OVERVIEW
VF6 Infinity Vista D-11
Pulse Oximetry (SpO
2
) with Masimo SET Pod
Parameter display Saturation (%SpO
2
), pulse rate, perfusion
Measuring range %SpO
2
: 1 - 100%
Pulse rate: 25 - 240 /min
Perfusion: 0.02 - 20%
Measuring accuracy:
Saturation (%SpO
2
) - During No Motion Conditions:
(1)
0 to 69% not specified
70 to 100%:
Adults, Pediatrics ±2 digits
Neonates ±3 digits
Saturation (%SpO
2
) - During Motion Conditions:
(2, 3)
0 to 69% not specified
70 to 100%:
Adults, Pediatrics
(2)
±3 digits
Neonates
(3)
±3 digits
Pulse Rate (bpm) - During No Motion Conditions:
(1)
Adults, Pediatrics, Neonates 25 - 240 bpm ±3 digits
Pulse Rate (bpm) - During Motion Conditions:
(2, 3)
Adults, Pediatrics, Neonates 25 - 240 bpm ±5 digits
(1) The Infinity® Masimo SET® SpO2 SmartPod™ pulse oximeter with LNOP-Adt sensors has been validated
for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the
range of 70-100% 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 SET® pod with LNOP-Adt 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 a 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 - 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.
(3) The Masimo SET® pod with LNOP-Neo and Neo Pt sensors has been validated for motion and no 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 a 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 - 100% SpO2 against a
laboratory co-oximeter and ECG monitor. 1% has been added to the results to account for the effects of fetal
hemoglobin. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation
encompasses 68% of the population.
Nominal wavelength Red: 660 nm
IR: 905 nm
Radiant Power at 50 mW pulsed Min: 0.13 mW
Max: 0.79 mW
Resolution SpO
2
:1%
Pulse rate:1 b/min
Low Perfusion Performance
(4)
>0.02% Pulse Amplitude:Saturation (%SpO
2
) ±2 digits
and %Transmission >5%:Pulse rate ±3 digits
(4) The Masimo SET® pod 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.
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