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14 Etiquetado y símbolos

Número de catálogo

Precaución

Cantidad

Código de lote

No reutilizar

NON

STERILE

No estéril

Fabricante

Fecha de fabricación

No utilizar si el envase está

dañado

Consúltense las instrucciones de uso electrónicas

Consúltense las instrucciones

de uso

Precaución: De acuerdo a la ley federal norteamericana este producto solo

puede venderse a facultativos o ser recetado por ellos («médico con licencia»).

RM compatible en determina-

das condiciones – un producto

que no evidencia ningún riesgo

conocido en el entorno de RMI

específico

Marca CE con número de

identificación del organismo

notificado

Consúltense las instrucciones

de ensamble y desensamble

con instrucciones de limpieza

especiales

2019-09-10

Содержание Obelisc

Страница 1: ...ns 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 Bruksanvisn...

Страница 2: ...lteH he DiesekannnurdurchweiteresDrehendesKegelradesver ndertwerden DiefinaleFixierung erfolgt mittels einer Fixierschraube Das obelisc Implantat kann durch seinen Platz sparenden Spreizmechanismus mi...

Страница 3: ...zur beschleunigten Materialerm dung mit der M glichkeit eines Materialbruches sowie zur Zunahme der in den K rper abgegebenen Metallbestandteile f hren Korrosion wird beg nstigt durch die Ber hrung v...

Страница 4: ...des Implantats im K rper k nnen folgende Komplikationen auftreten 1 Korrosion mit lokaler Gewebeentz ndung oder Schmerzen 2 Migration des Implantats m glicherweise resultierend inVerletzungen 3 Risiko...

Страница 5: ...trumenten keine Feuchtigkeit Kondensat bildet sind gr ereTemperaturschwankungen zu vermeiden Chemikalien k nnen im direkten Kontakt Metall zerst ren oder D mpfe abgeben die korrosiv wirken Instrumente...

Страница 6: ...ler Herstellungsdatum Bei besch digterVerpackung nicht verwenden Elektronische Gebrauchsanweisung beachten Gebrauchsanweisung beachten Achtung Gem ss US Bundesgesetz darf dieses Produkt nur an rzte od...

Страница 7: ...e in the inserter The implant maintains the set height This can only be changed by turning the bevel gear further Final fixation is performed by means of a locking screw Thanks to its space saving exp...

Страница 8: ...l as increased release of metal components in the body Corrosion is promoted by the components made of different metals coming into contact and by damage to the implant s surface The ability to combin...

Страница 9: ...rolonged healing phase unsuccessful bony fusion or subsequent bone resorption or trauma can place undue stress on the implant which in turn could lead to implant failure Implant failure is possible ev...

Страница 10: ...itself To ensure traceability these data must be correspondingly documented in the hospital 12 Disposal of used products Follow country specific regulations regarding disposal of hospital waste when d...

Страница 11: ...al procedures in the thoracolumbar spine T1 L5 to replace a collapsed damaged or unstable vertebral body due to tumor or trauma e g fracture The obelisc is intended to be used with supplemental intern...

Страница 12: ...be necessary to correct some of these anticipated adverse reactions WARNINGS AND PRECAUTIONS The following warnings and precautions should be understood by the surgeon and explained to the patient Th...

Страница 13: ...d could loosen bend and or break if excessive demands are placed on it especially in the absence of complete bone healing An active debilitated or demented patient who can not properly use weight supp...

Страница 14: ...5 times with water and using a syringe Cleaning Immerse the products for 5 min into the 104 F warm freshly prepared cleaning solution e g Cidezyme LF and intensively clean them with a soft plastic br...

Страница 15: ...and load configurations Non sterile products are sterilizable by steam sterilization autoclaving NOTE CS 2934 CS 2938 measuring templates for x rays are not steril izable For initial sterilization an...

Страница 16: ...artificielle La hauteur requise de l implant obelisc se r gle sur le site op ratoire l aide d un engrenage conique pr vu dans l instrument d insertion L implant conserve alors la hauteur ainsi r gl e...

Страница 17: ...it d employer des implants ulrich medical avec des composants d implants d autres fabricants Il est galement interdit de les associer d autres implants ulrich medical Les couches passives des implants...

Страница 18: ...apport b n fice risque par un sp cialiste La pr sence de l implant dans le corps peut entra ner les complications suivantes 1 Corrosion avec inflammation locale des tissus ou douleurs 2 Migration de l...

Страница 19: ...e temp rature importantes pour emp cher l apparition d humidit condensation sur les instruments En contact direct avec un m tal certains produits chimiques peuvent le d truire ou lib rer des vapeurs c...

