INTENDED USE
The Destination Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.
PRECAUTIONS
• This device must only be used by a trained physician.
• This device is for single use only. Do not re-sterilize or re-use.
• Contents are sterile, non-toxic and non-pyrogenic in an unopened undamaged package.
• Do not use if the package or product is stained or damaged. Use the device immediately after opening the package and dispose of the device after use.
• Before use make sure the sheath size (Fr.) is appropriate for the access vessel and the interventional/ diagnostic device to be used.
• The entire procedure, from skin incision to sheath removal, must be carried out aseptically.
• Do not use a power injector through the side tube and 3-way stopcock. Excessive leakage may occur through the CCV valve with high/rapid flow injections such as an injection of contrast to provide a comprehensive image of the aortic arch.
• When inflating a balloon at, or close to, the sheath tip, be sure not to inflate it inside the distal end of the sheath . The radiopaque marker is located approx. 5 mm proximal to the tip and therefore does not actually mark the true distal tip of the sheath.
• Do not heat or bend the sheath tip. Damage to the sheath may result.