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Cardinal Health Cordis RAILWAY, Instructions For Use Manual

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Cardinal Health Cordis RAILWAY Instructions For Use Manual Download Page 68

Cordis Cashel

Cahir Road

Cashel

Co Tipperary, Ireland

Cordis Corporation

14201 North West 60th Avenue

Miami Lakes, Florida 33014

CORDIS, ADROIT

®

, VISTA BRITE TIP

®

, THE CORDIS LOGO, and 

RAILWAY

™

 are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

© 2018 Cardinal Health. All Rights Reserved. 

March 2018 

100000014624.4

PPE Specification

Labeling Specification

Spec for Railway IFU

100322810 | Rev:4

Released: 09 May 2018

CO: 100510027

Release Level: 4. Production

Summary of Contents for Cordis RAILWAY

Page 1: ...vely n lk li bevezet rendszer Instrukcja stosowania Bezos onowy system dost pu RAILWAY N vod na pou itie Bezpuzdrov pr stupov syst m RAILWAY RAILWAY Instruc iuni de utilizare Sistem de acces f r teac...

Page 2: ...vedbruk avetylenoksidgass Sterilizov no etyl noxidem Etil n oxiddal steriliz lva Wysterylizowano tlenkiem etylenu Sterilizovan etyl noxidom Sterilizat cu oxid de etilen Steriliseeritud et leenoksiidig...

Page 3: ...kking beschadigd is M ikke anvendes hvis emballagen er beskadiget Ei saa k ytt jos pakkaus on vaurioitunut Anv nd ej om f rpackningen r skadad M ikke brukes hvis emballasjen er skadet Nepou vejte je l...

Page 4: ...B B Penanda Proksimal B proksimalna oznaka B Proksimalni marker B B proksimalni ozna evalec Figure 2 Figure 2 Abbildung 2 Figura 2 Figura 2 Figura 2 Afbeelding 2 Figur 2 Kuva 2 Bild 2 Figur 2 2 Obr z...

Page 5: ...al B Proximale markering B Proksimal mark r B Proksimaalinen markkeri B Proximal mark r B Proksimal mark r B B Proxim ln zna ka B Proxim lis jel l s B Znacznik proksymalny B Proxim lna zna ka B B Marc...

Page 6: ...Indications The RAILWAY Sheathless Access System is indicated for use in radial arterial procedures requiring percutaneous introduction of intravascular devices III Contraindications Avoid the use of...

Page 7: ...thedilatorbeyondthesubclavianartery Furtheradvancementmaycausevascularcomplications refertoComplicationssection 13 Ifexchangeoftheguidingcatheterisnecessary a RefertotheWarningssection Failuretofollow...

Page 8: ...ntiplaquettaireappropri VI Complications Les complications possibles comportent sans toutefois s y limiter obstructionsoudained unvaisseau interventionsuppl mentaire r actionallergique dispositif prod...

Page 9: ...der 0 53 mm 0 021 Zoll Mini F hrungsdraht hydrophil ist ist die blanke Nadel nicht enthalten Hinweis DieDilatatorgr emussdenGr endesF hrungsdrahtesunddesF hrungskathetersentsprechen Informationenzurem...

Page 10: ...n zun chstdieUrsachedesWiderstandsbestimmen 5 DenMini F hrungsdrahtanseinerPositionhaltenunddieNadelherausziehen VORSICHT NachdemHerausziehenderIntrocanSafety IV Katheter NadeloderderblankenNadelundge...

Page 11: ...reguidada100cmcompatibile IlmarkerB ilmarkerpi distale vieneusatocomeriferimentoposizionalequandosiusauncatetereguidada90cmcompatibile Ago per catetere IV Per facilitare l inserimento iniziale nell ar...

Page 12: ...ldilatatorepervasisanguigni Nota quandoilMarkerB visibilenelmozzodelcatetereguida NONfaravanzareilcatetereguidaulteriormentesuldilatatorepervasisanguigni fareriferimentoalleFigure 8e9 Ilsuperamentodiq...

Page 13: ...oradial Derivaci nparahemodi lisis injertoof stulaarteriovenosaqueafectenalavasculaturadelasextremidadessuperiores IV Advertencias Antesdelosprocedimientosdeaccesoradial serecomiendaverificarelcorrect...

