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

1
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

2
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

3
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

4
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

5
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.

6
• 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.

7
• 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.

8
• 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