Who The Device Is Intended To Be Used On (Indications For Use); Intended Use; Indications For Use; Contraindications - Masimo SafetyNet Alert Manuel De L'utilisateur

Masimo Sensor - wireless, wearable sensor that provides the physiological data.
Masimo Chip - attaches to the wireless Masimo Sensor and connects wirelessly to the Home
Medical Hub.
Home Medical Hub - device that communicates monitoring data wirelessly from the medical
technologies to the Masimo Cloud.
Masimo Cloud - a server accessed over the internet that gathers and stores measured data
communicated wirelessly from the Home Medical Hub.
Who the Device is intended to be used on

(Indications for Use)

Intended Use

The Masimo SafetyNet Alert is intended for the continuous monitoring of physiological
parameters through communication to compatible medical technologies. Collected data from
compatible sensors are transferred and displayed via the subject device, providing a system that
allows physicians to monitor levels of SpO desaturation notifications.
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Indications for Use
The Masimo SafetyNet Alert is intended for the continuous monitoring of physiological
parameters through communication to compatible medical technologies.
The Masimo SafetyNet Alert is indicated for the continuous monitoring of functional oxygen
saturation of arterial hemoglobin (SpO ) and Pulse Rate (PR) in adult, pediatric, infant, and
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neonates during motion, no-motion and low perfusion conditions in hospital and home
environments.
The Masimo SafetyNet Alert is also indicated for the monitoring of adults and pediatrics for
substance induced oxygen desaturations (e.g. OIRD caused by oral or injectable opioids) in
hospital and home environments.

Contraindications

Masimo SafetyNet Alert is contraindicated for the monitoring of opioid users on supplemental
oxygen greater than 2.0 L/min.
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