M-TRACE 12-channel electrocardiograph with analysis and
Contents
1. Dz READ DELETE PRINT MEMORY PENDRIVE 5616 lt READ DELETE 20 24 M TRACE Electrocardiograph User s Manual Cleaning concurrent disinfection maintenance Caution Before any cleaning or maintenance unplug the appliance from the wall power outlet Do not use any abrasive cloths thinners alcohol spray or other chemical solvents Use only a soft clean cloth dry or slightly dampened with clean water It is recommended to do cleaning at least once per month Upon the heavy duty usage the cleaning should be done more frequently the electrodes should be disinfected after each examination They need to be subjected to the deproteinization process with a designated liquid e g Sekusept Pulver 2 activator 0 5 The electrodes should remain in this bath for at least 30 minutes Afterwards they need to be washed and dried Operating and transport environmental conditions Operating Environmental Conditions Surrounding Temperature 10 to 40 C 50 to 104 F Relative Humidity 25 to 95 non condensing Atmospheric pressure 70 to 106 kPa Transport and Storage Environmental Conditions Surrounding Temperature 20 to 60 C 4 F to 140 F Relative Humidity 25 to 95 non condensing Atmospheric pressure 70 to 106 kPa In every condition the surrounding air should be free from2. 25 50 mm s Setting active filters Each single push changes current active filters sequentially 50 35 35 50 25 25 50 Hz Setting the number of leads to be recorded Each single push changes the number of leads to be recorded sequentially up 3 6 12 Setting the group of leads to be recorded Number of iu Sapi Available eroups that can be set number of leads set to Each single push changes group eroups that be recorded can hose sequentially I II Ul aVR aVL aVF 3 4 VI V2 V3 i 4 V5 V6 I II III aVL aVF 6 2 VI V2 V3 VA V5 V6 12 1 12 Leads Current settings shown on the LCD screen 11 24 M TRACE Electrocardiograph User s Manual Arrangement of electrodes The appliance 15 equipped with 10 electrode wire cable The standard arrangement Lead type Lead Connection body location Red Right arm gt Yellow Left arm bipolar limb leads 4 electrodes Green Left leg Black Right leg reference point ground Strengthened aVR To Right arm electrode Goldberger s aVL unipolar limb To Left arm electrode fade aVF To Left leg electrode Vi placed to the right of the sternum in the fourth IV intercostal space V2 gt placed to the left of the sternum in the fourth IV intercostal space V3 placed directly between leads V2 and V4 V4 5 placed to the left of the sternum in the fifth Wilson S Intercostal V space in the midcla
3. Lubin G8 02 2009 Company s Representative 24 24
4. and safe tool e tis vital to check periodically the correct work and quality of accessories and device itself In case of doubts please contact qualified service personnel e Most vital thing is to instantly pay attention to power cord which should be free from any damage It will eliminate a risk of electric shock to persons e Using the device simultaneously with cardio stimulators or any other kind of electric stimulators does not expose both patients and personnel to any danger e tis very important not touch neither patient nor any device connected to him during defibrillation e Electrocardiograph can not be used simultaneously with any surgical devices operating on high frequency e To keep ECG record long time archived it is needed to make Xerox copy of printouts or print them on outside printer operating on regular copy paper Thermal paper which is used to work with the device 1s fragile to environmental factors what can cause the printouts unreadable after some time e The device is not adjusted to work in places where inflammable fumes combustibles occur e Incase of simultaneous connecting the electrocardiograph with other devices to patient it is necessary to check the risk that may occur of summarizing of leakage currents e Electrocardiograph has CF safety protection type It allows to do examinations directly on patient s heart e Always connect electrodes with maximum caution avoiding connectors not touch any met
