Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics CI-7322 Manual Del Usuario

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
5