NuMED TYSHAK NuCLEUS Gebrauchsanweisung Seite 3

INSTRUCTIONS FOR USE
Prior to valvuloplasty, 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.
NOTE: DO NOT REMOVE THE BALLOON PROTECTOR UNTIL AFTER THE PURGING PROCESS IS
COMPLETED.
Attach the 3-way stopcock to the balloon inflation extension of the catheter.
1.0
Fill the inflation device with pressure gauge with approximately 6cc of normal saline. Attach this device to
2.0
the straight port of the stopcock and turn the handle to close the vacant port.
Inject approximately ½ of the 6cc of fluid into the catheter. Draw back on the inflation device to apply full
3.0
vacuum. Repeat this procedure 2 or 3 times to insure total air evacuation.
Remove the inflation device and fill with a solution of either 50/50 or 75/25 saline to contrast medium.
4.0
Reattach the inflation device to the stopcock.
Purge the stopcock.
5.0
Attach a 20cc vacuum syringe to the remaining port of the stopcock. Turn the stopcock handle toward this
6.0
syringe and lock syringe in vacuum position.
Pull vacuum on the filled inflation device to evacuate any air in the stopcock.
7.0
Turn the stopcock handle to expose the catheter port to the 20cc vacuum syringe. This will pull a small
8.0
amount of fluid into the 20cc syringe.
Prepare a peripheral vein site for catheter insertion. The femoral vein is a recommended site for insertion.
9.0
10.0 Under fluoroscopic guidance advance the guidewire to the desired position. Remove the balloon protector
and pass the catheter over the guidewire using the percutaneous technique with an introducer sheath.
11.0 Advance the catheter into the heart and through the valve under fluoroscopic guidance. Position the
catheter so the center image band is located within the valve.
12.0 After correct positioning is confirmed, turn the stopcock to close the vacuum syringe port.
13.0 Inject a small amount of fluid into the balloon. This will inflate the ends of the balloon and seat the balloon
into position in the valve.
14.0 After reconfirming proper positioning, balloon can be either partially or fully inflated to achieve dilatation.
The waist area of the balloon will be at rated size when RBP is reached. DO NOT EXCEED THE RBP.
15.0 Deflate the balloon by drawing a vacuum on the syringe. 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 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.
16.0 Apply pressure to the insertion site according to standard practice or hospital protocol for percutaneous
vascular procedures.
POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
Potential balloon separation following balloon rupture or abuse and the subsequent need to use a snare or other
medical interventional techniques to retrieve the pieces.
NOTE: There have been infrequent reports of larger diameter balloons bursting circumferentially, possibly due to
a combination of tight focal strictures in large vessels. In any instance of a balloon rupture while in use, it is
recommended that a sheath be placed over the ruptured balloon prior to withdrawal through the entry site. This
can be accomplished by cutting off the proximal end of the catheter and slipping an appropriately sized sheath
over the catheter into the entry site. For specific technique, refer to: Tegtmeyer, Charles J., M.D. & Bezirdijan
Diran R., M.D. "Removing the Stuck, Ruptured Angioplasty Balloon Catheter." Radiology, Volume 139, 231-232,
April 1981.
Potential complications and related adverse effects associated with the valvuloplasty catheter use include, but
are not limited to:
• Perforation
• Conduction System Injury
• Thromboembolic Events
• Hematoma
• Cardiovascular Injury
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.
• Arrhythmia Development
• Valvular Tearing or Trauma
• Restenosis Development
• Inflammation
• Infection
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