User's Manual

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Product Description, Indications for Use,
Contraindications, and Features
The following chapter contains the Radical-7 product description, key features and benefits,
indications for use, contraindications, and safety information, including cautions, warnings,
and notes.
Product Description
The Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2),
pulse rate (PR), and perfusion index (PI), along with optional measurements of hemoglobin
(SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet),
Pleth Variability Index (PVI), Acoustic Respiration Rate (RRa), and Pleth Respiration Rate
(RRp).
The Radical-7 can be used as either a Handheld or a Standalone monitor. The Radical-7
features a touchscreen Liquid Crystal Display (LCD) that continuously displays numeric values
for all parameters.
The Radical-7 provides graphical displays for plethysmographic waveform, respiratory
waveform, Signal Identification and Quality Indicator (Signal IQ).
The Radical-7 can also be used to interface with a multi-parameter patient monitor to send
Masimo SET pulse oximetry information to that monitor for display.
The Radical-7 has an embedded 802.11 wireless radio that can be used for connectivity.
Key Features
The following features are available for the Radical-7. Some features are optional:
• Masimo SET is clinically proven to satisfy all sensitivity and specificity
requirements for pulse oximeter technology.
• Rainbow technology uses 7+ wavelengths of light to continuously and
noninvasively measure carboxyhemoglobin (SpCO), methemoglobin (SpMet), and
total hemoglobin (SpHb), as well as providing a more reliable probe-off detection.
• Total oxygen content (SpOC) provides a calculated measurement of the amount of
oxygen in arterial blood, which may provide useful information about oxygen both
dissolved in plasma and combined with hemoglobin.
• Perfusion Index (PI) with trending capability indicates arterial pulse signal
strength and may be used as a diagnostic tool during low perfusion.
• Pleth Variability Index (PVI) may show changes that reflect physiologic factors
such as vascular tone, circulating blood volume, and intrathoracic pressure
excursions. [The utility of PVI is unknown at this time and requires further clinical
studies. Technical factors that may affect PVI include probe malposition and
patient motion.]
• Respiration rate can be determined by the acoustic (RRa) or plethysmographic
waveform (RRp).