Oticon Medical Digisonic SP User manual

EN - Instructions for use, pages 3 to 9
FR - Instructions d’utilisation, pages 11 à 17
DE - Bedienungsanweisungen, Seiten 19 bis 25
IT - Istruzioni per l’uso, pagine da 27 a 33
ES - Instrucciones de funcionamiento, páginas 35 a 41
SK - Návod na použitie, strany 43 až 49
PL - Instrukcja użytkowania, strony od 51 do 57
PT - Instruções de utilização, páginas 59 a 65
RO - Instrucţiuni de utilizare, paginile 67 până la 73
NL - Gebruiksinstructies, pagina’s 75 tot 81
TR - Kullanım talimatları, sayfa 83 ila 89
EL - Οδηγίες χρήσης, σελίδες 91 έως 97
RU - Инструкции по применению, стр. 99 - 105

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CONTENTS
1. DESCRIPTION ................................................................................................................. 4
Model Name ............................................................................................................ 4
Commercial Identication........................................................................................ 4
Device Description .................................................................................................. 4
2. PACKAGE CONTENTS.................................................................................................... 4
3. LIST OF COMPATIBLE ACCESSORIES......................................................................... 4
4. SYMBOLS AND MEANINGS........................................................................................... 4
5. INDICATIONS................................................................................................................... 4
6. MEDICAL CONTRAINDICATIONS.................................................................................. 5
7. ADVERSE SIDE EFFECTS.............................................................................................. 5
8. PRECAUTIONS................................................................................................................ 5
9. CAUTION, INTERACTION WITH CLINICAL TREATMENTS AND INVESTIGATIONS ......... 6
Caution .................................................................................................................... 6
High-Energy Electrical Field.................................................................................... 6
Electrotherapy ................................................................................................... 6
Electrosurgery................................................................................................... 6
Electroshock Therapy and Debrillation ........................................................... 6
Medical Diathermy................................................................................................... 6
Diagnostic Tests and Treatment with Ultrasound .................................................... 6
Radiation Therapy with Ionizing Radiation .............................................................. 6
Non-Ionizing Electromagnetic Radiation................................................................. 6
MRI (Magnetic Resonance Imaging) ................................................................ 6
10. INSTRUCTIONS FOR USE............................................................................................ 7
Electrosurgery ......................................................................................................... 7
Preoperative Management ...................................................................................... 7
Intraoperative Management .................................................................................... 7
Placing the Incision and Positioning the Receiver ............................................ 7
Handling the Implant......................................................................................... 7
Orientating the Implant...................................................................................... 7
Attaching the Implant........................................................................................ 8
Inserting the Electrode-Array ............................................................................ 8
Positioning the Reference Electrode................................................................. 8
Conrming Functioning of the Implant .............................................................. 8
11. EXPLANTATION ............................................................................................................ 9
12.TECHNICAL SPECIFICATIONS OF THE DIGISONIC®SP IMPLANT .......................... 9
13. PERFORMANCE CHARACTERISTICS ........................................................................ 9
14. SPECIFICATIONS AND CHARACTERISTICS OF THE ELECTRODE-ARRAY ........... 9

1. DEVICE DESCRIPTION
• Model Name
Digisonic®SP Cochlear Implant
• Commercial Identication
I-SP-SD
• Device Description
The Digisonic®SP is a multi-channel cochlear implant intended to rehabilitate bilateral severe (second degree)
to profound perceptive deafness. This transcutaneous cochlear implant functions with a behind the ear external
processor (DIGI SP/ SAPHYR® SP) or with a micro-behind the ear processor with remote battery (DIGI SP’K).
By means of electromagnetic coupling, an external antenna transmits the acoustic signal processed by the
processor to the Digisonic®SP implant implanted under the skin behind the auricle of the ear.
Le Digisonic®SP includes an electrode-array with 20 electrodes that is inserted into the cochlea (inner ear). Each
electrode stimulates a dierent set of auditory nerve bers and is associated with a frequency band of the sound
signal that is processed by the external processor. The implant and the external antenna contain a magnet; the
external antenna is thus kept in place relative to the implant by magnetic attraction. The Digisonic®SP does
not contain its own electric power source; it receives the energy necessary for functioning by electromagnetic
coupling. Consequently, when the external antenna is not correctly positioned relative to the Digisonic®SP, the
implant is passive.
2. PACKAGE CONTENTS
1 Digisonic®SP (I-SP-SD) implant, 1 silicone implant template, 1 attachment system, 1 wearer-ID card, and
accompanying documents.
