EDAN Norav NECG-12 Operating Manual
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EDAN Norav NECG-12 Operating Manual

EDAN Norav NECG-12 Operating Manual

Electrocardiograph
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Operating Manual for the
Electrocardiograph
Norav NECG- 12
Version 1.7.1
Part-No.: NV-54/NECG-12

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Summary of Contents for EDAN Norav NECG-12

  • Page 1 Operating Manual for the Electrocardiograph Norav NECG- 12 Version 1.7.1 Part-No.: NV-54/NECG-12...
  • Page 2 About this Manual P/N: NV-54/NECG-12 Release Date: July 2020 Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which the manufacturer cannot be held liable.
  • Page 3 Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1: Safety Guidance ...................... 1 1.1 Intended Use/Indications for Use ..................1 1.2 Warnings and Cautions ....................... 1 1.2.1 Safety Warnings ......................2 1.2.2 Li-ion Battery Care Warnings ..................5 1.2.3 General Cautions ......................6 1.3 List of Symbols ........................7 Chapter 2: Introduction ......................
  • Page 5 4.3 Screen Description ......................39 4.3.1 About the Main Screen....................39 4.3.2 About the System Setup Screen .................. 42 4.3.3 About the File Manager Screen .................. 43 4.4 Work Mode Description ....................46 Chapter 5 Entering Patient Information ................47 5.1 Entering Patient Information Manually ................
  • Page 6 Chapter 9: System Setup ......................71 9.1 Factory Defaults ....................... 71 9.2 Work Mode Setup ......................76 9.3 Filter Setup ........................77 9.4 Record Info Setup ......................78 9.4.1 Setup 1 ........................78 9.4.2 Setup 2 ........................81 9.4.3 Setup 3 ........................83 9.5 Patient Information Setup ....................

  • Page 7: Chapter 1: Safety Guidance

    NECG-12 Electrocardiograph User Manual Safety Guidance Chapter 1: Safety Guidance This chapter provides important safety information related to the use of NECG-12 electrocardiograph. 1.1 Intended Use/Indications for Use The intended use of NECG-12 electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes.

  • Page 8: Safety Warnings

    NECG-12 Electrocardiograph User Manual Safety Guidance 1.2.1 Safety Warnings WARNING 1. The electrocardiograph is intended to be used by qualified physicians or personnel professionally trained. They should be familiar with the contents of this user manual before operation. 2. Only qualified service engineers can install this equipment, and only service engineers authorized by the manufacturer can open the shell.
  • Page 9 NECG-12 Electrocardiograph User Manual Safety Guidance WARNING 12. Electrodes of dissimilar metals should not be used; otherwise it may cause a high polarization voltage. 13. The disposable electrodes can only be used for one time. 14. Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator.
  • Page 10 NECG-12 Electrocardiograph User Manual Safety Guidance WARNING 24. Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by the manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system.

  • Page 11: Li-Ion Battery Care Warnings

    NECG-12 Electrocardiograph User Manual Safety Guidance WARNING 31. The electrocardiograph shall not be serviced or maintained while in use with a patient. 32. The appliance coupler or mains plug is used as isolation means from supply mains. Position the electrocardiograph in a location where the operator can easily access the disconnection device.

  • Page 12: General Cautions

    NECG-12 Electrocardiograph User Manual Safety Guidance WARNING 10. If the battery is stored alone and not used for a long time, we recommend that the battery be charged at least once every 6 months to prevent over-discharge. 1.2.3 General Cautions CAUTION 1.

  • Page 13: List Of Symbols

    NECG-12 Electrocardiograph User Manual Safety Guidance 1.3 List of Symbols Symbol Description External output External input Equipment or part of CF type with defibrillator proof Caution Consult Instructions for Use Potential equalization Patient Cable Socket USB socket Net port Mains supply Battery indicator Battery recharging indicator - 7 -...
  • Page 14 NECG-12 Electrocardiograph User Manual Safety Guidance Delete key Enter key Esc key/Reset key Shift key Fn key Power On/Off key 1mV/COPY key MODE key SLEEP/WAKE UP key PRINT/STOP key Tab key/Feed paper key UP/DOWN Arrow key - 8 -...
  • Page 15 NECG-12 Electrocardiograph User Manual Safety Guidance LEFT/RIGHT Arrow key / Lead switch key Gender key Age Group key Recycle Part Number Serial Number Date of Manufacture Manufacturer Authorized Representative in the European Community The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning 2797 medical devices.
  • Page 16 NECG-12 Electrocardiograph User Manual Safety Guidance  Refer to User Manual  Consult instruction for use on this CD (Background: Blue; Symbol: White) Warning (Background: Yellow; Symbol&Outline: Black) Non- ionizing electromagnetic radiation Federal Communications Commission: Contains FCC ID: Contains FCC ID: YOPGS2011MIZ YOPGS2011MIZ NOTE: 1.

  • Page 17: Chapter 2: Introduction

    NECG-12 Electrocardiograph User Manual Introduction Chapter 2: Introduction NECG-12 electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms. The 12-channel ECG waves can be viewed on the LCD screen and printed out by using a high-quality thermal recorder.

