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CONCERTO

1. N ENGLISH CS E TINA CONCERTO COCHLEAR IMPLANT Standard Medium Compressed Split FLEX PE 2 AW 7846 Rev 1 0 OPENING INSTRUCTION Cs INSTRUKCE K OTEVREN CONCERTO Standard _ 126 E Standard electrode array CONCERTO Medium U i i F 1 9 20 9 0 8 Medium electrode array CONCERTO Compressed 126 Compressed electrode array CONCERTO Split E 102 8 CN 74 i Ga 9 6 06 44 010 SS gt 0 6 66 Split electrode array AW 7846 Rev 1 0 CONCERTO FLEX 126 FLEX O 7 electrode array CONCERTO FLEX FLEX electrode array Typical dimensions in mm Obvykl rozm ry v mm Recommended diameter of cochleostomy Doporu en pr m r kochleostomie Recommended insertion depth of electrode array Doporu en hloubka zaveden svazku elektrod only for non EAS indication pouze u jin ch indikac ne EAS AW 7846 Rev 1 0 ENGLISH INSTRUCTIONS FOR USE for the CONCERTO 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 coil with a magnet wi
2. zaveden elektrody do hloubky asi 15 mm Kochle rn implant ty CONCERTO Split jsou ur eny k pou it v kochlei s t kou obliteraci nebo osifikaci kde je nutno podle pot eby chirurga prov st dv kochleostomie e Kochle rn implant ty CONCERTO FLEX jsou ur eny k pou it v otev en kochlei bez obliterace i osifikace s mo nost zaveden elektrody do hloubky asi 31 mm Kochle rn implant ty CONCERTO FLEX pro non EAS indikace jsou ur eny k pou it v otev en kochlei bez obliterace i osifikace a podle pot eby chirurga s mo nost zaveden elektrody do hloubky asi 24 mm Kochle rn implant ty CONCERTO FLEX u van pro EAS jsou indikov ny pro nedosl chav jedince s percep n hluchotou v oblasti n zk ch frekvenc p ech zej c do t k percep n hluchoty v oblasti vysok ch frekvenc KONTRAINDIKACE Implantace nesm b t u pacienta provedena e pokud je zn mo e p ecitliv l na materi ly pou it v implant tu v etn silikonu platiny iridia a titanu pro l ka sk ely e pokud nem vyvinutu kochleu e pokud je p inou hluchoty nefunk nost sluchov ho nervu nebo horn sluchov dr hy e pokud je v uchu ve kter m m b t provedena implantace p tomna infekce zevn ho nebo st edn ho ucha nebo pokud je v n m perforovan bub nek e pokud jsou zdravotn kontraindikace v konu na st edn m uchu i p slu n anes
3. e b t r zn ho typu typem elektrody jsou d ny r zn varianty implant t ada implant t Toto za zen mus implantovat pouze pat i n pro kolen a zku en chirurg Implant t Ize pou vat ve stimula n m a telemetrick m re imu Stimula n sekvence bif zick ch a trif zick ch puls mohou b t vyd v ny sekven n nebo simult nn ve dvou nebo v ce kan lech V telemetrick m re imu p stroj umo uje funk n kontrolu technick ho stavu implant tu v etn komunikace pomoc transkut nn ho spojen a rovn zhodnocen impedance elektrod a z znam elektricky evokovan ch ak n ch potenci l sluchov ho nervu Implant t m hmotu 7 6 g obvykl hmota Hlavn rozm ry implant tu jsou uvedeny na n kresech na p ede l ch str nk ch Objem implant tu bez elektrody je 4 7 V p m m kontaktu s tk n lidsk ho t la jsou tyto materi ly silikon platina iridium a titan pro l ka sk ely V KONNOSTN CHARAKTERISTIKY e V stupn charakteristiky stimula n ho sign lu na resistoru kOhm maxim ln amplituda proudu st edn hodnota 1250 pA rozsah 500 pA maxim ln ka pulsu st edn hodnota 203 8 us rozsah 8 2 us e P esnost m en impedance je obvykle lep ne 5 e P i dodr ov n bezpe nostn ch pokyn uveden ch na zadance pro vy et en MRI spole nosti MED EL je implant t bezpe n p i zobrazen MR skene
4. Espa a Centro Empresarial Euronova Ronda de Poniente num 2 2 A Tres Cantos 28760 Madrid Spain Tel 34 91 80 41 527 Fax 34 91 80 44 348 office es medel com MED EL GmbH Sucursal em Portugal Av S da Bandeira 77 1 Dt Fte 3000 351 Coimbra Portugal Tel 351 239 098 804 Fax 351 239 842 180 office pt medel com MED EL UK Ltd Great Cliffe Court Dodworth Barnsley S75 3SP UK Tel 44 12 26 242874 Fax 44 12 26 771056 office medel co uk MED EL Corporation USA 2511 Old Cornwallis Road Suite 100 Durham NC 27713 USA Tel 919 572 2222 Fax 919 484 9229 Toll free 888 MED EL CI 633 3524 implants medelus com office Q medel com MED EL