Advanced Bionics ABBTE Wireless Hearing Instrument User Manual Naida CI IFU cover
Advanced Bionics AG Wireless Hearing Instrument Naida CI IFU cover
User Manual Naida CI
029-M304-85 Rev PC
Manufactured by:
Advanced Bionics LLC
California, U.S.A.
+1 661 362 1400
AdvancedBionics.com
© 2012 Advanced Bionics AG. All Rights Reserved.
Advanced Bionics AG
Laubisrütistrasse 28
8712 Stäfa, Switzerland
+41 58 928 78 00
Naída CI Q70
CI-5245
instructions for use
English, French, Spanish, German, Dutch, Portuguese
2013
1
Labeling symbols and their meanings:
European Community Mark of
Conformity. Authorized to affix the CE Mark in
20xx
Model
number
Date of
manufacture
Serial Number Manufacturer
Type of
Protection: B
Store at temperatures
between -20˚C (-4˚F)
and +55˚C (131˚F)
Fragile Do not get wet
Lot Number See Instructions
for Use
Suitable for atmospheric range between
70kPa and106kPa, which is equivalent to
3000m above sea level to 380m below
sea level.
Suitable for exposure to relative humidity
between 0-95%
Dispose of in accordance with applicable
national and local regulations
The Naída CI carries a rating of IP57. This rating
indicates that the Naída CI is protected against
the following conditions:
•Protection against dust
•Failure due to one time immersion for 30
minutes to a depth up to 1m and after drying
overnight in a dry and store unit
REF
2000-00
0
95
IP57
SN
LOT
2
Warnings and Cautions
Warnings
• CHOKING HAZARD: contains small parts that pose a
hazard of inhalation or choking.
• Do not use a ComPilot if recipient has a pacemaker, as
there is potential for interference. Contact a healthcare
professional for more information.
• Do not use or store the AB myPilot in shirt pockets if
the recipient has a pacemaker, as there is potential for
interference. Contact a healthcare professional for more
information.
• Ensure appropriate supervision when child is wearing
the Naida CI sound processor and accessories.
• Keep batteries and accessories out of children’s reach
as they may pose a choking hazard.
• If any parts are swallowed consult a physician or
hospital immediately.
• Do not allow children to play with or leave them
unattended with batteries.
• Do not place batteries in your mouth.
• Do not chew or swallow batteries. If this occurs, seek
immediate medical attention.
• Do not allow children to play with or operate the Zephyr
by Dry & Store® or desiccant unattended.
• Using your sound processor and accessories
contradictory to their intended use (e.g. mouthing,
chewing) may cause bodily harm
• Do not recharge disposable batteries.
• Do not allow leaking battery fluid to come into
contact with skin, mouth, or eyes.
Zephr by Dry & Store® is a registered trademark of Ear Technology Corporation
3
• Do not expose batteries to heat (e.g., do not store in
direct sunlight or in a hot car).
• Do not dispose of batteries in fire.
• Do not allow children to charge batteries unattended.
• Do not use any other power supply with the sound
processor, AB myPilot remote control or ComPilot
unless it is supplied by Advanced Bionics or Phonak.
If needed call Advanced Bionics for a power supply
replacement.
• Do not use the AB myPilot or the ComPilot when they
are plugged in to power sources such as wall
outlets or other power sources that are USB
compatible such as laptops.
• The ComPilot comes with a neck loop antenna; do not
touch the neck loop connectors at the same time.
• 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.
Cautions
• Remove external equipment to stop stimulation if
uncomfortable sounds are heard.
• It is important to have the correct magnet strength so
the recipient does not experience discomfort or
retention issues. If an insufficient number of magnets
is used in the headpiece, it may fall off more than
is acceptable. If too many magnets are used in the
headpiece, you may experience irritation or discomfort.
Consult a clinician if there are any concerns regarding
magnet strength. If deemed appropriate, an
4
audiologist may insert additional magnets or remove
magnets from the headpiece. Do not place additional
magnets in the headpiece unless under the direction of
a cochlear implant professional. If the recipient
experiences any redness, irritation, or discomfort,
discontinue use of the headpiece immediately and
contact a cochlear implant center. See the headpiece
“Instructions for Use” for additional information
regarding adjustment of headpiece magnet strength.
• If the sound processor or accessories become unusually
hot, or warm, discontinue use immediately and contact
Advanced Bionics or a clinician.
• Store additional headpieces away from items with
magnetic strips (e.g. credit cards, hotel room key cards),
as this may de-magnetize cards.
