TEG 6s User Manual Rev AD Oct 2016

Page 1

Hemostasis System

User manual

115191-IE(AD)

October 2016

Page 2

2

Publication Information

Publication Information

Publication date

October 2016

Part number

115191-IE(AD)

Copyright

notice

© 2015, 2016 Haemonetics Corporation

The contents of this manual are the property of the Haemonetics Corporation.

Any information or descriptions contained in this manual may not be

reproduced and released to any of the general public, or used in conjunction

with any professional instructions without written consent of Haemonetics

Corporation, USA.

Confidential/

proprietary

notices

Use of any portion(s) of this document to copy, translate, disassemble or

decompile, or create or attempt to create by reverse engineering (or otherwise)

the source code from the object code of Haemonetics products is expressly

prohibited.

Disclaimer

This manual is intended as a guide to provide the user with necessary

instructions on the proper use and maintenance of certain Haemonetics

Corporation products. 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 user 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 user to handle and

dispose of blood-contaminated material. Users must fully understand and

implement all regulations governing the safe handling of blood products and

waste, including the policies and procedures of their facility.

Handling and use of any blood products collected or stored using Haemonetics

equipment are subject to the decisions of the attending physician or other

qualified medical personnel. Haemonetics makes no warranty with respect to

such blood products.

Patient diagnosis is the sole responsibility of the attending physician or other

qualified medical personnel.

The screenshots appearing in this manual are provided for illustrative purposes

only, and may differ from the actual software screens. All organization, donor/

P/N 115191-IE, Manual revision: AD

Haemonetics® TEG® 6s User Manual

Page 3

Publication Information

3

patient, and user names in this manual are fictitious. Any similarity to the name

of an organization or person is unintentional.

The TEG 6s analyzer is licensed for sale or use only in in-patient hospitals and

any laboratories that are primary providers of such hospitals.

Document

updates

The document is furnished for information use only, is subject to change

without notice and should not be construed as a commitment by Haemonetics

Corporation. Haemonetics Corporation assumes no responsibility or liability for

any errors or inaccuracies that may appear in the informational content

contained in this material. For the purpose of clarity, Haemonetics Corporation

considers only the most recent version of this document to be valid.

Trademarks and

patents

Haemonetics, TEG, RapidTEG, and Thrombelastograph are trademarks or

registered trademarks of Haemonetics Corporation in the US, other countries,

or both. PlateletMapping is a registered trademark of Cora Healthcare, Inc.

Vacutainer is a registered trademark of Becton, Dickinson and Company.

US patent numbers 7,261,861, 7,879,615, 8,236,568, 6,787,363, 7,179,652,

and 9,068,966.

Reader

comments

Any comments or suggestions regarding this publication are welcomed and

should be forwarded to the attention of:

Corporate headquarters

Haemonetics Corporation

400 Wood Road

Braintree, MA 02184

U.S.A.

Tel.: +1 781 848 7100

Fax: +1 781 848 5106

Rx Only

International headquarters

Haemonetics S.A.

Signy Centre

Rue des Fléchères 6

P.O. Box 262

1274 Signy-Centre, Switzerland

Tel.: +41 22 363 9011

Fax: +41 22 363 9054

Caution: USA Federal Law restricts the sale, distribution, or use of this device

to, by, or on the order of a licensed healthcare practitioner.

Note: Availability of devices may vary from one country or region to another as

a result of specific local regulatory approval or clearance requirements.

Applicable laws may restrict the sale, distribution, or use of this device to, by,

or on the order of a licensed healthcare practitioner.

Haemonetics

worldwide

Please direct any written inquiries to the appropriate address. For a list of

worldwide office locations and contact information, visit

www.haemonetics.com/officelocations

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AD

Page 5

Table of

Contents

Chapter 1, Introduction

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

What is the TEG 6s system?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Customer Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Repair service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Product return guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Symbols found in this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Symbols found on the analyzer and packaging . . . . . . . . . . . . . . . . . . . 13

Chapter 2, TEG® Analyzer Description

TEG Analyzer Description Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Exterior Front Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

LCD touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Cartridge slot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Exterior Back Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Carrying handle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Cooling fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

USB ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Ethernet port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Fuse holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Power jack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

On/Off Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Disposable Assay Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Sample port. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Barcode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Chapter 3, Safety and Precautions

Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Storing and handling the analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Storing and handling the cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Transporting the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Warnings for the Operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Haemonetics® TEG® 6s User Manual

