IEC TR 61289:2011

High frequency surgical equipment - Operation and maintenance

IEC/TR 61289:2011(E) is a technical report giving guidelines to personnel in charge of operating high frequency surgical equipment covered by IEC 60601-2-2. It intends enabling them to attain the best conditions of safety and efficiency for their patients and themselves. It will also be useful to scientific/technical staff having responsibility for the maintenance of this equipment. This report assumes that the electrical installation of high frequency surgical equipment meets national and local regulations for medically used rooms. However, the guidelines in this report will still be helpful in utilizing devices not meeting the minimum requirements of current international standards. IEC/TR 61289:2011 cancels and replaces IEC/TR 61289-1:1994 and IEC/TR 61289-2:1994. It constitutes a technical revision and a combination.

General Information

• Status: Published
• Publication Date: 21-Nov-2011
• ICS: 11.040.01 - Medical equipment in general
• ICS: 29.130.20 - Low voltage switchgear and controlgear
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 17 - TC 62/SC 62D/MT 17
• Current Stage: DELPUB - Deleted Publication
• Start Date: 09-Feb-2018
• Completion Date: 10-May-2019

Relations

• Revised: IEC TR 61289:2019 - High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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

® Registered trademark of the International Electrotechnical Commission

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– 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

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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

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INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________



HIGH FREQUENCY SURGICAL EQUIPMENT –

OPERATION AND MAINTENANCE



FOREWORD

1) The International Electrotechnical 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. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
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with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
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4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
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6) All users should ensure that they have the latest edition of this publication.
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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 this 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 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

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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.

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– 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.

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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
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 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 following 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, definition 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, definition 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]

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– 8 – TR 61289 © IEC:2011(E)


2.4

ACTIVE ELECTRODE

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 HF 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 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 201.3.207]
2.9
BIPOLAR
HF output current to a patient via multiple-pole ACTIVE ELECTRODES
method of applying
[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 may 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 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,
except MONITORING NE, providing an alarm in the event of electrical discontinuity in the NE
cable or its connections

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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 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, definition 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 surgical application electrodes, including cords and connectors
for attachment to HF SURGICAL EQUIPMENT, as well as other associated equipment intended for connection to the HF
surgical patient circuit.
[SOURCE: IEC 60601-2-2:2009, definition 201.3.221]
2.18
HIGH FREQUENCY SURGICAL EQUIPMENT (HF SURGICAL EQUIPMENT)
MEDICAL ELECTRICAL EQUIPMENT, including its associated ACCESSORIES, intended for the
performance of surgical operations such as the CUTTING and COAGULATION of biological tissue
by means of HIGH FREQUENCY (HF) currents

[SOURCE: IEC 60601-2-2:2009, definition 201.3.222]
2.19
HF SURGICAL MODE
OPERATOR selectable HF output characteristics intended to provide a
any of a number of
specific indicated surgical effect at a connected ACTIVE ACCESSORY, such as CUTTING,
COAGULATION and the like
[SOURCE: IEC 60601-2-2:2009, definition 201.3.223]
2.20
LEAKAGE CURRENT
current that is not functional
[SOURCE: IEC 60601-1:2005, definition 3.47]

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2.21

MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT)

electrical equipment having an APPLIED PART or transferring energy to or from the patient or

detecting such energy transfer to or from the patient and which is:


− provided with not more than one connection to a particular supply mains; and

− intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a

patient; or for compensation or alleviation of disease, injury or disability


Note to entry: ME EQUIPMENT includes those ACCESSORIES as defined by the manufacturer that are necessary to

enable the normal use of the ME EQUIPMENT.

