Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics CI-5551 Instructions For Use Manual

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
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.
Bionic Ear System, the following
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