Pulse Oximetry (SpO2) Performance Product Specifications
29 - 40 V Series Operating Instructions
C. VPS with Masimo
1. Masimo SpO
2
Sensor Compatibility
• Masimo LNOP series and LNCS series
2. Masimo SpO
2
Saturation Accuracy
The Masimo pulse oximeter with sensors has 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.
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.
NOTE: 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
measurements are statistically distributed and about two-thirds of the
measurements are expected to come within the specified accuracy
range compared to CO-oximeter measurements.
• SpO
2
parameter minimum range is 70% to 100%.
• Invalid SpO
2
parameter displayed as (- -).
• SPO
2
parameter display resolution is 1%.
3. Masimo SpO
2
Performance Requirements
• Update Rate: Every 2 seconds
• 660 nm for the red LED and 890 nm for the infrared LED.
• Maximum optical power output for the LEDs is 4 mW.
NOTE: The sensor measurement wavelengths are nominal.
NOTE: The information about the wavelength range and maximum photic
output consumption can be especially useful to clinicians (for example,
when photodynamic therapy is performed).
SENSOR ACCURACY
The Pulse Oximetry Parameter accuracy (adult) Maximum error of 2% with no motion
The Pulse Oximetry Parameter accuracy (adult) Maximum error of 3% in the presence of
motion with motion resistant sensors.
The Pulse Oximetry Parameter accuracy (pediatric) Maximum error of 2% with no motion
The Pulse Oximetry Parameter accuracy (pediatric) Maximum error of 3% in the presence of
motion with motion resistant sensors.
The Pulse Oximetry Parameter accuracy (neonatal) Maximum error of 3% with no motion
The Pulse Oximetry Parameter accuracy (neonatal) Maximum error of 3% in the presence of
motion with motion resistant sensors.
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