Bard COVERA PLUS Instructions For Use Manual Download Page 22 | Manualshive

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22

SCHEDA INFORMATIVA DELL'IMPIANTO PER IL PAZIENTE

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-F JOGPSNB[JPOJ TV QB[JFOUF JNQJBOUP F TUSVUUVSB PTQFEBMJFSB EPWSBOOP FTTFSF SJQPSUBUF TVMMB TDIFEB7FSJGJDBSF DIF MhBEFTJWP
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Figura 9

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VCJDBUPTVMMBQBSUFTVFSJPSFEFMMhJNQVHOBUVSB

NOTA: per garantire un posizionamento preciso, è possibile eseguire un leggero riposizionamento durante

l'attivazione iniziale della rotella, mentre lo stent coperto è ancora compresso nel catetere.

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Figura 10

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NOTA: si potrebbero riscontrare forze di attrito maggiori con gli stent coperti di maggiore lunghezza.

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14. Postdilatare lo stent coperto con un palloncino per angioplastica opportunamente dimensionato in modo da garantire

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sano, non stenotico.

NOTA: si raccomanda di far avanzare il catetere a palloncino PTA attraverso lo stent coperto espanso sotto guida
fluoroscopica, al fine di garantire che lo stent coperto rimanga correttamente posizionato.

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Summary of Contents for COVERA PLUS

Page 1: ...rgeleri Navodila za uporabo Upute za uporabu B05884 Rev 2 05 18 Endoproth se vasculaire couverte Beschichteter Gef stent Stent coperto vascolare Stent vascular recubierto Beklede vasculaire stent Sten...

Page 2: ...Sis llysluettelo t Innholdsfortegnelse t Spis tre ci t Tartalom t Obsah t indekiler t t t t Kazalo vsebine t Sadr aj t t English 03 Fran ais 08 Deutsch 13 Italiano 18 Espa ol 23 Nederlands 28 Portugu...

Page 3: ...ition Figure 3 Figure 3 Handle Top View 1 Red Safety Lock F 2 Large DeploymentWheel for initial and slow deployment G 3 Small DeploymentWheel for faster deployment H Legend for Figures 2 3 Reference C...

Page 4: ...ime The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications or death t DO NOT use in patients with unc...

Page 5: ...UJPO PG UIF 3 TZTUFN 3 0 Tesla Temperature Rise In an analysis based on non clinical testing according to ASTM F2182 11a and computer modeling of a patient the single 6 x 100 mm COVERA PLUS Vascular C...

Page 6: ...wall apposition before completing deployment Figure 10 NOTE Ensure the selected covered stent length covers the entire lesion and both ends of the implant extend at least 5 mm into the non diseased se...

Page 7: ...the PTA balloon catheter through the deployed covered stent under fluoroscopy to ensure that the covered stent remains well positioned 15 Using standard procedures verify location and patency of the...

Page 8: ...gure 3 Figure 3 Poign e vue de dessus 7FSSPVJMMBHF EF T DVSJU SPVHF SBOEF NPMFUUF EF E QMPJFNFOU QPVS MF E QMPJFNFOU JOJUJBM FU MFOU 1FUJUF NPMFUUF EF E QMPJFNFOU QPVS VO E QMPJFNFOU QMVT SBQJEF HFOEF...

Page 9: ...UFSNJO F FT S TJEVT EF NBU SJBVY CJPMPHJRVFT QFVWFOU QSPNPVWPJS MB DPOUBNJOBUJPO EV EJTQPTJUJG QBS EFT QZSPH OFT PV EFT NJDSP PSHBOJTNFT QPVWBOU FOUSB OFS EFT DPNQMJDBUJPOT JOGFDUJFVTFT PV USF MhPSJH...

Page 10: ...BYJNBMF OF DPNQSPNFUUF QBT MF GMVY EBOT MB WFJOF BYJMMBJSF TPVT DMBWJ SF 7FJMMFS DF RVF MhFYUS NJU EF MhFOEPQSPUI TF DPVWFSUF E QBTTF EhBV NPJOT NN BV EFM EF MB DPVSCVSF EF MhBSDIF EBOT MF TFHNFOU EJT...

Page 11: ...endantled ploiement de l endoproth se couverte car cela peut g ner le d ploiement de l endoproth se couverte et conduire une mise en place erron e Figure 9 Figure 5 REMARQUE 7FJMMFS DF RVF MhFOEPQSPUI...

Page 12: ...TU EJMBUFS MhFOEPQSPUI TF DPVWFSUF BWFD VO CBMMPOOFU EhBOHJPQMBTUJF EF UBJMMF BQQSPQSJ F BGJO EF ThBTTVSFS EF MhBQQPTJUJPO EF MhFOEPQSPUI TF DPVWFSUF TVS MB QBSPJ EV WBJTTFBV EF S G SFODF WJUFS VOF EJ...

