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Manual Purpose

Observance of this manual is a prerequisite for proper operation and ensures patient and operator safety. If
you have any question about the device, please contact our customer service.

Intended Audience

This manual is provided for the clinical medical professionals. Clinical medical professionals are expected

to have working knowledge of medical terminology and procedures as required for the device operation.

Explanations of the used expressions in this Manual

NOTE

A NOTE symbol provides useful information and recommendations about device function.

Version Information

This manual has a version number. The version number changes whenever the manual is revised due to

software or technical specification changes. The version information of this manual is as follows:

WARNING

A WARNING symbol advises against certain actions or situations that could result in personal injury or
equipment damage.

Version number

Release date

D00912-V7

May 2021

Содержание Dena 650

Страница 1: ...User Manual Dena Electrocardiograph DENA 650 Linux AADAT Co D00912 7...

Страница 2: ...1 Fax 98 21 77964239 Customer Services Tel 98 21 73098000 98 21 77798910 Fax 98 21 77960761 Cell 98 912 1977157 Legal responsible Address Trionara Technologies AB Polygonv gen 21 18766 T by Sweden E M...

Страница 3: ......

Страница 4: ...ing Menu 22 Setting Menu 23 About 26 3 Patient information 27 Patient Data Entry 28 4 Patient preparation 31 Actions Before Recording 32 ECG Electrodes Connection 32 Detection of electrode disconnecti...

Страница 5: ...4 Maintenance 55 Cleaning Disinfection 56 Preventive Maintenance PM checklist 59 9 Troubleshooting and Error messages 61 Troubleshooting 62 Error messages 64 10 Technical specification 67 Appendix 1 A...

Страница 6: ...procedures as required for the device operation Explanations of the used expressions in this Manual NOTE A NOTE symbol provides useful information and recommendations about device function Version Inf...

Страница 7: ...patient applied part with a high degree of protection against shock and is suitable to use with defibrillator simultaneously For protection against defibrillator use only manufacturer recommended acc...

Страница 8: ...wire the equipment should run on the battery WARNING DENA 650 is intended to be used only by qualified medical staff Before use carefully read this manual and directions for use of any accessories DEN...

Страница 9: ...ted to grounded power receptacle If any liquid is spilled on the system or accessories immediately turn off the system and wipe up it by a soft cloth If water seeps into the device it should be inspec...

Страница 10: ...he device is designed to work well at temperatures between 5 and 40 degrees Celsius When the ambient temperature exceeds this range it adversely affects the measurement accuracy of the device and may...

Страница 11: ......

Страница 12: ...Chapter 1 Introduction 1 1 Introduction...

Страница 13: ...vice should be evaluated based on the patient s clinical condition and these results can not replace routine examinations Features Color display and touch screen Lightweight and portable Works with re...

Страница 14: ...evice Connect the other end of the power cable to a grounded power receptacle 3 Power on the DENA 650 Press the Power key to turn on the electrocardiograph 4 Connect the patient cable Connect all nece...

Страница 15: ...rder door Recorder to load recording paper and record ECG waveforms Control panel to control the system operation more information follows Display screen DENA 650 has a TFT color screen The 12 wave EC...

Страница 16: ...that by selecting any of the parameters that can be changed on the main page such as the patient s name and time you can more quickly refer to the relevant menu and make the necessary settings Touch...

Страница 17: ...Introduction 6 Control panel DENA 650 is designed in such a way that user can easily perform operations using some keys and touch screen Figure 1 3 illustrates these keys and indicators Figure 1 3 Con...

Страница 18: ...he screen Mode Use to select recording mode Start Stop Press to start stop ECG recording Sens Use to adjust the amplitude of ECG waveform on the screen and recording paper Battery indicator green if f...

Страница 19: ...elow 2 Open the recorder door WARNING Use only the manufacturer recommended record paper otherwise the recording quality may be poor and the thermal head may be damaged The thermal head and its surrou...

Страница 20: ...ction 9 3 Place the paper roll inclined in the recorder and push it 4 Place the other side of the paper roll in the recorder Open the paper roll to leave some of it out of the recorder 5 Close the rec...

Страница 21: ...Gender Height Weight Blood type HR value Rhythm lead Gain Filter Speed and Recording time Pacemaker status Measurement status Hospital Ward and Physician name System model and Software version NOTE Th...

