Sysmex CA-50 User Manual [nl]

OPERATOR’S MANUAL

Automated Blood Coagulation Analyzer

CA-50

CHAPTER 1: INTRODUCTION CHAPTER 2: ANALYSIS PREPARATION CHAPTER 3: SAMPLE ANALYSIS CHAPTER 4: DISPLAY OF ANALYSIS RESULTS CHAPTER 5: MAINTENANCE & SUPPLIES REPLACEMENT CHAPTER 6: QUALITY CONTROL CHAPTER 7: SETTING STANDARD CURVES CHAPTER 8: TROUBLESHOOTING CHAPTER 9: FUNCTIONAL DESCRIPTION CHAPTER 10: INSTRUMENT SETUP APPENDIX A: INSTALLATION APPENDIX B: TECHNICAL INFORMATION INDEX

SYSMEX CORPORATION

KOBE, JAPAN

All rights reserved. No part of this Operator’s Manual may be Code No. 461-2035-2 reproduced in any form or by any means whatsoever without PRINTED IN JAPAN prior written permission of SYSMEX CORPORATION. Date of Last Revision: February 2001

• Sysmex is a registered trademark of SYSMEX CORPORATION.

• Dade is a registered trademark of Dade Behring Inc.

• Actin and Ci-Trol are registered trademarks of Dade International Inc.

• Eppendorf is a registered trademark of Eppendorf-Netherler-Hinz GmbH.

• Other trademarks referenced are property of their respective owners.

• It is prohibited to reproduce part or all of the contents of this Manual without permission.

• The display screens shown in this manual may differ slightly from the actual displays.

• As a result of product improvements, details described in this manual may differ slightly

from the actual product.

• Patient names and doctor names are entered for information and illustration purposes only,

and do not imply real specific persons.

Sysmex CA-50 Operator’s Manual -- Revised July 1999

RECEIVING INSTRUCTIONS

The CA-50 has been thoroughly tested before shipment, and has been packaged carefully to prevent damage from shipping and handling. Reagents and options have also been sent and will arrive accompanying the analyzer. Follow these guidelines when the system arrives:

• Check to see that the arrows on the sides of the packages are pointing up. If the arrows do not point up, record this information on the bill of lading.

• Visually inspect the outside of the package for rips, dents, or possible shipping damage. Document any sign of damage on the bill of lading, regardless of how insignificant it may appear. This is for your protection!

• Notify your service representative that the CA-50 system and its components have arrived.

• Wait for your service representative to unpack the system and open the packages.

• Follow the unpacking and storage instructions provided on the outside of the package. Special requirements such as refrigeration are clearly marked on the outside of the carton and will be included in the unpacking instructions and package inserts.

WARRANTY INFORMATION

All instruments manufactured by Sysmex® are warranted against defective materials or workmanship for a period of one year commencing on the installation date at the customer's required location.

This Warranty does not cover any defect, malfunction, or damage due to:

1. Accident, neglect or willful mistreatment of the product

2. Failure to use, operate, service, or maintain the product in accordance with the

applicable Sysmex Operator's Manual

3. Failure to use the appropriate reagents or chemicals specified for the product

Sysmex CA-50 Operator’s Manual -- Revised July 1999

ENSURE SAFE OPERATION OF THE INSTRUMENT

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Before operating this instrument, carefully read the "Ensure Safe Operation of the Instrument" and OPERATOR’S MANUAL, and strictly follow the instructions given in them. This manual carries a variety of illustrations to make sure that the product can be used safely and correctly, thus preventing you 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.

Meaning of Signs

WARNING

CAUTION

•If this sign is ignored and the instrument is operated incorrectly, there is a potentiall in

•If this sign is ignored and the instrument is operated incorrectly, there is a potentiall operator, adverse effect on output, or ma

Caution on Diagnosis

CAUTION

•This product is a clinical examination instrument for screening. In makin clinical judgment based on analysis results, a physician is requested to take clinical examination results and other test results into consideration.

hazardous situation which could result in death or serious

of an operator, or grave property damage.

hazardous situation which may result in injury of an

cause property damage.

Sysmex CA-50 Operator’s Manual -- Revised July 1999

WARNING

• In the event the instrument emits abnormal odor or any smoke, turn OFF the

ower immediately and disconnect 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 Sysmex service representative for inspection.

• Take care not to spill blood or reagent, or drop wire staples or paper clips into the

instrument.

Those might cause short circuit or smoke emission. If such trouble should occur, turn OFF the power immediately and disconnect the power plug from the wall socket. Then contact your Sysmex service representative for inspection.

• Do not touch the electrical circuits inside the cover. Especially if your hands are

wet, there is a hazard that electrical shock may result.

• During an analysis, do not open the pipette guide and put in hands or fingers.

That could cause injury. When the pipette guide is opened during an analysis, an alarm sounds and the operation stops.

• Always wear rubber gloves when performing maintenance work or inspection.

Use specified tools and parts. After work is over, wash your hands with disinfectant.

There is a possibility that those areas of your hands which came in contact with blood could suffer

infection.

• Be careful when handling samples. Always wear rubber gloves; otherwise infection by bacteria could result. If sample splash happened

to enter your eye or a cut, wash it off with plenty of water, and immediately see a physician.

When Handling Reagent

• 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

lenty of water, and throw up.

• If it happens to adhere to your hands or skins, wash it off using plenty of water.

• When discarding used reaction tubes and instrument consumables, take proper

disposing steps as medical, infectious, and industrial wastes.

If they are contaminated with blood, infection of bacteria may result.

• Do not modify the instrument. Its modification is prohibited by Pharmaceutical Affairs Law.

Sysmex CA-50 Operator’s Manual -- Revised July 1999

WARNING

Power Supply, Connection, and Groundin

• Never put the power plug in any socket other than the AC 117, 220 or 240 V socket.

Otherwise, fire or electrical shock will result.

• When installing the instrument, be sure to ground it.

Otherwise, fire or electrical shock will result.

Handling Power Supply Cord

• Take care not to damage the power cord, place a heavy device on it, or pull it forcibly.

Otherwise, the wire may break causing fire or electrical shock.

• When connecting the instrument to a peripheral (host computer), be sure to switch OFF the power beforehand.

Otherwise, electrical shock or instrument failure may result.

Sysmex CA-50 Operator’s Manual -- Revised July 1999

CAUTION

Use of Reagents

• After unpacking, be sure not to allow dust, dirt, or bacteria to come in touch with the reagent.

• Do not use reagents which have expired.

• Handle a reagent gently to prevent formation of bubbles.

• Take care not to spill a reagent. If it spills, wipe it off immediately using a wet

cloth or the like.

• Follow other instructions described on the Package Insert in each reagent.

Use of Instrument

• When performing maintenance work or inspection, use specified tools and parts. Do not use substitute parts, or modify the instrument. It is hazardous.

• Those who have no or only limited experience in using instrument are recommended to have guidance or assistance of those with sufficient experience.

• If the instrument has developed a trouble by any chance, a person in charge of it should take steps within the range specified in the OPERATOR’S MANUAL. As to troubles other than mentioned, contact your Sysmex service representative for assistance or service.

• Unpacking, installation, and confirmation of initial setup must be done by your Sysmex service representative.

Environment for Use

• Install the instrument in a place which is not subject to water splash.

• Install the instrument in a place which is not subject to adverse effects of high

temperature, high humidity, dust, direct sunlight, strong lighting, etc.

• Do not give the instrument a strong vibration or impact.

• Do not install the instrument near a chemical storage or a place where a gas is

generated.

Recommended Pipette and Pipette Chip

• We recommended that you use the following pipettes and pipette chips to add plasma and dispense/add reagents.

• Pipette: Eppendorf reference 4910 (50 - 200 µL)

• Pipette Eppendorf 300 µL chip

For details on the usage of the pipette and pipette chip, refer to the instruction manuals attached to them.

Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

Thank you for purchasing the Sysmex® Automated Blood Coagulation Analyzer CA-50. Carefully read the OPERATOR’S MANUAL for correct use of the unit.

Keep this MANUAL in good condition after reading. It will continue to be of your help in finding specific information about this instrument.

Sysmex CA-50 Operator’s Manual -- Revised July 1999

CONTENTS OF THIS MANUAL

To make full use of the functions of this instrument, thoroughly read this manual and use the instrument as directed. The Operator’s Manual is made up of the ten chapters and appendices listed below.

Chapter 1: Introduction

Chapter 2: Analysis Preparation

Chapter 3: Sample Analysis

Chapter 4: Display of Analysis Results

Chapter 5: Maintenance & Supplies

Replacement

Chapter 6: Quality Control

Chapter 7: Setting Standard Curves

Chapter 8: Troubleshootin

Provides an overview of the instrument, explaining its equipment, operating procedures, and messages as well as points to be careful about during installation.

Explains how to prepare the instrument, reagents, and samples before performing analyses.

Describes how to analyze samples and explains registration procedures for sample ID numbers and analysis parameters.

Explains the screen displays and the processing of external output.

Explains the periodic maintenance procedures and how to replace reagent and other supplies.

Explains how to perform quality control analyses and how to print and store quality control data.

Explains how to prepare standard curves.

Explains the error messages and how to troubleshoot.

Chapter 9: Functional Description

Chapter 10: Instrument Setup

Appendix A: Installation

Appendix B: Technical Information

Explains the coagulation detection principles. Also lists the names and functions of the each parts.

Explains how to preset the instrument's various settings, such as the data measure settings (includin limits that indicate abnormal data) and the test protocol settings.

Explains how to install the CA-50.

Includes data output format for host computer and other reference materials.

Sysmex CA-50 Operator’s Manual -- Revised July 1999

VII

PREMISES FOR SIGNS

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Meaning of Signs

WARNING

CAUTION

CAUTION: •Indicates what we would like you to know to maintain instrument

NOTE: •Indicates information which will come handy in operating the instrument.

•If this sign is ignored and the instrument is operated incorrectly, there is a potentiall in

of an operator, or grave property damage.

•If this sign is ignored and the instrument is operated incorrectly, there is a potentiall operator, adverse effect on output, or ma

performance and prevent its dama

hazardous situation which could result in death or serious

hazardous situation which may result in injury of an

cause property damage.

Document Conventions

In explaining operation, this manual uses the conventions as shown below.

• The keys on the panel keyboard are expressed within square brackets.

For example: [Start], [Print], [

]

• The display on LCD appears within quotation marks.

For example: "PT", "QC"

NOTE: • LCD and printing described in this manual may differ from those in

practice.

• As a result of product improvements, details described in this manual ma

differ slightly from the actual product.

