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Product Description, Features, and
Indications for Use
Product Description and Features
Root® is a patient monitoring and connectivity platform. It offers multiple high-impact
innovations for broad applications across the continuum of care.
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Instantly interpretable, high-visibility display of Masimo’s breakthrough SET® and
rainbow® SET measurements.
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Intuitive, touchscreen navigation for easy and adaptable use in any hospital
environment.
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Flexible measurement expansion through Masimo Open Connect (MOC-9™).
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Designed for third-party measurement expansion to allow other companies to add
to the platform measurements.
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Built-in network connectivity gateway through Iris™ for standalone devices such as
IV pumps, ventilators, beds, and other patient monitors.
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Docking and charging station for Radical-7® and Radius-7™ Battery Module.
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Integrated noninvasive blood pressure (NIBP) technology.
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Integrated temperature technology.
For all prescribing information and instructions for use of the compatible medical devices
that are connected to Root, see Operator’s Manual or Instructions for Use for the specific
medical device.
Indications for Use
The Masimo Root Monitoring System is indicated for use by healthcare professionals for the
monitoring of multiple physiological parameters in healthcare environments. The Masimo
Root Monitoring System, when used with the optional ISA module, is not intended to be used
in road ambulances.
The Masimo Root Monitoring System can communicate with network systems for
supplemental remote viewing and alarming (e.g., at a central station).
The optional Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the
continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin
(SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation
(SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa). The Masimo
Radical-7 Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and
neonatal patients during both no motion and motion conditions, and for patients who are
well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
In addition, the Masimo Radical-7 Pulse CO-Oximeter and accessories are indicated to provide
the continuous non-invasive monitoring data obtained from the Masimo Radical-7 Pulse
CO-Oximeter and accessories of functional oxygen saturation of arterial hemoglobin (SpO2)
and pulse rate to multi-parameter devices for the display of those devices.
The optional Masimo Radius-7 Wearable Pulse Oximeter and Accessories are indicated for the
continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin