TEG 5000 User Manual Rev AC Dec 2010

Printed in USA © 1999, 2010, Haemonetics Corporation. All rights reserved.

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CONSUMER INFORMATION Proprietary rights

The contents of this manual are the property of Haemonetics Corporation. Haemonetics®, Haemoscope™, TEG®, RapidTEG™, and Thrombelastograph® are trademarks or registered trademarks of Haemonetics Corporation in the United States and/or other countries. PlateletMapping® is a registered trademark of CoraMed Technologies. Any information or descriptions contained in this manual may not be reproduced, released to the general public, or used in conjunction with any professional instruction without written consent of Haemonetics Corporation, Haemoscope Division, USA. Please direct any written inquiries to the appropriate address. Corporate headquarters Haemonetics Corporation 400 Wood Road Braintree, MA 02184 U.S.A. Tel.: +1 781 848 7100 Fax: +1 781 848 5106

International headquarters Haemonetics S.A. Signy Centre Rue des Fléchères 6 P.O. Box 262 Signy Centre, Switzerland Tel.: +41 22 363 9011 Fax: +41 22 363 9054

Haemonetics Corporation Haemoscope Division 6231 W Howard St Niles IL 60714 USA Tel. +1 847 588-0453 Fax +1 847 588-0455 Web www.haemonetics.com Email [email protected]

Disclaimer

This manual is intended as a guide to provide the operator with necessary instructions on the proper use and maintenance of the TEG analyzer. This manual should be used in conjunction with instruction and training supplied by qualified Haemonetics personnel. Any failure to follow the instructions as described could result in impaired product function, injury to the operator or others, or void applicable product warranties. Haemonetics accepts no responsibility for liability resulting from improper use or maintenance of its products. Utilization of Haemonetics products may require the operator to handle and dispose of blood-contaminated material. An operator must fully understand and implement all regulations governing the safe handling of blood products and waste, including the policies and procedures of their facility. Patient diagnosis is the sole responsibility of the attending physician or other qualified medical personnel.

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Haemonetics worldwide

Haemonetics Austria Handelsges.m.b.H. Mariahilfer Strasse 123 3rd Floor 1060 Wien, Austria Tel.: 0800 29 2777 Fax: 0800 29 2820 Haemonetics Belgium-NV Braine-L’Alleud Parc de L’Alliance 9 Boulevard de France, bât A 1420 Braine L’Alleud Belgium Tel.: (FR): 0800 754 80 Fax: 0800 75512 Tel. (NL): 0800 754 82 Fax: 0800 755 12 Haemonetics BV Claudius Prinsenhof Verlengde Poolseweg 34-46 4818 CL Breda The Netherlands Tel.: 0800 0222 707 Fax: 0800 0223 066 Haemonetics CZ, spol. s.r.o. Ptašínského 8 60200 Brno, Czech Republic Tel.: 800 143 243 Fax: 800 143 250 Haemonetics France SARL 46 bis, rue Pierre Curie Z.I. Les Gâtines 78370, Plaisir, France Tel.: 0800 90 11 58 Fax: 0800 91 48 76 Haemonetics GmbH Wolfratshauser Straße 84 81379 Munich, Germany Tel.: 0800 180 8890 Fax: 0800 182 8064

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Haemonetics (Hong Kong) Ltd. Rooms 2202, 22/F Harbour Centre, 25 Harbour Road Wanchai, Hong Kong Tel.: +852 2868 9218 Fax: +852 2801 4380 Haemonetics Hospitaler LTDA Avenida Bernardino de Campos, 98 Sobreloja, Paraisio, CEP 04004-040 City of São Paulo State of São Paulo, Brazil India Representative Office Haemonetics (Hong Kong) Ltd. JMD Regent Square Regus - Level 6 Mehrauli Gurgaon Road Gurgaon - 122 001 Haryana (Delhi-NCR) India Tel.: +91 124 471 1819 Fax: +91 981 027 3237 Haemonetics Italia SA Via Senigalia 18/2 - Torre A Milan 20161 Italy Tel.: 800 870 200 Fax: 800 870 375 Haemonetics Japan GK Kyodo Building, 16 Ichiban-cho, Chiyoda-ku Tokyo 102-0082, Japan Tel.: +81 3 3237 7260 Fax: +81 3 3237 7330 Haemonetics Korea, Ltd. 30th Floor ASEM Tower 159-1 Samsung-dong, Kangnam-ku Seoul 135-798, Korea Tel.: +82 2 6001 3280 Fax: +82 2 6001 3281

