Johnson & Johnson DePuy Synthes EXPEDIUM Spine System Manual Download Page 1

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Addendum to 0902-90-015

EXPEDIUM

Spine System

Cobalt-Chromium-Molybdenum

Rods

Revised January 2016

0902-90-069

Rev. B

0086

Summary of Contents for DePuy Synthes EXPEDIUM Spine System

Page 2: ...2 of 48 Directory en Page 3 cz Str 6 da Side 9 nl Pagina 12 fi Sivu 15 fr Page 18 de Seite 21 el 24 hu Oldal 27 it Pagina 30 no Side 33 pl Strona 36 pt P gina 39 es P gina 42 sv Sida 45...

Page 3: ...UM Spine System Expedium Spine System Cobalt chromium molybdenum rods of 4 5mm diameter should only be used with 4 35mm thread diameter and larger titanium screws LIMITED WARRANTY AND DISCLAIMER PRODU...

Page 4: ...icone Nitinol S SS Stainless Steel S A SS Al Stainless Steel Aluminum LOT LOT NUMBER REF REF CATALOG NUMBER QTY QUANTITY SZ SIZE MADE IN MADE IN NTI NEURAL TISSUE INSTRUMENT IOM NEUROMONITORING INSTRU...

Page 5: ...olybdenum P F PL FOAM Plastic Foam PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Polyether Ether Ketone Carbon Fiber Composite PEEK OPTIMA Polyether Ether Ketone P POLYMER Polymer P CM PE CoCrMo Pol...

Page 6: ...mu EXPEDIUM Ty inky ze slitiny kobaltu chromu a molybdenu spin ln ho syst mu Expedium o pr m ru 4 5 mm by m ly b t pou v ny pouze spolu s titanov mi rouby o pr m ru z vitu 4 35 mm a v t mi OMEZEN Z R...

Page 7: ...NOL Silikon nitinol S SS Nerezav j c ocel S A SS Al Nerezav j c ocel aluminium SBR SS Ba RADEL LOT SLO AR E REF REF KATALOGOV SLO QTY MNO STV SZ VELIKOST MADE IN VYROBENO NTI N STROJ NA NERVOVOU TK IO...

Page 8: ...itina titanu kobalt chrom molybdenov slitina PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Polyetheretherketon kompozit z uhl kov ch vl ken PEEK OPTIMA Polyetheretherketon P POLYMER Polymer P CM PE...

Page 9: ...bd nstave med en diameter p 4 5 mm til EXPEDIUM spinalsystemet b r kun bruges med titaniumskruer med en gevinddiameter p 4 35 mm eller mere BEGR NSET GARANTI OG ANSVARSFRASKRIVELSE PRODUKTER FRA DEPUY...

Page 10: ...l S A SS Al Rustfrit st l Aluminium LOT PARTINUMMER REF REF KATALOGNUMMER QTY M NGDE SZ ST RRELSE MADE IN FREMSTILLET I NTI INSTRUMENT TIL NEURALT V V IOM INSTRUMENTER TIL NEUROOVERV GNING Amerikansk...

Page 11: ...nium og eller kobolt krom molybd n P F PL FOAM Plast Skum PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Polyetheretherketon Carbonfiberkomposit PEEK OPTIMA Polyetheretherketon P POLYMER Polymer P CM...

Page 12: ...ven met een diameter van 4 5 mm voor het EXPEDIUM spinaal systeem dienen uitsluitend te worden gebruikt met een schroefdraaddiameter van 4 35 mm en grotere titanium schroeven BEPERKTE GARANTIE EN VRIJ...

Page 13: ...NUMMER QTY HOEVEELHEID SZ MAAT MADE IN VERVAARDIGD IN NTI INSTRUMENT VOOR ZENUWWEEFSEL IOM NEUROMONITORINGS INSTRUMENTEN Volgens de federale wetgeving in de VS mag dit hulpmiddel uitsluitend door of o...

Page 14: ...m P F PL FOAM Plastic schuim PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Polyetheretherketone koolstofvezelcomposiet PEEK OPTIMA Polyetheretherketon P POLYMER Polymeer P CM PE CoCrMo Polyethyleen...

Page 15: ...nkaj rjestelm n 4 5 mm n l pimittaisia kobolttikromimolybdeenitankoja on k ytett v ainoastaan l pimitaltaan 4 35 mm n tai suurempien titaaniruuvien kanssa RAJOITETTU TAKUU JA VASTUUVAPAUSILMOITUS ALKU...

Page 16: ...nitinoli S SS Ruostumaton ter s LOT ER KOODI REF REF LUETTELONUMERO QTY M R SZ KOKO MADE IN VALMISTUSMAA NTI NEURAALIKUDOS INSTRUMENTTI IOM NEUROMONITOROINTI INSTRUMENTIT Yhdysvaltain liitto valtion l...

