert hands or fingers, either
through the gap in the light shield cover or by opening
the cover. This is to avoid the risk of injury. If you open
the light shield cover during operation, the alarm will
beep and the instrument will stop.

Caution

When the power switch is turned off during operation,
the instrument will fail. Make sure the analysis has been
completed and the instrument status display is “Ready”
before turning off the power switch.

Important

During operation, the sampler cannot be pulled out as
the lock mechanism is activated to prevent injury and
damage to the instrument.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-25

Operation

Note

RESTRICTIONS DURING OPERATION

• Only [Stored Data], [↑], [↓], [Repeat], [ID No. Entry],

[HC], [Prev], [Next] in the Root Menu can be used during

operation.

• Once registered, analysis information cannot be changed.

5.15 Automatic Sensitivity Adjustment of the Detector (for CA-530, CA-540, CA-550 and CA-560 only)

At the start of analysis at either of the times below, sensitivity adjustment
of the detector is performed automatically.

• Start of first analysis after power-ON

• Start of analysis after each interval of 24 hours

Ready

Sysmex

Replace Rack? NO!

The Intensity of the LED in the 
Immunoassay channel 
is becoming weak. However analysis is
still possible. Please contact your
local SYSMEX representative for 
replacement of the LED.
Please press "Start" to continue 
the analysis.

Start Cancel

IP

Note

When Chromogenic Method parameters are included in the
parameters selected for group settings, adjustment is per­formed for the Chromogenic Method detectors. When Immu­nology Method parameters are included, adjustment is per­formed for the Immunology Method detectors.

First, 200 µL Owren’s Veronal Buffer is aspirated and dispensed in
the reaction tube. Then, using the buffer, automatic sensitivity adjust­ment is performed in the detectors for the Chromogenic Method and
Immunology Method (for CA-550 and CA-560 only) respectively.

If the results of sensitivity adjustment indicate that the detector
(LED) must be replaced, then a message will appear prompting the
operator to replace the detector. Contact your local service represent­ative.

The message varies as shown below according to the detector.

• For the Chromogenic Method detector:

“The Intensity of the LED in the Chromogenic channel is becom­ing weak.”

• For the Immunology Method detector :

“The Intensity of the LED in the Immunoassay channel is
becoming weak.”

• For both the Immunology Method detector and the Chromogenic

Method detector:
“The Intensity of the LED in the Chromogenic and Immunoassay
channels are becoming weak.”

5-26 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Analysis can still be performed after the replace-detector mes­sage has appeared.

Press [Start] key to continue with analysis.

To cancel analysis, press [Cancel] key.

5.16 Display Analysis Result

Analysis Status Display (Root Menu screen)

Analysis status of each sample is displayed on the Root Menu screen.

A sample is distinguishable by ID No. and rack position.

Analyzing

Sysmex

Stored

Data

Replace Rack? NO!

Main Menu
1 PT 2 APTT 3 Fbg

Rack ID No.

02-01 123-456-78901

02-02 123-456-78902
02-03 123-456-78903
02-04 123-456-78904
02-05 123-456-78905

4 TT 5 AT3

12345

Repeat

HC IP

Group 1

ID No.

Entry

INTERR

Prev

Next

HC

1. Press [Prev] key, [Next] key, [↑] key, or [↓] key to search for sam-

ples whose analysis status you want to check.

2. Current analysis status of each of the applicable samples is displayed
as follows:

Meanings of the analysis status symbols:

– : Analysis is not ordered for the parameter.

: Analysis is requested.

: Analysis is in progress.

Operation

Note

Display and Printout of Sample Data

HC IP

All Seq 0/142(142)

PT%APTT





88.1

88.1 

88.1

88.0 

87.9 

88.0 

87.9

More

Mark

Main

Menu

Revised January 2003 - 2.0_en

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

Graph

sec

11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

Prev Next

PT

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0



: Analysis is completed.

× : Analysis is not completed due to interruption or error.

1. Press [Stored Data] key on the Root Menu screen.

Analysis data will be displayed in the list format.

2. To display coagulation curves, press [Graph] key.

Move the cursor to the sample whose coagulation curve you wish to
display, and press [Graph] key.

Sysmex CA-500 series 5-27

Operation

Ready

Sysmex

0

Change

Scale

Replace Rack? YES!

60

Edit

ID No.

Output Delete

Stored Data 0/142(142)
ID No. 123-456-78901 36.8ûC
01-01 12/01 17 : 28
(PT : 100.0%)

HC IP

∗ 123.4 sec(50)

123.4%


--.--

--.--


mg/dl

--.-­ERR [ 8]
bH [ 56] dH [ 123]
CH No. [1]


Info

Return

5.17 Interrupt Analysis

Analyzing

Sysmex

Stored

Data

Replace Rack? NO!

Main Menu
1 PT 2 APTT 3 Fbg

Rack ID No.

02-01 123-456-78901

02-02 123-456-78902
02-03 123-456-78903
02-04 123-456-78904
02-05 123-456-78905

4 TT 5 AT3

12345

Repeat

HC IP

Group 1

ID No.

Entry

INTERR

Prev

Next

HC

For detail, refer to “6. Display and Processing of Analysis Results”.

The analysis process can be interrupted at any time.

1. Press [INTERR] key.

While analysis is being performed, [Start] key at the upper right cor­ner of the screen is replaced by [INTERR] key.

The Interruption Confirmation screen will be displayed.

Analyzing

Sysmex

Replace Rack? NO!

Interrupt sampling ?

AddReag AddOrder STAT

HC IP

Cancel

2. Press [AddReag] key, [AddOrder] key, [STAT] key, or [Cancel]
key.

[AddReag] key: The interruption process starts and no new analy-

sis is performed.

[AddOrder] key: The order addition process starts.

[STAT] key: The process moves to the STAT sample process-

ing. Refer to “5.19 Analyze STAT Sample”.

[Cancel] key: The screen returns to the original one.

Note

While the Interruption Confirmation screen is on, the instru­ment is performing analysis.
When all analyses are completed with this screen on, the Root
Menu screen returns and “Ready” is displayed.

5-28 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Ready

Sysmex

Replace Rack? YES!

1 PT 2 APTT 3 Fbg

Rack ID No.
02-01 123-456-78901
02-02 123-456-78902
02-03 123-456-78903

02-04 123-456-78904

02-05

Order remains.
OK?

Start Cancel

4 TT 5 AT3

12345



HC IP

Group 1





Operation

3. During the analysis interruption process, [Resume] key is displayed

at the upper right corner of the screen.
When you want to interrupt analysis, do not press [Resume] key.
When [Resume] key is pressed:

Analysis restarts.

When [Resume] key is not pressed:

When analysis for dispensed samples is completed, and there are

still parameters remaining to be analyzed, a screen is displayed to
confirm analysis continuation. If reagent is to be added, add it at
this time.

4. When you want to interrupt analysis, press [Cancel] key.

[Start] key: Analysis restarts.
[Cancel] key: Analysis is canceled and the screen returns to the Root

Menu.

Note

The samples whose analysis has been canceled have “X” dis­played in the Work List.

5.18 Add Samples

Sysmex

Main Menu Group 1

1 PT 2 APTT 3 Fbg

Rack ID No.
02-01 123-456-78901

02-02 123-456-78902
02-03 123-456-78903
02-04 123-456-78904

02-05 000-00001

Waiting
Replace Rack? YES!

4 TT 5 AT3

12345

Repeat

HC IP

ID No.

Entry

Resume

AddOrder

Cancel

Next

HC

1. Press [INTERR] key.

The Interruption Confirmation screen will be displayed.

2. Press [AddOrder] key on the Interruption Confirmation screen.

Analysis of the new sample will be interrupted, and the Sample
Addition screen will be displayed.

3. When the analysis interruption process is completed, “Replace Rack?
YES!” is displayed.

Then the sampler can be pulled out.

