Terumo Ryujin Plus Mode D'emploi page 21

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.
CAUTIONS
5-3 If the improvement of the stenosis is not sufficient, increase the inflation pressure of the balloon gradually to the
RBP, or pressurize it repeatedly until no further improvement can be attained. Usually, repeated inflation of the
balloon brings about sufficient improvement of the stenosis, which can be confirmed by coronary angiography.
6. Exchange of the dilatation catheter
6-1 Loosen the hemostatic valve of the Y connector.
6-2 Keep the guide wire in position and remove the dilatation catheter.
6-3 Remove the dilatation catheter while maintaining the position of the guide wire in the lesion. Wipe the guide
wire surface to avoid problems when inserted in the next catheter.
WARNING
CAUTION
6-4 Insert the next catheter over the proximal end of the guide wire as previously described while maintaining the
guide wire position.
CAUTION
6-5 Follow the directions for use labelled "Insertion of the dilatation catheter" after 4-7 and inflate/exchange
dilatation catheters.
7. Removal of the dilatation catheter
After completion of dilatation, deflate the balloon completely and remove the dilatation catheter and guide wire after
loosening the hemostatic valve. It is recommended to keep the guide wire in position for a while after the procedure,
preparing for any possible unexpected incidents.
• 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.
• While the guide wire is in the vessel, remove the catheter in a straight line along the
guide wire.
• Do not remove the catheter if it is bent at the Y connector port. If removal of a bent
catheter is attempted, excessive pressure is applied to the area near the guide wire
port, possibly damaging or breaking the catheter.
When inserting or exchanging the dilatation catheter, 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 catheter over such residues adhered to the guide wire or
over a half-wetted wire, may result in the separation or laceration of dilatation
catheter. This may necessitate the recovery of the catheter fragments.
Monitor the guide wire position under high resolution fluoroscopy during the exchange.
Read the manufacturer's instructions when catheters other than the
"RyujinPlus OTW" are used.
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