Norav Medical NECG-12C Operating Manual
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Norav Medical NECG-12C Operating Manual

Electrocardiograph
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Operating Manual for the
Electrocardiograph
Norav NECG-12C
Version 1.2.1
Part-No.: NV-54/NECG-12C

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Summary of Contents for Norav Medical NECG-12C

  • Page 1 Operating Manual for the Electrocardiograph Norav NECG-12C Version 1.2.1 Part-No.: NV-54/NECG-12C...
  • Page 2 NORAV MEDICAL (hereinafter called NORAV MEDICAL) cannot be held liable. NORAV MEDICAL owns the copyrights of this manual. Without prior written consent of NORAV MEDICAL, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages.
  • Page 3 A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE: A NOTE provides useful information regarding a function or a procedure. NORAV Medical GmbH Marketing Authorization Holder: Norav Medical GmbH...

  • 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 ......................1 1.2.2 Li-ion Battery Care Warnings ..................4 1.2.3 General Cautions ......................5 1.3 List of Symbols ........................6 Chapter 2: Introduction ......................
  • Page 5 4.3.3 About the File Manager Screen .................. 38 4.4 Work Mode Description ....................41 Chapter 5: Entering Patient Information................42 5.1 Entering Patient Information Manually ................42 5.2 Entering Patient Information by Using a Bar Code Reader (Optional) ......43 Chapter 6: Printing ECG Reports ..................
  • Page 6 9.5 Patient Information Setup ....................78 9.6 Transmission Setup ......................80 9.7 Lead Setup ........................81 9.8 Display&Sound Setup ...................... 82 9.9 Date&Time Setup ......................84 9.10 File Setup ........................85 9.11 System Maintenance Setup ..................... 87 9.12 Other Setup ........................88 Chapter 10: Hint Information ....................

  • Page 7: Chapter 1: Safety Guidance

    1.1 Intended Use/Indications for Use The intended use of NECG-12C 12-channel electrocardiograph (hereinafter called NECG-12C) is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.
  • Page 8 NECG-12C Electrocardiograph User Manual Safety Guidance WARNING 2. Only qualified service engineers can install this equipment, and only service engineers authorized by the manufacturer can open the shell. Otherwise, safety hazards may happen. 3. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of flammable anesthetic mixtures with oxygen or other flammable agents.
  • Page 9 NECG-12C Electrocardiograph User Manual Safety Guidance WARNING 17. The use of equipment that applies high frequency voltages to the patient (including electrosurgical equipment and some respiration transducers) is not supported and may produce undesired results. Disconnect the patient data cable from the electrocardiograph, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment.

  • Page 10: Li-Ion Battery Care Warnings

    NECG-12C Electrocardiograph User Manual Safety Guidance WARNING 27. Parts and accessories used must meet the requirements of the applicable IEC/EN 601 series safety standards, and/or the system configuration must meet the requirement of the IEC/EN 60601-1-1 medical electrical systems standard.

  • Page 11: General Cautions

    NECG-12C Electrocardiograph User Manual Safety Guidance WARNING 4. Do not heat or splash the battery or throw it into fire or water. 5. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle;...

  • Page 12: List Of Symbols

    NECG-12C Electrocardiograph User Manual Safety Guidance CAUTION 5. The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of them together with house-hold garbage.
  • Page 13 NECG-12C Electrocardiograph User Manual Safety Guidance Net port Mains supply Battery indicator Battery recharging indicator Enter key Delete key Esc key RESET key Shift key Fn key Power On/Off key 1mV/COPY key MODE key PRINT/STOP key Tab key FEED Paper key...
  • Page 14 NECG-12C Electrocardiograph User Manual Safety Guidance Lead switch key/LEFT/RIGHT Arrow key UP/DOWN Arrow key REVIEW 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...
  • Page 15 NECG-12C 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...

