KARDiVAR system
Contents
1. Mechanical resistance According to IEC 60601 1 23 KARDIVAR system User s Guide amp Specification 6 3 Electromagnetic compatibility Guidance and manufacturer s declaration electromagnetic emissions The KARDiVAR system is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The KARDiVAR system uses RF energy only for CISPR 11 its internal 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 KARDiVAR system is suitable for use in all CISPR 11 establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions Not applicable IEC 61000 3 2 Voltage Not applicable fluctuations flicker emissions TEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The KARDiVAR system is intended for use in the electromagnetic environment specified 24 KARDIVAR system User s Guide amp Specification Guidance and manufacturer s declaration electromagnetic immunity below The customer or the user of the de2. 3 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using 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 NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people KARDIVAR TV 27
3. KARDIVAR TV KARDIVAR system for stress level evaluation User s Guide Read Me First Rev 1 0 Warnings e Use IEC60601 1 1 standard to combine the KARDiVAR system with other devices computers and peripherals see chapters 4 1 and 4 2 e Do not operate KARDiVAR 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 6 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 KARDiVAR 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 KARDiVAR system in water e Take care of the system s components Avoid 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 KARDiVAR system And this system must not be configured or
4. L 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 18 KARDIVAR system User s Guide amp Specification 4 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 less than Intel Celeron1000MHz e Run under Microsoft Windows XP OS e Has two free USB1 1 or compatible port 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 4 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 nicke
5. P 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 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 Hardware Wizard Please choose your search and installation options Sezch 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 wil be installed V Search removable media floppy CD ROM E Include this location in the search ONDived I Don t search wil 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 13 KARDIVAR system User s Guide amp Specification 4 Windows will show the installation progress for driver s files within few seconds At the end of installation press Finish button Foun New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for KARDIDSP mS Click Finish to close the wizar
6. a disk that contains the diver you want to instal cick Have Disk Z Show compatible hardware Mode KARDIDSP Install From Disk Insert the manufacturer s installation disk and then make sure that the correct drive is selected below Copy manufacturer s files from CAKARDI2 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 Select the manufacturer and model of your hardware device and then click Next If you CRSP have a disk that contains the diver you want to install cick Have Disk Show compatible hardware Model KARDIDSP a This dver is nck Gokaly soned Tell me why driver sic isi 16 KARDIVAR system User s Guide amp Specification 3 2 Software installation and operation The installation description of the VARICARD KARDi software you can find in the applicable document VARICARD KARDi software User s Manual This document includes the operation documentation too 3 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 KARDi12 4 The second part of t
7. 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 KARDiVAR system is intended for screening analysis of the ECG signals only for adults It is not suitable for children up to the age of 18 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 KARDIVAR system User s Guide amp Specification The KARDiVAR system does not diagnose The system functions to define index of regulatory system activity by a heart rate variability analysis and inform about the presence of the deviations The KARDiVAR system is not a substitute the other clinical methods of heart diagnostics it gives the additional information about the heart rate variability The drug taking can influence on the accuracy of the index of regulatory system activity 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 KARDIVAR system User s Guide amp Specification Manufacturer a
