Validation of the device Hingmed DBP-01P, a Clinical Automatic Blood Pressure Monitor with wide-range cuff, evaluated in a general population according to the ISO 81060-2:2018 protocol. This validation study assessed the performance of the device “DBP-01P”, a Clinical Automatic Blood Pressure Monitor designed and manufactured by Shenzhen Hingmed Medical Instrument Co.,Ltd. according to the ISO 81060-2:2018 protocol. Devices under test (SN: 30120220415002) are representative samples from mass production. The clinical investigation was performed in a general population. Clinical protocol : ISO81060-2:2018 BP measurement: Same arm sequential method Test Device : Hingmed DBP-01 P Cuff Size : One wide-range cuff was used for arm sizes ranging from 17 cm to 42 cm Place of test : Villa Maria Hospital, Via Delle Melette, 20 - 35138 Padova, Italy Hospital Staff: Dr Claudio Fania, MD (Principal investigator); Antonella Giletto, RN; Valentina Zanello, RN (Villa Maria Hospital). Handling and processing of data: Prof. Paolo Palatini (Studium Patavinum, University of Padova, Padova, Italy).

Standard Deviation (Refer to Table 1) Additional subjects evaluated but not included in the analysis (n=10) • Between-observer differences > 4 mmHg (n=5) • Within-subject SBP or DBP differences > 12/8 mmHg (n=3) Clinical test of the BP measurement for Hingmed DBP-01P upper-arm BP monitor: Criterion1 was satisfied because the mean device-observer difference was < 5 mmHg and SD was < 8 mmHg for both systolic BP and diastolic BP. Criterion 2 was also satisfied because SD was below the values reported in table 1 of the protocol for both systolic BP and diastolic BP. The Hingmed DBP-01P met the specifications...

Scatter plots of systolic and diastolic blood pressure differences between the device and the observers (y-axis) against the average of the test device and observer pressure values (x-axis).