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Instruction leaflet - Please read prior to use

ORTHOFIX

PREFIX

GENERAL WARNINGS

• In order to counter-act the tightening forces it is advisable to use the Clamp Holder (92017) to grip the Rod Clip Clamp, the Screw Clip

Clamp or the Transfixing Pin Clamp while locking them with the Universal T-Wrench or the 5mm Allen Wrench.

• When using the Multi-Screw Clamp, two rods must always be used to increase frame stiffness.

ASPECTS OF MRI COMPATIBILITY

MRI machine: PHILIPS Achieva 1.5T A‐series

Device Position: isocenter of MRI scanner

Magnetic Field Strength: 1.5 Tesla

Spatial gradient field: 9.37mT/m

Please note that temperature changes reported apply to the designated MRI system and characteristics used. If a different

MRI system is used, temperature changes may vary. Contact is advised with the supplier of the MRI system and Orthofix.

Prefix

System is designed as MRI conditional up to 1.5 Tesla. The MRI components have been tested according to ASTM Standards F2052,

F2182, F2213 and F2119. All Prefix

Clamps are blue and MRI conditional. They are marked with “MR”. Prefix

System can only be guaran-

teed for MRI when using Orthofix XCaliber Bone Screws and the following rods to build a frame.

CLAMPS

Code Description

92012

Blue Rod Clip Clamp

92016

Blue Screw Clip Clamp

92026

Blue Transfixing Clip Clamp

92031

Blue Multi Screw Clamp

XCALIBER SCREWS

Thread Length (mm)

Total

Length

(mm)

30 40 50 60 70 80 90

150

911530 911540 911550 911560 911570 911580 911590

260

912630 912640 912650 912660 912670 912680 912690

RODS

Code Description

92125

Rod 125mm long

92175

Rod 175mm long

92275

Rod 275mm long

92350

Rod 350mm long

Содержание PREFIX 2

Страница 1: ...FIX2 70 ORTHOFIX PREFIX2 6 ORTHOFIX PREFIX2 10 ORTHOFIX PREFIX2 14 ORTHOFIX PREFIX2 18 ORTHOFIX PREFIX2 22 ORTHOFIX PREFIX2 26 ORTHOFIX PREFIX2 30 ORTHOFIX PREFIX2 34 ORTHOFIX PREFIX2 38 IT FR DE ES D...

Страница 2: ...rent MRI system is used temperature changes may vary Contact is advised with the supplier of the MRI system and Orthofix Prefix2 System is designed as MRI conditional up to 1 5 Tesla The MRI component...

Страница 3: ...x92016 Blue Screw Clip Clamp Blue Multi Screw Clamp A maximum temperature increase of 4 0 C has been measured at the tip of the indicated screws Maximum Whole Body averaged SAR of 2W kg for 6 minutes...

Страница 4: ...ocedure is undertaken to ensure patient safety Since different frame configurations and frame sizes might lead to higher temperature increases Orthofix recommends that the SAR settings are minimised a...

Страница 5: ...p 2x911560 Self Drilling XCaliber Screw L 150mm thread length 60mm Pulse Sequence Spin echo Gradient echo TR ms 500 334 TE ms 4 8 4 6 Slice Thickness mm 5 5 Matrix size 230x288 230x289 Flip Angle 90 3...

Страница 6: ...a RM differente le variazioni di temperatura possono cambiare Si consiglia di contattare il fornitore del sistema RM e Orthofix Il sistema Prefix2 stato progettato per essere RM conditional fino a 1 5...

Страница 7: ...0 Vite XCaliber L 150 60mm 4x92016 Morsetto Clip per Vite Morsetto multivite Sulla punta delle viti indicate stato misurato un aumento massimo della temperatura di 4 0 C SAR massimo mediato sull inter...

Страница 8: ...ma di eseguire la procedura RM Dato che differenti configurazioni e dimensioni della struttura possono determinare aumenti maggiori nella temperatura Orthofix raccomanda di minimizzare per quanto poss...

Страница 9: ...per Vite 2x911560 Vite XCaliber L 150 60mm Sequenza impulsi Spin echo Gradient echo TR ms 500 334 TE ms 4 8 4 6 Spessore strato mm 5 5 Dimensioni matrice 230x288 230x289 Angolo di ribaltamento 90 30...

Страница 10: ...i un autre syst me RM est employ Il est alors recommand de contacter Orthofix et le fournisseur du syst me RM Le syst me Prefix2 est con u pour tre compatible avec l IRM jusqu 1 5 Tesla Les composants...

Страница 11: ...2016 M choire clip fiche bleue M choire multi fiches bleue Une hausse maximale de la temp rature de 4 C a t mesur e l extr mit des fiches indiqu es SAR moyen pour Corps entier maximal de 2 W kg pour 6...

