A-11
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% SpO
2
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% SpO
2
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 ISO9919
Measurement range 0 to 100%
Resolution 1%
Response time ≤ 30 s (PI > 0.3, no disturbance, SpO
2
value sudden change within 70% - 100%)
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.
Information of the Test Subjects of the Clinical Study Report:
Skin color Gender Number Age (years) Health
Black Male 1
28.2±9.19
Healthy
Female 1
Yellow Male 3
Female 9
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