Nissei DS-500

Device Model:DS-500
Manufacturer:Nissei Japan Precision Instruments Inc., 2508-13 Nakago Shibukawa, Gunma 377-0293, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment: The technology used in the Nissei DS-500, to measure blood pressure, has passed in three validation studies, between general, pregnancy and other specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Device Family:Beurer BM-60D, Nissei DS-400D (D DET Equivalence)
Validation Publications for Equivalent Devices

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)

Nissei DS-400

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)