5. necessary to charge the battery Plug the device in to a power and switch the button on rear side to on position Constant light of the LED on the keyboard indicates the batteries are being loaded Blinking of the LED informs that the battery is fully charged and ready to use 9 24 M TRACE Electrocardiograph User s Manual Paper loading The loading thermal paper in to the built in printer is very easy To do it open the paper cover releasing it with button located at the end of papers exit hole refer to the picture below Put the roll of the paper in its place in the printer and lead out the end of it outside of the cover Pay attention to the paper s direction head its active squared side up Finish the whole process closing the paper cover Push it till it s locked properly in the printing mechanism Paper cover release button 10 24 M TRACE Electrocardiograph User s Manual Setting up recording parameters Before starting the examination it is needed to set up the required recording parameters Turning the appliance on automatically recalls parameters last set in the setup menu If adjusting of some of them is needed it can be done by pressing one of the following keyboard function buttons OOO Setting recording sensitivity Each single push changes the sensitivity value sequentially up 2 5 5 10 20 mm mV Setting recording speed Each single push changes the speed value sequentially up 5 10
6. CE Electrocardiograph User s Manual Configuration The settings of M TRACE Electrocardiograph configuration are adjustable in wide range They can be set according the user s actual needs Turning the appliance on brings the default initial settings and not adjustable during the normal using parameters e g clock time date language To enter the configuration setup press then pick SETTINGS option To configure the automatic examination 5 report use REPORT option The REPORT configuration screen will look like this H REPRESENTATIUE H DIAGNOSTICS H MEASUREMENT H PRINT PRINTER The following options available in the section Option Description TIME AUTO The duration of ECG examination in automatic mode REPRESENTATIVE The most characteristic representative of P QRS T will be shown DIAGNOSTICS Text description of examination of electrocardiogram will be shown MEASUREMENT time and amplitude measurements of the representative will be shown Sets the printout target Available are PRINT Roll thermal paper USB external printer connected to the USB port To configure the initial settings use INITIAL SETTINGS option Initial settings can be easily changed during normal using with the navigation keys The set presets will always appear after each turning on the device 17 24 M TRACE Electrocardiograph User s Manual The INITIAL SETTINGS configuration screen should look
7. M4Medicai Sp Z 0 0 Nedical M TRACE Electrocardiograph user s manual Edition II M TRACE Electrocardiograph User s Manual Edition Date Changes Editor Format changes 02 08 00 00 Added CE Declaration of Conformity Improved functionality added configuration option of AUTO Examination printout DM 2124 M TRACE Electrocardiograph User s Manual Contents CONTENTS INTRODUCTION PRECAUTIONS AND SAFETY INSTRUCTIONS DESCRIPTION INSIDE THE BOX SUPPLIED ACCESSORIES OVERVIEW ELECTROCARDIOGRAPH UNIT STEERING TOP PANEL KEYBOARD FUNCTION KEYS LCD SCREEN TECHNICAL SPECIFICATIONS USING THE APPLIANCE FUNCTIONAL ABILITIES PRELIMINARIES PAPER LOADING SETTING UP RECORDING PARAMETERS ARRANGEMENT OF ELECTRODES ENTERING PERSONAL INFORMATION OF THE PATIENT EXAMINATION IN AUTOMATIC MODE EXAMINATION IN MANUAL MODE MAKING THE COPY OF EXAMINATION MANAGING THE MEMORY CONFIGURATION MENU NAVIGATION MAP CLEANING CONCURRENT DISINFECTION MAINTENANCE OPERATING AND TRANSPORT ENVIRONMENTAL CONDITIONS MANUFACTURER S DECLARATION OF CONFORMITY FOR THE ELECTROMAGNETIC COMPATIBILITY IS 22 3 24 M TRACE Electrocardiograph User s Manual Introduction Electrocardiogram is the graphic presentation ECG diagram of electrical activity of the heart over time It allows to examine the mechanism and place where electrical impulses occur also enables to check how 1t w
