Cochlear Baha 5 Manual Del Usuario página 8

sound to be conducted via the skull bone directly to the
cochlea, which improves hearing performance. The sound
processor can be used together with the Baha Softband.
The fitting is to be done either at a hospital, by an
audiologist, or in some countries, by a hearing care
professional.
List of countries:
Not all products are available in all markets. Product
availability is subject to regulatory approval in the
respective markets.
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). The declaration of conformity may
be consulted at www.cochlear.com.
• 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-BAHA5 and
model no.: IC model: Baha
• 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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