Chapter 1 General Information
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Non-Invasive Blood Pressure Monitoring
The X Series unit’s NIBP option is intended for use to make non-invasive measurements of
arterial pressure and heart rate, and to alarm if either parameter is outside of the limits set by the
user. Measurements are made using an inflatable cuff on the patient's arm or leg. The patient
population will range from newborn (neonate) to adult.
Temperature Monitoring
The X Series 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 X Series 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 X Series 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 X Series 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 X Series 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.
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