TEG® 5000 System - User Manual - Haemonetics Corporation Haemoscope Division 6231 W Howard St, Niles, IL 60714, USA P/N 06-510-US, Manual revision: AD December 2011 Printed in USA © 1999, 2010, 2011 Haemonetics Corporation. All rights reserved. iii CONSUMER INFORMATION Proprietary rights The contents of this manual are the property of Haemonetics Corporation. Haemonetics®, Haemoscope™, TEG®, RapidTEG™, and Thrombelastograph® are trademarks or registered trademarks of Haemonetics Corporation in the United States and/or other countries. PlateletMapping® is a registered trademark of CoraMed Technologies. Any information or descriptions contained in this manual may not be reproduced, released to the general public, or used in conjunction with any professional instruction without written consent of Haemonetics Corporation, Haemoscope Division, USA. Please direct any written inquiries to the appropriate address. 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 Signy Centre, Switzerland Tel.: +41 22 363 9011 Fax: +41 22 363 9054 Haemonetics Corporation Haemoscope Division 6231 W Howard St Niles IL 60714 USA Tel. +1 847 588-0453 Fax +1 847 588-0455 Web www.haemonetics.com E-mail info@haemoscope.com Disclaimer This manual is intended as a guide to provide the operator with necessary instructions on the proper use and maintenance of the TEG analyzer. 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 operator 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 operator to handle and dispose of blood-contaminated material. An operator must fully understand and implement all regulations governing the safe handling of blood products and waste, including the policies and procedures of their facility. USA Federal Law restricts the sale, distribution or use of this device to, by or on the order of a physician. Patient diagnosis is the sole responsibility of the attending physician or other qualified medical personnel. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD iv Haemonetics worldwide Haemonetics Austria Handelsges.m.b.H. Mariahilfer Strasse 123 3rd Floor 1060 Wien, Austria Tel.: 0800 29 2777 Fax: 0800 29 2820 Haemonetics Belgium-NV Braine-L’Alleud Parc de L’Alliance 9 Boulevard de France, bât A 1420 Braine L’Alleud Belgium Tel.: (FR): 0800 754 80 Fax: 0800 75512 Tel. (NL): 0800 754 82 Fax: 0800 755 12 Haemonetics BV Claudius Prinsenhof Verlengde Poolseweg 34-46 4818 CL Breda The Netherlands Tel.: 0800 0222 707 Fax: 0800 0223 066 Haemonetics CZ, spol. s.r.o. Ptašínského 8 60200 Brno, Czech Republic Tel.: 800 143 243 Fax: 800 143 250 Haemonetics France SARL 46 bis, rue Pierre Curie Z.I. Les Gâtines 78370, Plaisir, France Tel.: 0800 90 11 58 Fax: 0800 91 48 76 Haemonetics GmbH Wolfratshauser Straße 84 81379 Munich, Germany Tel.: 0800 180 8890 Fax: 0800 182 8064 P/N 06-510-US, Manual revision: AD Haemonetics (Hong Kong) Ltd. Rooms 2202, 22/F Harbour Centre, 25 Harbour Road Wanchai, Hong Kong Tel.: +852 2868 9218 Fax: +852 2801 4380 Haemonetics Hospitaler LTDA Avenida Bernardino de Campos, 98 Sobreloja, Paraisio, CEP 04004-040 City of São Paulo State of São Paulo, Brazil India Representative Office Haemonetics (Hong Kong) Ltd. JMD Regent Square Regus - Level 6 Mehrauli Gurgaon Road Gurgaon - 122 001 Haryana (Delhi-NCR) India Tel.: +91 124 471 1819 Fax: +91 981 027 3237 Haemonetics Italia SA Via Senigalia 18/2 - Torre A Milan 20161 Italy Tel.: 800 870 200 Fax: 800 870 375 Haemonetics Japan GK Kyodo Building, 16 Ichiban-cho, Chiyoda-ku Tokyo 102-0082, Japan Tel.: +81 3 3237 7260 Fax: +81 3 3237 7330 Haemonetics Korea, Ltd. 30th Floor ASEM Tower 159-1 Samsung-dong, Kangnam-ku Seoul 135-798, Korea Tel.: +82 2 6001 3280 Fax: +82 2 6001 3281 TEG® 5000 System User Manual v Haemonetics Medical Devices (Shanghai) International Trading Company Room 1103-06 Evergo Mansion No. 1325 Middle Huaihai Road 200031 Shanghai, China Tel.: +86 21 3406 0700 Fax: +86 21 5466 8852 Haemonetics Scandinavia AB Ideon 223 70 Lund, Sweden Tel.: 020 797 150 Fax.: 020 794 670 Haemonetics Asia Incorporated Taiwan Branch 26F-1, No. 102, Roosevelt Road Sec. 2 Taipei, Taiwan Tel.: +886 2 2369 0722 Fax: +886 2 2364 3698 TEG® 5000 System User Manual United Kingdom Sales Office Haemonetics Ltd. Suite 1/Building 5 5 Hercules Way Leavesden Park Watford WD25 7GS United Kingdom Tel.: 0808 234 4817 Fax: 0808 234 4845 Lebanon Representative Office Haemonetics SA c/o The Regus Group Azarieh Bldg., Block 3, 5th floor Regus, Beirut, Lebanon PO Box 11-503 Russia Representative Office Haemonetics SA Smolenskaya Passage Smolenskaya Square 3 121099 Moscow Russia Tel.: +7 495 937 8239 P/N 06-510-US, Manual revision: AD Table of Contents Chapter 1, Introduction OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What is the TEG System? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CUSTOMER SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Repair service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Product return guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Symbols found in this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Symbols found on the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 1-2 1-2 1-3 1-3 1-4 1-4 1-4 1-4 1-5 1-5 1-5 Chapter 2, TEG Analyzer Description TEG ANALYZER DESCRIPTION OVERVIEW. . . . . . . . . . . . . . . . . . . . . . . . EXTERIOR FRONT COMPONENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cupwell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carrier ribbon cable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Column . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lever . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Temperature controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Front cover. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Motor indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Carrier shafts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Leveling feet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . EXTERIOR BACK COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rear cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Leveling bubble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Serial port for the A/D interface box . . . . . . . . . . . . . . . . . . . . . . . . . . . . Potentiometer adjustment screw - CAL . . . . . . . . . . . . . . . . . . . . . . . . . . Potentiometer adjustment screw - BASE . . . . . . . . . . . . . . . . . . . . . . . . . Power supply connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEG® 5000 System User Manual 2-2 2-3 2-3 2-3 2-4 2-4 2-4 2-4 2-4 2-5 2-5 2-5 2-5 2-5 2-6 2-7 2-7 2-7 2-7 2-7 2-7 P/N 06-510-US, Manual revision: AD viii Chapter 3, Safety and Precautions STORAGE AND HANDLING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Storing and handling the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Storing and handling the disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . Storing and handling the reagents and controls. . . . . . . . . . . . . . . . . . . . Transporting the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WARNINGS FOR THE OPERATOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical Shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Power outlet connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Bloodborne pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 3-2 3-2 3-2 3-2 3-3 3-3 3-3 3-3 Chapter 4, TEG Analyzer Technology Overview TEG ANALYZER TECHNOLOGY OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . 4-2 Principles of design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 TEG ANALYZER PARAMETERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Primary clot formation and lysis parameters . . . . . . . . . . . . . . . . . . . . . . 4-4 Secondary clot formation parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Secondary clot lysis parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Secondary clot kinetic, strength, and stability parameters . . . . . . . . . . . . 4-9 Velocity parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10 Interrelationship of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11 TEG SAMPLE TYPES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 TEG sample types overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 TEG sample type descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14 Chapter 5, TEG Analytical Software (TAS) Overview TEG ANALYTICAL SOFTWARE (TAS) OVERVIEW . . . . . . . . . . . . . . . . . . . . 5-2 About the Enabled and Remote versions. . . . . . . . . . . . . . . . . . . . . . . . . 5-2 TAS features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 LOGGING IN TO TAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Timing out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7 UNDERSTANDING THE TAS MAIN SCREEN . . . . . . . . . . . . . . . . . . . . . . . 5-8 TEG parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8 Identifying Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 Data tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Selecting a sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Status bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12 UNDERSTANDING THE TOOLBAR ICONS . . . . . . . . . . . . . . . . . . . . . . . 5-13 UNDERSTANDING THE TEG SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 Accessing the TEG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17 Channel colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 Selecting an active channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 UNDERSTANDING THE MENU OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . 5-19 P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual ix Chapter 6, Configuring User Profiles CONFIGURING USER PROFILES OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . 6-2 About user profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Accessing the User profile setup screen . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 TESTS TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Accessing the Tests tab features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Adding a new test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Renaming a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Moving a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 Including tests in the TAS display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 NORMAL VALUES TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 Accessing the Normal Values tab features. . . . . . . . . . . . . . . . . . . . . . . . 6-8 Viewing reference range values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Adding test values to a sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Changing reference range values for a test . . . . . . . . . . . . . . . . . . . . . . 6-10 SAMPLE TYPES TAB. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 Accessing the Sample Types tab features . . . . . . . . . . . . . . . . . . . . . . . 6-11 Adding a sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12 Moving a sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Including sample types in the TAS display . . . . . . . . . . . . . . . . . . . . . . 6-13 SOFTWARE TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15 Setting software options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15 VIDEO TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20 Accessing the Video tab features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20 Changing a color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21 Changing a line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22 Resetting video preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23 LOGIN TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24 Setting login defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24 ECONSULT TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25 Accessing the eConsult tab features . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25 Setting up your e-mail account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26 Defining e-mail server settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27 Defining an eConsult recipient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27 Removing an eConsult recipient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28 Chapter 7, Operating the TEG Analyzer OPERATION OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Daily operation tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ADJUSTING THE TEMPERATURE SET POINTS . . . . . . . . . . . . . . . . . . . . . . Setting column 1 set point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting column 2 set point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONDUCTING DAILY MAINTENANCE CHECKS . . . . . . . . . . . . . . . . . . . . Leveling the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Checking the carrier ribbon cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEG® 5000 System User Manual 7-2 7-2 7-3 7-4 7-4 7-5 7-6 7-6 P/N 06-510-US, Manual revision: AD x Checking the temperature controller display . . . . . . . . . . . . . . . . . . . . . 7-6 Performing an eTest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Running quality control samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 LOADING AND EJECTING CUPS AND PINS . . . . . . . . . . . . . . . . . . . . . . 7-14 Loading the cups and pins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14 Ejecting the cups and pins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16 COLLECTING AND PREPARING BLOOD SAMPLES . . . . . . . . . . . . . . . . . 7-17 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17 Before you begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18 Collecting a non-citrated blood sample . . . . . . . . . . . . . . . . . . . . . . . . 7-18 Collecting a citrated blood sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19 Collecting a heparin blood sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 Preparing TEG blood samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 RUNNING SAMPLES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26 Before you begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26 Starting samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26 Terminating samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27 CLEANING THE TEG ANALYZER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28 Materials needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28 Cleaning the analyzer surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28 Cleaning the lower column and skewer . . . . . . . . . . . . . . . . . . . . . . . . 7-28 Chapter 8, Viewing and Annotating TEG Analyzer Data TEG ANALYZER DATA OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 VIEWING TRACINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Viewing parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Tracing lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Maximizing a tracing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Displaying data for a tracing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6 Displaying multiple tracings (comparing samples) . . . . . . . . . . . . . . . . . 8-7 Navigating between multiple tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 Printing a single tracing using Quick Print . . . . . . . . . . . . . . . . . . . . . . 8-10 Using reference tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10 Using normal tracings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12 When no tracing appears . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13 Viewing PlateletMapping® tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13 Viewing Functional Fibrinogen tracings . . . . . . . . . . . . . . . . . . . . . . . . 8-16 Viewing RapidTEG™ tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17 USING FILTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19 Using Quick filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20 Using the Advanced filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21 USING THE GUIDE FEATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-30 Using the Show Me option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-30 Manually selecting a tracing in Guide . . . . . . . . . . . . . . . . . . . . . . . . . 8-32 Using the coagulopathy library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-33 P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual xi GENERATING AND PRINTING REPORTS. . . . . . . . . . . . . . . . . . . . . . . . . Generating patient reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Generating quality assurance reports . . . . . . . . . . . . . . . . . . . . . . . . . . Generating the operator report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIEWING AND ENTERING SAMPLE DETAILS. . . . . . . . . . . . . . . . . . . . . . Viewing details on the Detail screen. . . . . . . . . . . . . . . . . . . . . . . . . . . Entering details on the Tracing tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . Entering details on the Sample tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . Entering details on the Notes tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . USING THE NOTES FEATURE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adding or viewing SNotes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adding or viewing Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-37 8-37 8-45 8-49 8-50 8-50 8-53 8-56 8-58 8-59 8-59 8-60 Chapter 9, Managing Databases MANAGING DATABASES OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 About the TEG system databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 OPENING A DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3 CHANGING A QC DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4 SWITCHING BETWEEN QC AND PATIENT DATABASES . . . . . . . . . . . . . . 9-5 Switching to a QC database from a patient database . . . . . . . . . . . . . . . 9-5 Switching to a patient database from a QC database . . . . . . . . . . . . . . . 9-5 CREATING A NEW DATABASE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6 EXPORTING A DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 Export formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 Exporting a patient or QC database . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 DELETING A DATABASE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13 BACKING UP A DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14 Backing up database files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14 Scheduling Backups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15 REPAIRING DATABASE CORRUPTION . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16 Compacting a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16 Merging Databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17 USING EXPORT FILES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Importing into Excel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Importing into Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21 Chapter 10, Managing Patient Records MANAGING PATIENT CASE RECORDS OVERVIEW . . . . . . . . . . . . . . . . . About managing patient case records . . . . . . . . . . . . . . . . . . . . . . . . . . ADDING A PATIENT CASE RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . Adding a patient case record using the Records menu . . . . . . . . . . . . . Adding a patient case record using the Case icon . . . . . . . . . . . . . . . . . ADDING A SAMPLE RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DELETING A PATIENT CASE RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . Deleting a patient case record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Deleting a sample record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . TEG® 5000 System User Manual 10-2 10-2 10-3 10-3 10-5 10-6 10-8 10-8 10-9 P/N 06-510-US, Manual revision: AD xii EDITING A PATIENT CASE RECORD. . . . . . . . . . . . . . . . . . . . . . . . . . . . Procedure tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rx tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Products tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Notes tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Other tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Locking tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinicians tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clusters tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Samples tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10 10-12 10-13 10-13 10-14 10-14 10-15 10-15 10-16 10-17 Chapter 11, Quality Assurance QUALITY ASSURANCE OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2 LABORATORY TECHNIQUES AND PRECAUTIONS . . . . . . . . . . . . . . . . . 11-3 Precautions for blood samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 Avoiding clot activation in samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 QUALITY CONTROL METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Functional checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Operational checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Quality Assurance Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5 Use of approved accessories and consumables. . . . . . . . . . . . . . . . . . . 11-5 Quality control schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5 QUALITY CONTROL SAMPLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6 About the quality control samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6 Establishing quality control ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8 About the quality control database . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8 MANAGING LOT NUMBERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9 Creating a new lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9 Updating a lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12 Deleting a lot number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12 Archiving a lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13 Restoring a lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13 REFERENCE RANGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15 Local reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15 Updating reference ranges in TAS. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15 Reference ranges for native samples . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16 Establishing reference ranges for quality controls . . . . . . . . . . . . . . . . 11-17 Chapter 12, Communicating TEG Data COMMUNICATING TEG DATA OVERVIEW . . . . . . . . . . . . . . . . . . . . . . USING THE ECONSULT FUNCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . About eConsult . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . eConsult prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sending patient data using eConsult . . . . . . . . . . . . . . . . . . . . . . . . . . . USING THE CAPTURE FUNCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . P/N 06-510-US, Manual revision: AD 12-2 12-3 12-3 12-3 12-3 12-8 TEG® 5000 System User Manual xiii Appendix A, Troubleshooting TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 Login errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Database errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 eTest errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 Cup and pin errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11 Quality control (Level I and Level II) sample errors . . . . . . . . . . . . . . . . A-12 Unexpected tracing results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-16 Blood sample errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-19 Temperature errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20 Reference ranges errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21 Remote workstation access errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-22 Printing errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23 Accessing Help errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-26 Appendix B, Specifications and Performance Characteristics SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 LIMITATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 Sensitivity factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 Interference factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 PERFORMANCE CHARACTERISTICS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6 Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6 Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7 Sensitivity and specificity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8 Reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8 Appendix C, Glossary GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2 Appendix D, Initial Setup INITIAL SETUP OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-2 UNPACKING THE ANALYZER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3 SETUP AND INSTALLATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4 Positioning the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4 Connecting to the interface box and computer . . . . . . . . . . . . . . . . . . . .D-4 Connecting to power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5 Disconnecting from power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5 Connecting multiple analyzers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5 Installing the software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6 Conducting maintenance checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6 ACTIVATING THE CHANNELS FOR A NEW ANALYZER . . . . . . . . . . . . . .D-7 Index INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .I-2 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Chapter 1 Introduction OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Purpose of the manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 What is the TEG System? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 CUSTOMER SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Clinical training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Repair service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 Product return guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4 SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Symbols found in this document. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 Symbols found on the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 1-2 Introduction OVERVIEW Purpose of the manual The TEG 5000 System User Manual provides users with the information needed to effectively operate the TEG® Thrombelastograph® hemostasis analyzer using the 5000 series analyzer and version 4.2 series of the TEG Analytical Software (TAS). The manual includes: Detailed descriptions of the analyzer and all components. An overview of the science that supports the analyzer. How to operate the analyzer and troubleshoot any difficulties. How to properly handle and maintain the analyzer. Use this manual in combination with training supplied by qualified Haemonetics® personnel. What is the TEG System? The Thrombelastograph (TEG) analyzer is a non-invasive diagnostic instrument designed 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 analyzer measures a clot’s properties using a small cup that holds the blood and slowly oscillates. A pin, held by a thin wire, is suspended in the blood. When a clot forms, it links the pin and cup together and the torsion of the pin is measured and converted to electrical signals which are monitored by a computer. The TEG system consists of the following parts: TEG analyzer: the electro-mechanical instrument. TEG Analytical Software (TAS): the software that processes data generated by the TEG analyzer. TAS is distributed in two versions - TEG-enabled for operators running samples on the analyzer and Remote for clinicians who only view the data. Disposables: the single-use material for running blood samples on the analyzer including cups and pins. Reagents: substances added to the blood sample. The TEG 5000 system (analyzer and software) is an FDA 510(k) cleared medical device. Note: The TEG models 3000, or earlier, are no longer supported. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Introduction 1-3 Indications for use The TEG analyzer is indicated for use with adult patients where an evaluation of their blood coagulation properties is desired. Coagulation evaluations are commonly used to assess clinical conditions such as post-operative hemorrhage and/or thrombosis during and following cardiovascular surgery, organ transplantation, trauma, and cardiology procedures. Intended use The TEG analyzer is intended to be used to provide a quantitative and qualitative indication of the coagulation state of a blood sample by monitoring, measuring, analyzing and reporting coagulation parameter information. The TEG analyzer records the kinetic changes in a sample of whole blood, plasma or platelet rich plasma as the sample clots, retracts and/or lyses (breaks apart). Results from the TEG analyzer should not be the sole basis for a patient diagnosis; TEG results should be considered along with a clinical assessment of the patient’s condition and other coagulation laboratory tests. For Professional Use Only. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 1-4 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 info@haemoscope.com. 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. Warning: 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. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Introduction 1-5 SYMBOLS Symbols found in this document The terms Note, Caution and Warning are used in this manual with the following symbols to emphasize certain details for the operator. Note: provides useful information regarding a procedure or operating technique when using Haemonetics material. Caution: advises the operator against initiating an action or creating a situation which could result in damage to equipment or impair the quality of the blood products; personal injury is unlikely. Warning: 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 The following symbols may appear on the analyzer or its 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> TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 1-6 Introduction Contains sufficient for <n > tests Do not reuse Temperature limitation Control Use by CE mark General warning, caution, risk of danger Warning, biological hazard Consult instructions for use TUV certification (Technical Inspection Association) 06-510-US, Manual revision: AD TEG® 5000 System User Manual Chapter 2 TEG Analyzer Description TEG ANALYZER DESCRIPTION OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . 2-2 EXTERIOR FRONT COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Carrier . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Cupwell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3 Carrier ribbon cable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Column . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Lever . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Power switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Temperature controller . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4 Front cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Motor indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Carrier shafts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Platform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 Leveling feet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5 EXTERIOR BACK COMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6 Rear cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Leveling bubble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Serial port for the A/D interface box . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Potentiometer adjustment screw - CAL . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Potentiometer adjustment screw - BASE . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 Power supply connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 2-2 TEG Analyzer Description TEG ANALYZER DESCRIPTION OVERVIEW This chapter identifies the main components of the TEG® 5000 analyzer and explains their intended functions. The components are located in the following positions on the analyzer: Exterior front Exterior back Note: Any references made to “front” or “back” are from the perspective of an operator facing the TEG analyzer. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Description 2-3 EXTERIOR FRONT COMPONENTS 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 8 Carrier (x2 Cupwell (x2) Carrier ribbon cable (x2) Column Lever in Load position Power switch Temperature controller Front cover Motor indicator Lever in Test position Carrier shafts (x4) Platform Front leveling foot (x2) 9 7 6 5 10 4 11 3 2 1 12 13 Figure 2-1, TEG analyzer, exterior front components Carrier The two carriers hold the blood samples and are raised and lowered on the carrier shafts. When the analyzer is in operation, each carrier slowly oscillates through an angle of approximately 5 degrees. When a blood sample is run, the carrier is manually raised until the top surface of the carrier is flush with the bottom of the column. Cupwell The cylindrical cupwell in each carrier holds a disposable cup that contains a blood sample. Each cupwell contains a heating element that controls the temperature of the blood sample. The temperature of the cupwells is determined by the set point entered in the temperature controller. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 2-4 TEG Analyzer Description A spring-loaded disk (or “pusher”) at the bottom of each cupwell allows the disposable cup to be ejected from the cupwell when the carrier is lowered to the bottom of the carrier shafts and pushed against the bottom platform. When the carrier is in the fully raised position, the pusher is also used to seat the pin onto the skewer tip. Carrier ribbon cable The two carrier ribbon cables run from the analyzer to the back of each carrier and communicate the temperature set point to the heating element in each cupwell. Column The two columns each contain a skewer, the tip of which holds a disposable pin. The skewer, held by a thin wire, suspends the pin in the blood in the disposable cup. The movement of the pin in the oscillating cup is converted by a sensor into graphic and metric output on a computer. Note: The thin wire that suspends the skewer is very fragile. Make sure that you protect the skewer tip, especially when the lever on the column is in Test position. Lever The lever on each column can be moved into three positions–Load, Test, and Eject. Load: When a test is not being run, the lever must remain in the Load position. This secures and protects the skewer during the loading of the pin. Test: When a disposable cup and pin are in place and the carrier is fully raised, the lever is moved to the Test position to start a test. In the Test position, the pin on the skewer tip is suspended freely in the cup. Eject: After a test is finished, the lever is returned to the Load position and then pressed downward in order to eject the pin from the tip of the skewer. Power switch The green push-button power switch allows the analyzer to be turned on and off and is illuminated when it is in the on position. When the power is on, all functions of the analyzer are enabled. Temperature controller The temperature controller provides a digital readout of the set point temperature that the analyzer maintains for each channel/column in degrees Celsius. The temperature set point for each cupwell is indicated on the controller and is illuminated in red for channel 1 and green for channel 2. The default set point for the analyzer is 37 °C but can be adjusted upward or downward for each channel using the buttons on the temperature controller. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Description 2-5 Front cover The plastic front cover protects the analyzer’s interior components and should be removed only by a qualified service technician. Motor indicator The yellow motor indicator, when illuminated, indicates that the motor is engaged. Carrier shafts The carrier shafts support the carriers and allow them to be raised and lowered. The tops of the carrier shafts connect to the motor which controls the oscillation of the carriers. Platform The platform is designed to catch spills and can be removed for cleaning. The two depressions in the platform provide a surface for the pusher on the bottom of the carriers to engage, releasing the cup from the cupwell. Leveling feet The three leveling feet allow the operator to adjust the front, sides and back of the analyzer to ensure that it is level. The black, grooved ring located above each foot can be turned in either direction to bring the analyzer level. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 2-6 TEG Analyzer Description EXTERIOR BACK COMPONENTS 1. 2. 3. 4. Back leveling foot Rear cover Leveling bubble Serial port for A/D interface box 5. Potentiometer adjustment screw - labeled CAL (x2) 6. Potentiometer adjustment screw - labeled BASE (x2) 7. Power supply connection 3 2 1 Figure 2-2, TEG analyzer, exterior back view 5 6 7 4 Figure 2-3, Detail, exterior back 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Description 2-7 Rear cover The plastic rear cover protects the analyzer’s interior components and should be removed only by a qualified technician. Leveling bubble The leveling bubble is a clear, bull’s eye level located on the top of the analyzer which provides the operator with a visual confirmation that the analyzer is level. The analyzer is leveled by adjusting the front and back leveling legs until the bubble is centered within the two concentric circles printed on the glass. Note: Leveling the analyzer is a daily maintenance requirement. Serial port for the A/D interface box The serial port is located at the back of the analyzer and is the connection point for the DB-9 cable that attaches the Analog/Digital (A/D) interface box to the analyzer. Potentiometer adjustment screw - CAL The two potentiometer adjustment screws, labeled CAL, are located at the back of the analyzer, on either side of the serial port. The CAL potentiometer screws are used to calibrate the analyzer and must be adjusted only by a qualified service technician. Caution: Adjustment of the CAL potentiometer screws must be performed only by a qualified service technician with the correct calibration tools. Improper adjustment can cause incorrect parameter values to be written to the computer. Potentiometer adjustment screw - BASE The two potentiometer adjustment screws, labeled BASE, are located at the back of the analyzer, on either side of the serial port. Each screw is used to adjust the eTest base values for the column that it is closest to. The screws are adjusted using a trimmer adjustment tool provided by Haemonetics. Power supply connection The power supply connection is located at the back of the analyzer and is the 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 per your institution’s policy. Use an Uninterruptible Power Supply (UPS) unit between the analyzer and the power source. Caution: Grounding reliability can be achieved only when the analyzer is connected to a properly grounded outlet. Caution: Do not unplug the male 4-pin connector end of the power cord from the analyzer while leaving the power cord connected to a live power source. Electrical shorting and power supply damage may occur. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Chapter 3 Safety and Precautions STORAGE AND HANDLING. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Storing and handling the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Storing and handling the disposables . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 Storing and handling the reagents and controls. . . . . . . . . . . . . . . . . . . . 3-2 Transporting the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2 WARNINGS FOR THE OPERATOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Electrical Shock hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Power outlet connection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 Bloodborne pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 3-2 Safety and Precautions STORAGE AND HANDLING Safe and successful operation depends in part on the proper routine handling of the TEG® analyzer, disposables, reagents and blood samples. The operator should be aware of the problems that could result if these items are stored, installed, or used incorrectly. Storing and handling the analyzer Storing and handling the disposables Refer to Table B-2, “Environmental specifications” in Appendix B for the environmental conditions in which to store and operate the TEG analyzer. Caution: If the TEG analyzer has been stored at a temperature outside the operating temperature range, allow sufficient time for the analyzer to equilibrate to room temperature before use. The storage and handling of disposable cups and pins differs depending on their type: plain or heparinase. Refer to each product insert for storage and handling instructions. Caution: Do not touch the working surfaces of the disposable cup and pin, or allow these surfaces to be contaminated. Storing and handling the reagents and controls The storage and handling of Haemonetics® reagents (e.g., Kaolin, PlateletMapping® Assay, etc.) and Level I and II quality control samples differ depending on the type of reagent or control. Refer to each product insert for storage and handling instructions. Transporting the analyzer Before transporting the TEG analyzer from one location to another, ensure that both levers on the columns are in the Load position. This secures the skewer and protects it from damage. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Safety and Precautions 3-3 WARNINGS FOR THE OPERATOR Electrical Shock hazards The TEG analyzer operates at the low-rated current of 0.42A, with a maximum power uptake of 50W. The risk of electrical shock is, therefore, minimal. However, the operator should never remove the analyzer’s covers. Maintenance that requires the removal of these covers remains the responsibility of a Haemonetics-trained technician. Power outlet connection Do not power the device using a power cord other than the one originally supplied by Haemonetics for the TEG analyzer. Always ensure the power cord is connected to an appropriately grounded power source per your institution’s policy. Caution: Grounding reliability can only be achieved when the equipment is connected to a properly grounded outlet. Caution: Do not unplug the male 4-pin connector end of the power cord from the analyzer while leaving the power cord connected to a live power source. Electrical shorting and power supply damage may occur. Bloodborne pathogens Although the TEG 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. Warning: 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. At a minimum, use the following precautions when handling blood and disposing of blood-contaminated material: While operating the TEG analyzer, wear powder-free examining gloves and wash hands immediately after removing the gloves. Wear fluid-resistant clothing. Proper Handling of blood contaminated material Even though the only working surfaces that routinely come into contact with blood are the plastic disposable cups and pins, any TEG analyzer surface that could be contaminated by a blood spill should be properly cleaned and decontaminated with an appropriate disinfectant (refer to “Cleaning The TEG Analyzer” on page 7-28). This should be done after completion of procedures, at the end of the work shift, and immediately after any blood spill. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 3-4 Safety and Precautions Precautions must be taken to eliminate or reduce the hazards involved with removing the TEG analyzer from its point of use, transporting it from one place to another, or disposing of the analyzer. If any blood-contaminated material must be returned to Haemonetics for further inspection, see “Product return guidelines” on page 1-4 for instructions. Warning: 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. Units returned to Haemonetics for repair are subject to biohazard charges if any component is contaminated with blood or blood products. Proper disposal of biologically contaminated materials Any disposable material used during a procedure is considered to be biologically contaminated and biohazardous. It must be disposed of according to local standard operating procedures for the removal of such material and should not be mixed with non-biohazardous waste. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Chapter 4 TEG Analyzer Technology Overview TEG ANALYZER TECHNOLOGY OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . 4-2 Principles of design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2 TEG ANALYZER PARAMETERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4 Primary clot formation and lysis parameters . . . . . . . . . . . . . . . . . . . . . . 4-4 Secondary clot formation parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6 Secondary clot lysis parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8 Secondary clot kinetic, strength, and stability parameters . . . . . . . . . . . . 4-9 Velocity parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10 Interrelationship of parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11 TEG SAMPLE TYPES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 TEG sample types overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12 TEG sample type descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-14 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 4-2 TEG Analyzer Technology Overview TEG ANALYZER TECHNOLOGY OVERVIEW Principles of design The TEG® analyzer’s approach to the monitoring of patient hemostasis is based on the following: 1. The end result of the hemostasis process is the clot. 2. The clot’s physical and developmental properties (rate, strength, and stability) affect whether the patient will have normal hemostasis, will hemorrhage or will develop thrombosis. How the TEG analyzer works The TEG analyzer includes a sample cup that oscillates constantly at a set speed through an arc of 4°45'. The cup rotates left and right for 2.375 degrees each at 10 second intervals. A whole blood sample of 360 µL is placed in the cup, and a stationary pin attached to a torsion wire is immersed in the blood. When the first measurable clot forms, it begins to bind the cup and pin, causing the pin to oscillate in phase with the cup. The rate of increased movement of the pin is a function of clot development. 1. 2. 3. 4. Torsion wire Pin Cup Heating element, sensor and controller 5. 0.36 mL whole blood (clotted) 1 2 3 5 4 Figure 4-1, TEG sample cup design As the fibrin-platelet bonding links the cup and pin together, the torque of the rotating cup is transmitted to the immersed pin. The strength of these fibrinplatelet bonds affects the magnitude of the pin motion, such that strong clots move the pin to a greater degree. Thus, the magnitude of the output is directly related to the strength of the formed clot. If lysis occurs, some bonds are broken and the degree of pin motion is diminished. The degree of rotational movement by the pin is converted by a mechanical-electrical transducer to an electrical signal which is monitored by a computer. The monitoring produces a graphical tracing that reflects a hemostasis profile of clot formation. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Technology Overview 4-3 The resulting hemostasis profile is a measure of the time it takes for the first measurable clot to be formed, the kinetics of clot formation, the strength of the clot (in shear elasticity units of dyn/cm2) and the breakdown of the clot, or fibrinolysis (figure 4-2). 1. 2. 3. 4. 5. R: Reaction time K: K-time Angle MA: Maximum Amplitude LY30: Percent Lysis 30 minutes after MA Figure 4-2, TEG tracing parameters Individual points in the hemostasis profile indicate specific parameters of patient hemostasis. Some of the primary parameters such as R, K, Angle (, MA, and LY30 are indicated in the above diagram. The next section describes the TEG analyzer parameters in detail. Note: For information about the specifications and performance characteristics for the TEG analyzer, see Appendix B, “Specifications” on page B-2 and “Performance characteristics” on page B-6. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 4-4 TEG Analyzer Technology Overview TEG ANALYZER PARAMETERS The TEG analyzer measures a number of primary and secondary clot formation and clot lysis parameters. It also measures clot kinetics, strength, stability and velocity parameters. This section provides definitions for each parameter. Primary clot formation and lysis parameters To evaluate the graphic information displayed by the TEG analyzer, the following primary parameters of clot formation and lysis are measured: R (Reaction time) K (K-time) Angle () MA (Maximum Amplitude) LY30 (Percent Lysis 30 minutes after MA) CI (Coagulation Index) TEG-ACT (Activated Clotting Time) R or R-time Reaction time. The time from the start of a sample run until the first significant levels of detectable clot formation (amplitude = 2 mm in the TEG tracing). This most represents the enzymatic portion of coagulation. This is the point at which most traditional coagulation assays reach their endpoints. R-time is prolonged by anticoagulants and factor deficiencies and is shortened by hypercoagulable conditions. K or K-time Achievement of a certain clot strength. K is a measure of the time from R until a fixed level of clot strength is reached (amplitude = 20 mm). This most represents initial clot kinetics. K is shortened by increased fibrinogen level and, to a lesser extent, by increased platelet function, and is prolonged by anticoagulants that affect both. If the amplitude does not reach 20 mm, K is undefined. Caution: If the MA of the sample is less than 25 mm, do not use K for clinical decisions. In these samples, use angle. Angle () Angle or measures the rapidity of fibrin build-up and cross-linking (clot strengthening). This most represents fibrinogen level. Angle relates to K, since both are a function of the rate of clot formation. Angle is more comprehensive than K, since there are hypocoagulable conditions in 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Technology Overview 4-5 which the final level of clot strength does not reach an amplitude of 20 mm (in which case K is undefined). Similar to K, Angle is made larger by increased fibrinogen levels and, to a lesser extent, by increased platelet function, and is decreased by anticoagulants that affect both. MA MA, or Maximum Amplitude, is a direct function of the maximum clot strength. In tests where platelets are part of the clot, this parameter most reflects platelet function/aggregation. Clot strength is the result of two components - the modest contribution of fibrin and the much more significant contribution of the platelets. Approximately 80% of the contribution to MA is from platelets, and the remaining 20% from fibrin. This remaining 20% is the only component measured by the traditional PT and aPTT tests. LY30 Percent lysis 30 minutes after MA is reached. The LY30 measurement is based on the reduction of the tracing area that occurs between the time that MA is measured until 30 minutes after the MA is defined. For more information about clot lysis, refer to “Secondary clot lysis parameters” on page 4-8. CI The CI, or Coagulation Index, is derived from the R, K, Angle (), and MA and describes the patient’s overall coagulation status. Positive values above the range suggest overall hypercoagulability, whereas negative values below the range suggest overall hypocoagulability. Equations involving whole blood or kaolin-activated whole blood, or both combined are available. The equations should be validated before applying them clinically. Since the reference range of sodium citrated blood is very similar to non-citrated blood, the same coefficients are applied to sodium citrated native blood as best estimates. The equation for the TEG coagulation indices are simple linear combinations of the variables as follows: Index Equation Native Whole Blood CI = –0.2454R + 0.0184K + 0.1655MA – 0.0241 – 5.0220 Kaolinactivated Whole Blood CI = –0.6516Rc – 0.3772Kc + 0.1224MAc + 0.0759c -7.7922 Combined CI = –0.112R – 0.222K + 0.040MA – 0.042 – 0.578Rc + 0.370Kc + 0.111MAc + 0.097c – 8.397 Table 4-1, TEG coagulation indices equation TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 4-6 TEG Analyzer Technology Overview Note: R and K values must be in minutes. Parameters that have the subscript “c” are measured for Kaolin-activated samples. When MA < 20 mm, K is undefined and CI is not calculated. TEG-ACT Calculates an ACT (Activated Clotting Time) value from the TEG R for RapidTEG™ samples. TEG-ACT accelerates the clotting process by simultaneously stimulating the intrinsic and extrinsic coagulation pathways and is used to monitor heparin anti-coagulation. Secondary clot formation parameters In addition to the major parameters described above, the following secondary clot formation parameters are measured: PMA (Projected MA) TMA (Time to MA) A (Amplitude) G (Shear elastic modulus strength) E (Elasticity constant) TPI (Thrombodynamic Potential Index) SP (Split Point) PMA Projected MA. PMA estimates whether the MA value will achieve at least the lower limit of the normal value for samples treated with Kaolin. PMA facilitates earlier detection of platelet dysfunction and earlier therapy decisions before MA is available. Note: PMA is not calculated for sample types L1, L2, Functional Fibrinogen (FF), FF with heparinase, S1, S2, Plasma (PL) and PL with heparinase. PMA begins to display when Amplitude reaches 5 mm, and is finalized when the rate of clot formation slows (Angle is final). PMA is displayed as either: 0 (to indicate that it is likely that MA will reach the lower limit of normal). 