ARCTIC FRONT ADVANCE™ 2AF233 & 2AF283

M949606A_fc.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
ARCTIC FRONT ADVANCE™
2AF233 & 2AF283
Cardiac CryoAblation Catheter
Cathéter de cryoablation cardiaque
Kardialer Kryoablationskatheter
Catéter de crioablación cardíaca
Cardiale Cryoablatiekatheter
Catetere per crioablazione cardiaca
Kardialt kryoablasjonskateter
Cardiac CryoAblation-kateter
Καρδιακός καθετήρας κρυοκατάλυσης
Kardielt kryoablations-kateter
Cateter cardíaco de crioablação
Kardiális krioablációs katéter
Cewnik do krioablacji serca
Srdeční katétr pro kryoablaci
Катетер для внутрисердечной криоабляции
Kardiálny kryoablačný katéter
Kardiyak CryoAblasyon Kateteri
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_fc.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
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.
La liste suivante comprend des marques commerciales ou des marques
déposées de Medtronic aux États-Unis et éventuellement dans d'autres pays.
Toutes les autres marques sont la propriété de leurs détenteurs respectifs.
Die folgende Liste enthält Marken oder eingetragene Marken von Medtronic in
den USA und möglicherweise auch in anderen Ländern. Alle anderen Marken
sind Eigentum ihrer jeweiligen Inhaber.
La siguiente lista contiene marcas comerciales o marcas comerciales
registradas de Medtronic en Estados Unidos y posiblemente en otros países.
Todas las demás marcas comerciales son propiedad de sus respectivos
propietarios.
Onderstaande termen zijn 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.
L'elenco seguente comprende i marchi o i marchi registrati di Medtronic negli
Stati Uniti e in altri Paesi. Tutti gli altri marchi sono di proprietà dei rispettivi
titolari.
Den følgende listen inneholder varemerker eller registrerte varemerker for
Medtronic i USA og eventuelt i andre land. Alle andre varemerker tilhører sine
respektive eiere.
Följande lista omfattar varumärken eller registrerade varumärken som tillhör
Medtronic i USA och möjligen i andra länder. Alla övriga varumärken tillhör
respektive innehavare.
Η ακόλουθη λίστα περιλαμβάνει εμπορικά σήματα ή σήματα κατατεθέντα της
Medtronic στις Ηνωμένες Πολιτείες και πιθανώς σε άλλες χώρες. Όλα τα άλλα
εμπορικά σήματα αποτελούν ιδιοκτησία των αντίστοιχων κατόχων τους.
Følgende liste indeholder varemærker eller registrerede varemærker tilhørende
Medtronic i USA og muligvis andre lande. Alle andre varemærker tilhører de
respektive ejere.
A lista seguinte inclui marcas comerciais ou marcas comerciais registadas da
Medtronic nos EUA e, possivelmente, noutros países. Todas as outras marcas
comerciais são propriedade dos respectivos detentores.
A következő felsorolásban a Medtronic védjegyei vagy bejegyzett védjegyei
szerepelnek, az Egyesült Államokra és esetleg más országokra vonatkozóan
is. Minden egyéb védjegy a megfelelő védjegytulajdonos tulajdona.
Poniższa lista zawiera znaki towarowe lub zastrzeżone znaki towarowe firmy
Medtronic w Stanach Zjednoczonych i ewentualnie w innych krajach.
Wszystkie pozostałe znaki towarowe są własnością odpowiednich podmiotów.
Následující seznam obsahuje ochranné známky nebo registrované ochranné
známky společnosti Medtronic v USA a případně v jiných zemích. Všechny
ostatní ochranné známky jsou majetkem příslušných vlastníků.
Следующий перечень включает товарные знаки или зарегистрированные
товарные знаки корпорации Medtronic в США и, возможно, в других
странах. Все другие товарные знаки являются собственностью их
владельцев.
Nasledovný zoznam obsahuje ochranné známky alebo registrované ochranné
známky spoločnosti Medtronic v USA a prípadne v iných krajinách. Všetky
ostatné ochranné známky sú majetkom ich príslušných vlastníkov.
Aşağıdaki listede, Medtronic şirketinin Amerika Birleşik Devletleri ve
muhtemelen diğer ülkelerdeki ticari markaları veya tescilli ticari markaları
bulunmaktadır. Diğer ticari markaların tümü ilgili sahiplerinin mülkiyetindedir.
Achieve, Arctic Front, Arctic Front Advance, FlexCath, Medtronic
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
Explanation of symbols / Explication des symboles / Erläuterung der
Symbole / Explicación de los símbolos / Verklaring van de symbolen /
Simboli utilizzati / Symbolforklaring / Förklaring av symboler /
Επεξήγηση των συμβόλων / Symbolforklaring / Explicação dos
símbolos / A szimbólumok magyarázata / Objaśnienia symboli /
Vysvětlení symbolů / Объяснение символов / Vysvetlivky k symbolom /
Sembollerin açıklaması
Refer to the package labels to see which of the following symbols apply to this product / Se reporter aux
étiquettes de l'emballage pour voir quels symboles parmi les suivants s'appliquent à ce produit. / Nur die auf
den Verpackungsetiketten aufgedruckten Symbole der nachfolgenden Auflistung gelten für dieses Produkt. /
Consulte las etiquetas del envase para comprobar qué símbolos se aplican a este producto. / Controleer het
verpakkingslabel om te zien welke van onderstaande symbolen op dit product van toepassing zijn / Fare
riferimento alle etichette sulla confezione per vedere quali dei seguenti simboli si applicano a questo prodotto. /
Se på pakningsetikettene for å finne ut hvilke symboler som gjelder for dette produktet / Se
förpackningsetiketterna för de symboler som gäller denna produkt / Ανατρέξτε στις σημάνσεις της συσκευασίας
για να δείτε ποια από τα ακόλουθα σύμβολα ισχύουν για το παρόν προϊόν / Se mærkaterne på emballagen for
at se, hvilke af følgende symboler der gælder for dette produkt / Consulte as etiquetas da embalagem para ver
quais dos símbolos seguintes se aplicam a este produto. / A termékre vonatkozó szimbólumok a külső
csomagoláson találhatók. / Aby stwierdzić, które symbole dotyczą niniejszego produktu, należy zapoznać się
z etykietami na opakowaniu / Symboly týkající se tohoto výrobku naleznete na štítcích na obalu / См. на
этикетках упаковки, какие символы применимы к данному продукту. / Prezrite si označenie na obale a
zistite, ktoré z nasledovných symbolov sa vzťahujú na tento produkt / Bu üründe aşağıdaki sembollerden
hangilerinin geçerli olduğunu görmek için ambalaj etiketlerine bakın.
