CS-2000i and CS-2100i Instructions for Use sw ver V00-61 March 2012

Table of Contents

Table of Contents Chapter 1 1.1 1.2 1.3 1.4 1.5

Chapter 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15

Design and Function ... 3-1

Overview... 3-1 Main Unit ... 3-2 Information Processing Unit (IPU) ... 3-8 Pneumatic Unit ... 3-9 Options ... 3-11

Chapter 4 4.1 4.2 4.3

Safety Information... 2-1

Specified conditions of use... 2-1 General information ... 2-1 Installation ... 2-2 Electromagnetic compatibility (EMC) ... 2-2 Avoidance of infection... 2-2 Handling of reagents ... 2-3 Quality control materials... 2-4 Laser ... 2-4 Maintenance... 2-4 Disposal of materials ... 2-5 Markings on the instrument ... 2-6 Personnel ... 2-12 Computer virus ... 2-13 Use of other software ... 2-13 Operating System... 2-14

Chapter 3 3.1 3.2 3.3 3.4 3.5

Introduction ... 1-1

Manual composition ... 1-2 Hazard information in this manual ... 1-4 Protected names ... 1-5 Assay parameters (analysis parameters and calculated parameters)... 1-6 System overview ... 1-7

Operation ... 4-1

Overview... 4-1 Overview of operation... 4-1 Composition of the IPU menu screen... 4-2

Chapter 5

Sample Preparation ... 5-1

Revised March 2012

5.1 5.2 5.3 5.4 5.5 5.6

Overview... 5-1 Inspection before turning power ON... 5-2 Turning ON the power ... 5-2 Analysis reagent preparation... 5-6 Replenishing cuvettes ... 5-27 Placing a SB Cuvette (cuvette containing a stir bar) ... 5-28 5.7 Setting Trash Box Liner CS2 (optional) ... 5-37 5.8 Confirm calibration curve... 5-39 5.9 Running quality control... 5-41 5.10 Preparing samples ... 5-47

Sysmex CS-2000i/CS-2100i Instructions for Use

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Table of Contents

Chapter 6 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 6.10

Chapter 7 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10

Troubleshooting ... 8-1

Overview... 8-1 When you suspect an error ... 8-3 Display of errors... 8-4 How to display the error log ... 8-5 Troubleshooting by error messages... 8-7 System confirmation ... 8-52

Chapter 9 9.1 9.2 9.3 9.4 9.5

Maintenance and Supplies Replacement ... 7-1

Overview... 7-1 Maintenance checklist ... 7-3 Checking and performing maintenance ... 7-4 Daily maintenance ... 7-6 Weekly maintenance ... 7-17 Monthly maintenance ... 7-20 As-needed maintenances... 7-21 Confirming the cycle counts ... 7-32 Replacement of supplies ... 7-33 Supply parts list ... 7-42

Chapter 8 8.1 8.2 8.3 8.4 8.5 8.6

Analysis ... 6-1

Overview... 6-1 Order registration... 6-2 Order confirmation... 6-4 Analysis ... 6-5 STAT sample analysis... 6-10 Checking the amount of remaining reagent... 6-12 Emergency stop... 6-14 Shutdown... 6-14 Sleep mode ... 6-16 Logging off... 6-17

Technical Information... 9-1

Instrument specifications ... 9-1 Principles ... 9-8 Package contents ... 9-13 Installation ... 9-13 ID barcode specifications ... 9-34

Revised March 2012

Index

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Sysmex CS-2000i/CS-2100i Instructions for Use

CHAPTER 1

Introduction

1. Introduction Thank you for purchasing this Sysmex CS-2000i/CS-2100i fully automated blood coagulation analyzer. The CS-2000i/CS-2100i is a fully automated blood coagulation analyzer for In Vitro Diagnostic use that can quickly analyze a large volume of samples with a high degree of accuracy. This instrument can analyze samples using coagulation, chromogenic, immunoassay and aggregation methods. The analyzed data can be retained in the stored joblist, displayed and printed. (Printing is only possible if the optional printer is connected.) The instrument also has a number of built-in functions, including automatic setting of reagent by a barcode, priority processing of STAT samples and quality control. A cap piercer unit can be installed as a factory option. * CS-2000i: without cap piercer unit CS-2100i: with cap piercer unit The contents of screens illustrated in this manual are as displayed under Windows XP. Contact Address Manufacturer SYSMEX CORPORATION 1-5-1 Wakinohama-Kaigandori Chuo-ku, Kobe, Hyogo 651-0073 JAPAN Authorized Representative

