Microlife BP 3AC1-2
The technology used in the Microlife BP 3AC1-2, to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
|Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|ESH (Europe)||Self-measurement||Published evidence|
Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.
Microlife BP 3AC1-1
Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two devices for self-measurement of brachial blood pressure according to the International Protocol of the European Society of Hypertension: the SEINEX SE-9400 and the Microlife BP 3AC1-1. Blood Press Monit. 2005 Dec;10(6):325-31. PMID: 16330959.
ESH-IP:2002 - Pass General population
Microlife BP 3AC1-1 PC
Thompson AM, Eguchi K, Reznik ME, Shah SS, Pickering TG. Validation of an oscillometric home blood pressure monitor in an end-stage renal disease population and the effect of arterial stiffness on its accuracy. Blood Press Monit. 2007 Aug;12(4):227-32. PMID: 17625395.
ESH-IP:2002 - Pass ESRD (n=33)
Xu J, Wu Y, Su H, Hu W, Li J, Wang W, Liu X, Cheng X. The value of a BP determination method using a novel non-invasive BP device against the invasive catheter measurement. PLoS One. 2014 Jun 23;9(6):e100287. doi: 10.1371/journal.pone.0100287. PMID: 24955577. Available from: PMC4067298.
IA protocol General population (Note: IA validation (n≤48))