Page 13: ...icherheitsverschluss F 2 Gro es Applikationsr dchen f r die anf ngliche und langsame Freisetzung G 3 Kleines Applikationsr dchen f r eine schnellere Freisetzung H Legende f r die Abbildungen 2 und 3 R...

Page 14: ...f r eine unbestimmte Zeit mit K rperfl ssigkeiten oder Gewebe mit potenziell pyrogener oder mikrobieller Kontamination in Kontakt war Reste biologischer Materialien k nnen die KontaminationdesProdukts...

Page 15: ...den proximalen Bogen der Vena cephalica w hlen Sie die L nge so dass die ostiale L sion vollst ndig abgedeckt ist und das proximale Ende des beschichteten Stents den Blutfluss in die Vena axillaris V...

Page 16: ...unkelbraunen Katheterabschnitt da dadurch die Freisetzung beeintr chtigt wird und dies eine Fehlplatzierung zur Folge haben kann Abbildung 9 Abbildung 5 HINWEIS Stellen Sie sicher dass die L nge des b...

Page 17: ...fernen 14 Den beschichteten Gef stent mit einem Angioplastie Ballon angemessener Gr e nachdilatieren um das vollst ndige Anliegen an die Wand des Referenzgef es zu gew hrleisten Vermeiden Sie die Dila...

Page 18: ...ugnatura 1 Blocco di sicurezza rosso F 2 Interruttore rotante grande per espansione iniziale ed espansione lenta G 3 Interruttore rotante piccolo per espansione rapida H Legenda delle Figure 2 e 3 Rif...

Page 19: ...icrobica siano entrati in contatto con il dispositivo medico per un periodo di tempo non determinabile Il residuo di materiale biologico pu favorire la contaminazione del dispositivo con pirogeni o mi...

Page 20: ...coperto vascolare COVERA PLUS 13 COMPATIBILIT CON LA RISONANZA MAGNETICA RM Test non clinici hanno dimostrato che lo stent coperto vascolare COVERA PLUS pu essere sottoposto a RM in modo condizionale...

Page 21: ...arrone scuro durante l espansione dello stent coperto in quanto ci pu interferire con l espansione dello stent coperto e potrebbe portare a un posizionamento non corretto Figura 9 Figura 5 NOTA WFSJGJ...

Page 22: ...operto ancora compresso nel catetere PQP VOhFTQBOTJPOF EJ DJSDB NN BUUFOEFSF BMDVOJ TFDPOEJ BGGJODI MhFTUSFNJU EJTUBMF EFMMP TUFOU DPQFSUP TJ FTQBOEB UPUBMNFOUF 7FSJGJDBSF MhBQQPTJ JPOF EFMMP MP TUFOU...

Page 23: ...bloqueada Figura 3 Figura 3 Vista superior del mango 1 Cierre de seguridad rojo F 2 Rueda de despliegue grande para despliegue inicial y lento G 3 Rueda de despliegue peque a para despliegue m s r pid...

Page 24: ...los tejidos o l quidos corporales con posible contaminaci n pir gena o microbiana han FOUSBEP FO DPOUBDUP DPO EJDIPT EJTQPTJUJWPT N EJDPT EVSBOUF VO QMB P JOEFUFSNJOBCMF PT SFTJEVPT EF NBUFSJBM CJPM H...

Page 25: ...icos demostraron que el stent vascular recubierto COVERA PLUS es compatible con RM condicionalmente para la colocaci n de un solo stent recubierto en los vasos del brazo y para la colocaci n de un sol...

Page 26: ...ante el despliegue del stent recubierto ya que ello podr a interferir con el despliegue del stent recubierto y provocar una colocaci n incorrecta Figura 9 Figura 5 NOTA Aseg rese de que la longitud se...

Page 27: ...T EF EFTQMFHBSMP BQSPYJNBEBNFOUF NN FTQFSF WBSJPT TFHVOEPT QBSB QFSNJUJS RVF FM FYUSFNP EJTUBM EFM TUFOU SFDVCJFSUP TF FYQBOEB DPNQMFUBNFOUF TFH SFTF EF RVF FM TUFOU SFDVCJFSUP FTU ZVYUBQVFTUP DPOUSB...

Page 28: ...Afbeelding 3 Bovenaanzicht handgreep 1 Rode veiligheidsvergrendeling F 2 Groot plaatsingswiel voor het begin en een langzame plaatsing G 3 Klein plaatsingswiel voor een snellere plaatsing H Legenda vo...

Page 29: ...yrogene of microbi le contaminatie gedurende een niet vast te stellen tijdsduur in contact zijn gekomen met het medische hulpmiddel Het residu biologisch materiaal kan de contaminatie van het hulpmidd...

