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Zoncare iMAC 120 User Manual

Digital multi-channel electrocardiograph machine
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Preface
Welcome to use Digital Multi-Channel Electrocardiograph Machine (hereinafter referred to
as ECG machine, also referred to as the ―product‖, ―device‖, or ―unit‖). In order to enable
you to skillfully operate the ECG machine as soon as possible, we provide you this
accompanying manual with specific instructions for use. Please read it carefully when you
install and use this device for the first time. Be sure to keep this manual aside the device, if
damaged or lost, please contact the manufacturer for purchase.
Manufacturer is the owner of this manual, it is the reference material for purpose of the
operation and maintenance of electronic products, any other party may not disclose the
contents of this manual without written permission from manufacturer. All contents of this
manual are regarded as correct; manufacturer is not responsible for any accidental or
consequential damage because of wrongful installation or misoperation. Manufacturer is
not providing or transferring any privilege or copyrights. For any consequences by infringing
copyright law or violating the third party rights, manufacturer is not responsible.
Parts of the contents in this manual are subject to change without notice.
The User Manual Version Number：2.0
Revision date：2017-05-02
I

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Summary of Contents for Zoncare iMAC 120

  • Page 1 Preface Welcome to use Digital Multi-Channel Electrocardiograph Machine (hereinafter referred to as ECG machine, also referred to as the ―product‖, ―device‖, or ―unit‖). In order to enable you to skillfully operate the ECG machine as soon as possible, we provide you this accompanying manual with specific instructions for use.
  • Page 2 Product Information: Name: Digital Multi-Channel Electrocardiograph Machine Type: iMAC 120 Manufacturer: Wuhan Zoncare Bio-medical Electronics Co., Ltd Registered Address: #380, High-tech 2 road, Eastlake high-tech district, Wuhan, Hubei, P. R. China Manufacture Address: #380, High-tech 2 road, Eastlake high-tech district, Wuhan, Hubei, P.
  • Page 3 All illustrations in this manual are provided as examples only. Depending on system configuration, screens in the manual may differ from the screens on your system. Responsibility of the Manufacturer Zoncare is responsible for the safety, reliability and performance of hardware supplied by Zoncare only if the following conditions are met: ...
  • Page 4 Safety Conventions in this manual A Hazard is a source of potential injury to a person, property, or the device. This manual uses the term WARNING, CAUT ION, and NOTICE to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with the following defin itions and their significance.

  • Page 5: Table Of Contents

    Contents Chapter1 Safety Information and Introduction ..............1 1.1 Safety Information....................1 1.1.1 Hazards ....................1 1.1.2 Warning ....................1 1.1.3 Cautions ....................3 1.2 Device Symbols ....................5 1.3 Introduction......................6 1.3.1 Precautions....................6 1.3.2 Product Performance ................6 1.3.3 Product Composition.................6 1.3.4 Intended Application .................6 1.3.5 Contraindication ..................7 1.3.6 Theory of Operation ..................7 1.3.7 Main Features...................7 1.3.8 Intended Places and Users ...............8...
  • Page 6 2.3.7 Report Management Interface..............29 2.3.8 Application Interface ................30 Chapter 3 Installation .....................31 3.1 Preparation for Installation ................31 3.1.1 Open-package Check ................31 3.1.2 Environment Requirements..............32 3.2 Power Selection....................34 3.2.1 Connecting to the AC Power ..............34 3.2.2 Battery Power ..................34 3.3 Installing the Recording Paper ................35 3.3.1 Installing the Paper Block................35 3.3.2 Installing the Recording Paper ..............36 3.4 Connecting the Patient Cable ................38...
  • Page 7 5.3 Electrode Selection and Usage .................57 5.3.1 Preparing the Patient’s Skin ..............57 5.3.2 Electrode Selection .................58 5.4 Electrode Placement..................62 5.4.1 ECG Patient Cable..................62 5.4.2 Limb Lead Placement ................63 5.4.3 Chest Lead Placement................63 5.4.4 Pediatric Electrode Placement ..............64 5.5 Electrode Connection..................64 5.6 Lead-off Handling .....................64 5.7 Entering Patient Information................64 Chapter 6 ECG Acquisition and Recording ..............65...
  • Page 8 9.1 Cleaning and Disinfection .................81 9.1.1 Cleaning ....................82 9.1.2 Disinfection .....................84 9.1.3 Sterilization .....................84 9.2 Routine Inspection and Test ................84 9.2.1 Daily Inspection ..................84 9.2.2 Regular Inspection ..................85 9.3 Battery Usage & Maintenance................86 9.3.1 Overview....................86 9.3.2 Battery Charging ..................87 9.3.3 Battery Replacement ................87 9.3.4 Battery Guidance ..................87 9.3.5 Battery Maintenance ................88 9.3.6 Battery Recycling ..................90...

