Terumo Elemano2 ES-H56D

Device Name:

Elemano2

Device Model:

ES-H56D

Manufacturer:

Terumo Corporation, 2-44-1 Hatagaya, Shibuya-ku, Tokyo 151-0072, JAPAN.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for professional use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

Japan

Description:

The Terumo Elemano2 ES-H56D is a palm-style semi-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 professional use.

Assessment:

The technology used in the Terumo Elemano2 ES-H56D, 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	Japanese Society of Hypertension	Self-measurement and professional use (Latest: 2021-2022)	Implied equivalence to the Terumo ES-H55

Device Family:

Terumo Elemano ES-H55J, Terumo Elemano ES-H55DJ, Terumo Elemano2 ES-H56J, Terumo Elemano2 ES-H56DJ, Terumo Elemano ES-H55DNJ
Legend: J JHS Implied 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.

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