Abstract：
Pulse oximeters\' (POs) varying performance based on skin tones has been highly publicised. Compared to arterial blood gas analysis, POs tend to overestimate oxygen saturation (SpO2) values for people with darker skin (occult hypoxemia). The objective is to develop a test bench for assessing commercial home and hospital-based POs in controlled laboratory conditions. A laboratory simulator was used to mimic different SpO2 values (~ 70 to 100%). Different neutral density and synthetic melanin filters were used to reproduce low signal and varying melanin attenuation levels. Six devices consisting of commercial home (Biolight, N = 13; ChoiceMMed, N = 18; MedLinket, N = 9) and hospital-based (Masimo Radical 7 with Neo L, N = 1; GE B450 Masimo SET with LNCS Neo L, N = 1; Nonin 9550 Onyx II™, N = 1) POs were reviewed and their response documented. Significant variations were observed in the recorded SpO2 values among different POs when exposed to identical simulated signals. Differences were greatest for lower SpO2 (< 80%) where empirical data is limited. All PO responses under low signal and melanin attenuation did not change across various simulated SpO2 values. The bench tests do not provide conclusive evidence that melanin does not affect in vivo SpO2 measurements. Research in the areas of instrument calibration, theory and design needs to be further developed.
摘要：
脉搏血氧计（PO）根据肤色变化的性能已广为人知。与动脉血气分析相比，对于皮肤较黑（隐匿性低氧血症）的人，PO倾向于高估氧饱和度（SpO2）值。目的是开发一个测试台，用于在受控的实验室条件下评估商业家庭和医院的PO。使用实验室模拟器来模拟不同的SpO2值(〜70至100%)。使用不同的中性密度和合成黑色素过滤器来再现低信号和变化的黑色素衰减水平。由商业家庭组成的六种设备(Biolight，N=13；选择MMed，N=18；MedLinket，N=9）和基于医院的（MasimoRadical7与NeoL，N=1;GEB450MasimoSETwithLNCSNeoL,N=1；Nonin9550OnyxII™，N=1)对PO进行了审查，并记录了它们的反应。当暴露于相同的模拟信号时，在不同PO之间记录的SpO2值中观察到显着差异。在经验数据有限的情况下，较低的SpO2（<80％）差异最大。在低信号和黑色素衰减下的所有PO响应在各种模拟的SpO2值上没有变化。台架试验未提供黑色素不影响体内SpO2测量的确凿证据。在仪器校准领域的研究,理论和设计需要进一步发展。
