Key result
Accutension XYZ-110 kit meets ANSI/AAMI/ISO standards with a ~2.5 mmHg mean systolic difference versus mercury.
Why the study?
Does the Accutension XYZ-110 blood pressure kit accurately measure blood pressure compared to a mercury sphygmomanometer in adults?
Cross-Sectional (n=85)
Does the Accutension XYZ-110 blood pressure kit accurately measure blood pressure compared to a mercury sphygmomanometer in adults?
The Accutension XYZ-110 smartphone auscultatory blood pressure kit meets ANSI/AAMI/ISO 81060-2:2013 accuracy standards and is suitable for clinical and home use.
Accutension XYZ-110 meets validation standards in cross-sectional testing; extends auscultatory kit evidence but should not yet alter practice.
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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Chu et al. (2017) conducted a cross-sectional in Blood pressure measurement (n=85). Accutension XYZ-110 blood pressure kit vs. Mercury sphygmomanometer was evaluated on Mean device-observer difference in systolic and diastolic blood pressure (MD 2.45). The Accutension XYZ-110 blood pressure kit met ANSI/AAMI/ISO standards with a mean device-observer difference of 2.45±2.24 mmHg for SBP and 0.69±2.09 mmHg for DBP.
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