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•  When the electrode array is inserted, the small marker on the electrode lead 

indicates the contact orientation at the electrode array base. For FLEX electrode 
variants the marker is coloured.

•  Insertion of the electrode array into the cochlea will probably destroy any remain‑

ing 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 squeezing the electrode array or the electrode lead and without 
touching the electrode contacts. To minimise 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 fi xed so that no postoperative movement 

will occur. The excess electrode lead must be looped in the mastoid cavity well be‑
low 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 pres‑
sure 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 fi xation or placement 
of the electrode lead may also result in premature failure of the implant.

•  Good physical and thus stable electrical contact between stimulation reference 

electrode and surrounding tissue is essential for electrical stimulation. Therefore 
do not place any fi xation sutures directly over the reference electrode and do not 
recess the stimulator too deeply to avoid any air gap over the reference electrode.

•  Other risks after surgery may be avoided by following the instructions in the ap‑

plicable MED‑EL audio processor user manual and the MED‑EL application software 
user manual.

•  Cochlear implantation in partially deaf individuals with low frequency hearing car‑

ries the risk of partial or total hearing loss which should be clearly explained to 
the individual by the surgeon prior to implantation. However, studies have shown 
benefi ts using electrical stimulation solely in this group of recipients even if residual 
hearing is lost. Aetiology, duration of partial deafness and hearing aid benefi t 
should be taken into consideration and hearing preservation surgical technique 
should be applied.

•  In case of a magnet exchange surgery MED‑EL recommends the use of the fol‑

lowing tools: The Magnet Removal Tool Ms050206 or the Magnet Insertion Tool 
Ms050205 can be used in combination with the Non‑Magnetic Spacer Ms010107 or 
the Replacement Magnet Ms010108. Please refer to the applicable Instructions for 
Use of these devices for further surgical precautions and warnings.

Summary of Contents for Mi1250 SYNCHRONY 2

Page 1: ...Cochlear Implants English Kochleárny implantát Mi1250 SYNCHRONY 2 Standard Medium Compressed FLEXSOFT FLEX28 FLEX26 FLEX24 FLEX20 FORM24 FORM19 Slovenčina AW38654_1 0 Slovak ...

Page 2: ...2 3 5 6 8 7 9 1 Opening instruction 4 Inštrukcie na otváranie ...

Page 3: ... FLEX26 105 2 Mi1250 FLEX24 104 2 Mi1250 FLEX20 99 7 Mi1250 FORM24 102 7 Mi1250 FORM19 97 7 4 5 15 30 3 3 0 9 24 18 8 47 3 29 111 2 Mi1250 Standard 111 2 Mi1250 Medium 111 2 Mi1250 Compressed 111 2 Mi1250 FLEXSOFT 110 9 Mi1250 FLEX28 108 2 Mi1250 FLEX26 105 2 Mi1250 FLEX24 104 2 Mi1250 FLEX20 99 7 Mi1250 FORM24 102 7 Mi1250 FORM19 97 7 4 5 15 30 3 3 0 9 24 18 8 47 3 29 Compressed Electrode Array M...

Page 4: ...0 FORM24 102 7 Mi1250 FORM19 97 7 4 5 15 30 3 3 0 9 24 18 8 47 3 29 105 2 Mi1250 Standard 111 2 Mi1250 Medium 111 2 Mi1250 Compressed 111 2 Mi1250 FLEXSOFT 110 9 Mi1250 FLEX28 108 2 Mi1250 FLEX26 105 2 Mi1250 FLEX24 104 2 Mi1250 FLEX20 99 7 Mi1250 FORM24 102 7 Mi1250 FORM19 97 7 4 5 15 30 3 3 0 9 24 18 8 47 3 29 FLEX26 Electrode Array FLEX28 Electrode Array FLEXSOFT Electrode array 31 5 2 4 26 4 Ø...

Page 5: ...ORM24 102 7 Mi1250 FORM19 97 7 4 5 15 30 3 3 0 9 24 18 8 47 3 29 102 7 Mi1250 Standard 111 2 Mi1250 Medium 111 2 Mi1250 Compressed 111 2 Mi1250 FLEXSOFT 110 9 Mi1250 FLEX28 108 2 Mi1250 FLEX26 105 2 Mi1250 FLEX24 104 2 Mi1250 FLEX20 99 7 Mi1250 FORM24 102 7 Mi1250 FORM19 97 7 4 5 15 30 3 3 0 9 24 18 8 47 3 29 FORM24 Electrode Array FLEX20 Electrode Array 24 1 9 20 9 Ø 0 3 Ø 0 5 Ø 0 8 FLEX24 Electr...

