While the technology used in the Maestro HL858JA, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared 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.|
|BIHS (UK and IRL)||Self-measurement||Manufacturer declaration of equivalence|
|ESH (Europe)||Self-measurement||The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.|
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.
de Greeff A, Shennan AH. The Health and Life device (HL888HA): accuracy assessment in an adult population according to the British Hypertension Society protocol. Blood Press Monit. 2007 Apr;12(2):107-11. PMID: 17353654.
BHS:1993 - Pass (A/A) General population
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: 2003)