Haemonetics TEG 6s User manual

User manual
HAEMONETICS S.A.
Signy Centre
Rue des Fléchères 6
1274 Signy-Centre
Switzerland

2Publication Information
P/N 115191-IE, Manual revision: AB Haemonetics® TEG®6s User Manual
Publication Information
Publication date June 2015
Part number 115191-IE(AB)
Copyright
notice © 2015 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.
Handlinganduseof 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.

Publication Information 3
Haemonetics® TEG®6s User Manual P/N 115191-IE, Manual revision: AB
Thescreenshotsappearinginthismanualareprovidedforillustrativepurposes
only, and may differ from the actual software screens. All organization, donor/
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.HaemoneticsCorporation assumes no responsibilityorliability 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.
Trademarksand
patents Haemonetics, TEG, RapidTEG, and Thrombelastograph are trademarks or
registered trademarks of Haemonetics Corporation in the United States and/or
other countries. PlateletMappingis a registered trademark of Cora Healthcare,
Inc. Vacutainer is a registered trademark of Becton, Dickinson and Company
Corporation.
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 International headquarters
Haemonetics Corporation Haemonetics S.A.
400 Wood Road Signy-Centre
Braintree, MA 02184 6, Rue des Fléchères
U.S.A. P.O. Box 262
Tel.: [phone] Signy-Avenex
Fax: [phone] Switzerland
Tel.: [phone]
RxOnly Caution: USA Federal Law restricts 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: AB
Table of
Contents
Chapter 1, Introduction
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
What is the TEG 6s system?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
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

6Table of Contents
P/N 115191-IE, Manual revision: AB Haemonetics® TEG®6s User Manual
Power outlet connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Bloodborne pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
Handling of glass objects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27
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
Start the analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Log into the analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
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
Chapter 5, Operating the TEG®Analyzer
Operation Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Disposable assay cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Blood samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Running a Patient Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Quick guide for running a patient test . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Detailed guide for running a patient test . . . . . . . . . . . . . . . . . . . . . . . . .55
Stopping a Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Viewing Stored Patient Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Quick guide for viewing stored patient data. . . . . . . . . . . . . . . . . . . . . . .65
Detailed guide for viewing stored patient data. . . . . . . . . . . . . . . . . . . . .65
Chapter 6, Quality Control
Performing Quality Control Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Quick guide for running a QC test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .70
Detailed guide for running a QC test. . . . . . . . . . . . . . . . . . . . . . . . . . . .71

Table of Contents 7
Haemonetics® TEG®6s User Manual P/N 115191-IE, Manual revision: AB
Viewing Stored QC Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77
Quick guide for viewing stored QC data . . . . . . . . . . . . . . . . . . . . . . . . .77
Detailed guide for viewing stored QC data . . . . . . . . . . . . . . . . . . . . . . .77
Chapter 7, Troubleshooting and Maintenance
Errors and Alerts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Error messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .82
Warning messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Critical alert messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
Error message table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84
Cleaning and Disinfecting the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
Materials needed. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
Clean the analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91
Clean the filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
Chapter 8, Specifications and Performance Characteristics
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Physical specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Environmental specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Electrical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88
Printer specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
FCC Compliance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90

Haemonetics® TEG®6s User Manual P/N 115191-IE, Manual revision: AB
Chapter 1
Introduction
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
What is the TEG 6s system?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
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

10 Chapter 1, Introduction
P/N 115191-IE, Manual revision: AB Haemonetics® TEG®6s User Manual
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.
Usethis manualincombinationwith trainingsuppliedby qualified Haemonetics
personnel.
What is the TEG
6s system? The TEG Thrombelastograph Coagulation 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
agel-likestateduringclotting,the modulusofelasticityand 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 or syringe 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-Maintenance-
Settings (SMS) software provides the interface for an administrator or qualified
service technician to change configuration settings, update, backup, and
restore software and data files, and manage analyzer calibration parameters.
For more information about the SMS software, consult the TEG 6s Site
Administrator Guide.
Intended use The TEG®6s Hemostasis Analyzer is a non-invasive diagnostic instrument
designed to monitor and analyze the coagulation state of a blood sample in