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3

Inflating the Balloon Catheter

1.  Fill the inflation device (

e

agle

™ inflation device) with sterile, liquid media.

2.  Attach the inflation device to the balloon lumen.

3.  Open the stopcock and inflate the balloon.

4.  Once dilation has been attained, advance the sheath over the balloon.

Warning:  Do not use air or any gaseous substances as a balloon inflation media, always use sterile 

liquid media.

 

Note: The use of an inflation device with a pressure gauge is highly recommended to make sure  

adequate pressure is applied and the maximum limits of the balloon are not exceeded.

 

Note: Slight reduction in balloon pressure may be required if resistance is encountered when advancing 

the sheath over the balloon.

Caution:  Do not exceed the recommended rated burst pressure (RBP) for this device.  Balloon rupture may 

occur if the RBP rating is exceeded.  Please refer to the device label for the recommended RBP.

Deflating the Balloon Catheter

Deflate the balloon using an inflation device.  Since deflation times vary based on balloon sizes and lengths, 

check fluoroscopically to confirm deflation before attempting to withdraw.

1.  Attach the inflation device (

e

agle

™ inflation device) and remove the solution from the balloon by pulling 

back on the inflation device.

2.  Remove the inflation device from the balloon catheter.  This will allow ambient pressure to enter, 

relaxing the balloon.

3.  Gently withdraw the catheter.  Use of a gentle counterclockwise twisting motion is recommended when 

removing the catheter.

Warning:  If resistance is felt when removing either the catheter or the guidewire from the working 

sheath, stop and consider removing them as a single unit to prevent damage to product.  Applying 

excessive force to the catheter can result in tip breakage or balloon separation.

Using the Refolding Tool

The balloon catheter is supplied with a refolding tool.  This aids in preparing the balloon for another insertion 

during the procedure. To use:

1.  Manually compress the balloon.

2.  Position the refolding tool at one end.

3.  Twist the refolding tool counter clockwise and push down on the balloon until it goes the entire length of 

the balloon.

4.  Once the balloon is folded, remove the refolding tool and proceed with the procedure.

 

Storage

Store in a cool, dry and dark place.  Do not store near radiation or ultraviolet light sources as these may 

damage product materials.

Bard, Eagle and X-Force are trademarks and/or registered trademarks of C. R. Bard, Inc.

Copyright ©2017 C. R. Bard, Inc.  All Rights Reserved.

Содержание X-Force N30

Страница 1: ...an Deutsch 8 Italian Italiano 10 Spanish Espa ol 12 Dutch Nederlands 14 Portuguese Portugu s 16 Greek 18 Danish Dansk 20 Swedish Svenska 22 Finnish Suomi 24 Norwegian Norsk 26 Polish Polski 28 Hungari...

Страница 2: ...ristics of the device which may lead to device failure and or lead to injury illness or death of the patient Precautions Only a physician who has an understanding of the clinical applications technica...

Страница 3: ...gle inflation device and remove the solution from the balloon by pulling back on the inflation device 2 Remove the inflation device from the balloon catheter This will allow ambient pressure to enter...

Страница 4: ...ue d infection pour le patient ou l utilisateur compromettre l int grit structurale et ou le mat riau essentiel et les caract ristiques de conception du dispositif ce qui est susceptible de conduire u...

Страница 5: ...ment d pend de la taille et de la longueur du ballonnet v rifier le d gonflement par radioscopie pour confirmer qu il est d gonfl avant d essayer de le retirer 1 Fixer le dispositif de gonflement disp...

Страница 6: ...Zum Aufblasen des Ballons d rfen weder Luft noch gasf rmige Substanzen sondern nur sterile fl ssige Medien verwendet werden Dieses Produkt ist nur zur einmaligen Verwendung vorgesehen Kein Teil dieses...

Страница 7: ...finden sich auf dem Etikett des Produkts Entleeren des Ballonkatheters Zum Entleeren des Ballons eine Aufblasvorrichtung verwenden Da die zum Entleeren ben tigte Zeit je nach Gr e und L nge des Ballon...

Страница 8: ...ns fare uso sempre di mezzi liquidi sterili Il dispositivo monouso Non risterilizzare alcuna porzione di questo dispositivo Il riutilizzo e o il riconfezionamento possono creare un rischio di infezion...

Страница 9: ...are il palloncino mediante un dispositivo di insufflazione Poich i tempi di desufflazione variano a seconda delle dimensioni e della lunghezza del palloncino prima di tentare la ritrazione del cateter...

Страница 10: ...ncias gaseosas como medios de insuflaci n del bal n use siempre medios l quidos est riles Se trata de un dispositivo de un solo uso No reesterilizar ninguna parte de este dispositivo La reutilizaci n...

Страница 11: ...le el bal n utilizando un dispositivo de insuflaci n Puesto que el tiempo de desinflado var a en funci n del tama o y la longitud del bal n realice una comprobaci n radiosc pica para confirmar si se h...

Страница 12: ...andere gassen als opblaasmedium voor de ballon maar altijd steriele vloeistoffen Dit is een hulpmiddel voor eenmalig gebruik Geen enkel onderdeel van dit hulpmiddel mag opnieuw worden gesteriliseerd...

Страница 13: ...allon leeglopen met een opblaashulpmiddel Aangezien de tijd die hiervoor nodig is wisselt met de dikte en lengte van de ballon moet u onder doorlichting bevestigen dat de ballon leeg is alvorens te pr...

Страница 14: ...ncias gasosas como meio para insuflar o bal o utilize sempre meio l quido est ril Este dispositivo de utiliza o nica N o reesterilizar nenhuma parte deste dispositivo A reutiliza o e ou reembalagem p...

