CardioFocus HeartLight X3 Manual De Instrucciones página 12

Catheter exists within the Sheath until the shaft indicator mark is flush with the hemostatic valve. This mark
denotes that the radiopaque tip of the Balloon Catheter is near the end of the HeartLight Sheath and continued
advancing of the Balloon Catheter should be completed under fluoroscopy. Once the indicator is no longer
visible, the Balloon catheter may be protruding from of the HeartLight Sheath.
 Note: This mark is only applicable when used with the HeartLight Sheath.
 Note: Balloon Catheter positioning should be completed under proper visualization with fluoroscopy.
Note: Make sure that the Lesion Generator is positioned inside the Balloon, before insertion of the
Balloon Catheter into the sheath. The Lesion Generator should remain in this portion of the Balloon
Catheter during insertion into the sheath, during manipulation in the atrium and during removal from the
sheath. The Lesion Generator should not be made to traverse a tight bend in the Balloon Catheter.
Malfunction of the Lesion Generator may result.
2. Designate the correct vein name on the Console Treatment Screen to file any images taken under the
appropriate vein name.
3. Advance the sheath and Balloon Catheter tip into the ostium of the pulmonary vein under fluoroscopic or ICE
guidance.
4. Advance the Balloon Catheter using fluoroscopy to observe the distal tip of the Balloon Catheter. Do not
advance the Balloon Catheter if the Balloon tip is bent.
5. For initial inflation at the ostium of a given vein, press the '+ side of the rocker switch to start inflating the
Balloon. Inflate the Balloon such that the distal tip of the Balloon is just inside the pulmonary vein ostium.
Caution: Do not attempt to inflate the Balloon when located within the sheath.

6. Advance the inflated Balloon until it occludes the pulmonary vein ostium. Manipulation of Balloon Catheter
position and adjustment of the balloon size may be used to optimize contact. Use the endoscopic image to
determine when contact is optimized. Elements of optimal balloon size include a wrinkle free balloon surface and
visibility of the proximal white balloon mark in the endoscopic view. Fluoroscopic visual confirmation is
encouraged if the balloon is inflated and the proximal white balloon mark is not in the endoscopic field of view.
Do not use excessive force when advancing, positioning or rotating the Balloon Catheter.
7. Orient endoscopic image:
a. A 'Z' shaped radiopaque orientation marker, Z-Marker, is located on the proximal neck of the Balloon (see Figure 1:
Distal Tip Configuration). This Z-Marker allows the user to determine the rotational orientation of the Balloon relative to
the patient anatomy.
b. Figure 2 below illustrates typical radiographic AP views of the Balloon and orientation marker for the LSPV.
Views A-D show how the Z-Marker will appear depending on its orientation to the anatomy. Interpretation of the
Z-Marker orientation for other pulmonary veins follows the same strategy.
c. If desired, using the orientation marker as a guide, adjust the endoscopic image by rotating the proximal
Endoscope fitting relative to the camera so the superior, anterior, inferior and posterior directions are displayed
in typical convention on the display. Figure 3: LSPV Endoscopic Views shows the corresponding examples of
endoscopic views for each of the LSPV-AP angiographic views.
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
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