Note: Make sure to introduce the pointed distal end of the balloon introducer at the center of the
rubber hemostasis valve disk, not at the edge of the disk. Dislodgement and leakage of the valve could
occur if the pointed end of the balloon introducer is introduced at the edge of the disk.
8. Advance the Balloon Catheter through the balloon introducer just enough so that the balloon is past the
hemostasis valve.
9. Pull the balloon introducer back out of the hemostasis valve.
10. Advance the catheter the rest of the way through the sheath as needed to position the catheter in the left
atrium as desired.
Caution: Do not advance the catheter without a heparinized saline drip, as a vacuum can be created
that will result in air ingress into the sheath. Maintain a continuous heparinized saline drip while the
device is in the vessel.
Warning: Do not advance the deflectable sheath into the pulmonary veins, as this may cause injury
or serious complications.
Warning: Do not attempt to withdraw the deflectable sheath back across the septum without having
adjusted the deflection mechanism to the non-deflected position.
Warning: The deflection mechanism should be adjusted to the non-deflected position before
removal of the deflectable sheath. Verify that the sheath is in the non-deflected position via
fluoroscopy before removal. Failure to do so can result in patient injury.
7.8 HEARTLIGHT X3 ENDOSCOPIC ABLATION PROCEDURE
7.8.1 PATIENT PREPARATION
The standard procedures for EP studies will be followed.
1. Perform a transseptal puncture using standard techniques. At the option of the physician an additional
transseptal puncture may be performed to provide access for other catheters into the left atrium.
2. It is recommended to administer heparin to achieve a therapeutic ACT per standard of care and to maintain
this level of anticoagulation from the time of transseptal puncture and throughout the ablation procedure until the
Balloon Catheter and sheath are withdrawn into the right atrium.
3. Introduce the sheath into the left atrium in accordance with the sheath's Instructions for Use.
4. Pre-ablation mapping may be performed at the discretion of the physician.
7.8.2 PROCEDURE
The Balloon Catheter must be used with the HeartLight X3 Console. Please refer to the HeartLight Endoscopic
Ablation System Operation and Maintenance Manual 06-4955 for recommended procedural steps.
1. Prepare a Balloon Catheter for the first vein to be treated. Insert the Balloon Catheter into the sterile
compatible deflectable sheath as described in the sheath's Instructions for Use.
A white indicator line on the proximal portion of the Balloon Catheter shaft indicates the interior length of the
catheter within the HeartLight Sheath. When advancing the Balloon Catheter inside the Sheath, the Balloon
HeartLight X3 Catheter Instructions for Use
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