Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

Exclusion Criteria

• •1. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\]
• •2. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\]
• •3. Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion \[self-reported\]
• •4. Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic)
• •5. Negative Allen's test for radial and ulnar patency
• •6. Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\]
• •7. Is pregnant
• •8. Has anemia as measured by co-oximetry \[values specific for sex\]
• •9. Has a history of sickle cell trait or thalassemia \[self-reported\]
• •10. Has an abnormal hemoglobin electrophoresis test \[lab measurement\]
• •11. Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\]
• •12. Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\]
• •13. Has a clinically significant abnormal ECG \[assessment by PI or delegate\]
• •14. Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\]
• •15. Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\]