Advanced Bionics Naida CI M30 User manual

Naída™CI M30 Sound Processor
CI-5294
instructions for use
English, Français, Español

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SYMBOLS TABLE
Labeling symbols and their meanings
Date of Manufacture
Manufacturer
Model number
Serial number
Unique Device Identifier
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 further information)
XXXX-XX-XX

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Dispose of in accordance with applicable
national and local regulations
MR Unsafe
IPxx Ingress Protection Rating
Limitations and Contraindications
There are no known limitations or contraindications for
theNaída™ CI M30 sound processor.
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NaídaCIM30 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

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touched, disconnect the power source and contact your
local Advanced Bionics representative.
• Do not use any other 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.
• Do not dispose of batteries in fire.
• 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.

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• 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.
• 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.

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• 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 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
NaídaCIM30 sound processor does not respond to the
implant device because of an unusual field disturbance,
move away from the disturbing field. Consult Guidance
and Manufacturer’s Declaration section in this IFU for
determining safe EM field levels.

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• Use of the Naída CI M30 sound processor next to
or stacked with other equipment should be avoided
because it could result in improper operation (e.g.,
poor sound quality, cutouts in sound, delay in response
when making adjustments, or loss of lock). If such use is
necessary, the Naída CI M30 and the other equipment
should be observed to verify that they are operating
normally.
• Use of components, accessories, and cables other
than those specified in the Compatibility section of this
document could result in increased electromagnetic
emissions or decreased electromagnetic immunity of
this equipment and result in improper operation (e.g.,
poor sound quality, cutouts in sound, delay in response
when making adjustments, or loss of lock).
• Portable RF communications equipment (including
devices such as antenna cables and external antennas)
should be used no closer than 12 inches (30 cm) to any
part of the Naída CI M30 sound processor, including the
headpiece cable. Decreased performance of the sound
processor, headpiece, or other accessories could result
(e.g., poor sound quality, cutouts in sound, delay in
response when making adjustments, or loss of lock).
• The NaídaCIM30 sound processors and accessories
should be used in accordance with the electromagnetic
compatibility information provided in the Guidance and
Manufacturer’s Declaration section of this document.
• Although electromagnetic emissions of your
NaídaCIM30 sound processor have been confirmed
within safe limits, some other devices could be sensitive

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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
NaídaCIM30 sound processor and accessories;
however, there is no safety hazard associated with
suchequipment.
• Do not expose any part of the NaídaCIM30 sound
processors or accessories to extreme heat, such as an
oven, microwave, or hair dryer.
• AutoSense OS™ 3.0 operating system, Fixed
Directional mode, and UltraZoom programs may
dampen sounds that are not in front of the recipient.
• 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 and
UltraZoom 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.
• The Naída CI M30 sound processor has a datalogging
feature that collects information about the listening
environments encountered by the user, including
information regarding presence or absence of speech
or music and noise types and levels. This feature

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does not collect sensitive personal information. Please
contact your hearing care professional if you would like
to have this feature disabled.
• 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M30 system
may include skin irritation and discomfort from pressure on
the ear, device overheating, or overly loud sounds. Ifany
undesirable side eect is encountered, please remove
your sound processor and consult your cochlear implant
professional.
Product Description and Performance
Characteristics
The NaídaCIM30 Sound Processor is a behind-the-ear
(BTE) sound processor for use with an Advanced Bionics
cochlear implant. The NaídaCIM30 is comprised of the
components pictured below.
Bluetooth®is a registered trademark of Bluetooth SIG, Inc.

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Microphone ports
Light Emitting Diode
(LED)
Headpiece cable
connector
Multifunction
button
Battery connector
The NaídaCIM30 sound processor features direct
connectivity to wireless accessories and Bluetooth®
technology enabled devices. The NaídaCIM30 oers
multiple power options and wearing options for the user.
The system is designed to provide useful hearing to
individuals with severe-to-profound hearing loss.
Intended Use
The NaídaCIM30 is a behind-the-ear (BTE) sound
processor that converts sound picked up by the
microphone or streamed via wireless communication
intoelectrical signals that are used by the cochlear
implant to enable hearing.
The intended users of the NaídaCIM30 sound processor
are recipients of Advanced Bionics cochlear implants.
The intended use environments of the NaídaCIM30 sound
processor are healthcare and daily living environments.

