The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.
This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.
Study Type
OBSERVATIONAL
Enrollment
11
OLV-4202 pulse oximeter SW version: 01-15)
UCSF Hypoxia Research Laboratory
San Francisco, California, United States
Accuracy of Sensor Oxygen Saturation by Arms Calculation
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter (SpO2i) to that obtained from a blood sample (SRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((SpO2i - SRi) squared) / n)
Time frame: 30 seconds
Accuracy of Sensor Pulse Rate by Arms Calculation
Accuracy will be determined by comparing the noninvasive pulse rate measurement of the pulse oximeter (PRi) to the heart rate obtained from an electrocardiography reference device (HRRi) and calculating the arithmetic root mean square (Arms) error value as follows: Arms =Square root (sum of n samples of ((PRi - HRRi) squared) / n)
Time frame: 30 seconds
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