Page 17: ...P F PL FOAM Muovi vaahtomuovi PY Polyesteri PEEK C PEEK CARBON FIBER COMPOSITE Polyeetterieetteriketoni hiilikuitukomposiitti PEEK OPTIMA Polyeetterieetteriketoni P POLYMER Polymeeri P CM PE CoCrMo Po...

Page 18: ...obalt chrome molybd ne de 4 5 mm de diam tre du syst me rachidien EXPEDIUM ne doivent tre utilis es qu avec des vis en titane plus grandes et un filetage de 4 35 mm de diam tre GARANTIE LIMIT E ET CLA...

Page 19: ...RO DE LOT REF REF NUM RO DE CATALOGUE QTY QUANTIT SZ DIMENSIONS MADE IN FABRIQU EN NTI INSTRUMENT POUR TISSU NERVEUX IOM INSTRUMENTS DE NEUROMONITORAGE Selon la loi f d rale am ricaine cet appareil ne...

Page 20: ...stique mousse PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Composite poly ther therc tone fibre de carbone PEEK OPTIMA Poly ther therc tone P POLYMER Polym re P CM PE CoCrMo Poly thyl ne cobalt chr...

Page 21: ...inem Durch messer von 4 5 mm des EXPEDIUM Wirbels ulensystems sollten nur zusammen mit Titanschrauben mit einem Gewindedurchmesser von 4 35 mm oder gr er verwendet werden BESCHR NKTE GARANTIE UND HAFT...

Page 22: ...REF REF BESTELLNUMMER QTY MENGE SZ GR SSE MADE IN HERGESTELLT IN NTI NEURAL GEWEBEINSTRUMENT IOM NEUROMONITORING INSTRUMENTE Laut Gesetz ist der Verkauf dieses Produkts in den USA nur auf rztliche An...

Page 23: ...um P F PL FOAM Kunststoff Schaum PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Polyetheretherketon Kohlefaser Verbundstoff PEEK OPTIMA Polyetheretherketon P POLYMER Polymer P CM PE CoCrMo Polyethyle...

Page 24: ...24 of 48 el 0902 90 015 EXPEDIUM 0902 90 015 4 5 mm EXPEDIUM EXPEDIUM 4 5 mm 4 35 mm DEPUY SYNTHES PRODUCTS INC DEPUY SYNTHES SPINE 1 800 365 6633 1 508 880 8100...

Page 25: ...de RADEL STA SS Ti Al Nitride A S U SS ULTEM Ultem T Ti PY PEEK C PEEK CARBON FIBER COMPOSITE PEEK OPTIMA P POLYMER P CM PE CoCrMo P C POLYMER CARBON FIBER COMPOSITE fi Si NITINOL S SS S A SS Al LOT R...

Page 26: ...L Ti Al Nitride RADEL STA SS Ti Al Nitride A S U SS ULTEM Ultem T Ti S R SS RADEL RADEL R T POLYOLEFIN RUBBER Ti T A Ti Al PY PEEK C PEEK CARBON FIBER COMPOSITE PEEK OPTIMA P POLYMER P CM PE CoCrMo P...

Page 27: ...rudakat haszn lja Az EXPEDIUM gerincr gz t rendszer r sz t k pez 4 5 mm es tm r j kobalt kr m molibd n rudakat csak legal bb 4 35 mm k ls tm r j tit ncsavarokkal szabad haszn lni A GARANCIA KORL TOZ...

Page 28: ...OT GY RT SI SZ M REF REF KATAL GUSSZ M QTY MENNYIS G SZ M RET MADE IN K SZ LT NTI IDEGSZ VET ESZK Z IOM NEUROMONI TOROZ SI ESZK Z K Az USA sz vets gi t rv nyei rtelm ben az eszk z csak orvos megrendel...

Page 29: ...PY Poli szter PEEK C PEEK CARBON FIBER COMPOSITE Poli ter ter keton sz nsz las sszetett anyag PEEK OPTIMA Poli ter ter keton P POLYMER Polimer P CM PE CoCrMo Polietil n kobalt kr m molibd n P C POLYME...

Page 30: ...mo molibdeno del sistema spinale EXPEDIUM con diametro di 4 5 mm devono essere utilizzate solo con viti in titanio filettate di diametro 4 35 mm o maggiore GARANZIA LIMITATA E CLAUSOLA ESONERATIVA DI...

Page 31: ...EF REF NUMERO DI CATALOGO QTY QUANTIT SZ DIMENSIONI MADE IN PRODOTTO IN NTI STRUMENTO PER TESSUTI NEURALI IOM STRUMENTI PER NEUROMONITORAGGIO La legislazione federale americana prevede la vendita di q...

Page 32: ...PL FOAM Plastica gomma spugnosa PY Poliestere PEEK C PEEK CARBON FIBER COMPOSITE Polietereterchetone Composto di fibra di carbonio PEEK OPTIMA Polietereterchetone P POLYMER Polimero P CM PE CoCrMo Pol...