4. Pull out the sample rack only, without opening the light shield cover,
and register the parameters to be added.

Important

• Registered sample ID Nos. and orders cannot be
modified.

• Additional orders can only be registered to a position
after the final rack position of the registered orders.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 5-29

Operation

5. Register sample ID Nos. and analysis parameters for additional
orders.

• When entering sample ID Nos. manually, press [ID No. Entry]

key, and input sample ID Nos.
Refer to “5.11 Set Sample Nos.”, or “Automatic Inquiry (without
barcode scanner)” of “5.13 Automatic Inquiry”.

• Press [HC] key to receive sample ID Nos. and analysis parame -

ters from the host computer.
Refer to “5.12 Manual Inquiry”.
This registration process is not required when sample ID Nos. are
read using an optional barcode scanner, and analysis parameters
are sent automatically from the host computer.

Note

To cancel addition of orders, press [AddOrderCancel] key.

6. Press [Resume] key.
Analysis restarts.

5.19 Analyze STAT Sample

Waiting

Sysmex

Sysmex

Replace Rack? NO!

12345

Waiting
Replace Rack? YES!

4 TT 5 AT3

12345

Main Menu Group 1

1 PT 2 APTT 3 Fbg 4 TT 5 AT3

Rack ID No.

01-07 123-456-78901
01-08 123-456-78902
01-09 123-456-78903
01-10 123-456-78904

01-00 000-00001

Main Menu

1 PT 2 APTT 3 Fbg

Rack ID No.

01-06 123-456-78901
01-07 123-456-78902
01-08 123-456-78903
01-09 123-456-78904

01-00 000-00001

HC IP

ID No.

Entry

HC IP

Group 1

ID No.

Entry

Cancel

STAT

HC

Start

STAT

Cancel

STAT

HC

1. Press [INTERR] key.
The Interruption Confirmation screen will come on.

2. Press [STAT] key.
Analysis of the new sample will be interrupted.

3. When the analysis interruption process is over, “Replace Rack?
YES!” is displayed, and the sampler can now be pu lled out.

4. Set a STAT sample in a STAT sample rack.

5. Register ID Nos. and analysis parameters for STAT samples.
When entering sample ID Nos. manually, press [ID No. Entry] key,

and input sample ID No.
Refer to “5.11 Set Sample Nos.”.
Press [HC] key to receive sample ID Nos. and analysis parameters

from the host computer.
Refer to “5.12 Manual Inquiry”.

Note

To cancel registration of STAT samples, press [Cancel
STAT] key.

5-30 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Waiting

Sysmex

Replace Rack? YES!

1 PT 2 APTT 3 Fbg

Group 1

4 TT 5 AT3

HC IP

Operation

6. Press [Start STAT] key.

Analysis of a STAT sample starts.

Rack ID No.
01-06 123-456-78901
01-07 123-456-78902
01-08 123-456-78903
01-09 123-456-78904

01-00 000-00001

Replace STAT Sample.
OK?

Start Cancel

12345



5.20 Emergency Stop

Note

When [Start STAT] key is pressed without pulling out the
sampler, the message “Replace STAT Sample. OK?” will
appear. Press [Cancel] key, and STAT Sample Order Setting
screen returns without starting STAT analysis.

7. When STAT analysis is completed, analysis of the original rack con­tinues.

Note

• Rack Nos. 01-00, 02-00, 03-00, and 99-00 of STAT sam-

ples are displayed and 99-00 is followed by 01-00.

• While STAT sample is being dispensed, [INTERR] key is

not displayed.

By pressing the Mechanical Stop switch, analysis operation can be
stopped immediately.

Revised January 2003 - 2.0_en

Important

• Should the analyzer need to be shut down in an
emergency, such as an unexpected outage of power
to the laboratory, immediately turn off the power
switch to the main unit.

• Note that the above-mentioned switch differs from
the emergency mechanical stop switch (red switch)
on the front of the instrument. When the red mechan­ical stop switch is pressed, the mechanical system
comes to a stop but the power supply is not turned
off.

Sysmex CA-500 series 5-31

Operation

Mechanical Stop Switch

1. Press the Mechanical Stop switch (red switch).
Analysis operation will stop immediately.

2. When the Mechanical Stop switch is pressed during photo detection,
the screen for confirming whether to stop photo detection comes on.

Analyzing

Sysmex

Yes

Sysmex

Replace Rack? NO!

Analyzing
Replace Rack? NO!

Mechanical Stop

Mechanical Stop

HC IP

Stop Analysis?

Please wait until analysis is completed

HC IP

Discard/Start rinse operation?

3. To stop analysis, press [Yes] key.
When the sample tube is not in place at the detector, the following

screen comes on:

Caution

• When photo detection is stopped and discard/rinse
operation starts, the sample data being analyzed is
discarded.
Reanalyze sample data marked with “×” in the Work
List.

• If the sampler table is pulled out when the sample
probe is lowered in the tube, the sample probe will be
permanently damaged.

4. To start discard/rinse operation, press [Yes] key.

The screen will display the message “Discard/Rinse in progress.
Please wait.”.

The discard/rinse operation will be executed.

Note

No

Yes

In what case is rinse operation not possible
The system is stopped and starting operation could damage the
sample probe.

Analyzing

Sysmex

Mechanical Stop

Replace Rack? NO!

HC IP

5. When rinse operation cannot be performed, press [No] key.

6. When an unanalyzed order remains, the screen for choosing whether
to continue analysis comes on.

Discard/Rinse in progress
Please wait.

5-32 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Operation

Ready

Sysmex

Replace Rack? YES!

1 PT 2 APTT 3 Fbg

Rack ID No.
01-06 123-456-78901
01-07 123-456-78902
01-08 123-456-78903
01-09 123-456-78904
01-00 000-00001

Order remains.
OK?

Start Cancel

4 TT 5 AT3

12345



Group 1



HC IP

7. Press [Start] key or [Cancel] key.

5.21 Shutdown

Turn OFF the Power

Confirm that the instrument status is “Ready” before turning off the
power switch.

Operation after Analysis Completion

At the conclusion of the day's analyses or after the instrument has been
run for at least 24 hours, perform the following daily maintenance:

[Start] key: Starts analysis.
[Cancel] key: Interrupts analysis and returns the screen to Root

Menu.

1) Discard the used reaction tubes.

2) Dispose of waste fluids.

3) Remove dew from the reagent holders.

4) Clean the sample probe.

For detail, refer to “11. Maintenance and Supplies Replacement”.

Caution

If the power is turned off when the rinse bottle or waste
bottle are lying flat, the solution may flow back into the
instrument.
Before turning off the power switch, confirm that the bot­tles are not lying flat.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 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

Revised January 2003 - 2.0_en

Sysmex CA-500 series

Display and Processing of Analysis Results

6. Display and Processing of Analysis Results

The instrument displays analysis results and information that helps inter­pret analysis results, and outputs them to external devices. This chapter
describes the processing of analysis results, including display of stored
data and output to external devices.

6.1 List Display/Graphic Display

The instrument can store analysis results of up to 300 samples (1500
tests) and reaction curves of the latest 600 tests. The stored data is kept
even when the power switch is turned off and will be displayed unless
erased.

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

PT

sec

11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

HC IP

All Seq 0/142(142)

PT%APTT



88.1

88.1

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0



Mark



88.1 

88.0 

87.9 

88.0 

87.9

1. Press [Stored Data] key on the Root Menu screen.

The analysis result will appear in List Display together with Local
Menu of Stored Data.

By pressing [More] key, Local Menu can be changed-over. When a
desired Local Menu is not displayed, press [More] key.

Graph

Prev Next

List Display

More

Main

Menu

When [Stored Data] key on the Root Menu is pressed, the Analysis
Result screen appears. While the Graphic Display screen is on, press
[Return] key on Local Menu to view the analysis results.