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Haemonetics Medical Devices (Shanghai) International Trading Company Room 1103-06 Evergo Mansion No. 1325 Middle Huaihai Road 200031 Shanghai, China Tel.: +86 21 3406 0700 Fax: +86 21 5466 8852 Haemonetics Scandinavia AB Ideon 223 70 Lund, Sweden Tel.: 020 797 150 Fax.: 020 794 670 Haemonetics Asia Incorporated Taiwan Branch 26F-1, No. 102, Roosevelt Road Sec. 2 Taipei, Taiwan Tel.: +886 2 2369 0722 Fax: +886 2 2364 3698

TEG® 5000 System User Manual

United Kingdom Sales Office Haemonetics Ltd. 960 Capability Green Luton LU1 3PE United Kingdom Tel.: 0808 234 4817 Fax: 0808 234 4845 Lebanon Representative Office Haemonetics SA c/o The Regus Group Azarieh Bldg., Block 3, 5th floor Regus, Beirut, Lebanon PO Box 11-503 Russia Representative Office Haemonetics SA Smolenskaya Passage Smolenskaya Square 3 121099 Moscow Russia Tel.: +7 495 937 8239

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Table of Contents Chapter 1, Introduction OVERVIEW... 1-2 Purpose of the manual... 1-2 What is the TEG System?... 1-2 Indications for use... 1-3 Intended use... 1-3 TECHNICAL SUPPORT... 1-4 Contacting technical support... 1-4 Returned material authorization (RMA) procedure... 1-4 SYMBOLS... 1-5 Symbols found in this document... 1-5 Symbols found on the analyzer... 1-5

Chapter 2, TEG Analyzer Description TEG ANALYZER DESCRIPTION OVERVIEW... 2-2 EXTERIOR FRONT COMPONENTS... 2-3 Carrier... 2-3 Cupwell... 2-3 Carrier ribbon cable... 2-4 Column... 2-4 Lever... 2-4 Power switch... 2-4 Temperature controller... 2-4 Front cover... 2-5 Motor indicator... 2-5 Carrier shafts... 2-5 Platform... 2-5 Leveling feet... 2-5 EXTERIOR BACK COMPONENTS... 2-6 Rear cover... 2-7 Leveling bubble... 2-7 Serial port for the A/D interface box... 2-7 Potentiometer adjustment screw - CAL... 2-7 Potentiometer adjustment screw - BASE... 2-7 Power supply connection... 2-7

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Chapter 3, Safety and Precautions STORAGE AND HANDLING... 3-2 Storing and handling the analyzer... 3-2 Storing and handling the disposables... 3-2 Storing and handling the reagents and controls... 3-2 Transporting the analyzer... 3-2 WARNINGS FOR THE OPERATOR... 3-3 Electrical Shock hazards... 3-3 Power outlet connection... 3-3 Bloodborne pathogens... 3-3

Chapter 4, TEG Analyzer Technology Overview TEG ANALYZER TECHNOLOGY OVERVIEW... 4-2 Principles of design... 4-2 TEG ANALYZER PARAMETERS... 4-4 Primary clot formation and lysis parameters... 4-4 Secondary clot formation parameters... 4-6 Secondary clot lysis parameters... 4-8 Secondary clot kinetic, strength, and stability parameters... 4-9 Velocity parameters... 4-10 Interrelationship of parameters... 4-11 TEG SAMPLE TYPES... 4-12 TEG sample types overview... 4-12 TEG sample type descriptions... 4-14

