Terumo Crosstella OTW Скачать руководство пользователя страница 10 | Manualshive

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3) Under fluoroscopy, verify the position of the radiopaque

marker in the balloon and determine the dilatation site.

4) Attach the inflation device securely to the balloon inflation

port.

5) Inflate the balloon gradually to the target diameter verifying

the inflation pressure and dilate the stenotic lesion (for
inflated balloon diameters, consult the balloon compliance
chart provided in Table 1. at the end of this Instructions for
Use).

4. Removal of the catheter

1) After applying negative pressure to deflate the balloon

completely, remove the catheter.

5. Re-insertion of the catheter

1) If a re-insertion of the removed catheter with deflated

balloon is required, ensure the balloon is completely deflated
and folded before re-inserting it into the patient’s blood
vessel. On re-insertion use the catheter as per “Insertion
and inflation of the balloon catheter” section herein.

2) If any resistance is encountered while re-inserting the

catheter, stop advancing it and carefully remove it out of the
patient’s blood vessel. Prepare to use a new Crosstella
OTW in accordance with the procedures provided above in
this section of this Instruction for Use.

[Complications]

Device Failures:

・

Balloon rupture

・

Insufficient inflation / deflation of the balloon

・

Breakage of the balloon and / or the catheter shaft

・

Difficulty in removing the device

・

Leakage of inflation fluid

Adverse Events:

・

Local or systemic infections

・

Local internal bleeding or hematoma

・

Intimal rupture

・

Vascular dissection

・

Vascular perforation

・

Vascular rupture

・

Aneurysm

・

Arrhythmia

・

Acute vascular occlusiond

・

Venous thromboembolism

・

Vasospasm

・

Formation of pseudoaneurysm

・

Arteriovenous fistula

・

Bleeding requiring transfusion

・

Allergic response to the contrast media / renal failure

・

Ache or pressing pain

・

Death

・

Embolism

・

Endocarditis

・

Fever

・

Hypertension / Hypotension

・

Inflammation

・

Myocardial Infarction

・

Sepsis

・

Shock

・

Stroke

・

Transient Ischemic Attack

[Storage and expiration date]

1. Store in a cool, dry, dark place. Avoid exposure to water, direct

sunlight.

2. The expiration date is indicated on the box. Do not use after the

expiration date.

[Package]

1 set/box

[Name and address of manufacturer]

Manufacturer : KANEKA CORPORATION

Address: 3-18, 2-chome, Nakanoshima, Kita-ku, Osaka-city,

OSAKA, 530-8288 JAPAN

TEL No.: (+81)-(0) 6-6226-5256
FAX No.: (+81)-(0) 6-6226-5143

Authorized representative in the European Community:
KANEKA PHARMA EUROPE N.V.

Address: Nijverheidsstraat 16, 2260 Westerlo-Oevel, Belgium
TEL No.: (+32)-(0) 14-256-297
FAX No.: (+32)-(0) 14-256-298

EU Distributor : TERUMO EUROPE N.V.

Address: INTERLEUVENLAAN 40,3001 LEUVEN, Belgium
TEL No.: (+32)-(0) 16 381 211
FAX No.: (+32)-(0) 16 400 249

USA Distributor : TERUMO MEDICAL CORPORATION

Address: 2101 Cottontail Lane, Somerset, NEW JERSEY,

08873, U.S.A.

TEL No. : (+1) 800-888-3786
FAX No.: (+1) 800-411-5870

Terumo and CROSSTELLA are trademarks of TERUMO
CORPORATION.

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Содержание Crosstella OTW

Страница 1: ...allon dilatationskateter PTA ballongdilatasjonskateter PTA pallolaajennuskatetri PTA Balonowy cewnik dylatacyjny do PTA PTA T g t Ballonkat ter Bal nkov dilata n kat tr pro PTA PTA bal nikov dilata n...

Страница 2: ...o do Upotrebljivo do Data de expirare Upotrijebiti do P Sterilized using ethylene oxide St rilis l oxyde d thyl ne Sterilisation mit Ethylenoxid Esterilizado con xido de etileno Esterilizado com oxido...

Страница 3: ...robeno V robca retici firma Toodetud Ra ots Gamintojas Izdelovalec Proizvodja Fabricat de Proizvo a Nominal Pressure Pression nominale Nenndruck Presi n nominal Press o nominal Pressione nominale Nomi...