• Portable and mobile RF communications equipment,
including radios and cellular phones, may affect sound
quality of the Naida CI sound processor and
accessories; however, there is no safety hazard
associated with such equipment.
• The Naida CI sound processor and accessories should
be used in accordance with the electromagnetic
compatibility (EMC) information provided in the
‘Guidance and Manufacturer’s Declaration’ section of
this Instructions for Use.
• Only use the charger provided for charging AB
PowerCel™ batteries. DO NOT use it to charge other
batteries. Do not try to charge Naida CI PowerCels
using a charger other than the one provided by
Advanced Bionics.
• Remove batteries from your sound processor when they
are drained to prevent damage from possible leaking.
• Do not expose any part of the Naida CI sound
5
processor or accessories to extreme heat, such as an
oven, microwave or hair dryer.
• Do not use your AB myPilot or ComPilot accessories
when instructed not to use wireless electronic devices,
such as on airplanes.
• The AB myPilot should not come within 1 cm (1/2”) of
the Naida CI processor while stimulating the implant.
Doing so could cause the implant and sound processor
to lose lock. If this happens, power down the processor
and re-power on (done by disengaging the battery and
reattaching).
• 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 fields, it may be necessary
to be at least 60 cm (24”) away to ensure proper
operation. If the Naida CI does not respond to the
implant device because of an unusual field disturbance,
move away from the disturbing field.
• If the AB myPilot stops being able to transmit
commands to the sound processor, it may be
necessary to re-pair the AB myPilot with your sound
processor. Consult the previous section of this user
manual for instructions on re-pairing the AB myPilot.
• If volume commands from your AB myPilot to your
sound processor seem erratic, re-pair the AB myPilot
and the Naida CI.
• Ultrazoom will dampen sounds that are not in front of
the recipient.
• Do not use Ultrazoom in an off-the-ear wearing
configuration.
6
The Naida CI is a behind-the-ear (BTE) sound processor
that converts sound picked up by the microphone into
electrical signals that are used by the cochlear implant
to enable hearing.
7
Using the Naída CI Q70 Sound Processor
Powering the Naída CI
The processor is turned ‘on’ when a charged battery
is attached to the processor. In order to power ‘off’ the
processor, the battery cartridge must be removed. When
the battery is engaged, the orange LED located in the
middle of the rocker switch will flash to indicate battery
charge.
The Naída CI will always power on in Program 1 with
the volume and sensitivity at the default settings.
To power down the Naída CI, simply remove the battery
cartridge.
Note: The T-Mic 2 Cover should be replaced at regular
intervals to maintain sound quality.
Removing the Battery
1
Hold the Naída CI in one hand.
In the other hand hold the battery cartridge.
Rotate RF cable upward in order to avoid
bumping it upon battery removal.
8
2
Firmly slide the battery cartridge away
from the earhook or T-Mic 2.
3
Continue sliding the battery cartridge until
it separates from the processor.
Replacing the Battery
1
Hold the Naída CI in one hand. Rotate RF cable
upward in order to avoid bumping it upon
battery placement
9
2
Align the battery cartridge connector with the
processor housing side of the connector.
3
Slide the battery onto the processor until it
clicks into place.
NOTE: Do not force the battery cartridge onto the
processor. The battery cartridges are designed to be
inserted in only one direction; applying force
may damage the equipment.
10
Understanding Naída CI LEDs
The LED is a programmable feature providing
visual information about Naída CI status, battery
life, program position, and sound processor error
conditions.
Color Behavior Programmable Indication
Orange Blinks at
start-up
Battery
indicator is
only
available with
use of the
rechargeable
PowerCels
and the Naída
CI Power
Adapter.
Battery life
indicators are
not available
with Zn-Air
cells.
• 4 quick blinks indi-
cate that the battery
is fully charged
• 2 - 3 quick blinks
indicate that the
battery is sufficiently
charged to power
the Naída CI
• 1 quick blink indi-
cates that the battery
is nearly depleted
• No blinking indicates
depleted battery. Re-
place with charged
or new battery
Solid Yes The battery is almost
depleted
Blinks
twice
every
three
seconds
Yes The battery is depleted
and cannot support
stimulation (Sleep
Mode)
Fades
Out
No Naída CI entering
Standby Mode
11
Color Behavior Programmable Indication
Red Blinks
once per
second
Yes Loss of lock with the
implant
Blinks
rapidly
(more
than once
per
second)
No IntelliLink™: Wrong
implant connected
Solid No Sound processor error
condition. Fully remove
and re-insert battery to
reset processor
Blinks 5
times
No - if using
AB myPilot,
this pattern is
the default
Response to AB
myPilot’s request to
‘Find Paired Devices’.
