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根据ANSI/AAMI/ISO81060-2:2013指南对欧姆龙HEM-9700T自动坐位和仰卧位血压自测装置的验证

Validation of an automatic device for the self-measurement of blood pressure in sitting and supine positions according to the ANSI/AAMI/ISO81060-2: 2013 guidelines: the Omron HEM-9700T.

作者信息

Kuwabara Mitsuo, Harada Kanako, Hishiki Yukiko, Kario Kazuomi

机构信息

Department of Medicine, Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi.

Omron Healthcare Co. Ltd, Kyoto, Japan.

出版信息

Blood Press Monit. 2019 Jun;24(3):146-150. doi: 10.1097/MBP.0000000000000368.

Abstract

AIM

We evaluated the performance of the Omron HEM-9700T, an automatic upper-arm-type device for the self-measurement of blood pressure (BP), in the sitting and supine positions according to the ANSI/AAMI/ISO81060-2:2013 guidelines.

PARTICIPANTS AND METHODS

We screened 106 participants for the validation study in both positions. After excluding 21 participants, a total of 85 participants [38 (44.7%) men; 47 (55.3%) women] with mean±SD age of 54.5±12.2 years (range: 21-78 years) were included. Their arm circumference was 27.5±1.4cm (range: 17.9-40.8cm). The arm circumference distribution met the ANSI/AAMI/ISO81060-2:2013 requirement. The participants' BP measurements alternated between the use of a conventional mercury sphygmomanometer and the automatic device according to the ANSI/AAMI/ISO81060-2:2013 guidelines to measure their BP.

RESULTS

The mean differences between reference BPs and HEM-9700T readings in the sitting and supine positions were -0.6±6.4/1.3±5.5 and -1.0±6.2/1.9±5.4mmHg for systolic BP/diastolic BP, respectively.

CONCLUSION

The Omron HEM-9700T fulfilled the validation criteria of the ANSI/AAMI/ISO81060-2:2013 guidelines for both the sitting and supine positions.

摘要

目的

我们根据ANSI/AAMI/ISO81060-2:2013指南,评估了欧姆龙HEM-9700T(一种用于自测血压的上臂自动式设备)在坐姿和仰卧位时的性能。

参与者与方法

我们筛选了106名参与者进行两个体位的验证研究。排除21名参与者后,共纳入85名参与者[38名(44.7%)男性;47名(55.3%)女性],平均年龄±标准差为54.5±12.2岁(范围:21-78岁)。他们的臂围为27.5±1.4厘米(范围:17.9-40.8厘米)。臂围分布符合ANSI/AAMI/ISO81060-2:2013要求。根据ANSI/AAMI/ISO81060-2:2013指南,参与者的血压测量在使用传统汞柱式血压计和自动设备之间交替进行,以测量他们的血压。

结果

坐姿和仰卧位时,参考血压与HEM-9700T读数之间的平均差异,收缩压/舒张压分别为-0.6±6.4/1.3±5.5和-1.0±6.2/1.9±5.4mmHg。

结论

欧姆龙HEM-9700T符合ANSI/AAMI/ISO81060-2:2013指南中坐姿和仰卧位的验证标准。

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