3. LIST OF COMPATIBLE ACCESSORIES
The implant is supplied with the following accessories:
• 1 silicone implant gauge used during the surgery to verify the correct positioning of the implant under the
skin.
• 2 self-tapping screws used to x the implant in position; these do not require any pre-drilling.
4. SYMBOLS AND MEANINGS
Catalog reference Important. Read the accompanying
documentation
Sterilization method: ethylene oxide
Product delivered sterile Maintain humidity level between 15% and 75%.
Single-use device, do not reuse Manufacturing date
STORAGE: store in a cool dry place.
Storage temperature between -20° C
and +50° C. Batch code
Fragile; handle with care Use by date
Do not use if package is damaged Serial number
Do not re-sterilize Manufacturer
Waste electrical and electronic equipment
(WEEE) Instructions for use
5. INDICATIONS
The multi-channel Digisonic®SP cochlear implant is designed to rehabilitate patients who have 2nd degree
severe to total bilateral hearing loss with a speech intelligibility level of less than 50% at 60 dB HL in open-set
format with the use of a hearing aid (professional medical opinion required).
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6. MEDICAL CONTRAINDICATIONS
The Digisonic®SP cochlear implant is not indicated in patients with perceptive hearing loss accompanied by
signicant lesions of the cochlea (major cochlear malformation, fracture of the petrous part of the temporal bone,
signicant ossication in the cochlea), auditory nerve (axonal neuropathy, tumor near or on the auditory nerve
such as a neurinoma, complete destruction of both auditory nerves), a severe anomaly of the auditory pathways,
acute or chronic middle ear conditions (including tympanic membrane perforation), is psychologically unstable
or has a contact allergy to implant materials (silicone, platinum iridium, titanium). Other types of implants may
be recommended.
7. ADVERSE SIDE EFFECTS
For patients who meet the indications, implantation has typical risks associated with surgery (eects from
general anesthesia, infections, etc.) which is independent of the product itself. However, there is also a risk
that the patient’s body may reject the implant or a part of the implant; this risk has been reduced by using
biocompatible materials in the design.
Complications associated with the cochlear implant operating technique (temporary or permanent facial
paralysis, risk of meningeal irritation syndrome, changes in taste, dizziness, tinnitus, etc.) are rare, but should
be considered carefully. It is important to inform every cochlear implant candidate about these potential risks.
Specic information should be given to the patient regarding the symptoms and the initial signs of meningeal
irritation syndrome. According to current recommendations, pneumococcal vaccination is also strongly
recommended.
Once the implant is in place, there remain certain risks that may result in explantation. Explantation requires
another surgical intervention under general anesthesia. Explantation may occur in the following cases:
- Medical complication
- Implant malfunction
- Displacement of the device as a result of trauma
- Extrusion of the implant
These potential problems were evaluated during product design and the materials and design of the implant
have been chosen to minimize these risks.
Finally, the long-term eects from trauma associated with the insertion of electrodes and chronic electrical
stimulation are unknown at the present time. These eects may include cochlear ossication or degeneration
of the nerve bers, and may require replacement of the implant or lead to a reduced response to stimulation.
8. PRECAUTIONS
Information to give the Patient
- Inform the patient of the benets of a cochlear implant, and also the adverse side eects which could occur
(see §7).
- The supplied identication card must be fully completed and given to the wearer.
- Inform the patient that they must present the identication card prior to any medical examination or treatment.
- Advise the patient to carefully read the user instructions supplied with his/her external processor, in particular
the section relating to the warnings for use.
- Tell the patient to contact the implantation center In case of failure or malfunction of the cochlear implant
system.
- Contact sports (rugby, boxing, etc.) are strongly discouraged, since strong impacts to the area of the implant
can damage it.
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- Scuba diving: Recreational scuba diving is not recommended at depths below 20m. Excess pressure can
damage the implant. Moreover, engaging in professional deep-sea diving activities is strongly discouraged,
since the implant is not guaranteed against repeated high pressure stresses.
- Access to restricted areas: Please consult a physician before entering restricted access areas (MRI exam
room, walk-through metal detectors, 3D scanning booths, etc.).
9. CAUTION, INTERACTION WITH CLINICAL TREATMENTS AND INVESTIGATIONS
-Caution: Implantable device parts should not be reused if they have been previously implanted in another
patient.
- High-energy electrical eld:
- Electrotherapy: Electrotherapy may send currents of varying strengths. The use of high-voltage electric-
current electrotherapy techniques is prohibited due to the risk of damage to the implant system. However,
low-voltage electrotherapy may be considered only if the electrodes are not placed in areas of the head or
neck.
