Medtronic R65CS1 Instructions for Use
Cardioblate® CryoFlex
Surgical Ablation Console
Конзола за хирургична аблация
Konzole pro chirurgickou ablaci
Kirurgisk ablationskonsol
Konsole für die chirurgische Ablation
Κονσόλα χειρουργικής κατάλυσης
Consola de ablación quirúrgica
Kirurgilise ablatsiooni konsool
Kirurginen ablaatiokonsoli
Console d'ablation chirurgicale
Konzola za kiruršku ablaciju
Sebészi ablációs konzol
Console per ablazione chirurgica
Chirurginės abliacijos pultas
Ķirurģiskās ablācijas konsole
Chirurgische ablatieconsole
Konsoll for kirurgisk ablasjon
Konsola do ablacji chirurgicznej
Consola de ablação cirúrgica
Consolă pentru ablație chirurgicală
Консоль для хирургической абляции
Konzola na chirurgickú abláciu
Konzola za kirurško ablacijo
Konzola za hiruršku ablaciju
Kirurgisk ablationskonsol
Cerrahi Ablasyon Konsolu
®
Operator's Manual • Ръководство за работа • Uživatelská příručka • Brugsanvisning • Gebrauchsanweisung • Εγχειρίδιο χειριστή •
Manual del usuario • Kasutusjuhend • Käyttöopas • Manuel de l'utilisateur • Priručnik za rukovatelje • Kezelői kézikönyv •
Manuale dell'operatore • Naudotojo vadovas • Operatora rokasgrāmata • Gebruikershandleiding • Brukerhåndbok • Podręcznik operatora •
Manual do operador • Manual de utilizare • Руководство оператора • Príručka pre obsluhu • Priročnik za operaterje •
Priručnik za rukovaoca • Användarmanual • Teknik Kullanıcı El Kitabı
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Cardioblate® and CryoFlex® are trademarks of Medtronic.
Cardioblate® и CryoFlex® са търговски марки на Medtronic.
Cardioblate® a CryoFlex® jsou ochranné známky společnosti Medtronic.
Cardioblate® og CryoFlex® er varemærker tilhørende Medtronic.
Cardioblate® und CryoFlex® sind Marken von Medtronic.
Το Cardioblate® και το CryoFlex® είναι εμπορικά σήματα της Medtronic.
Cardioblate® y CryoFlex® son marcas comerciales de Medtronic.
Cardioblate® ja CryoFlex® on ettevõtte Medtronic kaubamärgid.
Cardioblate® ja CryoFlex® ovat Medtronic-yhtiön tavaramerkkejä.
Cardioblate® et CryoFlex® sont des marques commerciales de Medtronic.
Cardioblate® i CryoFlex® žigovi su tvrtke Medtronic.
A Cardioblate® és a CryoFlex® a Medtronic védjegye.
Cardioblate® e CryoFlex® sono marchi di fabbrica di Medtronic.
„Cardioblate®“ ir „CryoFlex®“ yra „Medtronic“ prekių ženklai.
Cardioblate® un CryoFlex® ir uzņēmuma Medtronic preču zīmes.
Cardioblate® en CryoFlex® zijn handelsmerken van Medtronic.
Cardioblate® og CryoFlex® er varemerker for Medtronic.
Cardioblate® i CryoFlex® są znakami towarowymi firmy Medtronic.
Cardioblate® e CryoFlex® são marcas comerciais da Medtronic.
Cardioblate® și CryoFlex® sunt mărci comerciale ale Medtronic.
Cardioblate® и CryoFlex® являются товарными знаками Medtronic.
Cardioblate® a CryoFlex® sú ochranné známky spoločnosti Medtronic.
Cardioblate® in CryoFlex® sta blagovni znamki družbe Medtronic.
Cardioblate® i CryoFlex® su žigovi preduzeća Medtronic.
Cardioblate® och CryoFlex® är varumärken som tillhör Medtronic.
Cardioblate® ve CryoFlex® Medtronic şirketinin ticari markalarıdır.
Explanation of Symbols / Обяснение на символите / Vysvětlení symbolů / Symbolforklaring / Erläuterung der
Symbole / Επεξήγηση των συμβόλων / Explicación de los símbolos / Sümbolite seletus / Symbolien merkitykset /
Explication des symboles / Objašnjenja simbola / Jelmagyarázat / Spiegazione dei simboli / Simbolių paaiškinimas /
Apzīmējumu skaidrojums / Verklaring van de symbolen / Symbolforklaring / Objaśnienie symboli / Explicação dos
símbolos / Explicarea simbolurilor / Объяснение символов / Vysvetlivky k symbolom / Razlaga simbolov /
Objašnjenje simbola / Förklaring av symboler / Sembollerin Açıklaması
Conformité Européenne (European Conformity). This symbol means that the device fully complies with
European Council Directive 93/42/EEC. / Conformité Européenne (Европейско съответствие). Този символ
означава, че устройството напълно съответства на Директива 93/42/ЕИО на Съвета на Европейския
съюз. / Conformité Européenne (Evropská shoda). Tento symbol znamená, že prostředek zcela splňuje
požadavky směrnice Evropské rady 93/42/EHS. / Conformité Européenne (Europæisk standard). Dette symbol
betyder, at enheden fuldt ud overholder Det Europæiske Råds direktiv 93/42/EØF. / Conformité Européenne
(Europäische Konformität). Dieses Symbol besagt, dass das Gerät allen Vorschriften der Europäischen
Richtlinie 93/42/EWG entspricht. / Conformité Européenne (Ευρωπαϊκή Συμμόρφωση). Το σύμβολο αυτό
σημαίνει ότι το προϊόν συμμορφώνεται πλήρως με την Οδηγία 93/42/ΕΟΚ του Ευρωπαϊκού Συμβουλίου. /
Conformité Européenne (Conformidad Europea). Este símbolo indica que el dispositivo cumple totalmente la
Directiva 93/42/CEE del Consejo Europeo. / Conformité Européenne (Euroopa vastavusmärgis). See sümbol
tähendab, et seade vastab täielikult Euroopa Liidu Nõukogu direktiivi 93/42/EMÜ nõuetele. / Conformité
Européenne (eurooppalainen vaatimustenmukaisuus). Tämä symboli tarkoittaa, että laite on kaikilta osin
Euroopan unionin neuvoston direktiivin 93/42/ETY mukainen. / Conformité européenne. Ce symbole signifie
que l'appareil est entièrement conforme à la Directive européenne 93/42/CEE. / Conformité Européenne
(Usklađenost s europskim standardima). Taj simbol znači da je uređaj potpuno usklađen s direktivom Vijeća
EU-a 93/42/EEZ. / Conformité Européenne (európai megfelelőség). Ez a szimbólum azt jelenti, hogy az eszköz
teljes mértékben megfelel az Európai Tanács 93/42/EGK jelű irányelve követelményeinek. / Conformité
Européenne (Conformità europea). Questo simbolo indica che il dispositivo è conforme alla Direttiva del
Consiglio Europeo 93/42/CEE. / Conformité Européenne (Europos atitiktis). Šis simbolis reiškia, kad prietaisas
visiškai atitinka Europos Tarybos direktyvą 93/42/EEB. / Conformité Européenne (atbilstība Eiropas Savienības
prasībām). Šis simbols norāda, ka ierīce pilnībā atbilst Eiropas Padomes Direktīvai 93/42/EEK. / Conformité
Européenne (Europese Conformiteit). Dit symbool betekent dat het product volledig voldoet aan de Europese
Richtlijn 93/42/EEG. / Conformité Européenne (samsvar med europeisk standard). Dette symbolet betyr at
enheten er fullstendig i samsvar med EU-direktiv 93/42/EØF. / Conformité Européenne (zgodność z normami
Unii Europejskiej). Symbol ten oznacza, że urządzenie spełnia wszystkie wymagania europejskiej dyrektywy
Rady 93/42/EWG. / Conformité Européenne (Conformidade Europeia). Este símbolo significa que o dispositivo
está em total conformidade com a Diretiva do Conselho Europeu 93/42/CEE. / Conformité Européenne
(Conformitate europeană). Acest simbol indică faptul că dispozitivul este pe deplin în conformitate cu Directiva
93/42/CEE a Consiliului European. / Conformité Européenne (Европейское соответствие). Этот символ
обозначает, что устройство полностью соответствует требованиям директивы Европейского Совета
93/42/EEC. / Conformité Européenne (Zhoda s požiadavkami EÚ). Tento symbol znamená, že zariadenie je v
plnom súlade s ustanoveniami smernice Európskej rady 93/42/EHS. / Conformité Européenne (Evropska
skladnost). Ta simbol pomeni, da je pripomoček popolnoma skladen z Direktivo Evropskega sveta
93/42/EGS. / Conformité Européenne (usklađenost sa evropskim standardima). Ovaj simbol znači da je
sredstvo u potpunosti usklađeno sa Direktivom Saveta Evrope 93/42/EEC. / Conformité Européenne
(Europeisk standard). Denna symbol betyder att enheten helt följer rådets direktiv 93/42/EEG. / Conformité
Européenne (Avrupa Normlarına Uygunluk). Bu sembol, cihazın 93/42/EEC sayılı Avrupa Konseyi Direktifi ile
tamamen uyumlu olduğu anlamına gelir.
