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81

This document is valid only on the date printed. If unsure of the print date, re-print to ensure use of the latest version of the IFU. The onus resides with 

the user to ensure that the most up-to-date IFU is used.

Имплантаты поставляются стерильными, повторная обработка либо стерилизация имплантата запрещена. Повторная обработка 

может привести к повреждению материала и ухудшение его функции.

При очистке, дезинфекции и стерилизации нестерильных инструментов следует соблюдать «Инструкцию по обработке имплантатов 

и инструментов» UH 1100, которая входит в полный комплект документов к системе. Для отдельных инструментов, маркированных 

соответствующим образом в операционной технике, обязательно соблюдение «Инструкции по сборке и разборке со специальными 

указаниями по очистке», которая предоставляется с полным комплектом документов к системе.

Данные документы также доступны на интернет-сайте: 

www.ifu.ulrichmedical.com

.

14  Маркировка и символы

Номер по каталогу

Код партии

Количество

Изготовитель

Дата изготовления

Использовать до

Не использовать при 

повреждении упаковки

Запрет на повторное 

применение

Радиационная стерилизация

Внимание! В соответствии с федеральным законодательством США 

изделие разрешено продавать только врачам или по рецепту врача

Внимание

См. инструкцию по сборке и разборке и специальные указания по очистке

Обратитесь к инструкции по 

применению

Маркировка CE с идентификационным номером нотифицированного 

органа

Нестерильно

MR

Условно совместимо с МР-окружением.

 Изделие не представляет никаких известных опасностей в среде МРТ при 

выполнении определенных условий

NON

STERILE

2019-07-02

Summary of Contents for tezo titanium cage Series

Page 1: ...Instructions for use Instructions for use Mode d emploi Istruzioni per l uso Instrucciones de uso Instru es de utiliza o Brugsanvisning Bruksanvisning K ytt ohje Kullan m K lavuzu Gebruiksaanwijzing B...

Page 2: ...ischenwirbelraum eingebracht werden Die zus tzliche stabilisierende Instrumentierung zum Beispiel mit einem Pedikelschrauben Stab System ist erforderlich 2 Produktbeschreibung tezo sind Implantate zur...

Page 3: ...e der entsprechenden ulrich medical Systeme sind ausschlie lich mit den daf r vorgesehenen systemspezifischen Instrumenten zu verwenden sofern nicht anderweitig angegeben Die Verbindung von ulrich med...

Page 4: ...innerhalb der Operationsstelle w hrend eines maximal 2 j hrigen Heilungsprozesses Nachdem die Operationsstelle fusioniert ist ist das Implantat fest im Knochen verankert Das Implantat ist daher nicht...

Page 5: ...cken gelagert werden Instrumentek nnenbeiLagerungunterung nstigenBedingungenkorrodieren Umdieszuvermeiden sinddiesetrockenundstaubgesch tzt zu lagern Damit sich auf den Instrumenten keine Feuchtigkeit...

Page 6: ...rVerpackung nicht verwenden Nicht wiederverwenden Strahlensterilisiert Achtung Gem ss US Bundesgesetz darf dieses Produkt nur an rzte oder auf deren Anordnung verkauft werden Achtung Montage und Demon...

Page 7: ...ys be inserted with bone or bone graft material into the intervertebral space Additional stabilizing instrumentation is necessary for example with a pedicle screw rod system 2 Product description tezo...

Page 8: ...his purpose unless otherwise indicated Connecting ulrich medical implants to implant components of other manufacturers is not permitted A combination with other implants from ulrich medical is not per...

Page 9: ...cur due to the presence of the implant in the body 1 Corrosion with local tissue inflammation or pain 2 Implant migration possibly leading to injuries 3 Risk of additional injuries caused by post surg...

Page 10: ...ly exposed to metal chemical substances may destroy this metal or release corrosive fumes Therefore instruments must not be stored together with chemical substances The system specific trays are to be...