[SOURCE: IEC 60601-1:2005, definition 3.63]
2.22
MONITORING NE
NE intended for use with a CONTACT QUALITY MONITOR
[SOURCE: IEC 60601-2-2:2009, definition 201.3.225]
2.23
MONOPOLAR
method of applying HF output current to a patient via an ACTIVE ELECTRODE and returning via a
separately-connected NE or via the patient’S body capacitance to earth
[SOURCE: IEC 60601-2-2:2009, definition 201.3.226]
2.24
NEUTRAL ELECTRODE (NE)
electrode of a relatively large area for connection to the body of the patient, intended to
provide a return path for the HIGH FREQUENCY current with such a low current density in the
body tissue that physical effects such as unwanted burns are avoided
Note to entry: The NEUTRAL ELECTRODE is also known as plate, plate electrode, passive, return or dispersive
electrode,
[SOURCE: IEC 60601-2-2:2009, definition 201.3.227]
2.25
OPERATOR
person handling equipment
[SOURCE: IEC 60601-1:2005, definition 3.73]
2.26
RATED LOAD

value of non-reactive load resistance which, when connected, results in the maximum HF
output power from each HF SURGICAL MODE of the HF SURGICAL EQUIPMENT
[SOURCE: IEC 60601-2-2:2009, definition 201.3.229]
2.27
RATED OUTPUT POWER
for each HF SURGICAL MODE set at its maximum output setting, the power in watts produced
ACTIVE OUTPUT TERMINALS which can be activated simultaneously are connected to
when all
their respective RATED LOADs
[SOURCE: IEC 60601-2-2:2009, definition 201.3.230]

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TR 61289 © IEC:2011(E) – 11 –


2.28

SWITCH SENSOR

part of HF SURGICAL EQUIPMENT or ASSOCIATED EQUIPMENT which controls activation of HF output

in response to operation of a connected FINGERSWITCH or footswitch


[SOURCE: IEC 60601-2-2:2009, definition 201.3.231]


3 General information regarding HF SURGICAL EQUIPMENT


HF SURGICAL EQUIPMENT is MEDICAL ELECTRICAL EQUIPMENT which delivers HIGH FREQUENCY

currents to perform surgical modification of tissue. The most common forms of tissue

modification are CUTTING and COAGULATION but may also include tissue ablation, lesioning,
shrinkage, sealing or fusion.
The current is conducted to and from the patient in the following ways:
MONOPOLAR application with an ACTIVE ELECTRODE of a small area and a large NEUTRAL
– in
ELECTRODE;
– in MONOPOLAR application of HF SURGICAL EQUIPMENT with a RATED OUTPUT POWER less than
50 W and not provided with a NEUTRAL ELECTRODE, the circuit for the HIGH FREQUENCY
current being completed through the capacitive coupling between the patient and the
earthed environment;
– in BIPOLAR application with a BIPOLAR electrode only, for example forceps where the legs
are electrically insulated from each other;
– in multipolar application where a multitude of ACTIVE ELECTRODES are present. In this type
of application the current passes from one or more of the ACTIVE ELECTRODES to either a
large NEUTRAL ELECTRODE in a MONOPOLAR-like arrangement or to one or more small area
electrodes in the immediate vicinity in a BIPOLAR-like arrangement;
– in an application where the current delivery is augmented by the use of argon or saline
between the ACTIVE ELECTRODE(S) and the target tissue.
The output power may vary considerably depending on the intended use, from a few watts for
special procedures, for example in ophthalmology, up to 300 W or more for some equipment.
The peak output voltage from some equipment may be as high as 6 000 V.
The use of HIGH FREQUENCY (HF) current is a possible HAZARD to the patient, the OPERATOR and
other personnel present and to the surroundings. Other equipment connected to the patient
may be affected. The safe operation of HIGH FREQUENCY SURGICAL EQUIPMENT depends mainly
on the following factors:
– safe use, which depends on:

• OPERATOR's knowledge of the safe methods of use of the equipment,
• OPERATOR's knowledge of safety characteristics of the equipment,
• availability and readability of accompanying documents;
– safety of the equipment;
– an effective maintenance scheme;
– safety of the installation;
4 Recommended practices
4.1 Inspection of HF SURGICAL EQUIPMENT before use
Before surgery the OPERATOR should check the HF SURGICAL EQUIPMENT and ACTIVE
ACCESSORIES as listed below.

