Safety Issues; Manufacturer Responsibility; Ymbols; Noahlink Symbols - Himsa NOAHlink Manual Del Usuario

NOAHlink Users Manual

2.1 Manufacturer Responsibility

The manufacturer is to be considered responsible for effects on
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

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

the equipment is used in accordance with the instructions for use
2.2 Symbols

2.2.1 NOAHlink Symbols

SYMBOL
NOAHlink carries this symbol to indicate compliance with Type BF
of EN 60601-1.
NOAHlink carries this symbol when it is important that 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.
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.
NOAHlink carries this symbol to identify the positioning of the
battery inside the battery compartment.
NOAHlink carries this symbol to indicate that, in France, it is only
permitted to use the device indoors.
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2 Safety Issues

DESCRIPTION