Validation of Telli BP01 Oscillometric Blood Pressure Monitor According to AAMI/ESH/ISO Standard

The aim of the study was to evaluate the accuracy of a home-based oscillometric upper-arm blood pressure (BP) monitor (Telli BP01) in accordance with the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/ International Organization for Standardization (AAMI/ESH/ISO) Universal Standard. Participants were recruited to fulfill the age, sex, BP, and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard. Both the test device and the aneroid sphygmomanometer (observer BP) were connected to the BP cuff to measure BP simultaneously at rest and during maximal static hand grip (SHG). Ninety-two participants were recruited, and 85 were analyzed. Eleven participants were asked to perform SHG during the test. For validation Criterion 1, the mean ± SD of the differences (the test device minus observer BP) for all BP readings was − 1.8 ± 6.6/-3.7 ± 5.7 mmHg (systolic/diastolic). For validation Criterion 2, the SD of all participants' averaged BP differences (the test device minus observer BP per participant) was 5.5/4.9 mmHg (systolic/diastolic). Both criteria were fulfilled in the present validation study. In conclusion, the Telli BP01 BP monitor fulfilled the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and can be recommended for use at home.