BiOSENCY BORA Band SpO2 Validation 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.)
• •Female subjects that are actively trying to get pregnant or are pregnant (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential).
• •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 is used)
• •Subjects with severe allergies to 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
• •Wrist size should be between 15-23 cm (5.9 - 9 inches)