Omron M3 Comfort (HEM-7134-E)
The technology used in the Omron M3 Comfort (HEM-7134-E), to measure blood pressure, is among the best rated for accuracy by Medaval Ltd. It has passed in two clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
| Accuracy Assessment | Recommendation | Basis | ||
|---|---|---|---|---|
| Medaval | ★★★ Recommendation | Recent clinical validation; recent protocol; multiple clinical validations | ||
| BIHS (UK and IRL) | Self-measurement | Published evidence | ||
| MDR Criteria | During pregnancy | |||
Topouchian J, Hakobyan Z, Asmar J, Gurgenian S, Zelveian P, Asmar R. Clinical accuracy of the Omron M3 Comfort® and the Omron Evolv® for self-blood pressure measurements in pregnancy and pre-eclampsia - validation according to the Universal Standard Protocol. Vasc Health Risk Manag. 2018 Aug 31;14:189-97. doi: 10.2147/VHRM.S165524. PMID: 30214220. Available from: PMC6124447. eCollection 2018.
81060-2:2013 - Pass Normotensive Pregnancy, Hypertensive Pregnancy and Pre-eclampsia (n=45) (Note: Only one set of ISO results provided.)
BHS:1993 - Pass (A/A) Normotensive Pregnancy, Hypertensive Pregnancy and Pre-eclampsia (n=45)
Validation under the "Universal Protocol" is claimed, though only a consensus document was written, at that time, as referenced. Analysis appears to be according to Criterion 1 of ISO 81060-2:2013 and to BHS 1993.
Takahashi H. 欧州高血圧学会国際プロトコル(ESH-IP)改訂2010年版による家庭血圧監視装置Omron EVOLV(HEM-7600T-E),HEM-9210T,およびM3Comfort(HEM-7143-E)の妥当性確認. [Validation of Home Blood Pressure-monitoring Devices Omron EVOLV (HEM-7600T-E), HEM-9210T, and M3 Comfort (HEM-7134-E) According to European Society of Hypertension International Protocol (ESH-IP) Revision 2010.] 日本臨床生理学会雑誌 [Jpn J Clin Physiol]. 2018;48(1):29-38.
ESH-IP:2010 - Pass General population
No abstract provided. "Pass" understood from BIHS recommendation.
