3
5)
Do not modify this microcatheter for any reason. Use of a modified product may cause damage
to blood vessels and/or accidents.
6)
This microcatheter must be used under the condition that surgical operation can be performed.
(If an emergency surgical operation is unavailable, life-threatening events may occur.)
7)
This microcatheter must be used under fluoroscopy only by a physician who is fully trained in
PTA treatment. (Unskillful procedure may cause an error in operation or misjudgment, leading
to damage to the blood vessel. In the worst case, life-threatening adverse events may occur.)
8)
Do not use this microcatheter for patients who are or could be pregnant. (The fetus may be
affected by X-rays under fluoroscopy.)
9)
Do not use the microcatheter after the expiration date indicated on the label. Discard any device
that exceeds the expiration date.
10)
The injection pressure must not exceed the maximum injection pressure. (The maximum
injection pressure is labeled on the product label.)
11)
Excess rotational load must not be applied if the microcatheter is bent. (The microcatheter may
be damaged.)
12)
If any resistance or something abnormal is felt when operating this product, do not continue the
operation while the causes are unclear. If it is suspected that the product is not operating
correctly, avoid excessive manipulations, and carefully remove the entire catheter system while
paying full attention to avoid complications. (Continuing the operation while the cause of the
problem is not identified may cause damage to or separation of the catheter, and damage the
blood vessel. Life-threatening adverse events may occur.)
13)
The microcatheter must always be operated under high-resolution fluoroscopic guidance.
Particular attention should be paid when inserting or withdrawing the microcatheter into stenotic
areas and narrower vessels than the product. (Abrasion may result in damage or separation of
the microcatheter. This may cause vascular injury and perforation, possibly leading to a life-
threatening adverse event.)
14)
Do not insert the guide wire by force or advance it rapidly when the microcatheter is bent or
twisted. Such manipulations may cause breakage or damage of the microcatheter, or perforation
of the blood vessel.
15)
Always advance the guide wire ahead of the microcatheter before attempting any manipulation
of the microcatheter. (If the guide wire is not advanced ahead of the microcatheter, the blood
vessel may be damaged or perforated, or the microcatheter may be damaged.)
16)
Always hold the connector with one hand and turn the microcatheter carefully while regularly
releasing the accumulated torsion of the microcatheter. Never turn the microcatheter
continuously while holding the connector with both hands or use any other means to apply force.
When releasing the accumulated torsion, be sure to open the hemostatic valve on the Y-
connector. Do not turn the microcatheter in the same direction, either clockwise or
counterclockwise, for more than 10 consecutive turns. (Continuing rotation may damage or
break the microcatheter or damage the blood vessels. In the worst case, life-threatening adverse
events may occur.)
17)
This microcatheter is coated with hydrophilic coating. Therefore, the microcatheter is highly
lubricious. Always confirm the position of the distal end of this microcatheter and manipulate
this microcatheter carefully.
18)
Do not infuse contrast media when the microcatheter is bent or occluded. It may cause damage
to the microcatheter such as expansion or breakage.