1 (MA is unlikely to reach the lower limit of normal). Once the MA value approaches the lower limit of normal, it should be used for evaluation instead of PMA. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Technology Overview 4-7 TMA Time to MA. TMA is a global measurement of the dynamics of clot kinetics. TMA combines the rate of clot development from the start of a sample run until the clot reaches its maximum strength. A Amplitude. The A parameter measures the amplitude of the tracing at the latest time point. The A parameter is available from the beginning of the sample, while the MA does not display until after the R. While MA is interim, if the sample is increasing slowly, the A might be slightly higher than MA. A is a function of clot strength or elasticity and is measured in mm. G Shear elastic modulus strength (SEMS). The MA parameter can be transformed into the actual measure of clot strength (G) using the formula below, and is measured in dyn/cm2 divided by 1000 (displayed in the software as Kd/sc). The absolute SEMS of the sample can be calculated from MA as follows: G = (5000MA/(100-MA))/1000 An amplitude of 50 mm corresponds to a SEMS of 5000 dyn/cm2. An increase in MA from 50 mm to 67 mm is equivalent to a two-fold increase in the SEMS. The G parameter not only provides a measurement of clot firmness in force units, but also is more indicative of small changes in the clot strength or clot breakdown than is the amplitude in mm because it is an exponential reflection of MA. E Elasticity constant. E is a normalized G parameter. In the formula (the above formula for G), 5000MA is replaced with 100MA. TPI Thrombodynamic Potential Index. TPI = EMX/K, relative elastic shear modulus divided by the kinetics of clot development, where EMX is E at maximum amplitude (MA), i.e., EMX = (100*MA)/(100-MA), and K is measured in mm. SP Split point (time to initial amplitude). The point at which the tracing starts to split, i.e., “clot”. R value = the time to when the split first reaches 2mm. A 2mm split is considered a significant enough split to reflect that the clot is moving the pin. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 4-8 Secondary clot lysis parameters TEG Analyzer Technology Overview A clinical fibrinolytic state involves the presence of tissue plasminogen activator (t-PA), which produces fibrin degradation products. Characteristically, fibrinolysis leads to clot dissolution, depending on the severity and stage (early or late) of the fibrinolytic process. Therefore, the following sets of parameters are measured to quantify the fibrinolytic state, relying on the loss of clot strength with time after the maximum clot strength (MA) is reached: LY60 (Percent Lysis 60 minutes after MA) A30 and A60 (Amplitude 30 and 60 minutes after MA) C30 and C60 (Whole blood clot lysis indices based on A30 and A60) EPL (Estimated Percent Lysis) CLT (Clot Lysis Time) LTE (Lysis Time Estimate) LY60 Percent lysis 60 minutes after MA is reached. The LY60 measurement is based on the reduction of the area under the TEG tracing from the time MA is measured until 60 minutes after the MA. Note: For a description of LY30, the primary clot lysis parameter, see “Primary clot formation and lysis parameters” on page 4-4.) A30 and A60 Amplitude 30 minutes and 60 minutes after MA is reached. A30 and A60 are point measurements that look only at the TEG tracing amplitude A at 30 and 60 minutes after MA. Note: LY30 and LY60 contain more information than A30 and A60 because they look at the reduction in tracing area between MA and 30 (or 60) minutes after MA. CL30 and CL60 Whole Blood Clot Lysis Index. A30 and A60 are sometimes presented in an alternate form called the Whole Blood Clot Lysis Index (CL30 or CL60), which presents the values of A30 or A60 relative to MA. The formulas are: CL30 = 100 x (A30 / MA) CL60 = 100 x (A60 / MA) The smaller the value of CL30 or CL60, the greater the severity of the fibrinolytic process. Note: CL30 and CL60 measure fibrinolysis in terms of the reduction in amplitude, whereas the LY30 and LY60 parameters measure the reduction in area. Generally, when LY30 and LY60 are high (i.e., fibrinolytic activity is high), CL30 and CL60 are low, and vice versa. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Technology Overview 4-9 EPL Estimated Percent Lysis. EPL is the estimated percent lysis at 30 minutes after MA. This parameter is computed 30 seconds after the MA is finalized, and is continually updated until 30 minutes after MA is reached, when EPL becomes equal to LY30. This parameter gives an idea of the percent lysis prior to 30 minutes after MA. EPL is computed by finding the slope connecting MA to any point between MA and 30 minutes after, then extrapolating to A30. EPL is then 100 (MA-A30)/MA, until A30 is reached and it becomes equal to LY30. Note: In the software, the EPL value is almost always twice the LY30 value until LY30 defines (asterisks disappear from the screen). Then it becomes equal to LY30. CLT Clot Lysis Time. CLT is the elapsed time between MA and 2 mm amplitude or less post MA. LTE Lysis Time Estimate. Lysis Time Estimate (LTE) is an estimate of CLT. It is computed 30 seconds after MA and is continually updated until 60 minutes after MA or when an amplitude of 2mm is reached, whichever comes first. If LTE is greater than three hours, the value is displayed as “>3 hrs.” LTE is derived by calculating the slope of the tracing and extrapolating to an amplitude of 2 mm. Secondary clot kinetic, strength, and stability parameters The following parameters can aid in determining clot kinetics, strength, and stability: % Inhibition % Aggregation FLEV (Functional Fibrinogen Level) % Inhibition Indicates the reduction in platelet contribution to overall clot strength. A low % inhibition means there is little effect on platelet activation. A high % inhibition means there is a large effect on platelet activation. % Inhibition is displayed for the PlateletMapping® Assay. % Aggregation The percent of platelets not inhibited, determined by comparing the uninhibited platelet contribution to the baseline platelet contribution. % Aggregation is displayed for the PlateletMapping® Assay. Note: For more information, refer to “Viewing PlateletMapping® tracings” on page 8-13 and to the TEG 5000 System - Guide to the PlateletMapping® Assay. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 4-10 TEG Analyzer Technology Overview FLEV Functional Fibrinogen Level. FLEV is the concentration of fibrinogen in milligrams per decilitre or grams per litre. It is calculated from the MA of Functional Fibrinogen tests. Note: The FLEV parameter is available for interpretation as long as the sample is a Functional Fibrinogen (FF) type. For more information, refer to “Viewing Functional Fibrinogen tracings” on page 8-16. Velocity parameters The following Velocity, or velocity curve (VCurve), parameters are generated from the mathematical first derivative of the standard TEG tracing. These parameters describe the formation of the thrombus, as well as the lysis of the thrombus. TMRTG (Time to Maximum Rate of Thrombus Generation) MRTG (Maximum Rate of Thrombus Generation) TG (Total Thrombus Generated) TMRL (Time to Maximum Rate of Lysis) MRL (Maximum Rate of Lysis) L (Total Lysis) Figure 4-3, Velocity parameters Note: The VCurve parameters outlined in this section are the MA versions of the parameters. Each of these also has a “G” calculated version. The G version has the same name, but with a “G” appended to the end (TMRTGG, MRTGG, TGG, TMRLG, MRLG, and LG). 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Technology Overview 4-11 TMRTG Time to initiation of clot formation (i.e., lag time) plus the time it takes for clot development to reach its maximum rate of clot strength development. MRTG The maximum rate at which strength develops within a developing clot. TG The positive area under the curve (AUC). Represents the total amount of clot strength generated during clot growth. TMRL The time from the start of the coagulation process until the maximum rate of thrombus lysis is achieved. Reflects clot stability. MRL Represents the maximum rate of clot breakdown. L Reflects the extent of clot strength reduction due to clot lysis or retraction. Represents the amount of clot strength lost during clot disintegration. Interrelationship of parameters The TEG analyzer, using a small blood sample of whole blood, measures the net product of the interaction of platelets with protein coagulation cascade from the time of placing the blood in the TEG analyzer until initial fibrin formation, clot rate, strengthening, and fibrin-platelet bonding via GPIIb/IIIa, to eventual clot lysis. Time, rate, strength, and stability of clot indicate whether the patient has normal, hypocoagulable, or hypercoagulable hemostasis, and provide an indication of the treatment necessary to normalize it. Each TEG parameter, R, K, Angle, MA and LY30, represents a different aspect of the clot’s physical properties. However, due to the interactive nature of hemostasis, these parameters are interrelated. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 4-12 TEG Analyzer Technology Overview TEG SAMPLE TYPES This section describes the TEG sample types that are used with the TEG analyzer and the conditions under which to use various blood modifiers. TEG sample types overview TEG sample types are selected in the TEG Analytical Software (TAS) before running on the analyzer for analysis. The sample types that are available in TAS can be categorized as follows: Primary: These are the commonly used and currently supported sample types. Secondary: These are legacy sample types that can still be used for research and study purposes. Note: For instructions on preparing different types of samples for analysis, refer to “Collecting and Preparing Blood Samples” on page 7-17. Primary TEG sample types The following table lists the primary TEG sample types, the reason each is used, and examples for each type. Note: In the table below it is common for an example to reflect multiple sample types Sample Type Purpose Examples Kaolin (K) Used as an activator to reduce sample run time. K (Kaolin) CK* (Citrated Kaolin) KH** (Kaolin w/Heparinase) CKH (Citrated Kaolin w/Heparinase) Functional Fibrinogen (FF) Used to measure only the fibrinogen contribution to clot strength. FF (Func. Fibrinogen) FFH (Func. Fibrinogen w/Heparinase) CFF (Citrated Func. Fibrinogen) CFFH (Citrated Func. Fibrinogen w/Heparinase) RapidTEG (RT) Used as an activator to reduce sample run time. RT (RapidTEG) RTH (RapidTEG w/Heparinase) CRT (Citrated RapidTEG) CRTH (Citrated RapidTEG w/Heparinase) 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Technology Overview 4-13 Sample Type Purpose Examples Quality Control (QC) Ensures correct functioning of the TEG analyzer. L1 (Level I) L2 (Level II) PlateletMapping® Used to measure a patient’s response to antiplatelet therapy. A (Activated) ADP (Adenosine Diphosphate) AA (Arachidonic Acid) Native N (Non-activated native whole blood) NWB (Native Whole Blood) CN (Citrated Native) Provides a global evaluation of coagulation Table 4-2, Primary TEG Sample Types * C indicates Citrate was used as a preservative to prolong storage. ** H indicates Heparinase was used to reverse the effects of heparin. Secondary TEG sample types The following secondary TEG sample types are included in TAS as legacy types from previous software versions: Note: In the current version of the software, only Tissue Factor appears by default in the Sample Types drop-down list. The Site Administrator controls which legacy sample types appear in the software. TF - Tissue Factor PL - Plasma ECT - Ecarin Clotting Time APR - Aprotinin S1 - Special ST1 from V2 S2 - Special ST2 from V2 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 4-14 TEG Analyzer Technology Overview TEG sample type descriptions This section describes the modifiers that are added to the blood samples before running on the TEG analyzer. Native whole blood samples The basic TEG measurements can be determined using a native whole blood sample, which is whole blood without the addition of any modifiers (for example, activators). Although native whole blood samples are highly sensitive, they are highly variable. In addition, it takes a long time to complete a run. Therefore, for most applications, native samples will not be an ideal sample. Sodium-citrated whole blood samples Sodium citrate is used to prevent the blood sample from clotting by chelating the calcium ions. Additional calcium is added when the sample is run. Citrated TEG samples are used for conditions where it is impractical to transport the non-anticoagulated to the TEG analyzer within four to six minutes of phlebotomy. Note: It is recommended that the sample be recalcified and run within two hours of the draw. The same reagents that are added to non-anticoagulated whole blood samples can also be added to a citrated whole blood sample. Modified TEG whole blood samples Native whole blood samples can be modified by adding reagents or activators to the in vitro sample to determine if a possible therapy might be effective for a coagulopathy, to improve speed of analysis, or to reverse a clinical condition (e.g., heparinization). These techniques involve the addition of the following reagents to the native whole blood sample: Activators (Kaolin reagent, RapidTEG reagent) Heparin neutralizers (Heparinase cup and pin) Platelet function assessment (PlateletMapping assay) Fibrinogen function assessment (Functional Fibrinogen assay) Adding an activator (Kaolin, RapidTEG™) Kaolin is used to reduce variabilities and to reduce the running time of a native whole blood TEG sample. Kaolin activates the blood via the intrinsic pathway and stimulates the reserve clotting ability of a blood sample. RapidTEG (TEG-ACT) reagent is a potent combination of Tissue Factor and Kaolin that activates coagulation by both the intrinsic and extrinsic pathways to give an even faster clotting time than Kaolin alone. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analyzer Technology Overview 4-15 Adding a heparin neutralizer (Heparinase cup and pin) Heparinase I, from Flavobacterium heparinum, is an enzyme that rapidly and specifically neutralizes the anticoagulant properties of unfractionated Heparin (UFH), and Low Molecular Weight Heparin (LMWH). Heparinase acts by cleaving the heparin molecule into small inactive fragments without affecting the function of other blood components involved in coagulation. Heparinase can be added to TEG samples by using a Heparinase cup and pin (source: Haemoscope). Adding heparinase to the blood sample allows visualization of any developing coagulopathies during perioperative cardiopulmonary bypass (CPB) that are masked by high levels of therapeutic heparin or are masked by heparin released from the mast cell of the donor liver during liver transplantation. Compare the R parameter of heparinase-modified TEG samples and nonheparinase-modified samples for patients undergoing cardiopulmonary bypass surgery or liver transplantation. If the R parameters are the same, it would suggest that enough protamine was given to neutralize all administered heparin. Adding a platelet function assessment (PlateletMapping® assay) The TEG PlateletMapping Assay measures a patient’s hemostatic balance and response to antiplatelet therapy. The assay involves running a thrombin sample (kaolin activated), an activated sample (A), and an agonist sample (ADP or AA). The results of the assay are used to measure the following: Interactions of clotting factors, platelets, and fibrinolysis. Percent platelet inhibition which indicates the reduction in platelet contribution to overall clot strength. Adding a fibrinogen function assessment (Functional Fibrinogen assay) The TEG Functional Fibrinogen assay is used to determine the independent contributions of platelets and fibrinogen to a patient’s hemostatic balance. The assay inhibits platelet aggregation, which makes it possible to measure only the functional fibrinogen contribution to clot strength (MA). The assay measures the Functional Fibrinogen Level (FLEV) and all other TEG parameters. The TEG analyzer calculates the FLEV through the transformation of the MA value. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Chapter 5 TEG Analytical Software (TAS) Overview TEG ANALYTICAL SOFTWARE (TAS) OVERVIEW . . . . . . . . . . . . . . . . . . . . 5-2 About the Enabled and Remote versions . . . . . . . . . . . . . . . . . . . . . . . . . 5-2 TAS features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3 LOGGING IN TO TAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5 Timing out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7 UNDERSTANDING THE TAS MAIN SCREEN . . . . . . . . . . . . . . . . . . . . . . . 5-8 TEG parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8 Identifying Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9 Data tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Selecting a sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11 Status bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12 UNDERSTANDING THE TOOLBAR ICONS . . . . . . . . . . . . . . . . . . . . . . . 5-13 UNDERSTANDING THE TEG SCREEN . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 Accessing the TEG Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16 Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17 Channel colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 Selecting an active channel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18 UNDERSTANDING THE MENU OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . 5-19 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-2 TEG Analytical Software (TAS) Overview TEG ANALYTICAL SOFTWARE (TAS) OVERVIEW This chapter provides an overview of the TEG Analytical Software (TAS) and includes the following information: About the Enabled and Remote versions Differences between the Remote and Enabled versions of the software Logging into TAS Understanding the TAS Main screen Understanding the toolbar icons and menu options Selecting a sample Using Quick Print Printing a patient report Printing multiple tracings Exiting TAS The TEG Analytical Software is distributed in two versions: TEG-Enabled - for operators who run samples on the TEG® analyzer. Remote - for clinicians and others who view and analyze data generated by the analyzer. The main difference between the two versions of the software is that only the Enabled version includes the features necessary to run and maintain the analyzer. The following section outlines the interface and functional differences between the Enabled and Remote versions. Interface Differences Toolbar icons Enabled version includes the Start, Stop and TEG icons Remote version does not System icons on the desktop, system tray, and screen title bar Enabled version is green Remote version is red Menu bar Enabled version includes the Options > Maintenance menu Remote version does not 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-3 Functional Differences Components TAS features Enabled version includes the TEG Analyzer module Remote version does not TAS provides a great deal of flexibility in viewing and managing TEG samples. TAS can be run with or without a TEG® analyzer attached to your computer - for example when you are in an operating suite and viewing tracings generated in a central lab. The software includes the following features: For clinicians, operators, researchers Selective data retrieval You can choose to view all tracings or filter the tracings by multiple criteria including patient name, test result ranges, site (such as OR1, lab, etc.), status (active samples only or all), date, etc. Guide You can overlay patient tracings with tracings of common coagulopathies for comparison. Clot graphic You can view the TEG output in an additional graphic format that displays the major clotting and lysis tests in the form of a clot droplet. Projected MA The program projects whether the MA will reach the lower limit of normal for certain sample types. Customized sample types and data views You can define which tests appear and the order in which tests are displayed. Reference tracings You can set a reference tracing (baseline or other) that can be viewed together with other samples for that patient and with reference range values for a given sample type. Formatted reports The program produces formatted patient reports including graphical and numeric information about the sample and the patient. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-4 TEG Analytical Software (TAS) Overview User profiles You can customize the settings used by the program to your own preferences, saving steps when you are logging in and using the program. For researchers Data export You can export tracings for use in other software packages such as Microsoft® PowerPoint or other graphics packages, and can export data for analysis to such packages as Microsoft® Excel or Systat. For operators Entry of related data In addition to selectively viewing the data generated by the TEG analyzer, you can also enter pre-defined commonly used hematologic tests (such as PT, aPTT, etc.,) that correspond to a TEG sample, or add other data (such as blood pressure, pulse, medication dosage, etc.). Automated quality control samples data storage The software automatically stores your quality control samples according to lot number in a separate database to generate reports and facilitate analysis. This is true only if Transfer QC Samples is selected in the active configuration (enabled version only). Maintenance history TAS stores the readings taken during maintenance procedures and can produce a report of all maintenance performed on the attached TEG analyzers. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-5 LOGGING IN TO TAS When TAS is installed, a default user profile for “Site Administrator” is included automatically. Using this user profile, the Site Administrator can log into the TAS Configuration Utility to modify this default profile, and to set up user profiles for other users. As an example, Figures 5-1 to 5-3 in the procedure below show that the Site Administrator previously created a user profile called “Lab personnel,” set a password for that profile, and then set up five associated operator IDs with that user profile. To log into TAS: 1. Double click the TEG program icon on the desktop or navigate to the TEGV4 program folder from the Start menu and select TEG V4.2. The Login screen displays. Figure 5-1, Login screen 2. In the User name field, select a user name from the drop-down list. Note: In the TEG-enabled version of the software, a QC database field automatically displays under Databases when you select a user name. 3. If applicable, enter a password in the Password field. Note that passwords are case sensitive; upper and lower case letters must match exactly. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-6 TEG Analytical Software (TAS) Overview Figure 5-2, Enter user name and password in Login screen 4. Ensure that the correct patient and QC databases appear in the Databases section of the screen. If you do not see the desired database, click the Locate button and do the following: a. In the Find window, choose one of the following options: Click... To... Find Have the system search a specific drive for database files with the extension “.teg”. Do the following: 1. Select a drive and click Find. 2. From the list of results, select a database and click Done. Browse Navigate to a folder containing a database by doing the following: 1. In the Open window, select a database from the default folder (C:\TEG), or navigate to select from a different folder. 2. Click Open. 3. Click OK. The TAS Main screen displays. 4. In the Logon window that appears in the upper left of the TAS Main screen, select your operator ID and enter your password. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-7 Figure 5-3, Logon window for operator name and password 5. Click Logon. Timing out Your System Administrator may have configured your system to time out after a set period of inactivity. If this is the case, a black screen appears and you must log in again to view data. If the system times out when active sample are running, no data is interrupted or lost during the time-out period. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-8 TEG Analytical Software (TAS) Overview UNDERSTANDING THE TAS MAIN SCREEN After you log in to TAS, the TAS Main screen displays. This central screen allows you to access many features of TAS and displays sample test results in graphic and numeric formats. On the left side of the TAS Main screen are thumbnail tracings that reflect sample test results. The right side displays the numerical data generated by the TEG® analyzer for each test run for the patient sample. If you choose to include hematology tests, these will also display in this section. These results are referred to as the TEG parameters. The middle section contains sample identifying information. At the bottom of the screen, a status bar provides more information about the selected sample and the environment. Figure 5-4, TAS Main screen TEG parameters The TEG parameters aid in evaluating the tracings that appear on the left side of the TAS Main screen. The tracings and numbers are generated by the TEG analyzer. Although there are many parameters or tests available, the five main parameters of clot formation and lysis (clot breakdown) include the following: 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview Parameter 5-9 Description R Reaction or clotting time representing the length of time for the initial clot to form K Time that is takes for the tracing to reach 20mm. This is considered clot formation time Angle Rate of clot growth MA Maximum amplitude representing the clot’s full strength LY30 Clot breakdown 30 minutes after the MA is reached You can specify which tests you want and customize the order in which they appear. Identifying Information The middle section of the TAS Main screen contains sample identifying information, including the colors and symbols that may appear. Figure 5-5, TAS Main screen Colors The background color indicates the status of a sample as explained below: Color... Indicates that the sample is… Blue (Selected) Selected for activation, data entry, or data acquisition Note: If you select a sample that is running, the background remains blue and the green Active button at the bottom of the screen begins to flash. Green (Active) Running and data is being collected for the sample White (Completed) Completed or that the record was manually created TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-10 TEG Analytical Software (TAS) Overview Symbols Sometimes, a symbol may appear in a Patient name or Sample description field. Refer to the following table for the meaning of the symbol: Symbol... Indicates … § A note that pertains only to the sample was entered. This symbol displays at the beginning of the Sample description field for that patient. To access the sample note, highlight the sample and click . ¶ A note about the case was entered. This symbol displays above the tracing and at the beginning of the Sample description field for that patient. To access the note, highlight the sample and click * . Data is calculating and the number that displays can change until the test is finalized. Sample was terminated before final values were calculated if a sample has a white background. Note: This symbol will display only for parameter data. Sorting/channel order By default, the data on the screen is organized by date, with the most recent samples on top. Channel numbers are sorted or listed by starting time with the last channel started appearing as the first channel listed. You can customize the sample order by clicking on any of the column headings (not the actual sample row for a patient). To sort a sample order: 1. Click the desired heading, either Channel, Patient name, ST, or Sample description. 2. Click once to sort in ascending order 3. Click a second time to sort in descending order For example, if you click the Channel heading, the channel order will appear in ascending order, from 1 to as many channels that were used. If you click the heading again, the channels will appear in descending order. Likewise, if you click once on the Patient name heading, patient names will sort in ascending order, from A to Z. If you click again, the names will sort in descending order from Z to A. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-11 Channel error codes Sometimes, an error code will appear in front of the channel number in the sample identification area of the TAS Main screen. Figure 5-6, Channel error code Possible error codes are as follows: Code... Data tracings Indicates... E eTest error I Interrupted (sample did not terminate properly) While the sample is running, data is collecting and the various TEG tracing parameters are calculating. Data begins to display in the parameter section of the TAS Main screen while the tracing section begins to display the results graphically. The data and tracings change every minute until the sample is done processing. Sometimes, a tracing may not appear. This indicates that the record was manually created and that no tracing data exists in the database for that record. Or, the sample was terminated immediately on starting so no data was collected. For a detailed description of tracings, refer to Chapter 8Chapter 8, “Viewing and Annotating TEG Analyzer Data.” Selecting a sample To select a sample from the TAS Main screen, click one of the following: The tracing Anywhere in the sample data row Notice that the tracing border, the sample identifying information, and the numeric results turn blue. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-12 TEG Analytical Software (TAS) Overview Figure 5-7, Selecting a sample in the TAS Main screen Status bar A status bar is located at the bottom of the TAS Main screen. Refer to the example below to understand the data displayed. Figure 5-8, TAS status bar 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-13 UNDERSTANDING THE TOOLBAR ICONS Listed below is a brief description of each icon that displays on the TAS Main screen. Note: The background of some of the icons change to blue when they are clicked. This indicates that the particular feature is active. When the icon is clicked again, the blue disappears indicating that the feature is no longer active. Displays the Patient screen for selecting the patient whose tracings you want to view on the TAS Main screen Activates or cancels the patient filter when a patient filter is in place Displays the Select Site ID screen for selecting a specific site and viewing all samples at a particular site Activates or cancels the site filter when a site filter is in place Switches between active samples and all samples Activates or cancels the filter Displays the Filter criteria screen for you to select criteria for the type of records to view. When a filter is active, clicking this icon will cancel the filter. Displays the selected tracing in maximized view. Allows you to select multiple tracings and display them in a maximized view. Displays multiple tracings in superimposed mode where the tracings overlay each other. Displays multiple tracings in offset mode where the tracings are staggered. Displays the Sample info screen TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-14 TEG Analytical Software (TAS) Overview Shows the percent inhibition and aggregation for PlateletMapping® samples Shows or hides a normal tracing for a particular population sample type on a maximized tracing Shows or hides the patient’s reference tracing on a maximized tracing Displays the Detail screen for a particular sample Displays the Notes tab on the Detail screen, ready for sample note entry. The § symbol displays in the Sample description field on the TAS Main screen, indicating that there is a note that is related only to this particular sample Displays the note about the sample Displays the TEG screen. Enabled version only. Displays the TAS Main screen Prints the selected tracing that shows the TEG analyzer results Generates the TEG Analysis Report for placement in the patient’s file Copies the currently selected tracing(s) to the Windows® clipboard for use in other programs Displays the Patient case mode screen that allows you to add or edit a patient case record 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-15 Starts the selected sample. This icon is only enabled on the TEG screen. Enabled version only. Stops the selected sample. Enabled version only. Enlarges certain screens or certain selections of a screen making it easier to touch and select data, or to see information more easily Allows you to scan a patient ID for a bar coded sample when you have a scanner attached to your computer Displays the Edit case screen allowing for the entry of notes about the patient case. The ¶ symbol displays above the tracing and in the Sample description field of the TAS Main screen after note entry. This symbol will appear with every sample run for this patient Displays the notes about the patient case Helps teach the different TEG tracing shapes Provides electronic consultation with colleagues and specialists by sending tracings or TEG data files through e-mail Undoes the last action on the current screen Allows you to log back onto TAS after logging off Allows you to temporarily log off TAS while the system is running without exiting TAS Transforms the TEG profile data into a velocity curve (VCurve) and provides further information about the dynamic properties of clot formation TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-16 TEG Analytical Software (TAS) Overview UNDERSTANDING THE TEG SCREEN The TEG screen is the only screen in the software where you can start a sample. Note: Remote sites cannot access the TEG screen. There are a few important features that you need to understand to successfully run a sample, including the fields and the colors displayed. The middle section of the TEG screen is shown below followed by explanatory information. Figure 5-9, Middle section of TEG screen Accessing the TEG Screen To access the TEG screen: Before you begin, you must be logged into TAS. 1. From the TAS Main screen tool bar, click . A screen similar to the following displays: 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-17 Figure 5-10, TEG screen Note: If this is the first sample that you are running for the day or if a maintenance check needs to be conducted according to your institution’s protocol, a Maintenance check message automatically displays on the TEG screen. Fields For more information on... Refer to the following Performing daily maintenance checks “Conducting Daily Maintenance Checks” on page 7-5 Adding patient records “Adding a Patient Case Record” on page 103 Running samples “Running Samples” on page 7-26 The fields that you need to complete on the TEG screen are as follows: Field Description Sample Type (Required) The type of sample that will be run. Patient name (Required) The lot number of the quality control sample or the name of the patient and medical record number. Sample Description A free form field that allows you to enter descriptive information according to your institution’s protocol. This field is commonly used to describe the treatment phase such as “baseline,” “post-protamine,” “rewarming,” etc. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 5-18 Channel colors Selecting an active channel TEG Analytical Software (TAS) Overview The background color of the channel on the TEG screen indicates the channel’s status: Color... Indicates that the channel is… Yellow (Pending) Available for activation Blue (Selected) Selected for activation, data entry, or data acquisition Green (Active) Is running an active sample and data is being collected for the sample If you select a channel that is running, the background for the channel number field remains green and the background for the accompanying fields changes to blue. 06-510-US, Manual revision: AD TEG® 5000 System User Manual TEG Analytical Software (TAS) Overview 5-19 UNDERSTANDING THE MENU OPTIONS The following five menu options are available on the TAS menu bar. These menu options are available from any screen in TAS. File Records QC Options Help The actions available under each menu are highlighted below. Menu Option File Purpose Open an existing database Create a new database Compact a Database Import a previous version of the database to the current database Export a database Merge a database Exit TAS Create a patient case record Records Create a record to manually enter data Delete a patient and all affiliated records Delete a specific sample record Generate the TEG Database Patient List Report Generate the TEG Analyzer Audit Report Archive a lot number QC TEG® 5000 System User Manual Add a new lot number Update dates and sample types associated with a lot number Restore old values Delete a lot number Generate the TEG Lot Number History Generate the Levey Jennings Report Access a different QC database Switch between the patient and QC database P/N 06-510-US, Manual revision: AD 5-20 TEG Analytical Software (TAS) Overview Menu Option Options Help Purpose Activate the channels on the analyzer Conduct the daily maintenance task of performing an eTest (Enabled version only) Generate a Daily Log or Service History report Set the default name of the database to open automatically when you log Create and/or modify User profile options for the Tests, Normal values, Sample Types, Software, Video, Login, and eConsult features Enable the Touch feature Access information for TEG operation Access descriptions of TEG supported tests Display the current TEG Analytical Software version Note: If you are running TAS on Windows 7 and your version of Adobe Acrobat is 5.0 or lower, a Program Compatibility Assistant message appears when you try to open the PDF files on the Help menu. Click Run Program to view the files. Note: In some locations in the software, you can click a Help or More Info button to display topics in a Help file. If you are running TAS on Windows 7, you will need to download a free utility from Microsoft to allow you to view the Help file. On the Microsoft Download website, search for “WinHlp32.exe” to access the utility. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Chapter 6 Configuring User Profiles CONFIGURING USER PROFILES OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . 6-2 About user profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 Accessing the User profile setup screen . . . . . . . . . . . . . . . . . . . . . . . . . 6-2 TESTS TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Accessing the Tests tab features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3 Adding a new test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4 Renaming a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5 Moving a test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 Including tests in the TAS display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6 NORMAL VALUES TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8 Accessing the Normal Values tab features. . . . . . . . . . . . . . . . . . . . . . . . 6-8 Viewing reference range values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Adding test values to a sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9 Changing reference range values for a test . . . . . . . . . . . . . . . . . . . . . . 6-10 SAMPLE TYPES TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11 Accessing the Sample Types tab features . . . . . . . . . . . . . . . . . . . . . . . 6-11 Adding a sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12 Moving a sample type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13 Including sample types in the TAS display . . . . . . . . . . . . . . . . . . . . . . 6-13 SOFTWARE TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15 Setting software options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15 VIDEO TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20 Accessing the Video tab features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20 Changing a color . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21 Changing a line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22 Resetting video preferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23 LOGIN TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24 Setting login defaults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24 ECONSULT TAB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25 Accessing the eConsult tab features . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25 Setting up your e-mail account . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26 Defining e-mail server settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27 Defining an eConsult recipient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27 Removing an eConsult recipient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-2 Configuring User Profiles CONFIGURING USER PROFILES OVERVIEW The TEG® Analytical Software (TAS) includes user profiles that contain each user’s operational preferences. This chapter describes how the user profiles are customized. Note: Depending on your user type, certain options described in this chapter may not be available. The User Profile Setup option allows you to do the following: About user profiles Set the default name of the database to open automatically when you log in to TAS. Access the Tests, Normal values, Sample Types, Software, Video, Login, and eConsult features. Your Site Administrator performed a master system configuration during TAS installation. As part of that configuration, users were defined with security user login names and optional passwords along with other profile settings. However, you can customize or set many of your own preferences, which are stored in the user profile. The following are examples of customizations you may want to do: Accessing the User profile setup screen Specifying the default name of the database to open so that you do not have to enter it each time Selecting which tests appear and the order in which they appear on the TAS Main screen and other screens Adding a related test to the database that the system does not contain Changing the color of tracings and related text To access the User profile setup screen: 1. From the TAS Main screen menu, choose Options > User Profile Setup. The User profile setup screen appears. Figure 6-1, User profile setup screen The following sections describe the tabs on the User profile setup screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles 6-3 TESTS TAB The Tests tab allows you to: Accessing the Tests tab features Add a new test for recording data Rename a test created by the user Change the order in which a test is displayed on your screen Specify which tests to display in the TAS software The Tests tab lists all the tests that the Site Administrator has made available in TAS along with a concise description and the units of measure for those tests. Before you begin Select Options from the TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To access the Tests tab features: 1. From the User profile setup screen, click the Tests tab. Figure 6-2, User profile setup screen, Tests tab 2. Continue at the appropriate section: TEG® 5000 System User Manual If you want to… Continue at … Add a new test to TAS “Adding a new test” on page 6-4 Rename a test “Renaming a test” on page 6-5 Change the order in which a test is displayed in TAS “Moving a test” on page 6-6 Specify which tests appear in TAS “Including tests in the TAS display” on page 6-6 P/N 06-510-US, Manual revision: AD 6-4 Adding a new test Configuring User Profiles You can add a new test to TAS and assign values for each sample run for that particular test. These test values will display for any sample that you enter in TAS. Note: After you add a test name, be sure to add the reference range values for the test using the Normal values tab. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To add a new test to TAS: 1. From the User profile setup screen, click the Tests tab. 2. Click Add new. The Add test screen appears: Figure 6-3, Add test screen 3. Complete the following fields: 06-510-US, Manual revision: AD Field Description Test name Type the name of the test. This name will appear as a heading on the data panel section on the TAS Main screen so you will want to keep the name short Description Type a brief description of the test. For example, for the test name R, enter Reaction Time as the description. Units Type the units that the test is measured in. TEG® 5000 System User Manual Configuring User Profiles 6-5 4. Choose one of the following: If you want to… Do the following… Save the data and end the session Click Done. Add another test Click Add another. The Add test screen clears. Repeat steps 3 and 4 for each test that you want to add. 5. Go to the Normal values tab to enter the reference range values for each test that you added. For detailed instructions, refer to “Changing reference range values for a test” on page 6-10. Renaming a test You can rename only user-defined tests, which have a white background. The default TEG® tests cannot be renamed. All TEG tests have a gray background. If a test cannot be renamed, the Rename button is shaded out, indicating that it is disabled. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To rename a user-defined test: 1. From the User profile setup screen, click the Tests tab. 2. Highlight the test you want to rename, checking to make sure that it has a white background or that the Rename button is not shaded out. 3. Click Rename. The Rename screen appears, showing the current name, as shown: Figure 6-4, Rename screen 4. Type the new test name and click OK. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-6 Moving a test Configuring User Profiles You can change the order in which a test is displayed on your screen. You can move the test up or down by using the appropriate button. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To change the order of a test on the screen: 1. From the User profile setup screen, click the Tests tab. 2. Highlight the test that you want to move. 3. Click the appropriate button: If you want to… Do the following… Move the test up one line in the display Click Move up Move the test down one line in the display Click Move down The test moves up or down one line, depending on the button you use. Click the appropriate button as many times as necessary to place the test in the desired location. 4. Click Done. Including tests in the TAS display You can specify which tests you want displayed in TAS. No other user is affected by your selections. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To include tests in the TAS display: 1. From the User profile setup screen, click the Tests tab. 2. Click Include. The Include screen appears. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles 6-7 Figure 6-5, Include screen 3. In the Include column, do one of the following: To have a test… Go to the Include column and… Display Click the box that corresponds to the desired test. A checkmark appears in the box. Note: If the test is not listed, contact your Site Administrator and ask that it be included. Not display Clear the box that corresponds to the test. 4. Click OK. The Include screen closes. If you included a test, then it displays as the last entry on the Tests tab. If you chose to make a test unavailable, then it no longer displays on the Tests tab. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-8 Configuring User Profiles NORMAL VALUES TAB The Normal values tab allows you to: Accessing the Normal Values tab features View reference range values for a test that is associated with a particular sample type Add test values to a sample type Change reference ranges for a test associated with a particular sample type The Normal values tab allows you to view, add, or change reference range values for a sample type. When you add a test on the Tests tab, you should enter the values on the Normal values tab. Before you begin Select Options from the TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps 1. From the User profile setup screen, click the Normal values tab. Figure 6-6, User profile setup screen, Normal values tab 2. Continue at the appropriate section: 06-510-US, Manual revision: AD If you want to… Continue at … View defined reference range values for a sample type “Viewing reference range values” on page 6-9 Add a test value to a sample type “Adding test values to a sample type” on page 6-9 Change the high or low reference range value for a test “Changing reference range values for a test” on page 6-10 TEG® 5000 System User Manual Configuring User Profiles Viewing reference range values 6-9 You can view the reference range values for a sample type. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To view the reference range values for a sample type: 1. From the User profile setup screen, click the Normal values tab. 2. In the Select Sample type field, select a sample type. The reference range values for each test appear. Note: If a test does not appear in the list, then no reference ranges exist for that test in that sample type. Figure 6-7, Reference ranges on the Normal values tab Adding test values to a sample type You can add a test to a sample type and then assign reference range values to the test. