ECG1012ECG1012Express User Manual-V1.2

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    DIXION VERTRIEB MEDIZINISCHER GERTE GMBH

    Manual Ver: V1.2Release Date: February 2011Part Number: UM01-12-13-V1.2

    ECG1012/ECG1012E

    xpress

    Electroca

    rdiograph

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    -I-

    Copyright

    Copyright DIXION VERTRIEB MEDIZINISCHER GERTE GMBH 2007-2008. All rights

    reserved.

    Statement

    Dixion Vertrieb medizinischer Gerte GmbH (hereinafter called DIXION) makes no warranty of

    any kind with regard to this material, including, but not limited to the implied warranties of

    merchantability and fitness for a particular purpose. DIXION assumes no responsibility for any

    error that may appear in this document, or for incidental or consequential damage in connection

    with the furnishing, performance or use of this material.

    No part of this document may be photocopied, reproduced or translated to another language

    without prior written consent of DIXION.

    All information contained in this publication is believed to be correct. DIXION shall not be

    liable for errors contained herein nor for incidental or consequential damages in connection with

    the furnishing, performance, or use of this material. This publication may refer to information

    and protected by copyrights or patents and does not convey any license under the patent rights

    of this company, nor the rights of others. This company does not assume any liability arising out

    of any infringements of patents or other rights of third parties.

    The information contained in this document is subject to change without notice.

    Responsibility of the Manufacturer

    DIXION only considers itself responsible for any effect on safety, reliability and performance of

    the equipment if:

    Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

    persons authorized by DIXION, and

    The electrical installation of the relevant room complies with national standards, and

    The instrument is used in accordance with the instructions for use.

    NOTE: This device is not intended for home use.

    WARNING : This device is not intended for treatment.

    P/N: UM01-12-13-V1.2.

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    Upon request, DIXION may provide, with compensation, necessary circuit diagrams, and other

    information to help qualified technician to maintain and repair some parts, which DIXION may

    define as user serviceable.

    Using This Label Guide

    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 CAUTIONlabel 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.

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    Table of Contents

    1 Safety Guidance ................................................................................... 11.1 General Warnings .................................................................................................11.2 General Cautions ..................................................................................................31.3 Preparation and Operation Warnings (For ECG 1012 Express Exercise Test)

    ........................................................................................................................................51.4 Contraindications (For ECG 1012 Express Exercise Test) ............................6

    2 Introduction........................................................................................... 82.1 Function Features ........................................................................................................92.2 List of Symbols ...........................................................................................................10

    3 General Information ........................................................................... 133.1 Top Panel .................................................................................................................... 13

    3.1.1 LCD Screen ......................................................................................................133.1.1.1 Main Screen of Resting ECG .....................................................................143.1.1.2 Main Screen of Exercise Test (optional) ..................................................153.1.2 Keyboard and Keys .........................................................................................18

    3.2 Front Panel .................................................................................................................213.3 Rear Panel .................................................................................................................. 223.4 Right Panel .................................................................................................................233.5 Bottom Panel ..............................................................................................................27

    4 Operation Preparations...................................................................... 294.1 Power and Earthing ...................................................................................................294.2 Loading/Replacing Recording Paper......................................................................304.3 Patient Cable and Electrodes Connection for Resting ECG...............................32

    4.3.1 Patient Cable Connection ..............................................................................324.3.2 Electrode Connection......................................................................................32

    4.4 Patient Cable and Electrodes Connection for Exercise Test ..............................354.4.1 Patient Cable Connection ..............................................................................354.4.2 Electrodes Connection....................................................................................36

    4.5 Inspection before Power-On ....................................................................................385 General Operation .............................................................................. 39

    5.1 Switching On...............................................................................................................395.2 General operation ......................................................................................................395.3 Enter the Main Screen of Exercise Test (optional)...............................................425.4 Switch Off.................................................................................................................... 43

    6 Operation Instructions for Resting ECG .......................................... 446.1 Freeze..........................................................................................................................44

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    6.2 Auto Mode................................................................................................................... 466.3 Manual Mode ..............................................................................................................476.4 Rhythm mode .............................................................................................................486.5 R-R mode .................................................................................................................... 486.6 Copy.............................................................................................................................496.7 Setup............................................................................................................................49

    6.7.1 Work Mode Setup............................................................................................496.7.2 Filter Setup .......................................................................................................516.7.3 Record Info Setup............................................................................................526.7.4Patient Question Setup...................................................................................566.7.5 Transmission Setup ........................................................................................586.7.6 Patient Information ..........................................................................................596.7.7 Lead Setup .......................................................................................................606.7.8 Display Setup ...................................................................................................616.7.9 Sound Setup.....................................................................................................626.7.10 Date&Time Setup ..........................................................................................636.7.11 More Setup .....................................................................................................64

    6.8 File................................................................................................................................686.9 AUTO Mode Record ..................................................................................................75

    6.9.1 Example of 6!2+1rhy......................................................................................756.9.2 Example of 3!4+1rhy......................................................................................80

    6.10 RHYTHM Mode Record..........................................................................................816.11 MANUAL Mode Record ..........................................................................................826.12 R-R Mode.................................................................................................................. 836.13 ECG Report ..............................................................................................................87

    7 Operation Instructions for Exercise ECG (optional) ....................... 897.1 Patient Information.....................................................................................................897.2 Setup............................................................................................................................90

    7.2.1 General Information Setup .............................................................................907.2.2 Record Information Setup ..............................................................................957.2.3 Protocol Management.....................................................................................96

    7.3 Recommended Operation Steps .............................................................................998 Hint Information................................................................................ 1009 Technical Specifications.................................................................. 10210 Cleaning, Care and Maintenance .................................................. 105

    10.1 Cleaning ..................................................................................................................10510.1.1 Cleaning the Main Unit and Patient Cable ..............................................10510.1.2 Clean the Electrodes (For Resting ECG) ................................................105

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    10.1.3 Clean the Print Head ..................................................................................10510.2 Disinfection .............................................................................................................10610.3 Care and Maintenance .........................................................................................106

    10.3.1 Recharge and Replacement of Battery....................................................10610.3.2 Recording Paper..........................................................................................107

    10.3.3 Maintenance of Main Unit, Patient Cable & Electrodes ........................108

    11 Warranty and Service Policy ......................................................... 11011.1 Warranty..................................................................................................................11011.2 Service Policy .........................................................................................................110

    12 Accessories .................................................................................... 11212.1 Standard Accessories ...........................................................................................11212.2 Optional Accessories ............................................................................................113

    13 EMC Information............................................................................. 115

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    1 Safety Guidance

    In order to use the electrocardiograph safely and effectively, avoiding possible dangers caused

    by improper operations, please read through the user manual and be sure to be familiar with allfunctions of the equipment and proper operation procedures before use.

    Please pay more attention to the following warning and caution information.

    1.1 General Warnings

    WARNING :

    1. The electrocardiograph is provided for the use of 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 DIXION can open the shell.

    3. The results given by the equipment should be examined with respect to the

    overall clinical condition of the patient, and it can not substitute for regularchecking.

    WARNING :

    4. EXPLOSION HAZARD-Do not use the electrocardiograph in the presence of

    flammable anesthetic mixture with oxygen or other flammable agents.

    5. SHOCK HAZARD-The power receptacle must be a hospital grade grounded

    outlet. Never try to adapt the three-prong plug to fit a two-slot outlet.

    6. If the integrity of external protective conductor in installation or arrangement is

    in doubt, the equipment should be operated by using a built-in rechargeable

    battery.

    7. Do not use this equipment in the presence of high static electricity or high

    voltage equipment which may generate sparks.

    8. This equipment is not designed for direct cardiac application.

    WARNING :

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    9. Only patient cable and other accessories supplied by DIXION can be used. Or

    else, the performance and electric shock protection can not be guaranteed.

    10. Be sure that all electrodes have been connected to the patient correctly before

    operation.11. Be sure that the conductive parts of electrodes and associated connectors,

    including neutral electrode, should not contact with earth or any other

    conducting objects.

    12. Electrodes with defibrillator protection should be used while defibrillating.

    13. Always use electrode gel with reusable electrodes during defibrillation as ECG

    recovery will take longer than 10 seconds. DIXION recommends the use of

    disposable electrodes at all times.