Lot number / Numéro de lot / Losnummer / Número de
lote / Partijnummer / Numero di lotto / Lotnummer /
Lotnummer / Αριθμός παρτίδας / Partinummer / Número
de lote / Gyártási szám / Numer partii produkcyjnej / Číslo
šarže / Номер партии / Číslo šarže / Lot numarası
Reorder number / Numéro de commande /
Bestellnummer / Número de referencia / Bestelnummer /
Numero di riordine / Bestillingsnummer /
Återbeställningsnummer / Αριθμός νέας παραγγελίας /
Genbestillingsnummer / Número para nova encomenda /
Utánrendelési szám / Numer do ponownego zamawiania /
Číslo pro novou objednávku / Номер для заказа / Číslo
pre ďalšie objednávky / Yeniden sipariş numarası
Use by / À utiliser jusqu'au / Zu verwenden bis
einschließlich / Fecha de caducidad / Te gebruiken tot en
met / Data di scadenza / Siste forbruksdag / Använd före /
Χρήση έως / Anvendes inden / Não utilizar depois de /
Lejárat / Termin przydatności do użycia / Datum
použitenosti / Срок годности / Dátum najneskoršej
spotreby / Son kullanma tarihi
Sterilized using ethylene oxide / Stérilisation par oxyde
d'éthylène / Sterilisiert mittels Ethylenoxid / Esterilizado
mediante óxido de etileno / Gesteriliseerd met
ethyleenoxide / Metodo di sterilizzazione: ossido di
etilene / Sterilisert med etylenoksid / Steriliserad med
etylenoxid / Αποστειρωμένο με οξείδιο του αιθυλενίου /
Steriliseret med ethylenoxid / Esterilizado com óxido de
etileno / Etilén-oxiddal sterilizálva / Produkt sterylizowany
tlenkiem etylenu / Sterilizováno ethylenoxidem /
Стерилизовано с использованием этиленоксида /
Sterilizované etylénoxidom / Etilen oksit kullanılarak
sterilize edilmiştir
Do not reuse / Ne pas réutiliser / Nicht wiederverwenden /
No reutilizar / Niet opnieuw gebruiken / Monouso / Skal
ikke brukes flere ganger / Får ej återanvändas / Μην το
επαναχρησιμοποιείτε / Må ikke genbruges / Não
reutilizável / Kizárólag egyszeri használatra / Nie używać
powtórnie / Nepoužívejte opakovaně / Не подлежит
повторному использованию / Nepoužívajte opakovane /
Yeniden kullanmayın
Do not resterilize / Ne pas restériliser / Nicht
resterilisieren / No reesterilizar / Niet hersteriliseren / Non
risterilizzare / Skal ikke resteriliseres / Får ej
omsteriliseras / Μην το επαναποστειρώνετε / Må ikke
resteriliseres / Não reesterilizar / Ne sterilizálja újra / Nie
resterylizować / Neprovádějte resterilizaci / Не подлежит
повторной стерилизации / Opakovane nesterilizujte /
Yeniden sterilize etmeyin
Do not use if package is damaged / Ne pas utiliser si
l'emballage est endommagé / Darf bei beschädigter
Verpackung nicht verwendet werden / No usar si el
envase está dañado / Niet gebruiken als de verpakking
beschadigd is / Non utilizzare se la confezione è
danneggiata / Skal ikke brukes hvis pakningen er skadet /
Får ej användas om förpackningen är skadad / Μην το
χρησιμοποιείτε εάν η συσκευασία έχει υποστεί βλάβη / Må
ikke anvendes, hvis emballagen er beskadiget / Não
utilizar se a embalagem estiver danificada / Sérült
csomagolás esetén nem használható / Nie używać, jeśli
opakowanie jest uszkodzone / Nepoužívejte, pokud je
balení poškozeno / Не использовать, если упаковка
повреждена / Nepoužívajte, ak je obal poškodený /
Ambalaj hasar görmüşse kullanmayın
Package contents / Contenu de l'emballage /
Packungsinhalt / Contenido del envase / Inhoud van de
verpakking / Contenuto della confezione / Pakningens
innhold / Förpackningens innehåll / Περιεχόμενα
συσκευασίας / Pakkens indhold / Conteúdo da
embalagem / A csomag tartalma / Zawartość
opakowania / Obsah balení / Содержимое упаковки /
Obsah balenia / Ambalaj içeriği
Cardiac CryoAblation Catheter / Cathéter de cryoablation
cardiaque / Kardialer Kryoablationskatheter / Catéter de
crioablación cardíaca / Cardiale Cryoablatiekatheter /
Catetere per crioablazione cardiaca / Kardialt
kryoablasjonskateter / Cardiac CryoAblation-kateter /
Καρδιακός καθετήρας κρυοκατάλυσης / Kardielt
kryoablations-kateter / Cateter cardíaco de crioablação /
Kardiális krioablációs katéter / Cewnik do krioablacji
serca / Srdeční katétr pro kryoablaci / Катетер для
внутрисердечной криоабляции / Kardiálny kryoablačný
katéter / Kardiyak CryoAblasyon Kateteri
Consult instructions for use / Consulter le mode d'emploi /
Gebrauchsanweisung lesen / Consultar las instrucciones
de uso / Raadpleeg gebruiksaanwijzing / Consultare le
istruzioni per l'uso / Se i bruksanvisningen / Se
bruksanvisning / Συμβουλευτείτε τις οδηγίες χρήσης / Se
brugsanvisningen / Consultar instruções de utilização /
