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Summary of Contents for oticon Neuro One
- Page 1 Neuro One Instructions for use Neuro – The Cochlear Implant System NEURELEC (2015) 2720 Chemin Saint-Bernard, 06220 Vallauris – France 0459 TEL: +33 (0)4 93 95 18 18, FAX: +33 (0)4 93 95 38 01...
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Page 2: Table Of Contents
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 ........................ - Page 3 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 ....................
- Page 4 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...
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Page 6: Introduction
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. -
Page 7: Implant Compatibility
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. -
Page 8: How It 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). -
Page 9: Packaging Contents
11. Sound processor registration form (activation of the warranty) x 1 12. Silhouette x1 13. Identification Stickers Left/Right Pictures are not contractually binding Note: The references are provided in this IFU in the section “References of Neuro One sound processor, spare parts and accessories”... -
Page 10: Neuro One Sound Processor Description
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). -
Page 11: Using The Neuro One Sound Processor
• 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... -
Page 12: Ear Hook
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. -
Page 13: Powering The Sound Processor
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. -
Page 14: Private Alarm
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. -
Page 15: Inserting/Changing Batteries
• 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. -
Page 16: Programme Button
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.). -
Page 17: Indicator Light
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. -
Page 18: List Of Available Accessories
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. -
Page 19: Assistive Listening Systems
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). -
Page 20: 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). -
Page 21: Cleaning
Desiccation system In case your sound processor is stopped for prolonged periods (for example during the night), we recommend removing both batteries and placing the Neuro One in the desiccation box (Perfect Dry ® provided for absorbing the residual humidity. Refer to the user instructions before use or to the "Accessories user manual"... -
Page 22: Risks And User Instructions
Concerned about the preservation of our environment, Oticon Medical is a member of the environmental body Récylum (France) for the collection and recycling of our devices. You can send us your system (or via your distributor) so that your hearing system can be recycled. -
Page 23: Settings
The MRI exam has to be processed with head first. Settings Each sound processor is programmed by a clinician authorised by Oticon Medical for personal use and must not under any circumstances be lent to or exchanged with another person. -
Page 24: Tools And Troubleshooting
Tools and Troubleshooting 1. Testing tools Various functionalities and tools are made available to you in order to check that the Neuro One sound processor and its accessories are working properly: • Indicator light. • Private alarm to detect the end of battery life. -
Page 25: Microphone Earphones
Microphone earphones The Neuro One sound processor is equipped with an auxiliary socket that enables one to listen to the audio signals which enter the sound processor. This accessory is used to identify problems on the microphone: microphone entry blocked, faulty microphone. - Page 26 Quick flashing indicator light for one minute 1. Change both batteries. The sound processor restarts and the indicator light flashes quickly then extinguishes The sound processor detects an error. If the problem remains, contact your local distributor or the Oticon Medical after-sales service.
- Page 27 2. Ask for advice from your implant centre in order to obtain a stronger magnet. Note: The first time the magnet is unscrewed may prove difficult. Important: Any equipment sent to your local distributor or the Oticon Medical after-sales service must be accompanied by a detailed description of the symptoms.
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Page 28: Miscellaneous Information
Miscellaneous Information 1. Technical characteristics Sound processor Maximum dimensions: 50.5 x 50 x 10.6 mm Weight (with batteries): 11.4 g Power supply Operating range of the device: from 1.8 V to 3.7 V 2 disposable 675 Zinc-Air batteries Maximum consumption: 60 mW Maximum transmission power: 35 mW Storage and Transport Storage and transport temperature: -20°C to 50°C... -
Page 29: Symbols
2. Symbols Refer to instruction manual. Waste electrical and electronic equipment (WEEE) Type B device Switching the sound processor on/off P675: "675" (European designation) or "PR44" (international designation) Zinc Air batteries +: Battery positioning direction Operating instructions Temperature limit to which the medical device can be exposed Humidity limit to which the medical device can be exposed 1060 hPa Atmospheric pressure... -
Page 30: Profile Of The Person Handling The Sound Processor
Neuro One sound proces- sor. Therefore, these devices should be kept as far away as possible from the Neuro One and its accessories in order to avoid such effects. - Page 31 Guidelines and manufacturer's declaration – Electromagnetic emissions The Neuro One sound processor is intended for use in the electromagnetic environment specified below. The Neuro One user should ensure that it is used in such an environment. Emissions tests Compliance CISPR 11 RF emissions...
- Page 32 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test IMMUNITY Band frequency Service Modulation Maximum power (W) Distance (m) TEST LEVEL (MHz) (MHz) (V/m) Pulse 380 – 390 TETRA 400 modulation 18 Hz FM ± 5 kHz deviation GMRS 460, 430 –...
- Page 33 5240 Pulse WLAN 802, 5500 5100 – 5800 modulation 11 a/n 217 Hz 5785 Date of last review: 2018-01 Essential performance: The Neuro One sound sound processor should stimulate below the thresholds defined in DigiMap USB within a 10% tolerance.
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Page 34: References Of Neuro One Sound Processor, Spare Parts And Accessories
References of Neuro One sound processor, spare parts and accessories: • Neuro One sound processor: M80336, M80337, M80338, M80339, M80340, M80341, M80342 • Antenna: M80344, M80346, M80793, M80795, M80343, M80345, M80792, M80794 • Antenna cable: A-SP9-ANL2-BL-6, A-SP9-ANL2-NBR-6, M80790, M80791; A-SP9-ANL2-BL-10, A-SP9-ANL2-NBR-10, M80923, M80924 •... - Page 36 Oticon Medical NEURELEC 2720 Chemin Saint-Bernard 06220 Vallauris France TEL: +33 (0)4 93 95 18 18 FAX: +33 (0)4 93 95 38 01 info@oticonmedical.com www.oticonmedical.com...
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