E:\Prodotti\PulsePenLab\User Manual Eng V1_1.wpd
Contents
1. Aluminum Plate Two adjustable arms Two Micromanipolators Two fixing arrangements for the Pressure Probes Generic accessories Usb memory with software Two 1 5 V AA Alkaline batteries This manual Guarantee Carrying bag Note the Pulse Penlas must be connected to a computer provided by the user in order to be able to visualize the signals and process the significant parameters The connection to the computer is galvanically insulated and is made using the fiber optic cable and the AF002 adapter PulsePen 1 Pressure sensor 2 Freeze button 3 Signal offset lowering button 4 Signal offset raising button 5 Signal attenuation button 6 Signal amplification button 7 Connecting cable for the Base Unit Base Unit 8 9 On Off button with battery life LED indicator 10 Fiber optic connector with ring nut for link with the Fiber Optic USB Adapter 11 12 Connectors for Pulse Pes 13 Battery compartment gt gt e com Didlecne gt www diatecn Fiber Optic USB Adapter 14 Fiber optic connector with ring nut for link with Base Unit 43 B 15 Data indicator LED O 16 USB P C Connector Intended use In this manual when writing about device or equipment the reference is to all its component units unless otherwise indicated The Fiber Optic Cable and the Fiber Optic USB Adapter AF002 are support parts for connecting the device to2. User Manual Pulse Pen Lal device is manufactured by DiaTecne s r l with Headquarters in Milan Italy AN This manual is an integral part of the product and must be kept together with it The Pulse PesnLal is a non invasive device for the Pulse Wave Velocity assessment in small laboratory animals It provides an enhanced sensitivity a reduced plunger size and a higher sample rate than the standard PulsePen device The Pulse PenLatb allows longitudinal studies with repeated measurements during the life of the animals avoiding their sacrifice in opposition to the invasive method Moreover the required time for examinations is quite short compared to the invasive method Animals are sedated and put in place directly on a metal plate or interposing an external heated layer for better comfort The pressure probes are fixed on adjustable arms with two micromanipolators Composition The PulsePenLab device code PPLab2 is made up of the following parts contained in the package Battery powered Base Unit code EC004 for the connection of the tonometric probes equipped with fiber optic interface for data transmission Two PulsePen code TN4Lab Tonometric probes for the acquisition of a pressure signal with the non invasive applanation tonometry method connected to the Base Unit powering them Accessories for the computer connection Fiber optic cable Fiber Optic USB Adapter code AF002 Mechanical Assembly
3. loosen it before pulling out the fiber optic cable Run the Pulse PenLab software on the PC and switch on the Base Unit by pressing the On Off button until you hear the acoustic signal and the LED starts blinking about 1 5 sec When the LED is green it means that the batteries are ok while red indicates they are running down In that case replace the batteries with new ones as soon as possible The LED on the AF002 adapter is on when the signal transmission on the Optic Fiber takes place Place the Pulse Pes probes on the region to be explored the acquired signals will be displayed on the computer screen Proceed according to the online software instructions To switch off the system keep pressed the OnVOff button until you hear an acoustic signal and the LED stops blinking about 1 5 sec Note The device will automatically switch off in case of absence of tonotometric signal for more than 5 minutes b WPulsePen 1 2 3 4 Key for the patient selection in order to start a new examination Key to archive access Setup key On line Help Key Indicator of correct data flow from the fiber adapter Indicator of Usb adapter connected green Graphical battery gauge Numeric battery gauge Icon for Ecg or Tonometric active sensor Bar that shows data from Usb adapter waiting for processing shorter it means higher computer speed The positive battery terminal becomes yellow during standby Sensor 1 corresponds to the r
4. the computer For the operational functions pls refer to the online manual of the Pulse PesLab software This device has been designed solely for veterinary laboratory research uses It therefore must not be used for a direct diagnosis or check of vital physiological processes The primary functions are L Calculation of the Pulse Wave Velocity PWV 2 Graphic representation of the pressure curves with the automatic calculation of several significant parameters It is necessary for a qualified skilled operator to be present one familiar with the applanation tonometry method for the use of the equipment The morphology and amplitude of the acquired pressure signals and as a result the parameters automatically calculated are strongly influenced by the operator s handling of the instrument For the correct and complete use of the device it is necessary to enter the systolic and diastolic blood pressure values obtained independently using a sphygmomanometer or an alternative instrumentation Pulse wave velocity is defined as propagation velocity of the pressure waves from the center to the periphery and is obtained by dividing the distance between two points and the related transit time Technical Specifications Pulse Pen Adjustment buttons base line Offset and amplitude Gain Signal Freeze button Resolution 0 00976 mmHg Dynamic range 640 mmHg Acquisition 16 bit 1000Hz Output connections cable with conne
