OM2 Low Saturation Verification

Eligibility Criteria

• 1. Healthy volunteers 18 to ≤39 years
• 2. Subject is willing and able to comply with study procedures and duration
• 3. Subject is willing to sign an informed consent
• 4. Subject weighs \>40kg
• 5. Subject is a non-smoker or has not smoked within 2 days prior to the study
• 6. Cleared same day health assessment form and health screening
• 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. Subjects 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 known concurrent, active 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)
• 5. 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 and/or with respiratory sinus arrhythmia, at the discretion of the Principal Investigator or designee
• 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
• 6. 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 such as 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