For US Audiences Only / Само за САЩ / Pouze pro uživatele z USA / Gælder kun i USA / Gilt nur für Leser in
den USA / Μόνο για πελάτες εντός των ΗΠΑ / Solo aplicable en EE. UU. / Ainult kasutajatele Ameerika
Ühendriikides / Koskee vain Yhdysvaltoja / Ne s'applique qu'aux États-Unis / Samo za korisnike u SAD-u /
Csak egyesült államokbeli felhasználóknak / Esclusivamente per il mercato statunitense / Tik JAV
naudotojams / Tikai lietotājiem ASV / Alleen van toepassing voor de VS / Gjelder bare USA / Dotyczy tylko
klientów w USA / Apenas aplicável aos E.U.A. / Numai pentru clienții din SUA / Только для США / Len pre
používateľov v USA / Samo za uporabnike v ZDA / Samo za SAD / Gäller endast i USA / Sadece ABD'deki
Kullanıcılar İçin
i
Medical - General Medical Equipment with respect to electrical shock, fire, and mechanical hazards only in
accordance with UL 60601-1:2006, CAN/CSA C22.2 No. 601.1-2005, ANSI / AAMI ES60601-1(2005), and
CAN/CSA C22.2 No. 60601-1(2008). 75HN / Медицинско оборудване – общо медицинско оборудване,
отговарящо на изискванията за безопасност по отношение на електрически удар, пожар и механични
рискове в съответствие с UL 60601-1:2006, CAN/CSA C22.2 № 601.1-2005, ANSI / AAMI ES60601-1(2005)
и CAN/CSA C22.2 № 60601-1(2008). 75HN / Zdravotnický prostředek – Obecný zdravotnický prostředek
splňující předpisy na zabezpečení proti úrazu elektrickým proudem, požáru a mechanickému poškození pouze
podle požadavků norem UL 60601-1:2006, CAN/CSA C22.2 č. 601.1-2005, ANSI / AAMI ES60601-1(2005) a
CAN/CSA C22.2 č. 60601-1(2008). 75HN / Medicinsk - Generelt medicinsk udstyr, hvad angår risiko for
elektrisk stød, brandfare og mekanisk skade kun i overensstemmelse med UL 60601-1:2006, CAN/CSA C22.2
nr. 601.1-2005, ANSI/AAMI ES60601-1(2005) og CAN/CSA C22.2 nr. 60601-1(2008). 75HN / Medizinisch –
Allgemeines medizinisches Gerät, erfüllt bezüglich Stromschlag, Feuer und mechanischer Gefahren die
Anforderungen von UL 60601-1:2006, CAN/CSA C22.2 Nr. 601.1-2005, ANSI/AAMI ES60601-1 (2005) und
CAN/CSA C22.2 Nr. 60601-1 (2008). 75HN / Ιατρικός - Γενικός ιατρικός εξοπλισμός αναφορικά με τους
κινδύνους ηλεκτροπληξίας και πυρκαγιάς, καθώς και τους μηχανικούς κινδύνους μόνο, πληροί τα πρότυπα
UL 60601-1:2006, CAN/CSA C22.2 υπ. αριθμόν 601.1-2005, ANSI /AAMI ES60601-1(2005) και
CAN/CSA C22.2 υπ. αριθμόν 60601-1(2008). 75HN / Médico: equipo médico general con respecto a peligros
mecánicos, de descargas eléctricas y de incendio conforme a las normas UL 60601-1:2006, CAN/CSA C22.2
N.º 601.1-2005, ANSI/AAMI ES60601-1(2005) y CAN/CSA C22.2 N.º 60601-1(2008). 75HN / Meditsiiniline –
üldised meditsiiniseadmed vastavad ainult elektrilöögi-, tule- ja mehaaniliste ohtude osas standarditele
UL 60601-1:2006, CAN/CSA C22.2 nr 601.1-2005, ANSI/AAMI ES60601-1(2005) ja CAN/CSA C22.2
nr 60601-1(2008). 75HN / Lääkinnällinen − yleinen lääkinnällinen laite; suojaus vain sähköiskuilta, tulipalolta ja
mekaanisilta vaaroilta standardien UL 60601-1: 2006, CAN/CSA C22.2 nro 601.1-2005, ANSI / AAMI
ES60601-1 (2005) ja CAN/CSA C22.2 nro 60601-1 (2008) 75HN mukaisesti. / Médical - Équipement médical
général en ce qui concerne les risques de choc électrique, d'incendie et mécaniques uniquement
conformément aux normes UL 60601-1:2006, CAN/CSA C22.2 n° 601.1-2005, ANSI/AAMI ES60601-1 (2005)
et CAN/CSA C22.2 n° 60601-1 (2008). 75HN / Medicinska – opća medicinska oprema koja je samo s obzirom
na opasnost od strujnog udara, požara i mehaničkih oštećenja usklađena s normama UL 60601-1:2006,
CAN/CSA C22.2 br. 601.1-2005, ANSI / AAMI ES60601-1(2005) i CAN/CSA C22.2 br. 60601-1(2008). 75HN /
Orvosi – általános orvosi berendezés a következő szabványok szerinti érintésvédelem, tűzvédelem és
mechanikai sérülés elleni védelem tekintetében: UL 60601-1:2006, CAN/CSA C22.2 No. 601.1-2005, ANSI /
AAMI ES60601-1(2005) és CAN/CSA C22.2 No. 60601-1(2008). 75HN / Dispositivo medico - dispositivo
medico generico conforme alle normative UL 60601-1:2006, CAN/CSA C22.2 n. 601.1-2005,
ANSI/AAMI ES60601-1(2005) e CAN/CSA C22.2 n. 60601-1(2008) limitatamente al rischio di scosse
elettriche, di incendio e di pericoli di natura meccanica. 75HN / Medicininė, bendrosios paskirties medicininė
įranga tik elektros šoko, gaisro ir mechaninių pavojų atžvilgiu atitinka reikalavimus pagal UL 60601-1:2006,
CAN/CSA C22.2 Nr. 601.1-2005, ANSI / AAMI ES60601-1(2005) ir CAN/CSA C22.2 Nr. 60601-1(2008).
75HN / Medicīnas — vispārīgas lietošanas medicīnas iekārta, kas attiecībā uz elektriskās strāvas triecienu,
uguns un mehānisko apdraudējumu atbilst tikai standartu UL 60601-1:2006, CAN/CSA C22.2 Nr. 601.1-2005,
ANSI/AAMI ES60601-1(2005) un CAN/CSA C22.2 Nr. 60601-1(2008) prasībām. 75HN / Medisch Veiligheidsvereisten voor algemene medische apparatuur ten aanzien van elektrische schok, brand en
mechanische gevaren, uitsluitend volgens UL 60601-1:2006, CAN/CSA C22.2 No. 601.1-2005, ANSI / AAMI
ES60601-1(2005) en CAN/CSA C22.2 No. 60601-1(2008). 75HN / Medisinsk utstyr – Generelt medisinsk utstyr
med hensyn til elektrisk støt, brann og mekaniske farer bare i samsvar med UL 60601-1:2006, CAN/CSA
C22.2 No. 601.1-2005, ANSI / AAMI ES60601-1(2005) og CAN/CSA C22.2 No. 60601-1(2008). 75HN /
Medyczne – urządzenie medyczne kategorii ogólnej pod względem niebezpieczeństwa porażenia prądem
elektrycznym, pożaru i urazów mechanicznych zgodne wyłącznie z normami UL 60601-1:2006, CAN/CSA
C22.2 No. 601.1-2005, ANSI / AAMI ES60601-1(2005) i CAN/CSA C22.2 No. 60601-1(2008). 75HN / Médico –
Equipamento médico geral, em relação a choques elétricos, incêndios e perigos mecânicos, apenas em
conformidade com as normas UL 60601-1:2006, CAN/CSA C22.2 N.º 601.1-2005, ANSI/AAMI
ES60601-1(2005) e CAN/CSA C22.2 N.º 60601-1(2008). 75HN / Medical - Echipament medical general
clasificat în raport cu riscurile de electrocutare, de incendiu și mecanice numai în conformitate cu standardele
UL 60601-1:2006, CAN/CSA C22.2 No. 601.1-2005, ANSI / AAMI ES60601-1(2005) și CAN/CSA C22.2 No.
60601-1(2008). 75HN / Медицина — медицинское оборудование общего назначения по риску поражения
электрическим током, возгорания и механических повреждений только в соответствии со стандартами
UL 60601-1:2006, CAN/CSA C22.2 No. 601.1-2005, ANSI / AAMI ES60601-1(2005) и CAN/CSA C22.2 No.
60601-1(2008). 75HN / Zdravotnícke zariadenie – všeobecné zdravotnícke zariadenie je len z hľadiska rizika
ii
zásahu elektrickým prúdom, protipožiarneho a mechanického zabezpečenia v súlade s normami
UL 60601-1:2006, CAN/CSA C22.2 č. 601.1-2005, ANSI/AAMI ES60601-1(2005) a CAN/CSA
C22.2 č. 60601-1(2008). 75HN / Medicinska oprema – Splošna medicinska oprema, skladna s standardi
UL 60601-1:2006, CAN/CSA C22.2 št. 601.1-2005, ANSI/AAMI ES60601-1(2005) in CAN/CSA C22.2
št. 60601-1(2008), kar zadeva nevarnost električnega udara, požara in mehanskih poškodb. 75HN / Medicinski
– opšta medicinska oprema samo na osnovu opasnosti od strujnog udara, požara i mehaničkih nesreća u
skladu sa standardima UL 60601-1:2006, CAN/CSA C22.2 br. 601.1-2005, ANSI / AAMI ES60601-1(2005) i
CAN/CSA C22.2 br. 60601-1(2008). 75HN / Medicinteknik – Allmän medicinteknisk utrustning som endast med
avseende på risken för elektrisk stöt, brandrisken och mekaniska risker överensstämmer med
UL 60601-1:2006, CAN/CSA C22.2 nr 601.1-2005, ANSI/AAMI ES60601-1 (2005) och CAN/CSA C22.2
nr 60601-1 (2008). 75HN / Sadece UL 60601-1:2006, CAN/CSA C22.2 Sayı 601.1-2005,
ANSI / AAMI ES60601-1(2005) ve CAN/CSA C22.2 Sayı 60601-1(2008) 75HN uyarınca elektrik çarpması,
yangın ve mekanik tehlikeler açısından Tıbbi - Genel Tıbbi Ekipman.
