Cochlear Baha 5 SuperPower Manual Del Usuario página 2

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
The Cochlear Baha 5 SuperPower 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 65 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
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
5 SUP.
®