TEG 6s Service Manual March 2018.pdf
Page 1
Hemostasis System
Service manual
SM-TEG6-03-EN(AD)
March 2018
Page 2
2
Publication Information
Publication Information
Copyright
notice
© 2015–2018 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/
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.
P/N SM-TEG6-03-EN, Manual revision: AD
Haemonetics® TEG® 6s Service Manual
Page 3
Publication Information
3
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, Thrombelastograph, TEG Manager, and 1800-GET-A-TEG 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 Corporation. Citrix is a trademark of Citrix
Systems Inc. Phillips is a trademark of Phillips Screw Company. Allen is a
trademark of Apex Brands Inc. Loctite is a trademark of Henkel IP & Holding
GmbH. Windows is a trademark of Microsoft 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
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
1274 Signy-Centre, Switzerland
Tel.: +41 22 363 9011
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Rx Only
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 Service Manual
P/N SM-TEG6-03-EN, Manual revision: AD
Page 5
Table of
Contents
Chapter 1, Introduction
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Symbols found in this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Symbols found on the analyzer and packaging . . . . . . . . . . . . . . . . . . . 13
Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Electrical safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Bloodborne pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Technical support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Before You Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Install SMS on the field service computer . . . . . . . . . . . . . . . . . . . . . . . . 17
Obtain analyzer firmware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Obtain cartridge library files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Obtain Reliance Nitro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Assemble tools and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Chapter 2, Device Description
Operational and Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operational description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Functional description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Subsystem 1: Enclosure and Chassis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Safety and regulatory considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Subsystem 2: Electronics Monitor and Control . . . . . . . . . . . . . . . . . . . . . . 27
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Subsystem 3: LCD Touchscreen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Haemonetics® TEG® 6s Service Manual
P/N SM-TEG6-03-EN, Manual revision: AD
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Subsystem 4: Cartridge Clamp Assembly . . . . . . . . . . . . . . . . . . . . . . . . . .31
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31
Movement control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32
Alignment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Primary functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34
Subsystem 5: Pneumatics Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35
Regulation of bellows pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37
Subsystem 6: Sample Temperature Control . . . . . . . . . . . . . . . . . . . . . . . . .38
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Primary functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Sound Level Management Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Chapter 3, Principles of Operation
Assay Cartridge Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
Cartridge components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Cartridge operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .43
Cartridge components - valves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
Analyzer Self-Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Power on self-test (POST). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46
Pre-test diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .48
In-use monitoring tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .49
Electronic Calibration (EC) Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Cartridge operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Storage and operating conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50
Service Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Water cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Pulse width modulation cartridge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Regulator adjustment cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51
Chapter 4, Installation and Calibration
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .54
Tools and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .55
Obtain Software from the Download Center. . . . . . . . . . . . . . . . . . . . . . . . .56
Obtain product software and field service tools. . . . . . . . . . . . . . . . . . . .56
Obtain the Master Password Generator . . . . . . . . . . . . . . . . . . . . . . . . .58
P/N SM-TEG6-03-EN, Manual revision: AD
Haemonetics® TEG® 6s Service Manual
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Table of Contents
7
Step 1: Set Up the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Unpack the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Connect the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .60
Log into the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Obtain a master password. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Update the field service password . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
Calibrate the touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .65
Check LAN settings, firmware version, and IP address . . . . . . . . . . . . .66
Step 2: Configure the Analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Start SMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68
Log into the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .69
Connection error message . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .71
Successful login. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Create an administrator account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72
Configure analyzer settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .74
Add analyzer to TEG Manager network . . . . . . . . . . . . . . . . . . . . . . . . .77
Upload cartridge library to analyzer. . . . . . . . . . . . . . . . . . . . . . . . . . . . .79
Set analyzer time zone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .80
Set analyzer date and time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81
Step 3: Calibrate the Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83
On-screen calibration report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .87
Successful calibration report PDF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89
Failed calibration report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90
Step 4: Run a PWM Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .92
Step 5: Run L1 and L2 QC Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95
Chapter 5, Preventive Maintenance
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .98
Tools and Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .99
