Medtronic 1351 Instructions for Use

Intersept™ 1351/CB1351

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Filtered Cardiotomy Reservoir Kardiotomireservoir med filter Kardiotomiereservoir mit Filter Δεξαμενή φιλτραρισμένου αίματος καρδιοτομής Reservorio de cardiotomía con filtro Suodattimellinen kardiotomiasäiliö Réservoir de cardiotomie avec filtre Cardiotomo filtrato Gefilterd cardiotomiereservoir Kardiotomireservoar med filter Reservatório de cardiotomia com filtro Rezervor de cardiotomie cu filtru Кардиотомный резервуар с фильтром Kardiotomireservoar med filter

Instructions for Use • Brugsanvisning • Gebrauchsanweisung • Οδηγίες χρήσης • Instrucciones de uso • Käyttöohjeet • Mode d'emploi • Istruzioni per l'uso • Gebruiksaanwijzing • Bruksanvisning • Instruções de utilização • Instrucţiuni de utilizare • Инструкция по эксплуатации • Bruksanvisning

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. Følgende liste indeholder varemærker eller registrerede varemærker tilhørende Medtronic i USA og muligvis i andre lande. Alle andre varemærker tilhører de respektive ejere. Die folgende Liste beinhaltet Marken oder eingetragene Marken von Medtronic in den USA und möglicherweise in anderen Ländern. Alle anderen Marken sind Eigentum ihrer jeweiligen Inhaber. Ο ακόλουθος κατάλογος περιλαμβάνει εμπορικά σήματα ή σήματα κατατεθέντα της Medtronic στις Ηνωμένες Πολιτείες και πιθανόν σε άλλες χώρες. Όλα τα άλλα εμπορικά σήματα είναι ιδιοκτησία των

αντίστοιχων κατόχων τους. La siguiente lista incluye marcas comerciales o marcas registradas de Medtronic en los Estados Unidos y posiblemente en otros países. Todas las marcas comerciales son propiedad de sus propietarios

respectivos. Seuraava luettelo sisältää Medtronic-yhtiön tavaramerkit ja rekisteröidyt tavaramerkit Yhdysvalloissa ja mahdollisesti muissa maissa. Kaikki muut tavaramerkit ovat niiden omistajien omaisuutta. La liste suivante inclut des marques commerciales ou des marques déposées de Medtronic aux États-Unis et eventuellement dans d'autres pays. Toutes les autres marques commerciales sont la propriété de leurs

détenteurs respectifs. L'elenco seguente include marchi di fabbrica o marchi registrati della Medtronic negli Stati Uniti ed eventualmente in altri Paesi. Tutti gli altri marchi di fabbrica sono di proprietà dei rispettivi proprietari. In de onderstaande lijst staan de gedeponeerde of geregistreerde handelsmerken van Medtronic in de Verenigde Staten en mogelijk in andere landen. Alle andere handelsmerken zijn het eigendom van de

desbetreffende eigenaar. Den følgende listen inneholder varemerker eller registrerte varemerker for Medtronic i USA og eventuelt i andre land. Alle andre varemerker tilhører de respektive eierne. A lista que se segue inclui marcas comerciais ou marcas comerciais registadas da Medtronic nos EUA e possivelmente noutros países. Todas as outras marcas comerciais são propriedade dos respetivos

detentores. Următoarea listă include mărcile comerciale sau mărcile comerciale înregistrate ale Medtronic în Statele Unite ale Americii şi, posibil, în alte ţări. Toate celelalte mărci comerciale sunt proprietatea deţinătorilor

respectivi. Следующий список включает товарные знаки или зарегистрированные товарные знаки корпорации Medtronic в США и, возможно, в других странах. Все другие товарные знаки являются

собственностью их владельцев. Följande lista innehåller varumärken eller registrerade varumärken som tillhör Medtronic i USA och möjligen i andra länder. Alla övriga varumärken tillhör respektive innehavare.

Cortiva, Intersept, Medtronic

Explanation of symbols on package labeling • Forklaring til symbolerne på emballagens mærkater • Erläuterung der Symbole auf der Verpackung • Επεξήγηση των συμβόλων στη σήμανση της συσκευασίας • Explicación de los símbolos que aparecen en la documentación del envase • Pakkausetiketin symbolien selitykset • Explication des symboles des étiquettes sur l’emballage • Spiegazione dei simboli presenti sulle etichette della confezione • Verklaring van de symbolen op de verpakkingslabels • Forklaring av symboler på pakningen • Explicação dos símbolos na documentação da embalagem • Legenda simbolurilor cuprinse în etichetele de pe ambalaj • Пояснение к символам на этикетках упаковки • Förklaring av symboler på förpackningsmärkningen

Refer to the outer package label to see which symbols apply to this product. • Se mærkaten på den ydre emballage for de symboler, der gælder for dette produkt. • Welche Symbole für dieses Produkt zutreffen, entnehmen Sie bitte dem Etikett auf der Verpackung. • Ανατρέξτε στην ετικέτα της εξωτερικής συσκευασίας για να δείτε ποια σύμβολα ισχύουν για το παρόν προϊόν. • Consulte la etiqueta del envase exterior para comprobar qué símbolos son aplicables a este producto. • Katso ulkopakkauksen etiketistä, mitkä symbolit koskevat tätä tuotetta. • Se référer à l’étiquette sur l’emballage extérieur pour savoir quels symboles s’appliquent à ce produit. • Fare riferimento all’etichetta sulla confezione esterna per sapere quali simboli si applicano a questo prodotto. • Controleer het label op de buitenverpakking om te zien welke symbolen op dit product van toepassing zijn. • Se på etiketten på den ytre pakningen for å fastslå hvilke symboler som gjelder for dette produktet. • Consultar a etiqueta exterior da embalagem para ver quais os símbolos que se aplicam a este produto. • Consultaţi eticheta dispozitivului pentru simbolurile aplicabile acestui produs. • См. на этикетке внешней упаковки, какие символы применимы к данному продукту. • Se etiketten på ytterförpackningen för de symboler som gäller denna produkt.

Conformité Européenne (European Conformity) This symbol means that the device fully complies with applicable European Union acts.

