A-6
PI measurement range 0.02% to 20%
SpO
2
Resolution 1%
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 1 s
Response time
≤ 20 s (PR 75 bpm, average time 8 s, SpO
2
value rises from 60%
to 95%)
SpO
2
averaging time 2-4 s, 4-6 s, 8 s, 10 s, 12 s, 14 s, 16 s
Low perfusion conditions
Pulse amplitude: >0.02%
Light penetration: >5%
Low perfusion SpO
2
accuracy
2
±2%
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.
Nellcor SpO
2
Module
Standards Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Accuracy
70 to 100%: ±2% (adult/pediatric)
70 to 100%: ±3% (neonate)
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