Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics M Zn-Air CI-5501 Gebrauchsanweisung

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 Zn-Air Battery Pak. 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 Zn-Air Battery Pak and to troubleshoot problems.

Limitations and Contraindications

As the M Zn-Air Battery Pak is a component 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.
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 Zn-Air Battery Pak or battery cells.
Do not allow children to place the M Zn-Air Battery Pak
•
or battery cells in the mouth or nose.
Do not connect the M Zn-Air Battery Pak to the M
•
Battery Charger. The charger is to be used with the
rechargeable M Batteries only.
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