Cardinal Health Cordis RAILWAY Instructions For Use Manual

Sheathless access system

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PPE Specification

Labeling Specification

Spec for Railway IFU

100000014624.4

Instructions for Use

RAILWAY™ Sheathless Access System

Mode d' e mploi

Système d'accès sans gaine RAILWAY™

Gebrauchsanweisung

RAILWAY™-Zugangssystem ohne Schleuse

Istruzioni per l'uso

Sistema di accesso senza introduttore RAILWAY™

Instrucciones de uso

Sistema de acceso sin vaina RAILWAY™

Instruções de utilização

Sistema de acesso sem bainha RAILWAY™

Gebruiksinstructies

RAILWAY™ toegangssysteem zonder sheath

Brugsanvisning

RAILWAY™ hylsterløst adgangssystem

Käyttöohje

Holkiton RAILWAY™-vientijärjestelmä

Bruksanvisning

RAILWAY™ hylslöst åtkomstsystem

Bruksanvisning

RAILWAY™ hylseløst tilgangssystem

Oδηγίες χρήσης

Σύστημα πρόσβασης χωρίς θηκάρι RAILWAY™

Návod k použití

Bezplášťový systém přístupu RAILWAY™

Használati útmutató

RAILWAY™hüvely nélküli bevezetőrendszer

Instrukcja stosowania

Bezosłonowy system dostępu RAILWAY™

Návod na použitie

Bezpuzdrový prístupový systém RAILWAY™

Инструкции за употреба

Система за достъп без дезиле RAILWAY™

Instrucțiuni de utilizare

Sistem de acces fără teacă RAILWAY™

Kasutusjuhend

RAILWAY™ ümbriseta juurdepääsusüsteem

Lietošanas pamācība

RAILWAY™ bezapvalka piekļuves sistēma

Naudojimo instrukcijos

RAILWAY™ prieigos sistema be movos

Kullanma Talimatları

RAILWAY™ Kılıfsız Erişim Sistemi

Инструкции по применению

Безоболочечная система доступа RAILWAY™

Інструкція з застосування

Безоболонкова система доступу RAILWAY™

Пайдалану нұсқаулары

RAILWAY™ өткізгішсіз қол жеткізу

жүйесі

使用说明

RAILWAY™ 无鞘通路系统

使用說明

RAILWAY™ 無鞘式通路系統

사용 설명서

RAILWAY™시스가 없는 접근 시스템

คำ � แนะนำ � ในก�รใช้ ง �น

RAILWAY™ Sheathless Access System

Petunjuk Penggunaan

Sistem Akses Tanpa Selubung RAILWAY™

Upute za upotrebu

Pristupni sustav bez obloge RAILWAY™

Uputstvo za upotrebu

RAILWAY™ sistem sa pristupom bez košuljice

Упатство за употреба

Систем за пристап RAILWAY™ без

обвивка

Navodila za uporabo

Sistem za dostop brez ovoja RAILWAY™

RAILWAY™

100322810 | Rev:4

Released: 09 May 2018

CO: 100510027

Release Level: 4. Production

‫تعليامت االستخدام‬

‫نظام الوصول عديم الج ر اب‬

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Summary of Contents for Cardinal Health Cordis RAILWAY

