Philips M1193A, M1194A Specifications, Sensor Accuracy, Light Emitting Diode Wavelength Ranges

Specifications

Sensor Accuracy

A-Series Sensors: For A-Series sensor SpO2 and Pulse Rate accuracy specifications, reference your Philips/Agilent/HP instrument’s Instructions for Use.

B-Series Sensors: SpO2 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): SpO2 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 SpO2 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 SpO2 simulator cannot be used to assess the accuracy of pulse oximeter Sensors.

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