The present study aimed to evaluate the accuracy of the Omron HBP-9031C automated oscillometric upper-arm blood pressure (BP) measurement device for professional office BP monitoring, according to the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) in the general population. The device was assessed by using it on 85 participants, who fulfilled our inclusion criteria involving the ranges of arm circumference and systolic and diastolic BP. The validation and data analysis were performed as per the protocol. In the ANSI/AAMI/ISO 81060-2:2013 validation procedure (criterion 1), the mean ± SD of the differences between the test device and reference BP was 1 ± 8/-2 ± 6 mmHg (systolic/diastolic). The mean differences between the two observers and the Omron HBP-9031C were 1 ± 7 mmHg for systolic BP and -2 ± 6 mmHg for diastolic BP, according to criterion 2. The two ANSI/AAMI/ISO criteria were fulfilled. The OMRON HBP-9031C professional BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard and can be recommended for clinical use.

中文翻译：

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根据 ANSI/AAMI/ISO 81060-2:2013 协议，在普通人群中验证 Omron HBP-9031C 专业办公室血压监测仪。

本研究旨在根据 ANSI/AAMI/ISO 81060-2:2013 协议 (ANSI/AAMI /ISO) 在一般人群中。通过在 85 名参与者身上使用该设备进行了评估，他们符合我们的纳入标准，涉及臂围和收缩压和舒张压的范围。根据协议进行验证和数据分析。在 ANSI/AAMI/ISO 81060-2:2013 验证程序（标准 1）中，测试设备和参考血压之间差异的平均值 ± SD 为 1 ± 8/-2 ± 6 mmHg（收缩压/舒张压）。两位观察者与 Omron HBP-9031C 之间的平均差异收缩压为 1 ± 7 mmHg，舒张压为 -2 ± 6 mmHg，根据标准 2。满足两个 ANSI/AAMI/ISO 标准。欧姆龙 HBP-9031C 专业血压监测仪符合 ANSI/AAMI/ISO 验证标准的要求，可推荐用于临床。