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 Directive
2014/53/EU (RED).
• Other identified applicable
international regulatory requirements
in countries outside the EU and
US. Please refer to local country
requirements for these areas.
• In Canada the Sound Processor
is certified under the following
certification number:
IC: 8039C-BAHA5POWER
and model no.:
IC model: Baha
®
5 Power.
• This device complies with Industry
Canada licence-exempt RSS
standard(s).
• This Class B digital apparatus
complies with Canadian ICES-003. Cet
appareil numérique de la classe B est
conforme à la norme NMB-003 du
Canada.
• Operation is subject to the following
two conditions: (1) this device may
not cause interference, and
(2) this device must accept any
interference, including interference
that may cause undesired operation of
the device. L’exploitation est autorisée
aux deux conditions suivantes :
(1) l’appareil ne doit pas produire
de brouillage, et (2) l’utilisateur de
l’appareil doit accepter tout brouillage
radioélectrique subi, même si le
brouillage est susceptible d’en
compromettre le fonctionnement.
Equipment includes RF transmitter.
NOTE:
The sound processor is suited for use
in a home healthcare environment.
The home healthcare environment
includes locations such as homes,
schools, churches, restaurants,
hotels, cars, and airplanes, where
equipment and systems are less likely
to be administered by healthcare
professionals.
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