TEG 6s User Manual Rev AF April 2018

Publication Information

3

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.

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, TEG Manager, 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

Haemonetics® TEG® 6s User Manual

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

P/N 115191-IE, Manual revision: AF

4

Rx Only

Publication Information

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

P/N 115191-IE, Manual revision: AF

Haemonetics® TEG® 6s User Manual

Table of Contents Publication Information... 2 Publication date... 2 Part number... 2 Copyright notice... 2 Confidential/proprietary notices... 2 Disclaimer... 2 Document updates... 3 Trademarks and patents... 3 Reader comments... 3 ... Rx Only4 Haemonetics worldwide... 4

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

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AF

6

Table of Contents

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 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...52 Disposable assay cartridges...52 Blood samples...52 Running a Patient Test...54

P/N 115191-IE, Manual revision: AF

Haemonetics® TEG® 6s User Manual

Table of Contents

7

Quick guide for running a patient test...54 Detailed guide for running a patient test...54 Stopping a Test...62 Viewing Stored Patient Data...64 Quick guide for viewing stored patient data...64 Detailed guide for viewing stored patient data...64

Chapter 6, Quality Control Performing Quality Control Tests...68 Quick guide for running a QC test...68 Detailed guide for running a QC test...69 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...90 Materials needed...90 Clean the analyzer...90 Clean the filter...91

Chapter 8, Specifications and Performance Characteristics Specifications...94 Physical specifications...94 Environmental specifications...94 Electrical specifications...94 Printer specification...95 Performance Characteristics...96 FCC Compliance...96 Warranty...96

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AF

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

P/N 115191-IE, Manual revision: AF

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® 6s hemostasis 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 6s hemostasis system consists of the following components: 

TEG 6s analyzer



Disposable cartridges with preloaded dried reagents



Service-Maintenance-Settings (SMS) software interface



TEG Manager ® 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. TEG Manager is an accessory application that provides remote viewing of TEG analyzer test results and administration of all connected analyzers. TEG Manager interfaces with analyzers to obtain clinical data and retrieves patient information from an external Hospital Information System (HIS). For more information about TEG Manager, consult the TEG Manager User and Site Administrator Guide. P/N 115191-IE, Manual revision: AF

Haemonetics® TEG® 6s User Manual

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

P/N 115191-IE, Manual revision: AF

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 7-90. 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. Alert: 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.

P/N 115191-IE, Manual revision: AF

Haemonetics® TEG® 6s User Manual

Chapter 1, Introduction

13

Symbols Symbols found in this document

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. 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.

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> Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AF

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

P/N 115191-IE, Manual revision: AF

Haemonetics® TEG® 6s User Manual

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: AF

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

P/N 115191-IE, Manual revision: AF

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.

P/N 115191-IE, Manual revision: AF

Haemonetics® TEG® 6s User Manual

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

P/N 115191-IE, Manual revision: AF

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.

P/N 115191-IE, Manual revision: AF

Haemonetics® TEG® 6s User Manual

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. Attention: 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: AF

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: AF

Haemonetics® TEG® 6s User Manual

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

Haemonetics® TEG® 6s User Manual

P/N 115191-IE, Manual revision: AF