User Manual
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© 2015–2017, 2019 Haemonetics Corporation The contents of this manual are the property of 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. This product contains mbedTLS, which is licensed under the Apache License, Version 2.0 (the "License"). You may not use that file except in compliance with the License. You may obtain a copy of the License at: http://www.apache.org/licenses/LICENSE-2.0 Unless required by applicable law or agreed to in writing, software distributed under the License is distributed on an "AS IS" BASIS, WITHOUT WARRANTIES OR CONDITIONS OF ANY KIND, either express or implied. See the License for the specific language governing permissions and limitations under the License.
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, including use of materials or products not provided or recommended by Haemonetics, 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.
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Haemonetics® TEG® 6s User Manual
Publication Information
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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 laboratories that are primary providers to such hospitals.
Document updates
The document is furnished for information use only, is subject to change without notice and should not be construed as a commitment by Haemonetics Corporation. Haemonetics Corporation assumes no responsibility or liability for any errors or inaccuracies that may appear in the informational content contained in this material. For the purpose of clarity, Haemonetics Corporation considers only the most recent version of this document to be valid.
Trademarks and patents
Haemonetics, TEG, RapidTEG, Thrombelastograph, TEG Manager and 1-800-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 & Company. US patent numbers 7,261,861, 7,879,615, 8,236,568, 6,787,363, 7,179,652, 7,732,213, and 9,068,966.
Reader comments
Any comments or suggestions regarding this publication are welcomed and should be forwarded to the attention of: Corporate headquarters Haemonetics Corporation 400 Wood Road Braintree, MA 02184 U.S.A. Tel.: +1 781 848 7100 Fax: +1 781 848 5106
Rx Only
International headquarters Haemonetics S.A. Signy Centre Rue des Fléchères 6 P.O. Box 262 1274 Signy-Centre, Switzerland Tel.: +41 22 363 9011 Fax: +41 22 363 9054
Caution: USA Federal Law restricts the sale, distribution, or use of this device to, by, or on the order of a licensed healthcare practitioner. Note: Availability of devices may vary from one country or region to another as a result of specific local regulatory approval or clearance requirements. Applicable laws may restrict the sale, distribution, or use of this device to, by, or on the order of a licensed healthcare practitioner.
Haemonetics® TEG® 6s User Manual
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Haemonetics worldwide
Publication Information
Please direct any written inquiries to the appropriate address. For a list of worldwide office locations and contact information, visit www.haemonetics.com/officelocations
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Haemonetics® TEG® 6s User Manual
Table of Contents Chapter 1, Introduction Overview... 10 Purpose of the manual... 10 What is the TEG 6s System?... 10 Intended use... 11 Essential performance... 12 Precautions... 12 Cybersecurity... 13 Customer Service... 14 Clinical training... 14 Repair service... 14 Preventive maintenance... 14 Product return guidelines... 14 Symbols... 15 Symbols found in this document... 15 Symbols found on the analyzer and packaging... 15
Chapter 2, TEG® Analyzer Description TEG Analyzer Description Overview... 20 Exterior Front Components... 21 LCD touch screen... 21 Cartridge slot... 21 Exterior Back Components... 22 Carrying handle... 22 Cooling fan... 22 USB ports... 22 Ethernet port... 23 Fuse holder... 23 Fuse... 23 Power jack... 23 On/Off Switch... 23 Disposable Assay Cartridges... 24 Sample port... 24 Barcode... 24
Chapter 3, Safety and Precautions Storage and Handling... 26 Storing and handling the analyzer... 26 Storing and handling the cartridges... 27 Transporting the analyzer... 27
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Table of Contents
Warnings for the Operator...28 Electrical shock hazards...28 Power outlet connection...28 Bloodborne pathogens...28 Handling of glass objects...29
Chapter 4, Getting Started Overview...32 TEG Analyzer Design...33 Principles of design...33 TEG Analyzer Parameters...34 TEG Analyzer Tests...35 Setting Up and Logging into the Analyzer...36 Set up the analyzer...36 Start the analyzer...37 Log into the analyzer...37 Update your password...38 Log out of the analyzer...39 Turn off the analyzer...39 Exploring the Touchscreen...40 Home screen...40 Icons...41 Viewing Test Results...42 Test results screen...42 Tracing screens...43 Configuring Settings...45 Configure date and time settings...45 Change the time zone...46 Configure LAN settings...48 Calibrate the touchscreen...50 View information about the analyzer...50
Chapter 5, Operating the TEG® Analyzer Operation Overview...54 Disposable assay cartridges...54 Blood samples...54 Running a Patient Test...56 Quick guide for running a patient test...56 Detailed guide for running a patient test...56 Stopping a Test...64 Viewing Stored Patient Data...66 Quick guide for viewing stored patient data...66 Detailed guide for viewing stored patient data...66