EC

REP

European Representative SYSMEX EUROPE GmbH Bornbarch 1 D – 22848 Norderstedt, Germany Phone: +49 40 5 27 26-0 Fax: +49 40 5 27 26-100

Americas SYSMEX AMERICA, Inc. 1 Nelson C. White Parkway, Mundelein, IL 60060 U.S.A. Phone: +1-847-996-4500 Fax: +1-847-996-4505 Asia-Pacific

Revised March 2012

SYSMEX ASIA PACIFIC PTE LTD. 9 Tampines Grande, #06-18, Singapore 528735 Phone: +65-6221-3629 Fax: +65-6221-3687 Ordering of Supplies and Replacement Parts If you need to order supplies or replacement parts, please contact your local Sysmex representative. Service and Maintenance Please contact the Service Department of your local Sysmex representative.

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CHAPTER 1

Introduction

1.1 Manual composition The CS-2000i/CS-2100i manual comprises the following two sections. Read it carefully so that you can use the equipment correctly. After reading the manual, store it carefully where it will be available any time you need it. (1) CS-2000i/CS-2100i Instructions for Use (Volume 1) This manual gives a summary of the CS-2000i/CS-2100i and explains its basic operation and analysis procedures. (2) CS-2000i/CS-2100i Software Guide (Volume 2) This manual explains the operation procedure for each screen. Table 1-01: Composition of the Instructions for Use CHAPTER 1 Introduction

Manual composition, meanings of symbols used in this document, trademarks, system overview

CHAPTER 2 Safety Information

Safety information for usage

CHAPTER 3 Design and Function

Nomenclature and function summary

CHAPTER 4 Operation

Screen composition and basic operations

CHAPTER 5 Sample Preparation

Procedure from switching the power ON until the start of analysis * The screen explanations give reference destinations in the Software Guide. For details on the operation procedures for each screen, see the Software Guide.

CHAPTER 6 Analysis

Procedure from the start of analysis until shutdown * The screen explanations give reference destinations in the Software Guide. For details on the operation procedures for each screen, see the Software Guide.

CHAPTER 7 Maintenance and Supplies Replacement

Maintenance items, replacement of supplies, supplies list

CHAPTER 8 Troubleshooting

Error log, error handling methods, error messages

CHAPTER 9 Technical Information

Device specifications, functional descriptions, packing, checkpoints for before and after installation

Revised December 2010

The provided instructions, reagents, instrument, software and customizable features have been validated for this system to optimize product performance and meet product specifications. User defined modifications are not supported as they may affect performance of the system and test results. It is responsibility of the user to validate any modifications made to these instructions, reagents, instrument or software.

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CHAPTER 1

Introduction

Table 1-02: Composition of the Software Guide Manual composition, meanings of symbols used in this document, trademarks

CHAPTER 2 Order Registration

Order related screens, functions and operation procedures

CHAPTER 3 Joblist

Joblist related screens, functions and operation procedures

CHAPTER 4 Browser

Browser related screens, functions and operation procedures

CHAPTER 5 Reagent Screen

Reagent related screens, functions and operation procedures

CHAPTER 6 Quality Control

Quality control related screens, functions and operation procedures

CHAPTER 7 Calibration Curve

Calibration curve related screens, functions and operation procedures

CHAPTER 8 System Setup

Setup related screens, functions and operation procedures

CHAPTER 9 Utility Tools

Utility tool related screens, functions and operation procedures

CHAPTER 10 GNU General Public License

GNU General Public License explanation

Revised December 2010

CHAPTER 1 Introduction

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CHAPTER 1

Introduction

1.2 Hazard information in this manual Note, Information, Caution and Warning statements are presented throughout this manual to call attention to important safety and operational information. Noncompliance with this information compromises the safety features incorporated in the analyzer.

Risk of infection This symbol indicates a possible hazardous situation which, if not avoided, may result in infection by pathogens and others.

Warning! High risk. Ignoring this warning could result in personal injury to the operator.

Caution! Average risk. Ignoring this warning could result in property damage or incorrect measurement results.

Information Minor risk. Observe these considerations when operating this instrument.

