Validation of Next Generation Cerebral and Tissue Oximeter

Inclusion criteria

• Healthy, male or female subjects between the ages of 18 to ≤46 years;
• Completion of a health screening for a medical history by a licensed physician, nurse practitioner or physician assistant;
• Minimum weight 40kg;
• BMI within range 18.0 - 30.0.

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 breastfeeding;
• Has anemia [lab values specific for gender];
• Has a history of sickle cell trait or thalassemia [self-reported];
• Has an abnormal hemoglobin electrophoresis test [lab measurement];
• Has a positive urine cotinine test or urine drug screen or oral ethanol test [POC testing];
• Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate];
• Has a clinically significant abnormal ECG [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]