Note

Using [Select Display] and [ID No./Seq] keys, you can
change a stored data to be displayed and its chronological
sequential arrangement. When the power switch is turned off
or the display is returned to the Main Menu, however, all
stored data return to the previous list in chronological analysis
sequence.

The Stored Data List Display screen can display up to 8 samples per
screen. When the first List Display screen appears after the power switch
is turned on, data of the last 8 samples is displayed. When latest analyses
are completed, those sample data are automatically added to the last of
the List. The List Display screen is composed of the analysis results,
showing 3 data parameters at a time, and the sample information. Use
[←] and [→] keys to switch between pages.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 6-1

Display and Processing of Analysis Results

Ready

Sysmex

Replace Rack? YES!

ID No.

123-456-78901
123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906

123-456-78907

123-456-78908

Graph

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

Graph

sec

11.5 88.232.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

Prev Next

sec

11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

Prev Next

HC IP

All SeqStored Data

PT



All Seq 0/142(142)
PT



2/142(142)

PT%APTT



88.1

88.1

88.1

88.0

87.9

88.0

87.9

More

HC IP

PT%APTT



88.1

88.1 

88.1

88.0 

87.9 

88.0 

87.9

More

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0
Mark

Main

Menu

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0



Mark

Main

Menu

Key operation on the List Display screen is as follows:

[Prev] key: Scrolls down one display screen (8 samples).
[↑] key: Moves the cursor up one sample position.

When the cursor is at the top of the screen, the List
scrolls down.

[↓] key: Moves the cursor down one sample position.

When the cursor is at the bottom of the screen, the List
scrolls up.

[Next] key: Scrolls the List up one screen (8 samples).
[←] [→] key: Turns over a page (scrolls sideways).
[Mark] key: Attaches or deletes marking.

When you press [Mark] key on the List Display screen, a mark ( ) can
be put on an analysis data in the current cursor position. The mark will
appear at left side of the data.

When an analysis data is already attached with a mark, pressing [Mark]
key causes the mark to be deleted.

Analysis Result Screen

When [Stored Data] key on the Root Menu screen is pressed, the Analy­sis Result screen appears first. This screen also appears when you press
[→] key on the Sample Information screen.

The Analysis Result screen displays the results for calculation para mete r
and coagulation time that were selected in the test protocol and standard
curve parameter setting. Analysis parameters are shown with
3 parameters on each page. [←] and [→] keys can be used to change
parameters.

The following contents are displayed on the Analysis Result screen.
ID No.:

Sample ID Nos. entered by operator, transmitted from host computer,
and read by barcode scanner are displayed.

Calculation parameters, coagulation time, ∆OD/min:
The calculation results and coagulation time or ∆OD/min for each

parameter are displayed. If the calculation did not take place nor­mally for any parameter, one of the following is displayed.

***.* : Analysis data was not obtained due to an error or other cause.

- - -.- : The calculation parameter could not be calculated.
+++.+ : The c alculated value was large and exceeded the number of

available display digits.

6-2 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Display and Processing of Analysis Results









Abnormal Flag:

Abnormal flags displayed on the right or left of an analysis data indi­cate the following:

m (on right of ID No.): The data is a mean. The parameter ha s been

calculated from mean data of seconds or
∆OD/min.

! (on right of ID No.): A dilution ratio other than 100% was used for

the data.

* (on left of data): Some kind of error has occurred, or there is

deviation in repeated analysis.
> (on left of data): A data that exceeds the Upper Report Limits
< (on left of data): A data that exceeds the Lower Report Limits
+ (on right of data): A data that exceeds the Upper Mark Limits

- (on right of data): A data that exceeds the Lower Mark Limits

Note

“*” has a higher display priority than “>” and “<” flags.

Ready

Sysmex

Replace Rack? YES!

DATE TIME RACKID No.



12/31

12:55

12/31

12:57

12/31

12:58

12/31

12:59

12/31

12:56

12/31

12:57

12/31

12:58

12/31

12:59

Graph

Prev Next

SEQ

123-456-78901

1

123-456-78902

2

123-456-78902

3

123-456-78902

4

123-456-78905

5

123-456-78906

6

123-456-78907

7

123-456-78908

8



All



HC IP
SeqStored Data

More

0101

0102
0103
0104
0105
0106
0107
0108



0/142(142)

OUT

HP

HP
HP
HP
HP
HP
HP
HP

Mark

Main
Menu

Sample Information Screen

When [←] key is pressed on the first page of the Analysis Result Screen,
the Sample Information screen will be displayed.

Contents of Sample Information Screen
DATE: The date the analysis was conducted.
TIME: The time the analysis result was obtained.
SEQ: A sequential sample number counted from power turn-on.
ID No.:

The sample No. entered by operator, transmitted from host computer,
or read by barcode scanner.

RACK:

The rack number and tube position number are displayed as follows:

Rack No. Tube Position No.

Normal Sample, QC Data 01 - 99 01 - 10
STAT Sample 01 - 99 00
Standard Curve 00 01 - 06

OUT:

Data output flag:
H: When output to the host computer, the flag disappears.
P: When output to the built-in printer, the flag disappears.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 6-3

Display and Processing of Analysis Results

Graphic Display

Using the cursor, specify a sample to be graphically shown on the List
Display screen, then press [Graph] key on the Local Menu. This enables
displaying the coagulation curve of the sample chosen from the stored
data.

While Graphic Display is on, press [↑] key to display a sample one posi­tion above on the List; and press [↓] key to display a sample one position
below.

By pressing [←] and [→] keys, a parameter for an identical sample can
be shifted to another parameter.

(1)
(2)
(3)

Stored Data 0/142(142)

(4)

ID No. 123-456-78901 36.8˚C
01-01 12/01/2001 17 : 28
(PT : 100.0%)

(5)
(6)
(7)
(8)

Sysmex

x 4

0

Ready
Replace Rack? YES!

ERR [ 8]
dH [ 123] bH [ 56]
CH No. [1]

60



HC IP

∗ 123.4 sec(50)

123.4%


--.--

--.--


mg/dl

--.--

Info

(11)
(12)

(13)
(14)

(15)
(16)

(9)

(10)

Change

Scale

Edit

ID No.

Output Delete

Return

The following contents are displayed on the Graphic Display screen.

1. Analysis Time
Time of day the analysis result was obtained

2. ID No.
Sample ID No. entered by operator, transmitted from host computer,

or read by barcode scanner

3. Analysis Date
Date the analysis was conducted

4. Rack No./Tube Position No.
Rack No. and tube position No. where sample was placed:
00 - 99: Rack No. (00 indicates standard curve analysis.)
00 - 10: Tube position No. (00 indicates STAT sample holder.)

5. Analysis Parameter Name/Dilution Ratio
Analysis parameter and dilution ratio of the displayed reaction curve

6. Scale of Scattered Light Intensity
If an enlarged graph is available, an enlarged graph with the scale

such as “x4” is displayed when [Change Scale] key is pressed.

6-4 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Display and Processing of Analysis Results

7. Reaction curve
A graph is plotted with time on the horizontal axis and the scattered

light intensity or light absorbance variation on the vertical axis.
Time scale is shown at right end.
When the reaction curve graph area is pressed, the Graphic Enlarge-

ment window will be displayed. Refer to “Graphic Enlargement
Window” described later.

8. Error code
Error code when an error occurs in analysis result
When there is no error, 0 appears.

9. dH
Increase of scattered light intensity in reaction process

10. CH No.
Detection channel in which analysis was conducted

11. Abnormal Flag
Abnormal flags displayed on the right or left of an analysis data.

12. Coagulation Time or Light Absorbance Variation
Time taken for coagulation or change in light absorbance

13. Analysis Temperature
Temperature of the detector at the start of analysis

14. Coagulation detection point
Coagulation detection point set
It is not displayed in case of analyses by Chromogenic Method and

Immunology Method.

