Intended Use - Cochlear Baha 5 Power Manual Del Usuario

• Cochlear Baha wireless devices include an RF
transmitter that operates in the range of
2.4 GHz–2.48 GHz.
• For wireless functionality, only use Cochlear
Wireless accessories. For further guidance
regarding e.g. 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 Power, 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.
CT scanners and diathermy systems
Potential disruption might occur due to
electromagnetic emissions, f you are to undergo a
CT scan (computed tomography) or have surgery
where diathermy is used. If this occurs, you should
turn off the sound processor.
Theft and metal detection systems and
Radio Frequency ID (RFID) systems:
Devices such as airport metal detectors,
commercial theft detection systems, and RFID
scanners may produce strong electromagnetic
fields. Some Baha users may experience a distorted
sound sensation when passing through or near one
of these devices. If this occurs, you should turn off
the sound processor when in the vicinity of one
of these devices. The materials used in the sound
processor may activate metal detection systems.
For this reason, you should carry the Security
Control MRI Information Card with you at all times.
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Electrostatic discharge
A discharge of static electricity can damage the
electrical components of the sound processor
or corrupt the program in the sound processor.
If static electricity is present (e.g. when putting
on or removing clothes over the head or getting
out of a vehicle), you should touch something
conductive (e.g. a metal door handle) before your
sound processor contacts any object or person.
Prior to engaging in activities that create extreme
electrostatic discharge, such as playing on plastic
slides, the sound processor should be removed.
If disruptions keep occurring, please contact your
clinician to resolve the issue.
Sound processor type designations for
models included in this User Manual are:
FCC ID: QZ3BAHA5POWER IC: 8039C-BAHA5POWER,
IC model: Baha® 5 Power.
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 device 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 device 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 the device does cause harmful
interference to radio or television reception, which can
be determined by turning the device 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 device and
receiver.
• Connect the device 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 device.

Intended use

The Cochlear Baha System uses bone conduction to
transmit sounds to the cochlea (inner ear) with the
purpose of enhancing hearing. The Baha 5 Power Sound
Processor is intended to be used as part of the Cochlear
Baha System to pick up surrounding sound and transfer
it to the skull bone via a Baha Implant, Baha Softband or
Baha SoundArc and can be used unilaterally or bilaterally.
Indications
The Baha System is indicated for patients with conductive
hearing loss, mixed hearing loss and single-sided
sensorineural deafness (SSD). The Baha 5 Power Sound
Processor is indicated for patients with up to 55 dB SNHL.
Clinical benefit
Most recipients of a bone conduction hearing solution will
experience improved hearing performance and quality of
life compared to unaided listening.
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).
• 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-BAHA5POWER and model no.:
IC model: Baha® 5 Power.
• 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.
English
• 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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