Preventive Maintenance Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .100
TEG 6s Service Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .106
Chapter 6, Troubleshooting
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
Operating System and Firmware Procedures . . . . . . . . . . . . . . . . . . . . . .150
Analyzer hangs with hourglass indicator . . . . . . . . . . . . . . . . . . . . . . . .150
Upgrade operating system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
Upgrade firmware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .150
Revert to previous firmware. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .152
Instrument software update checklist . . . . . . . . . . . . . . . . . . . . . . . . . .153
Diagnostic Workflows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Check regulators during POST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .155
Run water test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .158
Run diagnostic temperature pre-test . . . . . . . . . . . . . . . . . . . . . . . . . . .159
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Table of Contents
Run diagnostic pressure pre-test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .160
Run individual EC workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .161
Diagnostic Tools . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165
Lock and unlock the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .165
Upload configuration and calibration files . . . . . . . . . . . . . . . . . . . . . . .166
View real-time messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .166
View and save test results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .168
Manipulate mechanical functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . .171
Monitor pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .172
Run pressure pre-test for troubleshooting . . . . . . . . . . . . . . . . . . . . . . .173
Monitor temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .175
Log Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177
Download and view logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .177
Delete logs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .178
Collecting Data for Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .179
SMS backup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .179
Copy data from SD card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .180
Chapter 7, Disassembly and Repair
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .182
Tools and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .183
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184
Top cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .184
Front panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185
Bottom cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .186
Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .186
SD card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .187
LCD touchscreen assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .188
Manifold assembly/solenoid board . . . . . . . . . . . . . . . . . . . . . . . . . . . .189
Datum A assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .190
Cartridge switch assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195
Manifold valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .197
RT controller assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .198
Heater assembly/optical sense board . . . . . . . . . . . . . . . . . . . . . . . . . .198
Optical detector assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .200
Piezo actuator assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
IOE board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .202
Piezo board assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .203
Back panel assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .204
Fan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .205
Pressure and vacuum regulators. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .205
Barcode scanner assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .212
Pressure sense board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213
Fan filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .214
Compressor assembly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .214
Clamp motor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .215
Flange nut . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .216
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Table of Contents
9
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217
Replace fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217
Replace IOE board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217
Add analyzer serial number to IOE board memory . . . . . . . . . . . . . . . .223
Appendix A, Spare Parts
Spare Parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .228
Appendix B, Schematic Diagrams
Pneumatic Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .236
Electronics Communication and Control . . . . . . . . . . . . . . . . . . . . . . . . . .237
Wiring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .238
Appendix C, User Account Roles
User Account Roles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .240
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Chapter 1
Introduction
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Symbols found in this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Symbols found on the analyzer and packaging . . . . . . . . . . . . . . . . . . . 13
Prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Electrical safety precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Bloodborne pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Technical support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Before You Start. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Install SMS on the field service computer . . . . . . . . . . . . . . . . . . . . . . . . 17
Obtain analyzer firmware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Obtain cartridge library files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Obtain Reliance Nitro . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Assemble tools and supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
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Chapter 1, Introduction
Overview
Purpose of the
manual
This manual provides trained technicians with instructions for maintaining and
servicing the TEG® 6s analyzer.
Use this manual in conjunction with the TEG 6s SMS Site Administrator Guide,
the TEG 6s User Manual, and training from qualified Haemonetics personnel.
This manual consists of the following chapters:
Symbols found
in this
document
Chapter 1, "Introduction," on page 11
Describes symbols, general precautions, technical support, and what
you need to know before you start.
Chapter 2, "Device Description," on page 19
Describes and illustrates the subsystems of the analyzer.
Chapter 3, "Principles of Operation," on page 41
Outlines the analyzer’s internal tests and cartridge tests.
Chapter 4, "Installation and Calibration," on page 53:
Details how to set up the analyzer, connect it to a router, log into it from
SMS, create user accounts, configure settings, perform electronic
calibration, and test essential functionality.
Chapter 5, "Preventive Maintenance," on page 97:
Details preventive maintenance procedures.
