CA-1500 Operators Manual sw ver V00-18 May 2009

Revision History Version Manual Revised November 2001 Revised September 2002 Revised October 2003 Revised September 2005 Revised May 2009

Software 00-16 00-18 00-18 00-18 00-18

Date

Changes

11/01 09/02 10/03 09/05 05/09

Update Version Software Update To conform with IVD Directive

Minor Correction Addition of APPENDIX D and E

Sysmex is a registered trademark of SYSMEX CORPORATION in the USA, in Germany and other countries. CA CLEAN I and CA CLEAN II are trademarks of SYSMEX CORPORATION in the USA, in Germany and other countries. Actin, Ci-Trol, Data-Fi, Innovin, Dade, Pathromtin, Multifibren, Thromborel, Berichrom and INNOVANCE are trademarks of Siemens Healthcare Diagnostics.

• • • • • • • • • • • • •

Canon is a registered trademark of Canon, Inc. Cubitainer is a registered trademark of Hedwin Corporation. DeskJet and LaserJet are registered trademarks of Hewlett-Packard Corporation. EPSON is a registered trademark of Seiko Epson Corporation. MS-DOS is a registered trademark of Microsoft Corporation. Teflon is a registered trademark of E.I. du Pont de Nemours & Co., Inc. VACUTAINER is a registered trademark of Becton Dickinson and Company. HEMOGARD is a trademark of Becton Dickinson and Company. VACUETTE is a registered trademark of C.A. GREINER und Söhne GmbH. LIP-VAC is a registered trademark of LIP (EQUIPMENT AND SERVICES) LTD. MONOVETTE is a registered trademark of SARSTEDT. VENOJECT is a registered trademark of TERUMO Corporation. 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-1500 System Operator’s Manual -- Revised May 2009

RECEIVING INSTRUCTIONS The CA-1500 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 at approximately the same time as 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, remark 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-1500 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-1500 System Operator’s Manual -- Revised November 2001

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Ensure Safe Operation of The Instrument 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 users and others from suffering injuries and damage to property. The illustrations and meaning are described in the following. Please ensure you understand what they mean before proceeding to the text of the MANUAL. Meaning of Signs

RISK OF INFECTION: • Indicates the presence of a biohazardous material or condition.

WARNING:• If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which could result in death or serious injury of an operator, or grave property damage.

CAUTION: • If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which may result in injury of an operator, adverse effect on output, or may cause property damage.

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

CE-mark The IVD-system described in this manual is marked with a CE-mark which confirms the observance of the essential requirements of the following European directive: -98/79/EC in-Vitro Diagnostics Directive

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Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

WARNING:

• In the event the instrument emits an abnormal odor or any smoke, turn OFF the power switch immediately and disconnect the power plug from the wall socket. If the instrument is used continuously in that state, there is a potential that fire, electrical shock, or injury may result. Contact your service representative for inspection. • Take care not to spill blood or reagent, or drop wire staples or paper clips into the instrument. These might cause a 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 service representative for inspection. • Do not touch the electrical circuits inside the cover. Especially if your hands are wet, there is a potential that electrical shock may result. • During an analysis, do not open the light shield lid and put in hands or fingers. That could cause injury. When the light shield lid is opened during an analysis, an alarm sounds and the operation stops. • Always wear Latex or non Latex examination 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 Latex or non Latex examination 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 waste liquid, or disassembling/assembling the related parts, do not touch the waste liquid. If it is contaminated with blood, infection of bacteria may result. If you should touch the waste liquid inadvertently, wash it off with disinfectant first, then wash it off with soap. When Handling Reagent • If a reagent happens to enter your eye, wash out your eyes immediately using plenty of water, and take medical treatment at once. • If you should swallow it inadvertently, call for a physician immediately, drink plenty of water, and induce vomiting. • If it happens to adhere to your hands or skin, wash the affected area using plenty of water. • When discarding waste liquid, instrument consumables and instrument, take proper disposing steps as these are 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-1500 System Operator’s Manual -- Revised May 2009

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WARNING:

Power Supply, Connection, and Grounding • 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, etc.), be sure to switch OFF the power beforehand. Otherwise, electrical shock or instrument failure may result.