Страница 4: ...age kui pakend on kahjustatud Nelietot ja sterilais iepakojums ir boj ts Jei pakuot pa eista nenaudoti Ne uporabljajte ga e je ovojnina po kodovana Ne upotrebljavati ukoliko je pakovanje o te eno A nu...

Страница 5: ...iseren F r ej omsteriliseras M ikke resteriliseres M ikke re steriliseres Ei uudelleen sterilointia Nie sterylizowa ponownie Nem steriliz lhat jra Nesterilizujte opakovane Neresterilizujte Yeniden ste...

Страница 6: ...n uzak tutunuz Kaitsta otsese p ikesevalgus eest Sarg t no saules stariem Saugoti nuo saul s viesos Izogibajte se son ni svetlobi Ne izlagati sun evoj svetlosti A se p stra la umbr Dr ati dalje od sun...

Страница 7: ...altion lain mukaan t m tuote voidaan myyd vain l k rille tai h nen m r yksest n UWAGA Prawo federalne U S A przewiduje e urz dzenie to mo e by sprzedawane tylko przezlub na zam wienie lekarza FIGYELME...

Страница 8: ...aneurysm 3 Patients who are pregnant 4 Patients who cannot tolerate antiplatelet therapy or anticoagulant therapy WARNINGS AND PRECAUTIONS Warnings 1 This device is for single use only Do not reuse Do...

Страница 9: ...ntroducer guide sheath 23 Always use the catheter along a guidewire inserted into the guidewire lumen Operational Instructions Materials typically required for PTA with the Crosstella OTW PTA balloon...

Страница 10: ...t Difficulty in removing the device Leakage of inflation fluid Adverse Events Local or systemic infections Local internal bleeding or hematoma Intimal rupture Vascular dissection Vascular perforation...

Страница 11: ...ressure atm Balloon Diameter mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20...

Страница 12: ...yant d velopp une st nose anastomotique dans le mois suivant la mise en place d une d rivation AV shunt 2 Patients pr sentant des l sions communiquant avec un pseudo an vrisme 3 Patientes enceintes 4...

Страница 13: ...tourner le cath ter lors de sa manipulation 21 Lors de l insertion de ce dispositif dans le vaisseau sanguin ou de son retrait hors du vaisseau sanguin s assurer de la d flation totale du ballonnet Le...

Страница 14: ...onform ment aux proc dures d crites ci dessus dans cette section des instructions d utilisation Complications D faillances du dispositif Rupture du ballonnet Inflation d flationinsuffisante du ballonn...

Страница 15: ...W Pression atm Diam tre du ballonnet mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28...

Страница 16: ...ion KONTRAINDIKATIONEN 1 Bei Patienten die innerhalb von einem Monat nach Anlage eines arterioven sen Shunts eine Stenose im Bereich der Anastomose entwickelt haben 2 Bei Patienten die mit einem Pseud...

Страница 17: ...erfahren des Krankenhauses als medizinischer Abfall zu entsorgen 19 Keine Substanzen mit organischen L sungsmitteln oder lhaltige Kontrastmittel verwenden Ein Kontakt mit diesen Mitteln kann zu Sch de...

Страница 18: ...enn bei der Wiedereinf hrung des Katheters Widerstand zu sp ren ist den Katheter nicht weiter vorschieben Stattdessen den Katheter vorsichtig aus dem Blutgef des Patienten entfernen Die Verwendung ein...

Страница 19: ...Ballone Druck atm Ballondurchmesser mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28...

Страница 20: ...pia anticoagulante ADVERTENCIAS Y PRECAUCIONES Advertencias 1 Este producto es para un solo uso No reutilizar No reesterilizar No reprocesar El reprocesamiento puede comprometer la esterilidad la bioc...

Страница 21: ...Dispositivo de inflado con man metro Jeringuilla con bloqueo Luer V lvula de tres v as M todo de manipulaci n o instrucciones de uso 1 Selecci n del cat ter Antes del uso y bajo fluoroscopia verificar...

Страница 22: ...de seudoaneurisma F stula arteriovenosa Sangrado que requiere transfusi n Respuesta al rgica al medio de contraste fallo renal Dolor o dolor a la presi n Muerte Embolia Endocarditis Fiebre Hipertensi...

