Saphyr CX User manual

0459
®
USER’S MANUAL
Behind The Ear Processor
MANUEL DE L’UTILISATEUR
Processeur contour d’oreille
BEDIENUNGSANLEITUNG
HdO-Prozessor
MANUALE DELL’UTENTE
Processore retroauricolare
MANUAL DE USUARIO
Procesador retroauricular
POUŽÍVATEĽSKÁ PRÍRUČKA
Záušný procesor
INSTRUKCJA OBSŁUGI
Zauszny procesor mowy
MANUAL DO UTILIZADOR
Processador retroauricular
MANUALUL UTILIZATORULUI
Procesor retroauricular
HANDLEIDING VOOR DE GEBRUIKER
Achter-het-oor processor
KULLANIM KILAVUZU
Kulak Arkası İşlemci
ΕΓΧΕΙΡΙΙΟ ΧΡΗΣΗΣ
Οπισθοωτιαίο επεξεργαστή
РУКОВОДСТВО ПОЛЬЗОВАТЕЛЯ
Заушный процессор
® ®
,
1

EN - Instructions in English are found on pages 03-24
FR - Les instructions en français se trouvent pages 25 à 46
DE - Anweisungen in deutscher Sprache nden Sie auf den
Seiten 47 bis 68
IT - Le istruzioni in italiano sono presenti nelle pagine da 69 a 90
ES - Las instrucciones en español se pueden encontrar entre
la página 91 y 112
SK - Návod v slovenčine sa nachádza na stranách 113 až 134
PL - Instrukcje w języku polskim znajdują sie na stronach od
135 do 156
PT - Poderá encontrar instruções em português da página
157 à página 178
RO - Instrucţiunile în limba română se regăsesc de la pagina
179 la pagina 200
NL - Instructies in het Nederlands vindt u op pagina’s 201
tot222
TR - Türkçe talimatlar 223 ile 244 sayfaları arasında yer
almaktadır
ΕL - Οι οδηγίε στα Ελληνικά βρίσκονται στι σελίδε 245
έω 266
RU - Инструкциинарусскомязыкенаходятсянастраницах
267 - 288
289
300
2

CONTENTS
INTRODUCTION 4
Indications 4
Contraindications 4
Reliability – Quality 4
Compatibility with Older Implant Generations 4
HOW IT WORKS 6
The External Part 6
The Internal Part 6
CONTENTS OF THE SAPHYR® BOX 7
DESCRIPTION OF THE
SAPHYR®PROCESSOR 8
Saphyr® SP 8
Saphyr® CX 9
USING THE SAPHYR®PROCESSOR 10
1  CONNECTING THE COMPONENTS 10
2  ENSURING THE BEST FIT 10
- Magnet 10
- Hook 11
- Holding Buckle 11
3  POWER SOURCE OF THE PROCESSOR 11
- Type of Batteries 11
- Battery Lifespan 11
- User Recommendations 11
- Private Warning Sound - Changing the Batteries 12
- To replace the batteries 12
4  TURNING ON/OFF 13
5  PROGRAM SELECTOR 13
6  SELECTOR WHEEL 13
7  INDICATOR LIGHT 14
ASSISTIVE LISTENING DEVICES 14
1  INTEGRATED TELECOIL 14
2  OTHER DIRECT AUDIO INPUT DEVICES 14
MAINTENANCE AND USER
RECOMMENDATIONS 15
1  MAINTENANCE 15
- Precautions 15
- Cleaning 15
- Storage 16
- Drying Unit 16
- Recycling 16
2  RISKS AND USER RECOMMENDATIONS 16
- Accessories 16
- Playing Sports 167
- Medical Examinations 17
- Settings 17
- Electrostatic Discharge 17
- Passing Through Security Gates 17
- Travelling by Air 17
TROUBLESHOOTING: TOOLS  PROBLEMS
AND SOLUTIONS 18
1  TESTING TOOLS 18
- Using the Tester 18
- Microphone Earphones 18
2  PROBLEMS AND SOLUTIONS 19
- No Sound is perceived 19
- Intermittent sound 19
- Reduced or distorted sound 19
- Insucient battery life (<2 days) 19
- Problem keeping the antenna in place 20
MISCELLANEOUS 21
1  TECHNICAL SPECIFICATIONS 21
2  SYMBOLS 21
3  OPERATOR PROFILE 21
4  MANUFACTURER’S DECLARATION 22
2
3