8. Press then pick PATIENT MEMORY DELETE Deleting the patient s Afterwards pick the particular patient from the list and confirm data Enter the choice with With removing the patient from the memory all his stored examinations are being deleted too Caution This operation cannot be undone The copy of the examination can be saved after the automatic Saving the examination mode recording 15 done First press then pick COPY MEMORY SAVE If there 15 no previous data of the current patient stored in the memory it will be stored now Otherwise the current record will be added to his existing previously 15 24 M TRACE Electrocardiograph User s Manual Deleting the examination stored data The patient can be identified by his surname name and the ID assigned during the first data storing The particular stored examination can be determined by its date and time Press then pick MEMORY DELETE The screen should look like this SMITH JOHH With the arrow keys 1 gt mark the particular patient on the list and pick him pressing Afterwards the screen should look like this PRTIEHT EAM 21 18 2888 28 31 51 FAAS 21 18 2888 28 32 33 Now chose from the appeared list the examination to be deleted and confirm with ene Caution The chosen examination is permanently deleted and cannot be undone 16 24 M TRA
9. Voltage Voltage Dips test level dip Duration Short Ut Ut Interruptions 0 5 and Voltage lt 5 gt 95 genis Typical hospital or Variations 40 60 S commercial establishments 70 30 22 periods lt gt 95 5 seconds 22 24 M TRACE Electrocardiograph User s Manual IEC 61000 4 8 Power Frequency Magnetic Fields IEC 61000 4 6 Conducted Disturbances IEC 61000 4 3 Radiated RF Electromagnetic Fields 3A m 3Vrms 150kHz to SOMHz 3Vrms SOMHz to 2 5GHz Typical hospital or commercial establishments 3V m Mobile devices 3V m 224 24 M TRACE Electrocardiograph User s Manual Declaration of Conformity Deklaracja Zgodno ci Manufacturer M4Medical Sp z Producent ul Ogrodowa 10 7 20 075 Lublin Poland We declare under our sole responsibility that Deklarujemy na nasz w asn odpowiedzialno the medical device Electrocardiograph medyczne urz dzenie Elektrokardiograf models M TRACE model of class lla Rule X klasyfikacja covered by the Technical Files rev 1 00 dated 04 02 2009 spe nione w Technical Files meets all provisions of the directive 93 42 EEC which apply to it spe niaj wszystkie regulacje dyrektywy 93 42 EEC kt re maj zastosowanie Conformity assessment procedure Zgodno wed ug procedury Annex 11 3 of 93 42 EEC directive Notified Body TUV Rheinland Product Safety GmbH Certification Office Am Grauen Stein 51105 Cologne CCo
10. a z o o Ogrodowa 10 7 0197 20 075 Lublin Poland 5 24 M TRACE Electrocardiograph User s Manual Overview Electrocardiograph unit paper cover release button paper feeder power socket SB connectors LCD display az SSO O O gt 20920909 v keyboard electrodes connector Steering top panel keyboard Electrocardiograph 7 merlin medical 00000000 0000000090 2000000092 e 9 000000099 E 6 24 M TRACE Electrocardiograph User s Manual Function keys Recording automatic mode Recording manual mode Stop recordine Setting recording sensitivity Setting recording speed Setting active filters Setting the number of leads to be recorded Setting the group of leads to be recorded O O O O O O IO IOO Configuration mode LCD screen recording recording speed sensitivity active filters Current HR 18mn nU eee unmuuuuuuuuuuumu U1 U2 J l 06 U3 A A An EA aUR u aUL us nn ___ U6 rnn STOP I II III aUR aUL aUF work mode leads being battery charge recorded indicator M TRACE Electrocardiograph User s Manual Technical specifications Dimensions W x H x D Weight Power Supply Built in Battery Power Consumption ECG leads Sensitivity Recording Speed Common Mode Rejection Ratio Frequency Ban
11. allic parts including ground 4 24 M TRACE Electrocardiograph User s Manual e Do not attempt to service the appliance yourself as opening or removing covers may expose you to dangerous voltage or other hazards Refer all servicing to qualified service personnel e Relocating the device between places with extremely different temperature may cause moisture condensation inside If condensation does occur neither plug the appliance to the power nor turn it on Wait a few hours till the unit will have warmed up and any condensation will have evaporated Description electrocardiograph is a sophisticated and modern electronic device It is dedicated to record ECG impulses in full range of 12 standard channels Printout is made on thermal paper The device 15 equipped with high resolution linear thermal printing unit and color LCD The built in battery allows to use 1t quickly wherever it is necessary Aesthetic plastic cover together with membrane keyboard makes the device easy to keep clean Inside the box supplied accessories Make sure you have the following accessories In Box Qty l The device M TRACE electrocardiograph 1 pc 2 Clamp electrodes 4 pcs 3 Sucker electrodes 6 pcs 4 ECG cord 1 pc 5 Power cord 1 pc 6 ECG thermal paper 112mm wide l pc 7 ECG eel 1 pc 8 User s manual 1 pc If some of above accessories are missing please contact your reseller or supplier MANUFACTURER M4Medical Sp k
