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The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility. The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.

The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. It is for prescription use in a home or healthcare facility and is used by physicians and polysomnographic (PSG) technologists as a support tool to aid in the evaluation and diagnosis of sleep disorders. A PSG tecnologist must edit, score, and review the data before sleep reports are generated. The Cerebra Sleep System is capable of collecting data required for Level 2 PSG and Level 3 HSAT studies. A Level 3 HSAT study is a home sleep apnea test with a minimum of 4 channels that include oxygen saturation, electrocardiogram (ECG) or heart rate, airflow (e.g., nasal flow), and respiratory effort (e.g., chest band). A Level 2 PSG study is an unattended sleep test with a minimum of 7 channels that include electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG) or heart rate, chin electromyogram (EMG), and all signals from Level 3. The Cerebra Sleep System (CSS) is comprised of three main areas: - Prodigy: This is a PSG recorder capable of performing Level 2 and Level 3 sleep studies. It includes the Head Mounted Unit (HMU), which is worn on the patient's head, the Chest Mounted Unit (CMU), which is affixed to a chest effort belt, the Table Top Unit (TTU), which receives data wirelessly, and third party accessories including an oximeter. - Cerebra Analytics Suite (CAS): The CAS has 4 components Web Processing (for signal processing of data), Web Scoring (for generating scoring results, which encompasses autoscoring), Cerebra Viewer (for viewing and editing PSG studies and scoring results) and Web Reporting (for generating reports). A PSG technician must edit, score, and review the data before reports are generated. These components utilize well-defined file formats to enable communication; communication with each component is done through the internet, via the Cerebra Portal. - Cerebra Portal: All areas of the CSS product are managed by the Portal software. The Portal is used to configure a study on the TTU and allows sleep analysis service providers to manage inventory, patients, and sleep studies. It also configures Prodigy system hardware for an individual sleep study to be performed by a patient.