  • Page 18: Keyboard And Keys

    NECG-12 Electrocardiograph User Manual Introduction 2.2 Keyboard and Keys Figure 2-2 NECG-12 Keyboard Name Explanation NOTE: Stress ECG functions are not supported Function Key Press to select menu functions on the screen. Press to quickly select the gender for the patient when Gender Key Gender is selected in the Patient Information Setup window.
  • Page 19 NECG-12 Electrocardiograph User Manual Introduction Pressing Tab can move the cursor forward, and pressing Shift + Tab can move the cursor backward. Press to feed paper: If Paper Marker is set to Yes, pressing Tab can advance the recorder paper to the next black marker; if Paper Marker is set to No, pressing Tab can advance the paper for 2.5cm.

  • Page 20: Front Panel

    NECG-12 Electrocardiograph User Manual Introduction NOTE: A large polarization voltage may cause baseline drift. On the main screen, pressing Esc can decrease the polarization voltage and draw the baseline to zero quickly. Press Shift + Tab to move the cursor backward. Press Shift and a number key to input the special character in the top right corner of the key.

  • Page 21: Rear Panel

    NECG-12 Electrocardiograph User Manual Introduction 2.4 Rear Panel Figure 2-4 NECG-12 Rear Panel Name Explanation Mains Supply Socket AC SOURCE: alternating current supply socket Potential Equalization Potential equalization conductor provides Conductor connection between the unit and the potential equalization bus bar of the electrical installation. Handle Part for people to hold Heat Emission Hole...

  • Page 22: Right Panel

    NECG-12 Electrocardiograph User Manual Introduction 2.5 Right Panel Figure 2-5 NECG-12 Right Panel Name Explanation Patient Cable Socket Connecting to the patient cable Connecting to a PC Serial Port 1 USB Socket 1 (Optional) Standard USB socket, connecting to a PC Standard USB socket, connecting to a U disk, a USB Socket 2 (Optional) bar code reader or a USB printer recommended...
  • Page 23 NECG-12 Electrocardiograph User Manual Introduction 1) Patient Cable Socket : Applied part of type CF with defibrillator proof : Caution Definitions of corresponding pins: Signal Signal Signal C2 / V2 F / LL C1 / V1 C3 / V3 or NC C4 / V4 C1 / V1 C5 / V5...
  • Page 24 NECG-12 Electrocardiograph User Manual Introduction 3) Serial Port 2 Definitions of corresponding pins: Signal Signal TxD (output) RxD (input) 4) External Input/Output Socket Definitions of corresponding pins: Signal Signal ECG Signal (input) ECG Signal (output) 5) USB Socket 1/USB Socket 2 (Optional) - 18 -...

  • Page 25: Bottom Panel

    NECG-12 Electrocardiograph User Manual Introduction CAUTION Only the USB equipment recommended by the manufacturer can be connected to the USB interface. Definitions of corresponding pins: Signal Signal WARNING 1. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g.
  • Page 26 NECG-12 Electrocardiograph User Manual Introduction Name Explanation Speaker Hole Path for sound from speaker Battery Compartment Compartment for battery Fuse The specification is: T3.15AH250V, Ø5×20mm Heat Emission Hole Path for internal heat emission Label Position for product information label 1) Battery Compartment The rated voltage and the rated capacity of the battery pack are as follows: NECG-12: Rated Voltage: 14.8V;...

  • Page 27: Features

    NECG-12 Electrocardiograph User Manual Introduction 2.7 Features ♦ Supporting AC and DC power supply modes, internal rechargeable li-ion battery with professional battery powered circuit, battery management and protection systems ♦ Supporting multi-language ♦ Full alphanumeric keyboard (For NECG-12, touch screen is available) ♦...

  • Page 28: Chapter 3: Operation Preparations

    NECG-12 Electrocardiograph User Manual Operation Preparations Chapter 3: Operation Preparations WARNING Before use, the equipment, patient cable and electrodes should be checked. Replace them if there is any evident defectiveness or aging which may impair the safety or the performance, and make sure that the equipment is in proper working condition. 3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes WARNING...

  • Page 29: Connecting The Patient Cable To Electrodes (For Resting Ecg)

    NECG-12 Electrocardiograph User Manual Operation Preparations 3.1.2 Connecting the Patient Cable to Electrodes (for Resting ECG) Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the reusable electrodes or the alligator clips. Firmly attach them. The identifiers and color codes of electrode connectors used comply with IEC/EN requirements.

  • Page 30: Preparing The Patient

    NECG-12 Electrocardiograph User Manual Operation Preparations 3.2 Preparing the Patient 3.2.1 Instructing the Patient Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases the patient’s anxiety. Reassure the patient that the procedure is painless. Privacy is important for relaxation.

  • Page 31: Electrode Placement (For Resting Ecg)

    NECG-12 Electrocardiograph User Manual Operation Preparations 3.3.1 Electrode Placement (for Resting ECG) The electrodes’ positions on the body surface are shown in the following table and figure. Standard 12-Lead Placement Only for the Disposable Electrodes Only for the Reusable Electrodes European American Electrode Placement...
  • Page 32 NECG-12 Electrocardiograph User Manual Operation Preparations NEHB Placement European American Electrode Placement Label Label Attachment point of the second rib to the right sternal edge Fifth intercostal space on the left posterior axillary line Left mid-clavicular line in the fifth intercostal space Right arm Left arm N or RF...

