Proven Accuracy Compared to Laboratory Devices1
- > In Masimo’s FDA submission, SpHb was validated in a range of 8 to 17 g/dL with accuracy of
1.0 g/dL ± at one standard deviation.2 - > An independent study in the surgical intensive care unit evaluated 471 hemoglobin measurements from 62 patients. SpHb, a satellite laboratory CO-Oximeter (Siemens RapidPoint 405), and a point-of-care device (HemoCue 301) were compared to reference hemoglobin from the central laboratory hematology analyzer (Sysmex XT2000i).
- > The bias ± precision of each method was as follows:
| > SpHb | 0.0 ± 1.0 g/dL |
| > CO-Oximeter | 0.9 ± 0.6 g/dL |
| > Point-of-care device | 0.3 ± 1.3 g/dL |
- > In the same study, changes in SpHb compared to changes in the reference hemoglobin showed the same correlation as the laboratory CO-Oximeter and better correlation than the point-of-care device.1
SpHb is Proven to Help Clinicians Reduce Blood Transfusions during Surgery2
- > In a randomized controlled trial in orthopedic surgery at a major U.S. teaching hospital, clinicians using SpHb transfused their patients 87% less often than clinicians not using SpHb (0.6% vs. 4.5%).
Trend Hemoglobin with Confidence Between Invasive Blood Samples
SpHb Measurements During Liver Transplant Surgery
In this research case, SpHb values were blinded to the clinicians so that the frequency of lab measurements was unaffected.
PDF Resources
Sell Sheet:SpHb
Brochure:Total SpHb Solutions
Technical Bulletin:Accuracy of Noninvasive and Continuous Hemoglobin Measurement by Pulse CO-Oximetry™: Data Submitted by Masimo as Part of FDA 510(k) Clearance
REFERENCES
- 1 Frasca D et al. Crit Care Med. 2011 Oct;39(10):2277-82.
- 2 Ehrenfeld JM et al. ASA. 2010. LB05.




