NuMED DH Instrucciones De Utilizacion página 3

3. Perform dilatations using either a 50/50 or a 75/25 solution of saline and contrast medium, respectively.
4. Attach an inflation device with pressure gauge half filled with the contrast solution to the balloon port of the
catheter.
5. Purge the catheter through lumen thoroughly, observing for leaks.
6. To check inflation/deflation times, use a stopwatch. Repeat the procedure several times to verify the inflation /
deflation time.
7. Point inflation device with pressure gauge nozzle downward, aspirate until all air is removed from the balloon,
and bubbles no longer appear in the contrast solution.
8. Turn the stopcock off to maintain the vacuum in the balloon.
9. Remove guidewire.
INSERTION: VASCULAR
1. Enter the vessel percutaneously using the standard Seldinger technique over the appropriate guidewire for
the size catheter being used.
2. 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.
3. Referring to the balloon-sizing chart, inflate the balloon with contrast medium until the desired diameter is
achieved or the RBP is reached, whichever comes first. DO NOT EXCEED THE RBP.
DEFLATION AND WITHDRAWAL
1. 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.
2. 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.
3. Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous
vascular procedures.
WARNING: 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.
Catheters and accessories are sold in an 'as is' condition. The entire risk as to the quality and performance of
the catheter is with the buyer. NuMED disclaims all warranties, expressed or implied, with respect to catheters
and accessories, including but not limited to, any implied warranty of merchantability or fitness for a particular
purpose. NuMED shall not be liable to any person for any medical expenses or any direct or consequential
damages resulting from the use of any catheter or accessory or caused by any defect, failure, or malfunction of
any catheter or accessory, whether a claim for such damages is based upon warranty, contract, tort, or
otherwise. No person has any authority to bind NuMED to any representation or warranty with respect to
catheters and accessories.
Warranty and Limitations
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