11.2 Intended Use
Faros device is an ambulatory recorder and transmitter for ECG and motion (accelerometer) data. Faros can
perform ECG measurement, R-R interval data measurement and capture patient motion. All data is
recorded to device internal memory.
Faros device monitors patient ECG and generates event markers using the in-built arrhythmia detection
algorithms. Data recorded by the device can be analyzed by other processing systems to provide reports or
transferred via Bluetooth to companion systems for further analysis. These systems can be either third
party systems or designed, maintained and/or owned by Bittium.
Faros device is intended for adult and pediatric patients who require vital sign monitoring inside or outside
hospital or healthcare facility environment.
Faros device does not provide interpretive statements. Final interpretation and diagnosis is the
responsibility of a physician.
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