    14. There is no danger for patients to use pacemaker. However, if a pacemaker is

    used, the results given by the equipment may be invalid, or lose the clinical

    significance.

    15. Do not touch the patient, bed, table or equipment while using the ECG together

    with a defibrillator or a pacemaker.

    16. In order to avoid being burnt, please keep the electrode far away from the radio

    knife while using electrosurgical equipment simultaneously.

    WARNING :

    17. Accessory equipment connected to the analog and digital interfaces must be

    certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for

    data processing equipment and IEC/EN 60601-1 for medical equipment).

    Furthermore all configurations shall comply with the valid version of the

    standard IEC/EN 60601-1-1. Therefore anybody, who connects additionalequipment to the signal input connector or output connector to configure a

    medical system, must make sure that it complies with the requirements of the

    valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our

    technical service department or your local distributor.

    18. The summation of leakage current should never exceed leakage current limits

    while several other units are used at the same time.

    19. The potential equalization conductor can be connected to that of otherequipment when necessary, to make sure that all these equipment are

    connected with the potential equalization bus bar of the electrical installation.

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    WARNING :

    20. Improper operation may cause the battery to be hot, ignited or exploded, and it

    may lead to the declination of batterys capacity. It is necessary to read the user

    manual carefully and pay more attention to warning messages.21. Only qualified service engineer authorized by DIXION can open the battery

    compartment and replace the battery, and the battery of same model and

    specification provided by manufacturer should be used.

    22. Danger of explosion -- Do not reverse the anode and cathode when connecting

    the battery.

    23. Do not heat or splash the battery or throw it into fire or water.

    24. When leakage or foul smell is found, stop using the battery immediately. If your

    skin or cloth comes into contact with the leakage liquid, cleanse it with clean

    water at once. If the leakage liquid splashes into your eyes, do not wipe them.

    Irrigate them with clean water first and go to see a doctor immediately.

    25. When the batterys useful life is over, contact with the manufacturer or local

    distributor for disposal or dispose the battery according to local regulations.

    26. Only when the device is off can the battery be Installed or removed.

    1.2 General Cautions

    CAUTION :

    27. Federal (US) law restricts this device to sale by or on the order of a physician.

    28. Avoid liquid splash and excessive temperature. The temperature must be kept

    between 5and 40 while working, and it should be kept between -20and

    55 during transportation and storage.

    29. Do not use the equipment in dusty environment with bad ventilation or in the

    presence of corrosive.

    30. Be sure that there is no intense electromagnetic interference source around the

    equipment, such as radio transmitter or mobile phone etc. Attention: large

    medical electrical equipment such as electrosurgical equipment, radiological

    equipment and magnetic resonance imaging equipment etc. are likely to bring

    electromagnetic interference.

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    CAUTION :

    31. Before use, the equipment, patient cable and electrodes etc. should be checked.

    Replacement should be taken if there is any evident defectiveness or aging

    symptom which may impair the safety or performance.

    32. The following safety checks should be performed at least every 24 months by a

    qualified person who has adequate training, knowledge, and practical

    experience to perform these tests.

    a) Inspect the equipment and accessories for mechanical and functional

    damage.

    b) Inspect the safety relevant labels for legibility.

    c) Inspect the fuse to verify compliance with rated current and breakingcharacteristics.

    d) Verify the device functions properly as described in the instructions for

    use.

    e) Test the protection earth resistance according to IEC/EN 60601: Limit 0.1

    ohm.

    f) Test the earth leakage current according to IEC/EN 60601: Limit: NC 500

    uA, SFC 1000uA.

    g) Test the patient leakage current according to IEC/EN 60601: Limit: 10 uA(CF).

    h) Test the patient leakage current under single fault condition with mains

    voltage on the applied part according to IEC/EN 60601: Limit: 50uA (CF).

    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.

    33. Ruptured fuse must only be replaced with that of the same type and rating as

    the original.

    34. 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.

    CAUTION :

    35. Turn off the power before cleaning and disinfection. If mains supply is used, thepower cord should be drugged out of the outlet. Prevent the detergent from

    seeping into the equipment.

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    36. Do not immerse the unit or patient cable into liquid under any circumstances.

    37. Do not clean the unit and accessories with abrasive fabric and avoid scratching

    the electrodes.

    38. Any remainder of detergent should be removed from the unit and patient cableafter cleaning.

    39. Do not use chloric disinfectant such as chloride and sodium hypochlorite etc.

    1.3 Preparation and Operation Warnings (For ECG 1012

    Express Exercise Test)

    WARNING :

    1. Ensure that the electrocardiograph and treadmill have a good grounded state.

    2. Always have an emergency termination test every time the treadmill is

    connected to the power supply to ensure that the emergency termination button

    is under a valid state.

    3. In the exercise test process, ensure that there are 2 or above experienced

    physicians are absent. One of them takes care of the patients state and is ready

    to deal with the emergency at any moment.

    4. In the same room equipped with the electrocardiograph for Exercise Test, the

    necessary first-aid equipments like defibrillator and blood-pressure meter

    should be prepared, and these equipments should be measured and examined

    periodically according to relative regulation to ensure their validity. At the sametime, the necessary valid medications should also be prepared.

    5. Before defibrillating for the patient, the emergency termination button of the

    treadmill should be pressed to avoid hazard brought to the patient or user.

    WARNING :

    6. Locate the treadmill or bicycle on a horizontal place without any obstacle.

    7. Use a special grounded socket to get accurate voltage and current.

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    8. Put the power cable far away from treadmill area and calorific surface.

    9. Examine the treadmill or bicycle carefully before using it.

    10. Do not do any exercise test when the treadmill or bicycle is wet.

    11. Do not use this treadmill or bicycle in the open air.

    12. The patient to have an exercise test should wear suitable clothes and shoes.

    13. During the course of exercise test, do not get on or off the treadmill.

    14. Remind every patient to avoid falling down from the treadmill.

    15. Do not approach the moving components with the hand, foot or clothes.

    16. Before stop running the treadmill, slow its speed to the minimum.

    17. Children are prohibited approaching the treadmill or bicycle alone.

    18. Do not drop or insert any object into the open part of the treadmill.

    19. If any abnormal thing happens with the treadmill, please press down the

    emergency termination button on the treadmill to stop test immediately.

    1.4 Contraindications (For ECG 1012 Express Exercise Test)

    Absolute Contraindications:

    1. Acute MI (within 2 days)

    2. High-risk unstable angina

    3. Uncontrolled cardiac arrhythmia causing symptoms of hemodynamic

    compromise

    4. Active endocarditis

    5. Symptomatic severe aortic stenosis

    6. Decompensated symptomatic heart failure

    7. Acute pulmonary embolus or pulmonary infarction

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    8. Acute noncardiac disorder that may affect exercise performance or be

    aggravated by exercise (eg, infection, renal failure, thyrotoxicosis)

    9. Acute myocarditis or pericarditis

    10. Physical disability that would preclude safe and adequate test performance

    11. Inability to obtain consent

    Relative Contraindications:

    12. Left main coronary stenosis or its equivalent

    13. Moderate stenotic valvular heart disease

    14. Electrolyte abnormalities

    15. Tachyarrhythmias or bradyarrhythmias

    16. Atrial fibrillation with uncontrolled ventricular rate

    17. Hypertrophic cardiomyopathy

    18. Mental impairment leading to inability to cooperate

    19. High-degree AV block

    Note: The warnings and cautions of Chapter 1.3 and Chapter 1.4 are listed for the

    Exercise Test function of ECG 1012 Express.

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    2 Introduction

    12-channel electrocardiograph gathers 12 leads simultaneously, and carries out visual display

    of operation menu, ECG parameters as well as electrocardiogram.

    12-channel waves can be viewed on the LCD (liquid crystal display) screen simultaneously,

    and it can be recorded by a high-quality thermal recorder.

    Manual, auto, rhythm or R-R work mode can be chosen freely.

    For ECG 1012 Express, Exercise Test is optional. Exercise Test function of the ECG 1012

    Express fits for shadiness coronary heart disease, non-typical angina and labor force

    identification, and it also can identity the effect of operation and so on.

    Either mains supply or built-in rechargeable Lithium battery can be used as power.

