CardioFocus HeartLight X3 Manual De Instrucciones página 14

A - Superior
Posterior
Superior
Posterior
C - Inferior
11. When concomitant phrenic nerve pacing is used, monitoring of the phrenic nerve during energy delivery by
palpation of the strength of diaphragmatic excursion or other methods is recommended. Energy delivery to the
RSPV (or RIPV) must be discontinued if movement of the diaphragm slows or changes during energy delivery.
12. Advance the Lesion Generator. Turn on the aiming beams. Rotate and determine a plan for energy deliveries
that will create a circumferential lesion. Energy should be delivered fully into 'tissue' or into 'tissue and moving
blood' (5.5W dose only), but never into stagnant blood. Energy should be delivered as proximal (antral) as
contact allows. Energy should be delivered in an overlapping fashion to avoid gaps between lesions.
 WARNING: 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 tissue and moving
blood. Only use 5.5W 30 seconds when delivering energy into tissue and moving blood.
13. The Lesion Generator will need to be moved proximally in order to visualize tissue contact and the possibility
of stagnant or moving blood, which may lie behind the Lesion Generator. When delivering lesions behind the
Lesion Generator, lower doses should be used (5.5W) to avoid inadvertently delivering energy into blood at
higher doses.
14. Determine the desired dosage and power delivery mode using the touchscreen on the Console. The power
parameter refers to the output power that the console delivers through the Balloon Catheter to the target tissue.
It is measured as watts (W). The HeartLight X3 System can be operated in two modes, 1) Manual mode and 2)
RAPID mode. In Manual mode, the Console delivers a fixed dose (W) for a fixed amount of time (seconds) while
the lesion generator is stationary. In RAPID mode, the Console delivers a constant dose (W) and rotates the
lesion generator in the vein for as long as the user presses the footswitch.
15. In Manual mode, 8.5W for 20 seconds should be used as a starting dose in most situations. In RAPID mode,
13W RAPID should be used as a starting dose. Power levels may be reduced or increased based on physician
judgment. In general, less energy should be used:
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
Orientation Marker
Anterior
Inferior
Central Lumen "Blind Spot"
Anterior
Figure 3: LSPV Endoscopic Views
Superior
Posterior
Inferior
Superior
D- Posterior
Inferior
B - Anterior
Anterior
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