Masimo Root Operator's Manual page 12

Root NIBPT
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
(SpO ), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation
2
(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 (SpO
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
(SpO ), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse
2
Oximeter 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.
The optional ISA product family consists of three types of side stream gas analyzers (ISA CO
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 CO : CO
2 2
ISA AX+: CO , N O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
2 2
ISA OR+: CO , O , N
2 2
ISA CO , ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for
2
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
CO is also intended to be used in road ambulances. The intended patient population is adult,
2
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 temperature module is indicated to measure temperature (oral, adult axillary,
pediatric axillary, and rectal) of adult and pediatric patients. The device is intended to be
used by clinicians and medically qualified personnel. It is available for sale only upon the
order of a physician or licensed health care provider.
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Product Description and Features, Intended Use and Indications for Use
O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
2
10
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2
,
2
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