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To add a test and its reference range values to a sample type: 1. From the User profile setup screen, click the Normal values tab. 2. In the Select Sample type field, select a sample type. The tests associated with the sample type display. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-10 Configuring User Profiles 3. In the Select a test to add to this table field, select the test that you want to add to this sample type. Notice that the test now displays in the Test column. 4. In the Low Value field, enter a number. 5. In the High Value field, enter a number. 6. Click Done. Changing reference range values for a test You can change the reference range values for a test. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To change the reference range values for a test: 1. From the User profile setup screen, click the Normal values tab. 2. In the Select Sample type field, select a sample type. The tests associated with the sample type display. 3. In the Low Value or High Value column, click to highlight the number you want to change. The number moves to the left side of the column. 4. Type the new number and press Enter. Notice that the new value centers in the column, indicating that the number was accepted by the system. 5. Repeat steps 3 and 4 for each test value that you want to change. 6. Click Done. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles 6-11 SAMPLE TYPES TAB The Sample Types tab allows you to do the following for your profile: Accessing the Sample Types tab features Add a new sample type Specify which sample types to include in TAS Change the order in which a sample type is displayed on the sample type drop-down menu in TAS The Sample Types tab lists all the sample types that are available in TAS and are displayed in the order in which you will see them when you click the sample type drop-down arrow on the TAS Main screen. Also included on the Sample Types tab is a concise description of each sample type along with an explanatory comment. Before you begin Select Options from the TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps 1. From the User profile setup screen, click the Sample Types tab. Figure 6-8, User profile setup screen, Sample Types tab 2. Continue at the appropriate section: TEG® 5000 System User Manual If you want to… Continue at … Add a new sample type to TAS “Adding a Sample Type” on page 6-12 Change the order in which a sample type is displayed in TAS “Moving a Sample Type” on page 6-13 Specify which sample types appear in the drop-down menu “Including Sample Types in the TAS Display” on page 6-13 P/N 06-510-US, Manual revision: AD 6-12 Adding a sample type Configuring User Profiles You can add a new sample type to TAS. Note: Make sure you enter the sample type name carefully as it cannot be edited. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To add a new sample type to TAS: 1. From the User profile setup screen, click the Sample Types tab. 2. Click Add new. The Add Sample type screen appears: Figure 6-9, Add Sample type screen 3. Complete the following fields: Field Description Define new Sample type Type the name of the sample type to appear in the drop down list. Typically, one letter or two letters are used to indicate the sample type. For example, K would be entered for Kaolin, or CK would be entered for Citrated Kaolin. Sample type description Type a brief description of the sample type. For example, you would enter “Kaolin” to correspond with K or “Citrated Kaolin” to correspond with CK. Sample type comment Type relevant comments for the sample type. For example, “should be run within 4-6 minutes from draw.” 4. Click OK. The screen closes and the sample type that you added appears at the bottom of the Sample Types tab. 5. If applicable, click the Normal values tab to enter the reference range values for the sample type. For detailed instructions, refer to “Adding test values to a sample type” on page 6-9. 6. Click Done to return to the TAS Main screen 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles Moving a sample type 6-13 You can change the order in which a sample type is displayed on the sample type drop-down menu in TAS. You can move the sample type up or down by using the appropriate button. Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To change the order of a sample type in the drop-down menu: 1. From the User profile setup screen, click the Sample Types tab. 2. Highlight the sample type that you want to move. 3. Click the appropriate button: If you want to… Do the following… Move the sample type up one line in the display Click Move up Move the sample type down one line in the display Click Move down The sample type moves up or down one line, depending on the button you use. Click the appropriate button as many times as necessary to place the sample type in the desired location. 4. Click Done to return to the TAS Main screen. Including sample types in the TAS display You can specify which sample types to display in the Sample types drop-down list in TAS. Unlike the Tests feature, you can choose to include sample types that the Site Administrator did not include. If a database contains a sample type that the Site Administrator did not include, then that sample type is added automatically to the sample type menu list. For example, if the Site Administrator did not include Kaolin as a sample type and you open a database that has a Kaolin sample, Kaolin is automatically added to the list of sample types. Once you add or hide a sample type, the change will be implemented in all of your patient databases. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-14 Configuring User Profiles Before you begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To select a sample type to display in TAS: 1. From the User profile setup screen, click the Sample Types tab. 2. Click Include. The Include screen appears: Figure 6-10, Include Sample type screen 3. In the Include column, do one of the following: To have a sample type… Then… Display for this TAS user Click the corresponding sample type box. A checkmark appears. Not display for this TAS user Clear the corresponding sample type box. 4. Click Done to exit the Include Sample type screen. If you included a sample type, it displays as the last entry on the Sample Types tab. If you chose to make sample type unavailable, then it no longer displays on the Sample Types tab. 5. Click Done to return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles 6-15 SOFTWARE TAB The Software tab allows you to customize many software options, including certain system displays and default values in TAS. These include the following: Setting software options Data displayed Show grid lines and flashing warnings Miscellaneous defaults for various program settings FLEV values, units for timed tests, and clock time Calculations and run terminations Velocity for VCurve features (per Site Administrator discretion) Before you begin Select Options from the TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To set the options for the software: 1. From the User profile setup screen, click the Software tab. Figure 6-11, User profile setup, Software tab 2. Complete the following desired field(s) to set as the default. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-16 Configuring User Profiles Data pop-up panel Field Description Show numeric data on data panel Select to have numeric tracing data automatically appear in the data portion of the Sample info pop-up panel. Otherwise, the data is suppressed and displays only by clicking the Data tab on the Sample info panel. Show clot on data panel Select to have the clot graphic automatically appear in the clot portion of the Sample info pop-up panel. Otherwise, the graphic is suppressed and displays only by clicking the Clot tab on the Sample info panel. Note: The Show clot on data panel checkbox may be disabled if this feature is not available at your site. Maximized view Field Description Show grid lines Select to have horizontal measuring lines shown every 10mm. Note: To set the grid line color and style, refer to the Video tab. Flash warning ranges Select to have the numeric value for specific tests flash when it is outside a particular range. Note: If you want to change the criteria for the values to flash, contact your Site Administrator. FLEV units Field Description FLev units Select the desired units for reporting the functional fibrinogen level (FLEV): either mg/dl or g/l. Note: Changing the FLEV units automatically changes any user-entered FLEV values. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles 6-17 SP, R, and K units Warning: Do not change the units to “Millimeters” for SP, R, and K. Field Description SP, R, and K units Select Minutes or Seconds as the units to appear in all screens and reports for the following timed tests: SP (Split Point) R (Reaction time) K (Time from reaction to 20mm) TMA (sec and min only) CLT (sec and min only) LTE (sec and min only) Time display Field Description 12-hour clock (AM/PM) Select to have the sample time appear in all screens and reports in 12-hour time format with AM and PM indicators. 24-hour clock Select to have the sample time appear in military time (24 hour time). Miscellaneous Field Description Enable touch screen Select to have the Touch screen automatically expand certain dialogue boxes to aid in touch screen usage. Transfer QC samples Select to have quality control (QC) samples transferred and kept in a separate QC database. Click the field that indicates whether quality control (QC) samples should be transferred to the QC database, or kept in the patient database. Quick Print in black and white Select to provide better readability when the Quick Print output is directed to a black and white printer. Display PM pop-up automatically Select to have the PM window automatically appear when viewing the percent inhibition for PlateletMapping®.samples. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-18 Configuring User Profiles Angle calculation Warning: Do not change the default value (“From SP to curve”) for angle calculation. MA calculation Warning: Do not change the default value (“Small deviation MA; 3 minutes”) for MA calculation. Run termination Field Description Default (after A60 achieved) Select to terminate the sample 60 minutes after the MA is defined. Fixed time < > minutes Select to terminate the sample when it reaches a specific number of minutes after starting. Enter the number of minutes in this field. Note: The maximum value is 180 minutes. Selected parameter Select to terminate the sample after the selected test is finalized. Terminate RT samples on R Select to terminate when the R finalizes for the RapidTEG™ (RT) samples. Note: This field applies to RT samples only and does not affect the termination of any other sample types. Terminate ECT samples on R The ecarin (ECT) reagent is not commercially available. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles 6-19 VCurve Field Description Convert VCurve to G Select to have VCurve converted to G. VCurve calculations will now be based on G values instead of MA values. The G parameter (dyn/cm2), like MA, reflects clot strength. Sensitivity level (odd number only) Type a positive odd number to specify how many points of the tracing data VCurve will average. The larger the number, the less sensitive the calculation. Zoom Level Type the magnification level for viewing the VCurve tracing using a number from 1 to 100, including decimals. All values in the curve will be multiplied by the number you enter. No calculations or tracings other than the VCurve will be affected. COM port Field Description COM port Select the appropriate com port number in the drop-down box. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-20 Configuring User Profiles VIDEO TAB The Video tab allows you to change: Accessing the Video tab features Test, tracing, tick mark, or background color that displays in maximized screens and in the TAS Main screen Thickness and style of the reference lines that appear in screens and reports Before You Begin Select Options from the TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To access the video tab features: 1. From the User profile setup screen, click the Video tab. Figure 6-12, User profile setup Video screen 2. Choose one of the following: 06-510-US, Manual revision: AD If you want to change… Do the following… Test, tracing or background color Continue at “Changing a Color” on page 6-21 Thickness and style of grid lines Continue at “Changing a line” on page 6-22 TEG® 5000 System User Manual Configuring User Profiles Changing a color 6-21 When you click a button in the Test colors, Miscellaneous, or Tracing colors sections on the Video tab, the Color screen displays. Figure 6-13, Color screen Click the desired color and click OK. The button then displays in the color you selected. Assigning test colors You can assign several tests their own color in the maximized screen display. Button Description R K Angle MA Click the button for the test that you want to change color. Note: The tracing lines and the test name and results that appear at the bottom of the TAS maximized screen will appear in the color selected. 5 minute marks Click this button to change the color for the tick marks on the MA line that indicate five-minute intervals. Miscellaneous You can specify a color for the grid lines on maximized tracings. Button Description Grid lines Click this button to specify a color for the grid lines that appear on maximized tracings. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-22 Configuring User Profiles Tracing colors You can assign a color to various tracings. Changing a line Button Description Sample tracing Click this button to change the tracing color for a single tracing and for the first color in a multi-tracing screen. This color will be the same on the following screens: main, detail, multi-tracing, and maximized. Note: The default is white and is automatically converted to black for printing. The tracing color cannot be the same as the background color. Tracing 2 – 16 Click the respective button for the tracing that you want to select a color for in a multi-tracing screen. Reference Click this button to select a color for the reference tracing. Normal Click this button to select a color for the normal tracing. Background Click this button to change the background color of the tracing. Note: The default is black and is automatically converted to white for printing. The background color cannot be the same as the sample tracing color. To change a line, click the drop-down arrow in the appropriate field and select the desired line style and thickness. Field Description Sample tracing Click the down-arrow and select the line to appear in all sample tracings for reports and screens. Selected tracing Click the down-arrow and select the line that easily identifies the tracing that you want to view with additional information. When the tracing is selected, the line changes, helping match the tracing to the sample numbers. Normal lines Click the down-arrow and select the line to appear on the maximized and multi-screen display to indicate the reference range values for the different tests. Grid Lines Click the down-arrow and select the line to appear on the maximized screen and multi-screen display for the horizontal measuring lines shown every 10mm. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles Resetting video preferences 6-23 Field Description Reference tracing Click the down-arrow and select the line to appear on the maximized screen and multi-screen display for the patient’s baseline tracing. Normal tracing Click the down-arrow and select the line to appear on the maximized screen and multi-screen display for a sample type’s normal shape for given population. Test value lines Click the down-arrow and select the line that identifies the test value on the maximized tracing. To change all colors and lines back to their original settings, click Reset. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-24 Configuring User Profiles LOGIN TAB The Login tab allows you to: Set the default for your patient database and QC database Set the default site ID to appear on all samples that you run These defaults will appear automatically when you log into TAS. Setting login defaults Before You Begin Select Options from the TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To set the log in defaults: 1. From the User profile setup screen, click the Login tab. Figure 6-14, User profile setup Login screen 2. Complete the following fields: Field Description Default patient database Enter the patient database that you want to appear automatically when you log on. Note: You can type in the complete path or use the Locate button. Default QC database Enter the QC database that you want to appear automatically when you log on. Note: You can type in the complete path or use the Locate button. Default site id Click the down-arrow and select the site ID that you want to be entered automatically for all samples that you run. Or, type it in. 3. Click Done to return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles 6-25 ECONSULT TAB The eConsult tab allows you to: Set up your e-mail address and password for sending patient files for an electronic consultation Define the e-mail server settings Define a recipient who can receive files from the eConsult feature Remove an eConsult recipient Note: For more information about the eConsult feature, refer to “Using the eConsult Function” on page 12-3. Accessing the eConsult tab features Before You Begin Select Options from the TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To access the eConsult tab features: 1. From the User profile setup screen, click the eConsult tab. Figure 6-15, User profile setup eConsult 2. Continue at the appropriate section: TEG® 5000 System User Manual If you want to… Continue at … Set your e-mail address and password “Setting up your e-mail account” on page 6-26 Define e-mail server settings “Defining e-mail server settings” on page 6-27 Add an eConsult recipient “Defining an eConsult recipient” on page 6-27 Remove an eConsult recipient “Removing an eConsult recipient” on page 6-28 P/N 06-510-US, Manual revision: AD 6-26 Setting up your e-mail account Configuring User Profiles In order for eConsult to access your e-mail account and send patient files, you must first set up your e-mail account. You can store your password in the eConsult feature or you can enter it each time. Before You Begin Select Options from TAS Main screen menu Select User Profile Setup from the Options drop-down menu The steps To set up your e-mail account for eConsult: 1. From the User profile setup screen, click the eConsult tab. 2. In the eConsult configuration section, complete the following fields: Field Description E-Mail user name Type your e-mail address. E-Mail password Type your password, remembering that it is case sensitive. Notice that asterisks appear as a security precaution. Save Select to save your password in eConsult so you do not have to enter it each time you use the eConsult feature. Enter Each Time Select to not save your password in eConsult. You will need to enter your password each time you use the eConsult feature. 3. If this is the first time you are defining your eConsult options, you need to: Define the e-mail server settings (refer to “Defining e-mail server settings” on page 6-27). Define the eConsult recipient(s) (refer to “Defining an eConsult recipient” on page 6-27). Otherwise, click Done. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Configuring User Profiles Defining e-mail server settings 6-27 Before eConsult can be used to send files, the e-mail server settings must be defined. Note: It is recommended that only an IT staff member who is familiar with the servers complete this process. Before You Begin Select Options from TAS Main screen Select User Profile Setup from the Options drop-down menu The steps To define e-mail server settings: 1. From the User profile setup screen, click the eConsult tab. 2. Click E-mail server settings to display the E-mail server settings screen. Figure 6-16, E-mail server settings screen 3. Complete the following fields: Field Description POP3 server Type the POP3 server that is used to retrieve and verify your e-mail. SMTP server Type the SMTP server that is used to send your e-mail. 4. Click Done. Defining an eConsult recipient In order to receive e-mail, a recipient must be defined in eConsult. Before You Begin Select Options from the TAS Main screen Select User Profile Setup from the Options drop-down menu The steps To define an eConsult recipient: 1. From the User profile setup screen, click the eConsult tab. 2. Click Add new to display a blank row for data entry. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 6-28 Configuring User Profiles Figure 6-17, eConsult tab, Add New button 3. Complete the following fields: Field Description Name Type the name of the recipient. Organization Type the name of the place to send the eConsult. E-mail (Required) Type the recipient’s e-mail address. Pager/Cell Mail Type the pager number or cell phone number that is to receive a text message, using the format designated by your company or provider. Example: pager@mail.com The text message alerts the recipient of an awaiting e-mail eConsult. Note: For a pager to receive a text message, it must have SMS capability. 4. Repeat steps 2 and 3 for each recipient that you want to define in eConsult. 5. Click Done to return to the TAS Main screen. Removing an eConsult recipient You can remove an eConsult recipient. Before You Begin Select Options from the TAS Main screen Select User Profile Setup from the Options drop-down menu The steps To remove an eConsult recipient: 1. From the User profile setup screen, click the eConsult tab. 2. Highlight a recipient and click Remove. 3. Repeat step 2 for each recipient that you want to remove. 4. Click Done to return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Chapter 7 Operating the TEG Analyzer OPERATION OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Daily operation tasks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 ADJUSTING THE TEMPERATURE SET POINT . . . . . . . . . . . . . . . . . . . . . . . 7-3 Setting column 1 set point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Setting column 2 set point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 CONDUCTING DAILY MAINTENANCE CHECKS . . . . . . . . . . . . . . . . . . . . 7-5 Leveling the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Checking the carrier ribbon cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6 Checking the temperature controller display . . . . . . . . . . . . . . . . . . . . . 7-6 Performing an eTest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7 Running quality control samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9 LOADING AND EJECTING CUPS AND PINS . . . . . . . . . . . . . . . . . . . . . . 7-14 Loading the cups and pins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14 Ejecting the cups and pins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16 COLLECTING AND PREPARING BLOOD SAMPLES . . . . . . . . . . . . . . . . . 7-17 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-17 Before you begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18 Collecting a non-citrated blood sample . . . . . . . . . . . . . . . . . . . . . . . . 7-18 Collecting a citrated blood sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19 Collecting a heparin blood sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 Preparing TEG blood samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-20 RUNNING SAMPLES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26 Before you begin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26 Starting samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26 Terminating samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27 CLEANING THE TEG ANALYZER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28 Materials needed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28 Cleaning the analyzer surfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-28 Cleaning the lower column and skewer . . . . . . . . . . . . . . . . . . . . . . . . 7-28 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-2 Operating the TEG Analyzer OPERATION OVERVIEW This chapter explains how to operate the TEG® analyzer and includes instructions for the following: Adjusting the temperature set point Conducting daily maintenance checks Loading cups and pins Collecting, preparing, and running blood samples Cleaning the analyzer Caution: Before running samples on the TEG analyzer, you should be familiar with all necessary safety precautions outlined in Chapter 3, “Safety and Precautions.” Also, refer to Laboratory Techniques and Precautions on page 11-3. Daily operation tasks The tasks that you perform during the daily operation of the TEG analyzer occur in the following order: 1. Conduct the following daily maintenance checks: a. Level the analyzer. b. Check the carrier ribbon cables. c. Verify that the temperature controller display is lit and that the temperature readout for each column is correct. d. Perform an eTest. e. Load disposable cups and pins for QC samples f. Run QC samples. 2. Load disposable cups and pins for blood samples. 3. Collect and prepare blood samples. 4. Run the samples on the analyzer. 5. End the sample run. Detailed instructions for each of these steps are covered in the following sections. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-3 ADJUSTING THE TEMPERATURE SET POINTS The temperature set point for each column of the TEG analyzer is set to normal body temperature (37 °C) at the factory. In some cases, you may want the set points to be higher or lower than this (for example, the set points may need to be adjusted lower to reflect hypothermic regulation during surgery). Caution: The optimal set point temperature range is between 2 °C above ambient temperature and 42 °C. Do not adjust the set point for either column outside this range. Caution: Make sure you reset the temperature set points to 37 °C before running quality controls or normal (body temperature) clinical testing. To adjust the temperature set points on the TEG analyzer, you use the control buttons on the temperature controller. The controller information is displayed by column as follows: SP1 (Column 1-- Channel 1) SP2 (Column 2-- Channel 2) The red light indicator displays information for column 1 (on the left side of the analyzer) and the green light indicator displays information for column 2 (on the right side). The red SP1 light and the green SP2 light to the left of the temperature reading flash as the temperature cycles for each column. Figure 7-1, Temperature controller A = Index key B = Up and down arrows C = Enter key Note: Wait until the display readout matches the temperature you set within one half degree before using the column. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-4 Setting column 1 set point Operating the TEG Analyzer To set or change the temperature set point for column 1: 1. Press the Index key (A in figure 7-1) once. Information for column 1 displays. Figure 7-2, Setting column 1 temperature 2. Use the up and down arrow keys to set the desired temperature. 3. Press the Enter key (C in figure 7-1). The display flashes once. 4. Press the Index key (A in figure 7-1). The column display changes to SP2. 5. Press the Index key to exit. The temperature displays for both columns. Setting column 2 set point To set or change the temperature set point for column 2: 1. Press the Index key (A in figure 7-1) once. Information for column 1 displays. 2. Press the Index key again. Notice that information for column 2 displays. Figure 7-3, Setting column 2 temperature 3. Use the up and down arrow keys to set the desired temperature. 4. Press the Enter key (C in figure 7-1). The display flashes once. 5. Press the Index key to exit. The temperature displays for both columns. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-5 CONDUCTING DAILY MAINTENANCE CHECKS To ensure the proper test performance, test results reporting, and electronic functioning of the TEG analyzer, the following daily maintenance checks must be conducted: Level the analyzer Check the carrier ribbon cables (applies to carriers that do not include a metal retaining plate at the back) Verify that the temperature controller display is lit and that the temperature readout for each column is correct Perform an eTest Run Level I and Level II quality control samples These maintenance procedures are run daily, at the beginning of each shift, depending on your site’s procedures. No blood samples should be run until the maintenance checks have been completed. Note: Preventive maintenance, such as alignment and calibration of the analyzer, should be conducted semi-annually to ensure proper mechanical functioning. This testing is performed by trained TEG technicians or Haemonetics® technicians. Refer to the TEG 5000 System Preventive Maintenance and Service Manual for more information. As a reminder to complete the daily maintenance checks, the following prompt displays when you first enter the TEG screen in the TEG Analytical Software (TAS): Figure 7-4, Maintenance check screen If any of the maintenance checks reveal a problem with the analyzer, contact TEG System Technical Support for assistance (refer to “Customer Service” on page 1-4 for more information). Note: Refer to the illustrations in Chapter 2, “TEG Device Components,” to identify the components in the following sections. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-6 Leveling the analyzer Operating the TEG Analyzer Since the pin must be suspended exactly in the middle of the cup, it is important that the analyzer is completely level before a sample is added to the cup. To start up and level the analyzer: 1. Turn on the TEG analyzer by pressing the green power button. Ensure that the green power light and the yellow motor light are illuminated, which indicates that the analyzer is on. 2. Level the analyzer by adjusting the front and back leveling legs until the bubble is centered within the smallest circle on the leveling bubble on the top of the analyzer. Checking the carrier ribbon cables To ensure the proper functioning of the temperature controls, the carrier ribbon cables for both channels should be checked: Daily (older model carriers only) Note: It is not necessary to perform a daily check of the carrier ribbon cables if a metal retaining plate is attached to the back of the carriers. The metal plate helps to secure the cables to the carriers. Older carrier models may not include the metal plate. Any time the analyzer is moved If the temperature controller displays “Bad” or the temperature fluctuates more than 10 degrees To check the carrier ribbon cables: 1. Make sure each ribbon cable is fully inserted into the connectors on the back of the carrier and on the analyzer. The writing on the ribbon cable should be facing upward toward the column. 2. Check that there are no kinks and that the cables are not twisted. 3. Check that the temperature readout for each column is correct (refer to the following procedure) and that “Bad” does not appear on the temperature controller display. Checking the temperature controller display Before running samples on the TEG analyzer, ensure that the temperature controller is functioning correctly. To check the temperature controller: 1. Check that the temperature controller display on the front of the TEG analyzer is lit. Caution: If the analyzer is turned on but the temperature controller display does not light up, turn off the analyzer, unplug from the wall outlet, and contact TEG System Technical Support. 2. Check that the temperature readout for each column is 37.0 °C, ± 0.5. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer Performing an eTest 7-7 To ensure the proper electronic functioning of each channel on the TEG analyzer, you must perform an eTest before running any samples. The acceptable range for the eTest baseline values is between 1800 to 2300. If the eTest readings are out of range, you can make adjustments using the trimmer adjustment tool provided with the analyzer. The eTest should be performed: Daily Any time the analyzer has been turned off Any time the results from the quality control samples are not within the specified ranges. Performing an eTest To perform an eTest: 1. Log into the TEG Analytical Software (TAS). 2. From the TAS Main screen menu, choose Options > Maintenance. Figure 7-5, Options menu The Maintenance screen appears with the Daily Maintenance tab selected by default. Figure 7-6, Daily maintenance tab, Maintenance screen 3. Select a row for a connected channel and click eTest. Repeat for all connected channels. 4. On the analyzer(s), move the levers to Test. 5. Check the Min and Max fields to make sure the values that display fall between the acceptable range of 1800 and 2300. The ideal reading is between 1950 and 2050. 6. Check that the Message field for both channels reads eTEST value is OK. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-8 Operating the TEG Analyzer Figure 7-7, Message field, Daily Maintenance tab If one of the following messages displays, try the action indicated: Message Action Channel not at equilibrium Stabilize the analyzer. Make sure the analyzer is steady and that there is no vibration occurring that could affect the movement of the skewer. Wait until the skewer settles and the value in the Diff field is less than 10. eTest value off center Adjust the eTest value. Refer to “Adjusting the eTest baseline” below. 7. Click Done. The following reminder message appears: Figure 7-8, Maintenance reminder message 8. On the analyzer, move the levers to Load. 9. Click OK to close the reminder message. You are returned to the TAS Main screen. Adjusting the eTest Baseline You can make small adjustments to the potentiometer adjustment screws labeled BASE on the back of the analyzer to bring the eTest baseline readings in range. Caution: Do not adjust the adjustment screw labeled CAL. Only a trained TEG technician or Haemonetics technician can make calibration adjustments to the TEG analyzer. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-9 The eTest baseline adjustments are made using the trimmer adjustment tool that was provided with the TEG analyzer. To adjust the baseline eTest reading for a channel: 1. Make sure the Daily Maintenance tab is displayed in the TEG Analytical Software and that eTest has been performed on the channel. 2. Without moving the analyzer, locate the potentiometer adjustment screw labeled BASE on the back of the analyzer that corresponds to the channel that you are adjusting. Figure 7-9, Adjustment screws labeled BASE on the back of the analyzer 3. Use the trimmer adjustment tool to turn the BASE screw in one of the following directions: In the direction of the arrow to increase the eTest reading. In the opposite direction of the arrow to decrease the reading. Wait 15 seconds to allow the readings to stabilize after each adjustment. 4. Adjust the BASE screw to bring the eTest Min value between 1950 and 2050. 5. Repeat steps 1-4 for each channel that is being adjusted. Note: If the eTest baseline still remains out of range after adjusting the potentiometer adjustment screw(s), contact TEG System Technical Support for assistance (refer to “Customer Service” on page 1-4). Running quality control samples To verify that the analyzer’s settings are working properly and that it is giving reliable results, Level I and Level II quality control samples must be run at the start of each shift (or as dictated by institution policy). The quality control kits are available through Haemonetics. The Level I and Level II results are considered quality control values and can be stored in the QC database, which is separate from the patient database. Samples are run in the patient database and are automatically transferred to the QC database when the sample terminates or when you exit the software, depending on how your system is configured. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-10 Operating the TEG Analyzer For additional information about the quality control samples, refer to “Quality Control Samples” on page 11-6. Preparing and running the control samples Level I and Level II quality control samples must be run on each channel on the TEG analyzer. For each TEG analyzer that you are testing, you need to prepare one vial of Level I control and one vial of Level II control. The following outlines the order in which control samples should be prepared and run on each analyzer: Prepare 1 vial of Level I control material (enough for two samples). Simultaneously run the Level I samples on each channel of the analyzer. Ten minutes after the Level I tests have started, prepare 1 vial of Level II control material. When the MA has finished being defined (the asterisk next to the value no longer appears) for the Level I samples, terminate the samples. Simultaneously run the Level II samples on each channel of the analyzer. Verify control sample results Running the Level I Samples To run Level I quality control samples on one TEG analyzer: 1. Reconstitute one vial of Level I control material. Follow the instructions on the product insert in the control kit. Caution: After the control material has been reconstituted, the samples must be run within 2 hours. 2. In the TAS Main screen, click . The TEG screen displays. 3. Complete the following fields in the two channel sections that correspond to the analyzer: 06-510-US, Manual revision: AD Field Action Channel This field is pre-filled with the channel number that corresponds to the column on the analyzer. ST (Sample Type) (Required) From the drop-down list, select “L1 – Level I control.” TEG® 5000 System User Manual Operating the TEG Analyzer 7-11 Field Action Patient name (Required) Select or type the lot number. Note: If you type a lot number that is not in the list, a message displays when you click or tab out of the field. To create the new lot number: a. Click Yes in the message box. b. Complete the fields in the Enter Lot number information screen. c. Click Done. If necessary, update the reference ranges in the software to match the product insert (refer to “Updating reference ranges in TAS” on page 11-15). Sample description Enter a description that follows institution protocol. Examples: “Sample 1,” “S1,” “QC1” The following example shows Level I information completed for channels 1 and 2. Figure 7-10, Channel information, TEG screen 4. Load the cups and pins (refer to “Loading and Ejecting Cups and Pins” on page 7-14). 5. Pipette 20 µL of calcium chloride (CaCl2) into each cup. 6. Pipette 340 µL of reconstituted Level I control into each cup. 7. Immediately raise the carriers until they are flush with the bottom of each column. Caution: Do not raise the carriers too quickly. If a carrier is pushed up too quickly, the pin displaces the quality control material with enough force to splash material onto the flange of the cup. This can affect test results. 8. Move the levers to Test. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-12 Operating the TEG Analyzer 9. In the TEG screen, select the first channel and click (or press F10) and then repeat for the second channel. Notice that each channel in the TEG screen turns green, indicating it is active. The Active button flashes at the bottom of the screen when one of the active samples is selected. 10. To view the results, click Done to return to the TAS Main screen. 11. Allow the control samples to run approximately 15 to 20 minutes until the MA is defined in the software (that is, no asterisks appear next to the value). 12. From the TAS Main screen or the TEG screen, select the first channel to stop and click (or press F11). 13. Click Yes in the confirmation message that displays. The channel turns white, indicating that the sample is terminated. 14. Repeat steps 12 and 13 to stop the next channel. 15. Move the levers from Test to Load. Caution: Always terminate the control samples before moving the lever to Load. 16. Eject the control samples and properly dispose of them. Caution: Do not exert extreme pressure on the lever. If the pin does not eject, press down the lever and remove the pin by hand. Running the Level II samples To run the Level II quality control samples on the same analyzer, repeat steps 1 through 16 above, reconstituting Level II control material and entering Level II information for both channels in step 3. Investigating quality control sample errors If the quality control sample results are unsatisfactory, a pop-up QC Alert message displays indicating the parameter(s) or value(s) out of range for a particular channel. The system prompts you to enter a corrective action. Note: To troubleshoot quality control errors, refer to “Quality control (Level I and Level II) sample errors” on page A-12and “Unexpected tracing results” on page A-16. To respond to a QC alert message: 1. In the QC Alert message that displays when a parameter is out of range, click OK. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-13 Figure 7-11, QC error message 2. In the Corrective action screen, enter a description of the action(s) you will take to obtain satisfactory results. Figure 7-12, Corrective action screen If, after troubleshooting, the results are still out of range, contact TEG System Technical Support for assistance (refer to “Customer Service” on page 1-4). Verifying the sample results Before using the analyzer to run patient samples, verify that the control test results are within the ranges specified by the product insert (refer to the following instruction), or as calculated by your institution (refer to “Establishing quality control ranges” on page 11-8). To verify the control sample results: 1. In the TEG Analytical software, view the control sample results in the TAS Main screen. 2. Verify that each channel’s result is in the acceptable range by comparing it to the product insert or to the values displayed on the TAS Main screen. Generating quality assurance reports For Level I, at least three out of four values for R, K, Angle, and MA must be within range. For Level II, R, Angle, and MA must be within range. You can generate and print two quality assurance reports that track the quality control tests that you run on the analyzer: TEG Analyzer QC Summary report - provides a graphic view of the daily control sample tests. For more information, refer to “TEG Analyzer QC Summary report - Levey Jennings” on page 8-45. TEG Lot Number History report - contains a log of the quality control lot numbers and usage dates including the corresponding sample type and reference range values. For more information, refer to “TEG Lot Number History report” on page 8-47. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-14 Operating the TEG Analyzer LOADING AND EJECTING CUPS AND PINS Haemonetics® disposable cups and pins are manufactured and packaged to avoid any contamination of the working surfaces of the cups and pins. Take the following precautions with the cups and pins: Use only Haemonetics disposable cups and pins. Do not touch the outside of the pin or the inside of the cup. Store the cups and pins in their original packaging when not in use. Do not reuse the cups and pins. Disposable cups and pins have crush lines built into them so that they fit snugly into the cupwells and onto the skewer tip. These crush lines are spent after the first use. Loading the cups and pins To load the disposable cups and pins on the TEG analyzer: 1. Slide the carrier down to the platform, with the lever in the Load position. 2. Place a disposable cup, with the pin inside it, into the cupwell. Figure 7-13, Placing a cup and pin in the cupwell 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-15 3. Carefully slide the carrier all the way up until it is flush with the bottom of the column. Make sure the pin stays upright in the cup so that it can fit over the tip of the skewer. Figure 7-14, Slide the carrier up to the bottom of the column 4. Counterbalance the analyzer and firmly press upward on the pusher at the bottom of the carrier. This loads the pin on the skewer. Pusher Figure 7-15, Use the plastic pusher to load the pin on the skewer 5. Slide the carrier down and check at eye level to ensure that the tip of the skewer is touching the inside bottom of the disposable pin. Refer to the following illustrations for the correct (A) and incorrect (B) placement of the pin on the skewer. A Figure 7-16, Correct pin placement TEG® 5000 System User Manual B Figure 7-17, Incorrect pin placement P/N 06-510-US, Manual revision: AD 7-16 Operating the TEG Analyzer 6. Support the bottom of the carrier and press the cup firmly into the cupwell. When the cup is seated correctly, the flange of the cup touches the top of the carrier. Figure 7-18, Press the cup firmly into the cupwell Ejecting the cups and pins To eject the disposable cups and pins: 1. After a test is finished, return the levers to Load. 2. Press the lever down to the Eject position. 3. Slide the carrier down and ensure that the pin has dropped into the cup. 4. Press the carrier down firmly against the platform so that the plastic pusher located at the bottom of the carrier pushes the cup and pin out of the cupwell. Figure 7-19, Push the cup and pin out of the cupwell 5. Lift the raised cup and pin out of the cupwell and dispose of them properly. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-17 COLLECTING AND PREPARING BLOOD SAMPLES Overview This section describes the materials and procedures for collecting and preparing various types of TEG blood samples. Refer to “TEG Sample Types” on page 4-12 for information about the types of blood samples that can be run on the TEG analyzer. Caution: Before running samples on the TEG analyzer, you should be familiar with all necessary safety precautions and laboratory techniques outlined in Chapter 3, “Safety and Precautions.” The use of a standardized method for the collection and handling of blood samples ensures that TEG analyzer results are reproducible and reliable. Haemonetics recommends that the user follow locally established procedures for the collection and handling of specimens. The TEG analyzer sample cup holds a final blood volume of 360 microlitres (µL), unless specified otherwise in the product insert or procedure. Depending on the sample type and whether or not you are running whole blood or modified samples, you pipette between 330 µL and 360 µL into the cup, plus a fixed amount of an activator or modifier. Disposable cups and pins, as well as other analyzer supplies are available directly from Haemonetics. For reliability and ease of use, activators/modifiers are available either in pretreated disposable cup format or in pre-measured vials, depending on the reagent. This section contains instructions for the following procedures: Collecting a non-citrated blood sample Collecting a citrated blood sample Collecting a heparin blood sample Preparing TEG blood samples including: TEG® 5000 System User Manual Native samples Heparinase samples Activated samples - Kaolin Activated samples - RapidTEG™ PlateletMapping® assay Functional Fibrinogen samples P/N 06-510-US, Manual revision: AD 7-18 Before you begin Operating the TEG Analyzer Before you begin to collect and prepare blood samples, make sure you have the following supplies ready: Supplies for blood collection □ Discard tube (to be discarded or used for other tests) □ 21 gauge or larger needle, preferably a butterfly needle with 12 inch tubing Caution: Never use a smaller needle. Smaller needles may cause hemolysis and activation of clotting which can produce inaccurate results. □ Collection tube (polypropylene test tube, sodium citrated, or heparin) □ Disposable gloves Supplies for running TEG blood samples □ □ □ □ Collecting a noncitrated blood sample Disposable cups and pins Pipettors and tips Blood sample Disposable gloves If you are using an analyzer at a point-of-care site and can run a sample within 4 to 6 minutes of drawing the blood, you can use a non-citrated blood sample. Note: Ensure that reagents are prepared as per the product insert before drawing a non-citrated sample. A non-citrated blood sample must be run within 4 to 6 minutes after the draw. The Steps To collect a non-citrated blood sample (after first preparing the reagents): 1. Determine the appropriate site for blood collection and draw a discard tube: a. Venipuncture: Discard the first 3 mL. b. Central venous or pulmonary artery catheters: Draw from the appropriate port as per your institution policy and discard the first 3mL. c. Arterial lines: Discard the first 3 mL. 2. Draw slightly more than 1mL of blood into a syringe or tube. Avoid air bubbles and frothing. Do not shake. 3. Run the sample within 4 to 6 minutes of the draw. Note: Although the sample can be assayed between 4 and 6 minutes, reference ranges in TAS are based upon assay at 4 minutes. Sequential samples drawn from the same patient should be run at the same time interval between the draw and the assay. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer Collecting a citrated blood sample 7-19 If the sample cannot be run within 4 - 6 minutes for whole blood samples, use a citrated sample instead. This allows you to run the sample at any time within a 15 minute to 2 hour time frame. These samples are drawn into a 3.2% sodium citrate tube. Caution: Use only 3.2% sodium citrate tubes. Using any other percentage of sodium citrate can affect the R time. Sodium citrate chelates the calcium ions in the blood which suspends the clotting process. Before running the sample on the analyzer, you need to recalcify it by adding calcium chloride. Since it takes time for the sample to equilibrate, it is recommended that you wait a minimum of 15 minutes before running a citrated sample on the analyzer. A citrated sample must be run within 2 hours of drawing the blood. Note: It is important to set a consistent time (for example, 15 minutes after the blood draw) for running citrated blood samples. This reduces variability in test results. The Steps To collect a citrated blood sample: 1. Determine the appropriate site for blood collection and draw a discard tube: a. Venipuncture: Discard the first 3 mL. b. Central venous or pulmonary artery catheters: Draw from the appropriate port as per your institution policy and discard the first 3 mL. c. Arterial lines: Discard the first 3 mL. 2. Draw one sodium citrate tube of blood to the appropriate level. 3. Gently invert the tube 5 times to mix. 4. Place the tube horizontally on the table until it is time to analyze the blood. 5. Wait at least 15 minutes before running the sample and run it within 2 hours. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-20 Collecting a heparin blood sample Operating the TEG Analyzer If you are running a PlateletMapping® assay, the A, AA, and ADP samples must be prepared using blood samples preserved in heparin tubes. The blood is collected in a tube containing heparin, an anticoagulant that suppresses thrombin. Either sodium heparin or lithium heparin is acceptable. Note: Verify that the heparin tubes in use at your institution are non-gel heparin Vacutainer® tubes with 14.5 IU or greater heparin/mL blood. Note: Heparin tubes must be used when running A, AA, or ADP PlateletMapping samples. The Steps To collect a heparin blood sample: 1. Determine the appropriate site for blood collection and draw a discard tube: a. Venipuncture: Discard the first 3 mL. b. Central venous or pulmonary artery catheters: Draw from the appropriate port as per your institution policy and discard the first 3 mL. c. Arterial lines: Discard the first 3 mL. 2. Draw one heparin tube of blood to the appropriate level. 