IEC_TR_61289-2019.pdf

IEC TR 61289 Edition 2.0 2019-05 TECHNICAL REPORT High frequency surgical equipment and high frequency surgical accessories Operation and maintenance IEC TR 61289:2019-05(en)colourinside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2019 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.IEC Central Office Tel.:+41 22 919 02 11 3,rue de Varemb infoiec.ch CH-1211 Geneva 20 www.iec.ch Switzerland About the IEC The International Electrotechnical Commission(IEC)is the leading global organization that prepares and publishes International Standards for all electrical,electronic and related technologies.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 corrigendum or an amendment might have been published.IEC publications search-webstore.iec.ch/advsearchform The advanced search enables to find IEC publications by a variety of criteria(reference number,text,technical committee,).It also gives information on projects,replaced and withdrawn publications.IEC Just Published-webstore.iec.ch/justpublished Stay up to date on all new IEC publications.Just Published details all new publications released.Available online and once a month by email.IEC Customer Service Centre-webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance,please contact the Customer Service Centre:salesiec.ch.Electropedia-www.electropedia.org The worlds leading online dictionary on electrotechnology,containing more than 22 000 terminological entries in English and French,with equivalent terms in 16 additional languages.Also known as the International Electrotechnical Vocabulary(IEV)online.IEC Glossary-std.iec.ch/glossary 67 000 electrotechnical terminology entries in English and French extracted from the Terms and Definitions clause of IEC publications issued since 2002.Some entries have been collected from earlier publications of IEC TC 37,77,86 and CISPR.IEC TR 61289 Edition 2.0 2019-05 TECHNICAL REPORT High frequency surgical equipment and high frequency surgical accessories Operation and maintenance INTERNATIONAL ELECTROTECHNICAL COMMISSION ICS 11.040.01 ISBN 978-2-8322-6885-8 Registered trademark of the International Electrotechnical Commission Warning!Make sure that you obtained this publication from an authorized distributor.colourinside 2 IEC TR 61289:2019 IEC 2019 CONTENTS FOREWORD.4 INTRODUCTION.6 1 Scope.7 2 Normative references.7 3 Terms and definitions.7 4 General information regarding HF SURGICAL EQUIPMENT.12 5 Recommended practices before use.13 5.1 Inspection of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES before use.13 5.2 Preparation.13 5.3 Handling of NEUTRAL ELECTRODES,HF SURGICAL ACCESSORIES,cables and connections.14 5.4 PATIENTS with active implants(active implantable medical devices).14 5.5 Simultaneous use of two items of HF SURGICAL EQUIPMENT.15 5.6 Instructions for use.15 6 Recommended practices during use.15 7 Recommended practices after use.16 8 Nature of HAZARDS.16 8.1 General.16 8.2 HF SURGICAL EQUIPMENT related HAZARDS.16 8.2.1 Incompatible combinations.16 8.2.2 Electromagnetic compatibility.16 8.2.3 Misconnection of ACTIVE ACCESSORIES.16 8.2.4 Specialty HF SURGICAL EQUIPMENT.17 8.3 ACTIVE ACCESSORY related HAZARDS.17 8.3.1 Incompatible combinations.17 8.3.2 Environment of use.17 8.3.3 Misuse.18 8.4 OPERATOR-related HAZARDS.18 8.4.1 OPERATOR not reading or following the instructions for use.18 8.4.2 OPERATOR selecting inappropriate power or mode settings.18 8.4.3 OPERATOR using an HF SURGICAL ACCESSORY in an inappropriate manner.18 8.5 NEUTRAL ELECTRODE related HAZARDS.19 8.5.1 General.19 8.5.2 Inadequate contact area of a NEUTRAL ELECTRODE.19 8.5.3 Inappropriate application.19 8.5.4 Surgical procedures utilizing high currents or long duty cycles.19 9 Safety provisions of,and symbols on,HF SURGICAL EQUIPMENT.22 9.1 General.22 9.2 Colours of indicator lights.22 9.3 Markings on HF SURGICAL ELECTRICAL EQUIPMENT.22 9.4 Protection against electric shock and burns.24 9.4.1 Method of protection.24 9.4.2 Degree of protection.24 9.5 HF SURGICAL EQUIPMENT not properly marked.25 9.6 Monitoring the effectiveness of the NEUTRAL ELECTRODE.25 IEC TR 61289:2019 IEC 2019 3 9.7 Output indicators.25 10 Accompanying documents.26 11 Preventive maintenance.26 Annex A(informative)Concerns regarding high current surgical procedures or high duty cycles.27 Bibliography.28 Figure 1 Symbol used o