    With a high resolution thermal recorder, a 32-bit processor and a huge capacity memorizer,

    12-channel electrocardiograph has advanced performance and high reliability, and the compact

    size makes it suitable for clinic, hospital and ambulance use.

    12-channel electrocardiograph has two models: ECG 1012, ECG 1012 Express.

    Configuration: Main unit, power cord, patient cable for Resting ECG, chest electrodes, limb

    electrodes, thermal recording paper, fuses, lithium battery.To use Exercise Test function of the ECG 1012 Express, the following accessories should be

    included:

    RS232 Cable for BP Monitor, BNC External ECG Trigger Cable for BP Monitor, RS232 Cable

    for treadmill, Patient cable for Exercise ECG/(America or Europe), Belt, disposable adhesive

    electrodes.

    Intended use: The intended use of electrocardiograph 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 healthcarefacilities by doctors and trained healthcare professionals. The cardiogram

    recorded by the electrocardiograph can help users to analyze and diagnose

    heart disease. However the ECG with measurements and interpretive

    statements is offered to clinicians on an advisory basis only.

    WARNING : This equipment is intended for use on adult and pediatric patients

    only.

    WARNING : This equipment is not designed for direct cardiac application.

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    WARNING : The results given by the equipment should be examined with

    respect to the overall clinical condition of the patient, and it can not

    substitute for regular checking.

    2.1 Function Features

    ! Low weight and compact size

    ! Multi-language support

    ! 12-lead are gathered and amplified simultaneously, 12-Channel ECG waves are

    displayed and recorded simultaneously

    ! High resolution thermal recorder, recording frequency response "150Hz

    ! Flexible recording formats

    ! Big keyboard design, separate number and letter keys for easy operation (For ECG

    1012 Express, touch screen is available)

    ! Auto mode, manual mode, rhythm mode, R-R mode optional

    ! Convenient system setup and file management operation

    ! Auto measurement and auto interpretation optional

    ! Hint information for lead off, lack of paper and low battery capacity etc.

    ! Built-in rechargeable Lithium battery with high capacity

    !

    Automatic adjustment of baseline for optimal recording

    The following features are only for the Exercise Test function of ECG 1012 Express

    (optional)

    ! Real-time analysis, ST segment and trend are applied while sampling; real-time

    displaying and printing for 12-lead simultaneous ECG waveforms;

    ! ST segment analysis while sampling; ST position is adjustable at any time while

    sampling;

    ! Provide average templates of three rhythm leads in each stage, benefit to observe the

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    change of ST segments between every stages

    ! Automatically form elaborate reports, including Summary Report, ST Scope Report and

    Trend Graph Report

    ! Provide classical exercise protocols; Exercise protocols can be edited and created

    ! Automatically control and adjust the speed and grade of treadmill or the power of

    bicycle

    ! Support multi-types of treadmills or bicycle

    2.2 List of Symbols

    External Output

    External Input

    Equipment or Part of CF Type with Defibrillator Proof

    Attention General Warning (See accompanying document)

    Potential Equalization

    Mains Supply

    USB Port

    Battery Indicator

    Battery Recharging Indicator

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    Delete Key

    Enter Key

    Esc Key

    Shift Key

    Fn Key

    Power On/Off Key

    COPY Key

    MODE Key

    SLEEP/WAKE UP Key

    START/STOP Key

    Tab Key

    UP/DOWN/LEFT/RIGHT Arrow Key

    Recycle

    Part Number

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    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 medical

    devices.

    The symbol indicates that the device should be sent to the

    special agencies according to local regulations for separate

    collection after its useful life and that this unit was put on themarket after 13 August 2005.

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    3 General Information

    3.1 Top Panel

    Figure 3-1 ECG 1012 Express

    Figure 3-2 ECG 1012

    3.1.1 LCD Screen

    ECG 1012 adopts 320#240 dot single color LCD Screen; ECG 1012 Express adopts 800#600

    multicolor LCD Screen.

    LCD Screen

    Recorder Keyboard

    Indicator Lamps

    Keyboard

    Recorder

    LCD Screen

    Indicator Lamps

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    3.1.1.1 Main Screen of Resting ECG

    Figure 3-3 ECG 1012 Express Main Screen

    Figure 3-4 ECG 1012 Main Screen

    Name Explanation

    A Name Patient Name: Within 20 characters

    B ID Patient ID: Within 10 characters

    F

    H

    GE

    A

    P

    O N M L K J I

    C D

    B

    DB G

    P

    O N M L K J

    H

    I

    E F

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    3.1.1.2 Main Screen of Exercise Test (optional)

    Figure 3-5 ECG 1012 Express Main Screen (For Exercise Test)

    L

    K

    A

    V

    U T S R Q P O

    D

    B

    C

    E GF H

    N

    I

    M

    J

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    P Setup

    Enter System Setup Window. Refer to Chapter 7.2.

    When being in test, this item becomes Lead, and press this

    key to enter Lead Setup Interface; Refer to Chapter 6.7.7

    Q 100Hz EMG Filter: 25Hz, 35Hz or 45HzLowpass Filter: 75Hz, 100Hz or 150Hz

    R 10mm/mVGain: 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 10/5

    mm/mV or AGC

    S Post J: 80ms

    Post J is used to set the length after J point of ST segment.

    The user can set Post J as 0, 20ms, 40ms, 60ms or 80ms.

    Note: J Point is the connection point between the end of

    QRS complex and the start of ST segment. It is

    the standard point to fix the position of STsegment. Please select the proper option

    according to the patients actual ECG wave.

    T Hold

    Click on this key and the system will not follow the previous

    settings to change the speed and grade of treadmill, but keep

    the current speed and grade until this key is clicked again.

    U Patient Enter Patient Information Interface; Refer to Chapter 7.1.

    V ECG waveform Display ECG waveform

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    3.1.2 Keyboard and Keys

    Figure 3-6 ECG 1012 Express Keyboard

    Figure 3-7 ECG 1012 Keyboard

    A

    B

    C

    D

    E

    F

    G

    I

    H

    J K L M N O

    B

    C

    D

    J K L M N O

    E

    F

    G

    I

    H

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    Name Explanation

    PretestPress this key to enter the pretest phase. The length of

    pretest phase is not fixed.

    Exercise

    Press this key to enter the exercise phase. When being in

    the exercise phase, press this key to enter the next stage of

    the exercise phase.

    Recovery

    Press this key to enter the recovery phase. When being in

    the recovery phase, press this key to enter the next stage of

    the recovery phase.

    Test EndPress this key to display a prompt dialog-box, and then theuser can decide whether the exercise test should be

    terminated.

    Enter BP

    Press this key to drive the BP monitor to measure blood

    pressure values.

    Note: If the user directly uses the button on the BP

    monitor to drive the BP monitor to measure the

    blood pressure, the electrocardiograph can not

    get the measuring values.

    RecallDuring the exercise test, press this key to recall 10s data

    and print out the 12-Lead Report of the recalled 10s data.

    12 ldDuring the exercise test, press this key to sample 10s data

    and print out the 12-Lead Report of the sampled 10s data.

    MediansDuring the exercise test, press this key to print out the

    Average Template Report.

    Comment

    Press this key to display the Comment Dialog-box, andthen the user can enter comments in the Dialog-box. The

    entered comments will be displayed in the Summary

    Report. Press this key again to exit from the dialog-box.

    Speed +/-W

    Press Speed W +/- to change the speed of the treadmill

    during the exercise phase.

    Note: The two keys are available for the user-defined

    treadmill protocol only.

    A

    (optional)

    Grade +/-Press Grade +/- to change the grade of the treadmill duringthe exercise phase.

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    Note: The two keys are available for the user-defined

    treadmill protocol only.

    B Function Key Selecting menu functions on screen

    C Delete Deleting charactersD Enter Confirming operation

    E Tab

    Moving cursor

    On the Main Screen interface, pressing the Tab key to feed

    the recording paper to the next paper marker, (when Paper

    Marker is set as Yes)or get to 2.5cm(when Paper Marker

    is set as No), pressing the Tab key again to stop feeding.

    F Fn Press Fn + X to enter special characters

    G Spacebar Inserting spacebar

    H ShiftUsed to enter capital letters

    Shift + Tab= BackTab

    I Esc

    Canceling operation

    Note:A large polarization voltage may cause baseline

    drift. Pressing Esc key in the main screen can

    decrease polarization voltage and draw the

    baseline to zero quickly.