Страница 20: ...cation Ne pas utiliser si l emballage est endommag Consulter les pr cautions d emploi lectroniques Consulter les pr cautions d emploi Attention selon le droit f d ral des tats Unis ce dispositif ne pe...

Страница 21: ...tra mite un ingranaggio conico presente nell inseritore L impianto mantiene l altezza impostata Quest ultima pu essere cambiata solo girando ulteriormente la ruota conica Il fissaggio finale avviene...

Страница 22: ...l La corrosione degli impianti metallici molto bassa per via della presenza di strati passivi ma pu portare a un usura accelerata del ma teriale con la possibilit di frattura del materiale e l aumento...

Страница 23: ...del tessuto locale o dolori 2 Migrazione dell impianto con conseguente possibilit di lesioni 3 Rischio di ulteriori lesioni causate da un trauma postoperatorio 4 Piegamenti allentamenti o rotture 5 Do...

Страница 24: ...rli in un area asciutta e protetta dalla polvere Evitare oscillazioni di temperatura significative in modo da evitare la formazione di umidit condensa sugli strumenti Se poste a diretto contatto con i...

Страница 25: ...Non utilizzare se l imballaggio non integro Consultare le istruzioni per l uso in formato elettronico Consultare le istruzioni per l uso Attenzione la legge federale statunitense limita la vendita di...

Страница 26: ...situ mediante un engranaje c nico en el insertador El implante man tiene la altura ajustada Esta solo puede modificarse si se contin a girando el engranaje c nico La fijaci n final su efect a mediant...

Страница 27: ...as ulrich medical deben utilizarse exclusivamente con los instrumentos espec ficos del siste ma previstos al efecto siempre y cuando no se indique lo contrario No se permite combinar implantes de ulri...

Страница 28: ...st previsto para ser retirado salvo en caso de complicaciones fallo del mismo o fase de recuperaci n prolongada ausencia de fusi n en el t rmino de 2 a os circunstancias en las que se requiere la extr...

Страница 29: ...eriorados Si se almacenan en condiciones inadecuadas los instrumentos pueden corroerse Para evitar esto deben almacenarse en un lugar seco y protegido del polvo Se deben evitar las fluctuaciones consi...

Страница 30: ...envase est da ado Cons ltense las instrucciones de uso electr nicas Cons ltense las instrucciones de uso Precauci n De acuerdo a la ley federal norteamericana este producto solo puede venderse a facul...

Страница 31: ...ebrais A altura necess ria do implante obelisc ajustada exatamente no local atrav s de uma engrenagem c nica no introdutor O implante mant m a altura ajustada Esta pode ser alterada apenas rodando a e...

Страница 32: ...cos do sistema previstos para o efeito A combina o de implantes ulrich medical com componentes de implantes de outros fabricantes n o permitida Uma combina o com outros implantes da ulrich medical n o...

Страница 33: ...ecis o neste sentido s dever ser tomada ap s uma avalia o m dica especializada que considere os riscos e os benef cios associados A presen a do implante no corpo pode dar origem s seguintes complica e...

Страница 34: ...veis 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 ca...

Страница 35: ...fabrico N o utilizar o produto se a embalagem estiver danificada Respeitar as instru es de utiliza o eletr nicas Respeitar as instru es de utiliza o Cuidado a lei federal dos Estados Unidos restringe...

Страница 36: ...situ via en konisk tandhjulsudveksling i is tningsinstru mentet Implantatet holder den indstillede h jde Denne kan kun ndres ved at dreje det koniske tandhjul yderligere Den endelige fiksering sker v...

Страница 37: ...ndre implantater fra ulrich medical er ikke tilladt Korrosion af metalimplantater er p grund af eksisterende passivlag meget lav kan dog medf re fremskyndet materialetr thed med mulighed for materiale...

Страница 38: ...raume 4 B jning l sning eller brud 5 Smerter problemer eller unormal f lsomhed p grund af implantatets tilstedev relse 6 Risiko for infektion eller inflammation 7 Knoglesvind p grund af stress shieldi...

Страница 39: ...hvis det er teknisk muligt kendetegnet p selve implantatet For at sikre sporbarheden skal disse data dokumenteres p sygehuset 12 Bortskaffelse af brugte produkter Brugt medicinsk udstyr skal bortskaff...

Страница 40: ...nomattvridadenkoniska kuggv xeln ytterligare Den slutgiltiga fixeringen sker med hj lp av en l sskruv obelisc implantatet kan anv ndas minimalinvasivt tack vare dess utrymmessparande expanderingsmekan...