Page 14: ...uerteresistenciamientrassehaceavanzaroseretiraelcat ter interrumpaelmovimientoydeterminela causaantesdecontinuar Sinosepuededeterminarlacausadelaresistencia retireelsistemacompleto AVISO Nohagaavanzar...

Page 15: ...odispositivodediagn sticoouinterven o Seodispositivoapresentardobrasousesentirumamaiorresist nciaaquandodainser oouavan ododilatadordevaso investigueacausaantesdeprosseguir Sen oforposs vel determinar...

Page 16: ...ngeleidekatheters Tabel1 Productmatrixenaanbevolencompatibiliteiten Cataloguscode Draad Vaatdilatator Aanbevolen geleidekathetercompatibiliteit1 en binnendiameter Voerdraadcompatibiliteit 2 dilatators...

Page 17: ...genofhetbeschermkapjeterugteplaatsen 6 Laaddedistaletipvandevaatdilatatoroverdemini voerdraadterwijldedraadpoortnaarbovenisgerichtenvoerdedilatatoroptotinhetvat Dedilatatorkanwordenopgevoerdtotde draa...

Page 18: ...snittet Klarg ring Bem rk at denne n l indeholder krom nikkel st l og ikke m anvendes til patienter hos hvem den kan fremkalde en allergisk reaktion Ikke belagt n l En ikke belagt adgangsn l medf lger...

Page 19: ...ateteriseringen 11 Dererblevetopn etensheath l sguidekateteradgangtilm lkarret Hvisdeterp kr vet kanderudf reskar angiografivedinjektionafkontrastmiddel Eninterventionel0 88mm 0 035 J wireellerananden...

Page 20: ...en l muotoilelaajentimendistaalik rke taiminiohjainvaijeriamanuaalisestikohdistamallaulkoistavoimaalaajentimeentaiminiohjainvaijeriinniidentaivuttamiseksitaimuodon muuttamiseksi Laajennintasaavied ete...

Page 21: ...N KAUPATTAVUUDESTATAI SOPIVUUDESTATIETTYYNTARKOITUKSEEN CORDIS EIVASTAA MISS N OLOISSA MIST NV LITT MIST SATUNNAISISTATAIV LILLISIST VAHINGOISTA JOITA SOVELLETTAVASSA LAISSA EI NIMENOMAISESTI MAINITA...

Page 22: ...ety IVkateter n lellerdenobelagdan lenipatientensk rlmed godk ndmedicinskteknikf rk rl tkomst 4 F rinminiledarensmjuka ndevarsamtgenomn lenellerdroppkanylenochinistr lbensart renochmanipuleradenf rsik...

Page 23: ...en i henhold til avsnittet Klargj ring Merk at denne n len inneholder krom nikkel st l og m ikke brukes i pasienter hvor dette kan for rsake en allergisk reaksjon Blank n l En blank tilgangsn l er sti...

Page 24: ...dekateteretblif rtforbiovergangentildilatatorspissen noesom kerpotensialetforvaskul rekomplikasjoner 9 Fjernkardilatatorenved trekkedenutgjennomledekateteretsamtidigsomledekateteretsposisjonoppretthol...

Page 25: ...ocan Safety 2 3 0 53 mm 0 021 0 53 mm 0 021 45 cm 4 1 II RAILWAY III RAILWAY IV Allen Ethiodol Lipiodol IntrocanSafety V VI VII 1 1 2 3 4 5 10cc 27gauge 0 53mm 0 021 21gauge 0 88mm 0 035 5 25cm 6 Intr...

Page 26: ...ydrofiln potah 6F zelen 6F Cordis ADROIT 1 83 mm 0 072 palce 0 53 mm 0 021 palce a 0 88 mm 0 035 palce 1 80 mm 0 071 palce RW6ADTB Hol RW6VBTH Hydrofiln potah 6F CordisVISTA BRITETIP 1 77 mm 0 070 pal...

Page 27: ...b za c vn komplikace nap natr en intimy disekce pseudoaneurysma perforace ruptura spazmus okluze VII N vod k pou it P prava 1 Zvoltec vn dilat torodpov daj c velikosti Informaceodoporu en kompatibilit...

Page 28: ...0 021 s 0 88 mm 0 035 1 97 mm 0 078 RW7VBTB Csupasz 1 A vezet kat ter kompatibilit s ra vonatkoz an A t g t k a CordisVISTA BRITETIP vagy a Cordis ADROIT kat terekhez t rt n illeszked sre vannak opti...

