delivery time (RAPID mode)
the red and green aiming beams flash on and off
•
'Laser Active' is displayed in the Message Area
•
22. During energy delivery, monitor the appearance of the tissue being ablated in the endoscopic view. If the
tissue begins to darken discontinue energy delivery.
23. During energy delivery, it is recommended to monitor esophageal temperature with a probe. If the
temperature exceeds 38.5 °C, the operator must immediately stop energy delivery.
24. During energy delivery
Manual Mode
When the energy delivery is complete, release the footswitch and verify that the Console displays the
'Laser Ready' state. The Console is now ready for another energy delivery.
RAPID Mode
Ablation will proceed as long as the footswitch remains depressed (up to 600 degrees or 1 2/3
rotations). Release the footswitch when desired ablation segment is complete. During energy
delivery, the laser's green aiming beam may be moved either in or out of the vein (distal or proximal)
by approximately one-half the width of the green aiming beam every 5 seconds to minimize the risk
of gap formation. This is done using the slider mechanism in the handle of the Balloon Catheter.
Note: An error message will display if the catheter rotation reaches 600 degrees.
25. A snapshot is automatically captured at the beginning of each energy delivery and at regular intervals in
RAPID mode. This enables the use of the 'Overlay Feature' which may be used to help locate subsequent
energy deliveries. To use the Overlay Feature, follow instructions in the Console Operations and Maintenance
Manual.
26. Observe the aiming beam during energy delivery. If the spot appears distorted at any point, terminate the
energy delivery, and replace the Balloon Catheter.
Note: If the Balloon Catheter is rotated and/or the Endoscope is rotated relative to the camera,
the snapshot overlay may need to be moved or rotated to correctly align the live image with the most
recently captured Energy Delivery snapshot using the Snapshot Overlay Position controls.
27. Continue ablation in the targeted vein until a circumferential lesion set has been created.
28. If desired, review the vein snapshots prior to moving to the next vein using instructions in the Console
Operations and Maintenance Manual.
29. Deliver more lesions as deemed necessary to complete a circumferential lesion set.
30. Deflate the Balloon and retract into sheath with Balloon Catheter tip extended beyond the tip of the sheath,
guide the Balloon Catheter to the next pulmonary vein.
Note: It is important to correctly label each vein prior to delivering energy and taking snapshots.
The snapshot review feature uses the vein label to sort the snapshots.
31. Repeat steps 2-30 until all pulmonary veins have been targeted and treated.
32. Deflate the Balloon while observing the endoscopic image to determine when the Balloon is fully deflated.
The Balloon will deflate in less than 60 seconds. Once it is fully deflated, retract the Balloon into the sheath and
withdraw the Balloon Catheter from the sheath.
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
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ECN-4541