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DiaTecne PulsePen WPP001-ET User Manual

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PulsePen device is manufactured by DiaTecne s.r.l.
⚠ This manual is an integral part of the product and must be kept together with it.
Composition
The PulsePen device, code WPP001-ET / WPP001-ETT includes the following parts:
• Tonometric unit, code wTn1, for the capture of a pressure signal with the non-invasive "applanation
tonometry" method. 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 one electrocardiographic lead capture.
• 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.
• 2 ECG cables with crocodile terminals , code CV010.
Generic accessories:
• USB memory with Software, Tutorial, this manual in pdf format.
• 2 or 3 Alkaline batteries 1.5 V - AAA - IEC LR03, depending on the model.
• Guarantee Certificate.
• Carrying Bag
WPP001-ET:
Note: the PulsePen works with a computer, supplied by the user, in order to display and save signals.
The computer connection is galvanically isolated due to the radio link with the wRs1 unit. Furthermore,
during patient examination, it is necessary to input the systolic and diastolic pressure values measured with
a validated sphygmomanometer supplied by the user.

User Manual
PulsePen
WPP001-ETT:
! 1
!
User Manual PulsePen - V. 4.6

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Summary of Contents for DiaTecne PulsePen WPP001-ET

  • Page 1 User Manual PulsePen PulsePen device is manufactured by DiaTecne s.r.l. ⚠ This manual is an integral part of the product and must be kept together with it. Composition The PulsePen device, code WPP001-ET / WPP001-ETT includes the following parts: • Tonometric unit, code wTn1, for the capture of a pressure signal with the non-invasive “applanation tonometry”...
  • Page 2 Tonometric unit: wTn1 1. On / Off button: keep pressed for about 1 sec. 2. Cap for battery replacement: pull away from the tonometer’s body. Push the old battery toward you from the hole of the opposite side of the opening. Gently insert the new fresh battery following the polarity specified on the label.
  • Page 3 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.

  • Page 4: Technical Specifications

    It includes patient database management and works on signals up to 10 ECG/ tonometric complexes. The patient report generated by this software must always be verified by medical staff who is familiar with tonometry. DiaTecne s.r.l. is not responsible for the final diagnosis.
  • Page 5 In order to install the Software contained in the included USB memory, proceed as described below avoiding insertion of the wRS1 unit in the USB port before completion of operations. 1. In the “WPulsePen x_x_x Install” folder, launch Setup.exe to install the WPulsePen software and the wRs1 receiver USB driver.
  • Page 6 8. Battery gauge for wEc1 and wTn1: change the battery when less than 10%. 9. Icon representing the ECG (QRS) or Tonometric (pressure wave) signals depending on active sensor. 10. Data coming from wRs1 to be processed: a short bar means better condition compared to a long bar (depends on computer speed, other running programs, …).
  • Page 7 The correct use of wEc1 and wTn1 units is based on the assumption that one of them must be set as Sensor1 and the other as Sensor2: wEc1 is always set as Sensor1 and cannot be modified while wTn1 can be set in the two different ways: pls refer to the software online Help for the operating instructions.

  • Page 8: Maintenance And Cleaning

    • In the case of any abrasion, sheath damage, or any kind of defects appears in the patient cable CV010, immediately suspend use of the device and contact Diatecne s.r.l. for repair/replacement. • Do not use the device if breakage occurs to any part, do not try to repair it but contact Diatecne s.r.l. for repair/replacement.
  • Page 9 • Use the equipment only for the purposes stated in this manual. • DiaTecne s.r.l. cannot be held responsible for any damages caused to persons, animals, or things if the user does not scrupulously follow the indications given in this manual.
  • Page 10 Tab. 1: 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. Emissions tests Compliance Electromagnetic Environment RF Emissions Group 1 The PulsePen uses RF energy only for its internal function.
  • Page 11 Power frequency 30 A/m IEC 60601-1-2 Power frequency magnetic fields should be at (50/60 Hz) Test level levels characteristic of a typical location in a Magnetic Field typical commercial or hospital environment. IEC 61000-4-8 Tab. 3: 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.
  • Page 12 Tab. 4: Immunity to proximity fields from RF wireless communication equipments 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 13: Notes On Recycling

    Notes on recycling DiaTecne s.r.l. is sensitive to environmental issues related to the production of waste. The user that wishes to discard the device at the end of its service life, should contact DiaTecne s.r.l. and will receive appropriate instructions.
  • Page 14 Symbols and Abbreviations Manufacturer information It’s mandatory to read the User Manual before using the apparatus ⚠ Warning: pay attention Class II device Applied parts are of type BF The device incorporates radio frequency transmitters (not ionizing radiations) The product must be discarded as electronic waste, separately from other waste, at the end of its service life SN: each unit is identified with a serial number.
  • Page 15 • select options “booklet”, “both sides”, “left binding ”, “page size A4", “vertical orientation” • print both sides, fold and bind as shown: Note: with the purpose of a continuous product improvement, Diatecne s.r.l. reserves the right to make any changes it deems necessary, without notice, both to this manual and to the PulsePen device, communicating these changes only to the competent bodies.
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  • Page 16 PulsePen PulsePen Ref: WPP001-ET Ref: WPP001-ETT SN: 0051 0051 is a trademark of DiaTecne s.r.l. - Italy ______ Copyright © 2014 - 2019 - V. 4.6 Eng / Jan. 2019 PulsePen ® ! 1 6 User Manual PulsePen - V. 4.6...

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