Page 1 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production 100000014624.4 Kasutusjuhend Instructions for Use RAILWAY™ Sheathless Access System RAILWAY™ ümbriseta juurdepääsusüsteem Mode d’ e mploi Lietošanas pamācība Système d’accès sans gaine RAILWAY™ RAILWAY™...
Page 2 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Explanation of symbols on labels and packaging: / Explication des symboles sur les étiquettes et l’ e mballage : / Erklärung der Symbole auf Etiketten und Verpackung: / Legenda dei simboli presenti sulle etichette e sulla confezione: / Explicación de los símbolos en las etiquetas y el envase: / Explicação dos símbolos dos rótulos e embalagem: / Verklaring van symbolen op etiketten en verpakking: / Forklaring af symboler på...
Page 3 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Consult Instructions for Use / Consulter le mode d’emploi / Gebrauchsanweisung beachten / Consultare le istruzioni per l’uso / Leer las instrucciones de uso / Consulte as Instruções de Utilização / Raadpleeg gebruiksaanwijzing / Se brugsanvisningen / Lue käyttöohjeet / Läs bruksanvisningen / Se bruksanvisningen / Συμβουλευτείτε...
Page 4 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Figure 1 / Figure 1 / Abbildung 1 / Figura 1 / Figura 1 / Figura 1 / Afbeelding 1 / Figur 1 / Kuva 1 / Bild 1 / Figur 1 / Εικόνα 1 / Obrázek 1 / 1. ábra / Rycina 1 / Obrázok 1 / Фигура 1 / รู...
Page 5 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Figure 7 / Figure 7 / Abbildung 7 / Figura 7 / Figura 7 / Figura 7 / Afbeelding 7 / Figur 7 / Kuva 7 / Bild 7 / Figur 7 / Εικόνα 7 / Obrázek 7 / 7. ábra / Rycina 7 / Obrázok 7 / Фигура 7 / 7-сурет...
Page 6 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production English STERILE. Sterilized with ethylene oxide gas. Nonpyrogenic. For single use only. Do not resterilize. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Components/Description ™...
Page 7 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production VII. Instructions for Use Preparation Select an appropriately sized vessel dilator. Refer to Table 1 and to the product labeling for recommended guiding catheter and guidewire compatibility. Remove the vessel dilator and components from the packaging using aseptic technique.
Page 8 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production est à noter que cette aiguille contient de l’acier au chrome-nickel et qu’ e lle ne doit pas être utilisée chez les patients susceptibles de développer une réaction allergique. Aiguille non couverte Une aiguille d’introduction non couverte, fournie à...
Page 9 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production indique que l’ e xtrémité du cathéter-guide de 90 cm se trouve à proximité de la transition conique du dilatateur vasculaire. Remarque : NE PAS faire progresser le cathéter-guide plus loin sur le dilatateur vasculaire lorsque le marqueur B est visible au niveau de l’...
Page 10 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • Eine Nichtbefolgung der Verfahrensschritte beim Austausch eines Führungskatheters kann zum Verlust des Gefäßzugangs führen. • Die distale Spitze des Dilatators oder Mini-Führungsdrahtes darf nicht manuell durch äußere Kraftanwendung umgeformt werden, um den Dilatator oder Mini-Führungsdraht zu biegen oder dessen Form zu verändern.
Page 11 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Siehe Abschnitt „Warnhinweise“. Ein Nichtbefolgen der Anweisungen kann zum Verlust des Zugangs führen. Sicherstellen, dass ein interventioneller 0,88-mm-(0,035-Zoll)-Führungsdraht mit einer Länge von mindestens 260 cm vorhanden ist, um den Zugang zu erhalten und anschließend den Führungskatheter entfernen.
Page 12 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Complicanze Tra le possibili complicazioni figurano, a titolo indicativo: • Chiusura improvvisa del vaso • Intervento aggiuntivo • Reazione allergica (al dispositivo, al mezzo di contrasto e ai farmaci) •...
Page 13 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production vascular compatible con una guía de 0,53 mm (0,021”), un dilatador vascular compatible con una guía de 0,88 mm (0,035”), una miniguía de 0,53 mm (0,021”), un catéter i.v. (compuesto de una cánula i.v.
