AAMI-TIR21-1998.pdf
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1、Technical Information Report AAMI TIR21:1998 AAMI Association for the Advancement of Medical Instrumentation Systems used to forecast remaining pacemaker battery service life Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Emp
2、loyees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI TIR No. 211998 Systems used to forecast remaining pacemaker battery service life Approved 30 January 1998 Abstract:This report describes the clinica
3、l expectations for the performance of systems that use “real-time” measurements telemetered by the pulse generator to forecast remaining battery service life. These systems combine the real-time measurements with assumptions provided by the clinician to forecast the remaining service life of the pac
4、emaker battery. The method described in this report is based on the use of battery voltage measurements. Other methods that use battery impedance or charge measurements can also be used. Keywords:pacemaker battery, implantable medical device, electromedical device, implants, battery depletion, batte
5、ry longevity Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- Published by As
6、sociation for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-5762 1998 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMI. No part of this publication may be repro
7、duced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this draft should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (wh
8、ether 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 use of all or any part of thi
9、s document, contact Kurt C. Larrick, Director, Technical Publishing, at AAMI, 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 ISBN 1-57020-110-2 Copyright Association for the Advancement of Medical Inst
10、rumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- AAMI TECHNICAL INFORMATION REPORT A technical information report (TIR) is a publicati
11、on of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the material presented in a TIR may need further evaluation by experts, there is value in releasing the information because of the immediate
12、need for it by the industry and the professions. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolu
13、tion of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, the American National Standards Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by
14、 a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted uponreaffirmed, revised, or withdrawnand the action formally approved usually every 5 years but at least every 10 years. For a TIR, AA
15、MI consults with a technical committee about 5 years after the publication date (and periodically thereafter) for guidance on whether the document is still usefulthat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circu
16、lation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice or because achieving consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issue
17、s. CAUTION NOTICE: This AAMI Technical Information Report may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ensure that they have also considered information that may be more recent than this document. Comments on this tech
18、nical information report are invited and should be sent to AAMI Standards Program, 3330 Washington Boulevard, Suite 400, Arlington, VA 22201-4598. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing
19、, Bernie Not for Resale, 03/21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/
20、21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- CONTENTS Committee representationvii Introductionviii 1Scope1 2Definitions1 3Pulse generator longevity and battery depletion.2 4Battery depletion and programming for optimum longevity.3 5The battery depletion
21、curve.4 5.1The prereplacement region5 5.2The predictable usage region.5 5.3The unpredictable performance region6 6Patient follow-up and battery depletion7 7Forecasting remaining longevity7 7.1Estimating remaining battery capacity.8 7.2Combination of errors.9 7.3Estimating the future average battery
22、current drain11 8Presentation of remaining longevity.13 8.1Typical remaining longevity .13 8.2Minimum remaining longevity14 9Summary.15 Annexes AFundamental system model .17 A.1The pulse generator circuit model .17 A.2The pacemaker battery model .22 A.3Programming pacing output for maximum longevity
23、 consistent with adequate safety margin27 BBattery variability .32 B.1Projection of battery variability.32 B.2Variability from accelerated testing.33 B.3Variability from life testing.34 B.4System error contribution due to battery variability.35 Copyright Association for the Advancement of Medical In
24、strumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:52:23 MDTNo reproduction or networking permitted without license from IHS -,-,- CRemaining battery longevity36 C.1Remaining deliverable battery capacity (Q) .36 C.
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