User's Manual

Table Of Contents
A - 12
Mindray SpO
2
Module
Nellcor SpO
2
Module
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.
Standards Meet standards of ISO 80601-2-61: 2011
*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 measurement are statistically distributed
and about two-thirds of the measurements are expected to come within the specified accuracy range compared to CO-
oximeter measurements.
Measurement range 0 to 100%
Resolution 1%
Response time < 30 s (normal perfusion, no disturbance, SpO
2
value sudden changes from
70% to 100%)
Accuracy 70 to 100%: ±2% (adult/pediatric mode)
70 to 100%: ±3% (neonate mode)
0% to 69%: Not specified.
* One percent was added to the accuracies for neonatal sensors to account for accuracy variation due to properties of fetal
hemoglobin. Studies were performed to validate the accuracy of Pulse Oximeter with neonatal SpO
2
sensors by contrast
with a CO-Oximeter. Some neonates aged from 1 day to 30 days with a gestation age of 22 weeks to full term were involved
in this study. The statistical analysis of data of this study shows the accuracy (Arms) is within the stated accuracy
specification. Please see the following table.
Sensor type Totally neonates Data Arms
518B 97 (51 male & 46 female) 200 pairs 2.38%
520N 122 (65 male & 57 female) 200 pairs 2.88%
The Pulse Oximeter with neonatal SpO
2
sensors was also validated on adult subjects.
Refreshing rate ≤1 s
Sensitivity High, Medium, Low
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