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Disetronic Profilomat II

Device Name:Profilomat II
Manufacturer:Sole: Disetronic Medical Systems AG (Roche), Kirchbergstrasse 190, CH-3401 Burgdorf, SWITZERLAND.
Measuring functions:Blood pressure
Primary Client Use:Intended for ambulatory blood pressure monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Intermittent measurements at specified intervals or times
Availability:Obsolete
Description: The Disetronic Profilomat II is a non-clinically-validated automatic blood pressure monitor. Measurements are taken from the upper arm and it is intended for ambulatory blood pressure monitoring. This device is now obsolete.
Assessment:

The technology used in the Disetronic Profilomat II, to measure blood pressure, has failed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed clinical validation.

Validation Publications

Mee F, Atkins N, O'Brien E. Evaluation of the Profilomat II ambulatory blood pressure system according to the protocols of the British Hypertension Society and the Association for the Advancement of Medical Instrumentation. Blood Press Monit. 1998;3(6):353-61. PMID: 10212377.

BHS:1993 - Fail (C/B) General population

SP10:1992 - Fail General population (Note: Failed SBP)