| Eligibility |
Inclusion Criteria:
1. Subject must have the ability to understand and provide written informed consent
2 Adult subjects 18 to 50 years of age.
3. Subject must be willing and able to comply with study procedures and duration.
4. Subject is a non-smoker or who has not smoked within 2 days prior to the study.
5. Any gender of any race.
6. Cleared same day Health Assessment form and health screening.
7. Cleared physical exam by a licensed physician, physician assistant, or advanced practice
nurse (medical exam includes 12-lead ECG, medical history and blood test to show no sickle
cell disease present)
8. Successful Perfusion Index Ulnar/Ulnar+Radial Ratio test showing adequate collateral
blood flow.
Exclusion Criteria:
1. Subject with sickle cell disease.
2. Subject is considered as being morbidly obese (defined as BMI >39.5)
3. 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.)
4. 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
5. Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
6. tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
7. MetHb = 2% as assessed by CO-Oximetry during the procedure
8. 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
9. 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 respiratory sinus arrhythmia
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
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. Subjects with known clotting disorders
10. history of bleeding disorders or personal history of prolonged bleeding from injury
11. history of blood clots
12. hemophilia
13. current use of blood thinner: prescription or daily use of aspirin
14. 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
15. Subjects with prior or known severe allergies to lidocaine (or similar pharmacological
agents, e.g. Novocain) or heparin
16. Arterial cannulation within the last 30 days prior to study date, (this may exclude
only one radial artery site. Left or right)
17. History of clinically significant complications from previous arterial cannulation.
18. A radial artery with ten or more arterial cannulations right or left, excludes that
site.
19. Unwillingness or inability to remove colored nail polish or colored artificial nails
other than clear from test digits.
20. Other known health condition, should be considered upon disclosure in Health
Assessment form
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