Instructions For Use - Terumo Pinnacle Destination Mode D'emploi

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.

INSTRUCTIONS FOR USE

Instructions for using the Tuohy-Borst Valve (TBV) are covered in
sections I and III.
Instructions for using the Cross Cut Valve (CCV) are covered in
sections II and III.
I. Using the Tuohy-Borst Valve (TBV)
1. Ensure that the valve and the sheath are tightly connected.
2. Connect a flushing line to the 3-way stopcock of the guiding
sheath. Fill the sheath assembly completely with heparinized
saline, removing all air.
3. Wet the distal 15 cm (150 mm) of the sheath with heparinized
saline. To maintain lubricity, this surface must be kept completely
wet.
4. Prime the dilator using a syringe with heparinized saline.
5. Insert the dilator completely into the sheath.
6. Tighten the Tuohy-Borst Valve around the dilator by turning the
cap clockwise. If desired, clip the dilator hub and the TBV
together using the dilator retaining clip provided (Figs. 2 & 3). Be
sure to note the correct orientation of the dilator retaining clip to
the dilator hub and TBV.
Fig. 2
4