H&L HL858GT Talking

Description:

The H&L HL858GT Talking is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.

Assessment:

The technology used in the H&L HL858GT Talking, to measure blood pressure, has been compared to a clinically validated device, but the results of the equivalence study have not been published and cannot be verified; nor can the protocol be checked for compliance with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BP	Stride BP	Self-measurement for adults (Preferred)	Equivalence claim without published evidence

Device Family:

H&L HL858GT TalkingP, H&L HL868EDP, H&L HL858A2-TP, Seagull S-868EDP
Legend: P Stride Equivalence

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.

H&L HL868ED

Zhang W, Lei L, Li Y, Wang JG. Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the British Hypertension Society Protocol. Blood Press Monit. 2019 Aug;24(4):203-207. Epub: 2019 May 23. doi: 10.1097/MBP.0000000000000384. PMID: 31136322. Erratum in: Blood Press Monit. 2021 Feb;26(1):85.

BHS:1993 - Pass (A/A) General population

Zhang W, Lei L, Li Y, Wang JG. Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010. Blood Press Monit. 2020 Feb;25(1):53-57. Epub: 2019 Oct. doi: 10.1097/MBP.0000000000000411. PMID: 31658108. Erratum in: Blood Press Monit. 2021 Feb;26(1):84.

ESH-IP:2010 - Pass General population