  • Page 16: Chapter 2: Introduction

    Introduction Chapter 2: Introduction NECG-12C 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 17: Keyboard And Keys

    When the device is powered on, the indicator flashes for a few seconds. Battery recharging indicator When the battery is being recharged, this indicator is lit. 2.2 Keyboard and Keys Figure 2-2 NECG-12C Keyboard - 11 -...
  • Page 18 NECG-12C Electrocardiograph User Manual Introduction Name Explanation Function Key Press to select menu functions on the screen. Press to select the gender for the patient when Gender is Gender Key selected in the Patient Information Setup window. Press to select the age group on the main screen when you set Age Group Key Age to Age Group in the Patient Information Setup window.

  • Page 19: Rear Panel

    Press Fn and a letter key to type special characters. Pressing Fn + a can type è. Press to cancel operation or return to the previous screen. Power On/Off Power-on/Power-off 2.3 Rear Panel Figure 2-3 NECG-12C Rear Panel - 13 -...

  • Page 20: Right Panel

    Part for people to hold Heat Emission Hole Path for internal heat emission Fuse The specification is: T3.15AH 250V Ø5×20 2.4 Right Panel Figure 2-4 NECG-12C Right Panel Name Explanation Patient Cable Socket Connecting to the patient cable SD Card Socket...
  • Page 21 NECG-12C 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 (input)/ F (input)/ V2 (input) LL (input) C3 (input)/ C1 (input) / V1 (input)
  • Page 22 NECG-12C Electrocardiograph User Manual Introduction Definitions of corresponding pins: Signal Signal Signal CD DAT3 DAT2 DAT0 DAT1 3) USB Socket 1/USB Socket 2/USB Socket 3 CAUTION Only the USB equipment recommended by the manufacturer can be connected to the USB socket 1/2.

  • Page 23: Bottom Panel

    4) External Input/Output Socket Definitions of corresponding pins: Signal Signal ECG Signal (input) ECG Signal (output) 2.5 Bottom Panel Figure 2-5 NECG-12C Bottom Panel Name Explanation Speaker Hole Path for sound from speaker Battery Compartment Compartment for the battery - 17 -...

  • Page 24: Function Features

    NECG-12C Electrocardiograph User Manual Introduction Heat Emission Hole Path for internal heat emission Position for product information label Label 1) Battery Compartment Rated Voltage: 14.8V Rated Capacity: 2500mAh WARNING 1. Improper operation may cause the battery to be hot, ignited or exploded, and it may lead to the decrease of the battery capacity.
  • Page 25 NECG-12C Electrocardiograph User Manual Introduction ♦ Correct detection for failure electrodes ♦ Convenient operation of recording by pressing the PRINT/STOP key with high efficiency ♦ High resolution thermal recorder, recording frequency response ≤300Hz ♦ Supporting external USB printer ♦ Supporting accurate digital filter to decrease the polarization voltage and other interferences ♦...

  • Page 26: Chapter 3: Operation Preparations

    NECG-12C 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.

  • Page 27: Connecting The Patient Cable To Electrodes

    NECG-12C Electrocardiograph User Manual Operation Preparations 3.1.2 Connecting the Patient Cable to Electrodes 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.

  • Page 28: Preparing The Skin

    NECG-12C Electrocardiograph User Manual Operation Preparations 3.2.2 Preparing the Skin Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifacts that distort the ECG signals. By performing methodical skin preparation, you can greatly reduce the possibility of noise caused by muscle tremor and baseline drift, ensuring high-quality ECG waves.
  • Page 29 NECG-12C Electrocardiograph User Manual Operation Preparations Standard 12-Lead Placement Only for the Disposable Electrodes Only for the Reusable Electrodes European American Electrode Placement Label Label Fourth intercostal space at the right border of the sternum Fourth intercostal space at the left border of the sternum...

  • Page 30: Attaching The Reusable Electrodes

    NECG-12C 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...

