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PYREXAR BSD-2000 3D Deep Regional Hyperthermia

Deep Regional system using an annular phased array configuration to shape and focus
thermal energy on targeted treatment using Sigma Eye Wave Guide.

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Product Certification for the Pyrexar BSD-2000 3D MR

BSD-2000 3D with Sigma Eye 12 channel Applicator

Three-Dimensional Hyperthermia Permits Superior Targeting and Optimal Results

The BSD-2000/3D provides targeted deep regional therapeutic hyperthermia to solid tumors by applying radiofrequency (RF) energy. The BSD-2000/3D delivers energy to a patient using a power source and an array of multiple antennae that surround the patient’s body. The twenty-four dipole antennas of the Sigma Eye maximize the 3D energy convergence at the targeted treatment location.

The BSD-2000/3D was designed to provide an optimized heating zone targeted to the tumor region by utilizing the adjustment of frequency, phase, and amplitude from multiple power sources. Dynamic 3D control and steering of the heating pattern size, shape, depth, and position provide optimized heating since the electromagnetic energy can be targeted specifically at the tumor region. The focus is not fixed at the center of the applicator, providing the system operator with significantly more freedom in positioning the applicator’s heating region. The BSD 2000/3D hyperthermia system is designed particularly for treating tumors in hard-to-reach locations. This model is currently sold outside of the U.S.

How is 3D Hyperthermia Applied?

The targeted treatment area of the patient’s body is enclosed by an eye-shaped applicator. Phase and amplitude steering is utilized to create the heating focus within the applicator. The 3D technology utilizes 24 dipole antennas of the Sigma Eye driven by 12 RF power channels to optimize the targeted heating. The 24 dipoles are arranged in three rings of eight antennas each. By varying the phase and amplitude of each of the 12 input channels, the operator can enhance the heating in the tumor and reduce the heating in non-target tissues.

Annular Phase Array

The Sigma applicators are annular phased array applicators that are comprised of a clear plastic shell, 24 radiating dipoles, and a bolus membrane. The Sigma Eye provides heat zone control in the X, Y and Z axis

Cooling System

Water system automatically fills the bolus and controls the bolus water temperature. This keeps patient exterior at comfortable temperature range.

Fabric Sling

Fabric sling comfortably supports patient inside the applicator for optimized patient comfort. Hydraulic lift system used for optimal positioning

Quick Drain Bolus

Quick drain capability allows fast access to the patient – 15 seconds for patient access and 30 seconds for a complete drain.

Sigma System

Three Interchangeable phased array applicators to support different patient sizes and indication specific applications.

Intuitive Interface

Full featured, user friendly, intuitive, graphical user interface. Touch screen  with step-by-step guide for setup and treatment procedure. Primary user features presented on main screen.

Monitoring

Closed-loop feedback system with automatic monitoring and control of treatment parameters, including power output, frequency, amplitude & phase, tissue & core temp., and treatment time.

Temp. Control

Control of power and tissue temperature to within ±0.1°C. in compliance with ESHO guidelines. Data regarding temperatures, RF power level, and RF power control updated every 2 seconds.

Safety Checks

The computer automatically performs safety checks to ensure proper operation of the system and ensure patient protections with auto shutdown features.

Phase & Amplitude

Solid-state amplifier with 4-channel independent phase and amplitude adjustment capability

500W per Channel

Maximum power output of 0 to 500 watts per channel. Phase accuracy within a 10 degree tolerance.

Phase Offset

Computer automatically monitors and controls forward and reflected power, phase, and power on each channel.

Treatment Plan

Optimized treatment settings are calculated through the use of treatment planning software tools provided with the system.

High Accuracy

Non-perturbing, electromagnetically insensitive, temperature sensors with an accuracy of ±0.2°C over a range of 25 to 52°C.

Auto Positioning

Automated positioning system allows the operator to map the sensor along the length of the catheter in order to determine the temperature profile.

Precise Calibration

Precise calibration reference sensor is accurate to ±0.05°C over a range of 0 to 60°C. New Thermal well for easy pre-treatment calibration.

Probe Mapping

Motorized probe mapping allows for the mapping of temperature in .5cm increments allong catheter path.

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