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Compex Sport - Compliance Standards; Understanding Device Symbols

Compex Sport
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36
IX. Practical Information
Standards
The
Compex® Sport
is manufactured in conformity with quality
standards ISO 9001, ISO 13845. According to IEC 60601-1, the
Compex® Sport
is a class II device unit with its own internal
electric power, with type BF applied parts. It is in conformity with
IEC 60601-1-2 requirements about electromagnetic compatibility and
IEC 60601-1 about medical electrical devices.
To guarantee your safety, the design, manufacture and
distribution of the
Compex® Sport
are in accordance with
the requirements of the European directive 93/42/CEE.
Normalized Symbols
IMPORTANT: Under some conditions, the effective
figure for the stimulation pulses can exceed 10 mA and
10 V. The information given in this handbook must be
strictly observed.
The
Compex® Sport
is a class II device unit with its
own internal electric power, with type BF applied
sections.
The “On/Off” switch is a multi-function key.
Functions
Symbol
(According to IEC 878)
On/Off (2 positions, stable) 01-03
Waiting or preparation for part of the unit 01-06
Stop (switching off) 01-10
SpUS Manuel EN:SpUS Manuel EN 31/01/08 15:59 Page 36

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