Chapter 5, TEG Analytical Software (TAS) Overview TEG ANALYTICAL SOFTWARE (TAS) OVERVIEW... 5-2 About the Enabled and Remote versions... 5-2 TAS features... 5-3 LOGGING IN TO TAS... 5-5 Timing out... 5-7 UNDERSTANDING THE TAS MAIN SCREEN... 5-8 TEG parameters... 5-8 Identifying Information... 5-9 Data tracings... 5-11 Selecting a sample... 5-11 Status bar... 5-12 UNDERSTANDING THE TOOLBAR ICONS... 5-13 UNDERSTANDING THE TEG SCREEN... 5-16 Accessing the TEG Screen... 5-16 Fields... 5-17 Channel colors... 5-18 Selecting an active channel... 5-18 UNDERSTANDING THE MENU OPTIONS... 5-19

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Chapter 6, Configuring User Profiles CONFIGURING USER PROFILES OVERVIEW... 6-2 About user profiles... 6-2 Accessing the User profile setup screen... 6-2 TESTS TAB... 6-3 Accessing the Tests tab features... 6-3 Adding a new test... 6-4 Renaming a test... 6-5 Moving a test... 6-6 Including tests in the TAS display... 6-6 NORMAL VALUES TAB... 6-8 Accessing the Normal Values tab features... 6-8 Viewing reference range values... 6-9 Adding test values to a sample type... 6-9 Changing reference range values for a test... 6-10 SAMPLE TYPES TAB... 6-11 Accessing the Sample Types tab features... 6-11 Adding a sample type... 6-12 Moving a sample type... 6-13 Including sample types in the TAS display... 6-13 SOFTWARE TAB... 6-15 Setting software options... 6-15 VIDEO TAB... 6-20 Accessing the Video tab features... 6-20 Changing a color... 6-21 Changing a line... 6-22 Resetting video preferences... 6-23 LOGIN TAB... 6-24 Setting login defaults... 6-24 ECONSULT TAB... 6-25 Accessing the eConsult tab features... 6-25 Setting up your e-mail account... 6-26 Defining e-mail server settings... 6-27 Defining an eConsult recipient... 6-27 Removing an eConsult recipient... 6-28

Chapter 7, Operating the TEG Analyzer OPERATION OVERVIEW... 7-2 Daily operation tasks... 7-2 ADJUSTING THE TEMPERATURE SET POINT... 7-3 Setting column 1 setpoint... 7-4 Setting column 2 setpoint... 7-4 CONDUCTING DAILY MAINTENANCE CHECKS... 7-5 Leveling the analyzer... 7-6 Checking the carrier ribbon cables... 7-6 Performing an eTest... 7-6

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Running quality control samples... 7-9 LOADING AND EJECTING CUPS AND PINS... 7-14 Loading the cups and pins... 7-14 Ejecting the cups and pins... 7-16 COLLECTING AND PREPARING BLOOD SAMPLES... 7-17 Overview... 7-17 Before you begin... 7-18 Collecting a non-citrated blood sample... 7-18 Collecting a citrated blood sample... 7-19 Collecting a heparin blood sample... 7-20 Preparing TEG blood samples... 7-20 RUNNING SAMPLES... 7-26 Before you begin... 7-26 Starting samples... 7-26 Terminating samples... 7-27 CLEANING THE TEG ANALYZER... 7-28 Frequency... 7-28 Materials Needed... 7-28 Procedure... 7-28