Caution / Внимание / Upozornění / Forsigtig / Vorsicht / Προσοχή / Precaución / Ettevaatust! / Varoitus /
Attention / Oprez / Figyelem! / Attenzione / Dėmesio / Uzmanību! / Let op / Forsiktig! / Przestroga / Atenção /
Atenție / Предупреждение / Upozornenie / Pozor / Oprez / OBS! / Dikkat
Consult Instructions for Use / Разгледайте инструкциите за употреба / Viz návod k použití / Se
brugsanvisningen / Gebrauchsanweisung beachten / Συμβουλευτείτε τις Οδηγίες χρήσης / Consultar las
instrucciones de uso / Lugege kasutusjuhendit / Katso käyttöohjeet / Consulter le mode d'emploi / Pogledajte
upute za upotrebu / Lásd a használati útmutatót / Consultare le istruzioni per l'uso / Skaitykite naudojimo
instrukcijose / Skatīt lietošanas pamācību / Raadpleeg gebruiksaanwijzing / Se i bruksanvisningen / Należy
zapoznać się z instrukcją użytkowania / Consultar instruções de utilização / Consultați instrucțiunile de
utilizare / См. инструкцию по эксплуатации / Pozrite si pokyny na používanie / Glejte navodila za uporabo /
Pogledajte uputstva za upotrebu / Läs bruksanvisningen / Kullanım Talimatlarına Bakın
Alternating Current / Променлив ток / Střídavý proud / Vekselstrøm / Wechselstrom / Εναλλασσόμενο ρεύμα
(AC) / Corriente alterna / Vahelduvvool / Vaihtovirta / Courant alternatif / Izmjenični napon / Váltakozó áram / A
corrente alternata / Kintamoji elektros srovė / Maiņstrāva / Wisselstroom / Vekselstrøm / Prąd przemienny /
Corrente alterna / Curent alternativ / Переменный ток / Striedavý prúd / Izmenični tok / Naizmenična struja /
Växelström / Dalgalı Akım
Serial Number / Сериен номер / Sériové číslo / Serienummer / Seriennummer / Αριθμός σειράς / Número de
serie / Seerianumber / Sarjanumero / Numéro de série / Serijski broj / Sorozatszám / Numero di serie / Serijos
numeris / Sērijas numurs / Serienummer / Serienummer / Numer seryjny / Número de série / Număr de serie /
Серийный номер / Sériové číslo / Serijska številka / Serijski broj / Serienummer / Seri Numarası
Date of Manufacture / Дата на производство / Datum výroby / Fabrikationsdato / Herstellungsdatum /
Ημερομηνία κατασκευής / Fecha de fabricación / Tootmiskuupäev / Valmistuspäivämäärä / Date de
fabrication / Datum proizvodnje / A gyártás dátuma / Data di fabbricazione / Pagaminimo data / Ražošanas
datums / Productiedatum / Produksjonsdato / Data produkcji / Data de fabrico / Data fabricării / Дата
изготовления / Dátum výroby / Datum izdelave / Datum proizvodnje / Tillverkningsdatum / Üretim Tarihi
Manufacturer / Производител / Výrobce / Fabrikant / Hersteller / Κατασκευαστής / Fabricante / Tootja /
Valmistaja / Fabricant / Proizvođač / Gyártó / Fabbricante / Gamintojas / Ražotājs / Fabrikant / Produsent /
Producent / Fabricante / Producător / Производитель / Výrobca / Izdelovalec / Proizvođač / Tillverkare /
İmalatçı
Catalog Number / Каталожен номер / Katalogové číslo / Katalognummer / Bestellnummer / Αριθμός
καταλόγου / Número de catálogo / Katalooginumber / Luettelonumero / Numéro de référence / Kataloški broj /
Katalógusszám / Numero di catalogo / Katalogo numeris / Kataloga numurs / Catalogusnummer /
Artikkelnummer / Numer katalogowy / Número de catálogo / Număr de catalog / Номер по каталогу /
Katalógové číslo / Kataloška številka / Kataloški broj / Katalognummer / Katalog Numarası
Fuse / Предпазител / Pojistka / Sikring / Sicherung / Ασφάλεια / Fusible / Sulavkaitse / Sulake / Fusible /
Osigurač / Biztosító / Fusibile / Lydusis saugiklis / Drošinātājs / Zekering / Sikring / Bezpiecznik / Fusível /
Siguranță fuzibilă / Плавкий предохранитель / Poistka / Varovalka / Osigurač / Säkring / Sigorta
iii
Temperature Limitation / Ограничение за температурата / Mezní hodnoty teploty / Temperaturbegrænsning /
Temperaturbereich / Περιορισμός θερμοκρασίας / Limitación de la temperatura / Temperatuuripiirang /
Lämpötilarajoitus / Limite de température / Ograničenje temperature / Hőmérséklethatárok / Limite di
temperatura / Temperatūros apribojimas / Temperatūras ierobežojums / Temperatuurbereik / Krav til
temperatur / Dopuszczalna temperatura / Limites de temperatura / Limitare de temperatură / Ограничение
температуры / Hraničné hodnoty teploty / Omejitev temperature / Ograničenje temperature /
Temperaturbegränsning / Sıcaklık Sınırlaması
Humidity Limitation / Ограничение за влажността / Mezní hodnota vlhkosti / Grænse for luftfugtighed /
Luftfeuchtigkeitsbereich / Όριο υγρασίας / Limitación de la humedad / Niiskusepiirang / Kosteusrajoitus / Limite
de l'humidité / Ograničenje vlažnosti / A páratartalom határértékei / Limite di umidità / Oro drėgnio apribojimas /
Mitruma ierobežojums / Vochtigheidsbereik / Krav til fuktighet / Ograniczenie wilgotności / Limites de
humidade / Limitare de umiditate / Пределы влажности / Obmedzenie pre vlhkosť / Omejitev vlažnosti /
Ograničenje vlažnosti / Luftfuktighetsbegränsning / Nem Sınırlaması
This Way Up / С тази страна нагоре / Touto stranou nahoru / Denne side opad / Diese Seite oben / Προς τα
πάνω / Este lado hacia arriba / See külg ülespoole / Tämä puoli ylöspäin / Ce côté vers le haut / Ovu stranu
okrenite prema gore / Erre legyen felfelé / Questa parte rivolta verso l'alto / Šia puse į viršų / Ar šo pusi uz
augšu / Deze zijde boven / Denne siden opp / Tą stroną do góry / Manter esta parte virada para cima / Această
parte în sus / Верх / Týmto smerom nahor / Ta stran navzgor / Ova strana gore / Denna sida upp / Bu Taraf
Yukarı Bakmalıdır
Lot Number / Партиден номер / Číslo šarže / Partinummer / Chargennummer / Αριθμός παρτίδας / Número de
lote / Partii number / Eränumero / Numéro de lot / Broj serije / Tételszám / Numero di lotto / Partijos numeris /
Partijas numurs / Partijnummer / Lotnummer / Numer partii / Número de lote / Număr de lot / Номер партии /
Číslo šarže / Številka serije / Broj serije / Lotnummer / Lot Numarası
Quantity / Количество / Množství / Antal / Menge / Ποσότητα / Cantidad / Kogus / Määrä / Quantité / Količina /
Mennyiség / Quantità / Kiekis / Daudzums / Aantal / Antall / Ilość / Quantidade / Cantitate / Количество /
Množstvo / Količina / Količina / Antal / Miktar
iv
Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to
local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product. / Не
изхвърляйте този продукт при несортирани обществени отпадъци. Изхвърляйте този продукт в
съответствие с местните разпоредби. За инструкции относно правилното изхвърляне на този продукт,
посетете http://recycling.medtronic.com. / Tento produkt nelikvidujte s netříděným komunálním odpadem.
Likvidaci tohoto produktu proveďte v souladu s místními předpisy. Informace o správném způsobu likvidace
tohoto produktu naleznete na adrese http://recycling.medtronic.com. / Produktet må ikke bortskaffes som
usorteret husholdningsaffald. Bortskaf dette produkt i overensstemmelse med lokale love og regler. Se
http://recycling.medtronic.com for instruktioner om korrekt bortskaffelse af dette produkt. / Dieses Produkt darf
nicht mit dem Restmüll/Hausmüll entsorgt werden. Bei der Entsorgung dieses Produkts sind die einschlägigen
Vorschriften zu beachten. Anweisungen zur korrekten Entsorgung dieses Produkts finden Sie unter
http://recycling.medtronic.com. / Μην απορρίπτετε το παρόν προϊόν στα κοινά δημοτικά απορρίμματα στα
οποία δεν γίνεται διαλογή. Απορρίψτε το παρόν προϊόν σύμφωνα με τους τοπικούς κανονισμούς. Για οδηγίες
σχετικά με τη σωστή απόρριψη του παρόντος προϊόντος, επισκεφθείτε τη διεύθυνση
http://recycling.medtronic.com. / No desechar este producto en los contenedores para residuos municipales sin
clasificar. Deseche este producto de acuerdo con la normativa local. Consultar http://recycling.medtronic.com
para obtener instrucciones sobre la correcta eliminación de este producto. / Seda toodet ei tohi kõrvaldada
sorteerimata olmejäätmete hulgas. See toode tuleb kõrvaldada vastavalt kohalikele eeskirjadele. Toote
korrektse kõrvaldamise juhised leiate aadressilt http://recycling.medtronic.com. / Älä hävitä tuotetta
lajittelemattoman yhdyskuntajätteen mukana. Hävitä tuote paikallisten määräysten mukaisesti. Katso ohjeet
tuotteen asianmukaisesta hävittämisestä osoitteesta http://recycling.medtronic.com. / Ne pas éliminer ce
produit dans une décharge municipale ne pratiquant pas le tri des déchets. Respecter la réglementation locale
en vigueur en la matière. Consulter le site http://recycling.medtronic.com pour obtenir des instructions sur
l'élimination adéquate de ce produit. / Ne odlažite ovaj proizvod u nerazvrstani gradski otpad. Proizvod odložite
u otpad u skladu s lokalnim propisima. Upute o odgovarajućem odlaganju ovog proizvoda potražite na adresi
http://recycling.medtronic.com. / A terméket tilos a válogatás nélküli (nem szelektív), kommunális hulladék közé
elhelyezni. A terméket a helyi előírásoknak megfelelően ártalmatlanítsa. A termék helyes ártalmatlanításának
az útmutatóját lásd a http://recycling.medtronic.com weboldalon. / Non smaltire questo prodotto insieme ai
rifiuti solidi urbani non differenziati. Attenersi alle normative in vigore per il corretto smaltimento. Per istruzioni
sul corretto smaltimento del prodotto, consultare il sito web http://recycling.medtronic.com. / Neišmeskite šio
gaminio su nerūšiuotomis buitinėmis atliekomis. Šį gaminį išmeskite atsižvelgdami į vietinius reikalavimus.