Страница 12: ...Les diff rents montages de fixateur et leurs diff rentes tailles pouvant conduire des hausses de temp rature plus lev es Orthofix recommande de minimiser autant que possible les r glages SAR Aucun de...

Страница 13: ...XCaliber auto perforante L 150mm longueur de filetage 60mm S quence d impulsion Echo de spin Echo de gradient TR ms 500 334 TE ms 4 8 4 6 Epaisseur de coupe mm 5 5 Taille de matrice 230x288 230x289 A...

Страница 14: ...anderen MR Systems k nnen die Temperatur nderungen unterschiedlich sein Es wird empfohlen sich an den Hersteller des MR Systems und Orthofix zu wenden Das Prefix2 System wird mit 1 5 Tesla als bedingt...

Страница 15: ...ue Schraubenclips Blaue Mehrschraubenclips An der Spitze der angegebenen Schrauben wurde ein maximaler Temperaturanstieg von 4 C gemessen Maximale vom gesamten K rper absorbierte durchschnittliche ele...

Страница 16: ...oder MRT Techniker testen zu lassen um die Sicherheit des Patienten sicherzustellen Da verschiedene Rahmenkonfigurationen und Rahmengr en zu st rkeren Temperatursteigerungen f hren k nnen empfiehlt Or...

Страница 17: ...clips 2x911560 XCaliber selbstbohrende Schraube L nge 150mm Gewindel nge 60mm Pulssequenz Spinecho Gradientenecho TR ms 500 334 TE ms 4 8 4 6 Schichtdicke mm 5 5 Matrixgr e 230x288 230x289 Anregungswi...

Страница 18: ...comendable ponerse en contacto con el proveedor del sistema de RM y de Orthofix Prefix2 Este sistema est dise ado para funcionar condicionado a una RM de hasta 1 5 Tesla Los componentes de RM han sido...

Страница 19: ...o azul Abrazadera del tornillo azul El aumento m ximo de temperatura detectado en el extremo de estos tornillos es de 4 C ndice de absorci n espec fica SAR m ximo medio de todo el cuerpo de 2 W kg par...

Страница 20: ...garantizar la seguridad del paciente Puesto que las diferentes configuraciones y tama os de los marcos pueden comportar aumentos superiores de la temperatura Orthofix recomienda minimizar al m ximo lo...

Страница 21: ...2x911560 Tornillos XCaliber autoperforantes L 150mm longitud de rosca de 60mm Secuencia de pulso Eco de esp n Eco de gradiente TR ms 500 334 TE ms 4 8 4 6 Anchura del corte mm 5 5 Tama o de la matriz...

Страница 22: ...m kan temperatur ndringer variere Det anbefales at du kontakter leverand ren af MR systemet og Orthofix Prefix2 System er fremstillet som MRI godkendt op til 1 5 Tesla MRI komponenterne er blevet test...

Страница 23: ...derklemme Bl multiskrueklemme En maksimal temperaturstigning p 4 C er blevet m lt ved spidsen af de angivne skruer Maksimal SAR v rdi SAR Specific Absorption Rate for helkropsgennemsnit p 2 W kg for 6...

Страница 24: ...specialist f r MRI proceduren foretages for at sikre patientsikkerheden Da de forskellige rammekonfigurationer og st rrelser kan f re til h jere temperaturstigninger anbefaler Orthofix at minimere SAR...

Страница 25: ...ueklemme 2x911560 selvborende XCaliber skrue l ngde 150mm gevindl ngde 60mm Pulssekvens Spin ekko Gradient ekko TR ms 500 334 TE ms 4 8 4 6 Skivetykkelse mm 5 5 Matrixst rrelse 230x288 230x289 Flipvin...

Страница 26: ...kset voivat olla erilaisia On suositeltavaa ottaa yhteys MR j rjestelm n toimittajaan ja Orthofixiin Prefix2 j rjestelm on suunniteltu MRI yhteensopivaksi 1 5 teslaan asti MRI komponentit on testattu...

Страница 27: ...n klipsiruuvinpidike Sininen moniruuvinpidike Osoitettujen ruuvien k rjess on mitattu enint n 4 C n l mp tilan nousu Koko kehon suurin keskiarvoinen SAR arvo on 2 W kg 6 minuutin magneettikuvausta koh...

Страница 28: ...suuden varmistamiseksi Koska erilaiset kehikkokokoonpanot ja kehikkojen koot saattavat johtaa suurempiin l mp tilan nousuihin Orthofix suosittelee mahdollisimman pienten SAR asetusten k ytt Mink n kom...