  • Page 33: Attaching The Reusable Electrodes (For Resting Ecg)

    NECG-12 Electrocardiograph User Manual Operation Preparations European American Electrode Placement Label Label Right mid-axillary line on the same horizontal level as C3 and C4 Sternum at the level of C3 and C4 Mid-clavicular line in the fifth intercostals space Left mid-axilary line on the same horizontal level as C3 Center of spine on the same horizontal level as C3 and C4 Neck, avoid carotid artery and jugular vein Right arm/Right deltoid...

  • Page 34: Attaching The Chest Electrodes

    NECG-12 Electrocardiograph User Manual Operation Preparations 3.3.2.2 Attaching the Chest Electrodes Suction Bulb Connecting to a Lead Wire Metal Cup Chest Electrode Chest Electrode Connection: 1) Ensure that the electrodes are clean; 2) Clean the electrode area on the chest surface with 75% alcohol; 3) Daub the round area of 25mm in diameter on each electrode site with gel evenly;...

  • Page 35: Inspection Before Power-On

    NECG-12 Electrocardiograph User Manual Operation Preparations Disposable Electrode Connection 1) Align all lead wires of the patient cable to avoid twisting, and connect the alligator clips to the lead wires. 2) Clean the electrode areas on the body surface with 75% alcohol. 3) Attach the disposable electrodes to the electrode positions on the body surface.

  • Page 36: Turning On/Off The Electrocardiograph

    NECG-12 Electrocardiograph User Manual Operation Preparations 4) Electrodes: ♦ Make sure that all electrodes are connected to lead wires of the patient cable correctly. ♦ Ensure that the chest electrodes do not contact with each other. 5) Patient: ♦ The patient should not come into contact with conducting objects such as earth, metal parts etc.

  • Page 37: Loading/Replacing Recorder Paper

    NECG-12 Electrocardiograph User Manual Operation Preparations CAUTION 1. If the electrocardiograph is turned off because of low battery capacity or unexpected power failure, the settings or the current ECG report may not be saved. 2. The electrocardiograph cannot print an ECG report when the battery is weak. 3.
  • Page 38 NECG-12 Electrocardiograph User Manual Operation Preparations When the recorder paper runs out or is not loaded, the hint message No Paper will appear on the screen. Then you should load or replace the recorder paper immediately. Groove Movable Movable Part 1 Part 2 Paper Tray Exit Edge...
  • Page 39 NECG-12 Electrocardiograph User Manual Operation Preparations Take off the wrapper of the new folded paper, and then put it in the paper tray. Pull the paper out with the grid side facing the thermal print head, and replace the casing on the recorder. Press down the recorder casing firmly.
  • Page 40 NECG-12 Electrocardiograph User Manual Operation Preparations Loading/Replacing Process of Rolled Paper: 1) Press the casing button downwards and remove the casing to open the recorder. 2) Take out the paper roller, and remove remainder paper from the roller if necessary. 3) Take off the wrapper of the new thermal paper roll, and then put the paper roll through the roller.
  • Page 41 NECG-12 Electrocardiograph User Manual Operation Preparations 6) Press down the recorder casing firmly. 7) Set Paper Marker to No in the Record Info Setup1 window. 8) Advance the recorder paper. When the main screen is displayed, you can press to advance the paper for 2.5cm.

  • Page 42: Chapter 4: Basic Operation Guidance

    NECG-12 Electrocardiograph User Manual Basic Operation Guidance Chapter 4: Basic Operation Guidance The following sections provide an overview of the main operations and functions. You can operate the electrocardiograph by using the touch screen (optional). CAUTION Do not touch the LCD screen with sharp things such as pencils or pens; otherwise, it will be damaged.

  • Page 43: Entering Data

    NECG-12 Electrocardiograph User Manual Basic Operation Guidance 4.1.2 Entering Data Take the Patient Information window for example: 1. Press F1 below Patient on the main screen1 to open the Patient Information window. 2. Press Tab or Shift + Tab to move the cursor to the Name textbox. ...

  • Page 44: Selecting An Item

    NECG-12 Electrocardiograph User Manual Basic Operation Guidance 4.1.3 Selecting an Item Take the Work Mode Setup window for example: Check Box Textbox Dropdown List Box 1. In the Work Mode Setup window, press Tab or Shift + Tab to move the cursor among different check boxes.

  • Page 45: Screen Description

    NECG-12 Electrocardiograph User Manual Basic Operation Guidance 4.3 Screen Description 4.3.1 About the Main Screen After the electrocardiograph is turned on, the main screen appears. Figure 4-1 NECG-12 Main Screen1 - 39 -...
  • Page 46 NECG-12 Electrocardiograph User Manual Basic Operation Guidance Figure 4-2 NECG-12 Main Screen2 Name Explanation Patient Name: within 60 ASCII characters or the equivalent Name number of other characters that can be supported by equivalent memory used by 60 ASCII characters When ID Mode is set to Manual, the patient ID is within 30 ASCII characters.
  • Page 47 NECG-12 Electrocardiograph User Manual Basic Operation Guidance Including DEMO, Module Error, Overload, Lead Name (When the leads are off, the lead names will be shown in black on a Hint Information 1 yellow background in NECG-12 . For details, please refer to Chapter 12 “Hint Information”.

