Validation of the FF680 upper-arm blood pressure monitor according to the AAMI/ESH/ISO universal standard (ISO 81060-2:2018)

This study evaluated the accuracy of blood pressure measurement in adults using FF680 electronic blood pressure monitors with the Korotkoff-Sound method, in accordance with the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) universal standards (ISO 81060-2 : 2018). The study was conducted at Shijiazhuang People’s Hospital and lasted 56 days, from May 26 to 21 July 2023. Participants, drawn from an adult demographic, underwent data verification and analysis with strict adherence to the trial protocol. For the FF680 electronic blood pressure monitor using the Korotkoff-Sound method, data from 85 valid participants were analyzed. The findings revealed mean differences (standard deviations) of −0.66 mmHg (2.45 mmHg) for SBP and −0.28 mmHg (2.09 mmHg) for DBP. SBP and DBP had standard deviations of ≤6.9 mmHg and ≤6.95 mmHg, meeting the standard requirements. FF680 devices are recommended for adult blood pressure monitoring because they meet the AAMI/ESH/ISO universal requirements (ISO 81060-2 : 2018).