根据 ANSI/AAMI/ISO 81060-2:2019 协议，对 Microlife BP B3 AFIB 上臂血压计在成人和青少年中的验证。

Validation of the Microlife BP B3 AFIB upper arm blood pressure monitor in adults and adolescents according to the ANSI/AAMI/ISO 81060-2:2019 protocol.

机构信息

Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.

出版信息

Blood Press Monit. 2021 Aug 1;26(4):299-304. doi: 10.1097/MBP.0000000000000530.

DOI:10.1097/MBP.0000000000000530

PMID:33734119

Abstract

OBJECTIVE

Aim of this study was to validate the Microlife BP B3 AFIB/enterprise resource planning (ERP) No: BP3KT1-3 N blood pressure (BP) monitor according to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI)/International Organization for Standardization (ISO) 81060-2:2019 in adolescents and adults from a general population.

METHODS

BP measurements on the upper arm were performed in 85 subjects (age range 12-88 years), using the Microlife BP B3 AFIB and a standard mercury reference sphygmomanometer.

RESULTS

A total of 255 valid BP comparisons were performed for the present validation analysis. The mean ± SD difference between the test and the reference device was 0.70 ± 7.05 mmHg for SBP (pass criterion ≤5 mmHg) and -0.85 ± 4.70 mmHg for DBP (pass criterion ≤5 mmHg) with the SD below the required value of ≤8 mmHg. The mean ± SD of the intraindividual differences between the test and the reference device was 0.70 ± 5.87 mmHg for SBP (pass criterion for the SD ≤6.90 mmHg) and -0.85 ± 4.19 mmHg for DBP (pass criterion for the SD ≤6.88 mmHg).

CONCLUSION

The Microlife BP B3 AFIB/ERP No: BP3KT1-3 N has passed the criteria of the ANSI/AAMI/ISO 81060-2:2019 protocol and can be recommended for home BP measurements in adolescents and adults.

摘要

目的

本研究旨在根据美国国家标准协会（ANSI）/医学仪器促进协会（AAMI）/国际标准化组织（ISO）81060-2：2019 标准，验证适用于普通人群青少年和成年人的 Microlife BP B3 AFIB/企业资源规划（ERP）No：BP3KT1-3N 血压（BP）监测仪。

方法

使用 Microlife BP B3 AFIB 和标准水银参考血压计在上臂对 85 名受试者（年龄范围 12-88 岁）进行 BP 测量。

结果

本验证分析共进行了 255 次有效 BP 比较。与参考设备相比，测试设备的收缩压（SBP）的平均差值±SD 为 0.70±7.05mmHg（通过标准≤5mmHg），舒张压（DBP）的平均差值±SD 为-0.85±4.70mmHg（通过标准≤5mmHg），SD 低于要求值≤8mmHg。与参考设备相比，测试设备的 SBP 个体内差异的平均差值±SD 为 0.70±5.87mmHg（SD 通过标准≤6.90mmHg），DBP 的平均差值±SD 为-0.85±4.19mmHg（SD 通过标准≤6.88mmHg）。