The right paired device
will identify itself with
this LED pattern
12
Color Behavior Programmable Indication
Green Flickers in
response
to loud
inputs
Yes The sound processor
and microphone are
responding to sound
Blinks at
start-up
after
battery
status
and upon
program
change
No • 1 blink indicates
program one
• 2 blinks indicate
program two
• 3 blinks indicate
program three
• 4 blinks indicate
program four
• 5 blinks indicate
program five
Solid No A processor that is
not yet programmed.
Blinks 4
times
No - if using
AB myPilot,
this pattern is
the default
Response to AB
myPilot’s request to
‘Find Paired Devices’.
The left paired device
will identify itself with
this LED pattern
Note: Use of some Naída CI accessories may obscure the
processor LED.
13
If the user would like to know the battery status of the
Zn-Air cells they are currently using and have an AB
myPilot paired to their device, they can conduct a
Battery Check readout of the Naída CI.
The Battery Check readout must be performed 15
minutes after the Zn-Air cartridge has been attached
to the Naída CI. After this short window of time the AB
myPilot will be able to give an accurate reading of the
Zn-Air cells in use by the Naída CI.
Please see the ‘Battery Check’ section of the AB myPilot
User Guide for instructions on how to conduct battery
status check using AB myPilot.
Approved Naída CI Power Supplies
Power Supply Rated
Voltage
Type Rated
Energy/
Power
PowerCel 3.7V Li-ion
(Rechargeable)
0.4 Wh-
0.9 Wh
Zn-Air 2.8V Zn-Air
(Disposable)
1,240mWh
Programming
Interface
5.0V DC 1,250mW
14
Understanding Naída CI Internal Alarms
Behavior Programmable Indication
Beeps upon
program
change
Yes • 1 beep indicates
program one
• 2 beeps indicate
program two
• 3 beeps indicate
program three
• 4 beeps indicate
program four
• 5 beeps indicate
program five
Short
Beep upon
increase/
decrease in
volume
Yes Beeps once per press
of the rocker switch
either up or down
(a double beep will
be heard when the
following settings are
reached: top of the
volume range;
baseline volume
setting; and bottom of
the volume range)
Long Beep
(once every
15 minutes)
Yes Low battery
15
Recommended Operating and Storage
Temperature Ranges
Condition Minimum Maximum
Operating Temperature 0°C (32°F) 45°C (115°F)
Storage Temperature -20°C (-4°F) 55°C (131°F)
Naída CI External Equipment and Accessories
Model Number Description
CI-5245-xxx Naída CI Sound Processor*
CI-5305 Universal Headpiece (UHP)*
CI-5605 Naída CI PowerCel Charger
CI-5615 Charger Power Supply with adapters
CI-5415-xxx Naída CI RF Cable*
CI-5511-xxx Naída CI PowerCel 110*
CI-5517-xxx Naída CI PowerCel 170*
CI-5523-xxx Naída CI PowerCel 230*
CI-5500-xxx Naída CI Zn-Air Battery Pak*
070-M006 Zn-Air Battery 6pk
*Applied part per IEC 60601-1
Note: The X’s denote model number variant related to
product color and/or length.
16
Guidance & Manufacturer’s Declaration
Per IEC 60601-1-2
Electromagnetic emissions
Emissions
test
Compliance Electromagnetic
environment - guidance
RF
emissions
CISPR 11
Group 1 The Naída CI uses RF
energy only for its internal
function. Therefore, its RF
emissions are very low
and are not likely to cause
any interference in nearby
electronic equipment.
RF
emissions
CISPR 11
Class B The Naída CI is suitable for
use in all establishments,
including domestic
establishments and those
directly connected to the
public low-voltage power
supply network that
supplies buildings used for
domestic purposes.
Harmonic
emissions
IEC 61000-
3-2
Not
applicable
Voltage
fluctuations/
flicker
emissions
IEC 61000-
3-3
Not
applicable
17
Electromagnetic immunity
The Naída CI is intended for use in the electromagnetic
environment specified below. The customer or the user
of the Naída CI should assure that it is used in such an
environment.
Immunity IEC
60601
test level
Compliance
levela
Electromagnetic
environment -
guidance
Electrostatic
discharge
(ESD) IEC
61000-4-2
± 6 kV
contact ±
8 kV air
± 6 kV
contact
± 8 kV air
Floors should be
wood, concrete
or ceramic tile. If
floors are covered
with synthetic
material, the
relative humidity
should be at least
30 %. As with the
operation of other
electronic devices,
precaution should
be taken to not
generate ESD.
