KANEKA IKAZUCHI Zero Mode D'emploi page 5

EN
[Contraindications]
1. For single use only. Do not reuse, reprocess or resterilize.
2. These components are contraindicated in the following
patients:
- Patients with unprotected lesion in the left coronary trunk
- Patients with coronary artery spasm in the absence of
significant stenosis
3. Do not inflate the balloon exceeding the diameter of the blood
vessel in the vicinity of the stenotic lesion.
(The blood vessel may be damaged or ruptured.)
4. Do not inflate the balloon to a pressure exceeding the
rated burst pressure. (The balloon may burst and the debris
may remain inside the body.)
5. The catheter is contraindicated for hand crimping of stent
components and as a stent delivery system.
6. The product is contraindicated to patients who cannot tolerate
antiplatelet therapy and anticoagulant therapy.
[Shape and structure]
1. Balloon catheter
<Representative schematics>
Balloon Guidewire lumen
Catheter shaft
Radiopaque
Guidewire port
marker Guidewire
＊It is not included
in the product
2. Flushing tool (with re-wrapping function）
Entry for flushing guidewire lumen and balloon re-wrapping
Note
Flushing tool is used for flushing guidewire lumen of this
product. In case of re-insertion after removing out from
the body, balloon may be inserted to Flushing tool to
make balloon wrap in slender shape.
For appropriate use of the Flushing tool, follow the
procedures described in 3) of "1.Preparations" in
[Operation method or instructions for use].
3. Catheter clip
Note
Catheter clip is used for binding up catheter shaft of this
product.
[Indication for use]
This product is intended to be used for dilating the
stenosis lesion in the coronary artery when performing
percutaneous transluminal coronary angioplasty
(PTCA).
Instructions for use
IKAZUCHI Zero
（KANEKA PTCA Catheter CO-R7）
PTCA Balloon Dilatation Catheter
[Product Specifications]
1. Balloon Compliance
・Nominal Pressure (NP)：0.6 MPa
・Rated Burst Pressure (RBP)：1.4 MPa
2. Maximum diameter of the guidewire
0.36 mm (0.014 inch)
[Operation method or instructions for use]
1. Preparations
1) After aseptically removing this catheter from the package
container, detach the protective materials such as a balloon
protective sheath. Carefully remove the catheter, and check
that there are no defects, such as a rupture.
2) Remove the air in the balloon and balloon inflation lumen
according to the following procedures.
(a) Attach the inflation device filled with the contrast media
diluted with sterilized physiological saline in the ratio of
1:1 (hereinafter, the inflation fluid) onto the balloon
inflation port (hereinafter, the inflation port), and place this
catheter with the distal tip facing downward.
(b) After applying the negative pressure using the inflation
Hub device for approximately 15 seconds, release the
negative pressure gradually allowing the inflation fluid to
fill the balloon and the balloon inflation lumen and to
expel the air.
Port for balloon
inflation
(c) Repeat the procedures (b) to expel the air completely.
(d) Remove the inflation device from the inflation port and
expel all the air in the inflation device.
(e) Reattach the inflation device to the inflation port and
Luer part for flushing
apply negative pressure. After checking that the air no
longer returns to the inflation device, release the negative
pressure gradually. (a syringe can be used in place of the
inflation device for the procedures (a)-(e).)
(f) Prior to inflation, immerse the balloon in sterilized
physiological saline for at least one minute.
3) Flush the guidewire lumen by the Flushing tool according to
the following procedures.
(a)Withdraw appropriate amount of heparinized saline into
the syringe and connect the Flushing tool to luer part for
flushing.
(b)Insert the distal tip of the product into entry for balloon
re-wrapping until the product come to a stop inside the
tool.
(c)Flush the guidewire lumen with heparinized saline using
the syringe and fill up the lumen with the saline.
2. Insertion and removal of the balloon catheter
1) Insert this catheter along the guidewire advanced to the
distal end of the lesion. Use a guiding catheter of 6 French
or larger with the catheter
catheter to make the radiopaque marker at the distal end of
4/110 (3216-0)
.
Under fluoroscopy, advance the