8. ctors see chapter 4 3 8 Read the VARICARD KARDi software User s Manual document and use the VARIAARD KARDi software to operate with KARDi2 4 9 Place the ECG electrodes to the patients wrists and ankles and start a new examination 3 1 1 Driver first time installation After first connection KARDi2 4 to PC see chapters 4 1 and 4 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 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 Found 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 O Yes this time only O Yes now and every time connect a device No not this time Click Next to continue 12 KARDIVAR system User s Guide amp Specification 2 Windows will ask to install software automatically or from specific location Select Install from a specific location and press Next Found Ney Hardware Wizard This wizard helps you install software for KARDIDS
9. d 5 To check that the driver installation was successful verify that in the Device Manager the KARDiDSP appears under the MCS USB Medical Devices Gompiiter Management Sy Fie Action View Window Hep gt oH es 2 E Computer Management Local Bh System Tools GJ Event Viewer J Shared Folders Local Users and Groups Gi Performance Logs and Alerts Ej Removable Storage Disk Defragmenter Disk Management BR Services and Applications aay Lynx mW Computer FF Se Disk drives Display adapters HQ DVD CD ROM drives amp Floppy disk controlers J Floppy disk drives ila Human Interface Devices IDE ATA ATAPI controllers E a IEEE 1394 Bus hast controllers S Keyboards KARDIDSP Mice and other pointing devices A Ports COM amp LPT MP Processors I Network adapters 1 amp SCSI and RAID controllers a Sound video and game controllers E g System devices Universal Serial Bus controllers ER A MCS USB Medical Devices Ge KARDIDSP 14 KARDIVAR system User s Guide amp Specification 3 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 Detai
10. e of manufacturing x Bili Separate collection with electrical and electronic equipments for recycling Abbreviations Term Meaning CPU Central processing unit DC Direct current ECG Electrocardiogramm EMC Electromagnetic compatibility IRSA Index of regulatory system activity LED Light emitting diode MCS Medical Computer Systems Ltd OS Operational system PC Personal computer RF Radio frequency USB Universal serial bus KARDIVAR system User s Guide amp Specification 1 Main features 1 1 Intended use The KARDiVAR is a computer system for stress level evaluation by a heart rate variability analysis utilize up to 6 standard ECG leads This system contains the PC ECG module KARDi2 4 and the VARICARD KARDi software that converts the ECG leads to heart rate variability parameters and calculate the stress level The KARDiVAR system will avail for medics psychologists staff managers special agents the fitness industry sports teams and emergency medical facilities 1 2 Basic Functionality The basic features of the KARDiVAR system are 1 the 5 minutes ECG acquisition of the 6 standard leads I II Il aVR aVL aVF by KARDi2 4 analyzing and visualization 2 heart rate variability analyzing and creating index of regulatory system activity later the RSA where a stress level indicator is displayed as the Traffic light 3 analyzing and visualization basic hear
11. eeeee ee eeeeeer reese 9 2 3 Ma inten ne ieste ee ite eap eei aaaeei 10 3 Installation E dies ESE EEA Mad ee ee ee a 11 3 1 Hardware installation ccccccccseceeeeeeeeeeeeneeeeeeeeeeeseneeeeeeeeees 11 3 2 Software installation and Operation ccecceeseeeseeeeeeeeneeteaes 17 3 3 The PC ECG module fixation c cccccssceeeeseeeeeseteeeeseneeeees 17 4 External Components cceesecceceseeceeeseeceeeseeeeeseseeeeseneesenenseaeenenenees 18 4 1 Safety with Syste M akore ep asdar iestades a kaasi ea eaaa 18 4 2 Computer and peripheral deViceS cccesceeeseeeeeeeeeneeeeneeteaes 19 4 3 ECG electrodes and electroconductive gels pastes 19 5 Malfunctions and their correction eee eeeeeeeeeseeeeeeeneeeeeeneeeeeenaeeeeneae 20 6 SPecifications erian ernan eA inane 22 6 1 Main UNCION S kesise aeae aaa rae aalala attra 22 6 2 KARDi2 4 PC ECG module ccccecceeeeeeeeeeeeeeeeseeeeeneeeeneeeeneees 22 6 3 Electromagnetic compatibility 0 0 0 eee eeseeeeeeeneeeeeeneeeeseneeeees 24 KARDIVAR system User s Guide amp Specification Symbols on labels Symbol Meaning Electrical medical device CLASS N EQUIPMENT Electrical medical device TYPE CF with defibrillator protection Attention Carefully read specification or instruction for use a gt e o 0535 This device conforms to Directive 93 42 EEC USB connector Serial number Dat
12. f 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 Tf the malfunction is not corrected contact the manufacturer representative The data analysis takes more time than 1 minute The VARICARD KARDi software has been run with the concurrently running programs especially with the antivirus monitors Close the other running programs especially the antivirus monitors 20 Malfunction All or one of the ECG signals are not displayed on the screen KARDIiVAR system Probable reason The electrodes or the electrode of this lead are not connected to the patient PC ECG module failure User s Guide amp Specification Corrective actions Check the electrode cable s connection Check the electrode cable s fixation in the electrode Check the connection between the electrode and the patient Tf the malfunction is not corrected contact the manufacturer representative All or one of the ECG signals are very noisy The electrodes or one electrode are not greased with the elect
