Accuracy Validation of a Pulse Oximetry Monitor

The description of this study is to conduct an oxygen saturation (SpO2) accuracy validation
comparing prototype pulse oximeter oxygen saturation measurements directly to arterial blood
saturation during non-motion conditions over the range of 60-100% SaO2 as measured by
Reference CO-Oximetry. Additionally, the prototype pulse oximeter pulse rate measurements
will be compared to 3-lead ECG heart rate measurements made via a multi-parameter monitor.

Inclusion Criteria:

- healthy

- non-smoking, or who have refrained from smoking for 2 days

- male or female of any race

- 18-45 years.

- Subjects must have the ability to understand and provide written informed consent as
well as be willing to comply with study procedures.

- To be eligible to participate in the study, the subject must clear a recent physical
(12-lead ECG, medical history and blood test for sickle cell disease.) prior to
enrollment

Exclusion Criteria:

- - morbid obesity (defined as BMI > 39.5),

- injuries, deformities or abnormalities or piercings that may prevent proper
application of the device under test, compromised circulation,

- subjects with known respiratory conditions (smokers with COHb levels >3%, flu,
pneumonia, bronchitis, shortness of breath/ respiratory distress, severe asthma,
emphysema, COPD),

- subjects with known heart or cardiovascular conditions (uncontrolled hypertension,
heart arrhythmias other than sinus arrhythmia, previous heart attack, blocked artery,
history of myocardial ischemia, angina, myocardial infarction, congestive heart
failure or cardiomyopathy, history of stroke, transient ischemic attack or carotid
artery disease),

- other known health condition (diabetes, thyroid disease, kidney disease / chronic
renal impairment, history of seizures (except childhood febrile seizures) or
epilepsy, or unexplained syncope, recent history of frequent migraine headaches,
recent head injury, cancer / chemotherapy

- women actively trying to get pregnant or are pregnant,

- clotting disorders (history of bleeding disorders or current use of blood thinners,
Hemophilia, blood clots)

- Sickle cell disease

- Severe contact allergies to standard adhesives, latex or other materials found in
pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other
medical sensors

- Unwillingness or inability to remove colored nail polish or artificial nails from
test digit(s)

- Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g.,
Novocain) or heparin

- Recent arterial cannulation (i.e., less than 30 days prior to study date), Six or
more arterial cannulations of each (right & left) radial artery, history of
clinically significant complications from previous arterial cannulation