Terumo Hiryu Manual Del Usuario página 22

4-3 Position the guiding catheter at the ostium of the desired coronary artery using accepted
protocol. Confirm the position of the guiding catheter under high resolution fluoroscopy. After the
catheter position is confirmed, administer an appropriate dose of a vasodilator.
4-4 Insert the dilatation catheter through the hemostatic valve of the Y connector attached to the
guiding catheter.
CAUTION
4-5 Under high resolution fluoroscopy, advance the dilatation catheter until it reaches a point 2-3 cm
proximal to the distal end of the guiding catheter. The depth marker on the shaft will help confirm
how far the catheter has been advanced.
4-6 Advance the guide wire into the desired coronary artery under high resolution fluoroscopy. Carry
out angiography through the guiding catheter to confirm that the guide wire has crossed the
stenotic lesion.
CAUTION
4-7 Advance the dilatation catheter over the guide wire until the balloon reaches the stenotic lesion.
WARNING
4-8 Advance the dilatation catheter to position the balloon at the site of the stenotic lesion with the
help of the radiopaque marker, and inflate it at a low pressure of 1-2 atm (101-203 kPa) after
tightening the hemostatic valve of the Y connector. Confirm that the balloon is positioned in the
centre of the stenotic lesion by checking the resultant unevenness (dumbbell effect).
CAUTION
5. Balloon inflation
5-1 Inflate the balloon with appropriate pressure for an appropriate time with the inflation/deflation
device equipped with a manometer; then deflate the balloon.
WARNINGS
CAUTION
5-2 Pull back the dilatation catheter to withdraw the completely deflated balloon into the guiding
catheter after inflation of the balloon, and carry out coronary angiography through the guiding
catheter to evaluate the improvement of the stenosis.
CAUTION
9
Make sure the hemostatic valve of the Y connector has been loosened. If
tight, the valve will not allow smooth passage of the balloon.
Confirm that the guide wire is correctly inserted into a target vessel by
performing contrast radiography from various angles.
If any resistance is felt, do not advance the guide wire or the dilatation
catheter by force. Before proceeding, determine the cause under high
resolution fluoroscopy. Advancement by force may result in damage to
the vessel and/or laceration or separation of the guide wire or the
dilatation catheter. This may necessitate recovery of fragments.
Do not tighten the hemostatic valve of the Y connector excessively as this
may affect the inflation/deflation time and/or kink the catheter shaft.
• Carefully inflate the balloon under the guidance of high-resolution
fluoroscopy, and ensure that compression inflates the balloon. If the
balloon does not inflate, do not apply excessive pressure, as this
could prevent the balloon from deflating.
• The inflation pressure of the balloon should not exceed the RBP.
Pressurization above the RBP may result in rupture of the balloon.
The RBP is based on results of in vitro testing. At least 99.9 % of the
balloons (with 95 % confidence) will not burst at or below their RBP.
• If a balloon rupture should occur due to pressurization above the
RBP, the balloon or its fragments might be released into the vessel,
retrieval of which may be needed.
• The short or long term effect of pressurization above the nominal
pressure on the coronary arteries is still under investigation.
• Do not inflate the balloon beyond the diameter of the coronary artery
proximal or distal to the stenotic lesion.
• Balloon inflation to expand a stent, inside a stent or calcified lesions
is combined with a possibility of the balloon rupturing before the
RBP is exceeded. Inflate the balloon with due caution.
The balloon may slip out of the lesion when inflated because of the
hydrophilic coating. Inflate the balloon carefully under the guidance of high-
resolution fluoroscopy so that the balloon does not change position in the
lesion.
• Do not move or remove the dilatation catheter before the balloon is
deflated completely. Removal of the dilatation catheter should be done
after loosening the hemostatic valve of the Y connector.