VIII

Sysmex CA-50 Operator’s Manual -- Revised July 1999

CA-50 OPERATOR’S MANUAL

TABLE OF CONTENTS

CHAPTER 1: INTRODUCTION

1. INTRODUCTION.........................................................................................1-1

2. INSTRUMENT OVERVIEW .......................................................................1-2

3. OUTLINE OF OPERATION ........................................................................1-3

4. ANALYSIS PARAMETERS AND CALCULATION PARAMETERS......1-4

5. LCD SCREEN AND INPUT KEYS.............................................................1-6

5.1 LCD Screen .........................................................................................1-6

5.2 Input Keys............................................................................................1-7

6. PASSWORDS ...............................................................................................1-8

7. ALARMS ...................................................................................................1-8

8. DETECTOR LED..........................................................................................1-9

9. PACKAGING................................................................................................1-9

10. INSTALLATION ENVIRONMENT..........................................................1-10

10.1 Installation and Relocation ................................................................1-10

10.2 Grounding..........................................................................................1-10

10.3 Installation Space...............................................................................1-11

10.4 Installation Environment ...................................................................1-11

11. INSTRUMENT SPECIFICATIONS...........................................................1-12

12. MENU TREE...............................................................................................1-16

13. MAIN MENU..............................................................................................1-17

CHAPTER 2: ANALYSIS PREPARATION

1. INTRODUCTION.........................................................................................2-1

2. BEFORE TURNING ON THE POWER ......................................................2-2

3. TURNING ON THE POWER.......................................................................2-2

4. REAGENT PREPARATION........................................................................2-4

4.1 Preparing the Reagents ........................................................................2-4

4.2 Setting the Reaction Tubes and Reagents............................................2-5

5. CHECKING THE STANDARD CURVES ..................................................2-6

6. QUALITY CONTROL..................................................................................2-7

7. SAMPLE PREPARATION...........................................................................2-8

CHAPTER 3: SAMPLE ANALYSIS

1. INTRODUCTION.........................................................................................3-1

2. WORK LIST..................................................................................................3-2

2.1 Selecting the Analysis Parameter ........................................................3-2

2.2 Registering the Sample ID Number.....................................................3-4

3. SAMPLE ANALYSIS...................................................................................3-6

3.1 Start of Analysis ..................................................................................3-7

3.2 Adding the Reagents............................................................................3-8

3.3 Registering and Analyzing the Next Sample.....................................3-11

4. SHUTDOWN ..............................................................................................3-12

Sysmex CA-50 Operator’s Manual -- Revised July 1999 i

Sysmex CA-50 Operator’s Manual -- Revised December 2000

CHAPTER 4: DISPLAY OF ANALYSIS RESULTS

1. INTRODUCTION...................................................................4-1

2. DISPLAYING AND PRINTING OUT ANALYSIS RESULTS .............4-1

2.1 Displaying the Analysis Results ...........................................4-1

2.2 Printing Out the Analysis Results..........................................4-3

3. DISPLAYING DETAILED ANALYSIS RESULTS ..........................4-5

4. OUTPUTTING ANALYSIS RESULTS.........................................4-7

CHAPTER 5: MAINTENANCE & SUPPLIES REPLACEMENT

1. INTRODUCTION...................................................................5-1

2. CA-50 MAINTENANCE CHECKLIST .........................................5-2

3. DAILY MAINTENANCE AND INSPECTION................................5-3

3.1 Cleaning the Reaction Tube Holder, Incubator, and Pipette guide....5-3

4. WEEKLY MAINTENANCE AND INSPECTION ............................5-4

4.1 Cleaning the Instrument.....................................................5-4

4.2 Cleaning by Blower..........................................................5-5

5. REPLACING SUPPLIES ..........................................................5-6

5.1 Replacing Fuses ..............................................................5-6

5.2 Replacing Printer Paper .....................................................5-7

5.3 Supply Parts List .............................................................5-8

CHAPTER 6: QUALITY CONTROL

1. INTRODUCTION...................................................................6-1

1.1 Quality Control File..........................................................6-1

1.2 Quality Control Analysis....................................................6-1

1.3 QC Error Check ..............................................................6-2

2. QUALITY CONTROL MENU....................................................6-3

2.1 Displaying the QC Chart....................................................6-3

3. SELECTING THE QUALITY CONTROL FILE ..............................6-4

3.1 Selecting the Quality Control Parameter..................................6-4

3.2 Selecting the Quality Control File .........................................6-5

4. PRINTING OUT THE QC CHART..............................................6-6

5. DELETING THE QUALITY CONTROL DATA..............................6-7

5.1 Deleting the Data.............................................................6-7

5.2 Deleting the File..............................................................6-8

6. QUALITY CONTROL SETTINGS ..............................................6-9

ii Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised December 1999

CHAPTER 7: SETTING STANDARD CURVES

1. INTRODUCTION.........................................................................................7-1

2. OBTAINING DATA FOR STANDARD CURVE.......................................7-1

3. STANDARD CURVE MENU ......................................................................7-4

4. PREPARING THE STANDARD CURVE...................................................7-6

4.1 Selecting the Analysis Parameter ........................................................7-6

4.2 Inputting the Standard Curve Data ......................................................7-7

5. PRINTING OUT THE STANDARD CURVE ...........................................7-10

6. SETTING THE CALCULATION PARAMETERS...................................7-11

6.1 Calculation Parameter Setting Menu.................................................7-11

6.2 Setting the Activity Percent and Concentration.................................7-12

6.3 Setting the Ratio ................................................................................7-14

6.4 Setting the INR ..................................................................................7-15

6.5 Setting the DFbg................................................................................7-16

6.6 Printing Out the Calculation Parameter Settings...............................7-17

7. DELETING THE STANDARD CURVE DATA .......................................7-18

CHAPTER 8: TROUBLESHOOTING

1. INTRODUCTION.........................................................................................8-1

2. WHEN YOU SUSPECT AN ERROR ..........................................................8-1

3. TROUBLESHOOTING BY ERROR MESSAGE........................................8-2

3.1 Troubleshooting Guide........................................................................8-2

3.2 Instrument Errors and Corrective Actions...........................................8-3

3.3 Analysis Data Errors and Corrective Actions......................................8-5

4. INSTRUMENT CHECK...............................................................................8-8

4.1 Test Program Menu .............................................................................8-8

4.2 Display of Temperatures......................................................................8-9

4.3 Sensor Test.........................................................................................8-10

4.4 Key Entry Test...................................................................................8-11

4.5 Built-in Printer Test...........................................................................8-11

4.6 Communication Test..........................................................................8-12

4.7 LCD Screen Test................................................................................8-12

CHAPTER 9: FUNCTIONAL DESCRIPTION

1. INTRODUCTION.........................................................................................9-1

2. DETECTION PRINCIPLES FOR COAGULATION METHOD ................9-2

2.1 Optical Detection Method (Scattered Light Detection Method) .........9-2

2.2 Blood Coagulation and Scattered Light Intensity................................9-3

2.3 Coagulation Point Detection Method

(Percentage Detection Method) ..........................................................9-4

2.4 Standard Curve for Coagulation Method.............................................9-5

2.5 Calculation of PT Ratio and INR Value..............................................9-5

2.6 Analysis Flow......................................................................................9-6

3. ANALYSIS MECHANISM........................................................................9-10

4. INSTRUMENT COMPONENTS AND FUNCTIONS ..............................9-11

4.1 Front, Top, and Right Side ................................................................9-11

4.2 Rear ..................................................................................................9-13

4.3 Bottom ...............................................................................................9-14

Sysmex CA-50 Operator’s Manual -- Revised July 1999 iii

Sysmex CA-50 Operator’s Manual -- Revised December 2000

CHAPTER 10: INSTRUMENT SETUP

1. INTRODUCTION.................................................................10-1

2. SETTING MENU .................................................................10-2

3. MEASURE SETTINGS ..........................................................10-3

3.1 Measure Setting Menu.....................................................10-3

3.2 Test Protocol Settings .....................................................10-4

3.3 Data Check Parameter & Mark Limit Settings......................... 10-9

3.4 Report Limit Settings.....................................................10-13

3.5 Replication Difference Limit Settings..................................10-17

3.6 Measure Mode & Sample Incubation Ready Check Settings .......10-20

3.7 Conversion Settings.......................................................10-23

4. I/O SETTINGS ...................................................................10-26

4.1 I/O Setting Menu..........................................................10-26

4.2 Built-In Printer Settings..................................................10-26

4.3 Host Computer Settings..................................................10-28

4.4 Printing Out I/O Settings.................................................10-31

5. SYSTEM SETTINGS............................................................10-32

5.1 System Setting Menu.....................................................10-32

5.2 Date Settings...............................................................10-32

5.3 Time Settings ..............................................................10-33

5.4 Password Settings.........................................................10-34

6. PRINTING OUT ALL SETTINGS............................................10-36

APPENDIX A: INSTALLATION

1. INTRODUCTION..................................................................A-1

2. CHECK BEFORE INSTALLATION ........................................... A-1

3. INSTALLATION SPACE ........................................................A-2

4. CHANGING THE INSTALLATION DIRECTION OF PIPETTE

GUIDE............................................................................... A-3

5. INSTALLING THE FILTER ..................................................... A-5

6. CONNECTING THE POWER CORD AND CONNECTION CORD ..... A-5

6.1 Connecting the Power Cord ............................................... A-5

6.2 Connecting the Connection Cord ......................................... A-7

7. ADJUSTING THE LCD BRIGHTNESS .......................................A-8

8. SETTING A PRINTER PAPER.................................................. A-9

APPENDIX B: TECHNICAL INFORMATION

1. OUTPUT FORMAT FOR HOST COMPUTER...............................B-1

1.1 Hardware .....................................................................B-1

1.2 Software......................................................................B-2

1.3 Text Format..................................................................B-3

2. FACTORY DEFAULT SETTINGS.............................................B-7

2.1 QC Parameters and Factory Default Settings ...........................B-7

2.2 Standard Curve Data and Factory Default Settings.....................B-8

2.3 Standard Curve Calculation Parameters and

Factory Default Settings...................................................B-11

2.4 Instrument Setting Parameters and Factory Default Settings ........B-12

INDEX

iv Sysmex CA-50 Operator’s Manual -- Revised July 1999

CHAPTER 1 INTRODUCTION

1. INTRODUCTION ................................................................................1-1

2. INSTRUMENT OVERVIEW ...................................................................1-2

3. OUTLINE OF OPERATION ....................................................................1-3

4. ANALYSIS PARAMETERS AND CALCULATION PARAMETERS....................1-4

5. LCD SCREEN AND INPUT KEYS ...........................................................1-6

5.1 LCD Screen .................................................................................1-6

5.2 Input Keys ..................................................................................1-7

6. PASSWORDS .....................................................................................1-8

7. ALARMS...........................................................................................1-8

8. DETECTOR LED .................................................................................1-9

9. PACKAGING.....................................................................................1-9

10. INSTALLATION ENVIRONMENT .........................................................1-10

10.1 Installation and Relocation .............................................................. 1-10

10.2 Grounding.................................................................................1-10

10.3 Installation Space .........................................................................1-11

10.4 Installation Environment................................................................. 1-11

11. INSTRUMENT SPECIFICATIONS.........................................................1-12

12. MENU TREE....................................................................................1-16

13. MAIN MENU ...................................................................................1-17

Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

1 . INTRODUCTION

The Sysmex® CA-50 is an automated blood coagulation analyzer For In Vitro Diagnostic Use to perform blood coagulation tests in clinical laboratories.

Chapter 1 provides an overview of the instrument and analysis procedures that should be read before the CA-50 is used in a daily routine. The major elements of Chapter 1 are listed below.

Instrument Overview

Provides an overview of the CA-50’s functions.

Analysis Procedure Overview

Provides an overview of the analysis procedure, LCD screen display, and key operation.

Installation Precautions

Explains matters that require confirmation before installing the instrument, such as the installation space, required equipment, and environmental conditions.

Instrument Specifications

Provides the instrument specifications.

Menu Tree

Shows a menu tree of the CA-50.

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-1

INTRODUCTION

2 . INSTRUMENT OVERVIEW

The CA-50 is an automated blood coagulation analyzer that can quickly analyze samples with a high degree of accuracy. The CA-50 can analyze samples using a Coagulation Method; and the analyzed data can be displayed on its LCD screen and printed by the built-in printer. The CA-50 also has some supplemental functions including quality control.

Figure 1-1: Overview of CA-50

1-2 Sysmex CA-50 Operator’s Manual -- Revised December 2000

3 . OUTLINE OF OPERATION

The CA-50 performs an analysis by the following procedure.

Table 1-1: CA-50 Analysis Procedure

Check before turning ON power

Power ON

Self-check

Ready

Preparation for analysis

Work List

Press [START] key

Execution of sample incubation

Addition of reagents

Execution of analysis

Discard used reaction tubes

Ready

Power OFF

Operation after analysis completion

INTRODUCTION

Ready

Indicates actions performed by the operator.

Indicates that the instrument is in the ready status. At this time, the detector LED of each channel will light up in green indicating that you can perform operations such as analysis and settin

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-3

INTRODUCTION

4 . ANALYSIS PARAMETERS AND CALCULATION PARAMETERS

The CA-50 can analyze and calculate the parameters shown below. Additional analysis and calculation parameters can be registered as well.

The following list shows the analysis and calculation parameters that can be analyzed by the CA-

50.

Table 1-2: CA-50 Analysis Parameters and Calculation Parameters

Method Analysis parameter Calculation parameter

Coagulation Method

Prothrombin Time (PT) Activated Partial Thromboplastin Time (APTT) Fibrinogen (Fbg) Thrombotest (TTO) Normotest (NT) Thrombin Time (TT) Extrinsic Factor Deficiency Assay

(II, V, VII, X) Intrinsic Factor Deficiency Assay

(VIII, IX, XI, XII)

Prothrombin Activity Percent Prothrombin Ratio INR Derived Fbg Fibrinogen Concentration Thrombotest Activity Percent Normotest Activity Percent Factor II Activity Percent Factor V Activity Percent Factor VII Activity Percent Factor VIII Activity Percent Factor IX Activity Percent Factor X Activity Percent Factor XI Activity Percent Factor XII Activity Percent

CAUTION

• If you analyze with a wrong reagent, correct analysis results will not be obtained.

NOTE: • You can set up to 3 types of calculation parameters each for an analysis

parameter.

1-4 Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

CAUTION

Interpretation of APTT Abnormal Early Reaction.

• APTT results less than or equal to 20.0 seconds, APTT results with NC (No Coagulation), SC (Slight Coagulation) or CCE (Coag. Curve Error) error messages, or abnormally short APTT results may be caused by an abnormal early reaction. APTT results with an abnormal early reaction can be identified in the analysis data.

• If an APTT result less than or equal to 20.0 seconds is obtained, the following steps should be taken:

1. Verify sample and reagent integrity along with maintenance procedures.

2. Print out the Analysis data.

See Chapter 4, Section 4: OUTPUTTING ANALYSIS RESULT and

Chapter 10, Section 4.2: Built-In Printer Settings.

Note that the stored analysis results will be deleted, when you start a next analysis on the same channel or you turn OFF the power or so on.

3. Observe time in the “2%” position.

4. If that time is equal to or less than 15 seconds, then an abnormal early reaction may have occurred.

5. Re-analyze the sample.

6. If result is the same, it should not be reported.

7. Review the previous patient history to determine acceptability of patient results. Results of the other parameters considered, then make overall evaluation.

8. Follow your laboratory's alternate protocol.

• An error code may or may not be associated with this result.

• An abnormal early reaction rarely occurs.

• The CA-50 should be set up so that any APTT results of less than or equal to 20.0 seconds will have a message of <20.1 seconds on the printout.

• To set up this function see Chapter 10, Section 3.4: Report Limit Settings and enter 20.1 for the APTT lower limit.

• Remember to change the Built-in Printer Settings back to “List” after review of the analysis data.

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-5

INTRODUCTION

5 . LCD SCREEN AND INPUT KEYS

5. 1 LCD Screen

The instrument’s status, analysis results, and all other information are displayed on the CA-50’s LCD screen. The screen is capable of displaying 16 characters by 2 lines maximum.

Display position of the each analysis channel on the screen

CH3 CH4

CH1 CH2

Figure 1-2: Display position of the each analysis channel on the screen

On the Analysis screen, the LCD screen is split into four parts to show the data of respective channels from 1 to 4. Analysis parameters are abbreviated into two characters as shown below:

• PT: PT • F5: Factor V

• AP: APTT • F7: Factor VII

• Fg: Fbg • F8: Factor VIII

• TO: TTO • F9: Factor IX

• NT: NT • 10: Factor X

• TT: TT • 11: Factor XI

• F2: Factor II • 12: Factor XII

Settings Screen

ID No. Entry

Select CH(1-4)?

Figure 1-3: Example of Settings Screen

On the Settings screen, parameters to be set or selected are displayed on the upper and lower lines.

1-6 Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

5. 2 Input Keys

By using the input keys, you can perform each setting such as entering numerals and selecting various parameters.

Figure 1-4: Input Keys

Table 1-3: Operation of Input Keys

Key Operation

1/PT Press to input the number "1" or select "PT".

2/APTT Press to input the number "2" or select "APTT".

3/Fbg Press to input the number "3" or select "Fbg".

4/TTO Press to input the number "4" or select "TTO".

5/NT Press to input the number "5" or select "NT".

6/TT Press to input the number "6" or select "TT".

7/IN Press to input the number "7" or select "intrinsic factor".

8/EX Press to input the number "8" or select "extrinsic factor".

9/PRINT Press to input the number "9" or print a menu.

0/ Press to input the number "0", scroll a menu up, or switch to the previous data.

-/./ Press to input a hyphen or a decimal point, scroll a menu down, or switch to the next data.

C Press to clear inputted data or stop an error beep.

SELECT Press to switch between Menu and Ready, cancel updated data (when confirmed), or

return to the previous screen.

QC Press to input "QC" (when inputting an ID number).

FEED Press to feed paper.

ENTER Press to set inputted data or execute updated data (when confirmed).

CAUTION: • When a key has two or more functions, the function will be changed over

depending on the situation when the key is pressed.

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-7

INTRODUCTION

6 . PASSWORDS

Important programs are protected by a password so that the programs can be executed under the control of a supervisor. When a menu that is protected by a password is to be executed, a Password Entry window will appear. To execute the menu, enter the preset password and press the [Enter] key. For details on how to set the password, see Chapter 10, Section 5.4: Password Settings.

7 . ALARMS

The CA-50 makes three types of alarm sounds.

1. Key Entry A short beep will sound each time an input key is pressed.

2. Reagent addition timing

Two short beeps followed by a long beep will sound to let you know the timing of adding reagents.

The time allowed for reagent addition is preset at 10 seconds as default; 5 seconds before and after the time of addition. If you wish to change the allowed time, see Chapter 10,

Section 3.2: Test Protocol Settings.