Nurodymų, kaip tinkamai išmesti šį gaminį, rasite adresu http://recycling.medtronic.com. / Neizmetiet šo
izstrādājumu kopā ar nešķirotiem sadzīves atkritumiem. Likvidējiet šo izstrādājumu saskaņā ar vietējiem
noteikumiem. Instrukcijas par pareizu šī izstrādājuma likvidēšanu skatiet http://recycling.medtronic.com. / Niet
met het gewone huisvuil wegwerpen. Werp dit product weg volgens de lokale afvalverwerkingsregels. Zie
http://recycling.medtronic.com voor instructies voor de juiste afvoer van dit product. / Dette produktet skal ikke
kastes i usortert kommunalt avfall. Produktet skal kastes i samsvar med lokale retningslinjer. På nettstedet
http://recycling.medtronic.com finner du instruksjoner om riktig deponering av dette produktet. / Produktu nie
wolno wyrzucać do niesegregowanych odpadów komunalnych. Produkt należy utylizować zgodnie z lokalnymi
przepisami. Instrukcje prawidłowej utylizacji produktu znajdują się pod adresem
http://recycling.medtronic.com. / Não elimine este produto juntamente com outros resíduos urbanos não
triados. Elimine este produto de acordo com as regulamentações locais. Consulte o Web site
http://recycling.medtronic.com para obter instruções sobre métodos de eliminação adequados deste produto. /
Nu aruncați acest produs la categoria deșeurilor municipale nesortate. Scoateți din uz acest produs respectând
reglementările locale. Consultați http://recycling.medtronic.com pentru instrucțiuni privind eliminarea
corespunzătoare a acestui produs. / Не выбрасывайте данный продукт вместе с неотсортированным
бытовым мусором. Утилизируйте данный продукт в соответствии с требованиями местного
законодательства. Указания по утилизации данного продукта см. по адресу
http://recycling.medtronic.com. / Nevyhadzujte tento produkt do netriedeného komunálneho odpadu. Tento
produkt zlikvidujte v súlade s miestnymi predpismi. Informácie o správnej likvidácii tohto produktu nájdete na
adrese http://recycling.medtronic.com. / Tega izdelka ne odlagajte med nesortirane komunalne odpadke.
Izdelek odstranite v skladu z lokalnimi predpisi. Navodila za ustrezno odstranjevanje izdelka si oglejte na
naslovu http://recycling.medtronic.com. / Odložite uređaj na predviđenu lokaciju za recikliranje. Odložite ovaj
proizvod u skladu sa lokalnim propisima. Posetite lokaciju http://recycling.medtronic.com za uputstva o
ispravnom odlaganju ovog proizvoda. / Kassera inte produkten bland osorterat kommunalt avfall. Kassera
v
produkten enligt lokala föreskrifter. På http://recycling.medtronic.com finns instruktioner om korrekt kassering
av produkten. / Bu ürünü ayrım yapılmayan belediye atık zincirinde bertaraf etmeyin. Bu ürünü yerel
düzenlemelere uygun olarak bertaraf edin. Bu ürünün doğru şekilde bertaraf edilmesiyle ilgili talimatlar için bkz.
http://recycling.medtronic.com.
Authorized Representative in the European Community / Упълномощен представител в Европейската
общност / Autorizovaný zástupce pro Evropské společenství / Autoriseret repræsentant i Det Europæiske
Fællesskab / Autorisierter Repräsentant in der Europäischen Gemeinschaft / Εξουσιοδοτημένος
αντιπρόσωπος στην Ευρωπαϊκή Κοινότητα / Representante autorizado en la Comunidad Europea / Volitatud
esindaja Euroopa Ühenduses / Valtuutettu edustaja Euroopan yhteisön alueella / Représentant agréé dans la
Communauté européenne / Ovlašteni predstavnik za Europsku zajednicu / Hivatalos képviselet az Európai
Közösségben / Rappresentante autorizzato nella Comunità europea / Įgaliotasis atstovas Europos Bendrijoje /
Pilnvarotais pārstāvis Eiropas Kopienā / Geautoriseerd vertegenwoordiger in de Europese Gemeenschap /
Autorisert representant i Det europeiske fellesskap / Autoryzowany przedstawiciel we Wspólnocie
Europejskiej / Representante autorizado na Comunidade Europeia / Reprezentant autorizat în Comunitatea
Europeană / Уполномоченный представитель в Европейском сообществе / Splnomocnený zástupca
v Európskom spoločenstve / Pooblaščeni predstavnik v Evropski skupnosti / Ovlašćeni predstavnik u Evropskoj
zajednici / Auktoriserad representant inom EG / Avrupa Topluluğu'ndaki Yetkili Temsilci
Type CF Applied Part / Приложна част тип CF / Aplikovaná část typu CF / Type CF anvendt del /
Anwendungsteil vom Typ CF / Εφαρμοζόμενο μέρος τύπου CF / Parte aplicada de tipo CF / CF-tüüpi
kontaktosa / Tyypin CF liityntäosa / Partie d'application de type CF / Primijenjeni dio, tip CF / CF típusú,
beteggel érintkező alkatrész / Parte applicata di tipo CF / CF tipo taikoma dalis / CF tipa kontaktējošā daļa /
Toegepast onderdeel voldoet aan veiligheidsnorm type CF / Type CF, pasienttilkoblet del / Część typu CF
wchodząca w kontakt z ciałem pacjenta / Peça aplicada do tipo CF / Componentă utilizată în contact cu
pacientul – tip CF / Деталь, находящаяся в контакте с пациентом, тип CF / Aplikovaná časť typu CF / Del
vrste CF / Primenjeni deo tipa CF / Applicerad del av typ CF / CF Tipi Uygulamalı Parça
Equipotentiality / Еквипотенциалност / Ekvipotencialita / Ækvipotentialitet / Potentialausgleich /
Ισοδυναμικότητα / Equipotencialidad / Ekvipotentsiaalsus / Potentiaalintasaus / Équipotentialité / Izjednačenje
potencijala / Ekvipotencialitás / Equipotenzialità / Vienodo potencialo / Ekvipotencialitāte / Equipotentiaal /
Ekvipotensialkontakt / Ekwipotencjalność / Equipotencialidade / Echipotențialitate / Эквипотенциальность /
Ekvipotencialita / Ekvipotencialnost / Ekvipotencijalnost / Ekvipotential / Eş Potansiyellik
Power ON / Включено захранване / Napájení ZAPNUTO / Tændt / Einschalten / Ενεργοποίηση / Encendido /
Toide SEES / Virta kytketty / Marche / Uključivanje / Bekapcsolás / ACCESO / Maitinimas įjungtas / Strāva ir
IESLĒGTA / Inschakelen / Strøm på / Włączanie zasilania / Ligar o sistema / Pornire alimentare / Включение
питания / Napájanie ZAPNUTÉ / Vklop / Napajanje UKLJUČENO / Ström påslagen / Güç AÇIK
Power OFF / Изключено захранване / Napájení VYPNUTO / Slukket / Ausschalten / Απενεργοποίηση /
Apagado / Toide VÄLJAS / Virta katkaistu / Arrêt / Isključivanje / Kikapcsolás / SPENTO / Maitinimas
išjungtas / Strāva ir IZSLĒGTA / Uitschakelen / Strøm av / Wyłączanie zasilania / Desligar a alimentação /
Oprire alimentare / Выключение питания / Napájanie VYPNUTÉ / Izklop / Napajanje ISKLJUČENO / Ström
avstängd / Güç KAPALI
Freeze Timer / Таймер за замразяване / Časovač mrazení / Fryseur / Gefrierzeit-Einstelltaste / Χρονόμετρο
ψύξης / Reloj de congelación / Külmutusaja taimer / Jäädytysaikalaskuri / Horloge de cryoablation / Mjerač
vremena zamrzavanja / Fagyasztásidőzítő / Timer del raffreddamento / Šaldymo laikmatis / Sasaldēšanas
taimeris / Timer voor bevriezen / Frysetidsur / Licznik czasu zamrażania / Temporizador do congelamento /
Cronometru înghețare / Таймер заморозки / Časovač zmrazenia / Merilnik zamrzovanja / Tajmer
zamrzavanja / Frysningstidtagare / Dondurma Zamanlayıcısı
Start Freeze Button / Бутон за начало на замразяването / Tlačítko Spustit mrazení / Knappen Start frysning /
Taste „Frosten starten“ / Κομβίο έναρξης ψύξης (Start Freeze) / Botón Iniciar congelación / Külmutamise
alustamise nupp / Jäädytyksen aloituspainike / Bouton démarrage de la cryoablation / Gumb za pokretanje
zamrzavanja / Fagyasztás indítása gomb / Pulsante Inizia raffreddamento / Šaldymo paleidimo mygtukas /
Poga Start Freeze (Uzsākt sasaldēšanu) / Knop Start Bevriezing / Knapp for start frysing / Przycisk Rozpocznij
zamrażanie / Botão para iniciar o congelamento / Buton Pornire înghețare / Кнопка пуска заморозки / Tlačidlo
Spustiť zmrazovanie / Gumb za začetek zamrzovanja / Taster za pokretanje zamrzavanja / Starta frysningknapp / Dondurmayı Başlat Düğmesi
vi
Vent Button / Бутон за изпускане на налягането / Tlačítko Odpustit plyn / Knappen Udluftning /
Entlüftungstaste / Κομβίο εξαερισμού (Vent) / Botón Ventilación / Ventileerimisnupp / Tyhjennyspainike /
Bouton de dépressurisation / Gumb za ispuštanje plina / Nyomáskiegyenlítés gomb / Pulsante Spurgo / Slėgio
išleidimo mygtukas / Ventilācijas poga / Knop Ontluchting / Avluftingsknapp / Przycisk Odpowietrzenie / Botão
de ventilação / Buton Ventilare / Кнопка сброса давления / Tlačidlo Odvzdušnenie / Gumb za odzračevanje /
