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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. 5.2...
- Page 2 20. Usage Problems and Solutions 21. Mutual interference with other systems 22. Technical Specifications 23. General Precautions and Warnings 24. Recorded values of Electromagnetic Compatibility 25. Useful Life 26. Disposal 27. Symbols and Abbreviations 28. Labels 29. Various User Manual PulsePen - V. 5.2...
- Page 3 1. Description The Medical Device (MD) object of this technical documentation is the "PulsePen", in the two available configurations as defined below. 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 non-invasive method of "applanation tonometry".
- Page 4 PulsePen software is less than 10%. The PulsePen must be connected to a computer, provided by the user, in order to view, record and analyze the signals. The connection to the computer is galvanically isolated as it is made via radio through the wRs1 unit.
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Page 5: Principle Of Operation
Consequently, it is necessary to carry out a calibration at each examination using a traditional User Manual PulsePen - V. 5.2... - Page 6 R wave of the 'ECG (R-fW). The difference between R-fW and R-cW represents the DeltaT which is the "transit time" of the pressure wave in the selected segment. This type of PWV determination can be obtained with both WPP001-ET and WPP001-ETT because both configurations have the wEc1 ECG User Manual PulsePen - V. 5.2...
- Page 7 Other similar situations are the presence of pacemakers, atrial fibrillation, branch block, .. 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...
- Page 8 PWV increases with age. This is due to the change of composition of the arterial walls with a reduction of the ratio between elastin fibers and collagen fibers. User Manual PulsePen - V. 5.2...
- Page 9 There is no indication for the simultaneous recording of pressure curves in the carotid artery and, even if it is not the correct use of the instrument, this potential risk condition has been clearly indicated in this manual. User Manual PulsePen - V. 5.2...
- Page 10 11. 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 11 (up to 10 ECG/ tonometric complexes) and long-term signal records (up tp 24 hours but in this case without signal analysis). 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 12 Direct contact of the electrodes with synthetic clothing which could cause disturbance must be avoided, in which case it is advisable to interpose a sheet of paper. User Manual PulsePen - V. 5.2...
- Page 13 - Sensor1 (1 beep when switched on) + wTn1 set as Sensor1 (1 beep when switched on): ✘ Both wTn1 modules set as Sensor1 (1 beep when switched on) or as Sensor2 (2 beeps when switched on): ✘ User Manual PulsePen - V. 5.2...
- Page 14 “subtractive method” - see the relevant paragraph. At this point a new panel will show the parameters automatically calculated by the software. fig. 3 Refer to the online Help for all the additional features available. User Manual PulsePen - V. 5.2...
- Page 15 Determination of the arterial stiffness: Immediately after saving the exam in progress or by recalling an exam from the patient database, the calculated parameters are automatically presented, including PWV (Pulse Wave Velocity) which represents the arterial stiffness index. User Manual PulsePen - V. 5.2...
- Page 16 10 minutes to preserve the battery: in fact, the stay in standby presupposes no acquisition of signals during this interval and therefore the inactivity of the same Sensors. The wEc1 and wTn1 units do not transmit radio frequency until the connection with wRs1 is established. User Manual PulsePen - V. 5.2...
- Page 17 18. Placement The PulsePen must be kept in a closed environment - enclosed by walls while maintaining the environmental operating conditions (temperature, humidity, pressure) as reported in the technical characteristics in this manual. The degree of protection is IP20. The use of explosive gases, flammable substances or anesthetic gases is not allowed.
- Page 18 • 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.
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Page 19: Technical Specifications
Operating mode signaling Power supply < 50 mA @ 5V, powered by the USB connector of the P.C. Weight 12 g Dimensions [mm] 67 (L) x 25 (W) x 11 (H) Material Bayblend FR3010 User Manual PulsePen - V. 5.2... - Page 20 • “Alkaline” identifies the internal chemical structure. It is a primary battery, i.e. non-rechargeable. • “1.5 V” indicates the nominal no-load voltage of the fresh battery. • "IEC LR03" is the IEC coding equivalent to "AAA - Alkaline" User Manual PulsePen - V. 5.2...
- Page 21 ECG Electrodes: The wEc1 unit and the CV010 cable set of the PulsePen MD must be used in combination with "disposable" ECG electrodes in order to perform their function. These electrodes must be provided by the user. The ECG electrodes are in turn a Medical Device and to work properly with the wEc1 unit, they must meet...
- Page 22 Computer: The software that is part of the MD PulsePen must be installed on a computer provided by the user, whose characteristics are listed below, and equipped with at least one USB port where the wRs1 unit can be inserted during operation.
- Page 23 • Do not immerse any part of the device in water or other substances or subject it to splashes. Never use Gel on the sensor of wTn1. • Do not carry out maintenance on the device that involves opening it; in case of device malfunction contact DiaTecne s.r.l. User Manual PulsePen - V. 5.2...
- Page 24 • Use the device only for the purposes specified in this manual. • DiaTecne s.r.l. cannot be held responsible for damage caused to people, animals or things in the event that the user does not scrupulously follow the instructions in this manual.
- Page 25 24. 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 26 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 27 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 28 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.
- Page 29 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 off as indicated in this Manual.
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Page 30: Symbols And Abbreviations
The device incorporates radio frequency transmitters (not ionizing radiations) The product at the end of its useful life must be disposed off as electronic waste, separately from other waste Battery symbol. Type “AAA - Alkaline 1.5V - IEC LR03“ Pay Attention User Manual PulsePen - V. 5.2... - Page 31 • Print both sides, fold and bind as shown: With a view to continuous product improvement, DiaTecne s.r.l. reserves the right to make any changes it deems necessary, both to this manual and to the PulsePen device, without prior notice, notifying the competent authorities only.
- Page 32 PulsePen ® is a trademark of DiaTecne s.r.l. - Italia ___________ Copyright © 2014 - 2023 - V. 5.2 Eng / Feb 2023 User Manual PulsePen - V. 5.2...
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