Страница 22: ...ibed in the Technical specificationTechnical specificationTechnical specification and also the duration of use Table 1 2 shows the battery status in different conditions WARNING If the device is not t...

Страница 23: ...t up check the local power supply and power cord connection If this problem persists contact after sales service The battery needs to be charged after transport or storage If in this case you turn on...

Страница 24: ...figure 1 5 shows the rear panel AC power input Side panel The following connectors are located at the right side of the device ECG cable connector USB port for data export and software update Figure...

Страница 25: ...Chapter 1 Introduction 14...

Страница 26: ...Chapter 2 System settings 15 2 System settings...

Страница 27: ...r to Menu About For setting the Measurement and Interpretation Saving the signals and enabling disabling the Pacemaker please refer to Menu User NOTE It is recommended that the device is set properly...

Страница 28: ...rded simultaneously i e recording of all leads starts at the same time In the Real time mode at the moment of recording each signal the signal received from the patient is used at the same time Rhythm...

Страница 29: ...val in periodic recording Available options are 5 60 min and Off If you select Off periodic recording will be stopped Periodic Rec Repetition Press to set repetition of recording Available options are...

Страница 30: ...AC frequency on the signals By selecting the On option the phrase HUM will be inserted on the screen and the record paper and if the Off option is selected the phrase on the screen and the record pap...

Страница 31: ...d decreases to about 10Hz when the signal slope is low WARNING The use of 25 35 and 75 Hz LowPass filters may reduce the amplitude of the cardiac signal and omit some useful signal details If you turn...

Страница 32: ...default settings F1 F2 F3 and F4 are available in the system These settings are shown in the below table that only F4 filter settings could be changed by user Table 2 1 Default filters Filter LowPass...

Страница 33: ...you select On for patients with pacemaker detected pacemaker signals will be marked on the ECG waveform as a white vertical line Measurement If you select Global or Details a measurement table will be...

Страница 34: ...ameters can be set through this menu Date Time Press to open menus shown in figure 2 7 and 2 8 The following parameters can be set in these menus Calendar Type Available options are Solar and Christia...

Страница 35: ...rd figure 2 9 and enter hospital or ward name in the below window Rec Test Used to test the recorder function By selecting this option the following menu is displayed and the test is done by selecting...

Страница 36: ...ry Pressing this key opens the virtual keyboard window Figure 2 9 Screen calibration settings hardware settings and Demo mode activation will be done in this menu The operator does not have access to...

Страница 37: ...le options are English and By selecting any language all the device menus and entries on the screen change to the same language About Select this item from the Main Menu to view product and manufactur...

Страница 38: ...Chapter 3 Patient information 27 3 Patient information...

Страница 39: ...ual keyboard Figure 2 9 After entering the ID by selecting the Save option the patient s ID is saved and you exit this menu It should be noted that a maximum of 20 letters can be entered By selecting...

Страница 40: ...n Patient information menu the following window will open to make sure about saving changes WARNING Enter patient information correctly Otherwise the stored information may be mistaken for other patie...

Страница 41: ...Chapter 3 Patient information 30...

Страница 42: ...Chapter 4 Patient preparation 31 4 Patient preparation...

Страница 43: ...temperature should be appropriate and the patient should not suffer from cold and tremors Make all necessary settings on the device before recording During the recording ask the patient to be as calm...

Страница 44: ...Use intact and clean electrodes only Electrodes with damaged surface may cause ECG waveform inaccuracy Use only the manufacturer recommended ECG cable with internal resistance Other ECG cables and le...

Страница 45: ...V6 Left mid axillary line at the horizontal level of V4 Detection of electrode disconnection DENA 650 continuously monitors the connection status of the electrodes and in the event of a disconnection...

Страница 46: ...code for electrodes Symbol for electrodes Site for electrodes Red R Right arm Yellow L Left arm Black N RF Right leg Green F Left leg White Red C1 Chest White Yellow C2 White Green C3 White Brown C4...

Страница 47: ...Chapter 4 Patient preparation 36 Lead Placement Diagram Figure 4 4 Lead placement digram...

Страница 48: ...Chapter 5 Recording Operation 37 5 Recording Operation...

Страница 49: ...he first 3 waveforms indicate the waveform of selected leads and the last one is the waveform of selected Rhythm lead Manual 6 In this mode 6 selected leads will be recorded Automatic Recording Press...

