Advanced Bionics M T-Mic CI-5837 Manual de usuario

M T-Mic™ Microphone and M Earhooks

CI-5837, CI-5711

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 11

COMPATIBILITY 11

OPERATING INSTRUCTIONS 11

Connecting the M T-Mic or M Earhook to

thesoundprocessor 11

Removing the M T-Mic or M Earhook 14

Attaching the T-Mic cover 15

Removing the M T-Mic cover 16

CARE AND MAINTENANCE 17

Storing the M T-Mics and M-Earhooks 17

Cleaning and Maintenance 17

Recommended Operating, Storage Temperature,

andHumidity Ranges 18

Expected Life 18

Ingress Protection (IP) Ratings 18

DISPOSAL AND HAZARDOUS MATERIALS 19

AVAILABLE PRODUCT OPTIONS AND

MODEL NUMBERS 19

M T-Mic 19

M Earhook 20

Earhook Pin and Pin Tool 20

CLINICAL BENEFITS 20

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

MD Medical Device

Type of Protection: BF

Suitable temperature range for transport

and storage

See Instructions for Use

Fragile

XXXX-XX-XX

Do not get wet

Suitable relative humidity range for transport

and storage

Caution (refer to “Cautions & Warnings”

section for further information)

Dispose of in accordance with applicable

national and local regulations

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 T-Mic and M Earhooks. It is also meant to

be used by hearing care professionals trained in theﬁtting

of cochlear implants to counsel recipients on the use of

theM T-Mic and M Earhooks and to troubleshoot problems.

Limitations and Contraindications

As the M T-Mic and M Earhooks are a component 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 T-Mic or M Earhook.

• Do not allow children to place the M T-Mic or

M Earhook 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 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.

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 T-Mic is an attachment to the Advanced Bionics

Naída™ CI M and Sky CI™ M sound processors. TheM

T-Mic is a microphone which is designed to ﬁt at the natural

opening of the ear canal when the sound processor is worn

in a behind-the-ear conﬁguration. This enables access to cell

phones, consumer audio electronics, and assistive listening

devices. Sound from this microphone is sent to the Naída

CI M or Sky CI M sound processor. There are three sizes of

the M T-Mic to accommodate dierent ear sizes and shapes:

Small, Medium and Large.

Connector

Microphone

The M Earhooks serve to hold the sound processor on

theear when the microphone within the sound processor

is utilized. The M Earhooks are available in two sizes:

small and standard, each one with or without an additional

retention grip.

Earhook without Grip

Earhook with Grip

The connector pins and pin removal tool are also included.

Conector Pin

Pin Removal

Tool

INDICATIONS FOR USE

The M T-Mic and M Earhooks are an external component

of the HiResolution 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.

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