Cautions For Use - Terumo Hiryu Manual Del Usuario

Please read all instructions prior to use.
INDICATIONS
The Hiryu ("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. Emergency CABG is required for
acute-phase ischemic complications.
3. Important safety instructions
WARNINGS
CAUTIONS
ENGLISH
• 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.
• Refer to the SPECIFICATIONS regarding the relation between the diameter
of the balloon and the rated burst pressure.
• Do not reuse the first balloon protection sheath which is on the catheter,
after removing it. Failure to observe this warning could cause the balloon
not to inflate or deflate due to balloon deformation and damage of the shaft.
• 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
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