MED-EL CONCERTO Compressed, Руководство пользователя

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AW 7846 Rev. 1.0
9
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, coil,
and all areas of the electrode.
• 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.
• Ultrasonic therapy and imaging must not be used in the area of the implant.
• magnetic Resonance Imaging (mRI) is possible in patients with meD-el implants 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 must be
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 (specific Absorption Rate) 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 reasons. In this
case it is strongly recommended to explant the device.
• If for any reason the device is not used anymore, it is strongly recommended to explant the device.
If an explantation is not performed functional checks of the implant on a regular basis are strongly
recommended.
• 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
biohazardous 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.
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 fulfill both safety and environmental requirements. For cremation, explantation of
the implant is requested for safety reasons.
rEturninG EXpLAntED DEvicEs
An explanted device should be placed in a leak-proof, disinfected (or sterile) container filled with saline and
returned to meD-el Headquarters. The device should be accompanied by written information including the
reason for explantation.
The Ce-mark was first applied in 2010.
Help and assistance are always available from your local office – please visit us at
www.medel.com
1 This Instructions for Use refers to all ConCeRTo implants with standard, medium, Compressed, split, FleX soFT or FleX eAs electrodes.
2 For shipping, the Implant Box shall be packed into a protective padded cardboard box (or similar).
3 The cardboard and plastic implant packaging (peTg and Tyvek) are manufactured from recyclable materials.
4 A paper reporting on the pathomechanisms, clinical symptoms, conservative and surgical treatments in cases of meningitis, published by
Arnold et al (oRl 2002;64:382-389), may be useful additional reading.