Propaq M Indications for Use
9650-000820-01 Rev. K
Propaq M Operator’s Guide
1-7
Temperature Monitoring
The Propaq M is intended for use to make continuous temperature measurements of rectal,
esophageal, or surface temperatures, and to alarm if the temperature is outside of the limits set
by the user. The patient population will range from newborn (neonate) to adult.
SpO
2
Monitoring
The Propaq M pulse CO-oximeter, with Masimo Rainbow
®
SET
®
technology, is intended for
use for continuous noninvasive monitoring of functional oxygen saturation of arterial
hemoglobin (SpO
2
), pulse rate, carboxyhemoglobin saturation (SpCO), and/or methemoglobin
saturation (SpMet), total hemoglobin (SpHb), oxygen content (SpOC), pleth variability index
(PVI), and/or perfusion index (PI). The pulse CO-oximeter and accessories are indicated for
use on 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, or in mobile
environments.
Respiration Monitoring
The Propaq M is intended for use to continuously monitor respiration rate and to alarm if the
rate falls outside of the range set by the operator. Because the measurement method actually
measures respiratory effort, apnea episodes with continued respiratory effort (such as
obstructive apnea) may not be detected. It is not intended to be used as an apnea monitor. The
patient population will range from newborn (neonate) to adult.
CO
2
Monitoring
The Propaq M is intended for use to make continuous noninvasive measurement and
monitoring of carbon dioxide concentration of the expired and inspired breath and breath rate.
The patient population will range from newborn (neonate) to adult.
Invasive Pressure Monitoring
The Propaq M is intended for use to display and make continuous invasive pressure
measurements from any compatible pressure transducer. The primary intended uses are arterial
blood pressure, central venous pressure and intracranial pressure monitoring. Any contra-
indications of the particular transducer selected by the user shall apply. The patient population
will range from newborn (neonate) to adult.
12-Lead Analysis
The 12-lead ECG Analysis is intended for use in acquiring, analyzing and reporting ECG data,
and to provide interpretation of the data for consideration by caregivers. The interpretations of
ECG data offered by the device are only significant when used in conjunction with caregiver
overread as well as consideration of all other relevant patient data. The 12-lead ECG Analysis
is intended for use on adults (> 18 years of age).