Страница 41: ...et inneb r en risk f r att materialet spricker och att m ngden metalldelar som avges till kroppen kar Korrosionen fr mjas om kompo nenter av olika metaller vidr rs samt genom skada p implantatets yta...

Страница 42: ...on f rekomst av benresorption eller trauma utg ra en avsev rd belastning p implantatet och leda till implantatsvikt Risk f r implantatsvikt f religger ven efter en lyckad fusion Avl gsnande av implant...

Страница 43: ...e dessa uppgifter dokumenteras p l mpligt s tt p kliniken 12 Kassering av anv nda produkter F lj landsspecifika f reskrifter f r kassering av sjukhusavfall vid kassering av anv nda medicintekniska pro...

Страница 44: ...tetussa korkeudessa Korkeutta voidaan muuttaa ainoastaan k nt m ll kartiopy r lis Kiinnitys varmistetaan lopuksi kiinnitysruuvilla Koska obelisc implantin levitysmekanismi vie vain v h n tilaa obelisc...

Страница 45: ...in v h ist Materiaalin v syminen saattaa kuitenkin nopeutua ja murtuminen on mahdollista Lis ksi metallikomponenttien vapautuminen kehoon saattaa lis nty Eri metalleista val mistettujen komponenttien...

Страница 46: ...n aiheuttamien lis vammojen riski 4 taipuminen l ystyminen tai murtumat 5 implantin l sn olosta johtuva kipu oireet tai ep tavallinen herkkyys 6 infektion tai tulehduksen riski 7 kuormituskatoilmi st...

Страница 47: ...elm kohtaisia s ilytyskoreja 11 Tunnistaminen ja j ljitett vyys Implanttien pakkausetikettiin sek mik li teknisesti mahdollista my s itse implantteihin on merkitty tuotenumero ja er koodi J ljitett vy...

Страница 48: ...ayarlanan y ksekli i korur Bu y kseklik sadece konik di li tekrar evrilerek de i tirilebilir Nihai sabitleme bir sabitleme vidas arac l yla ger ekle tirilir obelisc implant yerden tasarruf sa layan ge...

Страница 49: ...da metal implantlar n korozyonu olduk a azd r Yine de materyallerde h zland r lm yorul man n yan s ra k r lma olas l ile v cutta metal bile enlerin serbest b rak lmas nda art meydana gelebilir Korozyo...

Страница 50: ...ayda de erlendirmesi yap ld ktan sonra verilmelidir mplant n v cuttaki varl sebebi ile a a daki komplikasyonlar meydana gelebilir 1 Lokal doku enflamasyonu veya a r yla birlikte korozyon 2 mplant n ol...

Страница 51: ...birlikte saklanmamal d r mplantlar n ve enstr manlar n depolanmas i in sisteme zg delikli depolama tepsileri kullan lmal d r 11 Tan mlama ve izlenebilirlik mplantlar ambalaj etiketinin zerinde ve tek...

Страница 52: ...www ulrichmedical com 52 Thisdocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU...

Страница 53: ...oftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 6 1 www ifu ulrichmedical com 7 C arm UH 1100 ulrich medical u...

Страница 54: ...eprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 3 6 4 2 2 1 2 3 4 5 6 7 stress shielding 8 7 obelisc www ifu ulric...

Страница 55: ...hat the most up to date IFU is used EN ISO 10993 1 9 MR obelisc ulrich medical MR ASTM F2503 MR ASTM F2052 F2182 F2213 F2119 obelisc 1 5T 3 0T 30T m 3 000 G cm SAR 2 W kg Normal Operating Mode 30 5 0...

Страница 56: ...mentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 14 NON STERILE MR MR CE...

Страница 57: ...inbrenginstrument in situ exact ingesteld Het implantaat behoudt de ingestelde hoogte Deze kan alleen worden veranderd door het kegelwiel opnieuw te draaien De hoogte wordt definitief gefixeerd met e...

Страница 58: ...n ulrich medical mogen niet worden verbonden met implantaatcomponenten van andere fabrikanten Een combinatie met andere implantaten van ulrich medical is niet toegestaan Decorrosievanmetalenimplantate...

Страница 59: ...is Een beslissing daarover mag echter pas worden genomen na een zorgvuldige afweging van de risico s en baten door een medisch specialist Door de aanwezigheid van het implantaat in het lichaam kunnen...

Страница 60: ...emperatuurschommelingen moeten worden vermeden zodat er geen vocht condens op de instrumenten ophoopt Chemische substanties kunnen metalen bij direct contact vernietigen of dampen met een corrosieve w...

Страница 61: ...gebruiken als de verpak king beschadigd is Raadpleeg de elektronische gebruiksaanwijzing Raadpleeg de gebruiksaan wijzing Let op Volgens de Amerikaanse federale wetgeving mag dit hulpmiddel uitsluiten...