Page 33: ...er av koboltkrom molybden med en diameter p 4 5 mm for EXPEDIUM ryggs ylesystem skal bare brukes sammen med titanskruer med en gjengediameter p 4 35 mm eller st rre BEGRENSET GARANTI OG ANSVARSFRASKRI...

Page 34: ...l LOT PARTINUMMER REF REF KATALOGNUMMER QTY ANTALL SZ ST RRELSE MADE IN PRODUSERT I NTI NERVEVEVS INSTRUMENT IOM INSTRUMENTER TIL NEVROLOGISK OVERV KING I henhold til amerikansk lov kan dette produkte...

Page 35: ...PL FOAM Plast skum PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Polyetereterketon karbonfiberkompositt PEEK OPTIMA Polyetereterketon P POLYMER Polymer P CM PE CoCrMo Polyetylen kobolt krom molybde...

Page 36: ...u kr g w EXPEDIUM Pr t w kobaltowo chromowo molibdenowych o rednicy 4 5 mm systemu kr g w EXPEDIUM nale y u ywa wy cznie ze rubami tytanowymi o rednicy gwintu co najmniej 4 35 mm OGRANICZONA GWARANCJA...

Page 37: ...ATALOGOWY QTY ILO SZ ROZMIAR MADE IN WYPRODUKOWANO W NTI NARZ DZIE DO TKA NEK NERWOWYCH IOM INSTRUMENTY DO NEUROMONITORINGU Zgodnie z prawem federalnym USA urz dzenie to mo e by sprzedawane wy cznie p...

Page 38: ...P F PL FOAM Tworzywo sztuczne Pianka PY Poliester PEEK C PEEK CARBON FIBER COMPOSITE Polieteroeteroketon W kno w glowe PEEK OPTIMA Polieteroeteroketon P POLYMER Polimer P CM PE CoCrMo Polietylen Koba...

Page 39: ...XPEDIUM As hastes de Cobalto Cr mio Molibdeno com 4 5 mm de di metro do sistema espinal EXPEDIUM devem ser apenas utilizadas com parafusos de tit nio com um di metro de rosca de 4 35 mm GARANTIA LIMIT...

Page 40: ...DE CAT LOGO QTY QUANTIDADE SZ TAMANHO MADE IN FABRICADO EM NTI INSTRUMENTO DE TECIDOS NEURAIS IOM INSTRUMENTOS DE NEURO MONITORIZA O A lei federal dos Estados Unidos s permite a venda deste dispositiv...

Page 41: ...l stico Espuma PY Poli ster PEEK C PEEK CARBON FIBER COMPOSITE Poli ter ter cetona Composto de Fibra de Carbono PEEK OPTIMA Poli ter ter cetona P POLYMER Pol mero P CM PE CoCrMo Polietileno Cobalto Cr...

Page 42: ...UM Las varas de cobalto cromo molibdeno de 4 5 mm de di metro del sistema espinal EXPEDIUM s lo deben utilizarse con tornillos de titanio con roscas de 4 35 mm de di metro o m s grandes GARANT A LIMIT...

Page 43: ...OT N MERO DE LOTE REF REF N MERO DE CAT LOGO QTY CANTIDAD SZ TAMA O MADE IN FABRICADO EN NTI INSTRUMENTO PARA TEJIDO NEURAL IOM INSTRUMENTOS DE NEUROMONITO RIZACI N La ley federal de los EE UU s lo au...

Page 44: ...Molibdeno PY Poli ster PEEK C PEEK CARBON FIBER COMPOSITE Compuesto de poli ter ter cetona fibra de carbono PEEK OPTIMA Poli ter ter cetona P POLYMER Pol mero P CM PE CoCrMo Polietileno Cobalto cromo...

Page 45: ...XPEDIUM spinalsystem Stavarna av kobolt krom molybden p 4 5 mm i EXPEDIUM spinalsystem ska endast anv ndas med titanskruvar med en g nga p 4 35 mm i diameter eller mer BEGR NSAD GARANTI OCH FRISKRIVNI...

Page 46: ...st l aluminium SBR SS Ba RADEL LOT PARTINUMMER REF REF KATALOGNUMMER QTY ANTAL SZ STORLEK MADE IN TILLVERKAD I NTI NERVV VNADS INSTRUMENT IOM INSTRUMENT F R NEUROMONITORERING Enligt amerikansk federal...

Page 47: ...lybden P F PL FOAM Plast skumplast PY Polyester PEEK C PEEK CARBON FIBER COMPOSITE Polyetheretherketone kolfiberkomposit PEEK OPTIMA Polyeter eterketon P POLYMER Polymer P CM PE CoCrMo Polyetylen kobo...

Page 48: ...lismert gy rt val kapcsolatban l sd a term kc mk t Per conoscere il fabbricante legale fare riferimento all etichetta del prodotto Aktuell produsent er angitt p produktetiketten Informacja o uznanym p...

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