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BTL-08 MT Plus BTL-08 LT BTL-08 LT Plus BTL-08 LC

1. Part 2 51 Particular requirements for safety including essential performance of recording and analysing single channel and multichannel electrocardiographs Date of last revision 4 June 2010 TECHNICAL PARAMETERS PAGE 42 OF 43 IEC EN ISO MDD IEC 60601 1 A2 A11 a A12 IEC 60601 1 1 IEC 60601 1 2 EN 55011 IEC 61000 4 2 IEC 61000 4 3 IEC 61000 4 4 IEC 61000 4 5 IEC 60601 1 4 ISO 14791 ISO 10 993 1 MDD 93 42 EEC IEC 60601 2 25 A1 IEC 60601 2 51 1 MANUFACTURER This product is manufactured in accordance with the EU Medical Devices Directive by BTL Industries Ltd 161 Cleveland Way Stevenage Hertfordshire SG1 6BU United Kingdom E mail sales btInet com http www btInet com For service please contact the service department at service btInet com Ce All rights reserved No part of this manual may be reproduced saved in a research centre or transferred by any means incl electronic mechanic photographic or other records without previous approval from BTL Industries Limited BTL Industries Limited operates a policy of continuous development Therefore it reserves the right to make changes and improvements to the Product described in this manual without prior notice The contents of this document is provided as is Except as required by applicable law no warranties of any kind either expressed or implied are made in relation to the accuracy reliability or contents of this
2. SETUP MODE PAGE 31 OF 43 CSD 1 3 Profile Setup Here you can set options of all print profiles including the default profiles automat manual and print screen It is possible to add any number of additional user profiles of type manual automat or long It is possible to edit the existing profiles and possibly delete them except for the default profiles that cannot be deleted 4 1 3 1 Setting Auto Man Print Screen Profile Parameters For each profile you can set the following parameters e profile name name profile type manual automat type sensitivity sensitivity paper feed speed paper speed used filters select filters length of the printed and saved record rec duration only for the automat type profile select if the record will be printed or only saved in the memory printed print options print setup o number of leads printed on the page length of printing of the records only for the automat type and print screen type profiles leads to be printed only for the manual type profile in time or synchro automat print mode only for the automat type profile enable disable the check of loose leads before the start of printing only for the automat type profile centering data to be printed in the header of the record set the time of start of printing only for the automat and print screen type profiles the start time of the record may be up to 10 seconds before pressing the print button i e 10s If you wa
3. Bottom Cover of the A4 Series Equipment 0 ec eeceeeeeeeneeeeeeeeeeeneeeeaeeeeeeeeaeesaeesaeesaeeeaeeseaeeseeseaeesaeesaeesseeeenneeeaees Assembly and Putting into Operation Functions of the Keyboard Buttons man drift monitor leads patient print screen contrast form feed FF reset of the device Check of Loose Leads Printer and Paper Paper Sensitivity Tai Roll ECG Pape icici ceieccacicseds tes ctcpesetaia de tecd ives dagidan inan daade daitan dangoa e dediat Papada daanan dansado adadi iura dancoi edadia Ue daia Fax Paper without Grid sssrinin iat a aeaiee riae E E e ESEE E A E E aan aE ESEE SEE Z foldered Paper perforated USB Printer Set ee bes r SOl tION dpi arreeenerrer rere rRerre et peeeererrrecrerrerrrererrcrreverererrerrereer pers prevent rere rrreccrerr ter rrrperr reer a AEA rere errr er printer test oiiire atin Ait dan anneaseieain anti ads teenth disnae iter ducatanieie ate eini pdn Storage Conditions for Thermo Sensitive Paper Accumulator sssi asne ier rasiti AEN Eada sa aO Nece a A T E E EE AT E A T A A E A A E EXAMINATION e E MG Selection of Profile for ECG Recording Position of ElectrodeSs pp Limb Electrodes Chest Electrodes ccccccssssssssscsvssssssessscsessssesss Examination Process cccccccccccccsssssceceesesssseeeeeeees Examination in the Automat Profile Examination in the
4. e the supported operating system is Windows XP and Windows 2000 4 1 2 10 User Setup 4 1 2 10 1 Date Time Setting of date and time in the device This date and time are stored and printed together with the records The device remembers the set date and time even if it is unplugged from the mains and the accumulators are low 4 1 2 10 2 Display Contrast Here it is possible to set the required display contrast The function is the same as after pressing the contrast button in the on line screen For setting of contrast use the arrow buttons on the touch screen or on the keyboard Note At the colour display the change of contrast may lead to change of the colour representation of the current colour scheme SETUP MODE PAGE 29 OF 43 CSD 10 3 Select Language Setting of the language in which the equipment communicates The change of language does not occur before restart of the equipment 10 4 Touch Panel Calibration If after touching of the touch screen there react other display buttons than required it is necessary to calibrate the touch panel The process of calibration is described on the display follow the instructions For calibration use the touch pen If calibration does not proceed successfully you can interrupt it at any time by pressing esc For check of the result of calibration use the touch panel function test function 10 5 Repair of Files If the stored data are corrupt because of interference or a dev
5. new exchanges and mobile phones ATDP for pulse dialling older exchanges Example for calling the number 2 333 555 84 using the tone dialling enter ATDT233355584 Schematic connection of ECG at the data export to a PC via modem and dial up line Schematic connection of ECG at the data export to a PC via mobile phone SETUP MODE PAGE 27 OF 43 CSD 4 1 2 9 3 Transfer USB gt BTLO08 Export via USB serves for exporting all records from the Records database all patients from the Patients database and all physicians from the Physicians database into the PC via the USB A A cable During the export the computer displays a removable disk called ecg data which contains three directories Records Patients and Doctors 2101 x File Edit view Favorites Tools Help ae Back v Me wi K Search Ia Folders in Adres File and Folder Tasks x CJ RECORDS E Make a new folder Publish this Folder to the Web CJ DOCTORS E3 Share this Folder CJ PATIENTS Other Places 1 My Computer My Documents Shared Documents My Network Places Details ECG DATA E Removable Disk File System FAT The Records directory contains XML files called RecN xml where N is a number from 0 to 119 representing the position in the device s memory on which the file is saved Each file contains data of one record In addition a file called Records txt is created in this direc
6. set the ECG signal print line width line width select information to be displayed in the patient card patient card setup set optional patient data optional patient data select displaying of loose leads display loose leads set the print parameters and the used paper type setting of paper and print set the parameters of export of the stored records to PC export setup enter another user setup menu of the device user setup 4 1 2 1 Starting Profile Here you can select the profile that will be automatically set after switching the equipment on by the on off button SETUP MODE PAGE 25 OF 43 CSD 4 1 2 2 Max Heart Rate Here you can set the heart rate value which the equipment will consider the highest allowed If the measured heart rate is higher than this set value the equipment makes warning by high intermittent beeping If this maximum heart rate value is set to zero 0 the function is disabled 4 1 2 3 QRS Beep Here you can enable disable the acoustic signalling of QRS complex of the ECG curve 4 1 2 4 Rhythm Lead Here you can set from which lead the device will determine the heart rate In most cases it is not necessary to change the default settings in special cases the lead can be changed e g in some types of ergometric examination 4 1 2 5 Line Width Here you can set width of the ECG curve printed on the paper The setting shall be refined according to the used paper This setting influences only the
7. Manual Profile Examination in the Print Screen Profile Examination in the User Profiles pp Examination in the Long Profile pp Reliability of Measuring and Diagnostics ss US6 0f Filtersiveccse E E A AE EE E seag neetsacees tees ooh cokes EALE E Moma eee dh caus Audet ed SETUP MODE EE E tavdeusuaauusaseuabudedueasivtvaaasdddsunvansdssicedsasstatvess ae Record Databas eearri iiei eie eare LE thas sacs sacs ctensgheads ceateadewdes E aa AELE AEAEE 4 1 2 Unit SS TU Os enact fees cance cane cise e cg scesctacscesatiesvaschacedeicehanectantdecetoesensceagedeseechaaceshataascesatiesess cigs a a 4 1 2 1 Starting Profile a 4 1 2 2 Max Heart Rate tbs 4 1 2 3 QRS BOOP 4 1 2 4 PRY Sa PERRE EE EEEE etal nds denanedicoaig ates A EE A ER T 4 1 2 5 Line Width 4 1 2 6 Patient Card Setup jiis 4 1 2 7 Optional Patient Data 26 4 1 2 8 Setting of Paper and Print pe 1 26 4 1 2 9 Export Setupis ticcciediainvasdsnanedns 1 26 4 1 2 9 1 Transfer Serial Cable gt BTLO8 1 26 4 1 2 9 2 Transfer Modem gt BTLO8 0ce wel 4 1 2 9 3 Transfer USB gt BTLO8 pp 1 28 4 1 2 10 User SetU iiini idoira nas 29 4 1 2 10 1 Date Time pe 29 4 1 2 10 2 Display Contrast pp 1 29 4 1 2 10 3 Select anguage cciviesee ETTE Mande etaiin Ageia eg E E elena 30 4 1 2 10 4 Touch Panel Calibration isccccccceiseccsecited otceaetscaduave
8. This type of electrocardiograph is not designed for on line monitoring of ECG signal in workplaces connected to life support ICU operating rooms etc Owing to possible risk which could result from simultaneous connection of more various devices to the patient mutual influence possible endangerment of the patient by summation of the leaking currents we do not recommend to use this electrocardiograph in connection with other devices than stated in this User s Manual The equipment and the accessories must not be used in a way out of accord with this User s Manual During work with this equipment use the recommended protective means Keep the equipment out of reach of children The equipment does not contain any components which could be repaired by the user Do not remove any covers from the equipment All repairs should be done by the authorized BTL service department EQUIPMENT MAINTENANCE AND SAFETY PAGE 38 OF 43 CSD 6 3 WARRANTY The Manufacturer of this product warrants the product to be free from defects in workmanship and material for a period of twelve months after the date of shipment from the factory This warranty excludes any disposable items and accessories including but not limited to cables or leads power cords and electrodes The manufacturer agrees to correct such defects without charge or at its option to replace the item with a comparable model All costs of shipment are the responsibility of the purchaser Damage to
9. and table of analysis is not set but you still want to print it press the analyse button only the types with DIAGNOSTICS If you want to print the record again set the print options using the keyboard and then press the copy button To perform automatic recording of another patient press the print button EXAMINATION I PAGE 20 OF 43 CSD Examination in the Manual Profile Process of examination SWITCH ON the unit FASTEN THE ELECTRODES SELECT PROFILE using the man button Unit Setup START RECORDING using the print button TERMINATE or INTERRUPT recording using the stop button Before start of recording check and possibly modify the following parameters it is also possible to change them during recording e paper speed the mm s button sensitivity the mm mV button number of leads the number of leads button leads required to be printed the select leads button set the required filers using the filter and drift buttons Press the print button The device starts printing of the curves on the thermo sensitive paper To terminate recording press the stop button To print record of another patient press the print button Note In the manual mode the data of the ECG signal are not stored in the records database Examination in the Print Screen Profile Process of examination SWITCH ON the unit FASTEN THE ELECTRODES START RECORDING using the print screen button AUTOMATIC TERMINATION or INTERRUPTION by the st
