10
Participants
Start Date
February 19, 2019
Primary Completion Date
February 21, 2019
Study Completion Date
February 21, 2019
BORA Band SpO2 Validation Study
"Qualified healthy volunteers will be enrolled into the study. Subjects will recline for the study. Reference sensor(s) will be placed on each subject to evaluate the SpO2 accuracy and performance. Shield material may be used between any adjacent finger sensors to prevent optical crosstalk.~Simultaneous data collection will be set up for device under test and the control pulse oximeter. The data from the test device will be collected by the sponsor or trained Clinimark Study staff. Data will be collected for 1 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.~The investigational device will only be placed on the wrist. The control pulse oximeter may be alternated through fingers between subjects."
Clinimark Desaturation Laboratory, Louisville
Lead Sponsor
Clinimark, LLC
OTHER
Biosency
INDUSTRY