Brain Oximeter Calibration and Validation Study

Exclusion Criteria

• •Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self- reported\];
• •Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\];
• •Taking any medication other than birth control\[self-reported\];
• •Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self- reported\];
• •Has a negative Allen's Test to confirm non- patency of the collateral artery \[clinical assessment by PI or delegate\];
• •Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\];
• •Is female with a positive pregnancy test \[serum or urine\], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding;
• •Has anemia \[lab values specific for gender\];
• •Has heparin allergy
• •Has a history of sickle cell trait or thalassemia \[self-reported\];
• •Has an abnormal hemoglobin electrophoresis result \[lab measurement\];
• •Has a positive urine cotinine test or urine drug screen or oral ethanol test;
• •Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
• •Has a clinically significant abnormal EKG \[assessment by PI or delegate\];
• •Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\];
• •Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co- oximetry\].