Page 6: ...depth of electrode array 97 7 99 7 102 7 97 7 4 5 15 30 3 3 0 9 SYNCHRONY 2 FORM19 24 18 8 47 3 29 FORM19 Electrode Array FORM19 Electrode array 19 2 4 1 3 14 3 Ø 0 5 Ø 0 8 Ø 1 9 Typické rozmery v mm Odporúčaný priemer kochleostómie a okrúhleho okienka Odporúčaná hĺbka zavedenia elektródového poľa ...

Page 7: ...scutaneous 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 7g typical weight For principal dimensions of the implant refer to the drawings on the previous pages The volume of the implant without electrode is 3 9cm Following materials are in direct contact with human tissue...

Page 8: ...2 1 3 1 3 0 5 0 5 0 14 0 14 2 4 26 4 Medium 111 2 0 8 0 8 0 5 0 5 0 14 0 14 1 9 20 9 Compressed 111 2 0 7 0 7 0 5 0 5 0 14 0 14 1 1 12 1 FLEXSOFT 110 9 1 3 1 3 0 5 0 4 0 13 0 14 2 4 26 4 FLEX28 108 2 0 8 0 8 0 5 0 4 0 13 0 14 2 1 23 1 FLEX26 105 2 0 8 0 8 0 5 0 3 0 13 0 14 1 9 20 9 FLEX24 104 2 0 8 0 8 0 5 0 3 0 13 0 14 1 9 20 9 FLEX20 99 7 0 8 0 8 0 5 0 3 0 13 0 14 1 4 15 4 FORM24 102 7 0 8 0 8 0...

Page 9: ...ctrical stimulation of the auditory nerve A functional auditory nerve is thus a prerequisite for successful cochlear implantation MED EL strongly recommends using optimally fitted hearing aids for a minimum of three months before deciding that a cochlear implant is the preferential option However if an individual was deafened by an infectious disease which can lead to ossification and if there are...

Page 10: ...ed to be used in open cochleae no obliteration or ossification for an electrode insertion depth of about 20mm as per request of the surgeon Cochlear implants SYNCHRONY 2 FLEX20 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 high frequencies Cochlear implants SYNCHR...

Page 11: ...culties 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 sterilisation process and is supplied in sterile packaging Once the sterile packaging has been opened the im plant cannot be resterilised Do not use if sterile packaging is damaged The implant is for si...

Page 12: ... or face mask are worn care must be taken to ensure that the strap is not too tight over the site of the implant In case the MED EL implant user wants to dive the user should consult an experienced physician about the possibilities and personal restrictions when performing water sports especially in the case of SCUBA diving The implant is robust against pres sure changes which occur during SCUBA d...

Page 13: ...ostoperative movement and excessive mechani cal impact The anterior stimulator edge should not be recessed to a depth more than 2mm Additional immobilisation 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 The ...

Page 14: ...rode 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 Good physical and thus stable electrical contact between stimulation reference electrode and surrounding tissue is essential for electrical stimulation The...

Page 15: ...nducting a functionality check telemetry measurement as well as taking an x ray image of the device in implanted condition prior to the explantation of the device Further details regarding the device condition as found during explantation surgery are requested within MED EL s Device Explant Report Form AW8352 which is contained in MED EL s Explant Kit PN04175 Please make sure that the Device Expla...

Page 16: ...ed by Arnold et al ORL 2002 64 382 389 may be useful additional reading Warranty Please refer to the accompanying Warranty Statement for information on our warranty provisions Symbols CE marking First applied in 2019 Do not re use Reference number Catalogue number Serial number Caution Sterilised using ethylene oxide Use by date Date of manufacture Manufacturer MR Conditional Help and assistance a...

Page 17: ... implan tátu vrátane komunikácie prostredníctvom transkutánneho pripojenia a vyhodnotenie impedancií elektródy a záznamu elektricky vyvolaného zloženého akčného potenciálu sluchového nervu Implantát má hmotnosť 7 7g typická hmotnosť Základné rozmery implantátu zodpovedajú nákresom na predchádzajúcich stranách Objem implantátu bez elektródy je 3 9cm Nasledujúce materiály sú v priamom kontakte s ľud...

Page 18: ...a najvzdiale nejším kon taktom Standard 111 2 1 3 1 3 0 5 0 5 0 14 0 14 2 4 26 4 Medium 111 2 0 8 0 8 0 5 0 5 0 14 0 14 1 9 20 9 Compressed 111 2 0 7 0 7 0 5 0 5 0 14 0 14 1 1 12 1 FLEXSOFT 110 9 1 3 1 3 0 5 0 4 0 13 0 14 2 4 26 4 FLEX28 108 2 0 8 0 8 0 5 0 4 0 13 0 14 2 1 23 1 FLEX26 105 2 0 8 0 8 0 5 0 3 0 13 0 14 1 9 20 9 FLEX24 104 2 0 8 0 8 0 5 0 3 0 13 0 14 1 9 20 9 FLEX20 99 7 0 8 0 8 0 5 0...

