TEG 5000 User Manual Rev AC Dec 2010

Page 1

TEG® 5000 System

- User Manual -

Haemonetics Corporation

Haemoscope Division

6231 W Howard St, Niles, IL 60714, USA

P/N 06-510-US, Manual revision: AC

December 2010

Page 2

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 info@haemoscope.com

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.

TEG® 5000 System User Manual

P/N 06-510-US, Manual revision: AC

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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

P/N 06-510-US, Manual revision: AC

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

TEG® 5000 System User Manual

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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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Chapter 3, Safety and Precautions

STORAGE AND HANDLING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Storing and handling the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Storing and handling the disposables . . . . . . . . . . . . . . . . . . . . . . . . . . .

Storing and handling the reagents and controls. . . . . . . . . . . . . . . . . . . .

Transporting the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

WARNINGS FOR THE OPERATOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Electrical Shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Power outlet connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Bloodborne pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3-2

3-2

3-2

3-2

3-2

3-3

3-3

3-3

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Daily operation tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ADJUSTING THE TEMPERATURE SET POINT . . . . . . . . . . . . . . . . . . . . . . .

Setting column 1 setpoint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Setting column 2 setpoint . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CONDUCTING DAILY MAINTENANCE CHECKS . . . . . . . . . . . . . . . . . . . .

Leveling the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Checking the carrier ribbon cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Performing an eTest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

TEG® 5000 System User Manual

7-2

7-2

7-3

7-4

7-4

7-5

7-6

7-6

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

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VIEWING AND ENTERING SAMPLE DETAILS. . . . . . . . . . . . . . . . . . . . . .

Viewing details on the Detail screen. . . . . . . . . . . . . . . . . . . . . . . . . . .

Entering details on the Tracing tab . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Entering details on the Sample tab . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Entering details on the Notes tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

USING THE NOTES FEATURE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adding or viewing SNotes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adding or viewing Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8-50

8-50

8-53

8-56

8-58

8-59

8-59

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Locking tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clinicians tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Clusters tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Samples tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10-14

10-14

10-15

10-15

10-16

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 . . . . . . . . . . . . . . . . . . . . . .

USING THE ECONSULT FUNCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . .

About eConsult . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

eConsult prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sending patient data using eConsult . . . . . . . . . . . . . . . . . . . . . . . . . . .

USING THE CAPTURE FUNCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12-2

12-3

12-3

12-3

12-3

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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Introduction

1-3

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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Introduction

1-5

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

TEG® 5000 System User Manual

P/N 06-510-US, Manual revision: AC

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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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EXTERIOR FRONT COMPONENTS

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

8

Carrier (x2

Cupwell (x2)

Carrier ribbon cable (x2)

Column

Lever in Load position

Power switch

Temperature controller

Front cover

Motor indicator

Lever in Test position

Carrier shafts (x4)

Platform

Front leveling foot (x2)

9

7

6

5

10

4

11

3

2

1

12

13

Figure 2-1, TEG® analyzer, exterior front components

Carrier

The two carriers hold the blood samples and are raised and lowered on the

carrier shafts. When the analyzer is in operation, each carrier slowly oscillates

through an angle of approximately 5 degrees. When a blood sample is run, the

carrier is manually raised until the top surface of the carrier is flush with the

bottom of the column.

Cupwell

The cylindrical cupwell in each carrier holds a disposable cup that contains a

blood sample. Each cupwell contains a heating element that controls the

temperature of the blood sample. The temperature of the cupwells is determined

by the set point entered in the temperature controller.

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TEG Analyzer Description

A spring-loaded disk (or “pusher”) at the bottom of each cupwell allows the

disposable cup to be ejected from the cupwell when the carrier is lowered to the

bottom of the carrier shafts and pushed against the bottom platform. When the

carrier is in the fully raised position, the pusher is also used to seat the pin onto

the skewer tip.

Carrier ribbon

cable

The two carrier ribbon cables run from the analyzer to the back of each carrier

and communicate the temperature set point to the heating element in each

cupwell.

Column

The two columns each contain a skewer, the tip of which holds a disposable pin.

The skewer, held by a thin wire, suspends the pin in the blood in the disposable

cup. The movement of the pin in the oscillating cup is converted by a sensor into

graphic and metric output on a computer.

Note: The thin wire that suspends the skewer is very fragile. Make sure that you

protect the skewer tip, especially when the lever on the column is in Test

position.