Power
frequency
(50/60 Hz)
Magnetic
Field
IEC 61000-
4-8
3 A/m 3 A/m Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in
a typical
commercial or
hospital
environment.
18
Radiated
RF IEC
61000-
4-3
3 V/m
80
MHz
to 2.5
GHz 3
3
V/m
Portable and mobile RF
communications equipment
should be used no closer
to any part of the Naída CI,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
d = 1.2√P < 800 MHz
d = 2.3√P ≥ 800 MHz
where P is the maximum
output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m). Field
strengths from fixed RF
transmitters, as determined
by an electromagnetic
site survey,b should be less
than the compliance level
in each frequency range.c
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
19
Note 1: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects, and people.
a. Essential performance of the Naída CI per IEC
60601 requirements is defined as auditory stimulation
within safe amplitudes.
b. Field strengths from fixed transmitters, such as base
stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio
broadcast, and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electro-
magnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered.
If the measured field strength in the location in which the
Naida CI is used exceeds the applicable RF compliance
level above, the Naida CI should be observed to verify
normal operation.
c. Over the frequency range 150 kHz to 80 MHz, field
strengths should be less than 3 V/m.
20
Separation distances between RF
communications equipment and Naída CI
Recommended separation distances between portable
and mobile RF communications equipment and the
Naída CI
The Naída CI is intended for use in an
electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user
of the Naída CI can help prevent electromagnetic inter-
ference by maintaining a minimum distance between
portable and mobile RF communications equipment
(transmitters) and the Naída CI as recommended below,
according to the maximum output power of the
communications equipment.
Rated
Maximum
Output
Power of
Transmitter
(w)
Separation distance according to
frequency of transmitter (m)
d = 1.2√P < 800
MHz
d = 2.3√P ≥ 800
MHz
0.01 0.12 0.23
0.1 0.38 0.73
11.2 2.3
10 3.8 7.3
100 12 23
For transmitters rated at a maximum output power not
listed above, the recommended separation distance d in
meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer.
21
Note 1: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Compatibility Tables
Implant Type
Processor Type
C1 CII HiRes
90K
HiRes 90K
Advantage
Naída CI -✓5✓5✓5
Neptune -✓ 1✓1✓1
Harmony ✓2✓3✓3✓1
Auria -✓3✓3✓1
Platinum Sound
Processor (PSP) ✓4✓ ✓ ✓1
1 Requires SoundWave 2.1 or later
2 Requires SoundWave 2.0 or later
3 Requires SoundWave 1.4 or later
4 Requires SClin2000 and CPI-II
5 Requires SoundWave 2.2 and CPI-3
22
Implant Type
Software Type/Version
C1 CII HiRes
90K
HiRes 90K
Advantage
SClin2000 ✓ ✓ - -
SoundWave
(versions 1.x)
-✓ ✓ -
SoundWave 2.0 ✓1✓ ✓ -
SoundWave 2.1 ✓1✓ ✓ ✓
SoundWave 2.2 ✓1✓ ✓ ✓
1 Only on Harmony
Headpiece Type
Processor Type
Universal
Head-
piece
(UHP)
Aqua-
Mic
Auria
Head-
piece
Platinum
Head-
piece
(PHP)
Naída CI ✓ ✓ - -
Neptune ✓ ✓ - -
Harmony ✓-✓ ✓
Auria ✓-✓ ✓
PSP ✓- - ✓
23
Programming
Interface
C1 CII HiRes 90K HiRes 90K
Advantage
CPI-II ✓ ✓ ✓ ✓
CPI-3 ✓1✓ ✓ ✓
1 Only on Harmony
Cleaning & Maintenance
• Clean with a soft cloth. Do not immerse.
• Do not attempt to service or modify the Naida 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.
Performance Data
The HiRes 90K™ Advantage implant with the HiFocus™
Electrode and Naída CI processor support the
HiResolution family of sound processing strategies
including HiRes, HiRes with Fidelity 120 (HiRes 120),
and ClearVoice.
HiRes™ and HiRes 120™ Sound Processing
A clinical study was conducted in 50 adults implanted
with a CII/HiRes 90K device who used a Harmony
processor to document the benefits of HiRes 120 and
24
HiRes sound processing. Performance with HiRes was
assessed at the baseline visit and compared with HiRes
120 performance after three months of listening experi-
ence. Subsequently, subjects were refit and retested
with HiRes. Results showed equivalent mean CNC word
recognition scores for the two strategies. The mean
HINT sentence perception scores in quiet and noise
were significantly higher for HiRes 120 compared to
baseline with HiRes. For HINT sentences in noise, the
mean scores for HiRes 120 were significantly higher
than scores after subjects were refit with HiRes.
