ulrich medical tezo titanium cage Series Скачать руководство пользователя

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WS 3495-eIFU

R6.1/2019-03

ulrich GmbH & Co. KG

l Buchbrunnenweg 12 l 89081 Ulm l Germany

Phone: +49 (0)731 9654-0 l Fax: +49 (0)731 9654-2705

[email protected] l w ww.ulrichmedical.com

120

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.

系统：

tezo™ titanium cage family

语言：

中文

对于美国用户，只适用针对美国的特殊版本。

对于加拿大用户，只适用针对加拿大的特殊版本。
请仔细阅读所有说明。如果未遵守说明、警告提示和注意事项，可能会导致严重的后

果或对患者造成伤害。
在临床使用前，请认真遵守所有的产品资料。

所需产品资料是作为系统的总体文件进行编制的，包括：系统相关的使用说明、外科

技术及附录（如适用）、组装拆卸说明，以及“植入物和器械处理手册”UH 1100。

1 预期用途

tezo是一组植入物，由tezo-P、tezo-T和tezo-A组成，用于支持人体腰部与腰骶部脊柱部位的腰椎间盘

空间，起到支持椎骨完成骨融合的作用。tezo是单独或成对地安装在两个椎体之间。同时，这些植入物

还可用于恢复脊柱轮廓。为了实现骨融合，植入物应始终与骨或骨替代材料一起放入椎间盘空间中。需

要附加的稳定器械，例如椎弓根螺钉连接杆系统。

2 产品说明

tezo是用于帮助腰骶椎间融合的植入物。可以应用ALIF（前路腰椎椎体间融合术）、PLIF（后路腰椎椎体

间融合术）或TLIF（椎间孔腰椎椎体间融合术）技术。融合器用于桥接和稳定椎间空间，起到支持骨融合

的作用。尤其是通过融合器的尺寸、高度和角度将实现脊柱轮廓的重建。融合器内可填充骨/骨替代材

料，为骨融合提供最佳的空间。

3 适应症

融合手术的适应症例如有：

脊髓有感染的患者（例如椎间盘炎）

退行性椎间盘疾病

椎间盘切除术综合征

椎间盘手术后的修正

退行性不稳定

裂解性脊椎滑脱

先天性错位，例如脊柱侧弯

伴有临床不稳定的脊柱狭窄

不愈合

4 禁忌症

有发烧或白细胞增多症的患者

已证实有材料过敏或易受异物反应的患者

医学或心理健康状况不佳，由于植入物介入可能进一步使其恶化的患者；对于这些患者，应由主治外

科医生/医师慎重衡量利弊

骨质量或骨量不足的患者，例如严重的骨质疏松、骨质减少、骨髓炎

怀孕

5 可能的副作用

可能与植入物相关的并发症包括：

植入物松动、脱位和/或植入失败

由于材料排异导致的局部或全身反应

缺乏骨融合

相邻节段的连接退化

2019-07-02

Содержание tezo titanium cage Series

Страница 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...

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

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 115: ...svalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used tezo titanium cage family UH...

Страница 116: ...ed Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 6 1 www ifu ulrichmedical com 7 ulrich medical ulri...

Страница 117: ...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 ifu ulrichmedical com 8 tezo ISO 5832 3 ASTM F136 EN ISO 10993 1 9 MRT MR ulrich medical tezo ASTM F2503 MR MR ASTM F2052...

Страница 118: ...ate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used SAR 4W kg SAR MR 22mm FFE TR 100ms TE 15ms 30 SE TR 500ms TE 20ms 70 SE 10m...

Страница 119: ...entisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 14 CE MR MR MRI NON STERI...

Страница 120: ...e ulrichmedical com l www ulrichmedical com 120 Thisdocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that...

Страница 121: ...sureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 6 1 www ifu ulrichmedical com 7 ulrich medical ulrich medi...

Страница 122: ...up to date IFU is used 2 2 1 2 3 4 5 6 7 8 7 tezo www ifu ulrichmedical com 8 tezo ISO 5832 3 ASTM F136 EN ISO 10993 1 9 MR ASTM F2503 ulrich medical tezo MR MR ASTM F2052 F2182 F2213 F2119 tezo 1 5 T...

Страница 123: ...nted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 10 11 12 13 tezo UH 1100 www ifu ulrichmedical com...

Страница 124: ...124 Thisdocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 2019 07 02...

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