ivascular NC xperience Gebrauchshinweise Seite 4

BALLOON CATHETER FOR CORONARY DILATATION, WITH HYDROPHILIC COATING
- Do not rotate the catheter with the guide turned more than one revolution.
- Do not expose the product to organic solvents or to contrast media unsuitable for intravascular use.
5. Precautions
- Administer suitable medical therapy to the patient: anticoagulants, vasodilators, etc., in accordance
with the procedure for inserting coronary 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.
- 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 inserter be removed as a single unit.
- 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 recommended burst pressure (RBP) as the balloon could burst.
- Store in a cool, dry place away from direct sunlight.
- After use, this product may represent a biohazard. Handle and discard it according to accepted medical
practice and applicable local, state and federal laws and regulations.
6. Possible Adverse Effects / Complications
The possible adverse effects and/or complication which might arise before, during or after the procedure
include the following:
- Death
- Acute myocardial infarction
- Unstable angina
- Ictus / embolism / thrombosis
- Coronary artery spasms
- Haemodynamic deterioration
- Arrhythmia
- Aneurysm or pseudoaneurysm
- Infections
- Total occlusion of the artery
- Reocclusion of the area treated
- Perforation or dissection of the area treated
- Arteriovenous fistula
- Local haemorrhaging with haematoma at the access site
- Allergy to materials
7. How to Use
7.1. Equipment Required
- Heparinised normal saline solution
- Contrast medium (use contrast media suitable for intravascular use)
- Medication suitable for the procedure
- 0.014" guide wire; do not use any other size of guide wire
- Inserter with a haemostatic valve
- Guide catheter
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INSTRUCTIONS FOR USE.
NC xperience