Terumo Elemano2 ES-H56
The technology used in the Terumo Elemano2 ES-H56, 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.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | None | Although equivalence to another device is claimed, this has not been tested to MDR requirements. | ||
| Japanese Society of Hypertension | Self-measurement and professional use (2017-2019) | Implied equivalence to the Terumo Elemano (ES-H55) | ||
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.
Terumo Elemano ES-H55
Tochikubo O, Nishijima K, Ohshige K, Kimura K. Accuracy and applicability of the Terumo ES-H55 double-cuff sphygmomanometer for hospital use. Blood Press Monit. 2003 Oct;8(5):203-9. PMID: 14624170.
SP10:1992 - Pass General population