-Electrosurgery: Avoid the use of monopolar electrosurgical instruments. These instruments can create
radio-frequency elds with electrical voltages that could create coupling between the tip of the instrument
and the electrode-array. Induced currents could damage the cochlear tissue or produce permanent damage
to the implant. As soon as a cochlear implant is removed from its packaging in the operating room, any
monopolar scalpel should be turned o to avoid any damage to the implant. However, bipolar electric
scalpels may be used as long as it is not near or in direct contact with the cochlear implant.
-Electroshock therapy and debrillation: Sending several thousand volt electrical shocks through the body
is not advised in a patient wearing a cochlear implant. Electrical shocks can cause tissue damage in the
cochlea or permanently damage the implant.
In a life-threatening situation, only the medical team is in a position to make a decision. If the situation is not
life-threatening for the patient, please contact Neurelec.
-Medical diathermy: Electromagnetic diathermy cannot be used on patients with implants containing metal.
This may cause irreversible damage to tissue (burning of the cochlea) or the implant. However, ultrasonic
diathermy may be considered on areas of the body that do not touch the head or neck.
-Diagnostic tests and treatment with ultrasound: The implant should not be exposed to therapeutic levels of
ultrasonic energy. The device may inadvertently concentrate the ultrasound and be damaged.
-Radiation therapy with ionizing radiation: During radiation therapy sessions, we strongly advise against
direct irradiation of the implant area. Direct, massive exposure of the implant to radiation could lead to partial or
total loss of implant functions. This damage is not necessarily immediately noticeable.
-Non-ionizing electromagnetic radiation:
-MRI (Magnetic Resonance Imaging): The Digisonic®SP implant contains a permanent magnet. An
MRI exam or the application of an intense magnetic eld in the area of the implant could lead to damage
totheimplant and/or the patient. It is however possible to perform an MRI exam at 1.5 Tesla by following
therecommendations. In this case, the radiologist should ll out an exam form available from the website
www.neurelec.com.
Refer to the processor’s user manual for more information.
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Information
bone-side
surface
Manufacturer
name
Serial number (SN):
DR: Digisonic Receiver
00: year of manufacture
K : SP version
1234: incremental number
10. INSTRUCTIONS FOR USE
Please note!
Electrosurgery: Once the implant is put into place, the rest of the surgical procedure should not include the
use of any monopolar electrosurgical instruments. These instruments can create radio-frequency elds with
electrical voltages that could damage the implant. Bipolar electric scalpels can be used as long as they are
not used near or in contact with the cochlear implant.
Preoperative management
- Before performing the rst Digisonic®SP implantation, the operator should become familiar with the particular
technical specications of the Digisonic® SP cochlear implant and the associated surgical technique.
- Before implantation, patients should be informed of the benets of a cochlear implant and its possible
secondary risks (see §7).
Intraoperative management
- Placing the incision and positioning the receiver: Before making the incision for the skin ap, determining
the optimal site of the implanted system is recommended. In doing so, the location of the incision should account
for the fact that the implant should not be placed below the auricle but at a large enough distance for the patient
to wear the processor behind the ear without conicting with the position of external antenna. In addition, the
incision line should be far enough away from the implant to prevent the risk of postoperative extrusion or infection.
Using a sterile skin pencil to draw the retroauricular incision line oset about 1cm from the retroauricular crease
and the receiver’s position about 2 cm away from the auricle of the ear is therefore recommended. These
locations can be determined by using the implant template and the processor template (supplied separately
upon request) placed in position over the ear.
After making the incision, use the implant template to prepare the location necessary for the proper positioning
of the receiver. The surface of the bone should be checked to make sure it is at enough to subsequently attach
the receiver in place easily with screws.
- Handling the implant: Remove the implant from the sales packaging only after completing the standard
surgical procedures up to starting the cochleostomy. Open the outer packaging making sure the implant is not
damaged. After carefully cutting the suture threads holding the implant in place, gently remove the implant from
its sterile holder. Avoid touching and/or bending the electrode array. Do not use sharp surgical instruments that
could damage the electrode-array.
- Orientating the implant: The engraved surface of the Digisonic®SP implant (NEURELEC, BOTTOM) should
not be visible in conguration for use and should therefore be turned toward the skull. This titanium metal-plate
contains, as follows, important information with which to identify the implant:
Implant type (model): The
Digisonic® SP implant
is identied by the
DIGISONIC®SP inscription

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- Attaching the implant: No milling of the bone is needed for the implant bed. Simply slide the receiver under
the temporal muscle into the location prepared using the silicone template. Conrm that the implant is positioned
properly and cannot rock with application of nger pressure. Only access to the implant’s mounting tabs is
required for attaching the system. The implanted receiver has to be stabilized
to prevent any possible displacement, which could create tension and lead to
possible damage to the electrode wires. It is therefore recommended to secure
it in place with the two self-tapping screws provided in the packaging, and pre-
positioned in the implant holder. Follow the steps below to remove the screws from
the holder:
• Insert the screwdriver (provided with the initial surgical kit) into the screw
using rm axial pressure.
