User's Manual

Root Product Description, Features and Intended Use
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Masimo
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 can transmit data 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 (PR), 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 ISA product family consists of three types of sidestream gas analyzers
(ISA CO2, ISA AX+ and ISA OR+), intended to be connected to other medical
backboard devices for monitoring of breath rate and the following breathing gases:
ISA CO2: CO2
ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and
Desflurane
ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient
breathing circuit for monitoring of inspired/expired gases during anesthesia,
recovery and respiratory care.The intended environment is the operating suite,
intensive care unit and patient room. ISA CO2 is also intended to be used in road
ambulances. The intended patient population is adult, pediatric and infant patients.
The optional SEDLine Sedation Monitor is indicated for use in the operating room
(OR), intensive care unit (ICU), and clinical research laboratory. It is intended to
monitor the state of the brain by real-time data acquisition and processing of EEG
signals. The system includes the Patient State Index (PSI), a proprietary computed
EEG variable that is related to the effect of anesthetic agents.
The optional Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated
for the continuous non-invasive monitoring of functional oxygen saturation of
arterial hemoglobin (SpO2), pulse rate (PR) and/or respiratory rate (RRa). The
Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated for use with