• Conformité Européenne (Europæisk Standard) Dette symbol betyder, at enheden fuldt ud overholder den gældende EU-lovgivning. • Conformité Européenne (Europäische Konformität) Dieses Symbol besagt, dass das Gerät allen Vorschriften geltender EU-Gesetze entspricht. • Conformité Européenne (Ευρωπαϊκή Συμμόρφωση) Το σύμβολο αυτό σημαίνει ότι το προϊόν συμμορφώνεται πλήρως με τους ισχύοντες νόμους της Ευρωπαϊκής Ένωσης. • Conformité Européenne (Conformidad Europea) Este símbolo indica que el dispositivo cumple totalmente las leyes de la Unión Europea aplicables. • Conformité Européenne (eurooppalainen vaatimustenmukaisuus). Tämä symboli tarkoittaa, että laite on kaikilta osin Euroopan unionin soveltuvan lainsäädännön mukainen. • Conformité Européenne (Conformité Européenne) Ce symbole signifie que le dispositif est entièrement conforme aux lois en vigueur de l’Union européenne. • Conformité Européenne (Conformità europea) Questo simbolo indica che il dispositivo è conforme alle normative dell’Unione europea applicabili. • Conformité Européenne (Europese Conformiteit). Dit symbool betekent dat het product volledig voldoet aan de geldende wetgeving van de Europese Unie. • Conformité Européenne (samsvar med europeisk standard) Dette symbolet betyr at enheten er fullstendig i samsvar med gjeldende EU-rettsakter. • Conformité Européenne (Conformidade Europeia) Este símbolo significa que o dispositivo está em total conformidade com as leis da União Europeia aplicáveis. • Conformité Européenne (Conformitate Europeană) Acest simbol atestă conformitatea deplină a dispozitivului cu legislaţia relevantă a Uniunii Europene. • Conformité Européenne (European Conformity) Этот символ обозначает, что устройство полностью соответствует требованиям применимых директив Европейского Союза. • Conformité Européenne (Europeisk standard) Denna symbol anger att enheten uppfyller alla gällande lagar i den Europeiska unionen.

Nonpyrogenic fluid path • Ikke-pyrogen væskebane • Pyrogenfreier Flüssigkeitsweg • Μη πυρετογόνος διαδρομή υγρού • Vía de líquido apirógena • Pyrogeeniton nestereitti • Trajet des fluides apyrogène • Percorso per il liquido apirogeno • Niet-pyrogene vloeistofbaan • Pyrogenfri væskebane • Percurso de líquidos não pirogénico • Cale de fluid apirogenă • Пути тока жидкости апирогенны • Pyrogenfri vätskebana

Sterilized using ethylene oxide • Steriliseret med etylenoxid • Mit Ethylenoxid sterilisiert • Αποστειρωμένο με αιθυλενοξείδιο • Esterilizado mediante óxido de etileno • Steriloitu etyleenioksidilla • Stérilisé à l’oxyde d’éthylène • Sterilizzato a ossido di etilene • Gesteriliseerd met ethyleenoxide • Sterilisert med etylenoksid • Esterilizado utilizando óxido de etileno • Sterilizat cu oxid de etilenă • Стерилизовано этиленоксидом • Steriliserad med etylenoxid

Do not reuse • Må ikke genbruges • Nicht wiederverwenden • Μην επαναχρησιμοποιείτε • No reutilizar • Älä käytä uudelleen • Ne pas réutiliser • Non riutilizzare • Niet opnieuw gebruiken • Skal ikke brukes flere ganger • Não reutilizável • De unică folosinţă • Не использовать повторно • Får inte återanvändas

Do not resterilize • Må ikke resteriliseres • Nicht resterilisieren • Μην επαναποστειρώνετε • No reesterilizar • Älä steriloi uudelleen • Ne pas restériliser • Non risterilizzare • Niet opnieuw steriliseren • Skal ikke resteriliseres • Não reesterilizar • Nu resterilizaţi • Не стерилизовать повторно • Får inte omsteriliseras

Use-by date • Kan anvendes til og med • Verwendbar bis • Ημερομηνία «Χρήση έως» • Fecha de caducidad • Viimeinen käyttöpäivämäärä • Date de péremption • Utilizzare entro • Uiterste gebruiksdatum • Siste forbruksdag • Utilizar antes da data • A se utiliza până la data de • Срок годности • Utgångsdatum

Do not use if package is damaged • Må ikke anvendes, hvis emballagen er beskadiget • Nicht verwenden, wenn die Verpackung beschädigt ist • Μην το χρησιμοποιείτε εάν η συσκευασία έχει υποστεί ζημία • No utilizar si el envase está dañado • Älä käytä, jos pakkaus on vaurioitunut • Ne pas utiliser si l’emballage est endommagé • Non utilizzare se l’imballaggio non è integro • Niet gebruiken als de verpakking beschadigd is • Skal ikke brukes hvis pakningen er skadet • Não utilizar se a embalagem estiver danificada • Nu folosiţi dacă ambalajul este deteriorat • Не использовать, если упаковка повреждена • Får ej användas om förpackningen är skadad

Lot number • Partinummer • Chargennummer • Αριθμός παρτίδας • Número de lote • Eränumero • Numéro de lot • Numero di lotto • Partijnummer • Lotnummer • Número de lote • Număr de lot • Номер партии • Partinummer

Quantity • Antal • Menge • Ποσότητα • Cantidad • Määrä • Quantité • Quantità • Aantal • Antall • Quantidade • Cantitate • Количество • Antal

Consult instructions for use • Se brugsanvisningen • Gebrauchsanweisung lesen • Συμβουλευτείτε τις οδηγίες χρήσης • Consultar instrucciones de uso • Katso käyttöohjeet • Consulter le mode d’emploi • Consultare le istruzioni per l’uso • Zie gebruiksaanwijzing • Se i bruksanvisningen • Consultar as instruções de utilização • Consultaţi Instrucţiunile de utilizare • См. инструкцию по эксплуатации • Läs bruksanvisningen

For US audiences only • Gælder kun i USA • Gilt nur für Leser in den USA • Μόνο για πελάτες εντός των ΗΠΑ • Solo aplicable en EE. UU.

