CardioFocus HeartLight X3 Manual De Instrucciones página 3

1. Description
These instructions for use are intended for the HeartLight X3 Catheter with Excalibur Balloon (referred
to as the HeartLight X3 Catheter or Balloon Catheter). The Balloon Catheter is a sterile, single-use,
disposable device that delivers infrared laser energy to create a rise in tissue temperature resulting in
thermal ablation of the target tissue.
The HeartLight X3 Endoscopic Ablation System is comprised of the following basic elements and
features:
• A multi-lumen Catheter with tubing set.
An inflatable, compliant Balloon at the Balloon Catheter distal end. The Balloon is inflated with a sterile
•
Balloon Fill Media, Deuterium Oxide (D
Balloon Fill Media - Each 1 mL of Sterile, Non-Pyrogenic Deuterium Oxide contains: 123mg Diatrizoate
•
Sodium. Sodium Carbonate and Hydrochloric Acid added to adjust pH
A Balloon Remote for controlling balloon size.
•
• A Lesion Generator that delivers light energy.
An electric motor that can rotate the Lesion Generator to create longer arcs of ablation.
•
• Two optical fibers for illuminating the tissue with white light to permit visualization by the Endoscope
Endoscope (packaged separately) is a 2F, 145cm usable length, reusable device compatible with the
•
HeartLight X3 Catheter.
Use only the HeartLight X3 Catheter with the HeartLight X3 Console.
For details about the HeartLight X3 Console and how to use it as an integrated system with the
HeartLight X3 Catheter to perform ablation procedures, refer to the HeartLight X3 Endoscopic Ablation
System Operation and Maintenance Manual 06-4955.
1.1 Contents of package
The product is supplied sterile. The package contains all-inclusive product documentation and one of
the following items (each packaged separately):
HeartLight X3 Catheter
•
• Endoscope
Balloon Fill Media (D
•
2. Indications for Use
The HeartLight X3 Catheter is a single-use disposable device for the isolation of pulmonary veins to be
used in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an
Electrophysiology or Catheterization Laboratory. The Catheter is intended to be used with the
HeartLight X3 Endoscopic Ablation System. The HeartLight
direct light energy in the antrum of the pulmonary veins to create conduction block as a treatment for
atrial fibrillation in patients age 18 or older. In addition to the Balloon Catheter, the HeartLight X3
System consists of a sterile single use disposable Deflectable Sheath, Console, Endoscope, and
Balloon Fill Media.
HeartLight X3 Catheter Instructions for Use
06-5511 REV A
O) admixture (packaged separately)
2
O)
2
® X3 System is intended to be used to
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