Page 30: ...ena cephalica selecteert u de lengte dusdanig dat de ostiale laesievolledigbedektisenhetproximalebekledestenteindedestroomindeoksel subclaviculaireaderniethindert Zorgervoor dat het beklede stenteinde...

Page 31: ...tijdens de plaatsing van de beklede stent omdat dit de plaatsing van de beklede stent kan verstoren en tot een verkeerde plaatsing kan leiden afbeelding 9 Afbeelding 5 OPMERKING Zorg ervoor dat de le...

Page 32: ...is in de katheter Na plaatsing van ongeveer 15 mm wacht u enkele seconden om het distale einde van de beklede stent volledig te laten uitzetten Zorg ervoor dat de beklede stent tegen de wand geapposit...

Page 33: ...o man pulo 1 Bloqueio de seguran a vermelho F 3PEB EF DPMPDB P HSBOEF QBSB DPMPDB P JOJDJBM F MFOUB 3PEB EF DPMPDB P QFRVFOB QBSB DPMPDB P NBJT S QJEB Legenda para as Figuras 2 e 3 Refer ncia Informa...

Page 34: ...P N EJDP EVSBOUF VN QFS PEP EF UFNQP JOEFUFSNJOBEP 0T SFT EVPT EF NBUFSJBM CJPM HJDP QPEFN QSPNPWFS B DPOUBNJOB P EP EJTQPTJUJWP DPN QJSPH OJPT PV NJDSPSHBOJTNPT RVF QPEFN SFTVMUBS FN DPNQMJDB FT JOGF...

Page 35: ...E RESSON NCIA MAGN TICA IRM 5FTUFT O P DM OJDPT EFNPOTUSBSBN RVF P TUFOU WBTDVMBS DPCFSUP COVERA PLUS POEJDJPOBM QBSB 3 QBSB B DPMPDB P EF VN OJDP TUFOU DPCFSUP OBT WFJBT EP CSB P F DPMPDB P EF VN OJD...

Page 36: ...scuro durante a coloca o do stent coberto uma vez que isto poder interferir com a coloca o do stent coberto e poder levar a coloca o errada Figura 9 Figura 5 NOTA FSUJGJRVF TF RVF P DPNQSJNFOUP EP TUF...

Page 37: ...a esta comprimido no cateter Q T B DPMPDB P EF BQSPYJNBEBNFOUF NN BHVBSEF BMHVOT TFHVOEPT QBSB QFSNJUJS RVF B FYUSFNJEBEF EJTUBM EP TUFOU DPCFSUP TF FYQBOEB OB UPUBMJEBEF FSUJGJRVF TF RVF P TUFOU DPCF...

Page 38: ...LUS 1 X ePTFE 2 A Luer B C h 30 cm D E G H 2 COVERA PLUS F 3 3 1 F 2 G 3 H 2 3 B Luer C D E F G H COVERA PLUS 0 035 inch 0 89 mm 8F 9F 80 cm 120 cm COVERA PLUS AV 4 5 mm 9 mm COVERA PLUS t t 680 F 360...

Page 39: ...39 t t t t t t t t AV t t t COVERA PLUS bypass AV t t t t t PTA t t t t t t 9F t AV t 7 t AV 30 t t t t t h t t t t t t t 30 cm...

Page 40: ...mm 7 mm 0 5 mm 1 5 mm 5 5 mm 6 5 mm 8 mm 1 mm 2 mm 6 mm 7 mm 9 mm 1 mm 2 mm 7 mm 8 mm 10 mm 1 mm 2 mm 8 mm 9 mm 5 mm 10 mm 10 mm COVERA PLUS 13 MRI COVERA PLUS COVERA PLUS t 5FTMB 5FTMB t BVTT DN t 4...

Page 41: ...41 10 mm 6 9F 6 9 7 7 9F 0 035 inch 0 89 mm 4 PTA 5 1 6 7 Luer 4 4 8 5 5 5 mm 10 mm...

Page 42: ...42 10 8 8 h 9 9 11 15 mm 10 10 12 13 14 PTA...

Page 43: ...grebets verste del 1 R d sikkerhedsl s F 2 Stort inds ttelseshjul til indledningsvis og langsom inds ttelse G 3 Lille inds ttelseshjul til hurtigere inds ttelse H Forklaring til Figur 2 og 3 Signatur...

Page 44: ...n eller mikrobiel kontaminering har v ret i kontakt med anordningen i et ukendt tidsrum Resterne af biologisk materiale kan f re til kontaminering af anordningen med pyrogener eller mikroorganismer so...

Page 45: ...PSNBM UJMTUBOE 3 0 tesla temperaturstigning En analyse som var baseret p ikke klinisk testning i henhold til ASTM F2182 11a og computermodellering af en patient viste at en enkelt 6 x 100 mm COVERA PL...

