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Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding transfer standard and reference devices to assess oximeter calibration and accuracy.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy adult volunteers, ranging in pigmentation from light to dark.
Subject must have the ability to understand and provide written informed consent
Adult subjects 18 up 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.
Male or female of any race
Subject demographics include a range of skin pigmentations, including at least 1 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
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 who have a urine test positive for pregnancy on the day of the study
Subjects with known respiratory conditions such as:
uncontrolled / severe asthma,
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:
Hypertension: systolic >140mmHg, 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
previous heart attack
unexplained shortness of breath
congestive heart failure (CHF)
history of stroke
transient ischemic attack
carotid artery disease
Self-reported health conditions as identified in the Health Assessment Form
uncontrolled thyroid disease,
kidney disease / chronic renal impairment,
history of seizures (except childhood febrile seizures),
history of unexplained syncope,
recent history of frequent migraine headaches,
recent head injury within the last 2 months,
cancer / chemotherapy
Subjects with known clotting disorders
history of bleeding disorders or personal history of prolonged bleeding from injury
history of blood clots
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
Unwillingness or inability to remove colored nail polish or non-clear artificial nails from test digits.
Other known health condition, should be considered upon disclosure in health assessment form