SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry

Inclusion Criteria

• 10-15 Adults with a minimum of 3 males and a minimum of 3 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, toes, 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,
• respiratory or lung surgery,
• emphysema, chronic obstructive pulmonary disease (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 head injury
• 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 prior or known allergies to iodine or lidocaine (or similar pharmacological agents, e.g. Novocaine)
• Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test
• Unwillingness or inability to remove colored nail polish from test digits.
• Other known health condition, should be considered upon disclosure in health assessment form