Page 46: ...aptation inden inds ttelsen f rdigg res Figur 10 BEM RK S rg for at den bekl dte stent der v lges er lang nok til at d kke hele l sionen og at begge implantatets ender n r mindst 5 mm ind i den sygdom...

Page 47: ...ia den indsatte bekl dte stent ved hjalp af fluoroskopi for at sikre at den bekl dte stent forbliver i den nskede position 15 Brug standardprocedurer til at bekr fte den bekl dte stents placering og b...

Page 48: ...tt ovanifr n 1 R tt s kerhetsl s F 2 Stort placeringshjul f r initial och l ngsam placering G 3 Litet placeringshjul f r snabbare placering H Schema f r bild 2 3 Referens Motsvarande information A Ins...

Page 49: ...giskt material kan ka risken f r att enheten kontamineras med pyrogener eller mikroorganismer som kan leda till infektionskomplikationer eller d dsfall t F R EJ anv ndas p patienter med obotliga koagu...

Page 50: ...U 8 LH VOEFS NJOVUFST TDBOOJOH t PSNBMU ESJGUTM HF G S 3 TZTUFNFU Temperatur kning vid 3 0 tesla I en analys baserad p icke klinisk testning enligt ASTM F2182 11a och datormodellering av en patient vi...

Page 51: ...igger an mot v ggen innan resten av stenten vecklas ut Bild 10 OBS Se till att vald l ngd p den t ckta stenten t cker hela skadan och att implantatets b da ndar str cker sig minst 5 mm in i k rlets fr...

Page 52: ...t PTA ballongkatetern f rs fram genom den utplacerade t ckta stenten under fluoroskopi f r att se till att den t ckta stenten f rblir korrekt placerad 15 Kontrollera placering och stabilitet f r t ckt...

Page 53: ...n yl osa 1 Punainen turvalukko F 2 Suuri laajennuspy r alustavaan ja hitaaseen laajentamiseen G 3 Pieni laajennuspy r nopeampaan laajentamiseen H Kuvien 2 ja 3 selitykset Viite Vastaavia tietoja A Ase...

Page 54: ...set ovat olleet kosketuksessa l kinn lliseen v lineeseen m rittelem tt m n ajan Biologisen materiaalin j nteet voivat edist laitteen kontaminoitumista pyrogeeneill tai mikro organismeilla mik voi joht...

Page 55: ...F2182 11a ja potilaan tietokonemallinnukseen perustuvassa analyysiss yhden 6 x 100 mm COVERA PLUS Pinnoitetun vaskulaaristentin m ritettiin tuottavan potentiaalisesti pahimmassa tapauksessa alle 3 C n...

Page 56: ...en ennen laajentamisen suorittamista kuva 10 HUOMAUTUS Varmista ett valitun pinnoitetun stentin pituus peitt koko leesion ja implantin molemmat p t laajentuvat v hint n 5 mm suonen terveeseen segmentt...

Page 57: ...utuneen suonen segmentiss HUOMAUTUS On suositeltavaa ty nt PTA pallokatetri laajennetun pinnoitetun stentin l pi fluoroskopian aikana jotta varmistetaan pinnoitetun stentin pysyminen hyvin paikoillaan...

Page 58: ...tak sett ovenfra 1 R d sikkerhetsl s F 2 Stort implanteringshjul for innledende og langsom implantering G 3 Lite implanteringshjul for rask implantering H Tegnforklaring for figur 2 og 3 Referanse Kor...

Page 59: ...amineringen av enheten med pyrogener eller mikroorganismer som kan f re til infeksjonskomplikasjoner eller d d t IKKE bruk hos pasienter med koaguleringssykdommer som ikke kan behandles t IKKE bruk ho...

Page 60: ...EVTESJGU BW 3 TZTUFNFU 3 0 Tesla temperatur kning I en analyse basert p ikke klinisk testing i henhold til ASTM F2182 11a og datamodeller av en pasient ble det fastsatt at den ene 6 x 100 mm lange COV...

Page 61: ...etiket hier Fabrikant Angiomed GmbH Co Medizintechnik KG Wachhausstrasse 6 76227 Karlsruhe Tel 49 721 9445 0 Duitsland Fax 49 721 9445 111 Hier Sticker vom Produktetikett aufkleben Hersteller Angiomed...

Page 62: ...ent or overlapped covered stents in the iliac and superficial femoral arteries for all clinically relevant lengths Based upon the preclinical testing patients with the C OVERA P LUS Vascular Covered S...

Page 63: ...almistaja Angiomed GmbH Co Medizintechnik KG Wachhausstrasse 6 76227 Karlsruhe Puh 49 721 9445 0 Saksa Faksi 49 721 9445 111 Sett p det avtakbare klistremerket fra produktetiketten her Produsent Angio...

