User Manual

Intended use
The Cochlear™ Baha
®
5 Sound Processor
uses bone conduction to transmit
sounds to the cochlea (inner ear). It is
indicated for people with conductive
hearing loss, mixed hearing loss and
single sided sensorineural deafness (SSD).
Furthermore it is indicated for bilateral
and paediatric recipients. Fitting range
up to 45 dB SNHL. 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. 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
®
5.
• 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.
pairing, please refer to the user guide
of the relevant Cochlear Wireless
accessory.
• No modification of this equipment is
allowed.
• Portable RF communications
equipment (including peripherals
such as antenna cables and external
antennas) should be used no closer
than 30 cm (12 in.) to any part of your
Baha 5, including cables specified
by the manufacturer. Otherwise,
degradation of the performance of
this equipment could result.
• Use of accessories, transducers and
cables other than those specified or
provided by Cochlear could result in
increased electromagnetic emissions
or decreased electromagnetic
immunity of this equipment and result
in improper operation.
Sound processor type designations for
models included in this User Manual
are:
FCC ID: QZ3BAHA5, IC: 8039C-BAHA5, IC
model: Baha
®
5.
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.
14 15
English