Page 14 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production AVISO: Si no se lava el dispositivo antes de su uso, puede producirse un embolismo aéreo. Sumerja los 25 cm distales del dilatador vascular en solución salina heparinizada estéril o solución isotónica similar para activar el revestimiento hidrófilo. Si utiliza un alambre de acceso hidrófilo, empápelo también para activar el revestimiento.
Page 15 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Ambos os dilatadores de vaso têm dois marcadores proximais etiquetados com A e B na Figura 1. O marcador A (o marcador mais proximal) é utilizado como posição de referência aquando da utilização de um cateter-guia de 100 cm compatível.
Page 16 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production de complicações vasculares. Aquando da utilização de um cateter-guia de 90 cm – avance o cateter-guia até o conector avançar para o Marcador B (o marcador numa posição mais distal). Tal indica que a ponta do cateter-guia de 90 cm está...
Page 17 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • De dilatator mag alleen over een voerdraad worden opgevoerd. Als de dilatator niet over een voerdraad wordt opgevoerd, kan dit vaatcomplicaties veroorzaken. •...
Page 18 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Zoals beschreven in bovenstaande stappen, kan de dilatator worden verwijderd zodra de toegang via de nieuwe geleidekatheter tot stand is gebracht. De dilatator kan echter ook worden gebruikt ter ondersteuning van de geleidekatheter tijdens het opvoeren.
Page 19 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • Arteriovenøs fistel • Død • Emboli • Feber • Hæmatom på punkturstedet • Hæmoragi • Inflammation/infektion/sepsis • Iskæmi •...
Page 20 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Suositeltu ohjauskaterin yhteensopivuus Ohjainvaijerin yhteensopivuus Laajentimen Luettelokoodi Vaijeri Suonen laajennin (ja sisähalkaisija) (2 laajenninta) ulkohalkaisijan mitat RW6ADTH Hydrofiilinen ® 6 F:n Cordis ADROIT 0,53 mm:n (0,021 tuuman) ja 0,88 RW6ADTB Paljas...
Page 21 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ® HUOMIO: IV-katetrin Introcan Safety -neulan* tai paljaan neulan poistamisen ja (mahdollisen) suojakiinnikkeen aktivoinnin jälkeen hävitä neula. Älä yritä viedä neulaa uudelleen potilaaseen tai vaihtaa suojusta.
Page 22 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production som otillräckligt bör en alternativ åtkomstplats beaktas. • Använd inte kontrastmedlen Ethiodol eller Lipiodol** eller andra sådana kontrastmedel som innehåller delar av dessa medel, eftersom lösningsmedel som används i dessa medel kan skada enheten.
Page 23 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production För in dilatator- och ledarkateterkombinationen i kärlet samtidigt som den proximala änden på 0,88 mm (0,035-tumsledaren) fixeras. Såsom beskrivs i stegen ovan kan dilatatorn avlägsnas när den nya ledarkatetern fått åtkomst, eller så kan den användas som stöd till ledarkatetern under framförandet. Om de används för framförandet ska dilatatorn och ledaren avlägsnas så...
Page 24 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • blødning, • betennelse/infeksjon/sepsis, • iskemi, • hjerteinfarkt, • nekrose, • perifer nerveskade, • smerte, • nyresvikt, • slag, •...
Page 25 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production RW7VBTH Υδρόφιλο ® 7F Cordis VISTA BRITE TIP 0,53 mm (0,021 ιντσών) 7F, πορτοκαλί RW7VBTB Γυμνό (1,97 mm [0,078 ιντσών]) και 0,88 mm (0,035 ιντσών) 1,97 mm/0,078 ιντσών...
Page 26 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production είτε τη γυμνή βελόνα μέσα στο αγγείο του ασθενούς χρησιμοποιώντας την αποδεκτή ιατρική τεχνική για αγγειακή πρόσβαση. Εισάγετε απαλά το μαλακό άκρο του μίνι συρμάτινου οδηγού διαμέσου της βελόνας ή της ενδοφλέβιας κάνουλας μέσα στην κερκιδική αρτηρία, με προσεκτικούς χειρισμούς έτσι ώστε να αποφύγετε...
