MED-EL PULSARCI100 Instrucciones De Uso página 2

GB
ENGLISH
Instructions for use for the
PULSARci100 Cochlear Implant
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 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, recognized by a suffix
in the implant name (Implant family PULSARci100)
This device is intended to be implanted by adequately
trained and experienced surgeons only.
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.
PURPOSE OF THE DEVICE
Perception of environmental sound and potential for
improvement of communicational abilities.
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 optimal benefit from the cochlear implant,
the prospective implant users and their families shall
be highly motivated and have realistic expectations
about the expected benefit of the implant. Also
they shall understand the importance of returning
to the implant centre for regular speech processor
programming, implant system testing, assessment
sessions and training.
• A pre-operative assessment according to the local
professional standards must be conducted.
• Cochlear implants
intended to be fully inserted into an open cochlea (no
obliteration or ossification).
• Cochlear implants PULSARci100 S are intended to
be inserted into a cochlea, which is obliterated or
ossified or when insufficient lumen for insertion
can be detected and therefore an access to the
cochlea has to be drilled and only a short insertion
is possible.
• Cochlear implants PULSARci100 GB are intended to
be inserted into fully obliterated or ossified cochlea,
where two cochleostomies have to be drilled.
CONTRAINDICATION
A patient must not be implanted,
• if the individual is known to be intolerant of the
materials used in the implant (medical grade silicone,
platinum, platinum iridium)
• if there is an absence of cochlear development
• if the cause of deafness is non-functionality of the
auditory nerve and/or the auditory pathways
• 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 present against
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. In such
cases, using the cochlear implant must be carefully
considered prior to surgery
• if the psychological status of the patient is unstable or
if the patient has unrealistic expectations.
UNDESIRABLE SIDE-EFFECTS
RISKS RELATED TO THE IMPLANT
Possible post-operative
following: dizziness, increased vertigo, delay of healing
2 AW3748 rev. 6.0
PULSARci100 Standard 1 are
side-effects include the
of the scar, impairment of the sense of taste, potential
for swallowing difficulties, numbness, increased tinnitus,
stimulation of the facial nerve, temporary pain or
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 re-sterilized. Do not use, if
sterile packaging is damaged. The implant is for "single
use" only. Do not remove from sterile packaging until
required.
1 UNPACKAGING INSTRUCTIONS
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2
For unpacking refer to the unpacking instruction leaflet
inside the implant cardboard box.
STORAGE, SHIPMENT AND DISPOSAL
The sterilized implant may only be shipped
inside the Implant Box between 0°C (32°F) and 43°C
(109°F). Each device must be implanted before the 'use
before' date specified on the package. Packaging
be disposed of in accordance with local legislation.
INFORMATION ABOUT USE AND
GENERAL PRECAUTION AND
WARNINGS
• The device must not be altered and only 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.
• Sterility of the implant must be ensured at all times.
• The implant must never be dropped onto a hard
surface; damage to the implant or electrodes during
the operation will invalidate the warranty.
• Device failure may occur due to mechanical damage
of the implanted parts, e.g. results from a blow to the
head, or due to electronic or other technical failure
of the implant. Reimplantation is required in these
cases.
SURGICAL PRECAUTION AND
WARNINGS
RISK RELATED TO SURGERY
• Cochlear implant surgery is comparable to middle ear
surgery with additional access to the inner ear. The
normal risks of surgery and general anaesthesia are
applicable. Primary surgical risks include the following:
infection, inflammation, necrosis, haematoma, leakage
of CSF, damage to the facial nerve, pain, scarring of
the wound, swallowing difficulties and complications
related to general anaesthesia. Additionally,meningitis
can be a rare post-operative complication, but has the
potential to be serious.The risk of meningitis may be
reduced, for example by vaccination, antibiotic cover,
and surgical technique.
• If available, facial nerve monitoring is recommended
and if carried out, neural muscular blockade should be
avoided.
• To minimize the risk of postoperative infection,
care should be taken that the round window and
its membrane remain intact during drilling the
cochleostomy. All sharp edges of bone must be
removed and drilling should be completed before
the cochlea is opened to prevent any bone dust from
entering.
• Prophylactic use of antibiotics is recommended for all
patients unless medically contraindicated.
• Other risks after surgery may be avoided by following
the instructions in the applicable MED-EL Speech
Processor User Manual and the MED-EL application
software User Manual.
• Clear identification of the anatomical landmarks is
required.When drilling the mastoidectomy,care should
be taken to avoid exposing the dura inadvertently.
If the dura is exposed as a landmark, exposure
shall be kept to an absolute minimum. Exposure or
injury to the dura may reduce the barrier to future
infection and may increase the potential risk for future
meningitis. For example, neuro-radiological follow-up
in cases of fractures of the anterior skull base have
shown that foudroyantly progressing meningitis may
occur, even years later. Similar mechanisms may also
exist in respect of ear and mastoid surgery.
• The implant must be securely anchored in a bed
drilled in the temporal bone and the electrode leads
protected in a bony channel without sharp edges
in such a way that there will be no postoperative
movement. Continuous movement may result in
fatigue and subsequent premature failure of electrical
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