15. Calculated Parameters
Activity percentage, PT ratio, INR (PT), (Fbg concentration), etc.

16. bH
Scattered light intensity at the start of analysis

Note

Reaction curve is not displayed when some error occurred dur­ing analysis and no analysis data was obtained. The curve is
also not displayed for the mean data of repeated analysis.

Error Detail Window

When an analysis error has occurred, its detail can be displayed in the
window.

1. Press [Info.] key on the Graphic Display screen to display the Error
Detail window.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 6-5

Display and Processing of Analysis Results

Ready

Sysmex

Stored Data
ID No. 123-456-78901
01-01 12/01/2001 17:28
<PT :100.0%>

Replace Rack? YES!

0 60

HC IP

0/142(142)

33.0˚C

∗ 23.4 sec(50)

Temp Error

Return

Graphic Enlargement Window

Ready

Sysmex

Stored Data
ID No. 123-456-78901
01-01 12/01/2001 17:28
<PT :100.0%>

Replace Rack? YES!

HC IP

0/142(142)

33.0˚C

∗ 23.4 sec(50)

2. Press [Return] key of Error Detail Window.

The Error Detail window will be closed.

The reaction curve graph on the Graphic Display screen can be enlarged
on the window.

1. Press an area of the reaction curve graph on the Graphic Display
screen.

The Graphic Enlargement window will be displayed.

2. Press an area of reaction curve graph on the Graphic Enlargement
window.

The Graphic Enlargement window will be closed.

060

6.2 Search

With this program, a data can be moved to the top data point or the bot­tom data point in the List Display, and samples that agree with specified
conditions can be searched from stored data.

Top Data/Bottom Data

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

Top Bottom Search Seq

Edit

ID No.

11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

Output

HC IP

All Seq 0/142(142)
PT

PT%APTT

sec



Marked

AllClear



88.1

88.1

88.1

88.0

87.9

88.0

87.9

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0

Select

Display

ReturnDelete

The cursor in the screen can be moved to the top of the list or the end of
the list in the List Display.

[Top] key: Displays the top of analysis data at the head of the List.
[Bottom] key: Displays the bottom of analysis data at the tail of the List.

6-6 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Search by ID No.

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

All Seq 0/142(142)
PT

sec

11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5



HC IP

PT%APTT

sec



88.1

88.1

88.1

88.0

87.9

88.0

87.9



32.1

32.1

32.1

32.0

32.2

31.9

32.0

Display and Processing of Analysis Results

Analysis data of a specified sample ID No. can be searched from stored
data.

1. Press [Search] key on the Stored Data List Display screen.

The Local Menu for search will appear.

2. Press [Search ID No.] key.

The Search by ID No. screen will appear.

ID No.

ID No.

123−456−78902

Search

Date

Ready
Replace Rack? YES!

Ready
Replace Rack? YES!

Search

Sysmex

Stored Data − Search by ID No.

Sysmex

Stored Data − Search by ID No.

Not found

HC IP

7

4

1

0 −

C

HC IP

Return

ID No.

89

5

2

Enter

Q C

Quit

3. Enter sample ID No.
Using the ID No. numeric keys on the Search by ID No. screen, enter

a sample ID No. to be searched.

6

3

If [C] key is pressed when there is no entry, [QC] key will change to
[STD] key.

4. Press [Enter] key on the ID No. numeric keys.
Search by ID No. begins from the sample ID No. in the current cur-

sor position toward the latest sample. To cancel search by ID No.,
press [Quit] key on the ID No. numeric keys.

5. A List is displayed in which analysis data of the sample ID No.
entered is listed.

When analysis data of the specified ID No. is found, a list of analysis
data the List will indicate the analysis data at the head of the screen.
The cursor is on the analysis data corresponding to the ID No.

When analysis data corresponding to an entered ID No. is not found,
the Confirmation Message screen will appear.

Press [Conf.] key to return to the Search by ID No. screen.

Conf.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 6-7

Display and Processing of Analysis Results

Search by Date

The first analysis data of a specified date can be displayed at the head of
the screen.

1. Press [Search] key on the Stored Data List Display screen.

The Local Menu for search will appear.

2. Press [Search Date] key.

The Search by Date screen will appear.

Ready

Sysmex

MM/DD/YY

12/01/2001

Sysmex

Replace Rack? YES!

Ready
Replace Rack? YES!

Stored Data − Search by Date

Stored Data − Search by Date

HC IP

Date

89

7

4

5

1

2

0/

C

HC IP

6

3

Enter

Quit

3. Enter Date.
Using the date numeric keys in the Search by Date screen, enter a

date by which to search.

4. Press [Enter] key on the date numeric keys.
Search by date begins from the sample in the current cursor position

toward the latest sample.
To cancel search by date, press [Quit] key on the date numeric keys.

5. A List is displayed in which analysis data of the date entered is listed.
When analysis data of the specified date is found, the a list of analy-

sis data will be displayed. The cursor is on the first analysis data cor­responding to the date entered.

When analysis data corresponding to the date entered is not found,
the Confirmation Message screen will appear.

Press [Conf.] key to return to the Search by Date screen.

Not found

Conf.

6-8 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Display and Processing of Analysis Results

6.3 Sort in Sequence of Sample ID Nos. and Analyses

With this program, stored analysis data can be listed in a specified
sequence.

The Stored Data List Display screen displays [Seq] key when the data
are listed in the sequence of ID No. and [ID No.] key when the data are
listed in the chronological analysis sequence.

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

Top Bottom Search Seq

Edit

ID No.

sec

11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

Output

HC IP

All ID No. 0/142(142)

PT

PT%APTT



88.1

88.1

88.1

88.0

87.9

88.0

87.9

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0

Select

Display

ReturnDelete



Marked

AllClear

[ID No.] key: The analysis data are listed as rearranged in the sample

ID No. sequence.

[Seq] key: The analysis data are listed as rearranged in the chrono-

logical analysis sequence.

Note

While analysis is in progress, the program is automatically run
in the analysis sequence.

6.4 Select Display

All Data

Sysmex

Stored Data

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

Ready
Replace Rack? YES!

Mean CancelAll

All Seq 0/142(142)

PT

sec



11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

Not

Output

HC IP

PT%APTT

sec



88.1

88.1

88.1

88.0

87.9

88.0

87.9



32.1

32.1

32.1

32.0

32.2

31.9

32.0

With this program, the type of data to be list-displayed can be selected
from all stored data.

As the condition for displaying a list, All Data can be specified.

1. Press [Select Display] key on the Stored Data List Display screen.

The Local Menu for selecting a display will appear.

2. Press [All] key on the Local Menu.

All analysis data stored are displayed in the sequence chosen from ID
No. sequence and analysis sequence.

To cancel selection, press [Cancel] key. The Stored Data List Dis­play screen will return.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 6-9

Display and Processing of Analysis Results

Mean Data

Ready

Sysmex

Stored Data − Select Display

Replace Rack? YES!

No Data

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901
123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907

123-456-78908

Top Bottom Search Seq

Edit

ID No.

All Seq 0/142(142)
PT

sec



11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

Output

Not Output

HC IP

HC IP

PT%APTT



88.1

88.1

88.1

88.0

87.9

88.0

87.9

Marked

AllClear

Conf.

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0

Select

Display

ReturnDelete

As the condition for displaying a list, Mean Data can be specified.

When there is no sample to be displayed, the screen as shown at the left
will appear.

1. Press [Select Display] key on the Stored Data List Display screen.

The Local Menu for selecting a display will appear.

2. Press [Mean] on the Local Menu.

From among the stored data, only mean data are displayed in the
sequence chosen, either ID No. sequence or analysis sequence.

To cancel selection, press [Cancel] key. The Stored Data List Dis­play screen will return.

As the condition for displaying a list, the data that have not yet output
can be specified.

