Validation of the InBody BPBIO210 manual auscultatory hybrid device for professional office use in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard.

Abstract

OBJECTIVE\nTo evaluate the accuracy of the InBody BPBIO210 manual auscultatory mercury-free hybrid blood pressure (BP) measuring device for professional office use in a 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 (ISO 81060-2:2018).\n\n\nMETHODS\nSubjects were recruited to fulfil the age, sex, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in a general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22-32 (medium) and 32-42 cm (large).\n\n\nRESULTS\nA total of 94 subjects were recruited and 86 were analysed (mean age 53.7 ± 18.4 [SD] years, 50 men, arm circumference 32.5 ± 4.8 cm, range 22-42 cm). For the validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was -1.0 ± 4.1/-0.7 ± 2.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 2.65/1.59 mmHg (systolic/diastolic).\n\n\nCONCLUSIONS\nThe InBody BPBIO210 manual auscultatory hybrid device for professional office BP measurement fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in a general population and can be recommended for clinical use.