Comparing pulse oximeter performance using a common functional tester versus controlled desaturation studies on healthy participants
Authors' conclusion
The FPS8 did not reliably predict oximeter accuracy in human desaturation studies or under low signal conditions; current functional tester protocols are limited in predicting real-world oximeter performance.
Study context
- Population
- Pulse oximeters tested on a functional tester and in controlled desaturation studies in healthy adults
- Participants
- 12 oximeters
- Comparison
- Fluke ProSim8 (FPS8) functional tester protocols vs human controlled desaturation testing
- Outcome
- Whether FPS8 accurately predicts oximeter performance (ARMS) during human controlled desaturation studies
Methodological detailsfunctional tester vs controlled desaturation studies
- Functional tester vs controlled desaturation studies
Performance
As reported in the abstract
FPS8 prediction of oximeter performance in human controlled desaturation studies
- Oximeters passing (ARMS ≤ 3%) the SpO₂ plateau protocol, of 12
- 6
- Of these, failed (ARMS > 3%) human testing
- 3
- Oximeters passing (ARMS < 3%) the signal space protocol
- 10
- Of these, failed human testing
- 2
- Correlation of FPS8 with human performance, plateau protocol (R²)
- 0.08
- Correlation of FPS8 with human performance, signal space protocol (R²)
- 0.01
Further findings
SpO₂ plateau protocol at lower simulated saturations
- Most devices overestimated SpO₂
Signal space protocol under low signal conditions
- Failures to generate a reading out of 60 attempts (mean ± SD)
- 20.2 ± 7.2
- Good performance under high signal; many failed to produce readings or had SpO₂ errors > 3% under low signal
Original publication
Comparing pulse oximeter performance using a common functional tester versus controlled desaturation studies on healthy participants. J Clin Monit Comput. Published 14 November 2025. doi:10.
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