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Keep this study
Lead
Nihon Kohden
With
University of California, San Francisco
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.
Age
18–50
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Both male and female subjects who can give written informed consent
Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile below
Meeting the demographic requirements
You may not be if
Age below 18 or over 50
Pregnant women
Significant arrhythmia
Blood pressure above 150 systolic or 90 diastolic
Carboxyhemoglobin levels over 3%
Subjects whom the investigator consider ineligible for the study
Clareo Health | Accuracy of Pulse Oximeters With Profound Hypoxia At Rest (NIHO19)
