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: +33 (0)4 93 95 18 18, FAX: +33 (0)4 93 95 38 01
23
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
23
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.
67
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
89
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
10 11
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.
Table of contents
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