NEURELEC SAPHYR CX, User Manual

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This manual that comes with the Saphyr processor tells you about the use of the device and
about the precautions that should be taken in use.
The model of the processor (Saphyr SP and/or Saphyr CX) will be specified only when information
is specific to one or the other of the models. We urge you to read this document carefully before
using the device.
NB
: it is important that you always keep with you your cochlear implant owner card filled in by
your implantation centre and to present it every time you undergo a medical examination or
medical treatment.
Your implanted receptor contains a permanent magnet and is sensitive to electric currents.
Consult your implantation centre or Neurelec immediately before any electrotherapy or any
exposure to intense radiation (such as radiation therapy). Otherwise, please always remove
the external part before undergoing any medical examination (such as radiation therapy, MRI,
echography, scanning, etc).
Your implant system is compatible with 1.5 Tesla MRI imaging. Your processor should always be
removed if you are close to a place with a strong magnetic field. The MRI request form (available
at www.neurelec.com) should be immediately filled in by the radiology department involved and
returned to Neurelec before any examination is carried out.
The acquisition of a Saphyr processor requires a number of adjustments to achieve optimum
hearing quality. If there are any abnormal sensations or pain during use of your equipment, remove
the antenna and contact your implantation centre. For young children, parents and teachers are
advised to monitor the child’s behaviour when using the processor. An adjustment check by your
audiologist is necessary at least once a year for good functioning of your cochlear implant system.
Each processor is programmed using the adjustment software for your personal use by an
audiologist trained by Neurelec, and should in no case be lent to or exchanged with another
person. The use of the processor by another person could provoke very loud or distorted sound
sensations. Always consult your adjustment centre.
The Saphyr processor contains high performance electrical components. Avoid any exposure to
extreme temperatures, avoid dropping it or immersing it partially or totally in water. The equipment
does not contain any component which can be repaired by the user or the implantation centre;
if you try to open the processor, this will automatically void the warranty. If there is any problem,
your processor must always be returned to Neurelec after-sales service. In fact, any work carried
out on the Saphyr by someone not trained by Neurelec risks damaging the equipment and making
it dangerous to use.
We strongly advise you to take out insurance against loss, theft or irreparable damage. Enquire
about this at your implantation centre.
Throughout this document, only the cochlear implant system will be mentioned even if the Saphyr
processor is just as compatible with the various implants mentioned previously. The cochlear
implant system is an active implantable medical device. To ensure your safety, the Saphyr processor
is designed and manufactured in compliance with the requirements of the European directive
90/385/CEE. The device complies with the standard on the general rules on safety of electromedical
equipment NF EN 60601-1: 2006, as well as to the collateral standards NF EN 60601-1-1: 2001
(safety rules for electromedical systems), NF EN 60601-1-2: 2007 (electromagnetic compatibility),
NF EN 62304: 2006 (software life cycle process) and NF EN 60601-1-6: 2007 (usability).
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