Last reviewed · How we verify
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.
Details
| Lead sponsor | Masimo Corporation |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | Thu Jun 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Jul 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Healthy
Interventions
- R1-25 and R2-25 Pulse Oximeter Sensor
Countries
United States