Chapter 6, "Troubleshooting," on page 109:
Catalogs all service-related error messages and recovery actions;
details the diagnostic and troubleshooting functionality of SMS.
Chapter 7, "Disassembly and Repair," on page 181:
Details how to disassemble the analyzer and its subsystems to repair or
replace components.
Appendix A, "Spare Parts," on page 227:
Provides a spare parts list in assembly outline format.
Appendix B, "Schematic Diagrams," on page 235:
Contains selected schematic diagrams.
Appendix C, "User Account Roles," on page 239:
Describes capabilities of analyzer user account roles.
The following symbols are used in this manual to emphasize certain details for
the operator.
Note: Provides useful information regarding a procedure or operating
technique when using Haemonetics material.
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Chapter 1, Introduction
13
Tip: Provides additional information or an alternate method to perform a task
when using Haemonetics material.
Attention: 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.
Alert: Advises the operator against initiating an action or creating a situation
which could result in serious personal injury to the patient or operator.
Warning: Advises the user of an electric shock risk.
Symbols found
on the analyzer
and packaging
The following symbols may appear on the analyzer, consumables, or
packaging:
Electrical and electronic equipment waste (EU only)
Dispose of the device using a separate collection method
(according to EU and local regulation for waste electrical and
electronic equipment).
Manufacturer
Batch code
Catalog number
In vitro diagnostic device <ISO>
Contains sufficient for <n> tests
<n>
Do not reuse
Storage conditions, temperature level
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Chapter 1, Introduction
Control
Use by <date>
Type of venous blood collection tube to be used for the test.
Color-coded top conforms to ISO 6710:1995
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
UL listed to Canadian and US standards
Fuse
Direct Current
Power ON/OFF
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Chapter 1, Introduction
15
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
Prerequisites
Electrical safety
precautions
The following prerequisites must be met before a technician can perform
preventive maintenance or service procedures on the TEG 6s analyzer:
Has successfully completed service certification on the TEG 6s analyzer
from a Haemonetics® representative.
Is proficient in using the TEG 6s analyzer including reconstituting
controls, and running patient and QC cartridges.
Knows electrostatic discharge (ESD) procedures.
Use the following precautions when servicing a TEG 6s analyzer:
Do not power the device using a power cord other than the one originally
supplied by Haemonetics for the TEG 6s analyzer. Ensure the power
cord is connected to an appropriately grounded power source.
Attention: Grounding reliability can only be achieved when the
equipment is connected to a properly grounded outlet.
Always unplug the power cord from the wall outlet before replacing
components.
Attention: Do not unplug the male single-pin connector end of the
power cord from the analyzer while leaving the cord connected to a live
power source. Electrical shorting and power supply damage may occur.
Bloodborne
pathogens
Before removing the analyzer covers, follow electrostatic discharge
(ESD) practices.
Service technicians should adhere to Standard Precautions when handling or
using this device. This includes wearing protective clothing and gloves when
handling blood samples and QC materials. All parts of the analyzer system
should be considered potentially infectious and are capable of transmitting
blood-borne pathogens between patients and healthcare professionals.
Although the 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.
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Chapter 1, Introduction
Alert: 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.
Technical
support
Many factors affect the performance of blood analyzing instruments, including
the functional integrity of the device, the consistency of disposables used and
the quality of the blood sample.
When the TEG 6s analyzer is properly calibrated and maintained, the
instrument performs reliably and predictably. There may be times, however,
when a component may fail prematurely, or when damage may occur during
transportation or as the result of fluid contamination.
Haemonetics has made an attempt to predict all possible service scenarios in
designing this manual. There will certainly be situations that were not
predicted, and in such cases, TEG System Technical Support can be relied
upon to provide outstanding service support.
TEG System Technical Support is available 24 hours per day, 7 days per week
at 1-800-GET-A-TEG® (800-438-2834) or by e-mail at
ProductSupport@haemonetics.com.
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Chapter 1, Introduction
17
Before You Start
Before starting any service activity on the TEG 6s analyzer, assemble the
necessary software, tools, and supplies as described in this section.
