Omron HBP-1120 (HBP-1120-E)
Device Name:
HBP-1120
Device Model:
HBP-1120-E
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Omron HBP-1120 (HBP-1120-E) is an 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 Omron HBP-1120 (HBP-1120-E), 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 | Stride BP | Office use for adults and children (Preferred) | Equivalence to the Omron HBP-1320 (HBP-1320-E) claim without published evidence |
Device Family:
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.
Omron HBP-1320 (HBP-1320-E)
Saito K, Hishiki Y, Takahashi H. Validation of the Omron HBP-1320 for professional use according to the ANSI/AAMI/ISO 81060-2: 2013 protocol and the 2010 revision of the European Society of Hypertension International Protocol. Blood Press Monit. 2020 Jun;25(3):162-166. Epub: 2020 Feb 27. doi: 10.1097/MBP.0000000000000437. PMID: 32118675.
81060-2:2019 - Pass General population
ESH-IP:2010 - Pass General population