Страница 23: ...la OTW Presi n atm Di metro del bal n mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 2...

Страница 24: ...o shunt AV 2 Doentes com les es que contactem com um pseudoaneurisma 3 Doentes gr vidas 4 Doentes com intoler ncia a terapia antiplaquet ria ou anticoagulante ADVERT NCIAS E PRECAU ES Advert ncias 1 E...

Страница 25: ...l men do fio guia Instru es de Funcionamento Os materiais tipicamente requeridos para ATP com o cateter de dilata o de bal o para ATP Crosstella OTW incluem Fio s guia de di metro e comprimento adequa...

Страница 26: ...cal ou sist mica Hemorragia interna local ou hematoma Ruptura da ntima Dissec o vascular Perfura o vascular Ruptura vascular Aneurisma Arritmia Oclus o aguda do shunt Tromboembolia venosa Espasmo vasc...

Страница 27: ...Press o atm Di metro do bal o mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 2...

Страница 28: ...municanti con uno pseudoaneurisma 3 Pazienti in stato di gravidanza 4 Pazienti che non tollerano la terapia antiaggregante o terapia anticoagulante AVVERTENZE E PRECAUZIONI Avvertenze 1 Dispositivo mo...

Страница 29: ...hiesti per la PTA con il catetere con palloncino di dilatazione per PTA Crosstella OTW sono Filo guida di diametro e lunghezza adeguate Set introduttore introduttore guida e dilatatore appropriato Fla...

Страница 30: ...e o stelo del catetere Difficolt nel rimuovere il dispositivo Perdita di fluido di riempimento Eventi avversi Infezione locale o sistemica Sanguinamento locale interno o ematoma Rottura dell intima D...

Страница 31: ...Pressione atm Diametro palloncino mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16...

Страница 32: ...ARSCHUWINGEN EN VOORZORGSMAATREGELEN Waarschuwingen 1 Dit hulpmiddel is bestemd voor eenmalig gebruik Niet opnieuw gebruiken Niet opnieuw steriliseren Niet herwerken Het product herwerken kan de steri...

Страница 33: ...eschikte set met inbrenghuls geleideschacht en dilatator Flacon contrastmiddel Flacon steriele fysiologische zoutoplossing Inflatie instrument met manometer Luer lockspuit Driewegafsluitkraan Bedienin...

Страница 34: ...uur Aneurysma Aritmie Acute vaatocclusie Veneuze trombo embolie Vasospasme Vorming van een pseudo aneurysma Arterioveneuze fistel Bloeding waardoor bloedtransfusie nodig is Allergische reactie op het...

Страница 35: ...TW Druk atm Ballondiameter mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2...

Страница 36: ...Patienter som inte klarar trombocyth mmande behandling eller blodf rtunningsbehandling VARNINGAR OCH F RSIKTIGHETS TG RDER Varningar 1 Enheten r endast avsedd f r eng ngsbruk F r ej teranv ndas F r e...

Страница 37: ...diametern ska den mindre storleken v ljas 2 F rberedelser 1 Efter att denna kateter aseptiskt har tagits ur f rpackningsbeh llaren skall de skyddande materialen tas bort 2 Ers tt luften i ballongen o...

Страница 38: ...k ischemisk attack F rvaring och b st f re datum 1 F rvaras p sval torr m rk plats F r ej uts ttas f r vatten eller direkt solljus 2 B st f re datum anges p l dan F r ej anv ndas efter b st f re datum...

Страница 39: ...ella OTW Tryck atm Ballongdiameter mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 1...

Страница 40: ...omforarbejdes Omforarbejdning kan kompromittere steriliteten biokompatibiliteten og funktionen af produktet 2 M ikke bruges hvis produktet eller produktemballagen er blevet beskadiget 3 Ballonen m ik...

Страница 41: ...ebeholderen og fjern de beskyttende materialer fra kateteret 2 T m ballonen og ballonens inflationslumen for luft ved hj lp af inflationsv ske i overensstemmelse med nedenst ende procedurer a S t inde...

Страница 42: ...risk isk misk attak Opbevaring og udl bsdato 1 Opbevares k ligt t rt og m rkt M ikke uds ttes for vand eller direkte sollys 2 Udl bsdatoen er anf rt p sken M ikke anvendes efter udl bsdatoen Emballage...

Страница 43: ...e Tryk atm Ballondiameter mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2...

