IEC_TR_61289-2011.pdf

IEC/TR 61289 Edition 1.0 2011-11 TECHNICAL REPORT High frequency surgical equipment Operation and maintenance IEC/TR 61289:2011(E)Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-28-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2011 IEC,Geneva,Switzerland All rights reserved.Unless otherwise specified,no part of this publication may be reproduced or utilized in any form or by any means,electronic or mechanical,including photocopying and microfilm,without permission in writing from either IEC or IECs member National Committee in the country of the requester.If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,please contact the address below or your local IEC member National Committee for further information.Droits de reproduction rservs.Sauf indication contraire,aucune partie de cette publication ne peut tre reproduite ni utilise sous quelque forme que ce soit et par aucun procd,lectronique ou mcanique,y compris la photocopie et les microfilms,sans laccord crit de la CEI ou du Comit national de la CEI du pays du demandeur.Si vous avez des questions sur le copyright de la CEI ou si vous dsirez obtenir des droits supplmentaires sur cette publication,utilisez les coordonnes ci-aprs ou contactez le Comit national de la CEI de votre pays de rsidence.IEC Central Office 3,rue de Varemb CH-1211 Geneva 20 Switzerland Email:inmailiec.ch Web:www.iec.ch About IEC publications The technical content of IEC publications is kept under constant review by the IEC.Please make sure that you have the latest edition,a corrigenda or an amendment might have been published.Catalogue of IEC publications:www.iec.ch/searchpub The IEC on-line Catalogue enables you to search by a variety of criteria(reference number,text,technical committee,).It also gives information on projects,withdrawn and replaced publications.IEC Just Published:www.iec.ch/online_news/justpub Stay up to date on all new IEC publications.Just Published details twice a month all new publications released.Available on-line and also by email.Electropedia:www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 20 000 terms and definitions in English and French,with equivalent terms in additional languages.Also known as the International Electrotechnical Vocabulary online.Customer Service Centre:www.iec.ch/webstore/custserv If you wish to give us your feedback on this publication or need further assistance,please visit the Customer Service Centre FAQ or contact us:Email:csciec.ch Tel.:+41 22 919 02 11 Fax:+41 22 919 03 00 Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-28-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.IEC/TR 61289 Edition 1.0 2011-11 TECHNICAL REPORT High frequency surgical equipment Operation and maintenance INTERNATIONAL ELECTROTECHNICAL COMMISSION T ICS 11.040.01 PRICE CODE ISBN 978-2-88912-804-4 Registered trademark of the International Electrotechnical Commission Copyrighted material licensed to BR Demo by Thomson Reuters(Scientific),Inc.,,downloaded on Nov-28-2014 by James Madison.No further reproduction or distribution is permitted.Uncontrolled when printed.2 TR 61289 IEC:2011(E)CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope.7 2 Terms and definitions.7 3 General information regarding HF SURGICAL EQUIPMENT.11 4 Recommended practices.11 4.1 Inspection of HF SURGICAL EQUIPMENT before use.11 4.2 Preparation.12 4.3 Handling of NEUTRAL ELECTRODES,cables and connections.12 4.4 Patients with active implants(implantable electronic medical devices).12 4.5 Simultaneous use of two items of HF SURGICAL EQUIPMENT.13 5 Recommended practices during use.13 6 Recommended practices after use.14 7 Nature of HAZARDS.14 7.1 General.14 7.2 HF SURGICAL EQUIPMENT related HAZARDS.14 7.2.1 Incompatible combinations.14 7.2.2 Electromagnetic compatibility.14 7.2.3 Misconnection of ACTIVE ACCESSORIES.14 7.2.4 Specialty HF SURGICAL EQUIPMENT.15 7.3 ACTIVE ACCESSOR-related HAZARDS.15 7.3.1 Incompatible combinations.15 7.3.2 Environment of use.15 7.3.3 Misuse.16 7.4 OPERATOR-related HAZARDS.16 7.4.1 OPERATOR not reading and/or following the instructions for use.16 7.4.2 OPERATOR selecting inappropriate power or mode settings.16 7.4.3 OPERATOR using an ACTIVE ACCESSORY in an inappropriate manner.16 7.5 NEUTRAL ELECTRODE-related HAZARDS.17 7.5.1 General.17 7.5.2 Inadequate contact area of a NEUTRAL ELECTRODE.17 7.5.3 Inappropriate application.17 7.5.4 Surgical procedures utilizing high currents and/or long duty cycles.17 8 Safety provisions of,and symbols on,HF SURGICAL EQUIPMENT.20 8.1 General.20 8.2 Colours of indicator lights.20 8.3 Markings on HF SURGICAL ELECTRICAL EQUIPMENT.20 8.4 Protection against electric