10. any part such as by accident or misuse or improper installation or by use of any accessories or abrasive material not produced by the Manufacturer is not covered by this warranty Because of varying climatic conditions this warranty does not cover any changes in finish including rusting pitting corrosion tarnishing or peeling Servicing performed by unauthorized persons render this warranty invalid There is no other express warranty The Manufacturer hereby disclaims any and all warranties including but not limited to those of merchantability and fitness for a particular purpose to the extent permitted by law The duration of any implied warranty which cannot be disclaimed is limited to the time period as specified in the express warranty The Manufacturer shall not be liable for incidental consequential or special damages arising out of or in connection with product use or performance except as may be otherwise accorded by law This warranty may differ from the warranty terms and conditions provided by your supplier and by applicable laws in your country EQUIPMENT MAINTENANCE AND SAFETY PAGE 39 OF 43 CSD 7 TECHNICAL PARAMETERS Type Display dimensions mm resolution dots BTL 08 MT Plus ECG BTL 08 LT ECG BTL 08 LC ECG touch screen 171 x 128 640 x 480 VGA touch screen 118 x 89 640 x 480 VGA touch screen 118 x 89 640 x 480 VGA BTL 08 LT Plus ECG touch screen 118 x 89 640 x 480 VGA BTL 08 LC P
11. device print Press this button to start printing of the record and possibly saving in the memory in the set profile INSTRUCTION FOR USE PAGE 11 OF 43 CSD 5 stop Press this button to interrupt the running print If the device is busy e g by analysis of the signal the response for pressing the stop button may be delayed In such case wait until the device stops the running operation and then press the button again 6 analyse Button for printing of verbal interpretation and the table with the results of analysis of the last record taken in the automat or a derived mode It is active only if the DIAGNOSTICS module is implemented 7 Copy Button for reprinting of the last record taken in the automat or a derived mode Printing is performed with the current values of filters sensitivity and speed so if the values have changed since the last recording in the automat mode the result of the print may differ from the original If you need an absolutely identical copy set the speed sensitivity and filters the same as in the original and only then press copy 8 1mV Button for printing of the calibration signal of the amplitude 1 mV The mark is printed only when printing in the manual mode 9 restart Button for restarting of ECG inputs and ECG internal amplifiers Use this button if you are not sure about the quality of the measured ECG record or if the ECG curves are out of the display 10 number of leads Button for selectio
12. display It is possible to select the adaptive auto filter which on the basis of the signal analysis automatically activates the needed filter so that the quality of the resulting signal is maximum The adaptive auto filter cannot be combined with other filters Filters and their combinations can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the filters button there appears a screen containing all available filters Here it is possible to activate any filter or combination 6 monitor leads Button for cyclical switching among the leads displayed on the screen If the screen displays less than 12 leads at a time this button enables to switch cyclically to other leads which are not currently displayed The displaying and number of leads depends on the current display setting mode button The leads for displaying can be also switched on the touch screen After touching the display at any point there appears the top and bottom toolbars The monitor leads button on the screen has the same function as the analogous button on the keyboard 7 patient Button for opening of the diaro window for entering data of a new patient To save data press OK These data are printed in the record and stored in the memory together with the record and can be loaded from the database see Record Database in the menu viewed and or printed on the ECG paper The types of da
13. of paper stops shining The printer is ready INSTRUCTION FOR USE PAGE 15 OF 43 OR gt To check if the paper is inserted and set correctly check menu unit setup setting of paper and print after pressing the insert paper touch button The button for inserting paper or feed to the next page FF form feed is available also in the lower left corner of the on line screen after touching the screen at any point By this button you can eject the paper slightly from the printer at any time Tearing of paper It is recommended to tear the fax paper by pulling it from the bottom margin over the tearing edge towards the display ATTENTION It is essential to insert paper carefully and absolutely parallel to the tearing edge the grid on the paper must be parallel to the tearing edge otherwise it will later bend to a side and possibly crumple or tear Fax Paper without Grid BTL 08 ECG Series devices can also print on a standard thermo sensitive white fax paper without the pre printed grid or standard sheet of paper on external printer In such case it is necessary to enable the print grid item in menu unit setup setting of paper and print Other settings and handling are the same as for the paper with the pre printed grid ATTENTION It is essential to insert paper carefully and absolutely parallel to the tearing edge otherwise it will later bend to a side and possibly crumple or tear Z foldered Paper perforated Mo
14. printing starts INSTRUCTION FOR USE I PAGE 13 OF 43 CSD immediately after pressing this button and it is not necessary to start recording by the print button This profile also enables to set retrospective printing the minus time of the start of printing i e it is possible to print and save an event which has already passed up to 10 seconds back in time The profile is configured similarly to the auto profile This button is available only for BTL 08 Lx Series 2 4 21 contrast Button for prompt setting of the display contrast The contrast can be also changed in the equipment settings menu Note At the colour display the change of contrast may lead to change of the colour representation of the current colour Scheme 2 4 22 esc Button for rejection of a selection and or return to a higher dialogue window in the menu without saving the entered values The touch button on the screen if displayed has the same function as the keyboard button 2 4 23 enter Button for confirmation of a selection and saving of the value and or for entering the lower window in the menu The touch button on the screen if displayed has the same function as the keyboard button 2 4 24 up down arrow Buttons for movement in the menu and or for change of values The touch buttons on the screen if displayed have the same function as the keyboard buttons 2 4 25 on off Button for switching the device on off At switching off the devic
15. the ECG signal strong electromagnetic disturbance scanning of ECG without using of high conductivity gel and the like we recommend using the ADS filter 0 6sec Splines filter A new generation filter which is able to suppress the base line fluctuation almost perfectly while all important parameters of the ECG signal remain preserved It is based on the parameters of the record and on the precisely specified points in the record which enables it to eliminate considerable interference of this type All the stated filters can be mutually combined so that the filtration of the record is optimum EXAMINATION PAGE 24 OF 43 CSD 4 SETUP MODE 4 1 MAIN MENU To enter this menu press the button menu in the lead monitoring mode The menu can be also entered using the touch screen After touching the display at any point there appear the top and bottom toolbars After pressing the menu button in the lower right corner there opens the main menu Here you can select from the following options e Record Database Unit Setup Profile Setup Select Patient Displayed Leads Select Physician 4 1 1 Record Database This menu enables to open view and print the last taken records The records are stored in the memory automatically If the memory is full the next taken record overwrites the oldest stored record The records which are marked as archive mark button a sign is displayed in front of the record are not overwritten and remain in the m
16. to the Patients directory of the ecg data removable disk The names of the files must be PatN xml N number from 0 to 119 representing the position in the device s memory on which the file will be saved e the xml files of the physicians which you want to import must be copied in the PC to the Doctors directory of the ecg data removable disk The names of the files must be DocN xml N number from 0 to 119 representing the position in the device s memory on which the file will be saved Before leaving the export screen it is necessary to remove safely the USB device from the PC operating system in the same way as any other USB device After leaving the export screen in the Record Database all files of the records patients and physicians on the removable disk are saved in the device s memory and are available in the Record Database and in the Select Patient and Select Physician options Limitations e USB export import is supported only by units of version 110 and higher see manufacture label on the bottom cover e USB export import is supported for firmware version 1 42 and higher for firmware version see Unit Information e the recommended length of the USB cable is 1m for longer distances use the recommended USB HUB PC requirements e PC must be equipped with the USB port USB1 1 or USB2 0 e the minimum configuration necessary for direct online sending of data to the PC program BTL 08 Win is Intel Pentium III 1 0GHz RAM 128MB
17. 1 Medical electrical equipment Part 1 General requirements for safety 1 Collateral standard Safety requirements for medical electrical systems Medical electrical equipment Part 1 General requirements for safety 2 Collateral Standard Electromagnetic compatibility Requirements and tests Industrial scientific and medical ISM radio frequency equipment Radio disturbance characteristics Limits and methods of measurement Electromagnetic compatibility EMC Part 4 Testing and measurement techniques Section 2 Electrostatic discharge immunity test Basic EMC Publication Electromagnetic compatibility EMC Part 4 Testing and measurement techniques Section 3 Radiated radio frequency electromagnetic field immunity test Electromagnetic compatibility EMC Part 4 Testing and measurement techniques Section 4 Electrical fast transients burst immunity test Basic EMC Publication Electromagnetic compatibility EMC Part 4 Testing and measurement techniques Section 5 Surge immunity test Medical electrical equipment Part 1 General requirements for safety 4 Collateral standard Programmable electrical medical systems Medical devices Risk analysis Biological evaluation of medical devices Part 1 Evaluation and testing The Medical Devices Directive 93 42 EEC Medical electrical equipment Part 2 Particular requirements for safety of electrocardiographs Amendment to IEC 66001 2 25 Medical electrical equipment
18. BTL 08 MT Plus BTL 08 LT BTL 08 LT Plus BTL 08 LC BTL 08 LC Plus at x te Y 2 PAGE 2 OF 43 BEFORE YOU START Dear Customer Thank you for purchasing BTL technology All of us at BTL wish you every success with your system We pride ourselves on being as responsive as possible to our customers needs Your suggestions and comments are always welcome since we believe an ongoing relationship with our customers is critically important to our future product line While we would like you to start using your new equipment right away we encourage a thorough reading of this manual in order to fully understand the operational features of the system Please visit our corporate website at http www btInet com for the latest information on BTL products and services Again thank you for being a BTL customer BTL Industries Ltd CONTENTS PAGE 3 OF 43 GENERAL CHARACTERISTICS cccccscesssssssessnesseessesseesneseessaesseeseessessaesseesnesaesseseaeeseesaessaeseesaevansnaesanesaesonssaasseusaevanesaesaneas INSTRUCTION FOR USE Sitscvesissicssscntteastsisvesiansescieccausiasiiassessanssseacdassctesidansibnsiiessasiansssnadieddsissiadasescitssveicassshuandassnaageadevanedadste Outward appearance of BTL 08 MT Plus ECG Top Panel and Keyboard of the Equipment Rear Panel of the Equipment BTL 08 LX ECG Series pp Top Panel of the Equipment Keyboard pp Rear Panel of the Equipment
