A - 10
A.6.1.3 Nellcor SpO
2
Module Specifications
Information of the Test Subjects of the Clinical Study Report
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% 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.
Standards Meet standards of ISO 80601-2-61
Measurement range 0 to 100%
Resolution 1%
Accuracy 70 to 100%: ±2% ABS (adult/pediatric)
70 to 100%: ±3% ABS (neonate)
0% to 69%: Not specified.
Refreshing rate ≤ 1 s
Response time ≤ 30 s (normal perfusion, no disturbance, SpO
2
value
sudden change within 70% – 100%)
* 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.
Skin color Gender Number Age (years) Health
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