  • Page 48: About The System Setup Screen

    NECG-12 Electrocardiograph User Manual Basic Operation Guidance Freezing ECG waves. For details, please refer to Section 6.3 Freeze “Freezing ECG Waves”. Press to open the Patient Information window. For details, Patient please refer to Chapter 5, “Entering Patient Information”. ECG waveform Display ECG waveform Press to return to the main screen1.

  • Page 49: About The File Manager Screen

    NECG-12 Electrocardiograph User Manual Basic Operation Guidance On the System Setup screen, move the cursor on an item, and then press Enter to open the setup window of the item. 4.3.3 About the File Manager Screen Switch to the File Manager Screen 1/2 ...
  • Page 50 NECG-12 Electrocardiograph User Manual Basic Operation Guidance Figure 4-3 File Manager Screen1 Figure 4-4 File Manager Screen2 - 44 -...
  • Page 51 NECG-12 Electrocardiograph User Manual Basic Operation Guidance Name Explanation For example, 0% (1) space occupancy files stored electrocardiograph. File Count 1 is the current number of files stored in the electrocardiograph. For 10s AUTO data, the upper storage limit is 800. Files will be loaded and displayed in the file list.

  • Page 52: Work Mode Description

    NECG-12 Electrocardiograph User Manual Basic Operation Guidance 4.4 Work Mode Description There are five work modes in NECG-12 electrocardiograph. In the auto mode, the ECG data can be analyzed, saved, printed and AUTO: transmitted. The lead groups are switched automatically according to the lead sequence during the printing course.

  • Page 53: Chapter 5 Entering Patient Information

    NECG-12 Electrocardiograph User Manual Entering Patient Information Chapter 5 Entering Patient Information 5.1 Entering Patient Information Manually Operation procedures are as follows: 1. Configure the Patient Information Setup window. (Optional) 1) Select the desired items. 2) Select a mode from the ID list box. For details, please refer to Section 9.5 “Patient Information Setup”.

  • Page 54: Entering Patient Information By Using A Bar Code Reader (Optional)

    NECG-12 Electrocardiograph User Manual Entering Patient Information Race Patient Race (unknown/ Oriental/ Caucasian/ Black/ Indian/ Mongolian/ Hispanic/ Asian/ Pacific/ Chinese/ Malay/ other) Pacemaker Select Yes to detect very small pacemaker pulses. However, when Pacemaker is set to Yes, the system is very sensitive, and should not be close to equipment emitting high frequency radiation.

  • Page 55: Chapter 6: Printing Ecg Reports

    NECG-12 Electrocardiograph User Manual Printing ECG Reports Chapter 6: Printing ECG Reports NOTE: 1. The working mode cannot be changed during the printing course. Stop printing reports before changing the working mode. 2. Within three seconds after returning to the main screen, if you press the PRINT/STOP key to print an ECG report in the auto quick mode or the manual mode, the recorder will not respond.

  • Page 56: Manual Mode

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 2. Print an auto ECC report. 6.1.2 Manual Mode In the manual mode, the sampling or print time can be adjusted manually according to clinic needs. ECG data of arbitrary length can be sampled or printed. Operation Method: 1.

  • Page 57: Rhythm Mode

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 6.1.3 Rhythm Mode The rhythm mode contributes to discover the abiogenetic or frequent arrhythmia. The rhythm-lead ECG waveform of one lead or three leads can be sampled or printed for a long time. Operation Method: 1.

  • Page 58: R-R Analysis Mode

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 6.1.4 R-R Analysis Mode The R-R analysis mode contributes to get the related indicators of HRV (Heart Rate Variability). HRV analysis refers to the variability between durations of the two following heart rates, and it is a predicted indicator to sudden death caused by acute myocardial infarction and vicious arrhythmia.

  • Page 59: Vcg Mode

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 6.1.5 VCG Mode NOTE: This function is optional and needs to be activated in the Advanced Setting window first. VCG (Vectorcardiogram) is stereo images to show phase shifts of heart activities. As an advance and a complement to the cardiogram diagnosis, VCG excels in diagnosis of myocardial infarction, intraventricular conduction block and ventricular hypertrophy.
  • Page 60 NECG-12 Electrocardiograph User Manual Printing ECG Reports 3. If Preview is set to On in the Work Mode Setup window, pressing the PRINT/STOP key can preview an ECG report. 1) Select Waveform to display the waveform screen. 2) Select Loop to display the loop screen. - 54 -...

  • Page 61: Copy Printing

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 3) Select Measure to display the measure screen which shows the measurement information. 6.2 Copy Printing In the auto, rhythm and VCG modes, pressing the 1mV/COPY key can print the ECG report which was printed out last time. Pressing the PRINT/STOP key can stop printing the ECG report.
  • Page 62 NECG-12 Electrocardiograph User Manual Printing ECG Reports Figure 6-1 Freezing Screen (Auto/Manual/Rhythm/R-R Analysis mode) Figure 6-2 VCG Freezing Screen NOTE: Within 10 seconds after returning to the main screen, pressing F2 can not display the freezing screen. 3) Press PRINT/STOP or select Record on the freezing screen to print the current waveform. - 56 -...