  • Page 9: Chapter1 Safety Information And Introduction

    Chapter1 Safety Information and Introduction 1.1 Safety Information 1.1.1 Hazards This product does not involve any information of hazard level. 1.1.2 Warning WARNING ◆ This ECG machine can only be operated on one single patient at one time.  The unit, its accompanying cables and accessories shall be checked prior to use so as to guarantee that they work normally and safely.
  • Page 10 WARNING place where chemicals are stored or ventilation is poor. Keep the unit away from excessive humidity, temperature, dust, salt, and sulphate.  The ECG machine should be placed gently on a stable platform and be protected from tilting, excessive vibration, and/or shocking in the process of transportation.

  • Page 11: Cautions

    WARNING use standard disposable electrodes so as to prevent metal electrodes from burning the patient’s skin. While used together with other electrical stimulator, the unit shall be operated under instructions from professionals at present.  Do not touch the patient during defibrillation. Otherwise it will incur serious injury or death.
  • Page 12 equipment used in the vicinity of this unit must comply with relevant EMC requirements.  Before connecting the unit to an AC power outlet, please verify the power voltage and frequency comply with the label on the unit or the requirements specified in this manual.

  • Page 13: Device Symbols

    1.2 Device Symbols The following table describes symbols or icons that may be on your device and its packaging. Symbol Description Symbol Description Attention! Consult accompanying On/Off documentation DC power supply AC power supply Charging battery SD card Type equipment Equipotential equipped with...

  • Page 14: Introduction

    CAUTION  Do not damage any label on the unit.  These labels provide important information for the safety and operation of the unit. Damaging or moving the labels may lead to disoperation. 1.3 Introduction 1.3.1 Precautions You are required to read through the operating instructions before use the ECG machine so as to ensure proper operation of the unit.

  • Page 15: Contraindication

    1.3.5 Contraindication None 1.3.6 Theory of Operation Schematics: Only qualified field service engineer will be provided schematics and spare parts list for the ECG machine. Theory of Operation: The ECG machine acquires a microvolt level signal from human body surface via patient cable and electrodes.

  • Page 16: Intended Places And Users

    anti-baseline drift, which is convenient for waveform analysis and interpretation.  It has man-machine interaction interface, independent full alphanumeric keyboard and full touchscreen. Also it can be connected with external mouse and keyboard. It operates flexibly and easily, reduces workload, and improves work efficiency. ...

  • Page 17: Safety Standards And Requirements

    WARNING  Wherever the ECG machine is used, you must verify that it is connected with reliable dedicated grounding wire. 1.3.9 Safety Standards and Requirements  The ECG machine is manufactured in compliance with Standard No ： EN 60601-1:1990/AC: 1994 Medical electrical equipment Part 1: General requirements for basic safety and essential performance;...
  • Page 18  The ECG machine is an instrument of continuous operation and ordinary equipment. Avoid ingress of liquids into the unit. Explosion hazard. Do not use the unit in the presence of flammable anesthetics or gases. Classification： Type of protection against Class I internally powered equipment electrical shock Degree of protection against...

  • Page 19: Chapter 2 Structure Identification

    Chapter 2 Structure Identification 2.1 Identification of Front Panel, Buttons, Symbols and Expansion Slot 2.1.1 Top View Figure 2.1 Top View 1. Touch Screen: Displaying ECG parameters and waveforms, patient and system information; for more interface information, please see Section 2.3. 2.
  • Page 20 Identification of Front Panel Keys Function Real-time function keys, which correspond to the hotkeys displayed at F1~F7 bottom of screen. Power Switch, press it to turn ON/OFF the ECG machine For switch over the unit’s operation mode between Auto and Manual. Change leads in manual mode.