Lásd a használati útmutatót / Zapoznać się z instrukcją
użytkowania / Viz návod k použití / См. инструкцию по
эксплуатации / Pozrite si pokyny na používanie /
Kullanım talimatlarına başvurun
Fragile: handle with care / Fragile : À manipuler avec
précaution / Zerbrechlich: Mit Vorsicht behandeln! / Frágil:
manipular con cuidado / Breekbaar: voorzichtig hanteren /
Fragile: maneggiare con cura / Skal behandles med
forsiktighet / Ömtåligt: hanteras varsamt / Εύθραυστο:
χειριστείτε το με προσοχή / Skrøbeligt: Håndteres med
forsigtighed / Frágil: manusear com cuidado / Törékeny:
óvatosan kezelendő / Ostrożnie: produkt delikatny /
Křehké: manipulujte opatrně / Хрупкое изделие:
обращаться с осторожностью / Krehké: manipulujte s
opatrnosťou / Kırılabilir: dikkatle taşıyın
v
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
Keep dry / À conserver au sec / Trocken aufbewahren /
Mantener seco / Droog bewaren / Proteggere
dall'esposizione a condizioni climatiche avverse / Holdes
tørr / Förvaras torrt / ∆ιατηρήστε το στεγνό / Holdes tør /
Manter em local seco / Szárazon tartandó / Utrzymywać
w stanie suchym / Udržujte v suchu / Хранить в сухом
месте / Uschovajte v suchu / Kuru bir ortamda tutun
Product documentation / Documentation du produit /
Produktdokumentation / Documentación del producto /
Productdocumentatie / Documentazione del prodotto /
Produktdokumentasjon / Produktdokumentation /
Τεκμηρίωση προϊόντος / Produktdokumentation /
Documentação do produto / Termékdokumentáció /
Dokumentacja produktu / Průvodní dokumentace /
Документация по продукту / Dokumentácia k produktu /
Ürünle ilgili belgeler
Storage/transit temperature / Température de
stockage/transport / Temperatur bei Lagerung/Transport /
Temperatura de almacenamiento/transporte /
Opslag/transporttemperatuur / Temperatura di
conservazione/trasporto / Temperatur ved
oppbevaring/forsendelse /
Förvarings-/transporttemperatur / Θερμοκρασία
αποθήκευσης/μεταφοράς /
Opbevarings-/transporttemperatur / Temperatura de
armazenamento/transporte / Tárolási/szállítási
hőmérséklet / Temperatura przechowywania/transportu /
Teplota skladování/přepravy / Температура хранения /
транспортировки / Skladovacia teplota/teplota pri
preprave / Saklama/aktarma sıcaklığı
Open here / Ouvrir ici / Hier öffnen / Abrir aquí / Hier
openen / Aprire qui / Åpnes her / Öppnas här / Ανοίξτε
εδώ / Åbn her / Abrir aqui / Itt nyílik / Otwierać tutaj / Zde
otevřete / Открывать здесь / Tu otvoriť / Buradan açın
Use with / À utiliser avec / Verwenden mit / Usar con /
Gebruiken met / Utilizzare con / Brukes med / Används
tillsammans med / Χρήση με / Anvendes sammen med /
Utilizar com / Termékek, amelyekkel együtt használható /
Używać z / Používejte s / Использовать с / Použite s /
Birlikte kullanılır
Manufacturer / Fabricant / Hersteller / Fabricante /
Fabrikant / Produttore / Produsent / Tillverkare /
Κατασκευαστής / Fabrikant / Fabricante / Gyártó /
Producent / Výrobce / Производитель / Výrobca /
İmalatçı
Authorized representative in the European community /
Représentant agréé dans la Communauté européenne /
Autorisierter Repräsentant in der Europäischen
Gemeinschaft / Representante autorizado en la
Comunidad Europea / Geautoriseerd vertegenwoordiger
in de Europese Gemeenschap / Rappresentante
autorizzato nella Comunità europea / Autorisert
representant i Det europeiske fellesskap / Auktoriserad
representant inom EG / Εξουσιοδοτημένος
αντιπρόσωπος στην Ευρωπαϊκή Κοινότητα / Autoriseret
repræsentant i EF / Representante autorizado na
Comunidade Europeia / Meghatalmazott képviselő az
Európai Közösségben / Autoryzowany przedstawiciel we
Wspólnocie Europejskiej / Autorizovaný zástupce pro
Evropské společenství / Официальный представитель в
ЕС / Autorizovaný zástupca v Európskom spoločenstve /
Avrupa topluluğundaki yetkili temsilci
Conformité Européenne (European Conformity)
This symbol means that the device fully complies with
European Directive 93/42/EEC.
Conformité européenne
Ce symbole signifie que le dispositif est entièrement
conforme à la directive européenne 93/42/CEE.
Conformité Européenne (Europäische Konformität)
Dieses Symbol besagt, dass das Produkt allen
Vorschriften der europäischen Richtlinie 93/42/EWG
entspricht.
Conformité Européenne (Conformidad Europea)
Este símbolo indica que el dispositivo cumple totalmente
la Directiva Europea 93/42/CEE.
Conformité Européenne (Europese Conformiteit).Dit
symbool betekent dat het product volledig voldoet aan de
Europese Richtlijn 93/42/EEG.