Page 11: ...date Do not use if package is damaged Do not re use Sterilized using irradiation Caution U S federal law restricts this device to sale by or on the order of a physician Caution Consult assembly and di...

Page 12: ...rrect choice of patients the required training and the experience with choosing and administering implants A copy of the surgical technique manual for the implantation of tezo can be obtained free of...

Page 13: ...sical limitations of the product The postoperative level of activity will influence the service life of the implant and the durability of the implant in the bone The patient must therefore be instruct...

Page 14: ...the packaging leaflet of the implant and instrument concerned Only genuine implants must be used CLEANING DISINFECTION AND STERILIZATION Implant The implants are delivered sterile and do not have to b...

Page 15: ...ecting a cleaning agent system please ensure that It is suitable for cleaning the instruments If no thermal disinfection is used a suitable disinfectant with proven efficacy e g FDA clearance is addit...

Page 16: ...ut all damaged instruments Instruments that are still dirty must be cleaned and disinfected again Maintenance Reassemble all disassembled instruments Subject all instruments to a functional test Apply...

Page 17: ...should be reported to ulrich medical USA immediately by the customer or health care provider Furthermore if any of the implants malfunction i e do not meet any of their performance specifications or o...

Page 18: ...to S1 in skeletally mature patients who have had six months of non operative treatment The device is intended for use at either one level or two contiguous levels for the treatment of degenerative dis...

Page 19: ...ct contact with metal implants from other manufacturers is not allowed 5 2 Preoperative Implantation should only be considered when all other treatment options have been carefully weighed and ruled ou...

Page 20: ...ilure Implant failure is possible even after successful fusion The implant removal must be followed up accordingly Explanted implants must not be reused The patient should be informed about the necess...

Page 21: ...sive labels are included for documentation 11 Disposal of used products Follow country specific regulations regarding disposal of hospital waste when disposing of used medical devices 12 Cleaning disi...

Page 22: ...space intervert bral de toujours ajouter du tissu osseux ou du substitut osseux afin que le processus de fusion puisse s effectuer Une instrumentation de stabilisation suppl mentaire est indispensable...

Page 23: ...produit pourraient en tre compromises Sauf indication contraire les implants des diff rents syst mes ulrich medical doivent tre utilis s exclusivement avec les instruments pr vus cet effet et sp cifi...

Page 24: ...est donc pas con upour treretir saufencasdecomplications derupturedel implantoudephasedecicatrisationprolong e absencedefusiondans les deux ans qui suivent n cessitant un retrait de l implant Mais la...

Page 25: ...iter cela ils doivent donc tre stock s dans un endroit sec non poussi reux Il convient d viter les fluctuations de temp rature importantes pour emp cher l apparition d humidit condensation sur les ins...

Page 26: ...emballage est endommag Ne pas r utiliser St rilis par irradiation Attention selon le droit f d ral des tats Unis ce dispositif ne peut tre vendu qu ou que sur l ordre d un m decin Attention Consulter...

Page 27: ...le insieme a osso o materiale osseo sostitutivo necessaria una strumentazione stabilizzante aggiuntiva ad esempio con un sistema a viti peduncolari e barre 2 Descrizione del prodotto tezo costituito d...

Page 28: ...mente con gli appositi strumenti specifici per il sistema salvo diversa indicazione Non consentito collegare gli impianti ulrich medical con componenti implantari di altri fabbricanti Non consentito e...

Page 29: ...e di guarigione assenza di fusione entro 2 anni La decisione in merito dovrebbe essere presa dopo un attenta valutazione dei rischi e dei benefici da parte di un medico specialista La presenza dell im...

Page 30: ...i in condizioni sfavorevoli Per evitare questo problema conservarli in un area asciutta e protetta dalla polvere Evitare oscillazioni di temperatura significative in modo da evitare la formazione di u...