Page 64: ...wania 15 minut Standardowy tryb pracy systemu MR Powlekany stent naczyniowy C OVERA P LUS Wi cej informacji mo na znale w instrukcji u ycia produktu Potilaan nimi Implantin p iv m r Implantoinnin suor...

Page 65: ...ngiomed GmbH Co Medizintechnik KG Wachhausstrasse 6 76227 Karlsruhe Tel 49 721 9445 0 Nem ija Faks 49 721 9445 111 0WEKF QPTUBWJUF OBMKFQOJDV T FUJLFUF QSPJ WPEB Proizvo a Angiomed GmbH Co Medizintech...

Page 66: ...a opornica C OVERA P LUS Za dodatne informacije glejte navodila za uporabo posami nih izdelkov Ime pacijenta Datum implantacije Lije nik koji je obavio implantaciju Telefonski broj lije nika koji je o...

Page 67: ......

Page 68: ......

Page 69: ...s p at den tildekkede stenten ligger tett inntil karveggen f r implanteringen fullf res figur 10 MERK S rg for at den valgte lengden for den tildekkede stenten dekker hele lesjonen og at begge ender a...

Page 70: ...ongkateteret gjennom den implanterte tildekkede stenten under fluoroskopi for sikre at den tildekkede stenten fremdeles er i riktig posisjon 15 Verifiser sted og penhet for den tildekkede stenten ved...

Page 71: ...ekanego stentu blokada bezpiecze stwa musi zosta cofni ta z pozycji zablokowania do pozycji odblokowania rysunek 3 Rysunek 3 Widok uchwytu z g ry 1 Czerwona blokada bezpiecze stwa F 2 Du ek koimplanta...

Page 72: ...lub u ytkownika oraz pogorszy strukturaln integralno lub podstawowe cechy materia owe i konstrukcyjne urz dzenia co mo e spowodowa uszkodzenie urz dzenia lub doprowadzi do obra e cia a choroby lub mi...

Page 73: ...8 9 mm D ugo powlekanego stentu Nale y si upewni e wybrana d ugo powlekanego stentu pokrywa ca zmian chorobow a oba ko ce implantu pokrywaj PEDJOFL OBD ZOJB OJF NJFOJPOFHP DIPSPCPXP P E VHP DJ QS ZOB...

Page 74: ...miany chorobowej i wprowadzi prowadnik 0 035 cala 0 89 mm do zmiany 3 Podczas zabieg w przeciwstronnych nale y umie ci d ugi p aszcz introduktora typu crossover lub cewnik prowadz cy w obr bie rozwidl...

Page 75: ...ormacje o pacjencie implancie oraz szpitalu powinny by zapisane na karcie Przed przekazaniem karty pacjentowi nale y upewni si e odrywana naklejka z etykiety produktu zostanie przyklejona do karty Pac...

Page 76: ...F BHZ JOE U TJ L SHPNC JOE U TIP T MBTT CFWJUFMIF 3 Kis ind t si k rgomb gyorsabb bevitelhez H WNVUBU B T CS IP Referencia Megfelel inform ci k A FWJW SFOET FS IFHZF B Luer z ras csatlakoz h vely C 1S...

Page 77: ...BOZBHNBSBEW OZPL FM TFH UIFUJL B FT L QJSPH OFLLFM WBHZ NJLSPPSHBOJ NVTPLLBM WBM LPOUBNJO DJ K U BNJ GFSU TFT T W EN OZFLIF WBHZ IBM MIP WF FUIFU t TILOS B FT L U LF FMIFUFUMFO W SBMWBE TJ BWBSCBO T F...

Page 78: ...3 SFOET FS OPSN M N L E TJ N EK CBO 3 0 Tesla h m rs klet emelked s HZ OFN LMJOJLBJ KFMMFH 45 B WJ TH MBU T T N U H QFT CFUFH NPEFMMF TFO BMBQVM FMFN T TPS O B U B FSFEN OZU LBQU L IPHZ FHZFUMFO Y NN...

Page 79: ...T UFOU GBMIP WBM QPOUPT JMMFT LFE T U CSB MEGJEGYZ S LJW MBT UPUU GFEFUU T UFOU IPTT OBL LJ LFMM UFSKFEOJF B UFMKFT M J UFS MFU SF T B JNQMBOU UVN NJOEL U W H OFL MFHBM CC NN SFM U LFMM OZ MOJB B S FH...

Page 80: ...asolt a PTA ballonkat ter k per s t alatti bevezet se a behelyezett fedett sztentbe 4UBOEBSE FMK S TPL BMLBMNB T WBM FMMFO SJ F B GFEFUU T UFOU IFMZ U T UK SIBU T H U BETEGEK SZ M RA K SZ LT IMPLANT T...