Conformité Européenne (Conformità Europea)
Questo simbolo significa che il dispositivo è conforme alla
Direttiva Europea 93/42/CEE.
Conformité Européenne (samsvar med europeisk
standard)
Dette symbolet betyr at enheten er fullstendig i samsvar
med EU-direktiv 93/42/EØF.
Conformité Européenne (europeisk standard)
Denna symbol betyder att utrustningen helt följer rådets
direktiv 93/42/EEG.
Conformité Européenne (Ευρωπαϊκή Συμμόρφωση)
Το σύμβολο αυτό σημαίνει ότι το προϊόν συμμορφώνεται
πλήρως με την Ευρωπαϊκή Οδηγία 93/42/EOK.
Conformité Européenne (Europæisk standard)
Dette symbol betyder, at enheden opfylder kravene
i det Europæiske Råds Direktiv 93/42/EØF.
Conformité Européenne (Conformidade Europeia).
Este símbolo significa que o dispositivo está em total
conformidade com a Directiva Europeia 93/42/CEE.
Conformité Européenne (Európai megfelelőség)
Ez a szimbólum azt jelenti, hogy az eszköz teljes
mértékben megfelel a 93/42/EGK jelű európai irányelvnek
Conformité Européenne (zgodność z normami Unii
Europejskiej)
Ten symbol oznacza, że urządzenie spełnia wszystkie
wymogi wynikające z europejskiej dyrektywy 93/42/EWG.
Conformité Européenne (Evropská shoda)
Tento symbol znamená, že zařízení zcela splňuje
požadavky směrnice Rady 93/42/EHS.
Conformité Européenne (Европейское соответствие)
Этот символ обозначает, что устройство полностью
соответствует требованиям Европейской
директивы 93/42/EEC.
Conformité Européenne (Zhoda s požiadavkami EÚ)
Tento symbol znamená, že zariadenie úplne vyhovuje
požiadavkám uvedeným v smernici 93/42/EHS.
Conformité Européenne (Avrupa Normlarına Uygunluk)
Bu sembol, cihazın 93/42/EEC sayılı Avrupa Direktifine
tam olarak uygun olduğunu ifade eder.
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
1 Description
The Arctic Front Advance Cardiac CryoAblation Catheter (Arctic Front Advance
Cryoballoon) is a flexible, over-the-wire balloon catheter used to ablate cardiac tissue. It is
used together with the FlexCath Steerable Sheath (FlexCath sheath), the CryoConsole, and
related components. The balloon reaches cryoablation temperatures when refrigerant is
injected from the CryoConsole to the balloon segment. A thermocouple positioned inside the
balloon provides temperature reading capability. The catheter is introduced into the
vasculature by traditional minimally invasive techniques.
1.1 Radiopaque markers
There are two radiopaque markers on the balloon catheter and one radiopaque marker on
the FlexCath sheath to confirm the position of the balloon using fluoroscopy. The proximal
radiopaque marker is located approximately 10 mm (0.394 in) proximal to the balloon. The
distal radiopaque marker is located at the end of the injection tube. There is also one
radiopaque marker located approximately 5 mm (0.197 in) proximal to the tip of the sheath
(see Figure 1). When the proximal radiopaque marker and the sheath radiopaque marker
are aligned, the balloon is approximately 5 mm (0.197 in) outside of the sheath.
1.2 Shaft markers
There are two shaft markers on the proximal section of the catheter shaft to visually confirm
the position of the balloon within the FlexCath sheath. When the distal marker on the shaft
of the balloon catheter is aligned with the handle of the sheath, the balloon segment is
located inside the sheath. When the proximal marker on the shaft of the balloon catheter is
aligned with the handle of the sheath, the balloon segment is outside the sheath (see
Figure 1).
3
4
2
1
6
1
2
3
5
Distal catheter radiopaque marker
Deflated balloon segment
Proximal catheter radiopaque marker
4
5
6
Sheath radiopaque marker
Proximal catheter shaft marker
Distal catheter shaft marker
Figure 1. Arctic Front Advance Cardiac CryoAblation Catheter
The Arctic Front Advance Cryoballoon is available in 2 models, as described in the following
table:
Model
Inflated balloon diameter
2AF233
23 mm (0.91 in)
2AF283
28 mm (1.10 in)
For details about the CryoConsole and how to use it with the catheter to perform cryoablation
procedures, see the CryoConsole Operator’s Manual.
1.3 Contents of package
The catheter is supplied sterile. The package contains the following items:
1 Arctic Front Advance Cardiac CryoAblation Catheter
product documentation
■
■
2 Indications for use
The Arctic Front Advance Cardiac CryoAblation Catheter is intended for the treatment of
patients suffering from paroxysmal atrial fibrillation (PAF). Adjunct devices (Freezor MAX)
can be used with Arctic Front Advance Cryoballoon in the treatment of PAF.
3 Contraindications
The Arctic Front Advance Cardiac CryoAblation Catheter is contraindicated as follows:
in the ventricle because of the danger of catheter entrapment in the chordae tendineae
in patients with active systemic infections
in conditions where the manipulation of the catheter within the heart would be unsafe (for
example, intracardiac mural thrombus)
in patients with cryoglobulinemia
in patients with one or more pulmonary vein stents
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4 Warnings and precautions
Anticoagulation therapy – Administer appropriate levels of peri-procedural
anticoagulation therapy for patients undergoing left-sided and transseptal cardiac
procedures. Administer anticoagulation therapy during and post-procedure according to the
institution's standards.The Arctic Front Advance Cryoballoon was not studied for the safety
of changes in anticoagulation therapy in patients with paroxysmal atrial fibrillation.
Balloon inflation or deflation – If the balloon cannot be inflated or deflated using the
CryoConsole, have a Manual Retraction Kit on hand during the procedure. (Refer to the
operators manual for more detailed instructions on the Manual Retraction Kit).