  • Page 21: Side View

    2.1.2 Side View 3 4 5 Figure 2.2 Right Side View 1. Patient Cable Connector: To connect the patient cable for ECG data acquisition. 2. SD Card Slot: External SD storage. 3. USB Port: To connect external USB devices. 4. USB Port: To connect external USB devices. 5.

  • Page 22: Back View

    2.1.3 Back View Figure 2.4 Back View 1. Equipotential Terminal: When the ECG machine is used together with other devices, users shall connect its equipotential terminal with those of other devices so as to eliminate the potential difference (PD) among different devices thus ensuring safety. 2.

  • Page 23: Standard Mode

    2.2 Operation Mode 2.2.1 Standard Mode After the ECG machine is turned on, it enters into the standard mode automatically. Then you can perform ECG measurements, record waveforms and measured results, set system parameters, export the data and perform configuration management under this mode.

  • Page 24: Demo Mode

    2.2.3 Demo Mode Under this mode, some functions can be demonstrated through the ECG machine disconnected with the patient and accessories. Click ― ‖ at upper left, demo mode can be configured in Record Analyze →Demo Mode →On. Click ― ‖...
  • Page 25 check the unit, its cables and accessories so as to guarantee that they can work safely and normally. CAUTION  Once entering into the Demo Mode, the system cannot exit automatically. Even the ECG machine is turned off and on again it is still in demo mode. Therefore users need to press ―...

  • Page 26: Interface Display

    2.3 Interface Display 2.3.1 Waveform Acquisition Interface Figure 2.7 Waveform Acquisition Interface Patient and system information zone： Mode setting, press it to quick enter into mode setting dialog window Patient ID; Heart Rate Indication (tachycardia/bradycardia); Click it to quick enter into Heart Rate Indication menu;...
  • Page 27 WIFI connection state; Dark icon indicates network disconnection; Click it to quick set WIFI connection; Battery Information. White character indicates power capacity. Click it to enter into Power Management menu; Time Display; Click it to quick set the date and time; 2 Waveform zone: Displaying ECG waveforms.

  • Page 28: Standard Ecg", "Record Analyze", "Lead System" Interface

    2.3.2 “Standard ECG”, “Record Analyze”, “Lead System” Interface On Waveform Acquisition interface, click ― ‖ at upper left of screen to quick enter into the setting page of ―Standard ECG‖, ―Record Analyze‖, or ―Lead System‖ interface. 2.3.2.1 Standard ECG Figure 2.8 Standard ECG Interface Standard ECG Menu Item Options...
  • Page 29 Standard ECG Menu Item Options Defaults Illustration conditions, signal acquisition starts 2 seconds before the start point. Period sampling: perform sampling in periodic intervals Auto: While recording the ECG waveforms, the system automatically records each lead change per sampling time. Recording Auto Auto...

  • Page 30: Record Analyze

    2.3.2.2 Record Analyze Figure 2.9 Record Analyze Interface Record Analyze Menu Item Options Defaults Illustration Demo mode Off / On Turn on/off the Demo mode. Auto Diagnosis Off / On Turn on/off the Auto Diagnosis Auto Turn on/off the Auto Off / On Measurement Measurement.

  • Page 31: Lead System

    Record Analyze Menu Item Options Defaults Illustration waveform and printed out. 2.3.2.3 Lead System Lead system can freely change among Standard, Posterior Wall, Right Chest, Right Chest Posterior Wall, Previous Intercostal Space, Next Intercostal Space, CABRERA, and Custom. Figure 2.10 Lead System Interface...
  • Page 32 Lead System Menu Item Lead Label Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 Standard Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF, V1, V2, V3, V7, V8, V9 Posterior Wall Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF, V1, V2, V3, V3R, V4R, V5R Right Chest Right Chest...

  • Page 33: Patient Info Interface

    2.3.3 Patient Info Interface On Waveform Acquisition interface, Press F1 key on panel or hotkey at lower right of alphabetical keyboard, or directly touch ― ‖ to enter into Patient Info interface and then enter the information by keyboard. After entry, press key to save and return.