Latino America S R L Viamonte 2146 P 9 CIO56ABH Capital Federal Argentina Tel 54 11 4954 0404 Fax 54 11 4954 0404 medel ar medel com MED EL Middle East FZE Dubai Airport Free Zone P O Box 54320 54321 Dubai United Arab Emirates Tel 9714 299 4700 Fax 9714 299 4255 medeluae emirates net ae MED EL India 505 Pragati House 47 48 Nehru Place New Delhi 110019 India Tel 91 11 4160 7171 Fax 91 11 4164 2800 implants medel in MED EL Hong Kong Room 1301 Ashley Nine Tsim Sha Tsui Kowloon Hong Kong Tel 852 2730 5818 Fax 852 2730 5009 office hk medel com MED EL Philippines 1501 Richville Corporate Tower Industry Road Madrigal Business Park Ayala Alabang Muntinlupa City 1702 Philippi
5. a 0 8 mm pro kochle rn implant t CONCERTO Medium a CONCERTO Compressed Doporu en pr m r kochleostomie 1 3 mm pro kochle rn implant t CONCERTO FLEX99 a 0 8 mm pro kochle rn implant t CONCERTO FLEX Pro zaji t n spr vn elektrick stimulace je d le it zav st svazek elektrod s apik ln mi jednotliv mi kontakty sm rem k modiolu Pou it velk ho zv t en k zaost en na pi ku elektrody m e usnadnit nalezen spr vn orientace kontaktu Kdy je zaveden svazek elektrod mal zna ka na svodu elektrody ukazuje orientaci kontaktu na bazi svazku elektrod Zaveden m svazku elektrod do kochley bude pravd podobn zni en zbytek sluchu kter p ed operac je t mohl b t p tomen B hem procesu zav d n svazku elektrod je nutno pou vat pouze chirurgick n stroje schv len spole nost MED EL Implant t obsahuje siln magnet Nikdy nepou vejte magnetick chirurgick n stroje Svazek elektrod je nutno zav st do kochley a do doporu en hloubky ani by byl svazek komprimov n a ani by se chirurg dotkl kontakt elektrod Pro minimalizaci rizika poopera n infekce je nutno prov st oplach fascie i podobn ch tk n nedoporu uje se u sval Svazek elektrod na vstupu do kochley ut sn te aby byl zaji t n a aby byl uzav en otvor kochley Po zaveden mus b t svod elektrody fixov n tak aby po operaci nedo lo k pohybu Nadbyte n svod elektrody mus
6. 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 OFT and 0 8 mm for the Cochlear Implant CONCERTO FLEX 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 electro
7. kontrol Pokud je to mo n m lo by b t za zen vy ato bez po kozen i odst ihnut Zdravotni t pracovn ci mus dodr ovat v eobecn platn bezpe nostn opat en a zach zet s explantovan m za zen m jako s potenci ln kontaminovan m biologicky nebezpe n m materi lem Po explantaci mus b t implant t n le it o i t n a vydezinfikov n P i i t n je nutno odstranit zevn Ipici tk n ale pouze do t m ry aby nebylo riziko po kozen implant tu EXPLANTACE PO SMRTI PACIENTA Stejn jako ostatn v robci l ka sk ch za zen d spole nost MED EL aby byly implant ty po smrti pacienta explantov ny a vr ceny T m se z rove dodr bezpe nostn p edpisy a p edpisy pro ochranu ivotn ho prost ed P i kremaci je explantace implant tu nutn z bezpe nostn ch d vod VR CEN EXPLANTOVAN CH ZA ZEN Explantovan za zen mus b t vlo eno do vodot sn dezinfikovan nebo steriln n dobky napln n fyziologick m roztokem a vr ceno editelstv MED EL K za zen je nutno p ilo it p semnou informaci s uveden m d vodu explantace C Ozna en CE bylo poprv pou ito v roce 2010 0123 Tento N vod k pou it plat pro v echny implant ty CONCERTO s elektrodami Standard Medium Compressed Split FLEX i FLEX S P i odes l n mus b t pouzdro implant tu zabaleno do kartonov krabice s ochrannou v pln nebo p
8. tvo it smy ku v mastoide ln dutin dostate n pod povrchem kosti s kortik ln m lalokem kter ji dr na m st tak e se svazek elektrod nem e vysunout ven z kochley ani na n j nem e p sobit zevn tlak kter by vedl k pohybu a k po kozen elektrick ch spojen Stehy nezakl dejte p mo nad svodem elektrody Nep esn um st n svazku elektrod m e naru it vn m n zvuk pomoc za zen a m e si vynutit dal chirurgick v kon Nespr vn fixace i um st n svodu elektrod m e tak zp sobit p ed asn selh n implant tu Dal m poopera n m rizik m se lze vyhnout dodr ov n m pokyn v u ivatelsk p ru ce p slu n ho procesoru MED EL a v u ivatelsk p ru ce softwaru aplikace MAESTRO Kochle rn implantace u nedosl chav ch pacient se zachovan m sluchem v oblasti n zk ch frekvenc p edstavuje riziko pln ztr ty sluchu co mus chirurg pacientovi p ed operac jasn vysv tlit Studie v ak prokazuj p nos p i pou it elektrick stimulace pouze v t to skupin i kdy dojde ke ztr t residu ln ho sluchu Je nutno br t v vahu etiologii trv n nedosl chavosti a v hody sluchadel a je nutno pou t opera n techniku se zachov n m sluchu AW 7846 Rev 1 0 INTERFERENCE S JINYMI ZAR ZEN MI V oblasti hlavy a krku nesm j b t pou ity monopol rn elektrochirurgick n stroje Pokud mus byt pou ity bipol rn el
