Balloon Catheter For Coronary Dilatation, With Hydrophilic Coating - Ivascular Nc Xperience Gebrauchshinweise
Ballonkatheter für koronare dilatation, mit hydrophiler beschichtung
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Verfügbare Sprachen
BALLOON CATHETER FOR CORONARY DILATATION, WITH HYDROPHILIC COATING
1. Description of the Product
The NC Xperience balloon catheter for coronary dilatation is a rapid-exchange catheter, also referred to as
RX, because it features a single proximal lumen and dual coaxial distal lumen designed for percutaneous
transluminal angioplasty of the coronary arteries.
At the distal end of the catheter, before the tip, is the balloon or segment inflatable to different pressures
which dilates the artery when inflated by means of an infusion of contrast liquid inside it. The balloon is
designed to provide an inflatable segment of known diameter and length at the pressures recommended.
The catheter ends in a cone-shaped tip.
The body of the catheter features a combination of a single lumen at the proximal end and dual lumen at
the distal end.
- The single lumen at the proximal end allows contrast liquid to pass through between the proximal luer-
lock connector and the balloon in order to inflate the balloon. This lumen is connected to the distal
contrast liquid lumen at the end of the balloon.
- The coaxial dual lumen at the distal end has two functions:
• a lumen to carry the contrast liquid used to inflate the balloon, connected to the proximal lumen
• the guide wire passes through the other lumen to facilitate and allow the passage of the catheter
towards and through the stenosis to be dilated.
There are marks on the body of the catheter to help calculate the position of the catheter in relation to the
end of the guiding catheter (the marker located closer to the catheter luer-lock connector is for femoral
guiding catheters and the one further away is for brachial guiding catheters).
The distal part of the catheter is covered in a durable hydrophilic coating to lubricate the catheter so that it
can navigate through the arteries.
The maximum diameter of the guide wire must be no more than 0.36 mm = 0.014". The usable catheter
is 142 cm long. The balloon is preset to reach different diameters at different pressures (according to the
compliance curve shown on the primary packaging). To inflate the balloon, the proximal luer-lock connec-
tor must be connected to a manual pump fitted with a manometer. The balloon is inflated to predictable
diameters with the pressure shown by the manometer. On each end of the balloon, a radiopaque marker is
included in order to delineate the length and to help the user to know its location whenever it is inside the
patient. At the distal end of the balloon is the tip, which is rounded and atraumatic in shape in order to avoid
damaging the arteries while it is being advanced.
The NC Xperience product is sold under different reference numbers / variants, depending on the dimen-
sions of the balloon:
BALLOON DIMENSIONS
2.00
2.25
2.50
Diameters
2.75
(mm)
3.00
3.25
3.50
3.75
INSTRUCTIONS FOR USE.
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NC xperience
Lengths (mm)
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