• Unscrew the screw while slowly withdrawing it from the holder.
• The screw is now attached to the screwdriver and can be used.
Gently position the rst screw into one of the xation system’s titanium inserts. It is recommended to hold the
screwdriver vertical to the implant’s axis to make attachment easier. Tighten the screw until feeling resistance,
then progressively free the screwdriver by applying a slight circular motion to it. Check that it is secure, then
repeat the same procedure for the second screw.
Note: Neither the surgeon nor any person not authorized by Neurelec may make changes to the implant (such
as to the xation system).
-Inserting the electrode-array: Orient the electrode-array so as to insert following the cochlear spiral. Guide
the end of the electrode-array towards the base of the scala tympani using the insertion claw or small forceps,
then progressively insert the electrode-array forcing as little as possible. Finish the insertion by pressing down
on the silicone extracochlear push rings. Once insertion is complete, the rings should block the cochleostomy.
The electrode array may be attached to prevent the risk of migration. The attachment method and attachment
points will depend on the surgical access and the surgeon’s preferences.
-Positioning the reference electrode: Place the extracochlear reference ball electrode against the bone under
the temporal muscle.
-Conrming functioning of the implant: Impedance measurements, before or after closing the incision, can
conrm the proper functioning of the implanted device.
11. EXPLANTATION
If malfunction of the Digisonic®SP implant is suspected, an expert review of the system must be done with
the help of Neurelec clinical support. If malfunction of the implant is conrmed and the medical team decides
to explant, it is important to contact Neurelec, who will inform you of the explantation procedure to follow. It is
especially important to request an explantation kit from Neurelec so that the explanted system may be sent back,
and thus the expert review of the device may be performed.

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- In case of doubt about the specied performance, please contact Neurelec customer service for your safety.
- Should you have any comments or if the information provided is incomplete, please contact your manufacturer
or your local distributor.
Digisonic® SP is a registered trademark of Neurelec-France
12. TECHNICAL SPECIFICATIONS OF THE DIGISONIC® SP IMPLANT
Primary function Cochlear implant
Stimulation mode Balanced biphasic stimulation
Stimulation rate 24,000 pps maximum (pps: pulses per second)
Other available functions
- Impedance measurement
- Measurement of the implant’s power
- Integrity test*
- EABR (Evoked Auditory Brainstem Response)*
- Stapedius reex
Psychoacoustic tests (gap test, etc.)*
* With associated equipment
Weight 10.5 g
Dimensions Diameter 30.2 mm – Thickness: ranging from
4.9 (edge) to 5.75 mm (center)
Volume 4 cm3
Material in direct contact with human tissue
- LSR 40 shore A silicone
- Silicone HCR 35 shore A and HCR 50 shore A
- Silicone adhesive
- Platinum iridium 10%
- Titanium grade 2
- Titanium grade 5
13. PERFORMANCE CHARACTERISTICS
Characteristics of the output signal
(on resistance of 1 kΩ) Max 2V -255µs V: 0 to 4V
I: 10 µA to 2 mA
Δt: 10 µs to 255 µs
Impedance measurement Yes: Normal values: 500Ω – 5kΩ
MRI safety level Compatible with 1.5 Tesla. Refer to the
recommendations
Recommended methods for determining the proper
functioning of the system Yes. Impedance measurement and integrity test (with collection equipment)
14. SPECIFICATIONS AND CHARACTERISTICS OF THE ELECTRODE-ARRAY
Monopolar electrical congurations Common ground
Number of independent active electrodes 20
Reduced cochleostomy size 1 mm diameter
General shape Straight with shape memory
Shape at apex Soft tip
Shape at the base Two 1.5 mm diameter push rings
Constituent materials - Connecting wire: Platinum iridium 10%
- Stimulation electrodes: Platinum iridium 10%
Insulation PEI (polyesterimide)
Dimensions
- Length: 26mm
- Diameter at the base and at the apex: 1.07 mm and
0.5 mm
- Minimum and maximum surface area of the
stimulation electrodes: 0.39 mm² and 0.77 mm²
- Distance between electrodes: 0.7 mm
- Maximum distance between proximal and distal
electrodes: 22.3 mm

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