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The Hillrom™ Heart and Respiration Rate Monitoring System powered by Early Sense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lb (318 kg).

The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense is designed for continuous and contact-free measurement of heart and respiratory rate (also referred to as Bed Sensing Unit). This device is used with a hospital bed system which is exempt from 510(k) premarket submission requirements. The Bed Sensing Unit (sensor) plugs into the bed frame to both receive power and to transmit data. Data from the System is available on the bed's graphical caregiver interface (GCI)/display unit and can be transmitted through wired and wireless communication channels to Hillrom Connectivity Solution (also known as (aka)- Hillrom Digital Health Gateway) for display, use, and storage. Additionally, the System can transmit alerts to an existing hardwired Nurse Call system, speakers, and/or on/off alert lights within a bed system. The healthcare professional can adjust monitoring parameters by interacting with the bed's GCl. These parameters include hospital-defined alert thresholds, display settings, and alert configurations. The system provides alerts when patient heart rate and/or respiratory rate are recorded that are above or below the predefined thresholds. The Hillrom™ Heart and Respiration Rate Monitoring System powered by EarlySense consists of: - The Bed Sensing Unit, placed on a bed frame under the mattress - Software for data analysis, display, and input - The device hardware, specifically the connection between the sensor and appropriate bed system

The Hill-Rom PrimaView Mouitor System is indicated for use in providing the clinician with a color video display of images that are generated from endoscopic, laproscopic or similar equipment (not supplied by Hill-Rom) during surgical procedures. This system may also be used to display radiographic images for reference only.

The Hill-Rom PrimaView Monitor System is considered and accessory item to an endoscopic or laproscopic system (not supplied by Hill-Rom) in that it provides a means to view images generated by an endoscopic or laparoscopic camera and their associated components. The PrimaView flat screen display is mounted in the operating room or other area of a medical facility where endoscopic or similar procedures are done. Output video signals from the camera and processing unit are fed into the appropriate input connector of the PrimaView System. The signal is then routed to the display for presentation to the clinician. The system can also be used to display reference quality (not for diagnosis) radiographic images

The contOR® Table Surface is intended to be used on existing operating room table in all surgical procedures to greatly reduce the likelihood of complications as a result of placement on the operating table surface, such as: - pressure ulcers (pressure relief) - tissue compromise (positioning) The contOR® Table Surface is intended to be used to support and position the patient and to provide warming and cooling during surgery. The surface will greatly reduce the likelihood of complications as a result of placement on the operating table surface such as: - Pressure ulcers - Tissue compromise

The control unit is a self-contained unit requiring only input of the local power system. The control unit contains the heat exchanger used to heat/cool the medium. In addition, the controi unit contains a pressure/vacuum pump and valve network for Inflating the positioning air bladders and deflating the beaded vacuum bags. The control unit also contains all the controls required to manipulate and monitor the previously mentioned subsystems as well as any other subsystems that might be required for the patient and/or table surface pad while being used in the O. R. Suite. The control unit, which utilizes membrane switch technology and LED screen display the functions of the contOR® Table Surface. Additionally there is a remote pendant that is wired to the control unit that performs the same functions as the main control unit's screen. The mattress set of the contOR® Table Surface Unit is designed to be used on different operating room tables in lieu of the standard mattress set. The mattress is 21 Inches wide, 72 to 84 inches long and 4 inches high. All aspects of the OR table surface pad are as modular in design as possible to facilitate serviceability and repair. The OR surface pad consists of 3 sections: a head section, a main body section, and a footleg section. The OR surface pad is a multi-ply system contained in an outer cover. The outer cover material has bi-directional stretch and is a nylon web substrate with urethane laminated on both sides. This outer cover will be cleanable throughout the life of the product using standard Hospital disinfectants that are alcohol or phosphate detergent based. The multi-ply system contained in the outer cover consists of several different layers. The contOR® Table Surface pads are interconnected using Colder fittings for air, vacuum and water supply. Each section is secured to the OR table by longitudinal Velcro strips placed down the center of the under surface each section.

The BRIGHTSTAR Surgical Light is intended for use in surgical and non-surgical applications to provide illumination of the surgical field or the patient. It is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.

The light is available in a single, double or 3 light head version. Each model offers the option of wall controls, integrated light controls or a combination of both. The light from a single bulb is distributed off a reflector in a controlled manner to provide a defined pattern. The size of the pattern is adjusted by changing the focal point of the bulb relative to the reflector. The light is comprised of seven main components: Suspension Arm, Extension Arm, Counterbalance Arm, Yoke, Light Housing, Light Core, and Controls. The BRIGHTSTAR uses software to coordinate the wall mounted and light mounted controls.

