NuMED BIB Instrucciones De Utilizacion página 4

passive contrast, until you no longer have bubbles when applying negative pressure. It will
be necessary to repeat this process several times. Repeat process with the outer balloon.
6. Leave both balloons on continuous negative pressure for insertion. Remove balloon
protector prior to removing the guidewire. Flush catheter lumen with heparinized flush.
I
NSTRUCTIONS FOR
Prior to angioplasty, carefully examine all equipment to be used during the procedure,
including the catheter, to verify proper function and that the catheter size is suitable for the
specific procedure for which it is intended. Also, inflate the dilatation catheter to the appropri-
ate RBP and deflate to verify proper function.
1. Enter the vessel percutaneously using the standard Seldinger technique over the appropriate
guidewire for the size catheter being used.
2. Under fluoroscopic guidance advance the guidewire to the desired position. Pass the
catheter over the guidewire. An introducer should be utilized to facilitate catheter insertion.
3. Advance the catheter across the lesion with fluoroscopic guidance using accepted
percutaneous transluminal angioplasty technique (see references). In most patients, the
balloon should meet with minimal resistance to insertion. Do not advance the catheter
unless the guidewire is in place. (Place the catheter to position the mid-length of the balloon
within the lesion. Radiopaque bands define both the inner and outer balloon shoulders.)
4. The distal lumen is provided for guidewire tracking. An inflation device with pressure gauge
is required to monitor inflation pressure [refer to package label for RBP].
5. Inflate the inner balloon to RBP or lower and close stopcock. Immediately inflate the outer
balloon to RBP to achieve dilatation. DO NOT exceed the RBP.
6. Immediately after dilatation, deflate both balloons. Both balloons are deflated
simultaneously. Deflate the balloon by drawing a vacuum with an inflation device with
pressure gauge. Note: The greater the vacuum applied and held during withdrawal, the
lower the deflated balloon profile. Gently withdraw the catheter. As the balloon exits the
vessel, use a smooth, gentle, steady motion. If resistance is felt upon removal, then the
balloon, guidewire and the sheath should be removed together as a unit under fluoroscopic
guidance, particularly if balloon rupture or leakage is known or suspected. This may be
accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing
both together, using a gentle twisting motion combined with traction.
7. Apply pressure to the insertion site according to standard practice or hospital protocol for
percutaneous vascular procedures.
W :
ARNING
NuMED catheters are placed in the extremely hostile environment of the human body.
Catheters may fail to function for a variety of causes including, but not limited to, medical
complications or failure of catheters by breakage. In addition, despite the exercise of all due
care in design, component selection, manufacture and testing prior to sale, catheters may
be easily damaged before, during, or after insertion by improper handling or other
intervening acts. Consequently, no representation or warranty is made that failure or
cessation of function of catheters will not occur or that the body will not react adversely to
the placement of catheters or that medical complications will not follow the use of catheters.
NuMED cannot warrant or guarantee NuMED accessories because the structure of the
accessories may be damaged by improper handling before or during use. Therefore, no
representations or warranties are made concerning them.
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