Страница 50: ...e there are always six channels of recording on the paper NOTE In all Manual recording types press Lead and Lead keys to switch lead lead group during the recording In Manual recording types after the...

Страница 51: ...ic Manual and Rhythm recordings during Periodic recording For this purpose 1 select the recording mode and desired settings 2 Press the Start Stop key After the recording in the selected mode is finis...

Страница 52: ...Chapter 6 ECG analysis and measurement 41 6 ECG analysis and measurement...

Страница 53: ...ters in Global mode In Global mode reported signal specifications are not dependent on individual ECG leads and are generally calculated for the ECG signal Table 6 1 Reported parameters in Global Desc...

Страница 54: ...t in a specific direction The normal cardiac vector is in the range of 30 to 90 degrees The following figure shows the angles corresponding to each lead QTc Parameter The QT Interval is from the begin...

Страница 55: ...al from the beginning to the end of the S wave S Dur ms Time interval from the beginning to the end of the secondary R wave R Dur ms Time interval from the beginning to the end of the secondary S wave...

Страница 56: ...of report and is written in first line R Corresponds the rhythm interpretation D Indicates the details of the signal analysis and identifies the diagnostic terms S Shows a summary of the signal analy...

Страница 57: ...al that the specialist doctor make a definite statement about the patient s condition The specific code of the expressions is reported according to the type of signal and the presence of cardiac abnor...

Страница 58: ...Chapter 7 Data management 47 7 Data management...

Страница 59: ...est data Transferring the saved data is possible through the Export menu using a flash memory NOTE Signal storage is always done as Sync Archive Menu Select Archive from the Main Menu to access the be...

Страница 60: ...Delete Press Delete to delete the highlighted record An alert message Are you sure you want to delete this file will appear that asks you to confirm your selection By selecting Yes the record will be...

Страница 61: ...and ID Date and time of recording NOTE The information in this window is related to the recording time Touch keys are disabled in this window You can only return to the Archive menu with the key The...

Страница 62: ...etely By selecting Start while the flash memory is not connected to the system the message Mass Storage Not Exists will appear If the export procedure is done successfully Exported successfully will a...

Страница 63: ...vant software on the personal computer by connecting the port to the computer via a USB cable it is possible to transfer data online When installing this software a quick user guide and software insta...

Страница 64: ...Chapter 8 Care and Cleaning 53 8 Care and Cleaning...

Страница 65: ...turns itself off and then recharge the battery If you find any damage in DENA 650 stop using it on patient and contact the biomedical engineer of the hospital or the manufacturer After Sales Service...

Страница 66: ...daily Accessory physical health Accessory function It is recommended that the following be checked weekly Cleanliness of the device Physical health of the device body screen keys indicators door and...

Страница 67: ...erial or your fingernail to remove stubborn stains 5 Do not let the cleaning agent enters into the chassis of the system 6 Do not leave the cleaning agents on any part of the equipment WARNING Before...

Страница 68: ...deteriorates the print quality Clean the head elements and platen roller surface using alcohol and a cotton swab Wait until the alcohol dries then close the recorder door Accessories Refer to the acco...

Страница 69: ...the Instructions for Use that accompany the accessories and supplies or when stipulated as necessary in the Hospital Maintenance Schedule Trolley In between patients and as required use Isopropyl alco...

Страница 70: ...of the keyboard 3 Cleaning and disinfection according to the user manual 4 Correct display of Waveform area and information Display screen 5 Unplugging the system check the battery function Battery 6...

Страница 71: ...Chapter 8 Care and Cleaning 60...

Страница 72: ...Chapter 9 Troubleshooting and Error messages 61 9 Troubleshooting and Error messages...

Страница 73: ...all After Sales Services The device is unable to run on the battery Battery is discharged Faulty fuse Charge the battery for 5 hours Check the battery fuse Call After Sales Services NO ECG waveform EC...

Страница 74: ...sufficient gel perform actions before recording Patient preparation chapter Relax patient in a comfortable position Press Reset key If the problem still persists use Drift filter High frequencies and...

Страница 75: ...connected to patient The message is displayed in red color on the screen CHECK C5 Improper connection of C5 electrode Make sure that C5 electrode is properly connected to patient The message is displa...