Lever

The lever on each column can be moved into three positions–Load, Test, and

Eject.

z

Load: When a test is not being run, the lever must remain in the Load

position. This secures and protects the skewer during the loading of the

pin.

z

Test: When a disposable cup and pin are in place and the carrier is fully

raised, the lever is moved to the Test position to start a test. In the Test

position, the pin on the skewer tip is suspended freely in the cup.

z

Eject: After a test is finished, the lever is returned to the Load position and

then pressed downward in order to eject the pin from the tip of the skewer.

Power switch

The green push-button power switch allows the analyzer to be turned on and off

and is illuminated when it is in the on position. When the power is on, all

functions of the analyzer are enabled.

Temperature

controller

The temperature controller provides a digital readout of the set point temperature

that the analyzer maintains for each channel/column in degrees Celsius. The

temperature set point for each cupwell is indicated on the controller and is

illuminated in red for channel 1 and green for channel 2. The default set point for

the analyzer is 37°C but can be adjusted upward or downward for each channel

using the buttons on the temperature controller.

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Front cover

The plastic front cover protects the analyzer’s interior components and should be

removed only by a qualified service technician.

Motor indicator

The yellow motor indicator, when illuminated, indicates that the motor is

engaged.

Carrier shafts

The carrier shafts support the carriers and allow them to be raised and lowered.

The tops of the carrier shafts connect to the motor which controls the oscillation

of the carriers.

Platform

The platform is designed to catch spills and can be removed for cleaning. The two

depressions in the platform provide a surface for the pusher on the bottom of the

carriers to engage, releasing the cup from the cupwell.

Leveling feet

The three leveling feet allow the operator to adjust the front, sides and back of

the analyzer to ensure that it is level. The black, grooved ring located above each

foot can be turned in either direction to bring the analyzer level.

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TEG Analyzer Description

EXTERIOR BACK COMPONENTS

1.

2.

3.

4.

Back leveling foot

Rear cover

Leveling bubble

Serial port for A/D

interface box

5. Potentiometer adjustment

screw - labeled CAL (x2)

6. Potentiometer adjustment

screw - labeled BASE (x2)

7. Power supply connection

3

2

1

Figure 2-2, TEG® analyzer, exterior back view

5

6

7

4

Figure 2-3, Detail, exterior back

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Rear cover

The plastic rear cover protects the analyzer’s interior components and should be

removed only by a qualified technician.

Leveling bubble

The leveling bubble is a clear, bull’s eye level located on the top of the analyzer

which provides the operator with a visual confirmation that the analyzer is level.

The analyzer is leveled by adjusting the front and back leveling legs until the

bubble is centered within the two concentric circles printed on the glass.

Note: Leveling the analyzer is a daily maintenance requirement.

Serial port for the

A/D interface

box

The serial port is located at the back of the analyzer and is the connection point

for the DB-9 cable that attaches the Analog/Digital (A/D) interface box to the

analyzer.

Potentiometer

adjustment screw

- CAL

The two potentiometer adjustment screws, labeled CAL, are located at the back

of the analyzer, on either side of the serial port. The CAL potentiometer screws

are used to calibrate the analyzer and must be adjusted only by a qualified

service technician.

Caution: Adjustment of the CAL potentiometer screws must be performed only

by a qualified service technician with the correct calibration tools. Improper

adjustment can cause incorrect parameter values to be written to the computer.

Potentiometer

adjustment screw

- BASE

The two potentiometer adjustment screws, labeled BASE, are located at the back

of the analyzer, on either side of the serial port. Each screw is used to adjust the

eTest base values for the column that it is closest to. The screws are adjusted

using a trimmer adjustment tool provided by Haemonetics®.

Power supply

connection

The power supply connection is located at the back of the analyzer and is the

connection point for the power cord that is supplied by Haemonetics. Do not

replace the cord with a substitute. If necessary, contact the local Haemonetics

representative for a replacement. Always ensure that the power cord is

connected to an appropriately grounded power source per your institution’s

policy. Use an Uninterruptible Power Supply (UPS) unit between the analyzer

and the power source.

Caution: Grounding reliability can be achieved only when the analyzer is

connected to a properly grounded outlet.

Caution: Do not unplug the male 4-pin connector end of the power cord from

the analyzer while leaving the power cord connected to a live power source.

Electrical shorting and power supply damage may occur.

TEG® 5000 System User Manual

P/N 06-510-US, Manual revision: AC