Terumo Ryujin Plus Mode D'emploi page 20

2. Flushing and Insertion of guide wire
2-1 Introduce heparinized physiological saline solution into the catheter through the guide wire port to remove air
bubbles.
2-2 Visually confirm that the balloon is fully deflated.
2-3 Insert a guide wire (not more than 0.014" (0.36 mm) in diameter) through the guide wire port, and advance the
guide wire until it reaches the distal end of the dilatation catheter. This manipulation should be carried out with
the dilatation catheter held as straight as possible.
WARNING
CAUTIONS
3. Connection of an inflation/deflation device equipped with a manometer to the dilatation catheter
3-1 Fill an inflation/deflation device equipped with a manometer with the contrast media and expel air from the
device.
3-2 Attach the inflation/deflation device firmly to the balloon inflation port on the dilatation catheter. To ensure that
no air enters the system, the inflation device must be filled adequately with contrast media.
4. Insertion of the dilatation catheter
4-1 Insert an introducer sheath into the blood vessel as described in the manufacturer's instruction manual.
4-2 Select a guiding catheter that conforms to the label indication, and suitable to the position of the lesion and the
patient's anatomy. Flush the guiding catheter with heparinized physiological saline solution before use.
CAUTION
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 Loosen the hemostatic valve of the Y connector attached to the guiding catheter and insert the dilatation
catheter with care to avoid kinking.
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 to 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
7
Before inserting the guide wire through the guide wire port, soak it in physiological
saline solution to remove the blood or contrast media on the surface of the guide
wire. If the blood or contrast media is difficult to remove, 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 which are adherent to the guide wire or
over a half-wetted wire, may result in the separation or laceration of the dilatation
catheter.This may necessitate the recovery of the catheter fragments.
• Take care not to kink the distal tip of the dilatation catheter and advance slowly/carefully
when inserting the proximal end of the guide wire into the distal tip of the dilatation
catheter.
• Carefully insert the guide wire, and use caution to prevent the distal end from damaging
the guide wire lumen.
• If the catheter is placed into a bowl of physiological saline solution, carefully coil the
shaft to avoid accidental contamination.
• When proximal shaft of the catheter is bent or kinked, do not use the catheter. It may
cause the separation of shaft.
Administer appropriate anticoagulation therapy to the patient before insertion of the guiding
catheter.
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.