Validation of a smartphone auscultatory blood pressure kit Accutension XYZ-110 in adults according to the ANSI/AAMI/ISO 81060-2: 2013 standard

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Abstract

Objective

The aim of this study was to validate the accuracy of the Accutension XYZ-110 blood pressure (BP) kit according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard.

Participants and methods

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured simultaneously on the same arm in 85 Chinese adults (female : male=48 : 37) with a mean age of 43.2 years using the mercury sphygmomanometer (two observers) and the Accutension XYZ-110 device (one supervisor). The ANSI/AAMI/ISO 81060-2:2013 standard for the validation of BP-measuring devices in adults was followed precisely. A total of 255 comparison pairs were obtained for analysis.

Results

The mean device–observer difference in the 255 separate BP data pairs was 2.45±2.24 mmHg for SBP and 0.69±2.09 mmHg for DBP. The data were in accordance with the criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤5±8 mmHg). In addition, the mean device–observer difference of the 85 participants was 2.45±1.47 mmHg for SBP and 0.69±1.36 mmHg for DBP. The device accuracy also fulfilled the criterion 2 with the SD of less than or equal to 6.47 for SBP and less than or equal to 6.90 mmHg for DBP.

Conclusion

The Accutension XYZ-110 BP kit fulfilled the requirements of the ANSI/AAMI/ISO 81060-2:2013 standard, and hence could be recommended for both clinical and self/home BP measurement in adults.

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