oticon Neuro One User manual

Neuro – The Cochlear Implant System
Neuro One
Instructions for use
0459
(2015)
NEURELEC
2720 Chemin Saint-Bernard, 06220 Vallauris – France
TEL: [phone], FAX: [phone]

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Table of content
Introduction................................................................................................................................ 6
Indications.................................................................................................................................. 6
Contra-indications....................................................................................................................... 6
Reliability-quality........................................................................................................................ 6
Implant compatibility .................................................................................................................. 7
How it works............................................................................................................................. 8
The external part......................................................................................................................... 8
The internal part ......................................................................................................................... 8
Packaging contents.................................................................................................................. 9
Neuro One sound processor description...............................................................................10
Using the Neuro One sound processor.................................................................................. 11
1. Connecting the components.................................................................................................... 11
2. Optimising hold ..................................................................................................................... 11
Magnet .................................................................................................................................. 11
Ear hook ................................................................................................................................ 12
Holding buckle....................................................................................................................... 12
3. Powering the sound processor................................................................................................ 13
Type of batteries that can be used .......................................................................................... 13
Battery life ............................................................................................................................. 13
User instructions for batteries ................................................................................................ 13
Private alarm..........................................................................................................................14
Battery compartment..............................................................................................................14
Inserting/changing batteries .................................................................................................. 15

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4. Switching on/off..................................................................................................................... 15
5. Programme button..................................................................................................................16
6. Setting selector wheel............................................................................................................16
7. Indicator light......................................................................................................................... 17
8. List of available accessories ...................................................................................................18
Assistive Listening Systems...................................................................................................19
1. Integrated telecoil...................................................................................................................19
2. Auxiliary Socket......................................................................................................................19
Care and User Instructions.................................................................................................... 20
1. Care ...................................................................................................................................... 20
Precautions........................................................................................................................... 20
Cleaning ................................................................................................................................ 21
Storage.................................................................................................................................. 21
Desiccation drying system...................................................................................................... 21
Recycling ............................................................................................................................... 21
2. Risks and User Instructions ....................................................................................................22
Accessories............................................................................................................................22
Playing sport..........................................................................................................................22
Medical examinations ............................................................................................................22
Settings .................................................................................................................................23
Electrostatic discharge ...........................................................................................................23
Passing through security gates ...............................................................................................23
Travelling by plane .................................................................................................................23

4
Tools and Troubleshooting.................................................................................................... 24
1. Testing tools .......................................................................................................................... 24
Self Check function ............................................................................................................... 24
Microphone earphones ..........................................................................................................25
2. Problems and solutions..........................................................................................................25
Miscellaneous Information.................................................................................................... 28
1. Technical characteristics ........................................................................................................ 28
2. Symbols................................................................................................................................ 29
3. Profile of the person handling the sound processor................................................................ 30
4. Manufacturer's declaration.................................................................................................... 30
5. References of Neuro One sound processor, spare parts and accessories................................. 34

67
Introduction
You have just received your Neuro One sound processor, commercialised by Oticon Medical. This manual is intended for
the patient, the caregiver and the audiologist by providing important information and instructions on how to use the
Neuro One sound processor.
• Patient : person implanted with a cochlear implant, non-healthcare professional, without relevant specialized training
• Caregiver: adolescent or adult with a minimum of 8 years of education, non-healthcare professional, without relevant
specialized training
• Audiologist: healthcare professional with at least 3 years of studies in audiology, with specialized training in the
usage of the device
This manual for the Neuro One sound processor explains how to use the device as well as the precautions for use to be
observed. If the information provided in this manual and in the packaging of the Neuro One sound processor is incom-
plete or illegible, please contact the manufacturer or your local distributor.
Indications
The Neuro One sound processor is designed for adults and children of all ages, diagnosed with unilateral and bilateral
severe to profound sensorineural hearing loss (and hearing aid use does not provide adequate amplification for speech
audiometry), fitted with a Neuro Zti cochlear implant.
Contra-indications
The Neuro One sound processor is not appropriate for patients fitted with an implant other than that specified in the
indications. The Neuro One sound processor is not appropriate for patients with implants whose auricle is too small
and/or too soft to support the device.
Reliability – quality
The cochlear implant system is an active implantable medical device. To ensure your safety, the Neuro One sound
processor is designed and manufactured in accordance with the requirements of European Directive 90/385/EEC.
The device conforms to standard EN 45502-2-3: 2010, on Active Implantable Medical Devices (AIMD) – cochlear and
auditory brainstem implant systems, as well as standards relating to the safety of Medical Devices.

