Validation of the automated oscillometric upper-arm cuff home blood pressure monitor Prolife PA5 Comfort AF (BP 136A) in a general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension

This study evaluated the accuracy of the automated oscillometric upper-arm cuff blood pressure (BP) measuring device Prolife PA5 Comfort AF (BP 136A) 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). The requirements of the Universal Standardand its amendments for a validation study in a general population using the same arm sequential measurement method were applied. Participants were recruited to fulfill the age, sex, BP level, arm circumference, and cuff size distribution criteria. The test device measures BP during inflation and uses a wide-range cuff for arm circumference 22-42 cm. One-hundred-twenty-eight individuals were recruited and 85 were analyzed [mean age: 54.9 ± 15.0 (SD) years, 36 (42%) men, arm circumference: 31.7 ± 5.4 cm, range: 22.5-41.9 cm). For validation Criterion 1, the mean difference ± SD between the test device and reference BP readings (N = 255) was -2.1 ± 7.5/-0.3 ± 5.3 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) were 6.44/5.07 mmHg (systolic/diastolic; threshold: ≤6.62/6.95 mmHg). The automated oscillometric home BP monitor Prolife PA5 Comfort AF (BP 136A) fulfills all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2 : 2018) and its amendments (1 : 2020 and 2 : 2024) for a general population and can be recommended for clinical use.