19. C via the RS232 line 24 connector for connection to PC printer via USB 25 anti interference clamp on the bottom cover of the equipment 26 type label 27 manufacture and warning label on the bottom cover of the equipment INSTRUCTION FOR USE PAGE 9 OF 43 25 26 27 2 4 Bottom Cover of the A4 Series Equipment 28 slots for fixing the paper in 295 x 210 mm dimension 29 slots for fixing the paper in 280 x 210 mm dimension default position 30 earth connection 31 slots for fixing the paper in 150 x 210 mm dimension 32 holes for fixing the device on the cart 2 3 ASSEMBLY AND PUTTING INTO OPERATION Unpack the equipment and place it on a stable horizontal surface proportioned for the equipment s weight out of reach of sunlight During the operation the equipment gets warm therefore it must not be located close to heat producing devices Do not put any heat producing devices on the equipment neither objects containing water or other liquid Do not place the equipment close to devices producing strong electromagnetic electric or magnetic field diathermy X rays etc otherwise the equipment could be undesirably influenced The ECG paper is heat sensitive and therefore should be also located out of reach of heat emitters including sunlight see Storage Conditions for Thermo Sensitive Paper In case of any questions please contact the authorized BTL service department All BTL 08 ECG Series devices have its ow
20. D Cleaning of Accessories Which Come into Contact with the Patient e g electrodes We recommend cleaning these parts after treating of each patient For cleaning use agents which were approved by the competent health officer e g Sekusept Bacilol Incidur spray for the accessory cables and the like SAFETY ATTENTION A oh In the connector marked as above only the original BTL patient cable shall be connected which is the only cable to ensure the resistance to defibrillation The applied part is of the CF type The clamp marked as above is connected with the equipment s frame If the ECG signal is considerably interfered it is possible to connect the clamp to the potential of the patient ground e g the metal frame of the bed Safety Precautions e Before first switch on of the equipment read carefully the User s Manual e All staff to use the equipment must be instructed of the way of operation maintenance and checking of the equipment and of the safety principles of its use e The electrical cabling which the equipment will be connected to must be installed and tested according to the existing valid standards IEC 364 If you are not sure that the mains are completely OK get them inspected by an inspection engineer e Check if the parameters of the mains correspond to the requirements of the equipment according to Chapter Technical Parameters and if the voltage switch located on the rear panel of the equipment is switch
21. LJ 1022 For actual information on list of compatible printers please contact your distributor 2 6 5 1 resolution dpi This item is used to change resolution used in USB print For faster print 200 dpi is recommended 300 dpi is dedicated for better quality of printing Print test page to see which resolution is appropriate for your printer 2 6 5 2 printer test 6 For checking right connection or settings test page can be printed only on USB printer Page contains dimensions for checking of right resolution used resolution USB printer description and unit description Compare effective dimensions of printed area with those presented on paper to see if correct resolution is selected Storage Conditions for Thermo Sensitive Paper The printer is designed for thermo sensitive paper To achieve as long as possible time stability of the printout it is essential to keep the following terms of storage of new as well as of the printed paper e storage temperature 25 and lower e relative humidity 65 and lower e do not expose paper to the sunlight e do not expose paper to long lasting radiation of fluorescent sources tubes etc e prevent contact of paper with glue based on alcohol ester ketone etc Use only dispersive glue based on starch PVA or CMC e prevent any direct contact of the paper with PVC packages These packages contain substances based on ester which would spoil the thermo sensitive layer and cause vanish
22. PAGE 32 OF 43 CSD 4 1 4 Select Patient The equipment provides the database of patients in which it is possible to enter edit and delete the patients The new patient can be also entered in the on line mode by pressing the patient button The data to be entered in the patient card can be set in the unit setup see Patient Card Setup The number of patients is limited only by the capacity of the equipment s memory The information about the patient is printed in the header of the record according to the profile setup The saved patients remain in the memory even after switching the equipment off The set current patient always sets to blank after switch on 4 1 5 Displayed Leads Here it is possible to configure displaying of the leads on the on line screen it is possible to change the arrangement of displaying as well as which signals shall be displayed in the individual windows the select leads button The device remembers the setting even after being switched off To overwrite the setting press the mode button 4 1 6 Select Physician The equipment provides the database of physicians in which it is possible to enter edit and delete the physicians The number of physicians is limited only by the capacity of the equipment s memory The information about the physician is printed in the footer of the record according to the profile setup The saved physicians remain in the memory even after switching the equipment off The set current physic
23. Quality of the ECG record is particularly dependent on the contact between the electrode and the patient s skin To keep the contact as good as possible please observes the following principles e the skin should be warm and the patient relaxed e before fastening the electrode cleanse the skin with alcohol e apply sufficient layer of gel on the electrode It is recommended to fasten the electrodes in the following order e first fasten the N electrode to the right leg e then fasten the other limb electrodes R L F e finally fasten the chest electrodes in the following order V4 V2 V1 V3 V6 V5 The following two parts of this document contain the detailed description of the electrodes position EXAMINATION I PAGE 19 OF 43 CSD 3 1 Limb Electrodes R red right arm L yellow left arm F green left leg N black right leg 3 2 Chest Electrodes V1 red the fourth intercostals space to the right from the sternum V2 yellow the fourth intercostals space to the left from the sternum V3 green in the middle between V2 and V4 V4 brown the fifth intercostals space in the MDCL line V5 black at the level of V4 in the front auxiliary line evenly between V4 and V6 V6 violet at the level of V4 in the central auxiliary line 3 4 EXAMINATION PROCESS e Switch on the equipment by the on off button on off e To enter the name of the patient to be printed in the record press the button rt
24. RD button 1 2 10 20 Delete Patient After Recording Here you can enable disable the possibility of deleting the patient after recording 1 2 10 21 Save Current Physician This function enables disenabled the possibility to save the name of current physician 1 2 10 22 Next This button opens additional items of the user setup submenu 4 1 2 10 22 1 Automat Profile Print Speed The speed of resulting printing in the profiles derived from the automat profile is always constant and independent of setting of the recording speed This option enables to change the basic speed Middle speed is 25mm s and provides high quality print on most of the paper types When using better paper it is possible to set higher speed 50mm s and thus speeds up the routine operation of the device In isolated cases e g if worse paper is used it is possible to set lower speed 10mm s This setting applies only for the automat modes and does not influence the print speed in the manual mode 4 1 2 10 22 2 Hospital name This function enables to enter the name of hospital that will be printed with the record 4 1 2 10 22 3 Colour Schemes and Colours of Leads These options are active only in the colour device model LC They enable to change the colour representation of the display Several colour schemes are factory preset in addition it is possible to create edit and delete the user colour schemes You can also assign a colour to each displayed lead and element
25. a to the PC At the same time it is possible to configure the channel In most cases the default setting is sufficient Data are transferred from the unit to the BTL 08 Win or BTL 08 Ergo program The selected communication channel will be used in the export option in the Record database see Record Database 4 1 2 9 1 Transfer Serial Cable gt BTLO8 SETUP MODE PAGE 26 OF 43 CSD When exporting data to the PC via the cable no special setting is necessary The connection speed is 115200baud The BTLO8Win Ergo program must be running on the PC and the receiving form must be open The option enable online export through serial cable enables direct online sending of data via the serial line to the PC program BTL 08 Win Data will be sent whenever the BTL 08 Win program on the PC is run in the Automat mode and the leads are being drawn on the on line screen 4 1 2 9 2 Transfer Modem gt BTLO8 When exporting via the phone line a modem or a mobile phone equipped with a hardware modem must be connected to the ECG Write in the init string box the initialization text string for putting the modem into the required mode For details on individual commands in the initialization string see the User s Guide of the modem The default settings work with most of the standardly sold modems The dial string box contains the phone number of the called telephone Enter the phone number including the test string at the beginning ATDT for tone dialling
26. aceteztetdperste 5 1 ACCOSSOMCS aons edad aidaa iaeiiai chan caagaadesocesden cadacadeegigtaseaagateteenad deadaadaeeaigitalsai ddeeeatebad naan 5 2 Upgrade wise cicsncacieiiesiiss 5 3 ECG Paper recommended types 6 EQUIPMENT MAINTENANCE AND SAFETY ccsccscseseesceseeseeeeeeeseeeneseneeeeeseesaeseeeseaeseeseeseeseaessaesaeseeseaeeseeseseeeeeeeneesesenes 35 6 1 Cleaning of the Equipment s Surface and of lts Parts 4 35 6 1 1 Cleaning of the TOUCH Scre icisevtsicaicecascacttecedi gots dea gece tanedadedeeans daniu dagen tnsevied aiaiai piradi caiiint pdeng 6 1 2 Cleaning of the Paper Sensors 6 1 3 Cleaning of the Printer Head pp 6 1 4 Cleaning of the Bearings of the Rubber Roller 6 1 5 Cleaning of Accessories Which Come into Contact with the Patient e g electrodes 6 2 SAPO secs seecuae cided ETE T E EEA 6 3 aE lice Ug WY E ere eeriepeerercente cere trreees ieee re re yereeetee A rey T 7 TECHNICAL PARAMETERS a cceicsnesctsscesccstcccccseteseesdencte sccevetsnddetseccestnsceeddesctecceedehned ctbeceescteecesddetedscdcttessecdetserendvtecencdehesesedti 40 7 1 Ma 43 gt PAGE 4 OF 43 C6 96 eS 1 GENERAL CHARACTERISTICS BTL 08 ECG Series devices are up to date ECG systems for monitoring and recording of resting electrocardiogram They provide detailed analysis diagnostics and printing of ECG records The outstanding features including a wide variety of functions and easy operation make the unit an excellent card
27. ally only do not unplug it from the adapter the accumulator recharges even during standard operation of the device Thus the accumulator gets so called formatted and will keep working longer without recharging 2 8 LITHIUM BATTERY The device contains a lithium battery for backup of date and time The type of the battery is written in Chapter TECHNICAL PARAMETERS Its replacement is provided by the authorized BTL service department INSTRUCTION FOR USE PAGE 18 OF 43 rox gt EXAMINATION ON LINE MODE This mode is automatically started after switch on of the equipment The display in this mode displays the recorded ECG signal and the following information the selected print profile auto manual long heart rate HR paper speed set sensitivity set filters loose leads if any names of the displayed leads number and names of leads to be printed ECG curve during saving of a 10 sec long to 80 sec long record in the equipment s memory there is displayed description and indicator of the progress e if the device is busy e g by analysis or interpretation the display shows the message please wait After touching the screen in the on line mode there appear the top and bottom toolbars with buttons serving for setting of parameters similarly as the keyboard After approximately 2 seconds without a touch the toolbars automatically hide After switch on the equipment permanently monitors the input ECG signal and