Chapter 8, Viewing and Annotating TEG Analyzer Data TEG ANALYZER DATA OVERVIEW... 8-2 VIEWING TRACINGS... 8-3 Viewing parameters... 8-3 Tracing lines... 8-3 Maximizing a tracing... 8-4 Displaying data for a tracing... 8-6 Displaying multiple tracings (comparing samples)... 8-7 Navigating between multiple tracings... 8-8 Printing a single tracing using Quick Print... 8-10 Using reference tracings... 8-10 Using normal tracings... 8-12 When no tracing appears... 8-13 Viewing PlateletMapping® tracings... 8-13 Viewing Functional Fibrinogen tracings... 8-16 Viewing RapidTEG™ tracings... 8-17 USING FILTERS... 8-19 Using Quick filters... 8-20 Using the Advanced filters... 8-21 USING THE GUIDE FEATURE... 8-30 Using the Show Me option... 8-30 Manually selecting a tracing in Guide... 8-32 Using the coagulopathy library... 8-33 GENERATING AND PRINTING REPORTS... 8-37 Generating patient reports... 8-37 Generating quality assurance reports... 8-45 Generating the operator report... 8-49 P/N 06-510-US, Manual revision: AC

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VIEWING AND ENTERING SAMPLE DETAILS... 8-50 Viewing details on the Detail screen... 8-50 Entering details on the Tracing tab... 8-53 Entering details on the Sample tab... 8-56 Entering details on the Notes tab... 8-58 USING THE NOTES FEATURE... 8-59 Adding or viewing SNotes... 8-59 Adding or viewing Notes... 8-60

Chapter 9, Managing Databases MANAGING DATABASES OVERVIEW... 9-2 About the TEG system databases... 9-2 OPENING A DATABASE... 9-3 CHANGING A QC DATABASE... 9-4 SWITCHING BETWEEN QC AND PATIENT DATABASES... 9-5 Switching to a QC database from a patient database... 9-5 Switching to a patient database from a QC database... 9-5 CREATING A NEW DATABASE... 9-6 EXPORTING A DATABASE... 9-9 Export formats... 9-9 Exporting a patient or QC database... 9-9 DELETING A DATABASE... 9-13 BACKING UP A DATABASE... 9-14 Backing up database files... 9-14 Scheduling Backups... 9-15 REPAIRING DATABASE CORRUPTION... 9-16 Compacting a Database... 9-16 Merging Databases... 9-17 USING EXPORT FILES... 9-20 Importing into Excel... 9-20 Importing into Access... 9-22

Chapter 10, Managing Patient Records MANAGING PATIENT CASE RECORDS OVERVIEW... 10-2 About managing patient case records... 10-2 ADDING A PATIENT CASE RECORD... 10-3 Adding a patient case record using the Records menu... 10-3 Adding a patient case record using the Case icon... 10-5 ADDING A SAMPLE RECORD... 10-6 DELETING A PATIENT CASE RECORD... 10-8 Deleting a patient case record... 10-8 Deleting a sample record... 10-9 EDITING A PATIENT CASE RECORD... 10-10 Procedure tab... 10-12 Rx tab... 10-13 Blood Products tab... 10-13

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Notes tab... 10-14 Other tab... 10-14 Locking tab... 10-15 Clinicians tab... 10-15 Clusters tab... 10-16 Samples tab... 10-17

Chapter 11, Quality Assurance QUALITY ASSURANCE OVERVIEW... 11-2 LABORATORY TECHNIQUES AND PRECAUTIONS... 11-3 Precautions for blood samples... 11-3 Avoiding clot activation in samples... 11-3 QUALITY CONTROL METHODS... 11-4 Functional checks... 11-4 Operational checks... 11-4 Quality Assurance Reports... 11-5 Use of approved accessories and consumables... 11-5 Quality control schedule... 11-5 QUALITY CONTROL SAMPLES... 11-6 About the quality control samples... 11-6 About the quality control database... 11-7 MANAGING LOT NUMBERS... 11-9 Creating a new lot number... 11-9 Updating a lot number... 11-12 Deleting a lot number... 11-12 Archiving a lot number... 11-13 Restoring a lot number... 11-13 REFERENCE RANGES... 11-15 Local reference ranges... 11-15 Updating the reference ranges in TAS... 11-15 Reference ranges for native samples... 11-16

Chapter 12, Communicating TEG Data COMMUNICATING TEG DATA OVERVIEW... 12-2 USING THE ECONSULT FUNCTION... 12-3 About eConsult... 12-3 eConsult prerequisites... 12-3 Sending patient data using eConsult... 12-3 USING THE CAPTURE FUNCTION... 12-8

