Directions For Use - Terumo Tercross Mode D'emploi

• After withdrawing the dilatation catheter, soak it in physiological saline solution to remove the blood on the surface of the dilatation
catheter. If the blood is difficult to remove, wipe the dilatation catheter once with gauze soaked with physiological saline solution.
• Before reinserting the same dilatation catheter, inspect the entire dilatation catheter that neither the lubricity of the surface has
decreased, nor any foreign substances are on the dilatation catheter. To remove the blood from the guide wire lumen, flush the
dilatation catheter with heparinized physiological saline solution.
• Refer to the attached compliance sheet regarding the relation between the diameter of the balloon and the rated burst pressure.

DIRECTIONS FOR USE

CAUTIONS
• Before using the dilatation catheter, read the instructions of the accompanying pharmaceutical products and medical devices.
• Before use, confirm that all apparatus including the dilatation catheter is functioning properly. Confirm whether the dilatation
catheter is damaged or not, and that the design of the balloon meets the criteria of the procedure and the technique to be used.
1. Preparation of the dilatation catheter
1-1 Carefully remove the dilatation catheter from the holder tube.
CAUTIONS
• Remove the dilatation catheter in a straight line from the end of the holder tube without bending the catheter.
• Do not remove the dilatation catheter by force if resistance is encountered. Forced removal could cause the balloon not to
inflate or deflate.
1-2 After wetting the balloon protection sheath with physiological saline solution, carefully remove the balloon protection sheath
and stylet not to damage the balloon part.
CAUTION
Do not remove the balloon protection sheath by force if resistance is encountered. Forced removal could
cause the balloon not to inflate or deflate.
1-3 Draw 5 mL of an appropriate contrast media (for example: a 1:1 mixture of contrast media and physiological saline solution)
into a 20 mL syringe.
WARNING
Do not use air, gases or liquids other than contrast media to inflate the balloon. In case of leakage
from the balloon, such fluids could have serious adverse effects on the patient's health.
1-4 Connect the syringe containing contrast media to the balloon inflation port of the dilatation catheter.
1-5 Holding the syringe with its tip down, aspirate air for 15 – 30 seconds.
1-6 While holding the syringe with its tip pointing downwards, inject the contrast media slowly.
1-7 Repeat steps 1-5 and 1-6 several times until contrast media fills the outer lumen completely.
1-8 Introduce heparinized physiological saline solution into the dilatation catheter through the guide wire port to remove air
bubbles.
2. Connection of an inflation/deflation device equipped with a manometer to the dilatation catheter
2-1 Fill an inflation/deflation device equipped with a manometer with the contrast media and expel air from the device.
2-2 Attach the inflation/deflation device firmly to the balloon inflation port on the dilatation catheter. To ensure that no air enters
the system, the inflation device must be filled adequately with contrast media.
3. Insertion of the dilatation catheter
3-1 Insert the guiding catheter / introducer sheath, with Y connector, into the artery using standard techniques. Advance the
guide wire to the desired position or artery, then cross the stenosis in accordance with accepted PTA techniques.
3-2 Backload the distal tip of the dilatation catheter onto the guide wire. And advance the dilatation catheter slowly through the
hemostatic valve of the Y connector attached to the guiding catheter / introducer sheath while the balloon is completely
deflated.
WARNINGS
• If any resistance is felt, do not advance the guide wire or the dilatation catheter by force. Before proceeding,
determine the cause under fluoroscopy. Advancement by force may result in damage to the artery and/or
laceration or separation of the guide wire or the dilatation catheter. This may necessitate recovery of fragments.
• Before insertion of the guide wire , soak it in physiological saline solution to remove the blood or contrast media
on the surface of the guide wire. If the blood or contrast media is difficult to remove, wipe the guide wire once with
gauze soaked with physiological saline solution. Inspect the entire guide wire that neither the lubricity of the
surface has decreased, nor any foreign substances are on the wire.
• Moving the dilatation catheter over such residues which are adherent to the guide wire or over a half-wetted wire,
may result in the separation or laceration of the dilatation catheter. This may necessitate the recovery of the
dilatation catheter fragments.
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