The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
447
Noninvasive pulse oximeter that measures hemoglobin
Site 4
Burbank, California, United States
Site 5
Burbank, California, United States
Site 2
Irvine, California, United States
Site 7
Lake Forest, California, United States
Accuracy of hemoglobin measurement
Accuracy willl be determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.
Time frame: Up to 2 hours per subject
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Site 3
National City, California, United States
Site 6
Torrance, California, United States
Site 1
Charlotte, North Carolina, United States