Terumo Destination Mode D'emploi page 4

Valve
Each Destination Peripheral Guiding Sheath comes packaged with
either a Cross Cut Valve assembly (CCV) or a Y-shaped Tuohy-
Borst Valve (TBV). Both valve types are equipped with a three-way
stopcock connected by a side tube.
Cross Cut Valve Assembly (CCV)
Y-Shaped Tuohy-Borst Valve (TBV)
Dilator Retaining Clip
(US patents 6,719,722 and D467,399. Patent pending in other
countries) – only available with TBV.
The clip provides a positive mechanism for locking the dilator
hub and the TBV together. The clip prevents axial movement of
the dilator while the sheath is being advanced (Fig. 2).
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 (Fig. 6). 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 (Fig. 1).
• Do not heat or bend the sheath tip. Damage to the sheath may
result.
CAUTION
• Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Fig. 2
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