Table 1-4: Reagent Addition Timing Alarm

Reagent addition allowed time (start)

Two short beeps

5 seconds before

No sound A short

beep

• • •

A short beep A long beep A short beep A long beep

One beep per second

Reagent addition

For 0.5 seconds

Allowed time for reagent addition

3. Error A long beep will sound when an error occurs on the instrument. The beep will continue to sound until the [C] key is pressed.

• • •

One beep per second

Reagent addition allowed time (end)

An error beep

1-8 Sysmex CA-50 Operator’s Manual -- Revised December 2000

8 . DETECTOR LED

The detector LED of each channel indicates the status as shown in the table below.

Table 1-5: Operation of Detector LED

INTRODUCTION

During

warming-up

Turns off Lights up in

Ready During

green

Reagent

incubation

Blinks in red Blinks in green Lights up in red Lights up in

addition timing

During photo

detection

green

9 . PACKAGING

The CA-50 is thoroughly checked before it is shipped from the factory, and is carefully packaged to withstand shocks during shipment. After the CA-50 has been delivered, check the packaging. Make sure that the instrument is free of exterior damage. Your Sysmex service representative will unpack and install the instrument after delivery and will also set the initial settings.

Ready

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-9

INTRODUCTION

10. INSTALLATION ENVIRONMENT

10.1 Installation and Relocation

The CA-50 is installed by your Sysmex Service representative. In case relocation becomes necessary after installation, see Appendix A: INSTALLATION to install the instrument correctly.

WARNING

CAUTION

• When relocating the CA-50, be sure to wear rubber gloves. After the relocation, wash your hands with disinfectant solution. If your hands are contaminated with blood, infection by bacteria or the like can occur.

• When relocating the CA-50, hold the instrument securely. If the instrument falls, you can get injured or the instrument can be damaged.

10.2 Grounding

The instrument power supply cord uses a 3-prong plug. When the power supply socket is 3prong (with grounded), simply plug it to the socket.

117 VAC Spec. 220 VAC Spec. 240 VAC Spec.

Figure 1-5: Plugs

WARNING

NOTE: • The number of power supply sockets required is 1.

• Make sure to ground the instrument. Inadequate grounding could cause electrical shocks.

1-10 Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

10.3 Installation Space

To ensure that the instrument fulfills its function, it is important to install it in an appropriate place:

• Select a place that is close to the power supply.

• Secure a place spacious enough for maintenance and service. Giving consideration to heat

radiation by the instrument, provide at least 10 cm distance from the wall to the rear panel.

The instrument dimensions are shown below. The power supply cord is 1.8 m long.

Table 1-6: Instrument Dimensions

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

327 302 113 4.5

327 mm

113 mm

302 mm

Figure 1-6: Instrument Dimensions

10.4 Installation Environment

• Use the instrument at an ambient temperature of 15°C - 35°C (optimum: 23°C).

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

• Avoid a place that can become extremely hot or cold.

• Avoid a place that can be exposed to direct sunlight.

• Choose a well-ventilated place.

• Avoid a place close to a wireless telegraph or communication facility where high frequency

waves can be generated or radio interference can occur.

• Do not use in dusty areas.

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-11

INTRODUCTION

11 . INSTRUMENT SPECIFICATIONS

Analysis parameters/Calculation parameters

See Section 4: ANALYSIS PARAMETERS AND CALCULATION PARAMETERS in this chapter.

Simultaneous Random Analysis of 4 Parameters

Random analysis is possible.

Required Sample

Prothrombin Time (PT): 50 µL Activated Partial Thromboplastin Time (APTT): 50 µL Fibrinogen (Fbg): 10 µL Thrombotest (TTO): 20 µL Normotest (NT): 10 µL Thrombin Time (TT): 100 µL Extrinsic Factor Deficiency Assay (II, V, VII, X): 5 µL Intrinsic Factor Deficiency Assay (VIII, IX, XI, XII): 5 µL

Analysis Principles

Coagulation Method

1. Coagulation Reaction Detection Method (Scattered Light Detection Method) Irradiates red light (660 nm) onto a mixture of blood plasma and reagent and detects the change in turbidity (when the fibrin clots are formed) as the change in scattered light. And measures the coagulation time.

2. Coagulation Point Detection Method (Percentage Detection Method) Calculates the coagulation time as the time required to achieve the amount of scattered light that is set for the coagulation detection point, using the amount of scattered light that is present just after the start of detection as 0%, and the amount of scattered light that is present at the completion of coagulation as 100%.

Range of Analysis

Fibrinogen Concentration Can analyze from 50 mg/dL to 450 mg/dL.

Detection Time

Detects within the maximum detection time, and measures the result. Typical maximum detection time: 100 seconds for PT and Fbg; 190 seconds for others. Maximum detection time: 600 seconds for each parameter

1-12 Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

Reproducibility

Prothrombin Time (PT): C.V. 2% or less Activated Partial Thromboplastin Time (APTT): C.V. 2% or less Fibrinogen (Fbg): C.V. 4% or less Thrombotest (TTO): C.V. 4% or less Normotest (NT): C.V. 4% or less Thrombin Time (TT): C.V. 10% or less Extrinsic Factor Deficiency Assay (II, V, VII, X): C.V. 5% or less Intrinsic Factor Deficiency Assay (VIII, IX, XI, XII): C.V. 5% or less

* The data above are variation coefficients for coagulation times (in seconds) or for the amount

of change in activity% taken from 10 analyses of Dade Behring Ci-Trol Level 1 (control plasma), with the reagents below used.

Thromboplastin•C plus Dade Behring Actin Activated Cephaloplastin Reagent 20 mM Calcium Chloride Solution Dade Behring Fibrinogen Determination Reagents Owren's Veronal Buffer CA Series Complex Factor TTO CA Series Complex Factor HPT Dade Behring Factor-deficient Plasma

Display

Displays characters on a liquid crystal display (LCD).

Printing

Permits graphic printing through a built-in printer. (Printer paper specification: F1-1, width: 58 mm)

External Input/Output

Equipped with an RS-232C serial port (bit serial voltage signal).

Detector

Detector: 4 wells (Scattered light detector)

Incubator

Incubator: 5 wells

Reaction Tube Holder

Reaction tube holder: 8 wells

Temperature Control

Detector: 37°C±0.5°C Incubator: 37°C±1°C Applies when room temperature is within 15°C - 35°C.

Time to Reach Temperature Setting

Reaches preset temperature within 30 minutes after power is turned ON (when the room temperature is within the specified range).

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-13

INTRODUCTION

Quality Control

control (L-J control): 50 points × 3 files, 14 parameters

Standard Curve

6 points, 14 parameters

Power

Rated voltage: 117 VAC±10%, 230 VAC±15% Frequency: 50 Hz or 60 Hz Power consumption: 90 VA or less Temperature Compensation Required: Approx. 307 BTU/h (77 kcal/h)

Environmental Requirements

15°C - 35°C

Dimensions/Weight

Main Unit: 327 (W) × 302 (D) × 113 (H) mm; approx. 4.5 kg

1-14 Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

CAUTION

Interpretation of APTT Abnormal Early Reaction.

• If an APTT result less than or equal to 20.0 seconds is obtained, the following steps should be taken:

1. Verify sample and reagent integrity along with maintenance procedures.

2. Print out the Analysis data.

See Chapter 4, Section 4: OUTPUTTING ANALYSIS RESULT and

Chapter 10, Section 4.2: Built-In Printer Settings.

Note that the stored analysis results will be deleted, when you start a next analysis on the same channel or you turn OFF the power or so on.

3. Observe time in the “2%” position.

4. If that time is equal to or less than 15 seconds, then an abnormal early reaction may have occurred.

5. Re-analyze the sample.

6. If result is the same, it should not be reported.

7. Review the previous patient history to determine acceptability of patient results. Results of the other parameters considered, then make overall evaluation.

8. Follow your laboratory's alternate protocol.

• An error code may or may not be associated with this result.

• An abnormal early reaction rarely occurs.

• The CA-50 should be set up so that any APTT results of less than or equal to 20.0 seconds will have a message of <20.1 seconds on the printout.

• To set up this function see Chapter 10, Section 3.4: Report Limit Settings and enter 20.1 for the APTT lower limit.

• Remember to change the Built-in Printer Settings back to “List” after review of the analysis data.

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-15

INTRODUCTION

12 . MENU TREE

Ready

Analysis Start

MAIN MENU

Chapter 2, 3

Chapter 3, 3.1

Chapter 1, B

1. Select Test

2. ID No. Entry

3. Display Data

4. QC

5. Standard Curve

6. Settings

Chapter 3, 2.1

Chapter 3, 2.2

Chapter 4, 3

Chapter 6, 2

Chapter 7, 3

Chapter 10, 2

Press the [Start] switch.

Press the [SELECT] key.

1. Select Test

2. Select File

3. Print

4. Delete a Point

5. Settings

6. Clear a File

1. Select Test

2. Input

3. Print

4. Settings

5. Clear

1. Meas. Settings

Chapter 6, 3.1

Chapter 6, 3.2

Chapter 6, 4

Chapter 6, 5.1

Chapter 6, 6

Chapter 6, 5.2

Chapter 7, 4.1

Chapter 7, 4.2

Chapter 7, 5

Chapter 7, 6.1

Chapter 7, 7

Chapter 10, 3.1

1. Activity/Conc.

2. Ratio

3. INR

4. Dfbg

5. Print Settings

1. Test Protocol

2. Mark Limits

3. Report Limits

4. Diff. Check

5. Measure Mode

6. Conversion

Chapter 7, 6.2

Chapter 7, 6.3

Chapter 7, 6.4

Chapter 7, 6.5

Chapter 7, 6.6

Chapter 10, 3.2

Chapter 10, 3.3

Chapter 10, 3.4

Chapter 10, 3.5

Chapter 10, 3.6

Chapter 10, 3.7

Chapter 10, 4.2

Chapter 10, 4.3

Chapter 10, 4.4

Chapter 10, 5.2

Chapter 10, 5.3

Chapter 10, 5.4

7. Test Programs

2. I/O Settings

3. System Setting

4. Print Settings

Chapter 8, 4.1

: The password has to be entered if it is set.

1. Temperature

2. Sensor

3. Key

4. Printer

5. Host Computer

6. LCD

Chapter 10, 4.1

Chapter 10, 5.1

Chapter 10, 6

Chapter 8, 4.2

Chapter 8, 4.3

Chapter 8, 4.4

Chapter 8, 4.5

Chapter 8, 4.6

Chapter 8, 4.7

1. Printer

2. Host Computer

3. Print Settings

1. Date

2. Time

3. Password

1-16 Sysmex CA-50 Operator’s Manual -- Revised December 2000

INTRODUCTION

13 . MAIN MENU

The Main Menu screen shows the menu for selecting and utilizing the functions provided with the CA-50.

When you press the [SELECT] key on the Ready screen, the Main Menu screen will appear. For details on the Ready screen, see Chapter 2, Section 3: TURNING ON THE POWER. You can scroll the menu up and down by using the [ ] and [ ] keys.

MAIN MENU

1.Select Test

2.ID No. Entry

3.Display Data

4.QC

5.Standard Curve

6.Settings

7.Test Programs

Figure 1-7: Main Menu Screen

Pressing the following key will select each menu function. [1] key: Moves the screen to the selection of analysis parameters (Select Test). [2] key: Moves the screen to the entry of ID numbers (ID No. Entry). [3] key: Moves the screen to the display of detailed analysis results (Display Data). [4] key: Displays the quality control menu (QC). [5] key: Displays the standard curve menu (Standard Curve). [6] key: Displays the setting menu (Settings). [7] key: Displays the test program menu (Test Programs). [PRINT] key: Prints out the main menu. [SELECT] key: Returns the screen to the Ready screen.

Sysmex CA-50 Operator’s Manual -- Revised December 2000 1-17

CHAPTER 2 ANALYSIS PREPARATION

1. INTRODUCTION ................................................................................2-1

2. BEFORE TURNING ON THE POWER ......................................................2-2

3. TURNING ON THE POWER ..................................................................2-2

4. REAGENT PREPARATION....................................................................2-4

4.1 Preparing the Reagents ....................................................................2-4

4.2 Setting the Reaction Tubes and Reagents................................................2-5

5. CHECKING THE STANDARD CURVES ...................................................2-6

6. QUALITY CONTROL ...........................................................................2-7

7. SAMPLE PREPARATION......................................................................2-8

Sysmex CA-50 Operator’s Manual -- Revised July 1999

ANALYSIS PREPARATION

1. INTRODUCTION

Before beginning analysis, it is necessary to prepare the instrument, reagents, and samples. Prepare for analysis by following the steps described below.

Table 2-1: Analysis Flow Chart

Check visually before Turning ON the Power

Turn ON the Power

Prepare Reagents

Set Reaction Tubes and Reagents

Check Standard Curves

Run Quality Control

Prepare Samples

Make Work List

Analyze Samples

Start an Analysis

Add Reagents

All are explained in this chapter.

Refer to

Chapter 3: SAMPLE

ANALYSIS.

Shutdown

Sysmex CA-50 Operator’s Manual -- Revised July 1999 2-1

ANALYSIS PREPARATION

2 . BEFORE TURNING ON THE POWER

Before turning ON the power to the instrument, check the following items:

1 . CA-50 Instrument Visual Check

Make sure that the power cord is securely plugged into the AC outlet. Also, check whether the used reaction tube is not left in the detector.

2 . Printer Paper

If a printer is provided, make sure that it contains the amount of paper necessary for the number of samples to be processed that day. Prepare extra paper when the remains of paper run short.

3 . TURNING ON THE POWER

When you turn ON the power switch that is located on the right side, the instrument will automatically perform a self-check.

(1) Turn ON the power switch.

A self-check will automatically be performed. When the self-check is completed without finding any error, "OK" will be displayed on the screen and the built-in printer will output a test print. If an error occurs during the self-check, see Chapter 8: TROUBLESHOOTING.

Sysmex CA-50 Self Test OK

Figure 2-1: Self-Check Screen

15/06/1999 09:00

This is CA-50. Blood Coagulation Analyzer Produced by Sysmex

Figure 2-2: Example of Test Print

When the self-check is completed, the detector and the incubator will be warmed up.

During the warming-up, "warm" will be displayed on each channel of the screen.

NOTE: • The analysis parameter that was used in the previous analysis is

displa

ed on each channel.

2-2 Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised August 1999

ANALYSIS PREPARATION

Fg warm AP warm PT warm AP warm

Figure 2-3: Warming-Up Screen

The "warm" will disappear and the detector LED will light up in green one by one as soon as each channel completes the warming-up. It takes about 5 minutes to 30 minutes until the "warm" disappears. This status is called "Ready." You can perform various operations such as analysis and settings on the channel that has entered the "Ready" status.

