Operator's Manual

Root NIBPT Product Description and Features, Intended Use and
Indications for Use
www.masimo.com 16 Masimo
ISA OR+: CO
2
, O
2
, N
2
O, Halothane, Isoflurane, Enflurane, Sevoflurane and
Desflurane
ISA CO
2
, 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 CO
2
is also intended to be used in road ambulances. The
intended patient population is adult, pediatric, infant, and neonatal 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