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Implant Compatibility
The Neuro One sound processor is only compatible with the Neuro Zti implant.
Note: it is important to always keep the cochlear implant patient card with you provided by your implant centre and to show it at the time of any examination or medical
treatment.
In the case of a bilateral cochlear implantation (each ear has a cochlear implant system):
patients wearing two cochlear implant systems are strongly advised against using a sound processor programmed for
one ear on the opposite ear. The implant is designed to recognise the sound processor which has been specifically
configured for it (paired). If the sound processor is changed, the implant will not work. To facilitate the recognition of the
left/right sound processor and prevent switching them, different colour foolproof keys (stickers) are provided with the
product. The Left/Right stickers need to be stuck on a part of the sound processor which is not in contact with the skin.
Finally, in case of a fault with one of the sound processors, contact Oticon Medical or your local distributor for a solution.
Neuro One sound processor
compatible with the implants
opposite:
Neuro Zti Cochlear Implant

2
3
1
5
4
Antenna
Implant
Electrodes
Neuro One sound processor
To the brain
Antenna Cable
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How Neuro One Works
The cochlear implant system consists of an external part and an internal part.
External part
• A Neuro One behind-the-ear hearing device (1) with two microphones.
• An external antenna (2) connected to the sound processor via an antenna cable (3).
The sound captured by the microphones is digitally processed by the sound processor.
The stimulation signal is then sent to the implant via the antenna through the skin.
Internal part
The Neuro Zti implant is a small casing (4) placed under the skin. It contains an electronic stimulator which will
distribute the sound to the electrodes (5) placed in the cochlea.

Pictures are not contractually binding
89
Packaging contents
1. Neuro One sound processor x 1
2. Antenna with magnet x 1
3. Antenna Cable x 1
4. Case x 1
5. "Perfect Dry" heating desiccation drying system x 1
6. Zinc-Air battery boxes x 3
7. Accessories box x 1 containing:
7.a Additional antenna cable x 1
7.b Additional antenna x 2
7.c Additional magnet x2
7.d Additional ear hook x 4
7.e Holding buckle x 1
7.f Microphone earphones x 1
7.g Screwdriver x 1
8. Carrier x 1 containing:
8.a Cleaning wipes x 2
8.b Cover Clip x 1
N-A 6 Battery blister pack x 1
9. USB memory stick for backing up the settings
that also contains the Accessories user manual
(9.a) x 1
10. Sound processor User Manual x 1
11. Sound processor registration form (activation of
the warranty) x 1
12. Silhouette x1
13. Identification Stickers Left/Right
Note: The references are provided in this IFU in the section “References of Neuro One sound processor, spare parts and accessories”

A
B
C
D
E
F
G
H
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Sound processor Description
A. Microphone 1
B. Microphone 2
C. Setting selector wheel with on-off switch
0: Stop
1: Position 1
2: Position 2
3: Position 3
D. Programme button: choice of programmes (press once
to select the following programme P1-> P2-> P3-> P4-> P1
etc.) – checking that the system works (press for
longer)
E. Orange indicator light
F. Antenna socket: connection of the antenna cable
G. Auxiliary socket: connection of external accessories
(FM systems, microphone earphones, etc.)
H. Connection socket for the settings
The sound processor is identified visually by its marking
and serial number.
The serial number of your Neuro One sound processor is indicated on the inside of
the battery compartment: “Pxxxx” (for example P1495/P = sound processor
generation / xxxx = serial number).
It is recommended that you write down and keep this number, as you may need
it in the future.
Note: All parts indicated above are applied parts.

