Philips Efficia DFM100 - SpO2 Pulse Oximetry

19: Specifications Specifications
206
SpO
2
Pulse Oximetry
SpO
2
Measurement Range: 0-100%
SpO
2
Resolution: 1%
SpO
2
Update Period: 1-2 sec typical; maximum of ≤ 30 sec
NOTES: Accuracy outside the range specified for each sensor is not indicated. The above referenced sensors
were validated for use with the Efficia DFM100 using the Philips picoSAT II SpO
2
module with
Fourier Artifact Suppression Technology (FAST).
While the SpO
2
module is able to report values below 70% and alarm limits can be set below 70%,
the accuracy of measurements less than 70% has not been validated.
SpO
2
accuracy was validated in human studies against arterial blood sample references measured
with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation
levels between 70-100% SaO
2
were studied. The population characteristics for those studies were
approximately 50% male and 50% female, ranging in age from 19-39 with skin tone from light to
dark.
Pulse oximetry equipment measurements are statistically distributed, therefore only two-thirds of
pulse oximeter equipment measurements can be expected to fall within ±Arms of the value measured
by a CO-oximeter.
Functional test equipment designed for SpO
2
testing cannot be used to assess the accuracy of the
SpO
2
readings.
See the sensor’s instructions for use for the maximum temperature possible at the sensor-skin
interface and other information such as intended patient population, sensor application sites and use
criteria.
The Efficia DFM100 is calibrated to display functional oxygen saturation.
Ambient Light Sensitivity: Interference from fluorescent light is <2% SpO2 under the following
conditions: 0.3 and 1% perfusion, 50 nA/mA transmission, 10 to 1000 lx light intensity, 50/60Hz
power line frequency ±0.5 Hz line frequency.
SpO
2
Alarm Range:
• Low Limit: 50-99% (Adult and Infant/Child)
• High Limit: 51-100% (Adult and Infant/Child)
SpO
2
and Pulse High/Low Alarm Signal Generation Delay: 10 seconds
SpO
2
Response Time (90 to 80%): average 18.9 seconds, standard deviation 0.88 seconds
SpO
2
and Pulse Averaging Time: 10 sec
Emitted Light Energy: ≤15 mW
Table 59 Sensor Accuracy*
Sensor Accuracy Sensor Accuracy Sensor Accuracy
M1191B ±2% M1196S ±3% 989803160621 ±3%
M1191BL ±2% 989803128631 ±3% 989803160631 ±3%
M1192A ±2% 989803160611 ±3% 989803174381 ±3%
M1196A ±3%
* - Specified accuracy is the root-mean-square (RMS) difference between the measured values and reference values.