oticon Neuro One, Инструкция по эксплуатации

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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.