American National ANSI/AAMI/ISO EC57:1998/(R)2008 Standard Testing and reporting performance results of cardiac rhythm and sT-segment measurement algorithms AAMI Association for the Advancement of Medical Instrμmentation Noreproductionornetworking permited without licensefrom HS American National Standard ANSI/AAMI EC57:1998/(R)2008 (Revision of AAMI ECAR:1987) Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms Corrected Copy Developed by Association for the Advancement of Medical Instrumentation Approved 29 October 1998 and reaffirmed 4 December 2008 by American National Standards Institute, Inc. Abstract: algorithms used to detect cardiac rhythm disturbances, including the ST segment. Keywords: arrhythmia database, arrhythmia monitoring, ST segments, heart rate variability ent of Medical Instrumentatior No reproduction or networking permited withou license from IHS AAMl Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMl) recommended practice implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMl recommended practice does not AAMl recommended practices are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI recommended practice may be revised or withdrawn at any time. AAMI procedures writing AAMl. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 1999bytheAssociationfortheAdvancementofMedical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMl. No part of this publication may be reproduced or distributed in any draft should be submitted to AAMl. It is illegal under federal law (17 U.S.C. s 101, et seq.) to make copies of all or any part Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages Director, Technical Publishing, at AAMl, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201. Phone: (703) 525-4890, Ext. 239; Fax: (703) 525-1067. Printed in the United States of America ISBN1-57020-116-1 nent of Medical Instrumentatior No reproduction or networking permitted without license from IHS Not for Resale,02/01/2009 00:23:07MST Contents Page Committee representation .... v Foreword .... vi General .. 1.1 1.3 Exclusions. Definitions of abbreviations 2 3 Algorithm testing .. 2 3.1 Databases..... 2 3.1.1 2 General description of available databases. Records to be excluded during testing 3.1.2 3 3.2 Testing requirements . 3.3 Test environment .. 3.4 Multiple-lead analysis. 3.5 Requirements for the evaluation report.. 3.5.1 Required statistics 3.5.2 Requirements for all arrhythmia algorithms ... 3.5.3. Requirements for algorithms with optional capabilities. 5 3.6 Simulated test patterns ........ Automated analysis ... 7 Use of standard databases 4.1 4.2 Use of annotation files . 8 Beat-by-beat comparison.... 9 4.3 4.3.1 General description... 9 Method for beat-by-beat comparison ... 4.3.2 9 Heart rate, and heart rate or RR interval variability... 4.3.3 10 4.3.3.1 Heart rate measurement.. 10 4.3.3.2 Heart rate variability or RR interval variability measurement from databases ... 10 4.3.3.3 Heart rate variability or RR interval variability measurement of test patterns .. 12 4.4 Run-by-run comparison.. 14 4.4.1 General description.. 14 4.4.2 15 Terms and symbols Run sensitivity summary matrix 4.4.3 15 4.4.4 Run positive predictivity summary matrix. 16 4.5 VF and AF comparisons .. 16 4.6 ST comparison.. 17 Annex Rationale and additional guidance.. 22 A Tables Requirements for all arrhythmia algorithms . 1 5 2 Requirements for algorithms with optional capabilities, 5 3 Beat label classifications... 9 12 4 AHA and MIT-BIH database labels distributed for use by HRV algorithms 5 13 Example of noise floor calculation results.... Example of HRV test results .. 14 6 7 R