ivascular luminor 18 Instructions D'utilisation page 5

PACLITAXEL ELUTING PERIPHERAL BALLOON DILATATION CATHETER,
Nevertheless, caution must be exercised when CYP3A4 or CYP2C8 substrates (such as terfenadine, cyclo-
sporin, lovastatin, midazolam y ondansetron)or drugs with high PPB (Plasma Protein Binding) are adminis-
tered concomitantly.
8. How to Use
8.1 Equipment Required
- Heparinized normal saline solution
- Contrast medium (use contrast media suitable for intravascular use)
- 0.018" guide wire (secondarily 0.014")
- Introducer with a haemostatic valve of the size specified on the label. Do not use smaller sizes as
these might damage the catheter. If an introducer is used that is greater than 25 cm in length or
that has a mesh configuration, it may be necessary to increase the size of the introducer to avoid
scratching the catheter
- Three-way stopcock
- 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. Inspect the catheter, if any abnormality is no-
ticed, do not use it. 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
extension 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 nega-
tive pressure, this may be a clear indication that the balloon catheter has leaks, is broken or the
connections 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 manu-
facturer or distributor for inspection.
8.3 Technique for Insertion / Treatment
- Position the 0.018" guide wire across the lesion using PTA techniques, using fluoroscopy to deter-
mine its position at all times. If a guidewire measuring 0.014" was placed previously, it is not neces-
sary to remove it since the catheter is also compatible with a guidewire of this size.
- 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 coat-
ing 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 (1/2-1/3 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.
FOR 0.018" GUIDEWIRE
luminor 18
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