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Maintenance and Cleaning 

No particular periodic maintenance or calibration operations are required on the instrument. 

 In the case of prolonged non-use, remove batteries.  

 Before use, the metallic disc of the wTn1 probe, the patient cable CV010 and the probe’s case must be 

cleaned, using a clean, dry cloth or dampened with a small quantity of alcohol.  

 Be very careful to keep the alcohol or other liquids from penetrating into the wTn1 probe or into the 

other units because this could cause serious problems, irreparably damaging internal parts.   

 The CV010 Ecg cables are thin and flexible in order to be easily handled. One must avoid pulling or 

bending them at sharp angle so as not to damage them. 

Warnings and Precautions for Use 

 It is very important to read the following items before the use of the device. Improper use may cause 

very severe consequences. 

• This equipment is intended to be used only by medical/paramedical personnel in medical environment. 
• Do  not  use  the  equipment  in  operating  room,  or  in  any  case  where  there  are  inflammable  gases/

substances. 

• Do not use the equipment for invasive or intra-cardiac applications or at direct contact with internal body 

parts. 

• Data elaboration must be performed by the doctor through dedicated software. 
• Do not sterilize neither in autoclave nor with liquid substances. 
• Avoid mechanical shocks to the pressure plunger of the 

wTn1 

probe, like collisions or falls. 

• Regularly clean the disc of the 

wTn1

 probe, the terminals of the patient cable 

CV010

 and the case after 

each use, as indicated in the “Maintenance and Cleaning”. 

• Keep the units 

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 it to sprays. Absolutely 

never use Gel on the pressure sensor of 

wTn1

• Do not open the device for any kind of maintenance work; in the case of malfunction of the device, contact 

DiaTecne s.r.l. 

• 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. 

• Do not make changes of any kind to the device and never use accessories other than those provided. 
• Keep the tonometric probe 

wTn1

 and patient cable 

CV010 

terminals away from electrical outlets/sockets 

and surfaces where there may be potentially dangerous voltages. 

• Use a battery-powered (portable) computer or, alternatively, an AC-powered computer, compliant with the 

current medical regulations. 

 

 

 

 

• Use the device at a safe distance from sources of electromagnetic disturbance such as cordless telephones 

operating  at  radio  frequency/cellular  phones,  Bluetooth  and  WiFi  devices  or  other  equipments  emitting 
high frequency electromagnetic waves.  

• During examination, keep the 

wEc1

 unit at a distance of at least 20 cm away from both the patient and 

operator,  limit  the  duration  of  contact  of  the 

wTn1

  unit  with  both  patient  and  operator  for  the  time 

!

8

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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