9. 0 0 52 x 0 50 0 14 0 14 2 4 26 4 CONCERTO Medium 0 77 x 0 75 0 52 x 0 50 0 14 0 14 1 9 20 9 CONCERTO Compressed 0 66 x 0 64 0 52 0 50 0 14 0 14 1 1 12 1 CONCERTO Split 0 66 x 0 64 0 60 x 0 58 0 14 0 14 1 1 4 4 0 57 x 0 55 6 6 CONCERTO FLEX 1 02 x 1 00 0 50 x 0 37 0 13 0 14 2 4 26 4 CONCERTO FLEXF S 0 77 x 0 77 0 50 x 0 34 0 13 0 14 1 9 20 9 The implant does not have any connector 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 Additionally the MED EL Cochlear Implant System used in combination with the implant variant CONCERTO FLEX is intended to evoke auditory sensations via electrical stimulation or via combined electric acoustic stimulation EAS of the auditory pathways for partially deaf individuals who obtain benefit from acoustic amplification in the lower frequencies only PURPOSE OF THE DEVICE The purpose of the device is the perception of environmental sound and potential for improvement of communicational abilities AW 7846 Rev 1 0 INDICATIONS e 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 reco
10. 2 8580 Fax 81 3 5842 8582 info A medel co jp MED EL Liaison Office Australasia ESIA Bldg Suite 5 Gnd Floor Salvado Road Subiaco Perth WA 6008 Australia Tel 61 8 9380 9774 Fax 61 8 9380 9893 office au medel com VIBRANT MED EL Hearing Technology France Village d Entreprise Green Side 400 av Roumanille BP 309 06906 Sophia Antipolis Cedex France Tel 33 4 9300 1124 Fax 33 4 9300 1125 office fr medel com
11. ETURNING 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 C The CE mark was first applied in 2010 0123 N Help and assistance are always available from your local office Please visit us at ww w medel com This Instructions for Use refers to all CONCERTO implants with Standard Medium Compressed Split FLEXS or FLEX electrodes For shipping the Implant Box shall be packed into a protective padded cardboard box or similar The cardboard and plastic implant packaging PETG and Tyvek are manufactured from recyclable materials 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 AW 7846 Rev 1 0 9 10 CS CESTINA NAVOD K POUZITI kochlearniho implantatu CONCERTO POPIS ZARIZENI Implantat je implantovateln st kochlearniho implant tov ho syst mu MED EL a m e b t pou it pouze s kompatibiln mi extern mi komponentami zna ky MED EL Za zen se skl d ze stimul toru c vky s magnetem ve st edu c vky referen n elektrody referen n elektrody EAP a aktivn elektrody permanentn p ipojen ke stimul toru Aktivn elektroda m
12. RGICK M V KONEM V kon p i kochle rn implantaci je srovnateln s operac st edn ho ucha s dodate n m vstupem do vnit n ho ucha Existuj obvykl rizika chirurgick ho v konu a celkov anestezie Mezi hlavn chirurgick rizika pat infekce z n t nekr za hematom nik mozkom n ho koku po kozen l cn ho nervu bolest jizven r ny polykac pot e a komplikace souvisej c s celkovou anestezi Meningitis je vz cnou poopera n komplikac m e v ak b t z va n Riziko meningitidy m e b t sn eno nap klad o kov n m antibiotick m kryt m a chirurgickou technikou Doporu uje se monitorov n l cn ho nervu pokud je dostupn pokud se prov d je nutno se vyhnout neuromuskul rn blok d Profylaktick pou it antibiotik se doporu uje u v ech pacient pokud nen kontraindikov no Je nutn jasn stanoven anatomick ch orienta n ch bod P i vrt n je nutno zabr nit ne mysln mu obna en dury Pokud je dura obna ena jako orienta n bod je nutno prov st odkryt pouze v absolutn minim ln m rozsahu Ne mysln velk obna en nebo poran n dury m e zeslabit p ek ku pro budouc infekci a m e zv it riziko meningitidy v budoucnu Neuroradiologick sledov n p pad fraktur p edn baze lebn nap klad prok zalo e i po letech m e doj t k meningitid s foudroyantn m pr b hem Podobn mechanismy se mohou uplatnit ta