  • Page 31: Attaching The Chest Electrodes

    NECG-12C Electrocardiograph User Manual Operation Preparations Limb Electrode Connection: 1) Ensure that the electrodes are clean; 2) Clean the electrode area which is a short distance above the ankle or the wrist with 75% alcohol; 3) Daub the electrode area on the limb with gel evenly;...

  • Page 32: Attaching The Disposable Electrodes

    NECG-12C Electrocardiograph User Manual Operation Preparations 3.3.3 Attaching the Disposable Electrodes CAUTION The disposable electrodes can only be used for one time. Disposable Electrode: Alligator Clip: Disposable electrodes must be used together with alligator clips. Disposable Electrode Connection 1) Align all lead wires of the patient cable to avoid twisting, and connect the alligator clips to the lead wires.

  • Page 33: Turning On/Off The Electrocardiograph

    NECG-12C Electrocardiograph User Manual Operation Preparations 1) Environment: ♦ Make sure that there is no electromagnetic interference source around the equipment, especially large medical electrical equipment such as electrosurgical equipment, radiological equipment, magnetic resonance imaging equipment etc. Turn off these devices when necessary.
  • Page 34 NECG-12C Electrocardiograph User Manual Operation Preparations The electrocardiograph can be powered by either the mains supply or the battery. To turn on the Electrocardiograph: ♦ When operating on AC power Make sure that the mains supply meets the requirements (refer to A1.4 Power Supply...

  • Page 35: Loading/Replacing Recorder Paper

    NECG-12C Electrocardiograph User Manual Operation Preparations To turn off the Electrocardiograph: ♦ When operating on AC power Hold down the key to display the hint System is shutting down… on the screen. Then the device will be off a few seconds later. Remove the plug from the outlet.
  • Page 36 NECG-12C Electrocardiograph User Manual Operation Preparations Remove the remainder paper from the paper tray if necessary. Take off the wrapper of the new folded paper, and then put it in the paper tray. NOTE: If the paper with black markers is used, make sure that the markers are on the bottom.
  • Page 37 NECG-12C Electrocardiograph User Manual Operation Preparations next black marker; if Paper Marker is set to No, you can press FEED to advance the paper for 2.5cm. Pressing FEED again can stop advancing the paper. - 31 -...

  • Page 38: Chapter 4: Basic Operation Guidance

    NECG-12C 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 39: Entering Data

    NECG-12C 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 40: Selecting An Item

    NECG-12C 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 41: Screen Description

    NECG-12C 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-12C Main Screen1 Figure 4-2 NECG-12C Main Screen2 - 35 -...
  • Page 42 NECG-12C Electrocardiograph User Manual Basic Operation Guidance 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 43 NECG-12C Electrocardiograph User Manual Basic Operation Guidance Gain: 1.25mm/mV, 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 10/5 mm/mV or AGC Gain NOTE: This setup modified on the main screen is only effective for the current patient. In the manual mode, you can set Speed to 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s or 50mm/s.

  • Page 44: About The System Setup Screen

    NECG-12C Electrocardiograph User Manual Basic Operation Guidance 4.3.2 About the System Setup Screen Select Setup on the main screen2 to display the System Setup screen. NOTE: If you set the system password in the System Maintenance window, you need enter the password before opening the System Setup screen. For details, refer to Section 10.11, “System Maintenance Setup”.
  • Page 45 NECG-12C Electrocardiograph User Manual Basic Operation Guidance Figure 4-4 File Manager Screen1 Figure 4-5 File Manager Screen2 - 39 -...
  • Page 46 NECG-12C Electrocardiograph User Manual Basic Operation Guidance Name Explanation Trans All Press to transmit all the files to the PC. Press to export all the files from the electrocardiograph to the U Export All disk or SD card. Del All Press to delete all the files from the electrocardiograph.

  • Page 47: Work Mode Description

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

  • Page 48: Chapter 5: Entering Patient Information

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 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. Select the desired items in the Patient Information Setup window, and then press Enter to confirm.