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Chapter 6, Quality Control Overview...70 IQCP...70 Analyzer Quality Control (internal QC)...70 Reagent Quality Control (external QC)...71 Performing Citrated Reagent QC...72 Citrated controls...72 General procedure: run QC in a patient assay cartridge...72 Run normal blood in a Citrated Multichannel or Citrated: K, RT, FF assay cartridge...76 Run Abnormal QC in a Citrated Multichannel cartridge...77 Run Abnormal QC and Lysis QC in a Citrated: K, RT, FF cartridge...78 Performing PlateletMapping® Reagent QC...80 PlateletMapping controls...80 Run a QC blood sample in a PlateletMapping cartridge...80 Viewing Stored QC Data...82 Quick guide for viewing stored QC data...82 Detailed guide for viewing stored QC data...82
Chapter 7, Troubleshooting and Maintenance Errors and Alerts...86 Error messages...86 Warning messages...87 Critical alert messages...87 Error message table...88 Cleaning and Disinfecting the Analyzer...94 Materials needed...94 Clean the analyzer...94 Clean the filter...95
Chapter 8, Specifications and Performance Characteristics Specifications...98 Physical specifications...98 Environmental specifications...98 Electrical specifications...98 Printer specification...99 Analytical Measurement Ranges...99 Performance Characteristics...101 FCC Compliance...101 Warranty...101
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Table of Contents
Appendix A, IEC/EN 60601-1-2 Standard Requirements Operation Precautions...104 Power supply...104 Electro-magnetic immunity...104 Electromagnetic Compatibility...105
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Haemonetics® TEG® 6s User Manual
Chapter 1
Introduction Overview...10 Purpose of the manual...10 What is the TEG 6s System?...10 Intended use... 11 Essential performance...12 Precautions...12 Cybersecurity...13 Customer Service...14 Clinical training...14 Repair service...14 Preventive maintenance...14 Product return guidelines...14 Symbols...15 Symbols found in this document...15 Symbols found on the analyzer and packaging...15
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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 Hemostasis Analyzer
Disposable assay cartridges with preloaded dried reagents
Service-Maintenance-Settings (SMS) software interface
TEG Manager ® software interface
The TEG 6s 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-US, Manual revision: AE
Haemonetics® TEG® 6s User Manual
Chapter 1, Introduction
Intended use
11 The TEG® 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer, TEG 6s PlateletMapping Assay Cartridge, TEG 6s Citrated Multichannel Cartridge, and TEG 6s Citrated: K, RT, FF Assay Cartridge. The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide qualitative assessment of platelet function and semi-quantitative indications of the hemostasis state of a venous blood sample. The TEG 6s Hemostasis System records the kinetic changes in a sample of heparinized or 3.2% citrated whole blood as the sample clots. The PlateletMapping Assay Cartridge provides four channels of dried-in-place reagents, HKH (Kaolin with Heparinase), Activator F, AA, and ADP (one reagent in each channel). In combination, MA parameter results from these four reagents are used to calculate the parameters platelet % Inhibition and % Aggregation for AA and ADP. A PlateletMapping ADP Assay Cartridge is available without the AA reagent. The Citrated Multichannel Cartridge contains four independent assays (CK, CRT, CKH and CFF) and the system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The Citrated: K, RT, FF Assay Cartridge contains three independent assays (CK, CRT and CFF) and the system output consists of a table of numerical values for parameters R, LY30, and MA. The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. Clotting characteristics are described by the functional parameters R (clotting time) and LY30 (fibrinolysis after 30 minutes of reaching maximum clot strength). The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. Clotting characteristics are described by the functional parameter MA (maximum clot strength). The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing clotting times (R) between the two tests. The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s Hemostasis System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameter MA (maximum clot strength). Results from the TEG 6s analysis 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, further hemostasis tests. The indication for TEG 6s Hemostasis System use is with adult patients (18 years and older) where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the TEG 6s Hemostasis System using the PlateletMapping Assay Cartridge and Citrated Multichannel Cartridge is used
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Chapter 1, Introduction to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions. Hemostasis evaluation with the TEG 6s Hemostasis System using the Citrated: K, RT, FF Assay Cartridge is used to assess clinical conditions in a trauma setting to assess hemorrhage or thrombosis conditions. For professional use only.