Страница 76: ...Low Vol 1 The print head voltage is low 2 The battery voltage is low 1 Turn the system off and on 2 Make sure that the battery is sufficiently charged If the problem still exists contact the manufactu...

Страница 77: ...Chapter 9 Troubleshooting and Error messages 66...

Страница 78: ...Chapter 10 Technical specification 67 10 Technical specification...

Страница 79: ...72 Waveforms 12 Lead ECG Rhythm Lead Numeric Parameters HR Operation Method Membrane Keys and Touch Displayed data Waveforms Patinet Information Name and ID Data Time Recording Speed Sensitivity Opera...

Страница 80: ...er Recording Mode Normal Periodic Recording Format Auto 1 1 Auto 3 Auto 3 1 Auto 6 Manual 1 1 Manual 3 Manual 3 1 Manual 6 and Rhythm GENERAL Safety Class I Based on IEC60601 1 Protection Against Defi...

Страница 81: ...Chapter 10 Technical specification 70...

Страница 82: ...Appendix 1 Accessories 71 Appendix 1 Accessories...

Страница 83: ...ay cause improper device performance patient injury and inadequate protection during defibrillation Accessories Part Diagnostic EKG Cable 10 wires Launch Ref 60101010 P28041 EKG Clamp electrodes Adult...

Страница 84: ...Appendix 2 System parameters 73 Appendix 2 system parameters...

Страница 85: ...wn Unknown Print Mode Print Modes Auto Manual Rhythm Auto Auto Manual Modes 1 1 3 3 1 6 3 Rec State Auto Sync Real Time Sync Header ON OFF ON Rhythm Lead I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 I Rhyth...

Страница 86: ...Filter On EMG Filter Off F4 Low Pass Filter HUM Filter Drift Filter EMG Filter Low Pass Filter 150 Hz HUM Filter Off Drift Filter Off EMG Filter Off User Setting Menu Save Enabale Disable Disable Pace...

Страница 87: ...Appendix 2 System parameters 76...

Страница 88: ...Appendix 3 Electromagnetic compliance EMC 77 Appendix 3 Electro magnetic compliance...

Страница 89: ...that DENA 650 is used in the electromagnetic environment specified To prevent EMC effect on DENA 650 the system should not be used adjacent to or stacked with other equipment and that if adjacent or...

Страница 90: ...F emissions CISPR 11 Group 1 The DENA 650 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipm...

Страница 91: ...power 2 kV 100 kHz repetition frequency Mains power quality should be that of a typical commercial or hospital environment Signal input output parts 1 kV 100 kHz repetition frequency Surge IEC 61000...

Страница 92: ...RE 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000 4 3 ENCLOSURE Refer to the following table table 9 of EN 60601 1 2 2015 Test specifications...

Страница 93: ...Appendix 3 Electromagnetic compliance EMC 82...

Страница 94: ...Appendix 4 The GLASGOW program 83 Appendix 4 The GLASGOW program...

Страница 95: ...re right axis deviation CONDUCTION DEFECTS Left bundle branch block Incomplete LBBB Right bundle branch block RBBB with left anterior fascicular block RBBB with RAD possible left posterior fascicular...

Страница 96: ...IVENTRICULAR HYPERTROPHY Biventricular hypertrophy Possible biventricular hypertrophy MYOCARDIAL INFARCTION INFERIOR INFARCTION STATEMENTS INFERIOR INFARCT POSSIBLY ACUTE Inferior infarct age undeterm...

Страница 97: ...Q waves of undetermined cause Anterior QRS changes may be due to ventricular hypertrophy Anterior QRS changes may be due to corrected transposition QRS changes V3 V4 may be due to LVH but cannot rule...

Страница 98: ...MYOCARDIAL INFARCTION EXTENSIVE INFARCT POSSIBLY ACUTE Extensive infarct age undetermined Possible extensive infarct age undetermined Abnormal Q waves of undetermined cause Q waves may be due to card...

Страница 99: ...g Ventricular pacing A V sequential pacemaker Pacemaker rhythm Possible ectopic atrial rhythm Possible ectopic atrial tachycardia Possible ectopic atrial bradycardia Irregular ectopic atrial rhythm Ir...

Страница 100: ...ponse with slow ventricular response with PACs with frequent PACs with 1st degree A V block with borderline 1st degree A V block with 2nd degree A V block Mobitz I Wenckebach with 2nd degree A V block...

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