  • Page 63: Printing A Stored Ecg Report

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 6.4 Printing a Stored ECG Report 6.4.1 Printing on the File Manager Screen1/2 Operation Method: 1. Select a file on the File Manager screen1. 2. Press PRINT/STOP to print the file, or press Select to display the File Manager screen2, and then press PRINT/STOP to print the file.

  • Page 64: Resting Ecg Reports

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 6.5 Resting ECG Reports 6.5.1 Auto ECG Report Quick Mode - 58 -...
  • Page 65 NECG-12 Electrocardiograph User Manual Printing ECG Reports The above figure (a) and (b) show an ECG report in the auto mode. Template is selected, and Record Style is set to 6×2+1R. The ECG report includes: 6×2+1R ECG waves Current Date and Time Name, ID, Gender, Age Patient Information: Measure Information:...
  • Page 66 NECG-12 Electrocardiograph User Manual Printing ECG Reports P/QRS/T Dominant direction of the average integrated ECG vectors; RV5/SV1 The maximum of the amplitude of R or R’ wave of one selected dominant beat from lead V5 / The maximum absolute value of the amplitude of S or S’ wave of one selected dominant beat from lead V1;...
  • Page 67 NECG-12 Electrocardiograph User Manual Printing ECG Reports Save Paper Mode - 61 -...
  • Page 68 NECG-12 Electrocardiograph User Manual Printing ECG Reports The above figure (a) and (b) show an ECG report in the auto mode. Template is selected, and Record Style is set to 6×2+1R. - 62 -...

  • Page 69: Auto Ecg Report Printed By The Usb Printer

    NECG-12 Electrocardiograph User Manual Printing ECG Reports 6.5.2 Auto ECG Report Printed by the USB Printer - 63 -...

  • Page 70: Chapter 7: Transmitting Ecg Data

    NECG-12 Electrocardiograph User Manual Managing Files Chapter 7: Transmitting ECG Data WARNING This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 71: Transmitting Ecg Data In Dat Format Through Serial Cable

    NECG-12 Electrocardiograph User Manual Managing Files 7.1.1 Transmitting ECG Data in DAT Format Through Serial Cable 1. If the PC has RS232 socket, connect the PC RS232 socket to the electrocardiograph RS232 socket with an RS232 cable. 2. If the PC has no RS232 socket, you can connect the PC USB socket to the electrocardiograph RS232 socket by RS232-USB Assembly.

  • Page 72: Transmitting Ecg Data In Scp/Fda-Xml/Pdf/Dicom Format Through Ethernet Cable

    NECG-12 Electrocardiograph User Manual Managing Files Transmission Setup window. 2) Set the Server IP item to the IP of the PC. For details, please refer to Section 9.6 “Transmission Setup”. 3) Press Enter to confirm, and then press Esc to return to the main screen. 3.

  • Page 73: Chapter 8: Managing Files

    NECG-12 Electrocardiograph User Manual Managing Files Chapter 8: Managing Files If you want to save the ECG data in the electrocardiograph, you should set Auto Save to to ECG in the File Setup window. Then the ECG data in the auto or rhythm mode will be saved on the File Manager screen automatically.

  • Page 74: Deleting Files

    NECG-12 Electrocardiograph User Manual Managing Files 4. Or select a file on the File Manager screen1, and then press Select to display the File Manager screen2. Select Export on the File Manager screen2 to export the selected file to the directory of ECGDATA\ECG-X\Export\Export Date and Time of the U disk. NOTE: 1.

  • Page 75: Importing Files

    NECG-12 Electrocardiograph User Manual Managing Files 8.5 Importing Files Operation procedures are as follows: 1. Connect the U disk recommended by the manufacturer to the electrocardiograph. 2. Save files to the directory of ECGDAT\Import of the U disk. 3. Select Import on the File Manager screen1 to import files from the directory of ECGDAT\Import of the U disk to the electrocardiograph.
  • Page 76 NECG-12 Electrocardiograph User Manual Managing Files The file preview screen displays the patient information, ECG waveform, measurement information and diagnosis information, as shown in the figure below: - 70 -...

  • Page 77: Chapter 9: System Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Chapter 9: System Setup Select Setup on the main screen1 to display the System Setup screen. 9.1 Factory Defaults Work Mode Setup Default Items Default (Only in the U.S.) Auto, Manual, Rhythm, Mode Options Auto, Manual, Rhythm Manual Style...
  • Page 78 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Default Items Default (Only in the U.S.) Record Style 6×2 3×4+1R Record Mode Save Paper Save Paper Record Sequence Sequential Sequential Gain 10mm/mV 10mm/mV Print Out Paper Marker Record Device Thermal Thermal Speed 25mm/s 25mm/s...
  • Page 79 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG (VCG function needs to be activated) Default Items Default (Only in the U.S.) XYZ Wave / Measure / Analysis QRS Gain 20mm/mV 20mm/mV Patient Information Setup Default Items Default (Only in the U.S.) Gender / Pacemaker First\Last Name / BP / Race / Height / Weight /...
  • Page 80 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Default Items Default (Only in the U.S.) Auto Transmission Transmission Mode Ethernet Ethernet FTP User Name / FTP Cleared Cleared Password/ FTP Path Lead Setup Default Items Default (Only in the U.S.) Lead Sequence Standard Standard...
  • Page 81 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Date & Time Setup Default Items Default (Only in the U.S.) Date Mode DD-MM-YYYY DD-MM-YYYY Time Mode 24 Hours 24 Hours Power Off/ LCD Off Cleared Cleared File Setup Default Items Default (Only in the U.S.) Auto Save To ECG...

