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The Pulsar Scientific device is not a life-supporting or life-sustaining device. It is a new, prescription use only [21 CFR 801 Subpart D] device for use with restricted mobility and non-ambulatory patients, or other patients as deemed appropriate by the physician. It is not intended for over-the-counter use [21 CFR 801 Subpart C]. The device is intended to function as an intermittent, external pneumatic compression device. The intended therapy of the device is to reduce the risk of the formation of deep venous thrombosis (DVT) by aiding in blood flow back to the heart, to increase blood flow to various body areas, as determined by the physician, to aid in the reduction and control of edema and venous stasis ulcers. Indications For Use: Compression therapy - Including, but not limited to: - Decrease the risk of deep venous thrombosis (DVT); . - Aid the blood flow back to the heart: . - Treat and assist healing of cutaneous ulceration (wounds). reduce wound healing time, . enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications; - Treatment of pain and swelling of acute periarticular processes, treatment of pain and . swelling following mobilization of shoulder stiffness under anesthesia, treatment of pain · and swelling postoperatively for bones, joints and soft tissue, treatment of pain and - swelling caused by musculoskeletal contusions and athletic injury; - Treatment of disorders associate with vascular or lymphatic insufficiency such as . Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic edema; - Reduction of edema associated with soft tissue injuries such as ligament sprains, . postoperative edema, and burns. Thermal therapy - Including but not limited to: - Reduction of general edema (swelling); ● - Reduction of edema associated with soft tissue injuries such as ligament sprains ● postoperative edema, and burns; - Treatment of pain and swelling of acute periarticular processes, treatment of pain and . swelling following mobilization of shoulder stiffness under anesthesia, treatment of pain and swelling postoperatively for bones, joints and soft tissue, treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.

The Recovery+ device is comprised of an electronically controlled, compartmentalized reusable pump used with a variety of single-patient use inflatable anatomical cuffs/wraps. The unit is light-weight and portable. The Recovery+ thermal component with standard pressure component and the DVT component (DVTherapy) of the pump are housed in separate compartments so that they can be used together, separately, or removed for portable usage of the DV.Therapy component. For purposes of this application we will refer to the components as the Recovery+ thermal compression unit and the DVTherapy unit. The Recovery+ device is designed to provide compression therapy and/or thermal therapy (cold or hot). The therapies may be used together or separately, as ordered by the physician. The thermal therapy provides chilled or heated fluid to the cuff affixed on an extremity therapy site and compresses the treatment site for optimum performance and fluid transfer. The compression therapy is accomplished by air pumped through the cuffs, which are affixed on an extremity therapy site, to provide intermittent, sequential pressure. This facilitates venous flow towards the center of the body and simulates the muscle contraction and blood flow of ambulation. The device utilizes microprocessor control with multiple sensors to ensure patient safety and system functionality, and to provide consistent and repeatable therapy modalities. Indicators are both visual on the unit display and audible. Settings are in place to detect any potentially unsafe situation and to terminate therapy to protect the patient and the system. The unit is light weight and portable. The thermal compression runs only on 115 VAC while the DVT unit can operate on batteries, connected to 115 VAC mains, or while docked in the thermal compression unit. The thermal compression unit has internal power supply while the DVT unit has an external power supply. The unit is protectively housed in a plastic shell, except for the outer membrane switch, the plastic quick-connect locks for tub connection, and an external power supply input jack.