HeartVUE system
Contents
1. Myocardium indicator The Myocardium indicator is relative characteristics which describe the total value of dispersion deviations and range from 0 to 100 Rhythm indicator The Rhythm describes the changes in the R R intervals variability characteristics in range from 0 to 100 Pulse indicator The Pulse shows the quantity of the heartbeats in a minute defining bradycardia tachycardia or normal condition Detailing indicator The Detailing describes the heart condition using the analysis of the described above indices 8 2 KARDi2 4 PC ECG module Parameter Number of channels Value The HeartVUE system has 3 monopolar channels The ECG leads are calculated on the PC by CardioDM 06 software Analog front end DC amplifiers Input range effective resolution for 500Hz output data rate 410 mV 2 uV Defibrillator protection on base semi conductors elements Input DC impedance greater 70 MOhm according to N electrode Check electrode connection Checking connection during registration by measure of DC offset Analog to digital conversion Sigma delta modulation with frequency 2048kHz simultaneously on all channels a digital filtration and 23 HeartVUE system User s Guide Parameter Value decimation up to frequency 16kHz Digital signal processing Filtration and decimation up to 500 Hz2. 17 HeartVUE system User s Guide 5 2 Software installation and operation The installation description of the CardioDM 06 software for heart screening you can find in the applicable document CardioDM 06 software for heart screening User s Manual This document includes the operation documentation too 5 3 The PC ECG module fixation For fixating the KARDi2 4 PC ECG module on the surface use the special fastener which consists of continuous strips of plastic backing with plastic mushroom shaped stems protruding up from the backing strip The first part of the fastener you can find on the back side of the KARDi2 4 The second part of the fastener is a substrate which can be found in the package The substrate has a protective liner Remove the protective liner and press firmly onto the substrate for full surface contact All surfaces must be clean dry and free of oil grease dust etc The special fastener is disposable and permanent Be attentive at a choice of an attachment place of the fastener When two pieces of the fastener are pressed together the mushroom heads interlock with one another with an audible snap To open simply pull apart 18 HeartVUE system User s Guide 6 External components 6 1 Safety with system For connecting the HeartVUE system with other devices computers and peripherals printers scanner etc use the IEC60601 1 1 standard about safety requirements of medical electrica
3. Term Meaning CPU Central processing unit DC Direct current ECG Electrocardiogramm EMC Electromagnetic compatibility LED Light emitting diode MCS Medical Computer Systems Ltd OS Operational system PC Personal computer RF Radio frequency USB Universal serial bus HeartVUE system User s Guide 2 Symbols on labels Symbol o Meaning Electrical medical device CLASS II EQUIPMENT iy Electrical medical device TYPE CF with defibrillator protection A Attention Carefully read specification or instruction for use CE 0535 This device conforms to Directive 93 42 EEC USB connector Serial number Date of manufacturing lt BIA Separate collection with electrical and electronic equipments for recycling HeartVUE system User s Guide 3 Main features 3 1 Intended use The HeartVUE is a computer system for easy and efficient non invasive screening of heart which provides a rapid 3 D colored image of heart by using 6 standard ECG leads 4 wires only from the patient s wrists and ankles This system contains the PC ECG module KARDi2 4 and the CardioDM 06 software that converts the electric conductivity of the cardiac tissue into a 3 dimensional color coded image which is simple for physicians to interpret The basic operating principals of the CardioDM 06 software are described in the CardioDM 06 software for heart screening User s Manual
4. The HeartVUE system will prove to be an invaluable screening tool for cardiologists general practitioners clinics hospitals the fitness industry sports teams and emergency medical facilities 3 2 Basic Functionality The basic features of the HeartVUE system are 1 the 30 or 60 second ECG acquisition of the 6 standard leads I II HI aVR aVL aVF by KARDi2 4 analyzing and visualization 2 analyzing and creating the 3D colored image of heart later the heart portrait where a state of the heart zones is displayed by colors 3 analyzing and showing the Myocardium Rhythm Pulse and Detailing indices 4 the conclusion and comments creating ECG P visualizati E atient CardioDM 06 s Visua ization J amp 1 Heart portraits j ma tion e Data visualization 7 PARDA gt ECG tere analysis a lL A ti a j ts y Detailing f y ECG Data index J Conclusion and i electrodes saving Se comments l k Myocardium Us Rhythm and Pulse indices Pic 1 The basic features diagram of the HeartVUE system HeartVUE system User s Guide 3 3 Classification The HeartVUE system is a Class Ia device according to Council Directive 93 42 EEC for medical devices The system is classified for CLASS II TYPE CF EQUIPMENT according to IEC 60601 1 protection aga
