ANSI EC57-2012 Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms.pdf

1、ANSI/AAMIEC57: 2012Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithmsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or rec

2、ommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to p

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24、 been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI EC57:2012 (Revision of ANSI/AAMI EC57:1998/(R)2008) Testing and reporting performance results of

25、cardiac rhythm and ST segment measurement algorithms Developed by Association for the Advancement of Medical Instrumentation Approved 18 December 2012 by American National Standards Institute, Inc. Abstract: This recommended practice establishes a method for testing and reporting the performance of

26、algorithms used to detect cardiac rhythm disturbances, including the ST segment. Keywords: arrhythmia database, arrhythmia monitoring, ST segments, heart rate variability AAMI Recommended Practice This Association for the Advancement of Medical Instrumentation (AAMI) recommended practice implies a c

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31、he adopting agency is responsible for enforcement of its rules and regulations. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Righ

32、ts Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association for the Advancement of Medical Instrumentation is strictly prohibited by law. It is illegal under fe

33、deral law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and da

34、mages of $100,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703525-1067. ISBN 1-57020-478-0 Contents P

35、age Glossary of equivalent standards . v Committee representation . vi Foreword vii 1 Scope 1 1.1 General 1 1.2 Inclusions . 1 1.3 Exclusions 1 2 Definitions of abbreviations . 1 3 Algorithm testing . 2 3.1 Databases . 2 3.1.1 General description of available databases 2 3.1.2 Records to be excluded

36、 during testing 3 3.2 Testing requirements . 3 3.3 Test environment . 3 3.4 Multiple-lead analysis 4 3.5 Requirements for the evaluation report . 4 3.5.1 Required statistics . 4 3.5.2 Requirements for all arrhythmia algorithms . 4 3.5.3. Requirements for algorithms with optional capabilities . 5 3.6

37、 Simulated test patterns 7 4 Automated analysis 7 4.1 Use of standard databases 7 4.2 Use of annotation files . 8 4.3 Beat-by-beat comparison. 9 4.3.1 General description . 9 4.3.2 Method for beat-by-beat comparison. 10 4.3.3 Heart rate, and heart rate or RR interval variability . 10 4.3.3.1 Heart r

38、ate measurement . 10 4.3.3.2 Heart rate variability or RR interval variability measurement from databases. 11 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 Terms and symbols . 15 4.4.3 Run

39、 sensitivity summary matrix . 16 4.4.4 Run positive predictivity summary matrix 16 4.5 VF and AF comparisons 16 4.6 ST comparison. 17 Annex A Rationale and additional guidance . 22 Tables Table 1Requirements for all arrhythmia algorithms 5 Table 2Requirements for algorithms with optional capabilitie

40、s 6 Table 3Beat label classifications 9 Table 4AHA and MITBIH database labels distributed for use by HRV algorithms . 12 Table 5Example of noise floor calculation results 13 Table 7Run sensitivity summary matrix 15 Table 8Run positive predictivity summary matrix . 15 Table A.1Records to be included

41、in a complete test 23 Table A.2Example of a line-format, beat-by-beat performance report . 26 Table A.2.1Condensed beat-by-beat summary matrix containing 11 elements . 26 Table A.2.2Summary table (matrix format) of beat-by-beat comparison 27 Table A.3Example of a line-format shutdown report 27 Table

42、 A.4Example of a line-format report . 28 Table A.5Example of VF performance report . 29 Table A.6Example of false VF performance report 29 Table A.7Example of a line-format couplet and run performance report 30 Table A.8Example of results of HRV program run on MITBIH database reference annotations 3

43、1 Table A.9Example of device measurements of synthetic test patterns 31 Table A.10Example of predicted ideal values for synthetic test patterns . 32 Table A.11Example of choice of test patterns 32 Table A.12Example of RMS interval differences 34 Table A.13Example of summary of frequency components .

44、 35 Table A.14Example of a line-format report . 36 Figures 1 Example of scatter plot of ST amplitude measurement . 18 2 Example of scatter plot of ST amplitude measurement . 18 3 Example of scatter plot of ST amplitude measurement (-200 microvolt to + 200 microvolt reference) 19 4 Example of scatter

45、 plot of ST slope measurement error . 20 5 Example of scatter plot of ST slope measurement 21 Table 6example of HRV test results . 14 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI EC57:2012 v Glossary of equivalent standards International Standards adopted in the United S

46、tates may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Available on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivale

47、ncy to the International Standard. www.aami.org/publications/standards/glossary.pdf vi 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI EC57:2012 Committee representation Association for the Advancement of Medical Instrumentation Electrocardiograph (ECG) Committee This recom

48、mended practice was developed by the ECG Committee of the Association for the Advancement of Medical Instrumentation. Committee approval of the standard does not necessarily imply that all committee members voted for its approval. At the time this document was published, the AAMI Electrocardiograph

49、Committee had the following members: Cochairs: Richard A. Sunderland Ahmet Turkmen Brian J. Young Members: Robert William Bain, CBET, Baltimore Medical Engineers “should” indicates that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is preferred but not necessarily required, or that (in the negative form) a certain possibility or course of action is discouraged but not prohibited; “may” is used to indicate that a course of action is permissible within th