Страница 62: ...gsinstrumentet Implantatet blir v rende i den innstilte h yden Dette kan kun endres ved at kjeglehjulet dreies ytterligere Den endelige fikseringen utf res ved hjelp av en fikseringsskrue obelisc impl...

Страница 63: ...materialtretthet med risiko for materialbrudd samt kning av de metallbestanddelene som avgis i kroppen Korrosjon fremmes ved ber ring mellom kompo nenter av forskjellige metaller samt skader p implant...

Страница 64: ...le ukjente eller uventede langsiktige virkninger En forsinket tilhelingsfase manglende benfusjon etter implanteringen kan benresorpsjon eller en traume f re til for h y belastning av implantatet og fo...

Страница 65: ...ysningene dokumenteres tilsvarende p sykehuset 12 Kassering av brukte produkter F lg landsspesifikke forskrifter vedr rende kassering av sykehusavfall ved kassering av brukte medisinske enheter 13 Reg...

Страница 66: ...www ulrichmedical com 66 Thisdocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IF...

Страница 67: ...ureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 6 1 www ifu ulrichmedical com 7 UH 1100 ulrich medical ulri...

Страница 68: ...heprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 3 6 4 2 2 1 2 3 4 5 6 7 8 7 obelisc www ifu ulrichmedical com 8 o...

Страница 69: ...th the user to ensure that the most up to date IFU is used 9 MR ulrich medical obelisc ASTM F2503 MR conditional ASTM F2052 F2182 F2213 F2119 obelisc 1 5 3 0 30 3000 SAR 2 Normal Operating Mode 30 5 0...

Страница 70: ...cumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 14 NON STERILE MR CE 2...

Страница 71: ...imea necesar a implantului obelisc se regleaz cu precizie in situ gra ie unui angrenaj cu pinioane conice din instrumentul de inser ie utilizat n l imea reglat este blocat automat Aceasta nu poate fi...

Страница 72: ...lanturilor ulrich medical la componentele unor implanturi fabricate de al i produc tori Combinarea cu alte implanturi de la ulrich medical nu este permis Coroziunea implanturilor metalice este foarte...

Страница 73: ...luat abia dup o atent chibzuire a medicului de specialitate care trebuie s c nt reasc bine riscurile i beneficiile Prin existen a implantului n corp pot ap rea urm toarele complica ii 1 coroziune cu i...

Страница 74: ...luctua 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 substan ele chimice pot s l distru...

Страница 75: ...a dac ambalajul este deteriorat Consulta i instruc iunile de utilizare n format electronic Consulta i instruc iunile de utilizare Aten ie legisla ia federal din Statele Unite restric ioneaz v nzarea a...

Страница 76: ...l com l www ulrichmedical com 76 Thisdocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to...

Страница 77: ...ureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 6 1 www ifu ulrichmedical com 7 UH 1100 ulrich medical ulri...

Страница 78: ...heprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 3 6 4 2 2 1 2 3 4 5 6 7 8 7 obelisc www ifu ulrichmedical com 8 o...

Страница 79: ...to ensure that the most up to date IFU is used 9 MR obelisc ulrich medical ASTM F2503 ASTM F2052 F2182 F2213 F2119 obelisc 1 5T 3 0T 30T m 3000 G cm SAR 2 W kg Normal Operating Mode 30 5 0 C 1 5T 3 0T...

Страница 80: ...cumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 14 NON STERILE MR CE 2...

Страница 81: ...enou v ku V ku lze zm nit pouze dal m ot en m ku elov ho kola Kone n fixace se prov d prost ednictv m fixa n ho roubu Implant t obelisc lze d ky jeho prostorov sporn mu rozp nac mu mechanismu aplikova...

Страница 82: ...t kovov ch implant t pou it ch v tomto syst mu P m kontakt s kovov mi implant ty jin ch v robc nen povolen 6 2 P edopera n informace Syst m obelisc je ur en k v hradn mu zachycov n axi ln ho kompresn...

Страница 83: ...v daj c m zp sobem prov d t n sledn p e Explantovan implant ty se nesm znovu pou t Pacientovi by se m la vysv tlit pravidla chov n nutn po implantaci v etn opat en kter je t eba u init v p pad mimo dn...

Страница 84: ...zdokumentovat 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 dezinfekce a sterilizace V...

Страница 85: ...wa co pozwala na zaopatrzenie uszkodze o wysoko ci do 132 mm Umo liwia to protezowanie od jednego do kilku trzon w kr g w Wymagana wysoko implantu obelisc ustawiana jest precyzyjnie in situ poprzez pr...