  • Page 49: Entering Patient Information By Using A Bar Code Reader (Optional)

    NECG-12C Electrocardiograph User Manual Printing ECG Reports If you select Pacemaker in the Patient Information Setup window, Pacemaker appears in the Patient Information window. If Pacemaker Pacemaker is set to Yes, the pacemaker signals are easy to be detected. If Pacemaker is set to No, the pacemaker signals are not easy to be detected.

  • Page 50: Chapter 6: Printing Ecg Reports

    NECG-12C Electrocardiograph User Manual Printing ECG Reports Chapter 6: Printing ECG Reports NOTE: 1. The working mode can not 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 51: Manual Mode

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 2. When the main screen is displayed, press the MODE key to select the auto mode. Press F3 to select a paper speed. Press F4 to switch the gain. Press F5 to set the EMG filter or the Lowpass filter.

  • Page 52: Rhythm Mode

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 2. When the main screen is displayed, press the MODE key to select the manual mode. Press F3 to select a paper speed. Press F4 to switch the gain. Press F5 to set the EMG filter or the Lowpass filter.

  • Page 53: R-R Analysis Mode

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 2. When the main screen is displayed, press the MODE key to select the rhythm mode. Press F3 to select a paper speed. Press F4 to switch the gain. Press F5 to set the EMG filter or the Lowpass filter.

  • Page 54: Review Printing

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 2. When the main screen is displayed, press the MODE key to select the R-R analysis mode. Press F4 to switch the gain. Press F5 to set the EMG filter or the Lowpass filter.

  • Page 55: Freezing Ecg Waves

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 6.3 Freezing ECG Waves You can freeze the ECG waves displayed on the main screen. Operation Method: 1) Press F3 to set the paper speed, press F4 to set the gain, and press F5 to set the filter on the main screen1.

  • Page 56: Printing A Stored Ecg Report

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 6.4 Printing a Stored ECG Report 6.4.1 Printing on the File Manager Screen1/2 On the File Manager screen 1: 1. Select File on the main screen to open the File Manager screen1. 2. Select a file on the File Manager screen1, and then press PRINT/STOP to print the file.

  • Page 57: Sample Ecg Reports

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 6.5 Sample ECG Reports 6.5.1 ECG Reports in the Auto Mode Quick Mode - 51 -...
  • Page 58 NECG-12C 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: Patient Information, Measure Information, Diagnosis Information, Report Confirmed by, Current Date and Current Time, 6×2+1r ECG waves, 0.67~100Hz (0.67Hz DFT Filter, 100Hz Lowpass Filter),...
  • Page 59 2*5s+1r (12 leads are printed in 2 groups of 6 with the ECG wave of one lead on the bottom, and every group is printed for about 5s), Software Version, Algorithm Version, NECG-12C (Electrocardiograph Model), Institution Name. Measure Information includes: Heart Rate P Dur P wave duration: the average P-wave duration from several selected dominant beats;...
  • Page 60 NECG-12C Electrocardiograph User Manual Printing ECG Reports Save Paper Mode The above figure shows an ECG report in the auto mode. The style is 6×2+1R. - 54 -...

  • Page 61: Ecg Reports Printed By The Usb Printer

    NECG-12C Electrocardiograph User Manual Printing ECG Reports 6.5.2 ECG Reports Printed by the USB Printer - 55 -...

  • Page 62: Chapter 7: Transmitting Ecg Data

    NECG-12C Electrocardiograph User Manual Transmitting ECG Data 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 63: Transmitting Ecg Data In Dat Format Through Ethernet Cable

    NECG-12C Electrocardiograph User Manual Transmitting ECG Data Ethernet 7.1.1 Transmitting ECG Data in DAT Format through Cable 1. Connect the electrocardiograph to the network of the PC with an Ethernet cable recommended by the manufacturer. 2. Configure the Transmission Setup window.
  • Page 64 NECG-12C Electrocardiograph User Manual Transmitting ECG Data 3. Set Auto Transmission to On in the Transmission Setup window. 4. In the auto or rhythm mode, ECG data will be transmitted through the net cable automatically after an ECG report is printed out. In the off mode, the sampled ECG data can be saved and will be transmitted through the net cable automatically after the PRINT/STOP key is pressed, but it can not be printed.