• Koskee vain Yhdysvaltoja • Ne s’applique qu’aux États-Unis • Esclusivamente per il mercato statunitense • Alleen van toepassing voor de VS • Gjelder kun USA • Aplicável apenas aos EUA • Numai pentru clienţii din SUA • Только для США • Gäller endast i USA

Transit temperature limit • Temperaturgrænse under transport • Grenzwerte Transporttemperatur • Όριο θερμοκρασίας μεταφοράς • Límite de temperatura de transporte • Kuljetuslämpötilaraja • Limite de température de transport • Limite della temperatura di trasporto • Bereik transporttemperatuur • Temperaturgrense, forsendelse • Limite da temperatura de transporte • Limita temperaturii de tranzit • Диапазон температуры транспортировки • Temperaturgräns vid transport

Date of manufacture • Fabrikationsdato • Herstellungsdatum • Ημερομηνία κατασκευής • Fecha de fabricación • Valmistuspäivämäärä • Date de fabrication • Data di fabbricazione • Productiedatum • Produksjonsdato • Data de fabrico • Data fabricării • Дата изготовления • Tillverkningsdatum

Manufacturer • Fabrikant • Hersteller • Κατασκευαστής • Fabricante • Valmistaja • Fabricant • Fabbricante • Fabrikant • Produsent • Fabricante • Producător • Производитель • Tillverkare

Serial number • Serienummer • Seriennummer • Αριθμός σειράς • Número de serie • Sarjanumero • Numéro de série • Numero di serie • Serienummer • Serienummer • Número de série • Număr de serie • Серийный номер • Serienummer

Catalog number • Katalognummer • Katalognummer • Αριθμός καταλόγου • Número de catálogo • Luettelonumero • Numéro de référence • Numero di catalogo • Catalogusnummer • Artikkelnummer • Número de catálogo • Număr de catalog • Номер по каталогу • Katalognummer

Authorized representative in the European Community • Autoriseret repræsentant i EU • Autorisierter Repräsentant in der Europäischen Gemeinschaft • Εξουσιοδοτημένος αντιπρόσωπος στην Ευρωπαϊκή Κοινότητα • Representante autorizado en la Comunidad Europea

• Valtuutettu edustaja Euroopan yhteisön alueella • Représentant autorisé dans la Communauté européenne • Rappresentante autorizzato nella Comunità europea • Geautoriseerd vertegenwoordiger in de Europese Gemeenschap • Autorisert representant i Det europeiske fellesskap • Representante autorizado na Comunidade Europeia • Reprezentant autorizat în Comunitatea Europeană • Уполномоченный представитель в Европейском сообществе • Auktoriserad representant inom EG

Manufactured in • Fremstillet i • Hergestellt in • Κατασκευάστηκε σε • Fabricado en • Valmistuspaikka • Lieu de fabrication • Fabbricato in

• Vervaardigd in • Produsert i • Fabricado em • Fabricat în • Произведено в • Tillverkad i

Figure 1. Intersept filtered cardiotomy reservoir 1351/CB1351 • Figur 1. Intersept kardiotomireservoir med filter 1351/CB1351 • Abbildung 1. Intersept Kardiotomiereservoir mit Filter 1351/CB1351 • Εικόνα 1. Δεξαμενή φιλτραρισμένου αίματος καρδιοτομής Intersept 1351/CB1351 •

Figura 1. Reservorio de cardiotomía con filtro Intersept 1351/CB1351 • Kuva 1. Suodattimellinen Intersept-kardiotomiasäiliö 1351/CB1351 • Figure 1. Réservoir de cardiotomie avec filtre Intersept 1351/CB1351 • Figura 1. Cardiotomo filtrato Intersept 1351/CB1351 • Afbeelding 1. Gefilterd

Intersept-cardiotomiereservoir 1351/CB1351 • Figur 1. Intersept-kardiotomireservoar med filter 1351/CB1351 • Figura 1. Reservatório de cardiotomia com filtro Intersept 1351/CB1351 • Figura 1. Rezervor de cardiotomie cu filtru Intersept 1351/CB1351 • Рисунок 1. Кардиотомный резервуар с фильтром Intersept 1351/CB1351 • Figur 1. Intersept kardiotomireservoar med filter 1351/CB1351

1 0.6 cm (0.25 in) nonfiltered prime port 2 0.6 cm (0.25 in) vent/vacuum port and vented cap 3 0.6 cm (0.25 in) filtered prime ports 4 0.6 cm (0.25 in) suction access ports

1 0,6 cm (0,25 in) primingport uden filter 2 0,6 cm (0,25 in) udluftnings-/vakuumport og udluftningshætte 3 0,6 cm (0,25 in) primingporte med filter 4 0,6 cm (0,25 in) sugeadgangsporte

1 0,6- cm(0,25- in)-Vorfüllanschluss ohne Filter 2 0,6- cm(0,25- in)-Entlüftungs-/Vakuumanschluss und

Entlüftungskappe 3 0,6- cm(0,25- in)-Vorfüllanschlüsse mit Filter 4 0,6- cm(0,25- in)-Saugleitungsanschlüsse

1 Θύρα πλήρωσης χωρίς φίλτρο 0,6 cm (0,25 in) 2 Θύρα εξαέρωσης/αρνητικής πίεσης 0,6 cm (0,25 in) και εξαεριζόμενο πώμα 3 Θύρες πλήρωσης με φίλτρο 0,6 cm (0,25 in) 4 Θύρες πρόσβασης αναρρόφησης 0,6 cm (0,25 in) 5 Πώματα γενικής χρήσης (8) 6 Στρώση αφαίρεσης αφρού και φυσαλίδων αίματος 7 Φίλτρο καλυμμένο με τρικό (tricot) χιτώνιο 8 Θύρα εξόδου 1,0 cm (0,39 in)

1 Puerto de cebado sin filtro de 0,6 cm (0,25 in) 2 Puerto de ventilación/vacío de 0,6 cm (0,25 in) y tapón ventilado 3 Puertos de cebado con filtro de 0,6 cm (0,25 in) 4 Puertos de acceso para succión de 0,6 cm (0,25 in) 5 Tapones universales (8) 6 Estrato desespumante 7 Filtro cubierto por funda de tricot 8 Puerto de salida de 1,0 cm (0,39 in)

1 0,6 cm:n (0,25 in) suodattimeton esitäyttöportti 2 0,6 cm:n (0,25 in) ilmaus-/alipaineportti ja ilmanpoistoaukollinen

suojus 3 0,6 cm:n (0,25 in) suodattimelliset esitäyttöportit 4 0,6 cm:n (0,25 in) imuliitäntäportit

1 Port d’amorçage sans filtre de 0,6 cm (0,25 in) 2 Port d’évent/d’aspiration de 0,6 cm (0,25 in) et capuchon d’évent 3 Ports d’amorçage avec filtre de 0,6 cm (0,25 in) 4 Ports d’accès d’aspiration de 0,6 cm (0,25 in)

1 Porta per il priming non filtrata da 0,6 cm (0,25 in) 2 Porta di sfiato/vuoto da 0,6 cm (0,25 in) e cappuccio con sfiato 3 Porte per il priming filtrate da 0,6 cm (0,25 in)

5 Universal caps (8) 6 Defoaming layer 7 Filter covered by tricot sleeve 8 1.0 cm (0.39 in) outlet port

5 Universalhætter (8) 6 Antiskumlag 7 Filter dækket af trikotmanchet 8 1,0 cm (0,39 in) udløbsport

5 Universalkappen (8) 6 Entschäumungsschicht 7 Mit Trikotstoffhülse bedeckter Filter 8 1,0- cm(0,39- in)-Ausgang

5 Yleissuojukset (8) 6 Vaahdonpoistokerros 7 Trikooholkilla peitetty suodatin 8 1,0 cm:n (0,39 in) poistoportti

5 Capuchons universels (8) 6 Couche démoussante 7 Filtre recouvert d’un manchon tricot 8 Port de sortie de 1,0 cm (0,39 in)

