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BeneVision N1 Patient Monitor Operator’s Manual
Masimo SpO
2
Module
A.14.4
PR Specifications
PR from Mindray SpO
2
Module
Accuracy
70 to 100%: ±2% (adult/pediatric)
70 to 100%: ±3% (neonate)
0% to 69%: Not specified.
When the SpO
2
sensor is applied for neonatal patients as indicated, the specified accuracy range is increased by ±1%, to
compensate for the theoretical effect on oximeter measurements of fetal hemoglobin in neonatal blood.
Measurement range
1 to 100%
Resolution
1%
Response time
≤20 s (normal perfusion, no disturbance, SpO
2
value sudden change from
70% to 100%)
Accuracy
1
70 to 100%: ±2% (adult/pediatric, without motion)
70 to 100%: ±3% (adult/pediatric, with motion)
70 to 100%: ±3% (neonate)
1% to 69%: Not specified.
Refreshing rate
≤ 2 s
SpO2 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 SpO2 accuracy
2
±2%
PI measurement range
0.02 to 20%
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.
Alarm limit
Range (bpm)
Step (bpm)
PR High
PR≤40: (low limit +2) to 40
PR>40: (low limit +5) to 295
PR≤40: 1
PR>40: 5
PR Low
PR≤40: 16 to (high limit - 2)
PR>40: 40 to (high limit - 5)
Measurement range
20 to 254 bpm
Resolution
1 bpm
Response time
<30 s (normal perfusion, no disturbance, PR value sudden changes from 25
bpm, to 220 bpm)
Accuracy
±3 bpm
Refreshing rate
≤1 s