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Table of Contents

7

Viewing Stored QC Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .75

Quick guide for viewing stored QC data . . . . . . . . . . . . . . . . . . . . . . . . .75

Detailed guide for viewing stored QC data . . . . . . . . . . . . . . . . . . . . . . .75

Chapter 7, Troubleshooting and Maintenance

Errors and Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

Error messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80

Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

Critical alert messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81

Error message table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82

Cleaning and Disinfecting the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

Materials needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

Clean the analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89

Clean the filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

Chapter 8, Specifications and Performance Characteristics

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

Physical specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

Environmental specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

Electrical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92

Printer specification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93

Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

FCC Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .94

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AD

Page 9

Chapter 1

Introduction

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

What is the TEG 6s system? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Customer Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Repair service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Preventive maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Product return guidelines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Symbols found in this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Symbols found on the analyzer and packaging. . . . . . . . . . . . . . . . . . . .13

Haemonetics® TEG® 6s User Manual

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10

Chapter 1, Introduction

Overview

Purpose of the

manual

The TEG® 6s User Manual provides users with the information needed to

effectively operate the TEG® Thrombelastograph® hemostasis analyzer using

the 6s series analyzer. This manual includes:



A detailed description of the analyzer.



Instructions for operating the analyzer and troubleshooting any difficulties.



Information on how to properly handle and maintain the analyzer.



Specifications and performance capabilities.

Use this manual in combination with training supplied by qualified Haemonetics

personnel.

What is the TEG

6s system?

The TEG Thrombelastograph hemostasis analyzer TEG 6s Series system

consists of the following components:



TEG 6s analyzer



Disposable cartridges with preloaded dried reagents



Service-Maintenance-Settings (SMS) software interface

The TEG analyzer monitors the harmonic motion of a pendant drop of blood in

response to external vibration. As the sample transitions from a liquid state to

a gel-like state during clotting, the modulus of elasticity and resonant frequency

increase. The analyzer measures these variations in resonant frequency

during clotting and lysis and displays the results on a touchscreen display.

Disposable cartridges are used for processing whole blood samples. Blood is

delivered by transfer pipette to a small port in the cartridge. Once a sample has

been added to the cartridge and testing has begun, the sample is inaccessible

to the user. The cartridges contain all necessary reagents for performing an

assay.

The TEG analyzer has two modes of operation: (1) Stand-alone, and (2)

computer-controlled through the network interface. Service-MaintenanceSettings (SMS) software provides the interface for an administrator or qualified

service technician to change configuration settings, update, backup, and

restore firmware and data files, and manage analyzer calibration parameters.

For more information about the SMS software, consult the TEG 6s Site

Administrator Guide.

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Haemonetics® TEG® 6s User Manual

Page 11

Chapter 1, Introduction

Intended use

11

The TEG® 6s Hemostasis Analyzer is a non-invasive diagnostic instrument

designed to be used in a laboratory or point of care environment 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 6s analyzer is

indicated for use with adult patients where an evaluation of blood coagulation

properties is desired.

Results from the TEG 6s analyzer should not be the sole basis for a patient

diagnosis, but should be evaluated together with the patient’s medical history,

the clinical picture and, if necessary, other coagulation tests.

Precautions

The operator should be aware of the following precautions:



Read and understand the entire contents of this manual before operating

the TEG analyzer - especially precautionary information and

specifications.



The TEG analyzer is to be operated by qualified personnel only.



If this equipment is used in a manner inconsistent with this manual,

protections provided by the device may be impaired.



Use only Haemonetics parts and accessories with the TEG analyzer.

Third-party accessories may cause improper performance.



DO NOT use malfunctioning equipment. Have the unit repaired by an

authorized Haemonetics service representative.



DO NOT place anything other than human blood, plasma or Quality

Control (QC) material into a cartridge.



Upon removal from the TEG analyzer, used cartridges must be

immediately disposed of according to local standard operating

procedures for the removal of biohazardous material and should not be

mixed with non-biohazardous waste.

Haemonetics® TEG® 6s User Manual

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Page 12

12

Chapter 1, Introduction

Customer Service

Clinical training

The local Haemonetics representative will provide staff training upon delivery

of the TEG system equipment and should be contacted to organize further

instruction, if needed.

Repair service

Haemonetics maintains a worldwide network of company-trained service

representatives responsible for responding to technical needs concerning

equipment. If service beyond the routine maintenance and cleaning described

in this manual is required, the local Haemonetics representative should be

contacted to provide specific instruction.