The RUMORS Dynamic Air Therapy® Unit is intended to be used on existing bed frames in areas throughout the patient care environment to treat or prevent pulmonary complications and pressure ulcers. The Unit can operate in rotation mode to reduce pressure shear, friction and maceration while gently rotating the patient from side to side; it can operate in percussion and vibration mode by delivering percussion and vibration to the patient's chest to loosen secretions from the lung wall; and it can also be programmed to operate in a sequential mode of percussion and vibration therapies with and without rotation with patients up to 400 lbs. in weight. The RUMORS Unit also provides low airloss therapy. 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. The RUMORS Dynamic Air Therapy® Unit is intended to be used to treat or prevent pulmonary complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from Continuous Lateral Rotation Therapy.

The RUMORS Dynamic Air Therapy® Unit consists of an Air Supply Unit, a Mattress, and Valves. The Air Supply Unit contains the blower and controller, which utilizes touchscreen technology and can be programmed for patients up to 84 inches tall and 400 lbs. The controller manages low airloss, rotation, percussion, vibration, and combinations of these therapies. The mattress is 8 inches high, 80 inches long, and has adjustable width (32 or 35 inches). It has two layers of cushions: a top sleep surface with five independently controlled cushions and a bottom working surface containing proportional and percussion/vibration valves. The Unit utilizes twelve proportional valves and one percussion/vibration valve capable of producing percussion from 1Hz to 5Hz and vibration from 6Hz to 25Hz.

The IncuWarmer is a mobile, caster mounted, neonatal device which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

The IncuWarmer is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The IncuWarmer provides thermal isolation primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The IncuWarmer offers access to the infant by allowing the cargiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two tubular stainless steel infrared heaters that provide supplementary heat when the canopies and side panels are closed and primary heat when the canopies are opened or the over head arm is raised. In addition to providing thermal support, the IncuWarmer is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. The IncuWarmer accessories are designed to operate with the IncuWarmer and consist of a humidification accessory, phototherapy accessory, and scale accessory for weighing the infant.

The product is a device intended for medical purposes that consists of a mattress and a control unit which provides automatic changes in distribution and control of interface pressure. It is used to prevent and treat conditions where reduction of interface pressure is beneficial. The device is intended to provide a patient surface suitable for use with the general patient population in a variety of health care environments as determined appropriate by health care professionals. The TotalCare.. Modular Therapy System (MTS) is intended to be used in conjunction with the TotalCare. Patient Support System (PSS). The MTS is not intended for use with patients with unstable cervical fractures.

The TotalCare~ Modular Therapy System (MTS) is a patient Air Flotation Bed surface operated by a microprocessor controlled air system and proportional air valves. The mattress surface is of a modular design This allows the healthcare facility to add treatment and/or prevention opiions as the patient condition requires. The Surface Control Modules contain the software and proportional air valves and dock with the TotalCarem Patient Support System (PSS) Bed. The MTS surface maintains peripheral circulation by even distribution of the patient's weight over bladders filled with air. The even distribution of pressure on the skin reduces capillary closure, thereby helping maintain tissue viability around bony prominences, such as the buttocks and heels, both areas prone to ulceration and bed sores. The surface cover is non-permeable and will not allow the accumulation of perspiration and other bacteria producing body fluids within the cover or bladder of the bed. By wiping of the cover to remove any accumulation of fluids, followed by wiping of the surface of the cover with an antiseptic agent, contamination of the patient is reduced or eliminated.

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.

The CLINITRON® RITE®HITE™ Air Fluidized Therapy is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid in circulation. This bed will be an ideal support for patients who have advanced pressure ulcers, flaps, grafts, or burns, and require frequent transfers or variable head elevation and any other conditions appropriate for air-fluidized therapy. The bed also can be used for intractable pain, extensive epidermal detachment, Stevens-Johnson Syndrome, purpura fulminans, aid in infection control, induce relaxation which may reduce need for sedative and pain medication, improve patient outcome, and reduce wound healing time. The bed will permit easy positioning and egress, thereby enhancing the independence of residents.

The CLINITRON® RITE®HITE™ Air Fluidized Therapy Unit combines the best features of the predicate devices, CLINITRON ELEXIS® (K943385)and the CLINITRON AT+HOME® (K942184), in order to meet the design objectives. The intent of the design is to provide an economical combinational therapeutic support surface on a mobile articulating frame specifically for use in the Long Term Care setting. Another design objective was to provide this type of surface on a frame that would go as low as possible. The CLINITRON® RITE®HITE™ tank edge is at 21.5 inches in its lowest position. This will permit easier positioning and egress. The combinational support surface includes both low airloss and air fluidized therapies. The upper half delivers low air loss therapy through low-friction support cushions which supports the upper half of the body (above the waist) and the lower half consists of air fluidized therapy which supports the lower half of the body (below the waist). This type of sleep surface is common to both the CLINITRON ELEXIS and the CLINITRON AT.HOME®

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.