  • Page 65: Transmitting Ecg Data In Scp/Fda-Xml/Pdf Format Through Ethernet Cable

    NECG-12C Electrocardiograph User Manual Transmitting ECG Data 7.1.2 Transmitting ECG Data in SCP/FDA-XML/PDF Format Ethernet through Cable NOTE: SCP/FDA-XML function can be activated on the Advanced Setup screen. For details, please contact the manufacturer or the local distributor. 1. Log into the FTP receiving software.

  • Page 66: Chapter 8: Managing Files

    NECG-12C 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, off or rhythm mode will be saved on the File Manager screen automatically.

  • Page 67: Transmitting Files

    NECG-12C Electrocardiograph User Manual Managing Files On the File Manager screen, files can be printed, transmitted, exported, displayed, edited searched or deleted. If there is no file on the File Manager screen, the following dialog box will pop up when you press function keys.

  • Page 68: Deleting Files

    NECG-12C Electrocardiograph User Manual Managing Files CAUTION It is forbidden to connect or disconnect a U disk, an SD card or a USB printer during the transmission course. NOTE: 1. Please insert the U disk or SD card recommended by the manufacturer. Please set the format to FAT or FAT32 when formatting the U disk or SD card.

  • Page 69: Importing Files

    NECG-12C Electrocardiograph User Manual Managing Files 8.5 Importing Files Operation procedures are as follows: 1. Connect the U disk or SD card recommended by the manufacturer to the electrocardiograph. 2. Save files to the directory of ECGDAT\Import of the U disk or SD card.

  • Page 70: Previewing A File

    NECG-12C Electrocardiograph User Manual Managing Files 8.8 Previewing a File Select Preview on the File Manager screen2 to open the file preview screen. The file preview screen displays the patient information, ECG waveform, measurement information and diagnosis information, as shown in the figure below:...

  • Page 71: Chapter 9: System Setup

    NECG-12C Electrocardiograph User Manual System Setup Chapter 9: System Setup Select Setup on the main screen 2 to display the System Setup screen. Figure 9-1 System Setup Screen 9.1 Factory Defaults Table 9-1 Factory Defaults Work Mode Setup Items Default...
  • Page 72 NECG-12C Electrocardiograph User Manual System Setup Filter Setup Items Default AC filter EMG filter DFT filter 0.67Hz 100Hz Lowpass filter Record Info Setup-Setup1 Items Default 6×2 Record Style Record Mode Save Paper Record Sequence Sequential Gain 10mm/mV Record Device Thermal...
  • Page 73 NECG-12C Electrocardiograph User Manual System Setup Ref-Physician \ Exam. Room ID Mode Auto ID Hint Age Mode H/W Unit cm/kg mmHg BP Unit Prompt Confirmed By Patient Information Refreshed Order Acquired Cleared User-defined Transmission Setup Items Default Auto Transmission FTP User Name/FTP Password/...
  • Page 74 NECG-12C Electrocardiograph User Manual System Setup Medium Hint Volume Key Volume Medium Notify Volume Medium Date & Time Setup Items Default DD-MM-YYYY Date Mode 24 Hours Time Mode Power Off/ LCD Off Cleared File Setup Items Default Auto Save To ECG File Format Delete After Trans.