Preventive

maintenance

General maintenance procedures should be performed as required. For

instructions, refer to “Cleaning and Disinfecting the Analyzer” on page 7-89.

Preventive maintenance procedures should be conducted annually to ensure

optimal mechanical functioning of the analyzer and are performed by a trained

Haemonetics representative.

Product return

guidelines

If, for any reason, merchandise must be returned to the company, the customer

should contact the local Haemonetics representative to arrange for repairs or

returns using procedures to ensure proper handling and subsequent analysis.

No returns will be accepted without advanced authorization.

Units returned to Haemonetics for repair are subject to biohazard charges if

any component is contaminated with blood or blood products.

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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Haemonetics® TEG® 6s User Manual

Page 13

Chapter 1, Introduction

13

Symbols

Symbols found

in this

document

The terms Note, Tip, 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.

Tip: provides additional information or an alternate method to perform a task

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 test

results; 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

and packaging

The following symbols may appear on the analyzer, consumables, or

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>

Contains sufficient for <n> tests

<n>

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14

Chapter 1, Introduction

Do not reuse

Temperature limitation

Control

Use by <date>

Type of venous blood collection tube to be used for the test.

Color-coded top conforms to ISO 6710:1995.

CE mark

General warning, caution, risk of danger

Biological risks

Consult instructions for use

(Applies to USA only)

USA Federal Law restricts the sale, distribution or use of this

device to, by or on the order of a physician.

USB (Universal Serial Bus) port

Ethernet port

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Haemonetics® TEG® 6s User Manual

Page 15

Chapter 1, Introduction

15

UL listed to Canadian and US standards

Fuse

Direct Current

Power ON/OFF

Indicates a push-push switch, where one position (marked with

a line) is on and the other position (marked with a circle) is off.

Serial number

Do not use if package is damaged

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AD

Page 17

Chapter 2

TEG® Analyzer Description

TEG Analyzer Description Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Exterior Front Components. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

LCD touch screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Cartridge slot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Exterior Back Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Carrying handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Cooling fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

USB ports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Ethernet port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Fuse holder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Fuse. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Power jack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

On/Off Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Disposable Assay Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Sample port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Haemonetics® TEG® 6s User Manual

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Page 18

Chapter 2, TEG® Analyzer Description

18

TEG Analyzer Description Overview

This chapter identifies the following main components of the TEG® 6s analyzer

system and explains their intended functions.



Exterior front components



Exterior back components



Disposable assay cartridges

Note: Any references made to “front” or “back” are from the perspective of an

operator facing the TEG analyzer.

The TEG 6s system consists of an analyzer and disposable assay cartridges.

The analyzer contains a user-friendly interface in the form of a color touchenabled display. Through this interface, the operator can control all operations

of the analyzer except turning it on and off, which is accomplished by accessing

a switch at the rear of the analyzer. The system is designed to accept a

disposable plastic cartridge, into which a blood sample can be placed. Once a

test is started, the analyzer processes the sample and reports the results on

the touchscreen display.

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Haemonetics® TEG® 6s User Manual

Page 19

Chapter 2, TEG® Analyzer Description

19

Exterior Front Components

1. LCD touch screen

2. Cartridge slot

1

2

Figure 1, TEG analyzer, exterior front components

LCD touch

screen

The 6.5" color LCD touchscreen displays instructions that guide the user

through TEG analyzer operations. All prompts, directions, selections, and

results are displayed on this screen.

Cartridge slot

The cartridge slot at the front of the analyzer accepts TEG analyzer assay

cartridges. During a test, the cartridge is locked in place. When the test is

complete, a lighted strip flashes around the perimeter of the cartridge slot.

Haemonetics® TEG® 6s User Manual

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Page 20

Chapter 2, TEG® Analyzer Description

20

Exterior Back Components

1.

2.

3.

4.

5.

6.

7.

Carrying handle

Cooling fan with filter

USB ports

Ethernet port

Fuse

Power jack

On/off switch

1

2

7

3

6

4

5

Figure 2, TEG analyzer, exterior back view

Carrying handle

The integrated carrying handle is located near the top of the analyzer and

allows the unit to be lifted and moved securely.

Cooling fan

The fan on the back of the analyzer ensures that the internal temperature of the

analyzer remains close to the ambient temperature. This allows the widest

possible range of sample temperatures to be selected without requiring active

cooling in the analyzer.