Страница 44: ...M ikke omproduseres Omproduksjon kan redusere steriliteten biokompatibiliteten og den fysiske helheten til enheten 2 Bruk ikke produktet dersom enheten eller emballasjen er skadet 3 Bl s ikke opp ball...

Страница 45: ...vt trykk i omtrent 10 sekunder p inflasjonsutstyret rett kateterspissen nedover og slipp ut det negative trykket langsomt for la v ske fylle ballongen og ballonginflasjonslumen og slippe ut luften c D...

Страница 46: ...brukes etter utl psdatoen Forpakning 1 sett boks Navn og adresse p produsent eller representant Produsent KANEKA CORPORATION Adresse 3 18 2 chome Nakanoshima Kita ku Osaka city OSAKA 530 8288 JAPAN T...

Страница 47: ...am Trykk atm Ballongdiameter mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20...

Страница 48: ...levat potilaat 4 Potilaat jotka eiv t kest verihiutaleiden toimintaa est v l kehoitoa tai antikoagulaatiohoitoa VAROITUKSET JA VAROTOIMENPITEET Varoitukset 1 T m laite on kertak ytt inen Ei uudelleenk...

Страница 49: ...tetrin suojamateriaalit 2 Korvaa pallossa ja pallon t ytt luumenissa oleva ilma t ytt nesteell seuraavien ohjeiden mukaisesti a Kiinnit t ytt nesteell t ytetty laajennuslaite ei sis lly t h n pakkauks...

Страница 50: ...ssa V lt altistamista vedelle ja suoralle auringonvalolle 2 Viimeinen k ytt p iv on mainittu pakkauksessa Ei saa k ytt viimeisen k ytt p iv n j lkeen Pakkaus 1 setti laatikko Valmistajan tai edustajan...

Страница 51: ...ko Paine atm Pallon halkaisija mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2...

Страница 52: ...r Crosstella OTW Crosstella OTW 1 0 018 0 46 mm 8 atm 14 atm PTA Crosstella OTW Crosstella OTW Complete SE Vascular Stent System Medtronic Inc S M A R T CONTROL Vascular Stent System Cordis Corporatio...

Страница 53: ...53 115 3212 1 1 2 3 4 1 2 5 6 7 8 9 DSA Digital Subtraction Angiography 10 11 12 13 14 15 16 17 18 19 20 21 22 23 PTA PTA Crosstella OTW Luer lock 1 2 1 2 10 3 4 PTA Crosstella OTW 3...

Страница 54: ...chome Nakanoshima Kita ku Osaka city OSAKA 530 8288 JAPAN 81 0 6 6226 5256 fax 81 0 6 6226 5143 KANEKA PHARMA EUROPE N V Nijverheidsstraat 16 2260 Westerlo Oevel Belgium 32 0 14 256 297 fax 32 0 14 25...

Страница 55: ...Crosstella OTW atm mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2 73 3 23...

Страница 56: ...Crosstella OTW OTW 0 018 0 46 Crosstella OTW Crosstella OTW 1 0 018 0 46 8 atm 14 atm Crosstella OTW Crosstella OTW Complete SE Medtronic Inc S M A R T CONTROL Cordis Corporation 1 2 3 4 1 2 3 4 5 1 2...

Страница 57: ...57 115 3212 1 1 2 3 4 1 2 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Crosstella OTW 1 2 1 2 a b 10 c b d e 3 4 Crosstella OTW...

Страница 58: ...akanoshima Kita ku Osaka city OSAKA 530 8288 JAPAN 81 0 6 6226 5256 81 0 6 6226 5143 KANEKA PHARMA EUROPE N V Nijverheidsstraat 16 2260 Westerlo Oevel Belgium 32 0 14 256 297 32 0 14 256 298 TERUMO EU...

Страница 59: ...1 1 Crosstella OTW 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2 73 3 23 4...

Страница 60: ...RZECIWWSKAZANIA 1 Pacjenci u kt rych stwierdzono zw enie zespoleniowe w ci gu jednego miesi ca od wytworzenia przetoki ylno t tniczej 2 Pacjenci u kt rych stwierdza si zmiany kt re cz si z pseudot tni...

Страница 61: ...o nale y si upewni e balon jest ca kowicie opr niony Wyr b z wi kszym lub d u szym balonem wymaga d u szego czasu opr niania 22 Je li podczas nast puj cego po zabiegu wycofywania wyrobu daje si wyczu...

