User Manual

Intended use

Generic air-conduction hearing instruments are wearable sound-amplifying devices intended to compen-

sate 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.

Specifcation 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 Directive

93/42/EEC for medical devices (MDD) and essential requirements and other relevant provisions of Direc-

tive 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 identif ed applicable international regulatory requirements in countries outside EU and US. Please

refer to local country requirements for these areas.

• Products are categorized as receiver category 2 according to EN 300 440

• In CA: This class B digital apparatus complies with the Canadian ICES-003.

Cet appareil numerique de la classe B est cinforme a la norme NMB-003 du Canada.

• In JP: This device has been granted a designation number by Ministry of Internal Affairs and Communications

under ´´Ordinance concerning Technical Regulations Conformity Certification etc. of Specified Radio Equipment

( )´´ Article 2-1-xx ´´This device should not be modified

(otherwise the granted designation number will be invalid)´´

400144000-GB-12.06-Rev.B.indd 2

01-06-2012 13:57:53