The medical device consists of the following parts:
• Tonometric unit PulsePen, code wTn1, for the capture of a pressure signal with the non-invasive
“Applanation Tonometry” method and radio transmission to wRs1. The number of such units included in
the package is one for the WPP001-ET device and two for the WPP001-ETT device.
• ECG unit, code wEc1, for the capture of one electrocardiographic lead and radio transmission to wRs1.
• Signal receiver unit, code wRs1, to be inserted in one USB port of the computer, for synchronization and
collection of signals coming from wTn1 and wEc1.
• The package includes the following accessory parts, supplied by the manufacturer:
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ECG cable set with crocodile terminals, cod. CV010.
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USB drive with Software, Quick Guide, Tutorial, User Manual in pdf format.
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Alkaline Batteries 1.5 V - AAA - IEC LR03.
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User Manual.
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Guarantee Certificate.
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Bag to carry the device with its accessories.
Below, speaking of device or instrument, we refer to all the units that compose it unless otherwise
indicated. Each unit, individually, does not provide any useful results.
The PulsePen must be connected to a computer, provided by the user, in order to view, record and
analyze signals. The connection to the computer is galvanically isolated being made via radio
through the wRs1 unit.
During the patient examination, it is necessary to input the systolic and diastolic pressure values
measured with a validated sphygmomanometer supplied by the user.
Intended Use
PulsePen is an active medical device, for diagnostic purposes, intended for recording the arterial pressure
curve and evaluating the stiffness of the arteries, using the "Applanation Tonometry" method.
Classification
Class IIa medical device according to the Regulation (EU) 2017/745.
Patients and Users
The PulsePen medical device is intended to be used with all types of patients (adults and children) who
may need it, both in a hospital setting in an inpatient ward and in an outpatient setting, or in clinical
research conditions.
The user of the medical device must be qualified medical / paramedical personnel who are familiar with
the "Applanation Tonometry" method. It is intended for use in hospitals, medical clinics or research
centers.
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User Manual
PulsePen
- V. 5.0_b