Page 81: ...n zabezpe ovac pojistka F WFML LPMF LP QSP BI KFO B QPNBM SP UBIPW O NBM LPMF LP QSP SZDIMFK SP UBIPW O Legenda k obr zk m 2 a 3 Ozna en Popis A QJ LB BW E D IP TZTU NV B Sami konektor Luer C 1SPYJN M...

Page 82: ...JUPV EPCV EP TUZLV T U MFTO NJ UFLVUJOBNJ J UL O NJ T QPUFODJ MO QZSPHFOO J NJLSPCJ MO LPOUBNJOBD CZULZ CJPMPHJDL IP NBUFSJ MV NPIPV QPEQPSPWBU LPOUBNJOBDJ QSPTU FELV QZSPHFOZ J NJLSPPSHBOJTNZ DP N F...

Page 83: ...MF EP HBVTT DN t NBYJN MO DFMPU MPW QS N S TQFDJGJDL N SZ BCTPSQDF 4 3 8 LH Q J NJOVUPW N TO NLPW O t 3 TZTU N W OPSN MO N QSPWP O N SF JNV Zv en teploty p i 3 0 tesla BOBM Z OFLMJOJDL DI UFTU QPEMF 4...

Page 84: ...QPUB FO TUFOU W QMO N LPOUBLUV T D WO TU OPV PCS FL POZN MKA 1PUB FO TUFOU KF U FCB VN TUJU UBL BCZ Q FLS WBM DFMPV M J B OB PCPV LPOD DI Q FTBIPWBM BMFTQP P NN EP ESBW IP TFHNFOUV D WZ 7 Q QBE Q FLS...

Page 85: ...ru uje se balonkov angioplastick kat tr v st rozta en m pota en m stentem pod fluoroskopickou kontrolou aby nedo lo k ne douc mu posunu pota en ho stentu 4UBOEBSEO N QPTUVQFN KF U PW UF VN TU O B QS D...

Page 86: ...1 K rm z G venlik Kilidi F 2 lk ve yava yerle tirme i in B y kYerle tirmeTekerle i G 3 H zl yerle tirme i in K kYerle tirmeTekerle i H ekil 2 ve 3 i in a klamalar Referans lgili Bilgiler A letim Sist...

Page 87: ...riski ta maktad r Biyolojik malzeme art klar cihaz n enfeksiy z komplikasyonlara veya l me neden olabilecek pirojenlerle ya da mikroorganizmalarla kirlenmesine neden olabilir t FMUJMFNFZFO LPBH MBTZP...

Page 88: ...emesine dayanarak ger ekle tirilen analizde UFL CJS Y NNhMJL COVERA PLUS BQM 7BTL MFS 4UFOUhJO 5FTMBM L CJS U N W DVU 3 TJTUFNJOEF EBLJLBM L CJS 3 UBSBNBT OEBO HF JSJMNFTJ TPOVDVOEB TUFOUJO PMBT FO L...

Page 89: ...i lemini tamamlamadan nce kapl stentin duvara dayanm oldu undan emin olun ekil 10 NOT Se ili kapl stent uzunlu unun t m lezyonu kaplad ndan veimplant n her iki ucunun damar n hastal kl olmayan segmen...

Page 90: ...ka n n NOT Kapl stentin do ru konumda kalmas n sa lamak i in PTA balon kateteri yerle tirilmi kapl stent i inden floroskopi alt nda ilerletmeniz tavsiye edilir 15 Standart prosed rleri kullanarak kap...

Page 91: ...COVERA PLUS 1 X ePTFE 2 A B C 30 cm D E G H 2 COVERA PLUS F 3 3 1 F 2 G 3 H 2 3 A B C D E F G H COVERA PLUS 0 035 inch 0 89 mm 8F 9F 80 cm 120 cm COVERA PLUS 4 5 mm 9 mm COVERA PLUS t t 680 F 360 C eP...

Page 92: ...4 5 mm 5 5 mm 7 mm 0 5 mm 1 5 mm 5 5 mm 6 5 mm 8 mm 1 mm 2 mm 6 mm 7 mm 9 mm 1 mm 2 mm 7 mm 8 mm 10 mm 1 mm 2 mm 8 mm 9 mm 5 mm 10 mm 10 mm COVERA PLUS 13 t t t t t PTA t t t t t t 9F t t t 30 t t t...

Page 93: ...A PLUS COVERA PLUS t 1 5Tesla 3Tesla t 3000 Gauss cm t 15 SAR 1W kg t 3 0 Tesla ASTM F2182 11a 6 x 100 mm COVERA PLUS 1 W kg SAR 3 0Telsa 15 3 C 1 5 Tesla ASTM F2182 11a 6 x 100 mm COVERA PLUS 1 W kg...