    J Power On/Off Power-on/Power-off

    K MODE

    Selecting Work mode: Manual, Auto, Rhythm

    Note: Only on the Work Mode Setup interface can

    R-R mode be selected.

    L SLEEP/ WAKE UP Used for resting and wakening electrocardiograph

    M COPY Reviewing the last ECG data recorded in the Auto mode

    N START/STOP Start/Stop recording

    O Arrow Keys

    Moving cursor (Up, Down, Left, Right)

    In the Manual Mode or Rhythm Mode, press Up/Down to

    switch the lead group.

    In the Exercise Test System, press Up/Down to switch the

    Display Mode, and when the Display Mode is 3#1, press

    Left/Right to switch the lead group.

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    3.2 Front Panel

    Figure 3-8 ECG 1012 Express Front Panel

    Figure 3-9 ECG 1012 Front Panel

    1) Indicator Lamp

    Symbol Name Explanation

    A Mains supply

    indicator lamp

    When the device is powered by mains supply, the

    lamp will be lit.

    BBattery indicator lamp

    When the device is powered by the built-in

    rechargeable Lithium battery, the lamp will be lit.

    C Battery recharging

    indicator lampWhen the battery is recharged, this lamp will be lit.

    2) Cable bracket(Optional)

    Used for supporting patient cable.

    Cable bracket

    (Optional)

    Cable bracket

    (Optional)

    A B C

    A B C

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    3.3 Rear Panel

    Figure 3-10 ECG 1012 Express Rear Panel

    Figure 3-11 ECG 1012 Rear Panel

    Name Explanation

    A Mains supply Socket AC SOURCE: alternating current supply socket

    BPotential

    Equalization

    Terminal

    Potential equalization conductor provides a connection

    between the unit and the potential equalization bus bar of the

    electrical installation.

    C Handle Part for people to hold

    D Heat Emission Hole Path for internal heat emission

    A

    D

    A

    D

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    3.4 Right Panel

    Figure 3-12 ECG 1012 Express Right Panel

    Figure 3-13 ECG 1012 Right Panel

    Name Explanation

    A Patient Cable Socket Connecting patient cable

    B Serial Port 1 Connecting PC

    C USB Socket 1(Optional) Standard USB socket, connecting PC

    DUSB Socket 2(Optional)

    Standard USB socket, connecting USB, USB printer

    recommended by DIXION

    E External Input/Output Socket Connecting external signal device

    F Serial Port 2 Reserved

    G Net port Standard net port, connecting PC

    D

    A F

    G

    C

    B E

    D

    A F

    G

    C

    B E

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    1) Patient Cable Socket

    : Applied part of type CF with defibrillator proof

    : Attention see accompanying document

    Definition of corresponding pins:

    Pin Signal Pin Signal Pin Signal

    1 C2 (input) 6 SH 11 F (input)

    2 C3 (input) 7 NC 12 NC

    3 C4 (input) 8 NC 13 C1(input)

    4 C5 (input) 9 R (input) 14 NC

    5 C6 (input) 10 L (input) 15 N or RF (input)

    2) Serial port 1

    WARNING :

    Serial port 1 is 1500V AC isolated intensity and the maximum voltage applied

    should not exceed +15V DC.

    Definition of corresponding pins:

    Pin Signal Pin Signal Pin Signal

    1 NC 4 NC 7 NC

    2 RxD (input) 5 GND 8 +12V

    3 TxD (output) 6 NC 9 NC

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    3) Serial port 2

    Definition of corresponding pins:

    Pin Signal Pin Signal

    1 TxD (output) 5 NC

    2 RxD (input) 6 +12V

    3 NC 7 GND

    4 +5V 8 GND

    4) External Input/Output Socket

    Definition of corresponding pins:

    Pin Signal Pin Signal

    1 GND 4 GND

    2 GND 5 ECG Signal (input)

    3 GND 6 ECG Signal (output)

    5) USB Socket 1/USB Socket 2 (Optional)

    2

    1

    3

    8

    5

    7

    6

    4

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    Definition of corresponding pins:

    Pin Signal Pin Signal

    1 VBUS 3 D+

    2 D- 4 GND

    WARNING : Only the USB equipment recommended by DIXION can be

    connected to the USB interface.

    WARNING :

    ! Accessory equipment connected to the analog and digital interfaces must

    be certified according to the respective IEC/EN standards (e.g. IEC/EN

    60950 for data processing equipment and IEC/EN 60601-1 for medicalequipment). Furthermore all configurations shall comply with the valid

    version of the standard IEC/EN 60601-1-1. Therefore anybody, who

    connects additional equipment to the signal input or output connector to

    configure a medical system, must make sure that it complies with the

    requirements of the valid version of the system standard IEC/EN 60601-1-1.

    If in doubt, consult our technical service department or your local distributor.

    ! The summation of leakage current should never exceed leakage current

    limits while several other units are used at the same time.

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    3.5 Bottom Panel

    Figure 3-14 ECG 1012 Express Bottom Panel

    Figure 3-15 ECG 1012 Bottom Panel

    Name Explanation

    A Speaker Hole Path for sound from speaker

    B Battery Compartment Compartment for Lithium battery

    C Fuse The specification is : AC100V-240V: T1A; 5#20

    D Heat Emission Hole Path for internal heat emission

    E Label Position for product information label

    B

    C

    E

    A

    D

    D

    B E

    A

    DD

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    1) Battery Compartment

    The rated voltage and rated capacity of rechargeable Lithium battery pack are

    ECG 1012 Express: Rated Voltage: 14.8V; Rated Capacity: 4000mAh/4400mAh

    ECG 1012: Rated Voltage: 14.8V; Rated Capacity: 2000mAh/2200mAh/2400mAh

    WARNING :

    Improper operation may cause the battery to be hot, ignited or exploded, and it

    may lead to the decrease of batterys capacity. Therefore, it is necessary to read

    the user manual carefully and pay more attention to warning messages.

    WARNING :

    When leakage or foul smell found, stop using the battery immediately. If theleakage liquid gets to your skin or cloth, cleanse it with clean water at once. If the

    leakage liquid gets into your eyes, do not wipe them. Irrigate them with clean

    water first and go to see a doctor immediately.

    WARNING :

    Only qualified service engineer authorized by DIXION can open the battery

    compartment and replace the battery, and the battery of same model and

    specification provided by manufacturer must be used.

    WARNING :

    Only when the device is off can the battery be installed or removed.

    Note: If the battery has not been used for two or three months or above, recharge

    should be done before you use the battery again.

    2) Fuse

    There are two same fuses installed on the bottom of the main unit. The specification is:

    AC100V-240V: T1A; 5#20.

    WARNING : Ruptured fuse must only be replaced with the same type and

    rating as the original.

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    4 Operation Preparations

    CAUTION :

    Before use, the equipment, patient cable and electrodes should be checked.

    Replace it if there is any evident defectiveness or aging which may impair the safety

    or performance, and be sure that the equipment is in proper working condition.

    4.1 Power and Earthing

    WARNING :

    If the integrity of external protective conductor in installation or arrangement is

    in doubt, the equipment should be powered by the built-in rechargeable battery.

    Power Supply

    The electrocardiograph can be powered by either mains supply or the built-in rechargeable

    lithium battery pack.

    ! Mains supply

    The mains connection socket is on the rear panel of the unit. If mains supply is used,

    connect the power cord to the socket first, and then connect the plug of the cord to the

    hospital grade outlet.

    Rated input voltage: 100V~240V

    Rated frequency: 50Hz/60Hz

    Rated input power: 70VA

    Make sure the mains supply meets the above requirements before power on, and then

    press Power ON/OFF key on the keyboard to power on the unit. Then the mains

    supply indicator lamp ( ) will be lit.

    If the built-in rechargeable battery is weak when mains supply used, it will be

    recharged automatically at the same time, and both the mains supply indicator lamp ( )

    and the battery recharging indicator lamp ( ) will be lit.

    ! Built-in rechargeable battery

    While using the built-in rechargeable lithium battery pack, turn on the unit by pressing

    Power ON/OFFkey on the keyboard and the battery indicator lamp ( ) will be lit.

