穿戴式耳内脉冲氧计有效地测量了70%至100%之间的氧气和:一项前性协议研究
Catherina Ab Bubb1,2, Michael Weber3, Nadine Kretsch1
1Technical University of Munich, School of Medicine and Health, Department of Anaesthesiology and Intensiv Care Medicine, Munich, Germany.
在健康的成年人中,c-med°α耳内传感器准确地测量氧和度 (SpO2) 和脉率. 这款经过验证的设备符合EN ISO 80601-2-61标准,用于非重症监护病房的监控.
科学领域:
- 医疗器械 医疗器械
- 生理监测 生理监测
- 生物医学工程 生物医学工程
背景情况:
- 在重症监护室以外的术后监测受限于缺乏适当的系统.
- 耳内c-med°α传感器为持续的生理监测提供了一个潜在的解决方案.
研究的目的:
- 为了验证c-med°α耳内传感器测量氧和 (SpO2) 和脉冲率的准确性.
- 根据EN ISO 80601-2-61标准,根据参考脉冲氧计来评估设备的性能.
主要方法:
- 一项前性协议研究,涉及12名健康的成年志愿者 (18-50岁).
- 参与者使用c-med°α传感器和参考指脉冲氧计 (Rad-5) 测量了他们的SpO2和脉冲率.
- 将SpO2水平降低到五个定义的平原 (99%至70%),以评估设备在一系列值的性能.
主要成果:
- c-med°alpha显示了SpO2测量的高精度 (Arms = 1.9%),具有非显著偏差 (-0.1%) 和 -4.0%至3.8%的协议极限.
- 脉冲率测量显示,与参考装置没有显著的偏差 (偏差:0.1分钟-1分钟,一致极限:-3.6到3.7分钟-1分钟,A次数rms:1.8分钟-1分钟).
- 两种设备对SpO2 (0.8%) 的重复系数都相同.
结论:
- 该c-med°α传感器符合EN ISO 80601-2-61标准的要求.
- 该设备足以准确地测量健康成人休息时的SpO2和脉率.
- 这验证了c-med°alpha在非重症监护机构的潜在使用.
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