Accuracy Verification of Wrist Electronic Sphygmomanometer:Based on the Latest International Standards(ISO 81060-2:2018+AMD1:2020)
Objective To verify the accuracy of the wrist electronic sphygmomanometer according to the latest international standard(ISO 81060-2:2018+AMD1:2020).Methods Eighty-six subjects were recruited from February 27,2024 to June 4,2024 in Fenglin Street Community Health Service Center,Xuhui District,Shanghai.In the measurement room of the center,according to the latest international standard(ISO 81060-2:2018+AMD1:2020),the same arm sequence method was selected to measure the blood pressure of the subjects.Each subject was measured up to 9 times to obtain 3 sets of effective blood pressure values,and they whether meet the requirements of subjects'gender,wrist circumference distribution,blood pressure distribution and the measured data of the sphygmomanometer in the latest international standard(ISO 81060-2:2018+AMD1:2020)were analyzed.The Bland-Altman scatter plot was drawn to evaluate the consistency of systolic blood pressure and diastolic blood pressure measured by mercury sphygmomanometer and them measured by wrist electronic sphygmomanometer.Results Finally,85 subjects were included and 255 groups of effective blood pressure values were obtained.The gender,wrist circumference distribution and blood pressure distribution of 85 subjects met the requirements of the latest international standard(ISO 81060-2:2018+AMD1:2020).The 255 groups of differences of systolic blood pressure and diastolic blood pressure measured by mercury sphygmomanometer and wrist electronic sphygmomanometer were(2.9±6.52)mmHg and(2.5±4.62)mmHg,respectively,which met the requirements of Standard 1 in the latest international standard(ISO 81060-2:2018+AMD1:2020).The differences between mean systolic and diastolic blood pressure measured by mercury sphygmomanometer and those measured by wrist electronic sphygmomanometer in 85 subjects were(2.9±5.89)mmHg and(2.5±4.06)mmHg,respectively,which met the requirements of Standard 2 in the latest international standard(ISO 81060-2:2018+AMD1:2020).The results of Bland-Altman scatter plot analysis showed that the 255 groups of differences of systolic blood pressure and diastolic blood pressure measured by mercury sphygmomanometer and wrist electronic sphygmomanometer were mostly within 95%CI of their average.The differences between average systolic blood pressure and diastolic blood pressure measured by mercury sphygmomanometer and wrist electronic sphygmomanometer in 85 subjects were mostly within 95%CI of their average.The differences of systolic blood pressure and diastolic blood pressure measured by mercury sphygmomanometer and wrist electronic sphygmomanometer in subjects with different wrist circumferences were mostly within 95%CI of their average.Conclusion OMRON HEM-6160 wrist electronic sphygmomanometer meets the accuracy requirements of the latest international standard(ISO 81060-2:2018+AMD1:2020).The blood pressure measured by OMRON HEM-6160 wrist electronic sphygmomanometer is in good agreement with the blood pressure measured by mercury sphygmomanometer,which can replace mercury sphygmomanometer for blood pressure detection.
万方数据
维普