5. For other version of Windows OS the dialog may be different 1 When Windows asks to connect to Windows Update select No not this time and the press Next button Foun Ney Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software Yes this time only Yes now and every time connect a device No not this time Click Next to continue 13 HeartVUE system User s Guide 2 Windows will ask to install software automatically or from specific location Select Install from a specific location and press Next Found New Hardware Wizard This wizard helps you install software for KARDIDSP if your hardware came with an installation CD Q or floppy disk insert it now What do you want the wizard to do O Install the software automatically Recommended Install from a list or specific location Advanced Click Next to continue lt test gt crea 3 Select Search for the best driver in these locations and check Include this location in the search Use Browse button to select directory where the driver s files are located for example D Driver and press Next Found New HardwarewWiraro Please choose your search a
6. Please choose your search and installation options Search for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best driver found will be installed ROM Dont search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware 16 HeartVUE system User s Guide 3 Press the Have Disk button Hardware Update Wizard Select the device driver you want to install for this hardware Select the manufacturer and model of your hardware device and then click Next If you RESP have a disk that contains the diver you want to install cick Have Disk Z Show compatible hardware KARDIDSP Install From Disk make sure that the correct drive is selected below Copy manufacturer s files from C AKARDI2 Driver InF 5 Then press Next button to start the installation process and wait till the finish dialog will appear Hardyare Update Wizard Select the device driver you want to install for this hardware Fe ie meraiactror and maae of ya hardware draon rod ihon dic Nad you ASSP have a disk that contains the diver you want to install click Have Disk Z Show compatible hardware Model p KARDIDSP
7. the PC meets the requirements of the chapters 6 1 and 6 2 4 Insert the CD disk with driver and CardioDM 06 software in the CD ROM 5 Plug the USB cable of the KARDi2 4 PC ECG module which has the USB cable label into the free USB port of the PC or of the USB hub with the external power source If it is for the first time the driver installation procedure will run automatically refer to chapter 5 1 1 12 HeartVUE system User s Guide 6 Install the CardioDM 06 application software see chapter 5 2 7 Plug the USB protection key which has the HeartVUE K label into another free USB socket of the PC The key should be plugged in the computer s free USB socket ONLY if the installation of the CardioDM 06 software is finished also see chapter 3 3 of the CardioDM 06 software for heart screening User s Manual 8 Connect ECG electrodes to the ECG connectors see chapter 6 3 9 Read the CardioDM 06 software for heart screening User s Manual document and use the CardioDM 06 software to operate with KARDi2 4 10 Place the ECG electrodes to the patients wrists and ankles and start a new examination 5 1 1 Driver first time installation After first connection KARDi2 4 to PC see chapters 6 1 and 6 2 by USB cable Windows will show the message Found new hardware and start the wizard dialog Found New Hardware Wizard for new device installation The dialog windows for Windows XP OS are shown below
8. applicable dip in UT for 5 cycles 10 UT 30 Not applicable dip in UT for 25 cycles lt 5 UT gt 95 Not applicable dip in UT for 5 sec Power frequency 3 A m 3 A m Power frequency magnetic 50 60 Hz magnetic field IEC 61000 4 8 26 fields should be at levels characteristic of a typical location in a typical commercial or hospital environment HeartVUE system User s Guide IEC 60601 Compliance Recommended separation Immunity test test level level distance Portable and mobile RF communications equipment should be used no closer to any part of the system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF IEC 3 Vrms 150kHz to 3 Vrms d 117 VP 61000 4 6 80MHz Radiated RF IEC 3 V m 80MHz to 80 MHz to 800 61000 4 3 2 5GHz 3 V m fe 1 17 P Z d 2 334 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the Cp following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 T
9. average service life is not less than 5 years if the mean time of system s operating does not exceed 80 hours per month Utilize the system according to your regional laws In the European Union use the requirements of the Directive 2002 96 EEC for the system utilization 10 HeartVUE system User s Guide 4 3 Maintenance Regularly use surface disinfectants but not less than one time in the month For material compatibility use the disinfectants based on the alcohol Factory testing and calibration ensure equipment accuracy and frequency response during the whole system s life cycle If necessary contact the manufacturer representative for factory re calibration 11 HeartVUE system User s Guide 5 Installation 5 1 Hardware installation F green L yellow black N gt red R Fastener HeartVUE system KARO 2M P CG module Dlneartvue Oxc Mode indicator Pic 2 The KARDi2 4 PC ECG module left picture the front side right picture the back side 1 Unpack the package and check that all parts of the system according to the chapter 4 1 have been received and are undamaged The face of PC ECG KARDi2 4 module is showed on the left picture the back side is showed on the right one 2 Fixate the KARDi2 4 PC ECG module on the surface using the special fastener see chapter 5 3 3 Turn on the PC and wait till the Windows OS will be loaded Make sure that