28. alue is displayed in the top status bar on the display Sensitivity can be also changed during printing in the manual mode Sensitivity can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the sensitivity touch button there appears a screen containing all possible values of record sensitivity INSTRUCTION FOR USE PAGE 12 OF 43 CSD 2 4 1 2 4 1 4 filter Button for setting of mains noise filter muscular filters and artefact filter The particular filters or their combinations cyclically shift when pressing the button The current filter or combination of filters is displayed in the top status bar on the display It is possible to select the adaptive auto filter which on the basis of the signal analysis automatically activates the needed filter so that the quality of the resulting signal is maximum The adaptive auto filter cannot be combined with other filters Filters and their combinations can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the filters button there appears a screen containing all available filters Here it is possible to activate any filter or combination 5 drift Button for cyclical switching among the base line filters Anti Drift System The current filter or combination of filters is displayed in the top status bar on the
29. always remembers the last 10 seconds of the signal This signal can be retrospectively stored and printed in a suitable profile and settings profile auto or print screen item start time lower than 0 0 start at the moment of pressing the button 10 start of printing of the signal 10 seconds before pressing the button SELECTION OF PROFILE FOR ECG RECORDING Profiles are pre set recording and printing parameters that serve for quick setting of the equipment for print Parameters of the profiles are preset by the manufacturer and can be changed in the equipment s menu Besides basic profiles automat auto button manual man button and print screen print screen button it is possible to set many user profiles when pressing the profile button the available profiles cyclically shift The set profile parameters can be changed by pressing of the respective button at any time before and or during recording To start recording of the signal press the print button Termination of recording is either automatic after the time set in the profile elapses or manual by pressing the stop button Depending on the set profile the device may record data or analyse the signal for some more time If the device is performing a background job a small blinking circle appears in the upper right corner of the display or a circle with the text wait please The analysis and storage of the signal may be very time consuming operations POSITION OF ELECTRODES
30. and marking of pulses emitted by the pacemaker To check if the DIAGNOSTICS module is implemented check menu unit setup more unit information 5 3 ECG PAPER RECOMMENDED TYPES Roll paper Roll paper Fax paper Z folded paper Z folded paper 112 mm 210 mm 210 mm A5 A4 Dimension 112 mm 50 mm 210 mm 50mm 210 mm 50 mm 150 x 210 mm 280 x 210 mm Thickness 50 70 g m2 50 70 g m2 50 70 g m2 50 g m2 50 g m2 Recommended _ _ SxS 5x Sim marker Marker colour 5 darkly black darkly black Length Sheets 25 m 25 m 25m 333 sheets 250 sheets ACCESSORIES AND UPGRADE PAGE 34 OF 43 rox gt 6 EQUIPMENT MAINTENANCE AND SAFETY A service inspection including the measuring of all parameters of the device including the safety test and functional test and relevant recalibration must be performed at intervals shorter than 30 months The inspection and recalibration must be performed by an authorized BTL service department on the basis of the user s order The inspection of the leakage currents must be done according requirements of the standard IEC 60601 1 If the inspection is not done at 30 month intervals the manufacturer does not guarantee the technical parameters or safe operation of the product Keep the device clean do not store or use it for a long time in enormously dusty environment and do not sink it in any liquid Before each use check if the equipment and its accessories especially
31. aper must be parallel to the tearing edge otherwise it will later bend to a side and possibly crumple or tear THE Z FOLDERED PAPER IS EXTREMELY SENSITIVE TO PROPER INSERTION IF IT IS INSERTED IMPROPERLY IT CRUMPLES AND TEARS DURING PRINTING INSTRUCTION FOR USE PAGE 16 OF 43 rox gt 6 5 USB Printer Set Pressing of USB printer set button open printer select screen where following items can be found resolution used in printing via USB resolution dpi button which is used to print test page on USB printer printer test and information about printer currently connected to unit Description of currently connected USB device includes manufacturer of device product supported languages available memory or maximum resolution supported by printer In some cases when non printing device or unsupported print device is connected to unit this information can be unreadable Limitations e USB print is supported only by units of version 110 and higher see manufacture label on the bottom cover e USB print is supported for firmware version 1 42 and higher for firmware version see Unit Information e the recommended length of the USB cable is 1 5m Printer requirements e USB1 1 or USB2 0 interface e PCL5 e HP compatible DeskJet or LaserJet ATTENTION Some printers which is not fully compatible with USB standard can be unrecognized by unit and cause slow data transmission on USB Actual version doesn t support model HP
32. ble sources of interference electrical appliances radios so that the quality of the records is not affected by the noise The conductive parts of the electrodes must not touch other conductive parts of the bed and the surroundings nor the ground 6 1 CLEANING OF THE EQUIPMENT S SURFACE AND OF ITS PARTS For cleaning of the equipment and its parts use only a soft cloth slightly moistened by water or by 2 solution of detergent Do not use agents containing alcohol ammonia benzine thinners etc For cleaning of the equipment do not use abrasive materials so as to prevent damage of the equipment s surface No part of the equipment needs to be aseptic or sterilized ZN Attention Never use GIGASEPT to disinfect the device and its accessories such as electrodes cables etc otherwise irreparable damage to the device or accessories may occur 6 1 1 Cleaning of the Touch Screen The surface of the touch screen can be cleaned using agents designed for cleaning of monitor screens or for cleaning of glass surfaces The agents may be applied only by means of a spray Sprinkle the centre of the touch screen SLIGHTLY with the cleaning agent and then wipe and polish the surface using a dry cloth Press the cloth VERY LIGHTLY otherwise the touch screen could crack ATTENTION The cleaning agent must not get under the edges of the touch screen otherwise it could penetrate into the equipment The cleaning agent should not get into contact with any other
33. bles longer operation of the device without recharging For details see 2 7 Accumulator FUNCTIONS OF THE KEYBOARD BUTTONS auto Pressing of the print button in this profile starts recording of ECG signal from 12 leads and for the types which are equipped with the DIAGNOSTICS software module it s printing with analysis and verbal interpretation Print reports depend on the type and settings for selection use buttons number of leads and select leads At the same time the internal memory of the equipment stores 10 or more seconds of the signal according to the settings which can be later printed analyzed and saved to the patient data buttons copy analyse patient menu The auto profile also enables setting of retrospective printing the minus time of start of printing i e it is possible to print and save an event which has already passed up to 10 seconds back in time To interrupt printings press the stop button This mode is indicated by the word automat in the status bar on the display The auto mode can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the profile button there appears a menu containing all profiles available in the device man Manual recording of ECG signal from 12 leads Number of printed leads depends on the settings for selection use buttons number of leads and select leads This mode serves only for
34. cables are not mechanically or otherwise damaged Do not use the equipment if it is damaged Replacement of fuse The fuse is located in the round black box 15 21 on the rear panel Before replacement make sure that the mains switch 12 20 is in the 0 position and unplug the mains cable from the unit Turn the segment of the fuse box to the left by a fitting screwdriver or coin and put the fuse out Insert new fuse and turn the box to the right It is forbidden to insert a fuse with another indication than stated on the label at the fuse box This action may only be done by a person acquainted with this procedure Transport and Storage We recommend keeping the packing of the equipment For transport it is suitable to pack the equipment in this packing which ensures its maximum protection Unplug the mains cable and the accessories cables Avoid big shocks The equipment shall be stored transported only on conditions defined in Chapter Technical Parameters BTL 08 ECG Series devices are designed for use in connection with the defibrillator The used defibrillator must comply with the Standard IEC 601 2 4 and its discharge must correspond to that which is described in the Standard IEC 601 2 25 The equipment is resistant to defibrillation only if the original BTL patient cable is used The examination couch for ECG recording should be placed as far as possible from interfering fields of mains mind the mains cables in walls and other possi
35. ct to the signal frequency content This approach gives more effective results in noise filtering and in preservation of signal amplitudes especially in QRS complexes The raw ECG signal Fig 1 is analyzed by rough curvature analyzing process resistant to power line and muscular noise which the control function is derived from Fig 2 The control function enters the decision and executive block consisting of four short FIR filters with different cutoff frequencies where all of the filters are executed but outputs of them are weighted by fuzzy rules and reconstructed to clean ECG signal according to the control function i e the parts of P wave or T wave are reconstructed with respect to their content of frequencies around 0 15 Hz and in the parts of the QRS complex frequencies of 0 100 Hz are kept for good spike and slope representation Fig 3 Figure 1 The original raw signal of ECG Figure 2 The control function as mentioned above in text EXAMINATION PAGE 22 OF 43 CSD citer oT eee ae P J Pa eo kat p A f z SL ae ce ened anne RA Casale Figure 3 Output signal with cutoff frequencies The adaptive filter as a complex filtering method is enhanced by cubic spline baseline wander filtering The baseline points are extracted from the original signal by ECG segment analysis and interpolated by piecewise cubic splines method to remove basel
36. d out with easy and intuitive operation that can be quickly mastered by anyone ECG recording can start immediately after switch on of the equipment These BTL 08 ECG Series devices have a patient database and enable to record and store in the memory many 10 second and longer records from all leads and or several minutes long records from two selected leads LONG type records The equipment can be also used for ergo metric examinations in connection with the BTL 08 Win Ergo software BTL 08 ECG Series devices can be also connected to the ergometry equipment which is controlled by the computer with the BTL 08 Win Ergo program For the latest information about BTL products and contact to BTL companies please visit our website http www btlnet com only if the equipment is upgraded by the Diagnostics software module GENERAL CHARACTERISTICS PAGE 5 OF 43 rox gt 2 INSTRUCTION FOR USE 2 1 OUTWARD APPEARANCE OF BTL 08 MT PLUS ECG 21 1 Top Panel and Keyboard of the Equipment For description of individual buttons see Functions of the Keyboard Buttons printer cover locking lever for printer head display with touch screen control light indicating the status of battery indication of ON status power indication of charging of accumulators charge indication of run down accumulators low bait indication of printer error printer patient cable connector keyboard to control printer keyboard to set record Se Ol Ne