  • Page 34: Paper Speed Interface

    2.3.4 Paper Speed Interface On Waveform Acquisition interface, touch the key or press F2 key on panel to change the paper speed. Paper speed can be selected among 5mm/s, 6.25mm/s, 12.5mm/s, 25mm/s and 50mm/s. Figure 2.12 Paper Speed Interface...

  • Page 35: Gain Amplitude Interface

    2.3.5 Gain Amplitude Interface On Waveform Acquisition interface, touch the key or press F3 on panel to change the gain amplitude. Gain amplitude can be selected among 2.5 mm/mv, 5 mm/mv, 10mm/mv, 20 mm/mv, 40 mm/mv and Auto. Figure 2.13 Gain Amplitude Interface...

  • Page 36: Lead Layout Interface

    2.3.6 Lead layout Interface On Waveform Acquisition interface, touch the key or press F4 key on panel to change the lead layout. Lead layout can be selected among 3×4, 3×4+1, 3×4+3, 6×2, 6×2+1, and 12×1. (Selected lead layout will be saved after the ECG machine is turned off) Figure 2.14 Lead Layout Interface...

  • Page 37: Report Management Interface

    2.3.7 Report Management Interface On Waveform Acquisition interface, directly touch the key or press F6 key to enter into Report Management interface. For operation details, please see Chapter 7 Report Management. Figure 2.15 Report Management Interface...

  • Page 38: Application Interface

    2.3.8 Application Interface On Waveform Acquisition interface, press F7 key on panel or directly touch the key to enter into Application interface. Figure 2.16 Application Interface...

  • Page 39: Chapter 3 Installation

    Chapter 3 Installation 3.1 Preparation for Installation CAUTION  This device shall be installed by the personnel authorized by the manufacturer.  Don’t open the device cover. Otherwise there might be risk of electrical shock. Only the service personnel authorized and trained by the manufacturer can maintain or update the device.

  • Page 40: Environment Requirements

    Please open the package in a correct way. Carefully take out the device and accompanying components from the box and check them one by one per the packing list. Check whether the device is damaged mechanically, or the goods are complete. For any questions, please contact the manufacturer immediately.
  • Page 41 WARNING  Please ensure that the device works under required specified environment. Otherwise it will not comply with the technical specifications alleged in this manual, which may lead to unpredictable consequences (damaging the device, etc).  Do not use the device in oxygen-rich environment, or the presence of flammable or explosive substances (anesthetics, etc) in case of fire or explosion.

  • Page 42: Power Selection

    3.2 Power Selection This ECG machine can be supplied by 220V AC power or lithium-ion rechargeable battery power. 3.2.1 Connecting to the AC Power Plug one end of accompanying three-core power cord into the power jack at the back of the machine, and the other end into the three-core socket with a grounding cable.

  • Page 43: Installing The Recording Paper

    manufacturer. CAUTION  To prevent data loss caused by accidental AC power interruption, a battery pack must always be installed in ECG machine.  Whenever the unit is connected to AC power and AC power is on, the battery is being charged. Therefore, it is recommended that the unit remain connected to AC power when not in use.

  • Page 44: Installing The Recording Paper

    B: Align the snap on the block with the slot on the metal rail; C: Make sure that the block is fully engaged with the metal rail and pull the block in the direction of the arrow until the catch is fully engaged. Fig 3.1 Schematic of Installing Paper Stock 3.3.2 Installing the Recording Paper The way of installing the Zip fold thermal paper of width in 210mm is the same as that of...
  • Page 45 Fig 3.2 Schematic of Installing the Recording Paper...

  • Page 46: Connecting The Patient Cable

     The black-marked end of recording paper should stay close to that of the recorder.  The grid side of recording paper should face up to the printer head.  The end page of recording paper is marked red. Make sure it is placed on the bottom.

  • Page 47: Power On

    3.5 Power on 3.5.1 Checks before Power on In order to ensure safe examination and stable printing out of electrocardiogram, you are required to make the above-mentioned checks before operating of the ECG machine.  Checks on Operation Environment Verify that the ground wire is well connected, the ground bolt is tight, and ground wire and its connector are properly connected.

  • Page 48: Ecg Machine Setting

    CAUTION  If the device is damaged or does not work, it cannot be used to acquire and record the patient ECG. Please contact the service personnel or the manufacturer immediately. 3.6 ECG Machine Setting There are some settings need to be done for the first time use, such as time, report storage modes etc.

