The technology used in the Nissei DS-400, to measure blood pressure, has passed in clinical validation studies, between general, pregnancy and other specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
|Medaval||★ Recommendation||Older clinical validation; older protocol; multiple clinical validations|
|ESH (Europe)||Self-measurement for adults and pregnancy||Published evidence|
|Stride BP||Self-measurement for adults||Published evidence|
Duhig KE, De Greeff A, Van Der Westhuizen A, Baker E, Shennan AH. Validation of the Nissei DS-400 in a low-resource setting. Blood Press Monit. 2009 Jun;14(3):132-5. doi: 10.1097/MBP.0b013e32832ce136. PMID: 19433979.
ESH-IP:2002 - Pass Low resource setting
de Greeff A, Shennan AH. Clinical accuracy of a low cost portable blood pressure device in pregnancy and pre-eclampsia: the Nissei DS-400. Trop Doct. 2015 Jul;45(3):168-73. Epub: 2015 Apr 23. doi: 10.1177/0049475515581542. PMID: 25911652.
BHS:1993 - Pass (A/A) Pregnancy and pre-eclampsia (n=45)
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.
Beurer BM 60
Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.
DHL:1999 - Pass General population (Note: 2011)