Terumo Hiryu Manual Del Usuario página 21

∗ 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. If necessary, dilatation
catheter may be coiled and secured using the CATHETERCLIP in accordance with "Directions for
use of CATHETERCLIP and balloon protection sheath".
CAUTION
1-3 Draw 3 mL of an appropriate contrast medium (for example: a 1:1 mixture of contrast media and
physiological saline solution) into a 20 mL syringe.
WARNING
1-4 Connect the syringe containing contrast medium to the catheter hub (hereafter referred to as
"balloon inflation port").
1-5 Holding the syringe with its tip down, aspirate air for 20 ~ 30 seconds.
1-6 While holding the syringe with its tip pointing downwards, inject the contrast medium slowly.
1-7 Repeat steps 1-5 and 1-6 several times until contrast medium fills the balloon completely.
2. Flushing and Insertion of guide wire
2-1 Insert the enclosed flushing needle into the distal tip of the dilatation catheter. Flush with
heparinized physiological saline solution in order to remove air bubbles.
CAUTION
2-2 Visually confirm that the balloon is fully deflated.
2-3 Insert the proximal end of a guide wire (not more than 0.014" (0.36 mm) in diameter) into the
distal tip of the catheter. Advance the wire through the guide wire lumen until it protrudes from the
guide wire port. Grasp the proximal end of the guide wire and pull it back through the guide wire
lumen until guide wire and catheter tip are appropriately positioned.
WARNING
CAUTIONS
3. Connection of an inflation/deflation device equipped with a manometer to the dilatation catheter
3-1 Fill an inflation/deflation device equipped with a manometer with the contrast medium and expel
air from the device.
3-2 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
medium.
4. Insertion of the dilatation catheter
4-1 Insert an introducer sheath into the blood vessel as described in the manufacturer's instruction
manual.
4-2 Select a guiding catheter that conforms to the label indication, and suitable to the position of the
lesion and the patient's anatomy. Flush the guiding catheter with heparinized physiological saline
solution before use.
CAUTION
Do not remove the sheath if resistance is felt. Using force may result in
damage to the balloon.
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.
Take care not to damage the dilatation catheter when inserting the enclosed
flushing needle.
When inserting the dilatation catheter, thoroughly wipe the guide wire
with gauze soaked with physiological saline solution to remove any
residue of blood or contrast media. Moving the 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 catheter fragments.
• Take care not to kink the distal tip of the dilatation catheter and advance
slowly/carefully when inserting the proximal end of the guide wire into the
distal tip of the dilatation catheter.
• Carefully insert the guide wire, and use caution to prevent the proximal end
from damaging the guide-wire lumen.
• If the catheter is placed into a bowl of physiological saline solution,
carefully coil the shaft to avoid accidental contamination.
• When proximal shaft of the catheter is bent or kinked, do not use the
catheter. It may cause the separation of shaft.
Administer appropriate anticoagulation therapy to the patient before insertion
of the guiding catheter.
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