Palatini Paolo, Dorigatti Francesca, Bonso Elisa, Ragazzo Fabio
Department of Clinical and Experimental Medicine, University of Padova, Padua, Italy.
Blood Press Monit. 2009 Feb;14(1):41-4. doi: 10.1097/MBP.0b013e32831e30d2.
The objective of this study was to determine the accuracy of the Microlife BP W100 device for blood pressure measurement. The device evaluations were performed in 85 participants, by using both the protocol of the European Society of Hypertension (ESH) and the protocol of the British Hypertension Society (BHS). Initially, the data from 33 participants were examined according to the ESH protocol. Furthermore, 52 participants were then enrolled to fulfill the BHS protocol requirements. In all participants, sequential same arm measurements were made by two trained observers. The device passed all three phases of the ESH protocol for systolic blood pressure (SBP) and diastolic blood pressure (DBP) and was graded A according to the criteria of the BHS protocol for both SBP and DBP. The A/A grade was achieved in low (<130/80 mmHg), medium (130-160/80-100 mmHg) and high (>160/100 mmHg) blood pressure categories. Mean blood pressure difference between BP W100 and observers in the 85 participants was 0.1+/-5.3 mmHg for SBP and 1.1+/-3.4 mmHg for DBP, and thus, the device also met the requirements of the Association for the Advancement of Medical Instrumentation. In conclusion, these data show that the Microlife BP W100 wrist monitor satisfied the recommended ESH accuracy levels and achieved A/A grade of the BHS protocol across a wide range of blood pressure.
本研究的目的是确定Microlife BP W100设备测量血压的准确性。通过使用欧洲高血压学会(ESH)的方案和英国高血压学会(BHS)的方案,对85名参与者进行了设备评估。最初,根据ESH方案检查了33名参与者的数据。此外,随后招募了52名参与者以满足BHS方案的要求。在所有参与者中,由两名经过培训的观察者对同一手臂进行连续测量。该设备在ESH方案的收缩压(SBP)和舒张压(DBP)的所有三个阶段均通过,并且根据BHS方案的标准,SBP和DBP均被评为A级。在低(<130/80 mmHg)、中(130 - 160/80 - 100 mmHg)和高(>160/100 mmHg)血压类别中均达到了A/A级。85名参与者中BP W100与观察者之间的平均血压差异,SBP为0.1±5.3 mmHg,DBP为1.1±3.4 mmHg,因此,该设备也符合医疗仪器促进协会的要求。总之,这些数据表明,Microlife BP W100腕式监测仪满足了ESH推荐的准确性水平,并在广泛的血压范围内达到了BHS方案的A/A级。