10. output data rate 20 bit resolution Internal low pass filters has the 3 dB level on 150 Hz and 5 level on 100 Hz accordingly Connectors type for electrode 4 mm banana jacks Galvanic isolation Reinforced according to IEC60601 1 from PC side Power line USB Voltage 5 V 10 Maximal current in active mode less 280 mA Computer Interface USB1 1 full speed mode plug and play support Status indicators and modes Bi color LEDs indication e green no error active mode The indicator is burning green during the new examination s making red error occurred USB cable Min length 3 m fixed to module Electrode cable s length not less than 140 cm Dimensions of enclosure 100x65x28 mm Weight with cables less 350 gram Working temperature 10 C 35 C Storage temperature 5 C 40 C Transportation temperature 30 C 50 C 24 Humidity up to 97 without condensation Mechanical resistance According to IEC 60601 1 HeartVUE system User s Guide 8 3 Electromagnetic compatibility Guidance and manufacturer s declaration electromagnetic emissions The HeartVUE system is intended for use in the electromagnetic environment specified below The customer or user of the system should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emi
11. HeartVUE system for non invasive screening of heart User s Guide Read Me First Rev 1 Pag HeartVUE system User s Guide Warnings e Use IEC60601 1 1 standard to combine the HeartVUE system with other devices computers and peripherals see chapters 6 1 and 6 2 e Do not operate HeartVUE system within 3 meters of an operating cellular phone similar radio transmitting device other powerful radio interference producing sources such as arc welders radio thermal treatment equipment x ray machines or any other equipment that produces electrical sparks see chapter 8 3 e Reusable electrodes present a potential risk of cross infection especially when are used on abraded skin unless they are restricted to a single patient or sterilized between patients The sterilization recommendations from electrode producer should be used e Explosion Hazard Do not use the HeartVUE system in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide e Do not immerse the any parts of HeartVUE system in water e Take care of the system s components Evoid the cables breaks kinks tension and other mechanical efforts e Take care of arranging Patient and USB cables wires to avoid the risk of patient entanglement or strangulation e The operator is responsible to ensure the safety of any devices controlled or triggered by any software or hardware receiving data from the HeartVUE system And this
12. e dick with the cleaning based on the alcohol Tf the malfunction is not corrected contact the manufacturer representative The New examination button is not active The PC ECG module is not plugged to the PC The driver is not installed Check the USB cable connection Make sure that the PC ECG module KARDi2 4 is plugged into the USB hub with the external source of power Install the driver see chapter 5 1 1 If the driver is installed update it see chapter 5 1 2 Restart the program The indicator Mode is red The error occurred Replug the PC ECG module Reinstall the system driver If the malfunction is not corrected contact the manufacturer representative The MCS USB Medical Devices is not appeared in the Computer management The KARDiDSP is not displayed in the Device Manager under the MCS USB Medical Devices The connection between PC and PC ECG module failure The system driver is not installed Check the connection between PC and PC ECG module or replug the PC ECG module Install the system driver If the malfunction is not corrected contact the manufacturer representative The heart portraits have a black line The fonts or buttons of the CardioDM 06 software s interface are changed The video drivers are not updated Update the video drivers 21 HeartVUE system User s Guide Malfunction The screening a
13. hese guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above the system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the system Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 27
14. inst electric shock The system classified by CISPR 11 standard as a Group 1 Class B equipment according to IEC 60601 1 2 electromagnetic compatibility For more information about EMC see chapter 8 3 HeartVUE system User s Guide 4 General information 4 1 Packaging The following items form the whole package 1 PC ECG module KARDi2 4 with fixed USB cable Clamp ECG electrodes see chapter 6 3 The CD disk with driver and CardioDM 06 software HeartVUE system User s Guide this document CardioDM 06 software for heart screening User s manual Special fastener for the system fixation see chapter 5 3 USB key for the software protection Optional PC and or printer oo Nx Aa FW NY Case for all aforementioned items 4 2 Warranty service life and utilization The system and all equipment according to the chapter 4 1 excluding the ECG electrodes special fastener and case are guaranteed to be free from defects in material and workmanship for 24 months from the date of purchase In the unlikely events that repair is necessary call the manufacturer representative to receive a Return Authorization Then send the unit back by a traceable method the manufacturer representative is not responsible for not received items We will repair or replace your unit s free of charge This warranty does not apply to damage incurred through accident alteration or abuse The HeartVUE systems
