Omron HBP-T105S-N
Device Model:
HBP-T105S-N
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
Availability according to Countries or Regions:
Japan
Description:
The Omron HBP-T105S-N 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-T105S-N, 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 | Professional use (Previous: 2016-2018) | Implied equivalence to the Omron HBP-T105, Pic Solution Professional Check, BP10 |
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-T105
Asmar R, Khabouth J, Mattar J, Pecchioli V, Germano G. Validation of three professional devices measuring office blood pressure according to three different methods: the Omron BP10, the Omron HBP T105 and the Pic Indolor Professional. J Hypertens. 2010 Mar;28(3):452-8. doi: 10.1097/HJH.0b013e3283340c2b. PMID: 20087217.
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