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Technical Specifications 

Classification 

Class IIa medical device according to the Directive 93/42/EEC 
 

Computer Connection 

WPP001-ET

 and 

WPP001-ETT

 devices connect to computer by inserting  

wRS1

 unit into one USB 1.0 / 2.0 - type A port: 

 

 

 

Software Installation 

The 

PulsePen

 system includes two softwares (x.x.x means the version): 

• WPulsePen  (WPP001-ETT-  x.x.x):  full-featured  software  for  capture,  display,  storage  and  analysis  of 

signals and calculation of significant parameters. 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.  

 

• WPulsePen-LP (WPP001 LP-ETT- x.x.x): software for capture, display and storage of long term signals. 

It does not analyze signals or manage patient database.  

wTn1: 

On / Off button 
Resolution: 0.004 mmHg 
Dynamic range: 

 220 mmHg 

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 
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 

µ

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 
Vibrations: 

 20 g @ 10 Hz - 2 KHz sinusoidal 

Weight: 36g without battery 
Dimensions [mm]: 49 (L) x 75 (W) x 21 (H) 

wRs1: 

P.C. Connection : USB 1.0 / 2.0 - type A 
Power supply: powered by P.C. connector 
Led: operating mode signaling  
Data Rx / Tx: radio link, ISM 2.4 GHz 
Weight: 12g  
Dimensions [mm]: 67 (L) x 25 (W) x 11 (H)

CV010: 

Universal terminals for tab, clip, press-stud electrodes. 
Connectors DIN 42802 compliant

General: 

Approximate autonomy (wEc1/wTn1): 50h 
Operating ambient temperature: 

+

̊

C to 

+

40 

̊

Transport and storage ambient temperature: 

-

25 

̊

C to 

+

70 

̊

Relative humidity: 30 - 80% non condensing 
Atmospheric pressure: 860 - 1060 hPa

Computer: 

Processor clock frequency 

 2GHz 

Ram memory 

 2 GB 

Free Hard Disk space 

 200 MB 

Graphical resolution 

 1280 x 800, 256 colors 

Operating system: Windows

®

 XP SP2/3, Vista, 7, 8, 10 - 

32/64 bit 
Free USB ports: 1 
IEC 60950-1 compliant

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4

User Manual   

PulsePen 

- V. 4.6

Содержание PulsePen WPP001-ET

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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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