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Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.
This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test subjects | Experimental | Each subject receives the Rad-67 and DCI Mini sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rad-67 and DCI Mini Sensor | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability and reproducibility of CO-oximeter and sensor | The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements. | 120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Clinical Laboratory | Irvine | California | 92618 | United States | ||
| Site 1 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Charlotte |
| North Carolina |
| United States |