Table des Matières
Publicité
Les langues disponibles
Les langues disponibles
BALLOON CATHETER FOR PERIPHERAL PREDILATION FOR 0.035" GUIDE WIRE.
1. Description of the Product
The balloon catheter is a dual lumen catheter from the connector to the tip, also known as OTW, designed
for percutaneous transluminal angioplasty of peripheral arteries.
The catheter has two lumens body from the connector to the tip.
On the distal part of the catheter, before the tip, is located the balloon or inflatable segment to different
pressures. The balloon dilates the artery when is inflated by means of infusion of contrast liquid inside it.
The connector is Y-shaped, with two ports:
- The side port allows contrast liquid passage to dilate the balloon.
- The straight port intended for guide wire insertion. The guide wire is inserted into the connector port
and comes out of the tip of the catheter to reach the lesion.
There is likewise a lumen through which the guide wire runs and a lumen through which contrast liquid
enters the balloon, directly connected to each of the ports in the luer or connector.
The maximum diameter of the guide wire must not exceed 0.89mm = 0.035 inches.
The useful length of the catheter is 80cm or 140cm depending on the item reference.
The balloon is supplied in the following lengths and diameters:
20
40
60
80
120
150
200
The balloon is intended to reach different diameters at different pressures (according to the compliance
curve shown on the primary packaging).
To inflate the balloon, the connector inflation port must be connected to an inflation device. The balloon is
inflated to predictable diameters with the pressure shown by the manometer. Two radiopaque markers are
located at each end of the balloon in order to mark its length and help the user to see the catheter while
inside the patient.
At the distal end is the tip, which is rounded and atraumatic in shape in order to avoid damaging the arteries
while it is being advanced.
Contents
- One OTW catheter covered by protection sheath for the balloon, inserted into a dispenser in a
sterile bag.
- One card with the compliance curve showing the nominal inflation pressure and the recommended
maximum pressure.
- One leaflet with instructions for use.
2. Indications
Indicated for dilation of stenosis located in the renal, iliac, femoral, popliteal and infrapopliteal arteries, and
for treating obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
3. Contraindications
Inability to cross lesion with a guide wire.
INSTRUCTIONS FOR USE
BALLOON DIAMETERS (mm)
3
4
5
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
6
7
8
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
oceanus 35
9
10
12
X
X
X
X
X
X
X
X
X
X
3
Publicité
Table des Matières