Fg AP PT AP

Figure 2-4: Ready Screen

If you press the [SELECT] key on this screen, the Main Menu screen will appear. For details on the Main Menu screen, see Chapter 1, Section 13: MAIN MENU.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 2-3

ANALYSIS PREPARATION

(

)

4. REAGENT PREPARATION

4.1 Preparing the Reagents

Prepare the required volume of coagulation reagents and Owren’s Veronal buffer for the anticipated work load.

Table 2-2: Reagent Preparation

Parameter Reagent Consumption/Test

PT PT Reagent 100 µL APTT APTT Reagent 50 µL

Calcium Chloride Solution 50 µL

Fbg Thrombin Reagent 50 µL

Owren's Veronal Buffer 90 µL

TTO Thrombotest Reagent 125 µL

Owren's Veronal Buffer 30 µL

NT Normotest Reagent 125 µL

Owren's Veronal Buffer 40 µL TT Thrombin Time Reagent 50 µL Extrinsic Factor PT Reagent 100 µL Deficient Factor-deficient Plasma 50 µL Assay Owren's Veronal Buffer 45 µL Intrinsic Factor APTT Reagent 50 µL Deficient Calcium Chloride Solution 50 µL Assay Factor-deficient Plasma 50 µL

Owren's Veronal Buffer 45 µL

When you prepare reagents, take into account the analysis parameters and the number of samples to be analyzed.

CAUTION: • We recommend that you use the following pipettes and pipette chips to

add plasma and dispense/add rea

• Pipette: Eppendorf reference 4910

• Pipette chip: Eppendorf 300 µL chip For details on the usa

e of the pipette and pipette chip, refer to the

instruction manuals attached to them.

ents.

50 - 200 µL

2-4 Sysmex CA-50 Operator’s Manual -- Revised July 1999

ANALYSIS PREPARATION

4.2 Setting the Reaction Tubes and Reagents

Set reaction tubes and reagents into the instrument. (1) Set reaction tubes into the reaction tube holder. Prepare a sufficient number of reaction

tubes beforehand.

Reaction tube

Reaction tube holder

Figure 2-5: Setting the Reaction Tubes

CAUTION: • Be sure to use the specified reaction tube (SU-40).

(2) Dispense the reagents to be used into the sample cups, and set them into the incubator.

Incubator

Sample cup

Figure 2-6: Setting the Reagents

Sysmex CA-50 Operator’s Manual -- Revised July 1999 2-5

ANALYSIS PREPARATION

(

WARNING

CAUTION: • Do not set the reagent of 2 mL or more in the incubator. The reagent will not

• Cap the sample cups that are set in the incubator if they are not used. If contaminants or dusts get in the reagent, or if the reagent evaporates, correct analysis results will not be obtained.

• Let the incubator incubate the reagents more than 10 minutes. If the incubation is insufficient, correct analysis results may not be obtained. As the reagent may deteriorate, do not use the APTT reagent incubated for 20 minutes or more and the other reagents incubated for 40 minutes or more.

• Do not replenish reagents. Correct analysis results may not be obtained.

reach the desired temperature.

• Be sure to use the specified sample cup e

uivalent).

Uniflex Conical 4 mL or the

5 . CHECKING THE STANDARD CURVES

Before performing an analysis, print out standard curves and make sure that they are correctly set. For the procedure to print out standard curves, see Chapter 7, Section 5: PRINTING OUT THE

STANDARD CURVE.

CAUTION: • If the standard curve is not set correctly, it is not possible to calculate the

calculation parameters such as the PT %.

If the settings are incorrect, set them correctly referring to Chapter 7: SETTING STANDARD CURVES.

2-6 Sysmex CA-50 Operator’s Manual -- Revised July 1999

ANALYSIS PREPARATION

6. QUALITY CONTROL

To maintain reliable analysis data, it is necessary to implement quality control. With the CA-50, a quality control file number (QC1 - QC3) can be registered as a sample ID number, the control material (control plasma) is analyzed, and the analysis data is stored in a quality control file. This data and a quality control program are used to monitor changes in the instrument and reagent system that take place over time (day-to-day or hour-to-hour).

For details on quality control, see Chapter 6: QUALITY CONTROL.

Implementing Quality Control

When performing a quality control analysis, dispense control material into a reaction tube. The procedure for a quality control analysis is the same as that for a sample analysis. For details, see Chapter 3: SAMPLE ANALYSIS.

(1) Register the analysis parameter in the channel used for the analysis. (2) Press the [QC] key on the ID No. Entry screen, and input the ID number for quality

control (any number from 1 to 3). (3) Dispense control material into a reaction tube and set it into the detector. (4) Press the [Start] switch. (5) Add a reagent at the indicated timing, and close the pipette guide.

The analysis will be performed, and the analysis data will be stored in a quality control

file. (6) Print out a QC chart and check the status of analysis data.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 2-7

ANALYSIS PREPARATION

7. SAMPLE PREPARATION

Prepare sample tubes containing plasma.

NOTE: • When handling the sample, be sure to wear rubber gloves. After the

operation is completed, wash Failure to do so can cause infection b

(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-cell components.

(3) Put only the centrifuged plasma into another test tube.

our hands with disinfectant solution.

bacteria.

CAUTION

Precautions when handling plasma:

• Containers should be plastic or silicone-coated glass tube.

• As anticoagulant, use 3.8%, 3.2% or 3.13% sodium citrate solution.

When any other anticoagulant is used, sedimentation may occur and correct analysis result may not be obtained.

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

• Store samples in the refrigerator and analyze within 4 hours of collecting.

After 4 hours, or if the ma

not be obtained.

are stored improperly, correct analysis results

2-8 Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised December 1999

CHAPTER 3 SAMPLE ANALYSIS

1. INTRODUCTION................................................................................ 3-1

2. WORK LIST...................................................................................... 3-2

2.1 Selecting the Analysis Parameter.........................................................3-2

2.2 Registering the Sample ID Number......................................................3-4

3. SAMPLE ANALYSIS ...........................................................................3-6

3.1 Start of Analysis ........................................................................... 3-7

3.2 Adding the Reagents.......................................................................3-8

3.3 Registering and Analyzing the Next Sample...........................................3-11

4. SHUTDOWN ....................................................................................3-12

Sysmex CA-50 Operator’s Manual -- Revised July 1999

SAMPLE ANALYSIS

1. INTRODUCTION

This chapter will explain the operating procedures for the order information registration and from the start of analysis to shutdown.

Table 3-1: Analysis Flow Chart

Check visually before Turning ON the Power

Turn ON the Power

Prepare Reagents

Set Reaction Tubes and Reagnets

Check Standard Curves

Run Quality Control

Prepare Samples

Make Work List

Analyze Samples

Start an analysis

Add Reagents

Shutdown

Refer to

PREPARATION.

All are explained in this chapter.

Chapter 2:

ANALYSIS

Sysmex CA-50 Operator’s Manual -- Revised July 1999 3-1

SAMPLE ANALYSIS

2 . WORK LIST

2.1 Selecting the Analysis Parameter

NOTE: • When the power is turned ON, the analysis parameter used in the

revious analysis is displayed on each channel.

(1) Press the [SELECT] key to enter the Main Menu screen.

MAIN MENU

1.Select Test

2.ID No. Entry

3.Display Data

4.QC

5.Standard Curve

6.Settings

7.Test Programs

Figure 3-1: Main Menu Screen

(2) Press the [1] key on the Main Menu screen.

The Channel Selection screen will appear.

Select Test Select CH(1-4)?1

Figure 3-2: Channel Selection Screen

If you press the [SELECT] key, the display will return to the Main Menu screen (Figure 3-

1).

3-2 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SAMPLE ANALYSIS

(3) Input the channel number (any number from 1 to 4) on which you wish to select the

analysis parameter, and press the [ENTER] key. However, when the replication measure mode is set (See Chapter 10, Section 3.6: Measure Mode & Sample Incubation Ready Check Settings.), select the channel number either 1 or 3. The Analysis Parameter Selection screen will appear. (The parameter set in the previous analysis is displayed.)

Select Test CH2 Test(PT-EX)? PT

Figure 3-3: Analysis Parameter Selection Screen

If you press the [SELECT] key, the display will return to the Channel Selection screen (Figure 3-2).

(4) Press the key for the desired parameter, and press the [ENTER] key.

In the case of an intrinsic factor assay (8, 9, 11, or 12), press the [IN] key. In the case of an extrinsic factor assay (2, 5, 7, or 10), press the [EX] key. When you press the [IN] or [EX] key, the Factor Number Entry screen will appear. When you press any of the other keys, the display will return to the Channel Selection screen (Figure 3-2). Set the analysis parameter of the other channels in the same manner.

Select Test CH2 IN(8,9,11,12)? 8

Figure 3-4: Factor Number Entry Screen

If you press the [SELECT] key, the display will return to the Channel Selection screen (Figure 3-2).

(5) In the case of an intrinsic factor assay, input any of 8, 9, 11, and 12.

In the case of an extrinsic factor assay, input any of 2, 5, 7, and 10. Then press the [ENTER] key. The display will return to the Channel Selection screen (Figure 3-2). Set the analysis parameter of the other channels in the same manner.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 3-3

SAMPLE ANALYSIS

2.2 Registering the Sample ID Number

(1) Press the [SELECT] key to enter the Main Menu screen.

MAIN MENU

1.Select Test

2.ID No. Entry

3.Display Data

4.QC

5.Standard Curve

6.Settings

7.Test Programs

Figure 3-5: Main Menu Screen

(2) Press the [2] key on the Main Menu screen.

The Channel Selection screen will appear.

ID No. Entry Select CH(1-4)?

Figure 3-6: Channel Selection Screen

If you press the [SELECT] key, the display will return to the Main Menu screen (Figure 3-

5).

(3) Input the channel number (any number from 1 to 4) on which you wish to register the

sample ID number, and press the [ENTER] key. The ID No. Entry screen will appear.

ID No. Entry CH2 123-456

Figure 3-7: ID No. Entry Screen

If you press the [SELECT] key, the display will return to the Channel Selection screen (Figure 3-6).

3-4 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SAMPLE ANALYSIS

(4) Input the ID number, and press the [ENTER] key.

The display will return to the Channel Selection screen (Figure 3-6). The sample ID number can be registered with up to 15 digits consisting of numerals and hyphens (-). The hyphens, however, cannot be used consecutively or as the first or last digits of the sample ID number. When a quality control analysis is performed, press the [QC] key and input any number from 1 to 3.

NOTE: • If you do not input a sample ID number after the power is turned ON, the

number will be se re

ardless of the channel or the analysis parameter.

• If a sam from the ID number in

arameter.

• When a h automatic increment will be the di For exam will be "990601-00."

• If "0" is in And, if "0", "QC1", "QC2", or "QC3" is in onl

le ID number is input, the number will be sequentially incremented

hen is used in the sample ID number, the subject of the

le, when the sample ID number is "990601-99", the next number

ut to the ID number, an external output will not be carried out.

one time at the input without automatic incrementing.

uentially incremented from "1" in each analysis

ut last regardless of the channel or the analysis

its after the hyphen.

ut, the ID number will become

Sysmex CA-50 Operator’s Manual -- Revised July 1999 3-5

SAMPLE ANALYSIS

pip

3. SAMPLE ANALYSIS

When the detector LED is lit in green, you can perform an analysis on this channel. It is possible to perform analyses on multiple channels simultaneously. The CA-50 has a function to turn off the detector LED indicating the Ready status and prevent an analysis from being started when the timings of reagent addition are expected to overlap one another.

WARNING

CAUTION

• Be sure to wear rubber gloves during the analysis. After the operation is com

leted, wash your hands with disinfectant solution. Failure to do so can

cause infection b

• Handle reaction tubes containin an

infection by bacteria. When discardin medical and infectious wastes.

• The total volume of blood and rea L. If the volume exceeds this range, sample may spill out of the reaction

tube when bein

• Be careful not to spill blood or reagents into the detector. This may damage

the instrument.

• Use the correct volume of blood and rea

correct anal not be detected. For the specific volume required for each analysis, see

Chapter 9, Section 2.6: Analysis Flow

• Use a new

one even when contaminated with the other sam not be obtained.

• Be careful so that rea

Correct anal

bacteria.

sample with extreme care in order to avoid

used reaction tubes, take proper disposing steps as

ents must be in the range of 150 to 200

mixed, resulting in infection by bacteria.

ents. If the volume is improper,

sis results may not be obtained, or addition of reagents ma

ette chip each time. Replace the pipette chip with a new

ou add the same reagent consecutively. If sample is

le or reagent, correct analysis results will

ents or contaminants will not get in the reaction tube.

sis results will not be obtained.

3-6 Sysmex CA-50 Operator’s Manual -- Revised July 1999

3.1 Start of Analysis

(1) Pipette plasma into a reaction tube and set it into the detector.

At this time, push it into the bottom of the detector firmly.

SAMPLE ANALYSIS

Reaction tube

Detector

Figure 3-8: Setting Plasma

(2) Press the [Start] switch.

Incubation of plasma will start. The reagent to be added and the countdown of the remaining time before the reagent addition timing will be displayed on the screen. The detector LED will blink in red.

PT Fg AP PT 179

Figure 3-9: Display of Countdown

CAUTION: • When you press the [Start] switch by mistake, you can cancel the

anal

sis by pressing the [Start] switch again. However, the alarm sounds

in this case, and sto

s the alarm by pressing the [C] key.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 3-7

SAMPLE ANALYSIS

)

(

)

3.2 Adding the Reagents

When a reagent addition timing comes, an alarm will begin to sound and the detector LED will blink in green. The detailed operations of the alarm and the detector LED are as shown below:

Table 3-2: Reagent Addition Timing Alarm

Reagent addition allowed time (start

Two short beeps

5 seconds before

No sound A short

bee

· · ·

A short beepA long bee

One bee

er second

Reagent addition

For 0.5 seconds

· · ·

A short beepA long bee

One bee

er second

Reagent addition allowed time

end

An error bee

Allowed time for reagent addition

The time allowed for reagent addition is preset at 10 seconds as default; 5 seconds before and after the time of addition. If you wish to change the allowed time, see Chapter 10, Section 3.2:

Test Protocol Settings.

Table 3-3: Operation of Detector LED

During warming-upRead

Turns off Lights up in

reen

Durin incubation

Blinks in red Blinks in green Lights up in red Lights up in

Reagent addition timin

During photo detection

Read

reen

(1) When the alarm begins to sound, take the reagent to be added with a pipette.

CAUTION

• When two or more reagents are set in the incubator, be careful not to mix

them. If an incorrect reagent is used, correct analysis results will not be

obtained.

• Use the rea

insufficient, correct anal Also, as the rea incubated for 20 minutes or more and the other rea

ent incubated more than 10 minutes. If the incubation is

sis results may not be obtained.

ent may deteriorate, do not use the APTT reagent

ents incubated for 40

minutes or more.

• Do not re

lenish reagents. Correct analysis results may not be obtained.