4 Porte di accesso per l’aspirazione da 0,6 cm (0,25 in) 5 Cappucci universali (8) 6 Strato antischiuma 7 Filtro coperto da guaina di tricot 8 Porta di uscita da 1,0 cm (0,39 in)

PT-PT

1 Ongefilterde vulpoort van 0,6 cm (0,25 in) 2 Ontluchtings-/vacuümpoort en ontluchtingskapje van 0,6 cm

(0,25 in) 3 Gefilterde vulpoorten van 0,6 cm (0,25 in) 4 Zuigpoorten van 0,6 cm (0,25 in)

1 0,6 cm (0,25 in) ikke-filtrert primingport 2 0,6 cm (0,25 in) ventilasjons-/vakuumport og ventilert hette 3 0,6 cm (0,25 in) filtrerte primingporter 4 0,6 cm (0,25 in) tilgangsporter for sug

1 Porta de enchimento sem filtro de 0,6 cm (0,25 in [pol.]) 2 Porta de ventilação/vácuo de 0,6 cm (0,25 in [pol.] ) e tampa ventilada 3 Portas de enchimento com filtro de 0,6 cm (0,25 in [pol.]) 4 Portas de acesso para aspiração de 0,6 cm (0,25 in) 5 Tampas universais (8) 6 Camada antiespumante 7 Filtro coberto com manga de tricô 8 Porta de saída de 1,0 cm (0,39 in [pol.])

1 Port de amorsă de 0,6 cm (0,25 in) fără filtru 2 Port de ventilare/vid și capac perforat de 0,6 cm (0,25 in) 3 Porturi de amorsă de 0,6 cm (0,25 in) cu filtru 4 Porturi de acces pentru aspiraţie de 0,6 cm (0,25 in) 5 Capace universale (8) 6 Strat de eliminare a spumei 7 Filtru acoperit cu manșon de tricot 8 Port de ieșire de 1,0 cm (0,39 in)

1 Порт заполнения без фильтра 0,6 cm (0,25 in) 2 Порт вентиляции/разрежения 0,6 cm (0,25 in) и колпачок с

отверстием 3 Порты заполнения с фильтром 0,6 cm (0,25 in) 4 Порты подключения отсоса 0,6 cm (0,25 in)

1 0,6 cm (0,25 in) fyllningsport utan filter 2 0,6 cm (0,25 in) avluftnings-/vakuumport och avluftningslock 3 0,6 cm (0,25 in) fyllningsportar med filter 4 0,6 cm (0,25 in) sugåtkomstportar

Figure 2. Setup • Figur 2. Opsætning • Abbildung 2. Einrichtung • Εικόνα 2. Συναρμολόγηση • Figura 2. Configuración • Kuva 2. Kokoonpano • Figure 2. Installation • Figura 2. Assemblaggio • Afbeelding 2. Opstelling • Figur 2. Klargjøring • Figura 2. Preparação • Figura 2. Configurarea • Рисунок 2. Настройка • Figur 2. Konfiguration

5 Universele kapjes (8) 6 Ontschuimende laag 7 Filter bedekt met tricot hoes 8 Uitlaatpoort van 1,0 cm (0,39 in)

5 Universalhetter (8) 6 Avskummingslag 7 Filter dekket av trikothylse 8 1,0 cm (0,39 in) utløpsport

5 Универсальные колпачки (8) 6 Слой пеногасителя 7 Фильтр, покрытый трикотажной муфтой 8 Выходной порт 1,0 cm (0,39 in)

5 Universallock (8) 6 Avskumningsskikt 7 Filter täckt med en trikåhylsa 8 1,0 cm (0,39 in) utloppsport

1 Chest drainage port (filtered prime port) 2 Second chest drainage port 3 0.6 cm (0.25 in) suction access ports 4 Shunt line 5 Infusion pump

6 1.0 cm (0.39 in) ID outlet port to 0.3 cm (0.12 in) ID infusion tubing 7 Vacuum line attached to vent/vacuum port 8 Chest tube drainage line 9 Nonfiltered prime port

1 Thoraxdrænport (primingport med filter) 2 Sekundær thoraxdrænport 3 0,6 cm (0,25 in) sugeadgangsporte 4 Shuntslange 5 Infusionspumpe

1 Thoraxdrainageanschluss (Vorfüllanschluss mit Filter) 2 Zweiter Thoraxdrainageanschluss 3 0,6- cm(0,25- in)-Saugleitungsanschlüsse 4 Shuntleitung 5 Infusionspumpe 6 Anschluss für Ausgang mit Innendurchmesser 1,0 cm (0,39 in) zu Infusionsschlauch mit Innendurchmesser 0,3 cm (0,12 in) 7 Am Entlüftungs-/Vakuumanschluss angeschlossene Vakuumleitung 8 Thoraxdrainageleitung 9 Vorfüllanschluss ohne Filter

1 Θύρα θωρακικής παροχέτευσης (θύρα πλήρωσης με φίλτρο) 2 Δεύτερη θύρα θωρακικής παροχέτευσης 3 Θύρες πρόσβασης αναρρόφησης 0,6 cm (0,25 in) 4 Γραμμή αναστόμωσης 5 Αντλία έγχυσης 6 Θύρα εξόδου εσωτερικής διαμέτρου 1,0 cm (0,39 in) προς σωλήνωση έγχυσης εσωτερικής διαμέτρου 0,3 cm (0,12 in) 7 Γραμμή αρνητικής πίεσης προσαρτημένη σε θύρα εξαέρωσης/αρνητικής πίεσης 8 Γραμμή θωρακικής παροχέτευσης 9 Θύρα πλήρωσης χωρίς φίλτρο

1 Puerto de drenaje torácico (puerto de cebado con filtro) 2 Puerto de drenaje torácico secundario 3 Puertos de acceso para succión de 0,6 cm (0,25 in) 4 Línea de derivación 5 Bomba de infusión 6 Puerto de salida de 1,0 cm (0,39 in) de DI a tubo de infusión de 0,3 cm (0,12 in) de DI 7 Línea de vacío conectada al puerto de ventilación/vacío 8 Línea de drenaje del tubo torácico 9 Puerto de cebado sin filtro