13. bvykl hodnota mm CONCERTO Standard 1 02 x 1 00 0 52 0 50 0 14 0 14 2 4 26 4 CONCERTO Medium 0 77 x 0 75 0 52 x 0 50 0 14 0 14 1 9 20 9 CONCERTO Compressed 0 66 x 0 64 0 52 x 0 50 0 14 0 14 LI 12 1 CONCERTO Split 0 66 x 0 64 0 60 x 0 58 0 14 0 14 LI 4 4 0 57 x 0 55 6 6 CONCERTO FLEX P 1 02 x 1 00 0 50 x 0 37 0 13 0 14 2 4 26 4 CONCERTO FLEX 0 77 x 0 77 0 50 x 0 34 0 13 0 14 1 9 20 9 implant tu neni zadny konektor UCEL POUZIT Kochle rn implant tov syst m MED EL je ur en k vytv en sluchov ch vjem elektrickou stimulac sluchov ch cest u jedinc s t k m sluchov m posti en m u kter ch zes len zvuku pomoc nejlep ch sluchadel p in pouze mal nebo dn u itek D le je kochle rn implant tov syst m MED EL pou van s variantou implant tu CONCERTO FLEX ur en k evokaci sluchov ch vjem elektrickou nebo kombinovanou elektrickou a akustickou stimulac EAS sluchov ch cest u nedosl chav ch jedinc u kter ch je p nosem zes len zvuku pouze v oblasti ni ch frekvenc EL ZA ZEN elem za zen je umo n n vn m n okoln ch zvuk vedouc ke zlep en mo nost komunikace AW 7846 Rev 1 0 INDIKACE Kochle rn implant t evokuje akustick vn m n elektrickou stimulac sluchov ho nervu Funk ni sluchovy je tedy nezbytnou podminkou pro sp nou kochle rn implantaci Spole nost MED EL d raz
14. d in cochleae with severe obliteration or ossification where two cochleostomies have to be drilled as per request of the surgeon Cochlear implants CONCERTO FLEX 9 are intended to be used in open cochleae no obliteration or ossification for an electrode insertion depth of about 3l mm e Cochlear implants CONCERTO FLEXF for non EAS indication are intended to be used in open cochleae no obliteration or ossification for an electrode insertion depth of about 24 mm as per request of the surgeon Cochlear implants CONCERTO FLEX used for EAS are indicated for partially deaf individuals with mild to moderate sensorineural hearing loss in the low frequencies sloping to a profound sensorineural hearing loss in the high frequencies CONTRAINDICATIONS A patient must not be implanted e ifthe individual is known to be intolerant of the materials used in the implant including medical grade silicone platinum iridium and titanium e if there is an absence of cochlear development e ifthe cause of deafness is non functionality of the auditory nerve and or the upper auditory pathway e if external or middle ear infections are present or if the tympanic membrane is perforated in the ear to be implanted e if there are medical contra indications to surgery of the middle and inner ear and anaesthesia as required ifanatomic abnormalities are present that would prevent appropriate placement of the stimulator housing in the bone
15. de 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 acous
16. ektrochirurgick n stroje je nutno dr et kauteriza n hrot nejm n 3 cm od stimul toru c vky a v ech oblast elektrody Je nutno pe liv uv it pou it ve ker ch postup ioniza n terapie a je nutno zv it riziko po kozen kochle rn ho implant tu proti zdravotn mu p nosu takov terapie V oblasti hlavy a krku nesm j b t pou ity elektrick v boje i elektrokonvulzivn l ba Nesm b t pou ita diatermie proto e m e v implantovan ch elektrod ch vzbudit hladiny proudu kter by mohly po kodit nervovou tk nebo implantovan za zen To plat tak pro iontofor zu a ve kerou zdravotn nebo kosmetickou l bu indukuj c proud V oblasti implant tu nesm b t pou ita l ba ultrazvukem ani ultrazvukov zobrazov n Zobrazov n magnetickou resonanc MRI je u pacient s implant ty MED EL mo n pouze se specifikovan mi modely p stroj magnetick resonance Je nutno zv it a dodr ovat adu bezpe nostn ch opat en Oblast obklopuj c implantovan za zen a do 5 cm nebude na MRI viditeln Spole nost MED EL doporu uje pou vat MRI pouze pokud nelze pou t jin diagnostick postupy nap CT PET atd Spole nost MED EL p ipravila danku na vy et en MRI obsahuj c p esnou informaci o parametrech za zen intenzita magnetick ho pole a pokyny k vy et en MRI za bezpe n ch podm nek Z danku na vy et en MRI mus vypln
