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Advanced Bionics CI-5551 - Purpose and Scope of Ifu; Limitations and Contraindications; Precautions, Cautions, and Warnings

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5
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 Batteries and M Battery Charger. 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 Batteries and M Battery
Charger and to troubleshoot problems.
Limitations and Contraindications
As the M Batteries and M Battery Charger are components
of the HiResolution
Bionic Ear System, 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.
It is recommended that you charge the M Batteries
fully prior to first use, as M Batteries shipped from
Advanced Bionics are not fully charged.
The M Battery Charger comes with a power supply
designed for the specifications of the M Battery
Charger. Do not use any other power supply unless
it is supplied by Advanced Bionics. If needed, call
Advanced Bionics for a power supply replacement.

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