Страница 29: ...1560 Itseporautuva XCaliber ruuvi pituus 150mm kierteen pituus 60mm Pulssisekvenssi Spinkaiku Gradienttikaiku TR ms 500 334 TE ms 4 8 4 6 Leikkeen paksuus mm 5 5 Matriisin koko 230x288 230x289 Poikkeu...

Страница 30: ...R system brukes kan temperaturendringene variere Det anbefales kontakte leverand ren av MR systemet og Orthofix Prefix2 systemet er konstruert for MRI opptil 1 5 tesla MRI komponentene er testet i hen...

Страница 31: ...l skrueklipsklemme Bl flerskrueklemme En maksimal temperatur kning p 4 C er m lt p spissen av de angitte skruene Maksimum gjennomsnittlig SAR for hele kroppen p 2W kg for 6 minutters skanning Kode Kod...

Страница 32: ...rt f r MRI unders kelsen gjennomf res for sikre pasientens sikkerhet Fordi ulike rammekonfigurasjoner og rammest rrelser kan f re til st rre temperatur kninger anbefaler Orthofix minimere SAR innstill...

Страница 33: ...klemme 2x911560 Selvborende XCaliber skrue L 150mm gjengelengde 60mm Pulssekvens Spinnekko Gradientekko TR ms 500 334 TE ms 4 8 4 6 Skivetykkelse mm 5 5 Matrisest rrelse 230x288 230x289 Vippevinkel 90...

Страница 34: ...ander MR systeem wordt gebruikt kunnen de temperatuurwijzigingen vari ren Neemt u eventueel contact op met de leverancier van het MR systeem en Orthofix Prefix2 System is ontworpen als MRI compatibel...

Страница 35: ...e schroefbevestigingsklem Blauwe multi schroefklem Een maximum temperatuurstijging van 4 C is aan het uiteinde van de aangegeven schroeven gemeten Maximum SAR gemiddeld over het gehele lichaam van 2W...

Страница 36: ...m de veiligheid van de pati nt te garanderen Aangezien andere frameconfiguraties en framegroottes tot hogere temperatuursti jgingen zouden kunnen leiden beveelt Orthofix aan om de SAR instellingen zo...

Страница 37: ...e multi schroefklem 2x911560 Zelfborende XCaliber schroef L 150mm draadlengte 60mm Pulssequentie Spin echo Gradient echo TR ms 500 334 TE ms 4 8 4 6 Plakdikte mm 5 5 Matrixgrootte 230x288 230x289 Flip...

Страница 38: ...de temperatura podem variar Entre em contato com o fornecedor do sistema de resson ncia magn tica e com a Orthofix Prefix2 O sistema foi projetado para condi es de resson ncia magn tica de at 1 5 Tes...

Страница 39: ...a de 60mm Cabe al para Parafuso Azul 4x92016 Cabe al Multiparafuso Azul Um aumento m ximo de temperatura de 4 C foi medido na ponta dos parafusos indicados SAR m dio m ximo de corpo inteiro de 2W kg p...

Страница 40: ...es e tamanhos das estruturas podem levar a aumentos maiores da temperatura a Orthofix recomenda minimizar as configura es SAR tanto quanto poss vel Nenhum dos componente deve se mover ou migrar nos a...

Страница 41: ...XCaliber Autoperfurante 2x911560 L 150mm comprimento da rosca de 60mm Sequ ncia de Pulso Spin eco Gradiente eco TR ms 500 334 TE ms 4 8 4 6 Espessura da fatia mm 5 5 Tamanho da matriz 230x288 230x289...

Страница 42: ...anv nds kan temperaturf r ndringar variera Det rekommenderas att du kontaktar leverant ren av MRT systemet och Orthofix Prefix2 Systemet har utformats f r att vara MR godk nd upp till 1 5 Tesla MRT k...

Страница 43: ...l mma Bl multiskruvkl mma En h gsta temperatur kning p 4 C uppm ttes vid spetsen av angivna skruvar Maximalt SAR v rde SAR Specific Absorption Rate f r helkroppsgenomsnitt p 2W kg f r 6 minuters under...

Страница 44: ...st innan MRT unders kningen genomf rs f r att s kerst lla patientens s kerhet Eftersom olika ramkonfigurationer och olika ramstorlekar kan leda till st rre temperatur kningar rekommenderar Orthofix at...

Страница 45: ...mma 1 x 911560 sj lvborrande XCaliber skruv L 150mm g ngl ngd 60mm Pulssekvens Spinneko Gradienteko TR ms 500 334 TE ms 4 8 4 6 Snittjocklek mm 5 5 Matrisstorlek 230x288 230x289 Tippningsvinkel 90 30...

Страница 46: ...46 EL...