15. l systems The system is typically used inside the PATIENT ENVIRONMENT area near 1 5 meters around the patient see pic 3 that is why all the other devices used with the system should be medical and meet the requirements of the IEC60601 1 standard for example PC Advantech POC 174 2 cere reo NOTE Dimensions shown are not prescriptive Pic 3 Example of the PATIENT ENVIRONMENT If non medical devices are connected to the system via USB and if it is inside the PATIENT ENVIRONMENT then 1 all devices have to be connected to the medical IEC60601 1 isolation transformer transformers with sufficient power supply for example AEL Group MIT Medical Isolation Transformers or 2 all devices should be powered from internal energy sources However the PC ECG module has minimum 3 meters cable to PC with USB connector fixation and touch protection construction The isolation transformer may not be used if the guaranteed minimal distance to any non medical device which meet the requirements of the IEC60601 1 1 standards will be more than 1 5 meters outside PATIENT ENVIRONMENT 19 HeartVUE system User s Guide 6 2 Computer and peripheral devices Connected computer as well as others peripheral devices like printers must have C mark and comply with the safety standard for office machines DIN VDE 0805 or EN60950 or IEC950 or any Computer must conform to minimal requirements e CPU with equivalent performance not
16. less than Intel Celeron1000MHz e Run under Microsoft Windows XP OS e Has two free USB1 1 or compatible port The CardioDM 06 software uses the graphic standard DirectX for the heart portraits visualization Make sure that all the latest updates for the Windows OS or its applications and that the latest USB patches or drivers made by the PC s or system board s developers are installed on the PC 6 3 ECG electrodes and electroconductive gels pastes For ECG acquisition the ECG electrodes must have the CE mark and the maximum polarization voltage less 300 mV should be used These electrodes or wire to electrode must have the 4 mm socket for connection For example the FIAB F9024 nickel silver or F9024SSC nickel silver chloride clamp electrodes may be used Other types of electrode connectors can be used by adapter 3 mm socket snap type etc For example the FIAB PG922 4T snap adapter may be used for disposable electrode connection The electroconductive gel paste used for the ECG acquisition must have the C mark For example NUPREP EEG amp ECG Skin Prepping Gel 20 7 Malfunctions and their correction HeartVUE system User s Guide The possible malfunctions and actions for their correcting are in the following table Malfunction The CD disk cannot be read by the CD ROM Probable reason The CD disk became dusty Corrective actions Extract the CD disk from the CD ROM and carefully clean th
17. nalysis takes more time than 1 minute Probable reason The CardioDM 06 software has been run with the concurrently running programs especially with the antivirus monitors Corrective actions Close the other running programs especially the antivirus monitors All or one of the ECG signals are not displayed on the screen The electrodes or the electrode of this lead are not connected to the patient PC ECG module failure Check the electrode cable s connection Check the electrode cable s fixation in the electrode Check the connection between the electrode and the patient If the malfunction is not corrected contact the manufacturer representative All or one of the ECG signals are very noisy 22 The electrodes or one electrode are not greased with the electroconductive paste gel Grease the electrodes or one needed electrode with the electroconductive paste gel Operate the system in the prescribed conditions Read the Warning about conditions of system s operating 8 Specifications 8 1 Main functions Function ECG acquisition HeartVUE system User s Guide Value The ECG acquisition of the 6 standard leads 1 II II aVR aVL aVF by KARDi2 4 PC ECG module Heart portrait The heart portrait is a snap shot on display as a result of calculating mean dispersion characteristics of low amplitude fluctuations during ECG input
18. nd installation options Seexch for the best driver in these locations Use the check boxes below to limit or expand the default search which includes local paths and removable media The best diver found wil be installed E Search removable media floppy CD ROM E Include this location in the search ODi g Don t search wil choose the driver to install Choose this option to select the device diver from a list Windows does not guarantee that the driver you choose will be the best match for your hardware 14 HeartVUE system User s Guide 4 Windows will show the installation progress for driver s files within few seconds At the end of installation press Finish button Found Ney Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for KARDIDSP Click Finish to close the wizard Back 5 To check that the driver installation was successful verify that in the Device Manager the KARDiDSP appears under the MCS USB Medical Devices Gomputer Management Fie Action View Window Help e ameasg E Computer Management Local BB System Tools J Event Viewer E gg Shared Folders f Local Users and Groups Performance Logs and Alerts Device Manager Gy Storage Removable Storage Disk Defragmenter Disk Management fp Services and Applications aux Computer E Se Disk drives i Display adapte