12. complex with particular marked waves conclusions of the measurements and calculations text ECG interpretation and the data of the patient 8 24 M TRACE Electrocardiograph User s Manual e Manual recording mode This mode enables users to choose how many lead signals 3 6 or 12 will be recorded at the same real time That mode allows to switch between lead groups change amount of recorded channels sensitivity and the speed of the recording process during the examination It is also available to activate or deactivate additional ECG signals interferences filters e Copy printout It provides function to make an automatic examination copy printout stored in appliance s internal memory The memory can store up to 100 ECG examinations The printout s form is similar to the automatic recording mode s one e Outside printer printout As connected to the electrocardiograph the outside printer enables to make printouts on regular paper or any media which the particular printer operates on The only thing required is that the outside printer uses USB port for connection and understands PCL script language e Saving examination s copy to the external USB device e g PenDrive The data is stored in accordance with the EN1064 2000 standard Preliminaries The appliance is equipped with a built in battery To indicate the device turned on press on the keyboard Before the first turning on or after the long period of not using the device it is
13. corrosive pollutions On user s request the producer can provide the qualified servicing personnel with all the necessary information required to maintain correct repairs and adjusting 21 24 M TRACE Electrocardiograph User s Manual Manufacturer s Declaration of Conformity for The Electromagnetic Compatibility Electromagnetic emission tests Tests Conformity Electromagnetic environment CISPR 11 M TRACE Electrocardiograph is the equipment in RF Disturbance Gron d which there is intentionally generated or used conductively coupled RF energy that is necessary for the internal functioning of the equipment itself CISPR 11 In household rooms the device can be the source of RF Disturbance Class A radio distortions In such case please take appropriate actions IEC 61000 3 2 Harmonic n a Distortion IEC 61000 3 3 Voltage E Fluctuation and Flicker Electromagnetic immunity tests eye Tests 0009 Compatibility level Electromagnetic netic Test level Environment IEC 61000 4 2 The floor should be wood Electrostatic ew p apa Mode concrete glazed If there s Discharge f D No an synthetic lining the 5 relative humidity should at least 30 EE o 2kV AC and DC power lines Typical hospital or Electrical Fast i I O lines commercial environment Transients IEC 61000 4 5 IkV Line to Line Typical hospital Surges 2kV Line to Ground commercial environment IEC 61000 4 1 l Voltage
14. d Input Impedance Control Range Resolution Sampling Frequency Digital Filters LCD Screen Safety Class Group Operating Environmental Conditions 260 W x 52 H x 220 D mm lt 1 8kg AC 90 240V 50 60Hz Li ion 7 2V 2 2Ah Can be replaced only by qualified servicing personnel lt 30VA 12 Standard ECG leads Einthoven s limb leads I IL III Goldberger s limb leads aVR aVL aVF Wilson s precordial leads V2 V4 V5 V6 2 5 5 10 20 mm mV 5 5 10 25 50 mm s 5 gt 100dB 0 05 150Hz gt 10MQ gt 300 mVpp 10 mVpp 2 5uV 1000Hz 50Hz 60Hz 35Hz 25Hz antidrift Color graphic display 320x240 Protection Type CF EN60601 1 Class I Class A Group 1 CISPR 11 Temperature 10 to 40 C 50 to 104 F Relative Humidity 25 to 9596 non condensing Input circuit is protected against defibrillation impulse After such impulse ECG waveform will appear again up to next 10 seconds Using the appliance Functional abilities Electrocardiograph can record signals from 12 channel standard ECG leads There are following operating modes available e Automatic recording mode 12 lead signals are being recorded in one 10 second time block Afterwards device automatically makes analysis including time and amplitude measurements of P QRS T complex determining the electrical axis of the heart and the rhythm analysis Full report printout includes the real ECG waveform averaged P QRS T
