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The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended to provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 lbs.

The TotalCare® Modular Therapy (Bed) System is a control unit (GUI) and frame which can house several therapeutic surfaces. The system can articulate to provide different positions for treatment, sleeping, up-in-bed, and other physician recommended positions. The Graphical Caregiver Interface/ Graphical User Interface can be set for alarms such as patient egress and head-of-bed angle.

The KinAir IV and Therpulse II beds are for supporting bedridden patients in a manner that helps prevent and treat complications of immobility such as skin breakdown and decubitus ulcers. More particularly, it employs a patient supporting mattress overlay having an arrangement of transverse inflatable cushions that can be controlled to provide slowly pulsating pressures beneath the patient, as well as bladders to assist in turning the patient to one side or the other. The KinAir IV, Therapulse II Air Bed bed is indicated to assist in the prevention and treatment of the complications of immobility, especially for patients who would benefit from a pressure relieving surface with the additional optional benefit of pneumatic pulsation.

The KinAir IV, Therapulse II (a.k.a. KT Air Bed) device is a pulsating low air-loss support mattress replacement system mounted on a commercially-available Stryker 3000 Acute Care Bed Frame, that also includes a Turn Assist feature. The mattress replacement system itself is essentially of the same general construction as the predicate Therapulse (510(k) No. K875321) and the KinAir (510(k) No. K880340 and the substantially equivalent TriaDyne device (510(k) No. K944094). It consists of the fabric support and the various cushions. The fabric support is a Gore-Tex fabric assembly for supporting and containing the twenty five upper cushions. Two additional inflatable cushions are on the underside of the fabric support, to assist the caregiver when turning the patient. All inflatable cushions are made of a vinyl Gore-Tex fabric to provide a low shear, low friction surface that is washable and durable. The KinAir IV, Therapulse II Air Bed has two general modes of operation: 1) static, and 2) turn assist, with an optional third mode, pulsation, available only on the Therapulse II. The Display membrane panel mounted on the footboard and in each foot siderail, are used to select the static and pulsing modes. For the static mode, four individually adjustable sections of upper cushions are inflated to support the patient with minimal air pressures. For the pulsing mode, over an adjustable cycle of between 2 1/2 and 40 minutes, some cushions are inflated and deflated more or less than others in order to alternate the pressures supporting the patient. The cycle repeats continuously until the pulse mode is deactivated. The Turn Assist mode is only available on the Home Display membrane panel mounted on the footboard. When the caregiver selects this mode to turn the patient either left or right, either the left or right bladder cushion will inflate and lean the patient approximately 15-20 degrees and stay inflated until the caregiver deactivates the turn assist mode. This feature was added to assist the caregiver when performing routine patient care, such as bathing, bedpan placement, etc. The blower unit and Air Supply Unit are mounted on the Stryker bed frame, beneath the mattress. They are controlled to achieve the various modes of operation according to user input through switches on the membrane panels mounted on the footboard and on the outside of the foot siderails. All user input is accomplished through these membrane panels. The membrane panels with the various settings and displays are illustrated throughout the KinAir IV and Therapulse II Quick Reference Guides. The Air Supply Unit's warmer is provided to warm air in the mattress for patient comfort. The blower is mechanically and electrically isolated to help prevent injury and reduce The warming element itself is a conventional resistive silicon heater. The warmer noise. actually warms the air in the Air Supply Unit's manifold, and the air then passively warms the patient to the degree selected by the patient's attendant. There are three settings: 1) LOW, 2) MEDIUM and 3) HIGH. At the HIGH setting, the heating element is capable of achieving maximum temperatures of roughly ten degrees Fahrenheit above ambient. Temperature feedback from sensors adjacent to the blower manifold allows for control of such temperatures. This is the same system that was used in the predicates Therapulse and KinAir. When first inflated, the KinAir IV and the Therapulse II are automatically set in the static mode. Pulsation therapy, available on the Therapulse II, only, when activated, begins alternating pressure between sets of cushions. When pulsation is first activated, the cushion closest to the footboard decreases its pressure, together with every other cushion along the mattress length, while the other pressures are increased. Once the first set of cushions reaches its lowest point and starts to increase, the second set of cushions starts to decrease. The second set reaches its minimum just as the first set reaches its maximum. The cycle then repeats all over again, resulting in a pulsating effect. The minimum cycle time of 2 1/2 minutes is the it takes for a pulsating cushion to partially deflate and then inflate again.

Prevention and treatment of decubitus ulcers, treatment of burns, flaps and grafts and to aid circulation.

This product provides the therapeutic surface features and leg elevation bed features of the Flexicair® Low Airloss Therapy Unit while eliminating the hospital bed frame. The intent of the design of the SILKAIR™ Low Airloss Therapy is to provide a zoned low airloss surface with the capabilities of head and leg elevation for non articulating bed frames or mattress box springs. SILKAIR attaches the low airloss surface to a positioning base which provides the head and leg articulation features. This positioning base can be attached to any flat surface such as a box spring, converting a regular bed into a hospital bed. The SILKAIR™ Low Airloss Therapy System is a zoned low airloss surface. The system distributes different pressures in different zones relative to the main air manifold pressure. This system uses basic, simple mechanical and electrical components. Head and leg articulation required by many patients in the home is achieved through the use of a positioning base. This positioning base consists of plastic support plates and accordion bladders to raise and lower the head and leg sections of the surface.

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Portable powered low air loss flotation therapy mattress.

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The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL) (K923077) (K923977). Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU) 2. The Air Floatation Mattress. Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a