ivascular luminor 18 Instructions D'utilisation page 6

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PACLITAXEL ELUTING PERIPHERAL BALLOON DILATATION CATHETER,

- 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.

- It is recommended that double antiplatelet therapy be administered for a minimum of four weeks

after the intervention, and the treatment may be prolonged at the operator's discretion.

9. Warranty

The device and all its components have been designed, manufactured, tested and packed with all precau-

tionary measures. LVD Biotech guarantees the product up to its expiry date providing its packaging is not

broken, tampered with or damaged.

STANDARDIZED SYMBOLS FOR USE IN LABELLING MEDICAL DEVICES

Catalogue reference

Manufacturer

Consult instructions

for use

FOR 0.018" GUIDEWIRE

(EN 980:2008 STANDARD)

Batch no.

Sterilized with ethylene

oxide

STERILIZE

Do not re-use

STERILIZE

Expiry date

Limitation in storage

temperature

STERILIZE

Do not re-sterilize

STERILIZE

luminor 18

Keep away from sunlight

Keep dry

Do not use if the pack is

damaged