CardioFocus HeartLight X3 Manual De Instrucciones página 6

 Do not deliver laser energy into stagnant blood. Delivery into stagnant blood can cause coagulum formation
or damage to the balloon. Laser energy can be delivered into moving blood. Only use 5.5W 30 seconds when
delivering energy into moving blood. Determination of whether blood is moving is made based on the
endoscopic image. Moving blood is evidenced by motion of the boundary between tissue and blood relative
to a fixed point on the Balloon surface consistent with the cardiac cycle.
 Do not deliver laser energy into folds which may appear in the Balloon. Folds in the Balloon may contain
stagnant blood. Delivery into stagnant blood can cause coagulum formation or damage to the balloon.
 The Console is in the ready state when 'Press Footswitch' is displayed. To avoid unintended laser emission
DO NOT press the footswitch before the Catheter is properly positioned.
 Energy should NOT be delivered beyond the distal white line found on the Balloon.

Stop delivering energy if the audible tone is active and aiming beams do not flash.
 In clinical studies the recommended overlap of successive energy deliveries in Manual mode was about 30%
to 50%. The risk of additional energy deliveries in the same location, especially in a short period of time
where energy delivery could create a cumulative effect, is unknown and should be avoided.
 Stop delivering energy if the live image is frozen.
 Failure to provide proper flow may result in patient injury due to overheated balloon, or damage to the Lesion
Generator.
 Do not leave an un-inflated Balloon in the circulatory system for more than one (1) hour. There is a risk of
thrombus formation in the folds of the un-inflated Balloon.
 If excessive resistance is felt while retracting the balloon into the sheath, stop and advance the balloon half
a centimeter and retract again. Do not continue to pull on the catheter if excessive resistance is felt.

Tissue perforation may occur due to excessive power and/or energy application. Do not use higher power
settings in areas of thinner atrial tissue or in areas where the energy is concentrated in the more distal
portion of the balloon.
 Verify that the Balloon and balloon cooling lines have been fully purged of air before insertion into
vasculature. If air is present, purge the balloon and cooling lines to remove all bubbles. Failure to fully
purge the system of air could result in patient injury.
 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.
 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. Mitigation of this event is to pull fluid back into the fill syringe.
 Caution: In the event the Low Fluid Alarm is activated, a small amount of Balloon Fill Media must be pushed
into the burette prior to clearing the alarm.
5. Adverse Events
Potential adverse events associated with cardiac catheter ablation procedures include, but are not limited
to, the following conditions:
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
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