background image

!

 

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, …). 

11. The  positive  battery  terminal  becomes  yellow  during  standby,  i.e.  when  “Freeze”  is  active  or  during 

situations different from run-time signals capture and display. 

12. Sensor1 corresponds to the red signal (Ecg or Tonometer) while Sensor2 corresponds to the blue signal 

(only Tonometer). 

Functions described below are related to the WPulsePen Sw, of which the WPulsePen_LP Sw is a simplified 
version.  
Select  the  “New  examination”  icon  and  insert  Patient  information  including  name,  surname,  birth  date, 
gender: at this point the keys corresponding to the Arteries will be enabled. Choosing one of them, a new 
window will be opened. Place the 

wTn1

 probe/s on the region of interest: captured signals will be displayed 

on  the  computer  screen. An  automatic  freeze  function  stops  the  signal  capture  in  case  of  no  activity  on 
Sensor2 (blue trace). 

In order to obtain good quality tonometric signals, the patient must be lying down on the bed. The operator 
must keep his/her elbow firmly lying on a stable surface and hold the 

wTn1

 probe as indicated in the figure 

below  with  his/her  fingers  touching  the  patient’s  skin,  reducing  in  such  way  tremors. The  probe  must  be 
kept perpendicular to the skin and not tilted. 
   
Once  a  good  quality  signal  has  been  captured,  when  the  traffic  light  on  the  top-
central screen shows green (more info from software Help), the operator can stop the 
capture  lifting  out  the  Sensor2.  The  last  10  cardiac  complexes  are  saved  and 
automatically  analyzed  by  pressing  the  icon  with  the  diskette  symbol  or  the  Enter 
key. At  this  point,  a  new  window  will  be  displayed  in  order  to  insert  systolic  and 
diastolic  pressures  measured  immediately  before  or  afterward  by  an  external 
sphygmomanometer. In case of peripheral artery, the operator should use, in addition, 
a  mea

sur

in

g  tape  to  obtain  three  distances,  in  millimeters,  between:  Carotid-

Peripheral  Artery,  Carotid-Suprasternal  Notch  and  Suprasternal  Notch-Peripheral 
Artery. In this way during the PWV assessment it’s possible to apply both methods 
for the distance evaluation suggested by the international guidelines, i.e. the “direct” 
method (direct distance multiplied by 0.8) and the “subtractive” one. 

WPulsePen  software  manages  the  patient  DataBase  “WPPArch.dbd”  located  in  the  “WPulsePen_Data” 
folder.  Selecting  the  “Patient Archive”  icon,  all  patients  are  shown  with  the  related  examinations  and  it’s 
possible to choose which one to display on the screen. 
WPulsePen_LP software saves single examinations in text format files (*.txt) in the subfolder “ASCII” of 
the “WPulsePen_Data” folder. 

The “Setup” icon allows to select language, date format, device programming, …, while the “Help” icon 
opens  a  window  with  the  software  instructions  (pls  refer  to  this  online  Help  for  updated  operating 
instructions). 
Activation of 

wEc1

 and 

wTn1

 units is shown on the computer screen (points 7, 8, 9, 11) of the software 

menu image. 
In order to switch off the Sensors 

wEc1

 and 

wTn1

, keep pressed the on/off key until the acoustic signal 

(about 1 sec). The 

wEc1

 and 

wTn1

 units automatically switch off when closing the program or when there 

is  no  connection  with  the 

wRs1

  unit  for  more  than  30  sec:  e.g.  when  the  software  WPulsePen  / 

WPulsePen_LP is not executing or distance between them is too long.  
The 

wEc1

  and 

wTn1

  units  don’t  transmit  radio-frequency  until  a  connection  with  the 

wRs1

  unit  was 

established. 

!

6

User Manual   

PulsePen 

- V. 4.6

Summary of Contents for PulsePen WPP001-ET

Page 1: ...1 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 WPP001 ETT Note the PulsePen works wi...

Page 2: ... unit wEc1 1 On Off button keep pressed for about 1 sec 2 Cap for battery replacement pull away from the unit s body Extract the old battery Gently insert the new fresh battery following the polarity specified on the label Put the cap on and push it until snap occurs 3 Patient cable sockets Signal Receiver unit wRs1 1 Led indicates the operating mode This Led blinks green when the PulsePen softwar...

Page 3: ...essure 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 velocit...

