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使用英国高血压协会(BHS)和医疗仪器促进协会(AAMI)协议指南对Datascope Accutorr Plus™进行验证。

Validation of Datascope Accutorr Plus™ using British Hypertension Society (BHS) and Association for the Advancement of Medical Instrumentation (AAMI) protocol guidelines.

作者信息

Khawaja Rajab Ali, Qureshi Riaz, Mansure Abdul Hay, Yahya Mohammad Emran

机构信息

Department of Family and Community Medicine, King Khalid University Hospital, King Saud University, Riyadh, Saudi Arabia.

出版信息

J Saudi Heart Assoc. 2010 Jan;22(1):1-5. doi: 10.1016/j.jsha.2010.03.001. Epub 2010 Mar 10.

Abstract

OBJECTIVE

To assure the accuracy and reliability of blood pressure measurement by non-invasive blood pressure monitor using Datascope Accutorr Plus™ (Paramus, NJ, USA) against mercury manometer, among adult male participants.

METHOD

Eighty participants from a family physician's office at a teaching hospital were recruited. One hundred and sixty measurements of blood pressure were performed according to BHS technique protocol.

STATISTICAL ANALYSIS

Descriptive analysis was done according to the AAMI and BHS protocol guidelines. The limits of agreement between the device and the standard were plotted using the method of Bland and Altman plot.

RESULTS

The mean difference ± SD between the Datascope Acutorr Plus™ and observer was 2.7 ± 5.2 mm Hg and 1.5 ± 3.26 mm Hg for systolic and diastolic blood pressure, respectively. Datascope Acutorr Plus™ obtained A/A grading for both systolic and diastolic blood pressure.

CONCLUSION

Datascope Accutorr Plus™ (Paramus, NJ, USA) satisfies BHS and AAMI validation protocols for both systolic and diastolic BP and may be recommended for everyday use for BP monitoring at home and in clinical use for adult population.

摘要

目的

在成年男性参与者中,使用美国新泽西州帕拉默斯市Datascope公司的Accutorr Plus™无创血压监测仪,对比汞柱式血压计,确保血压测量的准确性和可靠性。

方法

招募了一家教学医院家庭医生办公室的80名参与者。按照英国高血压学会(BHS)技术方案进行了160次血压测量。

统计分析

根据美国医疗器械促进协会(AAMI)和BHS方案指南进行描述性分析。使用布兰德-奥特曼图法绘制该设备与标准之间的一致性界限。

结果

Datascope Acutorr Plus™与观察者之间收缩压和舒张压的平均差值±标准差分别为2.7±5.2毫米汞柱和1.5±3.26毫米汞柱。Datascope Acutorr Plus™的收缩压和舒张压均获得A/A级评分。

结论

美国新泽西州帕拉默斯市Datascope公司的Accutorr Plus™满足BHS和AAMI关于收缩压和舒张压的验证方案,可推荐用于家庭日常血压监测以及成年人群的临床使用。

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