  • Page 75: Work Mode Setup

    NECG-12C Electrocardiograph User Manual System Setup 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 9-2 Work Mode Setup Window Item Description Mode Options Choose from: AUTO, MANU, RHYT, R-R, or OFF...
  • Page 76 NECG-12C Electrocardiograph User Manual System Setup Item Description Auto DispStyle Choose from: 3×4, 3×4+1R, 3×4+3R, 6×2, 6×2+1R or 12×1 Select 3×4 to display ECG waves of 12 leads in 4 groups of 3. Select 3×4+1R to display ECG waves of 12 leads in 4 groups of 3 with the ECG wave of one rhythm lead on the bottom.

  • Page 77: Filter Setup

    NECG-12C Electrocardiograph User Manual System Setup 9.3 Filter Setup Select Filter on the System Setup screen, and then press Enter to open the Filter Setup window. Figure 9-3 Filter Setup Window Item Description AC Filter Choose from: On or Off...

  • Page 78: Record Info Setup

    NECG-12C Electrocardiograph User Manual System Setup NOTE: To pass the distortion test, the electrocardiograph has to be configured with the highest bandwidth in filter settings. Otherwise, ECG signal may be distorted. 9.4 Record Info Setup Select Record Info on the System Setup screen, and then press Enter to open the Record Info Setup window.
  • Page 79 NECG-12C Electrocardiograph User Manual System Setup Item Description Record Mode Choose from: Save Paper or Quickly Select Save Paper, 10s after pressing the PRINT/STOP key on the main screen, an ECG report is printed. The patient information, measure information, interpretation and ECG waves are printed at the same time.
  • Page 80 NECG-12C Electrocardiograph User Manual System Setup Item Description Record Device NOTE: 1. During the USB printing course, pressing the PRINT/STOP key again can not stop printing ECG reports. 2. For details of the ECG report printed by the USB printer, please refer to Section 6.5.5, “ECG Reports Printed by the USB...
  • Page 81 NECG-12C Electrocardiograph User Manual System Setup Paper Style Paper Style is used to identify the style of the recorder paper. Choose from: 210×140mm, 216×140mm, A4 (210×295mm) or Letter (215×280mm) All the recorder paper related to the options of the Paper Style is shown below: 210×140mm...
  • Page 82 NECG-12C Electrocardiograph User Manual System Setup 210×295mm 215×280mm - 76 -...

  • Page 83: Setup 2

    NECG-12C Electrocardiograph User Manual System Setup 9.4.2 Setup 2 Press F2 to switch to the Setup 2 window. Figure 10-5 Record Info Setup2 Item Description Auto Record Info Select Position Marker, Analysis, Template, Measure or Minnesota Code, the item will be printed in the ECG reports.

  • Page 84: Patient Information Setup

    NECG-12C Electrocardiograph User Manual System Setup 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 10-6 Patient Information Setup Window Item Description Patient Options Select First/Last Name, Gender, Height, Weight, BP, Race,...
  • Page 85 NECG-12C Electrocardiograph User Manual System Setup Item Description ID Hint Choose from: On or Off In the auto, rhythm or off 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...

  • Page 86: Transmission Setup

    NECG-12C Electrocardiograph User Manual System Setup 9.6 Transmission Setup NOTE: 1. To transmit ECG data to the PC, the Norav PC-ECG software and NEMS-A software (D1 license) must be installed in the PC. You should have the NEcgBrkr.exe application running on the PC before start a transmission.

  • Page 87: Lead Setup

    NECG-12C Electrocardiograph User Manual System Setup Item Description FTP Information Enter data in the FTP Path, FTP User Name textboxes. IP Addresses Set Server IP, Local IP, Set Gateway, Set Subnet Mask For details, please refer to Section 7.1.1 “Transmitting ECG Data in DAT Format through Ethernet Cable”.

  • Page 88: Display&Sound Setup

    NECG-12C Electrocardiograph User Manual System Setup Item Description Rhythm Lead1/2/3 In the R-R analysis mode: The R-R analysis report of the rhythm lead selected in the Rhythm Lead1 list box will be printed. Lead Sequence Choose from: Standard or Cabrera...
  • Page 89 NECG-12C Electrocardiograph User Manual System Setup Item Description Brightness Set the brightness within 0~20. Key Volume Choose from: Low, Medium, High or Off Select Low, Medium or High, the electrocardiograph gives a short sound when you press keys on the keyboard.

