KANEKA IKAZUCHI Zero Mode D'emploi page 6

EN
the catheter reach the target site. Balloon should be deflated
during this procedure.
2) Determine the position of this balloon catheter and screw
the haemostatic valve tight enough to prevent blood leakage.
Be careful not to overtighten the valve when tightening the
valve. (This may restrict the flow of contrast media into the
inflation lumen and slow down the inflation and deflation of
the balloon.)
3) Inflate the balloon to the appropriate pressure for the lesion.
4) When the procedure is finished, deflate the balloon
completely and loosen the haemostatic valve.
5) After checking that the balloon is completely retracted into
the guide catheter under fluoroscopy, remove this catheter.
3. Exchanging PTCA catheter
1) Loosen the haemostatic valve.
2) Grasp the guidewire and the haemostatic valve with one
hand to prevent the dislocation of the guidewire from the
position in the coronary artery. Grasp the handheld part of
this balloon catheter with another hand and start pulling this
catheter out of the guide catheter. The position of the
guidewire should be monitored under fluoroscopy during this
procedure.
3) Withdraw this balloon catheter gradually until its guidewire
port comes out. While maintaining the position of the
guidewire passing through the coronary artery lesion, pull
this balloon catheter carefully out of the guidewire.
4) Close the haemostatic valve.
5) Referring to its package insert, prepare a rapid exchange
catheter and insert it in place.
[Precautions related to procedures]
1. Prior to use, expel all the air in the balloon and balloon
inflation lumen and replace it with the inflation fluid. (In case
of incomplete air removal, balloon inflation state can not be
observed under fluoroscopy.)
2. Use the inflation fluid to inflate the balloon. No gaseous
body such as air should be used for inflation.
3. Always immerse the balloon in sterilized physiological saline
for at least one minute before inflation as the strength of the
balloon may sometimes decrease.
4. Do not move this catheter while the balloon is inflated in the
blood vessel. (Moving the catheter with the balloon inflated
may lead to blood vessel injury, balloon burst, and catheter
breakage.)
5. The insertion and withdrawal of the catheter should be
performed slowly with caution. (If this procedure is
performed too fast, it may lead to kinking of or damage to
the catheter shaft.)
6. As for the medical devices used in conjunction with this
catheter, follow the package inserts of such devices.
7. Proceed with care to prevent PTCA dilatation catheter
kinking and collapse when forming loops of catheter.
8. Proceed with care to prevent shaft kinking and collapse
while removing the catheter clip.
9. If reinsertion of the catheter is necessary, flush the
guidewire lumen before insertion.
10. Secure the PTCA dilatation catheter with the catheter clip at
the stiffer, proximal end. Do not use the catheter clip on
the flexible, distal shaft or catheters, it may damage the
PTCA dilatation catheter.
11. Medical devices used with the product should be operated
in accordance with the instructions for use of each individual
device. (Refer to the Instructions for use of the stent
products in case of usage for post-dilatation after stenting.)
[Precautions during usage]
[Important basic precautions]
1. This catheter may be used only by physicians skilled in
percutaneous transluminal angioplasty.
2. The product should not be used in patients who are
pregnant or suspected for pregnancy unless it is determined
that the benefit to treat with the product may exceed the risk
to use the product.
3. For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk
of contamination of the device and/or cause patient infection
or crossinfection, including, but not limited to, the
transmission of infectious disease(s) from one patient to
another. Contamination of the device may lead to injury,
illness or death of the patient.
4. Do not use if the product or package is believed to be
damaged.
5. Use immediately after the sterile package is opened. Device
is to be regarded as contaminated waste after use.
6. Do not use agents containing organic solvents or
oleaginous contrast media. Contact with these agents may
lead to damage of the catheter.
7. Since PTCA procedure may induce dangerous
complications, perform the procedure only after having
prepared for emergency coronary artery bypass grafting
(CABG).
8. Since serious complications might arise when using this
catheter, operation should be done in the medical institution
where emergency procedure can be executed.
9. The physician in charge of the procedure should determine
the duration and number of balloon inflations based on
his/her past experiences.
10. Heparinized and sterilized physiological saline should be
infused for anti-coagulation while this balloon catheter is
inserted in the blood vessel.
11. This catheter can only be inserted with the use of a
guidewire. (Insertion of this catheter alone may lead to
damage to the vascular wall or perforation of vessels.)
12. Operate the catheter carefully in the blood vessel verifying
the location and movement of its tip under fluoroscopy.
13. Do not twist or turn this balloon catheter or the guidewire
during operation. (The catheter may be tangled increasing
the resistance.)
14. If abnormal or strong resistance is experienced during the
operation, the cause for such abnormality or resistance
should be verified and appropriate measures should be
performed before proceeding. (If such abnormality or
5/110 (3216-0)