Terumo Tercross Mode D'emploi page 9

CAUTIONS
• Do not insert the distal tip of the dilatation catheter into the hemostatic valve of the Y connector without the guide wire.
• When the proximal shaft of the dilatation catheter is bent or kinked, do not use the dilatation catheter. It may cause
separation of shaft.
• Take care not to kink the distal tip of the dilatation catheter and advance slowly/carefully to prevent the guide wire lumen
from damaging.
• In case of inserting the distal end of the guide wire through the dilatation catheter, insert the wire via the guide wire port into
the catheter.
• Make sure the hemostatic valve of the Y connector has been loosened before insertion of the dilatation catheter. If tight, the
valve will not allow smooth passage of the balloon part (dilatation catheter).
• Do not tighten the hemostatic valve of the Y connector excessively as this may affect the inflation/deflation time and/or kink
the dilatation catheter shaft.
4. Balloon inflation and deflation
4-1 Inflate the balloon with appropriate pressure for an appropriate time with the inflation/ deflation device equipped with a
manometer.
WARNINGS
• Carefully inflate the balloon under guidance of 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 or leak from the shaft of the dilatation catheter or high resistance of manipulation with the
guide wire. 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 artery, retrieval of which may be needed.
• The short or long term effect of pressurization above the nominal pressure is still under investigation.
• Do not inflate the balloon beyond the diameter of the 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.
CAUTION
4-2 Apply negative pressure to completely deflate the balloon. Confirm that the balloon is fully deflated under fluoroscopy.
CAUTION
4-3 Maintain negative pressure in the balloon, while withdrawing the dilatation catheter.
CAUTIONS
• Withdrawing of the dilatation catheter should be done after loosening the hemostatic valve of the Y connector.
• If any resistance is felt during withdrawing the dilatation catheter, remove the guiding catheter / introducer sheath and guide
wire together with the dilatation catheter.
4-4 The results of PTA should be checked by angiography.
PRECAUTION FOR STORAGE
Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.
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The balloon may slip out of the lesion when inflated because of the hydrophilic coating. Inflate the balloon
carefully under guidance of fluoroscopy so that the balloon does not change position in the lesion.
Do not move the dilatation catheter before the balloon is deflated completely.