3. Gently invert the tube 5 times to mix. 4. Place the tube horizontally on the table until it is time to analyze the blood. 5. Wait at least 15 minutes before running the sample and run it within 2 hours. Preparing TEG blood samples This section explains how to prepare the following TEG blood samples: Native (no reagent) Heparinase reagent Kaolin reagent PlateletMapping assay RapidTEG reagent Functional Fibrinogen reagent Note: With the exception of native blood samples, the instructions for preparing and running the samples are also in the product inserts for each reagent. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer Native samples (no reagent) 7-21 A native sample is whole blood with no added activator. A native sample can be: Anticoagulated using either sodium citrate or heparin. Run with or without heparinase cups. Procedure 1. In TAS, enter sample identification (refer to “Running Samples” on page 726). 2. Draw a blood sample (refer to “Collecting a non-citrated blood sample” on page 7-18 or “Collecting a citrated blood sample” on page 7-19). 3. For a non-citrated sample, wait four minutes. For a citrated sample, wait 15 minutes. 4. Pipette the following into the bottom of a plain or heparinase cup: Blood calcium chloride Non-citrated blood sample Citrated blood sample 360 µL 340 µL N/A 20 µL 5. Proceed with starting the sample run (refer to “Running Samples” on page 7-26). Heparinase samples Heparinase cups and pins (source: Haemoscope) are color-coded blue and are used to reverse the effects of up to 6 International Units (IU) of heparin per mL of blood. Each blue cup contains 2 IU of heparinase. You can use heparinase cups and pins for citrated or non-citrated samples and for native or activated samples. Heparinase cups and pins are used: When the patient is on heparin. When the sample has been drawn through a heparin-loaded line. When there is any chance that the sample has been contaminated with heparin. Post-Protamine to monitor adequate heparin reversal. Note: Heparinase cups are often run with plain cups to assess whether or not heparin is present or has ben adequately reversed. Procedure 1. In TAS, enter sample identification (refer to “Running Samples” on page 726). 2. Draw a blood sample (refer to “Collecting a non-citrated blood sample” on page 7-18 or “Collecting a citrated blood sample” on page 7-19). 3. Pipette the following into the bottom of a blue heparinase cup: Blood calcium chloride Non-citrated blood sample Citrated blood sample 360 µL 340 µL N/A 20 µL 4. Proceed with starting the sample run (refer to “Running Samples” on page 7-26). TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-22 Activated samples kaolin Operating the TEG Analyzer To reduce the time that a sample takes to start clotting, you can add kaolin, an activator, to a blood sample. Kaolin is available in premeasured vials (source: Haemoscope). A kaolin sample can be: Citrated (CK) or non-citrated (K). Run with heparinase cups (KH or CKH) or without. Figure 7-20, Kaolin sample types Procedure 1. In TAS, enter sample identification (refer to “Running Samples” on page 726). 2. Draw a blood sample (refer to “Collecting a non-citrated blood sample” on page 7-18 or “Collecting a citrated blood sample” on page 7-19). 3. Add 1 mL of blood to the vial containing the kaolin reagent (unless specified otherwise in a product insert or other procedure). 4. Cap the vial and gently mix by inversion five times. 5. Pipette the following into the bottom of a plain or heparinase cup: Blood & kaolin mixture calcium chloride Non-citrated kaolin sample Citrated kaolin sample 360 µL 340 µL N/A 20 µL 6. Proceed with starting the sample run (refer to “Running Samples” on page 7-26). 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer Activated samples RapidTEG™ 7-23 To reduce the time that a sample takes to start clotting, you can add the RapidTEG reagent, an activator, to a blood sample. RapidTEG reagent is available in premeasured vials (source: Haemoscope). A RapidTEG sample can be: Citrated (CRT) or non-citrated (RT). Run with heparinase cups (RTH or CRTH) or without. Figure 7-21, RapidTEG sample types Procedure 1. In TAS, enter sample identification (refer to “Running Samples” on page 726). 2. Draw a blood sample (refer to “Collecting a non-citrated blood sample” on page 7-18 or “Collecting a citrated blood sample” on page 7-19). 3. Prepare the RapidTEG reagent as outlined in the product insert. 4. Pipette the following into the bottom of a plain or heparinase cup: RapidTEG reagent Blood calcium chloride Non-citrated RapidTEG sample 10 µL 360 µL N/A Citrated RapidTEG sample 10 µL 340 µL 20 µL 5. Pipette up and down three times in the cup to mix. Note: To avoid creating bubbles during mixing, place the pipette tip at the bottom of the cup. 6. Proceed with starting the sample run (refer to “Running Samples” on page 7-26). TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-24 PlateletMapping assay Operating the TEG Analyzer The TEG PlateletMapping Assay measures a patient’s hemostatic balance and response to antiplatelet therapy. The assay involves running a thrombin sample (kaolin activated), an activated sample (A), and an agonist sample (ADP or AA). The PlateletMapping assay is available in the following three kit formats (source: Haemoscope): Full kit which includes AA and ADP AA kit ADP kit The kaolin sample can be: Citrated (CK) or non-citrated (K). Run with heparinase cups (KH or CKH) or without. The A, AA, and ADP samples must be run using heparin blood samples. The following graphic shows the samples for the full PlateletMapping kit (A, AA, and ADP) with non-citrated kaolin. This is only one option for running the PlateletMapping assay. For complete instructions, refer to the TEG 5000 System Guide to the PlateletMapping® Assay. Figure 7-22, Full PlateletMapping assay with non-citrated kaolin 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer Functional Fibrinogen (FF) samples 7-25 The Functional Fibrinogen (FF) reagent is used to produce a clot without platelet contribution. Functional Fibrinogen is available in premeasured vials (source: Haemoscope). A Functional Fibrinogen sample can be: Citrated (CFF) or non-citrated (FF). Run with heparinase cups (FFH or CFFH) or without. Figure 7-23, Functional Fibrinogen sample types Procedure 1. In TAS, enter sample identification (refer to “Running Samples” on page 726). 2. Draw a blood sample (refer to “Collecting a non-citrated blood sample” on page 7-18 or “Collecting a citrated blood sample” on page 7-19). 3. Add 500 µL of blood to the vial containing the Functional Fibrinogen reagent (unless specified otherwise in a product insert or other procedure). 4. Cap the vial and gently mix by inversion five times. 5. Pipette the following into the bottom of a plain or heparinase cup: Blood & FF mixture calcium chloride Non-citrated FF sample 360 µL Citrated FF sample 340 µL N/A 20 µL 6. Proceed with starting the sample run (refer to “Running Samples” on page 7-26). TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-26 Operating the TEG Analyzer RUNNING SAMPLES Note: Before running samples on the TEG® analyzer, you should be familiar with all necessary safety precautions and laboratory techniques outlined in Chapter 3, “Safety and Precautions.” Before you begin Starting samples Before you run a sample, make sure you have done the following: Performed maintenance checks if appropriate. Prepared the sample by collecting and processing the blood. Logged into TAS and displayed the TEG screen. 1. In the TEG screen, complete the Patient name field for the appropriate channel: If this is… Then do the following… A new patient a. Click screen. to display the Select case mode b. Select the Add case option and click Done. c. Complete the Create case screen. d. Click Done. An existing patient e. In the Patient name field that corresponds to the channel, click the down arrow and select the patient name. a. In the Patient name field that corresponds to the channel, click the down arrow and select the patient name. 2. In the ST (sample type) field that corresponds to the channel, select the sample type you want to run from the drop-down list. For example, to run a Kaolin sample, you would select “K-Kaolin.” 3. In the Sample description field, select or type a description. 4. Load the cups and pins for all the channels that you are going to run. For instructions, refer to “Loading the cups and pins” on page 7-14. 5. For the first channel, pipette the appropriate sample into the cup. 6. Immediately raise the carrier until it is flush with the bottom of the column. Caution: Do not raise the carriers too quickly. If a carrier is pushed up too quickly, the pin displaces the sample with enough force to splash material onto the flange of the cup. This can affect test results. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-27 7. Move the lever to TEST. 8. From the TEG screen, highlight the corresponding channel and click (or press F10). The channel in the TEG screen turns green, indicating it is active. The Active button flashes at the bottom of the screen when the sample is selected. 9. Repeat steps 5 to 8 for each channel on which you are running the test. 10. Click Done to return to the TAS Main screen. Terminating samples A sample automatically terminates when the end-of-run conditions specified by TAS have been met. For example, your system may be set to terminate a sample after LY30 is defined. You can manually terminate the sample earlier if you require only some parameters to be finalized. In TAS, a parameter is finalized when an asterisk no longer appears next to it on the tracing. To manually end a sample run: Note: All samples automatically terminate if you exit the software or terminate the database. 1. From the TAS Main screen, select the channel that you want to stop. 2. Click (or press F11). A message similar to the following appears: 3. Click Yes to terminate the sample. The channel turns white, indicating that the sample is terminated. 4. Eject the blood sample and properly dispose of it. See “Ejecting the cups and pins” on page 7-16. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 7-28 Operating the TEG Analyzer CLEANING THE TEG ANALYZER The surfaces of the TEG analyzer must be cleaned and disinfected weekly, or more frequently, if needed. The lower column and skewer tip must also be cleaned and disinfected as needed. The analyzer must also be cleaned and disinfected prior to return shipment if maintenance servicing is necessary. For further information, refer to “Product return guidelines” on page 1-4. Use the following recommended cleaning schedule: Materials needed □ □ □ □ □ □ Surfaces: As needed, but no less than weekly Lower column and skewer: As needed Disposable gloves 70- 95% ethyl or isopropyl alcohol Cotton swabs 2” x 2” gauze pad Disposable cup for the TEG analyzer Biohazard disposal system Caution: Do not use bleach as it is corrosive to analyzer components. Cleaning the analyzer surfaces To clean and disinfect the surfaces of the analyzer: 1. Put on disposable gloves. 2. Using disinfectant wipes or alcohol, thoroughly clean the following components: Outer surfaces of the analyzer Platform (remove first) Surfaces behind the carriers and above the columns Outer surface of columns and the column lever 3. Using an alcohol swab, disinfect the cupwell and the carrier surfaces. 4. Place all disinfectant materials, including the gloves, in a biohazard container. Cleaning the lower column and skewer To clean and disinfect the lower column and skewer tip: 1. Put on disposable gloves. 2. Fill a disposable cup with alcohol and place in the cupwell. 3. Cut the gauze pad in quarter sections. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Operating the TEG Analyzer 7-29 4. Ensure the lever is in Load position. Caution: Do not clean the skewer with the lever in Test position as this can damage the thin torsion wire attached to the skewer. 5. Wrap an alcohol soaked gauze section around the tip of the skewer. 6. Gently move the carrier to the raised position to hold the gauze in contact with the skewer. 7. After 10 minutes of contact, lower the carrier and remove the gauze. 8. Using an alcohol swab, clean the interior of the column, removing any residue. 9. Place all disinfectant materials, including the gloves, in a biohazard container. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Chapter 8 Viewing and Annotating TEG Analyzer Data TEG ANALYZER DATA OVERVIEW. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2 VIEWING TRACINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Viewing parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Tracing lines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3 Maximizing a tracing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4 Displaying data for a tracing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6 Displaying multiple tracings (comparing samples) . . . . . . . . . . . . . . . . . 8-7 Navigating between multiple tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8 Printing a single tracing using Quick Print . . . . . . . . . . . . . . . . . . . . . . 8-10 Using reference tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10 Using normal tracings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12 When no tracing appears . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13 Viewing PlateletMapping® tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-13 Viewing Functional Fibrinogen tracings . . . . . . . . . . . . . . . . . . . . . . . . 8-16 Viewing RapidTEG™ tracings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-17 USING FILTERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19 Using Quick filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20 Using the Advanced filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-21 USING THE GUIDE FEATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-30 Using the Show Me option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-30 Manually selecting a tracing in Guide . . . . . . . . . . . . . . . . . . . . . . . . . 8-32 Using the coagulopathy library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-33 GENERATING AND PRINTING REPORTS. . . . . . . . . . . . . . . . . . . . . . . . . 8-37 Generating patient reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-37 Generating quality assurance reports . . . . . . . . . . . . . . . . . . . . . . . . . . 8-45 Generating the operator report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-49 VIEWING AND ENTERING SAMPLE DETAILS. . . . . . . . . . . . . . . . . . . . . . 8-50 Viewing details on the Detail screen. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-50 Entering details on the Tracing tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-53 Entering details on the Sample tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-56 Entering details on the Notes tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-58 USING THE NOTES FEATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-59 Adding or viewing SNotes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-59 Adding or viewing Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-60 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-2 Viewing and Annotating TEG Analyzer Data TEG ANALYZER DATA OVERVIEW This chapter explains how to view and annotate TEG® analyzer data. It includes the types of tracings and filtering that you can display in the TEG Analytical Software (TAS) to help interpret sample data. It also covers the types of modifications you can make to sample data. This chapter includes the following sections: Viewing Tracings Using Filters Using the Guide Feature Generating and Printing Reports Viewing Sample Details Using the Notes Feature 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-3 VIEWING TRACINGS A tracing provides much information about a sample. The way in which you view or set a tracing may determine the information that displays or the type of information that you can access. This section covers information necessary for understanding, navigating, displaying and printing tracings. Viewing parameters Parameters from a sample test are displayed both as solid lines on the tracing and as numeric data along the bottom of the tracing as show in the example below. Figure 8-1, Tracing parameters Flashing parameters Your system may be configured to flash when a parameter reaches certain trigger values stored in the software. For example, if your Site Administrator set the option for flashing parameters, the MA value of 76.1on the above tracing would flash because it is outside the trigger values in the software. Tracing lines Several types of lines appear on a tracing. Some are vertical, horizontal, dotted, and in a different color. The line color corresponds to the test parameter. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-4 Viewing and Annotating TEG Analyzer Data Figure 8-2, Tracing lines The following is a description of the lines that you may see on a tracing. Solid Lines The solid line on a tracing graphically represents the actual value for a parameter. For example, in the tracing above the solid green line indicates the value for K. Colored dashed lines You will notice that the tracings contain dashed lines of different colors. These lines graphically represent the reference range of a particular TEG parameter. The line color corresponds to the test parameter. For example, in the tracing above, the purple, horizontal dashed lines indicate the reference ranges for the MA parameter. Notice that data for the MA parameter displays in purple in the bottom of the tracing, including its reference range and the actual value. Grid lines Horizontal, dotted grid lines on the background of the TEG tracing serve as a ruler, representing 10 millimeters between each line. When you view a single tracing in maximized view, these dotted lines appear white by default. Maximizing a tracing In the TAS Main screen, tracings appear in thumbnail format. You can maximize or enlarge the size of a tracing in order to display it in full-screen size. Thumbnail tracings on the TAS Main screen are shown in the example below. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-5 Figure 8-3, TEG tracings in thumbnail view on the TAS Main screen To maximize a tracing: From the TAS Main screen, either: Double-click on the desired tracing or Click anywhere on the sample data row and click . The thumbnail tracing shown on the bottom left in Figure 8-3 above is shown in maximized view in the example below: Figure 8-4, TEG tracing in maximized view To return to the TAS Main screen, double-click on the tracing or click TEG® 5000 System User Manual . P/N 06-510-US, Manual revision: AD 8-6 Displaying data for a tracing Viewing and Annotating TEG Analyzer Data You can display a Sample info pop-up window on a tracing that contains data in a panel. Sometimes a clot graphic displays on the screen depending on the configuration of your system and the data available. Data displays in different formats, allowing you to interpret data in the way that is most meaningful to you. Figure 8-5, Sample info screen displaying data for the tracing You can display data for a tracing in two ways: Clicking the tracing line with your mouse Clicking the Data icon on the toolbar Using the mouse To display data for a tracing using your mouse: 1. With the tracing in maximized view, hover your mouse anywhere over the tracing line until the cursor changes to a hand. 2. Click the tracing line. The Sample info screen appears on the tracing. 3. Click the X at the top right corner of the screen to close the Sample info screen. Using the Data icon To display data for a tracing using the Data icon: 1. Do one of the following: If you are on the... Then… TAS Main screen Select the thumbnail tracing you want to display data for. Maximized tracing Go to step 2. 2. On the toolbar, click . The Sample info screen appears. 3. Click the X at the top right corner of the screen to close the Sample info screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data Displaying multiple tracings (comparing samples) 8-7 You can view more than one tracing in maximized view, either offset or superimposed, with each tracing in a different color. In offset mode, the tracings are staggered while in superimposed mode the tracings overlay each other. You can toggle between offset and superimposed modes by clicking the respective icon on the tool bar. When the tracings are displayed in offset mode, the superimposed icon displays. Likewise, when the tracings are displayed in offset mode, the superimposed icon displays. To display multiple tracings: 1. From the TAS Main screen, click Notice that the icon changes to . . 2. Select the sample tracings that you want to view. 3. Click . The multiple tracings display by default either in offset mode (non PlateletMapping® samples) or superimposed mode (PlateletMapping samples), with each tracing in a different color. Note: If you select more than 16 tracings, the color cycle will repeat as only 16 colors are available. 4. To display the multiple tracings in offset or superimposed mode, do one of the following: Offset mode: on the toolbar, click . Figure 8-6, Viewing multiple tracings in offset mode TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-8 Viewing and Annotating TEG Analyzer Data Superimposed mode: on the toolbar, click . Figure 8-7, Viewing multiple tracings in superimposed mode Notice that the R for each tracing overlays each other. 5. To return to the TAS Main screen, double-click on the tracing or click Navigating between multiple tracings . When you have more than one tracing displayed, you can navigate from one tracing to the next using one of two methods: Using the Page Up and Page Down keys Clicking a tracing line with your mouse As you navigate between tracings, you’ll notice that each tracing has its own unique color. The currently selected tracing, the associated values and the text have the same color. In the following example, two tracings are displayed in offset mode with the “Baseline” sample tracing showing in green. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-9 Figure 8-8, Viewing the first tracing After pressing the Page Up or Page Down key or clicking the green tracing line with the mouse, the view changes to display the “Rewarming” sample as shown below in white. Figure 8-9, Viewing the second tracing Navigate using the Page Up and Page Down keys To navigate between multiple tracings using the Page Up and Page Down keys: 1. Press the Page Up or Page Down key to scroll through the tracings until the tracing you want is shown. Navigate using the mouse To navigate between multiple tracings using your mouse: 1. Hover your mouse anywhere over the tracing line of the tracing you want to view. The cursor changes to a hand. 2. Click the tracing line. The view changes to show that tracing. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-10 Printing a single tracing using Quick Print Viewing and Annotating TEG Analyzer Data At any time when you are in the TAS Main screen or viewing a maximized tracing, you can use the Quick Print feature to print a tracing. The tracing prints with exactly the information that you see on the maximized display on an 8.5 by 11 sheet of paper. To quickly print a TEG tracing: 1. Choose the appropriate action: If you are at the… Do the following… TAS Main screen Select the tracing that you want to print Maximized tracing Continue at step 2 2. On the toolbar, click . The Print screen appears. Note: If you want to send the tracing to the default printer without any prompts, press F6 instead of the Print button. 3. Select the appropriate printer and click Print. For instructions on printing full reports and multiple tracings, refer to “Generating and Printing Reports” on page 8-37. Using reference tracings The Reference tracing feature allows you to: Set a reference tracing Display or hide a reference tracing You can set a tracing as a reference to compare one sample to another. For example, during a clinical procedure you may want to compare a baseline sample to a sample after treatment. When you set a tracing as a reference tracing, it remains in effect until you exit TAS or decide to change it during the current session. Note: Each time you shut down the software or change databases, you need to reset the reference tracing. About the Reference icon While viewing a maximized tracing, the Reference icon on the toolbar allows you to display or hide the tracing that you set as a reference. A shaded out Reference icon when viewing a maximized tracing indicates that a reference tracing is not set. The Reference icon displays as active only on a maximized tracing and is always shaded out on the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-11 Setting a reference tracing You can set a reference tracing from the Sample info screen or from the Detail screen. Note: For more information on the Detail screen refer to “Viewing and Entering Sample Details” on page 8-50. To set a reference tracing: 1. Select the tracing to use as the reference. 2. Do one of the following: Click… And do the following... Display the Sample info screen and click the Reference button Display the Detail screen and click the Set reference button Displaying a reference tracing To display a reference tracing to compare to another tracing: 1. Select and maximize the sample tracing that you want to compare to the reference tracing. 2. Click . A screen similar to the following displays: Figure 8-10, Reference tracing Notice the following: The reference tracing displays in red dashes unless you changed the default color or line type. The dotted lines that show the ranges for the parameters disappear from the screen. Like a regular sample tracing, you can navigate to the reference tracing to see the results. 3. To hide the reference tracing, click TEG® 5000 System User Manual again. P/N 06-510-US, Manual revision: AD 8-12 Using normal tracings Viewing and Annotating TEG Analyzer Data A normal tracing represents the normal shape for a particular sample type and is saved from session to session. You have the option to set a patient’s tracing as normal. About the Normal icon A shaded out Normal icon on a maximized tracing indicates that a normal tracing is not set. The Normal icon displays as active only on a maximized tracing and is always shaded out on the TAS Main screen. Setting a normal tracing You can set a normal tracing from the Sample info screen or from the Detail screen. To set a normal tracing: 1. Select the tracing to use as the normal tracing. 2. Do one of the following: Click… And do the following... Display the Sample info screen and click the Normal button Display the Detail screen and click the Save as normal button 3. If a normal tracing has already been set for the sample, you are prompted to overwrite the previous normal tracing or cancel. Displaying a normal tracing To display a normal tracing to compare to another tracing: Note: Even though the screen with the normal tracing looks like a multi sample screen if you print a report, it will print as a single sample report. 1. Select and maximize the sample tracing that you want to compare to the normal tracing. 2. Click . A screen similar to the following appears. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-13 Figure 8-11, Normal tracing Notice the following: When no tracing appears The normal tracing displays in purple dashes unless you changed the default color or line type. If several tracings are displayed in maximized view, the normal changes to reflect the normal for the sample type of the currently selected tracing. Sometimes, a tracing may not appear and a message similar to the following displays: Figure 8-12, No tracing available This indicates that the record was manually created and no tracing data exists in the database for that record. Viewing PlateletMapping® tracings The tracings from running the TEG PlateletMapping® assay offer the following information about a patient’s condition and response to therapy: Patient’s risk for a bleeding or an ischemic event Patient’s response to a particular antiplatelet drug TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-14 Viewing and Annotating TEG Analyzer Data About the PlateletMapping Assay The PlateletMapping assays use a whole blood sample to measure the: Percent aggregation which indicates the degree to which the platelets participate in clot formation. Percent platelet inhibition which indicates the degree that platelet participation is reduced. The PlateletMapping assays include running a kaolin sample, an activated sample, and an ADP or AA sample, depending on the patient’s needs. Clot strength is measured by MA. The kaolin sample measures the maximum clot strength possible, which includes fibrin and uninhibited platelet function. This MA is referred to as MAThrombin and shows the patient’s underlying hemostasis. It typically serves as the baseline for the patient. The activator indicates clot strength without platelet participation and is referred to as MAA. The ADP (MAADP) and AA (MAAA) indicate how the patient responds to a particular drug. The relation of these samples is used to determine the degree of platelet inhibition. By using this result in conjunction with the underlying hemostasis, an assessment of thrombotic or bleeding risk can be made. Note: For a complete guide to the PlateletMapping assay, refer to the TEG 5000 System Guide to the PlateletMapping® Assay. Generating PlateletMapping results To generate PlateletMapping results, click and select the following three types of samples from the TAS Main screen: Kaolin sample (K, CK, KH, or CKH) Activator sample (A) Agonist sample (ADP or AA) TAS then calculates and displays the percent inhibition, the percent aggregation, and other related data. Viewing PlateletMapping tracings After the PlateletMapping assay is run and the results are displayed, the tracings will help determine whether a patient is: Hypercoagulable Hypocoagulable Normal The results aid in evaluating if a patient needs antiplatelet therapy due to platelet hypercoagulability and indicates the patient’s responsiveness or resistance to antiplatelet therapy. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-15 The following tracing shows a patient before taking aspirin. Figure 8-13, PlateletMapping tracing before taking aspirin The next tracing shows the effect of aspirin on this patient, indicating a 97.7% inhibition. Figure 8-14, PlateletMapping tracing after taking aspirin When PlateletMapping tracings are displayed in TAS, a small PM pop-up window displays on the tracing. The PM window displays the % inhibition, % aggregation, and the MA and G values, as shown in the example below. Figure 8-15, PM pop-up window TAS saves PlateletMapping data on the Clusters tab in the Edit case screen. For more information, refer to “Clusters tab” on page 10-16. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-16 Viewing Functional Fibrinogen tracings Viewing and Annotating TEG Analyzer Data Functional Fibrinogen (FF) assay tracings provide information about the contribution of functional fibrinogen to clot strength. Viewing an FF sample with a kaolin sample in Multiple Tracing mode can provide information about the contribution of platelets to the clot strength. About the Functional Fibrinogen assay The TEG Functional Fibrinogen (FF) assay is used to determine the independent contributions of platelets and fibrinogen to clot strength. The assay inhibits platelet contribution, which makes it possible to measure only the functional fibrinogen contribution to clot strength (MA). By using the FF assay in conjunction with a kaolin sample, the MA of the functional fibrinogen can be subtracted from the MA of the kaolin sample to calculate the contribution of the platelets to clot strength. All TEG parameters are measured during the FF test. The TEG software also calculates the Functional Fibrinogen Level (FLEV), the fibrinogen concentration in the blood. This estimate is derived through the transformation of the FF sample’s MA value. Viewing FF tracings Single tracing mode When you display the tracing of an active FF sample or an FF sample stored in the database, the program displays the FLEV value in concentration units in the upper left corner of the tracing. Note: If no value is shown for MA, there will be no value displayed for FLEV. While the MA is developing, interim FLEV values display, but the final FLEV value displays only when MA is defined. Figure 8-16, Functional Fibrinogen tracing showing the FLEV concentration 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-17 Multiple tracing mode In order to assess the platelet contribution to clot strength, you can view the FF sample in conjunction with a kaolin sample in Multiple Tracing mode. The following additional values appear at the top of the screen, replacing the sample description. MAP - The value of MA due to platelet contribution. This is the absolute difference between the MA value of the FF sample and the MA value of the kaolin sample. FLEV - The functional fibrinogen level is computed using the MA value of the FF sample. Figure 8-17, Functional Fibrinogen and kaolin tracing showing MAP and FLEV Viewing RapidTEG™ tracings RapidTEG sample tracings provide information about the activated clotting time (ACT). About the RapidTEG™ reagent When high levels of heparin anticoagulation are present, the RapidTEG reagent produces an accelerated R time that is mathematically transformed into an activated clotting time (ACT) value and is reported by the TEG software as TEG–ACT. The RapidTEG test produces TEG parameters sooner than the standard kaolin test. However, this highly concentrated, rapid activation can reduce the sensitivity in clot development for the time dependent parameters. To gain the most information about patient hemostasis in time-dependent parameters, the RapidTEG test and the kaolin test can be run simultaneously. While the RapidTEG test provides finalized TEG parameters more quickly, the standard kaolin test provides the time dependent parameters without losing sensitivity. Together, the tests provide both speed and accuracy. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-18 Viewing and Annotating TEG Analyzer Data Viewing RapidTEG tracings The RapidTEG tracing provides complete TEG results with one additional parameter, TEG–ACT, which is an ACT value. The TEG–ACT parameter displays at the bottom of a RapidTEG tracing, as shown in the example below. Figure 8-18, Tracing showing TEG ACT parameter Including the RapidTEG sample types in TAS The RapidTEG sample types are not configured to display by default in the sample type drop-down list in TAS. If your Site Administrator did not include the RapidTEG sample types during configuration setup, you can change your user profile setup to display them in TAS. You can include the following four RapidTEG sample types: RT - RapidTEG CRT - Citrated RapidTEG RTH - RapidTEG with heparinase CRTH - Citrated RapidTEG with heparinase For instructions on how to include sample types, refer to “Including sample types in the TAS display” on page 6-13. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-19 USING FILTERS This section explains how to use the four kinds of filters available in TAS. Three are considered quick filters because they have preset criteria for displaying particular sample records and one is a custom/advanced filter that allows you to specify the criteria. The filter feature enables you to specify the type of records that you want to view. The quick filters and custom filter have features that allow you to: Recognize when a filter is in use Remove a filter Use a combination of filters Recognizing a filter After you implement a filter, the desired sample record(s) appear on the TAS Main screen. The top half of the filter icon that you used becomes shaded in blue, indicating that a filter is in effect as shown in the following example: Removing a filter To remove a filter, click the filter icon that you used again. The blue disappears from the top portion of the icon, indicating that the filter is removed. Using a combination of filters You can use more than one filter at a time, including any combination of quick and custom filters. For example, you have a patient who has had different tests performed at various sites at your facility. You are interested in only those tests conducted in OR3. Therefore, you decide to first use the Patient filter to display records only for this specific patient and then use the Site filter to narrow the display to this patient’s records that pertain to OR3. If you choose, you could filter the samples even further by specifying more criteria through the Filter feature. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-20 Using Quick filters Viewing and Annotating TEG Analyzer Data Depending on how databases are used at your site, when a database is opened you may see either an empty TAS Main screen or one that is filled with samples, many which are not relevant to you. You can easily suppress the records that do not pertain to you by filtering. Three quick filters that TAS provides are: Patient Site Active The Patient filter enables you to display sample records that are for a specific patient only and the Site filter enables you to display records that are for a specific site only. Use the Active filter to display all samples that are still active. You can also use a combination of the quick filters. Patient filter The Patient filter allows you to select the patient(s) whose data you want to view on the TAS Main screen. To set the Patient filter: 1. From the TAS Main screen, click to display the Patient screen. Figure 8-19, Patient screen 2. Select the patient name(s) you want. 3. Click Done. The TAS Main screen displays sample records only for the patient(s) you selected. Site filter The Site filter allows you to display sample records only for the site(s) that you specify. To set the Site filter: 1. From the TAS Main screen, click 06-510-US, Manual revision: AD to display the Select Site ID screen. TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-21 Figure 8-20, Select Site ID 2. Select the site ID(s) you want. 3. Click Done. The TAS Main screen displays sample records only for the site(s) you selected. Active filter The Active filter allows you to view only samples that are active; that is, samples that are still running on the TEG® analyzer. If no samples are active, then no data displays on the TAS Main screen. To set the Active filter: 1. From the TAS Main screen, click are active. 2. Click Using the Advanced filters to display only sample records that again to display all sample records on the TAS Main screen. The Advanced Filter feature displays the Filter criteria screen, which consists of seven tabs, with each tab being a different filter type. These tabs or filters are cumulative. As a result, you can use all or a combination of the tabs to filter the data. You can select up to a maximum of 40 different criteria. The custom filter enables you to view records by: Ranges of values for test results Patient name or Patient ID Sample type Channel number Dates Type of case Any other field contained in the patient database Whenever you use one of the custom filters, the box on the left side of the screen which contains the filter’s name automatically becomes checked. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-22 Viewing and Annotating TEG Analyzer Data To access the Advanced Filter feature: 1. On the TAS Main screen toolbar, click screen. to display the Filter criteria Figure 8-21, Filter criteria screen 2. Continue at the appropriate section in this chapter. Test results tab If you want to filter by... Continue at... Ranges of values for test results “Test results tab” on page 8-22 Patient name or Patient ID “Patient tab” on page 8-24 Sample type “Sample type tab” on page 8-24 Channel number “Channel tab” on page 8-25 Date or date range “Dates tab” on page 8-26 Type of case “Case tab” on page 8-27 Any field contained in the patient database “Custom tab” on page 8-28 The Test results tab fallows you to display samples that have the test results that you specify. For example, to display only those samples whose R value is between 5 and 9, you would enter these values in the appropriate fields. You can specify test result criteria for more than one test at a time. To filter for particular test results: Before You Begin 06-510-US, Manual revision: AD Display the Filter criteria screen TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-23 The Steps 1. From the Filter criteria screen, click the Test results tab. 2. In the drop-down list, select the tests for which you want to filter. For example, if you want to view samples with R values within a specific range, select “R.” Figure 8-22, Filter criteria screen, Test results tab 3. In the next two fields, enter the beginning and ending values for the range that you want. Note: To view test results for a specific value only, enter the same number in both fields. You must complete both fields. 4. Do one of the following: TEG® 5000 System User Manual If you want to... Then click the... Add another test to the filter More button. Another line displays ready for you to add the test criteria data. Hide the last criteria line added through the More button Fewer button. Note: If you added more than one line, the Fewer button hides the last line added. If you click the More button the line reappears. Clear the data ranges you entered Clear all button. Clear all filter criteria entered and return to the TAS Main screen Cancel button. Include another type of filter criteria Desired tab. Continue at the appropriate section in this chapter. Display the samples that meet the criteria you specified Apply filter button. The TAS Main screen displays only those samples that meet the criteria you specified. P/N 06-510-US, Manual revision: AD 8-24 Patient tab Viewing and Annotating TEG Analyzer Data The Patient tab allows you to display only those records that you specify by patient name or by patient ID. Select as many patient names or patient IDs that you want to use as the filter criteria. Note: You cannot filter by patient name and patient ID at the same time. Before You Begin Display the Filter criteria screen The steps To filter by patient name or patient ID: 1. From the Filter criteria screen, click the Patient tab. Figure 8-23, Filter criteria screen, Patient tab 2. Select each patient name or patient ID whose sample records you want to view. 3. Do one of the following: Sample type tab If you want to... Then click the... Add another type of filter criteria Desired tab. Continue at the appropriate section in this chapter. Display the samples that meet the criteria you specified Apply filter button. The TAS Main screen displays only those samples that meet the criteria you specified. The Sample type tab allows you to display only those records that you specify by sample type. Select as many sample types that you want to use as filter criteria. Before You Begin 06-510-US, Manual revision: AD Display the Filter criteria screen TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-25 The steps To filter by sample type: 1. From the Filter criteria screen, click the Sample type tab. Figure 8-24, Filter criteria screen, Sample type tab 2. Select each sample type whose sample records you want to view. 3. Do one of the following: Channel tab If you want to... Then click the... Add another type of filter criteria Desired tab. Continue at the appropriate section in this chapter. Display the samples that meet the criteria you specify Apply filter button. The TAS Main screen displays only those samples that meet the criteria you specified. The Channel tab allows you to display only those samples that ran on the channel you specify. Select as many available channels as you want to use as filter criteria. Samples that ran on the specified channel(s) will display on the TAS Main screen. Before You Begin Display the Filter criteria screen The steps To filter by channel: 1. From the Filter criteria screen, click the Channel tab. Figure 8-25, Filter criteria screen, Channel tab 2. Select each channel that ran the samples that you want to view. You can select more than one channel to use as filter criteria. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-26 Viewing and Annotating TEG Analyzer Data Note: The list of channels includes a channel numbered “0.” This will filter for user-created samples. 3. Do one of the following: Dates tab If you want to... Then click the… Add another type of filter criteria Desired tab. Continue at the appropriate section in this chapter. Display the samples that ran on the channel(s) that you specified Apply filter button. The TAS Main screen displays only those samples that meet the criteria you specified. The Dates tab allows you to retrieve sample records for a specific date or for a range of dates. For example, to retrieve all sample records for July 1, 2007 you would enter “07/01/2007”. To retrieve all sample records from July 1, 2007 to July 15, 2007, you would enter “07/01/2007” and “07/15/2007” in the respective fields. Before You Begin Display the Filter criteria screen The steps To filter by date: 1. From the Filter criteria screen, click the Dates tab. Figure 8-26, Filter criteria screen, Dates tab 2. In the next two fields, enter a specific date in the first field or enter the beginning and ending values of a data range in both fields. Note: If you want to filter only by a specific date, leave the second field blank. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-27 3. Do one of the following: Case tab If you want to… Then click the… Add another type of filter criteria Desired tab. Continue at the appropriate section in this chapter. Display the samples that ran on the date(s) that you specified Apply filter button. The TAS Main screen displays only those samples that meet the criteria you specified. The Case tab allows you to retrieve only those cases that meet the criteria you specify. For example, to view only open heart cases, you would use the case filter feature. Before You Begin Display the Filter criteria screen The steps To filter by case: 1. From the Filter criteria screen, click the Case tab. Figure 8-27, Filter criteria screen, Case tab 2. Select the type of case that you want to view. 3. Do one of the following: TEG® 5000 System User Manual If you want to... Then click the… Add another type of filter criteria Desired tab. Continue at the appropriate section in this chapter. Retrieve the sample records for the type of case that you specified Apply filter button. The TAS Main screen displays only those samples that meet the criteria you specified. P/N 06-510-US, Manual revision: AD 8-28 Custom tab Viewing and Annotating TEG Analyzer Data The Custom tab allows you to filter records by any field contained in the patient database. For example, to search for a specific accession number, you select that entry from the drop-down menu in the first field, and enter other criteria in the respective fields. Before You Begin Display the Filter criteria screen The steps To filter by a specific field contained in the patient database: 1. From the Filter criteria screen, click the Custom tab. Figure 8-28, Filter criteria screen, Custom tab 2. In the drop-down list, select the field that you want. For example, to search for a specific first name, select “First Name. Figure 8-29, Field selection drop-down list 3. In the next two fields, enter a specific value in the first field or a range of values in both fields. For example, if you selected “First Name” in step 2, you could enter a specific name in the first field. If you selected “Age” in step 2, you could enter beginning and end values in both fields to filter for a range of ages. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-29 4. Do one of the following: TEG® 5000 System User Manual If you want to... Then click the... Add another field to the filter More button. Another line displays ready for you to add the criteria. Hide the last criteria line added through the More button Fewer button. Note: If you added more than one line, the Fewer button hides the last line added. If you click the More button the line reappears. Clear the data you entered Clear all button. Clear all filter criteria entered and return to the TAS Main screen Cancel button. Add another type of filter criteria Desired tab. Continue at the appropriate section in this chapter. Display the samples that meet the criteria you specified Apply filter button. The TAS Main screen displays only those samples that meet the criteria you specified. P/N 06-510-US, Manual revision: AD 8-30 Viewing and Annotating TEG Analyzer Data USING THE GUIDE FEATURE Hemostasis diagnosis and treatment decisions are sometimes difficult to determine. The Guide feature in TAS is one component that can help you learn about the different possibilities. Caution: Before making any decisions, the attendant physician must consider all clinical information about the patient’s condition, the procedure, and previous therapy. Guide is designed only as a training tool in order to familiarize the user with different common shapes and their possible interpretations. Frequently, published articles contain data that can assist in making decisions. Guide allows you to compare your patient’s sample(s) to common coagulopathies that are derived from various industry publications as one way to learn how to recognize differences in the signature tracing of the TEG® system. This section explains how to use Guide to: Using the Show Me option Automatically select a suggested tracing that helps train you to recognize patient data Manually select a tracing to visually compare to the patient’s tracing Add your own tracing to the coagulopathy tracing library Guide has a Show Me feature that automatically suggests the tracing that best matches the patient’s tracing according to the internal training algorithm, and when appropriate, lists other conditions to consider. The tracing that TAS automatically selects as the suggested match for training the user is derived from both a mathematical/statistical formula and a decision tree. Before You Begin Display the TAS Main screen The Steps To use the Show Me feature: 1. From the TAS Main screen, select the tracing and click Guide - Bleeding status screen. 06-510-US, Manual revision: AD to display the TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-31 Figure 8-30, Guide - Bleeding status screen 2. Under Bleeding status, choose the option that indicates whether the patient is currently Bleeding, Not bleeding, or Oozing. 3. Under Rx administered, choose one of the following options: If the patient received... Select... Platelet inhibiting drugs such as Plavix®, etc. Platelet inhibitors No drugs None 4. Click Next. The Guide - Pattern selection screen appears. Figure 8-31, Guide - Pattern selection screen 5. Click Show me to display the suggested match to consider and, if appropriate, other conditions for consideration. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-32 Viewing and Annotating TEG Analyzer Data Note: If the Show me button is greyed out, the feature is unavailable for the tracing that you selected. The software cannot always gather enough information to make a suggestion. The Guide - Pattern matching screen appears. Figure 8-32, Guide - Pattern matching screen Notice that the selected tracing is displayed over the patient’s tracing so that you can easily compare the two tracings. 