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Masimo SpO
2
Module
Nellcor SpO
2
Module
Accuracy* 70 to 100%:
70 to 100%:
0% to 69%:
±2% (in adult/pediatric mode)
±3% (in neonate mode)
Not specified
Refreshing rate ≤2 s
*Measurement accuracy verification: The SpO
2
accuracy has been verified in human experiments by comparing with
arterial blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically distributed
and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-
oximeter measurements.
Standard Meet standards of ISO 80601-2-61
Measurement range 1 to 100%
Resolution 1%
Response time ≤20 s (SpO
2
value sudden changes from 70% to 100%)
Accuracy
1
70 to 100%: ±2% (measured without motion in adult/
pediatric mode)
70 to 100%: ±3% (measured without motion in neonate
mode)
70 to 100%: ±3% (measured with motion)
1% to 69%: Not specified
Refreshing rate ≤2 s
SpO
2
averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
1
The Masimo pulse oximeter with 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% SpO2 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. One percent was added to the accuracies for neonatal sensors to account for accuracy variation due
to properties of fetal hemoglobin.
The Masimo pulse oximeter with 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% SpO2 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 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 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. Plus or minus one
standard deviation encompasses 68% of the population.
Standard Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Accuracy 70 to 100%:
70 to 100%:
0% to 69%:
±2% (in adult/pediatric mode)
±3% (in neonate mode)
Not specified
Refreshing rate ≤2 s
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