Cochlear Baha 5 SuperPower User Manual page 13

Sound processor
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Sound processor type designations for models
included in this User Manual are:
FCC ID: QZ3BAHA5SUP, IC: 8039C-BAHA5SUP, IC model:
Baha
5 SUP.
®
Statement:
This device complies with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) this device may not cause harmful interference, and
(2) this device must accept any interference received,
including interference that may cause undesired
operation.
Note: This equipment has been tested and found to
comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful
interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio
communications. However, there is no guarantee that
interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio
or television reception, which can be determined by
turning the equipment off and on, the user is encouraged
to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and
receiver.
• Connect the equipment into an outlet on a circuit
different from the one in which the receiver is
connected.
• Consult the dealer or an experienced radio/TV
technician for help.
• Changes or modifications can void the user's authority
to operate the equipment.
Intended use
Baha
5 SuperPower Sound Processor
The Cochlear
®
(Baha 5 SUP) uses bone conduction to transmit sounds
to the cochlea (inner ear). It works by combining a sound
processor and a small titanium implant that is placed
in the skull behind the ear. The skull bone integrates
with the titanium implant through a process called
osseointegration. This allows sound to be conducted via
the skull bone directly to the cochlea, which improves
hearing performance.
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
1999/5/EC (R&TTE). 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-BAHA5SUP
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
English
5 SUP.
®
13

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