DiaTecne PulsePen User Manual Download Page 1

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User Manual

PulsePen

PulsePen is a device manufactured by DiaTecne s.r.l.

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This manual is an integral part of the product and must be kept together with it.

User Manual

PulsePen

- V. 5.0_b

Summary of Contents for 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 1 User Manual PulsePen V 5 0_b ...

Page 2: ... wRs1 7 Technical Specifications 8 Computer Connection 9 Software Installation 9 Use of the device 10 Maintenance 13 General Precautions and Warnings 13 Mutual interference with other systems 15 Recorded values of Electromagnetic Compatibility 16 Usage Problems and Solutions 20 Useful life 21 Note on recycling 21 Symbols and Abbreviations 22 Labels 23 Various 23 2 User Manual PulsePen V 5 0_b ...

Page 3: ...ntly proceed with the calculation of the related parameters including the pulse wave velocity PWV a parameter related to the stiffness of the arteries The medical device is available in two different configurations WPP001 ET and WPP001 ETT the characteristics of which are shown below 1 Tonometric unit wTn1 2 Tonometric units wTn1 1 ECG unit wEc1 1 ECG unit wEc1 1 Signal Reicever unit wRs1 1 Signal...

Page 4: ...h unit individually does not provide any useful results The PulsePen must be connected to a computer provided by the user in order to view record and analyze signals The connection to the computer is galvanically isolated being made via radio through the wRs1 unit During the patient examination it is necessary to input the systolic and diastolic pressure values measured with a validated sphygmoman...

Page 5: ...ure wave not of the blood from the center to the periphery and is therefore obtained by dividing the distance between two examined points for example Carotid and Femoral by the related sphygmic wave transit time DeltaT PWV Distance B A DeltaT PWV it is conventionally expressed in m s meters second The transit time of the sphygmic wave can be assessed in two different ways I Using the wEc1 unit tog...

Page 6: ...l parameters by the software 6 User Manual PulsePen V 5 0_b 1 Direct Method The direct distance between the Carotid C and the Peripheral Artery P_A F Femoral in the example is measured The result is automatically multiplied by 0 8 by the software according to the accredited guidelines Measurement of distances for the Femoral Tibial Dorsalis Pedis Artery A tape measure is used to measure the distan...

Page 7: ...wEc1 1 On Off button keep pressed for about 1 sec 2 Cap for battery replacement pull away from the unit s body Remove the old battery Insert the new battery without ever forcing and respecting the polarity indicated by the appropriate label Put the cap back in its seat by pushing it until clicks 3 Patient cable sockets Signal Receiver unit wRs1 1 Operating mode signaling LED This LED blinks green ...

Page 8: ...060 hPA Resolution 0 004 mmHg Dynamic range 220 mmHg Data transmission Wireless ISM 2 4 GHz Acoustic Signals Power on off Power supply Alkaline Battery AAA 1 5V IEC LR03 indicative autonomy 50 hours 600 exams Max force to the sensor 4 5 Kg Vibrations 20 g 10 Hz 2 KHz sinusoidal Shock 150 g Weight 25 g without battery Dimensions mm 114 L x 25 W x 20 H Resolution 0 15 μV Dynamic range 5 mV Data tran...

Page 9: ...g displaying and saving long term signals It does not perform signal analysis or patient database management To install the software included in the supplied USB drive proceed by following the instructions given in the readme txt file both the WPulsePen and WPulsePen_LP software will be installed with their icons on the desktop and the USB drivers for the wRs1 receiver Refer to Usage Problems and ...

Page 10: ...ol turns yellow in standby i e when the Freeze is active or in situations other than that of real time acquisition and display of signals 12 Sensor1 corresponds to the red trace ECG or Tonometer while Sensor2 corresponds to the blue trace Tonometer only Preparation for the exam A Start the WPulsePen software B Insert the wRS1 receiver into a USB port and wait for the device to be recognized fig 1 ...

