STIHLER ELECTRONIC ASTOPAD, Инструкция по эксплуатации

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ASTOPAD
®
Instructions for Use
55
15 Conformity with international standards
Standard Title
IEC/EN 60601-1
ANSI/AAMI ES
60601-1
CAN/CSA C22.2
No. 60601-1
Medical electrical equipment – Part 1: General
requirements for basic safety, including essential
performance
IEC/EN 60601-1-2
Medical electrical equipment – Part 1-2: General
requirements for basic safety, including
essential performance – Supplementary standard:
Electromagnetic compatibility – Requirements
and tests
IEC/EN 60601-1-8
(applicable parts)
Medical electrical equipment – Part 1-8: General
requirements for basic safety, including
essential performance – Supplementary standard:
Alarm systems – General requirements, tests, and
guidance for alarm systems in medical electrical
equipment and medical electrical systems
IEC/EN 80601-2-35
Medical electrical equipment Part - 2-35: Particular
requirements for basic safety and essential
performance of heating devices using blankets, pads,
or mattresses and intended for heating in medical use
IEC/EN 60601-1-6
(IEC/EN 62366)
Medical electrical equipment - Part 1-6:
General requirements for basic safety and essential
performance - Collateral Standard: Usability
Definitions according to IEC/EN 80601-2-35:
Term Definition
ASTOPAD
applied parts
Over-blanket
Blanket designed to be used over
a patient
COV070/COV105/
COV150/COV155/
COV180
Under-blanket
Blanket designed to be used un-
der a patient COV070/COV105/
COV150/COV180