USB ports

Three Standard Type A USB ports are located to the left of the cooling fan and

can be used to attach a peripheral device, such as a printer or barcode

scanner, to the analyzer.

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Page 21

Chapter 2, TEG® Analyzer Description

Ethernet port

21

The analyzer may be connected via Ethernet cable to a stand-alone computer

or Ethernet switch or router for service, maintenance and setup. LED lights on

either side of the port have the following functions:

Left LED - Link Speed

Right LED - Link Activity



Amber: operating in 1000 BT mode



Blinking green: activity



Green: operating in 100 BT mode



Off: no link established



Off: operating in 10 BT mode

Fuse holder

The fuse holder is a cylindrical housing that protects and holds the fuse.

Fuse

The 250 Volt 5 Amp fuse is located inside the fuse holder on the back of the

analyzer.

Power jack

The power jack is located at the back of the analyzer and is the screw-on

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 (100 - 240 volt 50/60

Hz) per your institution’s policy. Use an Uninterruptible Power Supply (UPS)

unit between the analyzer and the power source.

Grounding reliability can be achieved only when the analyzer is connected to a

properly grounded outlet.

On/Off Switch

The power switch is located at the back of the analyzer. "I" indicates "on" and

"O" indicates "off".

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AD

Page 22

Chapter 2, TEG® Analyzer Description

22

Disposable Assay Cartridges

TEG analyzer disposable assay cartridges contain the components needed to

perform up to four simultaneous tests from the same blood sample.

Cartridges should be kept in their sealed pouches and in the specified storage

conditions (2-8 deg C) until just before use. Cartridges can be used directly

from the refrigerator; they do not need to reach room temperature before use.

1. Barcode

2. Sample port

1

2

Figure 3, TEG analyzer disposable assay cartridge

Sample port

A sample port at one end of the cartridge accepts an unmetered amount of

blood, delivered by transfer pipette.

Under instrument control, the cartridge pulls the blood sample into up to four

staging areas, mixes the sample with reagents that have been dried in place,

and then transfers a small amount into the test cells. Excess blood is moved to

a sealed waste area within the disposable.

Barcode

The barcode on the cartridge allows the analyzer to identify the cartridge type,

test type, expiration date, and lot number.

Cartridge Library

In addition to the barcode on the cartridge, the analyzer system also uses a

Cartridge Library file to determine the type of test the cartridge is intended to

perform. The Cartridge Library holds information that the analyzer needs to run

the appropriate scripts and display the correct parameters for each test.

Haemonetics periodically provides updates to the Cartridge Library which can

be downloaded to your system.

P/N 115191-IE, Manual revision: AD

Haemonetics® TEG® 6s User Manual

Page 23

Chapter 3

Safety and Precautions

Storage and Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Storing and handling the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Storing and handling the cartridges. . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Transporting the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Warnings for the Operator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Electrical shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Power outlet connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Bloodborne pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Handling of glass objects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

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Page 24

24

Chapter 3, Safety and Precautions

Storage and Handling

Safe and successful operation depends in part on the proper routine handling

of the TEG® 6s analyzer, disposables, and blood samples. The operator should

be aware of the problems that could result if these items are stored, installed,

or used incorrectly.

Storing and

handling the

analyzer

Unpacking the TEG analyzer

The TEG analyzer is packaged to reduce the risk of damage during shipment.

Remove all polystyrene inserts and carefully remove the TEG analyzer from

the box. The power adapter and cables are packaged separately.

Note: Save the shipping box and molded polystyrene inserts. If the TEG

analyzer needs to be returned for repair or preventive maintenance, it must be

shipped in its original packaging in order to avoid damage. Haemonetics will

charge for any repairs necessary due to improper packaging.

Placement of the TEG analyzer

Use the following guidelines to correctly place the TEG analyzer:



Place the TEG analyzer on a flat surface such as a table or lab bench.



Proper operation of the analyzer requires adequate airflow through the

cooling fan at the rear of the device. Ensure that the fan is not obstructed

by proximity to a wall or other equipment.



Isolate the analyzer from all sources of heat (for example, laptops,

heaters, or other heat-emitting equipment).



Make sure that the device is positioned so that it is easy to access the

power button and to disconnect the power cord.

Storage and handling of the TEG analyzer

The TEG analyzer must be operated at room temperature (10°- 32°C).

Although the device can be stored at a temperature between -20°C and +50°C,

it must be brought to operating temperature before use. The TEG analyzer is

designed for indoor use only.