19. rs E DVD CD ROM drives S Floppy disk controllers J Floppy disk drives a Human Interface Devices IDE ATAJATAPI controllers E Gp IEEE 1394 Bus host S Keyboards KARDDSP Mice and other pointing devices F Ports COM amp LPT E S Processors amp SCSI and RAID controllers Sound video and game controllers 1 System devices E B Universal Serial Bus controllers SRA MCS USB Medical Devices 15 HeartVUE system User s Guide 5 1 2 Driver update For updating the driver double click on the KARDiDSP device in the Device Manager From the dialog select Driver property page and press the Update Driver button 1 Alternatively right click on the KARDiDSP in the Device Manager and then select Update Driver from the context menu KARDIDSP Properties General Driver Det ee KARDiDSP Driver Provider Medical Computer Systems Driver Date 08 10 2004 Driver Version Not available Digital Signer Not digitally signed To view details about the driver files To update the driver for this device if the device fails after updating the driver roll back to the previously installed driver 2 F 5 a To uninstall the driver Advanced 2 Then follow the Hardware Update Wizard and perform the same steps as during the first time installation After getting to the following dialog select Don t search I will choose the driver to install Press Next button Hardware Update Wizard
20. ssions Group 1 The system uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The system is suitable for use in all establishments CISPR 11 other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not applicable Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are covered with IEC 61000 4 2 8 kV air 8 kV air synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power Not applicable transient burst supply lines TEC 61000 4 4 1 kV for 1 kV for input output lines input output lines 25 HeartVUE system User s Guide Guidance and manufacturer s declaration electromagnetic emissions Emission test Compliance Electromagnetic environment guidance Surge 1 kV Not applicable differential mode IEC 61000 4 5 2 kV common Not applicable mode Interruptions and lt 5 UT gt 95 Not applicable voltage variations dip in UT for on power supply 0 5 cycle input lines IEC 61000 4 11 40 UT 60 Not
21. system must not be configured or connected in such a way that failure in its data acquisition processing or control functions can trigger patient feedback stimulus that poses an unacceptable level of risk e Use the special ECG electroconductive gel paste for the ECG acquisition e Do not spread the electroconductive gel paste on wounded or scarred skin e The HeartVUE system is intended for screening analysis of the ECG signals only for adults It is not suitable for children up to the age of 12 years old The system can be used for children and teenagers up to age 12 18 years old only for monitoring the tendencies in dispersive parameter changes For children and teenagers the use of the system is determined by the doctor in each specific case HeartVUE system User s Guide The HeartVUE system does not diagnose The system functions to define earlier dispersive deviations in the heart boundary states and inform about the presence of the pathology The HeartVUE system is not a substitute the other clinical methods of heart diagnostics it gives the additional information about the microchanges in the myocardium state The drug taking can influence on the accuracy of the heart portraits visualization and forming the conclusion and comments If the system is used during the drug treatment it is necessary to compare the current data with the data collected before the drug taking HeartVUE system User s Guide Manufacturer and represen
22. tatives The Manufacturer is Medical Computer Systems Ltd ADDRESS PHONE FAX E MAIL INTERNET Passage 4922 4 2 Zelenograd Moscow 124460 Russia 7 495 913 31 94 7 495 913 31 95 mks mks ru www mks ru The European Representative is HeartView Europe ADDRESS PHONE FAX E MAIL Talstrasse 20 CH 8001 Zurich Switzerland 41 1 212 60 06 41 1 212 6007 gvgoh adelphia net The World Representative is Heart View LLC ADDRESS PHONE FAX E MAIL 6805 Mayfield Rd Ste 1203 Cleveland OH 44124 USA 1 440 829 55 90 1 440 442 56 29 gvgoh adelphia net Document number 3180 The manufacturer has the right to alter this document according to the changes made by manufacturer for improving the system Print errors which may be presented in this guide will be corrected in future editions HeartVUE system User s Guide Contents 1 Abprevatons Saeeeeeee ee eOr Der etn oe nD enn Oe enOD NN ODON One UIT nena Eey 6 2 Symbols on VANS insane deds dade dedednradeindeaeeeiiadas 7 3 Main I ase sii a cledaibeasnidaiiacatiniataadiniaitekadainiesnenan das 8 4 General information cece ee eeee sees eee esse eee eeees 10 Fe MAN NT sss asa nts nites A A A A A E OTA 12 6 External COMPONENIS ccc ccsenstsssnesneseeseensnnee 19 7 Malfunctions and their correction 21 8 SG peciheatoiis raanei antl eine 23 HeartVUE system User s Guide 1 Abbreviations
Download Pdf Manuals
Related Search