Beurer BM 60 - Medaval

Description:

The Beurer BM 60 is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Beurer BM 60, to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol
BP	DHL (DE)	General use (Previous: 2011)	Published evidence
BP	ESH (Europe)	Self-measurement	The DHL recommendation

	Consumer Body	Year(s)	Level	Comment
BP	Choice (Australia)	Previous	B

Device Family:

Beurer BM 60D, Nissei DS-400D, Nissei DS-500D
Legend: 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: 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.

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)