Page 19: ...uchový nerv Predtým ako usúdite že kochleárny implantát je najlepšou voľbou spoločnosť MED EL výrazne odporúča používať optimálne nasadené načúvacie pomôcky po dobu aspoň tri mesiace Ak však hluchotu u nejakej osoby spôsobila infekčné ochorenie ktoré môže viesť k osifikácii a ak existujú príznaky kochleárnej osifiká cie načúvaciu pomôcku nemusí byť potrebné vyskúšať V takýchto prípadoch by sa zvyč...

Page 20: ...roakustickú stimuláciu sú indikované pre čiastočne nepočujúce osoby s miernou až strednou senzoric ko nervovou stratou sluchu v nižších frekvenciách s nábehom k ťažkej senzoric ko nervovej strate sluchu vo vyšších frekvenciách Kochleárne implantáty SYNCHRONY 2 FORM24 sú určené na použitie pre volne prístupné kochley bez obliterácie alebo osifikácie alebo v prípade při malformácií kochley pri hĺbke...

Page 21: ...izácie etylénoxidom a dodáva sa v steril nom balení Po otvorení sterilného balenia nie je možné implantát opakovane steri lizovať Ak je sterilné balenie poškodené nepoužívajte ho Implantát je len na jedno použitie Neodstraňujte sterilné balenie pokiaľ to nie je potrebné Skladovanie dodávka a likvidácia Sterilizovaný implantát možno prepravovať len pri teplote od 29 C 20 2 F do 60 C 140 F a skladov...

Page 22: ... o možnostiach a osobných obmedzeniach pri vykoná vaní vodných športov najmä v prípade potápania Implantát je odolný voči zmenám tlaku ku ktorým dochádza pri potápaní do hĺbky 50m Chirurgické opatrenia a výstrahy Riziká spojené s chirurgickým zákrokom Kochleárne implantácie sú porovnateľné s operáciou stredného ucha s dodatočným vstupom do vnútorného ucha Existujú obvyklé riziká s ktorými sa musí ...

Page 23: ...hybom Postupný posun môže spôsobiť mechanickú únavu a následnú predčasnú poruchu elektrických spo jov Elektródu možno zaviesť do slimáka cez okrúhle okienko alebo prostredníctvom kochleostómie Pri vykonávaní kochleostómie je v záujme minimalizácie rizika poo peračnej infekcie potrebné dať pozor aby okrúhle okienko a jeho membrána zostali počas vŕtania neporušené Odporúčaný priemer kochleostómie a ...

Page 24: ...ciu je nevyhnutný dobrý fyzický a teda stabilný elektrický kontakt medzi stimulačnou referenčnou elektródou a okolitým tkanivom Preto neumiestňujte žiadne fixačné stehy priamo nad referenčnú elektródu a nezapúšťajte stimulátor príliš hlboko aby sa zabránilo vzniku vzduchovej medzery nad referenč nou elektródou Iným rizikám po operačnom zákroku sa možno vyhnúť dodržiavaním pokynov v príslušnom použ...

Page 25: ...robnosti o stave pomôcky pri chirurgickej explantácii sa žiadajú prostredníc tvom formulára MED EL Správa o explantácii pomôcky Device Explant Report Form AW8352 ktorá je súčasťou súpravy MED EL Súprava pre explantáciu Explant Kit PN04175 Uistite sa či je vyplnený formulár Správa o explantácii pomôcky Device Explant Report Form a odovzdaný spolu s výsledkami kontroly funkčnosti röntgenovými snímka...

Page 26: ...prípade meningitídy od Arnolda a kol ORL 2002 64 382 389 Záruka Informácie o našich ustanoveniach o záruke nájdete v priloženom vyhlásení o záruke Symboly Značka CE Prvýkrát pridelená v roku 2019 Nepoužívať opakovane Referenčné číslo katalógové číslo Sériové číslo Upozornenie Sterilizované pomocou etylénoxidu Použiteľné do Dátum výroby Výrobca MR podmienečne bezpečné MR Conditional Pomoc a poraden...

Page 27: ...25 ...

Page 28: ...MED EL Elektromedizinische Geräte GmbH Fürstenweg 77a 6020 Innsbruck Austria office medel com medel com ...

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