13. he 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 17 KARDIVAR system User s Guide amp Specification 4 External components 4 1 Safety with system For connecting the KARDiVAR system with other devices computers and peripherals printers scanner etc use the IEC60601 1 1 standard about safety requirements of medical electrical 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 M Mm NOTE Dimensions shown are not prescriptive Fig 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 AE
14. ic environment guidance test level level Portable and mobile RF communications equipment should be used no closer to any part of the KARDiVAR system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms 1 17VP TEC 61000 4 6 150kHz to d 7 80MHz Radiated RF 3 V m 3 V m d 1 174P IEC 61000 4 3 80MHz to 2 5GHz 80 MHz to 800 MHz d 2 33VP 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 Cp Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These 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 elec
15. l 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 19 KARDIVAR system User s Guide amp Specification 5 Malfunctions and their correction 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 the dick with the cleaning based on the alcohol Tf the malfunction is not corrected contact the manufacturer representative The Start button Start dv 1s not active or by pressing this button there is a message on an error 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 KARDi 2 4 is plugged into the USB hub with the external source of power Install the driver see chapter 3 1 1 If the driver is installed update it see chapter 3 1 2 Restart the program The indicator Mode is red The error occurred Replug the PC ECG module Reinstall the system driver T
16. ls amp gt KARDIDSP Driver Provider Medical Computer Systems Driver Date 08 10 2004 Driver Version Not available Digital Signer Not digitally signed Driver Details To view details about the driver files To update the driver for this device m If the device fails after updating the driver roll Roll Back Driver back to the previously installed driver 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 Please choose your search and installation options O 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 Include this location in the search C Root Work KARDI2 Evaluation Soft Host Driver Browse Dont search will choose the driver to install Choose this option to select the device driver from a list Windows does not guarentee that the driver you choose will be the best match for your hardware 15 KARDIVAR system User s Guide amp Specification 3 Press the Have Disk button sardar Uoer rre Select the device driver you want to install for this hardware a ao h n you REP have
17. nd representatives The Manufacturer is Medical Computer Systems Ltd ADDRESS Passage 4922 4 2 Zelenograd Moscow 124460 Russia PHONE 7 495 913 31 94 FAX 7 495 913 31 95 E MAIL mks mks ru INTERNET www mks ru The European Representative is JAN MICHAEL KUBIN C A T ADDRESS Gercenova 856 3 Prague The Republic of Czech 102 00 00420 728 130 912 00420 602 344 013 E MAIL info pansofia cz PHONE Medical device concerned Name of product KARDIVAR system Classification Class Ila Rule s used for classification Annex IX of MDD 93 42 ECC rule 10 Notified Body Eurocat 0535 Document number 4166 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 Document revision history Revision Comments 1 0 Original Release KARDIVAR system User s Guide amp Specification Contents W etaa Te EEEE ETETA TEAT E dea tins E 2 Manufacturer and representatives eeeeseieeeeieeriirsrrrnssriinerirrrerirnnrinnserinnnt 4 Symbols on labels senenin e a a A pree r a a a eT a ee abana eat eet 1 Main teatre Sesionet ee ea ee neoa ra tvectentdlniecs asetacnevice arae oaaae 1 1 Intended use 1 2 Basic Functi nalitya sis eiin ik n a 7 1 3 Classification 2 General information 2 1 Packaging 2 2 Warranty service life and utilization sssneeeeeeee
18. ording 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 decimation up to frequency 16kHz 22 Parameter Digital signal processing KARDIVAR system User s Guide amp Specification Value Filtration and decimation up to 500 Hz 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 USB 2 0 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 Humidity up to 97 without condensation
