Omron RX-M (HEM-628-E)

Device Name:

RX-M

Device Model:

HEM-628-E

Manufacturer:

Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for self-measurement and home use

Measurement Site:

Wrist

Measurement Occurrence:

Single measurements only

Availability:

Discontinued but still available

Description:

The Omron RX-M (HEM-628-E) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.

Assessment:

The technology used in the Omron RX-M (HEM-628-E), to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has failed a clinical validation.

Validation Publications:

Braam RL, Aslan B, Thien T. Accuracy of the Omron RX-M, an automated blood pressure measuring device, measuring blood pressure at the wrist, according to a modified British Hypertension Society protocol. Blood Press Monit. 2004 Feb;9(1):25-30. PMID: 15021075.

BHS:1993 - Fail (D/D) General population

ESH-IP:2002 - Fail General population

The Omron RX-M (HEM-628-E) measurements are also compared to those of the Omron HEM-705CP.

Only one observer was used in the main study.