  • Page 82: Work Mode Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG 9.2 Work Mode Setup Select Work Mode on the System Setup screen, and then press Enter to open the Work Mode Setup window. Figure 9-1 Work Mode Setup Window Item Description Mode Options Select a working mode.

  • Page 83: Filter Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description Sampling Mode Select Real-time Sample, 10s ECG data sampled after pressing the PRINT/STOP key will be printed out. (Only available in the auto mode) Select Triggered Sample, after pressing the PRINT/STOP key, if Arrhythmia data, including...

  • Page 84: Record Info Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description AC Filter Choose from: On or Off NOTE: AC frequency can be set to 50Hz or 60Hz on the Advanced Setup screen according local mains supply specifications. DFT Filter DFT Filter greatly reduces the baseline fluctuations without affecting the ECG signals.
  • Page 85 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Figure 9-3 Record Info Setup1 Item Description Record Style Select a style to print the ECG waves of 12 leads in the auto mode. Choose from: 3×4, 3×4+1R, 3×4+3R, 6×2, 6×2+1R or 12×1 Record Mode Choose from: Save Paper or Quickly Select Save Paper, 10s after pressing the PRINT/STOP key on the main...
  • Page 86 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description Record Sequence Select Synchronous, the lead group is printed one by one in a certain sequence. All leads are printed with the same start time. Gain You can set the indicated height of 1mV ECG on the paper. Choose from: 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV or 10/5mm/mV.

  • Page 87: Setup 2

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG printing. Error may occur if no paper is loaded in the USB Printer. Print Out Choose from: On or Off (Only available Select On, the ECG report can be printed out by pressing the PRINT/STOP key.
  • Page 88 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Figure 9-4 Record Info Setup2 Item Description Auto Record Info Select the item printed in the ECG reports. NOTE: 1. Template, Position Marker, Measure, Analysis Minnesota Code are available only in the auto mode, and Time Scale and Device No.

  • Page 89: Setup 3

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG 9.4.3 Setup 3 NOTE: 1. Only if the VCG function is activated, can the Record Info Setup3 window appear. For details on activating the VCG function, please contact the manufacturer or the local distributor.

  • Page 90: Patient Information Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG 9.5 Patient Information Setup Select Patient Info on the System Setup screen, and then press Enter to open the Patient Information Setup window. Figure 9-6 Patient Information Setup Window Item Description Patient Options Select the item displayed in the Patient Information window.
  • Page 91 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description ID Hint Choose from: On or Off In the auto, rhythm or VCG mode, when ID is set to Manual and ID Hint is set to On, if you do not input the patient ID before pressing the PRINT/STOP key, a hint will pop up to remind you to input the patient Choose from: Age, D.O.B or Age Group Select Age, you can enter the patient age manually in the Patient...

  • Page 92: Transmission Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG 9.6 Transmission Setup Select Transmission on the System Setup screen, and press Enter to open the Transmission Setup window. Figure 9-7 Transmission Setup Window Item Description Device No. Type the Device No., within 7 ASCII characters Auto Transmission Choose from: On or Off Select On, ECG data will be transmitted automatically after an ECG...

  • Page 93: Lead Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG 9.7 Lead Setup Select Lead on the System Setup screen, and press Enter to open the Lead Setup window. Figure 9-8 Lead Setup Window Item Description Rhythm Lead1/2/3 Choose from: І, П, Ш, aVR, aVL, aVF, V1, V2, V3, V4, V5, or V6 In the auto mode: When Record Style is set to 3×4+1R or 6×2+1R, the rhythm lead selected in the Rhythm Lead1 list box will be printed in the ECG reports;...

  • Page 94: Display&Sound Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description Lead Sequence Choose from: Standard or Cabrera Lead Lead group 1 Lead group 2 Lead group 3 Lead group 4 Sequence Standard І, II, Ш aVR, aVL, aVF V1, V2, V3 V4, V5, V6 aVL, І, -aVR II, aVF, Ш...

  • Page 95: Date&Time Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description Hint Volume Choose from: Low, Medium, High or Off Select Low, Medium or High, the electrocardiograph gives a sound when a hint such as Lead Off, Overload, Battery Weak etc. is displayed. Select Off, there is no hint sound.

  • Page 96: File Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG NOTE: Please set DATE&TIME correctly when it’s the first time you use the electrocardiograph. Item Description Date&Time Enter the current date and time displayed on the main screen and in the ECG reports. Date Mode Choose from: DD-MM-YYYY, MM-DD-YYYY or YYYY-MM-DD Time Mode...
  • Page 97 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description Auto Save Choose from: Off, To ECG or To U Disk Select Off, ECG data will not be saved. Select To ECG, ECG data in the auto or rhythm mode will be saved in the ECG automatically.