Page 31: ...io non integro Non riutilizzare Sterilizzato con radiazioni ionizzanti Attenzione la legge federale statunitense limita la vendita di questo dispositi vo ai medici o su prescrizione di un medico Atten...

Page 32: ...debe colocarse siempre junto a hueso o sustituto seo en el espacio intervertebral Es necesaria una instrumentaci n estabilizadora adicional por ejemplo con un sistema de tornillo pedicular varilla 2 D...

Page 33: ...tes Al m dico que realiza el tratamiento tambi n le corresponde decidir si deben conservarse los implantes despu s de la cirug a o si deben retirarse Debemanipularseyalmacenarseelproductoconcuidado No...

Page 34: ...evaluar la posibilidad de que se haya producido un fallo cl nico del implante y analizar con el paciente las medidas necesarias para favorecer la recuperaci n El implante sirve para favorecer la recon...

Page 35: ...ni se haya superado la fecha de caducidad El producto debe almacenarse en un lugar seco hasta su utilizaci n Si se almacenan en condiciones inadecuadas los instrumentos pueden corroerse Para evitar es...

Page 36: ...Esterilizado utilizando irradiaci n Precauci n De acuerdo a la ley federal norteamericana este producto solo puede venderse a facultativos o ser recetado por ellos m dico con licencia Precauci n Cons...

Page 37: ...implante dever ser sempre colocado no espa o intervertebral juntamente com osso ou material de substitui o ssea necess ria a instrumenta o estabilizadora adicional por exemplo com um sistema de hastes...

Page 38: ...ilidade e a resist ncia ao cansa o do produto podem estar comprometidas Salvo indica o em contr rio os implantes dos respetivos sistemas ulrich medical t m de ser utilizados exclusivamente com os inst...

Page 39: ...isso prevista uma remo o do implante a n o ser que surjam complica es uma falha do implante ou um retardamento da fase de cicatriza o ou seja nenhuma fus o num per odo de 2 anos que tornem necess ria...

Page 40: ...is Para evitar isto devem ser armazenados numa rea seca e limpa Oscila es significativas de temperatura devem ser evitadas para que n o se acumule qualquer humidade condensa o nos instrumentos Em caso...

Page 41: ...e a embalagem estiver danificada N o reutilizar Esterilizado por radia o Cuidado a lei federal dos Estados Unidos restringe a venda deste dispositivo a m dicos ou a pedido de um m dico Cuidado Respeit...

Page 42: ...plantatet altid anbringes sammen med knogler eller knogleerstatningsmateriale i hvirvelmellemrummet Ekstra stabiliserende instrumente ring f eks med et pedikelskrue stav system er n dvendig 2 Produkt...

Page 43: ...m ikke anvendes da dette kan p virke produktets styrke og tr thedsresistens Implantater fra de respektive ulrich medical systemer m kun anvendes med de dertil beregnede systemspecifikke instrumenter...

Page 44: ...om dette b r dog tr ffes efter en omhyggelig speciall gelig afvejning af risikoen i forhold til fordelen F lgende komplikationer kan optr de p grund af implantatet i kroppen 1 Korrosion med lokal v v...

Page 45: ...ugtighed kondensat p instrumenterne Kemikalier kan ved direkte kontakt del gge metal eller afgive dampe der virker korrosive Instrumenter m derfor ikke opbevares sammen med kemikalier Anvend de opbeva...

Page 46: ...kke anvendes hvis pakningen er beskadiget M ikke genbruges Steriliseret med str ling Forsigtig If lge amerikansk lovgivning m denne anordning kun s lges af eller p foranledning af en l ge Forsigtig Se...

Page 47: ...vertebralrummet tillsammans med ben eller beners ttningsmaterial Ut ver det kr vs stabiliserande instrumentering t ex ett stavsystem med pedikelskruvar 2 Produktbeskrivning tezo r implantat f r lumbos...

