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Terumo ES-R800SZ
Device Model:
ES-R800SZ
Manufacturer:
Terumo Corporation, 2-44-1 Hatagaya, Shibuya-ku, Tokyo 151-0072, JAPAN.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Terumo ES-R800SZ is an automatic blood pressure monitor. Although its blood pressure measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood pressure measurements are taken from the upper arm. It is intended for self-measurement and home use.
Assessment:
The technology used in the Terumo ES-R800SZ, to measure blood pressure, has been assessed, in a general population, according to a non-standard protocol.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.
BP Japanese Society of Hypertension Self-measurement (2016-2019) Possibly the intended device, listed as with an incomplete internal report
Device Family:
Terumo ES-R800STJ, Terumo ES-R800SZJ
Legend: J JHS Implied Equivalence
Validation Publications:

血圧計に関するワーキンググループ, 日本高血圧学会学術委員会 [Working Group on Sphygmomanometers, Academic Committee on Hypertension in Japan] [Test reports on the Terumo R800 and P2000] [Internet] Tokyo: JSH; 2010. Available from: www.jpnsh.jp.

JIS T 1115:2005 General population

JIS T 1115:2005 General population

There is insufficient information provided in either of two reports to enable scientific assessment. Furthermore, apart from the report and the JSH recommendation, there is no evidence of an R800 device per se but Terumo do make an ES-R800ST and an ES-R800SZ. The report is listed here, as the ES-R800SZ may be the device intended but caution is advised.

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.

Terumo ES-R800ST

血圧計に関するワーキンググループ, 日本高血圧学会学術委員会 [Working Group on Sphygmomanometers, Academic Committee on Hypertension in Japan] [Test reports on the Terumo R800 and P2000] [Internet] Tokyo: JSH; 2010. Available from: www.jpnsh.jp.

JIS T 1115:2005 General population

JIS T 1115:2005 General population

There is insufficient information provided in either of two reports to enable scientific assessment. Furthermore, apart from the report and the JSH recommendation, there is no evidence of an R800 device per se but Terumo do make an ES-R800ST and an ES-R800SZ. The report is listed here, as the ES-R800ST may be the device intended but caution is advised.