6. Click Cancel when you have finished using this feature. You are returned to the TAS Main screen. Manually selecting a tracing in Guide Guide has a feature that allows you to manually select a tracing that you think best matches the patient’s tracing. This method allows you to compare this patient’s tracing to other coagulopathies that cannot be ruled out based on available test data. For example, in the early stages of the tracing, more conditions are listed for consideration, since fewer parameters are available to exclude conditions. If you manually select a tracing that does not match the Guide’s suggestion, TAS indicates this and automatically lists other possible conditions. When more than one condition is listed, the first condition listed is the one that would have displayed if you had used the Show Me feature. Before You Begin Display the TAS Main screen The Steps To manually select a tracing in Guide: 1. Follow steps 1 - 4 under “Using the Show Me option” on page 8-30. 2. In the Guide - Pattern selection screen, select the tracing on the right side of the screen that you want to compare to the patient’s tracing, scrolling if necessary, and click Next. The Guide - Pattern matching screen appears. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-33 In the example below, the tracing that was manually selected was not the best match. Figure 8-33, Guide - Pattern matching screen Notice the following: The selected tracing is displayed over the patient’s tracing so that you can easily compare the two tracings. When applicable, a message indicating that this may not be the best match displays along with conditions that should not be ruled out. 3. Do one of the following: If you want to... Click the... Return to the Guide - Pattern matching screen and make another selection Back button Exit the Guide feature and return to the TAS Main screen Cancel button Display the most likely suggested match, and, if appropriate, other conditions for consideration. Show Me button (available only if the selection was not the best match) Using the coagulopathy library The six most commonly encountered coagulopathies are presented first in the Guide - Pattern selection screen. Adding a tracing to the library You can add a tracing to the coagulopathy library. The tracing will be available for selection in the Guide - Pattern Selection screen (see figure 8-32). However, the tracing that you add will not provide the same type of statistical/algorithmic evaluation as the standard library tracings. You can expand the library of tracings presented in the program to include tracings of your own. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-34 Viewing and Annotating TEG Analyzer Data Before You Begin Display the TAS Main screen The Steps To add a tracing to the coagulopathy library: 1. From the TAS Main screen, click status screen. to display the Guide - Bleeding 2. Click Next. 3. In the Guide - Pattern selection screen, click Add. The Add to Guide screen appears. Figure 8-34, Add to Guide screen 4. Complete the following fields: Field Description Coagulopathy The name of the coagulopathy. Suggested treatment The common treatment for this condition. For example, fresh frozen plasma. Comment A descriptive comment to display on the screen when this coagulopathy is superimposed over another tracing. 5. Under Bleeding status, choose the option that indicates the condition that is appropriate for the tracing: 06-510-US, Manual revision: AD If the bleeding status is... Select... Bleeding Bleeding Oozing Oozing Not bleeding Not bleeding Not applicable Ignore TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-35 6. Under Rx administered, choose the option that indicates the condition that is appropriate for the tracing: If the patient received... Select... Platelet inhibiting drugs such as Plavix®, etc. Platelet inhibitors No drugs None No applicable drugs Ignore 7. Click Save. Modifying a library entry You can change information for any tracing that you have entered. Note: You cannot modify any tracing that comes with the software. Before You Begin Display the TAS Main screen The Steps To modify a coagulopathy library entry: 1. From the TAS Main screen, click status screen. to display the Guide - Bleeding 2. Click Next. 3. In the Guide - Pattern Selection screen, select the tracing on the right side of the screen and click Modify. The Add to Guide screen displays. 4. Update the applicable field(s). 5. Click Save to save the changes. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-36 Deleting a library entry Viewing and Annotating TEG Analyzer Data Sometimes, you may want to delete a tracing because you no longer need it or because it is obsolete. You can delete any tracing that you added to the coagulopathy library. Note: You cannot delete any tracing that came with the software. Before You Begin Display the TAS Main screen The Steps To delete a coagulopathy library entry: 1. From the TAS Main screen, click status screen. to display the Guide - Bleeding 2. Click Next. 3. In the Guide - Pattern Selection screen, select the tracing on the right side of the screen and click Delete. Note: You can only delete tracings that you have added, not tracings that were included in the pattern selection at installation. The Delete button is enabled when you highlight a tracing available for deletion. 4. In the confirmation message that appears, click Yes to save the changes. The tracing pattern is removed. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-37 GENERATING AND PRINTING REPORTS TAS allows you to generate and print a number of formatted reports including the following: Patient Reports TEG Analysis (single-sample or multi-sample report) TEG Database Patient List (patient report) TEG Patient Hemostasis Summary (case summary report) Quality Assurance Reports TEG Analyzer QC Summary (Levey-Jennings report) TEG Lot Number History report TEG Analyzer Daily Maintenance Log report Operator Report TEG Analyzer Audit report Generating patient reports The patient reports include graphical and numeric information about samples and patients. TEG Analysis report The TEG Analysis report is designed to be added to a patient file and displays samples and test results. This report can be generated in the following two formats: Single-sample report The single-sample report displays the following: The tracing The first 10 tests (parameters) Optionally, all tests associated with the sample Multi-sample report The multi-sample report includes the following display options: Only the tracing Only the tests (first 10 or all) and statistics The tracing, tests (first 10 or all), and statistics TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-38 Viewing and Annotating TEG Analyzer Data To generate and print a single-sample or multi-sample TEG Analysis report: 1. Choose the appropriate action: If you want to generate a... Do the following… Single-sample report In the TAS Main screen, select the sample that you want to include in the report. Multi-sample report 1.In the TAS Main screen, click Multi. 2.Select the samples you want to include. If you include the tracing in the report, you are limited to 50 samples. Note: for reference ranges to print, all samples selected must be the same sample type. 3.Click Done. 4.Choose the offset or superimposed mode by clicking the appropriate icon on the toolbar. 5. Click . The Report options screen appears. The options that are available in the screen change depending on whether you selected single or multiple samples. The following image shows the available options for a single-sample report. Figure 8-35, Report options screen for a single-sample report 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-39 6. Complete the following fields: Field Description Tracing The tracing is included in the report. This option is available only when printing a multi-sample report and only if there are fewer than 50 samples that would be printed. A tracing is always included in a singlesample report. Clot The clot graphic is displayed in the report. This option is available only when printing a single-sample report. Grid lines The grid lines are displayed on the tracing. This option is available only when printing a single-sample report. Print text in black Overrides the default setting for printing multiple tracings in color. Default tests For each sample selected, the report will display data for only the first 10 tests. All Tests For each sample selected, the report will display data for all configured tests. Selected sample(s) Prints only the sample(s) selected in the TEG or TAS main screen. When multiple samples are selected, the total number of samples is reflected in the field. All samples (total of x) Prints all samples in the database. The field indicates the total number of samples in the database. If the Tracing option is also selected, the tracing displays the samples in offset mode. 7. Specify any optional report settings as necessary in the Graphics options, Numeric options, and Sample options sections of the screen. 8. Click Continue. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-40 Viewing and Annotating TEG Analyzer Data The TEG Analysis report appears in either single-sample or multi-sample format. The following example shows a single-sample report. Figure 8-36, TEG Analysis single-sample report Note: CPT codes for reimbursement purposes appear at the bottom of a single-sample report, but only when a parameter is finalized. CPT codes are not listed on a multi-sample report. No code is listed for interim values. This option is controlled by the Site Administrator. 9. If you want to print the report, click Print. Otherwise, click Done to close the report and return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data TEG Database Patient List report 8-41 The TEG Database Patient List report, also known as the patient report, lists all patients currently in the database. You can choose for data to appear by patient name or patient ID, in either ascending or descending order. To generate the TEG Database Patient List report: 1. From the TAS Main screen menu, choose Records > Patient report to display the Patient report sort screen. Figure 8-37, Patient report sort screen 2. Select the appropriate option to indicate whether you want data sorted by patient name or by patient ID. 3. Select the appropriate option to indicate whether you want data sorted in ascending or descending order. 4. Click Done. The TEG Database Patient List report displays. 5. If you want to print the report, click Print. Otherwise, click Done to close the report and return to the TAS Main screen. TEG Patient Hemostasis Summary report The TEG Patient Hemostasis Summary report, also known as the case summary report, displays the patient case record data for a patient (for more information on patient cases, refer to “Managing Patient Case Records Overview” on page 10-2). The report consists of three main parts: Numerical data summary - includes patient and procedure information, interventions, notes, TEG test numerical results. Trend graphs - includes the trend for each selected test, along with relevant therapy and blood product administration during the selected time period. TEG tracings - includes individual tracings for the selected samples. To generate and print the TEG Patient Hemostasis Summary report: 1. Click from the TAS main screen menu to display the Select case mode screen. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-42 Viewing and Annotating TEG Analyzer Data Figure 8-38, Select case mode screen 2. Select the Edit case option. 3. In the list, select the name of the patient. 4. Click Done. The Edit case screen appears. Figure 8-39, Edit case screen 5. Click Report. The Select samples screen appears. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-43 Figure 8-40, Select samples screen 6. Select the appropriate samples. Note: When you generate a case summary report, you may want to choose representative samples at critical protocol time points for display. The trend lines are generally more useful when the same sample type is selected so that the points are connected and the samples truly represent the progress of the patient’s procedure. 7. Click Continue. The Report options screen appears. Figure 8-41, Report options screen TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-44 Viewing and Annotating TEG Analyzer Data 8. Under Trend tests, use these steps to select tests: a. Select the desired test in the far left panel. b. Click the single arrow button to move the test to the right panel. c. Repeat as necessary to include all the desired tests. Note: To include all tests in the report, click the double arrow button. 9. To specify the data for report: a. Click the Data checkbox in the Sections area. b. Select one of the following options: As selected Default tests All tests 10. To specify Trend graph options for the report: a. Click the Trend graphs checkbox in the Sections area. b. In the Height field, slide the lever right or left to set an increase or decrease in the height of the graph. c. Select one of the following options: Graph on one line Graph on multiple lines 11. To specify tracings options for the report: a. Click the Tracings checkbox in the Sections area. b. Select one of the following Normal lines options: Display Do not display c. Select of the following Sort (sample date) options ASC DESC 12. Click Done. The TEG Patient Hemostasis Summary report displays. 13. If you want to print the report, click Print. Otherwise, click Done to close the report and return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-45 Generating quality assurance reports The quality assurance (QA) reports track the performance and service history of the TEG system. TEG Analyzer QC Summary report Levey Jennings The TEG Analyzer QC Summary (Levey Jennings) report is used to show that the lab is performing quality control tests as required and that the tests are passing the quality control criteria. This report separately plots the daily results for R, K, Angle, and MA for the Level I control and for the Level II control. The result is up to eight graphs for a particular month. If a control sample fails, then all points on the graph for that sample appear in red. The Levey Jennings report shows trends and makes it easy to spot shifts and outof-range results. Results are interpreted based on a 3 standard deviation. This will include 99.7% of all data points assuming a relatively normal distribution. The x axis reflects the day of the month and y axis reflects the test’s reading. The top of the report shows the test that data is for, the mean, standard deviation, coefficient variable, and the number of points on this particular graph. Figure 8-42, Levey Jennings Report In the above graph, the mean is 3.38 and with a 3 standard deviation, a point in the low end is 3.02 and a point in the high end is 3.74. The points within this graph are all within the acceptable range. In the following graph, three points appear in red, indicating a control sample that failed. Figure 8-43, Levey Jennings Report showing failures TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-46 Viewing and Annotating TEG Analyzer Data Also included in the report are the numerical results of each test for Level 1 and Level 2, including the operator ID and corrective action entered at the time of an out-of range QC. A sample section is shown below: Figure 8-44, TEG Analyzer QC Summary Report Generating the Report To generate and print the Levey Jennings report: 1. From the TAS Main screen menu, choose QC > Levey Jennings to display the QC report screen. Figure 8-45, QC report screen 2. Verify that the checkbox for the Include in report field is checked for Level I and Level 2 so the data will be included in the Levey-Jennings report. 3. Select the Start date for Level I and for Level 2. The system automatically sets an end date of one month after the selected start date. 4. Click Continue. The Levey-Jennings Report appears, titled TEG Analyzer QC Summary Report. 5. If you want to print the report, click Print. Otherwise, click Done to close the report and return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data TEG Lot Number History report 8-47 The TEG Lot Number History report is used to document the reference ranges for all lot numbers in the QC database that have been archived. It contains a log of the lot numbers and usage dates including the corresponding sample type and reference range values. To generate and print the TEG Lot Number History report: 1. From the TAS Main screen menu, choose QC > Report. The TEG Lot Number History report appears. Figure 8-46, TEG Lot Number History report 2. If you want to print the report, click Print. Otherwise, click Done to close the report and return to the TAS Main screen. TEG Analyzer Daily Maintenance Log The TEG Analyzer Daily Maintenance Log provides a list of the eTest and calibration results for a particular date or date range, including any notes entered. To generate and print the TEG Analyzer Daily Maintenance Log: 1. From the TAS Main screen menu, choose Options > Maintenance to display the Maintenance screen. Figure 8-47, Maintenance screen 2. Click Report. The Maintenance filter screen appears. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-48 Viewing and Annotating TEG Analyzer Data Figure 8-48, Maintenance filter screen 3. Under Type of report, ensure Daily log is selected. Note: For information on the Service history option, refer to “TEG Analyzer Service History Log” in the TEG 5000 System Preventive Maintenance and Service manual. 4. To limit the data that is included in the report, use the Filter by section to do one of the following: To generate the report... Do the following… For a date other than the current date a. Select the Date checkbox. b. Enter the start date and the end date in the respective fields. By analyzer a. Select the Analyzer checkbox. b. Highlight each analyzer to include. 5. Click Done. The TEG Analyzer Daily Maintenance Log displays, similar to the following sample: Figure 8-49, TEG Analyzer Daily Maintenance Log 6. If you want to print the report, click Print. Otherwise, click Done to close the report and return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-49 Generating the operator report The operator report, also known as the TEG Analyzer Audit Report, displays an audit trail of who logged in to TAS. TEG Analyzer Audit report The TEG Analyzer Audit report is used to show all the times a particular operator logged in to TAS, or it can show a history of all the operators logged in to TAS. To generate and print the TEG Analyzer Audit report: 1. From the TAS Main screen menu, choose Records > Audit report to display the Audit report data screen. Figure 8-50, Audit report data screen 2. Specify the type of data to include in the report: Include data for… Then do the following…. A particular operator only a. Ensure that the Operators option is selected. b. From the list, select the operator’s name. A specific time frame a. Select the Date range option. b. Type the desired start date and end date in the Start date and End date fields. Note: In version 4.2.3 of TAS, the Date range option is not available. Select All instead. All users and time frames in the system Click the All button. 3. Click Continue. The TEG Analyzer Audit Report displays with the data you specified: Figure 8-51, TEG Analyzer Audit Report 4. If you want to print the report, click Print. Otherwise, click Done to close the report and return to the TAS Main screen. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-50 Viewing and Annotating TEG Analyzer Data VIEWING AND ENTERING SAMPLE DETAILS This section explains how to use the Detail screen to do the following: Enter additional sample data that is not collected by the TEG analyzer Enter more detail about a particular sample Set a reference or normal tracing Enter optional tracing interpretation or staff participation Sample detail information is arranged on the following three tabs: Tracing tab - allows you to: View data collected for this sample Enter data that is not collected by the TEG analyzer Enter data for a manually created record Modify data that you entered Set a reference or normal tracing Sample tab - allows you to: Notes tab - allows you to: Viewing details on the Detail screen Enter optional information that is related to interpreting the sample tracing Enter more detail about a particular sample. You can view details for a tracing on the Detail screen by selecting a sample and clicking the Detail icon on the toolbar or the status bar located at the bottom of the TAS Main screen. Using the Detail icon To view details on the Detail screen using the Detail icon: 1. From the TAS Main screen, select the tracing that you want to view details for. 2. Click . The Detail screen displays with the Tracing tab selected, similar to the example below. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-51 Figure 8-52, Detail screen 3. Choose one of the following: If you want to…. Then continue at… Access and enter additional sample data that is not collected by the TEG Analyzer “Entering details on the Tracing tab” on page 8-53 Set a reference or normal tracing “Setting a reference tracing” on page 8-55 or “Setting a normal tracing” on page 8-55 Enter optional tracing interpretation or staff participation “Entering details on the Sample tab” on page 8-56 Enter notes “Entering details on the Notes tab” on page 8-58 Using the status bar To view details on the Detail screen using the status bar: 1. From the TAS Main screen, select the tracing that you want to view in detail mode. 2. On the status bar located at the bottom of the TAS Main screen, click any section except the patient ID section. Figure 8-53, Status bar on the TAS main screen The Detail screen displays with the Sample tab selected, similar to the example below: TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 8-52 Viewing and Annotating TEG Analyzer Data Figure 8-54, Detail view, Sample tab 3. After viewing the details, you can choose one of the following: 06-510-US, Manual revision: AD If you want to…. Then continue at… Access and enter additional sample data that is not collected by the TEG Analyzer “Entering details on the Tracing tab” on page 8-53 Set a reference or normal tracing “Setting a reference tracing” on page 8-55 or “Setting a normal tracing” on page 8-55 Enter optional tracing interpretation or staff participation “Entering details on the Sample tab” on page 8-56 Enter notes “Entering details on the Notes tab” on page 8-58 TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data Entering details on the Tracing tab 8-53 The Tracing tab summarizes all the numerical data for the selected sample while showing the tracing on the left side of the screen. On the Tracing tab, you can enter details that are not collected by the TEG analyzer. Figure 8-55, Detail view, Tracing tab Tests that appear in the Test name column are either generated by the TEG analyzer or were added by a user. When you select a test name and enter a value, notice the following: The Units and Normal Range fields complete automatically. The order of the test names change and appear according to the order defined in your configuration profile. When you add or modify a test, keep the following in mind: Entering tracing detail You can only add tests that are listed in the Test name drop-down list (this list displays after you click a blank Test name cell). You cannot change data calculated by the TEG analyzer. You can change data only for tests that you entered. You can enter tracing detail for data that is not collected by the TEG analyzer and for tests related to the sample. For user-defined samples, you can also enter data usually collected by the TEG system. All tests that relate to the sample are listed in the Test name drop-down menu. Before You Begin Select the sample for which to add test data. On the toolbar, click TEG® 5000 System User Manual and then click the Tracing tab. P/N 06-510-US, Manual revision: AD 8-54 Viewing and Annotating TEG Analyzer Data The steps To enter tracing details: 1. On the Tracing tab, at the bottom of the Test name column, click the blank cell. Notice that the cell becomes activated and a drop-down arrow appears. Figure 8-56, Activated cell 2. In the activated cell drop-down list, select the test for which you want to add related data. Figure 8-57, Test drop-down menu The test displays in the Test name field. 3. Click the Value field and enter the numeric value. Note: If you are entering a TEG System test for a user-created sample, you can enter a value as negative to have the system flag the sample as interim and show the value as positive. 4. Click the Interim field and notice the following: The Units and Normal Range fields automatically complete. Test names re-sort according to your profile configuration. 5. Repeat steps 1 through 5 for each designated test that you want to add to this sample. 6. Click 06-510-US, Manual revision: AD to return to the TAS Main screen. TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data Setting a reference tracing 8-55 From the Detail screen, you can save the tracing that is currently displayed as a temporary reference. You may want to set the tracing as a reference to compare one sample to another. For example, for a clinical procedure you may want to compare a baseline sample to a sample after treatment. Note: When you set a tracing as a reference tracing, it remains in effect until you exit TAS or decide to change it during the current session. Each time you shut down the software or change databases, you need to reset the reference tracing. Before You Begin Select the sample to set as a reference tracing From the toolbar, click and then click the Tracing tab. The steps To save a tracing as a temporary reference: 1. Click the Set reference button. You now have set this tracing as a temporary reference. 2. Click Setting a normal tracing to return to the TAS Main screen. From the Tracing tab, you can set a patient’s tracing as normal. A normal tracing represents the normal shape for a particular sample type and is saved from session to session. Before You Begin Select the sample to set as a normal tracing From the toolbar, click and then click the Tracing tab. The steps To save the tracing as a normal tracing: 1. Click the Save as normal button to set the tracing as a normal tracing. If a normal tracing already exists for the sample type, the Save Normal confirmation message appears. To overwrite the normal sample for the sample type, click Yes. Otherwise, click No. 2. Click TEG® 5000 System User Manual to return to the TAS Main screen. P/N 06-510-US, Manual revision: AD 8-56 Entering details on the Sample tab Viewing and Annotating TEG Analyzer Data The Sample tab allows you to enter optional information that is related to interpreting the sample tracing. Sample information that you can add includes the following: Who ordered and entered the test Patient status The R, K, angle, and MA values for the tracing appear on the Sample tab along with their respective reporting units and reference ranges. Figure 8-58, Detail view, Sample tab Before You Begin Select the desired sample From the toolbar, click and then click the Sample tab. The steps To enter additional information on the Sample tab: 1. On the Sample tab, complete the following fields: 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-57 Sample pane Field Description Description Click the arrow and select the description that applies or you can type in your own description. The description you enter will appear on the tracing. Accession # Type in the lab-generated number that identifies the particulars of the sample. This number indicates what the sample is and when it was run. It is tied to both the sample and patient. Ordered by Click the arrow and select the name of the doctor who ordered the test or type it in. Note: The individual who ordered the test may not be the person who interprets it. For example, a surgeon may have ordered the test and the anesthesiologist may be the one to interpret it. Operator ID If the operator ID does not automatically appear, select it from the drop-down list or type it in the field. Site ID If the site ID does not automatically appear, select it from the drop-down list or type it in the field. Temperature Type the sample temperature. Patient status section Field Description Bleeding status Click the arrow and select the appropriate option: “Bleeding,” “Oozing,” or “Not bleeding.” Temperature Type the patient temperature. Platelet inhibition drugs given Click either Yes or No to indicate whether the patient received platelet inhibiting drugs. Interpretation section TEG® 5000 System User Manual Field Description Reported Type the interpretation of the tracing. For example, “Hypercoagulable.” Reported By Type the name of the doctor who interpreted the tracing. Note: This person could be different than the one who ordered the test. Reported date Type the date on which the interpretation was made. P/N 06-510-US, Manual revision: AD 8-58 Entering details on the Notes tab Viewing and Annotating TEG Analyzer Data The Notes tab allows you to add or display a note for a sample. This note will only appear with the sample. When a sample is selected in the Main TAS screen, you can add notes for the sample in two ways: On the toolbar, click the Detail icon and then click the Notes tab. On the toolbar, click the SNotes icon. For more information on entering notes for samples and patient cases, refer to the following section, “Using the Notes Feature,” on page 8-59. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-59 USING THE NOTES FEATURE This section explains how to use the two options that are available to add and display notes. These options are: Adding or viewing SNotes SNotes (Sample Notes) - allows you to add or display a note for a sample. This note will only appear with the sample. Notes - allows you to add a note for the patient case. This means that the note will appear with every sample that is associated with that patient. The SNotes feature allows you to add a note to a sample and takes you directly to the Notes tab in Detail view for the sample you selected. Typically, this feature is used to explain a problem with a sample. For example, you may want to add a note if a sample was hemolyzed or if the analyzer was bumped during the test. All notes that you add for a sample will display in a TEG Analysis single-sample report. For more information, refer to “TEG Analysis report” on page 8-37. After you enter a note for the desired sample, the § symbol displays above the patient’s tracing and at the beginning of the sample description field on the TAS Main screen. Note: The § symbol will display only in front of this particular sample, not in front of every sample test run for this patient. Before You Begin Display the TAS Main screen The steps To add or view notes for a sample: 1. From the TAS Main screen, select the sample that you want to add a note to, and click TEG® 5000 System User Manual to display the Notes tab on the Detail screen. P/N 06-510-US, Manual revision: AD 8-60 Viewing and Annotating TEG Analyzer Data Figure 8-59, Detail view, Notes tab 2. Type a new note or view the existing note. 3. Click to return to the TAS Main screen. The § symbol now displays above the thumbnail tracing and at the beginning of the Sample description field on the TAS Main screen. Figure 8-60, TAS Main screen indicating a sample note Adding or viewing Notes The Notes feature allows you to add a note for a patient case. After you add a note, the ¶symbol displays above the thumbnail tracing and at the beginning of the Sample description field on the TAS Main screen for every sample that is associated with the patient. Note: The ¶ symbol will appear with every sample associated with this patient. Before You Begin 06-510-US, Manual revision: AD Display the TAS Main screen TEG® 5000 System User Manual Viewing and Annotating TEG Analyzer Data 8-61 The steps To add or view notes for a patient case: 1. From the TAS Main screen, select the sample that you want to add a note to, and click to display the Edit case screen. Figure 8-61, Edit case - Notes screen 2. Type a new note or view the existing note. 3. Click Done to return to the TAS Main screen. The ¶ symbol now displays above the tracing and at the beginning of the Sample description field for every sample that is associated with this patient. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Chapter 9 Managing Databases MANAGING DATABASES OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 About the TEG system databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2 OPENING A DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3 CHANGING A QC DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4 SWITCHING BETWEEN QC AND PATIENT DATABASES . . . . . . . . . . . . . . 9-5 Switching to a QC database from a patient database . . . . . . . . . . . . . . . 9-5 Switching to a patient database from a QC database . . . . . . . . . . . . . . . 9-5 CREATING A NEW DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-6 EXPORTING A DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 Export formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 Exporting a patient or QC database . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9 DELETING A DATABASE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13 BACKING UP A DATABASE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14 Backing up database files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14 Scheduling Backups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15 REPAIRING DATABASE CORRUPTION . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16 Compacting a Database . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-16 Merging Databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17 USING EXPORT FILES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Importing into Excel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-19 Importing into Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-2 Managing Databases MANAGING DATABASES OVERVIEW This chapter explains how to manage patient and QC databases for the TEG® analyzer using the TEG Analytical Software (TAS). The database options allow you to do the following: About the TEG system databases Open an existing database Change a Quality Control (QC) database Switch between QC and Patient databases Create a new database Import previous versions of a database into a current database Export a database Delete a database Back up a database Repair database corruption TAS is designed to have the databases reside on an Enabled computer rather than on a server. Storing the TAS databases on a server can have any or all of the following negative effects: Database corruption Loss of live data Poor system performance Database bloat These issues can be avoided by storing the databases locally rather than on a server and by setting up a schedule for compacting (see “Compacting a Database” on page 9-16)and backing up (see “Backing up Database Files” on page 9-14) the databases. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-3 OPENING A DATABASE You can open a database other than the one currently open. To open another database: 1. Log in to TAS (refer to “Logging in to TAS” on page 5-5). 2. From the TAS Main screen menu, choose File > Open Database. The Open screen appears. Figure 9-1, Open screen 3. Select the desired database by clicking on it. Note: If the database name does not appear in the default directory, navigate to the appropriate directory. 4. Click Open. The TAS Main screen appears, populated with the data from the database you selected. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-4 Managing Databases CHANGING A QC DATABASE You can access a quality control (QC) database other than the one currently selected or you can create a new QC database. Note: You can create a new QC database only if you are using the Enabled software. This option is not available in the Remote software. To open another QC database or create a new one: 1. With a QC database open in TAS, choose QC > Change QC. The Select database screen appears. Figure 9-2, Select database screen 2. Do one of the following: If you… Then do the following… Know the path name to the QC database a.Go to the QC database field b.Type in the complete path to the desired QC database Need to locate the QC database a.Click Browse b.Complete the Locate Database screen c.Click Done Want to create a new QC database Note: For detailed instructions, refer to “Creating a New Database” on page 9-6. a.Click New b.Complete the New Database screen c.Click Done 3. Click OK. You are returned to the TAS Main screen, which displays the desired QC database. Note: You can also change a QC database with a patient database currently open in TAS. In this case, the new QC database will not display in TAS but it will still be used for QC lot numbers and transferring QC samples. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-5 SWITCHING BETWEEN QC AND PATIENT DATABASES The GoTo option in the TEG Analytical Software (TAS) allows you to switch to the quality control (QC) database from the patient database and to switch back from the QC database to the patient database. You can tell which database you are in by checking the title bar at the top of the screen. Patient database names end in “.teg” and QC databases end in “.qc”. Note: You cannot start or stop samples while in a QC database nor can you access a QC database while a sample is running. Switching to a QC database from a patient database To switch to a QC database from a patient database: 1. With a patient database open, choose QC > GoTo from the TAS Main screen menu. Figure 9-3, QC menu 2. A check mark now displays in front of the GoTo submenu and the QC database displays. Switching to a patient database from a QC database To switch to a patient database from a QC database: 1. With a QC database open, choose QC > GoTo from the TAS Main screen menu. Figure 9-4, QC menu (with check mark) 2. The check mark is removed from the GoTo submenu and the patient database displays. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-6 Managing Databases CREATING A NEW DATABASE When you create a new database, the system automatically places the correct extension on the new database name–”.teg” for a patient database and “.qc” for a QC database. Note: You can create a new QC database only if you are using the Enabled software. This option is not available in the Remote software. To create a new patient or QC database: 1. From the TAS Main screen menu, choose File > New Database to display the New screen. Figure 9-5, New screen 2. Select either Patient database or QC database to indicate the type of database to create. 3. Click OK. The New database screen appears: Figure 9-6, New database screen 4. In the File name field, type the database name. 5. If you do not want to add the new database to the default folder, navigate to the folder in which to add the database. 6. Click Save. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-7 7. The following message appears: 8. Click Yes to make the new database the default or click No to not make the new database the default. You are returned to the TAS Main screen displaying the database you just created. No data displays in the database because it is new. Importing a Database You can import previous versions of a patient or QC database into the current database. For example, to use a version 3 database, you must first import it into the version 4.2.3 database. You can import patient databases only when you are in a patient’s database, and you can import QC databases only when you are in a QC database. Note: Before you begin, make sure that you are in the database that you want to import into. To import a database: 1. From the TAS Main screen menu, choose File > Import to display the submenu of databases available to import. Figure 9-7, Import menu 2. Choose the database version that you want to import. A screen similar to the following displays: TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-8 Managing Databases Figure 9-8, Open screen 3. Select the database that you want to import. Note: If the database you want to import is not located in the default location (C:/TEG), navigate to the location of the desired database. 4. Click Open. An Import progress message appears. While importing, the number of imported samples is displayed on the left side of the progress message. When the import has successfully completed, the TAS Main screen displays. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-9 EXPORTING A DATABASE The Export option allows you to save a copy of the data from the database that you are currently in into a file format used by different applications. You can export data from the current database only. For example, to export QC data, you must be in the QC database, not just connected to it. After creating an export file, you can import the data into other software applications. For more information, refer to “Using Export Files” on page 9-19. Export formats You can export a patient or QC database in the following formats: TEG database Tab-delimited TEG database format The TEG database format allows you to export all or part of a TEG database into a new database. If you are exporting part of a database, you may first set the filter to specify the data or choose the samples in the export wizard. Tab-delimited format The tab-delimited format allows you to export a database into a format that can be used by a spreadsheet application such as Microsoft® Excel or any database or program that accepts tab-delimited data. However, before you can export VCurve data, you must have Excel installed on your computer. Exporting a patient or QC database To export a patient or QC database: 1. From the TAS Main screen, choose File > Export to display the Export data wizard (1) screen. Figure 9-9, Export data wizard (1) screen TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-10 Managing Databases 2. Choose one of the following: To export… Do the following… All data in a database a.Click All b.Click Next c.Continue at “Export data wizard(2) screen” on page 9-11. Data specified through a filter Note: You must set the filter before exporting a.Click Subset b.Click Next c.Continue at “Export data wizard(2) screen” on page 9-11. Specific samples a.Click Subset b.Click Let me pick samples c.Click Next Continue at “Select samples screen” on page 9-10. One particular tracing Note: You must select the tracing before exporting a. Click Single Tracing b. Click Next c. Continue at “Export data wizard(2) screen” on page 9-11. Select samples screen If you selected Let me pick samples from the Export data wizard(1) screen, the Select samples screen appears. Figure 9-10, Select sample screen 1. Highlight the samples you want and click OK. The following message appears: 2. Click OK. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-11 The Export data wizard (2) screen displays. Continue at “Export data wizard (2) screen” next. Export data wizard (2) screen 1. In the Export data wizard (2) screen, select the database format and, if applicable, additional content to include in the export. Figure 9-11, Export data wizard (2) screen Refer to the following table: TEG® 5000 System User Manual If you want to export… Select… Patient and test information Tab delimited Coordinates for all the tracings being exported Export coordinates to a CRD file Names of the clinicians who entered case information Export clinicians to a CL file Platelet mapping information Export clusters to a CS file Blood products, prescriptions, and patient output entered Export bio products to BP, RX, and PO files Velocity information (this requires Excel to be installed on your computer) Export VCurve to a VEL file Entire TEG database, part of a TEG database, or a single tracing in the TEG database TEG database P/N 06-510-US, Manual revision: AD 9-12 Managing Databases 2. Click Next. The Save As screen appears. Notice that in the following illustration, a TEG database is being saved. If a tab delimited file was being saved, then “TAB Databases (*.txt)” would appear in the Save as type field. Figure 9-12, Save as TEG database 3. In the File name field, type the database name. 4. Click Save. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-13 DELETING A DATABASE It may be necessary to delete a database if you want to free up space on a hard drive or if you need to delete data that is no longer required. Databases are manually deleted using Windows® Explorer. Note: Your ability to delete a TEG database depends on your Windows user permissions for the computer. If your user permissions do not allow you to delete files in Windows, you cannot delete a TEG database. Caution: Deleting a database permanently removes all data in that database. Ensure that you create a backup of the database before deleting it (refer to “Backing up a Database” on page 9-14). Haemonetics cannot restore deleted databases. To delete a database: 1. Open the database that you want to delete (refer to “Opening a database” on page 9-3). 2. On the TAS title bar, note the location of the database. 3. Log out of TAS. Note: TAS must be closed before a database can be deleted. The delete action will fail if any user has the software application open locally or on the network. 4. Open Windows Explorer and browse to the location of the database. 5. Select the database file that you want to delete and then press the Delete key. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-14 Managing Databases BACKING UP A DATABASE If you are operating in a network environment, the TEG databases may be backed up automatically by your site’s computer services staff. However, even if this is the case, Haemonetics strongly recommends that you back up your own data. You can copy database files to a network location or to portable storage media such as a CD-RW or USB flash drive. The following table identifies files that should be regularly backed up: Name of file Hard drive location Contents <name>.teg Default: C:\TEG Patient databases <name>.qc Default: C:\TEG Quality control (QC) databases cfg.set Default (Windows 2000 and XP): C:\Program Files\TEGV4 System and user configuration file Guide.lib Default (Windows 2000 and XP): C:\Program Files\TEGV4 Coagulopathy library Table 9-13, Database files to back up Backing up database files During installation of the TEG Analytical Software, a folder named Backup is automatically created inside the installation parent folder (by default, C:\TEG). Each time you open a database in TAS, a copy is placed in the Backup folder. Caution: Do not use the Backup folder to store additional copies of databases. Storing manually created backups in this folder could cause the automatic backups to be overwritten. Caution: Do not use the databases in the Backup folder to view or run data unless directed to by TEG System Technical Support. It is good practice to create additional back ups of the database files and copy them to another location such as the following: Another network location Portable storage media such as a CD-RW or a USB flash drive Magnetic tape drive You can use standard Windows copy procedures to copy database files to another network location. Depending on how your computer is set up, you may be able to use the same Windows procedures to copy files directly to portable storage media, or you may need third-party software to do this. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-15 If you want to copy database files to magnetic tape, you must use third-party software. Scheduling Backups Haemonetics recommends that you create and maintain a schedule to ensure that backups are performed daily. You can also use third-party software to schedule automatic backups. Refer to the third-party documentation for instructions. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-16 Managing Databases REPAIRING DATABASE CORRUPTION If a database becomes corrupted, overly large (database bloat), or if the performance has slowed down, two options are available to solve the issues: Compacting a Database Compacting the database Merging the database Compacting a database acts as a general tune-up and will usually solve performance and corruption issues. Running the Compact Database option compresses the amount of space that the database takes on your computer’s hard drive. Compact a database if the system issues a warning that the database is nearing its 2 GB size limit, or if you notice the system is slowing down or becoming corrupted. Note: To protect the database in the event that samples are running or other users are modifying data, you cannot compact an open database. Note: It is highly recommended that you make a backup copy of the database (refer to “Backing up a Database” on page 9-14) before running Compact Database. To compact a database: 1. Make sure that the database you want to compact is not open in TAS. 2. From the File menu, choose Compact Database. Figure 9-14, Compact database option 3. The Open window appears. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-17 Figure 9-15, Select database to compact 4. Select the database file to compact and click Open. 5. The Compact Database function runs and a “Compacting complete” message displays. Click OK to close the message. Merging Databases If running the Compact Database option has not solved corruption issues in a database, merging the corrupted database into a new database will sometimes retrieve the data. Other reasons to merge databases include the following: A patient moves to another location and sample data is in two databases Data needs to be compiled for research purposes Data needs to be compiled for running general reports You merge data from one TEG database (the source) into another database (the target) using the Merge option. During the merge, the source database is left intact–only a copy of the data is merged into the target database. Caution: Do not merge databases that contain active samples either in the source or target database. Before you merge databases, make sure that the target database is open in TAS. To merge databases: 1. From the File menu, choose Merge. Figure 9-16, Merge database option TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-18 Managing Databases 2. The Open window appears. Figure 9-17, Select database to merge 3. Select the source database file and click Open. 4. The records from the source database are merged into the currently open database and all duplicate records are deleted. Note: A duplicate is defined as a record that matches another record for patient id, sample date, sample time, sample type, and channel number. 5. If the source database contains user-defined tests that are not contained in the current target database, a Merge screen appears, allowing you to skip or add the tests. Figure 9-18, Import tests during a merge 6. Click Add to current to add all the tests to the target database or click Skip tests to merge the records without adding the tests. When the merge has successfully completed, the TAS Main screen displays. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-19 USING EXPORT FILES After creating a tab-delimited export file (refer to “Exporting a Database” on page 9-9), you can import the data into other software applications for purposes such as the following: Generate customized reports. Analyze statistics for compliance with the US Clinical Laboratory Improvement Amendments (CLIA). Conduct research. This section provides instructions for importing TEG export files into two applications: Microsoft® Excel and Microsoft® Access. Note: This section presumes some proficiency with Excel and Access. If you need more instructions, refer to the application documentation. Importing into Excel To import a TEG tab-delimited export file into Excel: 1. In Excel, choose File > Open. 2. Navigate to the location of the tab-delimited export file that you created. 