19. roconductive 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 21 KARDIVAR system User s Guide amp Specification 6 Specifications 6 1 Main functions Function ECG acquisition Value The ECG acquisition of the 6 standard leads I Il I aVR aVL aVF by KARDi2 4 PC ECG module Stress level indicator Stress level evaluation by a heart rate variability analysis as a result of calculating IRSA Results of heart rate variability analysis Heart rate variability visualization graphic Basic heart rhythm variability parameters table Heart rhythm systems regulation status table Analysis conclusion The medical and physiological conclusions about functional states of autonomic regulation system on the basic of prenosological principles For more detail see VARICARD KARDi software User s Manual 6 2 Parameter Number of channels KARDi2 4 PC ECG module Value The KARDiVAR system has 3 monopolar channels The ECG leads are calculated on the PC by VARICARD KARDi 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 acc
20. ser s Guide this document VARICARD KARDi User s manual Special fastener for the system fixation see chapter 3 3 Optional PC and or printer oOo N A un A WH N Case for all aforementioned items 2 2 Warranty service life and utilization The system and all equipment according to the chapter 2 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 KARDiVAR systems 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 KARDIVAR system User s Guide amp Specification 2 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 freq
21. t rhythm variability parameters 4 the conclusion and comments creating ECG S visualization Patient VARICARD KARDi PF aN Stress level software E rhythm N Pa iivstectins systems VY Oe Data A regulation N KARDI 2 4 ECG acquisition gt Ei S status AS of N NA regulatory k Gn activity A a RSA d Heart rate gt rhythm PRE N variability i Y Data ECG saving paniy parameters g electrodes pes anaysie S HRV N Conclusion and P A ezm rate comments N variability visualization J eee Fig 1 The basic features diagram of the KARDiVAR system KARDIVAR system User s Guide amp Specification 1 3 Classification The KARDiVAR system is a Class Ila 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 against 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 6 3 KARDIVAR system User s Guide amp Specification 2 General information 2 1 Packaging The following items form the whole package 1 PC ECG module KARDi2 4 with fixed USB cable Clamp ECG electrodes see chapter 4 3 The CD disk with driver and VARICARD KARDi software KARDiVAR system U
22. tromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the KARDiVAR system is used exceeds the applicable RF compliance level above the KARDiVAR system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the KARDiVAR system P Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the KARDiVAR system The KARDiVAR system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the KARDiVAR system can help prevent electromagnetic interference by maintaining a minimum distance between 26 KARDIVAR system User s Guide amp Specification portable and mobile RF communications equipment transmitters and the KARDiVAR system as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum a output ee OOOO power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter 35 35 7 hi d NP d wvP d VP 3 3 3 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 2
23. uency response during the whole system s life cycle If necessary contact the manufacturer representative for factory re calibration 10 KARDIVAR system User s Guide amp Specification 3 Installation 3 1 Hardware installation black N red R F green L yellow Fastener Mode indicator Fig 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 2 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 3 3 3 Turn on the PC and wait till the Windows OS will be loaded Make sure that the PC meets the requirements of the chapters 4 1 and 4 2 4 Insert the CD disk with driver and VARICARD KARDi software in the CD ROM 11 KARDIVAR system User s Guide amp Specification 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 6 Install the VARICARD KARDi application software see chapter 3 2 7 Connect ECG electrodes to the ECG conne
24. vice should assure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment test level level guidance Electrostatic 6 kV contact 6kV contact Floors should be wood discharge concrete or ceramic tile If ESD 8 kV air 8 kV air floors are covered with IEC 61000 4 2 synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power Not transient burst supply lines applicable IEC 61000 4 4 41 KV for input output 1 kV for lines input output lines Surge 1 kV differential Not TEC 61000 4 5 mode applicable 2 kV common mode Not applicable Interruptions lt 5 UT gt 95 dip Not and voltage in UT for 0 5 cycle applicable variations on S power supply 40 UT 60 dip in Not input lines UT for 5 cycles applicable TEC 61000 4 70 UT 30 dip in Not 11 UT for 25 cycles applicable lt 5 UT gt 95 dip Not in UT for 5 sec applicable Power 3 A m 3 A m Power frequency magnetic frequency fields should be at levels 50 60 Hz characteristic of a typical magnetic field location in a typical IEC 61000 4 8 commercial or hospital environment The KARDiVAR system is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment 25 KARDIVAR system User s Guide amp Specification Immunity test IEC 60601 Compliance Electromagnet
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