OBL: Proton Healthcare, 2118 US Highway 41, Calhoun, GA 30701, UNITED STATES.
OEM: Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN ROC.
|BP||Medaval||None||Although equivalence to another device is claimed, this has not been tested to MDR requirements.|
|BP||BIHS (UK and IRL)||Self-measurement||Manufacturer declaration of equivalence|
|BP||ESH (Europe)||Self-measurement||The BIHS recommendation, despite the absence of the scientific evidence required by the same authors' criteria.|
Legend: B BIHS Derivative
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)