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 Waterproof Battery. It is also meant to
be used by hearing care professional trained in the fitting
of cochlear implants to counsel the recipients on the use
of the M Waterproof Battery and to troubleshoot problems.
Limitations and Contraindications
As the M Waterproof Battery is a component of the
HiResolution
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.
•
It is recommended that you charge the M Waterproof
Battery fully prior to first use, as the M Waterproof Battery
shipped from Advanced Bionics is not fully charged.
The M Waterproof Battery comes with a power supply
•
designed for the specifications of the M Waterproof
Battery. Do not use any other power supply unless
it is supplied by Advanced Bionics. If needed, call
Advanced Bionics for a power supply replacement.
•
The M Waterproof Battery and power supply should be
operated in an open area to ensure adequate airflow.
Bionic Ear System, the following
TM
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