Verification/Validation Activities

Verification Activities

1.1Spectrophotometer will be used to measure the wavelength of both the red and near IR lights.
Pass
2.1Use paint samples with given RGB corresponding to different wavelengths.
Pass
3.1Comparison of calculated SpO2 and known pulse oximeter. Model skin tone variance with pale-skinned subject. Test model skin at various SpO2 ranges by holding breath.
Fail



4.1 Manipulation of code to manually cause system alert
Pass
5.1Measure with digital caliper
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6.1Contrast Checker
Pass
7.1Leakage current test through analogous modeling of human body.
Fail
8.1Measure battery voltage and compare to needed
PassCorrectly measured voltage

Validation Activities

1.1SpO2 sensor outputting measurements based off of finger recording
Pass
2.1Device color recognition test with subjects of different skin tones
Pass
3.1Test model skin at various SpO2 ranges by holding breath
Pass
4.1User holds breath until SpO2 measures less than 95%, inducing the alert
Pass
5.1Survey users on comfort
Pass
6.1Survey on “user-friendly”
Pass
7.1Same as verification
Fail
8.1Measure voltage before/after use
PassCorrectly measured voltage