Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation

The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2 validation.

Inclusion Criteria:Healthy, male or female subjects between the ages of 18 to 50 yearsCompletion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistantPreviously measured hemoglobin electrophoresis with normal result recorded in Duke Epic EHRMinimum weight 40kg; BMI within range 18.0 - 35.0Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegateExclusion Criteria:Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain)Prior known severe allergies to medical grade adhesive/tape (Band-Aid)Taking any medication other than birth controlIs currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational interventional drug, device, or biologic studyHas a negative Allen's Test to confirm non patency of the collateral arteryHas made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedureIs female with a positive urine pregnancy test, or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feedingHas anemiaHas heparin allergyHas a history of sickle cell trait or thalassemia [self-reported]Has a positive urine cotinine test or urine drug screen or oral ethanol testHas a room air saturation less than 95% by pulse oximetryHas a clinically significant abnormal EKGHas a COHb greater than 3%, or MetHb greater than 2%Students and Employees under the direct supervision of PI or Sub-I