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The Circadia C100 System is indicated for both contactless spot checking and continuous measurement of respiratory rate data as part of a vital signs assessment. The system records, transmits, and displays respiratory rate from multiple connected devices for retrospective analysis only. The system is intended to be used under the care of clinicians and medically qualified personnel. The system is indicated for use in adult patients during no-motion conditions, for patients in health care facilities. It is available for sale only upon the order of a physician or licensed health care provider. The Circadia C100 System is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not intended to monitor vital signs. This system is not an apnea monitor.

The Circadia C100 System consists of three components: - "The Monitor" - Circadia Contactless Breathing Monitor: The Monitor is a contact-less breathing monitor placed at a bedside table. The Monitor records respiratory rate of adult patients in hospitals and clinical settings (e.g. post-acute care settings such as General Care Floors (GCF), Inpatient Rehabilitation Facilities (IRF), and Skilled Nursing Facilities (SNF)). The Monitor utilizes a UWB-based (Ultra-Wideband based) motion sensor to detect the movement of the abdomen and the chest to derive respiratory data. - "The App" - Circadia Pro Android App: The App allows Technical Support Staff to setup and configure monitors and allows Clinical Staff to review data collected by the monitors. The App is operated from the central "hub" of a ward or nursing station to monitor data collected by multiple monitors for retrospective analysis only, not for active patient monitoring. The App operates from an Android tablet and uses a USB-C connection for initial configuration. The App is designed to communicate with The Monitor and allow it to connect to a Wi-Fi network and subsequently, The Cloud Service. - "The Cloud Service" - Circadia Cloud Service: The Cloud Service offers a set of APIs that allows the monitor to connect to server, send respiratory data over a secure channel, and allows the monitor to track Clinical Staff's personal data and the patient's respiratory data.