Introduction; Indications; Contraindications; Reliability - Quality - Saphyr SP Manual De Usuario

INTRODUCTION

You have just received a Saphyr® processor that is designed, developed, and manufactured by
Neurelec. This Saphyr® manual provides information on how to use the device, as well as the
precautions you need to take.
The processor model (Saphyr® SP or Saphyr® CX) will be specified in this manual when it is
necessary to provide information specific to that model. We recommend that you carefully
read this manual before using your processor.
If you have difficulty reading the information contained in this manual or in the Saphyr®
processor packaging, or if the information provided is incomplete, please contact your
manufacturer or your local distributor.

Indications

The Saphyr® processor is designed for adults and children with 2nd degree severe to profound
bilateral perceptive hearing loss—assessed by inadequate level of speech audiometry even
with a hearing aid--who have received a Neurelec Digisonic® DX10/Convex, Digisonic® DX10,
Digisonic® SP, Digisonic® SP ABI or Digisonic® SP Binaural cochlear implant.

Contraindications

The Saphyr® processor is not indicated in patients who have received an implant other than
those specified in the indications paragraph above. It is also not suitable for children who
have an auricle that is too small or too flexible to support the external device. These patients
will be offered a remote battery-operated micro-processor (Digi SP'K processor).
Reliability – Quality
The cochlear implant system is an active implantable medical device. To ensure your safety,
the Saphyr® processor is designed and manufactured in accordance with the requirements
laid down in European Directive 90/385/EEC. The device complies with the standard EN 45502-
2-3:2010 on Active Implantable Medical Devices (AIMDs) - cochlear and auditory brainstem
implant systems, and with Medical Device safety standards.

Compatibility with Older Implant Generations

The Saphyr® processor is available in two different models (Saphyr® SP and Saphyr® CX) to go
with the implanted receivers shown in the diagram below.
Note: It is important to always carry the cochlear implant owner ID card given to you by
your implantation center and to present it prior to any medical examination or treatment.
The remainder of this document will only refer to the Digisonic® SP cochlear implant system, even
though the Saphyr® processor is also compatible with the different implants mentioned above.
For bilateral cochlear implantation: patients with two cochlear implant systems are urged not to
wear the processor on one ear that was fit by your audiologist to the implant system of the other
ear. Each processor is configured for a specific implant. To easily differentiate between the left and
the right processor and to avoid getting them mixed up, stickers in different colors are supplied in
the product packaging. The Left/Right stickers should be placed on the part of the processor that
is not in contact with the skin. In the event one of the sound processors stops working, contact
Neurelec to obtain a temporary device.
4