3. In the Files of type field, select “All Files,” then select your export file. Figure 9-19, Select the export file 4. Click Open. The Text Import Wizard screen opens. In the Text Import Wizard - Step 1 of 3 screen, ensure that the Delimited option is selected. A preview of the file displays at the bottom of the screen that shows where the tabs are located in the row. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-20 Managing Databases Figure 9-20, Select the data type 5. Click Next. 6. In the Text Import Wizard - Step 2 of 3 screen, under Delimiters, select the Tab option. A preview of the data displays at the bottom of the screen that shows how the columns are assigned. Figure 9-21, Select the delimiter 7. Do one of the following: Click Finish to complete the import with the default data types and columns. Click Next to set the data formats for each column and/or exclude columns. Continue at step 8. 8. In the Text Import Wizard - Step 3 of 3 screen, click the column title to select the column you want. Then, under Column data format, select an appropriate data type option. Repeat for each column. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-21 Figure 9-22, Select the column data formats 9. Click Finish. The data is imported into Excel, similar to the example below: Figure 9-23, TEG database information in Excel Importing into Access To import a TEG tab-delimited export file into Access: Note: Depending on which version of Access you are using, some of the prompts may differ slightly. 1. In Access, choose File > Open to navigate to the database that you want to import the TEG export file into. If you want to create a new database to import into, choose File > New instead. 2. Choose File > Get External Data and then click Import. 3. In the Import screen, navigate to the location of the tab-delimited export file that you created. 4. In the Files of type field, select “Text Files,” then select your export file. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-22 Managing Databases Figure 9-24, Select the export file 5. Click Import. The Import Text Wizard screen opens. 6. In the first wizard screen, ensure that the Delimited option is selected. A preview of the file displays at the bottom of the screen that shows where the tabs are located in the row. Figure 9-25, Select the data type 7. Click Next. 8. In the second wizard screen, under Delimiters, select the Tab option. 9. Select the First Row Contains Field Names checkbox and leave the Text Qualifier as “{none}”. A preview of the data displays at the bottom of the screen that shows how the columns are assigned. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Databases 9-23 Figure 9-26, Select the delimiter 10. Click Next. 11. In the third wizard screen, select one of the following options to store your data: In a New Table In an Existing Table Note: Select “In a New Table” unless you are adding onto a table you have imported previously. If you select “In an Existing Table,” make sure the data structure is exactly the same as the one you are importing or the import will generate errors. Figure 9-27, Select where to store the data 12. Do one of the following: Click Finish to complete the import, letting Access set the defaults. Skip to step 17. Click Next to set data options yourself. Continue at step 13. 13. In the fourth wizard screen, click the field title to select the field you want. Then, under Field Options, modify the field information as appropriate. Repeat for each field. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 9-24 Managing Databases If you want to exclude data from the import process, select the field and select Do not import field (Skip). Figure 9-28, Select optional field settings 14. Do one of the following: Click Finish to complete the import. Skip to step 17. Click Next to set primary key options. Continue at step 15. 15. In the fifth wizard screen, select one of the following options: Let Access add primary key. Choose my own primary key. No primary key. Figure 9-29, Set an optional primary key 16. Click Finish. 17. In the dialog box that appears, enter a name for the table. 18. Click Finish. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Chapter 10 Managing Patient Records MANAGING PATIENT CASE RECORDS OVERVIEW . . . . . . . . . . . . . . . . . 10-2 About managing patient case records . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2 ADDING A PATIENT CASE RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3 Adding a patient case record using the Records menu . . . . . . . . . . . . . 10-3 Adding a patient case record using the Case icon . . . . . . . . . . . . . . . . . 10-5 ADDING A SAMPLE RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-6 DELETING A PATIENT CASE RECORD . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8 Deleting a patient case record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8 Deleting a sample record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9 EDITING A PATIENT CASE RECORD. . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-10 Procedure tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12 Rx tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13 Blood Products tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-13 Notes tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14 Other tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14 Locking tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15 Clinicians tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-15 Clusters tab. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-16 Samples tab . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-17 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 10-2 Managing Patient Records MANAGING PATIENT CASE RECORDS OVERVIEW About managing patient case records This chapter explains how to manage patient case records in the TEG Analytical Software (TAS) including the following: Adding a patient case record Manually adding a sample record Deleting a patient and all affiliated records Deleting a sample record Note: Although this chapter includes instructions for deleting patient case records, you can do this only if your Site Administrator has enabled this feature for you. Typically, the Site Administrator is the only one allowed to use this feature. You can create more than one patient case record for the same patient. For example, if a patient is in the hospital one time for cardiovascular disease and another time for liver disease, you may choose to create a patient case record for each event. Or, if a patient was in the hospital two different times for cardiovascular disease, you may choose to create a patient case record for each hospital stay or you may choose to create only one patient case record. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Patient Records 10-3 ADDING A PATIENT CASE RECORD You can add patient case records using the Records menu or the Case button on the Main TAS screen toolbar. Adding a patient case record using the Records menu You can add one patient case record or several of them at a time. To add a patient case record using the Records menu: 1. On the TAS Main screen tool bar, click Records to display the drop-down menu: Figure 10-1, Records-New Menu 2. Select New > Patient to display the Create case screen. Figure 10-2, Create case screen 3. Complete the following fields on the Create case screen: Required Field Entry Patient ID Enter the number assigned by the hospital. Patient name Enter the last name, first name, and middle initial in the appropriate text boxes. 4. Enter information for the following optional fields in the Patient ID section: TEG® 5000 System User Manual Weight Gender Age P/N 06-510-US, Manual revision: AD 10-4 Managing Patient Records 5. Enter or select information in the following fields in the Procedure section: Procedure name (the accession number can also be entered here) Procedure type Note: The accession number is a lab-generated number that identifies the particulars of the sample including what the sample is and when it was run. This number is tied to both the sample and patient and, when included, will appear in a maximized tracing below the patient’s name. 6. Do one of the following: If you…. Then click the…. Are finished adding patient case records Done button You are returned to the TAS Main screen Want to add another patient case record Add another button The screen clears and is ready for you to enter a new patient record. Repeat steps 1 to 5. Want to exit the case record without saving Cancel button Want to revert the most recent change Undo button 7. After you add a patient case, the patient’s name appears in the Patient name drop-down list on the TAS Main and TEG screens. Note: You cannot edit a patient case until sample data has been collected. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Patient Records Adding a patient case record using the Case icon 10-5 To add a patient case record using the Case icon: 1. On the TAS Main screen tool bar, click screen appears. . The Select case mode Figure 10-3, Select case mode screen 2. Select Add case if it is not already selected. 3. Click Done. The Create case screen appears. Figure 10-4, Create case screen 4. Follow steps 3-6 of the “Adding a patient case record using the Records menu” instruction on page 10-3. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 10-6 Managing Patient Records ADDING A SAMPLE RECORD You can manually create a sample record. For example, you may need to do this if the initial sample record is lost and you have report data that contains the test parameters and/or other necessary details. TAS uses a manually created sample record in the same way as an automatically generated one, including using the data in trend reports. However, a manually created sample record will not have a tracing. Even though it is recommended that you create a patient case record before you manually create a sample record, you can manually create a sample record first. All sample records must be associated with a patient case record. To manually add a sample record: 1. From the TAS Main screen menu, choose Records > New > Record to display the Enter sample information screen: Figure 10-5, Enter sample information Screen 2. Complete the following fields: 06-510-US, Manual revision: AD Field Entry Patient Select the patient name from the drop-down list. Sample Type Select the sample type from the drop-down list. Date Today’s date displays. To change the date, type the new date in over the old. Time The time at which you accessed this screen displays. To change the time, type the new time in over the old. Site ID (Optional) If the site ID does not automatically appear, select it from the drop-down list or type it in. Operator ID (Optional) If your operator ID does not automatically appear, select the operator ID from the drop-down list. TEG® 5000 System User Manual Managing Patient Records 10-7 3. Click Continue. The Tracing tab of the Detail screen displays ready for you to enter additional information about the sample. 4. In the Accession # field, enter the accession number. Note: The accession number is a lab generated number that identifies the particulars of the sample, including what the sample is and when it was run. This number is tied to both the sample and patient and, when included, will appear in a maximized tracing below the patient’s name. 5. Click to return to the TAS Main screen. Notice that no tracing displays on the TAS Main screen for the sample record that you manually added. Figure 10-6, No tracing for a manually added sample record TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 10-8 Managing Patient Records DELETING A PATIENT CASE RECORD The Delete option allows you to delete: A patient case and all records related to that case Specific sample records for a patient Note: You can delete patient case records only if your Site Administrator has enabled this feature for you. Typically, the Site Administrator is the only one allowed to use this feature. Deleting a patient case record To delete a patient case and all sample records pertaining to this patient case: Caution: When you delete a patient case, every sample record related to the patient, including all notes is deleted. Note: If you delete more than one case, you can restore the last case only if you do it immediately before doing anything else. 1. From the TAS Main screen menu, choose Records > Delete > Patients to display the Delete Patient screen. Figure 10-7, Delete Patient screen 2. Highlight the name of the patient that you want to delete and click Delete. 3. Click OK in the confirmation message to confirm the delete. The name is removed from the Delete Patient screen. Note: If you accidently deleted the wrong patient, immediately click Undo to restore the patient case and all related records. 4. Repeat steps 2 and 3 for each patient case you want to delete. 5. Click Close when you are finished deleting. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Patient Records Deleting a sample record 10-9 To delete a sample record: Note: If you accidently delete the wrong sample record, you can restore it only if you immediately click the Undo button before doing anything else. 1. From the TAS Main screen menu, choose Records > Delete > Samples to display the Delete Sample screen. Figure 10-8, Delete Sample screen 2. Highlight the record you want to delete and click Delete. 3. Click Yes in the confirmation message to confirm the delete. The record is removed from the screen. Note: If you accidently deleted the wrong record, immediately click the Undo button to restore the record. 4. Repeat steps 2 and 3 for each sample record that you want to delete. 5. Click Close when you are done. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 10-10 Managing Patient Records EDITING A PATIENT CASE RECORD TAS supports the management of “case” data, so it is possible to generate summaries of cases and to isolate one procedure from another for a given patient. Note: Patient cases can be edited only after sample data has been collected. To update an existing patient record: 1. On the TAS Main screen tool bar, click screen appears. . The Select case mode Figure 10-9, Select case mode screen 2. Select Edit case and highlight the patient record to update. Because several patients may have the same name or the same patient may be tested at different times, make sure that you have highlighted the correct patient record. 3. Click Done. The Edit case screen appears. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Patient Records 10-11 Figure 10-10, Edit case screen 4. Click any of the tabs in the Edit Case screen to make additional modifications to the selected patient case. Each tab is discussed in the sections that follow. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 10-12 Procedure tab Managing Patient Records To edit fields on the Procedure tab: 1. Click the Procedure tab. Figure 10-11, Procedure tab 2. Optionally enter information in the following fields in the Procedure Times section: Start date Start time End date End time 3. Optionally enter information in the following fields in the Intervention section: Intervention On time Off time Total 4. Optionally enter information in the Patient output type section: a. Click New. b. Enter the output type and volume. 5. Optionally enter information in the following field in the Outcome section: 06-510-US, Manual revision: AD Patient outcome TEG® 5000 System User Manual Managing Patient Records Rx tab 10-13 To edit fields on the Rx tab: 1. Click the Rx tab. Figure 10-12, Rx Tab 2. To add a new drug: a. Click New. b. Enter the drug name, amount, and units. 3. To remove a drug from the list: a. Select the drug in the list. a. Click Delete. 4. To have the system calculate a running total for a drug, select the Total by Drug name and units checkbox. Blood Products tab To edit fields on the Blood Products tab: 1. Click the Blood Products tab. Figure 10-13, Blood Products tab TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 10-14 Managing Patient Records 2. To add a new blood product: a. Click New. b. Enter the blood product name, amount, and units. 3. To remove a blood product from the list: a. Select the blood product in the list. a. Click Delete. 4. To have the system calculate a running total for a blood product, select the Total by Blood prod and units checkbox. Notes tab To edit the field on the Notes tab: 1. Click the Notes tab. Figure 10-14, Notes tab 2. In the field, type a note for the patient. For additional information, refer to “Using the Notes Feature” on page 859. Other tab To edit fields on the Other tab: 1. Click the Other tab. Figure 10-15, Other tab 2. Optionally enter information in the following fields: 06-510-US, Manual revision: AD SSN Date of birth TEG® 5000 System User Manual Managing Patient Records Locking tab 10-15 To edit the field on the Locking tab: 1. Click the Locking tab. Figure 10-16, Locking tab 2. Select the Lock checkbox to lock out unintentional editing of data on completed cases. Clinicians tab To edit fields on the Clinicians tab: 1. Click the Clinicians tab. Figure 10-17, Clinicians tab 2. Optionally enter information in the following fields: TEG® 5000 System User Manual Surgeon Anesthesiologist Pathologist Hemotologist Perfusionist Cardiologist P/N 06-510-US, Manual revision: AD 10-16 Clusters tab Managing Patient Records To view the fields on the Clusters tab: 1. Click the Clusters tab. Figure 10-18, Clusters tab The information on the Clusters tab cannot be edited. This tab automatically collects data for any sample clusters that are created by the software for PlateletMapping® samples. Whenever a calculation for PlateletMapping samples is displayed either for ADP or Arachidonic Acid (AA), TAS creates a data “cluster” so that the samples included in the platelet inhibition calculation are identified and can be recalled for reporting or viewing. For more information about PlateletMapping tracings, refer to “Viewing PlateletMapping® tracings” on page 8-13. For a complete guide to the PlateletMapping assay, refer to the TEG® 5000 System Guide to the PlateletMapping Assay. Note: Deleting a sample that belongs to a cluster also deletes the cluster and the resultant percent inhibition calculation. To view a tracing of a cluster, click to select a cluster and then click Show me. The Cluster tracings pop-up window appears on the tracing. Figure 10-19, Cluster tracings pop-up window 06-510-US, Manual revision: AD TEG® 5000 System User Manual Managing Patient Records Samples tab 10-17 To edit fields on the Samples tab: 1. Click the Samples tab. Figure 10-20, Samples tab The Samples tab provides a summary of the samples analyzed for a patient and lists the bleeding status, temperature, and whether the patient is taking platelet inhibiting drugs. 2. Click to select a sample and then click Edit. The Sample tab on the Details screen displays. Figure 10-21, Details view - Sample tab 3. Edit the desired information and then click to the Samples tab in the Edit case screen. on the toolbar to return 4. Click Done. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Chapter 11 Quality Assurance Chapter 11, Quality Assurance QUALITY ASSURANCE OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2 LABORATORY TECHNIQUES AND PRECAUTIONS . . . . . . . . . . . . . . . . . 11-3 Precautions for blood samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 Avoiding clot activation in samples. . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3 QUALITY CONTROL METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Functional checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Operational checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-4 Quality Assurance Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5 Use of approved accessories and consumables. . . . . . . . . . . . . . . . . . . 11-5 Quality control schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-5 QUALITY CONTROL SAMPLES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6 About the quality control samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-6 Establishing quality control ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8 About the quality control database . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-8 MANAGING LOT NUMBERS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9 Creating a new lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-9 Updating a lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12 Deleting a lot number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12 Archiving a lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13 Restoring a lot number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-13 REFERENCE RANGES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15 Local reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15 Updating reference ranges in TAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-15 Reference ranges for native samples . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16 Establishing reference ranges for quality controls . . . . . . . . . . . . . . . . 11-17 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-2 Quality Assurance QUALITY ASSURANCE OVERVIEW The TEG® analyzer has been shown to be a reproducible and reliable clinical tool when a good quality assurance program is followed. This chapter describes the quality control methods to follow to ensure the accuracy of the electrical and mechanical output of the TEG analyzer and the reproducibility of the data. The quality control methods described in this chapter are based on the recommendations of the US Clinical Laboratory Improvement Amendments (CLIA), the Clinical and Laboratory Standards Institute (CLSI), and the performance standards of the TEG analyzer. This chapter includes the following sections: Laboratory techniques and precautions Quality control methods Quality control samples Managing lot numbers 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance 11-3 LABORATORY TECHNIQUES AND PRECAUTIONS The use of a standardized method for the collection and handling of specimens is of utmost importance to ensure that TEG analyzer results are reproducible and reliable. Haemonetics recommends that users follow locally established procedures for the collection and handling of specimens. All users of the TEG analyzer should be familiar with standard laboratory procedures, techniques, and precautions, particularly those that affect hematologic testing. Users should also be familiar with the operation and precautions for the TEG analyzer, and how samples are applied and removed. Users should abide by Federal, State, and local guidelines for ensuring quality control in clinical laboratories including: Maintaining training and proficiency testing schedules. Recording results in personnel files. An effective quality assurance program requires that you keep and regularly review records. The TEG software is set up to maintain these records and to export QC data that can be used in statistical computer packages for analysis. Precautions for blood samples Use the following precautions for drawing blood samples: Observe safety requirements for handling blood. Use the two-syringe technique to eliminate tissue fluids or contamination of catheter lines (refer to “Collecting and Preparing Blood Samples” on page 7-17). Avoid heparin contamination. If the catheter line is loaded with heparin or coated with heparin, a heparin-like TEG tracing will result unless precautions are taken to eliminate the heparin either before or after the phlebotomy. Haemonetics strongly recommends the use of heparinase (source: Haemoscope) to eliminate heparin contamination. Avoiding clot activation in samples Avoid touching the working surfaces of the disposable cups and pins before sample applications. Use the following precautions for avoiding clot activation in patient samples: To avoid clot activation in the drawn sample, do not expose the sample to wettable surfaces. The blood from the plastic syringe must be transferred to a non-wettable surface (e.g., polypropylene) test tube or a glass vial that has been siliconized to prevent activation. Avoid shaking the sample. Adhere to the time intervals established for native whole blood analysis. Blood samples should be placed in the TEG analyzer at 4 - 6 minutes after withdrawal if they have not been anticoagulated. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-4 Quality Assurance QUALITY CONTROL METHODS Quality control methods for the TEG analyzer consist of the following: Functional checks Performing functional checks Mechanical testing (alignment, calibration, gap) Electronics testing (eTest) Performing operational checks Run Level I quality control samples Run Level II quality control samples Generating and maintaining quality assurance reports Using approved accessories and materials Adhering to a recommended quality control schedule Functional checks, including mechanical and electronic testing, ensure that the TEG analyzer is performing correctly. Mechanical testing (preventive maintenance) Mechanical function tests and adjustments, including alignment of the TEG analyzer columns and calibration testing, verify and/or preventively maintain the mechanical functioning of the analyzer. Preventive maintenance should be performed at least semi-annually by certified TEG technicians. Refer to the TEG 5000 System Preventive Maintenance and Service Manual for details. Electronic testing The electronics test, or eTest, verifies and/or maintains the electronic functioning of the TEG analyzer. This test is performed daily before any samples are run on the analyzer. For instructions on performing the eTest, refer to “Performing an eTest” on page 7-7. Operational checks Running quality control samples on the TEG analyzer serves as the daily operational check for the device. These checks verify the proper test performance and test results reporting and are the basis for monitoring the quality control of the TEG analyzer. For more information, refer to “Quality Control Samples” on page 11-6. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance Quality Assurance Reports 11-5 You can generate two types of quality assurance reports for the TEG analyzer: Levey Jennings and Lot Number History. Levey Jennings (TEG Analyzer QC Summary) report The purpose of the Levey Jennings report is to show that the lab is performing quality control tests as required and that the tests are passing the quality control criteria. For more information, refer to “Generating quality assurance reports” on page 8-45. Lot Number History report The Lot Number History report provides a log of past and current lot numbers and usage dates. For more information, refer to “Generating quality assurance reports” on page 8-45. Use of approved accessories and consumables The accessories and consumables for use with the TEG analyzer are available through Haemonetics. Contact your Haemonetics® representative for more information. These materials are produced under strict specifications and stringent quality control guidelines and are strongly recommended for use with the analyzer. Unless otherwise specifically stated, use of other sources for consumables may void your warranty. Quality control schedule Haemonetics recommends adhering to the following quality control schedule for the TEG analyzer: Daily Run Level I and Level II quality control samples. Note: Haemonetics recommends that Level I and Level II quality controls be run at least daily. Your institution or other guidelines may recommend more or less frequent testing. Print and file the tracings (your institution may recommend less frequent filing) Perform electronics testing (eTest). Every six months Perform preventive maintenance (performed by a certified TEG technician). Review and file the Maintenance History report (provided by the technician). TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-6 Quality Assurance QUALITY CONTROL SAMPLES About the quality control samples The use of quality controls (Level I and Level II) serves as the operational check for the TEG analyzer, verifying that the analyzer’s settings are working properly and is giving reliable results, both quantitative and qualitative. The results from running daily quality controls form the basis for monitoring quality control of the analyzer. Haemonetics provides two levels of quality control: Level I (high MA) and Level II (low MA). The quality controls contain a preparation of animal citrated plasma and are defined as unassayed controls. The controls are not intended to represent particular concentrations of blood components (fibrinogen, platelets, etc.). Rather, they represent two distinct levels of clot strength. For each batch or lot number of control, the statistical parameters (mean, standard deviation, ranges, etc.) are defined. Haemonetics then provides the ranges for each master lot, based on the manufacturer’s recovery values for four parameters: R,K, Angle, and MA. Both control levels should be run daily (or as otherwise dictated by your institution’s policy) before running patient samples to ensure that the main test parameters (R, K, Angle and MA) are within range. The test results for the quality controls can be transferred into a separate quality control (QC) database for easy access. The control data can then be exported for analysis by a statistical software or spreadsheet package. Refer to Chapter 9, Managing Databases, for more information. Quality control sample output Haemonetics provides two quality control sample preparations, Level I and Level II, to use in your quality control protocol. Refer to the product inserts for details about what the controls contain and instructions on preparation, use, and expected results. Level I has been formulated to simulate a higher MA, while Level II simulates a lower MA. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance 11-7 For example, running the Level II control produces the following tracing: Figure 11-1, Level II tracing example Compare the above Level II tracing to a Level I tracing below: Figure 11-2, Level I tracing example Tracking the results of the Level I and Level II controls will help document the reliability of results obtained from patient samples. Patient results should be considered unreliable when the controls produce tracings that are out of their usual ranges, and should not be reported until this is corrected. Failure to obtain the expected value may be an indication of quality control sample deterioration, TEG analyzer, or procedural problems. For more information, refer to “Quality control (Level I and Level II) sample errors” on page A-12. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-8 Establishing quality control ranges Quality Assurance Depending on laboratory policy, it may be acceptable to use the manufacturer’s reference ranges for the quality controls. However, since the mean of those ranges may not be the exact target mean value in a given laboratory, each laboratory should consider establishing its own level of performance to monitor quality assurance. Follow your institution’s policy to establish mean target values and ranges for the quality controls based on the analysis of the materials. Note: The target mean values for all parameters should fall within the manufacturer’s reference ranges specified in the quality control product inserts. For more information, refer to the Clinical and Laboratory Standards Institute (CLSI) publication, C24-A3 Internal Quality Control Testing: Principles and Definitions. To use the TEG Analytical software (TAS) to obtain statistical values for establishing ranges, refer to “Establishing reference ranges for quality controls” on page 11-17. About the quality control database The TEG Analytical Software handles the tracking for L1 (Level I) and L2 (Level II) quality control sample types differently than patient sample types. The quality control samples are run in any patient database, but when the database closes, the data is transferred to the QC database. Note: Only type LI and L2 sample data is transferred to the QC database. This action can be disabled through the configuration settings by the Site Administrator. The results are placed in a database named “qc.qc” unless otherwise specified in the configuration settings or during login. Unless there are special circumstances that require the QC samples to remain in the patient samples database, Haemonetics recommends that you leave the defaults in place. Quality control sample alerts The software provides an option that is configured by the Site Administrator that defines the time interval between QC alerts. The alert is displayed when it is determined by the software that a particular interval has elapsed since the last QC sample has run. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance 11-9 MANAGING LOT NUMBERS New lots of Level I and Level II quality control samples are issued periodically. Whenever a new lot is received, you must update the lot information in the TEG analytical software (TAS). The Lot Number option in TAS allows you to do the following: Create a new lot number Update usage dates for a particular lot number Update the sample type associated with a lot number Delete a lot number Archive a lot number Restore an archived lot number New lots and reference ranges Note: For more information on reference ranges, refer to “Reference Ranges” on page 11-15. Typically, lots are issued once a year. Whenever you receive a new control lot, you should: 1. Archive the reference ranges for the previous lot. You do this by archiving the lot number and its accompanying reference ranges (refer to “Archiving a lot number” on page 11-13). 2. Enter the reference ranges for the new lot (refer to “Updating reference ranges in TAS” on page 11-15). Once the new reference ranges are entered, these values will display for both new and old samples. If you need to display the old reference ranges for an old sample, use the Restore feature. This displays the old lot number with its accompanying reference ranges. Lot Number History report You can generate a report to track the history of all lot numbers entered in the system. Refer to “TEG Lot Number History report” on page 8-47. Creating a new lot number Before you create a new lot number, archive the current lot number along with its accompanying values for future use. Refer to “Archiving a lot number” on page 11-13 for detailed instructions. To create a new lot number: 1. From the TAS Main screen menu, choose QC > Lot number to display the QC select Lot number screen. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-10 Quality Assurance Figure 11-3, QC select Lot number screen 2. Click Add. The Enter Lot number information screen appears. Figure 11-4, Enter Lot number information screen 3. Complete the following fields: Field Description Lot number Type the number of the lot exactly as it displays on the box or vial. Sample type Click Lot number expiration date Type the date on which the lot expires as indicated on the vial. Lot number use start date Type the date on which you begin to use the lot. Lot number use end date Type the date on which the lot can no longer be used. and select Level I or Level II. 4. Click Normal values. The following message displays asking if you want to save the lot number before continuing: Figure 11-5, Add Lot number screen 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance 11-11 5. Click Yes. The System Setup screen displays with the Normal values tab selected and the Select Sample type field pre-filled with the applicable sample type. Figure 11-6, System Setup screen 6. Using the information provided in the insert, complete the following fields for each test parameter (R, K, Angle, and MA): Field Description Low Value Click this field and enter the corresponding number for each test parameter. High Value Click this field and enter the corresponding number for each test parameter. 7. If you need to add a test for the sample type, select it from the drop down menu in the Select a test to add to this table field. 8. Click Done. You are returned to the QC select Lot number screen with the lot number you added displayed on the screen. Notice that #ACTIVE# displays next to the lot number that was created most recently. 9. Click Done to return to the TAS Main screen. When L1 or L2 is selected as the sample type, the new lot number displays in the Patient name drop-down menu. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-12 Updating a lot number Quality Assurance To update the usage date for a lot number or its sample type: 1. From the TAS Main screen menu, choose QC > Lot number to display the QC select Lot number screen. 2. Select the lot number that you want to update. 3. Click Manage. The Enter Lot number information screen displays with the existing data, similar to the following: Figure 11-7, Enter Lot number information 4. For each field that you need to update, enter the new information. Note: If necessary, click the Normal values button to update the lot number’s reference ranges (refer to “Updating the reference ranges in TAS” on page 11-15 for more information). Click Done when finished. You are returned to the QC select Lot number screen. 5. Click Done to return to the TAS Main screen. Deleting a lot number You can delete a lot number from the system. Caution: When you delete a lot number, you delete all samples associated with it. To delete a lot number: 1. From the TAS Main screen menu bar, choose QC > Lot number to display the QC select Lot number screen. 2. Select the lot number that you want to delete. 3. Click Delete. The Delete Lot number message displays. Figure 11-8, Delete Lot number message 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance 11-13 4. Click Yes to confirm the delete. You are returned to the QC select Lot number screen. The lot number that you deleted no longer displays on the QC select Lot number screen. 5. Click Done to return to the TAS Main screen. Archiving a lot number Before you add a new lot number, archive the current lot number for future use. When you archive a lot number, the accompanying sample types with their respective reference ranges are archived too. To archive a lot number: 1. From the TAS Main screen menu, choose QC > Lot number to display the QC select Lot number screen. 2. Select the lot number that you want to archive. 3. Click Archive. Note: If there is an existing archive, you are prompted to overwrite it before continuing. 4. Click OK in the “Archive complete” message that appears. You are returned to the QC select Lot number screen. 5. Click Done to return to the TAS Main screen. Restoring a lot number You can restore an old lot number to use that lot number’s reference ranges when viewing samples. Before restoring an old lot number, you must archive the current lot number. The Restore Lot number screen allows you to do this at the same time as restoring a previous lot number. Note: When you have finished viewing the old lot number’s reference ranges, you must restore the current lot number. To restore a lot number: 1. From the TAS Main screen menu, choose QC > Lot number to display the QC select Lot number screen. 2. Click Restore. The Restore Lot number screen displays: TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-14 Quality Assurance Figure 11-9, Restore Lot number screen 3. Under Archive, select the current lot number (the lot number that will be replaced). 4. Under Restore, select the lot number to restore. 5. Click Continue. 6. Click OK in the “Archive complete” message that appears. The following message displays indicating that you successfully restored the lot number: Figure 11-10, Restore successful message 7. Click OK. You are returned to the QC select Lot number screen. 8. Restore the current lot number by repeating steps 1 through 7, making sure to select the old lot number to be archived and the current lot number to be restored. 9. Click Done to return to the TAS Main screen. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance 11-15 REFERENCE RANGES Haemonetics has established manufacturer’s reference ranges that outline the normal maximum and minimum limits for R, K, Angle, and MA for the commonly used TEG sample types and quality controls. These values are encoded in the TEG Analytical Software (TAS) and are used by the software to determine if the test results come inside or outside the ranges. Note: Since the manufacturer’s reference ranges are periodically updated, always refer to the product inserts for the current manufacturer’s reference range values. Local reference ranges The TEG Hemostasis System reference ranges for TEG sample types are derived from running samples on a heterogeneous population of healthy donors and statistically analyzing the results to determine the values. Since patient populations may differ due to geography, age, diet, etc., sites should verify the manufacturer’s ranges or establish their own reference ranges to enter into the software. To verify the manufacturer’s reference ranges or to establish local reference ranges, follow the procedures in the TEG 5000 System Validation Guide. Updating reference ranges in TAS It may be necessary to update the reference ranges in the software when a new lot becomes available for a quality control or when studies are updated. If your institution establishes its own ranges, refer to “Establishing reference ranges for quality controls” on page 11-17 for information on recalculating ranges for a new master lot. Then, if necessary, change the ranges in the software to match the calculated ranges. If your institution uses the manufacturer’s reference ranges, compare the reference ranges in the product insert to the current values in the software. If necessary, change the reference ranges in the software to match the inserts. Caution: New reference ranges added to TAS apply to previously run samples in the database. Note: Before updating reference ranges in TAS for a quality control sample, archive the old values so that a history of the reference ranges is maintained for the quality control samples (refer to “Archiving a lot number” on page 11-13). To update reference ranges in TAS: 1. From the TAS Main screen, choose Options > User Profile Setup. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-16 Quality Assurance 2. In the User Profile Setup screen, click the Normal values tab. Figure 11-11, Normal values tab 3. In the Select Sample type drop-down list, select the sample type for which you want to update reference ranges. 4. Using the information provided in the insert, complete the following fields for each test parameter: Field Description Low Value Click this field and enter the corresponding number for each test parameter. High Value Click this field and enter the corresponding number for each test parameter. 5. Click Done. Reference ranges for native samples For sites that choose to run native whole blood samples (whole blood without the addition of any modifiers), the following reference ranges have been established, based on a group sample size of 132 donors: Sample type R (min) K (min) Angle (deg) MA (mm) G (kd/sc) Native (N) 12.1 – 26.5 3.2 – 12.8 13.6 – 46.4 41.8 – 63.0 3.2 – 7.1 Citrated Native (CN) 9.4 – 27.4 1.9 – 8.9 22.0 – 58.0 44.4 – 63.6 3.6 – 8.5 Table 11-12, Reference ranges for native whole blood samples 06-510-US, Manual revision: AD TEG® 5000 System User Manual Quality Assurance 11-17 Note: Sites wanting to run this type of sample should verify reference ranges or establish their own reference ranges following the procedure in the TEG 5000 System Validation Guide. Establishing reference ranges for quality controls If your institution chooses to establish its own ranges to monitor quality control (refer to “Establishing quality control ranges” on page 11-8), you can use the following procedure to obtain the Mean and Standard Deviation (SD) for the quality controls. Establishing a new Mean and SD To use the TEG Analytical Software (TAS) to establish the new Mean and SD for each level of quality control: 1. Run both levels of quality control a minimum of 20 times (refer to “Running quality control samples” on page 7-9). In TAS, in the Patient name field, use the naming convention, “Master Lot xxxx-xxxx Reference Range Study.” The master lot number can be found on the control vials. 2. From the TAS Main screen menu, choose QC > Go To to switch to the QC database. 3. Click . 4. On the Filter criteria screen, do the following: a. On the Sample type tab, highlight “L1” or “L2.” b. On the Patient tab, in the Patient name list, highlight “Master Lot xxxxxxxx Reference Range Study.” c. Click Apply filter. 5. On the TAS Main screen, click . 6. On the Report options screen, do the following: a. Clear the Tracing checkbox. b. Select Print text in black. c. Select Default tests (first 10). d. If applicable, clear the Normals checkbox. e. Make sure that All samples (total of n) is selected. f. Click Continue. 7. Print the page of the TEG Analysis Results report that contains the values for Mean, n, SD, Min, and Max. 8. Compare the Mean values in the report with the manufacturer’s reference ranges specified on the quality control product insert. If the Mean values are within range, each will be considered the “new Mean.” TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 11-18 Quality Assurance 9. Calculate each two SD range by multiplying the SD values in the report by two. 10. Incorporate the SD range around the new mean and monitor throughout the dating of the product. Next steps After establishing the ranges for a new master lot of quality control, do the following: Archive all previous lots of control. Refer to “Archiving a lot number” on page 11-13. Caution: Do not change the normal ranges in TAS until the reference range study is complete and the new master lot is in use. Change the LI and Level II ranges in TAS to match the laboratoryestablished ranges. Refer to “Updating reference ranges in TAS” on page 11-15). Following your institution’s policy, periodically recalculate the Mean and SD values during the life of the new lot. Note: If the TEG instrument is performing correctly, the SD should not change significantly from lot to lot. Establishing a preliminary Mean The following procedure may be used to set a “temporary Mean” until you have completed the 20 runs of each level of quality control necessary to set the “new Mean” for R, K, Angle, and MA. To establish a preliminary Mean and SD: 1. Run both levels of quality control 10 times. 2. Calculate the average Mean value for each parameter from these runs. 3. Ensure that the average Mean falls within the range specified in the quality control product insert. If the average Mean values are within range, each will be considered the “temporary Mean.” 4. Use the established laboratory SD from your installation report. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Chapter 12 Communicating TEG Data COMMUNICATING TEG DATA OVERVIEW. . . . . . . . . . . . . . . . . . . . . . . 12-2 USING THE ECONSULT FUNCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 About eConsult. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 eConsult prerequisites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 Sending patient data using eConsult . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3 USING THE CAPTURE FUNCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-8 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 12-2 Communicating TEG Data COMMUNICATING TEG DATA OVERVIEW You can use the eConsult and Capture features in TAS to communicate TEG® analyzer data by sending sample data through e-mail or by electronically copying and pasting single or multiple tracings into other documents. This chapter includes the following information: Using the eConsult function Using the Capture function 06-510-US, Manual revision: AD TEG® 5000 System User Manual Communicating TEG Data 12-3 USING THE ECONSULT FUNCTION About eConsult The eConsult feature allows you to consult electronically with colleagues and specialists by securely sending patient data through e-mail. The eConsult feature can send files and messages to e-mail recipients using various devices, including standard PCs, notebooks, and personal digital assistants (PDAs) as long as they are equipped to receive e-mail with graphical attachments. Depending on how you set up your eConsult profile, recipients can receive a short text message on their cell phone or pager informing them that they have email for an electronic consultation. eConsult prerequisites In order to use the eConsult feature, the following prerequisites must be met: The eConsult option must already be configured through the User profile setup screen. Typically, your Site Administrator will have set this up for you. However, if you need to add a recipient to eConsult or to define a server to send and receive mail, refer to “eConsult Tab” on page 6-25. Sending patient data using eConsult The computer being used must be on the network with access to the mail servers. The eConsult feature allows you to send patient data to a recipient’s PC, laptop, cell phone, or PDA. The eConsult wizard takes you through the process by providing screens to: Identify the patient for whom you are sending information while maintaining patient confidentiality. Select sample(s) to send, enter relevant clinical data and contact information. Specify the type of attachment to send and the recipient. Before You Begin Before you begin, you must have: TEG® 5000 System User Manual TAS Main screen displayed P/N 06-510-US, Manual revision: AD 12-4 Communicating TEG Data The steps To send patient data through eConsult: 1. From the TAS Main screen, click . The Introduction screen appears. Figure 12-1, Introduction screen 2. Select the name of the patient for whom you want to send information. 3. Type the code that indicates the selected patient according to your institution’s code identification guidelines. Note: For privacy purposes, the patient’s name is suppressed in the e-mail and the patient is identified only by the code that you enter. 4. Click Next. The Select samples screen appears, listing the samples for this patient: Figure 12-2, Select samples screen 06-510-US, Manual revision: AD TEG® 5000 System User Manual Communicating TEG Data 12-5 5. Click to select one sample or hold the Ctrl key down while you select multiple samples. 6. Click Next. The eConsult wizard (2) screen appears allowing you to enter clinical data and contact information. Figure 12-3, eConsult wizard (2)- Clinical and contact form screen 7. Complete the desired fields: Field Description Gender Select Male or Female. Age Type the age of the patient in years. Weight Kg, Pounds a. Type the patient’s weight.Select Kilograms or Pounds. Temperature Type the patient’s temperature in celsius. Procedure type Select the patient procedure type. Rx Administered a. Select each drug that the patient received for this procedure. b. Type the dose given to the patient in the Dose field that displays. Note: If you selected Other, type the drug name in the field that displays. Bleeding status TEG® 5000 System User Manual Click the option that indicates whether the patient is currently Bleeding, Not bleeding, or Oozing. P/N 06-510-US, Manual revision: AD 12-6 Communicating TEG Data Field Description Lab results Type the available lab results for the following in their respective fields: Platelet number Fibrinogen level PT INR PTT DDIMER Comments Type any relevant comments. Contact phone number Type the phone number of the person to contact for more information about this patient. Contact name and/or extension Type the name and/ or extension of the person to contact for more information about this patient. 