脉冲血氧计

脉搏血氧仪测量外周血氧饱和度。平均而言,15岁的人中氧饱和度水平较低,但这一比率在肥胖症中增加了三倍。脉搏血氧仪也已成为高原探险的重要监测工具。

脉冲血氧计的准确度

介绍

红细胞含有一种叫做血红蛋白的色素。这与氧分子结合,从肺部带来氧气,并将二氧化碳带回肺部。氧饱和度(SO 2)仅仅是含氧血红蛋白的细胞百分比。动脉中细胞的饱和水平是一个重要的基线,这称为动脉血氧饱和度(SaO 2)。脉搏血氧仪测量外周氧饱和度(SpO 2),这是对SaO 2的良好估计。当一个细胞处于氧合状态时,它比红光吸收更多的红外光,使其呈现鲜艳的红色;相反的情况是它脱氧,使它看起来更暗。脉搏血氧仪通过手指,脚趾或耳垂传递红光和红外光,并通过比较每种光被吸收的量,计算氧合细胞和脱氧细胞的百分比。这使它成为一个非常简单,快速和无痛的测试。

饱和度为95%至100%被认为是正常的;低于此值,如果低于90%,则称为低氧血症。

平均而言,只有超过6%的人口具有低氧饱和度水平(低于95%),但在BMI为35 kg /m²或更高的人群中,这一比例上升至近20%,在COPD患者中则为15.5%。男性高于女性,高于65岁的女性高于65岁。[1]脉搏血氧仪已成为监测高原探险旅行者健康状况的重要工具,氧饱和度的变化可能差异很大取决于个人和适应环境的持续时间。 [2]脉搏血氧计验证的发展

自1992年以来,ISO已经开发了用于验证脉搏血氧计的ISO协议,其中最新的是ISO 80601-2-61:2011。该标准是FDA上市前510k提交所必需的。 [3]然而,几乎完全没有同行评审的出版物显示脉搏血氧计的有效性。

脉冲血氧计的准确度 - 参考文献

参考

  1. Vold ML, Aasebø U, Hjalmarsen A, Melbye H. Predictors of oxygen saturation ≤95% in a cross-sectional population based survey. Respir Med. 2012 Nov;106(11):1551-8. doi: 10.1016/j.rmed.2012.06.016. Epub 2012 Jul 13. PMID: 22795506. Available here.
  2. Luks AM, Swenson ER. Pulse oximetry at high altitude. High Alt Med Biol. 2011 Summer;12(2):109-19. doi: 10.1089/ham.2011.0013. PMID: 21718156.
  3. US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Anesthesiology – General Hospital – Infection Control, and Dental Devices. Pulse Oximeters – Premarket Notification Submissions [510(k)s] – Guidance for Industry and Food and Drug Administration Staff. Silver Spring, Maryland, USA: FDA; 2013. Download here.

脉冲血氧计的验证协议

现行议定书

ISO/CEN

80601-2-61:2011

International Organization for Standardization Technical Committee 121/SC3. ISO 80601-2-61:2011 Medical Electrical Equipment – Part 2-61: Particular Requirements for Basic Safety and Essential Performance of Pulse Oximeter Equipment. Geneva, Switzerland: ISO; 2011.

以前的协议

ISO/CEN

9919:2009

European Committee for Standardization Technical Committee 215. EN ISO 9919:2009: Medical Electrical Equipment – Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical use. Brussels, Belgium: CEN; 2009.

9919:2005

International Organization for Standardization Technical Committee 121/SC3. EN ISO 9919:2005: Medical Electrical Equipment – Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical use. Geneva, Switzerland: ISO; 2005.

865:1997

European Committee for Standardization Technical Committee (DTC) 215. EN 865:1997: Pulse Oximeters – Particular Requirements. Brussels, Belgium: CEN; 1997.

9919:1992

International Organization for Standardization Technical Committee 121/SC3. ISO 9919:1992: Pulse oximeters for medical use – Requirements. Geneva, Switzerland: ISO; 1992.