Advanced Bionics Sky CI M90 Manuel utilisateur

Sky CI™M90 Sound Processor

User Guide

English, Français, Español, Deutsch, Nederlands, Italiano

Symbols Table

Labeling symbols and their meanings:

European Community Mark of Conformity. Authorized to

ax the CE Mark in 2021

XXX-XX-XX

Date of Manufacture

Manufacturer

Model number

Serial number

LOT number

European authorized representative

Unique Device Identiﬁer

Medical Device

Type of Protection: BF

Suitable temperature range for transport and storage

See Instructions for Use

Fragile

Suitable relative humidity range for transport and storage

Caution (refer to “Cautions & Warnings” section for fur-

ther information)

Dispose of in accordance with applicable national and

local regulations

MR Unsafe

IPXX Ingress Protection Rating

0123

Table of Contents

Precautions, Cautions, and Warnings �� 3

Introduction�� 8

The Sky CI M90 Sound Processor �� 8

Compatibility Information �� 10

How to Use your Sky CI M90 Sound Processor �� 11

Information about Sky CI M90 Accessories�� 26

M Batteries and M Battery Charger�� 26

Slim HP, Slim HP Mic, and Slim HP AquaMic�� 28

M Zn Air Battery Pak �� 32

M Waterproof Battery �� 38

M Wearing Clip, M Snuggie, and M Retention Cu�� 45

M Listening Check�� 50

AB Remote Mobile Application �� 55

Caring for Sky CI M90 and Accessories�� 56

Disposing of Sky CI M90 and Accessories �� 57

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. Using your sound processor and

accessories contradictory to their intended use (e.g. mouthing,

chewing) may cause bodily harm. If any parts are swallowed or

inhaled, consult a physician or hospital immediately.

• Ensure appropriate supervision when child is wearing the Sky CI™

M90 sound processor and accessories. Do not allow children to play

with or leave them unattended with the sound processor or any of its

accessories.

• Power supplies and battery chargers should be operated in an

open area to ensure adequate airﬂow. While no injury cases have

resulted, components may become hot during normal use or a fault

condition. If the device’s temperature results in discomfort or pain

when touched, disconnect the power source and contact your local

Advanced Bionics representative.

• Do not use any other charger or power supply with the sound

processor or accessories unless it is supplied by Advanced Bionics.

If needed, please call Advanced Bionics for a power supply

replacement.

• Do not use accessories when they are plugged into power sources

such as wall outlets, or other power sources that are USB compatible

(e.g. laptops).

• Do not allow leaking battery ﬂuid to come into contact with skin,

mouth, or eyes.

• Do not expose batteries to heat (e.g., do not store in direct sunlight or

in a hot car).

• Remove batteries from your sound processor when they are drained

to prevent damage from possible leaking. If a battery shows visible

signs of leakage, dispose of it in accordance with local regulations.

• Do not dispose of batteries in ﬁre.

• Do not immerse M Batteries or the M Battery Charger directly in

water.

• Carry M Batteries in the carrying case provided or in a sealed plastic

bag. M Batteries can short circuit if they come into contact with

metallic objects such as coins or keys.

• High levels of static electricity may damage electronic components

of your sound processor or implant. Care should be taken to avoid

exposure of the system to static electricity.

• Do not attempt to pair your sound processor to any accessories while

driving or operating heavy machinery.

• Pair the sound processor to Bluetooth devices only in a secure

environment, such as at home or in the hearing care professional’s

oce.

• Unwanted paired Bluetooth devices can be overwritten by pairing

with authorized devices or can be deleted during ﬁtting by your

cochlear implant professional.

• Do not stream audio to your sound processor while driving or

operating heavy machinery.

• Attenuating ambient sounds or adjusting environmental balance

while streaming audio (either with the multifunction button or with the

mobile application) may compromise situational awareness.

• Use your sound processor for hands-free phone use only where

permitted by law and only when you will not be distracted from the

safe operation of your vehicle.