Страница 86: ...zy te go usun Nale y zachowa ostro no podczas obchodzenia si z wyrobem i przechowywania go Nie wolno stosowa implant w z jakimikolwiek uszkodzeniami lub zarysowaniami poniewa mog one zmniejsza stabiln...

Страница 87: ...y do usuni cia chyba e wyst pi powik ania nieskuteczno implantu lub przed u aj cy si okres gojenia brak zrostu kostnego w ci gu 2 lat wskazuj ce na konieczno jego usuni cia Decyzj o usuni ciu mo e pod...

Страница 88: ...echowywanie narz dzi w niew a ciwych warunkach mo e prowadzi do powstania korozji Aby temu zapobiec nale y je przechowywa w suchym niezapylonym miejscu Nale y te unika wi kszych waha temperatury aby n...

Страница 89: ...ytw rca Data produkcji Nie u ywa je eli opakowanie jest uszkodzone Patrz instrukcja obs ugi w wersji elektronicznej Patrz instrukcja obs ugi Przestroga Prawo federalne USA dopuszcza sprzeda tego wyrob...

Страница 90: ...k prec zi ieregul ts oper jam viet ar konisko zobratu p rvadu kas atrodas ievieto anas instrument Implants saglab ieregul to augstumu To var main t tikai turpinot griezt konisko zobratu Gal g fiks cij...

Страница 91: ...i niec ga ta u t var izrais t pa trin tu materi la nogurumu ar materi la l zuma iesp ju k ar palielin t met la sast vda u daudzumu kas tiek atdots ermenim Koroziju veicina no at ir giem met liem iz ga...

Страница 92: ...n 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 r gi noslogot implantu p c ievieto anas un izrais t implanta atte...

Страница 93: ...i kl nik atbilsto i j dokument 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 dezinfekci...

Страница 94: ...natan no nastavi in situ s pomo jo sto astega zobnika v vstavitvenem instrumentu Implantat dr i nastavljeno vi ino Le to lahko spremenite le z na daljnjim obra anjem sto astega zobnika Kon no fiksira...

Страница 95: ...o kodbo povr ine implantata Zagotovljena je zdru ljivost kovinskih implantatov uporabljenih v tem sistemu Neposreden stik s kovinskimi implantati drugih proizvajalcev ni dovoljen 6 2 Predoperativni po...

Страница 96: ...krbeti za ustrezno pooperativno nego Odstranjenih implantatov ne smete znova uporabiti Bolnika morate obvestiti o zahtevanih vzorcih vedenja po vstavitvi implantata kar vklju uje ukrepe v primeru dogo...

Страница 97: ...dokumentirani v bolni nici s imer se zagotovi sledljivost 12 Odlaganje izrabljenih izdelkov Med odlaganjem izrabljenih medicinskih naprav upo tevajte pravilnike glede odlaganja bolni ni nih odpadkov...

Страница 98: ...epomocouku e ovejprevodovkyvzav dzacomn strojiinsitu Implant tsidr nastaven v ku T sa m e meni len al m ot an m ku e ovej prevodovky Kone n fix cia sa vykon pomocou fixa nej skrutky Priestorovo sporn...

Страница 99: ...plant tov je v aka pas vnym vrstv m ve mi n zka M e v ak vies k r chlej ej nave materi lu a mo nosti jeho zlomenia ako aj zv eniu mno stva kovov ch s ast uvo nen ch do tela Kor ziu podporuje dot kanie...

Страница 100: ...sti stress shielding 8 potenci lne nezn me alebo neo ak van dlhodob inky Oneskoren f za hojenia ch baj ca kostn f zia v skyt kostnej resorpcie a traumy m u sp sobova nadmern za a enie implant tu po im...

Страница 101: ...o daje mus zdravotn cke zariadenie zodpovedaj cim sp sobom zdokumentova 12 Likvid cia pou it ch v robkov Pri likvid cii pou it ch zdravotn ckych pom cok dodr iavajte nariadenia konkr tnej krajiny t ka...

Страница 102: ...l www ulrichmedical com 102 Thisdocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date...

Страница 103: ...eoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 6 6 1 www ifu ulrichmedical com 7 UH 1100 ulrich medical ulrich...

Страница 104: ...most up to date IFU is used 6 4 2 2 1 2 3 4 5 6 7 8 7 obelisc www ifu ulrichmedical com 8 obelisc ISO 5832 3 ASTM F136 EN ISO 10993 1 9 MRT MR ulrich medical obelisc ASTM F2503 MR MR ASTM F2052 F2182...

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