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The Masimo SafetyNet Opioid System is intended to monitor and alarm when a patient may be experiencing an opioid induced impairment of oxygenation. The Masimo SafetyNet Opioid System is indicated for the non-invasive continuous monitoring of individuals 15 years and older for the identification of when they may be experiencing a substance induced impairment of oxygenation (e.g., opioid induced respiratory depression (OIRD) caused by oral or injectable opioids) in hospital and home environments.

The Masimo SafetyNet Opioid System (device) is a system intended for noninvasively and continuously monitoring opioid users 15 years and older to identify substance induced impairment of oxygenation that can lead to opioid induced respiratory depression (OIRD) caused by oral or injectable opioids in hospital or home use environments. The device functions using a pre-determined notification escalation policy that provides the ability for the user to receive alerts and to establish a network of emergency contacts who can be contacted based on the level of alert/alarm as determined by the device. These emergency contacts are notified after previous notifications sent to the device user do not resolve the desaturation condition. As a final action, the device can notify Emergency Medical Service (EMS) dispatch to trigger a wellness call. If assistance is needed or the device user does not respond, the dispatch will request that EMS (i.e., ambulance service) be sent to the device user's location. The device consists of the following components: - Bedside Station Device component that communicates monitoring data wirelessly from the medical technologies to provide visual/audible alerts. - Masimo Sensor Wireless wearable pulse oximetry sensor that provides the monitoring data. - Masimo SafetyNet Opioid App - Software application installed on a smart device that provides the graphical user interface to display live monitoring data (e.g., pulse rate (PR), pulse waveform) and alarm condition status. - Opioid Halo Software that runs continuously to provide real-time detection of the severe OIRD risk based upon changes or patterns in oxygenation biomarker data (peripheral oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi)) found to be consistent with published understanding of physiological effects of OIRD. - Notification Escalation Policy - Policy that is used to add levels of awareness through the notification of the device user, emergency contact, or contracted Emergency Responders. - Masimo SafetyNet Cloud A server accessed over the internet that gathers and stores measured data communicated wirelessly from a Bedside Station.