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Omron RX-M (HEM-628-E)

Device Name:RX-M
Device Model:HEM-628-E
Manufacturer:Sole: 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
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.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed 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) values are also compared to those of the Omron HEM-705CP.

Only one observer was used in the main study.