3-8 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SAMPLE ANALYSIS

pip

)

pip

CAUTION: • We recommend that you use the following pipettes and pipette chips to

ette plasma and dispense/add reagents.

•Pi

ette: Eppendorf reference 4910 (50 - 200 mL

•Pipette chip:Eppendorf 300 mL chi For details on the usage of the pipette and pipette chip, refer to the instruction manuals attached to them.

• Use the

ette correctly calibrated.

(2) Add the reagent when a long beep sounds.

Add the reagent in a manner as to avoid bubbling the sample, while fixing the pipette chip to the pipette guide and applying the tip of the pipette chip to the inside wall of

the reaction tube.

Mark indicating the area where the pipette chip tip should be fixed

CAUTION

Pipette guide

When holding the pipette by the right hand

Area where the pipette chip tip should be fixed

When holding the pipette by the left hand

Figure 3-10: Adding the Reagent

• When you use multiple channels simultaneously, be careful not to mix u the detectors. If you add a reagent into an incorrect detector, correct anal

sis results will not be obtained.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 3-9

SAMPLE ANALYSIS

pip

prop

CAUTION: • Add the reagent to the reaction tube quickly after pipetting. However,

handle the

• Add the rea addition is not occur.

• The If

• When area shown in Fi not be detected.

• When shown in the fi not be detected properly, and the sensor may detect the tip of the pipette chi

ette guide is designed for the use of the recommended pipette chip.

ou use the other type of pipette chip, you may not be able to fix it

erly and reagent addition may not be detected.

ou add reagents, the tip of the pipette chip must be fixed in the

ou add reagents, the tip of the pipette chip must be in the area

as the reagent by mistake.

ette gently when dispensing and slowly when pipetting.

ent within the time allowed for the addition. If the reagent

erformed within the allowed time, an analysis error will

ure 3-10. If the tip is out of this area, reagent addition ma

ure below. If the tip is out of this area, reagent addition ma

9 mm

12 mm

• Do not add less than 50 mL of reagent. Reagent addition may not be detected

• Do not add rea more. Rea

NOTE: • You can prevent sample from bubbling by applying the tip of the pipette

chi

to the inside wall of the reaction tube.

erly.

ent when the volume of sample and reagent is 200 mL or

ent addition may not be detected properly.

When a reagent is added, mixing will start automatically, and the detector LED will light up in red. If the second reagent is required, the detector LED will blink in red and the countdown of the remaining time will appear again. Then go back to step (1) and add the reagent in the same manner. If the second reagent is not required, go to the next step.

(3) Close the pipette guide as soon as you add the reagent.

Photo detection will start. ">" will be displayed on the screen as the detection progresses.

PT Fg AP PT >>>

Figure 3-11: Display during Photo Detection

3-10 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SAMPLE ANALYSIS

CAUTION: • The pipette guide also serves as a lid to prevent disturbance light around

the detector. If the stand is not closed within two seconds after the addition of rea However, when addition of the rea except at the last rea

• Do not open the pipette occur.

ent, an analysis error will occur.

ou analyze the parameter for which the continuous

ent is necessary, it does not become an analysis error

ent addition.

uide during photo detection. An analysis error will

When the analysis is completed, the analysis parameter and analysis results will be displayed on the screen, and the detector LED will light up in green. For details on the data display, see Chapter 4: DISPLAY OF ANALYSIS RESULTS. The analysis results can be outputted to the built-in printer or the host computer. For details on the settings of output, see Chapter 10, Section 4: I/O SETTINGS.

(4) Discard the used reaction tube.

WARNING

CAUTION: • Close the pipette guide immediately after removing the used reaction tube.

• Be sure to wear rubber gloves during the analysis. After the operation is completed, wash cause infection b

• Handle reaction tubes containin an

infection by bacteria. When discardin medical and infectious wastes.

This will prevent the forei Also, if the pipette CH #” will occur.

our hands with disinfectant solution. Failure to do so can

bacteria.

sample with extreme care in order to avoid

used reaction tubes, take proper disposing steps as

n object etc. being entered into the detector.

uide is opened over 15 minutes, an error “Lid Open

3.3 Registering and Analyzing the Next Sample

When the analysis is completed at a certain channel, you can register the next sample and start an analysis even if the other channels are still in process. However, when the replication measure mode is selected, the registration and analysis of the next sample cannot be performed until both channels used in a pair complete the analysis.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 3-11

Sysmex CA-50 Operator’s Manual -- Revised December 1999

SAMPLE ANALYSIS

4. SHUTDOWN

Check the status of the instrument, and then turn the power OFF.

CAUTION: • At the end of each day’s operations or after operating the instrument for 24

hours,

MAINTENANCE & SUPPLIES REPLACEMENT.

erform daily maintenance. For details, see

Chapter 5:

3-12 Sysmex CA-50 Operator’s Manual -- Revised July 1999

CHAPTER 4 DISPLAY OF ANALYSIS RESULT

1. INTRODUCTION................................................................................ 4-1

2. DISPLAYING AND PRINTING OUT ANALYSIS RESULTS........................... 4-1

2.1 Displaying the Analysis Results..........................................................4-1

2.2 Printing Out the Analysis Results........................................................4-3

3. DISPLAYING DETAILED ANALYSIS RESULTS.........................................4-5

4. OUTPUTTING ANALYSIS RESULTS ...................................................... 4-7

Sysmex CA-50 Operator’s Manual -- Revised July 1999

DISPLAY OF ANALYSIS RESULT

play

1. INTRODUCTION

This chapter explains the method of displaying and outputting analysis results.

CAUTION: • The CA-50 stores only the last analysis results of each channel. Note that

the stored anal

• When

sis results will be deleted in the following cases: ou change the analysis parameter. ou change the sample ID number. ou change the measure mode. ou start the next analysis on the same channel.

ou turn OFF the power.

2. DISPLAYING AND PRINTING OUT ANALYSIS RESULTS

When an analysis is completed, the analysis parameter and the analysis results will be displayed on the screen. They can be printed out by the built-in printer at the same time.

2.1 Displaying the Analysis Results

Analysis parameter Analysis result

ch3

Fg+ 8.5AP ∗ 14.7 PT> 15.0PT 10.5

ch1

Flag

ch4 ch2

Figure 4-1: Analysis Results Screen

Analysis Parameter

The analysis parameter carried out on each channel is displayed.

Analysis Results

The analysis result of the preset data check parameter is displayed. For details on the data check parameter settings, see Chapter 10, Section 3.3: Data Check Parameter & Mark Limit Settings.

NOTE: • When the replication measure mode is selected, the mean data of two

channels’ anal each channel on the Dis

DISPLAYING DETAILED ANALYSIS RESULTS

Fg 8.5Fg 8.5 PT 15.0PT 15.0

sis results will be displayed. You can check the results of

Data screen (see

Chapter 4, Section 3:

.).

Figure 4-2: Analysis Results Screen

in the Replication Measure Mode

Sysmex CA-50 Operator’s Manual -- Revised July 1999 4-1

DISPLAY OF ANALYSIS RESULT

Flag

When the analysis results are judged to be abnormal, one of the flags shown below will appear on the left of the analysis results.

*: An error occurred, or data disparity exists between replication analysis results.

(Priority: high) >: Data exceeded the upper report limit. (Priority: middle) <: Data exceeded the lower report limit. (Priority: middle) +: Data exceeded the upper mark limit. (Priority: low)

- : Data exceeded the lower mark limit. (Priority: low) When two or more conditions are applicable, the flag of higher priority will be displayed.

The following figure shows the relation between the report limits and the mark limits. Note that this relation holds when the lower mark limit is smaller than the upper mark limit. For mark limits, it is possible that you set a smaller value (e.g. shorter time) as the upper limit and a larger value (e.g. longer time) as the lower limit. In this case, "+" will appear when the analysis results are smaller than the upper limit, and "-" will appear when the analysis results exceed the lower limit.

Lower report limit Upper report limit

Report Limit

Mark Limit

(Analysis range)

(Normal range)

Upper mark limitLower mark limit

Figure 4-3: Relation between Report Limits and Mark Limits

4-2 Sysmex CA-50 Operator’s Manual -- Revised July 1999

DISPLAY OF ANALYSIS RESULT

2.2 Printing Out the Analysis Results

For printing out analysis results, there are three types of formats - list, graph, and analysis. For details on the setting of printout formats, see Chapter 10, Section 4.2: Built-In Printer Settings.

15/06/1999 09:00

37.0 ˚C No. 123-456 PT 10.5 sec (50)

102.1 %

0.98 -

0.98 INR

210.0 mg/dL Coag.Curve Error

->Caution: Review Curve CH No. 2

Figure 4-4: Printout Example (List)

15/06/1999 09:00

37.0 ˚C No. 123-456 PT 10.5 sec (50)

102.1 %

0.98 -

0.98 INR

210.0 mg/dL Coag.Curve Error

->Caution: Review Curve

Date & time of analysis Temperature at the detector

Sample ID number Analysis parameter, coagulation time, and coagulation detection point Activity percent

Ratio INR DFbg

∗1 ∗2

Channel number

∗1 ∗2

Coagulation curve

0 60sec Err 8

dH 97 bH 79 CH No. 2

Error code Amount of scattered light change

in reactive process Amount of scattered light of sample

in detection starting point Channel number

Figure 4-5: Printout Example (Graph)

Sysmex CA-50 Operator’s Manual -- Revised July 1999 4-3

Sysmex CA-50 Operator’s Manual -- Revised August 1999

DISPLAY OF ANALYSIS RESULT

15/06/1999 09:00

37.0 ˚C No. 123-456 PT 10.5 sec (50)

102.1 %

0.98 -

0.98 INR

210.0 mg/dL Analysis 2 % 3.5 sec 4 % 3.9 sec

50 % -> 10.5 sec

78 % 10.8 sec 80 % 11.6 sec Coag.Curve Error

->Caution: Review Curve

Data is shown from 2 to 80 % in 2 % steps.

∗1 ∗2

Coagulation curve

0 60sec Err 8

dH 97 bH 79 CH No. 2

Error code Amount of scattered light change

in reactive process Amount of scattered light of sample

in detection starting point Channel number

Figure 4-6: Printout Example (Analysis)

*1: When there are errors in the analysis results, all the errors will be printed with messages.

• For details on the errors, see Chapter 8, Section 3.3: Analysis Data Errors and Corrective

Actions.

*2: This message will be printed when there is an abnormality in the coagulation curve.

• In the case of mean data, "MEAN CH1&2" or "MEAN CH3&4" will be printed under the date. There is no coagulation curve and analysis data for mean data.

• When the replication measure mode is selected, mean data and the data obtained on respective channels will be printed after the analysis is completed on two channels used in a pair.

4-4 Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised August 1999

DISPLAY OF ANALYSIS RESULT

3. DISPLAYING DETAILED ANALYSIS RESULTS

The Display Data screen displays detailed analysis results such as the results of all the calculation parameters selected.

(1) Press the [SELECT] key to enter the Main Menu screen.

MAIN MENU

1.Select Test

2.ID No. Entry

3.Display Data

4.QC

5.Standard Curve

6.Settings

7.Test Programs

Figure 4-7: Main Menu Screen

(2) Press the [3] key on the Main Menu screen.

The Channel Selection screen will appear.

Display Data Select CH(1-4)?

Figure 4-8: Channel Selection Screen

If you press the [SELECT] key, the display will return to the Main Menu screen (Figure 4-

7).

Sysmex CA-50 Operator’s Manual -- Revised July 1999 4-5

DISPLAY OF ANALYSIS RESULT

(3) Input the channel number (any number from 1 to 4) on which you wish to display detailed

analysis results, and press the [ENTER] key. The Display Data screen will appear. You can scroll the screen up and down by using the [ ] and [ ] keys.

ID No. 123-456 PT 10.5 sec

ID No. 123-456 PT 102.1 %

ID No. 123-456 PT 0.98 -

ID No. 123-456 PT 0.98 INR

ID No. 123-456 PT 210.0 mg/dL

ID No. 123-456 PT CH2 E: 8 PH

The ID number of the channel selected and coagulation time will be displayed.

This display is available when the activity percent is selected as a calculation parameter.

This display is available when the ratio is selected as a calculation parameter.

This display is available when the INR is selected as a calculation parameter.

This display is available when the DFbg is selected as a calculation parameter.

Channel number, error code, and output flag will be displayed. P: Data is not yet printed. This will not be displayed when the data has been printed. H: Data is not yet transmitted. This will not be displayed when the data has been transmitted. E: Error code

ID No. 123-456 PT CH2 37.0 C

Channel number and the temperature at the detector will be displayed. In the case of mean data, this screen is not available.

Figure 4-9: Display Data Screen

• When the replication measure mode is selected, the screen will be scrolled in the order of mean data, channel 1 (or 3), and channel 2 (or 4) each time the [

] key is pressed. In this

case, the same data will be displayed for both channel 1 (or 3) and channel 2 (or 4).

• When mean data is displayed, "m" will appear on the right of the analysis parameter. Also, the channel number in this case will be "1&2" or "3&4".

• If you press the [PRINT] key, the analysis results will be outputted to the designated device. For details on the settings of output, see Chapter 10, Section 4: I/O SETTINGS.

• If you press the [SELECT] key, the display will return to the Channel Selection screen (Figure 4-8).

• When the ID number consists of 11 digits or more, "ID No." will not be displayed. (Only the ID number will be displayed.)

4-6 Sysmex CA-50 Operator’s Manual -- Revised July 1999

DISPLAY OF ANALYSIS RESULT

4. OUTPUTTING ANALYSIS RESULTS

Output of analysis results will be performed automatically after the analysis is completed. If you wish to output the results again or when it was impossible to output them for some reason, you can output the data by the following procedure.

CAUTION: • The CA-50 stores only the last analysis results of each channel. Note that

the stored anal

• When

ou change the analysis parameter. ou change the sample ID number. ou change the measure mode. ou start the next analysis on the same channel. ou turn OFF the power.

(1) Press the [PRINT] key on the Display Data screen.

When it is set to output the analysis results to the host computer, the Output Device Selection screen will appear. When this is not set, output to the built-in printer will start.

sis results will be deleted in the following cases:

1.Printer

2.Host Computer

Figure 4-10: Output Device Selection Screen

If you press the [SELECT] key, the display will return to the Display Data screen (Figure 4-9).

(2) Select the desired output device.

If you wish to select the built-in printer, press the [1] key; if the host computer, press the [2] key.

If you press the [1] key, the following screen will appear and the built-in printer will start printing out the analysis results.

Printing Quit:SELECT

Figure 4-11: Printout Screen

• If you press the [SELECT] key, the printout will be canceled and the display will return to the Output Device Selection screen (Figure 4-10).