1 Pleuradreeniportti (suodattimellinen esitäyttöportti) 2 Toinen pleuradreeniportti 3 0,6 cm:n (0,25 in) imuliitäntäportit 4 Sunttiletku 5 Infuusiopumppu

1 Port de drainage thoracique (port d’amorçage avec filtre) 2 Second port de drainage thoracique 3 Ports d’accès d’aspiration de 0,6 cm (0,25 in) 4 Ligne de dérivation 5 Pompe de perfusion 6 Port de sortie de DI 1,0 cm (0,39 in) vers tubulure de perfusion de DI 0,3 cm (0,12 in) 7 Ligne d’aspiration attachée au port d’évent/d’aspiration 8 Ligne de drainage thoracique 9 Port d’amorçage sans filtre

1 Porta di drenaggio toracico (porta per il priming filtrata) 2 Seconda porta di drenaggio toracico 3 Porte di accesso per l’aspirazione da 0,6 cm (0,25 in) 4 Linea dello shunt 5 Pompa per infusione 6 Porta di uscita con diametro interno da 1,0 cm (0,39 in) a tubo di infusione con diametro interno da 0,3 cm (0,12 in) 7 Linea del vuoto collegata alla porta di sfiato/vuoto 8 Linea di drenaggio del tubo del torace 9 Porta per il priming non filtrata

1 Thoraxdrainagepoort (gefilterde vulpoort) 2 Tweede thoraxdrainagepoort 3 Zuigpoorten van 0,6 cm (0,25 in) 4 Shuntlijn 5 Infusiepomp

6 1,0 cm (0,39 in) ID-udløbsport til 0,3 cm (0,12 in) ID-infusionsslange 7 Vakuumslange, der er sluttet til udluftnings-/vakuumport 8 Pleuradræn 9 Primingport uden filter

6 Sisäläpimitaltaan 1,0 cm:n (0,39 in) poistoportti, johon liitetään

sisäläpimitaltaan 0,3 cm:n (0,12 in) infuusioletku 7 Alipaineletku, joka on liitetty ilmaus-/alipaineporttiin 8 Pleuradreeniletku 9 Suodattimeton esitäyttöportti

6 Uitlaatpoort-binnendiameter van 1,0 cm (0,39 in) naar

infusieslang-binnendiameter van 0,3 cm (0,12 in) 7 Vacuümlijn aangesloten op ontluchtings-/vacuümpoort 8 Thoraxdrainagelijn 9 Ongefilterde vulpoort

PT-PT

1 Brystdreneringsport (filtrert primingport) 2 Andre brystdreneringsport 3 0,6 cm (0,25 in) tilgangsporter for sug 4 Shuntslange 5 Infusjonspumpe

1 Porta de drenagem torácica (porta de enchimento com filtro) 2 Porta de drenagem torácica secundária 3 Portas de acesso para aspiração de 0,6 cm (0,25 in) 4 Linha de derivação (shunt) 5 Bomba de infusão 6 Porta de saída com 1,0 cm (0,39 in) de D.I. para tubo de infusão com D.I. de 0,3 cm (0,12 in) 7 Linha de vácuo ligada à porta de ventilação/vácuo 8 Linha de drenagem torácica 9 Porta de enchimento sem filtro

1 Port de drenaj toracic (port de amorsă cu filtru) 2 Al doilea port de drenaj toracic 3 Porturi de acces pentru aspiraţie de 0,6 cm (0,25 in) 4 Linie de derivaţie (șunt) 5 Pompă perfuzoare 6 Port de ieșire cu diametrul intern de 1,0 cm (0,39 in) la tubulatura perfuzoare cu diametrul intern de 0,3 cm (0,12 in) 7 Linie de vid atașată la portul de ventilare/vid 8 Linie de drenaj toracic 9 Port de amorsă fără filtru

1 Порт дренажа грудной клетки (порт заполнения с фильтром) 2 Второй порт дренажа грудной клетки 3 Порты подключения отсоса 0,6 cm (0,25 in) 4 Обводная линия 5 Инфузионный насос 6 Выходной порт с внутренним диаметром 1,0 cm (0,39 in) к инфузионной магистрали с внутренним диаметром 0,3 cm (0,12 in) 7 Линия отрицательного давления, подсоединенная к порту вентиляции/разрежения 8 Линия дренажа грудной клетки 9 Порт заполнения без фильтра

1 Port för thoraxdränage (fyllningsport med filter) 2 Andra port för thoraxdränage 3 0,6 cm (0,25 in) sugåtkomstportar 4 Shuntslang 5 Infusionspump

Figure 3. Setup with shunt activation • Figur 3. Opsætning med shuntaktivering • Abbildung 3. Einrichtung mit Shuntaktivierung • Εικόνα 3. Εγκατάσταση με ενεργοποίηση αναστόμωσης • Figura 3. Configuración con activación de derivación • Kuva 3. Kokoonpano suntin ollessa

käytössä • Figure 3. Installation avec activation de la dérivation • Figura 3. Assemblaggio con attivazione dello shunt • Afbeelding 3. Opstelling met shunt in gebruik • Figur 3. Oppsett med shuntaktivering • Figura 3. Montagem com derivação ativada • Figura 3. Configurarea cu activarea derivaţiei (șuntului) • Рисунок 3. Установка с активацией обхода • Figur 3. Konfiguration med shuntaktivering

6 Utløpsport med innvendig diameter på 1,0 cm (0,39 in) til

infusjonsslange med innvendig diameter på 0,3 cm (0,12 in) 7 Vakuumslange koblet til ventilasjons-/vakuumporten 8 Brystdreneringsslange 9 Ikke-filtrert primingport

6 Utloppsport med innerdiameter 1,0 cm (0,39 in) till infusionsslang

med innerdiameter 0,3 cm (0,12 in) 7 Vakuumslang fäst till avluftnings-/vakuumporten 8 Dränageslang för thoraxdränet 9 Fyllningsport utan filter

1 Chest drainage port (filtered prime port) 2 Second chest drainage port 3 0.6 cm (0.25 in) suction access ports 4 Shunt line 5 Infusion pump

6 1.0 cm (0.39 in) ID outlet port to 0.3 cm (0.12 in) ID infusion tubing 7 Vacuum line attached to vent/vacuum port 8 Chest tube drainage line 9 Nonfiltered prime port

1 Thoraxdrænport (primingport med filter) 2 Sekundær thoraxdrænport 3 0,6 cm (0,25 in) sugeadgangsporte 4 Shuntslange 5 Infusionspumpe

1 Pleuradreeniportti (suodattimellinen esitäyttöportti) 2 Toinen pleuradreeniportti 3 0,6 cm:n (0,25 in) imuliitäntäportit 4 Sunttiletku 5 Infuusiopumppu

