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1、Association for the Advancement of Medical Instrumentation ANSI/AAMI EC13:2002/(R)2007 Cardiac monitors, heart rate meters, and alarms American National Standard Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/111111
2、1001, User=Japan, IHS Not for Resale, 07/30/2008 01:41:22 MDTNo reproduction or networking permitted without license from IHS -,-,- The Objectives and Uses of AAMI Standards and Recommended Practices It is most important that the objectives and potential uses of an AAMI product standard or recommend
3、ed 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 patient
4、 care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with attention to these objectives and provided that arbitrary and restrictive us
5、es are avoided. A voluntary standard for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be con- sidered in qualifying the device for clinical use, and the measurement techniques that ca
6、n be used to determine whether the device conforms with the safety and performance criteria and/or to compare the per- formance characteristics of different products. Some standards em- phasize the information that should be provided with the device, including performance characteristics, instructio
7、ns for use, warnings and precautions, and other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformi
8、ty in reporting; reaching consensus on these tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing th
9、e criteria must be documented in the rationale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is
10、 used safely and effectively and that its performance will be maintained. Although a device standard is primarily directed to the manufac- turer, it may also be of value to the potential purchaser or user of the device as a fume of reference for device evaluation. Similarly, even though a recommende
11、d practice is usually oriented towards health care professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial
12、personnel on such subjects as sterilization processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whet
13、her an AAMI standard or recommended practice is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement a
14、uthorities). The application of a standard or recom- mended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial represen
15、tatives, whose work has been reviewed nationally (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limi
16、ted, however, in the sense that it responds generally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decisionmaking. Despite
17、 periodic review and revision (at least once every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for e
18、ach of its provisions. This review will reveal whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While
19、observed or potential risks with existing equipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equip- ment. No single source of information will serve to identify a particular produ
20、ct as “unsafe“. A voluntary standard can be used as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of th
21、e specific needs and resources of the individual institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is
22、 used in conjunction with other sources of information and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the
23、Manager for Technical Development. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any a
24、ppeals and upon publication of notice of interpre- tation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been deve
25、loped and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001,
26、User=Japan, IHS Not for Resale, 07/30/2008 01:41:22 MDTNo reproduction or networking permitted without license from IHS -,-,- American National Standard ANSI/AAMI EC13:2002/(R)2007 (Revision of ANSI/AAMI EC13:1992) Corrected Copy: 25 February 2008 Cardiac monitors, heart rate meters, and alarms Deve
27、loped by Association for the Advancement of Medical Instrumentation Approved 6 May 2002 by American National Standards Institute, Inc. Abstract: This American National Standard establishes minimum safety and performance requirements for cardiac monitors, heart rate meters, and alarms that are used t
28、o acquire and/or display electrocardiographic signals with the primary purpose of continuous detection of cardiac rhythm. Keywords: diagnostic, ECG, electromedical equipment, heart rate, medical electrical equipment, monitoring, waveform Copyright Association for the Advancement of Medical Instrumen
29、tation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:41:22 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standar
30、d implies a consensus of those substantially concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not
31、conforming to the standard. AAMI standards are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no
32、 later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, a
33、nd their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its ru
34、les and regulations. Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2002 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage
35、, 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 federal law (17 U.S.C. 101, et seq.) to make copies of all or
36、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 damages of $100,000 per offense. For permission regarding the
37、use of all or any part of this document, contact AAMI at 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of America ISBN 1570201749 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS u
38、nder license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:41:22 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Committee representationv Foreword.vi 1Scope1 1.1Inclusions.1 1.2Exclusions1 1.3Differences in monitor
39、s2 2Normative references2 3Definitions .2 4Requirements4 4.1Labeling requirements .4 4.1.1Device markings4 4.1.2Operator manual6 4.1.3Service manual8 4.1.4Pacemaker pulse rejection capability9 4.1.5Summary .10 4.2Performance requirements 11 4.2.1Operating conditions11 4.2.2Overload protection .12 4.
40、2.3Leakage current.12 4.2.4Auxiliary output12 4.2.5Respiration, leads-off sensing, and active noise suppression.12 4.2.6QRS detection .12 4.2.7Range and accuracy of heart rate meter.13 4.2.8Alarm system.13 4.2.9Special requirements for monitors with ECG waveform display capability14 4.2.10Electromag
41、netic compatibility17 4.2.11Summary .18 5Test methods 22 5.1Compliance with the labeling requirements.23 5.1.1Device markings23 5.1.2Operator manual23 5.1.3Service manual27 5.1.4Pacemaker pulse rejection capability27 5.2Compliance with the performance requirements .30 5.2.1Operating conditions30 5.2
42、.2Overload protection .30 5.2.3Leakage current.34 5.2.4Auxiliary output34 5.2.5Respiration, leads-off sensing, and active noise suppression.34 5.2.6QRS detection .34 5.2.7Range and accuracy of heart rate meter.35 5.2.8Alarm system.36 5.2.9Special requirements for monitors with ECG waveform display c
43、apability37 5.2.10Electromagnetic compatibility46 Annexes ARationale for the development and provisions of this standard 48 BCited references and bibliography 68 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/111111
44、1001, User=Japan, IHS Not for Resale, 07/30/2008 01:41:22 MDTNo reproduction or networking permitted without license from IHS -,-,- CCMR test fixture design and application notes70 DPacer pulse shaper test circuit and notes.77 Tables 1Patient electrode connection definitions and color code.6 2Summar
45、y of labeling/disclosure requirements 10 3Frequency response .16 4Summary of performance requirements18 5Lead combinations and number of defibrillator discharge tests32 6Patient electrode connections for pacemaker pulse display test 38 A.1Extreme expected values of impedance (1 electrode) for a typi
46、cal population .61 Figures 1Triangular wave signal (for method B) 16 2Test waveforms for T-wave rejection capability.24 3Test waveforms for verifying heart rate accuracy25 4Test waveforms for ventricular tachycardia (modified from Lindsay and Budkin, 1970) .26 5Pacemaker pulse test waveforms .28 6Te
47、st signal simulating the QRS complex of the ECG29 7Example of time and amplitude measurement29 8General test circuit 30 9ATest circuit for defibrillator overload tests (5.2.2.2.1 and 5.2.2.2.2) 33 9BTest circuit for operator safety test (5.2.2.2.3).33 10Test circuit for evaluating internal noise and
48、 common mode42 11Pacemaker overload test circuit43 12Electrosurgery test setup 44 13AElectrosurgery overload test circuit.45 13BElectrosurgery suppression test circuit .46 A.1Equivalent circuits for defibrillator discharge.56 C.1CMR test: Line-powered supply and buffer.74 C.2CMR test: Generator-powe
49、red buffer74 C.3Expanded offset capability, CMR fixture75 D.1Pacer pulse shaper circuit.78 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Japan, IHS Not for Resale, 07/30/2008 01:41:22 MDTNo reproduction or networking permitted without license from IHS -,