Validation of the JOYTECH DBP-6286B arm-type fully automatic digital blood pressure monitor in adults or adolescents with large arm circumference according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018 + Amd.1:2020)

The objective of this report is to evaluate the overall effectiveness and safety of the JOYTECH DBP-6286B arm-type fully automatic digital blood pressure monitor in adults and adolescents with an arm circumference of 40-56 cm. Subjects were recruited in adults and adolescents with large arm circumference. The test device was JOYTECH DBP-6286B and the reference device was a mercury sphygmomanometer. Using BP readings obtained from the mercury sphygmomanometer as the reference standard, the accuracy of the noninvasive BP module of the test device meets the specified requirements is evaluated. This study analyzed valid BP data from 85 subjects. According to Criterion 1, the mean difference of SBP between the test and reference device was -1.09 mmHg and the SD was 3.93 mmHg. The mean difference of DBP was -0.49 mmHg and the SD was 3.43 mmHg. The mean difference of both SBP and DBP was less than ±5 mmHg, and the SD was less than 8 mmHg, which met the requirements. According to Criterion 2, SD of SBP was 2.47 mmHg, which was less than 6.86 mmHg and met the requirements. The SD of DBP was 2.48 mmHg, which was less than 6.92 mmHg and met the requirements. The JOYTECH DBP-6286B complies with Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension (ESH)/International Organization for Standardization (ISO) Universal Standard (ISO 81060-2:2018 + Amd 1:2020), and the requirements of the Recognized Consensus Standards published by the FDA completely, and is recommended for BP measurement in adults and adolescents with an arm circumference of 40-56 cm for home and clinical use.