MED-EL PULSARCI100 Instrucciones De Uso página 3

connections.
• In order to achieve good magnetic holding power
and optimal coupling the distance between the lateral
side of the implant and the surface of the skin (with
hair) shall not exceed 6 mm. The Implant should be
recessed to a depth of 4 mm or less.The bed for the
Implant must be flat so that the implant is stable.
• The transition from the implant bed to the channel
for the electrodes has to be smooth, ramp-like, with
no sharp edges in order to avoid possible damage to
the electrode lead.
• The words „This Side Up" must be visible on the
implant before fixing it in place.
• The electrode array should be inserted as far as
possible into the cochlea without compressing the
array or touching the electrode contacts. Use fascia or
similar tissue (muscle is not recommended) to create
a seal around the electrode array at the entrance to
the cochlea to secure the electrode array and to seal
the cochleostomy.
• After insertion, the electrode lead shall be fixed so
that no postoperative movement will occur. The
excess electrode lead must be looped in the mastoid
cavity well below the surface of the bone, using the
cortical overhang to hold it in place, so that the
electrode array will not migrate out of the cochlea
or be subject to external pressure that could cause
movement and subsequent damage of electrical
connections.
• The cloverleaf of the reference electrode must be
gently placed under the periosteum beneath the
temporalis muscle on the bone, never in the muscle.
When positioning the reference electrode, it should
not be held by the cloverleaf (electrode contact).
• Do not place the sutures directly over the electrode
lead.
• Do not place the sutures directly over the EAP
reference electrode.
• Inaccurate placement of the electrode array may
impair acoustic perception with the device and may
necessitate additional surgery. Improper fixation or
placement of the electrode array may also result in
premature failure of the implant.
• Insertion of the electrode array into the cochlea will
probably destroy any remaining hearing that may have
been present in that ear pre-surgically.
• Only MED-EL approved surgical instruments must be
used during the insertion process.
• The implant contains a strong magnet. Never use
magnetic surgical tools.
INTERFERENCE WITH OTHER
EQUIPMENT
• Monopolar electrosurgical instruments must not
be used in the head and neck region. If bipolar
electrosurgical instruments must be used, the tips of
the cautery must be kept at least 3 cm away from the
stimulator and all areas of the electrodes.
• Long-term damage to neural tissue following
continuous chronic electrical stimulation has not been
observed with cochlear implants.
• Any necessary Ionizing Radiation Therapy should be
carefully considered and the risk of damage to the
cochlear implant has to be carefully weighed against
the medical benefit of such therapy.
• Electroshock or electroconvulsive therapy in the head
and neck region must not be used.
• Diathermy must not be used as it may induce current
levels in the implanted electrodes that could cause
damage to the neural tissue and /or implanted device.
This applies also to iontophoresis and any current
inducing medical and/or cosmetic treatment.
• A diagnostic level of ultrasonic energy of up to 500W/m
does not cause any damage to the implant.
• Magnetic Resonance Imaging (MRI) is possible in
patients with a MED-EL cochlear implant only with
specified models of MRI machines. Also a number of
precautions must be considered and followed. The
area of up to 5 cm surrounding the implanted device
will not be visible on MRI. MED-EL recommends using
an MRI only when other diagnostic procedures (i.e.
CT, PET, etc.) are not applicable. MED-EL has prepared
an MRI-Examination-Request-Form containing
precise information on device parameters (magnetic
field-strengths) and guidelines for an MRI examination
under safe conditions.
The MRI-Examination-Request-Form
completed by the requesting physician in cooperation
with the applicable radiology department and
reviewed and approved by MED-EL prior to
performing the MRI examination for safety reasons
and to avoid the loss of warranty coverage. Assure
appropriate fixation of the CI and assess thickness of
the bone under the CI to avoid the risk of torque.The
prospective MRI patient should have been implanted
for a minimum of 6 months. Imaging artefacts are
encountered around the implant.To prevent excessive
heating of the CI during an MRI examination, avoid
sequences with high SAR strain. Never run sequences
in the „first level operating mode." Before performing
an MRI examination all external parts of the CI system
must be removed.
MRI is not completely without risk to the implant
and the patient. In event of an MRI MED-EL must
be contacted. Advice has to be given on an individual
patient basis.
EXPLANTATION
• The implant may become non-functional, either by
accident or due to medical or technical reason. In
this case it is strongly recommended to explant the
device.
• If the device is not used, it is strongly
recommended to explant
an explantation is not performed functional
checks of the implant on a regular basis are
strongly recommended.
EXPLANTATION FOLLOWING DEATH
OF USER
In common with other medical device manufacturers,
MED-EL requests that implants be explanted and
returned upon a user's death. This is to fulfil both
safety and environmental requirements. For cremation,
explantation of the implant is requested for safety
reasons.
• If possible, the device should be removed without
damaging or cutting it.
• Staff should follow common universal precautions
and handle the explanted device as potentially
contaminated bio-hazardous material.
• After explantation,the implant should be appropriately
cleaned and disinfected. During cleaning, extraneous
tissue should be removed, but only to such an extent
that damage to the implant is not risked.
• The explanted device should be placed in a leak-proof,
disinfected (or sterile) container filled with saline and
returned to MED-EL with a covering letter.
TECHNICAL DATA OF STIMULATOR
• weight:
• thickness of stimulator:
The CE-mark was first applied in 2003.
Help and assistance are always available from your
local office – Please visit us at
2
The standard electrode is not identified by a suffix.
1
2 This Instructions for Use refers to all PULSARci100 implants
with standard, split or compressed electrodes (including H,
HS and HGB variants).
For shipping the Implant Box shall be packed into a protective
3
must be
padded cardboard box (or similar).
The cardboard box and plastic implant packaging (PETG and
4
Tyvek) are manufactured from recyclable materials.
A paper reporting on the pathomechanisms, clinical
5
symptoms, conservative and surgical treatments in cases of
meningitis, published by Arnold et al (ORL 2002;64:382-389),
may be useful additional reading.
the device. If
9.3 g (typical value)
4 mm (typical value)
AW3748 rev.6.0 3