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– 12 – TR 61289 © IEC:2011(E)


– Inspect the mains plug, connectors and cables, including handles for ACTIVE ACCESSORIES

and any reusable NEUTRAL ELECTRODES, for visible damage. If damaged, do not use.

Damaged instruments or cords may lead to injury to the patient or OPERATOR.

– Check that ACTIVE ACCESSORIES and NEUTRAL ELECTRODES are compatible with the HF

SURGICAL EQUIPMENT, the output modes that will be used and the output power settings

that will be used.

– Check that the EQUIPMENT has no visible damage including that warning signs and other

markings on the EQUIPMENT are readable.


– Check that all indicating lamps and audible tones are in working order.

– Check to verify that the circuits and/or systems associated with CONTINUITY MONITORS or

CONTACT QUALITY MONITORS used with NEUTRAL ELECTRODES are operating correctly.
WARNING: Do not try to test the HF SURGICAL EQUIPMENT by sparking against metal parts or
the NEUTRAL ELECTRODE.
4.2 Preparation
Before application of the NEUTRAL ELECTRODE, check the positioning of the patient.
– The patient, including his/her extremities, must be isolated from earthed metal parts.
– Skin-to-skin contact (for example between the arms and body of the patient) should be
avoided, for example by insertion of a dry towel.
– The use of flammable anaesthetics or oxidizing gases such as nitrous oxide (N O) and
2
oxygen should be avoided if a surgical procedure is carried out in the region of the thorax
or the head, unless these agents are suctioned or scavenged away.
– Non-flammable agents should be used for cleaning and disinfection wherever possible.
Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should
be allowed to evaporate before the application of HF surgery. There is a risk of pooling of
flammable solutions under the patient or in body depressions such as the umbilicus, and
in body cavities such as the vagina. Any fluid pooled in these areas should be removed
and the area dried before HF SURGICAL EQUIPMENT is used. Attention should be called to
the danger of ignition of endogenous gases. Some materials, for example cotton, wool and
gauze, when saturated with oxygen may be ignited by sparks produced in normal use of
the HF SURGICAL EQUIPMENT.
4.3 Handling of NEUTRAL ELECTRODES, cables and connections
Electrodes and connections must be placed with care. Special attention must be paid to the
following.
– The entire area of NEUTRAL ELECTRODES should be reliably in contact with the patient's
body.
– When HF SURGICAL EQUIPMENT and physiological monitoring equipment are used
simultaneously on the same patient, any monitoring electrodes should be placed as far as
possible from the ACTIVE ELECTRODES. Needle monitoring electrodes are not
recommended. In all cases, monitoring systems incorporating HIGH FREQUENCY current
limiting devices are recommended.
– The HF SURGICAL EQUIPMENT leads should be positioned in such a way that contact with the
patient monitoring or other leads is avoided.
– Temporarily unused ACTIVE ELECTRODES should be stored in a non-conductive location that
is isolated from the patient for example in a holster or quiver.
– The selection of ACTIVE ACCESSORIES should take into account their compatibility with HF
SURGICAL EQUIPMENT.
4.4 Patients with active implants (implantable electronic medical devices)
Patients with active implants, for example pacemakers, implantable neurostimulators or
implanted electrodes, may be affected by the application of HF SURGICAL EQUIPMENT. The

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TR 61289 © IEC:2011(E) – 13 –


effects could be irreparable damage to the active implant or impairment of its function. The

manufacturer of the active implant should be consulted prior to the surgery. Simultaneous

monitoring of such patients using suitable monitoring equipment is also recommended.


NOTE Currents induced in the implanted electrodes due to the use of HF SURGICAL EQUIPMENT may cause

irreversible changes in the tissue around the electrodes, causing malfunctioning of the implant.

The following guidelines should be taken into account.


– The selected output power should be as lo
...