  • Page 49: Chapter 4 System Applications

    Chapter 4 System Applications 4.1 Entering into Main Menu On Waveform Acquisition interface, press F7 key on panel or directly click key on touch screen to enter into Application interface, for whose layout, please refer to Section 2.3.8. Directly view the intended items by clicks on touch screen. 4.2 Application Interface 4.2.1 Convention Fig 4.1 Convention Interface...
  • Page 50 Report Setting Default Menu Item Options Illustration Value Local / SD / U Local Refer to Section 6.4.1 for details. Storage Location Disk Manual / Auto Storage Method Manual Refer to Section 6.4.2 for details. / Not Save Filter Setting Menu Item Options Default...
  • Page 51 Cardia Warnings Menu Item Options Default Description Value threshold value Bradycardia 40-80 bradycardia. threshold value Tachycardia 81-140 tachycardia. CAUTION  Settings of baseline drift filter and EMG filter will influence the range of frequency response of ECG machine. Whether the settings are too high or too low, precision of ECG waveform reduction will be influenced.

  • Page 52: Recorder Setting

    4.2.2 Recorder Setting Fig 4.2 Recorder Setting Interface...
  • Page 53 Recorder Setting Default Menu Item Options Illustration Value Built-in/External/ Printer Built-in Paperless Set the grid while exporting PDF reports. When it is set ―On‖, the waveform zone and footer zone will display grid background; Printing Grid Off/On When set ―Off‖, no grid will appear on the report.

  • Page 54: Machine Setting

    4.2.3 Machine Setting Figure 4.3 Machine Setting Interface Machine Setting Menu Item Options Default Description Value Adjust backlight brightness on display Brightness 1%-100% screen time machine automatically entering into standby mode. If the user does not perform Off, 5min, 10 operation within given...
  • Page 55 Set the automatic power-off time. If the user does not perform any Off, 5min, 10 operation within the given power-off min, 15 min, 20 Power Off time, ECG machine will automatically min, 25 min, 30 power off. Storage Device Menu Item Options Default Description...

  • Page 56: Institution Setting

    4.2.4 Institution Setting Figure 4.4 Institution Setting Interface...

  • Page 57: Email

    4.2.5 Email Click the key to open the Mail dialog window, and then you can send emails. Figure 4.5 Email Interface...

  • Page 58: Lan

    4.2.6 LAN Click the key to open the Wire Setting dialog window, and then you can make appropriate network settings. After settings, click key to take effect. Figure 4.6 Wire Setting Interface...

  • Page 59: Wifi

    4.2.7 WiFi Click the button to open the Wifi Setting dialog window. You can select to turn on or off the WiFi. Figure 4.7 Wifi Setting Interface...

  • Page 60: Ftp File Transfer

    4.2.8 FTP File Transfer Click the key to open the FTP File Transfer dialog window. Click the key to set FTP. After completion, click the key to confirm. Then you can check the file to be uploaded on the right, click the key to upload files.

  • Page 61: Rhythm Analysis

    4.2.10 Rhythm Analysis Click the icon to enter into Single Lead ECG Waveform Acquisition interface. Click the icon to set Lead System, Rhythm Index No., Sampling Time and Max Amplitude. After settings, click the icon to enter into Single Lead Rhythm Analysis interface.

  • Page 62: Ecg Machine Setting

    Fig 4.10 Rhythm Analysis Report Interface 4.3 ECG Machine Setting 4.3.1 Initial Setup When you use a new ECG machine, or an old one after its maintenance and renewal for the first time, be sure to check and complete the following settings: ...

  • Page 63: Setup Before Use

    CAUTION  When the machine is serviced and upgraded, usually it will be restored to factory setting. Then it will need resetting after maintenance and upgrading. 4.3.2 Setup before Use Before each use, be sure to check whether the following settings are proper. Set the following items based on actual needs: Settings based on actual needs Set suitable lead system and desired rhythm lead in Lead System.

  • Page 64: Chapter 5 Connecting Ecg Cable

    Chapter 5 Connecting ECG Cable  During defibrillation, don’t touch the patient, electrodes, patient cable and lead terminals. Otherwise it may result in serious injury or death.  For a pacemaker patient, ECG machine may interpret and record the pacemaker pulse as the QRS complex wave. Please carefully inspect the ECG waveform recorded by ECG machine.

