Beurer BM-60

Beurer BM-60
Device Model:BM-60
Manufacturer:

OBL: Beurer GmbH, Söflinger Strasse 218, 89077 Ulm, GERMANY.

OEM: 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 Beurer BM-60, 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.

*** Claim not defined *** It is recommended by the ESH for self-measurement.

Device Family:Nissei DS-400D, Nissei DS-500D (D DET Equivalence)
Validation Publications

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)

Validation Publications for Equivalent Devices

Note: Provisional list; equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) not proven

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)