  • Page 90: Date&Time Setup

    NECG-12C Electrocardiograph User Manual System Setup 9.9 Date&Time Setup Select Date&Time on the System Setup screen, and press Enter to open the Date&Time Setup window. Figure 9-10 Date &Time Setup Window NOTE: Please set DATE&TIME correctly when it’s the first time you use the electrocardiograph.

  • Page 91: File Setup

    NECG-12C Electrocardiograph User Manual System Setup 9.10 File Setup Select File on the System Setup screen, and press Enter to open the File Setup window. Figure 9-11 File Setup Window Item Description Auto Save Choose from: Off, To ECG or To External Memory Select Off, ECG data will not be saved.
  • Page 92 NECG-12C Electrocardiograph User Manual System Setup Item Description Delete After Trans. Choose from: On or Off Or Export Select On, the files will be automatically deleted from the File Manager screen after they are transmitted to the PC or exported to the U disk or SD card.

  • Page 93: System Maintenance Setup

    NECG-12C Electrocardiograph User Manual System Setup 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 or SD card...

  • Page 94: Other Setup

    NECG-12C Electrocardiograph User Manual System Setup 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.
  • Page 95 NECG-12C Electrocardiograph User Manual System Setup or Triggered, the electrocardiograph sends the signals which it receives. If External Input is set to Off, and External Output is set to Standard, the electrocardiograph sends ECG signals of rhythm lead 1. If External Input is set to Off, and External Output is set to Triggered, the electrocardiograph sends pulses with the height of 5V and the width of 40ms, based on the data of rhythm lead 1.

  • Page 96: Chapter 10: Hint Information

    NECG-12C 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 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 97: Chapter 11: Troubleshooting

    In the same way, if the transmission settings are configured, the ECG data could be transmitted to the PC without printing. Q4: The screen of NECG-12C is too shiny. Could it be possible to weaken the brightness of the screen? A4: There is a setup item named brightness in the Display &...
  • Page 98 NECG-12C Electrocardiograph User Manual Troubleshooting Q6: The hint “Memory full! Replace the earliest file?” pops up every time when I operate the electrocardiograph. What am I supposed to do? A6: The hint is used to remind you that the amount of stored file reaches the upper limit. You can just make a choice every time when the hint pops up.
  • Page 99 NECG-12C Electrocardiograph User Manual Troubleshooting 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 100 NECG-12C Electrocardiograph User Manual Troubleshooting If the problem still exists, please contact the manufacturer or the local distributor for further disposal. Q7: I set the filter, speed and gain on the main screen1, but these settings were changed after printing.

  • Page 101: Chapter 12: Cleaning, Care And Maintenance

    NECG-12C 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.

  • Page 102: Cleaning The Print Head

    NECG-12C 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 103: Recharge And Replacement Of Battery

    : 1/4 capacity; : Low capacity 2) Recharge NECG-12C electrocardiograph is equipped with the recharge control circuit together with the battery. When the unit is connected to the mains supply, the battery will be recharged automatically. Then the battery recharging indicator ( ) and the mains supply indicator ) will be lit at the same time.

  • Page 104: Recorder Paper

    NECG-12C Electrocardiograph User Manual Cleaning, Care and Maintenance WARNING 3. When the battery’s useful life is over, contact the manufacturer or the local distributor for disposal or dispose of the battery according to local regulations. 4. Remove the battery from the electrocardiograph when the electrocardiograph isn’t used for a long time.

