ulrich medical Obelisc, Instructions For Use Manual

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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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Page 106: ...com l www ulrichmedical com 106 Thisdocumentisvalidonlyonthedateprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to...

Page 107: ...heprintdate 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 med...

Page 108: ...t up to date IFU is used 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 MR ASTM F2503 ulrich medical obelisc MR MR ASTM F2052 F2182 F2213 F2119 obe...

Page 109: ...eprinted Ifunsureoftheprintdate re printtoensureuseofthelatestversionoftheIFU Theonusresideswith the user to ensure that the most up to date IFU is used 11 12 13 UH 1100 www ifu ulrichmedical com 14 N...