Страница 47: ...47...

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Страница 53: ...1x92350 350 mm 1x92012 1x92031 2x911560 150 mm 60 mm TR ms 500 334 TE ms 4 8 4 6 mm 5 5 230x288 230x289 90 30 mm 20 46 5 53...

Страница 54: ...54 CN...

Страница 55: ...55...

Страница 56: ...56...

Страница 57: ...57...

Страница 58: ...eodli n MRsyst m mohousezm nyteplotyli it Doporu ujesekontaktovatdodavatelepou it hoMRsyst muaOrthofixu Prefix2 Syst m je designovan jako vhodn pro MRI a do 1 5 Tesla MRI sou sti byly testov ny v soul...

Страница 59: ...0mm 4x92016 modr svorka ty roub Modr svorka pro v ce roub Maxim ln zv en teploty o 4 C bylo nam eno na pi ce ozna en ho roubu Maxim ln pr m rn celot lov SAR 2 W kg po dobu 6 minut sn m n K d Popis 2x9...

Страница 60: ...Ivy et en abybylazaji t nabezpe nostpacienta Jeliko rozd ln konfiguracer m avelikostir m mohou v st k v t mu vzestupu teploty spole nost Orthofix doporu uje minimalizovat nastaven SAR na nejni mo n ho...

Страница 61: ...oub 2x911560 Samovrtn X kaliber roub d 150mm d lka z vitu 60mm Pulzn sekvence Spin echo Gradient echo TR ms 500 334 TE ms 4 8 4 6 Tlou ka ezu mm 5 5 Velikost matrice 230x288 230x289 Precesn hel 90 30...

Страница 62: ...adku innego systemu MR zmiany temperatury mog si r ni Zalecany jest kontakt z dostawc systemu MR oraz firm Orthofix Prefix2 SystemjestoznaczonyjakowarunkowodopuszczonydoMRIprzynat eniupolamagnetyczneg...

Страница 63: ...wintu 60mm 4x92016 Niebieski zacisk ruby Niebieski zacisk wielo rubowy Na ko cu wskazanych rub zmierzono maksymalny wzrost temperatury rz du 4 C Maksymalna warto u rednionego dla ca ego cia a wsp czyn...

Страница 64: ...loga lub naukowca zajmuj cego si MR Poniewa r ne konfiguracje i rozmiary ramek mog powodowa wi ksze wzrosty temperatury firma Orthofix zaleca maksymalne mo liwe ograniczenie SAR aden z element w nie p...

Страница 65: ...0 ruba samowierc ca XCaliber d 150mm d ugo gwintu 60mm Sekwencja impulsu Echo spinowe Echo gradientowe TR ms 500 334 TE ms 4 8 4 6 Grubo skrawka mm 5 5 Rozmiar matrycy 230x288 230x289 K t przerzucenia...

Страница 66: ...rakteristike Pri uporabi druga nega MR sistema se lahko temp spremembe razlikujejo Priporo amo da stopite v stik z dobaviteljem MR sistema in Orthofixa Prefix2 Sistem je predviden kot MRI ki je nastav...

Страница 67: ...92016 Modra sponka z vijaki Modra sponka z ve vijaki Na vrhu obele enih vijakov je izmerjeno najve je pove anje temperature 4 C Maks prerez celotnega telesa SAR od 2W kg za 6 min skeniranja ifre Opis...

Страница 68: ...vnjak MR oceni okvir s imer se zagotavlja varnost pacienta Glede na to da se lahko zaradi razli nih konfiguracij in velikosti okvirjev povi a temperatura Orthofix priporo a da se SAR okvirji imbolj zm...

Страница 69: ...1560 Samoprivijajo i vijak X kaliber dolg 150mm dol ina navoja 60mm Sekvenca utripa eha valovne gostote in nagiba TR ms 500 334 TE ms 4 8 4 6 Debelina izseka mm 5 5 Velikost matrice 230x288 230x289 Ko...

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Страница 73: ...5 73...

Страница 74: ...formation ATTENZIONE Consultare le istruzioni per l uso per importanti informazioni di precauzione AVERTISSEMENT Consulter les instructions d utilisation pour plus d informations importantes ACHTUNG A...

Страница 75: ...IG Se bruksanvisningen for viktig forsiktighetsinformasjon OPGELET Volg de instructies voor gebruik voor belangrijke waarschuwingen CUIDADO Para mais informa o sobre cuidados especiais consulte as ins...

Страница 76: ...strukcji obs ugi Glej navodila za uporabo UPOZORN N D le it bezpe nostn informace najdete v n vodu k pou it UWAGA Nale y post powa zgodnie z informacjami zawartymi w instrukcji obs ugi POZOR Preberite...

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