Identifying performance differences between two pulse oximetry systems in simulated critical neonatal conditions.

Objective: Pulse oximetry is used to guide critical clinical decisions in neonatology. We used a vital signs simulator to compare performance of two pulse oximetry systems in conditions not tested in standardized clinical verification studies.

Study design: We devised a set of simulated tissue translucency, perfusion, peripheral oxygen saturation (SpO₂)_, and heart rate (HR) parameters to mimic challenging real-world neonatal data and applied them to two marketed pulse oximetry systems (Nellcor™ and Masimo®). At each combination of input parameters, we used the response from both systems to assess SpO₂ error.

Results: The mean SpO₂ error for Nellcor™ was below 1.1% across all parameters explored, while Masimo® showed significantly higher (p < 0.005) error at lower translucencies.

Conclusion: Significant performance differences can be observed when comparing pulse oximeters at low translucency and perfusion conditions. Patient simulators cannot replace clinical testing but provide a safe and cost-effective method for additional performance profiling.