IEC TR 61289-2011 High frequency surgical equipment - Operation and maintenance《高频手术设备的操作和维修》.pdf

1、 IEC/TR 61289 Edition 1.0 2011-11 TECHNICAL REPORT High frequency surgical equipment Operation and maintenance IEC/TR 61289:2011(E) THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2011 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be repr

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9、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 IEC/TR 61289 Edition 1.0 2011-11 TECHNICAL REPORT High frequency surgical e

10、quipment 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 2 TR 61289 IEC:2011(E) CONTENTS FOREWORD . 4 INTRODUCTION . 6 1 Scope . 7 2 Terms and definitions . 7 3

11、 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) 1

12、2 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

13、 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 instr

14、uctions 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 applica

15、tion . 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 shock and bu

16、rns . 21 8.4.1 Method of protection 21 8.4.2 Degree of protection 22 8.5 HF SURGICAL EQUIPMENT not properly marked . 22 8.6 Monitoring the effectiveness of the NEUTRAL ELECTRODE 23 8.7 Output indicators . 23 9 Accompanying documents 23 10 Preventive maintenance . 23 TR 61289 IEC:2011(E) 3 Bibliograp

17、hy 24 Table 1 Colours and significance of indicator lights according to IEC 60601-2-2 20 Table 2 Symbols used on HF SURGICAL EQUIPMENT 21 4 TR 61289 IEC:2011(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION _ HIGH FREQUENCY SURGICAL EQUIPMENT OPERATION AND MAINTENANCE FOREWORD 1) The International Elect

18、rotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields.

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27、his IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attention is drawn to the possibility that some of the elements of t

28、his 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 task of IEC technical committees is to prepare International Standards. However, a technical committee may propose the publication of a technical report

29、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 61289, which is a technical report, has been prepared by sub-committee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equip

30、ment 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 technical revision and combination. The text of this technical report is based on the following documents: Enquiry draft Report on voting 62D/929DTR 62D/95

31、6/RVC TR 61289 IEC:2011(E) 5 Full information on the voting for the approval of 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

32、and these are given in the text in SMALL CAPITALS. The definitions of these terms 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 t

33、o the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. A bilingual version of this publication may be issued at a later date. 6 TR 61289 IEC:2011(E) INTRODUCTION This report gives guidelines to personnel in charge of opera

34、tion of equipment covered by IEC 60601-2-2 to enable them to attain the best conditions of safety for their patients and themselves. TR 61289 IEC:2011(E) 7 HIGH FREQUENCY SURGICAL EQUIPMENT OPERATION AND MAINTENANCE 1 Scope This technical report contains guidelines for medical and nursing personnel

35、regarding the safe and effective operation of HIGH FREQUENCY SURGICAL EQUIPMENT (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 documen

36、t deal with the safe operation of HIGH FREQUENCY SURGICAL EQUIPMENT constructed 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

37、 guidelines in this report will still be helpful in utilizing these devices. 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 followin

38、g 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, defin

39、ition 3.3 2.2 ACTIVE ACCESSORY HF SURGICAL ACCESSORY intended for manipulation by the OPERATOR to produce surgical effects at the intended site on the patient, generally comprising an ACTIVE HANDLE, cord of an ACTIVE ACCESSORY, ACTIVE CONNECTOR and ACTIVE ELECTRODE SOURCE: IEC 60601-2-2:2009, defini

40、tion 201.3.201 2.3 ACTIVE CONNECTOR part of an ACTIVE ACCESSORY intended for connection to an ACTIVE OUTPUT TERMINAL, which may include additional terminals for connection of a FINGERSWITCH to a SWITCH SENSOR SOURCE: IEC 60601-2-2:2009, definition 201.3.202 8 TR 61289 IEC:2011(E) 2.4 ACTIVE ELECTROD

41、E part of an ACTIVE ACCESSORY extending from the ACTIVE HANDLE to the surgical site SOURCE: IEC 60601-2-2:2009, definition 201.3.203 2.5 ACTIVE HANDLE part of an ACTIVE ACCESSORY intended to be held by the OPERATOR SOURCE: IEC 60601-2-2:2009, definition 201.3.205 2.6 ACTIVE OUTPUT TERMINAL part of H

42、F SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an ACTIVE ACCESSORY and for delivery of HF current thereto SOURCE: IEC 60601-2-2:2009, definition 201.3.206 2.7 APPLIED PART part of ME EQUIPMENT that in normal use necessarily comes into physical contact with the patient for ME

43、 EQUIPMENT or an ME SYSTEM to perform its function SOURCE: IEC 60601-1:2005, definition 3.8 2.8 ASSOCIATED EQUIPMENT equipment other than HF SURGICAL EQUIPMENT that may be electrically connected to the PATIENT circuit and not intended for independent use SOURCE: IEC 60601-2-2:2009, definition 201.3.

44、207 2.9 BIPOLAR method of applying HF output current to a patient via multiple-pole ACTIVE ELECTRODES SOURCE: IEC 60601-2-2:2009, definition 201.3.208 2.10 COAGULATION use of HF current to elevate the temperature of tissue, e.g. to reduce or terminate undesired bleeding Note to entry: COAGULATION ma

45、y take the form of contact or non-contact COAGULATION. SOURCE: IEC 60601-2-2:2009, definition 201.3.210 2.11 cONTACT QUALITY MONITOR circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to a MONITORING NE providing an alarm in the event that NEUTRAL ELECTRODE (NE) contact

46、 with the patient becomes insufficient Note to entry: A CONTACT QUALITY MONITOR is functional only when used with a MONITORING NE. SOURCE: IEC 60601-2-2:2009, definition 201.3.211 2.12 CONTINUITY MONITOR circuit in HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT intended for connection to an NE, excep

47、t MONITORING NE, providing an alarm in the event of electrical discontinuity in the NE cable or its connections TR 61289 IEC:2011(E) 9 SOURCE: IEC 60601-2-2:2009, definition 201.3.212 2.13 CUTTING resection or dissection of body tissue caused by the passage of HIGH FREQUENCY current of high current

48、density at the ACTIVE ELECTRODE(S) SOURCE: IEC 60601-2-2:2009, definition 201.3.214 2.14 FINGERSWITCH device generally included with an ACTIVE ACCESSORY which, when manipulated by the OPERATOR, enables HF output to be produced and, when released, disables HF output SOURCE: IEC 60601-2-2:2009, defini

49、tion 201.3.216 2.15 HAZARD potential source of harm SOURCE: IEC 60601-1:2005, definition 3.39 2.16 HIGH FREQUENCY HF frequencies generally greater than 200 kHz SOURCE: IEC 60601-2-2:2009, definition 201.3.218 2.17 HIGH FREQUENCY SURGICAL ACCESSORY HF SURGICAL ACCESSORY ACCESSORY intended to conduct, supplement or monitor HF energy applied to the patient from HF SURGICAL EQUIPMENT Note to entry: HF SURGICAL ACCESSORIES include HF surgic