NuMED NuCLEUS-X Instrucciones De Utilizacion página 3

• Use only appropriate balloon inflation medium. Do not use air or gaseous medium to inflate
the balloon.
• The catheter is not intended for pressure measurement or fluid injection.
• Do not remove the guidewire from the catheter at any time during the procedure.
• This device is intended for single use only. Do not resterilize and/or reuse it, as this can
potentially result in compromised device performance and increased risk of cross-contamina-
tion.
• The catheter should be used prior to the 'Use Before' date noted on the package label.
• THE CATHETER IS NOT INTENDED FOR USE WITH STENTS.
P
RECAUTIONS
• Dilatation procedure should be conducted under fluoroscopic guidance with
appropriate x-ray equipment.
• Guidewires are delicate instruments. Care should be exercised while handling to help
prevent the possibility of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and
aspiration before proceeding to avoid air introduction into the system.
• Under no circumstances should any portion of the catheter system be advanced
against resistance. The cause of the resistance should be identified with fluoroscopy
and action taken to remedy the problem.
• If resistance is felt upon removal, then the balloon, guidewire, and the sheath should be
removed together as a unit, 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.
• Before removing the catheter from the sheath it is very important that the balloon is
completely deflated.
• Proper functioning of the catheter depends upon its integrity. Care should be used
when handling the catheter. Damage may result from kinking, stretching, or forceful
wiping of the catheter.
I
NSTRUCTIONS FOR
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 proce-
dure for which it is intended.
NOTE: DO NOT REMOVE THE BALLOON PROTECTOR UNTIL AFTER THE PURGING PRO-
CESS IS COMPLETED.
1.0 Attach the 3-way stopcock to the balloon inflation extension of the catheter.
2.0 Fill the inflation device with pressure gauge with approximately 6cc of normal saline. Attach
this device to the straight port of the stopcock and turn the handle to close the vacant port.
3.0 Inject approximately ½ of the 6cc of fluid into the catheter. Draw back on the inflation device
to apply full vacuum. Repeat this procedure 2 or 3 times to insure total air evacuation.
4.0 Remove the inflation device and fill with a solution of either 50/50 or 75/25 saline to contrast
medium. Reattach the inflation device to the stopcock.
5.0 Purge the stopcock.
6.0 Attach a 20cc vacuum syringe to the remaining port of the stopcock. Turn the stopcock han-
dle toward this syringe and lock syringe in vacuum position.
7.0 Pull vacuum on the filled inflation device to evacuate any air in the stopcock.
8.0 Turn the stopcock handle to expose the catheter port to the 20cc vacuum syringe. This will
pull a small amount of fluid into the 20cc syringe.
9.0 Prepare a peripheral vein site for catheter insertion. The femoral vein is a recommended site
for insertion.
10.0 Under fluoroscopic guidance advance the guidewire to the desired position. Remove the bal-
loon protector and pass the catheter over the guidewire using the percutaneous technique
with an introducer sheath.
U
SE
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