15. like this IHITIRL SENSITIVITY FILTER SETTINGS 2 5 mn 5 1 mm mU OFF 6 CHANNELS PRINT Using the arrow keys 1 gt mark the parameter to be changed and pick it pressing When configuration is finished confirm it with or reject any made changes with CANCEL The rest of the parameters can be set n CONFIGURATION The look of the suitable screen is like this CONFIGURATION HAIHS 5 1350 INE I 89 31 DATE 16 61 2689 FORMAT STANDARD QRS OFF LANGUAGE ENGLISH SURGERY CANCEL me The available values for it will be shown Accept the choice with me 18 24 M TRACE Electrocardiograph User s Manual Managing the advanced settings 15 similar to the presets configuration The list of available options in the advanced settings section Option MAINS ISOLINE TIME DATE FORMAT QRS LANGUAGE SURGERY Description Sets the frequency of the mains 50Hz or 60Hz Activates or deactivates the antidrift filter Sets the real time clock Sets the date Sets the printout format Available are Standard format Cabrera format Sound indication of the QRS complex detection Sets the interface language Allows to put the name of the consultation s office 19 24 M TRACE Electrocardiograph User s Manual w navigation map PATIENT COPY SETUP i REPORT INITIAL SETTINGS CONFIGRUATION NEW CURRENT MEMORY
16. nfirming it with mel Afterwards there are the following options to be chosen PRINT To print the last examination copy MEMORY To recall patient s data stored in electrocardiograph s memory PENDRIVE To save data on the external storage device After MEMORY RECALL option is taken please pick up the patient from the list and then choose his particular examination As confirmed it will be followed by starting the printing Just before the printing it is necessary to pick the destination THERMAL To print on the internal thermal printer PRINTER To print on the external A4 USB printer Before using the PENDRIVE option please make sure if the proper device 15 connected to the electrocardiograph s USB socket If so use the function pick the patient from the list his particular examination and after confirming it provide the file name under which it will be saved In case the file with the same name already exists it will be overwritten by the new file The data 1s stored in accordance with the EN1064 2000 standard Managing the memory Electrocardiograph is equipped with an internal memory Its capacity is up to 100 of complete ECG examinations Storing to the memory 1s available on two cases the patient s area or the ECG examination area Action How Saving the patient s data Press then pick PATIENT gt MEMORY SAVE While saving the copy of an examination the patient s personal information 1s being stored automatically
17. on Depolarization of atrial muscle Depolarization of atrioventricular node and atrioventricular bundle Conducting depolarization from sinoatrial node to ventricles muscle Depolarization of the ventricles muscle Slow repolarization of the ventricles muscle Fast repolarization of the ventricles muscle Slow and fast repolarization of the ventricles muscle Action potential of ventricles muscle Visible in 50 75 of ECGs One full heart s electric cycle Duration 100ms 50ms 150ms 90ms 120ms 120ms 280ms 370ms o00ms The format of printout of automatic examination can be configured in the MENU REPORT sub section of the SETTINGS section Examination in manual mode This mode enables users to choose how many lead signals 3 6 or 12 will be recorded at the same real time That mode allows to switch between lead groups change amount of recorded channels sensitivity and the speed of the recording process during the examination It 1s also available to activate or deactivate additional ECG signals interferences filters Every change 18 indicated on the printout instantly The manual mode examination can be initialized by pressing and runs till it is stopped by pressing eror 14 24 M TRACE Electrocardiograph User s Manual Making the copy of examination It is possible to print the copy of automatic mode examination It can be made by pressing followed by picking COPY option and co
