Össur POWER KNEE PKA01, Инструкция по эксплуатации

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LIABILITY
Össur does not assume liability for the following:
• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or environment.
Compliance
The device has been designed and tested according to the applicable international standards or in-house defined
standards when no international standard exists or applies.
The device complies with Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic equipment (ROHS3).
The device complies with Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on
the making available on the market of radio equipment.
This device has been tested according to ISO 10328 standard to three million load cycles.
The load level specification is ISO10328 - P5 - 116 kg
ISO - “P” - “m”kg *)
*)
Body mass limit not to be exceeded!
see manufacturer’s written instructions on
intended use!
SYMBOLS
Symbol Description
Medical Device
Caution Symbol
Type B Applied Part
Consult instructions for use
Device contains electronic components and/or batteries that should not be disposed of in
regular waste
Serial number
Year of manufacture
Model number
See operating instructions
Fragile, handle with care