Page 48: ...s vida inte annat anges Det r inte till tet att ansluta medicinska implantat fr n ulrich medical till implantatkomponenter fr n andra tillverkare En kombination med andra implantat fr n ulrich medica...

Page 49: ...nflammation eller sm rta 2 Implantatmigrering som eventuellt kan leda till kroppsskador 3 Risk f r ytterligare kroppsskador som orsakas av postoperativt trauma 4 Deflektioner avlossning eller frakture...

Page 50: ...instrumenten Vid direktexponering f r metall kan kemiska substanser f rst ra denna metall eller frisl ppa korroderande ngor Instrumenten f r d rf r inte f rvaras tillsammans med kemiska substanser De...

Page 51: ...v ndas om f rpack ningen r skadad F r inte teranv ndas Steriliserad med str lning F rsiktighet Enligt federal lagstiftning i USA f r denna enhet endast s ljas av l kare eller p uppdrag av l kare F rsi...

Page 52: ...sa on k ytett v stabiloivia lis instrumentteja kuten pedikkeliruuvi tanko j rjestelm 2 Tuotekuvaus tezo tuotteet ovat lanne ja ristirangan alueella nikamien luuhun kiinnikasvamisen edist miseen k ytet...

Page 53: ...on k ytett v ainoastaan t t k ytt tarkoitusta vastaavien j rjestelm kohtaisten instrumenttien kanssa ellei muuta ole ilmoitettu ulrich medical implanttien liitt mist muiden valmistajien implanttikomp...

Page 54: ...sesta huolellisen riskien ja hy tyjen arvioinnin j lkeen Mik li implanttia ei poisteta saattaa ilmet seuraavia komplikaatioita 1 sy pym joka johtaa paikalliseen kudostulehdukseen tai kipuun 2 implanti...

Page 55: ...tumista metallille kemialliset aineet saattavat tuhota metallin tai vapauttaa korrosiivisia h yryj N in ollen instrumentteja ei saa s ilytt yhdess kemiallisten aineiden kanssa Implanttien ja instrumen...

Page 56: ...t p iv m r Ei saa k ytt jos pakkaus on vaurioitunut Ei saa k ytt uudelleen Steriloitu s teilytt m ll Huomio Yhdysvaltain liittovaltion lain mukaan t t laitetta saa myyd vain l k ri tai l k rin m r yks...

Page 57: ...zasyon i in rne in pedik ler vidal ubuk sistemine sahip ek enstr man tasyon gereklidir 2 r n a klamas tezo lumbosakral intersomatik f zyon i in kullan lan implantlard r ALIF tekni i anterior lomber in...

Page 58: ...a kullan lmal d r ulrich medical implantlar n n di er reticilerin implant bile enleriyle birle tirilmesine izin verilmez ulrich medical in di er implantlar ile kombinasyona izin verilmez Pasif katmanl...

Page 59: ...a implant n kar lmas ng r lmemektedir Ancak bu konudaki karar uzman doktor taraf ndan titizlikle risk ve fayda de erlendirmesi yap ld ktan sonra verilmelidir mplant n v cuttaki varl sebebi ile a a da...

Page 60: ...Kimyasal maddeler metale do rudan temas ettiklerinde metali tahrip edebilir veya a nd r c duman sal n m na neden olabilir Bu nedenle enstr manlar kimyasal maddeler ile birlikte saklanmamal d r Enstr m...

Page 61: ...ihi Ambalaj hasar g rm ise kullanmay n Yeniden kullanmay n I nlama kullan larak sterilize edilmi tir Dikkat ABD federal kanunlar uyar nca bu cihaz sadece doktorlara veya doktor talimat yla sat labilir...

Page 62: ...ocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used tezo titanium cage fa...

Page 63: ...funsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 5 6 6 1 www ifu ulrichmedical com 7 C arm ulrich medical...

Page 64: ...d Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 3 tezo P 6 4 2 2 1 2 3 4 5 6 7 stress shielding 8 7...

