PulsePen User Manual
Contents
1. Table 4 Recommended separation distances between portable and mobile RF communications equipment and the Pulse Pest The Pulse Pen is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Pulse Pes can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitter and the Pulse Pen as recommended below according to the maximum output power of the communications equipment Rated maximum output power of the Separation distance according to frequency of transmitter transmitter m w 150 KHz 80 MHz 80 MHz 800 MHz 800 MHz 2 5 GHz d 12VP d 1 2vP d 2 3 VP 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 transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Notes at 80MHz and 800MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 11 Problems in use and solutions THE DEVICE DOES NOT TURN ON NO ACOUSTIC SIGNALING Check to see that the battery is of the required type2. User Manual Pulse Pen device is manufactured by DiaTecne s r l A This manual is an integral part of the product and must be kept together with it Composition The Pulse Pen device cod WPP001 ET WPP001 ETT includes the following parts Tonometric Unit Pulse Pes code wTn1 for the capture of a pressure signal with the non invasive applanation tonometry method and radio transmission to the wRs Unit 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 cod wEc1 for one ECG lead capture and radio transmission to the wRs Unit Signal receiver Unit cod wRs1 to be inserted in a Usb port of the computer for synchronization and signals collection 2 ECG cables with crocodile terminals cod CV010 Generic accessories Usb memory with Software Tutorial this manual in pdf format d Two 1 5 V AAA IEC LR03 Alkaline batteries Guarantee Certificate Carrying Bag 2x AAA 3x AAA Usb Mem Usb Mem cevoo cv010 WPP001 ET WPP001 ETT wEcl wEcl wTnl wRs1 wRsT winl winl Note the Pulse Pea 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 During patient examination is moreover necessary to insert the systolic and diastolic pressure values measured with a validated sphygmomanometer supplied by
3. and eco compatible waste processing contributes to avoiding detrimental effects on nature and on human health an promotes the reuse and recycling of the material of which the product is made Please note that inadequate disposal of the product entails the application of the normative sanctions of the country where this should take place 12 Symbols and Abbreviations sell Manufacturer information This symbols states that reading the user manual before using the apparatus is mandatory A Warning pay attention O Class II device This symbol advices that applied parts are of BF type The device incorporates radio transmitters not ionizing radiations A The crossed garbage can symbol indicates that when no longer functional the product should be disposed of separately from other waste as electronic waste SN the serial number is on each unit in the format yyppp first two digits are for production year remaining digits are for progressive counting hexadecimal code 13 Index pag COMPOSITION ses ti OA RA RA A RARA RGA DALE S s LEA rl GA bane TS a 1 Tonometmne UnitwInltas irreale ea 2 BECG UnitwEcl iicreaitote e i atene ian 2 Signal Receiver Unit wRSsl lle IS ee rio 2 Intended use a ie ea Bi e E E e e e 3 Technical Specifications iv cioe ir SR TALE LORETTA dee OE E e e 4 Classification un io ia in e ri A E co EE EE e ee a i 4 Computer Connection cser gi ar RE RR GAGS SON ATG i HAWS E RIE E 4 Softwar
4. the signal capture in case of no activity on Sensor 2 blue trace In order to obtain good quality tonometric signals the patient must be lying down on the bed while the operators elbow must firmly lye on a surface and the probe s handle is near the sensor in such a way that operator s fingers touch the patient s skin reducing in this way tremors see figure The probe must be kept perpendicular and not tilted Once a good quality signal has been captured of the required duration the hard disk FE storage is enabled by pressing the icon with the diskette symbol or the Enter key a new window will be displayed in order to insert systolic and diastolic pressures captured by an external sphygmomanometer In case of peripheral artery also O distance values are required measured in millimetres they are three and are related to 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 i e the direct method direct distance multiplied by 0 8 and the subtractive one The WPulsePen_LP software storage is in text format file txt in the subfolder ASCII of the WPulsePen_Data folder The initial part of the file contains patient data the explored artery Car Carotid Fem Femoral examination s date hour systolic and diastolic pressure values and distances betwe