1 Thoraxdrainagepoort (gefilterde vulpoort) 2 Tweede thoraxdrainagepoort 3 Zuigpoorten van 0,6 cm (0,25 in) 4 Shuntlijn 5 Infusiepomp

6 1,0 cm (0,39 in) ID-udløbsport til 0,3 cm (0,12 in) ID-infusionsslange 7 Vakuumslange, der er sluttet til udluftnings-/vakuumport 8 Pleuradræn 9 Primingport uden filter

6 Sisäläpimitaltaan 1,0 cm:n (0,39 in) poistoportti, johon liitetään

sisäläpimitaltaan 0,3 cm:n (0,12 in) infuusioletku 7 Alipaineletku, joka on liitetty ilmaus-/alipaineporttiin 8 Pleuradreeniletku 9 Suodattimeton esitäyttöportti

6 Uitlaatpoort-binnendiameter van 1,0 cm (0,39 in) naar

infusieslang-binnendiameter van 0,3 cm (0,12 in) 7 Vacuümlijn aangesloten op ontluchtings-/vacuümpoort 8 Thoraxdrainagelijn 9 Ongefilterde vulpoort

PT-PT

1 Brystdreneringsport (filtrert primingport) 2 Andre brystdreneringsport 3 0,6 cm (0,25 in) tilgangsporter for sug 4 Shuntslange 5 Infusjonspumpe

1 Port för thoraxdränage (fyllningsport med filter) 2 Andra port för thoraxdränage 3 0,6 cm (0,25 in) sugåtkomstportar 4 Shuntslang 5 Infusionspump

6 Utløpsport med innvendig diameter på 1,0 cm (0,39 in) til

infusjonsslange med innvendig diameter på 0,3 cm (0,12 in) 7 Vakuumslange koblet til ventilasjons-/vakuumporten 8 Brystdreneringsslange 9 Ikke-filtrert primingport

6 Utloppsport med innerdiameter 1,0 cm (0,39 in) till infusionsslang

med innerdiameter 0,3 cm (0,12 in) 7 Vakuumslang fäst till avluftnings-/vakuumporten 8 Dränageslang för thoraxdränet 9 Fyllningsport utan filter

1 Description

Model number Description

1351 Filtered cardiotomy reservoir CB1351 Filtered cardiotomy reservoir with Cortiva™ BioActive Surface

The Intersept filtered cardiotomy reservoir is a single-use device with a sterile, nonpyrogenic fluid path. The maximum capacity of each reservoir is 2600 mL. The maximum recommended flow rate is 2 L/min.

Each reservoir has eight 0.6 cm (0.25 in) ID access (luer) ports:

• 4 suction access ports

• 2 predefoamer access ports

• 2 postdefoamer access ports. One of the postdefoamer access ports is intended for use as a vent or a vacuum.

Note: The predefoamer access port labeled VENT/VACUUM is fitted with a yellow vented cap. All other access ports are fitted with nonventing universal caps. To convert a universal cap to a female luer fitting, twist the top portion of the cap completely off (clockwise). To provide an access port for 0.6 cm (0.25 in) ID tubing, turn the entire universal cap counterclockwise and remove.

Store the product at room temperature. Maximum transit temperature: Model 1351 50°C (122°F), Model CB1351 40°C (104°F).

1.1 Model 1351/CB1351

Each Intersept filtered cardiotomy reservoir, with or without Cortiva bioactive surface, contains an open cell polyurethane defoamer with a 20-micron microaggregate filter covered with a polyester sleeve.

Products coated with Cortiva bioactive surface include a “CB” prefix in the model number. Additional information regarding Cortiva bioactive surface is available in Chapter 7.

1.2 Accessories available separately

Model number

1358 Swivel holder

Description

2 Indications for use

2.1 Model 1351

The Intersept filtered cardiotomy reservoir is indicated for use in the cardiopulmonary bypass (CPB) circuit during surgery for:

• An air/fluid separation chamber

• A temporary storage reservoir for priming solution and blood

• The filtration of particulates from the bank blood and the storage and filtration of blood recovered from the field by suction

• The addition of medications or other fluids

The Intersept filtered cardiotomy reservoir is also indicated for use after open heart surgery for the postoperative collection of autologous blood from the chest and the aseptic return of blood to the patient for volume replacement.

2.2 Model CB1351

The Intersept filtered cardiotomy reservoir with Cortiva bioactive surface is indicated for use in the CPB circuit during surgery for:

• An air/fluid separation chamber

• A temporary storage reservoir for priming solution and blood

• The filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction

• The addition of medications or other fluids

3 Contraindications

Use the device only as indicated.

3.1 Model 1351

The Intersept filtered cardiotomy reservoir (Model 1351 only) is contraindicated for use in postoperative chest drainage or autotransfusion procedures when:

• There is an air leak in the lung or gross perforations to the chest wall exist

• A pericardial, mediastinal, pulmonary, or systemic infection or malignancy is present

• Gross contamination (for example, bone cement, lymphatic failure, or perforated intestine) is present or suspected

• Aspirating blood from a site containing topical hemostatic agents, bactericidal wound irritants, or antibiotics not intended for parenteral administration

• The chest is open and the vacuum is applied

• Protamine has been administered prior to the reservoir being removed from the bypass circuit

• The patient is returned to surgery for any reason

• Vented chest tubes not incorporating vent flow regulation, such as stopcock, are used

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Complications that have been associated with autotransfusion include blood trauma, blood coagulation, coagulopathies, and particulate or air embolism.

4 Warnings

Read all warnings, precautions, and instructions for use carefully before use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.

• Only persons thoroughly trained in CPB procedures should use this device. Perfusion must be carefully and constantly monitored.

• Each device is intended for single use only. Do not reuse or resterilize. Sterilized using ethylene oxide.

• To vent the reservoir, remove the yellow vented cap on the 0.6 cm (1/4 in) access port labeled VENT/VACUUM before use.

• The fluid pathway is sterile and nonpyrogenic. Inspect each package and device before use. Do not use the device if the package is opened or damaged, the device is damaged, or the protective caps are not in place.

• Use aseptic technique in all procedures.

• Attach the tubing in such a manner as to prevent kinks or restrictions that may alter blood flow.

• Do not allow alcohol, alcohol-based fluids, anesthetic liquids (such as isoflurane), or corrosive solvents (such as acetone) to come in contact with the device because they may jeopardize its structural integrity.

• If air bubbles or leaks are observed during priming or operation, these conditions may result in air embolism to the patient or fluid loss. Continually monitor the extracorporeal circuit. Do not use the device if these conditions are observed.

• Clear all gas emboli from the extracorporeal circuit before initiating bypass. Gas emboli are hazardous to the patient.

