ivascular oceanus 35 Mode D'emploi page 6

BALLOON CATHETER FOR PERIPHERAL PREDILATION FOR 0.035" GUIDE WIRE.
- Insert the proximal end of the guide into the distal tip of the balloon catheter.
- Carefully advance the balloon catheter on the guide wire, through the introducer and with the aid of
fluoroscopy, until it reaches the area to be treated. In the event that the balloon catheter selected can-
not be placed inside the lesion, take a smaller size to predilate the lesion.
- Connect the inflation device (1/3 of its capacity of contract 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 pres-
sure (RBP) on the label and the compliance curve.
- Apply pressure for 30-60 seconds depending on the lesion.
- Draw the plunger on the inflation device back to deflate the balloon. Keep up the negative pressure
for 20 to 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.
- Remove the guide wire.
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.
STANDARDISED SYMBOLS FOR USE IN LABELLING MEDICAL DEVICES
Catalogue reference
Manufacturer
Consult instructions
for use
6
INSTRUCTIONS FOR USE
(EN 980:2008 STANDARD)
Batch no.
Sterilised 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-sterilise
STERILIZE
STERILIZE STERILIZE
oceanus 35
Keep away from sunlight
Keep dry
2
2
2
Do not use if the pack is
damaged