Validation of the TMB-2296-BT blood pressure monitor in adults according to the ISO 81060-2:2018 + Amd.1:2020.

Abstract

This study aimed to validate the accuracy of the test device (TMB-2296-BT) blood pressure (BP) monitor in adults according to International Standard Organization (ISO) 81060-2:2018 + Amd.1:2020 universal standard protocol, which is a digital monitor. Three trained observers used the same arm sequential method to compare the SBPs and DBPs measured by the test device with those measured by the reference device (mercury sphygmomanometer). For the test device with cuff ranging from 22 to 32 cm, there are 88 adults, with a male-to-female ratio of 35 : 53. The mean difference and SD between reference BPs and test device BPs readings were (0.21 ± 2.59)/(0.66 ± 2.12) mmHg for SBP/DBP for criterion 1, and (0.21 ± 2.07)/(0.66 ± 1.76) mmHg for SBP/DBP for criterion 2. For the test device with cuffs ranging from 22 to 42 cm, there are 87 adults, with a male-to-female ratio of 49 : 38. The mean difference and SD between reference BPs and test device BPs readings were (-1.62 ± 2.80)/(0.12 ± 3.01) mmHg for SBP/DBP for criterion 1, and (-1.62 ± 2.35)/(0.12 ± 2.60) mmHg for SBP/ DBP for criterion 2. And for the test device with cuff arm circumference sizes of 22-32 cm and 22-42 cm fulfilled both validation criterion 1 and 2 of the ISO 81060-2:2018 + Amd.1:2020 standard and can be recommended for both clinical and self/home BP measurement in adults.