4
5
Intended use
Generic air-conduction hearing instruments are wearable sound-amplifying devices intended to
compensate for impaired hearing. The fundamental operating principle of hearing instruments is to
receive, amplify, and transfer sound to the ear drum of a hearing impaired person.
List of countries:
Products without wireless functionality are intended for worldwide sales.
Products with wireless functionality are intended for sale in countries within European Economic
Area as well as Switzerland.
Specication of restrictions: You are not allowed to operate the equipment within 20 km of the centre
of Ny Ålesund, Norway.
The products are in compliance with the following regulatory requirements:
• In EU: the device conforms to the Essential Requirements according to Annex I of Council Direc-
tive 93/42/EEC for medical devices (MDD) and essential requirements and other relevant provi-
sions of Directive 1999/5/EC (R&TTE).
The declaration of conformity may be consulted at www.resound.com
• In US: FCC CFR 47 Part 15, subpart C, section 15.249
• Other identied applicable international regulatory requirements in countries outside EU and US.
Please refer to local country requirements for these areas.
• Products are categorized as class 2 receiver according to EN 300 440
Komentarze do niniejszej Instrukcji