Do not inflate the balloon inside the sheath. Always verify with fluoroscopy or by using
the proximal shaft visual marker that the balloon is fully outside the sheath before
inflation to avoid catheter damage.
Do not inflate the balloon while the catheter is positioned inside a pulmonary vein.
Always inflate the balloon in the atrium and then position it at the pulmonary vein ostium.
Inflating the balloon in the pulmonary vein may result in vascular injury.
Biohazard disposal – Discard all used catheters and sterile components in accordance
with hospital procedures.
Cardioversion or defibrillation during ablation procedure – Disconnect the catheter's
electrical connection before cardioversion or defibrillation. Failure to do so may trigger
system messages indicating a need for catheter exchange.
Catheter handling –
Use extreme care when manipulating the catheter. Lack of careful attention can result in
injury such as perforation or tamponade.
Do not use excessive force to advance or withdraw the catheter, especially if resistance
is encountered.
Do not use the catheter if it is kinked, damaged, or cannot be straightened.
Straighten the balloon segment before inserting or withdrawing the catheter.
Do not at any time preshape or bend the catheter shaft or balloon segment. Bending or
kinking the catheter shaft may damage internal structures and increase the risk of
catheter failure. Prebending of the distal curve can damage the catheter
Catheter advancement should be performed under fluoroscopic guidance.
Do not position the cryoballoon catheter within the tubular portion of the pulmonary vein
to minimize phrenic nerve injury and pulmonary vein stenosis.
Catheter integrity – Do not use the catheter if it is kinked or damaged. If the catheter
becomes kinked or damaged while in the patient, remove it and use a new catheter. Before
injecting, the physician should ensure that there is no kink in the catheter.
Circular mapping catheter compatibility – Use only Medtronic circular mapping catheters
compatible with the inner lumen of the Arctic Front Advance Cryoballoon. Use of another
mapping catheter may damage the catheter or compromise the procedure.
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Arctic Front Advance Technical Manual
M949606A002
Rev A
English
5
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
Correct guide wire or circular mapping catheter insertion and positioning – Do not
advance the balloon beyond the guide wire or circular mapping catheter to reduce the risk
of tissue damage.
Ensure that the guide wire or circular mapping catheter is inserted into the catheter and
through the balloon portion for adequate support during vascular access insertion.
Failure to do so may result in catheter damage.
Cryoablation near prosthetic heart valves – Do not pass the catheter through a
prosthetic heart valve (mechanical or tissue). The catheter may become trapped in the valve,
damaging the valve and causing valvular insufficiency or premature failure of the prosthetic
valve.
Cryoadhesion – Do not pull on the catheter, sheath, umbilical cables, or console while the
catheter is frozen to the tissue, this may lead to tissue injury.
Do not resterilize – Do not resterilize this device for purpose of reuse. Resterilization may
compromise the structural integrity of the device or create a risk of contamination from the
device that could result in patient injury, illness, or death.
Embolism risk – Introducing any catheter into the circulatory system entails the risk of air
or gas embolism, which can occlude vessels and lead to tissue infarction with serious
consequences. Always advance and withdraw components slowly to minimize the vacuum
created and therefore minimize the risk of air embolism.
Environmental limits – Perform cryoablation procedures only within the environmental
parameters. Operating outside these parameters may prevent the start or completion of a
cryoablation procedure. Refer to the Specifications Table on page 7 for environmental
parameters.
Esophageal injury – Esophageal ulcerations have been observed in some subjects who
undergo cryoablation with the Arctic Front Cryoablation Catheter. As with other forms of left
atrial ablation, the physician should consider appropriate medical strategies to minimize the
risk of esophageal injury.
Fluid incursion – Do not expose the catheter handle or coaxial and electrical connectors to
fluids or solvents. If these components get wet, the Arctic Front Advance Cryoballoon
Catheter System may not function properly, and connector integrity may be compromised.
Fluoroscopy required for catheter placement – The use of fluoroscopy during catheter
ablation procedures presents the potential for significant x-ray exposure to both patients and
laboratory staff. Extensive exposure can result in acute radiation injury and increased risk for
somatic and genetic effects. Only perform catheter ablation after giving adequate attention
to the potential radiation exposure associated with the procedure, and taking steps to
minimize this exposure. Give careful consideration before using the device in pregnant
women.
For single use only – This device is intended only to be used once for a single patient. Do
not reuse, reprocess, or resterilize this device for purpose of reuse. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device or create a risk of
contamination of the device that could result in patient injury, illness, or death.
Frequent flushing of the guide wire lumen – . Flush the guide wire lumen prior to initial
insertion and then frequently throughout the procedure to prevent coagulation of blood in the
lumen. Flush the guide wire lumen with saline after each contrast injection.
Guide wire compatibility – Use only 0.081 cm (0.032 in) or 0.089 cm (0.035 in) guide
wires with the catheter. Using another guide wire may damage the catheter or compromise
the procedure.
Improper connection – Do not connect the cryoablation catheter to a radio frequency (RF)
generator or use it to deliver RF energy. This may cause catheter malfunction or patient
harm.
Induced arrhythmias – Catheter procedures may mechanically induce arrhythmias.
Leakage current from connected devices – Use only isolated equipment (IEC 60601-1
Type CF equipment, or equivalent) with the CryoConsole and catheters or patient injury or
death may occur.
Other catheters, devices, or wires – Avoid catheter entanglement with other catheters,
devices, or wires. Such entanglement may necessitate surgical intervention.
Phrenic nerve impairment – Stop ablation immediately if phrenic nerve impairment is
observed. Use continuous phrenic nerve pacing throughout each cryoablation application in
the right pulmonary veins. To avoid nerve injury, place a hand on the abdomen, in the
location of the diaphragm to assess for changes in the strength of the diaphragmatic
contraction or loss of capture. In case of no phrenic nerve capture, frequently monitor
diaphragmatic movement using fluoroscopy. Position the balloon as antral as possible and
not in the tubular portion of the pulmonary vein.