Revised December 2010

Note: Background information and practical tips.

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Introduction

1.3 Protected names • Sysmex is a registered trademark of SYSMEX CORPORATION. • CA CLEAN I and CA CLEAN II are trademarks of SYSMEX CORPORATION. • Dade, Actin and Berichrom are trademarks of Siemens Healthcare Diagnostics. • VENOJECT, Venosafe and VENOJECT II are registered trademarks of TERUMO Corporation. • 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. • MONOVETTE is a registered trademark of SARSTEDT. • Windows is a registered trademark of Microsoft Corporation in the United States and other countries. • Linux is a registered trademark or trademark of Linus Torvalds in the United States of America and other nations. • Other registered trademarks or trademarks referenced are property of their respective owners.

Revised December 2010

The fact that a trademark is not explicitly mentioned in this manual does not authorize its use.

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Introduction

1.4 Assay parameters (analysis parameters and calculated parameters) The CS-2000i/CS-2100i can perform analyses and calculations of the following parameters. Additional analysis and calculation parameters can be registered as well. Table 1-03: Analysis parameters and calculated parameters of CS-2000i/CS-2100i

Method Coagulation

Analysis parameters Prothrombin Time (PT)

Calculated Parameters Prothrombin Activity Percent* Prothrombin Ratio INR Derived Fbg

Activated Partial Thromboplastin Time (APTT) Fibrinogen clotting time (Fbg)

Fibrinogen concentration

Extrinsic Factor Activity Assay (II, V, VII, X)

Factor II Activity Percent Factor V Activity Percent Factor VII Activity Percent Factor X Activity Percent

Intrinsic Factor Activity Assay (VIII, IX, XI, XII)

Factor VIII Activity Percent Factor IX Activity Percent Factor XI Activity Percent Factor XII Activity Percent

Thrombin Time (TT) Lupus Anticoagulant Screening (LA1) Lupus Anticoagulant Confirmation (LA2)

LA1/LA2 Ratio

Chromogenic

Immunoassay

Aggregation

Protein S (PS Ac)

Protein S Activity Percent

Protein C (PC cl)

Protein C Activity Percent

Protein C (ProC Global)

Protein C Ratio

Factor V Leiden (FV Leiden with ProC Global)

Factor V Leiden Ratio

Antithrombin III (AT III)

Antithrombin III Activity Percent

α2-Antiplasmin (α2PI)

α2-Antiplasmin Activity Percent

Plasminogen (Plg)

Plasminogen Activity Percent

Protein C (PC)

Protein C Activity Percent

Coagulation Factor XIII [FXIII]

Factor XIII Activity Percent

Factor VIII Chromogenic (FVIII CH)

Factor VIII Activity Percent

Heparin (Hep)

Heparin IU/mL

C1-Inhibitor (C1)

C1-Inhibitor Activity Percent

Fibrin Degradation Product (FDP)**

FDP Concentration**

D-Dimer

D-Dimer concentration

von Willebrand Factor Antigen (VWF:Ag)*

von Willebrand Factor Antigen Percent*

von Willebrand Factor Ristocetin Cofactor (VWF:RCo)*

von Willebrand Factor Ristocetin Cofactor Percent*

* Not available in the USA. ** Available for use only in Asia.

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Revised December 2010

Batroxobin Time (BTX)

CHAPTER 1

Introduction

1.5 System overview The CS-2000i/CS-2100i is a fully automated blood coagulation analyzer for in vitro diagnostic use that can quickly analyze a large volume of samples with a high degree of accuracy. This instrument can analyze samples using coagulation, chromogenic, immunoassay and aggregation methods. The CS-2000i/CS-2100i comprises the following main devices. • CS-2000i/CS-2100i Main Unit: Performs sample analysis. • Information Processing Unit (IPU): Processes data generated by the Main Unit.

Revised December 2010

Caution! • Results should always be evaluated in conjunction with clinical conditions and other laboratory findings. • Independently of the concentration of the sample, non-specific reactions may occur in some cases and the dilution ratio and analysis result may not show the linearity in this case. • It may not be possible to obtain correct analysis results if the test protocol is changed. The operator is personally responsible for any such changes. Furthermore, the warranty for this product only covers the use in the factory default settings.