  • Page 65: Preparation

     The patient’s bed should be of suitable size to guarantee that the patient can naturally lie down, with hands and feet stretching naturally. 5.2 Preparation To acquire accurate ECG signals, the patient should be explained about the following information. ...

  • Page 66: Electrode Selection

    5.3.2 Electrode Selection The ECG machine is equipped with reusable chest bulbs and limb clamps. For your convenience, you can also purchase disposable electrode slices from the manufacturer. Use chest bulbs or disposable electrode slices to connect the chest leads (C1 ~ C6), while use limb clamps or disposable electrode slices to connect the limb leads ( R, F, L, RF).
  • Page 67  Well place the electrodes: squeeze the chest suction bulb to make the lower edge of the metal electrode tightly connected with the skin. Loosen the bulb to make the electrode adsorbed on the patient's skin;  Ensure that the ECG machine and its cable, electrodes and lead wires are firmly connected.
  • Page 68  Ensure the ECG machine and its patient cable, the electrodes and the lead wires are firmly connected. 5.3.2.3 Disposable Electrode Slice Disposable electrode slices are not accompanied with this ECG machine. Please contact the manufacturer or authorized representatives if needed. Steps of placing disposable electrode slices: ...
  • Page 69 electrodes only by set. Old and new electrodes cannot be mixed up. CAUTION  In order to achieve satisfactory ECG recording results, metal electrodes must be closely contacted with the skin evenly.  Metal electrodes must be clean. And the prepared sites contacting metal electrodes must be clean, free of grease and perspiration.

  • Page 70: Electrode Placement

    5.4 Electrode Placement 5.4.1 ECG Patient Cable Contrast Table of Electrodes and Lead Wires: Placement Symbol Color Code Right Arm Left Arm Yellow Left Foot Green Right Foot Black Chest Chest Yellow Chest Green Chest Brown Chest Black Chest Purple...

  • Page 71: Limb Lead Placement

    5.4.2 Limb Lead Placement R ——Right Arm L ——Left Arm RF——Right Foot F ——Left Foot Fig 5.3 Chest & Limb Lead Electrode Placement 5.4.3 Chest Lead Placement C1: Fourth intercostal space at the right sternal border. C2: Fourth intercostal space at the left sternal border C3: Midway between location C2 and C4.

  • Page 72: Pediatric Electrode Placement

    5.4.4 Pediatric Electrode Placement When acquiring pediatric ECG, C3 lead should be placed in C4R position rather than the site where standard C3 lead is placed, as shown in right figure. Fig 5.4 Pediatric Chest Lead Electrode Placement 5.5 Electrode Connection Plug chest lead wires and limb lead wires respectively into connection holes of the chest electrode bulbs and limb electrode clamps.

  • Page 73: Chapter 6 Ecg Acquisition And Recording

    Chapter 6 ECG Acquisition and Recording 6.1 Acquisition Preparation To secure the patient and to record stable accurate electrocardiogram (ECG), please carefully check the following items before you power on the machine for measurement. 1）Check whether the exam room is appropriate; ...

  • Page 74: Acquisition And Recording

    6.2 Acquisition and Recording 6.2.1 Recording Setup After the checks are all right, power on the ECG machine, it enters into Waveform Acquisition interface, and then you can observe the waveforms after they become stable. Set the sampling mode, layout, gain, and paper speed on actual needs, and then press key to print ECG waveforms.

  • Page 75: Recording Report

    6.2.2 Recording Report A record report printed out by default is shown as follows: Fig 6.1 ECG Record Report 1 Date and Time 2 Patient ID 3 Age 4 Gender 5 Record Sequence 6 Configuration Info 7 Version 8 Measured Result 9 Interpretations 10 Physicians’...

  • Page 76: Ecg Waveform Description

    6.2.3 ECG Waveform Description Standard ECG waveform is shown as follows: Fig 6.2 Standard ECG Waveform Meaning and description of each segment of ECG waveform:  P wave is of blunt round shape, and its amplitude is lower than T wave’s. ...

