Medtronic ClearView CS0001 Mode D'emploi page 9

Clearview_EN_CH.fm 9/15/08 2:02 pm
Size 3.75 x 8.5 inches (95.25 mm x 215.9 mm)
ClearView
Intracoronary Shunt
Model
31100 1.00-mm tip
31125 1.25-mm tip
31150 1.50-mm tip
31175 1.75-mm tip
31200 2.00-mm tip
31225 2.25-mm tip
31250 2.50-mm tip
31275 2.75-mm tip
31300 3.00-mm tip
Description
These intracoronary shunts consist of a flexible tube. Both ends of the
tube feature a teardrop shaped tip made from radiopaque material. Tip
diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of
radiopaque material is permanently attached to the shunts.
Sterile, nonpyrogenic, disposable, single use only.
Indications
These shunts are intended for use to shunt blood by the arteriotomy
anastomosis site while the surgeon is making the anastomosis.
Contraindications
These shunts are not intended for use except as indicated above.
Warnings
Take care not to:
a. damage or scratch the shunt prior to insertion into the coronary
artery.
b. damage the intima of the coronary artery during product use.
c. attempt to force the shunt's tips past any vessel obstructions.
In some cases, shunts may not be detectable by x-ray due to the variances
in anatomical densities and x-ray techniques. Modifying the x-ray angle or
distance may aid in detection.
Precautions
The shunt is not an implantable device and may only be used temporarily
as described in the "Indications" above.
Check for any possible obstructions in the shunt's internal lumen before
placing the shunt in the artery.
The shunt, tether, and tag should remain intact. Do not separate the
components.
Note: Proper surgical procedures and techniques are necessarily the
responsibility of the medical professional. The described procedure is
furnished for informational purposes only. Surgeons must, of course,
evaluate the appropriateness of the procedure based on their own medical
training and experience and the type of surgical procedure.
Take care not to damage the shunt or ensnare the tether with the
cardiovascular needle or suture. Remove the shunt from the vessel prior
to completion of the anastomosis.
These shunts are designed and intended for single use only: DO NOT
REUSE.
Adverse Effects
None known.
06929 Rev. 5.0
Medtronic Confidential
CS0001
Instructions for Use English 7