18. on in automatic mode Automatic mode examination consists in the full 12 lead electrocardiogram recording 12 lead signals are being recorded in one 10 second time block Afterwards device automatically makes analysis including time and amplitude measurements of P ORS T complex determining the electrical axis of the heart and the rhythm analysis Full report printout includes the real ECG waveform averaged P QRS T complex with particular marked waves conclusions of the measurements and calculations text ECG interpretation and the data of the patient To get proper results in the interpretation it is neccessary to input sex and age of the patient Otherwise the analysis will set the patient as male 35 years old Each time the interpretation of ECG signals needs to be validated by a doctor The auto mode examination can be initialized by pressing Before it operator can determine the printout format After examination the data can be either printed out or stored in electrocardiograph s internal memory The capacity of the memory 18 up to 100 of complete ECG examinations 13 24 M TRACE Electrocardiograph User s Manual Schematic representation of normal ECG Part of RR P wave PQ segment PQ interval QRS Complex ST segment T wave ST interval QT interval U wave RR interval segment ST segment segment FX PO ORS ST interval Interval OT interval Acti
19. orks in electrical system and heart muscle and allows to learn its reactions Indirectly it allows to examine and diagnose heart muscle behavior its perfusion oxidation and tightness Deviations in ECG record can help to recognize morbid conditions causing invalid heart muscles work or its reaction to electrical stimulus reducing perfusion and oxidation of that muscle what causes bad impulses to occur or their incorrect flow Consider emphasized that ECG 1s only one of the supplementary examinations which reveals its full potential only with full clinical view of patient s condition Some exception can be the myocardial infraction not always where the ECG record is evident and unequivocal what enables to make right diagnosis showing also the exact place 1 heart muscle area without seeing the patient In the rest of heart illness cases ECG seems to be rare authoritative but it is a vital supplemental examination M TRACE Electrocardiograph allows to record on thermal paper heart impulses in full range of 12 standard channels The device is compact It has small dimensions and a built in battery It allows to conduct examinations in all conditions It 18 crucial for cardiologic departments as much as for family doctor s job Precautions and Safety Instructions e All the safety and operating instructions should be read before the appliance is operated It will help in correct using and servicing of the device making it long time life
20. vicular precordial leads 2 line even if the apex beat 15 displaced V5 placed to the left of the sternum in the fifth m V intercostal space horizontally with V4 in D the anterior axillary line V6 placed to the left of the sternum in the fifth V intercostal space horizontally with V4 and V5 in the midaxillary line The appliance constantly monitors the connection status of all the electrodes In case the electrode does not adhere the skin the diagram is shown in red color in the referring channel In order to get the proper signals from precordial leads it 1s vital the limb ones are connected properly That s why it is recommended to connect limb leads as first 12 24 M TRACE Electrocardiograph User s Manual Entering personal information of the patient The appliance allows to add the patient s personal information to his examination data To add new information first press then pick PATIENT Confirm the selection with mel Continuing pick one of the following options NEW To add a new patient CURRENT To edit the information about the current patient STORED To recall patient s data stored In electrocardiograph s memory Entering Editing form screen PATIENT SURHRHE SEX AGE ID COMMENT Use arrow buttons to navigate between the particular information to be edited The chosen field 1s enlighten Confirm entered data with OK or CANCEL if you want to reject any changes Examinati
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