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Welch Allyn Vital Signs 300 Series

Device Name:Vital Signs 300 Series
Manufacturer:Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only

The technology used in the Welch Allyn Vital Signs 300 Series, to measure blood pressure, has failed in a clinical validation study, in a specific population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed clinical validation.
BIHS (UK and IRL)NOT recommended for pregnancyPublished evidence

Validation Publications

Nzelu D, Yeung F, Couderq D, Shennan A, Kametas NA. An inaccurate automated device negatively impacts the diagnosis and treatment of gestational hypertension. Pregnancy Hypertens. 2017 Oct;10:28-33. Epub: 2017 May 3. doi: 10.1016/j.preghy.2017.05.001. PMID: 29143739.

ESH-IP:2010 - Fail Pregnancy (n=33)

Relevant Publications

Schoot TS, Weenk M, van de Belt TH, Engelen LJLPG, van Goor H, Bredie SJH. A New Cuffless Device for Measuring Blood Pressure: A Real-Life Validation Study. J Med Internet Res. 2016 May;18(5):e85. Epub: 2016 May 05. doi: 10.2196/jmir.5414. PMID: 27150527. Available from: PMC4873623.

The use of this device for the reference measurements, in contravention to the ESH-IP 2010 protocol requirements, means that this study can be considered only as a comparison with the Viatom Checkme Health Monitor. It cannot be considered as a validation study.