Page 94: ...86 10 8 8 9 9 11 15 mm 10 5 mm 10 mm 10 mm 6 9F 6 9 7 7...

Page 95: ...87 10 12 13 14 PTA 15...

Page 96: ...COVERA PLUS 1 X RAY ePTFE 2 A B C 30 cm D E G H 2 COVERA PLUS F 3 3 1 F 2 G 3 H 2 3 A B C D E F G H COVERA PLUS 0 035 0 89 mm 8F 9F 80 cm 120 cm COVERA PLUS 4 5 mm 9 mm COVERA PLUS t t 680 F 360 C ePT...

Page 97: ...US AV AV 1 6 mm 0 5 mm 1 5 mm 4 5 mm 5 5 mm 7 mm 0 5 mm 1 5 mm 5 5 mm 6 5 mm 8 mm 1 mm 2 mm 6 mm 7 mm 9 mm 1 mm 2 mm 7 mm 8 mm 10 mm 1 mm 2 mm 8 mm 9 mm t t t t t PTA t t t t t t 9F t AV t AV t t t t...

Page 98: ...RA PLUS 13 MRI COVERA PLUS MR COVERA PLUS t 5FTMB 3Tesla t BVTT DN t 1W kg SAR t 3 3 0 Tesla ASTM F2182 11a 6 x 100 mm COVERA PLUS 3 0 Tesla MR 15 MR 1 W kg SAR 3 C 1 5 Tesla ASTM F2182 11a 6 x 100 mm...

Page 99: ...91 9 7 7 10 8 8 9 5 5 mm 10 mm 10 mm 6 9F 6...

Page 100: ...92 9 11 15 mm 10 10 12 13 14 PTA 15...

Page 101: ...3 COVERA PLUS COVERA PLUS 1 30 D E G H 2 COVERA PLUS F 3 3 1 F 2 G 3 A B C D E F G H COVERA PLUS 0 035 inch 0 89 mm 8F 9F 80 120 cm COVERA PLUS 4 5 mm 9 mm COVERA PLUS t t 680 F 360 C t t t COVERA PLU...

Page 102: ...94 t t t t 30 t t t t t t t t t t t COVERA PLUS t t t t t t t t t t t 9F t t t 30 t t t t t t t t...

Page 103: ...6 mm 0 5 1 5 mm 4 5 5 5 mm 7 mm 0 5 1 5 mm 5 5 6 5 mm 8 mm 1 2 mm 6 7 mm 9 mm 1 2 mm 7 8 mm 10 mm 1 2 mm 8 9 mm 5 mm 10 mm NN COVERA PLUS 13 COVERA PLUS COVERA PLUS t 5FTMB t BVTT DN t 8 LH t 3 0 AST...

Page 104: ...96 NN 6 9F 6 9 7 7 1 9F 2 0 035 inch 0 89 mm 3 4 5 1 6 7 4 4 8 5 5 5 mm 10 mm...

Page 105: ...97 NN 10 10 12 13 14 15 10 8 9 9 11...

Page 106: ...tni zaklepni mehanizem F 2 Veliko kolesce za za etno in po asno namestitev G 3 Majhno kolesce za hitro namestitev H Legenda slik 2 in 3 Referenca Ustrezne informacije A Konica uvajalnega sistema B Vho...

Page 107: ...TOPWNJ BMJ mikroorganizmi ki lahko povzro ijo zaplete ali smrt zaradi oku b t NE uporabljajte pri bolnikih z neozdravljivimi motnjami strjevanja krvi t NE uporabljajte pri bolnikih ki se jih ne da us...

Page 108: ...nem testiranju v skladu z ASTM F2182 11a in ra unalni kim modeliranjem bolnika je bilo ugotovljeno da lahko enojna prekrita ilna opornica COVERA PLUS dimenzije 6 x 100 mm v najslab em primeru povzro i...

Page 109: ...namestitve zagotovite da se prekrita ilna opornica tesno prilega steni slika 10 OPOMBA Zagotovite da izbrana dol ina prekrite ilne opornice pokriva celotno lezijo in oba konca vsadka segata vsaj 5 mm...

Page 110: ...da pomikate balonski kateter PTA skozi name eno prekrito opornico pod fluoroskopijo da zagotovite da prekrita opornica ostaja dobro pozicionirana 15 S standardnimi postopki potrdile lokacijo in preho...

Page 111: ...F 2 Veliki kota za po etno i sporo otpu tanje G 3 Mali kota za br e otpu tanje H Legenda za slike 2 i 3 Referencija Odgovaraju e informacije A Vrh sustava za opskrbu B enski Luer priklju ak C Proksima...

