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The Loop System is intended for adult patients in the home environment for passive, intermittent data collection of physiological parameters that will later be transmitted to a web server for remote review by a clinician. The Loop System measures and records: - arterial oxygen saturation (SpO2) - heart rate (HR) - respiration rate (RR) All of these measurements are made when no motion is detected by the System. The Loop System device does not provide physiological alarms

The Loop System is a prescription-only medical device indicated for use by adult patients in the home environment for passive, non-invasive, intermittent data collection of resting (i.e., no motion) physiological parameters. The data is derived from reflectance-based photoplethysmogram (PPG) signals from the patient's wrist, collected by Light Emitting Diodes (LEDs) of varying wavelengths and photodiodes sensitive to said wavelengths embedded in the Loop Band. An accelerometer incorporated in the Loop Band determines when the patient is at rest by constantly monitoring the activity level of the patient. The data is recorded during those resting periods. Using filtering technology for removal of noise (including ambient light) and data processing algorithms, the Loop System stores the raw data collected until it is able to send to the Spry Server. Patients wear the Loop Band on their wrist for periods of up to 24 hours. Patients will then have to charge the Loop Band with a Loop Charging Station provided to them as part of the Loop System. During charging, the data is uploaded to the Spry Server. The Loop band can independently analyze and display resting heart rate and arterial oxygen saturation (SpO2). The data must be downloaded and analyzed by the Spry Server to determine respiration rate. All physiological measurements collected by the Loop System are reported on a comma separated value (CSV) file as a time-stamped series. The CSV can then be remotely accessed through a web interface for review and analysis by a clinician.