ivascular luminor 14 m Instructions D'utilisation page 5

INSTRUCTIONS FOR USE. PACLITAXEL ELUTING
PERIPHERAL BALLOON DILATATION CATHETER, FOR 0.014" GUIDEWIRE
these might damage the catheter.
- Three-way stopcock
- Line extensions
- Inflation device (manual pump with built-in manometer)
- Several standard 10-20cc syringes with saline solution for washing the system
8.2 Preparing the Catheter
- In case of occlusion or very calcified lesions, it is recommended to predilate the lesion with a con-
ventional balloon, without drug.
- Remove the catheter from the protective dispenser. Check that it is the right size. Gently remove the
protective sheath and stylet from the balloon.
- Connect a 10ml syringe containing sterile saline solution to the port for the guide wire (straight part
of the connector) and irrigate the lumen until the liquid comes out of the tip.
- Purge the whole system of air.
• Attach a three-way stopcock to the contrast liquid port (the side part of the connector). An exten-
sion line could be optionally placed between the balloon connector and the three-way stopcock.
• Close the air passage through the balloon
• Attach a 10-20ml syringe with a third part of saline solution to the three-way stopcock.
• Open the passage in the three-way stopcock between the syringe and the catheter
• With the syringe in a vertical position, withdraw the plunger upwards allowing the air bubbles
to exit to the liquid.
• When bubbles stop coming in, close the three-way stopcock at the catheter end and remove
the syringe
DANGER: If bubbles do not stop coming from the catheter into the syringe after 3 minutes of negative
pressure, this may be a clear indication that the balloon catheter has leaks, is broken or the connec-
tions between the syringe and the three-way stopcock are not properly closed. If bubbles continue
to be seen after checking the connections, do not use the device. Return it to the manufacturer or
distributor for inspection.
8.3 Technique for Insertion / Treatment
- Position the 0.014" guide wire across the lesion using PTA techniques, using fluoroscopy to deter-
mine its position at all times.
- Insert the proximal end of the guide wire into the distal tip of the balloon catheter.
- Advance carefully the balloon catheter along the guidewire, through the guide catheter and with the
help of flouroscopy, until the area to be treated is reached. Extreme care must be exercised when
the balloon catheter is passed through the hemostatic valve to make sure that the drug coating
is not damaged. In case the balloon catheter chosen cannot be placed inside the lesion, choose a
smaller size of a drugless conventional balloon in order to predilate the lesion.
- Connect the inflation device (1/3 of its capacity of contrast liquid mixture: saline solution) to the
three-way stopcock and open the passage between the balloon and the inflation device.
- Apply pressure to the inflation device so that the balloon inflates. Do not exceed the rated burst
pressure (RBP) on the label and the compliance curve.
- Keep the pressure for 30-60 seconds for an optimal release of the drug. Most of the drug is released
in the first 30 seconds of inflation but, in order to optimize the dilation of the lesion, it is possible to
use longer inflation times greater than 1 minute at the operator's discretion.
- Draw the plunger on the inflation device back to deflate the balloon. Keep up the negative pressure
for between 20 and 60 seconds depending on the size of the balloon. Make sure the balloon is fully
deflated (by means of fluoroscopy) before moving the catheter.
- With negative pressure in the inflation device and with the guide wire in position, carefully retract
the catheter until it can be removed through the introducer.
- Inject contrast liquid through the introducer to check the treated lesion before removing the guide wire.
luminor 14 m
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