Essential performance
The TEG 6s Hemostasis System has the following characteristics identified as essential performance: 1. The device shall accurately measure changes in a blood sample during clotting and lysis. 2. The device shall indicate test results that are out of range. 3. The device shall display an error message and prevent completion of a test if any electromechanical or pneumatic function of the analyzercartridge combination is not operating satisfactorily.
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.
Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.
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 materials 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.
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Haemonetics® TEG® 6s User Manual
Chapter 1, Introduction
Cybersecurity
13 Haemonetics recommends the following cybersecurity controls for the TEG 6s Hemostasis System:
The SMS software and TEG 6s analyzer should be installed behind a firewall and physically secured per your organization’s security guidelines.
User accounts should not be shared, and passwords should be kept confidential.
No Personally Identifiable Information (PII) or Protected Health information (PHI) should be entered in the analyzer’s Test Information field, as this field is not encrypted when stored locally.
TLS (Transport Layer Security) V1.2 should be enabled on the TEG Manager server.
SMS should be connected to the analyzer only on a secure Local Area Network (LAN).
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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, TEG System Technical Support should be contacted to provide specific instruction. 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].
Preventive maintenance
General maintenance procedures should be performed as required. For instructions, refer to “Cleaning and Disinfecting the Analyzer” on page 7-94. 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 TEG System Technical Support 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.
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Chapter 1, Introduction
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Symbols Symbols found in this document
The following symbols are used in this manual to emphasize certain details for the user. Note: Provides useful information regarding a procedure or operating technique. Tip: Provides additional information or an alternate method to perform a task. Attention: Advises the user 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 user against initiating an action or creating a situation which could result in serious personal injury to the patient or user. Warning: Notifies 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>
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Chapter 1, Introduction Do not reuse
Storage conditions, temperature level
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
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Haemonetics® TEG® 6s User Manual
Chapter 1, Introduction
17 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
MR Unsafe Keep away from magnetic resonance imaging (MRI) equipment.
Haemonetics® TEG® 6s User Manual
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Chapter 2
TEG® Analyzer Description TEG Analyzer Description Overview...20 Exterior Front Components...21 LCD touch screen...21 Cartridge slot...21 Exterior Back Components...22 Carrying handle...22 Cooling fan...22 USB ports...22 Ethernet port...23 Fuse holder...23 Fuse...23 Power jack...23 On/Off Switch...23 Disposable Assay Cartridges...24 Sample port...24 Barcode...24
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Chapter 2, TEG® Analyzer Description
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TEG Analyzer Description Overview This chapter identifies the following main components of the TEG® 6s analyzer system and explains their intended functions.
Exterior front components
Exterior back components
Disposable assay cartridges
Note: Any references made to “front” or “back” are from the perspective of an operator facing the TEG analyzer. The TEG 6s system consists of an analyzer and disposable assay cartridges. The analyzer contains a user-friendly interface in the form of a color touchenabled display. Through this interface, the operator can control all operations of the analyzer except turning it on and off, which is accomplished by accessing a switch at the rear of the analyzer. The system is designed to accept a disposable plastic cartridge, into which a blood sample can be placed. Once a test is started, the analyzer processes the sample and reports the results on the touchscreen display.
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Haemonetics® TEG® 6s User Manual
Chapter 2, TEG® Analyzer Description
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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.
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Chapter 2, TEG® Analyzer Description
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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. These ports can be used to attach an approved peripheral device, such as a printer or barcode scanner, to the analyzer.
P/N 115191-US, Manual revision: AE
Haemonetics® TEG® 6s User Manual