Dräger Infinity Delta, Instructions For Use Manual

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B-42 D
ELTA
/D
ELTA
XL/K
APPA
VF8
B T
ECHNICAL
D
ATA
Measurement accuracy, Neonatal mode
(1, 2, 3, 4, 5)
:
Saturation (%SpO
2
):
0 to 69% not specified
70 to 100% sensor-specific as follows:
Nellcor :
N-25, OxiMAX MAX-N ±3
Masimo :
LNOPNEO, LNOPNEO SS, LNOP-YI ±3
Pulse Rate: ±3 beats/min or ±3% (whichever is greater)
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) These accuracies have been validated using blood samples obtained from healthy adult
volunteers during induced hypoxia studies in the range of 70-100% SpO2 against a laboratory
co-oximeter and ECG monitor.
3) SpO
2
accuracies are expressed as ± "X" digits between indicated saturation levels. Accuracy
of the SpO
2
measurement is specified within 1 A
rms
of the value measured by a co-oximeter.
4) Accuracy of saturation measurements on neonates is decreased 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) 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.
Interfering Substances: Carboxyhemoglobin may erroneously increase
readings. The level of increase is approximately equal
to the amount of carboxyhemoglobin present. Dyes,
nail polishes and other substances, may absorb an
abnormal amount of red light, which can effect the
accuracy of the measurement. Be sure to apply the
sensor to a site free of any artificial pigments.
SpO
2
alarms: High:adjustable, 20 to 100 %
Low: adjustable, 20 to 100 %
Nominal wavelength: Dräger: Red: 660 nm IR: 905 nm
Masimo: Red: 660 nm IR: 905 nm
Nellcor: Red: 660 nm IR: 910 nm
Power: Dräger: Red: 1.8 mW(max.) IR: 2.0 mW(max.)
Masimo: Red: 0.9 mW(max.) IR: 0.9 mW(max.)
Nellcor: Red: 3 mW(max.) IR: 4 mW(max.)
Note : LED drive is current limited by hardware
mechanisms.
Degree of protection against electric
shock:
Type CF
Defibrillation protection: Defibrillation-proof applied part per IEC 60601-1