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The Sensus IORT System is indicated for radiation therapy treatments. The Sensus IORT System is an electron linear accelerator with a beam-forming x-ray target used for low energy to treat lesions, tumors, and conditions in or on the body where radiation is indicated. Only Sensus TVM Balloon Applicators can be used with the Sensus IORT System.

The Sensus IORT System is a mobile robotically-guided low-energy intraoperative radiotherapy device for treating cancer lesions and tissue beds during and post-surgery. The Xray source with beam shaping Morpheus provides radiation emission in the low energy therapy ranges of 50, 60, and 70 kV (a total of 3 kV modes) and is held and moved in place by an IEC 60601 medical certified robotic-arm. The robotic-arm uses a 7-axis motion system and is designed for human-robot collaboration for optimized treatment delivery and dosimetry. The robotic-arm and its control cabinet mounted in the base of the Sensus IORT System contains multiple sensory capabilities for safety and simple operator control that allows it to act as an assistant to the doctor. The robot's joint torque sensors allow it to touch the patient with enough sensitivity to move with respiratory tracking (dubbed Cybernetic Respiratory Motion Tracking, or CRMT) and allow hand-guided movement by the doctor to control and place the xray source into position to deliver therapy. The X-ray source held by the robotic arm consists of a drift tube and electron acceleration stage. In general, kilovoltage x-ray sources produce x-rays by accelerating electrons onto a tungsten target, which is a high-Z material. The electrons decelerate in the target, and their energy is converted to x-ray radiation (referred to as Bremsstrahlung, literally "braking" radiation), which is emitted in a roughly isotropic radiation pattern. The Morpheus x-ray gun enables the Sensus IORT System to deliver an optimal and effective therapy beam to the targeted tissue bed that requires localized treatment. The Morpheus x-ray gun is operated by the system's control circuits and software and it is being fed by the high voltage power supply (HVPS), which provides the high voltage through the HV Feedthrough to the Morpheus x-ray gun and the integrated cooling module, which circulates the cooling fluid in order to maintain the Morpheus x-ray gun at a stable and optimal thermodynamic condition. The currently available kV modes of the Morpheus x-ray gun are 50kV, 60kV, and 70kV (Gen 1.0). The high voltage potential from the HVPS is fed to the Cathode by the HV Feedthrough onto the Cathode Assy. Once the electron beam hits the Diamond-Tungsten-Molybdenum (CW-Mo) target, x-ray photons are generated in an isospheric pattern that is emitted towards the front and back of the target. The x-ray photons have no attenuating barrier in the front of the target (the attached Cooling Jacket is x-ray translucent) and the x-ray photons that are emitted from the back side of the target are emitted out with no significant attenuation through the SiC Window Sleeve. This allows the x-ray photons to be effectively generated and emitted from both sides of the target, thus rendering an optimal geometric distribution and coverage of the generating x-ray beam to deliver therapy. The system base unit is self-propelled with full battery backup, which allow the operators to move it between surgical suites and hospital facilities. It also features a 3KW back up UPS, which allows the operators to complete a full treatment, even if the hospital power grid goes off line. The Sensus IORT System is a stand-alone system that incorporates its own cooling module, power supplies, and networking. It consists of five separate core components: - Computer Control Console . - . Beam Shaping Morpheus / X-Ray Source (to delivery X-ray radiation) - Cybernetic Respiratory Motion Tracking (using the Robotic Arm) . - Base Unit with Drive/Propulsion System (device cabinet with motor) . - . Red-Diode laser for positioning The Sensus IORT System X-ray source interacts with a sterile tissue volume management (TVM) Balloon Catheter to act as a barrier between the X-ray source and the patient.

Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.

The Sensus TPS Workstation is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for radiation oncology facilities. For radiation oncology users, the TPS Workstation provides image-enabled electronic patient charting and record management. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, beam geometry planning, treatment plan review, and verification and record treatment setup and delivery. The Sensus Healthcare TPS Workstation is dedicated for use with the Sensus Healthcare IORT System only. The software is not a general-use product compatible with other IORT systems.

The Sensus Healthcare TVM Balloon Applicator is intended to support the delivery of high-dose-rate X-ray radiation in support for brachytherapy. The Sensus TVM Balloon Applicator is indicated for use with the Sensus IORT System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.

The Sensus Healthcare TVM Balloon Applicator is a component of the Sensus Healthcare IORT system, which utilizes an X-ray source and does not employ radioactive isotopes. The TVM Balloon Applicator supports the Sensus Healthcare IORT System's ability to deliver intraoperative brachytherapy wherever the physician chooses to delivery radiation therapy. The Sensus Healthcare TVM Balloon Applicator is provided in one size (variablevolume balloon) to support the achievement of proper fit within the varying patient anatomies. The applicator is a single-use disposable device that is provided sterile. Product sterility is achieved through the use of Gamma radiation (reference ISO 11137-1).

The SRT-100+ System is a low energy x-ray system, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include: (a) basal cell carcinoma; (b) squamous cell carcinoma; (c) Metatypic carcinoma; (d) cutaneous appendage carcinoma (e) Kaposi's Sarcoma; and (t) the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue. A red-diode laser is employed for the assisting with cone applicator placement.

The Sensus Healthcare SRT-100+ is a complete, stand-alone, x-ray radiation therapy system. It consists of four separate components: (a) control console; (b) base unit; (c) red-diode laser; and (d) applicators. - (a) Control Console: Specifically designed module housing the switches and indicators used by the operator to set up and execute x-ray exposures. The controls adjust the machine functions and settings only! There is no treatment planning capability. The Control Console is connected, through a cable, to the Base Unit. - (b) Base Unit: The base unit consists of a cabinet containing the high voltage generator, power supply components, cooling system, and an arm/positioning mechanism on which the x-ray tube housing assembly is mounted. A series of Applicators are included, which are affixed to the x-ray port on the x-ray tube housing assembly to limit the x-ray beam and provide fixed Source-to-Skin Distance (SSD). The X-ray Tube-Housing Assembly contains a motorized filter mechanism, which moves the appropriate beam filter: (a) 0.10 mm Al at 20 to 30 kV: (b) 0.45 mm A1 at 50kV: (c) 0.75 mm Al at 70 kV; and (d) 1.15 mm Al at 100 kV; into the beam path depending on the kV setting selected by the operator. - (c) Red-Diode Laser: A red-diode laser is integrated with the SRT-100+ System. The laser is manufactured by U.S. Laser and is classified as FDA Laser Class 3A. The application of the red-diode laser with the Sensus SRT-100 Vision has been tested in accordance with IEC 60825-1. - (d) Applicators: The system is shipped with a set of interchangeable treatment applicators, which define the source to skin distance (SSD) and the diameter of the treatment beam's exposure. The applicator size, therefore, determines the amount of total dose delivered per minute to the lesion and the actual area that will be treated by the system's x-ray beam. Each applicator is embedded with a unique magnet binary combination, which allows the system to automatically detect an applicator as it is mounted on the x-ray port. This provides the system with the information about the applicator's SSD and diameters, which allows it to correlate the applicable dose rate for each applicator that is attached to the x-ray port, thus allowing for a precise and user-error-free dose rate per minute calculation. There are a variety of applicator sizes available for use with the Sensus Healthcare SRT-100+ System, driven by the treatment modality.