Contraindications - Ivascular Nc Xperience Gebrauchshinweise

BALLOON CATHETER FOR CORONARY DILATATION, WITH HYDROPHILIC COATING
BALLOON DIMENSIONS
4.00
Diameters
4.50
(mm)
5.00
Content
- One rapid-exchange balloon catheter covered by protection for the balloon and a stylet in the guide
wire lumen, inserted into a dispenser and packed in a sterile bag
- One card with the compliance curve showing the working range of pressures
- One leaflet with instructions for use
2. Indications
NC Xperience balloon catheter is suitable for:
- Balloon dilatation of the stenotic portion of a coronary artery or of stenosis of bypass grafts replacing
coronary arteries, in order to improve myocardial perfusion, especially in hard lesions that require bal-
loons with high burst pressure.
- Post-dilatation, following implantation of a stent in the area where it has been placed for the purpose
of helping to position it against the vessel and improve its angiographic result.

3. Contraindications

Unprotected left main coronary artery. Coronary artery spasm without significant stenosis
4. Warnings
- The product is single use. It must not be re-sterilised or re-used once the procedure has been complet-
ed. Re-using the product in another patient may lead to cross contamination, infection or transmission
of infectious diseases from one patient to another. Re-use of the product may cause alterations to it
and limit its effectiveness.
- The device is for use by experienced doctors familiar with the percutaneous transluminal coronary
angioplasty (PTCA) technique.
- Percutaneous intervention must be carried out in hospitals equipped with emergency facilities to con-
duct open heart surgery or hospitals with easy access to other hospitals where this type of operation
can be performed.
- The product is supplied sterile. Check the expiry date and do not use products which are past this date.
- Inspect the pack before opening it. If you find any defect or the pack is damaged, discard the product.
- Use aseptic techniques when the product is taken out of the primary packaging.
- Select the balloon diameter depending on the diameter of the artery to be treated. Do not insert a
balloon with a diameter larger than that of the artery to be treated.
- Do not dry with gauze.
- Advance the product on the guide wire using fluoroscopy. Do not enable the advance of the product
without the guide wire inside.
- Do not use air or gaseous media to inflate the balloon.
- Do not manipulate, advance or retract either the catheter or the wire guide while the balloon is in-
flated.
INSTRUCTIONS FOR USE.
6 8 10
X X X
X X X
X X X
NC xperience
Lengths (mm)
12 15 20
X X X
X X X
X X X
25 30
X X
3