17. ge Packaging should be disposed of in accordance with local legislation INFORMATION ABOUT USE GENERAL PRECAUTIONS AND WARNINGS The device must not be altered and must only be 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 Long term damage to neural tissue following continuous chronic electrical stimulation has not been observed with cochlear implants Sterility of the implant must be ensured at all times The implant must never be dropped onto a hard surface or be held only by the electrode damage to the implant or electrodes during implantation will invalidate the warranty e Device failure may occur due to mechanical damage of the implanted parts e g resulting from a blow to the head or due to electronic or other technical failure of the implant Replacement of the device is required in these cases AW 7846 Rev 1 0 8 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 swallowi
18. h 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 Cl 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 R
19. it daj c l ka ve spolupr ci s p slu n m radiologick m odd len m a z bezpe nostn ch d vod a aby nedo lo ke ztr t platnosti z ruky mus ji p ed proveden m vy et en MRI zkontrolovat a schv lit spole nost MED EL Zajist te spr vnou fixaci kochle rn ho implant tu a odhadn te tlou ku kosti pod kochle rn m implant tem aby se p ede lo riziku torse Pacient kter m b t vy et en MRI mus b t minim ln 6 m s c po implantaci Okolo implant tu b vaj na zobrazen artefakty Aby se p ede lo nadm rn mu zah t kochle rn ho implant tu b hem vy et en MRI nepou vejte sekvence s vysokou SAR specifick m ra absorpce Nikdy neprov d jte sekvence v provozn 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 kontaktovat spole nost MED EL Rada mus b t poskytnuta u ka d ho pacienta individu ln EXPLANTACE Implant t se m e st t nefunk n m bu p i nehod anebo ze zdravotn ch nebo technick ch d vod V takov m p pad d razn doporu ujeme explantaci za zen Pokud nen za zen z jak hokoli d vodu d le pou v no d razn doporu ujeme jeho explantaci Pokud nen explantace provedena d razn doporu ujeme dal prov d n pravideln ch funk n ch
20. 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 Cl and assess thickness of the bone under the Cl 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 Cl during an MRI examination avoid sequences wit
21. k p i chirurgick m v konu na uchu i processus mastoideus Je nutno odstranit v echny ostr hrany kosti a vrt n je nutno prov st p ed otev en m kochley aby se do n nedostal kostn prach Aby se dos hlo dobr p dr n magnetick s ly a optim ln ho spojen nesm vzd lenost mezi later ln stranou implant tu a povrchem k e s vlasy p ekro it 6 mm V robn slo implant tu mus b t na implant tu p ed jeho um st n m viditeln Implant t mus b t pevn zasazen do ploch ho l ka pro stimul tor vyvrtan ho v kosti sp nkov a svod elektrody mus b t chr n n ikmo veden m kostn m kan lem bez ostr ch okraj P edn okraj stimul toru nesm b t zano en do hloubky v t ne 2 mm Oboj je nutno prov st tak aby po v konu nemohlo doj t k pohybu Neust l pohyb m e m t za n sledek mechanickou navu a n sledn p ed asn selh n elektrick ch spojen Je nutno prov st dodate nou imobilizaci implant tu nap stehy Mus b t provedena takov m zp sobem aby po v konu nemohlo doj t k pohybu Neust l pohyb m e m t za n sledek mechanickou navu a n sledn p ed asn selh n elektrick ch spojen Aby bylo minimalizov 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 CONCERTO Standard