    The battery symbol will be displayed on the LCD screen. Because of the consumption

    during storage and transport, the capacity of battery may not be full. If the symbol

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    or and the hint information BAT WEAK are displayed, which means the

    battery capacity is weak, please recharge the battery first.

    When the capacity of battery is full, ECG 1012 can work normally for nearly 2 hours;

    about 200 ECG Reports of 3#4+1r can be recorded in the Auto Mode. ECG 1012

    Express can work normally for nearly 3.5 hours; about 400 ECG Reports of 3#4+1rhy

    can be recorded in the Auto Mode.

    Please refer to the maintenance section for how to recharge the battery. During

    recharging the battery, electrocardiograph can be powered by mains supply.

    WARNING : Potential equalization conductor of the unit should be connected to

    the potential equalization bus bar of the electrical installation when

    necessary.

    4.2 Loading/Replacing Recording Paper

    Two kinds of paper can be used as ECG recording paper. One is Rolled thermal paper, another

    is folded thermal paper.

    Note:When using folded thermal paper, the Paper Roller should be removed.

    Note: When using the paper of 216mm width, the two movable parts should beremoved.

    Note:The Exit Edge can help the user tear the recording paper.

    CAUTION : Be sure that recording paper, especially rolled paper, should be

    installed in the central of the recorder, and the edge of paper should

    be parallel with the edge of casing in the direction of feeding paper,

    in order to avoid paper deviation and the damage to the edge of

    paper.

    When there is no paper loaded or it reaches the end of paper, hint message Paper Empty will

    be given on the screen. Under this circumstance, recording paper should be loaded or replaced

    immediately.

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    Loading/Replacing Process for Rolled paper:

    1) Press the Casing Button downwards with one hand and pull the casing upwards with

    another hand 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 paper roll, and then put through the roller with the papers grid

    side facing downward;

    4) Place the paper and roller gently in the recorder with the roller pin facing to the groove;

    5) Pull about 2cm of paper out from the Exit, and put down the recorder casing;

    6) Secure the casing by pressing it firmly.

    Loading/Replacing Process for Folded paper:

    1) Press the Casing Button downwards with one hand and pull the casing upwards withanother hand to open the recorder.

    2) Remove remainder paper in the Paper Tray if necessary;

    3) Take off the wrapper of folded paper, and then put it in the Paper Tray with the papers

    grid side facing right while putting the free end of paper upright;

    4) Pull about 2cm of paper out from the Exit, and put down the recorder casing;

    5) Secure the casing by pressing it firmly.

    Movable

    Part 2

    Movabl

    e

    Casing Button

    Paper Tray

    Groove

    Paper Roller

    Casing

    Exit

    Exit Edge

    (Edge for

    tearing paper)

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    4.3 Patient Cable and Electrodes Connection for Resting ECG

    4.3.1 Patient Cable Connection

    WARNING : The performance and electric shock protection can be guaranteed

    only if original DIXION patient cable and electrodes are used.

    Patient cable includes two parts, main cable and lead wires with associated connectors, which

    can be distinguished from the color and identifier on the connectors.

    Connect Main Cable:Plug the connector of main cable into the patient cable socket on the right side of the unit

    according to the direction of arrow on the plug, and then secure it with two screws.

    4.3.2 Electrode Connection

    Chest Electrode:

    Main CableLead Wires

    Connector

    Screw

    Electrode Connectors

    Suction Bulb

    ElectrodeMetal Cup

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    Limb Electrode:

    The identifier and color code of electrodes used complies with IEC/EN requirements. In order

    to avoid incorrect connections, the electrode identifier and color code are specified in Table

    4-1. Moreover the equivalent code according to American requirements is given in Table 4-1

    too.

    Table 4-1 Electrodes and their identifier and color code

    European American

    Electrodes Identifier Color code Identifier Color code

    Right arm R Red RA White

    Left arm L Yellow LA Black

    Right leg N or RF Black RL Green

    Left leg F Green LL Red

    Chest 1 C1 Red V1 Red

    Chest 2 C2 Yellow V2 Yellow

    Chest 3 C3 Green V3 Green

    Chest 4 C4 Brown V4 Blue

    Chest 5 C5 Black V5 Orange

    Chest 6 C6 Violet V6 Violet

    As the following figure shows, the chest electrodes positions on body surface are

    C1: Fourth intercostals space at right border of sternum

    C2: Fourth intercostals space at left border of sternum

    C3: Fifth rib between C2 and C4

    C4: Fifth intercostals space on left midclavicular line

    C5: Left anterior axillary line at the horizontal level of C4

    C6: Left midaxillary line at the horizontal level of C4

    Reed

    Electrode

    Clamp

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    The contacting resistance between the patient and the electrode will affect the quality of ECG

    greatly. In order to get a high-quality ECG, the skin/electrode resistance must be minimized

    while connecting electrodes.

    WARNING : Be sure that all electrodes have been connected to the patient

    correctly before operation.

    WARNING : Be sure that the conductive parts of electrodes and associated

    connectors, including neutral electrode, should not contact with earth

    or any other conducting objects.Chest electrodes connection:

    1) Ensure that the electrodes are clean;

    2) Align all lead wires of patient cable to avoid twisting, and connect the associated

    electrode connectors to corresponding electrodes according to the color and identifier;

    3) Clean electrode area on chest surface with alcohol;

    4) Daub the round area of 25mm in diameter on each electrode site with gel evenly;

    5) Place a small amount of gel on the brim of chest electrodes metal cup;

    6) Place the electrode on chest electrode site and squeeze the suction bulb. Unclench it and

    then the electrode is adsorbed on chest. Attach all chest electrodes in the same way.

    Limb electrodes connection:

    1) Ensure that the electrodes are clean;

    2) Align lead wires of patient cable to avoid twisting, and connect the electrode connectors

    to corresponding electrodes according to the color and identifier;

    3) Clean electrode areas on a short distance above the ankle or wrist with alcohol;

    4) Daub the electrode areas on limbs with gel evenly;

    C6

    C1

    C2

    C5

    C4

    C3

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    5) Place a small amount of gel on the metal part of limb electrode clamp;

    6) Connect the electrode to limb, and be sure that the metal part be placed on the electrode

    area above the ankle or wrist. Attach all limb electrodes in the same way.

    4.4 Patient Cable and Electrodes Connection for Exercise

    Test

    4.4.1 Patient Cable Connection

    WARNING : The performance and electric shock protection can be guaranteed onlyif original DIXION patient cable is used.

    Patient cable includes two parts, main cable and lead wires with associated electrode

    connectors. The electrode connectors can be distinguished from the colors and identifiers on

    them.

    Connect Main Cable:

    Plug the connector of main cable into the patient cable socket of the electrocardiograph accordingto the direction of arrow on the plug, and then secure it with two screws.

    Main Cable

    Lead Wires

    Connector

    ScrewElectrode Connectors

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    4.4.2 Electrodes Connection

    The identifier and color code of electrode connector used complies with IEC/EN requirements.

    In order to avoid incorrect connections, the electrode connector identifier and color code isspecified in Table 4-2. Moreover the equivalent code according to American requirements is

    given in Table 4-2 too.

    Table 4-2 Electrodes and their identifier and color code

    European American

    Electrodes Color code Electrodes Color code

    R Red RA White

    L Yellow LA Black

    N or RF Black RL Green

    F Green LL Red

    C1 Red V1 Red

    C2 Yellow V2 Yellow

    C3 Green V3 Green

    C4 Brown V4 Blue

    C5 Black V5 Orange

    C6 Violet V6 Violet

    The precordial electrodes positions on body surface are

    C1: Fourth intercostals space at right border of sternumC2: Fourth intercostals space at left border of sternum

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    C3: Fifth rib between C2 and C4

    C4: Fifth intercostals space on left midclavicular line

    C5: Left anterior axillary line at the horizontal level of C4

    C6: Left midaxillary line at the horizontal level of C4

    The extremity electrodes positions on body surface are

    The extremity electrodes should be placed below the clavicle or above the crista scapulae, and

    just above the spina iliaca superior or the crista iliaca, respectively.

    The quality of ECG waveform will be affected by the contacting resistance between the patient

    and the electrode. In order to get a high-quality ECG, the skin/electrode resistance must be

    minimized while connecting electrodes.

