MED-EL CONCERTO Compressed, Руководство пользователя

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AW 7846 Rev. 1.0
6
DEvicE DEscriptiOn
The implant is the implantable part of the meD-el Cochlear Implant system and can only be used together with
compatible meD-el external components. The device consists of a stimulator, a coil with a magnet within its
center, a reference electrode, an eAp reference electrode and an active electrode permanently attached to the
stimulator. The active electrode can be of different types, thus resulting in different implant variants (implant
family ConCeRTo)
1
. This device is intended to be implanted by adequately trained and experienced surgeons
only.
The implant offers a stimulation mode and a telemetry mode. stimulation sequences of biphasic and triphasic pulses
can be delivered sequentially or simultaneously on two or more channels. In telemetry mode the device allows a
functional check about the technical status of the implant including communication over the transcutaneous link
as well as the assessment of the electrode impedances and recording of the electrically evoked compound action
potential of the hearing nerve.
The implant has a mass of 7.6 g (typical weight).
For principal dimensions of the implant refer to the drawings on the previous pages.
The volume of the implant without electrode is 4.47 cm
3
.
Following materials are in direct contact with human tissue: medical grade silicone, platinum, iridium and
titanium.
pErFOrMAncE cHArActEristics
•
output characteristics of a stimulation signal on a 1 kohm resistor:
maximum current amplitude: median value = 1250 µA, range = 500 µA
maximum pulse width: median value = 203.8 µs, range = 8.2 µs
• The impedance measurement accuracy is typically better than 5%.
• When keeping to the safety guidelines listed on meD-el’s mRI examination Request Form the implant is
conditionally mRI safe for mR scanner field strengths of 0.2 Tesla, 1.0 Tesla and 1.5 Tesla. please contact
meD-el prior to any mRI scanning.
• There are no default factory settings of the implant system.
• proper functioning of the implantable part of the CI system can be checked by performing telemetry (refer
to mAesTRo application software user manual).
spEciFicAtiOn AnD cHArActEristics FOr EAcH LEAD AnD ELEctrODE ArrAY
•
The implant has 24 independent current sources stimulating 12 independent electrode channels in monopolar
mode.
• The electrode is made of medical grade silicone, platinum (electrode contacts) and platinum/iridium (90/10)
wires.
• All electrode variants have a straight design. The electrode does not deliver any medicinal substances.
• physical dimensions of the electrodes: length of the electrode lead = 126 mm (typical value), except for the
FleX
eAs
electrode: 114 mm.
Cross-sectional dimensions of the
electrode array geometric surface area per
channel Distance
electrode type at proximal end
of array
(typical value, mm)
at distal end of
array
(typical value, mm)
of smallest
stimulating
electrode
contact
(typical value, mm
2
)
of largest
stimulating
electrode
contact
(typical value, mm
2
)
between
contacts
(typical value, mm)
between most
proximal and
most distal
contact
(typical value, mm)
ConCeRTo standard 1.02 x 1.00 0.52 x 0.50 0.14 0.14 2.4 26.4
ConCeRTo medium 0.77 x 0.75 0.52 x 0.50 0.14 0.14 1.9 20.9
ConCeRTo Compressed 0.66 x 0.64 0.52 x 0.50 0.14 0.14 1.1 12.1
ConCeRTo split 0.66 x 0.64 0.60 x 0.58
0.57 x 0.55 0.14 0.14 1.1 4.4
6.6
ConCeRTo FleX
soFT
1.02 x 1.00 0.50 x 0.37 0.13 0.14 2.4 26.4
ConCeRTo FleX eAs 0.77 x 0.77 0.50 x 0.34 0.13 0.14 1.9 20.9
The implant does not have any connector.
intEnDED usE
The meD-el Cochlear Implant system is intended to evoke auditory sensations via electrical stimulation of the
auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from
acoustic amplification in the best aided condition.
Additionally the meD-el Cochlear Implant system used in combination with the implant variant
ConCeRTo FleX
eAs
is intended to evoke auditory sensations via electrical stimulation or via combined electric-
acoustic stimulation (eAs) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic
amplification in the lower frequencies only.
purpOsE OF tHE DEvicE
The purpose of the device is the perception of environmental sound and potential for improvement of
communicational abilities.
instructiOns FOr usE
for the ConCeRTo Cochlear Implant
en
EnGLisH