37. dels Lx Plus and Lx enable also using of thermo sensitive Z foldered paper with pre printed grid nominal width 210 mm for more detailed specification see Chapter Technical Parameters For high quality print we recommend exclusive use of paper supplied by the BTL companies For the Z foldered paper the paper type must be correctly selected in menu unit setup setting of paper and print type perforated Z foldered At the first use of a new type of Z foldered paper it is necessary to measure some of its dimensions and enter the measured values in the device The dimensions are page width of the used paper C mark width B and distance between the mark and perforation A The measured dimensions are indicated in the picture on the screen The arrow shows in which direction the paper gets out of the device If the wrong values are set the device will not eject the paper properly on the perforation which will prevent proper tearing of paper If paper with the pre printed grid is used disable the print grid item If there is inserted another type of paper than set in the unit setup the device reports an error at the attempt for printing Never insert more paper sheets in the paper stack than stated in Chapter TECHNICAL PARAMETERS Inserting paper Press button 2 to open the printer cover 1 Tilt the fax paper holder 11 away from the printer display Insert the Z foldered paper bundle in the paper stack the thermo sensitive layer grid fac
38. direct recording of the ECG signal the signal is not recorded in the memory The print parameters can be selected even during printing To start printing press the print button to stop printing press stop This mode is indicated by the word manual in the status bar on the display The manual mode can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the profile button there appears a menu containing all profiles available in the device profile Selection of one of possible user profiles all profiles except auto man and print screen see above which can be edited in profile setup The highlighting shifts cyclically on the available profiles Recording is run according to parameters which are preset in the equipments memory At the same time the internal memory of the equipment stores 10 or more seconds of the signal according to the settings which can be later printed analyzed and saved to the patient data buttons copy analyse patient menu only for profiles derived from the automat type To interrupt printings press the stop button The current mode is indicated in the bottom status bar on the display The profile can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the profile button there appears a menu containing all profiles available in the
39. document BTL Industries Limited reserves the right to revise this document or withdraw it at any time without prior notice TECHNICAL PARAMETERS PAGE 43 OF 43 CSD
40. e checks the status of the accumulators and if it finds them low it switches to the charging mode in the charging mode the display is dark and the power and charge indicators are shining After recharging of the accumulator the device automatically switches off completely The charging mode is activated only if the device is plugged in the mains and the mains rocker switch 12 20 on the rear panel is in the 1 position If the device is not connected or the switch 12 20 is in the 0 position the device switches off Note Checking of the accumulator status takes some time therefore the device may respond with a delay after switching off and then on again All saved data remain stored even if power supply is off 2 4 26 form feed FF This button is available only on the touch screen After touching the display at any point there appears the top and bottom toolbars The FF form feed button is in the bottom left corner After pressing this button the paper slightly ejects from the printer either to the next page Z foldered paper or by approx 3cm fax paper The button may be pressed repeatedly For details on how to work with paper see Printer and Paper 2 4 27 reset of the device If for some reason electromagnetic interference etc the device stops responding to the user s commands keyboard touch panel and the message please wait with small moving squares are not displayed the device can be put into the initial state by eit
41. e compressed the xml file can be read in Internet Explorer and the compressed leads are saved in the hexadecimal format e ultra fast export the signal data are compressed the xml file cannot be read in Internet Explorer and the compressed leads are saved as binary data Setting of the option enable online export through USB enables direct online sending of data via USB to the PC program BTL 08 Win However this program supports the USB import only for the versions 5 30 0 and higher Direct sending of data to BTL 08 Win depends on the speed of the PC It is also necessary to meet the below listed PC requirements otherwise there is a risk of the sent data dropout in such case the data loss message appears This risk on the slow PCs may be eliminated by closing all other applications except BTL 08 Win The export itself is run in the Record Database Unlike export via modem or serial cable always all records are exported not only the marked or selected ones After the export you can also perform import of records patients and physicians according to the following rules e the xml files of the records which you want to import must be copied in the PC to the Records directory of the ecg data removable disk The names of the files must be RecN xml N number from 0 to 119 representing the position in the device s memory on which the file will be saved e the xml files of the patients which you want to import must be copied in the PC
42. ed to the correct voltage according to the parameters of the mains e The equipment is designed for work in the environment defined in Chapter Technical Parameters It must not be used in the environment which implies e g the danger of explosion or penetration of water into the equipment The equipment must not be used in connection with inflammable anaesthetics or oxidizing fluids O2 N2O etc e Do not place the equipment within the reach of sunshine and strong electromagnetic fields so as to prevent undesirable mutual influence In case that this undesirable influence occurs place the equipment more distant from the source of interference or contact the authorized BTL service department e Inspect the equipment thoroughly before each use loose cables broken insulation of cables functions of display pilot lights controls etc in case of any inconsistency stop using the equipment and contact the authorized BTL service department If the equipment s behaviour differs from the function described in this Manual stop using the equipment and contact the authorized BTL service department e Ifthe equipment shows any defect or if you have doubts about its correct function terminate therapy immediately and disconnect the equipment from the patient If you do not determine the source of uncertainty after thorough study of the Manual contact the authorized BTL service department If the equipment is used out of accord with this Manual or is used even
43. els of sensitivity setting available It is recommended to test the setting on several printouts after any change of the paper type 6 2 Roll ECG Paper The device can print on the thermo sensitive fax roll paper with pre printed grid nominal width 112 mm or 210 mm for more detailed specification see Chapter Technical Parameters For high quality print we recommend exclusive use of paper supplied by the BTL companies For the fax paper 210 mm the paper type must be correctly selected in menu unit setup setting of paper and print type for fax When using the paper with the pre printed grid it is necessary to disable the print grid item on the same screen If the printer contains another type of paper than set in the unit setup the device reports an error after a short while of printing Inserting paper model MT Plus Open the printer cover 1 shift the locking lever 2 to the right and insert the paper roll Put the end of the paper under the roller The roller automatically starts to roll the paper on Close the cover and turn the locking lever back to the left Inserting paper models LT Plus LC Plus LT and LC Press button 2 to open the printer cover 1 Tilt the fax paper holder 11 towards the printer Insert the paper roll the thermo sensitive layer grid facing the printer head display so that the paper overlaps the tearing edge 13 Click the printer cover shut The pilot light 7 indicating that the printer is out
44. emory permanently if you want to delete them you have to do it manually With the selected record you can perform the following actions e reprint the record with the setting which it was recorded with or with any other setting e change the print profile e view the record on the display including analysis e mark unmark the record as archive e delete the selected record or all records at a blow e display the record optionally sorted according to the attribute archive date name or ID e export the selected record current record or all records to the PC To receive data from the unit the PC must be equipped with the registered BTL 08 Win or BTL 08 Ergo software The unit must be connected to the PC or modem by a cable Data are transferred via the selected transfer channel see Chapter Export Setup Note The records are stored in the memory in compressed format so that there can be stored as many records as possible That is why at first entering the archive the device has to convert these records into readable format This operation may take several seconds depending on the number of the stored records 4 1 2 Unit Setup This submenu includes the following options e select profile which the device starts with after switch on starting profile set maximum heart rate alarm max heart rate switch on off acoustic signalling of the QRS complex QRS beep set the lead from which the device determines the heart rhythm rhythm lead
45. g If the Demo mode is on the device behaves as if it were connected to the patient although it is not The Demo mode is indicated by bold letterings DEMO on the on line screen as well as on the printed record 10 11 More This button opens additional items of the user setup 10 12 Unit Information In this item all key information about the unit configuration is listed serial number firmware version until when the function of the device is limited version of diagnostics temperature of individual parts of the device version of firmware of the print module and configuration of the HW key This information will be needed in case of communication with the sales department 10 13 Detection Sensitivity of Lose Leads Here you can enable selecting the sensitivity detection of lose leads from four possibilities of sensitivity Higher middle lower or lowest sensitivity of detection the lose leads We do recommend using of middle sensitivity for standard ambient conditions and using the lowest sensitivity for the places with interference and for using with pacemaker SETUP MODE PAGE 30 OF 43 CSD 1 2 10 14 Pacemaker Signalling This function enables disables the pacemaker signalling of QRS complex of the ECG curve The presence of PCM the unit signalizes by dash line through the whole page 1 2 10 15 Mains Frequency Setting according to the mains frequency The applied mains filter retunes automatically according to the actual
46. her simultaneous pressing of the esc and restart buttons for BTL 08 Lx Series or by pressing the reset button on the rear panel of the device 18 BTL 08 MT Plus ECG After this action the device immediately restarts After the restart it is possible to continue the work with the device Note If the device is in the above described state no response the on off button is also disabled The only help is to reset the device as described above INSTRUCTION FOR USE PAGE 14 OF 43 CSD 2 5 CHECK OF LOOSE LEADS If an electrode is wrongly attached to the patient has bad contact or is not connected ECG warns of this fact by symbolic texts in the bottom status bar on the display texts RLFN V1 V2 V3 V4 V5 and V6 In such case it is recommended to check attachment of the electrodes press the restart button and record the ECG signal only after the equipment stops reporting error If you continue recording when the equipment reports a problem on a lead there may occur considerable distortion of the signal Note When using the automat profile the device checks the quality of signal connection of electrode before recording and starts recording only when all electrodes are properly connected This function can be enabled disabled in the profile configuration The individual stages of recording are clearly indicated on the display 2 6 PRINTER AND PAPER The used printer prints on thermo sensitive paper Quality of the paper may c
