ivascular oceanus 18 Mode D'emploi page 5

BALLOON CATHETER FOR PERIPHERAL PREDILATION,
FOR 0.018" GUIDE WIRE, WITH HYDROPHILIC COATING
6. Possible Adverse Effects / Complications
The possible adverse effects and/or complications which might arise before, during or after the procedure
include the following:
• Death
• Ictus / embolism / thrombosis
• Haemodynamic deterioration
• Acute elastic recoil
• Arrhythmia
• Aneurysm or pseudo-aneurysm
• Infections
• Total occlusion of the artery
• 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).
- 0.018" guidewire. Alternatively 0.014".
- Introducer with a haemostatic valve of The size specified on The label. Do not use smaller sizes as these
might damage The catheter.
- Three-way stopcock.
- Line extensions.
- 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. Examine the catheter, if there is any anomaly
do not use it. Check that it is the right size. Gently remove the protective sheath and stylet from
the balloon."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 air from the whole system, connectors and pump before starting inflation:
• Attach a three-way stopcock to the contrast liquid port (the side part of the connector). An
extension line could be optionally placed between the balloon connector and the three-way
stopcock.
• 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 negative
pressure, this may be a clear indication that the balloon catheter has leaks, is broken or the connec-
tions between the syringe and the three-way stopcock are not properly closed. If bubbles continue
INSTRUCTIONS FOR USE
oceanus 18
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