• For details on the printout format, see Section 2.2: Printing Out the Analysis Results.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 4-7

DISPLAY OF ANALYSIS RESULT

If you press the [2] key, the following screen will appear and the analysis results will be transmitted to the host computer.

Sending Quit:SELECT

Figure 4-12: Transmission Screen

• If you press the [SELECT] key, the transmission will be canceled and the display will return to the Output Device Selection screen (Figure 4-10).

• For details on the settings of the host computer, see Chapter 10, Section 4.3: Host Computer

Settings and Appendix B.

4-8 Sysmex CA-50 Operator’s Manual -- Revised July 1999

CHAPTER 5 MAINTENANCE &

SUPPLIES REPLACEMENT

1. INTRODUCTION ............................................................................... 5-1

2. CA-50 MAINTENANCE CHECKLIST ......................................................5-2

3. DAILY MAINTENANCE AND INSPECTION ............................................. 5-3

3.1 Cleaning the Reaction Tube Holder, Incubator, and Pipette guide..................5-3

4. WEEKLY MAINTENANCE AND INSPECTION..........................................5-4

4.1 Cleaning the Instrument .................................................................. 5-4

4.2 Cleaning by Blower.......................................................................5-5

5. REPLACING SUPPLIES ...................................................................... 5-6

5.1 Replacing Fuses ........................................................................... 5-6

5.2 Replacing Printer Paper...................................................................5-7

5.3 Supply Parts List..........................................................................5-8

Sysmex CA-50 Operator’s Manual -- Revised December 1999

MAINTENANCE & SUPPLIES REPLACEMENT

1. INTRODUCTION

To ensure the instrument will serve you in the optimal operating condition, it requires periodic maintenance. Follow the maintenance schedule as described below and keep the result in the Maintenance Checklist.

• Daily Maintenance

Clean the reaction tube holder Clean the incubator Clean the pipette guide

• Weekly Maintenance

Clean the instrument Cleaning by blower

This chapter describes supplies replacement in addition to those inspection items mentioned above:

• Supplies Replacement

Replace fuses Replace printer paper

Sysmex CA-50 Operator’s Manual -- Revised December 1999 5-1

MAINTENANCE & SUPPLIES REPLACEMENT

2. CA-50 MAINTENANCE CHECKLIST

Month Year

Date/Signature

10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Date/Signature

2 3 4 5 6 7 8 9

Day

Clean the instrument

Clean the reaction

tube holder

Maintenance item

DAILY MAINTENANCE

Clean the incubator

Clean the pipette guide

Signature

Maintenance item

WEEKLY MAINTENANCE/SUPPLIES REPLACEMENT

Cleaning by blower

Maintenance item

AS-NEEDED MAINTENANCE/SUPPLIES REPLACEMENT

Replace the printer paper

Replace the fuses

5-2 Sysmex CA-50 Operator’s Manual -- Revised December 1999

MAINTENANCE & SUPPLIES REPLACEMENT

3. DAILY MAINTENANCE AND INSPECTION

3.1 Cleaning the Reaction Tube Holder, Incubator, and Pipette

guide

If samples and/or reagents are contaminated with foreign matters, correct analysis results will not be obtained. Wipe off the reaction tube holder, incubator, and pipette guide after the operation is completed.

WARNING

• Before cleaning the reaction tube holder, incubator, and pipette guide, be sure to turn the power OFF and unplu to avoid the risk of electrical shock.

• Be sure to wear rubber completed, wash contaminated with blood, infection b

loves during the cleaning. After the cleaning is

our hands with disinfectant solution. If the instrument is

the power cord. This is necessar

bacteria can occur.

(1) Turn OFF the power and unplug the power cord. (2) Wipe off each part with a cloth that was moistened with water and wrung dry.

When dirt is hard to remove, wipe off the instrument with a cloth that was moistened with water and a neutral detergent, and then wipe again with a soft, dry piece of cloth.

CAUTION: • Never use any other cleaning solution than water and a neutral detergent.

Otherwise, the surface coatin

may be damaged.

Sysmex CA-50 Operator’s Manual -- Revised December 1999 5-3

MAINTENANCE & SUPPLIES REPLACEMENT

4. WEEKLY MAINTENANCE AND INSPECTION

4.1 Cleaning the Instrument

To maintain the instrument in good condition, it should be cleaned once a week.

WARNING

• Before cleaning the instrument, be sure to turn the power OFF and unplu the power cord. This is necessary to avoid the risk of electrical shock.

• Be sure to wear rubber completed, wash contaminated with blood, infection b

loves during the cleaning. After the cleaning is

our hands with disinfectant solution. If the instrument is

bacteria can occur.

(1) Turn OFF the power and unplug the power cord. (2) Wipe off the dirt of the instrument surface with a cloth that was moistened with water and

a neutral detergent, and then wipe again with a soft, dry piece of cloth.

(3) Remove the filter on the bottom surface. Wash it with water and dry it. Reinstall the filter

on the instrument.

Filter

Figure 5-1: Cleaning the Filter

CAUTION: • Never use any other cleaning solution than water and a neutral detergent.

Otherwise, the surface coatin

may be damaged.

5-4 Sysmex CA-50 Operator’s Manual -- Revised December 1999

MAINTENANCE & SUPPLIES REPLACEMENT

4. 2 Cleaning by Blower

Clean the detector and the built-in printer every week by using a blower brush provided in the supply part.

(1) Turn OFF the power and unplug the power cord.

(2) Remove the reagents placed in the incubator.

(3) Detach the brush from the end of a blower brush.

Figure 5-2: Detaching the brush

(4) Blow off dust on the surface of the instrument by using the blower with the pipette guide

closed.

(5) Blow off dust of the outlet of the built-in printer.

(6) Open the pipette guide and remove the reaction tube in the detector.

Blow off dust of the inside the detector hole with the blower. Blow the air approximately 20 times each channel. If a heavier dirt is expected, repeat blowing more.

Figure 5-3: Cleaning by blower

Sysmex CA-50 Operator’s Manual -- Revised December 1999 5-5

Sysmex CA-50 Operator’s Manual -- Revised February 2001

MAINTENANCE & SUPPLIES REPLACEMENT

5. REPLACING SUPPLIES

5.1 Replacing Fuses

If a fuse is blown, replace it as described in the procedure below.

WARNING

• To avoid risk of electrical shock, disconnect the power cord before

replacing the fuses.

(1) Turn OFF the power and unplug the power cord. (2) Using a regular screwdriver, pull out the two fuse holder caps on the rear face.

Fuse

Fuse holder cap

Figure 5-4: Replacing Fuses

(3) Replace the fuses and attach the fuse holder caps to the instrument.

CAUTION

• For continued protection against risk of fire, replace only with a fuse of

the specified type and current ratings.

Destination Specification Type Quantity

117V F1 250V 0.8A Time Lag 2

220 - 240V F1 250V 0.4A Time Lag 2

5-6 Sysmex CA-50 Operator’s Manual -- Revised December 1999

MAINTENANCE & SUPPLIES REPLACEMENT

[

5.2 Replacing Printer Paper

When the built-in printer has run out of paper, replace it in the procedure below. (1) Open the built-in printer cover. (2) Remove the remained print paper and the paper roll core.

CAUTION: • When you intend to remove a remained portion of the printer paper,

remove the roll core from the paper roll, press the pull the paper. At this time, pull the paper out in the direction to which the printer paper is e

ected at an ordinary print operation.

• Do not pull out the paper while printin

(3) Set a new printer paper roll, and insert the end of paper to the built-in printer.

Printer paper detection sensor

Direction to which the printer paper is pulled out

Printer paper

FEED] key, and then

Paper cutter

Figure 5-5: Setting a Printer Paper

Sysmex CA-50 Operator’s Manual -- Revised December 1999 5-7

MAINTENANCE & SUPPLIES REPLACEMENT

CAUTION: • Insert the printer paper straight to the built-in printer. Otherwise, the paper

may be caught or the life of the printer head may be shorten.

• Use a specified printer paper. Otherwise, print cannot be performed, or the paper may be caught. Specification: F1-1

• As for the printing side of the paper, insert the printer paper as shown in Figure 5-3.

• Do not make the printer paper detection sensor dirty. The presence of printing paper might not be able to be detected correctly when becoming dirty. Wipe off dirt with a soft and dry cloth.

• Do not replace the printer paper by the wet hand. It causes paper jam.

(4) Press the [FEED] key until the top of the printer paper comes out of the outlet.

CAUTION: • When paper jam occurs while printing, turn OFF the power of the Main

Unit, and remove the paper cutter by sliding it to the instrument rear side, and then remove the printer paper. When you install the paper cutter, push it until the click sound is heard according to the reversed procedure of removal.

5. 3 Supply Parts List

Part No. Description Remarks 904-0721-9 Reaction Tube SU-40 424-1251-0 921-0352-1 Printer Paper F1-1 266-5110-5 Fuse 250V 1A ST4-0.8A-N1 (N.Amer) Main Unit, for 117V spec. 266-7132-4 Fuse S504 T0.4A-T Main Unit, for 220V/240V specs. 369-5029-5 665-8038-1 Filter CA-5D 421-9350-9 Blower Brush

Sample Cup Conical 4 mL

Indication Mark No. 1014

*1 For the Sample Cup, Uniflex Conical 4 mL or the equivalent can be used. *2 Indication Mark No. 1014 is a label on which the analysis parameter is printed, and be

affixed on the incubator and/or around the detector etc.

5-8 Sysmex CA-50 Operator’s Manual -- Revised December 1999

Sysmex CA-50 Operator’s Manual -- Revised February 2001

CHAPTER 6 QUALITY CONTROL

1. INTRODUCTION................................................................................ 6-1

1.1 Quality Control File........................................................................6-1

1.2 Quality Control Analysis..................................................................6-1

1.3 QC Error Check............................................................................ 6-2

2. QUALITY CONTROL MENU .................................................................6-3

2.1 Displaying the QC Chart..................................................................6-3

3. SELECTING THE QUALITY CONTROL FILE ............................................ 6-4

3.1 Selecting the Quality Control Parameter.................................................6-4

3.2 Selecting the Quality Control File........................................................6-5

4. PRINTING OUT THE QC CHART ........................................................... 6-6

5. DELETING THE QUALITY CONTROL DATA............................................. 6-7

5.1 Deleting the Data...........................................................................6-7

5.2 Deleting the File............................................................................6-8

6. QUALITY CONTROL SETTINGS............................................................6-9

Sysmex CA-50 Operator’s Manual -- Revised July 1999

QUALITY CONTROL

1. INTRODUCTION

Quality control is implemented to ensure that highly reliable data is obtained over the long term and to constantly monitor the instrument condition to prevent inaccurate results from being reported. The CA-50 analyzes control plasma and other samples (hereafter, quality control samples) and statistically manages the results.

1.1 Quality Control File

The CA-50 can maintain three quality control files (QC1 - QC3), with each file capable of saving up to 50 items of data. Up to 14 analysis parameters can be saved per file.

NOTE: • To enable simultaneous quality control of both the current and new

sam

les when quality control sample lots are switched, quality control files QC1 and QC2 are used for current control, and the remainin file is used to evaluate the new sam

les.

1.2 Quality Control Analysis

QC3

A quality control analysis is performed using quality control samples in the same procedures as that for an ordinary analysis. The quality control file number (QC1 to QC3) is registered as the sample ID number. When the analysis is completed, it is automatically saved in the quality control file instructed by the ID number. (See Chapter 2, Section 6: QUALITY CONTROL.)

The two quality control methods listed below are available.

control: Analyzes QC samples with setting of the replication measure mode, and uses the

average value as control data.

L-J control: Analyzes QC samples with setting of the single measure mode, and uses the data

as control data. With L-J control, the range of control is easily affected by the reproducibility of analysis; thus, the range is wider than that of

CAUTION: • Use the quality control samples and reagents in accordance with the

usa

e methods described in the package insert accompanied in each

control material.

• Chan control.

e to the measure mode used usually after executing the qualit

control.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 6-1

QUALITY CONTROL

Here, the example for the quality control analysis is explained. (1) Prepare two kinds of the quality control samples (normality and abnormality).

(2) Assign the ID number for a normal sample to QC1, and analyze PT, APTT, and Fbg

respectively.

(3) Assign the ID number for an abnormal sample to QC2, and analyze PT, APTT, and Fbg

respectively.

(4) Select QC1 and PT respectively in the Quality Control Menu screen by referring to

Section 3: SELECTING THE QUALITY CONTROL FILE.

(5) Perform Section 4: PRINTING OUT THE QC CHART, and check the data by the

Quality Control Menu screen.

(6) Perform (4) and (5) for APTT, Fbg, and also analyze PT, APTT, and Fbg for QC2 as

well.

1.3 QC Error Check

To check quality control errors, you can use a Control Limit method.

Control Limit Method

Error checks are made based on control limits that are set (shown in the table below).

Control Limit Error Check Method/Action Upper Fla Target This is the target value for the quality control analysis. Lower Fla

If a quality control analysis result exceeds this value, a QC error is generated.

If a quality control analysis result is below this value, a QC error is generated.

6-2 Sysmex CA-50 Operator’s Manual -- Revised July 1999

2. QUALITY CONTROL MENU

2.1 Displaying the QC Chart

(1) Press the [SELECT] key to enter the Main Menu screen.

MAIN MENU

1.Select Test

2.ID No. Entry

3.Display Data

4.QC

5.Standard Curve

6.Settings

7.Test Programs

QUALITY CONTROL

Figure 6-1: Main Menu Screen

(2) Press the [4] key on the Main Menu screen.

The Quality Control Menu screen will appear. You can scroll the screen up and down by using the [ ] and [ ] keys.

QC QC1 PT

1.Select Test

2.Select File

3.Print

4.Delete a Point

5.Settings

6.Clear a File

Figure 6-2: Quality Control Menu Screen

Sysmex CA-50 Operator’s Manual -- Revised July 1999 6-3

QUALITY CONTROL

Pressing the following key will select each menu function. [1] key: Moves the screen to the selection of quality control parameters (Select Test).

[2] key: Moves the screen to the selection of quality control files (Select File). [3] key: Prints out a QC chart (Print). [4] key: Moves the screen to the deletion of quality control data (Delete a Point). [5] key: Moves the screen to the quality control settings (Settings). [6] key: Moves the screen to the deletion of quality control files (Clear a File). [PRINT] key: Prints out the quality control menu. [SELECT] key: Returns the screen to the main menu.

3. SELECTING THE QUALITY CONTROL FILE

3.1 Selecting the Quality Control Parameter

Select the quality control parameter for which you wish to perform quality control. “PT” is selected as a default setting.

(1) Press the [1] key on the Quality Control Menu screen.

The Quality Control Parameter Selection screen will appear.

Select Test QC1 Test(PT-EX)? PT

Figure 6-3: Quality Control Parameter Selection Screen

If you press the [SELECT] key, the display will return to the Quality Control Menu screen (Figure 6-2).