Post-ablation period – Closely monitor patients undergoing cardiac ablation procedures
during the post-ablation period for clinical adverse events.
Pressurized refrigerant – The catheter contains pressurized refrigerant during operation.
Release of this gas into the circulatory system due to equipment failure or misuse could
result in gas embolism.
Pulmonary vein narrowing or stenosis – Catheter ablation procedures inside or near
pulmonary veins may induce pulmonary vein narrowing or stenosis. Do not ablate in the
tubular portion of the pulmonary vein. The occurrence of this complication may necessitate
percutaneous angioplasty or surgical intervention.
Required use environment – Cryoablation procedures should be performed only in a fully
equipped facility.
RF ablation – Before powering up an RF generator or applying RF energy, disconnect the
cryoablation catheter from the CryoConsole to avoid an error message and unnecessary
catheter replacement.
Septal damage – Always deflate the balloon and withdraw it into the transseptal sheath
before removing it from the left atrium. Crossing the septum while the balloon is unsheathed,
inflated, or inflating in the septal puncture site may cause serious septal damage.
Steerable sheath compatibility – Use only the 12 Fr FlexCath sheath family with the Arctic
Front Advance Cryoballoon. Using another sheath may damage the catheter or balloon
segment.
Sterile package inspection – Inspect the sterile packaging and catheter prior to use. If the
sterile packaging or catheter is damaged, do not use the catheter. Contact your Medtronic
representative.
System compatibility – Use only Medtronic cryoablation catheters, refrigerant tanks, and
components with the CryoConsole. The safety and use of other catheters or components
has not been tested.
Qualified users – This equipment should be used only by or under the supervision of
physicians trained in left atrial cryoablation procedures.
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6 English
M949606A002
Arctic Front Advance Technical Manual
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
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4" x 12" (102 mm x 305 mm)
5 Adverse events
Potential adverse events associated with cardiac catheter cryoablation procedures include,
but are not limited to the following conditions:
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Anemia
Anxiety
Atrial flutter
Back pain
Bleeding from puncture sites
Blurred vision
Bradycardia
Bronchitis
Bruising
Cardiac tamponade
Cardiopulmonary arrest
Cerebral vascular accident
Chest discomfort, pain, pressure
Cold feeling
Cough
Death
Diarrhea
Dizziness
Esophageal damage (including atrioesophageal fistula)
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Fatigue
Fever
Headache
Hemoptysis
Hypotension, hypertension
Lightheadedness
Myocardial infarction
Nausea/vomiting
Nerve injury
Pericardial effusion
Pulmonary vein stenosis
Shivering
Shortness of breath
Sore throat
Tachycardia
Transient ischemic attack
Urinary infection
Vasovagal reaction
Visual changes
6 Instructions for use
6.1 Connecting the catheter
To connect the catheter, follow these steps. (For more detailed instructions, see the
CryoConsole Operator’s Manual.)
1. Connect the connection box to the CryoConsole.
2. Connect the Arctic Front Advance Cryoballoon to a sterile coaxial umbilical cable and a
sterile electrical umbilical cable.
3. Connect the coaxial umbilical cable to the CryoConsole and connect the electrical
umbilical cable to the connection box.
6.2 CryoAblation
To use the catheter for a cryoablation procedure, follow these steps. (For more detailed
instructions, see the CryoConsole Operator’s Manual.)
Note: Prior to introducing the Arctic Front Advance Cryoballoon into the patient, test the
deflection mechanism by pulling on the lever on the handle to ensure that it is operational.
Note: Always use the lever on the handle to straighten the balloon segment before insertion
or withdrawal of the catheter.
1. Using an aseptic technique, create a vascular access with an appropriate introducer.
Obtain left atrial, transseptal access using a transseptal sheath and needle.
2. Remove the transseptal sheath leaving the guide wire positioned preferably in the left
superior pulmonary vein (LSPV.)
3. Advance the FlexCath sheath and dilator into the left atrium.
4. Slowly remove the guide wire and dilator from the sheath.
5. Load the guide wire or circular mapping catheter into the Arctic Front Advance
Cryoballoon before inserting into the FlexCath sheath.
6. Insert the Arctic Front Advance Cryoballoon over the guide wire or circular mapping
catheter into the FlexCath sheath.
7. Set the treatment time on the CryoConsole screen.
8. Inflate the balloon in the left atrium.
9. Position the catheter at the ostium of the target pulmonary vein.
10.Verify the balloon position by injecting a mixture of 50/50 contrast/saline into the catheter
guide wire lumen port. Be sure to flush the guide wire lumen with saline after each contrast
injection.
Notes:
– To improve balloon stability and support, advance the circular mapping catheter into
a more distal position. If stable balloon position cannot be obtained exchange the
circular mapping catheter for a guide wire.
– Prior to exchanging the circular mapping catheter for a guide wire, retract the Arctic
Front Advance Cryoballoon into the FlexCath sheath.
11.Perform the cryoablation.
Note: The preset ablation duration is 240 seconds.
12.Wait for the cryoablation phase to complete (at the end of the preset time). The balloon
remains inflated and the Thawing phase begins.
13.During the Thawing phase, watch the temperature indicator on the screen. When it
reaches a minimum of 10 °C (50 °F), advance the blue tensioning button on the catheter
handle. Maintain pressure on the tensioning button until the balloon deflates. The balloon
deflates automatically when the temperature reaches 20 °C (68 °F).
Note: Advancing the tensioning button during balloon deflation causes the balloon to
extend to maximum length and to wrap tightly.
14.As needed, perform additional treatments by positioning the balloon differently in the
same pulmonary vein.
15.Position the catheter at the ostium of the next target pulmonary vein using the guide wire,
circular mapping catheter, and/or deflection capabilities. Return to Step 8 and continue
ablation.
