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Spo 2 Pulse Oximetry - Philips Efficia DFM100 Instructions For Use Manual

Defibrillator/monitor.
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19: Specifications
SpO
Pulse Oximetry
2
SpO
Measurement Range: 0-100%
2
SpO
Resolution: 1%
2
Update Period: 1-2 sec typical; maximum of ≤ 30 sec
SpO
2
Table 59
Sensor
M1191B
M1191BL
M1192A
M1196A
* - Specified accuracy is the root-mean-square (RMS) difference between the measured values and reference values.
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
Fourier Artifact Suppression Technology (FAST).
While the SpO
the accuracy of measurements less than 70% has not been validated.
SpO
accuracy was validated in human studies against arterial blood sample references measured
2
with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with saturation
levels between 70-100% SaO
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
SpO
readings.
2
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
Alarm Range:
2
Low Limit: 50-99% (Adult and Infant/Child)
High Limit: 51-100% (Adult and Infant/Child)
SpO
and Pulse High/Low Alarm Signal Generation Delay: 10 seconds
2
SpO
Response Time (90 to 80%): average 18.9 seconds, standard deviation 0.88 seconds
2
SpO
and Pulse Averaging Time: 10 sec
2
Emitted Light Energy: ≤15 mW
206
Sensor Accuracy*
Accuracy
±2%
M1196S
±2%
989803128631
±2%
989803160611
±3%
module is able to report values below 70% and alarm limits can be set below 70%,
2
were studied. The population characteristics for those studies were
2
Sensor
Accuracy
±3%
±3%
±3%
testing cannot be used to assess the accuracy of the
2
Specifications
Sensor
Accuracy
989803160621 ±3%
989803160631 ±3%
989803174381 ±3%
module with
2

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