The operator should wear protective gloves when handling the TEG analyzer.

Caution: If the TEG analyzer has been stored at a temperature outside the

operating temperature range, allow sufficient time for the analyzer to

equilibrate to room temperature before use.

Note: See “Specifications” on page 92 for a complete list of environmental

conditions in which to store and operate the TEG analyzer.

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Haemonetics® TEG® 6s User Manual

Page 25

Chapter 3, Safety and Precautions

25

Storing and

handling the

cartridges

The storage and handling of the TEG analyzer assay cartridges and quality

controls may differ depending on the type of reagent or control contained within

them. Refer to each product insert for storage and handling instructions.

Transporting

the analyzer

Before transporting the TEG analyzer from one location to another, ensure that

all plugs, cords, and cartridges are removed from the device. The analyzer

must also be cleaned and disinfected prior to moving the analyzer to a new

location, or for return shipment if servicing is necessary.

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Page 26

26

Chapter 3, Safety and Precautions

Warnings for the Operator

Electrical shock

hazards

The TEG analyzer operates at a low-rated voltage. The risk of electrical shock

is, therefore, minimal. However, the operator should never remove the

analyzer’s covers. Maintenance that requires the removal of these covers

remains the responsibility of a Haemonetics-trained technician.

Power outlet

connection

Do not power the device using a power supply other than the one originally

supplied by Haemonetics for the TEG analyzer. Always ensure that the power

cord is connected to an appropriately grounded power source per your

institution’s policy.

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

connected to a properly grounded outlet.

Caution: Do not unplug the male single-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.

Bloodborne

pathogens

Users should adhere to Standard Precautions when handling or using this

device. All parts of the TEG analyzer system should be considered potentially

infectious and are capable of transmitting blood-borne pathogens between

patients and healthcare professionals. Although the TEG analyzer does not

present a significant biohazard risk in itself, the unit is used to analyze human

blood, so care must be taken to properly handle, clean, and disinfect the

equipment as appropriate.

Warning: Special cleaning needs, such as a blood spill, should be dealt

with promptly. Follow local standard operating procedure for blood

precautions when cleaning up a blood spill or dealing with blood

contaminated components. Dispose of all cleaning materials as

biohazardous waste.

At a minimum, use the following precautions when handling blood and

disposing of blood-contaminated material:



While operating the TEG analyzer, wear powder-free protective gloves

and wash hands immediately after removing the gloves.



Switch gloves between patients and after completion of testing.



Wear fluid-resistant clothing.

P/N 115191-IE, Manual revision: AD

Haemonetics® TEG® 6s User Manual

Page 27

Chapter 3, Safety and Precautions

27

Proper handling of blood contaminated material

Even though the only working surfaces that routinely come into contact with

blood are the internal surfaces of the disposable assay cartridge, any TEG

analyzer surface that could be contaminated by a blood spill should be properly

cleaned and decontaminated with an appropriate disinfectant (see “Cleaning

and Disinfecting the Analyzer” on page 89). This should only need to be done

as required by laboratory protocol and immediately after any blood spill.

Precautions must be taken to eliminate or reduce the hazards involved with

removing the TEG analyzer from its point of use, transporting it from one place

to another, or disposing of the analyzer. If any blood-contaminated material

must be returned to Haemonetics for further inspection, see “Product return

guidelines” on page 12 for instructions.

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. Units

returned to Haemonetics for repair are subject to biohazard charges if

any component is contaminated with blood or blood products.

Proper disposal of biologically contaminated materials

Any disposable material used during a procedure is considered to be

biologically contaminated and biohazardous. It must be disposed of according

to local standard operating procedures for the removal of such material and

should not be mixed with non-biohazardous waste.

Handling of

glass objects

Glass objects such as blood collection tubes and Quality Control (QC) vials

should be handled with care.

Warning: In case of glass breakage, watch for sharp edges.

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AD

Page 29

Chapter 4

Getting Started

Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

TEG Analyzer Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

Principles of design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

TEG Analyzer Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

TEG Analyzer Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Setting Up and Logging into the Analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . .34

Set up the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

Update your password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

Log out of the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Turn off the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37

Exploring the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

Home screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38

Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39

Viewing Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

Test results screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41

Tracing screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42

Configuring Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Configure date and time settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44

Change the time zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45

Configure LAN settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .47

Calibrate the touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

View information about the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . .49

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AD