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EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric as follows: - · Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic - · Adult patients with PSGs obtained in a Hospital or Sleep Clinic - · Adult patients with Home Sleep Tests EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of arousals, leg movements, and sleep disordered breathing events including obstructive apneas (OSA), central sleep apneas (CSA), and hypopneas. All automatically scored events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician. Central sleep apneas (CSA) should be manually reviewed and modified as appropriate by a clinician. All events can be manually marked or edited within records during review. Photoplethysmography (PPG) total sleep time is not intended for use when electroencephalograph (EEG) data is recorded. PPG total sleep time is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

EnsoSleep is a software-only medical device that analyzes previously recorded physiological signals obtained during sleep. Users of EnsoSleep are consistent with the roles required to run a sleep clinic: sleep physicians, sleep technicians, clinic operations managers, and IT administrators. EnsoSleep can analyze at-home and in-lab sleep studies for both adult and pediatric patients who are at least 13 years old. Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of the following: respiratory events, sleep staging events, arousal events, movement events, cardiac events, derived signals, and calculated indices. EnsoSleep does not interpret the results, nor does it suggest a diagnosis. The device only marks events of interest for review by a physician who is responsible for diagnoses. The device does not analyze data that are different from those analyzed by human scorers. The signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report. The software consists of 4 major components: - The Application Platform runs on local clinic workstations and manages the detection, upload, and download of study records and scoring to and from the Storage Platform - The Processing Platform accepts raw physiological signals as inputs in order to recognize events, derive signals, and calculate indices - . The Storage Platform facilitates file and database storage in the EnsoSleep cloud through an API - The Dashboard is a web-based user interface to support configuration, clinic management, and sleep study scoring

EnsoSleep is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory related sleep disorders in adults only. EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals, leg movements, and sleep disordered breathing events including obstructive apneas. All automatically scored events are subject to verification by a qualified clinician. Central apneas, mixed apneas, and hypopneas must be manually marked within records.

EnsoSleep is a software application that analyzes previously recorded physiological signals obtained during sleep. The EnsoSleep software can analyze any EDF or EDF+ files. Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of: Sleep Stage Events - Wake - Stage N1 - Stage N2 - Stage N3 - Stage REM Respiratory Events - Sleep disordered breathing (apneas and hypopneas) - Apneas detected with airflow signal are classified as obstructive apnea (OSA), and can be edited to be central or mixed appeas - Sleep disordered breathing events not detected to be apneas are marked as hypopnea - Central apneas, mixed apneas, and hypopneas must be manually marked within records Arousal Events - Arousals Movement Events - Periodic Leg Movements during Sleep (PLMS) The EnsoSleep software can be used as a stand-alone application for use on Microsoft Windows 7 & 8 operating system platforms. All processing, scoring, and analysis of signal data occurs on the EnsoSleep cloud servers.