Omron HEM-1010
Device Model:
HEM-1010
Manufacturer:
Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for use as a public facility
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Device Manual:
Description:
The Omron HEM-1010 is a waiting-room blood pressure monitor. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for use as a public facility.
Assessment:
The technology used in the Omron HEM-1010, 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 | Japanese Society of Hypertension | Self-measurement (2016-2021) | Implied equivalence to the Omron HEM-1020 or i-Q132 SpotArm (HEM-1010-E) |
Device Family:
Omron HEM-1020J, Omron HEM-1010J, Omron HEM-1011J, Omron HEM-1021J, Omron HEM-1000J, Omron HEM-1025J
Legend: J JHS Implied Equivalence
Legend: J JHS Implied Equivalence
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 HEM-1020
Takahashi H, Yoshika M, Yokoi T. Validation of home blood pressure-monitoring devices, Omron HEM-1020 and Omron i-Q132 (HEM-1010-E), according to the European Society of Hypertension International Protocol. Blood Press Monit. 2011 Aug;16(4):203-7. doi: 10.1097/MBP.0b013e328348b688. PMID: 21701384.
ESH-IP:2002 - Pass General population