    WARNING : Be sure that all electrodes have been connected to the patient

    correctly before operation.

    WARNING : Be sure that the conductive parts of electrodes and associated

    connectors, including neutral electrode, should not contact with earth

    or any other conducting objects.

    Electrodes connection:

    1) Align all lead wires of patient cable to avoid twisting, and connect the disposable electrodes

    to the electrode connectors;

    2) Clean electrode area on chest surface with 75% alcohol;

    3) Attach the disposable electrodes on electrode sites of the chest.

    Note: The quality of the electrode and installation will directly influence the quality of

    exercise ECG. The wrong placement and usage of electrodes will cause incorrect

    analysis results. Please use the qualified electrodes which should be in the validperiod.

    CAUTION :

    The disposable electrodes should be deserted after used.

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    4.5 Inspection before Power-On

    In order to avoid safety hazards and get good ECG records, the following inspection procedure

    is recommended before power-on and operation.

    1) Environment:

    ! Check and make sure that there is no electromagnetic interference source around the

    equipment, especially large medical electrical equipment such as electrosurgical

    equipment, radiological equipment and magnetic resonance imaging equipment etc.

    Switch off these devices when necessary.

    ! Keep the examination room warm to avoid muscle action voltages in ECG signal

    caused by cold.

    2) Power Supply:

    ! If mains power is used, please check whether the power cord has been connected to

    the unit well, and the grounded outlet should be used.

    ! Recharge the battery first when the battery capacity is weak before use.

    3) Patient Cable:

    ! Check whether the patient cable has been connected to the unit firmly, and keep it faraway from the power cord.

    4) Electrodes:

    ! Check whether all electrodes have been connected to lead wires of patient cable

    correctly according to the identifier and color.

    ! Ensure that the electrodes do not contact with each other.

    5) Recording Paper:

    ! Ensure that there is enough recording paper loaded correctly.

    6) Patient:

    ! The patient should not contact conducting object such as earth, and metal part of bed

    etc.

    ! Ensure the patient is warm and relaxed, and breathes calmly.

    WARNING : The electrocardiograph is provided for the use of qualified physicians

    or personnel professionally trained, and they should be familiar with

    the contents of this user manual before operation.

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    5 General Operation

    5.1 Switching On

    ! While using mains supply, firstly connect the power cord, and the mains supply indicator

    lamp ( ) is lit. Then press Power ON/OFF key on the keyboard to turn on the unit.

    Equipment information, such as manufacturer, device name and version No., will be

    displayed on LCD screen after self-test. Then electrocardiograph is ready for examination

    and recording.

    ! While using built-in rechargeable lithium battery, press Power ON/OFF key on the

    keyboard directly to turn on the unit, and then the battery indicator ( ) is lit. After

    self-test, electrocardiograph is ready for examination and recording.

    5.2 General operation

    All the operations including ECG recording, parameter setting and file managing can be

    implemented by using the keyboard.

    For ECG 1012 Express, users can also carry out the operations by using the Touch Screen.

    WARNING : Do not touch the LCD screen with such sharp things as pencil or pen;

    otherwise, it will be damaged.

    Take these general operations required when using System Setup Window for example:

    (1) Entering System Setup Window

    Press the corresponding Function Key of Setup on the keyboard to enter the System Setup

    Window.

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    cursor to Cancel and press Enter key to cancel operation.

    (4) Inputting characters

    Take the Patient Information interface for example:

    Press Tab key to move the cursor to Name;

    Press Delete key to delete old information;

    Press the letter keys or number keys on the keyboard to input patient name and

    press Enter key to confirm.

    In the File Manage Window, the general operations of selecting ECG files, setting parameters and

    inputting characters are same as the content described above.

    This System Diagnostics Window is password protected and only the manufacturer authorized

    technician can access it.

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    5.4 Switch Off

    When built-in battery used, after finishing ECG record, press Power ON/OFFkey to display

    the information System is shutting down on the screen. After a few seconds, the device

    will be off.

    When mains supply used, after finishing ECG record, press Power ON/OFFkey to display the

    information System is shutting down on the screen. After a few seconds, the device will

    be off, and then pull off the plug from the outlet.

    Note: When switching off the device, please operate it according to the sequence

    above strictly, or else there will be something wrong on the screen.

    Note: Do not keep on pressing the Power ON/OFFkey when the device displays the

    hint information Halting System on the screen.

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    6 Operation Instructions for Resting ECG

    6.1 Freeze

    Note: For ECG 1012, Freezeis optional.

    Users can freeze the ECG wave displaying on the main screen.

    Operation Method:

    1) Press the corresponding Function Key of Freeze on the keyboard (hereinafter called

    Freeze function key) to freeze ECG wave;

    2) On the Freeze interface, Press 3x4+1rhy function key can set the style of recording.

    3) Press Reviewfunction key to review the ECG wave which has been frozen;

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    4) Press Pre Page/Next Pagefunction key to turn the pages;

    5) PressPre Sec/Next Secfunction key to view the ECG wave of pre second/ next second;

    6) Press Playfunction key to display ECG wave continuously;

    7) PressPausefunction key to stop playing ECG wave;

    8) Press Return function key toreturn to main screen;

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    6.2 Auto Mode

    In the Auto mode, the lead groups are switched automatically according to different lead

    sequence while recording. When ECG signal of one lead group has been recorded within a certain

    time, it will be switched to another lead group automatically and begins to record the ECG signal

    of that lead group. 1mV calibration mark will be recorded at the beginning of recording.

    Operation Method:

    1) Input patient information before recording;

    2) Enter Work Mode Setup interface to select Auto mode, and set Auto Display Style, Sample

    Mode and Preview;

    3) Enter Record Information Setup interface to select Record Control page, and set Record

    Style, Record Sequence and Record Mode.

    4) Enter Lead Setup interface to set Lead Sequence;

    5) After finish setting parameters, exit the System Setup Window;

    6) If Preview is set as off, press START/STOP key to begin recording. It will stop

    automatically after a full 12-lead ECG is recorded;

    7) If Preview is set as on, press START/STOPkey to enter the Preview Window. In Preview

    Window, pressing Measure function key can enter the Measure Window, pressing

    Diagnosisfunction key can enter the Diagnosis Window, pressing Continuefunction key

    can begin recording, and pressing Cancelfunction key can cancel recording.

    Note: For ECG 1012, Previewfunction is optional.

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    Preview Window

    Pressing START/STOP again during the course of recording can stop recording.

    Note: Whether in the auto, rhythm, R-R or manual mode, Work Mode can not be

    changed during the course of recording. Stop recording before choosing Work

    Mode.

    6.3 Manual Mode

    In the Manual mode, users can determine which lead group needs to be recorded and set the

    parameters according to different lead group.

    Operation Method:

    1) Input patient information before recording;

    2) Enter Work Mode Setup interface to select Manual mode, and set Manual Style;

    3) Enter Lead Setup interface to set Lead Sequence;

    4) After finish setting parameters, exit the System Setup Window;

    5) Press UPor DOWN key to select the lead group to be recorded;

    6) Press START/STOPkey to begin recording;

    7) Press START/STOPkey to stop recording after ECG is recorded.

    UP or DOWN key can be pressed to switch the lead group during the course of recording.Pressing START/STOP again during the course of recording can stop recording.

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    6.4 Rhythm mode

    In the Rhythm mode, users can record 60s rhythm-lead ECG waveform in Single Lead Style or

    20s rhythm-lead ECG waveform in Three Lead Style.Operation Method:

    1) Input patient information before recording;

    2) Enter Work Mode Setup interface to select Rhythm mode, and set Rhythm Style;

    3) Enter Lead Setup interface to select rhythm leads;

    4) After finish setting parameters, exit the System Setup Window;

    5) Press START/STOPkey and the hint information Sampling will be displayed in the

    hint information field, at the same time, sampling time will be counted. When the samplingtime reaches 60s in Single Lead Style or 20s in Three Lead Style, it begins to record;

    6) It will stop automatically after a full rhythm-lead ECG waveform is recorded.

    Pressing START/STOP again during the course of recording can stop sampling or recording.

    6.5 R-R mode

    In the R-R mode, users can select a lead to record its R-R Histogram, R-R Trend Chart, 180sECG waveform and all the R-R values.

