Welch Allyn StepBP Algorithm (Unspecified Device)

Device Name:

StepBP Algorithm

Manufacturer:

Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES.

Measuring functions:

Blood pressure

Primary Client Use:

Developed as a research version only - Never sold commercially

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Not made available

Description:

The Welch Allyn StepBP Algorithm (Unspecified Device) is an algorithm for measuring blood pressure. Its blood pressure measurement technology has been proven to be accurate. Blood pressure measurements are taken from the upper arm. It is intended for use only as a reasearch version.

Assessment:

The technology used in the Welch Allyn StepBP Algorithm (Unspecified Device), to measure blood pressure, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Legacy approval	Older clinical validation; older protocol

Validation Publications:

Alpert BS. Validation of the Welch Allyn SureBP (inflation) and StepBP (deflation) algorithms by AAMI standard testing and BHS data analysis. Blood Press Monit. 2011 Apr;16(2):96-8. doi: 10.1097/MBP.0b013e328345232f. PMID: 21412074.

SP10:2006 - Pass General population