ivascular oceanus 35 Instrucciones De Uso página 5

BALLOON CATHETER FOR PERIPHERAL PREDILATION FOR 0.035" GUIDE WIRE.
• Aneurysm or pseudo-aneurysm
• Infections
• Total occlusion of the artery
• Reocclusion of the treated area: restenosis
• Spasm
• Perforation or dissection of the treated area
• Arteriovenous fistula
• Local bleeding with haematoma at the access site
• Hypo/hypertension
• Allergic reactions to materials.
7. How to Use
7.1. Equipment Required
- Heparinized normal saline solution.
- Contrast medium (use contrast media suitable for intravascular use).
- 0.035" guide wire; do not use any other size of guide wire.
- 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 more than 25cm long or of the braided type is used, it may
be necessary to increase its size to avoid rubbing on 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.
7.2. Preparing the Catheter
- Remove the catheter from the protective dispenser. Check that it is the right size. Remove the protec-
tive sheath from the balloon.
- Wash the product with a sterile isotonic saline solution or similar on the outside and inside the channel
through which the guide wire passes, before inserting it into the patient.
- 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 connector port (the side part of the connector).
• 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 key are not properly sealed. If bubbles continue
to be seen after checking the connections, do not use the device. Return it to the manufacturer or
distributor for inspection.
7.3. Technique for Insertion / Treatment
- Position the 0.035" guide wire across the lesion using PTA techniques, using fluoroscopy to determine
its position at all times.
INSTRUCTIONS FOR USE
oceanus 35
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