5. ation this is in order to reduce the exposure time to the electromagnetic radiations due to radio signal transmission Use only 1 5V batteries of the indicated type inserting them as stated and checking their condition before each use dead or damaged batteries may cause leakage of acid Do not switch on or use the device if the cover of the battery compartment is not correctly closed Insert the patient cable CV010 connectors only into the corresponding sockets of the wEc1 unit Do not connect those plugs in any other way The equipment must never be used in situations where a defibrillator is required since it has not been designed for such use During Carotid pressure signals recording the compression of the Carotid bulbs may accidentally produce reduction of heart rate This kind of phenomenon could be more pronounced in old aged patients with accentuate vagal sensitivity It is highly recommended to stop the examination upon appearance of bradycardia We furthermore remember that is absolutely to avoid simultaneous compression of Carotid bulbs considering that this can cause syncope by arterial hypotension and severe bradyarrhythmias Install an antivirus software on the computer used for the capture of the signals coming from the device Reduce the probability of radio interference following prescription of the next paragraph Use the equipment only for the purposes stated in this manual DiaTecne s r l will n
6. attery Vibrations lt 20 g 0 2 KHz sinusoidal Weight 37g without battery Dimensions mm 49 L x 75 W x 21 H Classification Class Ila medical device according to the Directive 93 42 CE Computer Connection wRsl P C Connection USB Power supply powered by P C connector Led operating mode signalling Data Rx Tx radio link ISM 2 4 GHz Weight 11g Dimensions mm 67 L x 25 W x 11 H General Approximate autonomy 50h Ambient temperature 5 40 C Relative humidity 30 80 non condensing Atmospheric pressure 860 1060 hPa CV010 Universal terminals for tab clip press stud electrodes Connectors DIN 42802 compliant Computer Processor clock frequency gt 2GHz Ram memory gt 2 GB Free Hard Disk space gt 200 MB Graphical resolution gt 1280 x 800 256 colours Operating system Windows XP SP2 Vista Windows 7 Windows 8 32 64 bit Free USB ports 1 IEC 60950 1 compliant Connection of the WPP001 ET WPP001 ETT device to the computer occurs through the wRSJ unit by inserting it in one USB port I Software Installation Insert the included Usb memory drive in the computer port Pls wait the end of the following procedure before inserting the wRSJ unit in one Usb port Launch Setup exe the WPulsePen_LP SW will be installed creating a desktop icon together with the wRSI1 Usb drivers Upon finishing installation insert the wRSJ unit in th
7. both the wEcl unit included the patient cable and wTn1 Do not immerse any part of the device into water or other substances or expose it to sprays Never use Gel on the pressure sensor of wTn1 Do not carry out any maintenance work on the device opening it in the case of malfunctioning of the device contact DiaTecne s r l If any abrasions sheath tears or any kind of defects appear in the patient cable CV010 immediately suspend use of the device and send the defective part to Diatecne s r l for repair replacement Do not use the device in case of breakage of the case 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 Keep the tonometric probe wTn1 and patient cable terminals away from electrical outlets and surfaces where there may be potentially dangerous voltages Use a battery powered portable computer or alternatively an AC powered computer medical regulations in force compliant Use the device at a safe distance from sources of electromagnetic disturbance such as cordless telephones operating at radio frequency cellular phones Bluetooth devices and WiFi or other equipment emitting high frequency electromagnetic waves During examination keep the wEc1 unit at a distance at least of 20 cm from the patient and operator and limit the duration of contact of the wTn1 unit with patient and operator for the time required for the examin
8. d Femoral by the related sphygmic wave transit time DeltaT This propagation time can be assessed in two different ways A By using the wEc1 unit in association with the wTn1 unit in order to measure the delay time between the ECG R wave and the foot of the tonometric wave first in Carotid R cW and after in the peripheral artery under examination for example the Femoral Artery according to the figure R fW and obtaining the difference DeltaT B By using two wTn1 units to contemporary capture two tonometric signals one of them in Carotid and the other in the selected peripheral Artery obtaining the time interval DeltaT between the two wave s feet The ECG lead captured must only be used for PWV determination and never must be used for a diagnosis on the patient Technical Specifications wTnl On Off button Resolution 0 004 mmHg Dynamic range gt 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 5 5 Kg Vibrations lt 20 g 0 2 KHz sinusoidal Shock lt 150 g Weight 25g without battery Dimensions mm 114 L x 25 W x 20 H wEcl On Off button Resolution 0 15 uV Dynamic range gt 4 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 b