  • Page 105: Maintenance Of The Main Unit And The Patient Cable

    NECG-12C Electrocardiograph User Manual Cleaning, Care and Maintenance 12.3.4 Maintenance of the Main Unit and the Patient Cable CAUTION Besides the maintenance requirements recommended in this manual, comply with local regulations on maintenance and measurement. The following safety checks should be performed at least every 12 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.
  • Page 106 NECG-12C Electrocardiograph User Manual Cleaning, Care and Maintenance 1) Main Unit ♦ Avoid excessive temperature, sunshine, humidity and dirt. ♦ Put the dustproof coat on the main unit after use and prevent shaking it violently when moving it to another place.

  • Page 107: Chapter 13: Accessories

    Thermal Recorder Paper NECG12C-PZ Z-Folded, 210mm×140mm for NECG-12C – 150 pages=1 pack… (5 pack= 1 carton) Incl. NECG-12C paper platen; NECG12C-RA NECG-12C Printer cover Norav PC-ECG software PCECG1200 NEMS-A Software Key NEMS-A NECG-12C 7 inch LCD screen NECG12C-Screen - 101 -...
  • Page 108 NECG-12C Electrocardiograph User Manual Accessories Cable Arm for NECG-12C NECG3/12C-CA Rolling Stand (MT Cart for NECG-12C ECG System with 5 wheels NECG12C-T and adjustable in height) Descriptions: Chest reusable RE-SP electrodes Kit: 6 suction pumps Descriptions: Limbs reusable electrodes Kit: 4 clamps...

  • Page 109: Chapter 14: Warranty & Service

    NORAV MEDICAL will, at its discretion, repair or replace the defective part(s) free of charge. NORAV MEDICAL will not provide a substitute product for use when the defective product is being repaired.

  • Page 110: Appendix 1: Technical Specifications

    NECG-12C 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 IEC 60601-1-2:2007 Comply with: 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...
  • Page 111 Input Current: 0.9-0.4A Rated voltage: 14.8V Rated capacity: 2500mAh When the battery is fully charged, NECG-12C can work Li-ion Battery Pack: normally about 4 hours at a temperature of 23℃±3℃, and it can continually print about 300 ECG reports of 3×4+1R in the auto mode or print about 1.5 hours in the MANU...
  • Page 112 NECG-12C Electrocardiograph User Manual Technical Specifications A1.5 Performance Specifications Recording Recorder: Thermal dot-matrix recorder 8 dots per mm / 200 dots per inch (amplitude axes) Printing Density 40 dots per mm / 1000 dots per inch (time axes, @ 25...
  • Page 113 NECG-12C Electrocardiograph User Manual Technical Specifications Minimum Amplitude: 20 μVp-p Noise: ≤12.5 μVp-p Multichannel crosstalk ≤0.5mm AC Filter: 50Hz/60Hz/Off DFT Filter: 0.01Hz/0.05Hz/0.15Hz/0.25Hz/0.32Hz/0.5Hz/0.67Hz Filter EMG Filter: 25Hz/35Hz/45Hz/OFF LOWPASS Filter: 300Hz/270Hz/150Hz/100Hz/75Hz ≥140dB (AC ON) CMRR ≥123dB(AC OFF) Sampling Frequency 16000 Hz/lead Pacemaker Detection Amplitude ±750μV to ±700 mV...

  • Page 114: Appendix 2: Emc Information

    NECG-12C 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 115 NECG-12C 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 116 NECG-12C Electrocardiograph User Manual EMC Information 70% U 70% U mains interruptions, it is recommended that (30% dip in U (30% dip in U 12-channel for 25 cycles for 25 cycles electrocardiograph powered from <5% U <5% U uninterruptible power (>95% dip in U...
  • Page 117 NECG-12C Electrocardiograph User Manual EMC Information power rating of the transmitter in watts (W) according to the 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 frequency range.
  • Page 118 NECG-12C 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 are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the 12-channel...

  • Page 119: Appendix 3: Abbreviation

    NECG-12C 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...
  • Page 120 P/N: NV-54/NECG-12C 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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