User's Manual

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Product Description, Features and
Indications for Use
Product Description
The Radius-7 is a non-invasive device that measures arterial oxygen saturation (SpO2), pulse
rate (PR), perfusion index (PI), and Pleth Variability Index (PVI®) along with optional
measurements of hemoglobin (SpHb®), carboxyhemoglobin (SpCO®), total oxygen content
(SpOC), methemoglobin (SpMet®), Acoustic Respiration Rate (RRa®) and Pleth Respiration
Rate (RRp™).
The following key features are available for the Radius-7:
• Patient wearable device for continuous monitoring when the patient is
ambulatory.
• Bluetooth radio for transfer of parameter data to the Root patient monitoring and
connectivity platform.
• Masimo SET® and rainbow®SET technology performance.
• SpO2 and pulse rate monitoring in motion and low perfusion environments.
• Continuous and non-invasive monitoring of carboxyhemoglobin (SpCO),
methemoglobin (SpMet), and total hemoglobin (SpHb).
• Respiration rate determined by the acoustic (RRa) or plethysmographic waveform
(RRp).
Indications for Use
The Radius-7 and accessories are indicated for the continuous non-invasive monitoring of
functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR),
carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin
concentration (SpHb), and/or respiratory rate (RRa). The Radius-7 and accessories are
indicated for use with adult and pediatric patients during both no motion and motion
conditions, and for patients who are well or poorly perfused in hospitals and hospital-type
facilities.