Page 27 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production u pacientů, u kterých může vyvolat alergickou reakci. Holá jehla Holá jehla pro přístup se dodává jako alternativa k jehle i.v. katétru. Rovněž usnadňuje počáteční vstup do tepny. Po počátečním vstupu holé jehly do cílové cévy je možné umístit skrz hrdlo jehly mini vodicí...
Page 28 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production 11. Byl vytvořen bezplášťový přístup zaváděcího katétru do cílové cévy. V případě potřeby je možné provést cévní angiografii vstřiknutím kontrastní látky. Do zaváděcího katétru je možné zavést a posunovat intervenční...
Page 29 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • Használat előtt ellenőrizze, hogy az értágító mérete megfelelő-e a megnyitni kívánt érhez, valamint a használni kívánt vezetőkatéterhez és más tartozékokhoz. •...
Page 30 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Polski PRODUKT STERYLNY. Sterylizowano gazowym tlenkiem etylenu. Produkt niepirogenny. Tylko do jednorazowego użytku. Nie sterylizować ponownie. Przestroga: Prawo federalne Stanów Zjednoczonych zezwala na sprzedaż urządzenia tylko przez lekarza lub na jego zlecenie. Komponenty/Opis ™...
Page 31 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • zakrzepica; • powikłania naczyniowe (np. rozerwanie błony wewnętrznej naczynia, rozwarstwienie, pseudotętniak, perforacja, pęknięcie, skurcz, niedrożność). VII. Instrukcja stosowania Przygotowanie Wybrać rozszerzacz naczyniowy o odpowiednim rozmiarze. W Tabeli 1 oraz na etykietach produktu znajdują się informacje dotyczące kompatybilności cewnika prowadzącego i prowadnika.
Page 32 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production RW6ADTH Hydrofilný ® 6F Cordis ADROIT 0,53 mm (0,021 palca) RW6ADTB Holý (1,82 mm [0,072 palca]) a 0,88 mm (0,035 palca) 1,80 mm/0,071 palca 6F, Zelený RW6VBTH Hydrofilný...
Page 33 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Nasaďte distálny hrot cievneho dilatátora na mini vodiaci drôt, s portom drôtu smerujúcim nahor, a posúvajte ho do cievy. Dilatátor sa smie posúvať, kým nebude port drôtu v rozmedzí približne 3 cm od miesta punkcie.
Page 34 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production разтворителите, използвани в тези вещества, могат да повредят устройството. ® • Никога не поставяйте иглата на интравенозния катетър Introcan Safety * отново...
Page 35 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ВНИМАНИЕ: Ако по време на придвижване или изтегляне на катетъра възникне силно усукване или съпротивление, преустановете движението и определете причината за съпротивлението, преди да продължите. Ако причината за съпротивлението не може да бъде установена, изтеглете цялата система.
Page 36 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • Acest produs este destinat utilizării de către profesioniști calificați în diagnosticarea afecțiunilor coronariene și în efectuarea procedurilor de intervenție. •...
Page 37 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production LA O RESPONSABILITATE SAU GARANŢIE, CU EXCEPŢIA CELOR MENŢIONATE EXPLICIT ÎN ACEST DOCUMENT. Descrierile sau specificațiile din documentele tipărite Cordis, inclusiv documentul de față, sunt concepute în exclusivitate în scopul descrierii generale a produsului la momentul fabricării și nu constituie niciun fel de garanții explicite.
Page 38 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • tromboos; • vaskulaarsed tüsistused (nt intima rebend, dissektsioon, pseudoaneurüsm, perforatsioon, ruptuur, spasm, oklusioon). VII. Kasutusjuhend Ettevalmistus Valige sobiva suurusega veresoone laiendaja. Soovitatava juhtekateetri ja juhtetraadi ühilduvuse teavet vaadake tabelist 1. Eemaldage veresoone laiendaja ja koostisosad pakendist, kasutades aseptilist tehnikat.
Page 39 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ® Introcan Safety IV katetra* piekļuves adata ir nodrošināta, lai atvieglotu sākotnējo ievadīšanu artērijā. Izņemot adatu, IV kanula paliek vietā, lai atvieglotu mini vadstīgas ievadīšanu mērķa asinsvadā.
Page 40 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production 11. Ir izveidota vadītājkatetra piekļuve mērķa asinsvadam, neizmantojot apvalku. Ja nepieciešams, var veikt asinsvada angiogrāfiju, injicējot kontrastvielu. Invazīvo procedūru 0,88 mm (0,035 collu) J vadstīgu vai citu 0,88 mm (0,035 collu) vadstīgu, kam operators ir devis priekšroku, var ievadīt vadītājkatetrā...
Page 41 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • Nekeiskite šio gaminio. • Naudokite iki datos „Tinka iki“. • Šis gaminys skirtas naudoti per stipininės arterijos prieigą tik iki poraktikaulinės arterijos, bet ne toliau. Nesurinkta jokių duomenų, įrodančių šio gaminio saugumą ir veiksmingumą, naudojant jį...
Page 42 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ™ RAILWAY Kılıfsız Erişim Sistemi, 90 cm ve 100 cm uzunluklardaki 5F, 6F ve 7F Kılavuz Kateterleriyle uyumlu kılıfsız radyal bir erişim sistemidir. Sistem, 0,53 mm (0,021”) kılavuz tel uyumlu damar dilatörü, 0,88 mm (0,035”) kılavuz tel uyumlu damar dilatörü, 0,53 mm (0,021”) mini kılavuz tel, IV kateter (IV kanülü...
Page 43 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production etkinleştirmek için teli de daldırın. ® Kullanmadan önce erişim iğnesini (Introcan Safety IV Kateteri* iğnesi veya çıplak iğne) yıkamak için heparinize saline veya benzer izotonik çözeltiyle dolu bir şırınga kullanın. Önerilen Prosedür İlgili Kullanım Kılavuzu uyarınca uygun boyutta seçilen kılavuz kateterini hazırlayın.
Page 44 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production входит. Мини-проводник Мини-проводник диаметром 0,53 мм (0,021 дюйма) и длиной 45 см предназначен для формирования доступа к сосуду. См. рис. 4, где приведена информация о мини-проводнике. В зависимости...
Page 45 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production маркера). Он показывает, что кончик проводникового катетера длиной 100 см находится вблизи конусного перехода сосудистого дилататора. Примечание. Запрещается продвигать проводниковый катетер дальше по сосудистому дилататору, если маркер А виден у соединительной втулки проводникового катетера...
Page 46 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production тесту Аллена. Якщо постачання крові до руки по колатеральній судині виявиться недостатнім, необхідно розглянути можливість іншого місця доступу. • Не...
Page 47 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production провідникового катетера. 11. Доступ до планованої судини за допомогою безоболонкового провідникового катетера досягнуто. За потреби можна виконати ангіографію із введенням контрастної речовини. Щоб...
Page 48 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • Ethiodol немесе Lipiodol** контрасттық заттарын немесе құрамында құрылғыға кері әсер етуі мүмкін затта пайдаланылатын еріткіштер сияқты осы заттардың құрамдастары бар, басқа, осыған ұқсас контрасттық заттарды пайдаланбаңыз.
Page 49 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production жылжыту бағыттауыш катетер ұшының тамыр кеңейткіштің үшкір жолына жылжуына себеп болып, тамырдың асқыну мүмкіндігін арттырады. ә. 90 см бағыттауыш катетерді пайдалану кезінде төлке B таңбалауышына (алысырақ таңбалауыш) дейін жеткенше бағыттауыш...
Page 50 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ™ RAILWAY 无鞘通路系统旨在用于需要经皮引入血管内设备的桡动脉手术。 III. 禁忌症 ™ 避免将 RAILWAY 无鞘通路系统用于极端纡曲、钙化斑块或血栓形成的血管。以下患者忌用桡动脉通路系统： • 可通过动脉栓塞或无桡动脉脉搏病征印证的末端血液循环不足。 • 血液透析分流、移植物或累及上肢血管的动静脉瘘。警告 • 在实施桡动脉通路术之前，建议经由尺动脉核实侧支血管血流充足，例如通过 Al l e n 试验。如果认为流向双手的侧支供血不足， ...
Page 51 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production 器插入导引管，直至到达以上第 8 步所述的适当近端标记物。在荧光镜透视检查导引下，沿导丝将扩张器和导引管推进到不超过锁骨下动脉的区域。抽出扩张器和导丝，然后重新插入导引管内的导丝，并继续推进到目标部位。警示：必须始终沿着导丝推进扩张器，并按照第 8 步所述维持扩张器和导引管之间对准，否则可能会引起血管并发症。警示：导管推进或后退过程中如果遇到极端纡曲或很强的阻力，须中止移动，找出阻力原因后再继续进行。如果不能确定阻力原因，则退出整个系统。警示：切勿推进扩张器超出锁骨下动脉。进一步推进可能会引起血管并发症（详情请参阅“并发症”章节）。 13. 如果需要更换导引管：请参阅“警告”章节。未能遵守使用说明可能会导致血管通路丢失。确保至少 260cm 长的 0.88mm (0.035”) 介入性导丝放置妥当，以维持血管通路，并抽出导引管。在穿刺部位手动施加轻柔压力。藉由 0.88mm (0.035”) 兼容性血管扩张器加装新的导引管，然后推进到上述第 8 步所述的相应的近端标记物位置。藉由...
Page 52 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • 本產品僅適用於進入橈動脈並繼續向前追蹤，但不超出鎖骨下動脈。尚未採集到任何資料可以證明本產品用作診斷或介入治療設備的安全性和有效性。 • 如果設備彎曲，或在插入或推進血管擴張器時覺得阻力增加，則在繼續操作前查明原因。如果阻力原因無法確定和糾正，則中斷手術，並抽出血管擴張器。 • 如果在抽出血管擴張器時覺得阻力增加，則在繼續操作前查明原因，原因在於血管擴張器抽出期間用力過度會導致產品受損，或引起血管併發症。 • 在手術期間，給予患者適當的抗凝血劑或抗血小板治療。併發症可能的併發症包括但不限於： • 突發血管閉塞； • 需額外介入； • 過敏反應 (器械、造影劑和藥物過敏)； •...
