Service Manual
241 Pages
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Hemostasis System
Service manual
SM-TEG6-03-EN(AD) March 2018
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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.
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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.
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Publication Information
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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 Fax: +41 22 363 9054
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
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
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Table of Contents
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
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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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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
Haemonetics® TEG® 6s Service Manual
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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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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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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 [email protected].
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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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Haemonetics® TEG® 6s Service Manual
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
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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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