Masimo iSpO2, Operator'S Manual

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Citations
1. The Masimo SET® Technology used in the iSpO2 module has been validated for no motion accuracy in
human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100%
SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard
deviation which encompasses 68% of the population.
2. The Masimo SET Technology used in the iSpO2 module 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 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. This variation equals plus or minus one standard deviation
which encompasses 68% of the population.
3. The Masimo SET Technology used in the iSpO2 module 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 than 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 which encompasses 68% of the population.
4. The Masimo SET Technology used in the iSpO2 module has been validated for pulse rate accuracy for the
range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or
minus one standard deviation which encompasses 68% of the population.
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