Search Results

The standard FLEXICAIR® ECLIPSE™ , the FLEXICAIR® ECLIPSE™ PLUS the FLEXICAIR® ECLIPSE™ ULTRA Mattress Replacements are intended to provide low-airloss therapy for different ranges of patient weights. The standard FLEXICAIR® ECLIPSE™ , used on general Med-Surg or specialty beds covers all patient weights up to 300 lbs. The FLEXICAIR® ECLIPSE™ PLUS covers patient weights from 301 lbs to 450 lbs on Hill-Rom Centra and Advance 1000 bed frames and on the Stryker MPS bed frame. The FLEXICAIR® ECLIPSE™ ULTRA covers patient weights from 451 to 800 lbs on the Hill-Rom Magnum/Magnum II bed frames.

Air-fluidized and low airloss beds have been used for comfort and therapy for individuals who could not move themselves. Low airloss therapy has been demonstrated to reduce the risk of pressure ulcers caused by loss of capillary circulation as well as be a valuable aid in the treatment of bed sores.

Low airloss therapy maintains patient's peripheral circulation by distributing the patient's weight over cushions filled with air. The even distribution of pressure on the skin limits capillary closure, thereby helping maintain tissue viability around bony prominence such as the sacrum and heels. The numerous cushions in the FLEXICAIR® ECLIPSE™ help to decrease shear forces against the skin by moving independently of one another while the fabric helps to decrease friction.

A non-permeable cover, or coverlet, placed over the cushions prevents the transmission of perspiration and body fluids to the cushions.

The FLEXICAIR® ECLIPSE™ is a Portable Powered Flotation Therapy Mattress system. It consists of an air supply unit and mattresses. The air supply unit contains a blower, controller, and valves. The mattresses are composed of multiple air cushions attached to a substrate, with variations in height, number of cushions, and zoning depending on the specific model (Standard, PLUS, or ULTRA). The system utilizes proportional valves to control air pressure.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a medical device (FLEXICAIR® ECLIPSE™), which describes the device, its indications for use, and a comparison to predicate devices, but it does not detail specific performance studies or acceptance criteria that would typically be found in a clinical or performance validation report.

Therefore, I cannot fulfill the request using only the provided text.

Ask a specific question about this device