Page D-18 Infinity Gamma Series VF4
Measuring accuracy, Neonatal mode
(1, 2, 3, 4)
:
SpO
2
:
0 to 69% not specified
70 to 100% sensor-specific as follows:
Nellcor:
N-25 ..........................................................................................................±3
Masimo:
LNOPNEO, LNOPNEO SS, LNOP-YI.......................................................±3
Pulse Rate: ............................................. ±3 beats/min or ±3% (whichever is less)
Notes:
1) SpO
2
accuracies are expressed as ± "X" digits between indicated saturation
levels. Accuracy of the SpO
2
measurement is specified with 1 SD (standard
deviation), which represents approximately 68% of the population.
2) Saturation: increase tolerance by ±1 digit during motion
(5, 6)
(ECG monitoring
required).
3) Pulse Rate: increase tolerance by ±2 beats/min or ±2% (whichever is greater)
during motion
(5, 6)
(ECG monitoring required).
4) Accuracy of saturation measurements on neonates is increased by ±1 digit as
compared to accuracy on adult patients to account for the theoretical effect on
oximeter measurements of fetal hemoglobin in neonatal blood.
5) For Masimo devices, motion is defined as either:
• Periodic rubbing/tapping with an amplitude of 1-2 cm. at a periodic frequency of
2-4 Hz.
or:
• Aperiodic motion with an amplitude of 2-3 cm. at a frequency of 1-5 Hz.
6) For Nellcor devices, motion is defined as aperiodic rubbing/tapping motion with
an amplitude of 1-2 cm. at a frequency of 1-4 Hz.
SpO
2
Alarms High: Adjustable, 20 to 100%
Low: Adjustable, 20 to 100%
Defaults:
Adult and Pediatric: 100-90
Neonatal: 100-90
Nominal Wavelength Red: 660 nm
IR: 910 nm
Power Red: 3 mW (max.)
IR: 4 mW (max.)
Note: LED drive is current limited by hardware mech-
anisms.
Degree of Protection
Against Electric Shock
Type CF
Defibrillation Protection
In accordance with IEC 601-1A2
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