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 specied in this manual when it is
necessary to provide information specic to that model. We recommend that you carefully
read this manual before using your processor.
If you have diculty 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 specied in the indications paragraph above. It is also not suitable for children who
have an auricle that is too small or too exible to support the external device. These patients
will be oered 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 dierent 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 dierent 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 t by your audiologist to the implant system of the other
ear. Each processor is congured for a specic implant.To easily dierentiate between the left and
the right processor and to avoid getting them mixed up, stickers in dierent 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.
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In the event one of the sound processors stops working, contact Neurelec to obtain a temporary
device.
Saphyr® SP PROCESSOR
compatible with the implants shown
ontheright:
Digisonic® SP
Cochlear implant
Digisonic® SP Evo®
Cochlear implant
Digisonic® SP Binaural
Binaural cochlear implant
Digisonic® SP ABI
Brainstem implant
Saphyr®CX PROCESSOR
compatible with the implants shown
ontheright:
Digisonic® DX10 and Digisonic® Convex
Cochlear implants
Digisonic® ABI
Brainstem implant
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HOW IT WORKS
The cochlear implant system is made up of an external part and an internal part.
The External Part
• A miniature signal processor inside a Saphyr®behind-the-ear contour (1) containing two
microphones.
• An external antenna (2) connected to the processor by an antenna wire (3).
The sound picked up by the microphones is only processed by the processor.
The antenna then transmits the stimulation signal to the implant through the skin.
The Internal Part
The implant consists of a small ceramic shell (4) that is placed under the skin. It contains an
electronic stimulator that distributes the sound to the 20 electrodes (5) placed in the cochlea.
Antenna wire
Saphyr®processor
Antenna
Implant
Electrodes
To the brain
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CONTENTS OF THE SAPHYR®BOX
The Saphyr®processor is delivered in a box that contains:
Photos for information only
• 1 Saphyr® (1) processor
• 1 Antenna with 5/4 strength magnet (2)
• 1 Antenna wire (3)
• 1 Case(4)
• 1“Perfect Dry”heating drying box (5)
• 1 Pack of zinc-air batteries (6)
• 1 Accessories box containing:
- 1 Spare antenna wire
- 1 Additional 4/3 strength magnet (7)
- Additional hook (8)
- 1 Holding buckle (9)
- 1 Clip-on cover (10)
- 1 Silhouette (11)
- 1 Set of earphones (12)
• 1 Bag organizer (13) containing:
- 1 Tester (14)
- 1 Pack of 6 batteries
- 2 Cleaning wipes (15)
- 1 Desiccant packet
- 1 Storage media (16) containing:
- 1 Accessories User’s Manual (17)
- 1 User’s Manual (18)
• Other Documents:
- 1 Pocket Guide (19)
- 1 Settings and speech therapy record
book (20)
- 1
Activation/warranty registration form (21)
- Others (warranty certicate
for the processor, etc.)
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DESCRIPTION OF THE SAPHYR®PROCESSOR
• Microphone 1 (A)
• Microphone 2 (B)
• Selector wheel with switch (C)
0: Turn o - 1: Position 1 - 2: Position 2 - 3: Position 3
• 4-position program selector (D):
P1: Program 1 - P2: Program 2 - P3: Program 3 - P4: Program 4
• Two-color indicator light (E)
• “ANT” socket (F): for connecting the antenna wire
• “AUX” socket (G): for connecting external accessories (FM system, earphones, etc.)
• Connection socket in order to program settings (H)
The Saphyr® SP and Saphyr® CX processors are visually distinguishable by their markings, how
the serial numbers are identied, and some of their accessories (antenna, magnet, and antenna
wire). The illustrations and descriptions of each product below explain these dierences.
Saphyr®SP
Antenna with keyed connector
Antenna wire with keyed connector
Saphyr® SP processor
The serial number for your Saphyr®SP processor is located inside the battery compartment:
“N1495” for example (N = processor generation / XXXX = manufacturing no.).
You should write this number down and save it, as you may be asked for it later.
8

Saphyr®CX
Saphyr® CX processor
Antenna wire without keyed connector
Antenna without keyed connector
The serial number for your Saphyr® CX processor is located inside the battery compartment:
“M1245”for example (M = processor generation / XXXX = manufacturing no.).
You should write this number down and save it, as you may be asked for it later.
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5/4
-
5/4
+
USING THE SAPHYR® PROCESSOR
1 CONNECTING THE COMPONENTS
To avoid any confusion for the user, both ends of the antenna wire are exactly the same.
Toconnect the components:
• Connect the antenna to the antenna wire
• Plug the antenna wire into the“ANT”socket on the processor.
There is a keyed connector on both ends of the antenna wire and on the Saphyr®SP processor’s
antenna. Therefore, when plugging the antenna wire into either the processor or the antenna,
make sure that the keyed connector is facing the right way as you insert it into the socket (see
the paragraph“Description of the Saphyr® Processor”).
Important: The antenna wire connectors are designed to be handled only under specic
circumstances (replacement of a defective wire, etc.). To extend the life of these connectors,
we recommend that you store your Saphyr®processor in its case without disconnecting
theantenna wire.
2  ENSURING THE BEST FIT
Magnet
A magnet holds the antenna in place against the skin on the other side of the implanted receiver.
You can change the distance between the skin and the magnet at any time by tightening
orunscrewing the magnet.
To tighten or unscrew the magnet:
- Hold the antenna by pressing both sides of the magnet cover between two ngers, as shown
in the rst image below.
- To unscrew and remove the antenna magnet, turn the magnet clockwise, as shown in the
second image.
- To tighten the magnet, turn it counterclockwise.
The underside of the magnet provides information about the magnet strength (5/4 strength is
standard) and which processor model it is compatible with, as shown below:
Saphyr® SP – Underside
ofmagnet
Saphyr® CX – Underside
ofmagnet
Photo 2
Photo 1
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