Ready

Sysmex

IP Not Output
HC Not Output

Sysmex



Graph

12:55

12:57
12:58
12:59
12:56
12:57
12:58
12:59

Replace Rack? YES!

Ready
Replace Rack? YES!

Prev Next

SEQ

123-456-78901

1

123-456-78902

2

123-456-78902

3

123-456-78902

4

123-456-78905

5

123-456-78906

6

123-456-78907

7

123-456-78908

8



All Seq 0/142(142)Stored Data



Stored Data − Select Display

DATE TIME RACKID No.

12/31

12/31
12/31
12/31
12/31
12/31
12/31
12/31

1. Press [Select Display] key on the Stored Data List Display screen.

The Local Menu for selecting a display will appear.

HC IP

2. Press [Not Output] key on the Local Menu.

The Not Output Data Selection screen will be displayed.

To cancel the selection, press [Return] key. The Stored Data List
Display screen will return.

v

3. On the Not Output Data Selection screen, press the key to select the
Not Output data to display. The selected data is indicated with a “v”.

Return

To cancel the selection, press [Return] key. The screen will return to
the Stored Data List Display.

HC IP

0101

0102
0103
0104
0105
0106
0107
0108



Mark

OUT

HP

HP
HP
HP
HP
HP
HP
HP

The “v” alternately appears or disappears each time the key is
pressed.

IP Not Output: Stored analysis data that have not yet output to the

built-in printer are displayed in the sequence cho­sen, either ID No. sequence or analysis sequence.

HC Not Output: Stored analysis data that have not yet output to the

host computer are displayed in the sequence cho-

Main

More

Menu

sen, either ID No. sequence or analysis sequence.

6-10 Sysmex CA-500 series

Revised January 2003 - 2.0_en

6.5 Edit ID No.

Display and Processing of Analysis Results

Note

• When an output was performed with the display condition

“Not output data” selected, the output flag will be changed
but the data will remain in the “Not output data” display
even though the data has been output.

• In this case, exit from the “Not output data” display by

pressing [Main Menu] key, or change the display condi­tion, to update the contents of the “Not output data” dis­play.

With this program, ID No. of cursor-specified analysis data can be
changed.

1. Press [Stored Data] key on the Root Menu screen.

Ready

Sysmex

Stored Data − Edit ID No.

Replace Rack? YES!

Date/Time

12/01 20 : 28

Rack

34−01

Current ID No.

000000000000035

New ID No.

000000000000035

HC IP

7

4

1

0 −

C

ID No.

89

5

2

Enter

Q C

Quit

2. Press [↑] key or [↓] key to select data.

3. Press [More] key.

4. Press [Edit ID No.] key on the Stored Data List Display screen.

The Edit ID No. screen will display Date/Time, Rack position, and
sample ID No.

5. Enter a new sample ID No. on the ID No. numeric keys.

6. Press [Enter] key or [Quit] key on the ID No. numeric keys.
[Enter] key: Changes sample ID No. and returns you to the Stored

6

3

[Quit] key: Cancels editing sample ID No. and returns you to the

Data List Display screen.

Stored Data List Display screen.

Caution

There should be thorough control of sample ID Nos.
within the facility, so that when the sample ID No. is
changed, the new No. can be used to identify the pa tient.

Note

When ID No. sequence is chosen instead of analysis sequence,
change in sample ID No. will not automatically cause change
in arrangement of the samples. By pressing [Seq] key and then
[ID No.] key on the Stored Data List Display screen, the sam­ple arrangement will return to normal.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 6-11

Display and Processing of Analysis Results

6.6 Deletion

With this program, Stored Data can be deleted.
Data to delete can be specified on the Local Menus for Current Data,

Marked Data, and All Data.

Once deleted, data cannot be restored. Check carefully in
advance before deleting data.

Current Data

From the analysis data, the data in the current cursor position can be
deleted.

1. Press [Delete] key on the Stored Data List Display screen.

The Local Menu for deletion will appear.

Ready

Sysmex

Stored Data

Replace Rack? YES!

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906
123-456-78907
123-456-78908

11.5 88.2 32.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5

HC IP

All Seq 0/142(142)
PT

PT%APTT

sec





88.1

88.1

88.1

88.0

87.9

88.0

87.9

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0

2. Press [Current] key on the Local Menu.

The Deletion Confirmation screen will appear.

Note

Sysmex

Stored Data

Marked All CancelCurrent

Ready
Replace Rack? YES!

Current data will be deleted.

HC IP

3. Press [Set] key or [Cancel] key on the Deletion Confirmation screen.
[Set] key: Deletes analysis data in the current cursor position.
[Cancel] key: Cancels deletion and returns you to the Local Menu

for deletion.

CancelSet

6-12 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Marked Data

Ready

Sysmex

Replace Rack? YES!

ID No.

123-456-78901
123-456-78902
123-456-78902
123-456-78902
123-456-78905
123-456-78906

123-456-78907

123-456-78908

HC IP

All SeqStored Data
PT

PT%APTT

sec



11.5 88.232.0

11.6

11.4

11.5

m

11.7

11.6

11.8

11.5



88.1

88.1

88.1

88.0

87.9

88.0

87.9

2/142(142)

sec



32.1

32.1

32.1

32.0

32.2

31.9

32.0
Mark

Display and Processing of Analysis Results

From the analysis data, the marked data can be deleted.

1. Press [Mark] key on the Stored Data List Display screen and make a

mark.
When [Mark] key is pressed, the analysis data in the current cursor

position will be marked ( ). If the mark is already there, it will disap­pear.

Press [Marked All Clear] key to remove all marks.

Graph

Sysmex

Stored Data

All Data

Sysmex

Stored Data

Prev Next

Ready
Replace Rack? YES!

Marked data will be deleted.

Ready
Replace Rack? YES!

All data will be deleted.

More

HC IP

HC IP

Main

Menu

CancelSet

2. Press [More] key.

3. Press [Delete] key on the Stored Data List Display screen.

The Local Menu for deletion will appear.

4. Press [Marked] key on the Local Menu.

The Deletion Confirmation screen will appear.

5. Press [Set] key or [Cancel] key on the Deletion Confirmation screen.

[Set] key: Deletes marked analysis data.
[Cancel] key: Cancels deletion and returns you to the Local Menu

for deletion.

All data can be deleted.

1. Press [Delete] key on the Stored Data List Display screen.

The Local Menu for deletion will appear.

2. Press [All] key on the Local Menu.

The Deletion Confirmation screen will appear.

3. Press [Set] key or [Cancel] key on the Deletion Confirmation screen.

[Set] key: Deletes all analysis data.
[Cancel] key: Cancels deletion and returns you to the Local Menu

for deletion.

CancelSet

Revised January 2003 - 2.0_en

Sysmex CA-500 series 6-13

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

Revised January 2003 - 2.0_en

Sysmex CA-500 series

7. Output

7.1 Automatic Printout of Analysis Data

The instrument can automatically output analysis data to the built-in
printer or the host computer. Refer to “10.2 Setup of Automatic Transfer/
Printout”.

7.2 Output of Analysis Data

The instrument can output analysis data to the built-in printer or the host
computer.

Sysmex

Stored Data

ID No.

123-456-78901

123-456-78902
123-456-78902
123-456-78902
123-456-78905
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11.5 88.2 32.0

11.6

11.4

11.5

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32.2

88.0

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87.9

32.0

The data to be output to an external device can be specified via Local
Menu of Current Data, Marked Data, and All Data. To display this menu,
press [Output] key on the Stored Data List Display screen.

Output

Marked All CancelCurrent

Current Data

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IP Graph

IP List

Host Computer

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Return

The data in the cursor position can be output to the built-in printer or the
host computer.

1. Press [Current] key on the Local Menu for external output.

The Select Device screen will appear.

