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The Spire Health Remote Patient Monitoring System is intended for reusable bedside and mobile multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities or their own home. It is intended for monitoring of patients by trained healthcare professionals. The Spire Health Remote Patient Monitoring System is intended for longitudinal monitoring of the following parameters in adults: - Pulse Rate - Respiratory Rate - Sleep/Wake Behavior - Activity associated with Movement The Spire Health Remote Patient Monitoring System is intended only for general, non-diagnostic sleep and wake behavioral monitoring. It is not intended to assess sleep staging nor diagnose sleep disorders. The Spire Health Remote Patient Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms. The Spire Health Remote Patient Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Spire Health Remote Patient Monitoring System is not a substitute for an ECG monitor.

The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data and share this data with healthcare providers with a view to improving patient health and outcomes. The RPM is intended for longitudinal monitoring of pulse rate, respiratory rate, sleep/wake behavior, and activity associated with movement. The RPM solution is comprised of four components - a Medical Health Tag (MHT), a Spire Mobile Application (Mobile App), a Cloud Platform (Platform) and a Healthcare Professional Dashboard (HPD). The patient facing components of the MHT and Mobile App) are intended for daily use in professional healthcare facilities or in the home. The MHT is a component designed to be affixed semi-permanently via an adhesive backing to the patient's first layer of clothing (e.g. underwear, bras, or pajamas), passing through laundry cycles without detaching. It does not require charging by the user.