22. lines listed on MED EL s MRI Examination Request Form the implant is conditionally MRI safe for MR scanner field strengths of 0 2 Tesla 1 0 Tesla and 1 5 Tesla Please contact MED EL prior to any MRI scanning There are no default factory settings of the implant system Proper functioning of the implantable part of the Cl system can be checked by performing telemetry refer to MAESTRO 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 in monopolar mode The electrode is made of medical grade silicone platinum electrode contacts and platinum iridium 90 10 wires All electrode variants have a straight design The electrode does not deliver any medicinal substances Physical dimensions of the electrodes Length of the electrode lead 126 mm typical value except for the FLEX S electrode 114 mm Cross sectional dimensions of the Geometric surface area per Distance electrode array channel Electrode type at proximal end at distal end of of smallest of largest between between most of array array stimulating stimulating contacts proximal and typical value mm typical value mm electrode electrode typical value mm most distal contact contact contact typical value mm typical value mm typical value mm CONCERTO Standard 1 02 x 1 0
23. mmends 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 Toobtain the optimal benefit from the implant the prospective implant users and their families shall be highly motivated and have realistic expectations about the expected benefit of the implant and shall understand the importance of returning to the implant center for regular audio processor programming assessment sessions and training e A pre operative assessment according to the local professional standards must be conducted Cochlear implants CONCERTO Standard are intended to be used in open cochleae no obliteration or ossification for an electrode insertion depth of about 3l mm Cochlear implants CONCERTO Medium are intended to be used in open cochleae no obliteration or ossification with mild malformation for an electrode insertion depth of about 24 mm as per request of the surgeon Cochlear implants CONCERTO Compressed are intended to be used in cochleae with moderate obliteration ossification or malformation for an electrode insertion depth of about 15 mm as per request of the surgeon Cochlear implants CONCERTO Split are intended to be use
24. n doporu uje aby byly p ed rozhodnut m zda je kochle rn implantace nejlep volbou pou v na optim ln p izp soben sluchadla po dobu minim ln t m s c Pokud v ak pacient ohluchl v d sledku infek n ho onemocn n kter m e v st k osifikaci a pokud jsou zn mky kochle rn osifikace nemus b t nutn zkou et sluchadla V takov ch p padech by se obvykle nem lo s implantac ot let e Aby implant t p inesl optim ln prosp ch mus b t pacient kter m b t l en implantac a jeho rodina vysoce motivov ni a mus m t realistick o ek v n mo n ho p nosu implant tu a mus pochopit v znam kontrol v implanta n m centru k pravideln mu programov n audio procesoru pravideln mu hodnocen a instrukt i Musi b t provedeno p edopera n vy et en podle m stn ch odborn ch standard Kochle rn implant ty CONCERTO Standard jsou ur eny k pou it v otev en kochlei bez obliterace i osifikace s mo nost zaveden elektrody do hloubky asi 31 mm Kochlearni implant ty CONCERTO Medium jsou ur eny k pou it v otev en kochlei bez obliterace i osifikace s lehkou malformac a podle pot eby chirurga s mo nost zaveden elektrody do hloubky asi 24 mm Kochle rn implant ty CONCERTO Compressed jsou ur eny k pou it v kochlei se st edn z va nou obliterac osifikac nebo malformac a podle pot eby chirurga s mo nost
25. nes Tel 632 807 8780 Fax 632 807 4163 office ph medel com MED EL China 1012 Unit Tower D SOHO New Town NO 88 Jian Guo Road Chao Yang District Beijing China 100022 Tel 86 10 85893527 28 29 Fax 86 10 85893530 office medel net cn MED EL Thailand 202 Le Concorde Tower lOth Floor Room 1010 Ratchadapisek Road Huaykwang District Bangkok 10310 Tel 66 0 2694 1500 Fax 66 0 2694 1500 office th medel com MED EL Malaysia Lot N8 4 N9 Ground Floor CMC Centre Jalan Cerdas Taman Connaught Cheras 56000 Kuala Lumpur Malaysia Tel 603 9101 5900 Fax 603 9101 5910 office my medel com www medel com MED EL Singapore 4 Science Park Road The Gemini Lobby B 04 03A Singapore Science Park II Singapore 117610 Tel 65 677888 14 Fax 65 677888 12 office sg medel com MED EL Indonesia Talavera Office Park 28 F Suite M23 JI TB Simatupang Kav 22 26 Jakarta 12430 Indonesia Tel 62 21 680 86084 Fax 62 21 737 3514 office id medel com MED EL Korea Room 706 Jeil Building 256 13 Gongduk dong Mapo ku Seoul 121 803 Republic of Korea Tel 82 2 701 8036 Fax 82 2 701 8037 office kr medel com MED EL Vietnam 15 Floor TNA Building 192 198 Ngo Gia Tu Ward 4 District 10 Ho Chi Minh City Vietnam Tel 84 8 3927 4560 Fax 84 8 3927 4558 office vn medel com MED EL Japan 7F TIK Bldg 3 2 3 Hongo Bunkyo ku Tokyo 113 0033 Japan Tel 81 3 584