2. Select the device on the Select Device screen.

[IP Graph] key: Analysis data (with graph) at the cursor

position is output to the built-in printer.

[IP List] key: Analysis data (without graph) at the cursor

position is output to the built-in printer.

[Host Computer] key: Analysis data at the cursor position is output

to the host computer. (Displayed only when
“Connected” is selected.)

[Return] key: Cancels the device selection and returns the

screen to the Local Menu for External Out­put.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 7-1

Output

Important

• Referring to “IP Graph”, when Automatic Transfer/
Printout Setting is formatted for printout with graph, a
graph will be attached; when it is formatted for data
analysis printout, analysis result is printed out.
Refer to “10.2 Setup of Automatic Transfer/Printout”
for the procedures.

• However, analysis result will be lost if power has
been turned OFF then ON, and the data with graph
will be printed instead.

• When the graph is not stored, the data without graph
will be printed even if the data with graph is selected.
(The graph is stored for the latest 600 tests.)

• The scale of the coagulation curve automatically
changes depending on the error.

• Referring to “IP Graph” and “IP List”, when Automatic
Transfer/Printout Setting is formatted for auto change
depending on the error, an analysis data will be
attached.

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Output in progress

Marked Data

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3. Output of analysis data in the current cursor position begins.
The screen of output in progress will appear.
If [Cancel] key is pressed on the screen of output in progress, the

output stops and the Select Device screen returns.

Cancel

The marked data can be output to the built-in printer or the host compu­ter.

1. Press [Mark] key on the Stored Data List Display screen to make a
mark.

When [Mark] key is pressed, the analysis data in the current cursor
position will be marked ( ). When the mark is already there, it will
disappear.

Press [Marked All Clear] key to remove all the marks.

2. Press [More] key.

7-2 Sysmex CA-500 series

Revised January 2003 - 2.0_en

All Data

Output

3. Press [Output] key on the Stored Data List Display screen.

The Local Menu for external output will appear.

4. Press [Marked] key on the Local Menu to display the Select Device

screen.

5. Select the device on the Select Device screen.

6. Output of marked analysis data begins.
The screen of output in progress will appear.
If [Cancel] key is pressed on the screen of output in progress, the

output stops and the Select Device screen returns.

All data can be output to the built-in printer or the host computer.

1. Press [All] key on the Local Menu for external output.
The Select Device screen will appear.

2. Select a device on the Select Device screen.

7.3 Example of Printout

3. Output of all analysis data begins.
The screen of output in progress will appear.
If [Cancel] key is pressed on the screen of output in progress, the

output stops and the Select Device screen returns.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 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

Revised January 2003 - 2.0_en

Sysmex CA-500 series

8. Quality Control

8.1 Quality Control Methods

Quality Control

Quality control is performed to obtain high-reliability data over long
periods and also to constantly monitor the status of the instrument to pre­vent problem in advance.

This instrument analyses control plasma and other standard samples (QC
samples) and performs statistical control of the results.

With the CA-500, two QC Programs are available:
X

control: Uses an average data of two consecutive analyses made on

a QC sample (control plasma or pooled plasma). Because
an average is used as control data, this control method suf­fers virtually no effects of reproducibility during analysis.

L-J control: Uses data of a single analysis on a QC sample. The L-J

control is susceptible to effects of reproducibility so that its
control range is wider than X

control.

8.2 QC File Setting

Replicates Sets the times of quality control analysis.
Parameter Sets the parameters for analysis results that are the object of quality control.

Upper Stop If a QC data exceeds this upper limit, the instrument stops analysis.
Upper Flag If a QC data exceeds this upper lim it, the instrument flags the data as an error.
Target Target value of QC data

Limit

Lower Flag If a QC data exceed s this lower lim it, the instrument flags the data as an error.

Lower Stop If a QC data exceeds this lower limit, the instrument stops analysis.
Lot No. Sets a lot No. for samples to be used in quality control.
EXP. Sets an expiry date on samples to be used in quality control.

To execute the QC Program, it is necessary to set replication, control
parameters, control limits, Lot No., and expiry date.

The parameters to be set for QC File are:

Revised January 2003 - 2.0_en

Sysmex CA-500 series 8-1

Quality Control

Ready

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Quality Control
File No. PT QC01
Mean


SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

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Scale

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EXP. 12/31/2001

Cursor

100.0%
12/01/2001
15:09

110
107
100
93
90

1. On the Quality Control screen, display the QC Chart of the file to set
parameters for.

For how to display QC Chart, refer to “Select QC Chart” of
“8.4 Display QC Charts”.

2. Press [Settings] key on the Quality Control screen.
The current settings of the selected file are displayed on the Quality

Control Setting screen.

Delete

Sysmex

QC − Settings
File No. PT

Replicates
Parameter
Limit
Upper Stop
Upper Flag
Target
Lower Flag
Lower Stop
Lot No.
EXP.

Select

Print

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File

QC01

2

PT%


110.0%

107.0%

100.0%

93.0%

90.0%
TPC−747
12/31/2001

Auto

Calc.

Select

Test

HC IP

Next

Option

Main

Menu

Return

Using [↑] and [↓] keys, move the cursor to select the parameters to
be set.

3. Set replicates using [Next Option] key.
Each time [Next Option] key is pressed, “1” and “2” are changed

alternately.

4. Set a control parameter using [Next Option] key.
Each time [Next Option] key is pressed, a parameter set as a stand-

ard curve parameter is changed over.

Note

• As control parameters, you can select the analysis parame-

ters set in Test Name and Standard Curve Parameter set­ting.The parameters linked to the standard curve are
selected from the parameters which were set at link source.

• When changing control parameters, delete all control data

of a QC File to be changed.

Important

Analysis results will not be stored in a QC File if a Stand­ard Curve is not set and QC control parameters are set
as calculation parameters.

8-2 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Quality Control

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QC − Settings
File No. PT QC01


Replicates
Parameter
Limit
Upper Stop
Upper Flag
Target
Lower Flag
Lower Stop
Lot No.
EXP.

QC − Settings
File No. PT QC01


Replicates
Parameter
Limit
Upper Stop
Upper Flag
Target
Lower Flag
Lower Stop
Lot No.
EXP.

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1
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

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93.0%

90.0%
TPC−747
12/31/2001

1
PT−act


15.0% 

107.0%

100.0%

93.0%

90.0%
TPC−747
12/31/2001

Auto

Calc.

HC IP

Upper Stop

7

89

4

5

1

2

0.

C

HC IP

Next

Return

Option

Enter

Quit

5. Enter control limits using the numeric keys.

When the “Limit” parameter is selected, [Next Option] key will be
changed to [Numeric] key. Press [Numeric] key to display the

6

3

numeric keys.

Important

In setting control limits, the following conditions have to
be met.

Lower Stop ≤ Lower Flag ≤ Upper Flag ≤ Upper Stop
Lower Stop < Upper Stop

If the Quality Control Setting screen is quit without satisfying
the above conditions, the cursor will be positioned at the upper
control limit and the error message “Not correct limit value”
will appear. Since the cursor will not move, enter proper set­tings.

Revised January 2003 - 2.0_en

Note

Press [Auto Calc.] key, and the limit values will be automati­cally calculated from QC data stored in the file, as in the fol­lowing.

Target: Mean of control data

Upper Flag: Mean of control data + 2SD of control data

Lower Flag: Mean of control data - 2SD of control data

Upper Stop: Mean of control data + 3SD of control data

Lower Stop: Mean of control data - 3SD of control data

6. Press [Enter] key on the numeric keys.

The setting is changed to the entered numeral and the cursor moves
to the next parameter. For a parameter whose setting is not to be

changed, change the cursor position with [↑] and [↓] keys.

7. Press [Quit] key.

Setting by the numeric keys is completed.

