Specifications
Sensor Accuracy
• M1191T (Adult) and M1192T (Pediatric) sensor accuracy is +3% SpO
range from 70% to 100% SpO
• M1193T (neonate) sensor accuracy is +3% SpO
SpO
When sensors are used on neonatal subjects as recommended, the literature
2.
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
your monitoring instrument's Instructions for Use, or the Sensor & Instrument
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 blood
2
sample reference measured with a CO-oximeter. In a controlled desaturation study,
healthy adult volunteers with saturation levels between 70% and 100% SaO
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
simulator cannot be used to assess the accuracy of pulse oximeter
2
sensors.
.
2
and Pulse Rate accuracy specifications, reference
2
9
in the range from 70% to 100%
2
in the
2
were
2