DiaTecne PulsePen WPP001-ETT Gebruikershandleiding - Pagina 3

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Intended Use

In this manual, when talking about device or equipment, the reference is to all its parts, unless otherwise

noted. Each unit alone does not produce useful results.

This medical device is intended to determinate the arterial stiffness and to record the arterial

pressure wave, by means of the "applanation tonometry", for diagnostic purposes. It must be used by

qualified medical / paramedical personnel, familiar with the "applanation tonometry" method, in

medical environment or research centers.

The primary functions are capture, display and storage of the arterial tonometric

signal for later calculation of the related parameters including Pulse Wave Velocity -

PWV, that defines the arterial stiffness. This instrument is based on the applanation

tonometry principle. The user places the sensor on the skin, where the artery pulse is

found, with a moderate pressure that slightly compresses the artery (applanation

tonometry): in such way, a balance of the circumferential forces inside the vessel is

obtained and the sensor records the pressure inside the compressed artery.

Intermediate layers between sensor and vessel, with their thickness and rigidity, that

vary for each individual, influence the pressure measured by the sensor in a not, a

priori, quantifiable manner. For this reason it is necessary to calibrate tonometric

signals using the systolic and diastolic pressures obtained from an external

sphygmomanometer (supplied by the operator). The calibration process is based on

the assumption that diastolic and mean pressure substantially don't change along the

arterial tree.

The pulse wave velocity is defined as the

propagation velocity of the pressure wave

(not of the blood) from the center to the

periphery and is therefore obtained by

dividing the distance between two examined

points (for example Carotid and Femoral) by

the related sphygmic wave transit time

(DeltaT).

This propagation time can be assessed in two different ways (I or II):

I. Using the wEc1 unit together with the wTn1 unit, first for Carotid (R-cW) and then for the peripheral

artery (e.g. the Femoral Artery in figure, R-fW ) , to measure the delay time between the R peak of the

ECG wave and the "foot" of the tonometric waves, time A and B, and then the difference between them,

DeltaT.

II. Using two wTn1 units to contemporarily capture two tonometric signals, one of the Carotid and the

other of the selected peripheral Artery, to obtain the time interval DeltaT between the two waves' "feet".

⚠ The ECG lead captured must only be used for PWV estimation and must never be used for any kind

of diagnosis on the patient!  

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User Manual PulsePen - V. 4.6