9/115(3212-1)
6. The physician in charge of the procedure should determine
the duration and number of balloon inflations based on his/her
past experiences.
7. Heparinized saline should be infused for anti-coagulation
while this balloon catheter is inserted in the blood vessel.
8. Never inflate the balloon or advance the guidewire with the
catheter bent or kinked.
9. Manipulate the catheter carefully in the blood vessel verifying
the location and movement of its tip under fluoroscopy or DSA
(Digital Subtraction Angiography) monitoring.
10. Always inflate the balloon while observing its inflation state
under fluoroscopy. Inflate the balloon carefully while verifying
its movement with the radiopaque markers. If any abnormality
is found such as a little resistance, immovable catheter during
manipulation or kinked distal tip of the guidewire, the
procedure should be discontinued immediately and this
catheter should be removed slowly together with the
guidewire.
11. Do not insert or remove the catheter rapidly. (Operating
rapidly may damage the catheter or injure the vascular
intima.)
12. Do not move the catheter with the balloon inflated. (Moving
the catheter with the balloon inflated may result in balloon
burst or catheter shaft breakage.)
13. Do not inflate or deflate the balloon rapidly in the blood
vessel. (Rapid inflation or deflation may damage the blood
vessel or cause the balloon to burst resulting in the debris left
inside the body.)
14. Do not use an injector (automatic injection device) for inflating
the balloon.
15. Precautions should be taken to prevent any damage to the
catheter by a surgical knife or scissors.
16. If any abnormality such as strong resistance is experienced
while manipulating the catheter, the procedure should be
discontinued immediately. The cause should be verified and
appropriate measures should be taken. (Continuing the
operation with excessive force may result in damage to the
catheter or in vascular wall injury.)
17. Always pay attention to the patient's condition and monitor
the body temperature, pulse, and breathing. When any
abnormality is found, discontinue the use of the catheter
immediately or take appropriate measures for the patient's
condition on the discretion of the physician.
18. After use dispose the catheter as medical waste according to
hospital procedures.
19. Do not use agents containing organic solvents or oleaginous
contrast media. Contact with these agents may lead to
damage of the catheter.
20. While manipulating this catheter, do not twist or rotate the
catheter.
21. While inserting this device into the blood vessel or removing
this device from the blood vessel, make sure that the balloon
is completely deflated. A device with larger and longer balloon
requires a longer deflation time.)
22. If resistance is felt during post procedual withdrawal of this
device, it is recommended to withdraw the entire system
together with the introducer / guide sheath.
23. Always use the catheter along a guidewire inserted into the
guidewire lumen.
[Operational Instructions]
Materials typically required for PTA with the Crosstella OTW PTA
balloon dilatation catheter include:
・
Guidewire(s) of appropriate diameter and length
・
Appropriate introducer/guide sheath and dilator set
・
Vial of contrast medium
・
Vial of sterile saline
・
Inflation device with manometer
・
Luer-lock syringe
・
Three-way stopcock
[Operation method or instructions for use]
1. Selection of the catheter
Prior to use, verify the blood vessel inner diameter proximal and
distal to the stenotic lesion under fluoroscopy, and select the
catheter with appropriate balloon size. If two sizes are applicable to
the diameter verified, select the smaller size.
2. Preparations
1) After aseptically removing the catheter from the package
container, remove the protective materials from the catheter.
2) Replace the air in the balloon and balloon inflation lumen with
inflation fluid according to the following procedures.
a) Attach the inflation device (not included in this kit) filled with
the inflation fluid onto the balloon inflation port.
b) After applying negative pressure for approximately 10
seconds to the inflation device, direct the catheter shaft tip
downward and release the negative pressure slowly to allow
the fluid to fill the balloon and balloon inflation lumen and to
expel the air.
c) When any air is found in the balloon and balloon inflation
lumen, repeat the procedure b) until the air is expelled
completely.
d) Detach the inflation device from the balloon inflation port and
remove air from the cylinder of the inflation device.
e) Reattach the inflation device onto the balloon inflation
port and maintain negative pressure. Verify that the air no
longer returns into the syringe.
3) Flush the guidewire lumen with heparinized saline and fill the
lumen with the heparinized saline.
4) Immerse the entire Crosstella OTW PTA balloon dilatation
catheter in saline.
3. Insertion and inflation of the balloon catheter
Prior to use, please check if this catheter is compatible to the guide
catheter (not included in this kit), the introducer sheath (not
included in this kit), and the guidewire (not included in this kit) by
the following table.
Catalogue
number
Balloon
diameter
(mm)
Compatible
sheath
(Fr/mm)
Maximum
diameter for
the guidewire
(inch/mm)
BD-F20020MW
～
BD-F60200LW
2mm,2.5mm,3mm,
4mm,5mm(excluding
120mm,150mm,200mm
Balloon Length),
6mm (20mm, 40mm
Balloon Length)
4Fr/1.35mm
0.018
inch
(0.46mm)
5mm (120mm,150mm,200mm
Balloon Length),
6mm (excluding 20mm,40mm
Balloon Length)
5Fr/1.66mm
When using the catheter inserted in the introducer sheath or guide
catheter
1) When using the catheter in the guide catheter, loosen the
hemostatic valve while keeping it tight enough to prevent blood
leakage.
2) Gradually insert the catheter, with the balloon deflated
completely, into the introducer sheath or guide catheter over
the guidewire and advance to the distal periphery of the lesion.
Under fluoroscopy, advance the catheter slowly to make its
radiopaque marker in the balloon reach the target site.
