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The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.
Start data collection system(s) and allow them to run 15 minutes prior to study start of each subject.
Confirm that the subject meets inclusion/exclusion criteria and has signed the current IRB- approved Informed Consent Form
Collect Demographic and Anthropometric Data from the subject.
Place Pulse Oximetry Sensors
Place nasal cannula for capnography recordings
A summary of Respiratory rate protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oximeters | Comparison of respiratory rates with other devices in normal subjects as observational with other pulse oximeters. No treatment of interventions will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic | Diagnostic Test | Diagnostic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Rate Accuracy | Values from the test device will be compared to the values from co-oximetry devices | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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A minimum of 30 subjects will be included in this study. The subject selection will be an approximately equal mix of males and females with varying skin tones. At a rate of 3-4 subjects per day, enrollment will take approximately 7-10 days to complete.
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| Name | Affiliation | Role |
|---|---|---|
| Walter Holbein, Ph.D | Nonin Medical, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nonin Medical, Inc. | Plymouth | Minnesota | 55441 | United States |
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| ID | Term |
|---|---|
| D003933 | Diagnosis |
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