MED-EL CONCERTO Compressed, Руководство пользователя

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AW 7846 Rev. 1.0
7
inDicAtiOns
•
The cochlear implant evokes acoustic perception via electrical stimulation of the auditory nerve. A functional
auditory nerve is thus a prerequisite for successful cochlear implantation.
• meD-el strongly recommends using optimally fitted hearing aids for a minimum of three months before
deciding that a cochlear implant is the preferential option. However, if a patient was deafened by an infectious
disease, which can lead to ossification and if there are signs of cochlear ossification there may be no need to
try a hearing aid. In these cases, implantation should not usually be delayed.
• To obtain the optimal benefit from the implant, the prospective implant users and their families shall be highly
motivated and have realistic expectations about the expected benefit of the implant and shall understand the
importance of returning to the implant center for regular audio processor programming, assessment sessions
and training.
• A pre-operative assessment according to the local professional standards must be conducted.
• Cochlear implants ConCeRTo standard are intended to be used in open cochleae (no obliteration or
ossification) for an electrode insertion depth of about 31 mm.
• Cochlear implants ConCeRTo medium are intended to be used in open cochleae (no obliteration or
ossification) with mild malformation for an electrode insertion depth of about 24 mm as per request of the
surgeon.
• Cochlear implants ConCeRTo Compressed are intended to be used in cochleae with moderate
obliteration, ossification, or malformation for an electrode insertion depth of about 15 mm as per request of
the surgeon.
• Cochlear implants ConCeRTo split are intended to be used in cochleae with severe obliteration or
ossification where two cochleostomies have to be drilled as per request of the surgeon.
• Cochlear implants ConCeRTo FleX
soFT
are intended to be used in open cochleae (no obliteration or
ossification) for an electrode insertion depth of about 31 mm.
• Cochlear implants ConCeRTo FleX
eAs
for non-eAs indication are intended to be used in open cochleae
(no obliteration or ossification) for an electrode insertion depth of about 24 mm as per request of the
surgeon.
• Cochlear implants ConCeRTo FleX eAs used for eAs are indicated for partially deaf individuals with mild to
moderate sensorineural hearing loss in the low frequencies, sloping to a profound sensorineural hearing loss
in the high frequencies.
cOntrAinDicAtiOns
A patient must not be implanted,
•
if the individual is known to be intolerant of the materials used in the implant (including medical grade silicone,
platinum, iridium and titanium);
• if there is an absence of cochlear development;
• if the cause of deafness is non-functionality of the auditory nerve and / or the upper auditory pathway;
• if external or middle ear infections are present or if the tympanic membrane is perforated in the ear to be
implanted;
• if there are medical contra-indications to surgery of the middle and inner ear and anaesthesia as required;
• if anatomic abnormalities are present, that would prevent appropriate placement of the stimulator housing in
the bone of the skull, or prevent placement of the chosen electrode array into the cochlea, using the implant
shall be carefully considered prior to surgery;
• if the psychological status of the patient is unstable or if the patient has unrealistic expectations.
Implantation of Cochlear implants ConCeRTo FleX
eAs
used for eAs is contra-indicated for partially deaf
individuals with strong progressive hearing loss who are unable to use amplification devices and / or have cochlear
malformations.
unDEsirABLE siDE‑EFFEcts – risks rELAtED tO tHE iMpLAnt
possible post-operative side-effects include the following: dizziness, increased vertigo, delay of healing of the scar,
impairment of the sense of taste, potential for swallowing difficulties, numbness, increased tinnitus, stimulation of
the facial nerve, temporary pain and uncomfortable sounds during stimulation.
stEriLitY
The implant has been subjected to a validated ethylene oxide sterilization process and is supplied in sterile
packaging. once the sterile packaging has been opened, the implant cannot be resterilized. Do not use, if sterile
packaging is damaged. The implant is for single use only. Do not remove from sterile packaging until required.
stOrAGE, sHipMEnt AnD DispOsAL
The sterilized implant may only be shipped
2 between -20°C (-4°F) and +55°C (+131°F) and stored inside the
implant box at room temperature. each device must be implanted before the “use by” date specified on the
package. packaging 3 should be disposed of in accordance with local legislation.
inFOrMAtiOn ABOut usE – GEnErAL prEcAutiOns AnD WArninGs
•
The device must not be altered and must only be used as intended.
• expected performance with the cochlear implant cannot be accurately predicted. The prospective implant
users and their families shall be highly motivated and have realistic expectations about the expected benefit
of the implant.
• long-term damage to neural tissue following continuous chronic electrical stimulation has not been observed
with cochlear implants.
• sterility of the implant must be ensured at all times.
• The implant must never be dropped onto a hard surface or be held only by the electrode; damage to the
implant or electrodes during implantation will invalidate the warranty.
• Device failure may occur due to mechanical damage of the implanted parts, e.g. resulting from a blow to the
head, or due to electronic or other technical failure of the implant. Replacement of the device is required in
these cases.