  • Page 98: System Maintenance Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG 9.11 System Maintenance Setup Select Maintenance on the System Setup screen, and press Enter to open the System Maintenance window. Figure 9-12 System Maintenance Window Item Description Export Settings Press to export the system settings to the U disk. Import Settings Press to load the system settings from the U disk to the electrocardiograph.

  • Page 99: Other Setup

    NECG-12 Electrocardiograph User Manual Operation Instructions for ECG 9.12 Other Setup Select Other on the System Setup screen, press Enter to open the Other Setup window. Figure 9-13 Other Setup Window Item Description Institution Input the institution name manually within 40 ASCII characters. NOTE: The total number of supported characters may be fewer if special Latin characters are entered.
  • Page 100 NECG-12 Electrocardiograph User Manual Operation Instructions for ECG Item Description External Output The external output socket is equipped in the electrocardiograph, through which the electrocardiograph can send rhythm lead signals to the external equipment. Choose from: Off, Standard or Triggered Select Standard, the electrocardiograph sends ECG signals of rhythm lead 1.

  • Page 101: Chapter 10: Hint Information

    NECG-12 Electrocardiograph User Manual Hint Information Chapter 10: Hint Information Hint information and the corresponding causes provided by the electrocardiograph are listed in Table 10-1. Table 10-1 Hint Information and Causes for Resting ECG Hint Information Causes Electrodes fall off the patient or the patient cable falls off the unit , Lead off or a high polarization voltage occurs.

  • Page 102: Chapter 11: Faq

    NECG-12 Electrocardiograph User Manual Chapter 11: FAQ 1. Operating Problems Q1: I was trying to select a file from the file list on the File Manage screen, but the file was in the middle of the long list. Is there any way to make the selection faster? A1: Actually, the system provides a method for fast moving: pressing Shift + Up or Down arrow can move the cursor up or down in the file list very fast.
  • Page 103 NECG-12 Electrocardiograph User Manual Q6: Memory Full is displayed on the main screen; Or, the hint Memory full! Replace the earliest file? pops up every time when I save an ECG report to the electrocardiograph. What am I supposed to do? A6: Memory Full is used to remind you that the amount of stored file reaches the upper limit.
  • Page 104 NECG-12 Electrocardiograph User Manual Reload the paper in the paper tray, close the recorder casing firmly. If the problem still exists, please contact the manufacturer or the local distributor for further disposal. Q4: I want to print the hospital name in the report, but I can’t find the place to enter it, where is A4: Please open the Other Setup window, and move the cursor to the Institution textbox, and then input the hospital name.
  • Page 105 NECG-12 Electrocardiograph User Manual 3. Transmitting Problems Q1: The ECG doesn’t respond to any keys after a long time of transmission. It transmits nothing for there is no new data appearing on the screen of the PC software. What should I do? A1: Some error may occur during the transmission course, for example, the connection between the ECG and the net cable may loosen.

  • Page 106: Chapter 12: Cleaning, Care And Maintenance

    NECG-12 Electrocardiograph User Manual Cleaning, Care and Maintenance Chapter 12: Cleaning, Care and Maintenance CAUTION 1. Turn off the power before cleaning and disinfection. The mains supply must be switched off if it is used. 2. Prevent the detergent from seeping into the equipment. 12.1 Cleaning CAUTION Any remainder of detergent should be removed from the unit and the patient cable after...

  • Page 107: Cleaning The Print Head

    NECG-12 Electrocardiograph User Manual Cleaning, Care and Maintenance CAUTION Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes. 12.1.3 Cleaning the Print Head 1. Open the recorder casing and remove the paper. 2. Wipe the print head gently with a clean soft cloth damped in 75 alcohol.

  • Page 108: Care And Maintenance

    NECG-12 Electrocardiograph User Manual Cleaning, Care and Maintenance 12.3 Care and Maintenance CAUTION Operate the cardiograph, charge the battery, and store the battery at a temperature of 40℃ (104ºF) or lower. Exposure to higher temperature may reduce battery life, damage the battery, and degrade overall cardiograph performance.

  • Page 109: Recorder Paper

    NECG-12 Electrocardiograph User Manual Cleaning, Care and Maintenance 3) Replacement When the useful life of the battery is over, or foul smell and leakage are found, please contact the manufacturer or the local distributor for replacement. WARNING 1. Only qualified service engineers authorized by the manufacturer can open the battery compartment and replace the battery, and the battery of the same model and specification provided by the manufacturer must be used.

  • Page 110: Visual Inspection

    NECG-12 Electrocardiograph User Manual Cleaning, Care and Maintenance 12.3.3 Visual inspection Perform a visual inspection of all equipment and peripheral devices daily. If you notice any items that need repair, contact a qualified service engineer to make the repairs.  Check the case and display screen for cracks or other damage. ...
  • Page 111 NECG-12 Electrocardiograph User Manual Cleaning, Care and Maintenance The leakage current should never exceed the limit. The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired.

