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The VITAHEAT™ Patient Warming System is intended to prevent or treat hypothermia and to provide warmth to patients. The VITAHEAT™ Patient Warming System should be used in circumstances in which patients may not maintain a state of normothermia. The System is intended primarily for use in hospitals and surgical centers including without limitation operating, recovery and emergency rooms and on medical/surgical floors.

The VITAHEAT™ Patient Warming System consists of a Controller, a reusable Warming Mattress, single use disposable covers and accessories. The Controller is powered by a rechargeable 18V lithium ion battery and a separate charging unit is provided with the device. Each System also includes a second rechargeable 18V lithium ion battery to allow for uninterrupted operation. Typical battery life is 3-5 hours maximum on a fully charged battery depending on the usage. Other accessories provided with the device include a non-heating Thigh Pad that may be used by the patient for thigh support while lying on the mattress and an extension cord to connect the Controller to the Warming Mattress. The specific mechanism of action/heating is detailed further in Section 12.3. To operate the VITAHEAT™ Patient Warming System, the Controller is connected to the reusable Warming Mattress using the extension cord provided with the device. The Controller may be placed on hospital bed rail, stretcher rail or on patient bed. The reusable Warming Mattress is then placed into a pocket on a single use disposable sheet cover also provided with the device. The patient then lies on top of the covered Warming Mattress for safe warmth. After the patient is in position on the covered Warming Mattress, it is recommended that the VITAHEAT™ Thigh Pad be placed under the patient's thighs to provide thigh support. The VITAHEAT™ Patient Warming System is designed to be controlled by either the patient or the clinician. The output temperature range of the device is 35°C - 38.5°C ± 1.5°C: temperatures are adjusted to depending on the power setting selected by the user. From the time the device is turned ON, it takes 8-10 minutes for the Warming Mattress to reach the maximum temperature of 38.5℃ ± 1.5℃ when the highest power setting is selected. When the 'LOWER' button is pressed, the desired temperature setpoint is lowered and correspondingly when the HIGHER button is pressed, the setpoint is raised gradually. A different set of LED lights on the Controller indicate the battery life. If the temperature of the Warming Mattress exceeds a maximum safety limit of 41ºC, an automatic system cutoff initiates and the Warming Mattress is discontinued and the unit becomes inoperable. The VITAHEAT™ device contains a controllable thermal warming component comprised of a series of connected lines printed with conductive ink on a substrate.