Spo2 Performance Test; Expected Test Results; Measurement Validation - Philips Avalon FM20 Service Manual

Expected Test Results

Test
Accuracy test
Leakage test
Linearity test
Valve Test

SpO2 Performance Test

This test checks the performance of the SpO
Tools required: none
Connect an adult SpO
1
Measure the SpO
2
The value should be between 95% and 100%.
3
Expected Test Results
Test
SpO Performance Test
2

Measurement Validation

The SpO
2
measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with
saturation levels between 70% and 100% SpO
The population characteristics for those studies were:
• about 50% female and 50% male subjects
• age range: 19 to 39
• skin tone: from light to dark brown
NOTE
A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor.
However, it can be used to demonstrate that a particular pulse oximeter monitor reproduces a
calibration curve that has been independently demonstrated to fulfill a particular accuracy
specification.
Pulse rate accuracy has been validated with an electronic pulse simulator.
Expected test results
x1 = value displayed by monitor
Difference ≤3 mmHg
x2 = leakage test value
x2 <6 mmHg
x3 = value displayed by monitor
Difference ≤3 mmHg
x4 = value <10 mmHg
transducer to the SpO
2
value on your finger (this assumes that you are healthy).
2
accuracy has been validated in human studies against arterial blood sample reference
measurement.
2
connector.
2
Expected test results
95%—100%
were studied.
2
7 Testing and Maintenance
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