Vascular Restorer CoCr Instructions D'utilisation page 8

therapies for living
- With negative pressure in the inflation device and with the guidewire still in position, withdraw the
catheter from the lesion. Keep the guidewire across the dilated stenosis
- Perform an angiography to confirm the stent's correct positioning.
- Maintain the guide across the dilated stenosis for 30 minutes after the angioplasty. In case a throm-
bus is visualized around the stent, administer thrombolytic agents. When the angiography confirms
dilatation, carefully withdraw the guidewire.
- Leave the introducer in situ until the haemodynamic profile is back to normal. Suture if necessary,
in the usual manner.
Further dilation of stented segments
If the stent size with respect the vessel is insufficient, the technique of stent post-dilation may be ap-
plied with the delivery system thereof or with a larger balloon. To this end, a balloon catheter is inserted
in the stent area (it might be non-distensible) and the dilatation is performed according to the manufac-
turer's recommendation.
As an additional recommendation, a "small stent" must not be post-dilated beyond 7 mm, a "medium
stent" must not be post-dilated beyond 9 mm and a "large stent ", must not be post-dilated beyond 11
mm.
Withdrawing an unexpanded stent
If the stent does not go across the lesion, it may be necessary to withdraw it unexpanded. To this end,
follow the instructions recommended in the precautions in this leaflet and withdraw the system as a
single unit.
8. Warranty
The device and all its components have been designed, manufactured, tested and packed with a maximum
level of precaution. LVD Biotech warrants the device until its expiration date, provided the packaging is not
broken, tampered with or damaged.
STANDARDIZED SYMBOLS FOR USE IN LABELLING MEDICAL DEVICES
Catalogue reference
Manufacturer
Consult instructions
for use
8
INSTRUCTIONS FOR USE
PERIPHERAL STENT SYSTEM CoCr
(EN 980:2008 STANDARD)
Batch no.
Sterilized with ethylene
oxide
2
2
STERILIZE
STERILIZE
2
Do no re-use
STERILIZE
Expiry date
Limitation in storage
temperature
2 2
2
2
STERILIZE
STERILIZE STERILIZE
STERILIZE
STERILIZE STERILIZE
2 2
Do not re-sterilize
STERILIZE
STERILIZE STERILIZE
restorer
Keep away from sunlight
Keep dry
2
2
2
Do not use if the pack is
damaged