Abstract
Functional testers are designed to evaluate select pulse oximeter characteristics but are often misused to validate device accuracy, potentially providing false reassurance. This study evaluated whether the Fluke ProSim8 (FPS8) could accurately predict oximeter performance during human controlled desaturation studies or identify performance differences under low signal conditions. 12 oximeters were tested using two FPS8 protocols: (1) an 'SpO₂ plateau' protocol which mimicked controlled desaturation studies by evaluating device performance over a range of simulated SpO(2) (70-100%), and (2) a 'signal space' protocol designed to assess device accuracy under varying modulation and transmission conditions. Each device also underwent controlled desaturation testing in healthy adults. Six of the 12 oximeters passed (ARMS ≤ 3%) the SpO₂ plateau protocol; however, three of these failed (ARMS > 3%) human testing. At lower simulated saturations, most devices overestimated SpO₂. In the signal space protocol, oximeters performed well under high signal conditions, but many failed to produce readings or showed SpO₂ errors > 3% under low signal conditions. On average, oximeters failed to generate a reading 20.2 ± 7.2 times out of 60 attempts. Ten devices passed (ARMS < 3%) the signal space protocol, but two of these failed human testing. Oximeter performance on the FPS8 did not correlate with human performance (R² = 0.08 for the plateau protocol; R² = 0.01 for the signal space protocol). 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.