This study is designed to evaluate the repeatability and reproducibility of ORi using an investigational Masimo rainbow sensor and FDA cleared rainbow sensors connected to the Masimo Radical-7 pulse oximeter and Masimo Root monitor in healthy volunteers as the subjects undergo a controlled hyperoxygenation protocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
53
Noninvasive pulse oximeter sensor
Masimo Corporation
Irvine, California, United States
Repeatability of Masimo Rainbow Sensors
The Repeatability of ORi for Masimo Rainbow Sensors refers to the ability of a sensor to consistently produce the same readings under similar conditions (hyperoxia level). 1. A Repeatability Error is defined as the difference between ORi measurements from one sensor at different time points under similar operating conditions. 2. The mean of the absolute of all the repeatability errors obtained across different conditions and sensors is represented as the Repeatability of ORi. 3. Since ORi is a unit-less parameter, the Repeatability of ORi is also unit-less. ORi values range from 0-1, with 0 indicating normoxia while 1 indicating moderate to high hyperoxia.
Time frame: 1-1.5 hours
Reproducibility of Masimo Rainbow Sensors
The Reproducibility of ORi for Masimo Rainbow Sensors refers to the ability of two sensors to produce similar ORi results when measurements are taken under the same conditions (hyperoxia level). 1. A Reproducibility Error is the difference between 2 ORi measurements obtained from each of a pair of sensors at the same time and under the same operating conditions. 2. The mean of absolute of all the reproducibility errors are represented as the Reproducibility of ORi. 3. Since ORi is a unit-less parameter, the Reproducibility of ORi is also unit-less. ORi values ranges from 0-1, with 0 indicating normoxia while 1 indicating moderate to high hyperoxia.
Time frame: 1-1.5 hours
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