Table 1
Mean Speech Scores for HiRes and HiRes 120
Sound
Processing Group HiRes HiRes 120 HiRes
Test Interval Baseline 3 Months 3 Months
CNC Words 63 65 63
HINT Sentences
in Quiet 88 93* 91
Hint Sentences
in Noise (+8 dB
SNR)
64 70** 65
* HiRes 120 score significantly different from baseline
HiRes score (p<.05)
**HiRes 120 score significantly different from baseline
and 3-month HiRes scores (p<.05)
25
Forty-three of 50 subjects (86%) preferred HiRes 120
over HiRes. Subjects rated strength of preference for
the two strategies on a scale from 1 (weak preference)
to 10 (strong preference). The mean strength of prefer-
ence for the 43 subjects who preferred HiRes 120 was
7.9 (range: 1-10). The strength of preference was rated
as 8 or higher by 26 of the 43 subjects, and 16 of the
43 subjects rated their preference as 10 (strong prefer-
ence). For the 7 subjects who preferred HiRes, the mean
strength of preference was 4.4 (range: 1-9).
ClearVoice
A clinical study was conducted in 46 adults who had at
least six months experience with HiRes 120 sound pro-
cessing and at least moderate speech perception abili-
ties to investigate the benefits of ClearVoice. ClearVoice
has three adaptive gain settings that allow individuals to
select the setting that provides the best hearing—Low,
Medium, and High. A two-week randomized, crossover
design was used to evaluate ClearVoice-Medium and
ClearVoice-High. ClearVoice-Low was evaluated acutely
during an initial test session. Speech benefit was com-
pared for ClearVoice vs. HiRes 120 without ClearVoice
(Control) using the AzBio sentence test.
Speech understanding in speech-spectrum noise was
significantly better with ClearVoice- Medium and
ClearVoice-High compared to the Control (p < .0001).
26
ClearVoice-Medium significantly improved speech
understanding in multi-talker babble (p< .02). Speech
understanding was no worse than the Control when
listening in quiet for both ClearVoice-Medium and
ClearVoice-High (p < .0001). Speech understanding
with ClearVoice-Low was no worse than the Control
in quiet, in speech-spectrum noise, and in multi-talker
babble (p <.001).
Table 2
Mean AzBio Sentence Scores for HiRes 120 with and
without ClearVoice
Study
Group Control
Clear-
Voice
Low
Control
Clear-
Voice
Medium
Control
Clear-
Voice
High
Quiet 87.3 87.8 88.6 88.3 86.8 87.7
Speech-
Spectrum
Noise
48.0 55.6 49.5 58.2 47.7 58.3
Multi-
Talker
Babble
42.8 47.2 44.9 48.1 44.9 46.2
Preference ratings indicated that 42 out of 45 subjects
(93%) preferred ClearVoice to the Control for everyday
listening (one subject did not complete the question-
naire). The mean strength of preference for the 42
subjects who preferred ClearVoice was 7.9 (1 = weak
preference, 10 = strong preference). Of the 42 subjects
preferring ClearVoice, 22 indicated they would use it all
27
of the time, 17 indicated they would use it most of the
time, and 3 indicated they would use it some of the time.
Of the 3 subjects preferring the Control, all indicated
they would use ClearVoice some of the time.
ClearVoice is not approved for pediatric use in the United
States.
ClearVoice is only available in markets where ClearVoice
has received regulatory approval. Contact Advanced
Bionics for more information.
This instrument is certified under:
FCC ID: S2B-ABBTE
IC: 10870A-ABBTE
This device complies with Part 15 of the FCC Rules
and with RSS-210 of Industry Canada. Operation is
subject to the following two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received,
including interference that may cause undesired
operation.
Changes or modifications made to this equipment
not expressly approved by Advanced Bionics may void
the FCC authorization to operate this equipment.
28
This Class B digital apparatus complies with Canadian
ICES-003.
This equipment has been tested and found to comply
with the limits for a Class B digital device, pursuant to
Part 15 of the FCC Rules.
These limits are designed to provide reasonable
protection against harmful interference in a residential
installation. This equipment generates, uses, and can
radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause
harmful interference to radio communications. However,
there is no guarantee that interference will not occur
in a particular installation.
If this equipment does cause harmful interference to
radio or television reception, which can be determined
by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving antenna
• Increase the separation between the equipment and
receiver
• Connect the equipment into an outlet on a circuit
different from that to which the receiver is connected
• Consult your clinic or an experienced radio/TV
technician for help