Page 29: ...jel l st aproxim lisabbjel l st Ezaztjel li hogya100cm es vezet kat terv geaz rt g t elv konyod tmenet n lvan Megjegyz s Netoljatov bbavezet kat tertaz rt g t n haaz A jel l savezet kat tercsatlakoz...

Page 30: ...a prowadnik w zawartych w ka dym zestawie Nale y zauwa y e prowadnik z pow ok hydrofilow zawiera nikiel i nie nale y go stosowa u pacjent w u kt rych mo e powodowa reakcj alergiczn II Wskazania Bezos...

Page 31: ...dnielekiprzezgniazdocewnikaprowadz cego abyzmniejszy ryzykopotencjalnegowyst powaniapowik a zmniejszy dyskomfortpacjentaiskurcznaczy krwiono nychpodczascewnikowania 11 Bezos onowydost pcewnikaprowadz...

Page 32: ...comdr te Pos vaniedilat tora ke dr tniejenasvojommieste m esp sobi vaskul rnekomplik cie Osobysalergick mireakciaminanikelm uvykazova alergick reakciunakomponentytejtopom cky Rizikoop tovn hopou itia...

Page 33: ...oromavodiacimdr tomtrebazachova zarovnaniepod akroku8 vopa nom pr padem ed js kcievnymkomplik ci m UPOZORNENIE Pokia prizas van ivy ahovan kat tranaraz tenaextr mnezakriveniealebosiln odpor preru tepo...

Page 34: ...2 5cm 3 Introcan Safety 4 5 IntrocanSafety 6 3cm 5 7 6 8 7 a 100cm A 100 8 9 b 90 B 90 B 8 9 9 10 10 11 0 88mm 0 035 J 0 88mm 0 035 12 0 88mm 0 035 0 88mm 0 035 8 8 PPE Specification Labeling Specific...

Page 35: ...irului de ghidare n vasul int Pentru detalii despre cateterul intravenos consulta i Figura 2 Sp la i acul conform instruc iunilor din sec iunea Preg tire Re ine i c acul con ine o el crom nichel i nu...

Page 36: ...carefirulvafireintrodus indiferentdemotiv terge icuuntampondetifonumezit iscufunda i nsolu iesalin heparinizat sausolu ieizotonic similar p n laurm toareautilizare 8 Lafixareacap tuluidistalaldilatato...

Page 37: ...53 mm 0 021 l bim duga 45 cm pikkune minijuhtetraat Minijuhtetraadi ksikasju vaadake jooniselt 4 S ltuvalt konfiguratsioonist on minijuhtetraat kas katteta v i kaetud h drofiilse kattega Tabelis 1 on...

Page 38: ...aiendajajajuhtekateetrijoondatusetapi8kohaselt selletegemataj tminev ib p hjustadaveresoontet sistusi ETTEVAATUST Kuikateetrisisestamiselv iv ljat mbamiselontunda rmuslikkuk verustv itugevattakistust...

Page 39: ...anosprosto an s papilduiejauk an s aler iskareakcija ier ce kontrastvielaunz les amput cija aritmija arteriovenozafistula n ve embolija drudzis hematomapunkcijasviet asi o ana iekaisums infekcija sept...

Page 40: ...mm 0 021 col ir 0 88 mm 0 035 col 1 97 mm 0 078 col RW7VBTB Paprasta 1 Kreipiamojo kateterio suderinamumas pl tikliai optimizuoti kad tikt arba CordisVISTA BRITETIP arba Cordis ADROIT kateteriams kaip...

Page 41: ...aujagysl spl tikliok gioformosper jimo Pastaba Nestumkitekreipiamojokateteriotoliauperkraujagysl spl tikl kaiA ymeklismatytikreipiamojo kateterio vor je r 8ir9pav Perkeliantkreipiamojokateterio vor u...

Page 42: ...lar Radyaleri improsed rlerinden nce Allentestigibibiry ntemleulnararterdeyeterlikollateralak oldu ununteyitedilmesi nerilmektedir Elekolateralkanbeslemesininyetersizoldu u d n l rse alternatifbireri...