When Using the Sample Barcode • Use the check-digit as much as possible. If the check-digit cannot be used, the potential of the incorrect reading of the barcode label may be increased.

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Sysmex CA-1500 System Operator’s Manual -- Revised November 2001

CAUTION

Use of Reagents • After unpacking, be sure not to allow dust, dirt, or bacteria to come in contact with the reagent. • Do not use reagents which have expired. • Handle a reagent gently to prevent formation of bubbles. • A reagent is a chemical substance employed for external diagnosis and cannot be used for any medical treatment. • 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 service representative for assistance or service. • Unpacking, installation, and confirmation of initial setup must be done by your 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, etc. • Do not give the instrument a strong vibration or impact. • Do not install the instrument near chemical storage or a place where a gas is generated.

Sysmex CA-1500 System Operator’s Manual -- Revised May 2009

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INTRODUCTION Thank you for purchasing the Sysmex® Automated Blood Coagulation Analyzer CA-1500. 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. Ordering of Supplies and Replacement Parts If you need to order supplies or replacement parts, please contact your local representative. Service and Maintenance Please contact the Service Department of your local representative. Training courses For further information please contact the representative in your country. Personnel This instrument may only be operated by trained personnel having been instructed in its operation. Only persons who have appropriate training must perform maintenance and repair work.

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Sysmex CA-1500 System Operator’s Manual -- Revised May 2009

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 eleven chapters and appendices listed below. Chapter 1:

Introduction

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

Chapter 2:

Sample Preparation

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

Chapter 3:

Work List

Explains how to register sample ID numbers and analysis parameters.

Chapter 4:

Sample Analysis

Describes how to analyze samples and explains operating procedures, from order information entry to shutdown.

Chapter 5:

Display & Processing of Analysis Results

Explains stored data screen displays and the processing of external output and other analysis results.

Chapter 6:

Maintenance & Supplies Replacement

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

Chapter 7:

Quality Control

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

Chapter 8:

Setting Standard Curves

Explains how to prepare standard curves.

Chapter 9:

Troubleshooting

Explains the error messages and how to troubleshoot.

Chapter 10:

Functional Description

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

Chapter 11:

Instrument Setup

Explains how to preset the instrument’s various settings, such as the data analysis settings (including limits that indicate abnormal data) and detailed reagent information settings.

Appendix A: Installation

Explains how to install the CA-1500.

Appendix B: Technical Information

Includes host computer data format and communication specifications, ID barcode specifications, test protocol list, and other reference materials.

Appendix C: Wand Barcode Reader

The wand barcode reader is explained here. (The wand barcode reader is an option.)

Appendix D: Vacuum Adjustment

Explains how to adjust the vacuum pressure.

Appendix E: External Pneumatic Unit

Explains the external pneumatic unit.

Sysmex CA-1500 System Operator’s Manual -- Revised May 2009

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PREMISES FOR SIGNS Meaning of Signs RISK OF INFECTION: • Indicates the presence of a biohazardous material or condition.

WARNING:• If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which could result in death or serious injury of an operator, or grave property damage.

CAUTION: • If this sign is ignored and the instrument is operated incorrectly, there is a potentially hazardous situation which may result in injury of an operator, adverse effect on output, or may cause property damage.

CAUTION:

• Indicates what we would like you to know to maintain instrument performance and prevent its damage.

NOTE:

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

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: "Ready", "Validated" NOTE:

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• LCD and printing described in this manual may differ from those in practice. • As a result of product improvements, details described in this manual may differ slightly from the actual product.

Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

Markings on the Instrument CA-1500 Main Unit

1)

4)

2) 1) 1) 3)

5) 6)

1)

Push here, and this door will open.

CAUTION 2)

3)

Transportation arm will suspend operation when this lid is open.

WARNING To avoid hardware damage, do not push the STAT cover when LED lights in red.

4)

Turn this knob to control brightness.

Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

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5)

Fast Stop (Mechanical Stop)

RISK OF INFECTION 6)

In principle, all parts and surfaces of the instrument must be regarded as infective.

Reaction Tube Hopper

1)

2) Sysm

ex

CAUTION 1)

2)

x

Do not fill the hopper above the red line. Hopper capacity is approximately 300 tubes.

Push here, and this door will open.

Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

Front Interior 1)

2) 3)

*

4)

*

CAUTION 1)

When moving the arm, pull up the pipette to the top.

CAUTION 2)

Use the buffer solution after equilibrating to the room temperature.

WARNING Piercer Inside

3)

*

4)

* Handle the piercer with care.

WARNING The tip of the piercer is sharp. If it touches your hands or fingers, you may be injured or be infected. Be careful especially when replacing.

* These Markings are affixed only when a Cap Piercer Unit is Installed.

Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

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Rear

1) 2)

1) Name Plate

SN

Serial Number Date of Manufacture Name of Manufacturer

IVD 2)

For In Vitro Diagnostic Use

WARNING To avoid electrical shock, disconnect supply before servicing.

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Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

Right Side

1) 2) 3) 5)

4) Rns

6)

W Rns W

1)

RS-232C Serial Port

2)

RS-232C Serial Port (HC Connector)

3)

Parallel Port (GP Connector)

4)

Parallel Port (DP Connector)

5)

WARNING Remove the power before attempting to replace the lamp. Perform lamp calibration after replacing the lamp.

WARNING! - IF THE LAMP IS HOT, USE HEAVY GAUZE OR APPROPRIATE PROTECTION WHEN HANDLING THE LAMP. - REMOVE THE POWER BEFORE ATTEMPTING TO REPLACE THE LAMP.

6) The meanings of these abbreviations are: Rns: W:

Rinse Waste

Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

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Left Side

1) 2)

3)

RISK OF INFECTION 1)

To avoid contact with biohazardous materials, gloves must be worn when handling the tube trash and used reaction tubes. Wash your hands with an antimicrobial solution after completing the procedure.

WARNING 2)

- To avoid electrical shock, disconnect supply before servicing. - For the continued protection against risk of fire, replace only with fuse of the specified type and current ratings.

WARNING This equipment must be

earthed. CAUTION 3)

xiv

Before running, set the trash box to the right position.

Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

Rinse Tank

1) 2)

CAUTION 1)

- Fill with distilled water only. - Thoroughly clean the inside once a week.

2) The meaning of this abbreviations is: Rns: Rinse

Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

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Waste Tank (Option)

1) 2)

RISK OF INFECTION 1)

The waste tank and contents should be considered potentially biohazardous. Do not handle the waste tank without proper protective equipment. Wear gloves when handling. Wash your hands with an antimicrobial solution after completing the procedure.

2) The meaning of this abbreviations is: W: Waste

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Sysmex CA-1500 System Operator’s Manual -- Revised October 2003

External Pneumatic Unit (Option) Front of the Pneumatic Unit

1)

RISK OF INFECTION 1)

In principle, all parts and surfaces of the instrument must be regarded as infective.

Rear of the Pneumatic Unit 2)

1)

WARNING 1)

• To avoid electrical shock, disconnect supply before servicing. • For the continued protection against risk of fire, replace only with fuse of the specified type and current ratings.

WARNING 2)

Do not block the exhaust openings on the rear of the pneumatic unit.

Sysmex CA-1500 System Operator’s Manual -- Revised May 2009

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Sysmex CA-1500 System Operator’s Manual -- Revised May 2009