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

Objective To 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). Methods Subjects 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). Results A 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). Conclusions The 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.

Automated summary

This study evaluated the accuracy of the InBody BPBIO210 manual auscultatory hybrid blood pressure measuring device in a general population and demonstrated its compliance with the AAMI/ESH/ISO Universal Standard, making it suitable for clinical use.