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Nellcor OxiMax Performance Specifications
Pulse Oximetry Performance Specifications
SpO2
Range
The specified
Accuracy
accuracy is the root-
mean-square (RMS)
difference between
the measured values
and the reference
values
Low perfusion
accuracy
Resolution
Pulse
Range
Accuracy
Low perfusion
accuracy
Resolution
Numeric update rate
Sensors
1. M1901B/MAXN:
Clinical functionality has been demonstrated on a population of hospitalized neonate patients. The observed SpO
accuracy was 2.5% in a study of 42 patients with ages of 1 to 23 days, weight from 750 to 4100 grams, and 63
observations made spanning a range of 85 to 99% SaO
2. The accuracy specification has been determined between saturations of 80%–100%.
3. SoftCare SC-PR-I, SCNEO-I:
Clinical functionality has been demonstrated on a population of hospitalized neonate and infant patients. The observed
SpO
accuracy was 3.0% in a study of 57 patients with ages of 24 to 40 weeks, weight from 710 to 5,000 grams, and 185
2
observations made spanning a range of 63 to 100% SaO
4. Neonatal accuracy: When sensors are used on neonatal subjects as recommended, the specified accuracy range is
increased by ± 1 digit, as compared to adult usage, to account for the theoretical effect on oximeter measurements of
fetal hemoglobin in neonatal blood. For example, Oxicliq N accuracy on neonates is ± 3.5 digits, rather than ± 2.5.
5. Specification applies to the performance of the device. Reading accuracy in the presence of low perfusion (detected
IR pulse modulation amplitude 0.03% - 1.5%) was validated using signals supplied by a patient simulator. SpO
pulse rate values were varied across the monitoring range over a range of weak signal conditions and compared to the
known true saturation and pulse rate of the input signals.
1 to 100%
1
M1901B
, M1902B, M1903B, M1904B, MAXA, MAXAL, MAXP, MAXI, MAXN
MAXFAST: adult/infant = 2% (70% to 100%)
M1902B, M1903B, M1904B, MAXA, MAXAL, MAXP, MAXI, MAXN
=3% (60% to 80%)
1
MAXN
:neonate = 2% (70% to 100%)
Oxicliq A, Oxicliq P, Oxicliq L, Oxicliq N
4
Oxicliq N
:neonate = 3.5% (70% to 100%)
2
MAXR
, D-YSE, D-YSPD: adult/infant = 3.5% (70% to 100%)
SoftCare SC-A (adult/infant), SoftCare SC-PR-I
2% (70% to 100%)
DS-100A-I, D-YS, Oxiband OXI-A/N, Oxiband OXI-P/I:adult/infant = 3% (70% to 100%)
4
D-YS
, Oxiband OXI-A/N
2% (70 - 100%)
5
1%
25 to 300 bpm
+/- 3 bpm (25 to 250 bpm)
+/- 3 bpm (25 to 250 bpm)
5
1 bpm
typical 1 second, max ≤60 seconds
Wavelength range: 500 to 1000 nm
Emitted Light Energy: ≤15 mW
Information about the wavelength range can be especially useful to clinicians (for instance,
when photodynamic therapy is performed)
4
: adult/infant =2.5% (70% to 100%)
3
(neonate), SoftCare SCNEO-I
4
: neonate = 4% (70% to 100%)
while monitored with Nellcor OxiMax N-595 pulse oximeters.
2
while monitored with Nellcor OxiMax N-595 pulse oximeters.
2
24 Specifications
1
,
1
, MAXFAST: adult
3
: (neonate) =
2
and
2
303

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