Note: Determine effective ablation of the cardiac tissue by assessing electrical isolation
of the pulmonary vein from the left atrium (entrance and exit block) after the cryoablation
treatments have been completed.
16.After all treatments are completed, and after the balloon is deflated, its length is
maximized and it is tightly wrapped, retract the catheter into the sheath.
17.Remove the catheter from the patient.
7 Specifications
Catheter shaft size
Recommended introducer sheath
12 Fr FlexCath family
Inner diameter of guide wire lumen
1.27 mm (0.050 in) nominal
Inflated balloon diameter
Effective length (with balloon inflated)
95.0 ±2.0 cm (37.40 ±0.80 in)
Number of thermocouples
1
Environmental parameters
Storage
15 °C to 30 °C (59 °F to 86 °F)
Transit
-35 °C to 45 °C (-31 °F to 113 °F)
Operation
15 °C to 30 °C (60 °F to 86 °F) at altitudes less than
2400 meters (8000 feet) above sea level
Arctic Front Advance Technical Manual
M949606A002
Rev A
English
7
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
8 Medtronic limited warranty
For complete warranty information, see the accompanying limited warranty document.
9 Service
Medtronic employs highly trained representatives and engineers located throughout the
world to serve you and, upon request, to provide training to qualified hospital personnel in
the use of Medtronic products. Medtronic also maintains a professional staff to provide
technical consultation to product users. For more information, contact your local Medtronic
representative, or call or write Medtronic at the appropriate telephone number or address
listed on the back cover.
8 English
M949606A002
Arctic Front Advance Technical Manual
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
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Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
12 Fr (gamme FlexCath)
Nombre de thermocouples
1
Transport
M949606A002
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Refer to the “CathAF_IFU” category
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Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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M949606A002
Gebrauchsanweisung Arctic Front Advance
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3,5 mm (10,5 Fr; 0,14 Zoll)
3 mm (9 Fr; 0,19 Zoll)
Anzahl Thermoelemente
1
Transport
M949606A002
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Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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2AF233
23 mm (0,91 pulg.)
2AF283
28 mm (1,10 pulg.)
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Manual técnico de Arctic Front Advance
M949606A002
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in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
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M949606A002
Rev. A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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3,5 mm (10,5 Fr; 0,14 pulg.)
3 mm (9 Fr; 0,19 pulg.)
Familia FlexCath de 12 Fr
1,27 mm (0,050 pulg.), valor nominal
Manual técnico de Arctic Front Advance
M949606A002
Rev. A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
2AF233: 23 mm (0,91 pulg.)
2AF283: 28 mm (1,10 pulg.)
95,0 ± 2,0 cm (37,40 ± 0,80 pulg.)
1
15 °C a 30 °C (59 °F a 86 °F)
Transporte
-35 °C a 45 °C (-31 °F a 113 °F)
M949606A002
Manual técnico de Arctic Front Advance
Rev. A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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Radiopake markering op de sheath
Proximale katheterschachtmarkering
Distale katheterschachtmarkering
Diameter van de gevulde
ballon
2AF233
23 mm (0,91 inch)
2AF283
28 mm (1,10 inch)
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Technische handleiding voor de Arctic Front Advance
M949606A002
Rev A
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Instructions.
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Medtronic Confidential
CathAF_IFU_R1.0
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Rev A
Technische handleiding voor de Arctic Front Advance
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in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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7 Specificaties
Grootte katheterschacht
3,5 mm (10,5 Fr; 0,14 inch)
3 mm (9 Fr; 0,19 inch)
Aanbevolen introducer sheath
12 Fr FlexCath-serie
1,27 mm (0,050 inch) nominaal
M949606A002
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4" x 12" (102 mm x 305 mm)
Diameter van de gevulde ballon
2AF233 - 23 mm (0,91 inch)
2AF283 - 28 mm (1,10 inch)
95,0 ±2.0 cm (37,40 ±0,80 inch)
Aantal thermokoppels
1
Omgevingsparameters
Opslag
15 °C tot 30 °C (59 °F tot 86 °F)
Transport
-35 °C tot 45 °C (-31 °F tot 113 °F)
M949606A002
Rev A
Technische handleiding voor de Arctic Front Advance
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
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2AF233
23 mm (0,91 ")
2AF283
28 mm (1,10 ")
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Arctic Front Advance - Manuale tecnico
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Italiano
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Arctic Front Advance - Manuale tecnico
Rev A
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Instructions.
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CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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4" x 12" (102 mm x 305 mm)
3 mm (9 Fr; 0,19 ")
1,27 mm (0,050 ") nominale
95,0 ±2,0 cm (37,40 ±0,80 ")
1
M949606A002
Arctic Front Advance - Manuale tecnico
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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23 mm (0,91 in)
2AF283
28 mm (1,10 in)
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ArcticFront Advance – teknisk håndbok
M949606A002
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Norsk
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30 Norsk
M949606A002
ArcticFront Advance – teknisk håndbok
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Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
5 Bivirkninger
Mulige bivirkninger forbundet med kateterkryoablasjonsprosedyrer i hjertet omfatter, men er
ikke begrenset til, følgende tilstander:
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12 F FlexCath-serien
Indre diameter på guidewirens lumen
95,0 ±2.0 cm (37,40 ±0,80 in)
Antall termoelementer
1
Bruk
ArcticFront Advance – teknisk håndbok
M949606A002
Rev A
Norsk
31
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
32 Norsk
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
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5
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6
Röntgentät markering på hylsan
Proximal markering på kateterskaftet
Distal markering på kateterskaftet
Figur 1. Arctic Front Advance Cardiac CryoAblation-kateter
Arctic Front Advance-kryoballong finns i två modeller, vilka beskrivs i följande tabell:
Modell
2AF233
23 mm (0,91 in)
2AF283
28 mm (1,10 in)
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M949606A002
Rev A
33
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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M949606A002
Rev A
35
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
12 Fr FlexCath-sortimentet
95,0 ± 2,0 cm (37,40 ± 0,80 in)
1
Transport
Drift
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
4
5
6
2AF233
23 mm (0,91 in)
2AF283
28 mm (1,10 in)
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M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
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M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
95,0 ± 2,0 cm (37,40 ± 0,80 in)
1
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
2AF233
23 mm (0,91")
2AF283
28 mm (1,10")
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M949606A002
Rev A
Dansk
41
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
42 Dansk
M949606A002
Arctic Front Advance Teknisk håndbog
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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Spidsens udvendige diameter
12 Fr FlexCath-serien
95,0 ±2,0 cm (37,40 ±0,80")
1
Transport
Drift
M949606A002
Rev A
Dansk
43
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
44 Dansk
M949606A002
Arctic Front Advance Teknisk håndbog
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
2AF233
2AF283
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M949606A002
Rev A
45
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
M949606A002
Manual técnico do Arctic Front Advance
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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M949606A002
Rev A
47
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3,5 mm (10,5 Fr; 0,14 pol.)
