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BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient's physiological signals during sleep and scores apneas and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.

BresoDX1 is a lightweight data acquisition system intended for use by Health Care Professional (HCP) as an aid in the diagnosis of moderate to severe sleep apnea for adults. It is suitable for independent use in unattended settings, like in the home, or with minimal assistance in clinic settings. BresoDX1 is to be worn while sleeping and consists of: (1) a BresoSensor which is placed on the patient's suprasternal notch with a disposable BresoSensor Frame (2) a BresoHub, which is located at the bedside; (3) a Nonin WristOx2® pulse oximeter, which is worn on the patient's wrist, where the oximeter sensor is to be placed on the patient's finger; and (4) BresoDX1 software. The BresoSensor and the Nonin WristOx2® pulse oximeter sensor will record patient's tracheal breathing sounds, neck/body position and movement, tracheo-sternal movement, arterial oxyhemoglobin saturation and heart rate overnight during sleep. Recorded data on the BresoSensor and oximeter will be sent to the BresoHub wirelessly via Wi-Fi and Bluetooth for pre-processing and storing. When the patient returns the BresoDX1 system to the health care professional, stored data that had been uploaded will be processed for analysis and sleep study report generation. The generated report will show the following channels: heart rate, SpO2, airflow, respiratory effort, and body position. The health care professional will be able to use the software to review data, edit automated scoring, and re-generate a sleep study report based on the edited scoring for further interpretation. The health care professional will reprocess the device after each use.