CardioFocus HeartLight X3 Manual De Instrucciones página 15

when the Lesion Generator position is more distal
•
when the Balloon size is smaller
•
• when the aiming beam spot size appears smaller
16. The available dosages are listed in Table 1 below. Please see the section of Procedural Data in the Clinical
Summary for ablation settings used in the HeartLight clinical study.
17. If there is any doubt about the presence of moving blood or the location relative to the distal white line,
consider lowering the power to 5.5W for 30 seconds.
 WARNING: Do not deliver energy into blood in RAPID mode.
18. Ensure that circumferential tissue contact exists via the endoscopic image and that the aiming beam is
targeted at the desired lesion location. The black rectangular marks visible in the endoscopic field of view are
intended to aid in proper rotational spacing of the lesion placement. Rotating the aiming beam one mark
advances the lesion generator adequately to overlap the lesions.
19. If desired, a reference snapshot may be captured using the Console prior to treating a vein. A reference
snapshot may also be captured at any time during the procedure.
20. Move the aiming beam to the start of the treatment area, select the RAPID mode dose, then pick the direction
of rotation (Clockwise or Counter Clockwise).
Manual Mode
Dose
Power
(Watts) (seconds)
5.5W
5.5W
7.0W
8.5W
8.5W
10W
12W
21. Enable the Laser using the Console. With the Lesion Generator aiming at a properly selected ablation site,
depress the footswitch to deliver energy. When energy is being delivered the following will occur:
• an audible tone sounds
the console will display the current power setting in Watts
•
the message area counts down energy delivery time remaining (Manual mode) or displays laser energy
•
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
Table 1: Available Manual and RAPID mode Ablation Settings
Recommendations
Time
Tissue and moving blood. Use when any
30s
possibility of moving blood exists
When user desires lower dose, for
30s
example, to avoid excessive esophageal
temperature rises
30s
20s
Recommended starting dosage
30s
Areas of possible thicker tissue
20s
Areas of possible thicker tissue
20s
Areas of possible thicker tissue
Tissue only
Tissue only
Tissue only
Tissue only
Tissue only
Tissue only
RAPID Mode
Equivalent Dose
Power (Watts)
No Equivalent Dose,
Use Manual Mode
No Equivalent Dose,
Use Manual Mode
13W RAPID
No Equivalent Dose,
Use Manual Mode
15W RAPID
No Equivalent Dose,
Use Manual Mode
ECN-4541
Page 15