• Do not use your Advanced Bionics wireless accessories when

instructed not to use wireless electronic devices, such as on

airplanes.

• Remove your sound processor and headpiece before entering

a room where an MRI scanner is located and prior to having any

surgeries that involve electrocautery and diathermy.

• Remove your sound processor and consult your cochlear implant

professional if uncomfortable sounds are heard or in case of

discomfort, pain or skin irritation.

• If the sound processor or accessories become unusually hot or

warm, discontinue use immediately and contact Advanced Bionics or

your cochlear implant professional.

• Do not use a headpiece, magnet, or any associated part, that is

broken, damaged, or cracked.

• The color cap must be attached when the headpiece is in use.

• Due to increased risk of strangulation, do not use cables longer than

81cm (32”) with young children.

• The large Slim HP Color Cap is for use by recipients older than 3

years of age, as this color cap and the Slim HP magnet may become

displaced upon dropping.

• Do not remove or replace the Slim HP cable from the sound

processor or waterproof wearing solution while underwater. If the

cable becomes accidently detached during water use, remove the

headpiece and sound processor from the water and dry both devices

prior to re-connecting the cable to the sound processor.

• It is important to have the correct magnet strength, so you do not

experience discomfort or retention issues. If magnet strength is

insucient, the headpiece may fall o more than is acceptable.

If magnet strength is excessive, you may experience irritation or

discomfort. Consult your cochlear implant professional if there are

any concerns regarding magnet strength. If deemed appropriate, an

audiologist may change the strength of the magnet in the headpiece.

Do not change magnet strength unless under the direction of a

cochlear implant professional. If you experience any redness,

irritation, or discomfort, discontinue use of the headpiece immediately

and contact a cochlear implant professional. See the headpiece

instructions for use for additional information regarding adjustment of

headpiece magnet strength.

• Store additional headpieces away from items with magnetic strips

(e.g., credit cards, hotel room keys, etc.) as they may de-magnetize

cards.

• The magnetic ﬁeld created by the headpiece magnet may alter the

programming of magnetic shunts. Users of magnetic shunts should

consider o-the-shelf retention methods.

• The digitally-coded, inductive transmission technology used in this

device is extremely reliable and experiences virtually no interference

from other devices. It should be noted, however, that when operating

the device near a computer terminal or other strong electromagnetic

ﬁeld (e.g. RFID system, metal detectors, electromagnetic anti-theft

systems), it may be necessary to be at least 24” (60 cm) away to

ensure proper operation. If the Sky CI M90 sound processor does

not respond to the implant device because of an unusual ﬁeld

disturbance, move away from the disturbing ﬁeld.

• The Sky CI M90 sound processors and accessories should be used

in accordance with the electromagnetic compatibility information

provided in the Guidance and Manufacturer’s Declaration section of

your instructions for use document.

• Although electromagnetic emissions of your Sky CI M90 sound

processor and accessories have been conﬁrmed within safe limits,

some other devices could be sensitive to such emissions. If you

notice other devices do not behave as expected when your sound

processor is nearby, separate the devices.

• Portable and mobile radio frequency (RF) communications

equipment, including radios and cellular phones, may aect sound

quality of the Sky CI M90 sound processor and accessories; however,

there is no safety hazard associated with such equipment.

• Do not expose any part of the Sky CI M90 sound processors or

accessories to extreme heat, such as an oven, microwave, or hair

dryer.

• AutoSense Sky™ OS, Speech in Loud Noise, Fixed Directional mode,

UltraZoom, UltraZoom + SNR Boost, and Speech in 360 programs

may dampen sounds that are not in front of the recipient.

• Use of WindBlock, EchoBlock, SoundRelax, NoiseBlock, and/or

WhistleBlock may aect the quality of sound.

• Do not use any programs other than an o-ear program when utilizing

any o-ear wearing conﬁguration (e.g., in a clip, in the M Waterproof

Battery).