    Operation Method:

    1) Input patient information before recording;

    2) Enter Work Mode Setup interface to select R-R mode;

    3) Enter Lead Setup interface to select a lead in the field of Rhythm Lead 1;

    4) Enter Recording Information Setup interface to select the style of R-R analysis Report.

    5) After finish setting parameters, exit the System Setup Window;

    6) Press START/STOP key to begin to count the sampling time. When the sampling

    time reaches 180s, it begins to record;

    7) It will stop automatically after a full R-R analysis is recorded.

    Pressing START/STOP again during the course of recording can stop recording.

    Note: In the R-R mode, users can not set speed. The constant speed is 25mm/s.

    Because when recording in the R-R mode, the ECG wave is compressed to one

    fifth of the original wave, and then 25mm/s is equal to 5mm/s.

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    6.6 Copy

    Pressing COPYkey can recall the ECG data that was recorded last time. During the course of

    recording, pressing START/STOP again can stop recording.Note: After return to the main interface from any other interfaces, the user should not

    immediately press START/STOP key to record in the AUTO mode or MANUAL

    mode within three seconds. Otherwise, the recorder will not respond.

    6.7 Setup

    6.7.1 Work Mode Setup

    On the Work Mode Setup interface, users can set up Work Mode, Manual Style, Rhythm Style,

    Auto Display Style, Sampling Mode and Preview.

    (1) Work Mode

    Manual:In the Manual mode, users can determine which lead group needs to be recorded and set

    the parameters according to different lead group.

    Auto: In the Auto mode, the lead groups are switched automatically according to different lead

    sequence while recording. When ECG signal of one lead group has been recorded within a certain

    time, it will be switched to another lead group automatically and begins to record the ECG signalof that lead group.

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    Rhythm:In the Rhythm mode, users can select rhythm leads to record 60s or 20s rhythm wave.

    R-R: In the R-R mode, users can select a lead to record its R-R Histogram, R-R Trend Chart,

    180s ECG waveform and all the R-R values.

    (2) Manual Style

    When Manual Style is set as 3 channel, users can record 3 leads ECG wave simultaneously.

    When Manual Style is set as 6 channel, users can record 6 leads ECG wave simultaneously.

    When Manual Style is set as 12 channel, users can record 12 leads ECG wave simultaneously.

    (3) Auto DisplayStyle

    When Auto Display Style is set as 3!4, 12 leads are displayed in 4 columns and 3 rows.

    When Auto Display Style is set as 3!4+1rhy, 12 leads are displayed in 4 columns and 3 rows,

    with one rhythm lead at the bottom of the paper.

    When Auto Display Style is set as 3!4+3rhy, 12 leads are displayed in 4 columns and 3 rows,

    with three rhythm leads at the bottom of the paper.

    When Auto Display Style is set as 6!2, 12 leads are displayed in 2 columns and 6 rows.

    When Auto Display Style is set as 6!2+1rhy, 12 leads are displayed in 2 columns and 6 rows,

    with one rhythm lead at the bottom of the paper.

    When Auto Display Style is set as 12!1, 12 leads are displayed in 12 channels.

    (4) Rhythm Style

    When Rhythm Style is set as Single Lead, in the Rhythm Work Mode, 60s ECG wave of the

    appointed single rhythm lead will be recorded.

    When Rhythm Style is set as Three Lead, in the Rhythm Work Mode, 20s ECG wave of every

    appointed rhythm lead will be recorded.

    (5) Sampling Mode

    When Sampling Mode is set as Pre-Sample, 10s ECG data sampled before pressing

    START/STOP key will be recorded while recording.

    When Sampling Mode is set as Real-time Sample, 10s ECG data sampled from the time of

    pressing START/STOP key will be recorded while recording.

    When Sampling Mode is set as Trigger Sample, after pressing START/STOP key, if Arrhythmia

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    ECG data, including Asystole, Ventricular Fibrillation/Ventricular Tachycardia, 5>PVCS>=3,

    Paired PVCS, Bigeminy, Trigeminy, R ON T, single PVC and Missed Beat, are detected during

    the course of sampling, recording will be triggered automatically.

    When Sampling Mode is set as Periodic Sample, first users should set Total Time and Interval

    on the Record Control Setup interface of the Record Info setup. For example, if Interval is set

    to 2 minutes, the Total Time set to 24 minutes, by Pressing START/STOP key, it will record

    every 2 minutes and totally 12 times.

    Note: No saving, copying or transmitting in the Period Sample Mode.

    Note: Patient information will not be changed while carrying out the period recording.

    Note: Total Timemust be greater than Interval, or else the setting will not be effective.

    Note: For ECG 1012, Pre-Sampleand Trigger Sampleare optional.

    (6) Preview

    When Preview is set as on, users can preview the ECG wave to be recorded.

    When Preview is set as off, users can not preview the ECG wave to be recorded.

    6.7.2 Filter Setup

    (1) AC Filter

    AC Filter suppresses AC interference without attenuating or distorting the ECG signal. Select On

    to turn on the function and select Offto turn off.

    (2) DFT Filter

    DFT Filter greatly reduces the baseline fluctuations without affecting the ECG signal. The

    purpose of this filter is to keep the ECG signals on the baseline of the printout. The setting value

    is the low limit of the frequency range, including 0.05Hz, 0.15Hz, 0.25Hz, 0.5Hz.

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    (3) EMG Filter

    EMG Filter suppresses disturbances caused by strong muscle tremor. The cutoff frequency is

    defined at 25Hz, 35Hzor 45Hz. Select Offto turn off the function.

    (4) Lowpass FilterLowpass Filterrestricts the bandwidth of input signal. The cutoff frequency is defined at 150Hz,

    100Hzor 75Hz. All the input signals whose frequency is higher than the setting cutoff frequency

    will be attenuated.

    6.7.3 Record Info Setup

    There are three pages on the Record Info Setup interface: Recorder, Record Ctrl and Record Info.

    The users can Press F1or F2 function key to switch them.

    6.7.3.1 Recorder

    (1) Recorder Device

    Users can set the Recorder Device as Thermal, DeskJet or LaserJet.

    When DeskJet or LaserJet is selected, the user should connect the USB printer recommended byDIXION to the USB Socket 2 of electrocardiograph with specialized cable.

    Note: please refer to Chapter 6.13 to see the ECG Report printed by USB printer.

    Note: USB printing works only in AUTO Pre-Sample mode, AUTO Real-time Sample

    mode, Copy, Freeze, Review and File Manage Window.

    Note: Make sure that paper has been installed in USB printer before printing. Paper

    Empty may results in error.

    Note:The USB printer can not be cancelled by Start/Stop key.

    WARNING : It is forbidden to frequently insert and pull out U disk or USB printer.

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    (2) Paper Length

    Users can set the length of one page of folded paper. 140mm or 295mm is available.

    (3) Paper Width

    Users can set the width of paper. 210mm or 216mm is available.When the paper of 216mm width is used, the two movable parts in the Paper Tray and Casing of

    the recorder should be removed.

    (4) Speed

    Users can set the paper speed as 5, 6.25, 10, 12.5, 25 or 50mm/s. In the AUTO mode and Rhythm

    mode, only 25mm/s and 50mm/s are available. In the R-R mode, only 25mm/s is available.

    (5) Gain

    Users can set the indicated length of 1mV ECG on the paper.Users can set Gain as 10mm/mV, 20mm/mV, 10/5mm/mV, AGC, 2.5mm/mV or 5mm/mV.

    AGC means auto gain control. When ECG signal varies greatly, AGC can be selected to adjust

    the gain automatically according to actual signal.

    10/5mm/mV means the gain of limb leads is set as 10mm/mV, while the gain of chest leads is set

    as 5mm/mV.

    (6) Paper Marker

    The Paper Marker is used to identify the start point of each page of the paper.When the paper with black markers on the bottom is used and Paper Marker is set as Yes, the

    device can identify the start point of each page of the paper while recording.

    When Paper Markeris set as No, the device can not identify the start point of each page of the

    paper while recording.

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    (4) Periodic Sample

    The Interval and Total Time can set for Periodic Sample in AUTO mode.

    Note: please refer to Chapter 6.7.1 to see the Periodic Sample in Work Mode Setup.

