OM2 Motion Verification Study

Exclusion Criteria

• •1. Subject is considered as being morbidly obese (defined as BMI \>39.5)
• •2. Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
• •3. Females of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study
• •4. Subjects with COHb levels \>3% as assessed by CO-Oximetry during the procedure
• •5. tHb \< 10 g/dl as assessed by CO-Oximetry during the procedure
• •6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
• •7. Subjects with known respiratory conditions such as:
• •1. uncontrolled / severe asthma
• •2. flu or influenza type infection
• •3. pneumonia / bronchitis
• •4. shortness of breath / respiratory distress
• •5. unresolved respiratory or lung surgery
• •6. emphysema, COPD, lung disease
• •7. recent COVID (last 2 months)
• •8. Subjects with known heart or cardiovascular conditions such as:
• •1. hypertension: systolic \>140mmHg, or Diastolic \>90mmHg on 3 consecutive readings
• •2. have had cardiovascular surgery
• •3. chest pain (angina)
• •4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
• •5. previous heart attack
• •6. blocked artery
• •7. unexplained shortness of breath
• •8. congestive heart failure (CHF)
• •9. history of stroke
• •10. transient ischemic attack
• •11. carotid artery disease
• •12. myocardial ischemia
• •13. myocardial infarction
• •14. cardiomyopathy
• •15. implantable active medical device such as pacemaker or automatic defibrillator
• •9. Self-reported health conditions as identified in the Health Assessment Form
• •1. diabetes
• •2. uncontrolled thyroid disease
• •3. kidney disease / chronic renal impairment
• •4. history of seizures (except childhood febrile seizures)
• •5. epilepsy
• •6. history of unexplained syncope
• •7. recent history of frequent migraine headaches
• •8. recent symptomatic head injury, within the last 2 months
• •9. cancer requiring chemotherapy, radiation, or current treatment
• •10. subjects with known clotting disorders
• •11. history of bleeding disorders or personal history of prolonged bleeding from injury
• •12. history of blood clots
• •13. hemophilia
• •14. sickle cell trait or disease
• •15. current use of blood thinner: prescription or daily use of aspirin
• •16. subjects with Severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
• •17. participants with severe allergy to iodine (only applicable if iodine is used)
• •18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
• •19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
• •20. history of clinically significant complications from previous arterial cannulation
• •21. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
• •22. other known health condition, upon disclosure in Health Assessment form