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Introduction

Revised December 2010

Blank page

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Sysmex CS-2000i/CS-2100i Instructions for Use

CHAPTER 2

Safety Information

2. Safety Information This chapter will present safety information for using this product safely and correctly. Read this chapter carefully before use.

2.1 Specified conditions of use The CS-2000i/CS-2100i is intended solely for In Vitro diagnostic use. The primary sample for analysis is the plasma component of human blood with added anticoagulant (sodium citrate). Any other use is regarded as non-specified. Only reagents and cleaning solutions mentioned in this manual are permitted for use. The specified conditions of use also entail the observance of the cleaning and maintenance procedures described in these instructions.

2.2 General information Read the manual before operating the CS-2000i/CS-2100i. Keep this manual for future reference.

Revised December 2010

Warning! • The unpacking, setup and confirmation of correct initial operation is performed by your local Sysmex technical representative. • Take care to keep long hair, fingers and clothing away from rotating parts. • Should the instrument emit any unusual odors or smoke, turn the main switch OFF immediately and unplug the power cable. Contact your local Sysmex technical representative. Failure to do so could result in fire, electrical shock or injury. • Take care not to spill blood or reagent, or drop wire staples or paper clips into the instrument as this might cause a short or smoke. Should the instrument malfunction, turn the main switch OFF immediately and unplug the power cable. Contact your local Sysmex technical representative. • The operator should not touch any electrical circuitry inside the cover. The danger of electrical shock is particularly high when one’s hands are wet. • This instrument must not be connected to a power outlet rated at anything other than specified in the rating plate. Please note that the instrument must be grounded, or fire or electrical shock may result. • Do not damage the power cable, place heavy objects on it or pull it with excessive force. Doing so may cause a fire or shock due to an electrical short or broken wiring. • Switch OFF the power supply before connecting any peripheral devices (host computer, printer), or electrical shock or instrument failure may result.

Sysmex CS-2000i/CS-2100i Instructions for Use

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CHAPTER 2

Safety Information

2.3 Installation

Caution! • Install in a place which is not subject to water splash. • Install in a place which is not subject to adverse effects of high temperature, high humidity, dust, direct sunlight, etc. • Make sure the instrument is not exposed to strong vibration or impact. • Install in a well-ventilated area. • Avoid installation of the instrument near devices that emit electrical interference, such as a centrifuge. • Do not install the instrument close to stores of chemical substances or other sources of gas emissions. • Do not use this instrument in any operating environment which has electroconductive or flammable gases, including oxygen, hydrogen and anesthesia. • This instrument was designed for indoor use only.

2.4 Electromagnetic compatibility (EMC) This instrument complies to the following IEC (EN) standards: z IEC61326-2-6:2005 (EN61326-2-6:2006) Equipment for measurement, control and laboratory use - EMC-Requirements. z EME (Electro magnetic Emission) For this standard the requirements of class A are fulfilled. z EMI (Electro magnetic Immunity) For this standard the minimum requirements with regards to immunity are fulfilled.

Risk of infection • In principle, all parts and surfaces of the instrument must be regarded as infective. • Waste fluid and parts which have come into contact with it, should never be touched with bare hands. • Should you inadvertently come in contact with potentially infective materials or surfaces, immediately rinse skin thoroughly with water, then follow your laboratory’s prescribed cleaning and decontamination procedures. • Take appropriate care in handling samples. Use of protective garments and gloves is strongly recommended when operating, maintaining, servicing or repairing the instrument. If something should get in your eyes or an open wound, rinse thoroughly with water and then contact your physician immediately. • Control blood must be regarded as potentially infectious. When performing quality controls, use protective garments and gloves. If something should get in your eyes or an open wound, rinse thoroughly with water and then contact your physician immediately. • Take appropriate care in handling waste fluids. If you get them on your skin or clothes, wash them.