9. e Installation 2 316 ss aspre oh RED curs RE ERA SERI a 4 Use ofihe device edo ia iena ao enne 5 Maintenance and cleaning 0 eect teen een tenet ene eee nee 7 Warnings and precautions for use LL di Reciprocal interferences with other equipments 8 Problems in use and solutions srar etiri snos in nE Eey eA o EE POETOE EER OEE PEED EEREN 12 Notes omrecycin nuri aenta ariano REL RETRO TAI oe Si 12 Symbols and Abbreviations L LL 13 Document printing In case more printed copies of the document are necessary open the corresponding pdf file with the Adobe Reader program or similar select options booklet both sides left binding page size A4 print fold and bind as shown Note with a view to constant 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 Pulse Pea device communicating these changes only to the competent bodies 14 15 Pal HAPen DiaTecne s r l DiaTecne s r l Via G di Vittorio 190 Via G di Vittorio 190 20097 S Donato Milanese 20097 S Donato Milanese Milano Italia Milano Italia PulsePen PulsePen Ref WPP001 ET SN Ref WPP001 ETT SN E DAD C Eos AA C Eos Pulse Pen is a trademark of DiaTecne s r l Italy Copyright 2015 V 4 3 Eng Oct 2015
10. e Usb port and wait for the correct device identification In case of problems manually reinstall the drivers that are in the following folder wRs Usb Driver Run the software WPulsePen_LP The associated software release is WPPOO1LP ETT 1 1 0 Use of the device Insert the wRSI receiver in one Usb port and wait for device recognition Extract the cap from the wEcI and wTn1 units insert batteries into the battery compartment strictly following the indicated polarity see pg 2 and reinsert the cap A Use only 1 5V IEC LR03 AAA Alkaline batteries Note dead batteries must be disposed of in the special containers since they are high pollution wastes Using fresh disposable ECG electrodes Ag AgCl with incorporated gel to be used for crocodile clips position them as follows R red subclavian right region B black subcostal left region The suggested position can be modified according to the operator opinion when altered ECG signals are present for example in case of pathologies Direct electrodes contact with synthetic dresses must be avoided because it s cause of superimposed noise in this case it s useful to interpose one sheet of paper Connect patient cable crocodiles to related electrodes according to their type type A or type B see figure at side and insert connectors from the other side in the corresponding wEc1 sockets Start the Software WPulse Pen _LP on the Computer Switch on the wEc1
11. e primary functions are capture display and storage of the arterial tonometric signal in order to later proceed to the calculation of the related parameters and of the Pulse Wave Velocity PWV that defines the arterial stiffness This instrument is based on the applanation tonometry principle According to this method the sensor is placed over the skin were the artery is found applying a moderate pressure in this way the artery comes slightly compressed applanation tonometry with a balance of the circumferential forces inside the vessel In this way the sensor records the pressure in the middle of the compressed artery Intermediate layers between sensor and vessel with their thickness and rigidity that change for each individual case influence the pressure measured by the sensor in a not a priori quantifiable manner For this reason it is necessary to calibrate tonometric signals using an external sphygmomanometer supplied by the operator in order to assess the systolic and diastolic pressures The calibration process is based on the assumption that diastolic and mean pressures substantially don t change along the arterial tree R Ecg lt gt DeltaT A B Carotid Femoral The pulse wave velocity is defined as the propagation velocity of the pressure wave from the center to the periphery and is therefore obtained by dividing the distance between two examined points for example Carotid an
12. en capture points manually inserted by the operator and after that two columns with signal samples of the two sensors Ecg Tonometer or two Tonometers Selecting the Archive icon all the examinations are shown and it s possible to choose which one to display on the screen The Setup icon allows to select language date format while the Help icon opens a window with the on line instructions pls refer to this online help for updated operating instructions In order to switch off the sensors keep pressed the on off key until the acoustic signalling about 1 sec Activation of wEc1 and wTn1 units is shown on the computer screen points 7 8 9 11 12 of the previous image as the battery level and the active standby state Closing the program automatically switches off the wEcl e wTnl units it also occurs in case of no connection with the wRs1 units for more than 30 sec The last situation takes place also when the software WPPOO1LP ETT is not executing wEc1 e wTnl units wait for connection with the wRs1 unit without transmitting data Maintenance and cleaning No particular periodic maintenance or calibration operations are necessary on the instrument A In the case of prolonged non use remove the batteries Before use the metallic disc of the Pulse Pes probe the patient cable and the probe s case must be cleaned using a clean dry cloth or dampened with a small quantity of alcohol Pay attention especially to the pr
