Masimo Root, Operator'S Manual, Page: 12 / 152

Root Product Description, Features, and Indications for Use
www.masimo.com 10 Masimo
(SpO2), pulse rate, and/or respiratory rate (RRa). The Masimo Radius-7 Wearable Pulse
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 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 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.
The optional non-invasive blood pressure (NIBP) module is indicated for the noninvasive
measurement of arterial blood pressure in healthcare environments. The NIBP module is
designed to measure blood pressure for patient population described in the following table:
Patient Population Approximate Age Range
Newborn (neonate) Birth to 1 month of age
Infant 1 month to 2 years of age
Child 2 to 12 years of age
Adolescent 12-21 years of age
Adult 21 years of age and older
Contraindication
None.