Taster za pražnjenje / Luftningsknapp / Tahliye Etme Düğmesi
Buttons for increasing or decreasing the freeze duration / Бутони за увеличаване или намаляване на
продължителността на замразяване / Tlačítka k prodloužení nebo zkrácení doby mrazení / Knapper til at
øge eller mindske frysningsvarigheden / Tasten zum Erhöhen oder Senken der Gefrierdauer / Κομβία αύξησης
ή μείωσης της διάρκειας ψύξης / Botones para aumentar o disminuir la duración de la congelación /
Külmutamise kestuse pikendamise ja lühendamise nupud / Painikkeet, joilla pidennetään ja lyhennetään
jäädytyksen kestoaikaa / Boutons d'augmentation ou de diminution de la durée de cryoablation / Gumbi za
povećavanje ili smanjivanje trajanja zamrzavanja / A fagyasztás időtartamának növelésére és csökkentésére
szolgáló gombok / Pulsanti per aumentare o diminuire la durata del raffreddamento / Mygtukai šaldymo trukmei
padidinti arba sumažinti / Sasaldēšanas laika paildzināšanas vai saīsināšanas pogas / Knoppen voor het
verhogen en verlagen van de bevriezingsduur / Knapper for økning eller reduksjon av frysetid / Przyciski do
zwiększania lub zmniejszania czasu trwania zamrażania / Botões para aumentar e diminuir a duração de
congelamento / Butoane pentru mărirea sau micșorarea duratei de înghețare / Кнопки для увеличения или
уменьшения продолжительности заморозки / Tlačidlá na predĺženie alebo skrátenie doby trvania
zmrazovania / Gumba za povečanje ali zmanjšanje trajanja zamrzovanja / Tasteri za povećavanje ili
smanjivanje trajanja zamrzavanja / Knappar för att öka eller minska frysningstiden / Dondurma süresini artırma
veya azaltma düğmeleri
Buttons for increasing or decreasing the target temperature / Бутони за повишаване или понижаване на
целевата температура / Tlačítka ke zvýšení nebo snížení cílové teploty / Knapper til at øge eller mindske
måltemperaturen / Tasten zum Erhöhen oder Senken der Zieltemperatur / Κομβία αύξησης ή μείωσης της
θερμοκρασίας-στόχου / Botones para aumentar o disminuir la temperatura deseada / Sihttemperatuuri
suurendamise ja vähendamise nupud / Painikkeet, joilla suurennetaan ja pienennetään tavoitelämpötilaa /
Boutons d'augmentation ou de diminution de la température cible / Gumbi za povećavanje ili smanjivanje ciljne
temperature / A célhőmérséklet növelésére és csökkentésére szolgáló gombok / Pulsanti per aumentare o
diminuire la temperatura target / Mygtukai reikalingai tikslinei temperatūrai padidinti arba sumažinti / Mērķa
temperatūras paaugstināšanas vai samazināšanas pogas / Knoppen voor het verhogen en verlagen van de
doeltemperatuur / Knapper for økning eller reduksjon av måltemperatur / Przyciski do zwiększania lub
zmniejszania temperatury docelowej / Botões para aumentar e diminuir a temperatura-alvo / Butoane pentru
mărirea sau micșorarea temperaturii-țintă / Кнопки для увеличения или уменьшения целевой
температуры / Tlačidlá na zvýšenie alebo zníženie cieľovej teploty / Gumba za povečanje ali zmanjšanje ciljne
temperature / Tasteri za povećavanje ili smanjivanje ciljne temperature / Knappar för att höja eller sänka
måltemperaturen / Hedef sıcaklığı artırma veya azaltma düğmeleri
Alignment Symbol / Символ за подравняване / Symbol vyrovnání / Justeringssymbol / Ausrichtungssymbol /
Σύμβολο ευθυγράμμισης / Símbolo de alineación / Joondamise sümbol / Kohdistussymboli / Symbole
d'alignement / Simbol poravnanja / Igazítás szimbólum / Simbolo di allineamento / Lygiuotės simbolis /
Līdzināšanas simbols / Uitlijningssymbool / Justeringssymbol / Symbol wyrównania / Símbolo de alinhamento /
Simbol pentru aliniere / Символ выравнивания / Symbol zarovnania / Simbol za poravnavo / Simbol za
poravnavanje / Inriktningssymbol / Hizalama Sembolü
Target Temperature / Целева температура / Cílová teplota / Måltemperatur / Zieltemperatur / Θερμοκρασίαστόχος / Temperatura deseada / Sihttemperatuur / Tavoitelämpötila / Température cible / Ciljna temperatura /
Célhőmérséklet / Temperatura target / Tikslinė temperatūra / Mērķa temperatūra / Doeltemperatuur /
Måltemperatur / Temperatura docelowa / Temperatura alvo / Temperatură țintă / Целевая температура /
Cieľová teplota / Ciljna temperatura / Ciljna temperatura / Måltemperatur / Hedef Sıcaklık
Stop Freeze Button / Бутон за край на замразяването / Tlačítko Zastavit mrazení / Knappen Stop frysning /
Taste „Frosten stoppen“ / Κομβίο διακοπής ψύξης (Stop Freeze) / Botón Detener congelación / Külmutamise
peatamise nupp / Jäädytyksen lopetuspainike / Bouton Arrêt de la cryoablation / Gumb za prekidanje
zamrzavanja / Fagyasztás leállítása gomb / Pulsante Arresta raffreddamento / Šaldymo sustabdymo
mygtukas / Poga Stop Freeze (Apturēt sasaldēšanu) / Knop Stop Bevriezing / Knapp for stopp frysing /
Przycisk Zatrzymaj zamrażanie / Botão de interrupção do congelamento / Buton Oprire înghețare / Кнопка
остановки заморозки / Tlačidlo Zastaviť zmrazovanie / Gumb za ustavitev zamrzovanja / Taster za
zaustavljanje zamrzavanja / Avbryt frysning-knapp / Dondurmayı Durdur Düğmesi
vii
User Message Indicator / Индикатор за налично съобщение за потребителя / Indikátor hlášení pro
uživatele / Indikator for brugermeddelelser / Anzeige von Benutzermeldungen / Ένδειξη μηνύματος χρήστη /
Indicador de mensaje al usuario / Kasutajateate näidik / Käyttäjäviestin ilmaisin / Témoin de message destiné à
l'utilisateur / Pokazatelj poruke korisniku / Felhasználói üzenet jelzője / Indicatore di messaggi per l'operatore /
Naudotojo pranešimų indikatorius / Lietotāja ziņojumu indikators / Berichtindicator / Brukermeldingsindikator /
Wskaźnik komunikatu dla użytkownika / Indicador de mensagem do utilizador / Indicator de mesaje pentru
utilizator / Индикатор сообщения для пользователя / Indikátor hlásení pre používateľa / Indikator sporočila
za uporabnika / Indikator poruka za korisnika / Indikator för användarmeddelande / Kullanıcı Mesajı Göstergesi
Manufacturing Site / Място на производство / Místo výroby / Fabrikationssted / Produktionsstätte /
Εργοστάσιο κατασκευής / Centro de fabricación / Tootmiskoht / Valmistuspaikka / Site de fabrication / Mjesto
proizvodnje / A gyártás helye / Luogo di fabbricazione / Pagaminimo vieta / Ražotne / Productieplaats /
Produksjonssted / Miejsce produkcji / Local de fabrico / Locul fabricației / Место изготовления / Miesto
výroby / Kraj izdelave / Mesto proizvodnje / Tillverkningsplats / Üretim Yeri
viii
Table of Contents
Table of Contents
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Device Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
2 System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
3 Pre-Op Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4 Performing Cryoablation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5 Post-Op Take Down . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Refrigerant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Refrigerant Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Shipping the Refrigerant Tank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Changing the Refrigerant Tank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Cleaning the Cardioblate CryoFlex Surgical Ablation Console and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Internal Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
8 Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Surgical Cryoablation System Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
How Supplied . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Electromagnetic Emissions and Immunity Declarations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
9 Warranties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Limited Warranty for the Cardioblate® CryoFlex® Surgical Ablation Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Disclaimer of Warranty for the Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Operator's Manual English 1
Chapter 1
Introduction 1
Device Description
The Cardioblate CryoFlex Surgical Ablation Console is a cryoablative surgical device that is used in the cryosurgical
treatment of cardiac arrhythmias. The system utilizes an argon-based cryogen for fast, controlled freezing.
The system consists of the Cardioblate CryoFlex Surgical Ablation Console, connection components and accessories,
and disposable cryoablation probes.
Cryoablation
During a cryoablation procedure, pressurized argon gas flows from the gas tank through the regulator, which maintains
the gas flowing through the control panel at a constant pressure. The pressurized argon gas inside the control panel
flows through a valve, which controls gas delivery to the cryoablation probe through the high-pressure connector on the
front of the control panel. The console is equipped with a vent-valve that relieves the pressure for storage between
uses. As the pressurized argon gas reaches the ablation segment of the probe, it passes through microholes that
cause the pressure to drop dramatically. This pressure drop causes the temperature of the argon gas to decrease and
results in freezing temperatures at the ablation segment of the probe.
Indications
The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures,
including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, and 10-S probes plus the
Cardioblate CryoFlex Clamp and Cardioblate CryoFlex Surgical Ablation Console freeze target tissue and block the
electrical conduction pathways by creating an inflammatory response and cryonecrosis.
Contraindications
The Cardioblate CryoFlex Surgical Ablation Console, Clamps, and Probes are not designed for use inside a beating
heart.
Warnings
■
Refer to product literature included for each disposable device, including cryoablation probes and clamps, for
further instructions and warnings specific to those devices.
■
Cryoablation probes contain pressurized refrigerant during operation. Discontinue treatment immediately if a
breach in the probe is suspected, as this may result in release of pressurized gas and injury to the patient or the
user.
■
Avoid contact between the cryoablation probe and the phrenic nerve to avoid injury.
■
If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop Freeze
button on the control panel.
■
If you are unable to stop the injection, immediately turn the system off by using the power switch located on the
side of the control panel or by disconnecting the power cord.
■
Do not attempt to disconnect the probe or gas line during operation in the freeze mode as the sudden release of
pressure may cause the probe or gas line to recoil, which may injure the operator. The system must be vented prior
to disconnecting the probe and gas line.
■
If the injection of refrigerant spontaneously stops before the preset time on the control panel has elapsed, replace
the probe.
■
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
■
The power cord may be used to disconnect the device from electrical power. Do not position the control panel so
that it is difficult to remove the power cord.
■
Do not modify this equipment.
■
To avoid the risk of electric shock, do not touch the patient when installing or handling the Pressure Sensor Cable.
2 Operator's Manual English
■
Use caution when transporting the CryoFlex Console over rough or uneven surfaces with changes in height greater
than 10 mm.
■
The device should only be used in a hospital environment away from sources of high-intensity electromagnetic
disturbances, such as MRI devices.
■
Use of this device with accessories, transducers, and cables other than those specified or provided by the
manufacturer of this device can result in improper device operation, increased electromagnetic emissions, or
decreased electromagnetic immunity.
■
The emissions characteristics of this device make it suitable for use in industrial areas and hospitals (CISPR 11
class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this device
might not offer adequate protection to radio frequency communication services. The user might need to take
mitigation measures, such as relocating or reorienting the device.
■
Portable radio frequency communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 in) to any part of the device, including cables specified by the
manufacturer. Otherwise, device performance may be degraded.
■
To minimize the potential for RF interference, do not stack or attach additional instrumentation to the device.
■
Power cord and CryoFlex pressure sensor cable length must not exceed 3 m (118 in).
Precautions
Introduction
■
Only appropriately trained personnel in a fully equipped facility should perform cardiac cryoablation procedures.
■
Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or
nitrous oxide.
■
This device is designed for use in an electromagnetic environment and may generate or be susceptible to
electromagnetic interference. Refer to the electromagnetic compatibility section for the recommended environment
for electromagnetic emissions and immunity.
■
Ensure that equipment used with the system is electrically safe and does not expose the patient to hazards.
■
Ensure that all pressure and regulator lines are securely connected.
■
Always turn off the main gas cylinder valve prior to venting the inlet pressure line to ensure that excess pressure is
safely vented.
■
Perform a test injection before placing a probe on tissue to be ablated.
■
Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.
■
To prevent unwanted movement of the Surgical Ablation Console on an incline, position the locking casters on the
low side of the incline.
■
Do not disconnect the probe from the control panel until the procedure is finished, unless the probe needs to be
replaced.
■
Discard all used probes and clamps in accordance with hospital procedures.
Adverse Effects
Potential adverse effects with this device are similar to other cardiac surgery procedures and may include the following:
■
bleeding
■
reoperation
■
extension of extracorporeal bypass
■
heart rhythm disturbances (atrial and/or ventricular)
■
pericardial effusion
■
pericarditis
■
cardiac tamponade
Operator's Manual English 3
Chapter 1
■
■
■
■
■
■
■
■
■
■
■
Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is
unknown whether cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will have such an effect, but as in
all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during cryoablation.
pleural effusion
mediastinitis
conduction disturbances (SA/AV node)
acute ischemic myocardial event
thrombus formation
low cardiac output
stroke
renal, gastrointestinal, or respiratory complications
sepsis
adjacent structural damage
death
4 Operator's Manual English
System Setup
4
3
2
1
7
6
5
System Setup 2
Console
1. Pressure Sensor Cable
2. Regulator
3. Gas Hose
4. Control Panel
5. Argon Gas Tank (stored inside the tank carrier)
6. Probe Connector
7. Tank Carrier
Figure 1.
Surgical cryoablation probes and clamps are used to apply freezing temperatures to the heart. Refer to product
literature included with cryoablation probes for further information. Products that are compatible with the Cardioblate
CryoFlex Surgical Ablation Console include:
■
Cardioblate CryoFlex Surgical Ablation Probe, 7 cm
■
Cardioblate CryoFlex Surgical Ablation Probe, 10 cm
■
Cardioblate CryoFlex 10-S Surgical Ablation Probe, 10 cm
■
Cardioblate CryoFlex Clamp and Surgical Ablation Probe, 10 cm
Note: The probes and clamps are Type CF applied parts and are designed for single patient use. The control panel
can be locked to the tank carrier or used separately. A 3 m (10 ft) power cord is shipped separately.
The tank carrier holds the tank and allows for safe transport and storage of the argon tank. It consists of two pieces:
the front white section holds the control panel, and the back blue section holds the argon gas tank. The two pieces
should be locked together during use and transport.
The regulator attaches the gas tank to the control panel and regulates the pressure of argon gas supplied to the
control panel. The 2.4 m (8 ft) gas hose (shipped separately) connects the gas tank and regulator to the control panel.
The 2 m (6 ft) pressure sensor cable is shipped with the regulator.
Operator's Manual English 5
Chapter 2
1
2
4
5
3
6
7
Control Panel
1. Display Screen: Shows freeze time duration, temperature of ablation segment, and user messages.
2. Freeze Timer Window: Use the black arrow keys to change the duration (in seconds) of the freeze. The timer
on the Display Screen counts up from zero.
3. Target Temperature Window: Use the red and blue arrow keys to increase or decrease the target
temperature.
4. Start Freeze Button: Press and hold for 2 seconds to start the injection of refrigerant into the probe. The
green light above the button remains lit while refrigerant is flowing.
5. Message Indicator: Lights up when there is a message on the Display Screen for the user to read.
6. Stop Freeze Button: Press at any time to stop the injection of refrigerant.
7. Vent Button: Press to depressurize the gas line.
Figure 2. Control Panel
Installation
Caution: Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.
Caution: The Cardioblate CryoFlex Surgical Ablation Console meets the requirements of Underwriters Laboratories
(UL). It is the user’s responsibility after installation to verify and ensure that the system meets the applicable electrical
safety requirements with respect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1,
CAN/CSA C22.2 No. 601.1-1, ANSI / AAMI ES60601-1, and CAN/CSA C22.2 No. 60601-1.
Unpacking
The system and its accessories are shipped in boxes and packed for protection. Upon receipt, open all the boxes to
ensure that all equipment and accessories are included and that there is no evident shipping damage. Manage
disposal in accordance with local statutory regulations.
Gather the following items to assemble the Console:
■
Control Panel, shipped with the Operator's Manual
■
Tank Carrier (blue and white sections)
■
Power Cord appropriate for geography
■
Gas Tank Regulator (supplied with wrench)
■
Pressure Sensor Cable (provided with regulator or available separately)
■
Argon Gas Tank (not supplied by Medtronic; obtain from hospital supplier)
■
Gas Hose
Verify Voltage Setting
This control panel is capable of running 120V or 230V AC power. Inspect the fuse block next to the power switch to
verify that the setting is correct for your location. If the setting is not correct, refer to "Replacing Fuses" in Chapter 6 for
instructions on how to change the voltage setting.
6 Operator's Manual English
System Setup
1
1
1 2 3 4
1 2 3 4
2
3
4
5
6
7
8
9
Figure 3. Fuse Block in 120VAC Configuration
Selecting the Language for the Control Panel
The control panel displays English by default. To change the displayed language, power off the control panel and set
the DIP switches to the desired language as shown in Figure 5.
1. DIP Switches
Figure 4.
1. English
2. French
3. Italian
4. German
5. Danish
6. Spanish
7. Swedish
8. Portuguese
9. Dutch
Figure 5.
Operator's Manual English 7
Chapter 3
1
2
4
5
3
6
7
Pre-Op Setup 3
Caution: Only appropriately trained personnel in a fully equipped facility should perform cardiac cryoablation procedures.
Caution: Ensure that equipment used with the console is electrically safe and does not expose the patient to hazards.
