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验证适用于成年中国人的穿戴式 HUAWEI WATCH D 腕部血压测量手表的准确性。

Validation of the watch-type HUAWEI WATCH D oscillometric wrist blood pressure monitor in adult Chinese.

机构信息

Department of Cardiovascular Medicine, State Key Laboratory of Medical Genomics, Shanghai Key Laboratory of Hypertension, Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

出版信息

Blood Press Monit. 2022 Oct 1;27(5):353-356. doi: 10.1097/MBP.0000000000000608. Epub 2022 May 27.

Abstract

OBJECTIVE

The aim of this study was to evaluate the accuracy of the watch-type automated oscillometric wrist blood pressure (BP) monitor HUAWEI WATCH D in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard.

METHOD

Subjects were recruited to fulfill the age, sex, BP and cuff distributions of the AAMI/ESH/ISO Universal Standard in the general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for wrist circumference of 13-16 cm (medium) and 16-20 cm (large), respectively.

RESULTS

One-hundred and nine subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.4 ± 6.47/-0.2 ± 5.85 mmHg (systolic/diastolic). For criterion 2, the SD of the average BP differences between the test device and reference BP per subject was 5.66/5.48 mmHg (systolic/diastolic).

CONCLUSION

The HUAWEI WATCH D watch-type wrist BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard in the general population and can be recommended for self-measurement.

摘要

目的

本研究旨在根据医疗器械促进协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)通用标准评估华为 WATCH D 腕式自动示波法血压(BP)监测仪在普通人群中的准确性。

方法

采用相同手臂顺序 BP 测量方法,根据 AAMI/ESH/ISO 通用标准在普通人群中的年龄、性别、BP 和袖带分布招募受试者。该测试设备的两个袖带分别适用于 13-16cm(中号)和 16-20cm(大号)的腕周。

结果

共招募 109 名受试者,其中 85 名进行了分析。对于验证标准 1,测试设备和参考 BP 读数之间差值的平均值±SD 为-1.4±6.47/-0.2±5.85mmHg(收缩压/舒张压)。对于标准 2,每个受试者的测试设备和参考 BP 之间的平均 BP 差值的 SD 为 5.66/5.48mmHg(收缩压/舒张压)。

结论

华为 WATCH D 腕式腕部 BP 监测仪满足普通人群中 AAMI/ESH/ISO 通用标准的所有要求,可推荐用于自我测量。

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