26. ng difficulties and complications related to general anaesthesia Additionally meningitis 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
27. odobn Kartonov krabice a plastov obal implant tu PETG a Tyvek jsou vyrobeny z recyklovateln ch materi l M e b t u ite n p e st si l nek o patologick ch mechanismech klinick ch p znac ch konservativn m a chirurgick m l en p pad meningitidy kter publikovali Arnold et al ORL 2002 64 382 389 M stn kancel je v dy p ipravena poskytnout v m pomoc nav tivte n s pros m na adrese www medel com AW 7846 Rev 1 0 13 14 7846 1 0 AW 7846 Rev 1 0 15 MED EL Elektromedizinische Gerate GmbH Worldwide Headquarters F rstenweg 77a A 6020 Innsbruck Austria Tel 43 512 28 88 89 Fax 43 512 29 33 81 MED EL GmbH Niederlassung Wien Liechtensteinstr 22 1 22 5 1090 Wien Austria Tel 43 1 317 2400 Fax 43 1 317 2400 14 office at medel com MED EL Deutschland GmbH Moosstr 7 2 OG 82319 Starnberg Germany Tel 49 8151 77 03 0 Fax 49 8151 77 03 23 office medel de MED EL Deutschland GmbH B ro Berlin SchloBstr 57 14059 Berlin Germany Tel 49 30 383779 50 Fax 49 30 383779 55 office berlin medel de MED EL Office Helsinki Valimotie 13a 00380 Helsinki Finland Tel 358 9 473072 1 Fax 358 9 473072 19 office fi medel com MED EL Unita Locale Italiana Via Maso della Pieve 60 A 39100 Bolzano BZ Italy Tel 39 0471 250131 Fax 39 0471 234200 ufficio italia medel com MED EL GmbH Sucursal
28. of the skull or prevent placement of the chosen electrode array into the cochlea using the implant shall be carefully considered prior to surgery ifthe psychological status of the patient is unstable or if the patient has unrealistic expectations Implantation of Cochlear implants CONCERTO FLEX used for EAS is contra indicated for partially deaf individuals with strong progressive hearing loss who are unable to use amplification devices and or have cochlear malformations UNDESIRABLE SIDE EFFECTS RISKS RELATED TO THE IMPLANT Possible post operative side effects include the following dizziness increased vertigo delay of healing of the scar impairment of the sense of taste potential for swallowing difficulties numbness increased tinnitus stimulation of the facial nerve temporary pain and 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 resterilized Do not use if sterile packaging is damaged The implant is for single use only Do not remove from sterile packaging until required 5 SHIPMENT AND DISPOSAL The sterilized implant may only be shipped between 20 C 4 F and 55 C 131 and stored inside the implant box at room temperature Each device must be implanted before the use by date specified on the packa
29. plot mezi 20 C 4 F a 55 C 131 F a mus b t uchov v n v pouzdru implant tu p i pokojov teplot Ka d za zen mus b t implantov no p ed uplynut m data pou itelnosti uveden ho na obalu Obal mus b t likvidov n podle m stn ch z konn ch p edpis INFORMACE O POU IT OBECN BEZPE NOSTN OPAT EN A VAROV N e Za zen nesm b t upravov no a mus b t pou ito pouze ke stanoven mu elu Pfedpokl danou funk nost kochle rn ho implant tu nelze p edem p esn odhadnout Pacient kter m b t l en implantac a jeho rodina mus b t vysoce motivov ni a mus m t realistick o ek v n mo n ho p nosu implant tu kochle rn ch implant t nebylo po kontinu ln chronick stimulaci pozorov no dlouhodob po kozen nervov tk n e je nutno zajistit sterilitu implant tu Implant t nesm spadnout na tvrd povrch ani nesm b t dr en pouze za elektrodu po kozen implant tu i elektrod b hem implantace ru platnost z ruky K selh n za zen m e doj t v d sledku mechanick ho po kozen implantovan ch st t j n sledkem deru do hlavy nebo v d sledku poruchy elektroniky i jin technick poruchy implant tu V takov ch p padech je nutn v m na za zen AW 7846 Rev 1 0 12 BEZPE NOSTN OPAT EN A VAROV N T KAJ C SE CHIRURGICK HO V KONU RIZIKA SPOJEN S CHIRU
