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IEC TR 61289
Edition 2.0 2019-05
TECHNICAL
REPORT
colour
inside
High frequency surgical equipment and high frequency surgical accessories –
Operation and maintenance
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IEC TR 61289
Edition 2.0 2019-05
TECHNICAL
REPORT
colour
inside
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
– 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
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 on Class II equipment . 24
Figure 2 – Symbol used with an earth referenced PATIENT circuit . 25
Figure 3 – Symbol used with an HF ISOLATED PATIENT CIRCUIT . 25
Table 1 – Colours and significance of indicator lights according to IEC 60601-2-2 . 22
Table 2 – Symbols used on HF SURGICAL EQUIPMENT . 23
– 4 – IEC TR 61289:2019 IEC 2019
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
HIGH FREQUENCY SURGICAL EQUIPMENT AND HIGH FREQUENCY
SURGICAL ACCESSORIES – OPERATION AND MAINTENANCE
FOREWORD
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The main task 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 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 second edition cancels and replaces the first edition published in 2011. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) general adaption to IEC 60601-2-2:2017;
b) refinement and additions to the defined terms;
c) separation of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES;
d) consideration of the HIGH CURRENT MODE;
e) update of symbols.
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62D/1652/DTR 62D/1662A/RVDTR
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.
In this document, the following print types are used:
– T
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