The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage Systemanalyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected duringsleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders,where it may inform or drive clinical management for children, adolescents and adults.The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcareprofessionals in diagnosis and management of sleep disordered breathing.The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualifiedhealthcare professional.
An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].