新腕式全自动电子血压计 DBP-2242 有效性验证：符合 ISO 81060-2:2018+AMD 1:2020 标准。
Validation of the validity of the new wrist-type fully automatic blood pressure monitor: DBP-2242 according to ISO 81060-2:2018+AMD 1:2020.
机构信息
Gastroenterology Department.
Gastroenterology Department, Suzhou Ninth Hospital affiliated to Soochow University, Suzhou, Jiangsu Province, China.
出版信息
Blood Press Monit. 2024 Dec 1;29(6):317-320. doi: 10.1097/MBP.0000000000000716. Epub 2024 Jul 16.
OBJECTIVE
Evaluation of the accuracy of the wrist-type fully automatic blood pressure (BP) monitor: DBP-2242 in adolescent and adult populations according to ISO 81060-2 : 2018+Amd.1 : 2020.
METHODS
BP measurements were taken from the subjects using the same-arm sequential method, and BP data measured by a mercury sphygmomanometer was used as the standard.
RESULTS
This study analyzed 262 sets of data from 89 subjects. According to criterion 1, the mean difference between the SBP of the test and reference devices was -0.57 ± 7.31 mmHg, and the DBP was -2.27 ± 7.17 mmHg, which is in accordance with the requirements. According to criterion 2, the average difference between the SBP was -0.57 ± 6.25 mmHg and the DBP was -2.27 ± 5.99 mmHg, which is in accordance with the requirements.
CONCLUSION
Wrist-type fully automatic BP monitor: DBP-2242 complies with ISO 81060-2 : 2018+Amd.1 : 2020 and can be used for BP measurement in adolescent and adult populations.
目的
根据 ISO 81060-2:2018+Amd.1:2020 评估腕式全自动血压（BP）监测仪 DBP-2242 在青少年和成年人群中的准确性。
方法
采用同臂序贯法对受试者进行 BP 测量，以水银血压计测量的 BP 数据为标准。
结果
本研究分析了 89 名受试者的 262 组数据。根据标准 1，测试设备和参考设备的 SBP 平均差值为-0.57±7.31mmHg，DBP 为-2.27±7.17mmHg，符合要求。根据标准 2，SBP 的平均差值为-0.57±6.25mmHg，DBP 的平均差值为-2.27±5.99mmHg，符合要求。
结论
腕式全自动 BP 监测仪 DBP-2242 符合 ISO 81060-2:2018+Amd.1:2020，可以用于青少年和成年人群的 BP 测量。
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