Sysmex CA-500 series 8-3

Quality Control

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G

M

S

X

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H

N

T

Y

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1
PT%


110.0%

107.0%

100.0%

93.0%

90.0%
TPC−747

12/31/2001

QC − Settings
File No. PT QC01


QC − Settings
File No. PT QC01


Replicates
Parameter
Limit
Upper Stop
Upper Flag
Target
Lower Flag
Lower Stop
Lot No.
EXP.

I

O

U

Z

Lot.No

D

J

P

V

BS

HC IP

EF

K

L

R

Q

Enter

W

Quit

CHG.

HC IP

EXP.

89

7

4

5

1

2

/

0

C

6

3

Enter

Quit

8. Set Lot No.
By moving the cursor to Lot No., [Next Option] key will be changed

to [Lot No] key.
Press [Lot No.] key to display the Lot No. Entry Screen.
Each time the [CHG.] key is pressed, the enter mode changes from

capital alphabet → small alphabet → the numeric keys in this order.
Lot No. up to 12 digits can be set.

9. Press [Enter] key on the Lot No. Entry screen.
The setting is changed to the Lot No. entered and the cursor moves to

the next parameter. To cancel setting, press [Quit] key, and the
screen will return to the Quality Control screen without changing the
setting.

10. Enter Expiry date using the numeric keys.
When the cursor is moved to “EXP.”, [Next Option] key will be

changed to [Date] key. Press [Date] key to display the numeric keys.
Using the numeric keys, enter the date in accordance with System

Setting - Date Format.

11. Press [Enter] key on the numeric keys.
The setting will be changed to the expiry date entered and the cursor

will move to the next parameter.
To cancel setting, press [Quit] key, and the screen will return to

Quality Control screen without changing the setting.

Sysmex

QC − Setting

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Note

• When the entered date is in a wrong format, the expiry

date will not be corrected by pressing [Enter] key. The
cursor also does not move. Enter again in a correct format.

• If you attempt to use the QC File that has passed its expiry

date, then the confirmation screen with the error message
will appear immediately after [Start] key is pressed.

12. Press [Return] key on the Quality Control Setting screen.
The Renew Confirmation screen will appear.

13. Press [FIX] key, [Continue] key, or [Cancel] key.
[FIX]: Renews the setting and returns to the Quality Control

screen.

[Continue]: Returns to the Quality Control Setting screen and

allows continuous operation.

[Cancel]: Cancels the renewed setting and returns to the Quality

ContinueCancel FIX

Control screen.

Revised January 2003 - 2.0_en

8-4 Sysmex CA-500 series

8.3 Execute Quality Control

Quality Control

To maintain the reliability of analyzed data, quality control has to be per­formed. When QC sample (control plasma, pooled plasma, etc.) is regis­tered with ID No. (QC01 - QC06) and then analyzed, the analysis data is
kept in the QC File. It is by processing this analysis data with the QC
Program that instrument and reagent stability that varies from time to
time is monitored.

1. Set quality control samples on the sample rack.

2. Register the QC Sample Nos.

Press [ID No. Entry] key in the Root Menu screen, and using the
numeric keys, enter ID Nos. for quality control ([QC] [0] [1] - [QC]
[0] [6]).

3. Register the analysis parameters.

Specify samples in the Root Menu screen using [↑] and [↓] keys and
analysis parameter keys. Mark “O” for the parameters to be
analyzed.

4. Press [Start] key at the right upper corner in the screen.

Analysis data is automatically kept in the QC File.

8.4 Display QC Charts

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Quality Control
File No. PT QC01
Mean


SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

Change

Scale

Select

File

HC IP

Lot. No TR-463
EXP. 12/31/2001

Cursor

100.0%
12/01/2001
15:09

Select

Test

Main

Menu

110
107
100
93
90

Note

Analysis data with “Slight Coagulation” and "Analysis Time
Over" error will be also stored. Other error data cannot be
stored.

5. Confirm the QC Chart.
The instrument executes QC Program and confirms the QC Chart.

QC data is displayed in the Quality Control screen which is the initial
screen of QC Program. When you press [QC] key on the Root Menu
screen, the Quality Control screen will appear.

The QC Chart shows the latest 60-point data. By pressing [Change
Scale] key, you can select the latest 60-point data or the stored 180-point
data.

Note

[Change Scale] key will appear only when there is data in a
file.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 8-5

Quality Control

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Quality Control
File No. PT QC01
Mean


SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

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180

Settings

PrintDelete

HC IP

Lot No TR-463
EXP. 12/31/2001

Cursor

100.0%
12/01/2001
15:09

Change

Scale

File

Select

Test

Select

110
107
100
93
90

Main

Menu

The Quality Control screen displays the following QC data:

File No.: Parameter and File No. in the QC Chart being displayed
Lot No.: Lot No. of the QC sample in use for Quality Control
Exp.: Expiry date of the QC sample in use for Quality Control
Mean: Mean of QC data
SD: Standard deviation of QC data
CV: Reproducibility coefficient of variation of QC data
N: No. of QC data. When analysis is made twice, its mean

value is taken as the data, so the number of data is 1.

Stop_UL: When result of QC analysis exceeds this limit, subsequent

analyses are canceled.

Flag_UL: When result of QC analysis exceeds this limit, it is QC

error.
TARGET: A target QC value
Flag_LL: When result of QC analysis goes below this limit, it is QC

error.
Stop-LL: When result of QC analysis goes below this limit, subse-

quent analyses are canceled.

Select QC Chart

Note

The point mark “ ” indicates data where the results of QC
analysis exceed STOP-UL or are below STOP-LL.

Cursor: The position of control data being displayed. You can

move it to right or left by using [←] and [→] keys. When

there is no data in the file, neither [←] key nor [→] key

will be displayed.
Cursor position data: Analysis data (calculated parameter) and analy-

sis date of the QC data in the cursor position

The instrument stores 6 different QC Files for each parameter (max 14
parameters).

To delete, set, or print a QC File, the QC Chart of the desired QC File has
to be displayed.

1. Press [QC] key on the Root Menu screen.

The Quality Control screen will appear.

2. Press [Select Test] key on the Quality Control screen.

The Local Menu for Select Test will appear.

8-6 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Quality Control

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PT

II

Plg

Quality Control
File No.PT

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QC01
12/01

QC04
12/01

QC01


QC02
12/01

QC05 QC06

HC IP

HC IP

IX

DDPl

Cancel

QC03
12/01

Cancel

3. Press the parameter key on the Local Menu.
The Select File screen for the selected parameter will appear.
To cancel the change of the parameter, press [Cancel] key. With the

parameter remaining unchanged, the Quality Control screen will
return.

Note

When the current parameter is one which has the QC Chart
displayed, press [Select File] key on the Quality Control
screen.

4. Press the key of a file on Select File Screen.
The QC Chart of the selected file will be displayed on the Quality

Control screen.
To cancel the change of the file, press [Cancel] key. With the param-

eter remaining unchanged, the Quality Control screen will return.

Note

The key for each file will display the date of the latest analy­sis. Those files with no analysis date do not have any data.

8.5 Delete QC File

To start Quality Control anew, the existing data in the QC Files has to be
deleted. Specifically, to change the type or lot of control plasma, it is
necessary to delete the existing data in the files.

With this program, data can be deleted for each analysis parameter of an
X

and L-J control file (QC01 - QC06).

Note

[Delete] key is not displayed when the file has no data.

1. Display the QC Chart of the desired file to be deleted.
For how to display the QC Chart, refer to “Select QC Chart” of

“8.4 Display QC Charts”.

2. Press [Delete] key on the Quality Control screen.
The Local Menu for deletion will appear.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 8-7

Quality Control

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QC File

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File No. : PT QCO1
All data will be deleted.