(2) Press the key for the desired parameter, and press the [ENTER] key.

Select Test QC1 IN(8,9,11,12)? 8

Figure 6-4: Factor Number Entry Screen

If you press the [SELECT] key, the display will return to the Quality Control Parameter Selection screen (Figure 6-3).

6-4 Sysmex CA-50 Operator’s Manual -- Revised July 1999

QUALITY CONTROL

(3) In the case of an intrinsic factor assay, input any of 8, 9, 11, and 12.

In the case of an extrinsic factor assay, input any of 2, 5, 7, and 10. Then press the [ENTER] key. The display will return to the Quality Control Menu screen (Figure 6-2).

3.2 Selecting the Quality Control File

Select the file for which you wish to perform quality control. “1” is selected as a default setting. (1) Press the [2] key on the Quality Control Menu screen.

The Quality Control File Selection screen will appear.

Select File PT File(1-3)? 1

Figure 6-5: Quality Control File Selection Screen

If you press the [SELECT] key, the display will return to the Quality Control Menu screen (Figure 6-2).

(2) Input the file number (any number from 1 to 3) and press the [ENTER] key.

The display will return to the Quality Control Menu screen (Figure 6-2).

Sysmex CA-50 Operator’s Manual -- Revised July 1999 6-5

QUALITY CONTROL

4 . PRINTING OUT THE QC CHART

You can print out the quality control data and the QC chart concerning the analysis parameters selected in Section 3.1: Selecting the Quality Control Parameter and the file selected in Section

3.2: Selecting the Quality Control File.

(1) Press the [3] key on the Quality Control Menu screen.

The Printing screen will appear, and the quality control data will be printed out. If the printout is completed, the display will return to the Quality Control Menu screen (Figure 6-2).

Printing Quit:SELECT

Figure 6-6: Printing Screen

If you press the [SELECT] key, the printout will be canceled and the display will return to the Quality Control Menu screen (Figure 6-2).

15/06/1999 09:00 QUALITY CONTROL

PT QC1 30 Sample

Date LL T UL 01/10 | | ∗ | | | 01/11 | | ∗ | | | 01/12 | | ∗ | | | 01/13 | | | | |

•

• 01/21 | | | ∗ | | 01/22 | | | | |

Mean 11.0 sec SD 0.1 CV 1.5 % UL 13.8 sec Target 11.5 sec LL 10.4 sec

Date & time of printout

Analysis parameter, file number, and the number of samples

Date of each data and a QC chart

Mean data Standard deviation Coefficient of variation

Upper limit Target value Lower limit

Figure 6-7: Printout Example of Quality Control Data and QC Chart

NOTE: • “UL”, “T”, and “LL” shown in Figure 6-7 represent the followings:

• UL: If the result of the a

uality control error will occur.

• T: This is the tar

• LL: If the result of the

uality control analysis exceeds this value,

et value for the quality control analysis.

uality control analysis is below this value,

a quality control error will occur.

6-6 Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised August 1999

QUALITY CONTROL

5. DELETING THE QUALITY CONTROL DATA

5.1 Deleting the Data

You can select and delete particular data from those concerning the analysis parameters selected in Section 3.1: Selecting the Quality Control Parameter and the file selected in Section 3.2:

Selecting the Quality Control File.

CAUTION: • Data that has been deleted cannot be recovered. Carefully verif

before deleting data.

(1) Press the [4] key on the Quality Control Menu screen.

The Deleting Data Selection screen will appear.

Delete QC1 Fbg 15/06 110.4mg/dL

Figure 6-8: Deleting Data Selection Screen

If you press the [SELECT] key, the deletion will be canceled and the display will return to the Quality Control Menu screen (Figure 6-2).

(2) Select the data that you wish to delete by using the [ ] and [ ] keys, and then press the

[ENTER] key. The Deletion Confirmation screen will appear.

15/06 110.4mg/dL Delete OK?

Figure 6-9: Deletion Confirmation Screen

If you press the [SELECT] key, the deletion will be canceled and the display will return to the Quality Control Menu screen (Figure 6-2).

(3) Press the [ENTER] key.

The selected data will be deleted, and the display will return to the Quality Control Menu screen (Figure 6-2).

Sysmex CA-50 Operator’s Manual -- Revised July 1999 6-7

Sysmex CA-50 Operator’s Manual -- Revised August 1999

QUALITY CONTROL

5.2 Deleting the File

You can delete all the data concerning the analysis parameters selected in Section 3.1: Selecting the Quality Control Parameter and the file selected in Section 3.2: Selecting the Quality Control File.

CAUTION: • Data that has been deleted cannot be recovered. Carefully verif

before deleting data.

NOTE: • All the data concerning the analysis parameter selected will be deleted.

The data concernin

(1) Press the [6] key on the Quality Control Menu screen.

The File Confirmation screen will appear.

the other parameters will remain.

File QC1 PT Clear?

Figure 6-10: File Confirmation Screen

If you press the [SELECT] key, the deletion will be canceled and the display will return to the Quality Control Menu screen (Figure 6-2).

(2) Press the [ENTER] key.

The Deletion Confirmation screen will appear.

Clear? Yes:ENTER No:SELECT

Figure 6-11: Deletion Confirmation Screen

(3) Press the [ENTER] key.

The file will be deleted, and the display will return to the Quality Control Menu screen (Figure 6-2).

6-8 Sysmex CA-50 Operator’s Manual -- Revised July 1999

QUALITY CONTROL

6. QUALITY CONTROL SETTINGS

You can perform settings concerning the quality control over the analysis parameters selected in

Section 3.1: Selecting the Quality Control Parameter and the file selected in Section 3.2: Selecting the Quality Control File.

(1) Press the [5] key on the Quality Control Menu screen.

The Control Parameter Selection screen will appear.

QC1 PT Param. Ratio

Figure 6-12: Control Parameter Selection Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 6-16) will appear.

(2) Select the desired control parameter by using the [

] and [ ] keys, and then press the [ENTER] key. The control parameter will be switched in the order of “analysis parameter” (coagulation time), “Act.” (“Conc.” in the case of Fbg), “Ratio”, “INR”, and “DFbg” each time the [ ] key is pressed. Note that only the parameters that have been selected as calculation parameters for the standard curve will be displayed. (See Chapter 7, Section 6: SETTING THE CALCULATION PARAMETERS.)

CAUTION: • When you change the control parameter, the saved quality control data will

be deleted.

The Upper Limit Entry screen will appear.

QC1 PT UL

11.5 sec

Figure 6-13: Upper Limit Entry Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 6-16) will appear.

(3) Input an upper limit and press the [ENTER] key.

If you do not change the value, press the [ENTER] key only. The Target Entry screen will appear.

QC1 PT Target

10.2 sec

Figure 6-14: Target Entry Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 6-16) will appear.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 6-9

QUALITY CONTROL

(4) Input a target and press the [ENTER] key.

If you do not change the value, press the [ENTER] key only. The Lower Limit Entry screen will appear.

QC1 PT LL

10.1 sec

Figure 6-15: Lower Limit Entry Screen

If you press the [ENTER] key, the display will return to the Control Parameter Selection screen (Figure 6-12).

(5) Input a lower limit and press the [ENTER] key.

If you do not change the value, press the [ENTER] key only. The Update Confirmation screen will appear.

Save? Yes:ENTER No:SELECT

Figure 6-16: Update Confirmation Screen

If you press the [SELECT] key, the update will be canceled and the display will return to the Quality Control Menu screen (Figure 6-2).

(6) Press the [ENTER] key.

The settings will be updated, and the display will return to the Quality Control Menu screen.

When the inputted upper limit is smaller than the lower limit, a setting error will occur.

Then an error message will appear on the screen and an alarm will sound.

QC Setting Err

Figure 6-17: Error Notice Screen

If you press the [C] key, the alarm will stop and the Upper Limit Entry screen (Figure 6-

13) will appear. Then go back to step (3) and input the upper and lower limits again.

NOTE: • “UL”, “Target”, and “LL” shown in Figures 6-13, 6-14 and 6-15

resent the followings:

• UL: If the result of the value, a

• Tar

• LL: If the result of the

et: This is the target value for the quality control analysis.

value, a quality control error will occur.

uality control error will occur.

uality control analysis exceeds this

uality control analysis is below this

6-10 Sysmex CA-50 Operator’s Manual -- Revised July 1999

CHAPTER 7 SETTING STANDARD CURVES

1. INTRODUCTION................................................................................ 7-1

2. OBTAINING DATA FOR STANDARD CURVE ........................................... 7-1

3. STANDARD CURVE MENU .................................................................. 7-4

4. PREPARING THE STANDARD CURVE.................................................... 7-6

4.1 Selecting the Analysis Parameter......................................................... 7-6

4.2 Inputting the Standard Curve Data....................................................... 7-7

5. PRINTING OUT THE STANDARD CURVE ..............................................7-10

6. SETTING THE CALCULATION PARAMETERS.........................................7-11

6.1 Calculation Parameter Setting Menu....................................................7-11

6.2 Setting the Activity Percent and Concentration........................................7-12

6.3 Setting the Ratio........................................................................... 7-14

6.4 Setting the INR............................................................................7-15

6.5 Setting the DFbg..........................................................................7-16

6.6 Printing Out the Calculation Parameter Settings.......................................7-17

7. DELETING THE STANDARD CURVE DATA ............................................7-18

Sysmex CA-50 Operator’s Manual -- Revised July 1999

SETTING STANDARD CURVES

1. INTRODUCTION

A standard curve is a parameter that is used to calculate the calculation parameters based on the coagulation time and dOD obtained by analysis.

CAUTION

• The standard curve determines the accuracy of calculation parameters. Prepare proper standard curves for the reagents be used.

2. OBTAINING DATA FOR STANDARD CURVE

In order to obtain standard curve data, let the instrument analyze the sample whose activity percent or concentration has been determined beforehand.

The following are explained as an example of analyzing PT, Fbg, TTO, and NT respectively by four points.

In the case of PT

Dilution Ratio

Dilution

Method

(1) Prepare 1 mL of sample whose activity percent has been determined. (2) Mix the diluent (500 mL) and the sample (500 mL) to make 50% sample. (3) Mix the diluent (500 mL) and the sample made in step (2) (500 mL), to make 25%

sample.

(4) Mix the diluent (500 mL) and the sample made in step (3) (500 mL), to make 12.5%

sample.

(5) Dispense 50 mL of sample for each dilution ratio into reaction tubes, and perform an

analysis.

(6) Input standard curve data based on the printed analysis results.

For the method of inputting the data, see Section 4: PREPARING THE STANDARD

CURVE.

(7) Print out the prepared standard curve for verification.

For the method of printing out the standard curve, see Section 5: PRINTING OUT THE STANDARD CURVE. If an abnormality is found in the standard curve, go back to step (1) and try the same procedure.

100 % (1/1) 50 % (1/2) 25% (1/4) 12.5 % (1/8)

Undiluted

sample

1mL

500uL

500uL 500uL

Diluent

500uL

Diluent

500uL

Diluent

CAUTION: • When you use commercially available calibrator plasma or a calibrator

packed in a reagent kit, follow the instruction in the manual attached to it.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-1

SETTING STANDARD CURVES

In the case of Fbg

Dilution Ratio

Dilution

Method

200 % (2/1) 100 % (1/1) 50 % (1/2) 25 % (1/4)

500uL

200uL

Undiluted sample

800uL

Diluent

500uL

Diluent

500uL

Diluent

500uL

Diluent

(1) Prepare 200 mL of sample whose concentration has been determined. (2) Mix the diluent (800 mL) and the sample (200 mL) to make 200% sample. (3) Mix the diluent (500 mL) and the sample made in step (2) (500 mL), to make 100%

sample.

(4) Mix the diluent (500 mL) and the sample made in step (3) (500 mL), to make 50%

sample.

(5) Mix the diluent (500 mL) and the sample made in step (4) (500 mL), to make 25%

sample.

(6) Dispense 100 mL of sample for each dilution ratio into reaction tubes, and perform an

analysis.

(7) Input standard curve data based on the printed analysis results.

For the method of inputting the data, see Section 4: PREPARING THE STANDARD

CURVE.

(8) Print out the prepared standard curve for verification.

For the method of printing out the standard curve, see Section 5: PRINTING OUT THE STANDARD CURVE. If an abnormality is found in the standard curve, go back to step (1) and try the same procedure.

7-2 Sysmex CA-50 Operator’s Manual -- Revised July 1999

In the case of TTO

SETTING STANDARD CURVES

Dilution Ratio

Dilution

Method

100 % (1/1) 50 % (1/2) 25 % (1/4) 12.5 % (1/8)

500uL

400uL

Undiluted sample

600uL

Diluent

500uL

Diluent

500uL

Diluent

500uL

Diluent

(1) Prepare 400 mL of sample whose activity percent has been determined. (2) Mix the diluent (600 mL) and the sample (400 mL) to make 100% sample. (3) Mix the diluent (500 mL) and the sample made in step (2) (500 mL), to make 50%

sample.

(4) Mix the diluent (500 mL) and the sample made in step (3) (500 mL), to make 25%

sample.

(5) Mix the diluent (500 mL) and the sample made in step (4) (500 mL), to make 12.5%

sample.

(6) Dispense 50 mL of sample for each dilution ratio into reaction tubes, and perform an

analysis.

(7) Input standard curve data based on the printed analysis results.

For the method of inputting the data, see Section 4: PREPARING THE STANDARD

CURVE.

(8) Print out the prepared standard curve for verification.

For the method of printing out the standard curve, see Section 5: PRINTING OUT THE STANDARD CURVE. If an abnormality is found in the standard curve, go back to step (1) and try the same procedure.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-3

SETTING STANDARD CURVES

In the case of NT

Dilution Ratio

Dilution

Method

200 % (2/1) 100 % (1/1) 50 % (1/2) 25 % (1/4)

500uL

400uL

Undiluted sample

600uL

Diluent

500uL

Diluent

500uL

Diluent

500uL

Diluent

(1) Prepare 400 mL of sample whose activity percent has been determined. (2) Mix the diluent (600 mL) and the sample (400 mL) to make 200% sample. (3) Mix the diluent (500 mL) and the sample made in step (2) (500 mL), to make 100%

sample.

(4) Mix the diluent (500 mL) and the sample made in step (3) (500 mL), to make 50%

sample.

(5) Mix the diluent (500 mL) and the sample made in step (4) (500 mL), to make 25%

sample.

(6) Dispense 50 mL of sample for each dilution ratio into reaction tubes, and perform an

analysis.

(7) Input standard curve data based on the printed analysis results.

For the method of inputting the data, see Section 4: PREPARING THE STANDARD

CURVE.

(8) Print out the prepared standard curve for verification.