47. ian always sets to blank after switch on SETUP MODE PAGE 33 OF 43 CSD 5 ACCESSORIES AND UPGRADE 5 1 ACCESSORIES The equipment is not designed for use in connection with other accessories and other medical devices except those stated in this Manual The lists in the following chapters include all accessories that can be supplied For details on particular accessories see the enclosed leaflet BTL accessories e mains cable limb electrodes EKK chest electrodes EPP self adhesive electrodes thermo sensitive paper for fax with grid without grid thermo sensitive paper perforated touch pen spare fuse BTL patient cable BTL patient cable for the self adhesive electrodes User s Manual suction cup electrodes set software BTL 08 Win software BTL 08 Win Ergo software BTL 08 ECG Modem ecgmodem exe 5 2 UPGRADE The basic version of these BTL 08 ECG Series devices is an n channel electrocardiograph without diagnostic interpretation of the measured data If you decide to upgrade the capabilities of your device by automatic diagnostics you can add the Diagnostics module which enables to get and print the following items e table of analysis results time intervals amplitudes of segments electric axes and heart rate e verbal interpretation draft interpretation of the measured results e leads averaging with indication of complexes in the record e 10 seconds of rhythm course of rhythm and analysis e pacemaker measuring
48. iances This noise is characterised by non harmonic waveform with short random period This filter removes the mains noise as well It is therefore useful to combine it with the mains filter setting 25 50Hz In certain cases this filter can influence some values of amplitudes of the QRS complex Anti Drift System base line filters for removing of the base line drift Use these filters in cases when the base line drift in the recorded examination is significant Follow this scheme As the starting filter always use the filter with the longest time constant ADS 3 2 sec If the base line drift is significant and the ECG record escapes from the record or from the display switch the ADS filter successively to the filters with faster reaction i e with shorter time constant That is from the original value ADS 3 2 sec towards the value of 0 1 sec However the value heart rate x time of reaction of the filter should always be much more than 10 so that the record is not significantly influenced When using these filters with fast reaction small number in the filter s name 0 1 sec it is necessary to keep in mind that filtration may in some cases result in some distortion of the P QRS T intervals This is especially true for the diagnostically important S T interval Good results are achieved with the setting of ADS 1 5sec we recommend using of this particular filter In case of complicated conditions during the recording of
49. ical for the given record The unit attempts to determine the parameters of every record automatically therefore it is necessary to ensure that at least three cycles typical for the record analysis are correctly averaged and that the number of aberrant cycles does not exceed the number of non aberrant ones A WARNING The automatic diagnosis and word interpretation is meant to be only a suggestion and should be always checked and modified by a physician Under no circumstances shall manufacturer or distributor be liable to any user of this product on account of wrongly suggested diagnosisand interpretation by the ECG device EXAMINATION PAGE 21 OF 43 CSD 3 6 USE OF FILTERS Fully automatic adaptive filter adaptive auto a filter which performs permanent analysis of the recorded signal and on the basis of the acquired data filters the signal so as to achieve the optimum result This filter comprises all other filters automatically therefore it CANNOT be combined with other filters ADAPTIVE AUTO FUNCTIONALITY DESCRIPTION The basic idea of muscle tremor filtering is based on the low pass filter with optional cutoff frequency However this can lead to unsatisfactory results in the ECG parts with low signal frequencies and also to the distortion of amplitudes in the parts with high frequency content e g the QRS complex The adaptive filter as a new technique processes the ECG signal in the same way as a simple low pass filter with respe
50. ice fault there may appear errors in the file system loss of some records loss of some of the stored patients This function starts diagnostics of the file system and tries to repair the fault without loss of the stored data if possible Depending on the amount of the stored data this function can take a very long time hours therefore we recommend running this function e g overnight If this function is run it is necessary to wait until it is complete or to reset the device see Chapter Functions of the Keyboard Buttons 10 6 File System Formatting This function initializes the entire file system i e it deletes all data stored in device and puts the device into the initialized state i e the same state as at purchase of the device This function should be used only in case of a serious breakdown or if the user wants to initialize the device completely 10 7 Default Setting No User Data Loss This function puts the device into the same state as at purchase setting of language colours etc and at the same time it keeps all stored data of profiles patients physicians and records 10 8 Sleep Mode Interval Here you can set the time of inactivity after which the equipment switches off 10 9 Battery Status Indication Here you can enable disable the acoustic signalling of low battery short fast beeping The visual indication cannot be disabled 10 10 Demo Here you can switch on off the demo mode of the signal recordin
51. if it shows functional differences from this Manual the user will be responsible for the damages caused by the equipment e Do not dismantle the equipment in any case Removal of protective covers implies the danger of electrical injury Possible replacement of the lithium battery and the lead accumulator may only be done by the authorized BTL service department e All material and parts which come into direct contact with the patient s body cleaners for the electrodes must comply with the respective standards related to irritability allergization toxicity genotoxicity and carcinogeneity ISO 10993 1 ISO 10993 3 ISO 10993 5 The user is responsible for all these materials and parts if not supplied by the BTL equipment vendor e The connectors for accessories as well as the other connectors must not be used for connection of anything else than they are designed for according to this Manual otherwise there is a danger of electric shock injury and serious damage to the equipment e During operation of ECG make sure that the conductive parts of electrodes including the N electrode and all other conductive patient applied parts do not touch other conductive parts in the office nor the ground e The equipment does not use or produce any toxic substances during its operation storage or transport under the stated conditions e After bringing the equipment from cold environment to the warmth do not plug it in the mains until the temperatures bec
52. ine wandering with respect to the low frequency content of ECG signals e g ST segments and the other slow parts A brief explanation is in Figure 4 Original ECG signal with baseline wandering and his spline baseline removal Adaptive filter of mains noise 50 Hz 60 Hz a filter designed for reduction of the noise that penetrates the record from the mains with the ability of adaptation to the changes in the frequency of the noise Harmonic sinus waveform with a period of approximately 1 mm at the record speed of 50 mm sec is typical for this type of noise The filter does not affect any of the diagnostically important parameters of the record Adaptive means that the filter can automatically adapt to both mains frequencies 50Hz and 60Hz For faster stabilization of the filter it is recommended to set the correct value according to the current mains in menu unit setup user setup more mains frequency Muscular filter 35 Hz a filter with cut off frequency 35 Hz designed for removing of muscular artefacts This noise is characterised by non harmonic waveform with short random period This filter removes the mains noise as well It is therefore useful to choose its combination with the mains filter setting 35 50Hz EXAMINATION PAGE 23 OF 43 CSD Muscular filter 25 Hz a filter with cut off frequency 25 Hz designed for removing of muscular artefacts and possible electromagnetic disturbance from other electric appl
53. ing of the record INSTRUCTION FOR USE PAGE 17 OF 43 CSD 2 7 ACCUMULATOR The type of the accumulator is stated in Chapter TECHNICAL PARAMETERS Its replacement is provided by the authorized BTL service department During operation the accumulator is continuously being recharged from the mains Its recharging and keeping charged is running even if the equipment is switched off and connected to mains and the mains switch 12 20 on the rear panel is in position I At switching off the device checks the status of the accumulators and if it finds them low it switches to the charging mode in the charging mode the display is dark and the power and charge pilot lights are shining After recharging of the accumulator the device automatically switches off completely Note that the charging process runs only if the device is plugged in the mains and the rocker switch 12 20 on the rear panel is in the I position Checking of the accumulator status may take some time therefore the device may respond with a delay after switching off and then on again For full charging of the accumulator let it recharge for approximately 6 hours preferably overnight A low accumulator is signalled in two levels of signalling e the accumulator is low but it is still possible to print for a short time the low batt indicator 4 6 is blinking e the accumulator is dead the device cannot print the low batt indicator 7 6 is shining permanently and at
54. ing the printer head display so that the paper overlaps the tearing edge 13 Paper always has to be inserted the black mark upwards Click the printer cover shut The pilot light 7 indicating that the printer is out of paper stops shining The printer is ready To check if the paper is inserted and set correctly check menu unit setup setting of paper and print after pressing the insert paper touch button if all dimensions of the paper are set correctly the paper ejects from the device up to the next perforation We recommend using this button after each insertion replacement of Z foldered paper The button for inserting paper or feed to the next page FF form feed is available also in the lower left corner of the on line screen after touching the screen at any point By this button you can eject the paper slightly from the printer at any time Tearing of paper We recommend not to tear the Z foldered paper over the tearing edge 13 which is designed particularly for the fax paper but over the edge of the printer cover away from the display Thus the paper will tear exactly along the perforation and its margin will not be damaged by the tearing edge Note For easier taking the Z foldered paper out serves the prop 12 which enables to lift the bundle up and then takes it in hand and pulls out of the paper stack ATTENTION It is essential to insert paper carefully and absolutely parallel to the tearing edge the grid on the p
55. iology tool BTL 08 ECG Series devices are equipped with accumulator batteries that make them fully portable equipment the use of which is not limited to the physician s office BTL 08 ECG Series devices are equipped with graphic display and enable printing of all twelve leads at a time The smaller as well as the larger colour display excel at the quality of displaying and are equipped with touch panel which enables control directly on the screen These devices differ mainly in the width of printer Therefore you can select a device that will meet your requirements as perfectly as possible BTL 08 Lx Plus ECG Series are unique devices equipped with 210 mm wide printer enabling A4 printing even in three different dimensions Of course BTL 08 Lx Plus ECG Series supports others paper formats for printing of A4 A5 format and you can use roll fax paper Therefore you can select the paper format which will suit to your needs the best BTL 08 Lx ECG Series devices are equipped with 210 mm wide printer enabling A5 format The devices enable printing also on the ordinary thermo sensitive fax paper which significantly reduces the operational costs BTL 08 Lx and BTL 08 Lx Plus ECG Series are intended rather for stationary using BTL 08 MT Plus ECG is equipped with 112 mm wide printer This Series supports using of roll fax paper BTL 08 MT Plus ECG is intended rather for portable using All mentioned BTL 08 ECG Series devices stan
