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The intended use of the BEACON Caresystem is to provide - respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU) - on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician Patients should be hemodynamically stable. The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.

BEACON Caresystem is an Intensive Care Unit (ICU) ventilation assist system. BEACON Caresystem will provide ICU clinicians with on-demand ventilator-dependent open-loop advice for ventilating adult patients. BEACON Caresystem uses inputs measured by BEACON Caresystem and data inputs from the ventilator and manual data entry by the clinician into a computer program that has been designed to provide advice for changes to the ventilator settings for the individual patient undergoing mechanical ventilation. BEACON Caresystem is an adjunct to third party legally marketed ICU mechanical ventilators. BEACON Caresystem consists of the following components: - BEACON Display Unit - BEACON Gas Module - BEACON Power Adaptor - NONIN XPOD SpO2 Analyzer BEACON Caresystem utilizes the following cleared accessories: - BEACON Flow Sensor (Adult) private label version of Metaphor E-Z Flow Sensor, Size Adult [K093080] - BEACON Water Trap (Adult) [K182075 & K171292] - NONIN Finger Clip SpO2 sensor NONIN 8000AA1 [K071285] - NONIN Ear Clip SpO2 sensor- NONIN 8000Q2 [K080255] - NONIN Forehead Reflectance SpO2 sensor NONIN 8000R [K071285] The BEACON Display Unit is a standard off-the-shelf tablet touch-screen computer. The BEACON display unit connects through a USB port to the NONIN XPOD SpO2 analyzer for pulse oximetry measurements and serial data ports for connection to the BEACON Gas Module and the connected ICU ventilator. The BEACON Display unit includes the BEACON Caresystem Software. The BEACON Gas Module performs measurement of patient airway flow and inspired and expired fractions of CO2 and O2 in the airway. As described above, BEACON Caresystem combines the functionalities of a spirometric monitor, respiratory gas monitor, and pulse oximeter. Each of these functions, respectively, is intended for: - Respiratory mechanics monitoring (i.e. airway flow/volume) - Measurement of expired and inspired breathing gases (CO2, O2) and respiration rate - Non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The BEACON Caresystem Software utilizes the monitored parameters above with data from the connected ICU ventilator and clinician entered values to generate on demand, open-loop advice for changes to the ventilator settings for an adult patient undergoing mechanical ventilation.