• NOTE: In the United States, Fixed Directional mode, StereoZoom,

UltraZoom, SoundRelax, NoiseBlock, WindBlock, and EchoBlock are

approved for use in pediatric recipients 6 years and above who are

1) able to complete objective speech perception testing in order to

determine speech performance and 2) able to report a preference for

dierent coding strategies or features.

• 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 Sky 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.

Electrostatic Discharge (ESD)

High levels of static electricity may damage electronic components

of your sound processor or implant. Care should be taken to avoid

exposure of the system to static electricity. ESD is present when you feel

a spark jump from your body or your hair stands on-end.

The following are examples of situations where high levels of

electrostatic charge may be created:

• Walking, crawling, or sliding on carpets.

• Sliding on plastic slides.

• Exiting an automobile.

• Pulling sweaters on and o.

• Touching TV or computer screens.

• Removing bedding materials.

To reduce the likelihood of electrostatic discharge damage:

• Touch a person or object with your ﬁngers prior to touching your or

your child’s headpiece, cable, or sound processor.

• Touch metal surfaces with your hand prior to allowing equipment to

contact the metal surface.

• This is particularly important on the playground where high levels of

static electricity can be generated. It is important to discharge any

static electricity by touching a metal surface with your hand prior

to allowing the sound processor, cable, or headpiece to come into

contact with the metal surface.

• Take care to avoid contact between your cochlear implant equipment

and metal surfaces when exiting a vehicle.

• Remove cochlear implant equipment prior to removing clothing that

may contain electric charge (e.g. sweaters).

• Do not touch TV or computer screens. If screens are touched, be

sure to touch an object other than your implant system to discharge

any charge build-up prior to touching any part of your implant

system.

• Use fabric softener on clothing and bedding.

Airport Security Metal Detectors

Metal detectors and security scanners, including full body scanners,

will not damage your implant system; however, metal detectors may be

activated as you pass through. To avoid hearing any unwanted sound

when walking through metal detectors or security scanners, you should

reduce the volume on the sound processor or remove your headpiece.

Ultrasonic Sensors

Ultrasonic sensors, sometimes used in lighting sensors and security

systems, will not damage your implant system; however, they may be

picked up by the headpiece microphone and lead to distorted sound

quality when you operate your sound processor in the immediate vicinity

of such a sensor. Additionally, if the ultrasonic sound is of a very high

intensity, the processor system microphone may become damaged. To

avoid hearing any unwanted sound, you should reduce the volume on

your sound processor or remove your headpiece when passing near an

ultrasonic sensor (e.g. in entrances to libraries).

X-Ray Machines

X-ray machines will not damage your sound processor or implant but

may damage your Sky CI M90 and headpiece microphones. Avoid

placing any system microphones in any checked or carry-on baggage

that is screened with X-ray. During airport security screenings, the

sound processor and microphone should be worn through the metal

detector or examined by hand.

Introduction

This user guide is designed to help recipients and caregivers

understand the use and care of the Sky CI M90 sound processor.

TheSky CI M90 sound processor, built on the Phonak Marvel platform,

features technologies exclusively available from Advanced Bionics

andPhonak designed for your best possible hearing experience.

The Sky CI M90 provides access to the latest sound processing and

connectivity innovations by Advanced Bionics. This guide will provide

all of the information needed to use and care for the Sky CI M90 and

its accessories. In addition, this guide will provide important safety

information. Please read the entire guide prior to using the Sky CI M90.

The Sky CI M90 Sound Processor

The Sky CI M90 sound processor is one part of a complete cochlear

implant system that enables hearing. The other necessary parts of

thesystem are the cochlear implant and headpiece (with cable).

The Sky CI M90 oers AutoSense Sky OS technology, which

dynamically adapts to every listening environment, automatically

adjusting the sound processor to optimize hearing in any listening

environment. The Sky CI M90 oers connectivity options that include

integrated Bluetooth®, RogerDirect, and compatibility with Phonak

wireless accessories.

This section with familiarize you with the Sky CI M90 Sound Processor

and Accessories.

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