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The ECOM Cardiac Output Monitoring System is intended for the monitoring of cardiac output by impedance cardiography. The ECOM System displays the R-Wave Detection and the Impedance Waveforms as well as the patient's Cardiac Output (CO), Stroke Volume (SV), Heart Rate (HR), Systolic and Diastolic Pressure. The ECOM System is indicated for use in patients who are expected to be intubated for 24 hours or less and in whom an arterial pressure line is used. The ECOM with the endotracheal cardiac output monitor system is intended for the monitoring of cardiac output by impedance cardiography while providing airway management by oral intubation with an ECOM endotracheal tube. The ECOM Double Lumen Endobronchial Tube is used to isolate the left lung of a patient for surgery, one lung ventilation or one lung anesthesia. The ECOM Endobronchial Tube is indicated for use in thoracic surgery, bronchspirometry, for the administration of endobronchial anesthesia and other uses commonly associated with endobronchial tubes. The tube allows isolation and selective insufflation or deflation of either lung.

The ECOM Cardiac Output Monitor System consists of a monitor, and various accessories. The line extension of the ECOM Double Lumen Endobronchial Tube to the systems line of Endotrachel tubes continues to apply a high frequency. low amplitude electrical current to a series of electrodes applied to the endobronchial tube. The resulting signals, when used in conjunction with an arterial pressure signal, allow for the calculation and display of Cardiac Output (CO), Cardiac Input (CI), Stroke Volume (SV), Stroke Volume Variation (SVV), Heart Rate (HR), Systemic Vascular Resistance (SVR), Systemic Vascular Resistance Index (SVRI), and systolic, diastolic and mean blood pressures. No changes have been made to the monitor system in K131765 or the endobronchial tube design in K092886.