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| Name | Class |
|---|---|
| Clinimark, LLC | OTHER |
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The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter.
The study is observational in nature which quantifies device performance and accuracy in compassion to a Reference Pulse Oximeter.
The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if needed, use the data to make improvements prior to an arterial blood hypoxia study.
A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2 calibration. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population
The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteer | Smoker or non-smoker |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Oximeter | Device | Measurement of physiological parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collect SpO2 data for accuracy statistical analysis by 12 subjects | Data is collected in a digital form for 4-6 SpO2 stable plateaus in a specified range from 100% to 70%. | 2 months |
| Accuracy data analysis | Bland-Altman graphical plots. An Accuracy Root Mean Square (ARMS) calculation is used as a means to define the SpO2 accuracy. Data analysis will follow ISO80601-2-61, Annex EE and the FDA Guidance Document for Pulse Oximeters (Martch 4, 2013). | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Error plots | SpO2 versus (SpO2-Ref SpO2) will be generated with linear regression fit, mean, and upper 95% and lower 95% limits of agreement. | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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Residents of the Denver metropolitan area
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| Name | Affiliation | Role |
|---|---|---|
| Leon Eisen, PhD | Oxitone Medical Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinimark Laboratories | Louisville | Colorado | 80027 | United States |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D056152 | Respiratory Rate |
| D001831 | Body Temperature |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D010829 | Physiological Phenomena |