MONITORING S PECIFICATIONS
VF8 DELTA/DELTA XL/KAPPA B-43
Pulse Oximetry
(Masimo SET SpO
2
via Pod )
Intendeduse 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 to100 %
Pulse rate:25 to 240 /min
Perfusion:0.02 to 20 %
Measurement accuracy
(1, 5)
:
The following are for all Masimo LNCS and LNOP sensors.
Saturation (%SpO2) - During No Motion Conditions:(2)
0 to 69% not specified
70 to 100%:
Adults, Pediatrics ±2
Neonates ±3
Saturation (%SpO2) - 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 25 - 240 bpm ±3
Pulse Rate (bpm) - During Motion Conditions:
(3, 4)
Adults, Pediatrics, Neonates 25 - 240 bpm ±5
NOTES:
1) Since pulse oximeter measurements are statistically distributed, only about two-thirds of those
measurements can be expected to fall within ±1 A
rms
of the value measured by a co-oximeter.
2) The Infinity® Masimo SET® SpO2 SmartPod™ pulse oximeter with LNOPAdt 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 ±1 A
rms
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% SpO2 against a laboratory co-oximeter and ECG monitor. This variation equals ±1 A
rms
of
the value measured by a co-oximeter.
4) 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.
5) The pulse rate accuracy has been validated on healthy adult volunteers during induced hypoxia
studies in the range of 70-100% SpO2 against a laboratory co-oximeter and ECG monitor. This
variation equals ±1 A
rms
of the pulse rate value measured by the ECG monitor.
Nominal wavelength: Red: 660 nm
IR: 905 nm
Radiant power at 50 mW
pulsed:
Min: 0.13 mW
Max: 0.79 mW
To Next Page
Loading...
