Supplement for Infinity Delta Series Software
100
Supplement – Infinity
®
Delta Series Software VF10.1
Pulse Oximetry (Masimo SET SpO
2
via Pod)
Description
Value
Intended use
The Infinity Masimo SET® pod and accessories are
indicated for use during both motion and non-motion
conditions and for patients who are well or poorly
perfused.
Parameter display:
Saturation (%SpO
2
), pulse rate, perfusion
Measurement range
%SpO
2
: 1 to 100%
Pulse rate: 25 to 239 /min
Perfusion: 0.02 to 20%
Measurement accuracy
(1, 5, 6)
:
The following are for all Masimo LNCS and LNOP sensors.
Saturation (%SpO
2
) - During conditions with no motion:
(2)
0 to 69% not specified
70 to 100%:
Adults, pediatrics
±2
Neonates
±3
Saturation (%SpO
2
) - During motion conditions:
(3,4)
0 to 69% not specified
70 to 100%:
Adults, pediatrics
(3)
±3
Neonates
(4)
±3
Pulse Rate (bpm) - During no motion conditions:
(2)
Adults, pediatrics, neonates
±3
Pulse Rate (bpm) - During motion conditions:
(3,4)
Adults, pediatrics, neonates
±5
NOTES:
1) Since pulse oximeter measurements are statistically distributed, only about two-thirds of those
measurements can be expected to fall within ±1 Arms of the value measured by a co-oximeter.
2) The Infinity Masimo SET SpO
2
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% SpO
2
against a laboratory co-oximeter and ECG monitor. This
variation equals ±1 Arms of the value measured by a co-oximeter.
3) 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% SpO
2
against a
laboratory co-oximeter and ECG monitor. This variation equals ±1 Arms of the value measured by a
co-oximeter.
4) The Masimo SET pod with LNOP-Neo PT 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% SpO
2
against a laboratory co-oximeter and ECG monitor. 1% has been added to
the results to account for the effects of fetal hemoglobin.
5) The pulse rate accuracy has been validated on healthy adult volunteers during induced hypoxia
studies in the range of 70-100% SpO
2
against a laboratory co-oximeter and ECG monitor. This
variation equals ±1 Arms of the pulse rate value measured by the ECG monitor.
6) A functional tester cannot be used to assess the accuracy of a Pulse oximeter probe or a Pulse
oximeter monitor.
