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.

Inclusion Criteria:

• Greater than 18 years old
• Healthy

Exclusion criteria:

• Do not understand the study and the risks involved
• Deemed ineligible by study test personnel