10 11
Using the Neuro One sound processor
1. Connecting the components
Both ends of the antenna cable are identical to avoid any confusion for the user. It is to be used according to the
following recommendations:
• Connect the antenna to the antenna cable.
• Connect the antenna cable to the sound processor via the antenna socket.
The ends of the antenna cable and of the Neuro One sound processor antenna are equipped with a foolproof key.
The connection of the antenna cable to the sound processor, as well as the antenna cable to the antenna, must ensure
that the foolproof key is facing in the right direction with respect to the socket and the cable (see paragraph "Sound
processor description").
Important: the antenna cable connectors are designed to be used occasionally (change of faulty cable, etc.). To prolong
this accessory's service life, we recommend that you store your Neuro One sound processor in its case without discon-
necting the antenna cable.
2. Optimising hold
Magnet
The antenna is held on the skin opposite the implant by means of a magnet.
You can adjust the distance between the skin and the magnet at any time by tightening or unscrewing the magnet.
To screw or unscrew the magnet, here are some instructions you can follow:
• Hold the antenna by grasping the magnet cap by its top and bottom, as shown in photo 1 below.
• To tighten the magnet, turn it in the opposite direction indicated by the arrows under the magnet cap (photo 2).
Photo 1 Photo 2

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The underside of the magnet indicates the magnetic force:
If the magnet force is insufficient, the antenna may not be held on the skin properly. It is then recommended to change
the magnet force (higher force).
If it is too strong, an irritation or skin redness may occur. A lower force (delivered in the box) may be advised.
If the magnet does not seem suitable, contact your implant centre which will advise you on the suitable force that
you can order from your local distributor or the Oticon Medical after-sales service.
Ear hook
The sound processor is provided with an ear hook to ensure that it is held on the ear. So that it can be adapted to each
patient, a different length of ear hook is provided in the box. The ear hook can be changed as follows:
• Remove the used ear hook.
• Clip on a new ear hook until you hear a "click".
Holding buckle
For an optimal fit of the sound processor on the ear (notably for paediatric use or active/sport activities),
we recommend that you use the silicon holding buckle provided in the Neuro One accessories box.
It is recommended that you refer to the “Accessories Instructions for use” to see how to fit this.
Note: The sound processor may also be held by using an open ear tip made by a hearing-aid specialist.
5
+
top part of the magnet bottom part of the magnet

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3. Powering the sound processor
Type of batteries that can be used
Your Neuro One sound processor works using 2 non-rechargeable 675 Zinc-Air batteries. It is important to only use "675"
(European designation) or "PR44" (international designation) Zinc-Air batteries, recommended by your implant centre or
Oticon Medical. Using another type of battery risks affecting the proper operation of the Neuro One (reduced battery life,
sound processor power supply fault).
For restocking on batteries, you can directly contact your local distributor or the Oticon Medical after-sales service.
Battery life
The battery life is variable depending on the patient, setting, acoustic environment and use of the device on a daily
basis.
User instructions for batteries
It is recommended that you keep the batteries in a dry place away from temperature variations and observe the expiry
date indicated on the packaging. The two batteries used for powering the Neuro One must be the same type and be
changed at the same time. It is important to remove the batteries when your sound processor is switched off for a
prolonged period (for example overnight).
The Zinc-Air batteries cannot be recharged and are for single-use, and must not be thrown away but returned to a
collection point (point of sale, waste disposal site, etc.) or in the containers provided for this purpose. Refer to current
legislation.
Important: The batteries are small components which could be a hazard if swallowed. Keep the batteries out of the
reach of children.