1. Position the Surgical Ablation Console in the desired location. Push down the locks on the front wheels.
Figure 6. Front Wheels
Caution: To prevent unwanted movement of the Surgical Ablation Console on an incline, position the locking casters on
the low side of the incline.
2. Remove the control panel from the console by grasping the handles and lifting straight up until the control panel clears the
hooks on the tank carrier, then tilt the control panel away from the tank carrier and toward the user. Set the control panel on
a table. (The control panel must be removed from the tank carrier to access the back connections.)
Note: The control panel can be operated while mounted on the tank carrier or without a tank carrier.
1. Handle
Figure 7. Control Panel Handle
3. Connect the regulator to the gas tank by attaching the nut on the regulator (Figure 8, number 7) to the port on the tank. Use
the wrench to tighten the nut.
Note: The nut on the North American regulator turns counterclockwise to tighten.
Caution: Ensure that all pressure and regulator lines are securely connected.
4. To connect the gas hose to the regulator, pull back on the outer collar of the gas hose to expose the inner collar. Place the
inner collar over the gas hose stem (Figure 8, number 5) on the regulator and release the outer collar. The connector locks
into place.
1. Regulator
2. Pressure Sensor Cable
3. Pressure Sensor Stem
4. Gas Hose
5. Gas Hose Stem
6. Auxiliary Vent Valve
5. Connect the other end of the gas hose to the metal gas inlet port on the back of the control panel (Figure 9, number 2).
(Both ends of the gas hose are the same.)
8 Operator's Manual English
Figure 8. Regulator and Connections
7. Nut
Pre-Op Setup
1
2
4
3
1
2
3
6. The pressure sensor cable comes attached to the regulator. If it is not attached, line up the 4-pin connector to the pressure
sensor stem (Figure 8, number 3) on the top of regulator and rotate the collar to tighten.
7. To connect the pressure sensor cable to the control panel, push the white plastic connector on the end of the pressure
sensor cable onto the pressure transducer connection (Figure 9, number 3). It will click into place.
1. Gas Hose
2. Gas Inlet Port
3. Pressure Transducer Connection
4. Pressure Sensor Cable
Figure 9. Control Panel Connections
8. Place the control panel back onto the tank carrier or position it on a table in the desired location.
9. Connect the power cable to the control panel, plug the power cord into an outlet, and turn on the power switch.
Note: An optional user-provided equipotentialization conductor may be attached to the equipotentialization connector. The
equipotentialization connector is used to connect the ground of the control panel to the ground of other instruments in a
clinical setting.
1. Equipotentialization Connection
2. Power Switch
3. Power Cord
Figure 10. Power Connections
10. Open the tank valve to begin the flow of gas and begin the self-test.
Figure 11.
Note: Before opening the gas tank, verify that the auxiliary vent valve on the regulator is closed by turning the handle
clockwise (Figure 8). If the auxiliary vent valve is not fully closed, gas will escape when the gas tank is opened.
11. Open the gas tank by turning the knob on the top of the tank counterclockwise.
12. The system performs a self-test then asks the user to attach the probe.
Note: The system will not perform the self-test unless the gas tank is open.
Operator's Manual English 9
Chapter 3
Figure 12.
13. To connect the probe to the control panel, orient the probe connector with the green arrow up (Figure 14) and the red stop
sign down.
14. Push the probe connector into the control panel connector until the grips snap into place. Hold the connector as shown
in Figure 13. Do not squeeze the grips.
Figure 13. Attach Probe
Note: Do not use excessive force to connect the probe. If resistance is felt, manually vent the system as described
in Chapter 6, Maintenance, and try connecting the probe again.
Note: Do not press the top and bottom grips while inserting the probe connector into the control panel. Only one hand is
required to make the connection.
15. Gently tug on the probe connector to ensure it is securely connected.
16. Pull out the single-use black pin on the left side of the probe connector and discard.
10 Operator's Manual English
Figure 14. Remove Pin
Pre-Op Setup
Caution: Do not pull the pin until the probe is securely connected.
Caution: Do not disconnect the probe from the control panel until the procedure is finished, unless the probe needs to be
replaced, as the probe will not function if reconnected.
17. Once the probe is attached, the control panel will display the time (defaults to zero), the temperature in Celsius (starts at
ambient temperature), and an estimated number of minutes of cryoablation that the gas remaining in the tank will permit.
Note: Change the tank if there is not enough gas to complete at least one full procedure. (See Changing the Refrigerant
Tank in Chapter 6 for details.)
Operator's Manual English 11
Chapter 4
1
2
Performing Cryoablation 4
Caution: Always perform a test injection before placing the probe on tissue to be ablated.
1. Perform a test injection with the probe in the air. Press the Start Freeze button for at least 2 seconds to start the injection of
refrigerant.
2. The green light above the Start Freeze button lights up to indicate that refrigerant is flowing.
Figure 15. Start Freeze Button
3. If performing a test injection with the probe alone, the temperature reading on the control panel should drop to −110°C
within 20 seconds if the equipment is operating properly. At the end of the default time (60 seconds), the injection stops
automatically and the temperature rises.
Warning: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop
Freeze button on the console control panel.
Warning: If you are unable to stop the injection, immediately turn the system off by using the power switch located on the
side of the control panel or by disconnecting the power cord.
Warning: Do not attempt to disconnect the probe or gas line during operation in the freeze mode. Always vent the system
at the end of the procedure before removing the gas line.
Note: If the probe needs to be replaced during a procedure, it is not necessary to vent the system. Refer to Step 6
in Chapter 5 for instructions on removing the probe.
4. Shape the probe and adjust the length of the freeze zone (if using the probe alone) by moving the white insulating sleeve
up or down.
1. Ablation Segment
2. White Insulation Sleeve
Figure 16. Surgical Ablation Probe
For instructions on use of specific probes or clamp, refer to the Instructions for Use supplied with those devices.
5. Select the target time and target temperature for cryoablation.
a. The default time for cyroablation is 1 minute. Press the black arrow keys to increase or decrease the ablation time. The
default time can be adjusted before or during an injection.
12 Operator's Manual English
Performing Cryoablation
Figure 17.
b. The default temperature for cryoablation is set to full power (coldest possible temperature), which is displayed as a
dashed line. The lowest targeted temperature that will display in the Target Temperature window is −95°C. Press the
red and blue arrow keys to increase or decrease the targeted temperature.
Figure 18.
6. Position the ablation segment of the probe onto the tissue to be ablated, ensuring all adjacent tissue is protected to avoid
inadvertent freezing.
Warning: Refer to product literature included for each disposable device, including cryoablation probes and clamps, for
further instructions and warnings specific to those devices.
7. Press and hold the Start Freeze button for 2 seconds to start cryoablation.
Note: The timer on the control panel does not start until the temperature on the control panel drops below −40°C.
Warning: Probes contain pressurized refrigerant during operation. Discontinue treatment immediately if a breach in the
probe is suspected, as this may result in release of pressurized gas and possible injury to the patient.
Warning: If the injection of refrigerant spontaneously stops before the default time on the control panel has elapsed,
replace the probe.
Warning: Do not attempt to disconnect the probe or gas line during operation in the freeze mode. Always vent the system
at the end of the procedure before removing the gas line.
8. Freezing stops at the end of the preset time unless it is terminated earlier by pressing the Stop Freeze button.
Figure 19. Stop Freeze Button
Warning: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop
Freeze button on the control panel.
Warning: If you are unable to stop the injection, immediately turn the system off by using the power switch located on the
side of the control panel or by disconnecting the power cord.
9. The system automatically vents after each injection. Venting is signaled by a loud hissing noise.
Operator's Manual English 13
Chapter 5
Post-Op Take Down 5
1. Close the gas tank by turning the knob on the top of the tank clockwise.
Important: The tank must always be closed before venting the system to avoid venting all the gas in the tank.
2. Press the Vent button on the control panel.
3. The display screen will read “Close Gas Tank Valve and Press Vent Button.” Ensure that the gas tank is closed and press
the Vent button again.
Figure 20.
4. The light above the button turns on to indicate that venting has been selected. The display screen will read “System
Venting.” A loud hissing noise will be heard as the gas is vented from the gas line between the tank and the regulator.
5. The auxiliary vent valve on the regulator assembly can also be used to vent any remaining gas in the gas line. Open the
auxiliary vent valve by turning the handle counterclockwise.
Caution: Always turn off the main gas cylinder valve prior to venting the inlet pressure line to ensure that excess pressure
is safely vented.
6. Disconnect the probe from the system.
Figure 21.
a. With one hand, press the top and bottom grips of the probe connector at the same time.
b. With the other hand, push the connector flange ring in slightly.
c. Pull back to disconnect the probe from the control panel connector.
d. Dispose of single-use accessories and probes according to hospital regulations.
7. Turn off the power at the switch on the side of the control panel.
8. Optional: Disconnect the gas hose from the regulator and control panel.
9. Optional: Disconnect the pressure sensor cable from the control panel.
10. Carefully store the reusable accessories.
14 Operator's Manual English
Maintenance
1
2
Maintenance 6
This section describes how to replace the fuses, change the refrigerant tank, and clean the outer surfaces of the console and
its nonsterile accessories.
Caution: Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.
Replacing Fuses
The fuse block is part of the power switch. Use a standard screwdriver to pop out the fuse block insert. Replace blown
fuses using the same amperage rating and physical geometry as the existing fuses. Reinstall the fuse block insert so
that the arrow for the correct voltage lines up with the arrow on the housing. The voltage setting must match the
supplied voltage for your location. Refer to Chapter 8 for correct fuse type.
