Cochlear Baha 5 Sound Processor, Руководство пользователя

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• 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.
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
Warnings
General advice
A sound processor will not restore normal
hearing and will not prevent or improve a hearing
impairment resulting from organic conditions.
• Infrequent use of a sound processor may not
enable a user to attain full benefit from it.
• The use of a sound processor is only part of
hearing rehabilitation and may need to be
supplemented by auditory and lip reading
training.
Warnings
• The sound processor is a digital, electrical,
medical instrument designed for specific use. As
such, due care and attention must be exercised
by the user at all times.
• The sound processor is not waterproof!
• Never wear it in heavy rain, in the bath or
shower!
• Do not expose the sound processor to extreme
temperatures. It is designed to operate
within the temperature 5 °C (+41 °F)
to +40 °C (+104 °F). In particular, battery
performance deteriorates in temperatures
under +5 °C. The processor should
not be subjected, at any time,
to temperatures below -20 °C
(-4 °F) or above +50 °C
(+122 °F).
• Contains small parts that
may present a choking
hazard.
• Adult supervision is recommended when the
user is a child
• This product is not suitable for use in flammable
and/or explosive environments.
• The sound processor and other external
accessories should never be brought into a
room with an MRI machine, as damage to the
sound processor or the MRI equipment could
occur.
• The sound processor must be removed before
entering a room where an MRI scanner is
located.
• If you are to undergo an MRI (Magnetic
Resonance Imaging) procedure, refer to the MRI
Reference Card included in the document pack.
• Portable and mobile RF (radio frequency)
communications equipment can affect the
performance of your sound processor.
• The sound processor is suitable for use in
electromagnetic environments with mains
power of typical commercial or hospital quality,
and power frequency magnetic fields of typical
commercial or hospital levels. It is intended
for use in an electromagnetic environment
in which radiated RF (radio frequency)
disturbances are controlled.
• Interference may occur in the
vicinity of equipment with the
symbol to the right.
• Dispose of batteries and electronic
items in accordance with your local regulations.
• Discard your device as electronic waste
according to local regulations.
• When the wireless function is activated, the
sound processor uses low-powered digitally
coded transmissions in order to communicate
with other wireless devices. Although unlikely,
nearby electronic devices may be affected. In
that case, move the sound processor away from
the affected electronic device.
• When using wireless functionality and the
sound processor is affected by electromagnetic
interference, move away from the source of this
interference.
• Be sure to deactivate wireless functionality
when boarding flights.
• Turn off your wireless functionality by using
the flight mode in areas where radio frequency
emission is prohibited.
• 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.
-20 °C
(-4 °F)
+50 °C
(+122 °F)