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(Inappropriate catheter selection may lead to acute
vascular occlusion.)

5. Use this catheter only when emergency surgery can be

performed at any time.

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

procedural 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 guide wire inserted into the

guide wire lumen.

[Operational Instructions]

Materials typically required for PTA with the Metacross 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 Metacross 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)