Polso SpO2 Accuracy Validation Study

This is an interventional diagnostic trial for Hypoxia Read More

Inclusion Criteria:

• 10-15 Adults with a minimum of 4 males and a minimum of 4 females, with the balance made up of either
• Subject must have the ability to understand and provide written informed consent
• Subject is 18 to 50 years of age
• Subject must be willing and able to comply with study procedures and duration
• Subject is a non-smoker or who has not smoked within 2 days prior to the study

Exclusion Criteria:

• Subject is considered as being morbidly obese (defined as BMI >39.5)
• Compromised circulation, injury, or physical malformation of fingers, wrist, 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 particular sites utilized.)
• Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
• Smoker Subjects who have refrained will be screened for COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)

• Subjects with known respiratory conditions such as: (self-reported)

  • uncontrolled / severe asthma,
  • flu,
  • pneumonia / bronchitis,
  • shortness of breath / respiratory distress,
  • unresolved respiratory or lung surgery with continued indications of health issues ,
  • emphysema, COPD, lung disease

• Subjects with known heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)

  • hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings (reviewed during health screen).
  • 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

• Self-reported health conditions as identified in the Health Assessment Form (self-reported)

  • 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 / chemotherapy

• Subjects with known clotting disorders (self-reported)

  • history of bleeding disorders or personal history of prolonged bleeding from injury
  • history of blood clots
  • hemophilia
  • 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 (self-reported)
• Subjects with severe allergies to iodine (only applicable if iodine or similar is used)
• Subjects with severe allergies lidocaine (or similar pharmacological agents, e.g. Novocaine)
• Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio < 0.4)
• Unwillingness or inability to remove colored nail polish from test digits.
• Other known health condition, should be considered upon disclosure in health assessment form