DiaTecne PulsePen WPP001-ET
Device Name:
PulsePen
Device Model:
WPP001-ET
Manufacturer:
DiaTecne s.r.l., Via Giuseppe di Vittorio 190, San Donato Milanese, Milano 20097, ITALY.
Measuring functions:
Blood Pressure and PWV
Primary Client Use:
Intended for professional use including central aortic pressure
Measurement Site:
Upper Arm, Wrist, Thigh, Calf, Foot, Neck (Brachial, Radial, Femoral, Tibial, Dorsalis Pedis, Carotid arteries)
Measurement Occurrence:
Continuous measurement over at least 10 cardiac cycles
Availability:
Available Currently
Description:
The DiaTecne PulsePen WPP001-ET is an arterial applanation tonometry based automatic blood pressure monitor. Accuracy claims for its blood pressure measurement technology are being verified by Medaval. Measurements are taken from the upper arm or abdomen. It is intended for professional use including central aortic pressure.
Assessment:
The DiaTecne PulsePen WPP001-ET is included in a current validation and equivalence audit, by Medaval. Validation details will be posted when this has been completed.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Audit | Validation under audit |
Relevant Publications:
Salvi P, Scalise F, Rovina M, Moretti F, Salvi L, Grillo A, Gao L, Baldi C, Faini A, Furlanis G, Sorropago A, Millasseau SC, Sorropago G, Carretta R, Avolio AP, Parati G. Noninvasive Estimation of Aortic Stiffness Through Different Approaches. Hypertension. 2019 Jul;74(1):117-129. Epub: 2019 May 28. doi: 10.1161/HYPERTENSIONAHA.119.12853. PMID: 31132954.
This study concludes that, with a mean difference of -0.61 m/s ± 2.57 m/s, the PulsePen WPP001-ET carotid-femoral PWV showed strong agreement with invasive aortic PWV.