    (4) 10-24s Sample

    Users can set the time of sampling printing from 10 to 24 seconds, or disable this function.

    When the Sample recording function is selected, in the Auto Mode, pressing START/STOP key

    on the Main Screen interface, the ECG waves are recorded according to the current setting.

    Note: Users should select the function on the Advanced Setup interface.

    6.7.3.3 Record Info Setup

    (1) Auto Record Info

    Auto Record Info includes Patient Info, Position Marker, Analysis, Template, Measure and

    Minnesota Code.

    When Patient Info, Position Marker, Analysis, Template, Measure or Minnesota Code is

    selected, it will be recorded while recording.

    WhenPatient Info, Position Marker, Analysis, Template, Measure orMinnesota Code is not

    selected, it will not be recorded while recording.

    (2) R-R Analysis

    R-R Analysisincludes R-R Histogram, R-R Waveform and R-R Interval List.

    When R-R Histogram, R-R Waveform or R-R Interval List is selected, it will be recorded

    while recording.

    When R-R Histogram, R-R Waveform or R-R Interval List is not selected, it will not berecorded while recording.

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    Note: Press Space key to select or cancel on the Record Information Setup interface.

    Note: The items on the Record Info Setup interface are valid only in the Auto mode, and

    Template and Position Marker do not work under the Auto Style of 3!4, 3!4+1rhy

    and 3!4+3rhy and the Style of 6x2 and 6x2+1rhy in the Quickly Mode.

    Note: To get more information about the above contents, please refer to Chapter 6.9

    Auto Mode Record.

    6.7.4Patient Question Setup

    (1) Gender/Height/Weight/BP/Race/Medication/Ward NO/Doctor/Technician

    When Gender, Height, Weight, BP, Race, Medication, Ward NO, Doctor orTechnician is

    selected, the item will display on patient information interface.

    When Gender, Height, Weight, BP, Race, Medication, Ward NO, Doctor or Technician is

    not selected,the item will not display on patient information interface.

    (2) ID Hint

    In the Auto mode and the rhythm mode, when ID Generate Mode is set as manual, press the

    START/STOPkey, if users have not input patient ID before operating, the Hint Information will

    pop up to remind users to input patient ID.

    (3) Next Patient

    In the Auto mode, when the Next Patient is selected, Press START/STOPkey, the system will

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    automatically turn into the Next Patient interface after a full ECG wave is recorded. In the Next

    Patient interface, pressing Same Patient function key can return to the Main Screen, all the

    patient information will keep the same; pressing Next Patient function key can return to the

    Main Screen, all the patient information will be cleared except for gender; pressing F3 function

    key can switch the Auto Record Style; pressing F4 function key can switch the paper speed, andpressing the F5 can switch the Gain.

    On the Next Patient interface, users can print the current ECG Report again, according to the

    Auto Style, speed and Gain settings.

    In the Auto mode, when Next patient is not selected, the system will not automatically turn into

    theNext patient interface.

    (4) H/W Unit\BP Unit\User Defined

    Not performed.

    (5) ID Mode

    Users can set the ID Modeas Auto, timeor manual.

    When ID Generate Mode is set asAuto,patient ID can be automatically generated. (Patient ID

    range: 0~1999, 999,999)

    When ID Generate Mode is set astime, patient ID can be automatically generated according tothe system time.

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    When ID Generate Mode is set as manual, patient ID can be manually inputted in patient

    information. (Only input ASCII code)

    NoteWhen the patient ID is generated by system time, it can not be displayed on the MainScreen.

    (6) Prompt

    When Prompt is set as Unconfirmed, Unconfirmed Report is recorded in the ECG Report.

    When Prompt is set asReviewed by, Report Reviewed by is recorded in the ECG Report.

    6.7.5 Transmission Setup

    Note: To transfer ECG data to PC, SMARTECG-VIEWER software of DIXION must be

    installed in PC. Receive ECG Data window in the software should be opened up,

    and transfer type should be selected.

    (1) Transmission Mode

    When Transmission Modeis set as off, ECG data can not be transferred;

    When Transmission Modeis set as Ethernet, firstly connect the net port of electrocardiograph

    and the net port of PC machine through an Ethernet cable recommended by DIXION. Secondly

    open the Receive ECG Data window of SMARTECG-VIEWER software in PC, select the

    transfer type Net Trans and press Connect key. Then set the Remote IP and Local IP in

    electrocardiograph. In the AUTO mode, ECG data can be transferred through net automatically

    after ECG recording is finished.

    When Transmission Modeis set as UART, firstly connect the serial port 1 of electrocardiograph

    and the serial port of PC machine through a serial cable recommended by DIXION. Then openthe Receive ECG Data window of SMARTECG-VIEWER software in PC, select the transfer

    type Serial Trans, set the right PortNum and press Connect key. In the AUTO mode or the

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    Rhythm mode, ECG data can be transferred through serial port automatically after ECG

    recording is finished.

    (2) Remote IP: Users can set Remote IP on Transmission Setup interface.

    (3) Local IP: Users can set Local IP on Transmission Setup interface.

    (4) Gateway: Users can set Gateway on Transmission Setup interface.

    (5) Subnet Mask: Users can set Subnet Mask on Transmission Setup interface.

    6.7.6 Patient Information

    Note: The patient information can not be set or changed during the course of recording.

    Name: Patient Name (ECG 1012: Within 12 characters; ECG 1012 Express: Within 20

    characters)

    ID: Patient ID (Within 10 characters; Range: 0~1999999999). For detail information, please refer

    to Chapter 6.7.4.Age:Patient Age (Range: 0~255)

    Gender: Patient Gender (Male/Female/Empty)

    Weight (kg):Patient Weight (Range: 0~999)

    Height (cm): Patient Height (Range: 0~999)

    BP (mmHg): Patient Systolic Blood Pressure/Diastolic Blood Pressure

    Race: Patient Race (unknown/ Oriental/ Caucasian/ Black/ Indian

    / Mongolian/ Hispanic/ Asian/ Pacific/ other)

    Medications: The medication which patient took previously (Within 20 characters)

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    Ward No: Ward Number (Within 10 characters)

    Medical: Medical Name (Within 20 characters)

    Technician: Technician Name (Within 20 characters)

    Note: Please refer to Chapter 5.2 for the method of inputting words on PatientInformation interface.

    6.7.7 Lead Setup

    (1) Rhythm Lead 1/ Rhythm Lead 2/ Rhythm Lead 3

    The rhythm lead can be one of 12 standard leads: $, %, &, aVR, aVL, aVF, V1, V2, V3, V4, V5,

    or V6.

    In the Auto mode, when Auto Style is set as 3#4+1rhy or 6#2+1rhy, the rhythm lead selected in

    Rhythm Lead 1 will be recorded while recording ECG; when Auto Style is set as 3#4+3rhy, 3

    rhythm leads selected in Rhythm Lead 1 and Rhythm Lead 2 and Rhythm Lead 3 will be

    recorded while recording ECG.In the Rhythm mode, when Rhythm Style is set as Single Lead, 60s waveform of the rhythm lead

    selected in Rhythm Lead 1 will be recorded while recording ECG; when Rhythm Style is set as

    Three Lead, 20s waveform of every rhythm lead selected in Rhythm Lead 1 and Rhythm Lead 2

    and Rhythm Lead 3 will be recorded while recording ECG;

    (2) Lead Sequence: Standard/Cabrera

    Lead Sequence Lead group 1 Lead group 2 Lead group 3 Lead group 4

    Standard $, II, & aVR, aVL, aVF V1, V2, V3 V4, V5, V6

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    Cabrera aVL, $, -aVR II, aVF, & V1, V2, V3 V4, V5, V6

    6.7.8 Display Setup

    (1) Brightness

    The brightness of LCD screen

    Users can set the brightness within 0~20.

    (2) Screen Colors (only for ECG 1012 Express)

    The colors of LCD screen

    Users can set the screen colors as Monochrome, Option1 or Option 2.

    (3) Antialiasing

    When Antialiasingis set as On, system will automatically make waveform smooth.

    When Antialiasingis set as Off, system will not make waveform smooth.

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    6.7.9 Sound Setup

    (1) Key Volume

    When users press keys on the keyboard, electrocardiograph gives a short beep sound, which is

    called Key Beep.