ivascular oceanus 18 Mode D'emploi page 6

FOR 0.018" GUIDE WIRE, WITH HYDROPHILIC COATING
to be seen after checking the connections, do not use the device. Return it to the manufacturer or
distributor for inspection.
- In order to activate the hydrophilic coating, it is recommended to wet the catheter with a sterile saline
solution immediately prior to its insertion through the introducer sheath.
7.3. Technique for Insertion / Treatment
- Position the 0.018" guide wire across the lesion using PTA techniques, using fluoroscopy to determine
its position at all times. If previously placed a 0.014"" guide there is no need to remove it, as the
catheter is also compatible with that size.
- Insert the proximal end of the guide wire 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. Do not allow advance of the product without
guidewire inside. In the event that the balloon catheter selected cannot be placed inside the lesion,
take a smaller size 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.
- 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 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.
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
6
INSTRUCTIONS FOR USE
BALLOON CATHETER FOR PERIPHERAL PREDILATION,
(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
oceanus 18
Keep away from sunlight
Keep dry
2
2
2
Do not use if the pack is
damaged