Страница 15: ...ver qual a RBP recomendada Desinsufla o do cateter com bal o Desinsufle o bal o utilizando um dispositivo de insufla o Como os tempos de desinsufla o variam com base nos tamanhos e comprimentos dos b...

Страница 16: ...16 Greek X Force X Force 24 8mm 30Fr 10mm XX ATM 0 97 mm 0 038 10 atm X Force X Force X Force X Force 1 2 3 4 5 3 4...

Страница 17: ...17 1 2 0 97 mm 0 038 1 Eagle 2 3 4 RBP RBP RBP 1 Eagle 2 3 1 2 3 4 Bard Eagle X Force C R Bard Inc Copyright 2017 C R Bard Inc...

Страница 18: ...ler v sentlige materiale og designegenskaber s ledes at anordningen risikerer at svigte og eller l dere eller inficere patienten og i v rste fald medf re dennes d d Forholdsregler Kun en l ge som kend...

Страница 19: ...tningsanordningen Eagle og t m opl sningen ud af ballonen ved at tr kke tilbage p oppustningsanordningen 2 Fjern oppustningsanordningen fra ballonkateteret Hermed tr nger det omgivende tryk ind og bal...

Страница 20: ...ruktionsegenskaper vilket kan leda till att produkten inte fungerar och eller till att patienten skadas insjuknar eller avlider rn eng ngsprodukt Ingen del av denna enhet f r omsteriliseras teranv ndn...

Страница 21: ...a bort v tskan fr n ballongen genom att dra uppumpningsanordningen bak t 2 Ta bort uppumpningsanordningen fr n ballongkatetern Detta g r s att omgivningstrycket kommer in i ballongen vilket medf r att...

Страница 22: ...kkoutumiseen tai pallon irtoamiseen l k yt pallon t ytt misess ilmaa tai mit n kaasumaisia aineita vaan k yt aina steriili nestett Kertak ytt inen laite l steriloi uudestaan mit n t m n laitteen osaa...

Страница 23: ...o suositeltu RBP laitteen etiketist Pallokatetrin tyhjent minen Tyhjenn pallo t ytt laitteella Koska tyhjennysaika vaihtelee pallon koon ja pituuden mukaan tarkista tyhjentyminen fluoroskooppisesti en...

Страница 24: ...g eller helt vesentlige material og designegenskaper Dette kan f re til at anordningen svikter og eller at pasienten blir utsatt for skader sykdom eller d r Forholdsregler Bare en lege med kunnskap om...

Страница 25: ...Eagle inflateringsanordning og fjern oppl sningen fra ballongen ved trekke tilbake p inflateringsanordningen 2 Fjern inflateringsanordningen fra ballongkateteret Dette gj r at ambient trykk kommer inn...

Страница 26: ...spowodowa z amanie ko c wki cewnika lub oderwanie balonu Do nape niania balonu nie nale y stosowa powietrza ani innych gaz w w tym celu zawsze trzeba u ywa ja owej p ynnej substancji To jest urz dzen...

Страница 27: ...Opr nianie cewnika balonowego Za pomoc urz dzenia do nape niania nale y opr ni balon Poniewa czas opr niania jest zale ny od rednicy i d ugo ci balonu przed pr b usuni cia cewnika trzeba sprawdzi za p...

Страница 28: ...v sa c lj b l mindig kiz r lag steriliz lt cseppfoly s k zeget alkalmazzon Egyszer haszn latos eszk z Ne steriliz lja jra a k sz l k egyetlen r sz t sem Az jrafelhaszn l s s vagy jracsomagol s fert z...

Страница 29: ...zt se A ballon leereszt s re a felf v s ra szolg l eszk zt kell haszn lni Mivel a leereszt shez sz ks ges id tartam a ballon m ret t l s hossz t l f gg en v ltozik ellen rizze fluoroszk pos m don a le...

Страница 30: ...paln m dium Tento prost edek je ur en pouze k jednor zov mu pou it Neprov d jte resterilizaci dn sti tohoto prost edku Opakovan pou it prost edku a nebo jeho op tovn zabalen m e v st k riziku infekce...

Страница 31: ...etru K deflaci bal nku pou ijte infla n ho za zen Doba deflace z le na velikosti bal nku a jeho d lce proto p ed pokusem o extrakci katetru v dy ov te jeho deflaci pomoc fluoroskopu 1 P ipojte infla n...

Страница 32: ...i bir par as n tekrar sterilize etmeyiniz Tekrar kullanma ve veya tekrar ambalajlama hasta veya kullan c da enfeksiyon riski olu turabilir cihaz n yap sal b t nl n ve veya elzem materyal ve tasar m ze...

Страница 33: ...cihaz kullanarak s nd r n z S nd rme s releri balonun b y kl ne ve uzunlu una g re de i mektedir Dolay s yla ekilmeden nce s nd rmenin kesinle ti ini floroskopik olarak kontrol ediniz 1 i irme cihaz...

Страница 34: ...hvis pakningen er beskadiget Anv nd inte om f rpackningen r skadad l k yt jos pakkaus on vaurioitunut M ikke brukes dersom pakningen er skadet Nie stosowa je li opakowanie zosta o uszkodzone Ne haszn...

Страница 35: ...oraz obowi zuj cymi przepisami i procedurami Haszn lat ut n a term k potenci lis biol giai vesz lyt jelenthet Kezel se s megsemmis t se sor n a bev lt orvosi gyakorlatnak s a vonatkoz helyi llami s s...

Страница 36: ...r ln z kon USA omezuje toto za zen na prodej l ka em nebo na l ka sk p edpis Uyar Federal yasa A B D bu malzemenin sat n n bir doktor taraf ndan ya da onun emriyle yap lmas n art ko ar Packaging compl...

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