CardioFocus HeartLight X3 Manual De Instrucciones página 10

Caution: Do not overfill the burette beyond the balloon fill line. Overfilling the burette will bypass

protection which prevents over inflation of the balloon. An over-inflated balloon has the potential to
lead to balloon rupture. If Balloon Fill Media is above the level of the solid line when the balloon is
fully deflated, pull fluid back into the fill syringe until the Balloon Fill Media is even with the solid line.
 Caution: In the event the Low Fluid Alarm is activated, a small amount of Balloon Fill Media can be
added to the burette to clear the alarm and restart the pump. Alternatively, the alarm may be cleared
by navigating to the Catheter Preparation screen on the console or opening the pump head, pressing
the '-'side of the Balloon Remote rocker switch to allow Balloon Fill Media to flow back into the
burette, and closing the pump head once the Balloon Fill Media level is above the lower burette clip.
 Caution: In the event Balloon Fill Media is added to the burette in order to clear the Low Fluid Alarm
and restart the pump, deflate the balloon and reset the Balloon Fill Media level even with the solid
line on the burette using the fill syringe.
3. Inspect the Balloon and all of the Balloon Catheter's flow paths for any signs of leakage. If leakage is due to a
loose fitting, tighten the fitting and confirm Balloon Catheter is leak free before use. If there is any sign of leakage
from the Balloon do not use that Balloon Catheter.
 Caution: Verify that the Balloon cooling lines have been fully purged of air before insertion into
vasculature.
 Caution: In the event an Emergency balloon deflation is required, fluid can be removed from the
balloon catheter by pulling back on a syringe connected to an endoscope lumen.
7.7 INTRODUCTION OF THE BALLOON CATHETER
1. Connect a saline bag tubing set and irrigation syringe (60cc) to the stopcock ports on the Deflectable Sheath
irrigation line.
2. Fully open the roller valve on the saline tubing set and flush the sheath with heparinized saline pressurized
to 300 mm Hg to remove air.
3. While keeping a 60 cc syringe and Deflectable Sheath side-port vertical, draw fluid into the syringe from the
sheath and re-inject to remove any remaining air. Perform this purging process twice before closing the
stopcock valve. Maintain the Deflectable Sheath side-port in the vertical position throughout the procedure.
4. Push back the balloon introducer, inflate balloon and submerge both in a sterile saline bath taking care to
eliminate all bubbles on the balloon's surface and inside the introducer.
5. Deflate and furl the balloon while still under saline then advance the balloon introducer sheath over balloon
and check for any trapped air bubbles between the furled balloon and introducer sheath. Remove any
trapped air by partially pulling the balloon out of the introducer sheath allowing the air to escape.
6. Fully open the roller valve allowing pressurized (300mm Hg) heparinized saline to flow. Then remove the
balloon and introducer sheath from the saline bath keeping the distal end pointing down to maintain a
column of water inside the balloon introducer.
7. Insert the distal end of the balloon introducer through the hemostasis valve and allow heparinized saline from
the sheath to flow back into the balloon introducer until drips are seen at the proximal end of the balloon
introducer.
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
Page 10
ECN-4541