MED-EL CONCERTO Compressed Manual Download Page 8

AW 7846 Rev. 1.0

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surGicAL prEcAutiOns AnD WArninGs – risks 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

4

 

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.

• 

prophylactic use of antibiotics is recommended for all patients unless medically contraindicated.

• 

Clear identification of the anatomical landmarks is required. When drilling, 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. Inadequate large 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.

• 

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.

• 

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 serial number of the implant must be visible on the implant before fixing it in place.

• 

The  implant  must  be  immobilized  in  a  flat  stimulator  bed  drilled  in  the  temporal  bone  and  the  electrode 

lead should be protected in a ramp-like bony channel without sharp edges. The anterior stimulator edge 

should not be recessed to a depth more than 2 mm. Both should be done in such a way that there will be no 

postoperative movement. Continuous movement may result in mechanical fatigue and subsequent premature 

failure of electrical connections.

• 

Additional immobilization of the implant needs to be done (e.g. with sutures). It should be done in such a way 

that there will be no postoperative movement. Continuous movement may result in mechanical fatigue and 

subsequent premature failure of electrical connections.

• 

To minimize the risk of postoperative infection, care should be taken that the round window and its membrane 

remain intact during drilling the cochleostomy. 

• 

The recommended diameter of the cochleostomy is 1.3 mm for the Cochlear Implant ConCeRTo standard 

and 0.8 mm for the Cochlear Implants ConCeRTo medium and ConCeRTo Compressed.

• 

The recommended diameter of the cochleostomy is 1.3 mm for the Cochlear Implant ConCeRTo FleX

soFT

 

and 0.8 mm for the Cochlear Implant ConCeRTo FleX

eAs

.

• 

To ensure proper electrical stimulation, it is important to insert the electrode array with the apical single 

contacts facing towards the modiolus. Using a higher magnification to focus on the electrode tip can facilitate 

finding  the  correct  contact  orientation.  When  the  electrode  array  is  inserted,  the  small  marker  on  the 

electrode lead indicates the contact orientation at the electrode array base.

• 

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 electrode array insertion process.

• 

The implant contains a strong magnet. never use magnetic surgical tools.

• 

The electrode array should be inserted into the cochlea up to the recommended depth without compressing 

the array or touching the electrode contacts. To minimize the risk of postoperative infection rinsed fascia or 

similar tissue (muscle is not recommended) should be used. Create a seal around the electrode array at the 

entrance into the cochlea to secure the electrode array and to seal the cochlea opening.

• 

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 move out of the cochlea or be subject to 

external pressure that could cause movement and subsequent damage of electrical connections.

• 

Do not place the sutures directly over the electrode lead.

• 

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  lead  may  also  result  in 

premature failure of the implant.

• 

other risks after surgery may be avoided by following the instructions in the applicable meD-el processor 

User manual and the mAesTRo application software User manual.

• 

Cochlear implantation in partially deaf patients with low frequency hearing carries the risk of partial or total 

hearing loss which should be clearly explained to the patient by the surgeon prior to implantation. However, 

studies have shown benefits using electrical stimulation solely in this group of patients even if residual hearing 

is lost. etiology, duration of partial deafness, and hearing aid benefit should be taken into consideration and 

hearing preservation surgical technique should be applied.

Summary of Contents for CONCERTO Compressed

Page 1: ...te GmbH Worldwide Headquarters F rstenweg 77a A 6020 Innsbruck Austria Tel 43 512 28 88 89 Fax 43 512 29 33 81 office medel com www medel com CONCERTO Coch le ar I m pl a nt Standard Medium Compresse...

Page 2: ...AW 7846 Rev 1 0 2...

Page 3: ...AW 7846 Rev 1 0 3 1 2 3 4 5 6 7 EN Opening instruction CS Instrukce k otev en...

Page 4: ...0 17 3 CONCERTO Compressed Compressed Electrode array S 15 0 5 1 1 12 1 0 8 Compressed electrode array 4 5 0 9 3 3 15 Medium Electrode 45 7 126 25 4 29 0 17 3 CONCERTO Medium 4 5 0 9 3 3 15 Medium El...

Page 5: ...EXEAS Electrode 114 45 7 25 4 29 0 17 3 CONCERTO FLEXEAS FLEXEAS Electrode array F 24 20 9 1 9 0 8 0 5 0 3 FLEXEAS electrode array Typical dimensions in mm Recommended diameter of cochleostomy Recomme...

Page 6: ...STRO application software user manual SPECIFICATION AND CHARACTERISTICS FOR EACH LEAD AND ELECTRODE ARRAY The implant has 24 independent current sources stimulating 12 independent electrode channels i...

Page 7: ...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...

Page 8: ...he round window and its membrane remain intact during drilling the cochleostomy The recommended diameter of the cochleostomy is 1 3 mm for the Cochlear Implant CONCERTO Standard and 0 8 mm for the Coc...

Page 9: ...un 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 patien...

Page 10: ...t mu lze ov it proveden m telemetrie viz u ivatelskou p ru ku softwaru aplikace MAESTRO SPECIFIKACE A CHARAKTERISTIKY JEDNOTLIV CH SOUSTAV SVOD A ELEKTROD Implant t m 24 nez visl ch zdroj proudu stimu...

Page 11: ...m vyvinutu kochleu pokud je p inou hluchoty nefunk nost sluchov ho nervu nebo horn sluchov dr hy pokud je v uchu ve kter m m b t provedena implantace p tomna infekce zevn ho nebo st edn ho ucha nebo p...

Page 12: ...nimalizov no riziko poopera n infekce je nutno db t na to aby kulat ok nko a membr na z staly b hem vrt n kochleostomie intaktn Doporu en pr m r kochleostomie je 1 3 mm pro kochle rn implant t CONCERT...

Page 13: ...rovozn m re imu prvn ho stupn P ed prov d n m vy et en MRI je nutno odstranit v echny extern sti kochle rn ho implant tu MRI nen pro implant t a pro pacienta pln bez rizika V p pad pou it MRI je nutno...

Page 14: ...AW 7846 Rev 1 0 14...

Page 15: ...AW 7846 Rev 1 0 15...

Page 16: ...k medel com MED EL Philippines 1501 Richville Corporate Tower Industry Road Madrigal Business Park Ayala Alabang Muntinlupa City RP 1702 Philippines Tel 632 807 8780 Fax 632 807 4163 office ph medel c...

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