1. Voltage Setting Arrows
2. Arrow on Housing
Refrigerant
The grade 4.8 argon gas refrigerant can be obtained from local gas suppliers. It must be pressurized as follows and of
a purity of at least 99.998%:
Europe
(50L tank)
31,000 kPa
(4,500 psi or 310 bar)
A tank of argon gas at these pressures can provide approximately 35 minutes (Europe) or 70 minutes (USA) of freeze
time. The control panel sounds an alarm when 2 minutes of gas time remain. At least one spare tank of argon gas
should be readily available for each procedure.
When you receive the gas tanks, check that the labels on the tank identify the gas and the purity. If the labels are
damaged or missing, call the gas supplier for a replacement.
Always move gas tanks carefully. Be sure that the outlet valve is fully closed and the valve protection cap is properly
secured. Always move gas tanks with carts or hand trucks designed for that purpose. Never drop the tanks or allow
them to strike another tank. After moving a tank to its point of use, secure it using stands, clamps, or other securing
devices recommended by the gas supplier.
Refrigerant Usage
■
The console operates with a refrigerant tank that contains high-pressure argon gas. Store and handle the argon
refrigerant tanks according to the hospital gas management policy.
■
Do NOT use refrigerant tanks on anesthetic equipment.
■
Do NOT open the valve on the argon tank until it is properly connected to the regulator and control panel.
Figure 22.
USA
(type BX, approximately 50L)
41,000 kPa
(6,000 psi or 410 bar)
Operator's Manual English 15
Chapter 6
Shipping the Refrigerant Tank
■
Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.
Changing the Refrigerant Tank
The tank carrier holds one tank of refrigerant at a time. To change the tank, you will need:
■
A full refrigerant tank (available from your hospital supplier)
■
An open-ended wrench (supplied with the system)
Caution: Only use Argon gas tanks that meet the requirements of local regulations. In Canada, only use Argon gas
tanks that meet CSA B51 requirements.
Caution: Follow standard guidelines for the safe handling and storage of high-pressure gas cylinders.
The blue section of the tank carrier can function as a dolly for loading and unloading the gas tank.
1. Close the tank by turning the knob on the top of the tank clockwise.
2. Press the Vent button on the control panel. The display screen will read “Close Gas Tank Valve and Press Vent
Button.”
3. Ensure the gas tank is closed and press the Vent button on the control panel a second time. The light above the
button lights up to indicate that venting has been selected. The following message appears on the display screen:
“System Venting”
4. A loud hissing noise will be heard as the gas is vented from the gas line between the tank and the regulator.
5. The auxiliary vent valve on the regulator assembly can also be used to vent any remaining gas in the gas line.
Open the auxiliary vent valve by turning the handle counterclockwise.
Caution: Always turn off the main gas cylinder valve prior to venting the inlet pressure line to ensure that excess
pressure is safely vented.
6. Use the power switch to turn off the control panel and disconnect the power cable.
7. Remove the control panel from the console by grasping the handles and lifting straight up until the control panel
clears the hooks on the tank carrier, then tilt the control panel toward the user. Disconnect the pressure sensor
cable and gas hose from the back of the control panel before moving it to a table.
Warning: ALWAYS remove the control panel from the tank carrier before changing the tank to prevent user harm.
If not, the tank carrier may fall forward when removing the tank.
8. Disconnect the regulator from the tank.
a. Use the supplied wrench to loosen the nut.
Note: The nut on the North American regulator turns clockwise to loosen.
b. Unscrew the nut until the regulator assembly can be separated from the tank.
c. Set the regulator assembly aside.
d. Fit a cap onto the tank valve.
9. Push down the levers on the front wheels of the console to lock the wheels.
10. Unlock the supporting legs of the tank carrier.
a. Pull on the knob at the back of the tank carrier and turn it 90 degrees to lock the knob open (Figure 23).
16 Operator's Manual English
Maintenance
Figure 23.
b. Pull the legs away from the tank carrier to extend them.
c. Release and turn the knob so it snaps into the lower hole on the legs and locks the legs in the extended
position (Figure 24).
Figure 24.
11. On the top of the tank carrier, a toggle clasp attaches to a post to lock the two pieces of the tank carrier together.
Unlock the tank carrier by releasing the black toggle clasp then lifting the hook away from the post (Figure 25).
Repeat on the other side.
Figure 25.
Warning: The tank carrier dolly is heavy. Be ready to take its weight.
Warning: Only use the tank carrier dolly for loading and unloading refrigerant gas tanks. Do not use the tank
carrier to transport refrigerant gas tanks.
12. Separate the dolly from the tank carrier by lowering the dolly until all four wheels are on the ground.
Operator's Manual English 17
Chapter 6
1
2
13. Wheel the dolly away from the front section of the tank carrier.
14. Wheel the dolly to the location of the new refrigerant tank.
15. Stand the dolly up in a vertical position. (The back wheels will now be off the ground.)
16. Unbuckle the black straps holding the empty tank in the dolly.
17. Remove the empty tank from the dolly and set it aside.
18. Set the full tank into the dolly and buckle the straps.
19. Wheel the dolly back to the tank carrier and dock it with the front section. Line up the dolly so the black pegs on
Figure 26.
both sides of the dolly fit into the hooks on the front section (Figure 27). Lift the dolly into a vertical position.
1. Hooks
2. Peg
Figure 27.
20. Lock the tank carrier together by placing the hooks on the top of the dolly over the posts on the front section. Press
the black toggle clasps down to lock the two sections together (Figure 28).
Figure 28.
21. To fold and lock the supporting legs of the dolly, pull and turn the knob on the back of the dolly to retract the legs
back into the tank carrier. Release the knob so it snaps back into the upper hole and locks the legs into place.
22. Connect the regulator assembly to the refrigerant tank.
a. Remove the cap from the full argon tank.
b. Connect the regulator assembly using the supplied wrench.
c. Replace the control panel on the tank carrier.
Cleaning the Cardioblate CryoFlex Surgical Ablation Console and Accessories
Ensure the console power is off and unplugged before continuing.
18 Operator's Manual English
Use a mild solution of soap and water or other suitable nonabrasive hospital cleaning agent to wipe the exterior
surfaces of the console and tank carrier.
Use care when cleaning keypad and display screen. If the control panel is deteriorated or worn, contact Medtronic
Customer Service immediately.
Caution: Do not expose the console, accessories, or electrical connectors to harsh cleaning fluids or solvents.
Internal Maintenance
The Cardioblate CryoFlex Surgical Ablation Console has no internal user serviceable parts or operator adjustments.
Contact Medtronic Customer Service for service contract information.
Maintenance
Operator's Manual English 19
Chapter 7
Troubleshooting 7
Warning: If an unanticipated event occurs, the injection of refrigerant can be stopped at any time by pushing the Stop Freeze
button on the control panel.
Warning: If you are unable to stop the injection, immediately turn the system off by using the power switch located on the side
of the control panel or by disconnecting the power cord.
If the symptom cannot be resolved, contact Medtronic Technical Support at the phone number on the back cover.
Symptom Possible Causes Suggested Actions
No power ■
No time and temperature
readings on the Display
Screen
Probe is difficult to connect ■
Probe is difficult to disconnect
Probe is connected but Display Screen says “0 minutes
of gas remain” or number of
minutes remaining fluctuates
Probe does not freeze ■
Probe is connected but is
unable to inject, or the system does not recognize the
probe
Cannot achieve therapeutic
temperatures and handle is
cold
Cannot achieve therapeutic
temperatures and device
temperature rises
System beeps ■
Power cord is not plugged in correctly
■
Cables and hoses are not securely
attached
■
Gas tank not open
■
Cables and hoses are not securely
attached
■
Probe or clamp is not securely attached
System is pressurized
■
Improper connection
■
Attempting to connect the probe improperly
■
Attempting to disconnect the probe incorrectly
■
System is pressurized
■
Argon tank is not open
■
Argon tank is empty
■
Regulator/pressure sensor is damaged
Start Freeze button not pressed long
enough
■
Wrong kind of gas
■
Gas is not flowing
■
Cable and hose connections are not
secure
■
Improper probe connection; electrical connection is loose/intermittent
■
Pressure sensor cable is loose
■
Argon tank is closed
■
Injection line is blocked or broken
■
Too much blood/fluid in the operating site
■
Using wrong gas (often helium)
2 minutes of gas or less remain in the
tank
■
Check that the power cord is securely plugged into the side of the control
panel.
■
Check that the power cord is plugged into a hospital-grade outlet.
■
Check that all cables and hoses are securely attached.
■
Check that the argon tank is open and properly connected to the regulator.
■
Check that the gas hose and the pressure sensor cable are connected to the
back of the control panel.
■
Check that the probe/clamp is connected to the control panel. Tug on the
cable to ensure that it is securely attached. Ensure that the pin is pulled out.
■
Manually vent the system (see Chapter 5).
■
Gently wiggle connector to connect.
■
Do not press the top and bottom grips while connecting.
■
Do not use excessive force to connect.
■
See Chapter 5, Figure 21
■
Manually vent the system (see Chapter 5).
■
Ensure tank is open.
■
Replace argon tank if empty.
■
Verify regulator and connections.
■
Press the Start Freeze button for 2 seconds to start a freeze.
■
Check the tank label to ensure that the argon gas being used is of the proper
purity and pressure.
■
Check that the gas hose and the pressure sensor cable are connected to the
back of the control panel.
■
Ensure black pin is pulled out.
■
Gently wiggle the connector.
■
If it still will not connect, remove probe and check connector site for damage.
■
Try connecting a second probe. If a second probe will not connect, contact
Medtronic Technical Support.
■
Check pressure sensor cable connection.
■
Ensure tank is open.
■
If frost is forming on handle, connect a second probe.
■
Remove excess fluid.
■
Turn Console off.
■
Change tank to Argon.
■
Verify Argon specs via certificate on tank.
■
Replace Argon tank.
20 Operator's Manual English