Omron Nightview (HEM-9601T-E3)

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)P
Legend: 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