Advanced Bionics M WEARING CLIP Bedienungsanleitung

M WEARING CLIP, M SNUGGIE™, AND

M RETENTION CUFF

CI-7322, CI-7325, CI-7326

instructions for use

English, Français, Español, Deutsch, Nederlands, Italiano

Contents

PURPOSE AND SCOPE OF IFU 5

LIMITATIONS AND CONTRAINDICATIONS 5

PRECAUTIONS, CAUTIONS, AND WARNINGS 5

UNDESIRABLE SIDE EFFECTS 6

PRODUCT DESCRIPTION 6

INDICATIONS FOR USE 8

INTENDED PURPOSE 9

Intended Users 10

Intended Use Environment 10

COMPATIBILITY 11

OPERATING INSTRUCTIONS 11

M Wearing Clip 11

M Snuggie 13

M Retention Cu 14

CARE AND MAINTENANCE 16

Storing the M Wearing Clip, M Snuggie,

and MRetention Cu 16

Recommended Operating, Storage Temperature,

and Humidity Ranges 17

Expected Life 17

Cleaning and Maintenance 17

DISPOSAL AND HAZARDOUS MATERIALS 17

AVAILABLE PRODUCT OPTIONS AND

MODEL NUMBERS 18

CLINICAL BENEFITS 18

SYMBOLS TABLE

Labeling symbols and their meanings

European Community Mark of Conformity.

Date of Manufacture

Manufacturer

Model number

LOT number

European authorized representative

Unique Device Identiﬁer

Suitable temperature range for transport

and storage

See Instructions for Use

Fragile

Suitable relative humidity range for transport

and storage

XXXX-XX-XX

Caution (refer to “Cautions & Warnings”

section for further information)

MR Unsafe

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 Wearing Clip, M Snuggie, and

MRetention Cu. 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Wearing Clip, M Snuggie, and M Retention Cu and to

troubleshoot problems.

Limitations and Contraindications

As the M Wearing Clip, M Snuggie, and M Retention Cu

are components of the HiResolutionTM 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 Wearing Clip, M Snuggie,

orMRetention Cu.

• Do not allow children to place the M Wearing Clip,

MSnuggie, or M Retention Cu in the mouth.

• In the event that you experience any issues with

your product, please contact your cochlear implant

professional or the manufacturer. Do not attempt to

service or modify the Naída CI 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.

Undesirable Side Effects

Undesirable side eects of your Naída CI M or Sky CI

M system may include skin irritation and discomfort

from pressure on the ear, device overheating, or overly

loudsounds.

Product Description

The M Wearing Clip holds the sound processor and

features a clip that can be attached to clothing, hair,

orinthe preferred wearing location.

Sound Processor

Enclosure

Latch

The M Snuggie has ﬂexible rings that secure the sound

processor to a band that can be secured around the ear.

Earhook Ring

Sound Processor

and Battery Bands

Band

The M Retention Cu holds the sound processor and

features a bendable wire that can be formed around

theear. The M Retention Cu is available in two sizes:

small and large.

Plastic Casing

Retention Wire

Small Large

INDICATIONS FOR USE

The M Wearing Clip, M Snuggie, and M RetentionCu

are an external component of the HiResolutionTM

BionicEar System, which is intended to restore a level of

auditory sensation to individuals with severe-to-profound

sensorineural hearing loss via electrical stimulation of

theauditory nerve.

Adults

• 18 years of age or older.

• Severe-to-profound bilateral sensorineural hearing loss

or severe-to-profound unilateral hearing loss.

• Post-lingual onset of severe or profound hearing loss.

• Limited beneﬁt from appropriately ﬁtted hearing aids,

deﬁned as scoring 50% or less on a test of open-set

sentence recognition (HINT Sentences).

Children

• 12 months through 17 years of age.

• Severe-to-profound bilateral sensorineural deafness or

severe-to-profound unilateral hearing loss.

• Use of appropriately ﬁtted hearing aids for at least

6months in children 2 through 17 years of age, or at

least 3 months in children 12 through 23 months of age.

The minimum duration of hearing aid use is waived if

x-rays indicate ossiﬁcation of the cochlea.

• Little or no beneﬁt from appropriately ﬁtted hearing

aids. In younger children (< 4 years of age), lack of

beneﬁt is deﬁned as a failure to reach developmentally

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