Страница 62: ...ania Powik ania Awarie wyrobu P kni cie balonu Niewystarczaj ce nape nienie opr nienie balonu P kni cie balonu i lub trzonu cewnika Trudno ci z usuni ciem wyrobu Wyciek p ynu do nape niania Zdarzenia...

Страница 63: ...Ci nienie atm rednica balonu mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20...

Страница 64: ...lata resteriliz ci ja nem megengedett Ism telt felhaszn l sra val el k sz t se nem megengedett mivel ez vesz lyeztetheti a term k sterilit s t biokompatibilit s t s funkcion lis integrit s t 2 Ne has...

Страница 65: ...tmutat s 1 A kat ter kiv laszt sa A beavatkoz s el tt r ntgen tvil g t ssal hat rozza meg a v red ny bels tm r j t a sztenotikus elv ltoz st l proxim lisan s diszt lisan s v lassza ki a megfelel m re...

Страница 66: ...V rz s transzf zi t ig nyl A kontrasztanyagra val allergi s reakci F jdalom vagy szor t f jdalom Hal l Emb lia Endokarditisz L z Magas vagy alacsony v rnyom s Gyullad s Sz vinfarktus Szepszis Sokk St...

Страница 67: ...at Nyom s atm Ballon tm r mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2...

Страница 68: ...ednor zov pou it Nelze pou t opakovan Opakovan nesterilizujte Nijak neupravujte Opakovan pou it m e ohrozit sterilitu biokompatibilitu a funk n celistvost prost edku 2 Pokud je po kozen v robek nebo o...

Страница 69: ...obalov n doby odstra te z n j ochrann materi l 2 N sleduj c m postupem nahra te vzduch v bal nku a v infla n m lumen bal nku infla n kapalinou a K infla n mu portu bal nku p ipojte infla n za zen nen...

Страница 70: ...datum exspirace 1 Skladujte v chladu suchu a temnu Chra te p ed vodou a p m m slune n m sv tlem 2 Datum exspirace je vyzna eno na obalu Nepou vejte po datu pou itelnosti Balen 1 set v krabici N zev a...

Страница 71: ...TW Tlak atm Pr m r bal nku mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2...

Страница 72: ...enti s l ziami v spojen s pseudoaneuryzmou 3 Tehotn pacientky 4 Pacienti ktor netoleruj antiagrega n alebo ani antikoagula n lie bu UPOZORNENIA A PREVENT VNE OPATRENIA UPOZORNENIA 1 T to pom cka je ur...

Страница 73: ...dra a dilat tora ampulka s kontrastn m m diom ampulka so steriln m fyziologick m roztokom nafukovacie zariadenie s manometrom strieka ka s konektorom luer lock trojcestn uzatv rac koh t Sp sob oper ci...

Страница 74: ...kl zia ven zny tromboembolizmus vazospazmus vytvorenie pseudoaneuryzmy arterioven zna fistula krv canie s nutnos ou transf zie alergick reakcia na kontrastn m dium zlyhanie obli iek boles alebo penliv...

Страница 75: ...ity Tlak atm Priemer bal nika mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 2...

Страница 76: ...mak bu r n n sterilli ini biyolojik uyumlulu unu ve fiziksel b t nl n tehlike alt nda b rakabilir 2 r n veya r n ambalaj hasarl ysa kullanmay n 3 Stenotik lezyona proksimal ve distal kan damar n n ap...

Страница 77: ...ak n b i irme cihaz na yakla k 10 saniye negatif bas n uygulad ktan sonra kateter aft ucunu a a do ru y nlendirin ve s v n n balon ve balon i irme l menine girip havay d ar atmas n sa lamak i in negat...

Страница 78: ...kutuda belirtilmi tir Son kullanma tarihinden sonra kullanmay n Paket 1 set kutu retici veya temsilcinin ad ve adresi retici firma KANEKA CORPORATION Adres 3 18 2 chome Nakanoshima Kita ku Osaka city...

Страница 79: ...blosu Bas n atm Balon ap mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2 7...

Страница 80: ...N UD Hoiatused 1 See seade on ette n htud ainult hekordseks kasutamiseks rge kasutage korduvalt rge steriliseerige rge puhastage ega steriliseerige toodet uuesti See v ib rikkuda seadme steriilsust bi...