8. Click Next. The eConsult wizard (3) screen appears allowing you to select the format for sending the data. Figure 12-4, eConsult wizard (3) - Records to send screen 9. Choose the type of records that you want to send: 06-510-US, Manual revision: AD If you want to send... Select... Numeric and tracing data for the selected sample(s) Samples with tracings Numeric data with tracings overlaying each other (superimposed) Samples with tracings and Superimpose tracings Numeric and tracing data according to the length of time that the sample ran Samples with tracings and, if appropriate, Superimpose tracings From the drop-down list, select the desired number of minutes for each tracing. Note: The user may truncate the sample so that it fits better on the recipient screen. TEG® 5000 System User Manual Communicating TEG Data 12-7 If you want to send... Select... Selected tracings in the TEG database format so the recipient can merge and manipulate the data. Database Note: The recipient must have TAS installed to open this file. 10. Click Next. The eConsult wizard (4) screen appears allowing you to select the recipient. Figure 12-5, eConsult wizard (4) - Recipient listing screen 11. Select the recipient to receive the transmission and click Finish. When the transmission is complete, a confirmation message appears. 12. Give the recipient the code that identifies this patient’s information. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD 12-8 Communicating TEG Data USING THE CAPTURE FUNCTION This section explains how to use the Capture feature to electronically copy and paste tracings into another document. Before You Begin Before you begin, you must have: TAS Main screen displayed The Steps To copy and paste a tracing into another document: 1. From the TAS Main screen, do one of the following: If you want to copy... Then... A single tracing Select the tracing you want. A superimposed or offset view of multiple tracings a. On the toolbar, click Multi and select the tracings you want. b. Click Done. c. To display a superimposed view of the tracings, click Super. Otherwise, continue at step 2. 2. Click . The Capture options screen appears. Figure 12-6, Capture options screen 06-510-US, Manual revision: AD TEG® 5000 System User Manual Communicating TEG Data 12-9 3. Select the appropriate options: If you want to capture... Then select... First 10 parameters displayed on the tracing Results No test results on the tracing No results Grid lines on the tracing Grid lines No grid lines on the tracing No grid lines White tracing with a black background Black background Black tracing with a white background White background Patient name on the tracing Show patient name No patient name on the tracing Suppress patient name 4. Click OK. The tracing is stored on the program’s clip board. The Capture options screen closes and you are returned to the TAS Main screen. 5. In the document that you want to paste the tracing(s) into, choose Edit > Paste or press Ctrl+V to paste the tracing(s). In the following example, a single tracing was captured with the following options selected in the Capture options screen: Results Grid lines Black background Suppress patient name Figure 12-7, Tracing pasted into a document using the Capture function TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Appendix A Troubleshooting TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2 Login errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Database errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7 eTest errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-9 Cup and pin errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11 Quality control (Level I and Level II) sample errors . . . . . . . . . . . . . . . . A-12 Unexpected tracing results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-16 Blood sample errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-19 Temperature errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20 Reference ranges errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21 Remote workstation access errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-22 Printing errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-23 Accessing Help errors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-26 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-2 Troubleshooting TROUBLESHOOTING This chapter contains troubleshooting tips for some of the most common issues and concerns experienced when using the TEG® analyzer. This chapter helps you solve problems associated with: Logging in to the TEG Analytical Software (TAS) Opening databases Performing an eTest Loading and ejecting cups and pins Running quality control samples Unexpected tracing results Running blood samples Temperature readouts Viewing reference ranges Accessing remote workstations Printing If a problem still exists after following the recommended actions outlined in the tables in this chapter, contact TEG System Technical Support to arrange for repairs or return (refer to “Customer Service” on page 1-4). 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-3 Login errors Problem Possible cause Recommended action The password does not work. The password is case sensitive. Check that the keyboard Caps Lock key is not on. The password has changed. Contact your Site Administrator for the new password. The cfg.set file on the user’s computer is read only. Contact your IT department to do the following: When logging in, the following messages appear: ”This file is either opened exclusively by another user or is Read Only …” followed by “The config file could not be opened…” 1.In Windows® Explorer, navigate to the application folder (e.g., C:\Program Files\TEGV4). 2.Locate the cfg.set file, rightclick it, and select Properties. 3.In the Properties dialog, on the General tab, make sure the Read only checkbox is not selected. You do not have the correct permissions. TEG® 5000 System User Manual Contact your IT department to set your permissions on the application folder (e.g., C:\Program Files\TEGV4) to Read, Write, and Modify. P/N 06-510-US, Manual revision: AD A-4 Troubleshooting Problem Possible cause Recommended action When the Patient database is selected, the message, “This file is either opened exclusively by another user or is “Read Only …” appears. The Patient database is read only. Contact your IT department to do the following: 1.In Windows® Explorer, navigate to the folder (e.g., C:\TEG) that contains the database you want to open. 2.Right-click the database file, and select Properties. 3.In the Properties screen, on the General tab, make sure the Read only checkbox is not selected. You do not have the correct permissions. Contact your IT department to set your permissions on the application folder (e.g., C:\Program Files\TEGV4) to Read, Write, and Modify. You are attempting to run the database from a CD or other media that is write-protected. Contact your IT department to do the following: 1.Copy the database from the media to the desktop. 2.In Windows® Explorer, rightclick the database file on the desktop, and select Properties. 3.In the Properties screen, on the General tab, make sure the Read only checkbox is not selected. When logging in, a Patient database name message, “does not exist” appears. The database is unavailable. On a network, make sure the network connections are secure and the network is running properly. If it is a local database, type the full path in the Login screen instead of just the database name. Contact your IT department if necessary. Cannot access a QC database. The QC database is unavailable. On a network, make sure the network connections are secure and the network is running properly. If it is a local database, type the full path in the Login screen instead of just the database name. Contact your IT department if necessary. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-5 Problem Possible cause Recommended action Cannot create a new QC or Patient database. You attempted to create a new QC database from the remote version of the software. Create the QC database on a computer where the TEG-enabled software is installed. The computer may not be connected to the network. Check that the computer is connected. You attempted to enter an invalid path. Type the full path making sure to include the server name. The Site Administrator may not have granted you permission to create a database. Contact your Site Administrator and check whether you are allowed to create a new database. The “Find” process only works if the database is on the drive selected at the top of the “Find” screen. If the database is on a different drive, or over the network, the “Find” function will not locate the database. Select another drive at the top of the Find screen. The Find process does not work if the drive that you selected in the Find screen is named. For example, instead of “C:”, the drive is named “C: [OS].” Do one of the following: Unable to find the database using the “Find” button. Use the Windows® search functionality to search for files named “*.teg” or “*.qc”. Contact your IT department to clear the name associated with the C: drive. My personal settings are not appearing after I selected my User name. The cursor is still in the User name field (you did not click or tab out of the field). Move the cursor out of the User name field by clicking somewhere else on the Login screen or pressing Tab. Your default settings will then display in the screen. After selecting the user and pressing Tab, the default patients (or QC) database did not load. You modified the database text field before selecting the user. This disables the default entry. Click Locate to select the database(s) you want or exit TAS, log in again, and select a user without modifying any fields. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-6 Troubleshooting Problem Possible cause Recommended action When attempting to access the TEG screen, a message appears indicating that the COM port is in use, or does not exist. Another program or driver is using the COM port such as a palm pilot or touch screen. Any software or driver that uses a COM port could cause this message to be issued. 1. Verify that no other instance of TAS is running and that the computer is restarted. 2. Contact your Site Administrator to check to see if any new programs or drivers were loaded since the last time TAS was run. 3. Your Site Administrator can complete the appropriate action: Use a different port for TAS. Use a different port for the software causing the problem. Uninstall the problem software. The wrong COM port was selected in the configuration utility. Check that the correct COM port was selected in the configuration utility. A 4.1 database has been accidentally converted to version 4.2. When a 4.1 database is opened in version 4.2, it is automatically converted to version 4.2. You can access a backup of the 4.1 database. A backup is automatically created when an older version database is converted to 4.2. By default, this backup is created in the C:\TEG\BackupV4 folder. Unable to log in as the Site Administrator because the Site Administrator is unavailable. Site Administrator password is unknown. Contact TEG System Technical Support. Unable to log into the configuration utility. The password is case sensitive. Check that the keyboard Caps Lock key is not on. The Site Administrator password was changed. Contact your Site Administrator to obtain the new password. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-7 Database errors Problem Possible cause Recommended action When opening a database, or when scrolling, the message “Object or With Block variable not set” appears. OR When opening a database, the message, “Search key not found” appears. OR While scrolling down or up, the same patient name stays in the top sample’s slot. OR The message, “Unrecognized database format” appears. OR The message, “Disk or Network” appears when the network connections are sound and the database is stored locally. The database may be corrupted. Do the following: Tracings or test values disappear from a database. The database may be corrupted. Refer to the row above for instructions on compacting the database. Samples were deleted from the database. To restore an earlier version of the database but preserve samples that have been run since the last backup: 1.Exit the patient database, make a copy/backup of the problem database, and then compact the original problem database (refer to Chapter 9, Managing Databases). 2.Enter the database and check to make sure that no data was lost. 3.If data was lost, delete the compacted database, and restore the copy/backup that you made. 4.Create a new database, and merge the problem database into the new database. 5.Repeat the process for the QC database. 1.Obtain an earlier backup copy of the database from your backup location and rename the file. 2.Copy the renamed backup database to your current database location. 3.Merge the backup database into the current database. 4.Remove the backup database after the merge. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-8 Troubleshooting Problem Possible cause Recommended action After compacting, the tracings or test results are missing. Possible corruption. Do the following: 1.In TAS, create a new database. 2.Choose File > Merge and navigate to the backup database that you created before compacting. 3.Click Open. 4.After merging, make sure the data is restored. After compacting, all the data is lost from a database. Possible corruption. Do the following: 1.In TAS, create a new database. 2.Choose File > Merge and navigate to the backup database that you created before compacting. 3.Click Open. 4.After merging, make sure the data is restored. When exiting the Edit Case screen, a gray screen appears. Known system error. In TAS, select Options > User Profile Setup, then exit the User profile setup screen. No changes are required in the User profile setup screen. During compacting, a message appears indicating that compacting cannot be completed. A temporary file from a previous compacting action still exists. Delete the temporary file, “teg compact.tmp”, located by default (Windows 2000 and XP) in C:\Program Files\TEGV4. An excluded sample type is staying included. The database contains samples with the same sample type as the one you are trying to exclude. Consider the following: Remove the samples that have the sample type you want to exclude. OR Change the sample type for those samples that you want to exclude. OR Create a new database You attempted to exclude an L1 or L2 sample type. 06-510-US, Manual revision: AD You cannot exclude an L1 or L2 sample type. TEG® 5000 System User Manual Troubleshooting A-9 eTest errors Problem Possible cause Recommended action When performing an eTest, the “Channel not at equilibrium” message appears. Data is still processing. Give the software a little more time to process the data, or click eTest again. The analyzer is picking up external vibrations. Check that the analyzer is on a secure surface that is not being exposed to any vibrations. The lever is in load. Move the lever to “Test” and click eTest again. The analyzer is not level. Use the bubble level at the top of the analyzer to ensure the analyzer is level. The eTest is off center. Adjust the corresponding “BASE” potentiometer in the back of the analyzer (refer to “Adjusting the eTest Baseline” on page 7-8). The eTest may be out of range. End the sample, perform the eTest, and make any necessary adjustments. The wrong channel was started. End the sample on the channel you accidentally started, and rerun the sample. The cup and pin are not loaded properly. Make sure the cup and pin are pushed firmly into place (refer to “Loading and Ejecting Cups and Pins” on page 7-14). After adjusting the eTest values, the message did not change to reflect the new MIN and MAX numbers. The message does not update to reflect any change in the eTest status until the eTest is run again. Highlight the channel you are using and click the eTest button again. The eTest results are not saved. The “Service mode” option may be checked on the Maintenance screen. In the Maintenance screen, clear the service mode checkbox. When performing an eTest, the “eTest value off center” message appears. While running samples, the following message appears: “An eTest-out-of-range error has occurred on channel <#>. This error may be due to: 1. A true eTest error or 2. Misloading of the disposables.” TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-10 Troubleshooting Problem Possible cause Recommended action An eTest result did not appear on a report. The Service mode option may be checked on the Maintenance screen. In the Maintenance screen, clear the Service mode checkbox. The data for each day appears on its own report page. Data for two days has at least two pages, even if each page only has one line of data. Check each page of the report. TAS is being run on the Windows 7 operating system.On Windows 7, eTest results do not always appear on the Service History Log and Daily Maintenance Log reports. No workaround is available. The Service mode option may be checked on the Maintenance screen or the final results have not been saved. Do the following: The serial number for the analyzer being tested does not display on the Daily Maintenance Log report. Although the eTest value may not appear on the report, it is stored in the software and recalculated each time a test is started. If the newly calculated eTest value is out of range, an alert warns that the date may be compromised. 1.In the Maintenance screen, clear the Service mode checkbox. 2.Click eTest and wait for a final message such as “eTest OK” or “eTest out of range.” 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-11 Cup and pin errors Problem Possible cause Recommended action The pin sometimes slips down into the cup. The pin is not loaded securely. Make sure the pin is pushed firmly into place, using the plastic pusher at the bottom of the carrier while applying counter pressure on top of the analyzer (refer to “Loading and Ejecting Cups and Pins” on page 7-14). The cup is not flush with the carrier. The cup is not fully seated after the pin is pushed up. With an index finger placed under the edge of the carrier, seat the cup by pushing down on it with both thumbs until the flange of the cup is touching the top of the carrier. The pin will not come off the skewer. The lever is not in the Eject position. Press the lever down to the Eject position and the pin should automatically drop off the skewer. If necessary, you can remove the pin manually while the lever is in the Load position. The cup does not easily come out of the carrier. The cupwell in the carrier may be dirty. Do the following: 1.Push the carrier firmly against the tray, then lift the cup out of the carrier. If necessary, you can lift the cup out of the cupwell using bent tip tweezers or a hemostat. 2.Clean the cupwell (refer to “Cleaning The TEG Analyzer” on page 7-28). TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-12 Troubleshooting Quality control (Level I and Level II) sample errors Problem Possible cause Recommended action The quality control samples are missing. The database was closed and all the QC samples were transferred to the QC database. From the TAS Main screen menu, choose QC > Go To to open the QC database. The software is configured to transfer the samples after they terminate, so it is possible that the samples transferred without the database being closed. From the TAS Main screen menu, choose QC > Go To to check if the samples transferred. When trying to enter a new lot number the screen to enter a new patient appears. The sample type was not set to L1 or L2. From the TAS screen, go to the sample type (ST) field and select either L1 or L2, whichever is appropriate. One or more parameters are out of range. Consider the following common causes: Hardware problems. Do the following: Quality control sample problems. Operator error. 1.Check the temperature (refer to “Temperature errors” on page A-20). 2.Ensure the analyzer is level. 3.Rerun the control sample: Make sure the cups and pins are loaded correctly (refer to “Loading and Ejecting Cups and Pins” on page 7-14), avoiding contamination of their surfaces. Reconstitute a new vial of quality control material, carefully following the instructions on the product insert. After the quality control material is added to the cup, raise the carriers immediately but not too quickly. This will ensure that no material gets splashed onto the flange of the cup. 4.If a problem still exists, contact TEG System Technical Support. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-13 Problem Possible cause Recommended action Elongated R time. The analyzer is out of specification. Contact TEG System Technical Support. The carrier is not raised. Make sure the carrier is fully raised. Calcium and or/activator were pipetted or reconstituted incorrectly or are contaminated. Prepare another sample and rerun the test. The cup/and or pin were loaded incorrectly. Make sure the cup and pin are pushed firmly into place (refer to “Loading and Ejecting Cups and Pins” on page 7-14). Check the temperature (refer to “Temperature errors” on page A20). The sample temperature is incorrect. Shortened R time. K is out of range. Angle is out of range. TEG® 5000 System User Manual Pipetting was inaccurate and/or the sample was prematurely activated. Prepare another sample and rerun the test. The sample temperature is incorrect. Check the temperature (refer to “Temperature errors” on page A20). Calcium and or/activator were dispensed incorrectly or are contaminated. Prepare another sample and rerun the test. The sample temperature is incorrect. Check the temperature (refer to “Temperature errors” on page A20). The analyzer is out of specification. Contact TEG System Technical Support. There was an electrical disruption to the analyzer. Rerun the test. The sample temperature is incorrect. Check the temperature (refer to “Temperature errors” on page A20). P/N 06-510-US, Manual revision: AD A-14 Troubleshooting Problem Possible cause Recommended action MA is out of range. The analyzer is out of specification. Contact TEG System Technical Support. The carrier is not flush with the lower column. Ensure that the carrier is fully raised. The cup and/or pin were loaded incorrectly. Make sure the cup and pin are pushed firmly into place (refer to “Loading and Ejecting Cups and Pins” on page 7-14). The analyzer is not level. Use the bubble level at the top of the analyzer and the leveling feet to ensure that the analyzer is level. There is excess calcium chloride on the pipette tip. Consider using a fresh pipette tip for each cup. MA in one channel is out of range after running multiple control samples. The analyzer is out of specification. Contact TEG System Technical Support. The MA in both channels is either low or high. The analyzer is not level. Use the bubble level and the leveling feet to ensure the analyzer is level. R and Angle are out of range, MA is within limits. The sample temperature is incorrect. Check the temperature (refer to “Temperature errors” on page A20). R in one channel is very short and the MA is very large, while the MA in the other channel is very small. The analyzer is not level. Use the bubble level at the top of the analyzer and the leveling feet to ensure that the analyzer is level. Parameter values are out of range according to the insert, but not according to the software. For R and K, TAS may be reporting the units in millimeters (mm) and the insert reports the units in minutes or seconds. Convert the mm to minutes, remembering that 2mm=1 minute. Convert the mm to seconds if this is the protocol at your site. You may have used a new lot that has different reference ranges. Enter the current reference ranges from the product insert into TAS. Unexpected tracing for Level I. Level I control was placed in the Do the following: sample cup but “L2” was selected as the sample type in the software. 1.Confirm that the wrong sample type was selected in the software. 2.Select the correct sample type. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-15 Problem Possible cause Recommended action Unexpected tracing for Level II. Level II control was placed in the Do the following: sample cup but “L1” was selected 1.Confirm that the wrong as the sample type in the software. sample type was selected in the software. 2.Select the correct sample type. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-16 Troubleshooting Unexpected tracing results Problem Possible Cause Straight line tracings. There is no communication between the analyzer and the computer. Recommended Action 1.Turn on the TEG analyzer. 2.Make sure that at least one analyzer is plugged into the TEG 1 port on the A/D box and that additional analyzers are plugged into their correct ports (TEG 2, 3, or 4). 3.Make sure that the power light on the A/D box is on. The A/D box is connected to the computer through a USB/serial converter. The A/D box is connected to the wrong COM port. 4.Tighten any loose connections between the analyzer and the A/D box or between the A/D box and the computer. Make sure the A/D box is connected through the COM port. Do the following: 1.From the TAS Main screen menu, choose Options > User Profile Setup. 2.On the Software tab, under COM port, select the corresponding port from the Select COM port drop-down list. 3.Click Done. 06-510-US, Manual revision: AD The incorrect channel was started. Start the correct channel. The motor is not on. Note: This applies only to older TEG analyzers with a motor switch that can be turned on or off independently of the power switch. Turn on the motor. The sample was not prepared correctly. Consider the following: If heparin is suspected, ensure a blue heparinase cup is used. Ensure 20 µL calcium chloride is added to a sodium citrate sample. Ensure 20 µL calcium chloride is added to a quality control sample. TEG® 5000 System User Manual Troubleshooting A-17 Problem Possible Cause Recommended Action Unusual dips and spikes in tracings. Loose pin. Stop the sample, reload a new cup and pin, and rerun the sample. Loose cup and pin. Stop the sample, reload a new cup and pin, and rerun the sample. Data from the A/D box was interrupted. Do the following: 1.Make sure that all cable connections are secure and that cables are not bent or kinked. 2.Go to the Windows® Control Panel, select Power Options, and make sure that all settings are set to Never. TEG® 5000 System User Manual The A/D box is connected to the computer through a USB/serial converter. Make sure the A/D box is connected through the COM port. Unstable environment/vibrations. Make sure the analyzer is in a low vibration environment. The analyzer was bumped during the sample run. Prepare another sample and rerun the test, making sure the analyzer is not bumped during the sample run. P/N 06-510-US, Manual revision: AD A-18 Troubleshooting Problem Possible Cause Recommended Action Double R: Angle not calculated from the split point (SP). The tracing below illustrates a double R. The Angle is incorrectly measured from the start of the double R (A) instead of from the split point (B). Unstable environment/vibrations. Make sure the analyzer is in a low vibration environment. Make sure the analyzer is not bumped during the sample run. An electrical surge occurred within the circuit (e.g., a refrigerator or air conditioning unit cycled on and off). Make sure the analyzer is plugged into a UPS (Uninterruptible Power Supply) unit. Isolate the analyzer on its own electrical circuit. The analyzer is not level and the Make sure the analyzer is level. pin is touching the side of the cup. The gap or alignment is out of specification and the pin is touching the bottom or side of the cup. Contact TEG System Technical Support. Sharp drop in MA. The lever was switched to Load before terminating the sample. If needed parameters were not defined, rerun the test. No R value. A preclot. There may have been a clot in the sample or there may have been a delay in starting the sample. Prepare another sample and rerun the test. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-19 Blood sample errors Problem Possible cause Recommended action Unable to start samples from the TAS Main screen. You must be in the TEG screen to run samples. From the TAS Main screen, click the TEG icon to display the TEG screen. Unable to access the TEG screen. You attempted to access the TEG screen from the remote version of the software. You must be using the TEGenabled version of the software to access the TEG screen. Unable to change information for active samples. You attempted to change information for an active sample from a computer other than the one used to start the sample. Go to the computer that started the sample and make the change from that computer. The “Select a patient” screen appears when terminating samples. You attempted to terminate a sample before selecting a patient. Click the appropriate button: Done to assign the selected patient to the sample. Create to display the Patient Creation screen. Ignore to assign the current time and date as the patient name to the sample. Notes: Ignore is meant to be temporary, until you can create and assign the correct patient name. Ignore is not available if your Site Administrator disabled it. Cancel to stop the termination of the sample. The “Select a patient” screen automatically appears when running samples. After clicking Cancel, the screen reappears every few seconds. Your samples are set to automatic termination, the criteria has been met, but the sample does not have a patient assigned to it. Do not click Cancel as it stops the termination and keeps the sample running. Either choose a patient now or click Ignore (if available) and assign a patient to that sample at a later time. A spike appeared in the tracing when the analyzer was bumped, but then disappeared. The software was filtering and optimizing the last minute of data to correct the aberration. None. A spike occurred at the end of the tracing and did not smooth out. The filtering process is still in progress. Allow additional time for the filter to complete. The sample terminated before the filter corrected. Rerun the sample. The disturbance lasted longer than or was greater than the filtering/optimization’s capacity for correction. Rerun the sample. A spike occurred at the end of the tracing and did not smooth out, even after running for an additional 10 minutes. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-20 Troubleshooting Problem Possible cause Recommended action After running a sample from the TEG screen and clicking the Done button, the sample does not show up on the TAS Main screen. The sample did not meet the filter criteria for displaying on the TAS Main screen. Remove or adjust the filter to allow for the display of this sample. Samples may be sorted. Locate the sample by the appropriate sort or sort by date. After entering the patient name for a sample and changing the sample type for a patient in the database, the message “The Lot number was not found” appears followed by a prompt to create the lot number. You attempted to change the sample type to L1 or L2 for a patient that is in the patient database but not the QC database. Change the sample type to the correct patient sample type. No value is displayed for CI. The sample is a PlateletMapping sample type (A, AA, ADP). None. The MA < 20 mm and K is left undefined. CI cannot be calculated without a value for K. None. The sample run was stopped early and/or values were not achieved for R, K, Angle, or MA. CI cannot be calculated with a 0 value for R, K, Angle or MA. Let the sample run until there are values greater than 0 for R, K, Angle and MA. Problem Possible cause Recommended action The temperature readout is flashing “BAD.” The ribbon cable is loose. Check that the ribbon cable connections between the carrier and the analyzer are tight. The ribbon cable and/or carrier is dirty. Clean the carrier and ribbon cable with alcohol. The carrier or ribbon cable is damaged or defective. Contact TEG System Technical Support. The ribbon cable is loose. Check that the ribbon cable connections between the carrier and the analyzer are tight. The ambient temperature is fluctuating. Make sure that the analyzer is not in front of a window or by an air duct. There is a loose connection inside the temperature controller. Contact TEG System Technical Support. The temperature controller is defective. Contact TEG System Technical Support. Temperature errors The temperature is high or there is a jump in temperature. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-21 Problem Possible cause Recommended action The temperature stays at room temperature and will not heat up to 37.0 degrees. The ribbon cable is loose. Check that the ribbon cable connections between the carrier and the analyzer are tight. The ribbon cable and/or carrier is dirty. Clean the carrier and ribbon cable with alcohol. The carrier or ribbon cable is defective. Contact TEG System Technical Support. The temperature controller is defective. Contact TEG System Technical Support. The temperature set point was changed. Reset the set point to 37.0 degrees. Problem Possible cause Recommended action Reference ranges do not appear in the TAS Main screen. The reference ranges do not display on the TAS Main screen. Select the desired tracing and then click the Max button. The reference ranges do not appear in the Max screen. No sample type was entered for that channel. From the TEG screen, select the desired sample type for the appropriate channel. No reference ranges were entered in TAS for that sample type. Enter the reference ranges. A test is being displayed that does not have reference ranges. Enter the reference ranges. The temperature readout is not at 37.0 degrees ± 0.5. Reference ranges errors TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-22 Troubleshooting Remote workstation access errors Problem Possible cause Recommended action Unable to run samples in the remote version of TAS. You cannot run samples in the remote version of TAS. Install the TEG-enabled version of TAS. When viewing a database over the network, the following error was issued: “The file is currently locked. Click “OK” to try again, or “Cancel” to terminate the program. “ Another user is trying to access Click “OK” to try again or wait the same record at the same time. until the other user is done. The database cannot be accessed over the network. The database drive is not shared and accessible. Contact your Site Administrator. The network is down. You do not have the correct permissions. Contact your Site Administrator to set your permissions on the application folder (e.g., C:\Program Files\TEGV4) to Read, Write, and Modify. When accessing a database over the network, the screen flickers periodically. TAS is refreshing. Your screen refreshes every 30 seconds while a sample is running or when you make a change to the database. None. When accessing a database over the network, you are unable to change the sample description of any active sample. You attempted to modify active samples from a computer other than the one running the samples. You can modify active samples only from the computer running the samples. Go to the computer running the sample(s) and make the change. When remotely viewing a database, a sample disappeared after TAS refreshed. Another user may have deleted the sample. None. A filter may be set that precludes this sample from displaying on the TAS Main screen. Change the filter criteria to include this sample (e.g., if the sample is terminated, undo the Active filter). The patient name for a sample was changed over the network, but when TAS refreshed, the sample still had the old name. Another user may be updating this field. Try updating at a later time. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-23 Printing errors Problem Possible cause Recommended action When trying to print, the following message appears: “This database has too many users printing on it, or is damaged.” The database may be corrupted. Do the following: 1.Exit the patient database, make a copy/backup of the problem database, and then compact the original problem database. 2.Enter the database and check to make sure that no data was lost. 3.If data was lost, delete the compacted database, and restore the copy/backup that you made. 4.Create a new database, and merge the problem database into the new database. 5.Repeat the process for the QC database. When trying to print, a message appears saying that a printer needs to be loaded on the computer. No default printer is set. Contact your Site Administrator. When trying to use Quick Print, the Print button is disabled. No tracing is selected. Highlight the tracing you want to print and click the Quick Print button. You attempted to print from the Multi screen which has the Print button disabled. Press the F6 key to send the tracing to the default printer. When using Quick Print, the printer must be selected, even though the default printer is selected already. This is according to design. Press the F6 key to send the tracing to the default printer. All pages of the report print, instead of the current page. You did not specify a particular subset or page. When you choose the printer, indicate the page(s) that you want to print. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD A-24 Troubleshooting Problem Possible cause Recommended action The Maintenance report does not display today’s results. The Service mode checkbox is selected on the Maintenance screen. Do the following: 1.In the Maintenance screen, clear the Service mode checkbox and run the maintenance test again. Any maintenance tests that were run with the Service mode box selected will not be retained or stored in the database. 2.Run the Maintenance report again. Values are missing from the printed report. A filter may be set that precludes including today’s results. You may have chosen to filter by date and excluded today. Change the filter to include today’s results. The data is not on the first page of the report. Check all pages of the report. You attempted to print test results that are not in the designated 10 default tests to print. Do the following when printing the report: 1.In TAS, click Report. 2. In the Report options screen, under Numeric options, select All tests. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Troubleshooting A-25 Problem Possible cause Recommended action When trying to print, a message appears indicating that a table (in the database) cannot be locked because another user is accessing it, and that the database compacting utility needs to be run. The database program creates an .ldb file that controls which records need to be locked for editing. In this situation, the database did not get released from the lock to allow other processes, such as printing, to access it. Do the following: 1.In TAS, open a different database than the one you were trying to print from. 2.Run the compact utility on the database you were trying to print from. 3.Try printing again. If the same message appears, contact your IT department to do the following: a. Exit the program and make sure that no one else is accessing that database. b. Using Windows® Explorer, navigate to the folder (e.g., C:\TEG) that contains the problem database. c. Find the file that has the same name as the database but with the extension “.ldb” (e.g., “Patients.ldb”). d. Select and delete the .ldb file. Caution: Do not delete any file with the extension “.teg” or “.qc” Nothing happens when trying to print. When trying to print a tracing by pressing F6, more than one copy prints. TEG® 5000 System User Manual If you are trying to print over the network, the network may be down. Check the status of the printer as well as the network. You may lack the correct permissions to print on the hosting computer. Check the permissions to print on the hosting computer or contact your network administrator. The printer default is set to print more than one copy. Contact your Site Administrator to set the printer default to print one copy only. P/N 06-510-US, Manual revision: AD A-26 Troubleshooting Accessing Help errors Problem Possible cause Recommended action When clicking the Help or More Info button, the Help file doesn’t open. TAS is being run on the Windows 7 operating system which doesn’t support Windows XP Help files. Contact your IT department to do the following: 1. On the Microsoft download website, search for “WinHlp32.exe.” 2.Follow the instructions to download the free WinHelp32 application. When opening a PDF file on the Help menu (e.g., choosing Help > Help Topics), a Program Compatibility Assistant message appears. Your version of Adobe Acrobat is 5.0 or lower. Do one of the following: In the Program Compatibility Assistant message, click Run Program. The file opens as expected. 06-510-US, Manual revision: AD Download the free Adobe Reader, version 8 or higher. TEG® 5000 System User Manual Appendix B Specifications and Performance Characteristics SPECIFICATIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Physical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Environmental Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2 Electrical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3 LIMITATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 Sensitivity factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 Interference factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4 PERFORMANCE CHARACTERISTICS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6 Accuracy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6 Precision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7 Sensitivity and specificity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8 Reference ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-8 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD B-2 Specifications and Performance Characteristics SPECIFICATIONS This section describes the physical, environmental, and electrical specifications for storing and operating the TEG® analyzer. Note: For additional information about sensitivity and interference factors, refer to “Limitations” on page B-4. Physical Specifications The physical specifications of the TEG analyzer are as follows: Characteristics Values Dimensions 11.6 in (29.5 cm) high x 10 in (25.5 cm) deep x 7.7 in (19.5 cm) wide. Weight 11.2 lb (5.08kg) Channels 2 independent measuring channels Cup drive Line-synchronized, with synchronous motor Temperature control Individual temperature control for each channel Measuring technique Shear elasticity of a coagulating sample, determined by motion of pin Transducer Electrical-mechanical transducer of movement of torsion wire connected to the suspended pin Sample volume 360 µL Initial warm-up time Less then 5 minutes to warm sample Operating position Level adjusted by leveling feet and level Table B-1, Physical specifications Environmental Specifications The environmental specifications for the operation and storage of the TEG analyzer are as follows: Conditions Value Use Indoor use Operating position Vibration-free; no solar radiation Operating temperature 50 °F to 95 °F (10 °C to 35 °C) Operating humidity Relative humidity 20-80% (non-condensing) 06-510-US, Manual revision: AD TEG® 5000 System User Manual Specifications and Performance Characteristics B-3 Conditions Value Transport and storage temperature –22 °F to 122 °F (–30 °C to 50 °C) Transport and storage humidity Relative humidity 5-95% (non-condensing) Pollution degree Pollution degree 2 Table B-2, Environmental specifications Electrical Specifications The electrical specifications for operating the TEG analyzer are as follows: Characteristics Value Power Power supply in protection class I, transformer with thermal cutoff and monitored safety insulation. Power supply must be plugged into a properly grounded outlet. Power the device using only the power adapter supplied by Haemonetics for the TEG analyzer. Use an Uninterruptible Power Supply (UPS) unit between the analyzer and the power source. Overvoltage Overvoltage Category II Mains supply fluctuations Not to exceed ±10% of the nominal voltage 220V model Operating voltage 230V, 50 Hz, rated current 0.20 A, max input power 46W. Thermal cutout and 1 A 2AG type Slo-Blo fuse provided. 120V model Operating voltage 120V, 60 Hz, rated current 0.38 A, max input power 46W. Thermal cutout and 1 A PICO II, Very Fast-Acting fuse provided. TEG 5000 Input power rating (from power supply) 24 VAC 30 W Table B-3, Electrical specifications Note: For more information about electrical precautions, refer to “Power outlet connection” on page 3-3. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD B-4 Specifications and Performance Characteristics LIMITATIONS Caution: The TEG analyzer is for in vitro diagnostic use only. Users of the TEG analyzer should be properly trained and should be appropriate medical or other health care professionals. The TEG analyzer output is for presentation purposes only, and may vary from time to time; users should use the actual data derived from their own samples and their own established reference ranges to quantify the output tracing as to the degree of abnormality. Results from the TEG analyzer should not be the sole basis for a patient diagnosis but should be considered along with the patient’s clinical condition and other laboratory tests. Sensitivity factors Interference factors Sensitivity factors that may affect the measurement capability and operation of the TEG analyzer are listed below. The maximum oscillation of the cup in the TEG instrument is approximately 5 degrees, as described in the Interference section below. Therefore, the maximum amplitude (MA parameter) cannot be measured beyond 96 mm. It is very rare for human blood to exceed this limit; if it should happen, the diagnosis is obvious-extreme hypercoagulability. The eTest value of the TEG instrument determines the zero starting point of the graphical output tracing. Therefore, out of range conditions may prevent the TEG graph from reaching its maximum amplitude (the MA parameter may not reach its maximum value). The software issues a warning if the eTest value is out of range when a sample is started. Non-anticoagulated whole blood samples that are placed on the analyzer later than six minutes after drawing may result in a clotted sample, leading to erroneous results. Testing sensitivity of the TEG analyzer is affected if the environmental and electrical specifications referenced in Table B-2 and Table B-3 are not met. Interference factors that may affect the performance or sensitivity of the TEG analyzer are listed below along with information on ways to mitigate the interference: The moving part of the TEG analyzer is a cylindrical cup that oscillates very slowly through an angle of approximately 5 degrees. This means the following: 06-510-US, Manual revision: AD The TEG analyzer must be level. A leveling bubble and leveling feet are built into the instrument. TEG® 5000 System User Manual Specifications and Performance Characteristics B-5 The TEG analyzer is sensitive to vibration and must be set up so that vibrations and jolting are avoided. The analog signal generated by the oscillating pin is converted (by an analog to digital board) at the rate of 10 samples per second. The digitized data is continuously transmitted to the software via a serial port (either COM1 or COM2). Therefore, any communication interference with these ports should be eliminated, and all sleep modes and screen and power savers should be disabled. The TEG analyzer analysis is very sensitive to anticoagulants, especially heparin. In the clinical setting, to prevent blood activation, most of the tubes (such as catheter lines) and extra-corporeal surfaces are coated with heparin, which occasionally is released into the blood stream in very small quantities, and results in heparin-contaminated samples being analyzed by the TEG instrument. Therefore, it is imperative to use heparinase (such as lyophilized heparinase cups) to eliminate heparin contamination. When the TEG analyzer is being used at a point-of-care site, the standard mode of operation is to draw a blood sample that is immediately placed in the TEG cup for analysis without being anti-coagulated. Because the clotting process begins as soon as the blood is drawn, a constant time interval for sample application onto the analyzer (e.g., four minutes) should be used to eliminate biases due to different time intervals in placing the blood in the TEG cup. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD B-6 Specifications and Performance Characteristics PERFORMANCE CHARACTERISTICS Through performance testing, the accuracy and precision of the TEG 5000 Series analyzer is supported. In addition, Haemonetics has identified reference ranges as well as factors that may affect the measurement capability, performance, and sensitivity of the analyzer. A summary of the accuracy, precision, sensitivity, and reference range characteristics for the TEG 5000 analyzer are discussed below. Accuracy To demonstrate the TEG analyzer measurement accuracy, Haemonetics conducted an evaluation comparing the sample measurement performance of the TEG 5000 series analyzer against the TEG 3000 series analyzer. Forty (40) lyophilized plasma samples were prepared for analysis following procedures in the TEG User Manual. Blood from each sample was placed simultaneously into a calibrated 5000 series TEG analyzer and a calibrated 3000 series TEG analyzer. The samples were then run simultaneously at 37 °C, following steps outlined in the User Manual and using the same TEG Analytical Software. The following four parameters, which are collected during routine TEG analyzer use, were determined for each sample run: Parameter Description R (mm) Time (minutes or seconds) to onset of coagulation K (mm) Time (minutes or seconds) to a standard clot strength (20 mm amplitude) MA (mm) Maximum clot strength (mm amplitude) Angle (deg) Proportional to the rate of clot growth Table B-4, Parameters for accuracy testing Data from the sample runs were analyzed using the Student’s t-test for independent samples, a statistical test that compares the means of two samples to test the null hypothesis that they are the same. The test results demonstrate that the 5000 Series TEG analyzer sample measurement performance is equivalent to the 3000 Series analyzer. The analysis shows no statistical significance in the TEG parameters, R, K, MA and Angle, between the 5000 Series and the 3000 Series results at P < 0.05. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Specifications and Performance Characteristics B-7 The results are tabulated below, as the means, standard deviations, differences between the means, standard deviations of the differences, t-values, and the 2-tail probability. Comparison of means of samples (n=40) Parameter R (mm) K (mm) Angle (deg) MA (mm) 5000 Series (Mean ± SD) 11.5625± 1.178 2.1500± 0.379 73.9625± 2.382 30.6250± 1.036 3000 Series (Mean ± SD) 11.7500± 1.276 2.2750± 0.423 73.3750± 3.061 30.4010± 1.261 DIFFERENCE (Mean ± SD) 0.1875± 0.354 0.1250± 0.090 0.5875± 0.613 0.2240± 1.498 T-VALUE .68 1.39 .96 .87 DF 78 78 78 78 0.497 .168 0.341 0.388 2-TAIL P-VALUE Table B-5, Parameter measurement comparisons Precision To demonstrate the TEG analyzer measurement precision, Haemonetics conducted an evaluation using the following activators: Silica particles - brand name: Celite; formerly supplied by Haemoscope Tissue factor - brand name: Hemoliance; manufactured by Instrumentation Laboratory Company (ILC) Thrombin - brand name: Thrombin (Sigma); manufactured by Sigma Kaolin - brand name: DAPTTIN®; manufactured by Immuno Kaolin - brand name: Kaolin; supplied by Haemoscope Following the steps outlined in the TEG User Manual, 10 mL of blood was drawn from each of five healthy individuals with no known hemostasis problems. Eight (8) TEG measurements were obtained from each blood sample. Using four (4) TEG analyzers, measurements were run over the course of two (2) days; for Haemoscope’s Kaolin, measurements were run over five (5) days. For each activator, a total of forty (40) measurements were obtained using the activated samples. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD B-8 Specifications and Performance Characteristics Based on the TEG measurement data, the precision of each TEG parameter expressed as a percentage using the coefficient of variation (CV) is as follows for each activator: Parameter Activator R K Angle MA Celite 8.7% 7.6% 2.4% 4.1% Tissue Factor 13.1% 12.9% 2.3% 3.3% Thrombin 13.2% 13.4% 3.5% 3.8% Kaolin (DAPPTIN) 12.7% 17% 2.8% 5.0% Kaolin (Haemoscope) 13.4% 4.4% 2.8% 6.3% Table B-6, Precision of parameters for each activator These CV values are relatively small in the TEG parameter comparison with other coagulation instruments, the majority of which are higher. Sensitivity and specificity Reference ranges Refer to “Limitations” on page B-4 for the following information on sensitivity and specificity: Sensitivity factors that may affect the measurement capability and operation of the TEG analyzer. Interference factors that may affect the performance or sensitivity of the TEG analyzer and ways to mitigate the interference. Haemonetics provides reference ranges in the TEG system software which were derived from data provided by a number of hospitals in the United States. Reference ranges for native whole blood samples are listed in Chapter 11. Refer to the appropriate product inserts for the reference ranges for other sample types. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Appendix C Glossary GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD C-2 Glossary GLOSSARY A TEG Activator sample. Constitutes one of the PlateletMapping® assay tests and is used to produce a clot without platelet contribution. The value of the activator sample is subtracted from the other samples to determine the platelet contribution to clot strength. AA TEG Arachidonic Acid sample. Constitutes one of the PlateletMapping assay tests and is used to determine how effective aspirin is in blocking platelet activation. It is also sensitive to other arachidonic acid pathway (COX-1, thromboxane pathway) inhibitors. ADP TEG Adenosine Diphosphate sample. Constitutes one of the PlateletMapping assay tests and is used to determine drug effectiveness when a patient is on ADP platelet inhibiting drugs (e.g., clopidogrel, prasugrel). It is also sensitive to GPIIb/IIIa inhibiting drugs (e.g., abciximab, tirofiban, eptifibatide). The ADP assay can also be used as an initial screening check for genetic inhibition, diet, or herbals that affect ADP platelet activation. A/D box A hardware component in the TEG system that converts the analog signal produced by the analyzer into a digital signal that is read by the TEG Analytical Software. aPTT Activated Partial Thromboplastin Time. A test that measures clotting time in plasma (the liquid portion of blood). It focuses on the intrinsic pathway in the blood clotting process and uses a contact activator (kaolin, celite, silica, or elagic acid) to speed up the test time. activator A substance that causes a reaction or speeds up a process. Also a TEG sample type (refer to “A” above). adenosine diphosphate A platelet agonist. Activates the ADP receptors on a platelet. aggregation The formation of a mass of cells due to binding of specific cell receptors. In platelets, the receptors associated with aggregation are the GPIIb/IIIa receptors. agonist A drug or other chemical that can combine with a receptor on a cell to produce a physiologic reaction typical of a naturally occurring substance. anticoagulant A substance that slows or prevents the clotting of blood. antifibrinolytic A drug or endogenous protein that decreases the breakdown of fibrin (e.g., amicar, transexamic acid, plasminogen activator inhibitor-1 (PAI-1)). antiplatelet drug A drug that reduces or inhibits platelet activation. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Glossary C-3 arachidonic acid A platelet agonist. Its action stimulates a pathway that results in activation of the thromboxane (TxA2) receptors on a platelet. aspirin An irreversible platelet inhibitor. It inhibits the action of the COX-1 enzyme in the arachidonic pathway leading to inhibition of thromboxane synthesis. TEG action: this drug will not alter the MA of a thrombin-activated TEG analysis. The AA PlateletMapping assay is required to observe the effects of this drug. Most significant TEG effect: decreases MAAA. CLIA Clinical Laboratory Improvements Amendment. Passed in 1988 by the United States government to establish quality standards for laboratory testing. CLSI Clinical and Laboratory Standards Institute. A global, nonprofit standards organization that promotes the development and use of voluntary laboratory consensus standards and guidelines. CPB Cardiopulmonary bypass. cardiopulmonary bypass Diversion of the flow of blood to the heart directly to the aorta, via a pump oxygenator, avoiding both the heart and the lungs. A form of extracorporeal circulation used in heart surgery. cilostazol An antiplatelet drug similar to dipyridamole. Also known as Pletal®. (Phosphodiesterase 3 inhibitor). citrate A substance used to anticoagulate blood by chelating calcium. Its action can be overridden by adding calcium. Used as a preservative in blood samples. clopidogrel (Plavix®) A potent oral antiplatelet agent often used in the treatment of coronary artery disease, peripheral vascular disease, and cerebrovascular disease. Also known as Plavix®. TEG action: this drug will not alter the MA of a thrombin-activated TEG analysis. The ADP PlateletMapping assay is required to observe the effects of this drug. Most significant TEG effect: decreases MAADP. coagulation The formation of a blood clot. coagulation factor A substance in the blood that is essential for blood clot formation. coagulopathy A disorder in which blood is either too slow or too quick to coagulate (clot). Coumadin® A vitamin K antagonist that interferes with the production of vitamin Kdependent clotting factors (Factors II, VII, IX, and X). Also known as warfarin. TEG effect: increases R. cryoprecipitate A concentrated product made from plasma that contains Factors VIII, XIII, fibrinogen, vWF, and fibronectin. TEG effect: decreases R. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD C-4 D-dimer Glossary A laboratory test for measuring cross linked fibrin breakdown. The results help rule out, diagnose, and monitor diseases and conditions that cause hypercoagulability. High D-dimer results can suggest that there has been significant clot (thrombus) formation and breakdown in the body, but it does not tell the location or cause. An elevated D-dimer may be due to a venous thrombotic event (VTE) or disseminated intravascular coagulation (DIC), but it may also be due to a recent surgery, trauma, or infection. Elevated levels are also seen with liver disease, pregnancy, eclampsia, heart disease, and some cancers. dipyridamole (Persantine®) An antiplatelet drug. Also known as Persantine®. TEG action: requires ADP PlateletMapping assay to demonstrate effects. Most significant TEG effect: decreases MAADP. dysfunction Abnormal or impaired functioning, especially of a bodily system or organ. Effient® See prasugrel. endothelium The single cell layer that lines all blood vessels. The function of the endothelium includes acting as a barrier between the blood and extravascular space, hemostasis regulation, and hemodynamic regulation. eTest An electronic test that is part of the daily maintenance for TEG analyzers connected via the serial port Analog/Digital interface box. enzymatic For coagulation, this relates to the coagulation factor reactions and their related substances. fibrin An elastic protein derived from fibrinogen by the action of thrombin and forms an insoluble network that provides a structure for the blood clot. fibrinogen A protein in the blood plasma that is essential for the coagulation of blood and is converted to fibrin by thrombin and ionized calcium. Also called Factor I. fibrinolysis The breakdown of fibrin in a blood clot, usually by the enzymatic action of plasmin. fibrinolytic An endogenous protein or drug that breaks down fibrin, either directly or through the generation of plasmin (i.e. tissue plasminogen activator (tPA), urokinase). FDP Fibrin degradation products. Protein fragments produced by the enzymatic action of plasmin on fibrin and fibrinogen. FFP Fresh frozen plasma. Plasma that is removed from a donor, separated, and frozen within 6-8 hours of collection. glycoprotein (GP) A macromolecule composed of a protein and a carbohydrate (a sugar). 06-510-US, Manual revision: AD TEG® 5000 System User Manual Glossary C-5 hemorrhage An escape of blood from the blood vessels, especially when excessive. Also called hemorrhea. heparin An anticoagulant that binds to antithrombin III to inhibit thrombin activity. Requires antithrombin III as a cofactor. Unfractionated heparin (UFH) and low molecular weight heparin (LMWH) are two forms of heparin. Some hemostasis tests are limited to being able to test one of these forms. TEG testing demonstrates the effect of both these types. Most significant TEG effect: increases R. heparinase An enzyme that breaks down heparin. hyper Above, beyond, or excessive. hypo Beneath, under, or deficient. in vitro In an artificial environment outside the living organism. in vivo Within a living organism. ischemia (ischemic) A decrease in the blood supply to an organ or tissue resulting in a reduced oxygen supply. kaolin A fine, white clay used to accelerate the clotting process. lysis The dissolution or destruction of cells, such as blood cells or bacteria, as by the action of a specific lysin (plural: lyses). PT Prothrombin time. A test that measures the clotting time of plasma (the liquid portion of the blood). It focuses on the extrinsic pathway in the blood clotting process and uses tissue factor as an activator. PTT Partial Thromboplastin Time. A test that measures clotting time in plasma (the liquid portion of blood). It focuses on the intrinsic pathway in the blood clotting process. In the 1970s, activators were added to activate contact factors to speed up the test time and the test became aPTT (see “aPTT”). parameter A measurable factor. Persantine® See dypyridamole. phospholipid The primary structural components of cell membranes. plasma The clear, yellowish fluid portion of blood, lymph, or intramuscular fluid in which cells are suspended. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD C-6 Glossary plasmin A proteolytic enzyme (i.e. breaks down proteins) that hydrolyzes peptides and esters of arginine and histidine and converts fibrin to soluble products. plasminogen The inactive precursor to plasmin that is found in body fluids and blood plasma. platelet A minute, irregularly shaped, disk-like cytoplasmic body found in blood plasma that promotes blood clotting and has no definite nucleus, no DNA, and no hemoglobin. Also called blood platelet or thrombocyte. Plavix® See clopidogrel. prasugrel A platelet inhibitor developed for patients with acute coronary syndromes who undergo percutaneous coronary intervention. Also known as Effient®. TEG action: this drug will not alter the MA of a thrombin-activated TEG analysis. The ADP-PlateletMapping assay is required to observe the effects of this drug. Most significant TEG effect: decreases MAADP. procoagulant An agent that promotes blood coagulation. protamine sulfate Used to neutralize the effect of heparin. rFVIIa Recombinant Factor VIIa. A prohemostatic drug that is used to improve hemostasis. TEG actions: decreases R, may increase MA. sepsis The inflammatory condition resulting from the presence of pathogens or their toxins in blood. serotonin A naturally occurring derivative of tryptophan found in platelets, cells of the brain, and the intestine. When blood vessels are damaged, activated platelets release serotonin which acts as a potent vasoconstrictor. vascular Of, relating to, or containing blood vessels. TEG® Thrombelastograph®. Thrombelastograph® A device used to measure the change in elastic properties during clot formation. thrombin The central clotting factor in the hemostasis process that facilitates the conversion of fibrinogen to fibrin, activates other clotting factors, and is the most potent activator of platelets. Thrombin generation is the pivotal point in the hemostasis process. This enzyme is formed in the blood from prothrombin. thrombosis Formation or presence of a blood clot (thrombus). thrombotic Of or relating to thrombosis. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Glossary C-7 thrombus A blood clot. The final product of blood coagulation from the hemostasis process. tracing For TEG testing, the graph that is produced that plots clot strength versus time. vascular Of, relating to, or containing blood vessels. von Willebrand Factor (vWF) A large multimeric glycoprotein present in blood plasma and produced constitutively in endothelium, megakaryocytes (alpha-granules of platelets), and subendothelial connective tissue. A protein required for platelet adhesion. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD Appendix D Initial Setup INITIAL SETUP OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-2 UNPACKING THE ANALYZER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3 SETUP AND INSTALLATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4 Positioning the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4 Connecting to the interface box and computer . . . . . . . . . . . . . . . . . . . .D-4 Connecting to power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5 Disconnecting from power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5 Connecting multiple analyzers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5 Installing the software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6 Conducting maintenance checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6 ACTIVATING THE CHANNELS FOR A NEW ANALYZER . . . . . . . . . . . . . .D-7 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD D-2 Initial Setup INITIAL SETUP OVERVIEW In most cases, a Haemonetics® representative is responsible for the initial unpacking and setup of the TEG® analyzer. The instructions in this section are provided in the event that a repaired analyzer is shipped back to you or that you need to relocate the analyzer. This appendix includes the following instructions: Unpacking the analyzer Setting up and installing single and multiple analyzers Activating the channels for a new analyzer 06-510-US, Manual revision: AD TEG® 5000 System User Manual Initial Setup D-3 UNPACKING THE ANALYZER The TEG analyzer is packaged to prevent damage to the instrument during shipping. Note: Save the shipping box and molded polystyrene support forms. If the TEG analyzer needs to be returned for repair or preventive maintenance, it must be shipped in its original packaging in order to avoid damage. Haemonetics will charge for any repairs necessary due to improper packaging. To unpack the analyzer from its shipping box: 1. Lift the analyzer, along with the polystyrene support forms, from the shipping box. 2. Carefully remove the following packaging: Support forms from each side of the analyzer Support forms for the carriers Tape holding each carrier and lever Tape holding the back foot TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD D-4 Initial Setup SETUP AND INSTALLATION Before setting up the analyzer, make sure you have the following components ready: Positioning the analyzer Computer with printer (refer to the TEG 5000 System Site Administrator’s Guide for system requirements). Power supply unit (cord and adapter) Uninterruptible Power Supply (UPS) unit Analog/Digital (A/D) interface box DB-9 cable (male-male) DB-9 cable(s) (female-female) - one per analyzer TEG Analytical Software installation CDs - Version 4.2.3 Enabled and, if applicable, Version 4.2.3 Remote. The analyzer should be set up in a location that meets the following requirements: Minimum of one cubic foot of clearance. Sturdy and level surface. Free of vibration and away from high traffic. Room temperature less than 30 °C. Out of the direct path of HVAC ducts or vents. Note: For more information on operation and storage requirements for the TEG analyzer, refer to “Storage and Handling” on page 3-2 and “Specifications” on page B-2. Connecting to the interface box and computer To connect the TEG analyzer to the analog/digital interface box and computer: 1. Insert one end of the female-female DB-9 cable into the 9-pin port labeled “I/O” on the back panel of the analyzer. 2. Insert the other end of the female DB-9 cable into the port labeled “TEG 1” on the interface box. Note: There must always be one analyzer connected to the TEG1 port and powered on. 3. Insert one end of the male-male DB-9 cable into the port on the interface box labeled “COMPUTER.” 4. Insert the other end of the male DB-9 cable into the 9-pin port on the computer. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Initial Setup D-5 5. Tighten the thumb screws on the ends of the plugs to ensure a good connection. Connecting to power To connect the analyzer to power: 1. Insert the male 4-pin connector end of the power cord into the receptacle labeled “Power” on the back panel of the analyzer. 2. Plug the other end of the power cord into a UPS unit and then into a grounded wall outlet as per the UPS manufacturer’s instructions. Warning: Always plug the power cord into the analyzer first, then into the UPS and then the wall outlet. This prevents the possibility of electrical shock or power supply damage. 3. Press the green POWER button on the front of the analyzer. The power button and yellow MOTOR button illuminate when the analyzer is powered on. 4. Check to ensure the green light on the interface box is illuminated; this indicates that all the cables are connected properly. Note: For more information on cautions and electrical requirements for the TEG analyzer, refer to “Power outlet connection” on page 3-3 and “Electrical specifications” on page B-3. Disconnecting from power To disconnect the analyzer from power: 1. Unplug the UPS unit from the wall outlet. Warning: Do not remove the power cord from the back of the analyzer without first unplugging the UPS from the wall outlet. This prevents the possibility of electrical shock or power supply damage. 2. Unplug the analyzer power cord from the UPS unit and then from the back panel of the analyzer. Connecting multiple analyzers You can connect up to four analyzers to a computer using one analog/digital interface box. Make sure you have the following components ready when connecting multiple analyzers: One power supply unit per analyzer (included with analyzer purchase). One female-female DB-9 cable per analyzer. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD D-6 Initial Setup To connect additional analyzers to the analog/digital interface box: 1. Insert one end of a female DB-9 cable into the 9-pin port labeled “I/O” on the back panel of the first additional analyzer. 2. Insert the other end of the female DB-9 cable into the port on the interface box labeled “TEG 2.” 3. Tighten all connections. 4. Plug the power supply unit into a designated outlet and the cord into the receptacle labeled “Power” on the back panel of the analyzer. 5. Repeat with each additional analyzer. 6. Press the green POWER button on the front of each analyzer. Installing the software For instructions on installing and uninstalling the software, refer to the TEG 5000 System Site Administrator’s Guide. Conducting maintenance checks After setting up an analyzer, maintenance checks must be performed to ensure that it is working correctly. For instructions, refer to “Conducting Daily Maintenance Checks” on page 7-5. If this is a new analyzer, refer to the following section to activate the channels. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Initial Setup D-7 ACTIVATING THE CHANNELS FOR A NEW ANALYZER Before working with a new analyzer, the channels must be activated in the TEG Analytical Software. The following steps are performed in the Maintenance screen: Add the analyzer serial number. Associate the serial number with each channel. Indicate the analyzer type. When information is entered for the Analyzer serial number, Channel attached, and Analyzer type fields, it is automatically copied to its “partner” channel. For example, when the serial number for channel 1 is entered, it is automatically copied to channel 2. To activate the channels in the TEG Analytical Software: 1. Log in to the TEG Analytical Software (TAS). For instructions, refer to “Logging In To TAS” on page 5-5 2. In the Main screen, on the Options menu, click Maintenance. Figure D-1, Options menu 3. In the Maintenance screen, click the Setup tab. Figure D-2, Setup tab, Maintenance screen 4. Complete the following fields: Note: The fields are completed in an order that is different than the order they appear on the screen. TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD D-8 Initial Setup Field Description Analyzer serial number Type the serial number of the analyzer. The serial number consists of 11 characters and is located on the label on the back of the analyzer. It is preceded by “HS No.” Note: TEG analyzers manufactured after August 2010 are assigned 10-character alpha-numeric serial numbers. Channel attached Click the checkbox for the channel number that corresponds to the serial number entered. Analyzer type In the drop-down list, select the appropriate analyzer model. Channel serial number (optional field) Select or type the serial number. Note: The channel (or column) serial number is located on the label on the back of the analyzer under the analyzer’s serial number. 5. Click the Daily maintenance tab. Figure D-3, Daily Maintenance tab, Maintenance screen 6. Select the first channel that was set up and click eTest. Repeat for the second channel. Wait for a final message to display (for example, “eTest value is OK” or “eTest value off center”). Note: This step is performed in order to save the information that you entered on the Setup tab. You are not performing an eTest at this step. For instructions on performing an eTest, refer to “Performing an eTest” on page 7-7. 7. Click Done. 06-510-US, Manual revision: AD TEG® 5000 System User Manual Index Index INDEX. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-2 TEG® 5000 System User Manual P/N 06-510-US, Manual revision: AD I-2 Index INDEX Symbols § (sample note) 8-59 ¶ (patient note) 8-60 assay Functional Fibrinogen 4-15 PlateletMapping 4-15 Audit report 8-49 Audit report data screen 8-49 A A (Activated) sample type 4-13 A (Amplitude) parameter 4-7 A/D interface box connecting multiple analyzers D-5 single analyzer D-4 serial port, description 2-7 A30 parameter 4-8 A60 parameter 4-8 AA (Arachidonic Acid) sample type 4-13 Access, importing databases into 9-21 accessories, approved use of 11-5 accuracy of TEG analyzer B-6 ACT (Activated Clotting Time). See RapidTEG activator kaolin 4-14 RapidTEG 4-14 active filter 8-21 Add Sample type screen 6-12 Add test screen 6-4 Add to Guide screen 8-34 ADP (Adenosine Diphosphate) sample type 4-13 advanced filters about 8-21 case 8-27 channel 8-25 custom 8-28 dates 8-26 patient 8-24 sample type 8-24 test results 8-22 Amplitude (A) 4-7 Amplitude, 30 mins (A30) 4-8 Amplitude, 60 mins (A60) 4-8 Analog/Digital interface box. See A/D interface box Analysis report (single-sample, multi-sample) 8-37 Angle calculation, warning 6-18 Angle parameter 4-4 APR (Aprotinin) sample type 4-13 archiving lot numbers 11-13 P/N 06-510-US, Manual revision: AD B backing up databases 9-14 BASE adjustment screw 2-7 baseline, adjusting eTest values 7-8 biological controls. See QC samples blood collection. See samples, collecting Blood Products tab (Edit case screen) 10-13 blood products, editing patient case records 10-13 blood samples. See sample types; samples bloodborne pathogens about 3-3 contaminated materials disposing of 3-4 proper handling 3-3 C cables carrier ribbon checking 7-6 description 2-4 power connecting D-5 description 2-7 disconnecting D-5 specification B-3 warnings 3-3 requirements for setup D-4 serial DB-9 female-female D-4, D-5 DB-9 male-male D-4 CAL adjustment screw 2-7 calibration about adjusting 2-7 preventive maintenance 11-4 Capture function, about 12-8 Capture options screen 12-8 carrier ribbon cables, checking 7-6 TEG® 5000 System User Manual Index carriers cleaning 7-28 description 2-3 ribbon cables about 2-4 checking 7-6 shafts 2-5 Case icon 10-5, 10-10 case records. See patient case records Case summary report. See Patient Hemostasis Summary report Case tab (Filter criteria screen) 8-27 CFF (Citrated Func. Fibrinogen) sample type 4-12 CFFH (Citrated Func. Fibrinogen w/Heparinase) sample type 4-12 channel error codes 5-11 Channel tab (Filter criteria screen) 8-25 CI (Coagulation Index) parameter 4-5 citrated blood samples about, sample type 4-14 collecting 7-19 CK (Citrated Kaolin) sample type 4-12 CKH (Citrated Kaolin w/Heparinase) sample type 4-12 CL30 parameter 4-8 CL60 parameter 4-8 cleaning precautions for blood 3-3 procedure for analyzer 7-28 clinical training 1-4 Clinicians tab (Edit case screen) 10-15 clinicians, editing patient case records 10-15 clot avoiding activation of 11-3 formation parameters primary 4-4 secondary 4-6 forming in cup 4-2, 4-3 graphic, showing on data panel 6-16 kinetic, strength, and stability parameters 4-9 kinetics, K parameter 4-4 lysis parameters primary 4-4 secondary 4-8 shear elasticity units 4-3 velocity parameters 4-10 Clot Lysis Time (CLT) 4-9 CLT parameter 4-9 Cluster tracings pop-up window 10-16 Clusters tab (Edit case screen) 10-16 CN (Citrated Native) sample type 4-13 TEG® 5000 System User Manual I-3 Coagulation Index (CI) description 4-5 equation 4-5 coagulopathy library (Guide) about 8-33 adding tracing 8-33 deleting library entry 8-36 modifying library entry 8-35 collection tubes 7-18 Color screen 6-21 colors 5 minute marks 6-21 channels on TEG screen 5-18 grid lines 6-21 tests 6-21 tracings 6-22 columns, description 2-4 COM ports avoiding communication interference B-5 setting 6-19 communication interference for analyzer B-5 compacting databases 9-16 component illustrations exterior back 2-6 exterior front 2-3 configuring user profiles about 6-2 eConsult 6-25 login 6-24 reference ranges 6-8 sample types 6-11 software 6-15 tests 6-3 video 6-20 consumables, approved use of 11-5 contaminated materials proper disposal of 3-4 proper handling for 3-3 Corrective action screen 7-13 corrupted databases, repairing 9-16 covers front 2-5 hazard if removing 3-3 rear 2-7 Create case screen 10-3, 10-5 CRT (Citrated RapidTEG). See RapidTEG CRTH (Citrated RapidTEG w/Heparinase). See RapidTEG cups and pins design 4-2 ejecting 7-16 P/N 06-510-US, Manual revision: AD I-4 formation of clot in 4-2 heparinase 4-15 loading 7-14 rotation mechanics 4-2 troubleshooting A-11 cupwells, description 2-3 Custom tab (Filter criteria screen) 8-28 customer service clinical training 1-4 contacting 1-4 repair service 1-4 D daily maintenance checks 7-5 Daily Maintenance Log report 8-47 Daily Maintenance tab (Maintenance screen) 7-7 daily operation tasks about 7-2, 7-5 checking carrier ribbon cables 7-6 leveling analyzer 7-6 loading cups and pins 7-14 performing eTest 7-7 running QC samples 7-9 Data icon 8-6 Data pop-up panel, customizing 6-16 data tracings. See tracings Database Patient List report (patient report) 8-41 databases about 9-2, 11-8 backing up 9-14 changing to QC database 9-4 compacting 9-16 creating new 9-6 deleting 9-13 exporting about 9-9 using tab-delimited format 9-9 using TEG database format 9-9 importing into Access 9-21 into another database 9-7 into Excel 9-19 merging 9-17 opening 9-3 repairing corruption 9-16 setting defaults 6-24 switching between patient and QC 9-5 troubleshooting A-7 date of birth, editing patient case records 10-14 P/N 06-510-US, Manual revision: AD Index Dates tab (Filter criteria screen) 8-26 DB-9 cables (male & female) D-4, D-5 decontamination precautions 3-3 Delete Patient screen 10-8 Detail icon 8-50, 8-58 Detail screen 8-51 about 8-50 accessing using Detail icon 8-50 using status bar 8-51 Notes tab 8-58, 8-59 Sample tab 8-56 Tracing tab 8-53 discard tube, using for blood collection 7-19 disinfecting precautions for 3-3 procedure for analyzer 7-28 display options changing sample types order 6-13 changing tests order 6-6 colors and lines 6-20 data pop-up panel 6-16 displaying clot graphic 6-16 flashing values 6-16 grid lines 6-16 including sample types 6-13 including tests 6-6 time 6-17 disposal handling contaminated material 3-4 drawings. See illustrations drugs used, editing patient case records 10-13 E E (Elasticity constant) parameter 4-7 eConsult about 12-3 defining recipient 6-27 defining server settings 6-27 prerequisites for using 12-3 removing recipient 6-28 sending patient data 12-3 setting up e-mail account 6-26 eConsult tab (User profile setup screen) 6-25 eConsult wizard screen 12-5 ECT (Ecarin Clotting Time) sample type 4-13, 6-18 Edit case - Notes screen 8-61 Edit case screen 8-42, 8-61, 10-10 Eject position, lever 2-4 TEG® 5000 System User Manual Index Elasticity constant (E) 4-7 electrical shock hazards 3-3, D-5 electrical specifications for analyzer B-3 e-mail defining eConsult recipient 6-27 defining server settings 6-27 removing eConsult recipient 6-28 sending records using eConsult 12-3 setting up account 6-26 E-mail server settings screen 6-27 Enabled version of TAS, about ending sample run 7-27 Enter Lot number information screen 11-10, 11-12 Enter sample information screen 10-6 environmental specifications for analyzer B-2 EPL parameter 4-9 errors error codes on TAS Main screen 5-11 QC samples 7-12 troubleshooting A-2 Establishing reference ranges for QC new Mean 11-17 preliminary Mean 11-18 Estimated Percent Lysis (EPL) 4-9 eTest about 7-7 adjusting values 7-8 BASE adjustment screw adjusting 7-8 description 2-7 procedure 7-7 sensitivity factors B-4 troubleshooting A-9 Excel, importing databases into 9-19 Export data wizard screen 9-9, 9-11 exporting a database 9-9 F FF (Func. Fibrinogen) sample type 4-12 FFH (Func. Fibrinogen w/Heparinase) sample type 4-12 fibrinolysis 4-3 File menu, about 5-19 Filter criteria screen 8-22 filters about using 8-19 advanced about 8-21 case 8-27 TEG® 5000 System User Manual I-5 channel 8-25 custom 8-28 dates 8-26 patient 8-24 sample type 8-24 test results 8-22 quick about 8-20 active 8-21 patient 8-20 site 8-20 using combination of 8-19 5 minute marks, setting color for 6-21 flashing parameter values about 8-3 customizing 6-16 FLEV parameter 4-10 units, setting 6-16 viewing value in FF samples 8-16 Functional Fibrinogen about 4-12, 8-16 assess platelet contribution to clot strength 8-17 FLEV parameter 4-10 preparing samples 7-25 sample type (FF) 4-15 viewing tracings 8-16 G G (clot strength) parameter 4-7 glossary terms C-2 GoTo menu 9-5 grid lines setting color 6-21 setting style of 6-22 showing 6-16 Guide about 8-30 coagulopathy library about 8-33 adding tracing to library 8-33 deleting library entry 8-36 modifying library entry 8-35 manually selecting tracing 8-32 Show Me feature 8-30 Guide - Bleeding status screen 8-30 Guide - Pattern matching screen 8-32 Guide - Pattern selection screen 8-31 P/N 06-510-US, Manual revision: AD I-6 Index H L hardware requirements, setting up analyzer D-4 hazards, electrical shock 3-3, D-5 Help menu, about 5-20 hemostasis profile 4-3 heparin about B-5 avoiding contamination B-5 blood sample, collecting 7-20 neutralizer (heparinase) 4-15 tubes (Vacutainer®) 7-20 heparinase description 4-15 preparing blood samples 7-21 L parameter 4-11 laboratory techniques avoiding clot activation in samples 11-3 precautions for blood samples 11-3 Level I and Level II controls. See QC samples leveling bubble 2-7 feet 2-5 instructions for analyzer 7-6 levers about 2-4 positions (Load, Test, Eject) 2-4 using ejecting pins 7-16 performing eTest 7-7 running samples 7-11, 7-27 Levey Jennings report 8-45, 11-5 LG parameter 4-10 library, coagulopathy 8-33 limitations for analyzer B-4 lines colored dashed on tracing 8-4 grid on tracing 8-4 setting style of 6-22 solid on tracing 8-4 viewing tracing 8-3 Load position, lever 2-4 locking patient case records 10-15 Locking tab (Edit case screen) 10-15 logging in to TAS how to 5-5 setting defaults for 6-24 system timeout 5-7 troubleshooting A-3 Login tab (User profile setup screen) 6-24 Lot Number History report 8-47 lot numbers about 11-9 archiving 11-13 creating new 11-9 deleting 11-12 generating history report 8-47 reference ranges for 11-9 restore old 11-13 updating 11-12, 11-15 LTE parameter 4-9 LY30 parameter 4-5 LY60 parameter 4-8 Lysis Time Estimate (LTE) 4-9 I icons on toolbar 5-13 illustrations exterior back 2-6 exterior front 2-3 Import Text Wizard screen 9-22 importing databases into Access 9-21 databases into another database 9-7 databases into Excel 9-19 Include screen 6-6, 6-14 infection control strategies 3-3 installing analyzer. See setup TEG Analytical Software (TAS) D-6 interface box. See A/D interface box interference factors for analyzer B-4 interrelationship of parameters 4-11 Introduction screen 12-4 K K (clot kinetics) parameter about 4-4 setting units for 6-17 kaolin about 4-12, 4-14 preparing samples 7-22 sample type (K) 4-12 KH (Kaolin w/Heparinase) sample type 4-12 kinetic, strength, and stability parameters 4-9 P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual Index I-7 M N MA (Maximum Amplitude) parameter about 4-5 calculation warning 6-18 limitations B-4 Maintenance check message 7-5 maintenance checks, conducting daily 7-5 Maintenance filter screen 8-47 Maintenance screen 8-47 manually terminate sample run 7-27 Maximized screen about 8-4 displaying data for tracing 8-6 multiple tracings 8-7 navigating between tracings 8-8 Maximum Amplitude (MA) 4-5 menu options, about 5-19 Merge screen 9-18 merging databases 9-17 messages Channel not at equilibrium 7-8, A-9 COM port is in use or does not exist A-6 Compacting could not be completed A-8 Database has too many users printing A-23 Delete Lot number 11-12 Disk or network A-7 Does not exist A-4 eTest out of range A-9 eTest value off center 7-8, A-9 File is read only A-3 Lot number not found A-20 No tracing available 8-13 Object or With Block variable not set A-7 QC Alert 7-12 Search key not found A-7 Table cannot be locked A-25 This may not be the best match 8-33 Unrecognized database format A-7 motor indicator button 2-5 MRL parameter 4-11 MRLG parameter 4-10 MRTG parameter 4-11 multiple analyzers, setting up D-5 multi-sample patient report 8-37 N (Native) sample type 4-13, 4-14 native blood samples about 4-13, 4-14 preparing 7-21 reference ranges for 11-16 needles used to collect samples 7-18 No tracing available message 8-13 non-citrated blood samples, collecting 7-18 normal tracings displaying 8-12 setting 8-12, 8-55 setting line style 6-23 Normal Values tab (User profile setup screen) 6-8 normal values. See reference ranges notes adding or viewing Notes (patient notes) 8-60 adding or viewing SNotes (sample notes) 8-59 editing for patient case records 10-14 Notes (sample) screen 8-60 Notes icon 8-61 Notes tab Detail screen 8-58, 8-59 Edit case screen 10-14 NWB (Native Whole Blood) sample type 4-13 TEG® 5000 System User Manual O off-set mode 8-7 operator report, Analyzer Audit 8-49 Options menu, about 5-20 Other tab (Edit case screen) 10-14 P parameters about 4-4, 5-8 flashing 8-3 interrelationship of 4-11 MA calculation, warning 6-18 primary clot formation and lysis Angle 4-4 CI (Coagulation Index) 4-5 K (clot kinetics) 4-4 LY30 (Percent Lysis, 30 mins) 4-5 MA (Maximum Amplitude) 4-5 R 4-4 TEG-ACT 4-6 P/N 06-510-US, Manual revision: AD I-8 secondary clot formation A (Amplitude) 4-7 E (Elasticity constant) 4-7 G (clot strength) 4-7 PMA (Projected MA) 4-6 SP (Split Point) 4-7 TMA (Time to MA) 4-7 TPI (Thrombodynamic Potential Index) 4-7 secondary clot kinetic strength, stability FLEV (Functional Fibrinogen Level) 4-10 secondary clot kinetic, strength, stability % Aggregation 4-9 % Inhibition 4-9 secondary clot lysis A30 (Amplitude, 30 mins) 4-8 A60 (Amplitude, 60 mins) 4-8 CL30 (Whole Blood Clot Lysis Index, 30 mins) 4-8 CL60 (Whole Blood Clot Lysis Index, 60 mins) 4-8 CLT (Clot Lysis Time) 4-9 EPL (Estimated Percent Lysis) 4-9 LTE (Lysis Time Estimate) 4-9 LY60 (Percent Lysis, 60 mins) 4-8 setting line styles for tracings 6-23 setting options for FLEV 6-16 SP, R, and K units 6-17 VCurve 6-19 velocity L 4-11 LG 4-10 MRL 4-11 MRLG 4-10 MRTG 4-11 MRTGG 4-10 TG 4-11 TGG 4-10 TMRL 4-11 TMRLG 4-10 TMRTG 4-11 TMRTGG 4-10 patient case records about 10-2 adding notes to 8-60 sample record to 10-6 using Case icon 10-5 using Records menu 10-3 deleting 10-8 P/N 06-510-US, Manual revision: AD Index editing about 10-10 blood products used 10-13 clinicians 10-15 drugs used 10-13 locking 10-15 notes 10-14 patient identification 10-14 procedures 10-12 sample information 10-17 viewing PlateletMapping clusters 10-16 patient data, sending using eConsult 12-3 patient databases backing up 9-14 compacting 9-16 creating new 9-6 deleting 9-13 exporting 9-9 importing into Access 9-21 into another database 9-7 into Excel 9-19 merging 9-17 opening 9-3 repairing corruption 9-16 switching to QC 9-5 troubleshooting A-7 patient filter 8-20 Patient Hemostasis Summary (case summary) report 8-41 Patient report screen 8-41 Patient report sort screen 8-41 patient reports Analysis (single-sample, multi-sample) 8-37 Database Patient List (patient report) 8-41 Patient Hemostasis Summary (case summary) 8-41 patient samples. See sample types; samples Patient tab (Filter criteria screen) 8-24 Percent Aggregation parameter 4-9 Percent Inhibition parameter 4-9 Percent Lysis 30 minutes (LY30) 4-5 60 minutes (LY60) 4-8 performance characteristics about B-6 accuracy B-6 precision B-7 sensitivity and specificity B-4, B-8 physical specifications for analyzer B-2 PL (Plasma) sample type 4-13 TEG® 5000 System User Manual Index platelet contribution 8-17 PlateletMapping about 4-15, 8-14 displaying % inhibition popup 6-17 generating results 8-14 % Aggregation parameter 4-9 % Inhibition parameter 4-9 preparing samples 7-24 sample types (A, ADP, AA) 4-15 viewing reports Patient Hemostasis Summary (case summary) 8-41 TEG Analysis (multi-sample) 8-38 viewing sample clusters 10-16 viewing tracings 8-13 platform on analyzer, about 2-5 PM pop-up window 8-15 PMA (Projected MA) parameter 4-6 POP3 server, specifying 6-27 potentiometer screws adjusting for eTest 7-8 BASE, about 2-7 CAL, about 2-7 power about supply connection 2-7 cables, about 2-7 connecting analyzer to D-5 disconnecting analyzer from D-5 indicator button 2-4 warnings for outlet connection 3-3 precautions blood samples 11-3 disposing of contaminated materials 3-4 electrical shock hazards 3-3, D-5 handling blood 3-3 laboratory techniques 11-3 storing analyzer 3-2 disposables 3-2 reagents and controls 3-2 transporting analyzer 3-2 precision of TEG analyzer B-7 Print icon 8-10 printing reports 8-37 tracings using Capture 12-8 tracings using Quick Print 8-10 troubleshooting A-23 Procedure tab (Edit case screen) 10-12 procedures, editing patient case records 10-12 product return guidelines 1-4 TEG® 5000 System User Manual I-9 profiles, configuring user 6-2 Projected MA (PMA) 4-6 Q QC Alert message 7-12 QC databases about 11-8 backing up 9-14 changing or creating new 9-4 compacting 9-16 creating new 9-6 deleting 9-13 exporting 9-9 importing into Access 9-21 into another database 9-7 into Excel 9-19 merging 9-17 opening 9-3 repairing corruption 9-16 setting defaults for 6-24 switching to patient 9-5 troubleshooting A-7 QC Lot Number screen 11-12 QC menu, about 5-19 QC report screen 8-46 QC samples about 7-9, 11-6 alerts 11-8 establishing reference ranges for about 11-8 obtaining Mean and SD using TAS 11-17 investigating errors 7-12 managing lot numbers 11-9 running Level I 7-10 running Level II 7-12 setting transfer options for 6-17 storage precautions for 3-2 troubleshooting A-12 updating reference ranges for 11-15 verifying the results for 7-13 QC select Lot number screen 11-9 QC Summary (Levey Jennings) report 8-45 quality assurance about 11-2 about quality control methods 11-4 functional checks for analyzer 11-4 managing lot numbers 11-9 operational checks for analyzer 11-4 P/N 06-510-US, Manual revision: AD I-10 QC samples about 11-6 establishing reference ranges for 11-8 obtaining Mean and SD using TAS 11-17 reference ranges 11-8, 11-15, 11-17 reports about 11-5 Daily Maintenance Log 8-47 Lot Number History 8-47 QC Summary (Levey Jennings) 8-45 schedule, quality control 11-5 using approved accessories & consumables 11-5 quality control reports. See quality assurance, reports quality control samples. See QC samples quick filters about 8-20 active 8-21 patient 8-20 site 8-20 Quick Print printing a tracing 8-10 setting options for 6-17 R R (or R-time) parameter about 4-4 setting units for 6-17 RapidTEG about 4-12, 4-14, 8-17 including sample types in software 8-18 preparing samples 7-23 sample types 4-12 setting termination options 6-18 TEG-ACT parameter 4-6, 8-18 viewing tracings 8-17, 8-18 Reaction time (R). See R (or R-time) parameter reagents, storage precautions for 3-2 recalcification 4-14 Records menu, about 5-19 records. See patient case records Reference icon 8-10 reference ranges about 11-15, B-8 assigning values to tests 6-9 changing values for a test 6-10 establishing QC ranges about 11-8 obtaining Mean and SD using TAS 11-17 for native samples 11-16 P/N 06-510-US, Manual revision: AD Index for new lots 11-9 Normal values tab 6-8 setting line styles 6-22 troubleshooting A-21 updating 11-15 viewing for samples 6-9 reference tracings displaying 8-11 setting 8-10, 8-55 setting the line style for 6-23 Remote version of TAS about 5-2 troubleshooting access for A-22 Rename screen 6-5 repair service 1-4 Report options screen 8-38, 8-43, 11-17 reports about 8-37 operator Analyzer Audit 8-49 patient Analysis (single-sample, multi-sample) 8-37 Database Patient List (patient report) 8-41 Patient Hemostasis Summary (case summary) 8-41 quality assurance Daily Maintenance Log 8-47 Lot Number History 8-47 QC Summary (Levey Jennings) 8-45 resetting color and line styles 6-23 Restore Lot number screen 11-13 return analyzer for repairs 1-4 ribbon cables. See cables, carrier ribbon RT (RapidTEG). See RapidTEG RTH (RapidTEG w/Heparinase). See RapidTEG run termination settings 6-18 running samples. See samples, running blood samples Rx tab (Edit case screen) 10-13 S S1 (Special ST1) sample type 4-13 S2 (Special ST2) sample type 4-13 safe operation of analyzer 3-2 Sample info pop-up panel 6-16, 8-6 Sample tab (Detail screen) 8-56 Sample type tab (Filter criteria screen) 8-24 TEG® 5000 System User Manual Index sample types about 4-12 adding new 6-12 adding test values for 6-9 including in display 6-13 L1 and L2 (quality control) legacy 4-13 modified whole blood 4-14 moving order on screen 6-13 native whole blood 4-14 quality control (QC) 11-6 sodium-citrated whole blood 4-14 viewing reference ranges for 6-9 Sample Types tab (User profile setup screen) 6-11 samples See also QC samples about collecting and preparing 7-17 adding SNotes (sample notes) 8-59 avoiding clot activation 11-3 collecting about 7-18 citrated 7-19 discard tube 7-18, 7-19 heparin 7-20 non-citrated 7-18 comparing multiple 8-7 deleting a record 10-9 editing for patient case records 10-17 entering details for about 8-50 on Notes tab 8-58, 8-59 on Sample tab 8-56 on Tracing tab 8-53 manually create record 10-6 precautions for 11-3 preparing about 7-20 Functional Fibrinogen 7-25 heparinase 7-21 kaolin 7-22 native (no reagent) 7-21 PlateletMapping 7-24 RapidTEG 7-23 running blood samples 7-26 ending sample run 7-27 QC samples 7-10 starting sample run 7-26 selecting on TAS Main screen 5-11 TEG® 5000 System User Manual I-11 setting normal tracings 8-55 reference tracings 8-55 termination options 6-18 supplies for collecting 7-18 troubleshooting A-19 updating reference ranges 11-15 using constant time intervals B-5 viewing details 8-50 tracings 8-3 Samples tab (Edit case screen) 10-17 schedule, quality control 11-5 Select case mode screen 8-41, 10-5, 10-10 Select samples screen 8-42, 9-10, 12-4 SEMS (Shear elastic modulus strength) 4-7 sensitivity factors for analyzer B-4 serial cables, DB-9 D-4, D-5 serial port, A/D interface box 2-7 servicing the analyzer 1-4 set points, adjusting 7-3 setup about D-2 connecting A/D interface box and computer D-4 multiple analyzers D-5 single analyzer D-4 to power D-5 disconnecting from power D-5 positioning analyzer D-4 requirements for D-4 unpacking analyzer D-3 shear elasticity units 4-3 Show me feature, Guide 8-30 single-sample patient report 8-37 site filter 8-20 site ID, setting defaults for 6-24 SMTP server, specifying 6-27 SNotes adding or viewing 8-59 icon 8-58, 8-59 sodium citrate See also citrated blood samples about 4-14 Software tab (User profile setup screen) 6-15 software. See TEG Analytical Software (TAS) SP (Split Point) parameter about 4-7 setting units for 6-17 SP, R, and K units, setting 6-17 P/N 06-510-US, Manual revision: AD I-12 specifications electrical B-3 environmental B-2, B-4 physical B-2, B-4, D-4 Split Point (SP). See SP (Split Point) parameter SSN, editing patient case record 10-14 status bar 5-12, 8-51 storage precautions analyzer 3-2 disposables 3-2 reagents 3-2 superimposed mode 8-7 support, contacting 1-4 symbols in the manual 1-5 in the software 8-59, 8-60 on the analyzer 1-5 System Setup screen 11-11 T tab-delimited format, database export 9-9 TAS Detail screen. See Details screen TAS Main screen about 5-8 error codes 5-11 selecting a sample 5-11 sorting sample order 5-10 status bar 5-12 symbols 5-10 toolbar icons 5-13 TAS Maximized screen. See Maximized screen TAS TEG screen. See TEG screen TAS. See TEG Analytical Software (TAS) technical support contacting 1-4 product return guidelines 1-4 repair service 1-4 TEG Analysis report (single-sample, multi-sample) 8-37 TEG Analytical Software (TAS) about Remote and Enabled versions 5-2 configuring user profiles 6-2 customizing about 6-15 Angle calculation, warning 6-18 colors and lines 6-20 data pop-up panel 6-16 eConsult settings 6-25 flashing values 6-16 P/N 06-510-US, Manual revision: AD Index FLEV units 6-16 grid lines 6-16 login defaults 6-24 MA calculation, warning 6-18 % inhibition popup 6-17 QC samples transfer options 6-17 Quick Print 6-17 run termination 6-18 SP, R, and K units 6-17 time display 6-17 touch screen 6-17 Vcurve 6-19 entering sample details 8-50 features overview 5-3 filtering sample records 8-19 generating and printing reports 8-37 installing D-6 logging in 5-5 main screens Detail 8-50 Maximized 8-4 TAS Main 5-8 TEG 5-16 managing databases 9-2 menu options 5-19 sending patient files with eConsult 12-3 timing out 5-7 troubleshooting A-2 viewing sample details 8-50 tracings 8-3 TEG analyzer See also daily operation tasks about 1-2 adjusting temperature set points 7-3 cleaning 7-28 collecting and preparing samples 7-17 daily maintenance 7-5 glossary C-2 how it works 4-2 illustrations 2-2 interference factors B-4 limitations B-4 loading cups and pins 7-14 models supported 1-2 operating overview 7-2 performance characteristics (accuracy, precision, sensitivity) B-6 precautions for operating 3-2 quality assurance and control 11-4 running samples 7-26 TEG® 5000 System User Manual Index sensitivity factors B-4 setting up D-2 specifications B-2 storage and handling 3-2 troubleshooting A-2 using approved accessories & consumables 11-5 TEG Analyzer Audit report 8-49 TEG Analyzer Daily Maintenance Log 8-47 TEG Analyzer QC Summary (Levey Jennings) report 8-45 TEG Analyzer QC Summary report 7-13 TEG Analyzer Service History Log 8-48 TEG Database Patient List report (patient report) 8-41 TEG Lot Number History report 7-13, 8-47 TEG Patient Hemostasis Summary (case summary) report 8-41 TEG sample types. See sample types TEG screen about 5-16 accessing 5-16 channel colors 5-18 completing fields 5-17 starting samples 7-26 terminating samples 7-27 TEG-ACT parameter description 4-6 viewing 8-18 temperature cables. See cables, carrier ribbon temperature controller adjusting set points 7-3 description 2-4 troubleshooting A-20 terminating samples 7-27 termination settings for sample run 6-18 terminology. See glossary terms Test position, lever 2-4 Test results tab (Filter criteria screen) 8-22 tests adding new test 6-4 normal ranges for 6-9 to sample type 6-9 changing reference values 6-10 including in display 6-6 moving order on screen 6-6 renaming 6-5 setting colors for 6-21 viewing reference ranges for sample type 6-9 Tests tab (User profile setup screen) 6-3 Text Import Wizard screen 9-19 TF (Tissue Factor) sample type 4-13 TEG® 5000 System User Manual I-13 TG parameter 4-11 TGG parameter 4-10 Thrombodynamic Potential Index (TPI) 4-7 time display 6-17 Time to MA (TMA) 4-7 timing out 5-7 TMA (Time to MA) parameter 4-7 TMRL parameter 4-11 TMRLG parameter 4-10 TMRTG parameter 4-11 TMRTGG parameter 4-10 toolbar icons 5-13 torsion wire, illustration 4-2 touch screen, enabling 6-17 TPI (Thrombodynamic Potential Index) parameter 4-7 Tracing tab (Details screen) 8-53 tracings about 5-11, 8-3 copying and pasting using Capture 12-8 displaying data on Sample info pop-up panel 8-6 multiple tracings 8-7 entering details for about 8-50 on Notes tab 8-58, 8-59 on Sample tab 8-56 on Tracing tab 8-53 lines (solid, dashed, grid) 8-3 navigating between multiple 8-8 printing reports 8-37 using Quick Print 8-10 setting color 6-22 line styles 6-22 normal tracings 8-12, 8-55 reference tracings 8-10, 8-55 troubleshooting unexpected results A-16 using Guide 8-30 viewing details for 8-50 Functional Fibrinogen tracings 8-16 in offset mode 8-7 in superimposed mode 8-8 in thumbnail format 8-4 maximized 8-4 parameters 8-3 PlateletMapping tracings 8-13 RapidTEG tracings 8-17 P/N 06-510-US, Manual revision: AD I-14 training 1-4 training, using Guide 8-30 transporting precautions 3-2 trimmer adjustment tool 7-9 troubleshooting about A-2 blood sample errors A-19 compacting errors A-8 cup and pin errors A-11 database errors A-7 eTest errors A-9 login errors A-3 printing errors A-23 QC sample errors A-12 reference ranges errors A-21 remote workstation access errors A-22 temperature errors A-20 unexpected tracing results A-16 Index W Whole Blood Clot Lysis Index 30 mins (CL30) 4-8 60 mins (CL60) 4-8 whole blood samples modified 4-14 no modifiers 4-14 sodium-citrated 4-14 workstation access, troubleshooting A-22 Z zoom level for VCurve 6-19 U Uninterruptible Power Supply (UPS) D-4 unpacking the analyzer D-3 User profile setup screen 6-2 user profiles about 6-2 accessing User profile setup screen 6-2 eConsult 6-25 login 6-24 reference ranges 6-8 sample types 6-11 software 6-15 tests 6-3 video 6-20 V Vacutainer® tubes 7-20 VCurve converting to G values 6-19 parameters 4-10 setting options for 6-19 velocity parameters See also VCurve about 4-10 verifying QC sample results 7-13 Video tab (User profile setup screen) 6-20 P/N 06-510-US, Manual revision: AD TEG® 5000 System User Manual