Philips Avalon FM30 - Spo2 Performance Test; Expected Test Results; Measurement Validation

7 Testing and Maintenance
85
Expected Test Results
SpO2 Performance Test
This test checks the performance of the SpO
2
measurement.
Tools required: none
1 Connect an adult SpO
2
transducer to the SpO
2
connector.
2 Measure the SpO
2
value on your finger (this assumes that you are healthy).
3 The value should be between 95% and 100%.
Expected Test Results
Measurement Validation
The SpO
2
accuracy has been validated in human studies against arterial blood sample reference
measured with a CO-oximeter. In a controlled desaturation study, healthy adult volunteers with
saturation levels between 70% and 100% SpO
2
were studied.
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.
Test Expected test results
Accuracy test x1 = value displayed by monitor
Difference ≤3 mmHg
Leakage test x2 = leakage test value
x2 <6 mmHg
Linearity test x3 = value displayed by monitor
Difference ≤3 mmHg
Valve Test x4 = value <10 mmHg
Test Expected test results
SpO
2
Performance Test 95%—100%