Страница 81: ...ja ballooni t itevalendikus olev hk t itevedelikuga j rgides allpool kirjeldatud protseduuri a Kinnitage t itevedelikuga t idetud t itmisseade ei kuulu komplekti ballooni t itmispordi k lge b P rast n...

Страница 82: ...S ilitamine ja aegumiskuup ev 1 Hoida kuivas jahedas pimedas kohas V ltida kokkupuudet vee ja otsese p ikesevalgusega 2 Aegumiskuup ev on n idatud karbil rge kasutage p rast aegumiskuup eva Pakend 1 k...

Страница 83: ...el R hk atm Ballooni diameeter mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2...

Страница 84: ...aneirismu 3 Pacient m gr tniec m 4 Pacientiem kuri nepanes antitromboc tu un antikoagulantu terapiju BR DIN JUMI UN PIESARDZ BAS PAS KUMI Br din jumi 1 ier ce paredz ta tikai vienreiz jai lieto anai N...

Страница 85: ...nas nor d jumi 1 Katetra izv le Pirms lieto anas p rbaudiet asinsvada iek jo diametru proksim li un dist li l dz stenotiskam asinsvada boj jumam izmantojot fluoroskopiju un izv lieties katetru ar atbi...

Страница 86: ...m nepiecie ama asins p rlie ana Aler isk reakcija uz kontrastvielu nieru atteice S pes vai spiedo as s pes N ve Embolija Endokard ts Drudzis Hipertensija hipotensija Iekaisums Miokarda infarkts Sepse...

Страница 87: ...atm Balona diametrs mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2 73 3...

Страница 88: ...rtotinai neapdoroti Pakartotinai apdorojus gali pablog ti renginio sterilumas biologinis suderinamumas ir fizinis vientisumas 2 Nenaudokite jeigu produkto arba renginio pakuot buvo pa eista 3 Nepripil...

Страница 89: ...r i pakuot s nuimkite nuo jo apsaugines med iagas 2 Pakeiskite or balion lyje ir jo pripildymo spindyje pripildymo skys iu vykdydami ias proced ras a Pritvirtinkite pripildymo rengin iame rinkinyje n...

Страница 90: ...okas Insultas Praeinantis smegen i emijos priepuolis Saugojimas ir galiojimo laikas 1 Laikykite v sioje sausoje tamsioje vietoje Saugokite nuo vandens tiesiogini saul s spinduli 2 Galiojimo data nuro...

Страница 91: ...Sl gis atm Balion lio skersmuo mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2...

Страница 92: ...bi Ni za ponovno uporabo Ni namenjeno ponovnemu steriliziranju Ne predelujte ponovno Predelovanje lahko ogrozi sterilnost biolo ko zdru ljivost in funkcionalno neokrnjenost priprave 2 Ne uporabljajte...

Страница 93: ...naslednjimi postopki a Na odprtino za polnjenje balona pritrdite napravo za polnjenje ni vklju ena v ta komplet napolnjeno s teko ino za polnjenje b Po tem ko pribli no 10 sekund ustvarjate negativni...

Страница 94: ...hranjevanje in rok uporabnosti 1 Hranite v hladnem suhem in temnem prostoru Ne izpostavljajte vodi neposredni son ni svetlobi 2 Rok uporabnosti je naveden na katli Ne uporabljajte po izteku roka upora...

Страница 95: ...dnosti Tlak atm Premer balona mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 2...

Страница 96: ...i ne podnose antiagregacionu ili antikoagulacionu terapiju UPOZORENJA I MERE PREDOSTRO NOSTI Upozorenja 1 Ovaj ure aj je namenjen samo za jednokratnu upotrebu Ne upotrebljavati ponovo Ne resterilisati...

Страница 97: ...ju i uvodnik i komplet za dilataciju Bo icu kontrastnog sredstva Bo icu fiziolo kog rastvora Sredstvo za naduvavanje sa manometrom pric sa luer blokadom Trokraku slavinu Metod rada ili uputstvo za upo...

Страница 98: ...seudoaneurizme Arteriovenska fistula Krvarenje koje zahteva transfuziju Alergijski odgovor na kontrastno sredstvo otkaz bubrega Dugotrajan ili pritiskaju i bol Smrt Embolija Endokarditis Groznica Viso...

