Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Microlife BP3KV1-5X (BP B6 Connect) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018)

OBJECTIVE: To evaluate the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) monitor Microlife BP3KV1-5X (BP B6 Connect) for home 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) 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 wide-range cuff of the test device was used for arm circumference 22-42 cm. RESULTS: One-hundred and twenty individuals were recruited and 85 were analyzed [mean age: 55.8 ± 15.6 (SD) years, 41 men, arm circumference 31.9 ± 5.1 cm, range: 23-41.8 cm]. For validation criterion 1, the mean difference ± SD between the test device and reference BP readings ( N = 255) was -0.8 ± 6.8/-2.3 ± 4.9 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 5.99/4.35 mmHg (systolic/diastolic; threshold ≤ 6.89/6.55 mmHg). CONCLUSION: The automated oscillometric home BP monitor Microlife BP3KV1-5X (B6 Connect) 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.