Quality Control
File No. PT QC01
Mean
SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

Quality Control

Change
Cursor



HC IP

Lot No TR-463
EXP. 12/31/2001

Cursor

100.0%
12/21/2001
15:09

HC IP

8.6 Delete QC Data

3. Press [Delete QC File] key on the Local Menu.

4. Press [Yes] key on the Local Menu.

110
107
100
93
90

CancelYes

The screen for confirming deletion of all data in a specified file will
appear.

5. Press [Set] key or [Cancel] key.
[Set]: Deletes all data in a specified file and returns to Quality

Control Screen.

[Cancel]: Cancels the deletion and returns to Quality Control

Screen.

CancelSet

Caution

Once data has been deleted, it cannot be recovered.

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Delete
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Delete
QC File

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100.0

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3.3

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%



%

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Quality Control
File No. PT QC01
Mean
SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

Quality Control
File No. PT QC01
Mean
SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

HC IP

Lot No TR-463
EXP. 12/31/2001

Cursor

100.0%
12/01/2001
15:09

Change
Cursor

HC IP

Lot No TR-463
EXP. 12/31/2001

Cursor

100.0%
10/10/2001
15:09

Change
Cursor

110
107
100
93
90

Cancel

110
107
100
93
90

When this process is selected, two cursors will be displayed, and the data
between those cursors can be deleted from the QC Chart.

1. Display the QC Chart from which you want to delete QC data.
For how to display the QC Chart, refer to “Select QC Chart” of

“8.4 Display QC Charts”.

2. Press [Delete] key on the Quality Control screen.
The Local Menu for deletion will appear and the cursor for setting

the range to be deleted will appear on the latest data.

3. Press [←] key on the Local Menu.
The cursor will move, forming two cursor lines, which are used to

highlight the data range to be deleted.

Yes

Cancel

8-8 Sysmex CA-500 series

Revised January 2003 - 2.0_en

Quality Control

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File No. : PT QC01 10/10-11/15
will be deleted.

Quality Control
File No. PT QC01
Mean
SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

Quality Control

Lot No TR-463
EXP. 12/31/2001

Cursor

100.0%
11/15/2001
15:09

Change
Cursor

8.7 Print QC data

HC IP

HC IP

110
107
100
93
90

Cancel

CancelEnter

4. Using [←] and [→] keys on the Local Menu, move the cursors and

set the data range to be deleted.
Press the [Change Cursor] key to select the range-setting cursor.
The cursor position data area displays the data for the range-setting

cursor.

5. Press [Yes] key on the Local Menu.

The screen confirming the range to be deleted will be displayed.

6. Press [Set] key or [Cancel] key on the Deletion Confirmation screen.

[Set]: Executes the deletion and quits the program.
[Cancel]: Cancels the deletion and returns to the Quality Control

screen.

The QC data can be printed by the built-in printer by the following pro­cedure:

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Output in progress

Quality Control
File No. PT QC01
Mean
SD
CV
N
Stop-UL
Flag-UL

Flag-LL
Stop-LL

Quality Control

HC IP

Lot No TR-463
EXP. 12/31/2001

Cursor

100.0%
12/21/2001
15:09

CancelList

HC IP

110
107
100
93
90

1. Display the QC Chart you want to print.
For how to display the QC Chart, refer to “Select QC Chart” of

“8.4 Display QC Charts”.

2. Press [Print] key on the Quality Control screen.
The Local Menu for print setting will be displayed.

3. Press [Graph] key or [List] key.

[Graph] key: Prints out QC data and QC chart.
[List] key: Prints out QC data and data lists.
[Cancel] key: Returns to the Quality Control screen without

printout.

When [Cancel] key is presse d on the “Output in progress” message
screen, printing will be canceled and the Quality Control screen will
return.

Cancel

Revised January 2003 - 2.0_en

Sysmex CA-500 series 8-9

Quality Control

Note

• The number of data that can be printed is all data for either

180 or 60 points, selected by [Change Scale] key.

• A ∗ mark at the right edge of the printed list indicates that

quality control analysis results for that data exceeded
STOP-UL or fell below STOP-LL.

Graphic printout

8-10 Sysmex CA-500 series

Revised January 2003 - 2.0_en

List printout

Quality Control

Revised January 2003 - 2.0_en

Sysmex CA-500 series 8-11

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

Revised January 2003 - 2.0_en

Sysmex CA-500 series

9. Setting Standard Curve

The Standard Curve is a set of parameters used to determine each calcu­lation parameter, based on the coagulation time and ∆OD/min in the
analysis results.

9.1 Display Standard Curve

Description is given here on standard curve data and how to make its
graphic display.

Data Display

Setting Standard Curve

Ready

Sysmex

Replace Rack? YES!

sec

11.4

17.4

27.9

52.6

11.4

1.73

0.0

0.0

(M)

PT
OVB

Graph

Cal Date 12/01/2001

Lot No. EXP.
Apc.63

Ref.

Standard

Analysis

Print

Standard Curve PT
PT%

%

100.0

50.0

25.0

12.5

6.3

3.1

Normal

ISI

Next

Select

Test

HC IP

Manual

Entry

Lot No.

Entry

12/31/2001
12/31/2001

12/31/2001

Select

Param.

Return

1. Press [Standard Curve] key on the Root Menu screen.
The PT Standard Curve Data screen will appear.
The contents displayed on the Standard Curve Data screen are:

(M): Displayed when some of standard curve data is

manually input.
Cal Date: The date on which the Standard Curve is set
Reagent Name: Name of reagent
Lot No.: Lot No. of reagent (up to 12 digits)
EXP.: Expiry date of a reagent

<Standard Curve Data>

Activity/Concentration:

Percent activity or concentration
Up to 6 points can be set for each parameter.
(A lower-position point indicates a lower activity or concentra-

tion.) Displayed when activity or concentration is set in [Select
Param.] key.

Coagulation Time - Reaction Speed:

Coagulation time or reaction speed for 6-point activity or concen­tration

Normal:

Normal value used for finding the ratio. Displayed when the ratio
or INR is set by [Select Param.] key.

ISI:

International Sensitivity Index to calculate INR. Displayed when
INR is set by [Select Param.] key.

Revised January 2003 - 2.0_en

Sysmex CA-500 series 9-1

Setting Standard Curve

Caution

When analysis is made after expiry date has passed,
coagulation activity (PT ratio, PT-INR, etc.) cannot be
accurately calculated.
In processing [Lot No. Entry], set a new reagent Lot No.
and expiry date. When [Start] key is pressed after expiry
date passed, the message “Check Reagent Expiry”
appears, with the alarm sounding.

Note

[Next] key is displayed when dFbg or PT-INR Calibration is
set by [Select Param.] key of standard curve for PT parame­ter.

Ready

Sysmex

Standard Curve

PT

VIII

Replace Rack? YES!

APTT Fbg TT

AT3 BCPC Hep

Graphic Display

Ready

Sysmex

Standard Curve PT

Expression
Correlation
rate
offset

Replace Rack? YES!

Log P
Log T=a∗Log P+b
r =−0.999
a =−8.663e+00
b = 1.993e+02

HC IP

HC IP

II

DDPl

Cancel

Log T

Return

2. Press [Select Test] key on the Standard Curve Data screen.

Note

The key for analysis parameters which have been linked to the
standard curve is masked.

3. Press the analysis parameter key to display the standard curve data of
the selected analysis parameter.

When [Cancel] key is pressed, the screen will return to the original
data's standard curve data screen.

1. Press [Graph] key on the Standard Curve Data screen.
The contents displayed on the Graphic Display screen are:
Standard Curve Graph: Plots activity or concentration on X axis and

coagulation time or reaction rate on Y axis.

Expression: Displays a expression such as

Log P = a * Log T + b from the plotted data.
P: Coagulation activity (Concentration)
T: Coagulation time (Reaction speed)
Correlation: Correlation coefficient of approximate expression
a, b: Constant derived from analysis results

9-2 Sysmex CA-500 series

Revised January 2003 - 2.0_en