• A standby reservoir should always be available during perfusion.

• Pressurizing the cardiotomy reservoir could result in leakage or damage. The reservoir must be vented at all times when using a roller pump in the suction lines.

• If a vacuum source is being used, negative pressure should not exceed −200 mmHg.

• Blood that has been in the cardiotomy reservoir for 4 hours or more must not be reinfused.

4.1 Model 1351 Only

• The safe reinfusion of collected fluids and the assurance that fluids collected are safe for reinfusion is the responsibility of the attending physician.

• Chest drainage should be autotransfused on an hourly basis unless fewer than 50 mL of blood and fluid are collected hourly.

• If the filter occludes, nonfiltered blood may pass through the external shunt and enter the reservoir on the filtered side (Figure 3, number 1). If the chest drainage volume is excessive, nonfiltered blood may pass through the external shunt to the vent connector and back into the reservoir on the filtered side of the reservoir (Figure 3, number 2). Any drainage that has passed to the filtered side of the cardiotomy reservoir through the external shunt must be filtered before autotransfusion.

• A minimum reservoir level of 25 mL of blood should always be maintained to prevent passing an air embolus during reinfusion.

• It is not recommended that autotransfusion continue for more than 18 hours following surgery.

• Follow all accepted medical and nursing care routines for patients undergoing chest drainage.

5 Precautions

• The maximum recommended flow rate is 2 L/min.

• Band all tubing connections.

• Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.

• This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and create a risk of contamination of the device, which could result in patient injury, illness, or death.

• Dispose of the devices in accordance with local hospital, administrative, and other government policies.

• Additional warnings and precautions applicable to specific procedures can be found at appropriate places in the instructions for use.

6 Adverse effects

The following known adverse effects are associated with the use of the product: blood loss, coagulopathy, death, excessive blood component activation or thrombogenicity, exsanguination, hemolysis, hemolytic anemia, hypotension, hypovolemia, infection, ischemia, neurological dysfunction, and organ dysfunction.

7 Information for products with Cortiva bioactive surface

The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa1.

Caution: Product coated with Cortiva bioactive surface is intended for single use only. Resterilization may adversely affect the Cortiva bioactive surface. Caution: Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.

8 Instructions for use

8.1 Operating room - cardiopulmonary bypass

When using Model 1351 or Model CB1351 for CPB in the operating room, follow this procedure:

Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.

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1. Remove the device from the packaging carefully to ensure a sterile fluid pathway.

Warning: Use aseptic technique during all stages of setup and use of this device. Warning: Before removing the device from the packaging, inspect the packaging and product for damage. If the packaging or product is damaged,

do not use the device, as the sterility of the device may have been compromised and performance may be affected.

2. Place the cardiotomy reservoir in an Intersept cardiotomy reservoir holder. Note: The cardiotomy reservoir should be mounted high enough (30.5 cm to 91.5 cm [12 in to 36 in]) above the oxygenator or venous reservoir to

ensure adequate gravity flow. Adjust the height as necessary during priming and perfusion.

3. To vent the reservoir, remove the yellow vented cap on the 0.6 cm (0.25 in) access port labeled VENT/VACUUM before use. A spare yellow nonvented luer connecting cap has been placed on the side of the unit for your convenience. If the cap is used as a luer connection site, ensure that the opening is complete and free of debris after twisting the top off of the cap.

Warning: Ensure that the vent port is open and vented. Failure to properly vent the port could result in air being introduced into the bypass circuit, causing serious injury or death to the patient.

Note: Do not open unused access ports.

4. Remove the protective cap from the outlet port at the bottom of the cardiotomy reservoir. Attach an appropriate length of 1.0 cm (0.39 in) ID tubing from the outlet port on the cardiotomy reservoir to the cardiotomy return port on the oxygenator inlet or venous reservoir.

5. Remove the universal cap from one of the suction access ports. Connect a 0.6 cm (0.25 in) ID cardiotomy suction line to the suction access port. Repeat this procedure for additional suction lines.

8.2 Operating room - postbypass chest drainage conversion

This procedure applies to Model 1351 only. The Intersept filtered cardiotomy reservoir may be converted after bypass to an autotransfusion system to recover blood from the chest. Autotransfusion

may be initiated after the patient reaches the intensive care unit, final setup is completed, and the hourly drainage rate is established. To convert the Intersept filtered cardiotomy reservoir to an autotransfusion system:

1. Remove the device from the packaging carefully to ensure a sterile fluid pathway.

do not use the device, as the sterility of the device may have been compromised and performance may be affected.

2. Place the reservoir in a holder on an IV pole, subthoracic to the patient, until ready for transfer to the ICU or CCU.

3. Using aseptic technique, carefully remove tubing from suction access ports (Figure 2, number 3 or Figure 3, number 3). Seal 3 of these ports with sterile (0.6 cm [0.25 in] ID) occluding plugs.

4. Remove tubing (if applicable) or the universal cap from the nonfiltered prime port (Figure 1, number 1; Figure 2 number 9; or Figure 3, number 9).

5. Attach sterile 0.6 cm (0.25 in) ID tubing to form a shunt (Figure 2, number 4 or Figure 3, number 4) between the 1 remaining unplugged suction access port (Figure 2, number 3 or Figure 3, number 3) and the nonfiltered prime port (Figure 2, number 9 or Figure 3, number 9).

6. Convert the 1.0 cm (0.39 in) ID outlet port to 0.3 cm (0.12 in) ID infusion tubing (Figure 2, number 6 or Figure 3, number 6) to permit connection to standard intravenous tubing for reinfusion.

7. Attach sterile 0.6 cm (0.25 in) ID tubing and a sterile 0.6 x 1.0 cm (0.25 x 0.39 in) connector to a filtered prime port (Figure 2, number 1 or Figure 3, number 1). Plug the unused port (Figure 2, number 2 or Figure 3, number 2).

8. Attach the chest drainage blood tubing (Figure 2, number 8 or Figure 3, number 8) from the chest to the 0.6 x 1.0 cm (0.25 x 0.39 in) connector on the filtered prime port (Figure 2, number 1 or Figure 3, number 1).

9. Using sterile tubing, connect the vent/vacuum port (Figure 2, number 7 or Figure 3, number 7) on the top of the unit to a vacuum source with approximately 11 mmHg to 15 mmHg of regulated vacuum.

Important: Use of a water seal device is recommended in all chest drainage cases.

8.3 Intensive care unit

This section applies to Model 1351 only.

1. Remove the device from the packaging carefully to ensure a sterile fluid pathway.

Warning: Use aseptic technique during all stages of setup and use of this device. Warning: Before removing the device from the packaging, inspect the packaging and the product for damage. If the packaging or product is

damaged, do not use the device as sterility of the device may have been compromised and performance may be affected.