Page 65: ...sed 8 tezo ISO 5832 3 ASTM F136 EN ISO 10993 1 9 MR tezo ulrich medical MR ASTM F2503 MR ASTM F2052 F2182 F2213 F2119 tezo 1 5T 3 0T 30T m 3 000 G cm SAR 2 W kg Normal Operating Mode 30 4W kg First Le...

Page 66: ...mentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 14 CE MR MR NON STERILE...

Page 67: ...moet altijd samen met bot of botvervangend materiaal in de intervertebrale ruimte worden ge mplanteerd om botfusie mogelijk te maken Verdere stabilisatie door middel van een pedikelschroef stangsystee...

Page 68: ...invloed kan hebben op de productstabiliteit en vermoeidheidsweerstand Implantaten in overeenkomende systemen van ulrich medical mogen uitsluitend worden gebruikt met de daarvoor bedoelde systeemspecif...

Page 69: ...an weefseldefecten in het operatiegebied gedurende een genezingsperiode van maximaal2jaar Nadatdefusieinhetoperatiegebiedisvoltooid ishetimplantaatsteviginhetbotverankerd Hetisdusnietdebedoeling dat h...

Page 70: ...ie kan optreden wanneer instrumenten worden opgeslagen onder ongunstige omstandigheden Om dit te voorkomen moeten ze wor den opgeslagen op een droge stofvrije locatie Grote temperatuurschommelingen mo...

Page 71: ...digd is Niet opnieuw gebruiken Gesteriliseerd met bestraling Let op Volgens de Amerikaanse federale wetgeving mag dit hulpmiddel uitsluitend worden aangeschaft door of in opdracht van een arts Let op...

Page 72: ...ellerbenerstatningsmateriale Ytterligerestabiliserendeinstrumenteringern dvendig f eks medetpedikkelskruestav system 2 Produktbeskrivelse tezo er implantater for lumbosakral intersomatisk fusjon ALIF...

Page 73: ...dusenter er ikke tillatt En kombinasjon med andre implantater fra ulrich medical er ikke tillatt Det er sv rt liten korrosjon p metallimplantater p grunn av passive lag men det kan fortsatt f re til f...

Page 74: ...lelse p grunn av implantatets tilstedev relse 6 Fare for infeksjon eller inflammasjon 7 Bentap p grunn av belastningsavskjerming 8 Potensielle ukjente eller uventede langsiktige virkninger En forsinke...

Page 75: ...11 Identifisering og sporbarhet Implantater er merket med bestillingsnummeret og partikoden p pakningsetiketten og hvis det er teknisk mulig er disse merket p selve implantatet For sikre sporbarheten...

Page 76: ...e brukes hvis pakningen er skadet Ikke til gjenbruk Sterilisert med str ling Forsiktig Amerikansk f deral lovgivning begrenser salg av dette utstyret til leger eller etter ordre fra leger Forsiktig Se...

Page 77: ...ocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used tezo titanium cage fa...

Page 78: ...d Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 5 6 6 1 www ifu ulrichmedical com 7 ulrich medical ulr...

Page 79: ...svalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 3 tezo P 6 4 2 2 1 2 3 4 5...

Page 80: ...p to date IFU is used 7 tezo www ifu ulrichmedical com 8 tezo ISO 5832 3 ASTM F136 EN ISO 10993 1 9 MR ulrich medical tezo ASTM F2503 MR conditional ASTM F2052 F2182 F2213 F2119 tezo 1 5 3 0 30 3000 S...

Page 81: ...onthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used UH 1100 www ifu ulrichmedical com 14 CE...

Page 82: ...s ntotdeauna mpreun cu osul sau materialul de nlocuire a osului n spa iul intervertebral Sunt necesare implanturi de stabilizare suplimentare de exemplu cu un sistem cu uruburi pedicul tij 2 Descriere...

