Product Description; Who The Device Is Intended For (Indications For Use); Who The Device Should Not Be Used On (Contraindications) - Masimo Opioid Halo User Manual

Product Description

Product Description
The Opioid Halo™ System is a monitoring solution designed to continuously monitor to help recognize
opioid induced respiratory depression (OIRD) while taking opioids. It uses Opioid Halo, a software, to
review your blood oxygen data to recognize when there may be trouble getting enough oxygen while on
opioids.
The Opioid Halo System includes the following pieces:
Home Medical Hub – Device that communicates monitoring data wireless from the medical
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technologies to provide visual/audible alerts.
Masimo Sensor - Wireless wearable sensor that provides the monitoring data.
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Masimo Halo™ App - Software application installed on a smart phone that provides the
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graphical user interface to display live monitoring data and alarm condition status.
Opioid Halo - Software that runs continuously to provide real-time detection of the severe
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Opioid-Induced Respiratory Depression (OIRD) risk based upon changes or patterns in your
oxygenation biomarker data (SpO
Notification Escalation Policy - Policy that is used to add levels of awareness through the
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notification of Emergency contact or contracted Emergency Responders.
Masimo SafetyNet Alert Cloud - A server accessed over the internet that gathers and
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stores measured data communicated wirelessly from a Home Medical Hub.

Who the Device is intended for (Indications for Use)

The Opioid Halo™ System is intended to monitor and alarm when a patient may be experiencing an
opioid induced impairment of oxygenation.
The Opioid Halo™ 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 caused by oral or injectable opioids) in hospital
and home environments.

Who the Device Should not be used on (Contraindications)

The Opioid Halo System is not indicated for users on supplemental oxygen greater than 2.0 L/min.
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