5. ctor for Base Unit Max force applicable to the sensor 1 Kg Shock lt 5g Vibrations lt 2 g 0 2 KHz sinusoidal Weight 34g with cable Dimensions mm 132 L x 23 W x 16 H Base Unit Button On Off with two colors LED signaling of reserve power Acoustic signal Buzzer Input connections 2x Pulse Pest Output connections Fiber optic cable Weight 87g without batteries Dimensions mm 144 L x 63 W x 31 H PC Connection Fiber optic adapter Connection to PC USB Power self powered by PC connector Fiber optic cable 3m 92 2 mm General Power Two IEC LR6 AA Alkaline penlight batteries Approximate autonomy 40h Temperature 0 40 C Relative humidity 30 80 non condensing Suggested computer features P C with processor gt 1 GHz RAM gt IGB Available hard disk space gt 300 MB Graphic resolution gt 1280 x 1024 256 colors Operating system Windows XP Vista 7 8 USB port Compliance EN60950 The Base Unit connection to the P C is made through the fiber optic by inserting the Fiber Optic USB Adapter code AF002 into a free USB port USB Connector Classification e a DE This device is intended for veterinary laboratory research purposes only and is CE marked Software Installation Insert the Usb memory included in the PulsePen package in the PC drive Run the Setup exe file in order to install the Pulse PesLat software on the computer and follow th
6. e instructions on the screen l Launch Setup exe the ZLZse Penlas software and Usb drivers will be installed and an icon on the desktop will be created 2 Upon finishing installation insert the AF002 Usb adapter in one free Usb port and verify that the device is correctly recognized In case of problems manually reinstall drivers that are in the following folder wRs Usb Driver 3 Launch the Pelse Penalas software Use of the device Insert the batteries into the Base Unit s battery compartment in the indicated way Use only 1 5V IEC LR6 AA Alkaline penlight batteries AN Note dead batteries must be disposed of in the special containers since they are high pollution wastes Connect the Pulse Pen probes by inserting each cable connector into the corresponding 3 pin socket of the Base Unit Insert the fiber optic cable into the specific connectors of the Base Unit on one side and the Fiber Optic USB Adapter on the other The fiber must be pushed in all the way and fastened by screwing the outside ring nut Note Due to mechanical tolerance and especially with new fibers the optic fiber may appear to be completely inserted when it actually is not Fiber correctly inserted Fiber NOT correctly inserted J y Note in order to avoid damaging the connector do not over tighten the ring nut It s enough that the fiber does not pull out during normal use of the equipment Remember to unscrew the ring nut to
7. ed signal Carotid while sensor 2 corresponds to the blue signal Peripheral artery pe OD E DI m pe pe OD Neo Select the Patient icon and insert information as name family 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 and use the micromanipolators for a fine regulation acquired signals will be displayed on the computer screen The hard disk storage is enabled by pressing the icon with the diskette symbol and a new window will be displayed in order to insert systolic and diastolic pressures and distances values 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 Selecting the Archive icon it is possible to choose which examination to display on the screen The Setup icon allows to select language date format The Help icon opens a window with the on line instructions Maintenance and cleaning No particular periodic maintenance or calibration operations are necessary on the instrument In the case of prolonged non use remove the batteries To clean the equipment use a clean dry cloth or dampened with a small quantity of alcohol Pay atte
8. ing these changes only to the competent bodies 11 DiaTecne s r l e Via G di Vittorio 190 20097 S Donato Milanese Milano Italia PulsePenLab Ref PPLab2 SN Ce Pulse Pen is a trademark of DiaTecne s r l Milan Italy Copyright O 2015 V 1 1 Eng
9. ntenance work on the device opening it in the case of malfunctioning of the device contact DiaTecne s r l e Do not make changes of any kind to the device e Do not step on the fiber optic cable or bend it sharply with a curvature radius of less than 3 cm e Keep the TN4Lab pressure probe and its cable away from electrical outlets and surfaces where there may be potentially dangerous voltages e Do not use the equipment for intracardiac applications e Connect to the electrical Earth the aluminum plate using one of the threaded holes e Use a battery powered portable computer or alternatively an AC powered computer with a medical standard insulation transformer If any abrasions sheath tears or defects appear in the TN4Lab pressure probe cables immediately suspend use of the device and send the defective part to Diatecne s r l for repair replacement Use the device at a safe distance from sources of electromagnetic disturbance such as wireless telephones or other equipment emitting high frequency electromagnetic waves e 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 Close the cover of the battery compartment before turning on the equipment Insert the connector of the TN4Lab pressure probe only into the corresponding 3 pin connector of the Base Unit ECO04 Do not use the 3 pin connector of the ECO004 fo