Страница 99: ...itisak atm Pre nik balona mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2...

Страница 100: ...doanevrism 3 Pacientele ns rcinate 4 Pacien ii care nu pot tolera tratamentul antiplachetar sau anticoagulant AVERTISMENTE I M SURI DE PRECAU IE Avertismente 1 Acest dispozitiv este de unic folosin Nu...

Страница 101: ...tru PTA Crosstella OTW includ Fir e de ghidaj cu diametru i lungime adecvate Teac de introducere ghidaj i set de dilatare adecvate Flacon cu substan de contrast Flacon cu solu ie salin steril Dispoozi...

Страница 102: ...ur de intim Disec ie vascular Perfora ie vascular Ruptur vascular Anevrism Aritmie Ocluzie vascular acut Tromboembolism venos Spasm vascular Formarea unui pseudoanevrism Fistul arteriovenoas Hemoragie...

Страница 103: ...Presiune atm Diametru balon mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20...

Страница 104: ...tella OTW OTW 0 018 0 46 mm Crosstella OTW Crosstella OTW 1 0 018 0 46 mm 8 14 Crosstella OTW PTA Crosstella OTW Complete SE Medtronic Inc S M A R T CONTROL Cordis Corporation 1 2 3 4 1 2 3 4 5 1 2 1...

Страница 105: ...6 7 8 9 DSA 10 11 12 13 14 15 16 17 18 19 20 21 22 23 PTA Crosstella OTW PTA 1 2 1 2 a 10 c e 3 4 Crosstella OTW PTA 3 BD F20020MW BD F60200LW 2 2 5 3 4 5 120 150 200 6 20 40 4 1 35 0 018 0 46 5 120 1...

Страница 106: ...256 81 0 6 6226 5143 KANEKA PHARMA EUROPE N V Nijverheidsstraat 16 2260 Westerlo Oevel Belgium 32 0 14 256 297 32 0 14 256 298 TERUMO EUROPE N V INTERLEUVENLAAN 40 3001 LEUVEN Belgium 32 0 16 381 211...

Страница 107: ...1 Crosstella OTW mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2 73 3 23...

Страница 108: ...lla OTW OTW over the wire 0 018 0 46 Crosstella OTW Crosstella OTW 1 0 018 0 46 8 14 Crosstella OTW o Crosstella OTW Complete SE Medtronic Inc S M A R T CONTROL Cordis Corporation 1 2 3 4 1 2 3 4 5 1...

Страница 109: ...109 115 3212 1 4 1 2 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Crosstella OTW 1 2 1 2 a b 10 c b d e 3 4 Crosstella OTW 3...

Страница 110: ...a Kita ku Osaka city OSAKA 530 8288 JAPAN 81 0 6 6226 5256 81 0 6 6226 5143 KANEKA PHARMA EUROPE N V Nijverheidsstraat 16 2260 Westerlo Oevel Belgium 32 0 14 256 297 32 0 14 256 298 TERUMO EUROPE N V...

Страница 111: ...1 1 Crosstella OTW 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20 2 73 3 23 4...

Страница 112: ...gritet ure aja 2 Nemojte koristiti proizvod ako su proizvod ili ambala a o te eni 3 Balon se ne smije napuhati tako da prelazi promjer krvne ile proksimalno i distalno prema leziji stenoze 4 Nemojte n...

Страница 113: ...aju za napuhivanje usmjerite vrh trupa katetera prema dolje i polagano oslobodite negativni tlak kako biste fluidom ispunili balon i inflacijski lumen balona te istisnuli zrak c Ako u balonu i inflaci...

Страница 114: ...eka je ozna en na kutiji Nemojte koristiti nakon isteka roka valjanosti Paket 1 komplet kutija Ime i adresa proizvo a a ili zastupnika Proizvo a KANEKA CORPORATION Adresa 3 18 2 chome Nakanoshima Kita...

Страница 115: ...ona Tlak atm Promjer balona mm 2 00 2 50 3 00 4 00 5 00 6 00 8 2 03 2 50 2 98 4 00 5 04 5 93 10 2 07 2 56 3 05 4 08 5 16 6 06 12 2 11 2 61 3 11 4 17 5 28 6 16 14 2 15 2 67 3 17 4 26 5 41 6 28 16 2 20...

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