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根据美国国家标准协会/医学仪器促进协会/国际标准化组织 81060-2:2013 协议验证欧姆龙 HEM-1040 血压计。

Validation of the Omron HEM-1040 Blood Pressure Monitor According to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 Protocol.

机构信息

Department of Cardiology, Biwako Central Hospital, Otsu City, Shiga 520-0834, Japan.

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

出版信息

Vasc Health Risk Manag. 2020 Dec 29;16:571-575. doi: 10.2147/VHRM.S287016. eCollection 2020.

DOI:10.2147/VHRM.S287016
PMID:33402825
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7778435/
Abstract

OBJECTIVE

The accuracy of the Omron HEM-1040 automated oscillometric upper-arm blood pressure (BP) monitoring device, designed for home self-measurements in adult populations, was tested according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 protocol.

METHODS

The requirements of this protocol were precisely followed with the recruitment of 85 individuals in whom sequential systolic BP (SBP) and diastolic BP (DBP) were measured in the same (left) arm and who fulfilled the inclusion criteria involving the ranges of arm circumference, SBP, and DBP.

RESULTS

The mean device-observer difference in the 255 separate pairs of BP data was -2.7 ± 7.14 mmHg for SBP and -3.3 ± 5.70 mmHg for DBP. The data were in accordance with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤ 5 ± ≤ 8 mmHg). In addition, the mean device-observer difference in the 85 participants was -2.7 ± 5.89 mmHg for SBP and -3.3 ± 4.99 mmHg for DBP, fulfilling criterion 2 with a standard deviation of ≤ 6.39 mmHg for SBP and ≤ 6.09 mmHg for DBP.

CONCLUSION

The OMRON HEM-1040 BP monitor fulfilled the requirements of the ANSI/AAMI/ISO validation standard.

摘要

目的

根据美国国家标准协会/医疗器械促进协会/国际标准化组织（ANSI/AAMI/ISO）81060-2:2013 协议，对欧姆龙 HEM-1040 自动示波法上臂血压（BP）监测仪进行了测试，该设备专为成人家庭自测设计。

方法

按照该协议的要求，招募了 85 名符合纳入标准的个体，这些个体的左臂同时进行了连续的收缩压（SBP）和舒张压（DBP）测量，纳入标准涉及臂围、SBP 和 DBP 的范围。

结果

255 对 BP 数据的设备-观察者差值的平均值为 SBP 为-2.7±7.14mmHg，DBP 为-3.3±5.70mmHg。这些数据符合 ANSI/AAMI/ISO 81060-2:2013 标准要求的标准 1（≤5±≤8mmHg）。此外，85 名参与者的设备-观察者差值的平均值为 SBP 为-2.7±5.89mmHg，DBP 为-3.3±4.99mmHg，SBP 的标准偏差为≤6.39mmHg，DBP 的标准偏差为≤6.09mmHg，符合标准 2。

结论

OMRON HEM-1040 BP 监护仪符合 ANSI/AAMI/ISO 验证标准的要求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd11/7778435/4da10a9516e3/VHRM-16-571-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd11/7778435/388c1ee5da13/VHRM-16-571-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd11/7778435/4da10a9516e3/VHRM-16-571-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd11/7778435/388c1ee5da13/VHRM-16-571-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd11/7778435/4da10a9516e3/VHRM-16-571-g0002.jpg

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