Page 112: ...NJNB UP mo e dovesti do komplikacija s infekcijama ili do smrti t NEMOJTE koristiti kod pacijenata s nepopravljivim poreme ajima koagulacije t NEMOJTE koristiti kod pacijenata koji se ne mogu ranije l...

Page 113: ...a se temelji na neklini kom testiranju u skladu s normom ASTM F2182 11a i ra unalnom modeliranju pacijenta utvr eno je da pojedina ni COVERA PLUS vaskularni pokriveni stent veli ine 6 x 100 mm u najgo...

Page 114: ...t poravnat sa stijenkom prije dovr etka uvo enja Slika 10 NAPOMENA Pobrinite se da odabrana duljina pokrivenog stenta pokriva cijelu leziju i da se oba kraja implantata prote u barem 5 mm u zdravi seg...

Page 115: ...ostavljeni pokriveni stent pod navo enjem fluoroskopa kako biste bili sigurni da je pokriveni stent ostao dobro postavljen 15 Potvrdite lokaciju i prohodnost pokrivenog stenta pomo u standardnih postu...

Page 116: ...COVERA PLUS ePTFE COVERA PLUS 1 ePTFE A 30 cm D G H 2 COVERA PLUS F 3 3 1 F 2 G 3 H 2 3 A B C D E F G H COVERA PLUS NN DN DN COVERA PLUS AV 4 5 mm 9 mm COVERA PLUS t t 680 F 360 C ePTFE t t t COVERA P...

Page 117: ...109 t t t t t t t t AV t t t COVERA PLUS AV AV t t t t t PTA t t t t t t 9 F t AV t 7 t AV 30 t t t t t t t t t t t t 30 cm...

Page 118: ...mm 5 5 mm 6 5 mm 8 mm 1 mm 2 mm 6 mm 7 mm 9 mm 1 mm 2 mm 7 mm 8 mm 10 mm 1 mm 2 mm 8 mm 9 mm 5 mm 10 mm NN COVERA PLUS 13 COVERA PLUS MR Conditional COVERA PLUS t 5 5 t DN t 4 3 8 LH t 3 0 T ASTM F21...

Page 119: ...111 9 F 6 9 7 7 8 3 4 PTA 5 1 6 7 4 4 5 5 5 mm 10 mm NN 6...

Page 120: ...112 10 12 13 14 PTA 8 9 9 11 NN F 10...

Page 121: ...113 COVERA PLUS ePTFE COVERA PLUS 1 ePTFE 2 Luer 30 COVERA PLUS 2 3 3 1 2 3 3 2 Luer COVERA PLUS 80 9F 8F 0 89 0 035 120 COVERA PLUS AV 9 4 5 COVERA PLUS ePTFE 360 680 COVERA PLUS...

Page 122: ...114 COVERA PLUS 1 6 1 5 0 5 5 5 4 5 7 1 5 0 5 6 5 5 5 8 2 1 7 6 9 2 1 8 7 10 2 1 9 8 10 5 10 13 COVERA PLUS PTA 9F 30 1 30...

Page 123: ...3 4 1 5 6 Luer 7 4 4 8 5 5 MRI COVERA PLUS COVERA PLUS 3 1 5 3000 15 1 3 0 ASTM F2182 11a 100 x 6 COVERA PLUS 15 1 3 3 0 1 5 ASTM F2182 11a 100 x 6 COVERA PLUS 15 1 3 1 5 ASTM F2119 07 5 5 5 5 1 5 MR...

Page 124: ...116 10 8 8 9 9 11 15 10 10 5 10 6 9F 6 7 9 7...

Page 125: ...117 10 12 13 14 PTA 15...

Page 126: ...r 3 DPOEJUJPOFFM r 3 POEJDJPOBM r MR betinget MR Conditional MRI ehdollinen 3 CFUJOHFU r 3 8BSVOLPXP r 3 L SOZF FUCFO NFHGFMFM r 1PEN OF O WIPEO QSP 3 r MR Ko ullu MR r r 1PHPKOP uporaben za MR MR uv...

Page 127: ...atum izdavanja etikete 2018 05 5SJBYJBM FMJWFSZ 4ZTUFN r 4ZTU NF EF NJTF FO QMBDF USJBYJBM r 5SJBYJBMFT NQMBOUBUJPOTTZTUFN r 4JTUFNB EhJOTFSJNFOUP USJBTTJBMF r 4JTUFNB EF BQMJDBDJ O USJBYJBM r 5SJBYJB...

Page 128: ...ra Plus are trademarks and or registered trademarks of C R Bard Inc Copyright 2018 C R Bard Inc All Rights Reserved Manufacturer Angiomed GmbH Co Medizintechnik KG Wachhausstrasse 6 76227 Karlsruhe Ge...

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