GN Otometrics A/S 1010 Manuel D’Utilisation
NOAHlink Users Manual
7
3 Safety Issues
3.1 Manufacturer Responsibility
The manufacturer is to be considered responsible for effects on
safety, reliability, and performance of the equipment ONLY IF:
safety, reliability, and performance of the equipment ONLY IF:
all assembly operations, extensions, re-adjustments,
modifications or repairs are carried out by the equipment
manufacturer or personnel authorized by the manufacturer
manufacturer or personnel authorized by the manufacturer
the electrical installation to which the equipment is connected
complies with EN/IEC requirements
the programming cable and connection to the hearing
instrument comply with the requirements in Section B.1.3 –
Patient Safety
Patient Safety
the equipment is used in accordance with the instructions for use
3.2 Symbols
3.2.1 NOAHlink Symbols
SYMBOL DESCRIPTION
NOAHlink carries this symbol to indicate compliance with
Type BF of EN 60601-1.
Type BF of EN 60601-1.
NOAHlink carries this symbol when it is important that
the user refer to associated warnings in this guide.
the user refer to associated warnings in this guide.
NOAHlink and this manual are CE-marked according to
the Medical Devices Directive 93/42/EEC.
the Medical Devices Directive 93/42/EEC.
Classified with respect to electrical shock, fire, mechanical
and other specified hazards in accordance with UL2601-1
and CAN/CSA-C22.2 NO 601.1-90.
and other specified hazards in accordance with UL2601-1
and CAN/CSA-C22.2 NO 601.1-90.
NOAHlink carries this symbol to identify the positioning
of the battery inside the battery compartment.
of the battery inside the battery compartment.