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The Faros Mobile system is intended for use in clinical long term ambulatory ECG monitoring, data transfer and analysis. Faros Mobile is indicated for adult and pediatric patients who require ECG monitoring inside or outside hospital or healthcare facility environments. Faros Mobile provides the detection and reporting features appropriate for the indications below - · Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmias. - · Evaluation of patients for ST segment changes - · Evaluation patients with pacemaker - · Evaluating patient rest and stress ECG - · Reporting heart rate variability analysis - · Wireless transmission of patient ECG data and arrhythmia events for further analysis. Interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. The Faros Mobile does not provide interpretive statements. Faros Mobile is contraindicated for - · Those patients requiring attended, in-hospital monitoring for life threatening arrhythmias - · Pediatric patients weighting less than 10 kg

Faros Mobile is used for long term registration of a patient's heart electrocardiogram (ECG) and the wireless or wired transmission of the registered electrocardiogram arrhythmia events to a receiver or analysis system running on computer. The device is connected to a patient via electrode leads and the patient wears the device during the recording period and/or while he or she performs normal daily activities. The device is used with commercially available snap ECG electrodes. Data is transferred to computer via USB. The ECG recording is analyzed at a medical facility using a Cardiac Navigator or Cardiac Explorer software. In wireless transmission mode, Bluetooth communication protocol enables use of the Faros sensor as a part of a Mobile Cardiac Telemetry (MCT) or Cardiac Event Monitor (CEM) system. Data is transferred from device to companion device. For clarity, all the data is stored on sensor memory when the device operates via Bluetooth. The communication protocol is provided for 30° party integration purposes. Device measurement configurations are managed via Faros Device Manager. The application operator can manage measurement configurations which include: ECG and motion data sampling frequencies, ECG channel count, heart rate variability, temperature, auto start and measurement auto stop features. Values for cardiac arrhythmia event detections are handled via Faros Manager application. Faros Mobile system consists of: - . Faros ECG sensor - o Bluetooth communication protocol and documentation for implementing interface for data collection from Faros sensor - channel and 3-channel cable sets o - general micro-USB cable for recharging device O - Faros Manager application - Cardiac Explorer application - Cardiac Navigator application