Advanced Bionics CI-5551 User manual

M Batteries and M Charger
CI-5551, CI-5552, CI-5553, CI-5555, CI-5607
(Small, Medium, Large, Standard, Charger)
instructions for use
English, Français, Español, Deutsch, Nederlands, Italiano

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Contents
PURPOSE AND SCOPE OF IFU 5
LIMITATIONS AND CONTRAINDICATIONS 5
PRECAUTIONS, CAUTIONS, AND WARNINGS 5
UNDESIRABLE SIDE EFFECTS 8
PRODUCT DESCRIPTION AND PERFORMANCE
CHARACTERISTICS 8
Battery Capacity 9
Charger Information 10
INDICATIONS FOR USE 10
INTENDED USE 11
Intended Users 12
Intended Use Environment 12
COMPATIBILITY 12
OPERATING INSTRUCTIONS 13
General Charging Information for M Batteries 13
Setting up the charger 14
Understanding M Battery Charger LED
(light-emitting diode) indicators 14
Inserting the M Batteries into the charger 15
Removing the M Batteries from the charger 16
Using the M Batteries with the Naída CI M
and Sky CI M Sound Processors 17

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CARE AND MAINTENANCE 19
Storing the M Batteries and M Battery Charger 19
Cleaning and Maintenance 19
Expected Life 20
Ingress Protection (IP) Ratings 20
DISPOSAL AND HAZARDOUS MATERIALS 21
AVAILABLE PRODUCT OPTIONS AND
MODELNUMBERS 21
M Battery Charger 21
M Battery Small 21
M Battery Medium 22
M Battery Large 23
M Battery Standard 24
CLINICAL BENEFITS 24

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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

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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

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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 Batteries and M Battery Charger. 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 Batteries and M Battery
Charger and to troubleshoot problems.
Limitations and Contraindications
As the M Batteries and M Battery Charger are components
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.
• It is recommended that you charge the M Batteries
fully prior to first use, as M Batteries shipped from
Advanced Bionics are not fully charged.
• The M Battery Charger comes with a power supply
designed for the specifications of the M Battery
Charger. Do not use any other power supply unless
it is supplied by Advanced Bionics. If needed, call
Advanced Bionics for a power supply replacement.

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• The M Battery Charger and power supply 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 cochlear implant professional.
• 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 Battery Charger or M Battery.
• Do not allow children to place the M Battery Charger or
M Battery in the mouth.
• Remove your sound processor and consult your
cochlear implant professional if uncomfortable sounds
are heard or in case of discomfort, pain or skin irritation.
• Do not dispose of M Batteries in fire, as they may explode.
• To prevent injury or burns, do not allow metal objects,
such as keys or coins, to contact or short circuit the
battery terminals. M Batteries may present risk of fire
or chemical burn if mistreated. Do not disassemble.
Do not heat above 100˚C/212˚F or incinerate.
• Remove M Batteries from your sound processor when
they are discharged to prevent damage from possible
leaking.

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• If an M Battery shows visible signs of leakage,
dispose of it in accordance with local regulations, as
detailed inthe “Disposal” section of this document.
• Do not allow leaking battery fluid to come into contact
with skin, mouth, or eyes.
• Do not expose M Batteries to heat (e.g., do not store
indirect sunlight or in a hot car).
• 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.
• Do not immerse the M Batteries or M Battery Charger
directly in water.
• 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.
• Only charge M Batteries using the charger(s)
recommended by the manufacturer.
• Do not recharge disposable batteries.
• Although electromagnetic emissions of the M Battery
Charger 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 M Battery Charger is nearby, separate the
devices.

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• 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 and Performance
Characteristics
The M Batteries are Lithium Ion rechargeable batteries.
There are four M Batteries: Small, Medium, Large,
andStandard.
Small StandardLargeMedium

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The M Battery Charger contains three M Battery charging
bays. The charging system consists of the charger
and micro USB power supply cable. The wall adapter
isshipped separately from Advanced Bionics.
charging bay
Light Emitting
Diode (LED)
indicators
Battery Capacity
Product Battery caPacity (mah)
M Battery Small 90
M Battery Medium 150
M Battery Large 220
M Battery Standard 170

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Charger Information
rated dc inPut Voltage rated dc inPut current
5V 500mA
INDICATIONS FOR USE
The M Batteries and M Battery Charger are external
components 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.
• 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 hearing loss
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.

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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 appropriate
auditory milestones (such as spontaneous response to
name in quiet or to environmental sounds) measured
using the Infant-Toddler Meaningful Auditory Integration
Scale or Meaningful Auditory Integration Scale or ≤20%
correct on a simple open-set word recognition test
(Multisyllabic Lexical Neighborhood Test) administered
using monitored live voice (70dBSPL). In older children
(≥ 4 years of age), lack of hearing aid benefit is defined
as scoring ≤12% on a dicult open-set word recognition
test (Phonetically Balanced-Kindergarten Test) or ≤ 30%
on an open-set sentence test (Hearing In Noise Test for
Children) administered using recorded materials inthe
sound field (70 dB SPL).
Intended Purpose
The M Batteries and M Battery Charger are accessories of an
auditory active-implantable system, the HiResolution Bionic
Ear system. The HiResolution Bionic Ear system is intended
to provide auditory sensation via electrical stimulation of the
auditory nerve for individuals with severe to profound bilateral
or unilateral sensorineural hearing loss. Severe hearing loss
is defined as audiometric thresholds greater than or equal
to 70 dB HL, but less than 90 dB HL. Profound hearing loss
is defined as audiometric thresholds greater than or equal
to 90 dB HL. The external components work together with
the implant to bypass the damaged part of the inner ear and

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convert sound picked up by the microphone or streamed via
wireless communication into electrical signals that are used
by the cochlear implant to enable hearing.
M Batteries are intended to power the AdvancedBionics
NaídaCIM and Sky CI M Sound Processors. The
MBattery Charger is intended to recharge only the
MBatteries. Placing acharged M Battery on the sound
processor will poweronthe sound processor. Removing
the M Battery will power o the sound processor.
Intended Users
The intended users of the M Batteries and M Battery Charger
are users of the Naída CI M or Sky CI M Sound Processors,
their caregivers if applicable, and hearing care professionals.
The recipient, or their caregiver, should, at a minimum,
becapable of changing the battery, connecting the earhook,
placing and removing the sound processor from their ear, and
placing and removing the headpiece from the implant site.
The hearing care professional should be trained in the use
and fitting of the cochlear implant system.
Intended Use Environment
The intended use environments of the M Batteries and M
Battery Charger are healthcare and daily living environments.
The M Batteries are designed to be worn daily during
the user’s normal waking hours. There is no minimum or
maximum duration of use for the M Battery Charger.

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Compatibility
Naída CI M Batteries are compatible with Naída CI M
and Sky CI M Sound Processors from Advanced Bionics.
TheM Battery Charger is compatible with only M Batteries.
Operating Instructions
General Charging Information for M Batteries
• The M Battery Charger provided with the sound
processor is designed to recharge up to three
MBatteries simultaneously. Using the supplied
power adapter, it takes approximately 3 to 4 hours to
fully recharge a depleted M Battery. If the M Battery
isstored for prolonged periods of time, it may take
approximately 5 to 6 hours to fully recharge the
battery.This will vary slightly for different M Battery
types.
• M Batteries do not need to be fully depleted before
charging. A partially charged M Battery may be fully
charged in a shorter time period.
• You can remove the M Battery from the charger at
any time.
• You will not damage the M Batteries if they remain
on the charger longer than the required charging
time or overnight.
• It is recommended to use and recharge the
MBatteries at least once every 3 months. Please
note that M Batteries will decrease in capacity with
age, even if not in use. This is normal behavior
for all rechargeable batteries and should not be
considered a defect.

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Setting up the charger
To use the M Battery Charger with a wall outlet for
charging:
Place the M Battery Charger on a flat surface.
Connect the micro USB end of the power supply cable
into the charger.
Connect the power supply cable to the USB wall adapter.
Plug the wall adapter into the wall outlet.
To use the M Battery Charger with a USB port for charging:
Place the M Battery Charger on a flat surface.
Connect the micro USB end of the power supply cable
into the M Battery Charger.
Insert the USB jack into a USB port (on a computer,
in a car, etc.).
Understanding M Battery Charger LED (light-emitting
diode) indicators
The M Battery Charger has dierent indicator lights that
are located at the base of each charging port, as well
as where the power cable enters the charger. If the light
near the power jack is lit and green in color, it means the
charger is connected to a power source and ready to
charge the M Batteries. If the light near the power jack is lit
and red in color, this indicates a fault condition.*

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The LEDs located at the base of each charging port have
3 color options:
• Blue: M Battery is charging.
• Green: M Battery is fully charged.
• Red: Fault condition.*
*Try to reinsert the power cable or M Battery. If the red
LED illuminates again, contact your cochlear implant
professional.
The charger has an automatic dimmer. The brightness
ofthe LEDs may vary depending on the brightness of the
room in which the charger is placed.
Inserting the M Batteries into the charger
Locate the slide tracks on the charger. Position the M Battery
so that the battery contact is facing down toward the base of
the charger and aligned with the tracks on the charger.

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Slide the M Battery along the tracks until it engages.
The charger is designed so the M Batteries can only be
inserted in one direction.
Removing the M Batteries from the charger
Gently slide the M Battery out of the slide tracks of the
charger, toward the front edge of the charger. Do not pull
directly up on the battery.

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Using the M Batteries with the Naída CI M and Sky CI
M Sound Processors
Putting the M Batteries on the sound processor
Hold the sound processor in one hand. Rotate headpiece
cable upward in order to avoid bumping it upon battery
placement.
Align the M Battery connector with the sound processor
housing side of the connector.

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Slide the M battery onto the sound processor until it clicks
into place. The sound processor will be powered on as
soon as a charged M Battery is fully attached.
NOTE: Do not force the M Battery onto the sound processor.
The M Battery is designed to be inserted in only one
direction; applying force may damage the equipment.
Removing the M Batteries from the sound processor
Rotate headpiece cable upward in order to avoid bumping
it upon M Battery removal.
Hold the sound processor in one hand. In the other hand
hold the M Battery. Firmly slide the M Battery cartridge
towards the back of the sound processor, away from any
earhook accessory.