Patient Parameter Specifications Appendix
5 - 8 0070-10-0603-01 Duo™ Operating Instructions
Masimo
®
Reference Footnotes
1
The Masimo MS-7 pulse oximeter with LNOP- Adt sensors have been validated for no
motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia
studies in the range of 70% to 100% SpO
2
against a laboratory co-oximeter and ECG
monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
2
The Masimo MS-7 pulse oximeter with LNOP- Adt sensors has been validated for motion
accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies
while performing rubbing and tapping motions at 2 to 4 Hz. At an amplitude of 1 to 2 cm
and 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% to 100% SpO
2
against a laboratory co-oximeter and
ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
3
The Masimo MS-7 pulse oximeter has been validated for low perfusion accuracy in bench
top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of
greater then 0.02% and a % transmission of greater than 5% for saturations ranging from 70
to 100%. This variation equals plus or minus one standard deviation. Plus or minus one
standard deviation encompasses 68% of the population.
NOTE: The sensor measurement wavelengths are nominally
660 nm for the red LED and 940 nm for the infrared LED.
Maximum optical power output for LED is 4 mW.