Install SMS on
the field service
computer
To perform service activities on the analyzer, you must install the following
software on the Windows computer you take to customer sites:
Haemonetics Service-Maintenance-Settings (SMS)
Any PDF reader (to view reports generated by SMS)
SMS can be obtained from the Download Center or installed from CD (118721US or 118721-MULTI).
Instructions for installing SMS are in the TEG 6s SMS Site Administrator Guide
(116420-US or 116420-IE).
Note: If you want the SMS and analyzer interfaces to appear in a language
other than English, install the international version. The US version does not
include language setting options.
Note: In this manual, instructions and screen shots relating to language
settings are for the international version of SMS.
Obtain analyzer
firmware
Obtain the most recent version of the analyzer firmware. The firmware zip file
can be obtained from the Download Center. Store the file on the SMS
computer.
Obtain cartridge
library files
Obtain or have access to the most recent version of the cartridge library for the
customer’s region. Cartridge library zip files can be obtained from the
Download Center. Store the file on the SMS computer. The following table lists
the library version and Agile part number for each region. (The library version
appears on the Cartridge Library and Reference Ranges tabs of SMS.)
Note: New analyzers are shipped with a default cartridge library that does not
contain information about patient test cartridges. To run patient tests, you must
upload a region-specific cartridge library to the analyzer.
Note: The Research Use Only cartridge library is not available in the Download
Center.
Cartridge library
version
Part number
Region
1.X
2.X
117175-00
117175-RUO
Default
Research Use Only
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Chapter 1, Introduction
Cartridge library
version
Part number
Region
3.X
4.X
9.X
117175-EU
117175-US
117175-IUO
Outside the US
Inside the US
Investigational Use Only
Obtain Reliance
Nitro
The Datalight Reliance Nitro file system driver enables the SMS computer to
read the analyzer’s SD card. The driver is available as an attachment to
TF9684-00 in Agile. If you have not already done so, install the driver on the
SMS computer.
Assemble tools
and supplies
Have the following tools and supplies available.
3/32 inch Allen® wrench
Phillips® screwdrivers:
8 inch
1 inch “stubby”
Small slotted screwdriver
90 degree angled pick
7 mm Hex Socket
Adjustable wrench
At least one each of the following cartridges:
TEG 6s EC cartridge (ECC-01-000)
TEG 6s Service - H2O cartridge (116120-00)
TEG 6s Service - PWM cartridge (116121-00)
TEG 6s Service - RegAdj cartridge (116230-00)
TEG 6s QC Level 1 cartridge (07-650)
TEG 6s QC Level 2 cartridge (07-651)
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Chapter 2
Device Description
Operational and Functional Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operational description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Functional description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Subsystem 1: Enclosure and Chassis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Safety and regulatory considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Subsystem 2: Electronics Monitor and Control . . . . . . . . . . . . . . . . . . . . . . 27
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Subsystem 3: LCD Touchscreen Display. . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Subsystem 4: Cartridge Clamp Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Movement control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Subsystem 5: Pneumatics Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Regulation of bellows pressure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Subsystem 6: Sample Temperature Control . . . . . . . . . . . . . . . . . . . . . . . . 38
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Primary functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Sound Level Management Strategy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
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Chapter 2, Device Description
Construction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Key component specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
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Chapter 2, Device Description
21
Operational and Functional Description
Operational
description
The TEG® 6s Analyzer System is made up of an electro-mechanical instrument
(analyzer) and a disposable assay cartridge. These integrated components
perform the clotting analysis.
The analyzer monitors the harmonic motion of a pendant drop of blood in
response to controlled vibration. As the blood sample transitions from a liquid
state to a gel-like state during clotting, the modulus of elasticity and resonant
frequency increases. The analyzer measures variations in the resonant
frequency during clotting and lysis. A piezo actuator is used to excite the blood
samples to resonant vibration. Optical sensors then monitor the frequency of
peak sample excitation.
The assay cartridges have an intake port for blood samples and can be
delivered by transfer pipette or syringe. Under instrument control, the cartridge
pulls this 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. Any excess blood is moved to a sealed waste area within the disposable.
As the analyzer processes the blood sample in the cartridge, the results are
reported on the touchscreen display.