56. lus ECG touch screen 171 x 128 640 x 480 VGA Keyboard combined combined combined combined combined touch panel touch panel touch panel touch panel touch panel Indication of acoustic discharaed batterv pilot light Check of loose leads ves individual leads Paper size A5 A5 A5 A4 A4 Paper width mm 112 210 210 210 210 Paper type roll for fax roll for fax roll for fax roll for fax roll perforated A5 perforated A5 perforated A4 A5 perforated A4 A5 Supported perforated 150 x 210 150 x 210 150 x 210 150 x 210 paper dimension 280 x 210 280 x 210 295 x 210 295 x 210 300 x 210 300 x 210 Printer resolution Y axis 200 dpi X axis 500 dpi Print type thermal external via USB Print speed mm s 5 10 25 50 Sensitivity mm mV 2 5 5 10 20 Number of leads 12 Number of channels 12 Number of displayed 12 Measured leads I Ill aVR aVL aVF V1 V2 V3 V4 V5 V6 Electrode set R L F N C1 C2 C3 C4 C5 C6 Number of printed auto mode 3 4 6 12 3x44 1 3X4 2 3x44 3 4x34 1 6x2 1 6x2 2 manual mode 3 4 6 12 long mode 2 Length of record auto mode seconds 10 20 30 40 50 60 70 80 long mode minutes 1 2 3 4 5 6 7 8 10 Record in auto mode synchro in time Saved 10 second lonq 100 Filters automatic adaptive auto mains filter Hz 50 60 muscular filters Hz 25 35 base line filters s 3 2 1 5 0 6 0 3 0 1 splines Detection of yes yes yes yes yes Diagnostics optional optional optional
57. mains interference frequency This setting sets the initial frequency on which the mains interference is looked for and thus shortens the response time of the mains filter 1 2 10 16 Setting of HW Key The device can be configured remotely For example if you decide to buy the DIAGNOSTICS upgrade later the manufacturer distributor sends you the 64 digit code so called HW key which you enter here and the device reconfigures according to the entered key For determination of the current HW configuration see Unit Information 1 2 10 17 Password Setting To prevent unauthorized handling of the device it is possible to activate the password request after the switch on Here it is possible to enable disable the password request and or change password The password is a numeric string of any length If you forget your password you can always use the string 00000000 1 2 10 18 Fast Data Processing Here you can set the speed of the data processing algorithm for data recording in modes derived from the automat mode Fast processing can significantly reduce the time elapsing from pressing the start button till completion of data processing and the following printing In some isolated cases slow processing may lead to better results We recommend keeping this option on which can considerably speeds up the routine operation of the device 1 2 10 19 Sound of Keyboard The device allows enable disable the sound of keyboard via the SOUND OF KEYBOA
58. n cooling which is provided by natural or forced air circulation Cooling vents are located at the bottom of the equipment and around the display and must not be covered Do not put the equipment on a soft surface so as not to obstruct airflow to the bottom cooling vents We recommend keeping the packing of the equipment for further possible transport Plug the device directly in the mains socket do not use any multi connection extension cable or adapter INSTRUCTION FOR USE PAGE 10 OF 43 CSD 2 4 4 2 3 4 Switching the device on Plug the mains cable in the mains socket switch the O I rocker switch according to the type of your device see no 12 in 2 1 2 Rear Panel of the Equipment alternatively no 20 in 2 2 3 Rear Panel of the Equipment on the rear panel to the I position and press the on off switch on the keyboard The ON status is indicated by the pilot light 5 4 The mains switch 12 20 should be permanently in the 1 position so that recharging of the accumulators is ensured Recharging of accumulator The device contains an internal accumulator which is sold in half charged status That is why we recommend formatting of the accumulator after purchase of the device connect the device to the mains with the mains rocker switch 12 20 in position for at least 48 hours without interruption The device will be recharged and the accumulator will be properly formatted The properly formatted accumulator ena
59. n of the number of leads to be printed To select the required combination press this button repeatedly The current combination is displayed in the top status bar on the display The resulting setting depends on the currently selected profile manual or automat The number of leads to be printed can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the print button there appears a screen containing all possible numbers of leads to be printed 11 Select leads Button for selection of groups of leads to be printed The groups of leads cyclically shift when pressing the button The Selected leads are displayed in the top status bar on the display The function is active only in the manual mode and only if less than 12 leads at a time are printed 12 mm s Button for setting of the paper feed speed The particular speed values cyclically shift when pressing the button The current paper speed is displayed in the top status bar on the display The paper speed can be also selected directly on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the speed button there appears a screen containing all possible values of the paper speed 13 mm mvV Button for setting of the sensitivity of print The particular sensitivity values cyclically shift when pressing the button The current sensitivity v
60. nt to record the signal starting with the moment of pressing the print button set the start time of recording to 0 o set averaging and analysis of signal only for the automat type profile and if the device is equipped with the DIAGNOSTICS module print leads averaging yes no print 10 seconds of rhythm print analysis print verbal interpretation setting of type of interpretation short long dictionary resizing to A5 page averages analysis and interpretation averages on top in case of printing everything on one page o interpretation in header o printer type a E e E o e e E a E 4 1 3 2 Setting Parameters of Long Type Profiles The long type profile long record enables to record and save in the equipment s memory a signal from any one or two leads of a length of up to 10 minutes The setting is similar as with other profile types Averaging and analysis are not possible It is only possible to select printing of the heart rate histogram For each profile you can set the following parameters e profile name name profile type long type sensitivity sensitivity paper feed speed paper speed used filters Select filters length of the printed and saved record rec duration data to be printed in the header of the record header print setup print of the HR histogram yes no histogram number of recorded and printed leads number of leads recorded and printed leads lead 1 and lead 2 printer type SETUP MODE
61. ome equal i e for at least 1 hour e The time interval between switching the equipment off and on must be at least 3 seconds e This equipment does not imply any danger for the patients with pacemakers EQUIPMENT MAINTENANCE AND SAFETY PAGE 37 OF 43 CSD The equipment is resistant to the defibrillation pulse It resumes recording the signal after 10 seconds For this purpose use only the original BTL cable Do not touch the equipment during the defibrillation discharge If after many years of operation it is necessary to discard the equipment it can be done in a way which is usual for this type of devices after removal of the lithium battery and the lead accumulator The batteries must be disposed of in a proper way not within the municipal waste The equipment does not contain any toxic materials which could harm the environment in case of normal way of liquidation Warning removal of batteries causes irreversible damage of unit Make only on environmental liquidation of unit Procedure Screw off the bottom cover of unit Remove the batteries with suitable tool placing of batteries see the picture BTL 08 Lx Plus and BTL 08 Lx ECG Series BTL 08 MT Plus ECG Bell ca a z This type of electrocardiograph is not designed for on line monitoring of ECG signal during the work with high frequency surgical devices It must not be connected to the patient if a high frequency surgical device is connected to him her
62. onsiderably affect quality of the printed ECG curves For high quality printing it is recommended to use only the BTL recommended paper The yellow pilot light 8 7 indicates printer error status Possible causes e printer is out of paper e bad pressure of the head on the paper for BTL 08 MT Plus ECG model only the printer head locking lever 2 is in the position unlocked shift the lever to the left to lock the head and make it ready for print e improperly closed printer cover or wrong type of paper or wrongly set type of paper At the same time there appears an error message with additional information on the display Another way to print with unit is to connect external printer with USB interface USB connector can be found at rear panel 20 24 and is designated for both connections to PC or to printer Detailed description of how to select printer follows 6 1 Paper Sensitivity Each type of paper has slightly different sensitivity to thermal impulses produced by the printer The resulting printout can be too bright and illegible or on the other hand too dark or even over burned over burned print has a white centre in the printed line For the above reasons the device is designed so that it adapts to various types of paper For setting the paper sensitivity use the paper sensitivity item in menu unit setup setting of paper and print The more sensitive paper is set the brighter is the resulting printout There are 5 lev
63. op button The process is very similar to that in the automat mode see Chapter Examination in the Automat Profile Examination in the User Profiles Process of examination SWITCH ON the unit FASTEN THE ELECTRODES SELECT PROFILE using the man button Unit Setup START RECORDING using the print button AUTOMATIC TERMINATION or INTERRUPTION by the stop button Further process of examination is very similar to that in the automat resp manual mode see Chapter Examination in the Automat Profile or Examination in the Manual Profile Examination in the Long Profile Process of examination SWITCH ON the unit FASTEN THE ELECTRODES SELECT PROFILE OF THE long TYPE using the man button Unit Setup START RECORDING using the print button AUTOMATIC TERMINATION or INTERRUPTION by the stop button Further process of examination is very similar to that in the automat mode see Chapter Examination in the Automat Profile RELIABILITY OF MEASURING AND DIAGNOSTICS Parameters that are analysed on the basis of an averaged heart cycle are considered correct if the relevant record is not distorted too much by the mains noise by artefacts of myopotentials or by other noises Another factor for reliability is that the unit correctly recognises the key points of the P QRS T complex The accuracy of parameters may be also affected by inclusion of aberrant cycles to the averaged cycle in case that the unit incorrectly classifies them as typ
64. optional e Select the print profile e g auto auto e Fasten the electrodes to the patient s body Make sure that all leads are properly connected and that ECG does not report any loose leads possibly check if the signal on the display is clear e f everything is OK press the print button to start printing print If in the automat mode the check of leads is ON in the profile the device waits for fastening of electrodes and starts recording only when contact of all electrodes is OK 4 1 Examination in the Automat Profile Process of examination SWITCH ON the unit using the on off button FASTEN THE ELECTRODES SELECT PROFILE using the auto button Unit Setup START RECORDING using the print button AUTOMATIC TERMINATION Before start of recording check and possibly modify the following parameters cannot be changed during recording e paper speed the mm s button sensitivity the mm mV button number of leads the number of leads button leads required to be printed the select leads button set the required filers using the filter and drift buttons Press the print button The device starts recording of the ECG signal and printing of the curves on the thermo sensitive paper at the same time the signal is stored in the records database Examination will be automatically terminated after the time set in the profile elapses it also can be interrupted at any time by the stop button If printing of diagnosis