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Private alarm
The Neuro One sound processor indicates the end of the battery life by consecutive audible beeps (private alarm) that
cannot be heard by those around you. Your clinician must first configure this functionality at the time of an adjustment, so
that you may benefit from this private alarm. Two consecutive series of three beeps notify you of the low battery life 30
minutes before the end of the batteries' life. The following six beeps indicate the end of the batteries' life and the cut-off of
the sound processor. On hearing the first two series of audible beeps or if the sound stops or has deteriorated, it is highly
recommended that you change the two batteries. These discharged batteries could spill corrosive liquid that may damage
your sound processor.
Battery compartment
The Neuro One sound processor is equipped with a battery compartment locking system, to keep the battery compart-
ment closed while wearing or if the sound sound processor is dropped. This closure system is optional and may be
activated or deactivated at any time using the specific screwdriver provided.
• To lock the battery compartment: make sure that the compartment is correctly closed. Use the screwdriver provided in
the box to turn the screw to the locked position (illustration below).
• To unlock the battery compartment: Use the screwdriver to turn the screw to the unlocked position. You can now freely
open and close the battery compartment.
Inserting/changing batteries:
1. Switch off the sound processor (selector wheel on "0")
2. Deactivate the lock, if required.
3. Remove the used batteries and place the two new batteries (remove the protective film) in the compartment observing
the polarity indicated on the compartment (the batteries can only be inserted on one side). Reactivate the lock, if
required.

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You can then switch on your sound processor (turn the selector wheel towards the top to the appropriate position).
The lock is not necessary to keep the compartment closed, but comes as an additional feature. This feature does not replace adult supervision. If the sound processor falls
down, verify that the battery compartment is still locked. If necessary, reactivate the lock. Regularly clean the battery compartment so as to prevent the deposit of any
substance.
4. Switching on/off
Turn the selector wheel towards the top to switch on the sound processor.
Select the programme using the push button (P1, P2, P3, P4).
Set the position of the selector wheel so as to optimise your listening comfort dependent on the acoustic environment
(according to the configuration defined with the clinician).
To stop the device, turn the selector wheel to the bottom so that it is in the “0” position, at which point a click can be felt.
In case the device is stopped for prolonged periods (for example during the night), we recommend observing the
following procedure:
• Switch off the device.
• Open the battery compartment and remove both batteries.
• Place your Neuro One in the desiccation drying system and follow the steps in the related instructions or in the
“Accessories user manual”, and close it until using the sound processor again.
+
Zinc Air 675
3
21

16 17
This operation enables the moisture accumulated during use of the device to be absorbed, the battery contacts to be
dried and therefore prevents possible malfunction of the sound processor.
Warning: This sound processor is equipped with an automatic restart device in case of malfunction. This leads to momentary power loss.
5. Programme button
The Neuro One sound processor enables four different programmes to be saved (P1, P2, P3, P4). The person responsible
for the settings can define these programmes according to your preferences and conditions of use (normal surroundings,
noisy surroundings, use of FM system, Telecoil, etc.).
Each quick press on the programme button enables the following programme to be accessed. The programmes follow
one another in the order P1, P2, P3, P4, P1 etc. The orange indicator light indicates the programme selected. It flashes
once for P1, twice for P2 and so on.
In the case where the clinician does not activate all the programmes, the sound processor will only select the pro-
grammes activated (for example, if only P1 and P2 are set, repeatedly pressing on the button will enable you to move
from P1 to P2, and then to P1, etc.).
This function may be locked on request during an adjustment session, according to your preferences or needs, so as to
simplify the use of your device, or prevent a child from changing the programme.
6. Setting selector wheel
This programmable function is used, according to the mode configured, to adjust your listening to the acoustic environ-
ment. Your clinician will set the most appropriate mode for your daily routine, and will indicate the suitable setting for
using each of the programmes.
Change the position of the selector wheel in order to find the most comfortable listening position. This function can also
be locked during an adjustment session, notably in the case of young children, to prevent any mishandling, or to
simplify the use of your device.