Page 83: ...ot fi afectate stabilitatea produsului i rezisten a la oboseal Implanturile sistemelor ulrich medical corespunz toare trebuie utilizate exclusiv cu instrumentele specifice sistemului destinate acestui...

Page 84: ...ie scos cu excep ia situa iilor n care apar complica ii nereu ita implant rii sau o perioad de vindecare ndelungat fuziunea nu are loc n decurs de 2 ani care fac necesar ndep rtarea implantului Decizi...

Page 85: ...ntr un spa iu uscat f r praf Fluctua iile semnificative de temperatur trebuie evitate astfel nc t umezeala condensul s nu se acumuleze pe instru mente Atunci c nd intr n contact direct cu metalul sub...

Page 86: ...e deteriorat A nu se reutiliza Sterilizat prin iradiere Aten ie legisla ia federal din Statele Unite restric ioneaz v nzarea acestui dispozitiv de c tre sau la recomandarea unui medic Aten ie Consulta...

Page 87: ...ocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used tezo titanium cage fa...

Page 88: ...d Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 5 6 6 1 www ifu ulrichmedical com 7 ulrich medical ulr...

Page 89: ...teprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 3 tezo P 6 4 2 2 1 2 3 4 5 6 7 8 7 tezo www...

Page 90: ...is used 8 tezo ISO5832 3 ASTMF136 EN ISO 10993 1 9 MR tezo ulrich medical ASTM F2503 ASTM F2052 F2182 F2213 F2119 tezo 1 5T 3 0T 30T m 3000 G cm SAR 2W kg Normal Operating Mode 30 4W kg First Level C...

Page 91: ...cumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 14 CE MR NON STERILE 2...

Page 92: ...ho prostoru Je zapot eb p davn stabiliza n instrumentace nap klad s pou it m syst mu pedikul rn ch roub ty e 2 Popis produktu tezo jsou implant ty pro lumbosakr ln intersomatickou f zi Je mo n pou t...

Page 93: ...vzhledem k existuj c m pasivn m vrstv m velmi n zk m e v ak v st k urychlen navy materi lu s mo nost poru en materi lu a rovn k p ib v n kovov ch slo ek uvoln n ch do t la Ke korozi p isp v dotyk komp...

Page 94: ...Zpo d n f ze hojen neuskute n n kostn f ze v skyt resorpce kosti nebo trauma mohou implant t po implantaci nadm rn zat ovat a v st k selh n implant tu Selh n implant tu je mo n i po sp n f zi Po odst...

Page 95: ...ilo eny p slu n t tky pro dokumentaci 12 Likvidace pou it ch v robk P i likvidaci pou it ch zdravotnick ch prost edk se i te p slu n mi n rodn mi p edpisy pro likvidaci nemocni n ho odpadu 13 i t n de...

Page 96: ...zvietot ja materi lu Vajadz gs papildus stabiliz jo s instrument rijs piem ram pedikul ro skr vju stie a sist ma 2 Produkta apraksts tezo ir implanti lumbosakr lai intersomatiskai f zijai Tos var izma...

Page 97: ...sve a ra ojuma implantu komponentiem Nav pie aujama kombin cija ar citiem ulrich medical implantiem Pateicoties pas vajai virsk rtai met la implantu korozija ir oti niec ga ta u t var izrais t pa trin...

Page 98: ...aisuma risks 7 Kaulu atrofija slodzes tr kuma d 8 Potenci li nezin mi vai negaid ti ilglaic gie efekti Ieilgusi atvese o an s f ze nenotikusi kaulu f zija g ta trauma vai kaulaudu uzs k an s var p rm...

Page 99: ...s uzl mes ko pievienot do kument cijai 12 Lietotu produktu utiliz cija Utiliz jot lietotus medic nas produktus iev rojiet valsts specifiskos noteikumus par slimn cu atkritumu utiliz ciju 13 T r ana de...