For the method of printing out the standard curve, see Section 5: PRINTING OUT THE STANDARD CURVE. If an abnormality is found in the standard curve, go back to step (1) and try the same procedure.

3. STANDARD CURVE MENU

(1) Press the [SELECT] key to enter the Main Menu screen.

MAIN MENU

1.Select Test

2.ID No. Entry

3.Display Data

4.QC

5.Standard Curve

6.Settings

7.Test Programs

Figure 7-1: Main Menu Screen

7-4 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SETTING STANDARD CURVES

(2) Press the [5] key on the Main Menu screen.

The Standard Curve Menu screen will appear. You can scroll the menu up and down by using the [

STD PT

1.Select Test

2.Input

3.Print

4.Settings

5.Clear

] and [ ] keys.

Figure 7-2: Standard Curve Menu Screen

Pressing the following key will select each menu function. [1] key: Moves the screen to the selection of analysis parameters (Select Test).

[2] key: Moves the screen to the entry of standard curve data (Input). [3] key: Prints out the standard curve (Print). [4] key: Displays the calculation parameter setting menu (Settings). [5] key: Moves the screen to the deletion of the standard curve data (Clear). [PRINT] key: Prints out the standard curve menu. [SELECT] key: Returns the screen to the main menu.

CAUTION: • You cannot use the [2], [3], and [5] keys when you have not selected

calculation

PARAMETERS.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-5

arameters in

Section 6: SETTING THE CALCULATION

SETTING STANDARD CURVES

4. PREPARING THE STANDARD CURVE

Prepare a standard curve, based on the data obtained in Section 2: OBTAINING DATA FOR STANDARD CURVE.

4.1 Selecting the Analysis Parameter

Select the analysis parameter for which you wish to prepare the standard curve. "PT" is selected as a default setting.

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

The Analysis Parameter Selection screen will appear.

Select Test STD Test(PT-EX)? PT

Figure 7-3: Analysis Parameter Selection Screen

If you press the [SELECT] key, the display will return to the Standard Curve Menu screen (Figure 7-2).

(2) Press the key for the desired parameter, and press the [ENTER] key.

Select Test STD IN(8,9,11,12)? 8

Figure 7-4: Factor Number Entry Screen

If you press the [SELECT] key, the display will return to the Analysis Parameter Selection screen (Figure 7-3).

(3) In the case of an intrinsic factor assay, input any of 8, 9, 11, and 12.

In the case of an extrinsic factor assay, input any of 2, 5, 7, and 10. Then press the [ENTER] key. The display will return to the Standard Curve Menu screen (Figure 7-2).

7-6 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SETTING STANDARD CURVES

play

4. 2 Inputting the Standard Curve Data

Input the following standard curve data concerning the parameter selected in Section 4.1: Selecting the Analysis Parameter. Items to be inputted will vary depending on the settings set in Section 6: SETTING THE CALCULATION PARAMETERS.

· Activity percent (concentration) and coagulation time: You can input data up to 6 points. Input 2 points at least.

· Normal: This is the value to calculate the ratio. This parameter is available when the ratio or the INR is selected as a calculation parameter.

· ISI: This is the value to calculate the INR. This parameter is available when the INR is selected as a calculation parameter.

· Standard concentration and dH:

This is the value to calculate the DFbg. This parameter is available when the DFbg is

selected as a calculation parameter.

CAUTION: • If the ratio is not selected as a calculation parameter but the INR has

been selected, the Normal Value Entr neither the dis case.

of the ratio nor the print of data are performed in this

screen will appear. However,

(1) Press the [2] key on the Standard Curve Menu screen.

The Activity Percent (Concentration) & Coagulation Time Entry screen will appear.

PT 100.0% STD1 12.5sec

Figure 7-5: Activity Percent (Concentration) &

Coagulation Time Entry Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 7-9) will appear.

(2) Input activity percent (concentration) and press the [ENTER] key.

If you do not change the value, press the [ENTER] key only. Then input coagulation time and press the [ENTER] key. If you do not change the value, press the [ENTER] key only. Each time the [ENTER] key is pressed twice, the item will be switched in the order of "STD1", "STD2", "STD3", "STD4", "STD5", and "STD6". The values should be inputted in decreasing order of concentration, from STD1 to STD 6. When you input the value for STD6 and press the [ENTER] key, the Normal Value Entry screen (Figure 7-6) will appear depending on the calculation parameter settings. When none of these calculation parameters has been selected, the display will return to the screen to input the value for STD1. For default values, see Appendix B.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-7

SETTING STANDARD CURVES

PT Normal?

12.0sec

Figure 7-6: Normal Value Entry Screen

· This parameter will be displayed only when you have selected the ratio or the INR as a calculation parameter.

· If you press the [SELECT] key, the Update Confirmation screen (Figure 7-9) will appear.

CAUTION: •Input is permitted to the decimal places shown below:

• Activit

•

• ISI: Two decimal

%, mg/dL, IU, and time: One decimal place

/L: Three decimal

(3) Input a normal value and press the [ENTER] key.

If you do not change the value, press the [ENTER] key only. Depending on the calculation parameter settings, either the ISI Entry (Figure 7-7) or the Standard Concentration & dH Entry screen (Figure 7-8) screen will appear. If neither of these calculation parameters has been selected, the display will return to the Activity Percent (Concentration) & Coagulation Time Entry screen (Figure 7-5).

laces

PT ISI?

1.00

Figure 7-7: ISI Entry Screen

• This parameter will be displayed only when you have selected the INR as a calculation parameter.

• If you press the [SELECT] key, the Update Confirmation screen (Figure 7-9) will appear.

(4) Input an ISI and press the [ENTER] key.

If you do not change the value, press the [ENTER] key only.

Depending on the calculation parameter settings, the Standard Concentration & dH Entry screen will appear. If this parameter has not been selected, the display will return to the Activity Percent (Concentration) & Coagulation Time Entry screen (Figure 7-5).

DFbg 200.0mg/dL dH 110

Figure 7-8: Standard Concentration & dH Entry Screen

• This parameter will be displayed only when you have selected the DFbg as a calculation parameter.

• If you press the [SELECT] key, the Update Confirmation screen (Figure 7-9) will appear.

7-8 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SETTING STANDARD CURVES

(5) Input the standard concentration and dH, and press the [ENTER] key.

If you do not change the value, press the [ENTER] key only. The display will return to the Activity Percent (Concentration) & Coagulation Time Entry screen (Figure 7-5).

CAUTION: • When you have inputted a wrong value, go back to the first step and

ut the value again.

(6) Press the [SELECT] key.

The Update Confirmation screen will appear.

Save? Yes:ENTER No:SELECT

Figure 7-9: Update Confirmation Screen

If you press the [SELECT] key, the update will be canceled and the display will return to the Standard Curve Menu screen (Figure 7-2).

(7) Press the [ENTER] key.

The settings will be updated, and the display will return to the Standard Curve Menu screen (Figure 7-2). If there is an error in the settings, an error message will appear on the screen and an alarm will sound.

STD Err PT

Figure 7-10: Error Notice Screen

If you press the [C] key, the alarm will stop and the display will return to the Activity Percent (Concentration) & Coagulation Time Entry screen (Figure 7-5).

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-9

SETTING STANDARD CURVES

5. PRINTING OUT THE STANDARD CURVE

Print out the content of standard curve settings for the parameter selected in Section 4.1: Selecting the Analysis Parameter.

(1) Press the [3] key on the Standard Curve Menu screen.

The Printing screen will appear and the printout of the content of standard curve settings will start. The subject of the printout is limited to the calculation parameters selected in Section 6: SETTING THE CALCULATION PARAMETER. When the printout is completed, the display will return to the Standard Curve Menu screen (Figure 7-2).

Printing Quit:SELECT

Figure 7-11: Printing Screen

If you press the [SELECT] key, the printout will be canceled and the display will return to the Standard Curve Menu screen (Figure 7-2).

15/06/1999 09:00

STANDARD PT 15/06/1999

100.0 % 12.0 sec

80.0 % 14.5 sec

60.0 % 18.2 sec

40.0 % 20.2 sec

Normal 12.5 sec ISI 1.01

200.0mg/dL 100 dH Log. Regress

LogP=a ∗LogT+b

r=0.996 a=-2.050E+00 b= 4.056E+00

Date & time of printout

Analysis parameter and date of setting

Activity percent (concentration) and coagulation time set in STD1 - STD6.

Normal value ISI Standard concentration and dH

Calculation method

Standard curve graph

Expression

Correlation coefficient Slope Intercept

Figure 7-12: Printout Example of Standard Curve

7-10 Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised August 1999

SETTING STANDARD CURVES

6. SETTING THE CALCULATION PARAMETERS

Set the calculation parameter for the analysis parameter selected in Section 4.1: Selecting the Analysis Parameter.

6.1 Calculation Parameter Setting Menu

If you press the [4] key on the Standard Curve Menu screen, the Calculation Parameter Setting Menu screen will appear. You can scroll the menu up and down by using the [ ] and [ ] keys.

Settings PT

1.Activity/Conc.

2.Ratio

3.INR

4.DFbg

5.Print Settings

Figure 7-13: Calculation Parameter Setting Menu Screen

Pressing the following key will select each menu function. [1] key: Moves the screen to the setting of activity percent and concentration.

[2] key: Moves the screen to the setting of ratio. [3] key: Moves the screen to the setting of INR. [4] key: Moves the screen to the setting of DFbg. (Can be used in the case of PT.) [5] key: Prints out the calculation parameter setting. [PRINT] key: Prints out the calculation parameter setting menu. [SELECT] key: Returns the screen to the standard curve menu.

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-11

SETTING STANDARD CURVES

6.2 Setting the Activity Percent and Concentration

Set whether to use the activity percent (concentration in the case of Fbg) as a calculation parameter.

(1) Press the [1] key on the Calculation Parameter Setting Menu screen.

The ON/OFF Selection screen will appear.

PT Activity ON

Figure 7-14: ON/OFF Selection Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 7-17) will appear.

(2) Select whether to use the activity percent (concentration in the case of Fbg) by using

the [ The display will be switched between "ON (use)" and "OFF (do not use)" each time the [ ] key is pressed. When "ON" is selected, the Unit Selection screen will appear.

] and [ ] keys, and then press the [ENTER] key.

PT Activity xxx.x %

Figure 7-15: Unit Selection Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 7-17) will appear.

(3) Select the desired unit by using the [

] and [ ] keys, and press the [ENTER] key. The display will be switched in the order of "xxx.x %", "xxx.x mg/dL", "x.xxx g/L", "xx.xx –", and "x.xxx IU" each time the [ ] key is pressed. The Calculation Method Selection screen will appear.

PT Activity Log.Pt.Pt

Figure 7-16: Calculation Method Selection Screen

If you press the [ENTER] key, the display will return to the ON/OFF Selection screen (Figure 7-14).

7-12 Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 Operator’s Manual -- Revised December 1999

SETTING STANDARD CURVES

(4) Select the desired calculation method by using the [ ] and [ ] keys, and press the

[SELECT] key. The display will be switched in the order of "Log. Pt. Pt", "Log. Regress", "Lin. Regress" each time the [ ] key is pressed. The Update Confirmation screen will appear.

Save? Yes:ENTER No:SELECT

Figure 7-17: Update Confirmation Screen

If you press the [SELECT] key, the update will be canceled and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

(5) Press the [ENTER] key.

The settings will be updated and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-13

SETTING STANDARD CURVES

6.3 Setting the Ratio

Set whether to use the ratio as a calculation parameter. (1) Press the [2] key on the Calculation Parameter Setting Menu screen.

The ON/OFF Selection screen will appear.

PT Ratio ON

Figure 7-18: ON/OFF Selection Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 7-19) will appear.

(2) Select whether to use the ratio by using the [

] and [ ] keys, and press the [ENTER] key. The display will be switched between "ON (use)" and "OFF (do not use)" each time the [ ] key is pressed. The Update Confirmation screen will appear.

Save? Yes:ENTER No:SELECT

Figure 7-19: Update Confirmation Screen

If you press the [SELECT] key, the update will be canceled and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

(3) Press the [ENTER] key.

The settings will be updated and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

7-14 Sysmex CA-50 Operator’s Manual -- Revised July 1999

SETTING STANDARD CURVES

6.4 Setting the INR

Set whether to use the INR as a calculation parameter. (1) Press the [3] key on the Calculation Parameter Setting Menu screen.

The ON/OFF Selection screen will appear.

PT INR ON

Figure 7-20: ON/OFF Selection Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 7-22) will appear.

(2) Select whether to use the INR by using the [

] and [ ] keys, and press the [ENTER] key. The display will be switched between "ON (use)" and "OFF (do not use)" each time the [ ] key is pressed. The Unit Selection screen will appear.

PT INR xx.xx -

Figure 7-21: Unit Selection Screen

If you press the [ENTER] key, the display will return to the ON/OFF Selection screen (Figure 7-20).

(3) Select the desired unit by using the [

] and [ ] keys, and press the [SELECT] key. The display will be switched between "xx.xx –" and "xx.xx INR" each time the [ ] key is pressed. The Update Confirmation screen will appear.

Save? Yes:ENTER No:SELECT

Figure 7-22: Update Confirmation Screen

If you press the [SELECT] key, the update will be canceled and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

(4) Press the [ENTER] key.

The settings will be updated and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

Sysmex CA-50 Operator’s Manual -- Revised July 1999 7-15

SETTING STANDARD CURVES

6.5 Setting the DFbg

Set whether to use the DFbg as a calculation parameter. (1) Press the [4] key on the Calculation Parameter Setting Menu screen.

The ON/OFF Selection screen will appear.

PT DFbg ON

Figure 7-23: ON/OFF Selection Screen

If you press the [SELECT] key, the Update Confirmation screen (Figure 7-25) will appear.

(2) Select whether to use the DFbg by using the [

] and [ ] keys, and press the [ENTER] key. The display will be switched between "ON (use)" and "OFF (do not use)" each time the [ ] key is pressed. The Unit Selection screen will appear.

PT DFbg xxx.x mg/dL

Figure 7-24: Unit Selection Screen

If you press the [ENTER] key, the display will return to the ON/OFF Selection screen (Figure 7-23).

(3) Select the desired unit by using the [

] and [ ] keys, and press the [SELECT] key. The display will be switched between "xxx.x mg/dL" and "x.xxx g/L" each time the [ ] key is pressed. The Update Confirmation screen will appear.

Save? Yes:ENTER No:SELECT

Figure 7-25: Update Confirmation Screen

If you press the [SELECT] key, the update will be canceled and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

(4) Press the [ENTER] key.

The settings will be updated and the display will return to the Calculation Parameter Setting Menu screen (Figure 7-13).

7-16 Sysmex CA-50 Operator’s Manual -- Revised July 1999

Sysmex CA-50 User Manual [nl]

Specifications and Main Features

Frequently Asked Questions

User Manual