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The Cowboy XV is designed to enhance blood circulation in the venules and arterioles in the lower extremities. The Cowboy XV Is designed to only patients with diabetic ulcers of the lower extremities. Cowboy XV is intended for patient's in the home who would benefit from increased blood flow to: - treat and assist healing of cutaneous ulceration (wounds). - reduce wound healing time. - enhance arterial circulation (blood flow). - prevent venous stasis (slowing of blood flow). - reduce compartmental pressures. - reduce edema (swelling). - reduce post-operative pain and swelling. - reduce the need for anticoagulant medications (medications that thin the blood). - prevent Deep Venous Thrombosis (DVT) (blood clots in deep veins).

The Cowboy XV pump is connected through tubing to a foot wrap(s). When inflated, these wraps mimic the normal physiological actions of walking, thus helping to open up and improve blood flow and circulation in the venules and arterioles in the lower extremities. This improved blood flow means a greater chance of prolonging the time before or preventing amputation as their wounds heal. Cowboy XV functions as an intermittent pneumatic compression device that enhances lower extremity blood circulation. Cowboy XV is not a life-supporting or life-sustaining device. Cowboy XV is not an implant (short-term or long-term), nor is it a sterile device. Cowboy XV is an electrically-operated (designed to meet UL 1431), software-driven, prescription device, which is used in the home environment. Cowboy XV is comprised of two major components – the reusable pump unit and a single-patient use inflatable foot wrap. Neither component contains a drug nor biological product as a subcomponent. Cowboy XV uses a 16 foot hospital grade power cord to supply a voltage of 115 volts AC at a frequency of 60 Hz with a maximum current consumption of 0.33 amperes and a maximum electrical leakage of less than 100 microamperes from its power source. An exterior shell made of Prism CM-200 material, measuring 12" long by 10 % " wide by 7" high, houses the 11 pound unit. The compressor inflates one or more of the wraps in minimum intervals of 20 seconds at a pressure of not less than 15 mmHg and not more than 180 mmHg (± 15 mmHg). The unit features a microprocessor that controls the unit's operation. The frequency and intensity of the compressions, as well as the duration of the compressions, are all preset values which are monitored and controlled by the microprocessor. The microprocessor also has detection capabilities to monitor the pressure in the wrap(s), adjusting the in and out flow of air as needed. If for any reason the target pressure cannot be maintained, the microprocessor alarm capabilities will activate both visual and audio alarms. These alarm capabilities are built into the unit to alert the user of any unit malfunction situations, should they ever occur. The non-sterile inflatable foot wraps are for single-patient use only. Each wrap is designed to fit around and compress the veins of the foot. The foot wrap is wrapped around the foot. Hook and loop fasteners are used to hold the foot wrap comfortably around the foot. This air bladder is RF-welded to create an air-tight seal, which can then be inflated by Cowboy XV. This air bladder is designed to create a pressure against the body.

The Inflatable Positioning Cushion with Remote Hand Control is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion (a.k.a. ImageAir) allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

The ImageAir Remote Hand Control is a remote control transmitter, utilizing 4 AA batteries. It is utilized in conjunction with an integrated Infrared receiver, located in the Main Control Panel of the Blower Assembly, to inflate and deflate the air cushions. The Remote Control transmitter incorporates a membrane keypad which provides control over the following functions: - Torso Strap On/Off . - Head Strap On/Off . - Height Adjust Up/Down . - Roll Adjust Left/Right . - Roll Adjust Level . - Lower All (Patient Exit) . The Blower Assembly incorporates a microprocessor control as an additional safety feature to ensure the valves which regulate air pressure to the various inflatable cushions are operated in the proper sequence. For example, it would be inadvisable to raise or lower the patient when the table locking straps are disengaged. The microprocessor inside the blower box monitors strap status and will not allow the valves which direct air into the height adjustment cushions to be operated until the straps are verified as being locked.

The Inflatable Positioning Cushion device is intended to be used on nuclear imaging tables for Scintimammography procedures. The Inflatable Positioning Cushion device allows for comfortable, anatomically correct, prone positioning of the patient during Scintimammography.

The Inflatable Positioning Cushion is designed to be used on a standard nuclear imaging table with cradle dimensions of 80" long by 14" wide, such as the SPECT Table manufactured by Medical Imaging Electronics. The Inflatable Positioning Cushion is comprised of a Head Section and Abdominal Section, containing foam cushions and inflatable cushions, and a Lower Body Section of foam cushions. The cushions are secured to the nuclear imaging table with Velcro straps and inflatable straps that wrap underneath the table. The blower for the inflatable cushions is in a separate enclosure that can hang at the end of the nuclear imaging table or sit on the floor.