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Compatibility
The NaídaCIM30 is compatible with the following implant
types from Advanced Bionics:
• CII
• HiRes™ 90K
• HiRes™ 90K Advantage
• HiRes™ Ultra
• HiRes™ Ultra 3D
The NaídaCIM30 is compatible with the following
Advanced Bionics products:
• M Batteries, M Zn-Air Battery Pak, MWaterproof Battery
• M T-Mic™ microphone and M Earhook
• Slim HP, Slim HP Mic, Slim HP AquaMic™ headpiece
• M Wearing Clip, M Snuggie™ accessory, M Retention
Cuff, M Listening Check™ accessory
The NaídaCIM30 is compatible with the following
programming interfaces:
• Advanced Bionics Clinical Programming Interface
CPI-3 with the M Programming Cable
• NoahLink Wireless programmer
The NaídaCIM30 is compatible with the following
accessory products
• AB Remote mobile application
• Phonak Roger transmitters

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• Phonak RemoteControl
• Phonak TV Connector
• Phonak PartnerMic
The NaídaCIM30 sound processor is Bluetooth 4.2
certified. Any mobile device that supports Bluetooth,
Hands Free Profile (HFP) and/or Advanced Audio
Distribution Profile (A2DP) should work with your
NaídaCIM30 sound processor. Bluetooth compatibility
information should be used as a reference guide only,
because hardware and software levels and releases may
vary, and numerous hardware and software combinations
are possible. Advanced Bionics assumes no responsibility
for the compatibility; thus, it is the user’s responsibility
to do product compatibility testing by himself before
making purchasing decisions on smartphones and other
Bluetooth-enabled devices.
Operating Instructions
Powering NaídaCIM30
The sound processor is turned on when a charged battery
is attached to the sound processor. When the battery
isfirst attached, the orange LED located in the middle of
the multifunction button will indicate battery charge.
The startup program is selected by the cochlear implant
professional during programming.
To power down the NaídaCIM30 sound processor, simply
remove the battery.

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Attaching the Battery
Hold the NaídaCIM30 in one hand. Rotate the headpiece
cable upward in order to avoid bumping it upon battery
placement.
Align the battery connector with the sound processor
housing side of the connector.

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Slide the battery onto the sound processor until it clicks into
place. Do not force the battery onto the sound processor.
The batteries are designed to be inserted in only one
direction; applying force may damage the equipment.
Removing the Battery
Hold the NaídaCIM30 in one hand. In the other hand,
hold the battery. Rotate the headpiece cable upward
inorder to avoid bumping it upon battery removal.

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Firmly slide the battery away from the M T-Mic or
MEarhook.
Continue sliding the battery until it separates from the
sound processor.
Approved NaídaCIM30 Power Supplies
Power SuPPly NomiNal
Voltage
tyPe rated
CaPaCity
M Battery 3.6V –
3.7V
Li-ion (recharge-
able)
0.3Wh –
0.8Wh

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Power SuPPly NomiNal
Voltage
tyPe rated
CaPaCity
M Waterproof
Battery
3.7V Li-ion (recharge-
able)
0.8Wh
M Zn-Air Battery
Pak
2.3V Zn-air (dispos-
able)
1.4Wh
Connecting the earhook to the sound processor
There are two earhook options for the NaídaCIM30 sound
processor: the M T-Mic and the M Earhook.
Beginning with the earhook disconnected, align the
earhook flush with the sound processor. Hold the earhook
firmly at the top and push towards the sound processor
until it meets flush with the sound processor.
Using the provided pin removal tool, place one of the pins
in the small hole on the side of the tool. This will help to
steady the pin as you line it up with the pin hole on the
earhook.

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Line up the pin with the hole in the earhook and gently
push it through the hole. The pin will move from one side
of the sound processor, through the earhook, to the other
side of the sound processor holding the earhook in place.
The pin should not come out the other side.
If a small portion of the pin extends beyond the sound
processor, use the side of the tool to push the pin inwards
so it lies flush with the sound processor.

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Pull the tool away from the sound processor, leaving the
pin inside the sound processor.
Removing the earhook
Align the pointed end of the tool with the hole on the
sound processor that contains the pin holding the earhook
on the sound processor.

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Gently press the tool in the hole, pushing the pin out the
other side.
The pin does not need to be removed from the sound
processor. As long as the tool is pushed in flush on one
side of the sound processor, the pin should be displaced
enough to adequately remove the earhook. Remove the tool
from the sound processor. Gently grasp the earhook at the
top near where it connects with the sound processor and
pull forward until it is separated from the sound processor.