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ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least one year of age. ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: * Minute Ventilation (MV) * Tidal volume (TV) * Respiratory rate (RR) ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate. The ExSpiron 1Xi system consists of: • Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure. o Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC. o Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate. There are no hardware changes included in this submission. Single-Patient Use ExSpiron Electrode PadSet: • A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.

ExSpiron 1Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients. ExSpiron 1Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: * Minute Ventilation (MV) * Tidal volume (TV) * Respiratory rate (RR) ExSpiron 1Xi measurements are used as an adjunct to other clinical information.

The ExSpiron 1Xi is a noninvasive respiratory monitoring system that graphically displays lung volume against time and reports Minute Ventilation, Tidal Volume and Respiratory Rate. The ExSpiron 1Xi system consists of: Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure. Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC. Computer: A tablet PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate. A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. The Electrode PadSet for the ExSpiron 1Xi is identical to that cleared for the Predicate device.