Oxitone Blood Validation
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 46 |
| Updated: | 8/17/2018 |
| Start Date: | August 9, 2016 |
| End Date: | August 11, 2018 |
Accuracy Validation of the Oxitone SpO2 System
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Oxitone
Medical Oxitone 1000 pulse oximeter during non-motion conditions over the range of 70-100%
SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.
This study is observational in nature which quantifies device performance and accuracy in
comparison to a Reference Standard.
Medical Oxitone 1000 pulse oximeter during non-motion conditions over the range of 70-100%
SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.
This study is observational in nature which quantifies device performance and accuracy in
comparison to a Reference Standard.
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Oxitone
Medical Oxitone 1000 pulse oximeter during non-motion conditions over the range of 70-100%
SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The
end goal is to show the SpO2 accuracy performance of the Oxitone 1000 pulse oximeter. It is
expected that the Accuracy Root Mean Square (Arms) performance of the Oxitone 1000 pulse
oximeter will meet a specification of 3 or better in non-motion conditions for the range of
70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification
Medical Oxitone 1000 pulse oximeter during non-motion conditions over the range of 70-100%
SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The
end goal is to show the SpO2 accuracy performance of the Oxitone 1000 pulse oximeter. It is
expected that the Accuracy Root Mean Square (Arms) performance of the Oxitone 1000 pulse
oximeter will meet a specification of 3 or better in non-motion conditions for the range of
70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification
Inclusion Criteria:
- healthy individuals between the age of 18-46 years.
Exclusion Criteria:
- Clotting disorders, diabetes, currently taking psychotropic medications.
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