Mindray ePM 10M, Operator'S Manual

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A - 13
Nellcor SpO
2
Module
Masimo SpO
2
Module
Recovery time <15 s (after defibrillation)
PI
Measurement range 0.05 to 20%
Resolution 0.05%~9.99%: 0.01%
10.0%~20.0%: 0.1%
Measurement range 0 to 100%
Resolution 1%
Refreshing rate ≤1 s
Response time ≤30 s (normal perfusion, no disturbance, SpO2 value sudden change from
70% to 100%)
Recovery time <15 s (after defibrillation)
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.
Standards meets the requirements of ISO 80601-2-61: 2011
Measurement range 1 to 100%
Resolution 1%
Response time ≤20 s (normal perfusion, no disturbance, 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.
Refresh rate ≤ 1 s
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%
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.