Page 53 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production 표 1: 제품 매트릭스 및 권장 적합성 카탈로그 권장 유도 카테터 적합성 가이드와이어 적합성 (및 내부 직경) (확장기 2개) 코드...
Page 54 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ® 사용하기 전에 헤파린이 첨가된 식염수 또는 유사한 등장액으로 채운 주사기를 사용하여 접근용 바늘(Introcan Safety IV 카테터* 바늘 또는 비피복 바늘)을 세척합니다. 권장...
Page 55 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ขย�ย โปรดด ู ค ำ � แนะน ำ � ก�รเตร ี ย มอ ุ ป กรณ ์ ท ี ่ ส ่ ว นก�รเตร ี ย มก�ร ช...
Page 56: Bahasa Indonesia
PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ถ่ � งขย�ยใกล้ ๆ ส่ ว นปล�ย เพื ่ อ ป้ องกั น ก�รลื ่ น หรื อ โค้ ง งอที ่ ผ ิ ว แนะนำ � ให้ ใช้ ผ ้ � ก๊ อ ซชุ บ น้ ำ � เกลื อ ผสมเฮพ�ริ น หรื อ ส�รละล�ยที ่ ม ี ค ว�มเข้ ม ข้ น เท่ � กั บ ส�รละล�ยภ�ยใน เพ...
Page 57 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Akses radial tidak boleh digunakan pada pasien yang memiliki: • Sirkulasi tidak memadai ke anggota badan sebagaimana terbukti dari tanda-tanda oklusi arteri atau tidak adanya denyut radial. •...
Page 58 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production 13. Jika perlu mengganti kateter pemandu: Lihat bagian Peringatan. Ketidakpatuhan terhadap petunjuk dapat menyebabkan hilangnya akses. Pastikan kawat pemandu intervensi 0,88 mm (0,035”) sepanjang minimal 260 cm berada di posisinya untuk mempertahankan akses, dan lepaskan kateter pemandu. Beri tekanan lembut secara manual pada lokasi tusukan.
Page 59 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production • Tijekom zahvata pacijentu dajte odgovarajuću antikoagulacijsku ili antitrombocitnu terapiju. Komplikacije Moguće komplikacije između ostalih obuhvaćaju: • naglo zatvaranje žile, •...
Page 60 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Tabela 1: Matrica proizvoda i preporučene kompatibilnosti Preporučena kompatibilnost uvodnog Dilatator krvnog katetera Kompatibilnost vodič-žice Dimenzije spoljašnjeg prečnika Kataloška šifra Žica suda (i unutrašnji prečnik)
Page 61 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Preporučeni postupak Pripremite odabrani, uvodni kateter kompatibilne veličine u skladu sa uputstvima za upotrebu. Postavite distalni vrh uvodnog katetera preko proksimalnog kraja dilatatora krvnog suda. Pogledajte tabelu 1 za informacije o preporučenoj kompatibilnosti proizvoda.
Page 62 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ® Иглата за пристап Introcan Safety ИВ Катетер* се доставува да го олесни првичниот влез во артеријата. Отстранувањето на иглата ја остава ИВ канила на своето место за да се олесни вметнување на мини жицата-водилка во целниот крвен сад. Видете...
Page 63 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Нека навлегува катетерот-водич над проксималниот крај на дилататорот сè додека врвот на катетерот-водич не биде приближно 5 cm проксимално до отворот за жица на дилататорот за крвни садови. Користете...
Page 64 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Tabela 1: Matrika izdelka in priporočljive združljivosti Združljivost priporočljivega vodilnega katetra Združljivost vodilne žice Mere zunanjega Kataloška koda Žica Dilatator žile (in notranji premer) (2 dilatatorja)
Page 65 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production Priporočen postopek Pripravite izbrani vodilni kateter z združljivo velikostjo glede na ustrezna navodila za uporabo. Distalno konico vodilnega katetra namestite prek proksimalnega konca dilatatorja žile. Za informacije o združljivosti priporočljivega izdelka glejte tabelo 1.
Page 66 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production ™ .‫يف ﻋﻤليﺎت اﻟ رش اﻳني اﻟشعﺎﻋيﺔ اﻟتﻲ تﺴتلزم إدخﺎل أﺟﻬزة داخﻞ اﻷوﻋيﺔ ﻋرب اﻟﺠلد‬ ‫ﻳ ُ ﻨصح ﺑﺎستخدام نظام الوصول عديم الج ر اب‬ RAILWAY ‫موانع...
Page 67 PPE Specification 100322810 | Rev:4 Labeling Specification Released: 09 May 2018 Spec for Railway IFU CO: 100510027 Release Level: 4. Production :‫إذا ﻟزم تغيري قﺴﻄﺮة اﻟتﻮﺟيﻪ‬ 13 . .‫ر اﺟﻊ قﺴم اﻟتﺤﺬﻳ ﺮ ات. قد ﻳؤدي ﻋدم اتﺒﺎع اﻟتعليامت إىل ﻓﻘدان اﻟﻮﺻﻮل‬ ‫أ‬...
Page 68 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...