  • Page 112: Chapter 13: Accessories

    NECG-12 Electrocardiograph User Manual Accessories Chapter 13: Accessories WARNING Only the patient cable and other accessories supplied by the manufacturer can be used. Or else, the performance and electric shock protection cannot be guaranteed. Accessory Part Number Patient Cable (European) NECG-C10-B-E-D (Banana Style) Patient Cable (American) NECG-C10-B-U-D (Banana Style)

  • Page 113: Chapter 14: Warranty & Service

    NECG-12 Electrocardiograph User Manual Warranty & Service Chapter 14: Warranty & Service 14.1 Warranty NORAV MEDICAL warrants that NORAV MEDICAL’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period.

  • Page 114: Appendix 1: Technical Specifications

    NECG-12 Electrocardiograph User Manual Technical Specifications Appendix 1: Technical Specifications A1.1 Safety Specifications IEC 60601-1:2005/A1:2012 EN 60601-1:2006/A1:2013 Comply with: IEC 60601-1-2:2007 EN 60601-1-2:2007/AC:2010 IEC/EN 60601-2-25 Anti-electric-shock type: Class І with internal power supply Anti-electric-shock degree: CF type with defibrillation-proof Degree of protection against Ordinary equipment (Sealed equipment without liquid proof) harmful ingress of water: Disinfection/sterilization...
  • Page 115 NECG-12 Electrocardiograph User Manual Technical Specifications 25%RH~93%RH 25%RH~80%RH Relative Humidity: Non-Condensing Non-Condensing Atmospheric Pressure: 70kPa ~106kPa 86kPa ~106kPa A1.3 Physical Specifications Dimensions NECG-12 : 420mm×330mm×120mm (16.5in×13.0in×4.7in) NECG-12 : approx. 6.5kg (14.3 lbs) Weight (Excluding recorder paper and battery) 320×240 dot single color LCD Screen Display 800×600 multicolor LCD Screen A1.4 Power Supply Specifications...
  • Page 116 NECG-12 Electrocardiograph User Manual Technical Specifications Effective Width: 210mm 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s Paper Speed: (±3%) Accuracy of data: ±5% (x-axis), ±5%(y-axis) HR Recognition Technique: Peak-peak detection HR Range: 30 BPM ~300 BPM Accuracy: ±1 BPM ECG Unit Leads: 12 standard leads Acquisition Mode:...
  • Page 117 NECG-12 Electrocardiograph User Manual Technical Specifications DFT Filter: 0.01Hz/0.05Hz/0.15Hz/0.25Hz/0.32Hz/0.5Hz/0.67Hz EMG Filter: Off/25Hz/35Hz/45Hz LOWPASS Filter: 300Hz/270Hz/150Hz/100Hz/75Hz ≥140dB (AC ON) CMRR ≥123dB(AC OFF) Sampling Frequency 16000 Hz Pacemaker Detection Amplitude ±750μV to ±700 mV Width 50μs to 2.0 ms Sampling Frequency 16,000/sec/channel External Input/Output (Optional) ≥100kΩ;...

  • Page 118: Appendix 2: Emc Information

    NECG-12 Electrocardiograph User Manual EMC Information Appendix 2: EMC Information Guidance and manufacture’s declaration - electromagnetic emissions – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic emission The 12-channel electrocardiograph is intended for use in the electromagnetic environment specified below.
  • Page 119 NECG-12 Electrocardiograph User Manual EMC Information Guidance and manufacture’s declaration – electromagnetic immunity - for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic immunity The 12-channel electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of 12-channel electrocardiograph should assure that it is used in such an environment.
  • Page 120 NECG-12 Electrocardiograph User Manual EMC Information IEC/EN 61000-4-11 40% U 40% U electrocardiograph requires continued (60% dip in U (60% dip in U operation during power for 5 cycles for 5 cycles mains interruptions, it is recommended that 70% U 70% U 12-channel (30% dip in U...
  • Page 121 NECG-12 Electrocardiograph User Manual EMC Information 800 MHz to 2.5 GHz  Where P is the maximum output power rating of the transmitter in watts (W) according transmitter manufacturer recommended separation distance in metres (m). Field strengths from fixed transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each...
  • Page 122 NECG-12 Electrocardiograph User Manual EMC Information Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM - for EQUIPMENT or SYSTEM that is not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the 12-channel Electrocardiograph The 12-channel electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 123: Appendix 3: Abbreviation

    NECG-12 Electrocardiograph User Manual Abbreviation Appendix 3: Abbreviation Abbreviation Statement Liquid Crystal Display Blood Pressure Electrocardiogram/Electrocardiograph Heart Rate Left Foot Augmented Lead Left Arm Augmented Lead Right Arm Augmented Lead Left Arm Left Leg Right Arm Right Leg Identification Alternating Current Universal Serial Bus Auto Gain Control Normal Condition...
  • Page 124 P/N: NV-54/NECG-12 Norav Medical GmbH Christof-Ruthof-Weg 10 55252 Mainz-Kastel Germany Telephone: +49 (0) 6134-567983-0 Faximile: +49 (0) 6134-567983-01 E-Mail: info@norav.com CE REPRESENTATIVE: Norav Medical GmbH Christof-Ruthof-Weg 10 55252 Mainz-Kastel Germany Telephone: +49 (0) 6134-567983-0 Faximile: +49 (0) 6134-567983-01 E-Mail: info@norav.com ...

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