26 Specifications and Standards Compliance
199
SpO2
Complies with ISO 9919:2005 / EN ISO 9919:2009 (except alarm system; alarm system complies with
IEC 60601-2-49:2001).
Measurement Validation: The SpO
2
accuracy has been validated in human studies against arterial
blood sample reference measured with a CO-oximeter. Pulse oximeter measurements are statistically
distributed, only about two-thirds of the measurements can be expected to fall within the specified
accuracy compared to CO-oximeter measurements. Display Update Period: Typical: 2 seconds,
Maximum: 30 seconds. Max. with noninvasive blood pressure INOP suppression on: 60 seconds.
SpO
2
Performance Specifications
SpO
2
The specified accuracy is
the root-mean-square
(RMS) difference
between the measured
values and the reference
values
Range 0 to 100%
Accuracy Philips Reusable Sensors:
M1191A/B, M1191AL/BL, M1191ANL, M1192A, M1192AN =
2% (70% to 100%)
M1191T, M1192T, M1194A, M1194AN, M1196A, M1196T = 3%
(70% to 100%)
Philips Disposable Sensors with M1943A(L):
M1131A, M1901B, M1903B, M1904B = 3% (70% to 100%)
M1133A, M1134A = ±2% (70% to 100%)
NellcorPB® Sensors with M1943A(L):
MAX-A, MAX-AL, MAX-P, MAX-N, D-25, D-20, N-25, OxiCliq A,
P, N = 3% (70% to 100%)
Masimo Reusable Sensors® with LNOP MP12 or LNC MP10:
LNOP DC-I, LNOP DC-IP, LNOP YI, LNCS DC-I, LNCS DC-IP:
2 % (70 % to 100 %)
LNOP TC-I, LNCS TC-I: 3.5 % (70 % to 100 %)
Masimo Disposable Sensors® with LNOP MP12 or LNC
MP10:
LNOP Adt, LNOP Adtx, LNOP Pdt, LNOP Pdtx, LNCS Adtx,
LNCS Pdtx: 2 % (70 % to 100 %)
LNOP Neo-L, LNCS Neo-L: 3 % (70 % to 100 %)
Resolution 1%
Pulse Range 30 to 300 bpm
Accuracy ±2% or 1 bpm, whichever is greater
Resolution 1 bpm
Sensors Wavelength range 500 to 1000 nm.
Information about the wavelength range can be especially useful to
clinicians (for instance, when photodynamic therapy is performed).
Emitted Light
Energy
≤ 15mW
Pulse Oximeter Calibration Range 70% - 100%
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