Specifications - Philips M1131A Instructions For Use Manual

Specifications

Sensor Accuracy
• M1131A (adult and pediatric) sensor accuracy is +3% SpO
70% to 100% SpO
• M1132A (infant) and M1133A, M1134A (adult, infant and neonate) sensor accu-
racy is +2% SpO
on neonatal subjects as recommended, the literature predicts the accuracy range
should be increased by +1% to account for affect on oximeter measurements due
to fetal hemoglobin in neonatal blood.
For more information on SpO
reference your monitoring instrument's Instructions for Use, or the SpO
Sensor Compatibility Sheet included with your sensor.
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 accuracy has been validated in human studies against arterial
2
blood sample reference measured with a CO-oximeter. In a controlled
desaturation study, healthy adult volunteers with saturation levels between
70% and 100% SaO
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
used to assess the accuracy of pulse oximeter sensors.
.
2
in the range from 70% to 100% SpO
2
and Pulse Rate accuracy specifications,
2
were studied. The population characteristics for
2
2
6
in the range from
2
. When sensors are used
simulator cannot be
2
2