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7. Indicator light
The orange indicator light is activated during an adjustment session and enables the status of the sound processor to
be easily identified, notably for people who are not familiar with the functioning of the device (teachers, educators, etc.).
Start-up test
At start-up, the light illuminates twice, and then extinguishes.
Stimulation indication
The light regularly flashes depending on the stimulation rate of the implant.
This light configuration can be activated upon request by your programming clinician.
Programme selection
Each quick press on the programme button is followed by one or more consecutive flashes of the light, indicating the
programme selected (once for P1, twice for P2 etc.).
Detecting Battery discharge
The light flashes for 30 seconds to warn of the low battery life. It flashes again 30 minutes later to indicate the full
discharge of the batteries and the cut-off of the sound processor.
This configuration can be deactivated at your request by your clinician.
Detection of any other errors
In case of a significant error that may alter the stimulation, the sound processor restarts (leading to momentary power
loss) and then the light flashes quickly and extinguishes. If the problem persists, contact your local distributor or the
Oticon Medical after-sales service.

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8. List of additional accessories available
For more information about the accessories and their use, refer to the accessories manual available on the USB memory
stick provided with the kit.
Cover Clip This Nylon and Spandex cover protects the sound
processor from moisture and perspiration, notably during
sporting activities or in case of a damp environment.
Carry case The case consists of several compartments that can be
used to store all of the necessary equipment (batteries,
accessories, etc.) for the system during your travels.
Screwdriver The screwdriver is used to activate or deactivate the
locking system of the sound processor’s battery compart-
ment.

18 19
Assistive Listening Systems
Assistive listening systems are used to improve the understanding of speech in noisy surroundings by reducing the
effect of distance between the sound source and the user.
1. Integrated telecoil
The Neuro One sound processor integrates a telecoil which enables enhanced listening in public places with a transmit-
ter (theatres, conference rooms, cinemas, airports, etc.). This telecoil is activated by simply selecting the programme
specified beforehand with your implant centre (P1, P2, P3 or P4).
2. Auxiliary Socket
The Neuro One sound processor integrates a direct connection (auxiliary socket) that is compatible with various external
hearing aid accessories (FM system, contralateral microphone, etc.), such as those shown below, that are commercially
available.
The use of such a system requires an adjustment at your implant centre in order to define a new specific programme.
You then just need to connect your system to the auxiliary socket of the Neuro One and select the programme specified
by your clinician (P1, P2, P3 or P4). Contact Oticon Medical to know which FM systems are compatible with the Neuro
One sound processor. For further information, please contact your clinician.
If an accessory is failing, the sound processor stops stimulating and the indicator light flashes slowly for 1 minute, then
the sound processor cuts-off.
Disconnect the auxiliary accessory before starting the sound processor.

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Care and user instructions
1. Care
Precautions
The Neuro One sound processor contains high performance electronic components that can be damaged. It must
therefore be handled with care and not be exposed to extreme temperatures. Secondly, under certain conditions, the
temperature (T°C) of your sound processor may reach 42°C maximum instead of 39°C (temperature when working
normally). Therefore, you may experience a warm sensation. In this case, remove the external part from the ear and
switch it off.
Important: If the device is dropped, check that it then works normally.
If in doubt, do not try to repair it yourself. The device does not contain any component that can be repaired by the user
or the implant centre; any attempt to open the unit will automatically lead to cancellation of the warranty. In case of a
problem, contact the Oticon Medical after-sales service which is alone capable of carrying out maintenance on its
products.
It is important not to immerse your sound processor in water in order to avoid damaging the electronic components.
Therefore, never wear the device in the shower, bath or while swimming. In the event of dropping it in dirty water, switch
off the sound processor, remove the batteries, immediately rinse the equipment in clean water and dry for 72 hours.
Make sure to always carefully disconnect the antenna cable by holding the socket with two fingers. You risk damaging
the cable by pulling directly above. It is highly recommended to keep one or more additional antenna cables. We recom-
mend that your device is serviced annually, which involves checking that it is working properly as well as checking the
calibration of the microphones, so as to optimise its service life.
Important: We strongly advise you to take out insurance to cover loss, theft or irreparable damage. Please contact your
implant centre for information.