SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions

Study Overview
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Brief Summary
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Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.

Detailed Description
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Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.

Official Title
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SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry

Conditions
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Hypoxia

Intervention / Treatment
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* Device: Pulse oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject is male or female The subject is of any racial or ethnic group The subject is > 30 kg (>66 pounds) in weight (self-reported) The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement) The subject is between 18 years and 45 years of age (self=reported) The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form The subject has given written informed consent to participate in the study The subject is both willing and able to comply with study procedures. Exclusion Criteria: The subject has a BMI greater than 31 (based on weight and height) The subject has had any relevant injury at the sensor location site (self-reported) The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination) The subject is current smoker (self-reported) The subject has a known respiratory condition (self-reported) The subject has a known heart or cardiovascular condition (self-reported) The subject is currently pregnant (self-reported) The subject is actively trying to get pregnant (self-reported) The subject has a clotting disorder (self-reported) The subject has Raynaud's Disease (self-reported) The subject is known to have a hemoglobinopathy (self-reported) The subject is on blood thinners or medication with aspirin (self-reported) The subject has unacceptable collateral circulation from the ulnar artery (based on examination) The subject is unwilling or unable to provide written informed consent to participate in the study The subject is unwilling or unable to comply with the study procedures The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Pulse oximeter|Hypoxia|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion |  | 3 days |