30. rem s intenzitou pole 0 2 Tesla 1 0 Tesla a 1 5 Tesla P ed skenov n m magnetickou resonanc se pros m v dy obra te na spole nost MED EL e Uimplantatov ho syst mu neexistuje dn v choz nastaven z v roby Spr vnou funkci implantovateln sti kochle rniho implant tov ho syst mu Ize 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 stimuluj c ch 12 nez visl ch kan l elektrod v monopol rn m re imu Elektroda je vyrobena z dr t ze silikonu platiny kontakty elektrod a platiny iridia 90 10 pro l ka sk ely e V echny varianty elektrod maj rovn tvar Elektroda nevyd v dn l iv l tky Fyzick rozm ry elektrod D lka svodu elektrody 126 mm obvykl hodnota vyjma elektrody FLEX 114 mm Rozm ry pr ezu svazku elektrod Geometrick plocha povrchu Vzd lenost na kan l T p elektrody na proxim ln m na dist ln m plocha plocha mezi kontakty mezi nejv ce konci soustavy konci soustavy nejmen ho nejv t ho obvykl hodnota mm proxim ln m obvykl hodnota mm obvykl hodnota mm kontaktu kontaktu a nejv ce stimula n stimula n dist ln m elektrody elektrody kontaktem obvykl hodnota mm obvykl hodnota mm o
31. tezie e pokud jsou p tomny anatomick abnormality kter by br nily dn mu um st n krytu stimul toru do lebn kosti anebo br nily um st n zvolen ho svazku elektrod do kochley mus b t p ed v konem pou it implant tu n le it zv eno e pokud je psychick stav pacienta nestabiln nebo pokud m pacient nerealistick o ek v n Implantace kochle rn ch implant t CONCERTO FLEX pou it ch pro EAS je kontraindikov na u nedoslychavych jedinc s v znamnou progresivn ztr tou sluchu kte nejsou schopni pou t zesilovac za zen nebo maj malformace kochley NE DOUC VEDLEJ INKY RIZIKA SOUVISEJ C S IMPLANT TEM Mezi mo n poopera n vedlej inky pat z vrat zhor en z vrat prodlou en hojen jizvy porucha vn m n chuti mo nost polykac ch pot sn en citlivost zv en hu en v u ch stimulace l cn ho nervu p echodn bolest a nep jemn zvuky p i stimulaci STERILITA Implant t byl podroben validovan mu procesu sterilizace etyl noxidem a dod v se ve steriln m obalu Jakmile je steriln obal otev en nelze implant t znovu sterilizovat Produkt nepou vejte pokud je steriln obal po kozen Implant t je ur en pouze pro jedno pou it Vyjm te jej ze steriln ho obalu a t sn p ed pou it m UCHOV V N ZAS L N A LIKVIDACE Sterilizovan implant t sm b t zas l n pouze p i te
32. thin its center 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 implant family CONCERTO This device is intended to be implanted by adequately trained and experienced surgeons only The implant offers a stimulation mode and a telemetry mode Stimulation sequences of biphasic and triphasic pulses can be delivered sequentially or simultaneously on two or more channels In telemetry mode the device allows a functional check about the technical status of the implant including communication over the transcutaneous link as well as the assessment of the electrode impedances and recording of the electrically evoked compound action potential of the hearing nerve The implant has a mass of 7 6 g typical weight For principal dimensions of the implant refer to the drawings on the previous pages The volume of the implant without electrode is 4 47 cm Following materials are in direct contact with human tissue medical grade silicone platinum iridium and titanium PERFORMANCE CHARACTERISTICS e Output characteristics of a stimulation signal on a kOhm resistor Maximum current amplitude Median value 1250 LA range 500 pA Maximum pulse width Median value 203 8 us range 8 2 us The impedance measurement accuracy is typically better than 5 When keeping to the safety guide
33. tic 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 AW 7846 Rev 1 0 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 lonizing 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

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