IEC TR 61289:2011

IEC/TR 61289 ®
Edition 1.0 2011-11
TECHNICAL
REPORT
High frequency surgical equipment – Operation and maintenance

IEC/TR 61289:2011(E)
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IEC/TR 61289 ®
Edition 1.0 2011-11
TECHNICAL
REPORT
High frequency surgical equipment – Operation and maintenance

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
T
ICS 11.040.01 ISBN 978-2-88912-804-4

– 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 shock and burns . 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 –
Bibliography . 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 Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

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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 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/956/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 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 to 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 operation 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 regarding the safe
and effective operation of HIGH FREQUENCY SURGICAL EQUIPMENT (also referred to as HF

in this document). It will also be of use to scientific/technical staff who
SURGICAL EQUIPMENT
have responsibility for the maintenance of this equipment.
The application guidelines in this document deal with the safe operation of HIGH FREQUENCY
SU
...