Page 4: ...ching Power supply Alkaline AAA 1 5V IEC LR03 battery Max applicable sensor force 4 5 Kg Vibrations 20 g 10 Hz 2 KHz sinusoidal Shock 150 g Weight 25g without battery Dimensions mm 114 L x 25 W x 20 H wEc1 On Off button Resolution 0 15 µV Dynamic range 5 mV Capture 16 bit 1000 S sec Data Rx Tx radio link ISM 2 4 GHz Acoustic signal On Off switching Power supply Alkaline AAA 1 5V IEC LR03 battery V...

Page 5: ...ion wastes This device requires fresh disposable ECG electrodes Ag AgCl incorporated with gel that can be used for crocodile clips Place them as indicated in the figure Red subclavian right region Black subcostal left region The suggested position can be modified at the operator s discretion when ECG signals are too low inverted or altered for example in case of pathologies Direct electrodes conta...

Page 6: ...complexes are saved and automatically analyzed by pressing the icon with the diskette symbol or the Enter key At this point a new window will be displayed in order to insert systolic and diastolic pressures measured immediately before or afterward by an external sphygmomanometer In case of peripheral artery the operator should use in addition a measuring tape to obtain three distances in millimete...

Page 7: ...as Sensor 2 2 beeps at switch on These are the factory settings for the WPP001 ET system and for the wTn1 unit with black ring of the WPP001 ETT system wTn1 set as Sensor 1 1 beep at switch on wTn1 set as Sensor 2 2 beeps at switch on These are the factory settings for the wTn1 units respectively with red and black ring of the WPP001 ETT system Wrong Combinations wEc1 Sensor 1 1 beep at switch on ...

Page 8: ...its wTn1 and wEc1 with its patient cable at a distance of no less than 1 5 meters from the computer and the same computer at no less than 1 5 meters from the patient Avoid touching simultaneously any part of the computer including the wRs1 unit and one or both of the wEc1 including the patient cable and the wTn1 units Do not immerse any part of the device into water or other substances or expose i...

Page 9: ...ents The PulsePen device was designed to be immune to electrical electromagnetic electrostatic and magnetic disturbances that are present in normal environment likewise the PulsePen produces a small amount of disturbances for other equipments It cannot however be excluded that in particular situations some functional anomalies could appear also in the form of signal alteration in this case it is n...

Page 10: ... an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Test level Compliance level Electromagnetic Environment Electrostatic Discharge ESD IEC 61000 4 2 8 KV contact 15 KV air IEC 60601 1 2 Test level Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast Transient Burst IEC 61...

Page 11: ... an electromagnetic environment as described below Immunity Test IEC 60601 1 2 Test level Compliance level Electromagnetic Environment Radiated RF IEC 61000 4 3 10V m 80 MHz 2 7 GHz 10V m Levels characteristic of a typical location in a typical commercial or hospital environment Conducted RF I C 61000 4 6 3V 150 KHz 80 MHz 6V ISM bands and amateur radio 150 KHz 80 MHz Not Applicable Levels charact...

Page 12: ...ecommended below according to the maximum output power of the communications equipment Test Frequency MHz Band MHz Max Power W Distance m Immunity Test Level V m 385 380 390 1 8 0 3 27 450 430 470 2 0 3 28 710 745 780 704 787 0 2 0 3 9 810 870 930 800 960 2 0 3 28 1720 1845 1970 1700 1990 2 0 3 28 2450 2400 2570 2 0 3 28 5240 5500 5785 5100 5800 0 2 0 3 9 Minimum separation distances for higher im...

Page 13: ... the system is not in Freeze mode due to absence of tonometric signal on the wTn1 probe Gently touch the pressure sensor with fingers In the Setup panel check if the radio channel of wRs1 wEc1 wTn1 units is the same Pls refer to the software on line Help for more details If the problems remain after the above attempts or if you have doubts regarding the function of the equipment please contact Dia...

Page 14: ...ng 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 14 User Manual PulsePen V 4 6 ...

Page 15: ...ce communicating these changes only to the competent bodies Composition 1 Tonometric unit wTn1 2 ECG unit wEc1 2 Signal Receiver unit wRs1 2 Intended Use 3 Technical Specifications 4 Classification 4 Computer Connection 4 Software Installation 4 Use of the device 5 Maintenance and Cleaning 8 Warnings and Precautions for Use 8 Reciprocal Interferences with other Equipments 9 Tab 1 Electromagnetic E...

Page 16: ...14 2019 V 4 6 Eng Jan 2019 16 User Manual PulsePen V 4 6 DiaTecne s r l Via G di Vittorio 190 20097 S Donato Milanese Milano Italia PulsePen Ref WPP001 ET SN 0051 DiaTecne s r l Via G di Vittorio 190 20097 S Donato Milanese Milano Italia PulsePen Ref WPP001 ETT SN 0051 ...

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