Related Manuals for DiaTecne PulsePen
Summary of Contents for DiaTecne PulsePen
- Page 1 User Manual PulsePen PulsePen is a device manufactured by DiaTecne s.r.l. ⚠ This manual is an integral part of the product and must be kept together with it. User Manual PulsePen - V. 5.0_b...
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Page 2: Table Of Contents
Software Installation Use of the device Maintenance General Precautions and Warnings Mutual interference with other systems Recorded values of Electromagnetic Compatibility Usage Problems and Solutions Useful life Note on recycling Symbols and Abbreviations Labels Various User Manual PulsePen - V. 5.0_b... -
Page 3: Description
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. The PulsePen must be used by qualified medical / paramedical personnel who are familiar with the “Applanation Tonometry” method, in medical clinics or research centers. -
Page 4: Intended Use
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. -
Page 5: Applanation Arterial Tonometry
As for the distance measurement, refer to the next paragraph. ⚠ The ECG lead captured must only be used for the PWV estimation and must never be used for any kind of diagnosis on the patient! User Manual PulsePen - V. 5.0_b... -
Page 6: Distance Measurement
Distance Measurement A tape measure is used to measure the distance between the landmarks: this can be estimated mainly in two ways, both supported by the PulsePen Software: 1) Direct Method: The direct distance between the Carotid (C) and the Peripheral Artery (P_A), (F - Femoral in the example) is measured. -
Page 7: Tonometric Unit - Wtn1
Signal Receiver unit - wRs1 1. Operating mode signaling LED. This LED blinks green when the PulsePen software is not running or if the USB driver is not properly installed. The LED is solid green during normal operations while it is red during reprogramming / updating. -
Page 8: Technical Specifications
Alkaline Battery AAA - 1.5V IEC LR03 (indicative autonomy ≥ 50 h / ≥ 600 exams) Vibrazioni ≤ 20 g @ 10 Hz - 2 KHz sinusoidal Shock ≤ 150 g Weight 36 g without battery Dimensions [mm] 49 (L) x 75 (W) x 21 (H) User Manual PulsePen - V. 5.0_b... -
Page 9: Computer Connection
10 ECG/ tonometric complexes. It’s also possible to make long-term signal records (see the online Help). This software allows for the generation of a patient report, the content of which must always be verified by a physician expert in the method. DiaTecne s.r.l. takes no responsibility for the final diagnosis. -
Page 10: Use Of The Device
"H". E. Using "fresh" gel-embedded disposable Ag / AgCl ECG electrodes, for crocodile clips, place them in the following way: • Red: right subclavian region • Black: left subcostal region fig. 2 User Manual PulsePen - V. 5.0_b... - Page 11 WPP001-ETT system: ✔ Wrong Sensor combinations wEc1 - Sensor1 (1 beep when switched on) + wTn1 set as Sensor1 (1 beep when switched on): ✘ User Manual PulsePen - V. 5.0_b...
- Page 12 “subtractive method” - see the relevant paragraph. At this point a new panel will show the parameters automatically calculated by the fig. 3 software. Refer to the online Help for all the additional features available. User Manual PulsePen - V. 5.0_b...
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Page 13: Maintenance
• Pay close attention so that alcohol, other liquids and dust do not penetrate inside the wTn1 probe or other units because this could cause serious problems, irreparably damaging the internal parts. User Manual PulsePen - V. 5.0_b... - Page 14 DiaTecne s.r.l. • If there are any abrasions, breaks in the sheath or any defect in the CV010 patient cable, use of the device must be immediately suspended and the defective part sent to DiaTecne s.r.l. for repair / replacement.
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Page 15: Mutual Interference With Other Systems
• Mobile radio frequency communication devices can disturb electromedical devices. • For the correct functioning of the PulsePen device, the wEc1 and wTn1 units must be within a radius of 3 meters from the wRs1 unit. Greater distances may cause incorrect operation. -
Page 16: Recorded Values Of Electromagnetic Compatibility
Recorded values of Electromagnetic Compatibility Tab. 1: Reference and Declaration of Manufacturer - Electromagnetic Emissions The PulsePen is suitable for use in the specified electromagnetic environment. The user of the PulsePen should assure that it is used in an electromagnetic environment as described below. - Page 17 Tab. 2: Reference and Declaration of Manufacturer - Electromagnetic Immunity The PulsePen is suitable for use in the specified electromagnetic environment. The user of the PulsePen should assure that it is used in an electromagnetic environment as described below. Immunity...
- Page 18 Tab. 3: Reference and Declaration of Manufacturer - Electromagnetic Immunity The PulsePen is suitable for use in the specified electromagnetic environment. The user of the PulsePen should assure that it is used in an electromagnetic environment as described below. Immunity...
- Page 19 Tab. 4: Recommended separation distances between portable / mobile RF communications equipment and the PulsePen The PulsePen is intended to be used in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the PulsePen can help prevent electromagnetic interference by maintaining a minimum distance between portable / mobile RF communication equipments (transmitters) and the PulsePen as recommended below, according to the maximum output power of the communications equipment.
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Page 20: Usage Problems And Solutions
• fig.1 - icon 6 green and icon 5 red: the wRs1 unit is recognized correctly but the firmware in it installed is not compatible with the version of the software running on your computer. Update firmware and / or software to the latest version. Contact DiaTecne s.r.l. in case of doubts or problems. -
Page 21: Useful Life
The declared useful life is 5 years from the manufacturing date. At the end of its useful life, a check may be carried out by DiaTecne s.r.l., for the extension of the same, otherwise the device must be disposed of as indicated in this Manual. -
Page 22: Symbols And Abbreviations
Applied parts are of type BF The device incorporates radio frequency transmitters (not ionizing radiations) The product at the end of its useful life must be collected as electronic waste, separately from other waste User Manual PulsePen - V. 5.0_b... -
Page 23: Labels
Name Serial Number In the above example it is the PulsePen device, code WPP001-ETT, serial number 22001, consisting of the units wRs1, wEc1, 2 x wTn1. Each unit, in order to be identified, also has a label showing its code (wRs1, wEc1, wTn1) together with the serial number. - Page 24 PulsePen ® is a trademark of DiaTecne s.r.l. - Italy ___________ Copyright © 2014 - 2021 - V. 5.0_b Eng / Nov 2021 User Manual PulsePen - V. 5.0_b...
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