2. Attach the cardiotomy reservoir holder to an IV pole and place the cardiotomy reservoir in the holder. Place the infusion pump (Figure 2, number 5 or Figure 3, number 5) on an IV pole.

3. Adjust the level of the cardiotomy reservoir to a subthoracic level. Maintain the cardiotomy reservoir at a subthoracic level to facilitate chest tube drainage.

4. Connect the chest tube drainage line (Figure 2, number 8 or Figure 3, number 8) to the chest drainage port.

5. Record the amount of drainage in the cardiotomy reservoir. Continually monitor drainage to determine the hourly drainage rate.

6. Using sterile tubing, connect the vent/vacuum port (Figure 2, number 7 or Figure 3, number 7) on the top of the unit to a vacuum source with approximately 11 mmHg to 15 mmHg of regulated vacuum.

7. Ensure that all of the unused inlet ports on the cardiotomy reservoir are covered with airtight caps.

8. As soon as the cardiotomy reservoir contains 50 mL of chest tube drainage, set up and prime the infusion pump tubing per the standard procedure.

9. Monitor the hourly rate of drainage.

10. Refer to the infusion pump manufacturer’s instructions for infusion of cellular fluids.

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11. Autotransfuse drainage collected in the cardiotomy reservoir on an hourly basis after assessment of the hourly drainage rate and the hemodynamic status of the patient.

9 Additional information

The following additional information and data are available upon request: sterilization method, materials of the blood pathway, blood cell damage, air-handling capability, antifoam characteristics, breakthrough volume, filtration efficiency, relevant tolerances for data in the instructions for use, protocol summaries, and test methods used to determine coverage, leaching, and bioactivity.

10 Important notice – limited warranty (US customers only)

A. This LIMITED WARRANTY provides the following assurances to the patient who receives an Intersept filtered cardiotomy reservoir, hereafter

referred to as the “Product”:

(1) Should the Product fail to function within normal tolerances due to a defect in materials or workmanship prior to its Use-by date, Medtronic will,

at its option: (a) issue a credit to the purchaser equal to the purchase price, as defined in Subsection A(2), against the purchase of the replacement Product or (b) provide a functionally comparable replacement Product at no charge.

(2) As used herein, purchase price shall mean the lesser of the net invoiced price of the original, or current functionally comparable, or

replacement Product.

B. To qualify for the LIMITED WARRANTY, these conditions must be met:

(1) The Product must be used prior to its Use-by date. (2) The unused portion of the Product must be returned to Medtronic and shall be the property of Medtronic. (3) The Product must not have been altered or subjected to misuse, abuse, or accident. (4) The Product must be used in accordance with the labeling and Instructions for Use provided with the Product.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) Except as expressly provided by this LIMITED WARRANTY, Medtronic is not responsible for any direct, incidental, or consequential

damages based on any defect, failure, or malfunction of the product, whether the claim is based on warranty, contract, tort, or otherwise.

(2) THIS LIMITED WARRANTY IS MADE ONLY TO THE PATIENT IN WHOM THE PRODUCT WAS USED. AS TO ALL OTHERS, MEDTRONIC

MAKES NO WARRANTY, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOMER, OR OTHERWISE. NO EXPRESS OR IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON.

(3) The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of

applicable law. If any part or term of this LIMITED WARRANTY is held to be illegal, unenforceable, or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid. This LIMITED WARRANTY gives the patient specific legal rights. The patient may also have other rights which vary from state to state.

(4) No person has any authority to bind Medtronic to any representation, condition, or warranty except this LIMITED WARRANTY.

Note: This LIMITED WARRANTY is provided by Medtronic, 710 Medtronic Parkway, Minneapolis, MN 55432. It applies only in the United States. Areas outside the United States should contact their local Medtronic representative for exact terms of the LIMITED WARRANTY.

11 Important notice – limited warranty (for countries outside the US)

Important: This limited warranty does not apply in Australia.

A. This LIMITED WARRANTY provides assurances for the purchaser who receives an Intersept filtered cardiotomy reservoir,hereafter referred to as

the “Product”, that, should the Product fail to function to specification, Medtronic will issue a credit, equal to the original Product purchase price (but not to exceed the value of the replacement Product) against the purchase of any Medtronic replacement Product used for that patient. The Warnings contained in the product labeling are considered an integral part of this LIMITED WARRANTY. Contact your local Medtronic representative to obtain information on how to process a claim under this LIMITED WARRANTY.

B. To qualify for the LIMITED WARRANTY, these conditions must be met:

(1) The Product must be used prior to its Use-by date. (2) The Product must be returned to Medtronic within 60 days after use and shall be the property of Medtronic. (3) The Product may not have been used for any other patient.

C. This LIMITED WARRANTY is limited to its express terms. In particular:

(1) In no event shall any replacement credit be granted where there is evidence of improper handling, improper implantation, or material alteration

of the replaced Product.

(2) Medtronic is not responsible for any incidental or consequential damages based on any use, defect, or failure of the Product, whether the claim

is based on warranty, contract, tort, or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of

applicable law. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

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1 Beskrivelse

Modelnummer Beskrivelse

1351 Kardiotomireservoir med filter CB1351 Kardiotomireservoir med filter med Cortiva™ BioActive-overflade

Intersept kardiotomireservoir med filter er en enhed beregnet til engangsbrug med en steril, ikke-pyrogen væskebane. Hvert reservoirs maksimale kapacitet er 2600 mL. Den anbefalede maksimumgennemløbshastighed er 2 L/min.

Hvert reservoir har otte 0,6 cm (0,25 in) ID-adgangsporte (luer):

• 4 sugeadgangsporte

• 2 adgangsporte til brug før antiskummiddel

• 2 adgangsporte til brug efter antiskummiddel. En af adgangsportene til brug efter antiskummiddel er beregnet til brug som en udluftning eller et vakuum.

Bemærk: Der hører en gul udluftningshætte til adgangsporten, mærket VENT/VACUUM (UDLUFTNING/VAKUUM), til brug før antiskummidlet. Alle andre adgangsporte er udstyret med ikke-ventilerende universalhætter. Hvis du vil ændre en universalhætte til et luer-hunstik, skal du dreje den øverste del af hætten helt af (med uret). Hvis du vil have en adgangsport til 0,6 cm (0,25 in) ID-slange, skal du dreje hele universalhætten imod uret og fjerne den.

Produktet skal opbevares ved stuetemperatur. Maksimal temperatur under transport: model 1351 50°C (122°F), model CB1351 40°C (104°F).