根据美国国家标准学会/美国医疗器械促进协会/国际标准化组织81060-2:2013标准协议以及欧洲高血压学会2010年国际协议修订版，对两款自动设备欧姆龙HEM-6232T和HEM-6181进行腕部自测血压的验证。

Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010.

作者信息

Saito Kanako, Hishiki Yukiko, Takahashi Hakuo

机构信息

Department of Technology Development, Omron Healthcare Co, Ltd., Mukou City, Kyoto, Japan.

Department of Cardiology, Biwako Central Hospital, Otsu City, Shiga, Japan,

出版信息

Vasc Health Risk Manag. 2019 Mar 6;15:47-55. doi: 10.2147/VHRM.S188089. eCollection 2019.

OBJECTIVE

The performance of Omron HEM-6232T and Omron HEM-6181 for monitoring blood pressure (BP) at the wrist was validated in accordance with the ANSI/AAMI/ISO 81060-2:2013 protocol (ANSI/AAMI/ISO) and the European Society of Hypertension International Protocol revision 2010 (ESH IP2).

METHODS

Three trained medical technologists validated the performance of these devices by comparing data obtained from these devices with those obtained using a standard mercury sphygmomanometer.

RESULTS

The mean differences between the devices and mercury readings for SBP and DBP were as follows: HEM-6232T, -0.4±6.7 mmHg and 1.6±5.4 mmHg, respectively; HEM-6181, -0.7±6.2 mmHg and -0.7±5.2 mmHg, respectively, satisfying the ANSI/AAMI/ISO protocol. The mean device-observer measurement difference was -0.9±5.7 mm Hg and 0.2±4.6 mm Hg for SBP and 0.5±4.9 mm Hg and 1.4±3.5 mm Hg for DBP, for HEM-6232T and HEM-6181, respectively, satisfying part 1 of the ESH-IP2. All differences for SBP and DBP in both devices satisfied part 2 of the ESH-IP2. The number of absolute differences in the values obtained using the devices and those measured by the observers fulfilled the requirements of the ANSI/AAMI/ISO and the ESH IP2.

CONCLUSION

The Omron HEM-6232T and HEM-6181 devices met all the requirements of the ANSI/AAMI/ISO and the ESH IP2.

目的

按照美国国家标准学会/美国医疗器械促进协会/国际标准化组织81060 - 2:2013协议（ANSI/AAMI/ISO）以及欧洲高血压学会2010年国际协议修订版（ESH IP2），对欧姆龙HEM - 6232T和欧姆龙HEM - 6181腕式血压监测仪的性能进行验证。

方法

三名经过培训的医学技术人员通过将这些设备获取的数据与使用标准汞柱式血压计获取的数据进行比较，来验证这些设备的性能。

结果

这些设备与汞柱式血压计在收缩压（SBP）和舒张压（DBP）读数上的平均差异如下：HEM - 6232T分别为 - 0.4±6.7 mmHg和1.6±5.4 mmHg；HEM - 6181分别为 - 0.7±6.2 mmHg和 - 0.7±5.2 mmHg，符合ANSI/AAMI/ISO协议。对于HEM - 6232T和HEM - 6181，设备与观察者测量的平均差异在SBP方面分别为 - 0.9±5.7 mmHg和0.2±4.6 mmHg，在DBP方面分别为0.5±4.9 mmHg和1.4±3.5 mmHg，符合ESH - IP2的第1部分。两种设备在SBP和DBP方面的所有差异均符合ESH - IP2的第2部分。使用这些设备获得的值与观察者测量的值的绝对差异数量满足ANSI/AAMI/ISO和ESH IP2的要求。