Omron RX3 Plus (HEM-642-E)
Device Name:
RX3 Plus
Device Model:
HEM-642-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:
Available Currently
Availability according to Countries or Regions:
Germany
Device Manual:
Description:
The Omron RX3 Plus (HEM-642-E) is an automatic blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the wrist. It is intended for self-measurement and home use.
Assessment:
The technology used in the Omron RX3 Plus (HEM-642-E), to measure blood pressure, has passed 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 | Legacy approval | Older clinical validation; older protocol |
| BP | DHL (DE) | General use (Previous: 2004) | Published evidence |
Validation Publications:
Tholl U, Lüders S, Bramlage P, Dechend R, Eckert S, Mengden T, Nürnberger J, Sanner B, Anlauf M. The German Hypertension League (Deutsche Hochdruckliga) Quality Seal Protocol for blood pressure-measuring devices: 15-year experience and results from 105 devices for home blood pressure control. Blood Press Monit. 2016 Aug;22(4):197-205. doi: 10.1097/MBP.0000000000000186. PMID: 26998590.
DHL:1999 - Pass General population (Note: 2004)