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AAMI TIR61289 2011

$93.55

AAMI/IEC TIR61289:2011 – High frequency surgical equipment – Operation and maintenance

Published By Publication Date Number of Pages
AAMI 2011 36
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This technical report contains guidelines for medical and nursing personnel regarding the safe and effective operation of high frequency surgical equipment. This report will be of use to scientific/technical staff who may have responsibility for the maintenance of this equipment. This report deals with the safe operation of the high frequency surgical equipment, including the requirements outlined in ANSI/AAMI/IEC 60601-2-2:2009.

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PDF Pages PDF Title
1 ANSI/AAMI/IEC TIR61289:2011, High frequency surgical equipment – Operation and maintenance
3 Title page
4 Copyright information
5 AAMI Technical Information Report

ANSI Technical Report
7 Contents
9 Glossary of equivalent standards
11 Committee representation
12 Background of ANSI/AAMI adoption of IEC/TR 61289:2011
13 Foreword
15 Introduction
17 1 Scope

2 Terms and definitions
21 3 General information regarding HF
surgical equipment
22 4 Recommended practices
4.1 Inspection of HF
surgical equipment before use
4.2 Preparation
23 4.3 Handling of neutral electrodes, cables and connections
4.4 Patients with active implants (implantable electronic medical devices)
4.5 Simultaneous use of two items of HF
surgical equipment
24 5 Recommended practices during use
6 Recommended practices after use
7 Nature of hazards
7.1 General
25 7.2 HF
surgical equipment related hazards
7.2.1 Incompatible combinations
7.2.2 Electromagnetic compatibility
7.2.3 Misconnection of active accessories
7.2.4 Specialty HF
surgical equipment
7.3 Active accessory- related hazards
7.3.1 Incompatible combinations
26 7.3.2 Environment of use
7.3.3 Misuse
27 7.4 Operator-related hazards
7.4.1 Operator not reading and/or following the instructions for use
7.4.2 Operator selecting inappropriate power or mode settings
7.4.3 Operator using an active accessory in an inappropriate manner
7.5 Neutral electrode-related hazards
7.5.1 General
28 7.5.2 Inadequate contact area of a neutral electrode
7.5.3 Inappropriate application
7.5.4 Surgical procedures utilizing high currents and/or long duty cycles
7.5.4.1 General considerations
7.5.4.2 High current risk identification
29 7.5.4.3 High current risk mitigation
31 8 Safety provisions of, and symbols on, HF
surgical equipment
8.1 General
8.2 Colors of indicator lights
8.3 Markings on HF
surgical electrical equipment
32 8.4 Protection against electric shock and burns
8.4.1 Method of protection
33 8.4.2 Degree of protection
8.4.2.1 Protection against mains frequency leakage currents
8.4.2.2 Protection against high frequency leakage currents
34 8.5 HF
surgical equipment not properly marked
8.6 Monitoring the effectiveness of the neutral electrode
8.7 Output indicators
9 Accompanying documents
10 Preventive maintenance
36 Bibliography
AAMI TIR61289 2011
$93.55