3 mm (9 Fr; 0,19 pol.)
Gama FlexCath de 12 Fr
2AF233 - 23 mm (0,91 pol.)
2AF283 - 28 mm (1,10 pol.)
1
15 °C a 30 °C (59 °F a 86 °F)
Trânsito
-35 °C a 45 °C (-31 °F a 113 °F)
15 °C a 30 °C (60 °F a 86 °F) para altitudes inferiores
a 2400 metros (8000 pés) acima do nível do mar
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
4
5
6
2AF233
2AF283
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M949606A002
Rev A
49
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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M949606A002
Rev A
51
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3,5 mm (10,5 French, 0,14 hüvelyk)
3 mm (9 French, 0,19 hüvelyk)
1
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
2AF233
2AF283
28 mm (1,10 cala)
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M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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M949606A002
Arctic Front Advance - Instrukcja techniczna
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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Arctic Front Advance - Instrukcja techniczna
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3 mm (9 Fr; 0,19 cala)
12 Fr, seria osłon FlexCath
2AF233 - 23 mm (0,91 cala)
2AF283 - 28 mm (1,10 cala)
95,0 ±2,0 cm (37,40 ±0,80 cala)
1
Transport
M949606A002
Arctic Front Advance - Instrukcja techniczna
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
4
5
6
2AF233
23 mm (0,91 palců)
2AF283
28 mm (1,10 palců)
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M949606A002
Rev A
Česky
57
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
58 Česky
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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3,5 mm (10,5 Fr; 0,14 palce)
3 mm (9 Fr; 0,19 palce)
12 Fr řada FlexCath
1
M949606A002
Rev A
Česky
59
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
60 Česky
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
2AF233
23 мм (0,91 дюйма)
2AF283
28 мм (1,10 дюйма)
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M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
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M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3,5 мм (10,5 French; 0,14 дюйма)
3 мм (9 French; 0,19 дюйма)
Семейство FlexCath 12 French
2AF233 – 23 мм (0,91 дюйма)
2AF283 – 28 мм (1,10 дюйма)
1
от 15 °C до 30 °C (от 59 °F до 86 °F)
от -35 °C до 45 °C (от -31 °F до 113 °F)
Эксплуатация
M949606A002
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
4
5
6
Röntgenkontrastný marker puzdra
Proximálny marker tela katétra
Distálny marker tela katétra
2AF233
2AF283
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Technická príručka ku katétru Arctic Front Advance
M949606A002
Rev. A
slovenčina
65
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
66 slovenčina
M949606A002
Rev. A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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3 mm (9 Fr; 0,19 palca)
12 Fr puzdro radu FlexCath
1
Preprava
M949606A002
Rev. A
slovenčina
67
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
68 slovenčina
M949606A002
Rev. A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
3
4
2
1
6
1
2
3
5
4
5
6
2AF233
23 mm (0,91 inç)
2AF283
28 mm (1,10 inç)
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Arctic Front Advance Teknik El Kitabı
M949606A002
Rev A
69
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
M949606A002
Arctic Front Advance Teknik El Kitabı
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
Medtronic Confidential
CathAF_IFU_R1.0
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
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3,5 mm (10,5 Fr; 0,14 inç)
3 mm (9 Fr; 0,19 inç)
12 Fr FlexCath ailesi
1
-35 °C ila 45 °C (-31 °F ila 113 °F)
Arctic Front Advance Teknik El Kitabı
M949606A002
Rev A
71
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_ch.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
M949606A002
Arctic Front Advance Teknik El Kitabı
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_bc.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
M949606A002
Rev A
Medtronic Confidential
CathAF_IFU_R1.0
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.
M949606A_bc.fm 3/14/12 10:45 am
4" x 12" (102 mm x 305 mm)
Medtronic Confidential
CathAF_IFU_R1.0
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604
USA
www.medtronic.com
Tel. +1-763-514-4000
Fax +1-763-514-4879
Manufacturer
Medtronic CryoCath LP
16771 Chemin Ste-Marie
Kirkland, QC H9H 5H3
Canada
www.medtronic.com
Tel. +1-514-694-1212
Fax +1-514-694-6279
Technical Support +1-877-464-2796
Medtronic E.C. Authorized
Representative
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. +31-45-566-8000
Fax +31-45-566-8668
Europe/Africa/Middle East
Headquarters
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.com
Tel. +41-21-802-7000
Fax +41-21-802-7900
Australia
Medtronic Australasia Pty Ltd
97 Waterloo Road
North Ryde, NSW 2113
Australia
Technical manuals:
www.medtronic.com/manuals
© Medtronic, Inc. 2012
M949606A002A
2012-03-14
Rev A
Refer to the “CathAF_IFU” category
in doc#163256 for Printing
Instructions.