10. ntion especially to the probe s plunger avoiding mechanical stresses Roll up the optic fiber cable following its natural curvature AN Note be very careful to keep the alcohol from penetrating into the Pulse Pen probe because this could cause serious problems AN The Pulse Pen cable is very thin and flexible in order to be easy to handle One must avoid pulling and bending it at a right angle so as not to damage it AN Optic Fiber can be damaged if trodden upon or bent at an angle Do not pull twist or bend the cable near the probe Do not pull or bend the cable near the connector Do not twist the cable near the connector X Do not bend fiber optic at a right angle AN Warnings and precautions for use Do not use in the operating room or in any case where there are inflammable gases substances Do not sterilize Clean the pressure probe TN4Lab with a cloth dampened with alcohol making sure the alcohol does not penetrate into the probe e Keep the ECO04 TN4Lab units at a distance of no less than 2 meters from the computer e Avoid touching simultaneously any part of the ECO004 TN4Lab units and the computer including the fiber optic adapter AF002 Do not immerse any part of the device into water or other substances or expose it to sprays Never use Gel on the sensor Do not submit the pressure plunger of the tonometric unit to shocks or stresses above limits Do not carry out any mai
11. pment 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 used Pulse Pen device should contact DiaTecne s r l and will receive appropriate instructions Adequate waste selection before recycling and 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 Symbols and Abbreviations E Manufacturer information This symbols recommends to read the user manual before using the apparatus Warning pay attention Class II Device This symbol advices that applied parts are of BF type The device incorporates radio transmitters The crossed garbage can symbol indicates that when no longer functional the product should be disposed of separately from other waste x pne 10 Index p8 COBIDOSIBIO 14 224 024 eared eto vette tee ee Nae a aE pd oe dabat osos ake iamen 1 PUES Od 5 cage tases UA a A a A EA E ST as ai aioe E one au ENE 2 Boe OUM eera Tr O Seats a E OE 2 Fiber Opties USB AOJDICE v0 fits a a e DIEN Esci A E E tete m dole ductu erbe bd EN 2 Ihi
12. r any other kind of connection The equipment must never be used in situations where a defibrillator is required since it has not been designed for such use e Use the equipment only for the purposes stated in this manual DiaTecne s r l will not be held responsible for any damages caused to persons animals or things if the user does not scrupulously follow the indications given in this manual Reciprocal interferences with other equipments The Pulse Pen Lal was designed to be immune to electrical electromagnetic electrostatic and magnetic disturbances that are normally present likewise the Pulse Pes Lab 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 the operator may easily recognize any anomalous functioning situation such as for example the presence of noise over the signal or alteration of the morphology and follow the indications suggested here Problems in use and solutions THE DEVICE DOES NOT TURN ON THE LED DOES NOT BLINK I5 Check to see that the batteries are inserted in the correct way and that they are not dead 14 Keep the On Off button pressed until the LED start
13. s to blink about 1 5 sec Eventually make a first test with the Pulse Pe probes disconnected NO SIGNALS ARRIVE TO THE COMPUTER 15 Check to see that the Base Unit device is turned on with the LED blinking green 16 Make sure that the LED on the AF002 Adapter is on 17 Make sure that the system is not in Freeze mode pressing the specific side button on the Pulse Pen probe 18 Disconnect the fiber optic cable unscrewing the ring nut of the Base Unit connector and check to see that a red light is turned on inside it 19 Check to see that the fiber optic cable is not damaged at both ends and is intact along its entire length the signal would suffer an excessive attenuation if a section were bent or crushed in this case if it is one extremity that is damaged cut off the end piece with a sharp cutter perpendicularly to the direction of the fiber itself the cut must be clean and not jagged 20 Insert the fiber optic cable all the way into the corresponding sockets of the Base Unit and the Fiber Optic USB Adapter screwing the ring nuts 21 Make sure that the Fiber Optic USB Adapter was installed correctly and that is inserted correctly into the computer 22 Ensure that the Computer Protection software such as Antivirus Firewall etc does not prevent access to external devices If you find it is not possible to solve the problems listed by yourself or if you have doubts regarding the functioning of the equi
14. tended use 53 vonelus feodo e Meet eco eset Mosis Moa S discere tease A dietus d bie Rc bee 3 Technical Specie attolli 2c s scm ehe ECCE Re Poe Pdl AC cath deme Alam eth aedi Atte hse an atat a Red e 4 DEC RIN CC Ta i Sata chase ees debut putent A a RA E E as E t SEE 4 DOIbWale InstallaHofi 2 100 den Soe Det E dedo dena dUE ieee dien drea de Pee duas ieee du 4 Vee ob We device 454 29 ieee Ee oa a vietato ai Reade NER ada adc dae andes usura aon B Maintenance and cleaniig eus oec a aia eh saan x bsp ge I ME ME P Ee E 6 Waminss and precautions TOUSE cese oh ED SP RED DE qE E wave Edd dude orate es 7 Reciprocal interferences with other equipments o iii 4 hed pae dle ua eae So a kane e ruta ea e o eo 8 Problems in use and SOMUONS wien ot sho arts rp reb epuCedc ori lese ee e tie arent Rees t tiene b eter ade 8 NOLES ONiCCVCUNG s cree xot mate 3m ae paetos ue RS sh a wee Aiea a aie deeded Rs 9 SV MOS and ADDV ANONS s uoa uo codo Gok eR ROS UP e OR Re OS Dee e Ue ERU ew oe 9 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 Penlab device communicat
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