Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics CI-7322 Manuel D'instructions

PURPOSE AND SCOPE OF IFU

This IFU is designed to help cochlear implant recipients,
and their caregivers if applicable, to understand the
use and care of the M Wearing Clip, M Snuggie, and
M Retention Cuff. It is also meant to be used by hearing
care professionals trained in the fitting of cochlear
implants to counsel the recipients on the use of the
M Wearing Clip, M Snuggie, and M Retention Cuff and to
troubleshoot problems.

Limitations and Contraindications

As the M Wearing Clip, M Snuggie, and M Retention Cuff
are components of the HiResolution
the following contraindications stated for the HiResolution
Bionic Ear System are applicable: Deafness due to lesions
of the acoustic nerve or central auditory pathway; cochlear
ossification that prevents electrode insertion; absence of
cochlear development.

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 Wearing Clip, M Snuggie,
or M Retention Cuff.
Do not allow children to place the M Wearing Clip,
•
M Snuggie, or M Retention Cuff in the mouth.
Bionic Ear System,
TM
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