OM2 Abbreviated Sensor Verification

To verify the SpO2 and pulse rate accuracy in comparison to reference-standard blood measurements. To achieve paired observations of SpO2 and SaO2 values over the specified SpO2 accuracy range of the prototype pulse oximeter on a group of healthy adult volunteers. The fraction of inspired oxygen (FiO2) delivered to test subjects is varied to achieve a series of targeted steady-state saturation periods. In this study, the investigational pulse oximetry PCBA system saturation measurements will be compared to saturation measurements made by a multi-wavelength CO-oximeter, taken from arterial blood samples from a diverse pool of healthy human subjects.

Inclusion criteria

• Male or female subjects 18 to 50 years of age
• Subject is willing and able to comply with study procedures and duration
• Subject is willing to sign an informed consent
• Subject weighs >40kg
• Subject is a non-smoker or has not smoked within 2 days prior to the study
• Cleared same day health assessment form and health screening
• Successful perfusion index ulnar/ulnar+radial ratio test showing adequate collateral blood flow.

Exclusion criteria

• Subject is considered as being morbidly obese (defined as BMI >39.5)
• 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)
• 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
• Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
• tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
• MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
• Subjects with known respiratory conditions such as:

• uncontrolled / severe asthma
• flu or influenza type infection
• pneumonia / bronchitis
• shortness of breath / respiratory distress
• unresolved respiratory or lung surgery
• emphysema, COPD, lung disease
• recent COVID (last 2 months)
• Subjects with known heart or cardiovascular conditions such as:

• hypertension: systolic >140mmHg, or Diastolic >90mmHg on 3 consecutive readings
• have had cardiovascular surgery
• chest pain (angina)
• heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
• previous heart attack
• blocked artery
• unexplained shortness of breath
• congestive heart failure (CHF)
• history of stroke
• transient ischemic attack
• carotid artery disease
• myocardial ischemia
• myocardial infarction
• cardiomyopathy
• implantable active medical device such as pacemaker or automatic defibrillator
• Self-reported health conditions as identified in the Health Assessment Form

• diabetes
• uncontrolled thyroid disease
• kidney disease / chronic renal impairment
• history of seizures (except childhood febrile seizures)
• epilepsy
• history of unexplained syncope
• recent history of frequent migraine headaches
• recent symptomatic head injury, within the last 2 months
• cancer requiring chemotherapy, radiation, or current treatment
• subjects with known clotting disorders
• history of bleeding disorders or personal history of prolonged bleeding from injury
• history of blood clots
• hemophilia
• sickle cell trait or disease
• current use of blood thinner: prescription or daily use of aspirin
• 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
• participants with severe allergy to iodine (only applicable if iodine is used)
• subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
• arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
• history of clinically significant complications from previous arterial cannulation
• unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
• other known health condition, upon disclosure in Health Assessment form