Figure 1, Operational block diagram
Note: For detailed information on the use of the TEG 6s analyzer, refer to the
Haemonetics® TEG 6s User Manual.
Functional
description
The TEG 6s analyzer operates through an interface to a test cartridge with
microfluidic pathways, various functional features and dried down chemical
reagents. There are several cartridge configurations to perform different and
unique hemostasis assays. The instrument is configured with several hardware
sub systems to effect the necessary microfluidic manipulations to prepare a
human blood sample for vibrational testing. Further, the instrument is equipped
for highly controlled resonance-frequency analysis that provides critical patient
blood hemostasis parameters more effectively than currently known and
accepted technology.
Figure 2 provides a visual overview of the primary, secondary, and tertiary
functions of the TEG 6s system. It also illustrates how the analyzer design is
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Chapter 2, Device Description
functionally distributed among a number of subsystems. Each subsystem
represents a functional unit with mechanical, electrical and software
components. These subsystems and their components and supported
functionality are described next.
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Page 23
Chapter 2, Device Description
23
Figure 2, Functional analysis summary diagram
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Chapter 2, Device Description
Subsystem 1: Enclosure and Chassis
Overview
The enclosure is constructed of several molded plastic parts that are attached
together with screws and a metal back panel. The base plate and sheet metal
inside the enclosure form the chassis structure to mount internal components.
The instrument touchscreen display fills a large space on the front panel.
Figure 3, Enclosure and chassis
Construction
The enclosure is constructed of several molded plastic parts that are attached
together with screws. These parts are painted in specific locations with
conductive paint to shield against electromagnetic radiation emanating from
within the instrument in aid of EMC compliance. The sheet metal inside the
enclosure forms the chassis structure to mount internal components. These
parts are passivated with a conductive RoHS compliant chromate treatment to
keep mating parts grounded. The front molding has a light pipe that provides
visual cues to the operator of the machine.
Figure 4, Enclosure - exploded view
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Chapter 2, Device Description
25
Figure 5, Chassis structure
Alignment
The only requirement for alignment of the covers is to provide a proper visual
interface between the mating parts with ease of assembly. This is
accomplished with slot/tabs, pull-in gaps between mating parts, and
gap-limiting hard stops molded into the components.
Primary
functions
The primary functions of the Enclosure and Chassis Subsystem are as follows:
Key component
specifications
House the instrument
Protect users from moving parts and high voltage
Provide interface to power supplies and data cables
Provide interface for the user to insert the cartridge
Support user I/O via the LCD touchscreen display
Support the internal components (chassis)
The following table outlines the specifications for the key components of the
Enclosure and Chassis Subsystem.
Component
Specification
Rear molding, base molding, and
front molding
Injection molded PC-ABS (SABIC
INNOVATIVE PLASTICS)
Cycoloy C6600, UL File number
E1215162
Properties: rigid hard plastic meeting UL
requirements UL94 V-1
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Safety and
regulatory
considerations
Chapter 2, Device Description
Component
Specification
Light pipe
Injection molded optical diffusion PC
(SABIC INNOVATIVE PLASTICS)
HF1140, UL File number E1215162
The enclosure prevents the operator from accessing a number of hazards
contained within the instrument:
High voltage (less than 120VDC) piezo drive circuit
Fireproof according to UL 61010-1
Moderate force (~200N clamp mechanism)
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Chapter 2, Device Description
27
Subsystem 2: Electronics Monitor and Control
Overview
The electronics consist of several printed wiring boards distributed in the
instrument. Sensors for the clamp and the cartridge, eight heater
temperatures, as well as 6 pressure sensors are monitored and fed back into
the software system. The electrical system controls the stepper motor for
clamp actuation, eight solenoid valves that control microfluidics in the
cartridge, and the dual diaphragm pump which generates the pressure and
vacuum. The electronics system also provides the power, I/O LCD interface,
barcode scanner interface and illumination, Light pipe control as well as driving
the piezo actuator. Sensors on the optical sense board detect the vibrational
characteristics of the blood in the cartridge.
Figure 6, Electronics monitor and control
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