Pan Feng, Wan Yi, Chen Wan, Li Ni, Tong Wei, Xu Yongyong
Institute for Health Informatics, China.
Blood Press Monit. 2010 Jun;15(3):167-70. doi: 10.1097/MBP.0b013e328337b4bb.
Blood pressure measuring devices should be subjected to an independent evaluation of accuracy before clinical use. The results of the validation of the Andon KD-575 automated blood pressure monitor according to the European Society of Hypertension International Protocol in adults are presented in this paper.
Sequential same-arm measurements of systolic and diastolic blood pressure were obtained in 33 participants using the mercury sphygmomanometer (two observers) and the test device (one supervisor). According to the validation protocol, 99 pairs of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants).
In phase 1, the Andon KD-575 device produced 26, 38 and 43 measurements within 5, 10 and 15 mmHg, respectively, for systolic blood pressure and 35, 44 and 45 mmHg, respectively, for diastolic blood pressure. However, in phase 2, the test device failed to meet the criteria for systolic blood pressure but comfortably passed all of the criteria for diastolic blood pressure with a mean (standard deviation) device-observer difference of 2.00+/-7.12 mmHg for systolic and 1.47+/-4.71 mmHg for diastolic blood pressure.
The Andon KD-575 automated blood pressure monitor cannot be recommended for clinical use in an adult population because it records systolic blood pressure inaccurately.
血压测量设备在临床使用前应接受准确性的独立评估。本文介绍了根据欧洲高血压学会国际协议对安冬KD - 575自动血压监测仪在成人中的验证结果。
使用汞柱式血压计（两名观察者）和测试设备（一名监督者）对33名参与者进行连续的同侧收缩压和舒张压测量。根据验证方案，在研究的两个阶段获得了99对测试设备和参考血压测量值（33名参与者每人3对）。
在第一阶段，安冬KD - 575设备测量的收缩压在5、10和15 mmHg范围内分别有26、38和43次，舒张压在5、10和15 mmHg范围内分别有35、44和45次。然而，在第二阶段，测试设备未达到收缩压标准，但轻松通过了所有舒张压标准，收缩压的设备与观察者平均差异为2.00±7.12 mmHg，舒张压为1.47±4.71 mmHg。
安冬KD - 575自动血压监测仪不能推荐用于成人临床，因为它记录的收缩压不准确。
