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Summary of Contents for Oticon Medical Neuro
- Page 1 Magnetic Resonance Imaging (MRI) Exam Instructions for Use Neuro – The Cochlear Implant System Neurelec S.A.S (2015) 2720 Chemin Saint Bernard, 06220 Vallauris – France 0459 TEL : +33 (0)4 93 95 18 18, FAX : +33 (0)4 93 95 38 01...
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Page 2: Table Of Contents
Table of content ....................3 MRI medical exam A. MRI exam with implanted magnet in place (at 1,5 Tesla) ........... 5 B. MRI exam with magnet removal (3 Tesla) ..............6 C. Dummy removal and magnet replacement ..............11 D. Magnet replacement ....................11... -
Page 3: Mri Medical Exam
There is a risk that prolonged exposure to high strength magnetic fields could demagnetize the implanted magnet held by the Neuro Zti. To reduce the risk of demagnetization, care should be taken to keep the longitudinal axis of the patient’s head parallel to the scanner’s principal... - Page 4 2. If the region of medical interest is likely to fall within the projected artifact produced by the Neuro Zti, the magnet may be removed prior to an MRI exam for MRI strengths at 1.5 Tesla to minimize artifacts.
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Page 5: Mri Exam With Implanted Magnet In Place (At 1,5 Tesla)
‘usual position’ (figure below). It is imperative that this position applies at least 30 cm before the beginning of the tunnel. Note: When carrying out an MRI exam with a Neuro Zti cochlear implant, do not use the Head Coil Array. -
Page 6: Mri Exam With Magnet Removal (3 Tesla)
Required tools: In order to extract the magnet of the Neuro Zti implant, the surgeon will need to have the three elements mentioned below: A Neuro Zti magnet extractor (M80177) that can be ordered directly from Oticon Medical or the local Oticon Medical distributor. - Page 7 A Neuro Zti dummy magnet (M80178). The dummy magnet is packed sterile. It shall be ordered directly from Oticon Medical or Oticon Medical local distributor and before performing a magnet extraction. The dummy magnet is an empty titanium casing that does not hold any magnet in order to avoid any harm caused by strong electromag- netic field.
- Page 8 Step 1: Make an incision and expose the magnet. Make a small incision to access the magnet. Cut any fibrosis tissue to expose the magnet. Decision on optimal incision size and location should be done on a case by case basis, aiming to minimize the probability of skin-flap complications.
- Page 9 Step 2: Remove the magnet When using the magnet extractor, place it facing the magnet to extract. In order to use the magnet extractor tool, 90 degree access with respect to the primary plane of the receiver is required (Figure 1). To grab the magnet that is placed in the implant receiver, lock the extractor tool to the magnet by turning ¼...
- Page 10 Step 3: Replace magnet with dummy magnet Remove the dummy from the sterile packaging (Figure 1). Using a finger, push the dummy at the center of the implant receiver until it stops. (Figure 2). Note: The dummy magnet is now in place and cannot be removed without the magnet extractor tool.
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Page 11: Dummy Removal And Magnet Replacement
Step 4: Close incision according to best surgical practice Note: Wait until incision is healed prior to wearing the external sound processor. C. Dummy removal and magnet replacement intervention Follow same procedures as in “B. MRI with magnet removal (3 Tesla)”. D. - Page 12 Oticon Medical Neurelec S.A.S 2720 Chemin Saint Bernard 06220 Vallauris – France TEL : +33 (0)4 93 95 18 18 FAX : +33 (0)4 93 95 38 01 info@oticonmedical.com www.oticonmedical.com...
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