Validation of the automated oscillometric home blood pressure monitor AViTA BPM82 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)

OBJECTIVE: To evaluate the accuracy of the automated upper-arm cuff oscillometric home blood pressure (BP) monitor AViTA BPM82 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) and its amendments (1 : 2020 and 2 : 2024). METHODS: Participants were recruited to fulfill the age, sex, BP, and arm distribution criteria of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its amendments (1 : 2020 and 2 : 2024) in a general population using the same arm sequential measurement method. A single 360° wide-range hard cuff of the test device was used for arm circumference 22-42 cm. RESULTS: One-hundred-twelve individuals were recruited and 85 were analyzed [mean age 58.1 ± 15.2 (SD) years, 34 men, arm circumference 32 ± 5.5 cm, range: 22-42 cm]. For validation of Criterion 1, the mean difference ± SD between the test device and reference BP readings ( N 255) was -1.6 ± 7.4/-1.5 ± 5.6 mmHg (systolic/diastolic; threshold: ≤5 ± 8 mmHg). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per individual ( N 85) was 6.20/5.11 mmHg (systolic/diastolic; threshold: ≤6.76/6.78 mmHg). CONCLUSION: The automated oscillometric home BP monitor AViTA BPM82 fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its amendments (1 : 2020 and 2 : 2024) in a general population and can be recommended for home use.