Department of Anesthesia and Perioperative Care, University of California San Francisco, San Francisco, California, USA.
Anaesthesia. 2013 Dec;68(12):1220-3. doi: 10.1111/anae.12382. Epub 2013 Aug 31.
Pulse oximetry is a standard of care during anaesthesia in high-income countries. However, 70% of operating environments in low- and middle-income countries have no pulse oximeter. The 'Lifebox' oximetry project set out to bridge this gap with an inexpensive oximeter meeting CE (European Conformity) and ISO (International Organization for Standardization) standards. To date, there are no performance-specific accuracy data on this instrument. The aim of this study was to establish whether the Lifebox pulse oximeter provides clinically reliable haemoglobin oxygen saturation (Sp O2 ) readings meeting USA Food and Drug Administration 510(k) standards. Using healthy volunteers, inspired oxygen fraction was adjusted to produce arterial haemoglobin oxygen saturation (Sa O2 ) readings between 71% and 100% measured with a multi-wavelength oximeter. Lifebox accuracy was expressed using bias (Sp O2 - Sa O2 ), precision (SD of the bias) and the root mean square error (Arms). Simultaneous readings of Sa O2 and Sp O2 in 57 subjects showed a mean (SD) bias of -0.41% (2.28%) and Arms 2.31%. The Lifebox pulse oximeter meets current USA Food and Drug Administration standards for accuracy, thus representing an inexpensive solution for patient monitoring without compromising standards.
脉搏血氧饱和度仪是高收入国家麻醉期间的标准护理设备。然而，中低收入国家 70%的手术环境中没有脉搏血氧饱和度仪。“生命盒”血氧仪项目旨在用符合 CE（欧洲合格评定）和 ISO（国际标准化组织）标准的廉价血氧仪来填补这一空白。迄今为止，尚无关于该仪器性能准确性的具体数据。本研究旨在确定 Lifebox 脉搏血氧饱和度仪是否能够提供符合美国食品和药物管理局 510(k)标准的临床可靠的血红蛋白氧饱和度 (SpO2)读数。使用健康志愿者，调整吸入氧分数以产生动脉血红蛋白氧饱和度 (SaO2)读数，范围为 71%至 100%，使用多波长血氧仪进行测量。Lifebox 的准确性通过偏差 (SpO2-SaO2)、精度（偏差的标准差）和均方根误差 (Arms) 来表示。在 57 名受试者的 SaO2 和 SpO2 同步读数中，平均（标准差）偏差为 -0.41%（2.28%），Arms 为 2.31%。Lifebox 脉搏血氧饱和度仪符合当前美国食品和药物管理局的准确性标准，因此代表了一种廉价的患者监测解决方案，不会降低标准。
