Terumo Ryujin Plus Mode D'emploi page 18

INDICATIONS
The Ryujin Plus OTW ("dilatation catheter") is intended to be used for percutaneous transluminal coronary angioplasty
(PTCA) for the purpose of improving myocardial blood flow in the localized stenotic lesion of the coronary arteries.
CAUTIONS FOR USE
1. Contraindications (patients/conditions in which PTCA must be avoided)
· Lesions in the left main trunk for which no compensation of blood flow by bypass or collateral circulation is
available. Failure to observe this warning could result in acute coronary occlusion.
· Patients who had previous coronary artery spasm due to the possibility of acute coronary occlusion.
· Pregnancy or suspected pregnancy. X-ray exposure could damage fetus.
2. Relative contraindications (patients/conditions in which PTCA may carry a higher than usual risk, and
should only be attempted if the procedure's benefit outweighs the risk)
· Patients in whom coronary bypass surgery is not applicable. In case of acute-phase ischemic complications;
emergency CABG is required.
3. Important safety instructions
WARNINGS
CAUTIONS
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ENGLISH
Please read all instructions prior to use.
• Advance the dilatation catheter carefully within the artery and, if any resistance is
felt, stop manipulating the dilatation catheter and determine the cause under high
resolution fluoroscopy. Continuing to advance the dilatation catheter may result in
damage to the vessel and/or separation or laceration of the dilatation catheter.
This may necessitate recovery of fragments of the dilatation catheter.
• Within the stent strut, advancement or removal or inflation of the dilatation
catheter should be done carefully under high resolution fluoroscopy. Failure to
take care could result in vascular injury or damage/breakage of the catheter due to
stent abrasion, and the balloon bursting below the rated burst pressure.
• Use an inflation/deflation device equipped with an accurate manometer. The balloon may
rupture if over-inflation occurs due to inaccurate determination of balloon pressure.
• Administer appropriate anticoagulant and coronary vasodilator to the patient during the
PTCA procedure. Carry out appropriate anticoagulant therapy under direction of the
physician in charge after completion of the PTCA procedure.
• Do not use agents containing organic solvents or oleaginous contrast media. Contact
with these agents may lead to damage of the dilatation catheter and/or rupture of the
balloon.
• Always handle catheters with care, and avoid kinks. Do not use if kinked.
A kink could damage or break the catheter.
• Operate the catheter with utmost care while performing the kissing balloon technique
or parallel wire technique, to avoid entanglement with the accompanying device. If
resistance is encountered, remove the catheter and the accompanying device together.
• Choose the appropriate balloon size from the diagnostic site and anatomic aspect.
• After withdrawing the catheter, soak it in physiological saline solution to remove the blood
on the surface of the catheter. If the blood is difficult to remove, wipe the catheter once
with gauze soaked with physiological saline solution.
Before reinserting the same balloon catheter, inspect the entire catheter that neither the
lubricity of the surface has decreased, nor any foreign substances are on the catheter.
To remove the blood from the guide wire lumen, flush the catheter with heparinized
physiological saline solution.
• Refer the SPECIFICATIONS regarding the relation between the diameter of the balloon
and the rated burst pressure.