Omron Nightview (HEM-9601T-E3)
Device Name:
Nightview
Device Model:
HEM-9601T-E3
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:
Upper Arm
Measurement Occurrence:
Single and intermittent measurements
Availability:
Available Currently
Device Manual:
Description:
The Omron Nightview (HEM-9601T-E3) 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 self-measurement and home use.
Assessment:
The technology used in the Omron Nightview (HEM-9601T-E3), 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 |
Self-measurement for adults |
Equivalence claim without published evidence |
Device Family:
Omron HEM-9601TP,
Omron Nightview (HEM-9601T-E3)PLegend:
P Stride 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-9601T
Kuwabara M, Harada K, Hishiki Y, Ohkubo T, Kario K, Imai Y. Validation of a wrist‐type home nocturnal blood pressure monitor in the sitting and supine position according to the ANSI/AAMI/ISO81060‐2:2013 guidelines: Omron HEM‐9601T. J Clin Hypertens (Greenwich). 2020 Jun;22(6):970-978. Epub: 2020 May 24. doi: 10.1111/jch.13864. PMID: 32447831. Available from: onlinelibrary.wiley.com.
81060-2:2013 - Pass Sitting position
81060-2:2013 - Pass Supine position, palm sideways
81060-2:2013 - Pass Supine position, palm upwards
81060-2:2013 - Pass Supine position, palm downwards