13. ker emissions IEC 61000 3 3 Table 2 Electromagnetic immunity The Pulse Pes is suitable for use in the specified electromagnetic environment The purchaser or user of the ulse Pes should assure that it is used in an electromagnetic environment as described below IEC 60601 1 2 Compliance Electromagnetic Environment Test level level Electrostatic 6 KV contact IEC 60601 1 2 Floors should be wood concrete or ceramic discharge ESD Test level tile If floors are covered with synthetic IEC 61000 4 2 8 KV air material the relative humidity should be at least 30 Electrical Fast 2 KV for power Not applicable Mains power quality should be that of a Transient Burst supply lines typical commercial or hospital environment IEC 61000 4 4 1 KV for input output lines gt 3 m Surge 1 KV differential Not applicable Mains power quality should be that of a IEC 61000 4 5 mode typical commercial or hospital environment 2 KV common mode Voltage dips short Interruptions and Voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz Magnetic Field IEC 61000 4 8 0 U for 0 5 cycles Not applicable 40 U for 5 cycles 70 U for 25 cycles 0 U for 5s TEC 60601 1 2 Test level Table 3 Electromagnetic immunity Mains power quality should be that of a typical commercial or hospital environment If the user of the Pulse Pen requires continued operation during powe
14. lled according to instructions in the following tables 1 4 Mobile devices for radio frequency communications may disturb electromedical devices For the correct use of the Pulse Pen device the wEc1 and wTnl units must be in a 3 meters radius from the wRs1 unit Higher distances could influence the correct operation The use of cables and accessories different from those in the original package could adversely influence the performances of the device Respect distances from other devices according to table 4 The Pulse Pen device transmits radiofrequency in the ISM 2 4 GHz band with MSK modulation ERP 2 dBm Table 1 Electromagnetic emissions The Pulse Pes is suitable for use in the specified electromagnetic environment The purchaser or user of the Pulse Pen should assure that it is used in an electromagnetic environment as described below Compliance Electromagnetic Environment RF emissions The Pulse Pen uses RF energy only for its internal function CISPR 11 Therefore the RF emission is very low and not likely to cause any interference in nearby electronic equipment RF emissions Class B The Pulse Pes is suitable for use in all establishments CISPR 11 including domestic establishments and those directly connected to the public low voltage power supply network that supplies Harmonic emissions Not IEC 61000 3 2 applicable buildings used for domestic purposes Not Voltage fluctuations applicable Flic
15. obe s plunger avoiding mechanical stresses Note be very careful to keep the alcohol or other liquids from penetrating into the Pulse Pen probe or into the other units because this could cause serious problems irreparably damaging internal parts A The Pulse Pes Ecg cables are very thin and flexible in order to be easy to handle One must avoid pulling and bending them at a right angle so as not to damage them A Warnings and precautions for use This instrument is intended to be used only by medical paramedical personnel in medical ambulatory Do not use in the operating room or in any case where there are inflammable gases substances Do not use for 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 either in autoclave neither with liquid substances Do not submit the pressure plunger of the tonometric unit wTn1 to mechanical shocks as impacts or falls Regularly clean the disc of the tonometric probe wTn1 the terminals of the patient cable CV010 and the case after each use as indicated in the previous paragraph Keep the wTn1 and wEc1 units with the related 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 included the wRs1 unit and one or
16. ot be held responsible for any damages caused to persons animals or things if the user does not scrupulously follows the indications given in this manual Reciprocal interferences with other equipments The Pulse Pen device was designed to be immune to electrical electromagnetic electrostatic and magnetic disturbances that are normally present likewise the Pulse Pes produces a small amount of disturbances for other equipments It cannot however be excluded that in particular situations some functioning anomalies could appear also in the form of signal alteration in this case it is necessary when possible to move away all potential sources of disturbance or to move to a more appropriate location Considering the intended use of the device that requires a medical qualified operator he she may easily recognize any anomalous functioning situation such as for example the presence of noise superimposed to the signal or alteration of the morphology and follow the indications suggested here Typical noise sources are the hotspot WiFi devices Bluetooth devices Zigbee devices and any kind of transmitter in the 2 4 GHz frequency band A Ensure that the WiFi Bluetooth functions of the computer and cellular phones are switched off during the use of the apparatus When available activate the aero mode on this devices Medical devices require special cautions for electromagnetic disturbances EMC and must be insta