Appendix A, Troubleshooting TROUBLESHOOTING... A-2 Login errors... A-3 Database errors... A-7 eTest errors... A-9 Cup and pin errors... A-10

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Quality control (Level I and Level II) sample errors... A-11 Unexpected tracing results... A-14 Blood sample errors... A-16 Temperature errors... A-18 Reference ranges errors... A-19 Remote workstation access errors... A-19 Printing errors... A-20

Appendix B, Specifications and Performance Characteristics SPECIFICATIONS... B-2 Physical Specifications... B-2 Environmental Specifications... B-2 Electrical Specifications... B-3 LIMITATIONS... B-4 Sensitivity factors... B-4 Interference factors... B-5 PERFORMANCE CHARACTERISTICS... B-6 Accuracy... B-6 Precision... B-7 Sensitivity and specificity... B-8 Reference ranges... B-8

Appendix C, Glossary GLOSSARY... C-2

Appendix D, Initial Setup INITIAL SETUP OVERVIEW...D-2 UNPACKING THE ANALYZER...D-3 SETUP AND INSTALLATION...D-4 Positioning the analyzer...D-4 Connecting to the interface box and computer...D-4 Connecting to power...D-5 Disconnecting from power...D-5 Connecting multiple analyzers...D-5 Installing the software...D-6 Conducting maintenance checks...D-6 ACTIVATING THE CHANNELS FOR A NEW ANALYZER...D-7

Index INDEX...I-2

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Chapter 1

Introduction OVERVIEW... 1-2 Purpose of the manual... 1-2 What is the TEG System?... 1-2 Indications for use... 1-3 Intended use... 1-3 TECHNICAL SUPPORT... 1-4 Contacting technical support... 1-4 Returned material authorization (RMA) procedure... 1-4 SYMBOLS... 1-5 Symbols found in this document... 1-5 Symbols found on the analyzer... 1-5

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Introduction

OVERVIEW Purpose of the manual

The TEG® 5000 System User Manual provides users with the information needed to effectively operate the Thrombelastograph® (TEG) System using the 5000 series analyzer and version 4.2 series of the TEG Analytical Software (TAS). The manual includes: z

Detailed descriptions of the analyzer and all components.

z

An overview of the science that supports the analyzer.

z

How to operate the analyzer and troubleshoot any difficulties.

z

How to properly handle and maintain the analyzer.

Use this manual in combination with training supplied by qualified Haemonetics® personnel.

What is the TEG System?

The Thrombelastograph (TEG) analyzer is a non-invasive diagnostic instrument designed to monitor and analyze the coagulation state of a blood sample in order to assist in the assessment of patient clinical hemostasis conditions. The TEG analyzer measures a clot’s properties using a small cup that holds the blood and slowly oscillates. A pin, held by a thin wire, is suspended in the blood. When a clot forms, it links the pin and cup together and the movement of the pin is converted to electrical signals which are monitored by a computer. The TEG system consists of the following parts: z

TEG analyzer: the electro-mechanical instrument.

z

TEG Analytical Software (TAS): the software that processes data generated by the TEG analyzer. TAS is distributed in two versions - TEG-enabled for operators running samples on the analyzer and Remote for clinicians who only view the data.

z

Disposables: the single-use material for running blood samples on the analyzer including cups and pins.

z

Reagents: substances added to the blood sample.

The TEG 5000 system (analyzer and software) is an FDA 510(k) cleared medical device. Note: The TEG model 3000 is no longer supported.

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Indications for use

The TEG analyzer is indicated for use with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations are commonly used to assess clinical conditions such as post-operative hemorrhage and/or thrombosis during and following cardiovascular surgery, organ transplantation, trauma, and cardiology procedures.

Intended use

The TEG analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The TEG analyzer records the kinetic changes in a sample of whole blood, plasma or platelet rich plasma as the sample clots, retracts and/or lyses (breaks apart). Results from the TEG analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a clinical assessment of the patient’s condition and other coagulation laboratory tests.

