Purpose And Scope Of Ifu; Limitations And Contraindications; Precautions, Cautions, And Warnings - Advanced Bionics M Listening Check CI-5827 Instrucciones De Uso

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 Listening Check. 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 Listening Check and to troubleshoot problems.

Limitations and Contraindications

As the M Listening Check 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

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 Listening Check.
Do not allow children to place the M Listening Check
•
in the mouth.
Do not attempt to service or modify the Naída CI M,
•
Sky CI M, or its accessories. Doing so may compromise
system performance and will void the manufacturer's
warranty. Products should be serviced only at
Advanced Bionics and damaged products should
be returned to Advanced Bionics.
TM
5