ivascular oceanus 35 Instrucciones De Uso página 4

BALLOON CATHETER FOR PERIPHERAL PREDILATION FOR 0.035" GUIDE WIRE.
4. Warnings
- The device should only be used by experienced doctors in the percutaneous transluminal angioplasty
(PTA) technique.
- The percutaneous procedure must be carried out in hospitals equipped with emergency facilities to
conduct open heart surgery or hospitals with easy access to other hospitals where this type of opera-
tion can be performed.
- The product is for single use. It must not be re-sterilised or re-used once the procedure has been com-
pleted. Re-using the product in another patient may lead to cross contamination, infection or transmis-
sion of infectious diseases from one patient to another. Re-use of the product may cause alterations
to it and affect its effectiveness.
- The product is supplied sterile. Check the expiry date and do not use products which are past this date.
- Inspect the packaging before opening it. If there are any defects or the packaging is damaged, do not
use the product.
- Use aseptic techniques when the product is taken out of the primary packaging.
- Select the balloon diameter according to the diameter of the artery to be treated. Do not insert a bal-
loon with a diameter larger than the artery to be treated.
- Do not dry with gauze.
- Do not expose the product to organic solvents or to contrast media not suitable for intravascular use.
- Do not use air or gaseous media to inflate the balloon.
- Advance the product on the guide wire using fluoroscopy. Do not allow the product to advance without
the guide wire inside it.
- Do not manipulate, advance or retract either the catheter or the wire guide while the balloon is in-
flated.
5. Precautions
- Administer suitable medical therapy to the patient: anticoagulants, vasodilators, etc., in accordance
with the procedure for inserting intravascular catheters.
- Before use, check the size and suitability of the catheter for its intended use.
- Proceed with extreme care so as not to damage the catheter while advancing it.
- The balloon must be inflated with a mixture of saline solution and contrast liquid (preferably 50/50,
though the proportion of contrast liquid can be reduced in large balloons).
- Do not exceed the rated burst pressure (RBP) as the balloon could burst.
- If any resistance is noted during advance, stop and determine its cause before continuing.
- If any resistance to withdrawing the catheter is noted, it is recommended that the balloon catheter, the
guide wire and introducer be removed as a single unit.
- Store in a cool, dry place away from direct sunlight.
- After use, this product may represent a biohazard. Handle and dispose it in accordance with accepted
medical practices and pertinent local, state or federal laws and regulations.
6. Possible Adverse Effect / 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
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INSTRUCTIONS FOR USE
oceanus 35