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Introduction

TECHNICAL SUPPORT Contacting technical support

TEG® System Technical Support is available 24 hours per day, 7 days per week at 1-800-GET-A-TEG® (800-438-2834).

Returned material authorization (RMA) procedure

If, for any reason, merchandise must be returned to the company, the customer should refer to the Haemonetics returned material authorization (RMA) procedure to ensure proper handling and subsequent analysis of the material. Any and all product returns require pre-approval by an authorized Haemonetics technical support representative. First, the customer should contact a Haemonetics representative (refer to “Technical support” on page 1-4) and provide the following information: z

Customer name and Haemonetics customer number

z

Product serial number, list number, lot number (if applicable), and manufacture and/or expiration date

z

Number of articles to be returned

z

Description of issue

z

Number of parcels being shipped

The Haemonetics representative may ask for additional details, depending on the nature of the problem. The customer should be prepared to provide a thorough description of the problem encountered, as well as the product information listed above. If a contaminated disposable must be returned by courier services, the Haemonetics representative may provide specific instructions concerning preparation for shipping blood-contaminated products. In addition to the Haemonetics guidelines, the consumer should strictly follow the local standard operating procedure related to the shipment of blood-contaminated materials and thus minimize any potential health hazards involved. In some cases, it may be necessary to dispose of the contaminated material after reporting the problem to the Haemonetics representative. This should be done according to the locally established guidelines pertaining to the disposal of biologically contaminated material. Warning: Haemonetics products must be properly cleaned and packaged prior to their return. It remains an important responsibility of the customer to reduce potential health hazards by being aware of the risks involved in the shipping, handling and testing of this material.

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SYMBOLS Symbols found in this document

The terms Note, Caution and Warning are used in this manual with the following symbols to emphasize certain details for the operator. Note: provides useful information regarding a procedure or operating technique when using Haemonetics material. Caution: advises the operator against initiating an action or creating a situation which could result in damage to equipment or impair the quality of the blood products; personal injury is unlikely. Warning: advises the operator against initiating an action or creating a situation which could result in serious personal injury to the patient or operator.

Symbols found on the analyzer

The following symbols may appear on the analyzer or its packaging: Electrical and electronic equipment waste (applies to EU only) Dispose of the device using a separate collection method (according to EU and local regulation for waste electrical and electronic equipment). Manufacturer (address for)

Batch code

Authorized representative in the European Community (address for) Catalog number

In vitro diagnostic device <ISO>

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Introduction Contains sufficient for <n > tests

Do not reuse

Temperature limitation

Control

Use by

CE mark

General warning, caution, risk of danger

Warning, biological hazard

Consult instructions for use

TUV certification (Technical Inspection Association)

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Chapter 2

TEG Analyzer Description TEG ANALYZER DESCRIPTION OVERVIEW... 2-2 EXTERIOR FRONT COMPONENTS... 2-3 Carrier... 2-3 Cupwell... 2-3 Carrier ribbon cable... 2-4 Column... 2-4 Lever... 2-4 Power switch... 2-4 Temperature controller... 2-4 Front cover... 2-5 Motor indicator... 2-5 Carrier shafts... 2-5 Platform... 2-5 Leveling feet... 2-5 EXTERIOR BACK COMPONENTS... 2-6 Rear cover... 2-7 Leveling bubble... 2-7 Serial port for the A/D interface box... 2-7 Potentiometer adjustment screw - CAL... 2-7 Potentiometer adjustment screw - BASE... 2-7 Power supply connection... 2-7

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TEG Analyzer Description

TEG ANALYZER DESCRIPTION OVERVIEW This chapter identifies the main components of the TEG® 5000 analyzer and explains their intended functions. The components are located in the following positions on the analyzer: z

Exterior front

z

Exterior back

Note: Any references made to “front” or “back” are from the perspective of an operator facing the TEG analyzer.

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