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Sysmex CS-2000i/CS-2100i Instructions for Use

Revised December 2010

2.5 Avoidance of infection

CHAPTER 2

Safety Information

2.6 Handling of reagents

Warning! • Do not directly touch the reagents. Reagents can cause irritation of the eyes, skin and mucous membranes. • Should you inadvertently come in contact with reagent, immediately rinse skin thoroughly with water. • If a reagent should get in your eyes, rinse thoroughly with water and contact your physician immediately. • If a reagent is accidentally swallowed, vomit or induce vomiting by drinking copious amounts of warm, salty water and contact your physician immediately. • CA CLEAN II is an acidic cleaning agent. It should not come in contact with skin or clothing. If it happens rinse skin or clothing with plenty of water to avoid injury or damage. • The CA CLEAN I detergent contains sodium hypochlorite. If CA CLEAN I comes in contact with the instrument’s surfaces, it will affect the surface finish and there is danger of corrosion. Immediately wipe up CA CLEAN I with a damp cloth. • Extra care should be taken to make sure CA CLEAN I is not mixed and used with acidic solutions such as CA CLEAN II. Direct mixing of CA CLEAN I and an acidic solution will result in the highly hazardous release of poisonous chlorine gas. • When handling samples or reagents, always wear latex or non-latex gloves. After completion of work, wash hands with disinfectant to avoid the risk of infection with pathogens etc.

Revised December 2010

Caution! • Follow directions on reagent labelings. • Avoid letting the reagent come in contact with dust, dirt or bacteria. • Reagents must not be used after their expiration date. • Handle reagents gently to avoid bubbling. • Take care not to spill reagents. • Handle and store reagents according to the instructions provided with each reagent. Reagent can also be stored cooled inside the instrument overnight. For the sake of the storage stability of the reagents, however, they should be stored cooled with their lids closed, or taken out of the instrument and stored in a refrigerator with lids closed, if no analyses will be conducted for a long period. Leaving reagents for long periods with open caps could affect data.

Sysmex CS-2000i/CS-2100i Instructions for Use

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CHAPTER 2

Safety Information

2.7 Quality control materials

Caution! • Do not inject or swallow. • Follow directions on reagent labelings. • Avoid letting the reagent come in contact with dust, dirt or bacteria. • Reagents must not be used after their expiration date. • Handle reagents gently to avoid bubbling. • Take care not to spill reagents.

2.8 Laser

Warning! A semiconductor laser barcode reader is used in the CS-2000i/CS-2100i reagent table. The laser barcode reader has a mechanism that prevents laser oscillation when the cover of the reagent table has been removed. Never look into the laser light source. There is a danger of causing eye pain or damage if one looks into the laser beam.

2.9 Maintenance

Risk of infection Always wear protective garments and gloves when processing with the instrument and during maintenance. After completion of work, wash hands with disinfectant, or infection by bacteria could result.

Caution! Do not leave the probe with aspirated reagent or sample inside it. The probe can get blocked as a result, so perform “Rinse Probe”.

Revised December 2010

Information When performing maintenance, use only the tools specially provided for such work.

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CHAPTER 2

Safety Information

2.10 Disposal of materials

Revised March 2012

Warning! • Waste fluids, instrument consumables and other waste materials must be disposed of appropriately in accordance with local laws, with due consideration of medical, infectious and industrial wastes. • A battery is incorporated in the circuit board located in the right side interior of the instrument in order to keep the stored data. When disposing of the instrument, remove and dispose of the battery properly for recycling. Do not throw the battery into a fire, otherwise bursting can result.

Sysmex CS-2000i/CS-2100i Instructions for Use

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CHAPTER 2

Safety Information

2.11 Markings on the instrument Front of the Main Unit (1)

WARNING Do not place your fingers and hands inside when analyzing. Doing so may result in injury.

(2)

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

(3)

CAUTION Use the buffer solution after equilibrating to the room temperature.

(4)

CAUTION When you open the cuvette hopper cover for removing the jammed cuvettes, check that the status of the instrument is “Ready”. Otherwise, measurement results could be affected.

(4)

(1)

(3) (2)

Revised March 2012

Figure 2-01: Front of the Main Unit

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Safety Information

Right of the Main Unit (1)

WARNING Do not place your fingers and hands inside when analyzing. Doing so may result in injury.

(1)

Revised March 2012

Figure 2-02: Right of the Main Unit

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CHAPTER 2

Safety Information

Left of the Main Unit (1)

WARNING • 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. Fuse rating 10A 250V time lag

(2)

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

(1)

(2)

Revised March 2012

Figure 2-03: Left of the Main Unit

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Safety Information

Interior left side of the Main Unit (1)

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

(1)

Figure 2-04: Interior left side of the Main Unit Front of the Pneumatic Unit (1)

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

(1)

Revised March 2012

Figure 2-05: Front of the Pneumatic Unit

Sysmex CS-2000i/CS-2100i Instructions for Use

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