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Specifications
Sensor Accuracy
A-Series Sensors: For A-Series sensor SpO
2
and Pulse Rate accuracy
specifications, reference your Philips/Agilent/HP instrument’s Instructions for Use.
B-Series Sensors: SpO
2
and Pulse Rate accuracy specifications for M1191B and
M1191BL sensors are the same as indicated for M1191A and M1191AL sensors in
your Philips/Agilent/HP instrument’s Instructions for Use.
Special Edition A-Series Sensors (AN-Series): SpO
2
accuracy (functional
saturation) for Special Edition A-Series sensors used in combination with M1020B
or M3001A, Option A02, specified as the root-mean-square (RMS) difference
between the measured values and the reference values, in the range 70 to 100% is:
2% for M1191ANL and M1192AN; 3% for M1193AN, M1194AN, and M1195AN.
Neonatal Applications: The claimed accuracy numbers for neonatal application
are already increased by an additional 1% to account for affect on oximeter
measurements due to fetal hemoglobin in neonatal blood, as predicted by the
literature.
Light Emitting Diode Wavelength Ranges
Wavelength ranges for the light emitting diodes used in these sensors are within
600nm-1000nm, with an optical output power of less than 15mW. Knowing the
wavelength range can be useful to clinicians performing photodynamic therapy.
Measurement Validation
The SpO
2
accuracy has been validated in human studies against arterial blood
sample reference measured with a CO-oximeter. In a controlled desaturation study,
healthy adult volunteers with saturation levels between 70% and 100% SaO2 were
studied. The population characteristics for those studies were:
• Approximately 50% female and 50% male ranging in age from 18-45
• Skin tone: from light to black
Because pulse oximeter equipment measurements are statistically distributed, only
approximately 2/3 of pulse oximeter equipment measurements can be expected to
fall within the +
Arms value measured by a CO-oximeter. Functional testers, such
as an SpO
2
simulator cannot be used to assess the accuracy of pulse oximeter
Sensors.