Page 43: ...eedilerekdamaranjiyografisiger ekle tirilebilir K lavuzkateterindenkullan c n ntercihine g regiri imselbir0 88mm 0 035 Jteliveyafarkl bir0 88mm 0 035 telyerle tiriliphedefb lgeyedo rugiri imseltel zer...

Page 44: ...y V VI VII 1 1 2 3 4 5 10 27 0 53 0 021 21 0 88 0 035 5 25 6 IntrocanSafety 1 1 2 5 3 IntrocanSafety 4 5 IntrocanSafety 6 3 5 7 6 8 7 100 A PPE Specification Labeling Specification Spec for Railway IF...

Page 45: ...35 1 45 0 057 RW5ADTB RW5VBTH 5F CordisVISTA BRITETIP 1 41 0 056 0 53 0 021 0 88 0 035 1 41 0 056 RW5VBTB RW6ADTH 6F 6F Cordis ADROIT 1 82 0 072 0 53 0 021 0 88 0 035 1 80 0 071 RW6ADTB RW6VBTH 6F Cor...

Page 46: ...0 021 21 0 88 0 035 5 25 6 IntrocanSafety 1 1 2 5 3 IntrocanSafety 4 5 IntrocanSafety 6 3 5 7 6 8 7 100 100 8 9 90 90 8 9 9 10 10 PPE Specification Labeling Specification Spec for Railway IFU 1003228...

Page 47: ...W5VBTH 5F Cordis VISTA BRITE TIP 1 41 0 056 0 53 0 021 0 88 0 035 1 41 0 056 RW5VBTB RW6ADTH 6F 6F Cordis ADROIT 1 83 0 072 0 53 0 021 0 88 0 035 1 80 0 071 RW6ADTB RW6VBTH 6F Cordis VISTA BRITE TIP 1...

Page 48: ...0 53 0 021 27 0 88 0 035 21 5 25 6 Introcan Safety IV 1 1 2 5 3 Introcan Safety IV 4 IV 5 Introcan Safety IV 6 3 5 7 6 8 7 100 100 8 9 PPE Specification Labeling Specification Spec for Railway IFU 100...

Page 49: ...45mm 0 057 RW5ADTB RW5VBTH 5F CordisVISTA BRITETIP 1 42mm 0 056 0 53mm 0 021 0 88mm 0 035 1 41mm 0 056 RW5VBTB RW6ADTH 6F 6F Cordis ADROIT 1 82mm 0 072 0 53mm 0 021 0 88mm 0 035 1 80mm 0 071 RW6ADTB...

Page 50: ...IntrocanSafety 1 IFU 1 2 5cm 3 IntrocanSafety 4 IV 5 IntrocanSafety 6 3cm 5 7 6 8 7 a 100cm A 100cm A 8 9 b 90cm B 90cm B 8 9 9 10 10 11 0 88mm 0 035 J 0 88mm 0 035 12 0 88mm 0 035 0 88mm 0 035 PPE S...

Page 51: ...53 mm 0 021 0 88 mm 0 035 1 41 mm 0 056 RW5VBTB RW6ADTH 6F 6F Cordis ADROIT 1 82 mm 0 072 0 53 mm 0 021 0 88 mm 0 035 1 80 mm 0 071 RW6ADTB RW6VBTH 6F CordisVISTA BRITETIP 1 77 mm 0 070 0 53 mm 0 021...

Page 52: ...8 8 13 a b 260cm 0 88mm 0 035 c 0 88mm 0 035 8 d 0 88mm 0 035 0 88mm 0 035 11 e 0 88mm 0 035 f 1 VIII CORDIS CORDIS CORDIS Cordis CordisCorporation IntrocanSafety B BraunMedicalInc Ethiodol Lipiodol G...

Page 53: ...035 1 77mm 0 070 RW6VBTB RW7VBTH 7F 7F CordisVISTA BRITETIP 1 98mm 0 078 0 53mm 0 021 0 88mm 0 035 1 97mm 0 078 RW7VBTB 1 CordisVISTA BRITETIP Cordis ADROIT 1 1 1 20cm 1 1 A B A 100cm B 90cm IV Introc...

Page 54: ...System 5F 6F 7F 90 100 0 53 0 021 0 88 0 035 0 53 0 021 IV 0 53 0 021 1 1 1 2 RW5ADTH 5F 5F Cordis ADROIT 1 47 0 058 0 53 0 021 0 88 0 035 1 45 0 057 RW5ADTB RW5VBTH 5F CordisVISTA BRITETIP 1 42 0 05...

