ANSI TIR61289-2011 High frequency surgical equipment C Operation and maintenance.pdf

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1、ANSI/AAMI/ IEC TIR 61289:2011Technical Information ReportHigh frequency surgical equipment Operation and maintenanceAn ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR61289:2011 High frequency surgical equipment Operation and maintenance Approved 19 December 2011 by Association for the Advan

2、cement of Medical Instrumentation Approved 18 December 2011 by American National Standards Institute Abstract: This technical report contains guidelines for medical and nursing personnel regarding the safe and effective operation of high frequency surgical equipment. This report will be of use to sc

3、ientific/technical staff who may have responsibility for the maintenance of this equipment. This report deals with the safe operation of the high frequency surgical equipment, including the requirements outlined in ANSI/AAMI/IEC 60601-2-2:2009. Keywords: high frequency surgical equipment, HF surgica

4、l equipment Published by Association for the Advancement of Medical Instrumentation 4301 N Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2012 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO,

5、 ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et

6、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 damages of $100,000 per offense

7、. 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 Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-43

8、5-7 AAMI Technical Information Report A technical information report (TIR) is a publication 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 eva

9、luation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between these documents. Standards and recommended practices

10、 are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standards Institute. A TIR is not subject to the same f

11、ormal approval process as a standard. However, a TIR is approved for distribution by 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 onreaffirmed, revised, or withdrawnand the action

12、formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five 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

13、 or of historical value. If the information is not useful, the TIR is removed from circulation. 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.

14、Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR 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 t

15、hat may be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasio

16、nally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Comments on this technical information report are invited and should be sent to AAMI, Attn: St

17、andards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report has been approved by the accredited standards de

18、veloper (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical Reports with ANSI. This document is not an American National Standard and the material contained herein is not normative in nature. Comments on this

19、technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. CONTENTS Glossary of equivalent standards . vii Committee representation . ix Background of AAMI adoption of IEC/TR 61289:2011 x FOREWORD xi IN

20、TRODUCTION xiii 1 Scope . 1 2 Terms and definitions 1 3 General information regarding HF SURGICAL EQUIPMENT 5 4 Recommended practices . 6 4.1 Inspection of HF SURGICAL EQUIPMENT before use 6 4.2 Preparation 6 4.3 Handling of NEUTRAL ELECTRODES, cables and connections . 7 4.4 Patients with active imp

21、lants (implantable electronic medical devices) . 7 4.5 Simultaneous use of two items of HF SURGICAL EQUIPMENT 7 5 Recommended practices during use 8 6 Recommended practices after use 8 7 Nature of HAZARDS . 8 7.1 General 8 7.2 HF SURGICAL EQUIPMENT related HAZARDS 9 7.2.1 Incompatible combinations .

22、 9 7.2.2 Electromagnetic compatibility . 9 7.2.3 Misconnection of ACTIVE ACCESSORIES 9 7.2.4 Specialty HF SURGICAL EQUIPMENT . 9 7.3 ACTIVE ACCESSOR- related HAZARDS 9 7.3.1 Incompatible combinations . 9 7.3.2 Environment of use 10 7.3.3 Misuse . 10 7.4 OPERATOR-related HAZARDS 11 7.4.1 OPERATOR not

23、 reading and/or following the instructions for use 11 7.4.2 OPERATOR selecting inappropriate power or mode settings . 11 7.4.3 OPERATOR using an ACTIVE ACCESSORY in an inappropriate manner 11 7.5 NEUTRAL ELECTRODE-related HAZARDS . 11 7.5.1 General 11 7.5.2 Inadequate contact area of a NEUTRAL ELECT

24、RODE 12 7.5.3 Inappropriate application 12 7.5.4 Surgical procedures utilizing high currents and/or long duty cycles 12 8 Safety provisions of, and symbols on, HF SURGICAL EQUIPMENT 15 8.1 General 15 8.2 Colors of indicator lights 15 8.3 Markings on HF SURGICAL ELECTRICAL EQUIPMENT 15 8.4 Protection

