Pronto
Chapter 7: Specifications
www.masimo.com
48
Masimo
Citations
1.
SpO2 accuracy was determined by testing on healthy adult volunteers in the range
60% - 100% SpO2, against a laboratory CO-Oximeter. Contact Masimo for testing
specifications.
2.
The Masimo sensors have been validated for no motion accuracy in human blood
studies on healthy adult male and female volunteers with light to dark skin
pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a
laboratory CO-Oximeter and ECG monitor.
3.
The Masimo sensors have been validated for motion accuracy in human blood
studies on healthy adult male and female volunteers with light to dark skin
pigmentation in induced hypoxia studies while performing rubbing and tapping
motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion
between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the
range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor.
4.
The Pronto has been validated for low perfusion accuracy in bench-top testing
against a Fluke Biotek Index 2
TM
* simulator and Masimo's simulator with signal
strengths of greater than 0.02% and transmission of greater than 5% for
saturations ranging from 70-100%.
5.
Masimo sensors have been validated for pulse rate accuracy for the range of
25-240 bpm in bench top testing against a Fluke Biotek Index 2 simulator.
6.
SpHb accuracy has been validated on healthy adult male and female volunteers
and on surgical patients with light to dark skin pigmentation in the range of 8
g/dL to 17 g/dL SpHb against a laboratory CO-Oximeter. The SpHb accuracy has
not been validated with motion or low perfusion.
7.
Continuous use is defined as consecutive spot check tests with each consecutive
spot check test initiated immediately upon the conclusion of the previous spot
check test.
*Registered trademark of Fluke Biomedical Corporation, Everett, Washington.