Page 100: ...ostnego implant musi by umieszczany w przestrzeni mi dzykr gowej zawsze razem z ko ci lub materia em ko ciozast pczym Wy magane jest dodatkowe instrumentarium stabilizuj ce na przyk ad system rub prze...

Page 101: ...Obowi zkiem lekarza prowadz cego jest r wnie ustalenie czy nale y implant pozostawi po zabiegu czy te go usun Nale y zachowa ostro no podczas obchodzenia si z wyrobem i przechowywania go Nie wolno sto...

Page 102: ...trukcj uszkodze tkankowych w okresie gojenia trwaj cym maksymalnie 2 lata Po pomy lnym zro cie operowanej okolicy implant jest na sta e zakotwiczony w ko ci Dlatego te implant nie jest przeznaczony do...

Page 103: ...astosowania nale y przechowywa wyr b w suchym miejscu Przechowywanie narz dzi w niew a ciwych warunkach mo e prowadzi do powstania korozji Aby temu zapobiec nale y je przechowywa w suchym niezapylonym...

Page 104: ...pakowanie jest uszkodzone Nie u ywa ponownie Sterylizowano radiacyjnie Przestroga Prawo federalne USA dopuszcza sprzeda tego wyrobu wy cznie przez lekarza lub na zlecenie lekarza Przestroga Patrz inst...

Page 105: ...tudi za ponovno vzpostavitev profila hrbtenice Za dosego fuzije je treba implantat vedno namestiti v medvreten ni prostor skupaj s kostjo ali kostnim nadomestkom Potrebna je dodatna stabilizacijska i...

Page 106: ...ruga e dolo eno Implantatov ulrich medical ne smete povezati s komponentami implantatov drugih izdelovalcev Kombinacija z drugimi implantati ulrich medical ni dovoljena Korozija kovinskih implantatov...

Page 107: ...ta 14 Tveganje oku be ali vnetja 15 Izguba kostne mase zaradi za ite pred po kodbami 16 Potencialni neznani ali nepri akovani dolgotrajni u inki Zakasnjeno celjenje neizvedena kostna fuzija resorpcija...

Page 108: ...ov morate uporabiti pladnje za skladi enje ki so namenjeni uporabi s sistemom 11 Identifikacija in sledljivost Implantati so ozna eni s katalo ko tevilko in kodo serije na etiketi embala e e je to mog...

Page 109: ...uporabljajte e je embala a po kodovana Ni za ponovno uporabo Sterilizirano z obsevanjem Pozor Zvezni zakon ZDA dovoljuje prodajo te naprave samo s strani zdravnika ali na zdravni ki recept Pozor Glejt...

Page 110: ...a mal implant t do priestoru medzi stavcami vlo i v dy spolu s kos ou alebo n hradn m kostn m materi lom Je potrebn aj al ia stabiliz cia napr pomocou syst mu pedikul rnych skrutiek a ty 2 Popis v rob...

Page 111: ...ri lu Implant ty v pr slu n ch zdravotn ckych syst moch od spolo nosti ulrich medical sa musia pou va v hradne s n strojmi pecifick mi pre dan syst m a ur en mi na dan el pokia nie je uveden inak Komb...

Page 112: ...ho lek ra Pr tomnos implant tu v tele m e sp sobi nasleduj ce komplik cie 1 kor zia s lok lnym z palom tkaniva alebo boles ami 2 migr cia implant tu ktor m e vies k zraneniam 3 riziko al ch zranen sp...

Page 113: ...m kontakte zni i kov alebo uvo ova ierav plyny N stroje sa preto nesm skladova spolu s chemick mi l tkami Na skladovanie n strojov pou ite lo n sitov ko e patriace k syst mu 11 Identifik cia a sledova...

Page 114: ...produkt ak je obal po koden Nepou vajte opakovane Sterilizovan o iaren m Pozor Feder lny z kon USA obmedzuje predaj tohto zariadenia iba prostred n ctvom alebo na objedn vku lek ra Pozor Pre tajte si...

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