25、 against electric shock and burns . 16 8.4.1 Method of protection 16 8.4.2 Degree of protection . 17 8.5 HF SURGICAL EQUIPMENT not properly marked 18 8.6 Monitoring the effectiveness of the NEUTRAL ELECTRODE . 18 8.7 Output indicators 18 9 Accompanying documents . 18 10 Preventive maintenance 18 Bib

26、liography 20 Table 1 Colors and significance of indicator lights according to IEC 60601-2-2 . 15 Table 2 Symbols used on HF SURGICAL EQUIPMENT 16 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR61289:2011 vii Glossary of equivalent standards International Standards a

27、dopted in the United States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents ar

28、e sorted by international designation. The code in the US column, “(R)20xx” indicates the year the document was officially reaffirmed by AAMI. E.g., ANSI/AAMI/ISO 10993-4:2002/(R)2009 indicates that 10993-4, originally approved and published in 2002, was reaffirmed without change in 2009. Other norm

29、atively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 Technical Corrigendum 1 and 2 ANSI/AAMI ES60601-1:2005/(R)2012 and ANSI/A

30、AMI ES60601-1:2005/A2:2010/(R)2012 ANSI/AAMI ES60601-1:2005/C1:2009/(R)2012 (amdt) Major technical variations C1 Identical to Corrigendum 1 any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organ

31、izations liaising with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical m

32、atters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC Nati

33、onal Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity,

34、IEC National Committees undertake to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC its

35、elf does not provide any attestation of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that

36、they have the latest edition of this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any natur

37、e whatsoever, whether direct or indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced

38、publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights. The main tas

39、k of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report when it has collected data of a different kind from that which is normally published as an International Standard, for example “state of the art“. IEC

40、 61289, which is a technical report, has been prepared by sub-committee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. This first edition of IEC 61289 cancels and replaces IEC 61289-1:1994 and IEC 61289-2:1994, of which it constitutes a techni

41、cal revision and combination. The text of this technical report is based on the following documents: Enquiry draft Report on voting 62D/929DTR 62D/956/RVC xii 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR61289:2011 Full information on the voting for the approval o

42、f this technical report can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. Certain terms are used with a defined meaning and these are given in the text in SMALL CAPITALS. The definitions of these te

43、rms are provided in Clause 2. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed,

44、 withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR61289:2011 xiii INTRODUCTION This report gives guidelines to personnel in charge of operation

45、 of equipment covered by IEC 60601-2-2 to enable them to attain the best conditions of safety for their patients and themselves. xiv 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR61289:2011 2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI/I

46、EC TIR61289:2011 1 AAMI Technical Information Report ANSI/AAMI/IEC TIR61289:2011 HIGH FREQUENCY SURGICAL EQUIPMENT OPERATION AND MAINTENANCE 1 Scope This technical report contains guidelines for medical and nursing personnel regarding the safe and effective operation of HIGH FREQUENCY SURGICAL EQUIP

47、MENT (also referred to as HF SURGICAL EQUIPMENT in this document). It will also be of use to scientific/technical staff who have responsibility for the maintenance of this equipment. The application guidelines in this document deal with the safe operation of HIGH FREQUENCY SURGICAL EQUIPMENT constru

48、cted according to the safety requirements of IEC 60601-1 and IEC 60601-2-2 (see Bibliography). Not all existing HIGH FREQUENCY SURGICAL EQUIPMENT meets the minimum requirements of current international standards, however, the guidelines in this report will still be helpful in utilizing these devices

49、. This report assumes that the electrical installation of HIGH FREQUENCY SURGICAL EQUIPMENT meets national and local regulations for medically used rooms. 2 Terms and definitions For the purpose of this document, the following terms and definitions apply. 2.1 ACCESSORY additional part for use with equipment in order to: achieve the intended use, adapt it to some special use, facilitate its use, enhance its performance, or enable its functions to be integrated with those of other equipment SOURCE: IEC 60601-1:2005, definition 3