17. r mains interruptions it is recommended that the computer used with the Pulse Pes be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment The Pulse Pen is suitable for use in the specified electromagnetic environment The purchaser or user of the Pulse Pen should assure that it is used in an electromagnetic environment as described below Radiated RF IEC 61000 4 3 Conducted RF IEC 61000 4 6 IEC 60601 1 2 Compliance Test level level 3V m 3V m 80 MHz 2 5 GHz 3V m Not applicable 150 KHz 80 MHz Electromagnetic Environment Portable and mobile RF communications equipment should be used no closer to any part of the Pulse Pes including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP 80 MHz 800 MHz d 2 3VP 800 MHz 2 5 GHz Where P is the maximum output rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths for fixed RF transmitter as determined by an electromagnetic site survey should be less then the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol C 10
18. that is inserted in the right way and that it s not dead Keep the On Off button pressed until the acoustic signaling about 1 sec Remove and reinsert the battery NO SIGNALS ARRIVE TO THE COMPUTER Check to see that the wEc1 and wTn1 units are turned on and that software icons related to the wRs1 unit are both green in case they are not close the software extract and reinsert the wRsl signal receiver restart the software In case the problem remains the Usb drivers reinstallation is suggested Ensure that the Computer Protection software such as Antivirus Firewall etc does not prevent access to external Usb devices Make sure that the system is not in Freeze mode due to absence of tonometric signal on the Pulse Pest probe Touch the sensor with fingers Check to see that the radio channel of wRs1 wEc1 wTnl units is the same Pls refer to the on line help for more details If you find it s not possible to solve the listed problems by yourself or if you have doubts regarding the functioning of the equipment please contact DiaTecne s r l by e mail at info pulsepen com You will receive technical assistance in a short time Notes on recycling DiaTecne is sensitive to environmental issues linked to the production of waste The user that wishes to dispose of the apparatus at its life end should contact DiaTecne s r l and will receive appropriate instructions Adequate waste selection before recycling
19. the user Tonometric Unit wTnl nN 3 1 On Off button keep pressed for about 1 sec 2 Cap for battery replacement pull away from the tonometer s body Extract the old battery pushing it from the opposite side of the opening Insert the new fresh battery never forcing and following the specified polarity Reinsert the cap in its final position pushing it until snap occurs 3 Active part of the tonometric sensor ECG Unit wEcl 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 Insert the new fresh battery never forcing and following the specified polarity Reinsert the cap in its final position pushing it until snap occurs 3 Patient cables connectors Signal Receiver Unit wRs1 1 Led signalling the operating mode This Led blinks green when the software is not running or in case the device is not correctly installed This Led is fixed green during normal operations while it s red during reprogramming update Intended use In this manual when writing about device or equipment the reference is to all its parts unless otherwise noted Each unit alone does not produce useful results This device is intended to be exclusively used by medical paramedical personnel Pls keep in mind that morphology and quality of the pressure signal acquired by not skilled people could give erroneous signal interpretation Th
20. wTn1 unit by keeping pressed the on off key until the acoustic signalling about 1 sec Such signal ends with a single beep in case of wEc1 or wTn1 programmed as Sensor1 red trace while ends with two beeps in case of wTn1 programmed as Sensor2 blue trace 1 2 3 4 1 Key for the patient selection in order to start a new examination 2 Key to archive access 3 Setup key and device programming 4 On line Help Key d Indicator of correct data exchange with the wRs1 receiver green 6 Indicator of wRs1 Usb device recognized green 7 Graphical battery gauge 8 Numeric battery gauge in case of less then 10 indication the battery must be replaced 9 Icon for Ecg or Tonometric active sensor 10 Bar that shows data from Usb adapter waiting for processing shorter it means higher computer speed 11 The positive battery terminal becomes yellow during standby i e when Freeze is active or during screens different from signals capture 12 Sensor 1 corresponds to the red signal Ecg or Tonometer while sensor 2 corresponds to the blue signal only Tonometer Select the Patient icon and insert information as 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 Pulse Pes probe on the region of interest captured signals will be displayed on the computer screen An automatic freeze function stops
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