Cochlear Baha 5 SuperPower Manual Del Usuario página 14

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
14
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-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
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.
5 SUP.
®