Advanced Bionics CI-5851 Manuel utilisateur
M ACOUSTIC EARHOOK
CI-5851
instructions for use
English, Français, Español
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SYMBOLS TABLE
Labeling symbols and their meanings
Date of Manufacture
Manufacturer
Model number
LOT number
Unique Device Identifier
Type of Protection: BF
Suitable temperature range for transport
and storage
See Instructions for Use
Fragile
Do not get wet
Suitable relative humidity range for transport
and storage
XXXX-XX-XX
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Caution (refer to “Cautions & Warnings”
section for further information)
Dispose of in accordance with applicable
national and local regulations
MR Unsafe
Limitations and Contraindications
There are no known limitations or contraindications for the
M Acoustic Earhook.
Precautions, Cautions, and Warnings
• This device should be used only by the individual for
whom it is prescribed.
• CHOKING HAZARD: Contains small parts that pose
a hazard of inhalation, choking, or ingestion. If any
parts are swallowed or inhaled, consult a physician or
hospital immediately.
• Do not leave children unattended with or allow children
to play with the M Acoustic Earhook.
• Do not allow children to place the M Acoustic Earhook
in the mouth.
• The M Acoustic Earhook should only be used by the
intended recipient and not by any other individual.
• Exposure of the M Acoustic Earhook to high humidity,
sweat, or water could damage the speaker unit.
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• Placing the M Acoustic Earhook within close proximity
to the headpiece magnet may damage the M Acoustic
Earhook.
• Remove your sound processor and consult your
cochlear implant professional if uncomfortable sounds
are heard or in case of discomfort, pain or skin irritation.
• Do not use the M Acoustic Earhook unless the earwax
protection is properly seated and the appropriate dome
is attached.
• In the unlikely event that the dome or earwax protection
becomes dislodged in the ear canal, contact your
cochlear implant professional. Do not try to remove the
dome or earwax protection from your ear canal yourself.
• If you observe any changes in sound quality with the M
Acoustic Earhook, please contact Advanced Bionics or
your cochlear implant professional.
• In the event that you experience any issues with
your product, please contact your cochlear implant
professional or the manufacturer. Do not attempt to
service or modify the Naída CI or its accessories.
Doing so may compromise system performance and
will void the manufacturer’s warranty. Products should
be serviced only at Advanced Bionics and damaged
products should be returned to Advanced Bionics.
Undesireable Side Effects
Undesirable side eects of your Naída CI M or Sky CI M
system may include skin irritation and discomfort from
pressure on the ear, device overheating, or overly loud
sounds.
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Product Description
The M Acoustic Earhook is an attachment to the
Advanced Bionics Naída™ CI M90 and Sky CI™ M90
sound processors. The M Acoustic Earhook allows for
the addition of acoustic amplification to the electrical
stimulation traditionally produced by a cochlear implant.
From the sound processor connector, a cable extends to
the speaker unit that transfers sound inputs through the
sound outlet into the ear canal. There are 5 sizes of the M
Acoustic Earhook for right and left ears to accommodate
dierent ear sizes and shapes. Domes attach to
the speaker unit of the acoustic earhook to provide
acomfortable fit in the ear canal.
Sound
Processor
Connector
Speaker
Power DomeVented Dome
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The connector pins and pin removal tool are also included.
Conector Pin
Pin Removal
Tool
Intended Use
The M Acoustic Earhook coupled with the Naída CI M90
or Sky CI M90 sound processor is intended to provide
acoustic amplification and electrical stimulation to
Advance Bionics cochlear implant recipients.
The intended users of the M Acoustic Earhook are users
of the Naída CI M or Sky CI M Sound Processors. The
M Acoustic Earhook coupled with the Naída CI M90 or
Sky CI M90 sound processor is indicated for unilateral or
bilateral use in patients with aidable low frequency hearing
sensitivity and severe-to-profound sensorineural hearing
loss. The intended use environments of the M Acoustic
Earhook are healthcare and daily living environments.
Compatibility
The M Acoustic Earhook is compatible with Naída CI M90
and Sky CI M90 sound processors from Advanced Bionics.
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Operating Instructions
Before using the M Acoustic Earhook, you must ensure:
• A dome is attached to the sound outlet over top of
the earwax protection.
• The M Acoustic Earhook is connected to your sound
processor.
• Your cochlear implant professional has programmed
your sound processor for use with your M Acoustic
Earhook.
• The M Acoustic Earhook is not placed within close
proximity to the headpiece magnet, as the magnet
may damage the M Acoustic Earhook.
Removing and Attaching the Dome
Remove the dome from the speaker unit by holding the
speaker unit in one hand and the dome in the other. Pull
o the dome to remove.
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Attach the dome by holding the speaker unit in one hand
and the dome in the other.
Slide the dome over the speaker unit sound outlet. The
speaker unit and the dome should fit perfectly together.
For a more custom fit, the Phonak SlimTip is an optional
earpiece that may be used in place of the provided
dome. The SlimTip must be ordered from Phonak; it is
not provided with the M Acoustic Earhook. Contact your
cochlear implant professional for more details.
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Exchanging the Earwax Protection
The M Acoustic Earhook is equipped with an earwax
protection (CeruShield) to protect the speaker unit from
earwax damage. Check the earwax protection regularly
and exchange it if it looks dirty or if volume or sound
quality is reduced. The earwax protection should be
replaced every four to eight weeks. The earwax protection
should be discarded after use.
Remove the dome from the speaker unit and clean the
speaker unit with a lint-free cloth.
Gently rotate the CeruShield Disk in the direction indicated
by the arrows until a free opening appears under the trash
icon.
.
To remove used earwax protection, carefully insert the
speaker unit into the free opening (under trash icon) until
it clicks.
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