Page 55: ...piodol IntrocanSafety IV IV IV IV V VI Arteriovenousfistula VII 1 1 2 3 4 5 10 27 0 53 0 021 21 0 88 0 035 IsotonicSolution 5 25 isotonic solution 6 isotonicsolution IntrocanSafety IV 1 IFU 1 2 5 3 In...

Page 56: ...kateter pemandu melalui kulit dengan membentuk transisi yang halus dan atraumatis dari kulit hingga jaringan subkutan dan ke dalam pembuluh Lihat Gambar 1 untuk detail dilator Lapisanhidrofilimenutupi...

Page 57: ...nSafety ataujarum terbuka sebelumpenggunaan Prosedur yang Dianjurkan 1 SiapkankateterpemanduberukurantepatyangsudahdipilihsesuaidenganPetunjukPenggunaan IFU Masukkanujungdistalkateterpemandumelaluiuju...

Page 58: ...lu ikaoreferencapolo ajatijekomupotrebekompatibilnogvode egkatetera od100cm OznakaB oznakakojasenalazidistalnouodnosunadrugu slu ikaoreferencapolo ajatijekomupotrebekompatibilnogvode egkateteraod90cm...

Page 59: ...rijelaznavrhdilatatoraitakopove atiopasnostodvaskularnihkomplikacija 9 Uklonitedilatator iletakodagaizvu etekrozvode ikateterodr avaju ipolo ajvode egkatetera pogledajtesliku10 Ako etezbogbilokojegraz...

Page 60: ...imamoguimati tetnodejstvonaure aj KodIntrocanSafety IVkateter igle neubacujteigluponovouIVkateterniujednomtrenutku Iglamo edao tetiIVkateter tomo erezultiratiembolusomIVkatetera Ukolikokoristitehidrof...

Page 61: ...po eljirukovaocasemo eumetnutiuuvodnikateteriplasiratidabiseomogu ilopra enjeuvodnogkateteraprekointerventne ice dociljanogmesta 12 Akojepotrebnadodatnapodr kaprilikomplasiranjauvodnogkateterakrozvask...

Page 62: ...RAILWAY IV Ethiodol Lipiodol Introcan Safety V VI VII 1 1 2 3 4 5 10 cc 27 0 53 mm 0 021 21 0 88 mm 0 035 5 25 cm 6 Introcan Safety 1 1 PPE Specification Labeling Specification Spec for Railway IFU 1...

Page 63: ...deli opis Sistem za dostop brez ovoja RAILWAY je sistem za radialni dostop brez ovoja ki je zdru ljiv z vodilnimi katetri velikosti 5 F 6 F in 7 F dolgimi 90cmin100cm Sistemsestavljajodilatator ile ve...

Page 64: ...nSafety nikolinevstavljajteigleponovnovIV kateter Iglabilahkopo kodovalaIV kateter karlahkopovzro iembolusvIV katetru euporabljatehidrofilno ico jeneuporabljajtezneprevle enoigloaliskovinskimpripomo k...

Page 65: ...8mm 0 035 gledena eljeoperaterjainjopomikati daomogo itesledenjevodilnegakatetraprek intervencijske icedociljnegamesta 12 ejepripomikanjuvodilnegakatetraskozi iljepotrebnadodatnapodpora vstavite0 88mm...

Page 66: ...6 6 IntrocanSafety 1 1 1 2 2 5 3 3 IntrocanSafety 4 4 5 5 IntrocanSafety 6 6 3 5 7 7 6 8 8 7 100 A 100 9 8 A 90 B 90 9 8 B 9 9 10 10 10 11 11 0 035 J 12 12 0 035 0 88 8 0 035 0 88 8 PPE Specification...

Page 67: ...1 VIII CORDIS CORDIS CORDIS Cordis CordisCorporation B Braun Medical Inc Introcan Safety Guerbet S A Lipiodol Ethiodol www cordis com Cordis PPE Specification Labeling Specification Spec for Railway I...

Page 68: ...THE CORDIS LOGO and RAILWAY are trademarks or registered trademarks of Cardinal Health All other marks are the property of their respective owners 2018 Cardinal Health All Rights Reserved March 2018...

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