65. optional optional User profiles of automat type unlimited of manual type unlimited of long type unlimited Weight max 3 2 kg 5 7 kg 5 7 kq 5 9 kg 5 9 kg Dimensions I x w x h 330 x 270 x 74 407x312x125 407x312x125 407x312x146 407x312x146 Operating conditions temperature 10 Tto 40T relative humidity 30 to 75 atmospheric pressure 700 hPa to 1060 hPa position horizontal operation type continuous Transport and storage temperature 10 Tto 55C relative humidity 25 to 85 atmospheric pressure 650 hPa to 1100 hPa position any max duration of 1 year transport only in the supplied packaging other conditions recharge the accumulators at least every six months TECHNICAL PARAMETERS PAGE 40 OF 43 Type Power supplv input mains voltage frequency protection class external fuse mains switch covering grade Internal chemical sources battery lead accumulator accumulator capacity charger Input impedance CMMR Sampling frequency Frequency range for 10 30 for 10 10 Amplitude accuracy Time accuracy Quantization noise Input noise A D converter Max range of input Applied part Connection to PC Connection to modem mobile phone TECHNICAL PARAMETERS PAGE 41 OF 43 BTL 08 MT Plus ECG 40 VA 99 V to 126 V 115 V nominal AC 198 V to 252 V 230 V nominal AC T1A 250V tube fuse 1x 12 V 1 2 Ah 48x97x52 mm main
66. part of the equipment than the touch screen 6 1 2 Cleaning of the Paper Sensors Once every 6 months wipe the dirt and dust from the sensors of paper by a fine brush or a dry cotton wool swab The sensors are located under the printer cover at the upper edge of the device two black boxes and they are accessible after removal of the printer cover from the device EQUIPMENT MAINTENANCE AND SAFETY PAGE 35 OF 43 gt 6 1 3 Cleaning of the Printer Head We recommend cleaning the printer head each 12 months or if the print quality gets worse Remove the printer cover from the device and wipe the surface indicated on the picture by cotton wool wetted with industrial spirit several times The cleaned printer head surface should be smooth and dark glossy Fouling of the head depends on the quality of the used paper In case of any problems contact the authorized service 6 1 4 Cleaning of the Bearings of the Rubber Roller We recommend cleaning the bearings of the rubber roller when they start to whistle because of settled down paper dust From the left side first take out the printer cover screw off the screw take out the cog wheel and the white bearing From the other side take out first the retaining washer and white bearing see the picture Both of bearings clean In case of any problems contact the authorized service EQUIPMENT MAINTENANCE AND SAFETY PAGE 36 OF 43 CS
67. printing of the ECG curve itself not the printing of other information texts grids pictures Using this setting together with setting of the suitable paper sensitivity see above it is possible to achieve the optimum appearance of the print 4 1 2 6 Patient Card Setup The enabled items appear during entering the patient data and can be filled in The data are stored with the patient In the patient card you can enable the following items e first name surname middle name ID birth date sex weight blood pressure height pacemaker race smoking 2 user defined items the meaning and description of which can be set in Optional Patient Data 4 1 2 7 Optional Patient Data Here you can define names of two optional items of the patient card e g diagnosis general state 4 1 2 8 Setting of Paper and Print Here it is possible to set many important parameters of printing if the resolution of USB printer is 300 dpi or 200 dpi if the print paper is perforated or for fax available only for Lx Plus and Lx Series if the grid shall be printed paper sensitivity and it is also possible to get the paper inserted after its replacement Setting of paper sensitivity is important for optimum printing and besides the line width it influences the print quality the most For details on paper settings see Chapter Printer and Paper 4 1 2 9 Export Setup Here you can select which of the available transfer channels will be used for export of dat
68. s O INSTRUCTION FOR USE I PAGE 6 OF 43 ON gt 1 z2 Rear Panel of the Equipment 12 13 14 15 16 17 18 19 20 mains switch positions 0 I mains plug communication connector for connection to PC via the RS232 line mains fuse manufacture and type label on the bottom mains voltage switch RESET button to restart the equipment if the unit does not react to any commands anti interference clamp on the bottom cover of the equipment connector for connection to PC printer via USB INSTRUCTION FOR USE PAGE 7 OF 43 2 2 BTL 08 LX ECG SERIES 2 1 Top Panel of the Equipment printer cover lever for opening the printer display with touch screen indication of ON status power indication of charging of accumulators charge indication of run down accumulators low bait indication of printer error printer connector for the patient cable keyboard for setting of print and record options 10 keyboard for setting of display view 11 holder for the fax paper 12 prop for the Z foldered paper 13 tearing edge for the fax paper OOND ROND INSTRUCTION FOR USE I PAGE 8 OF 43 OR gt ies 2s 2 3 Keyboard For description of individual buttons see Functions of the Keyboard Buttons Rear Panel of the Equipment 20 21 22 23 24 20 power switch positions 0 21 mains fuse 22 mains cable connector 23 communication connector for connection to P
69. seee savccsts ienet neriie irtasida NEAT E ia EEEa ESLa TEESE Tetai iNe ELin 30 4 1 2 10 5 Repair of Files 0 4 1 2 10 6 File System Formatting aie 4 1 2 10 7 Default Setting No User Data LOSS ee 30 4 1 2 10 8 Sleep Mode Interval sssini naranasan inisaidie asagada idad nani Aaa wearin aac 30 4 1 2 10 9 Battery Status Indication 1 30 4 1 2 10 10 DEMO iiiaae 1 30 4 1 2 10 11 More pe 30 4 1 2 10 12 Unit Information pp 30 4 1 2 10 13 Detection Sensitivity of Lose Leads 30 4 1 2 10 14 Pacemaker Signalling ppp zagi 4 1 2 10 15 Mains Frequency weal 4 1 2 10 16 Setting of HW Key 31 4 1 2 10 17 Password Setting 3 4 1 2 10 18 Fast Data Processing acd 4 1 2 10 19 Sound of Keyboard 31 4 1 2 10 20 Delete Patient After Recording 31 4 1 2 10 21 Save Current Physician 31 4 1 2 10 22 EX enrol 4 1 3 Profile Setup i e ae ne ar ae a e ra E aE ER E 1 32 4 1 3 1 Setting Auto Man Print Screen Profile Parameters 0 cccccccesceeseeeeeeeeeeeeneeeeseeeeeseaeeeeeaeeeeeeeeeeeeaeeeeseaeeeeeea 32 4 1 3 2 Setting Parameters of Long Type Profiles 4 32 4 1 4 Select Patient sisun pnan 4 1 5 Displayed Leads mae 4 1 6 Select PHYSICIAN irske esccain inae ace savteeecicatedscavdiiessedeasviasdayiviesdatvacsiai sarc kica dS aie TEETE Eniri 5 ACCESSORIES AND UPGRADE itcic ccccs ceca coccudssieseescccstes secscidssesnestaadennencesuessncsdenscisnecsdeecbsccceetcut soa ecedseeecicasebonde
70. ta to be entered and stored can be selected in the unit settings see Patient Card Setup 8 menu Button for activation of the menu containing the unit setup patient data management etc The menu can be also entered directly from the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the menu button in the lower right corner there appears a menu as after pressing the keyboard button 9 mode Button for selection of the arrangement of displaying of leads on the display from 3 leads on the display at a time up to all 12 lead in more columns All possible variants of displaying rotate on the screen when pressing the button This button is available only for BTL 08 Lx Series The appearance on the display can be also changed in details on the touch screen After touching the display at any point there appears the top and bottom toolbars After pressing the menu button on the keyboard or on the display the device menu appears which contains the displayed leads button After pressing the button there appears a screen containing all available display combinations including the possibility of assigning a certain lead to a certain window on the display 2 4 20 print screen Button for instant printing and saving of the screen status using the special print screen profile This profile serves for capturing of sudden artefacts which the operator spots on the display therefore recording and
71. tenance free 83 min printing of ordinary use approx 26 min or 36 17 m of continuous printing internal time for 100 charging approx 4 6 hours gt 98 dB 0 05 Hz 150 Hz 0 67 Hz 40 Hz BTL 08 LT Plus ECG BTL 08 LC Plus ECG BTL 08 LT ECG BTL 08 LC ECG 100 VA 100 VA 100 V to 230 V 115 230 V nominal 100 V to 230 V 115 230 V nominal alternating alternating 50 Hz to 60 Hz II with functional earthing according to IEC 536 and IEC 60601 1 T2A 250V tube fuse 5 x 20 mm acc to IEC 127 2 on the rear panel positions 0 and IP20 lithium battery CR2032 2x 12 V 1 2 Ah 48x97x52 mm maintenance free 2x 12 V 1 2 Ah 48x97x52 mm maintenance free 140 min printing of ordinary use approx 46 min or 99 min of ordinary use 140 min printing of ordinary use 99 min printing of ordinary use 55 76 m of approx 37 min or approx 46 min or approx 37 min or continuous 55 15 m of 55 76 m of 55 15 m of printing continuous printing continuous printing continuous printing internal time for 100 charging approx 4 6 hours gt 20 MQ gt 100 dB 2 000 Hz gt 100 dB 0 04 Hz 150 Hz 0 04 Hz 150 Hz 0 67 Hz 40 Hz 0 67 Hz 40 Hz 2 2 3 9 uV lt 8uV 13 bit AC 15 9 mV DC 400 mV CF type RS232 USB yes Applicable Standards Name Medical electrical equipment Part 1 General requirements for safety Amendments to IEC 60601
72. the same time there is a warning acoustic signal short intermittent beeping approx once every 20 seconds The acoustic signalling can be disabled see Chapter Battery Status Indication During charging of the accumulator the charge indicator 6 5 is shining If the low battery status is indicated it is likely that the equipment will not be able to print the entire ECG record During recording and printing the process may be interrupted However the data are still saved in the memory and can be printed after recharging of the accumulator To ensure a long lifetime of the accumulator we recommend keeping it permanently charged When it is possible connect the ECG to the mains and put the mains switch 12 20 to the 1 position The pilot light 6 5 will start shining after recharging it will go out and the accumulator will be automatically kept in the charged status If the device is left unplugged from the mains for a longer time even in the OFF status the accumulators gradually spontaneously discharge This effect is characteristic of the accumulators and cannot be removed therefore if the device has been off and unplugged for a longer time than approximately 2 3 months we recommend recharging it preferably for 48 hours without interruption For the same reason we recommend charging the device continuously for at least 48 hours immediately after purchase regardless of the accumulator status indication you can work with the device norm
73. tory containing the list of all exported files with the date of recording and the name of the patient whom the record belongs to The Patients directory contains XML files called PatN xml where N is a number from 0 to 119 representing the position in the device s memory on which the file is saved Each file contains data of one patient In addition a file called Patients txt is created in this directory containing the list of all exported files with the name of the patient The Doctors directory contains XML files called DocN xml where N is a number from 0 to 119 representing the position in the device s memory on which the file is saved Each file contains data of one physician In addition a file called Doctors txt is created in this directory containing the list of all exported files with the name of the physician You can copy the files of records patients and physicians from these directories to your PC s hard disk and or backup them on a CD DVD or another backup medium You can also import them to the database of our PC software BTLO8Win Ergo using the importing form in BTLO8Win Ergo SETUP MODE PAGE 28 OF 43 CSD Option type of exported data enables to set three various formats of the exported signal data e standard export the signal data are not compressed the xml file can be read in Internet Explorer and the samples of the signal are saved as a set of numbers for each lead e fast export the signal data ar

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