Page 11: ...ed as Sensor1 red trace while wTn1 programmed as Sensor2 blue trace produces two beeps Permitted Sensor Combinations The correct use of modules wEc1 and wTn1 is based on the assumption that one of the two is set as Sensor1 and the other as Sensor2 wEc1 is always set as Sensor1 and cannot be changed while wTn1 can be set in two ways refer to the Help online of the software for operating instruction...

Page 12: ...orial With the PulsePenHolder accessory stable signals are obtained without the operator s tremor Once a series of overlapping complexes has been obtained indicated by the green color of the traffic light at the top of the screen see the software Help the operator can interrupt the acquisition by lifting the wTn1 Sensor2 tonometer By pressing the icon with the disk symbol or the Enter key the last...

Page 13: ...connection with the wRs1 unit for more than 30 seconds for example if the WPulsePen software is not running or the distance between the units is excessive The Sensors also turn off automatically if they remain in standby for more than 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 Sensors...

Page 14: ... for repair replacement Do not make any modifications of any kind to the device and do not use any accessories other than those supplied Keep the wTn1 tonometric probe and the CV010 patient cable terminals away from power outlets and surfaces where potentially dangerous voltages are present Use a battery powered computer laptop or alternatively a mains powered computer that complies with current m...

Page 15: ... and magnetic disturbances normally present similarly the PulsePen produces a reduced quantity of disturbances towards the other devices However it cannot be excluded that in particular situations there may be operating anomalies also in the form of signal alteration in this case it is necessary to remove all potential sources of disturbance when possible or move to a more appropriate location Con...

Page 16: ...CISPR 11 Group 1 The PulsePen uses RF energy only for its internal function Therefore the RF emission is very low and not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B The PulsePen is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies build...

Page 17: ... 0 5KV 1KV differential mode 0 5KV 1KV 2KV common mode Not Applicable Mains power quality should be that of a typical commercial or hospital environment Voltage dips short Interruptions and Voltage variations on power supply input lines IEC 61000 4 11 Voltage dips 0 UT 0 5 cycles 0 45 90 135 180 225 270 315 0 UT 1 cycle 70 UT 25 30 cycles Single phase 0 Voltage interruptions 0 UT 250 300 cycles No...

Page 18: ... 2 7 GHz 80 AM at 1kHz Portable and mobile RF communications equipment should be used no closer to any part of the PulsePen including cables than the minimum recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P 150kHz to 80 MHz d 1 2 P 80MHz to 800 MHz d 2 3 P 800MHz to 2 5GHz Where P is the maximum outp...

Page 19: ...equency of transmitter m meters from 150 kHz to 80 MHz d 1 2 P from 80 MHz to 800 MHz d 1 2 P from 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at the maximum output power not listed above the recommended separation distance d in meters m can be estimated from the equation applicable to the frequency of the trans...

Page 20: ...the problem has not been solved with the previous suggestions fig 1 icon 6 green and icon 5 red the wRs1 unit is recognized correctly but the firmware in it installed is not compatible with the version of the software running on your computer Update firmware and or software to the latest version Contact DiaTecne s r l in case of doubts or problems fig 1 icons 5 e 6 both green but icons 12 red and ...

Page 21: ...eclared as a precaution equal to 10 years from the date of manufacture Note on recycling DiaTecne s r l is sensitive to environmental issues related to the production of waste The user who will have to get rid of this device once it has reached the end of life must contact DiaTecne s r l and follow the instructions he will receive Adequate separate collection for subsequent recycling treatment and...

Page 22: ...tification symbol of the medical device configuration Product Code Serial number identification symbol Insulation Class II Applied parts are of type BF The device incorporates radio frequency transmitters not ionizing radiations The product at the end of its useful life must be collected as electronic waste separately from other waste 22 User Manual PulsePen V 5 0_b ...

Page 23: ...onal copies of this document can be printed as follows Open the pdf file of this manual with Adobe Reader or similar Select the options booklet both sides left binding A4 paper size portrait orientation 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 PulsePe...

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