Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
brief summary
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 healthy volunteers at rest.
detailed description
This study will evaluate the accuracy of Nihon Kohden pulse oximeters and sensors in measuring arterial oxygen saturation (SpO₂) in healthy adult volunteers. Subjects will undergo controlled reductions in blood oxygen levels (down to 70%) while SpO₂ readings from the test devices are compared to reference values from arterial blood samples. The study is designed to meet current ISO and FDA requirements, and results may be used to support regulatory submissions. Data will be analyzed for overall accuracy and potential differences by skin tone and sex.