Cochlear Nucleus CR110 Guía de usuario descargar pdf (Pagina 95)

Certiﬁ cation and applied standards

The CP810 sound processor fulﬁ ls the essential requirements listed in

Annex 1 of the EC directive 90/385/EEC on Active Implantable Medical

Devices as last amended by EC Directive 2007/47/EEC. It was approved

for CE-Mark according to Annex 2 by Notiﬁ ed Body 0197 in 2009.

Equipment classiﬁ cation

Your processor is internally powered equipment Type B as described

in the international standard IEC 60601-1:1988 + A1:1991 + A2:1995 -

Medical Electrical Equipment Part 1: General Requirements for Safety.

IP rating of processor

The IP rating of your processor is as described in the section Caring for

your processor.

FCC (Federal Communications Commission) and

Canadian IC compliance

This device complies with part 15 of the FCC Rules and with RSS-210 of

Industry Canada. Operation is subject to the following two conditions:

This device may not cause harmful interference.•

This device must accept any interference received, including •

interference that may cause undesired operation.

Changes or modiﬁ cations made to this equipment not expressly

approved by Cochlear Limited may void the FCC authorization to

operate this equipment.

This equipment has been tested and found to comply with the limits

for a Class B digital device, pursuant to Part 15 of the FCC Rules. These

limits are designed to provide reasonable protection against harmful

interference in a residential installation. This equipment generates, uses

and can radiate radio frequency energy and, if not installed and used

in accordance with the instructions, may cause harmful interference

to radio communications. However, there is no guarantee that

interference will not occur in a particular installation. If this equipment

Other Information

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Cochlear Nucleus CR110 Guía de usuario Pagina 95