Clinical Validation of the Saadat Non-Invasive Blood Pressure Module According to the British Standard EN ISO ۸۱۰۶۰-۲ Protocol
Publish place: Signal Processing and Renewable Energy، Vol: 5، Issue: 1
Publish Year: 1400
نوع سند: مقاله ژورنالی
زبان: English
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شناسه ملی سند علمی:
JR_SPRE-5-1_003
تاریخ نمایه سازی: 31 فروردین 1400
Abstract:
This study was conducted according to the British Standard EN ISO ۸۱۰۶۰-۲ guidelines. The aim was to validate the Saadat non-invasive blood pressure (NIBP) module accuracy and reliability against manual auscultatory general practitioners (GP), readings. A total of ۲۹۸ measurements and comparison procedures were performed on ۹۵ adults without heart disease under the supervision of two GPs. In order to represent the relationships between the test device and the reference method, the Bland-Altman graphical plotting method was used. The mean differences and standard deviations (mean ± SD differences) between the readings of the Saadat NIBP module and determination of GPs as the reference method for systolic and diastolic were exceptionally close with: -۲.۲۲ ± ۶.۵۱ mmHg and -۳.۳۱±۶.۲۷ mmHg respectively. The Saadat NIBP module fulfilled the BS EN ISO ۸۱۰۶۰-۲ requirements, which states that the mean ± SD of lower than ۵±۸ mmHg can be recommended for clinical use.
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Authors
Mohammadamin Haghayegh
Najafabad Branch, Islamic Azad University
Neda Behzadfar
Najafabad Branch, Islamic Azad University