System Description

The System, illustrated in Figures 1 and 2 below, is designed to provide brachytherapy treatment. It is
comprised of the following:

Axxent® Controller
Axxent® HDR X-ray Source-2.2
Axxent® Cooling Tubing Set
Axxent® Skin Applicator
Axxent® Physics Accessories Kit
Axxent® Vacuum Pump

The Controller supplies high voltage, filament current, and circulates cooling water to the X-ray Source.

The Source is a miniaturized x-ray tube, operating at 50 kV, located at the tip of a cooling catheter
assembly that delivers radiation to provide conformal doses through the Applicator directly to the tissue.

The disposable Cooling Tubing set is used for cooling water circulation.

The Skin Applicator positions the X-ray Source in the desired location for radiation therapy.

The Vacuum Pump is used to remove cooling water from the Source after every day of Source usage.

The Axxent® System Controller and components are designed to be used only with each other.