  • Page 77: Freeze

    be upside down. In the leads of QRS wave group whose main wave is up, when T wave is low and smooth or upside down, it is common in myocardial ischemia or hypokalemia. CAUTION  Here is a simple description of ECG waveforms. For details, please see relevant references.

  • Page 78: Report Storage

    6.4 Report Storage 6.4.1 Report Storage Location Configure the report storage location in Application→ Convention→ General with options such as Local/SD card/U disk. Local: When sampling time is 10s, and layout is 12×1, you can store no less than 1500 reports. When sampling time is 2.5s, and layout is 12×1, you can store no less than 2000 reports.
  • Page 79  In manual recording mode, the system will not store the report when it finishes recording. If there is a need to store the report, press Freeze key and then store it.  When a lead is off the patient, freezing loses its effect, still it can print, but the system cannot store the recording results automatically.

  • Page 80: Chapter 7 Report Management

    Chapter 7 Report Management 7.1 Report Storage By default settings reports are stored in local memory with limited capacity. Therefore it is recommended to use the USB disk with larger capacity. Also it is easy for classification and storage. In order to avoid damage and loss of external storage devices, backup the reports from the storage device to a dedicated PC server.

  • Page 81: Editing Reports

    Fig 7.1 Searching Reports After search, press key to restore the report list before search. 7.2.3 Editing Reports Select the desired report and press key to enter into Edit interface. Then you can edit the report. Or press key to preview the report.

  • Page 82: Printing Reports

    Fig 7.2 Editing Reports 7.2.4 Printing Reports When preview a report, you can print it with key. CAUTION  When preview and edit the report, you can select only one report. 7.2.5 Deleting Reports Select a report and press key to delete it.

  • Page 83: Report Transmitting

    7.3 Report Transmitting Here are steps of transmitting reports: 1. Click key at bottom of Report Management interface. 2. Select a time option (Today, Week, All) 3. Select the report to be transmitted 4. Select the transmitting format (ECG/PNG/PDF/ DICOM/HL7) 5.

  • Page 84: Chapter 8 Troubleshooting

    Chapter 8 Troubleshooting To record a stable and accurate ECG, when a failure occurs, please find out its cause, and solve it with effective solutions. WARNING  ECG machine cover should be opened only by qualified service personnel. There are no user-serviceable parts inside the ECG machine. 8.1 Interference Problem During use, ECG machine will inevitably be disturbed by the environment, itself, human static electricity etc.

  • Page 85: Emg Interference

     Check whether the electrodes or lead wires are connected correctly, Electrodes and skin are well applied with conductive cream, clean the patient’s electrode sites with medical alcohol, apply conductive cream on the sites evenly, conductive cream on each electrode can't be cross-linked ...

  • Page 86: Baseline Drift

    feel uncomfortable,  Check the metal part on the connection of the lead wire and electrode is rusty or dirty, if it is, please clean it. 8.1.3 Baseline Drift Fig 8.3 Baseline Drift Waveform Graph 1）Environment Cause:  Check whether the exam room is comfortable, ...

  • Page 87: Recorder Failure

    8.2 Recorder Failure Failure Possible Cause Solutions As the paper-feeding device has been Tighten the transmission unit, and used for a long time, its transmission apply some lubricating oil on the gear ability is degraded by worn gear or loose and both ends of paper shaft.
  • Page 88 Failure Possible Cause Solutions Recording paper is out of specification. Replace it with our paper or with better paper same specification. It prints unclear or with breakpoints Paper shaft is dusty. Clean the paper shaft. Print head is dusty. Clean the print head. Recording paper is installed backwards.

  • Page 89: Chapter 9 Maintenance

    Chapter 9 Maintenance 9.1 Cleaning and Disinfection Please keep the ECG machine and its accessories clean. And in order to avoid damaging the ECG machine, please follow the regulations below:  Please dilute the cleaner and disinfectant according to the manufacturer's instructions, or use the cleaner and disinfectant whose concentration is as low as possible;...

  • Page 90: Cleaning

    CAUTION  If you accidently dump liquid onto the equipment or its accessories, cause damage, please contact our service department. 9.1.1 Cleaning Available detergents for cleaning the host are listed as follows: NaClO (Bleaching) Oxydol (3%) Ethanol (75%) Isopropyl alcohol (70%) It is recommended to clean the accessories with 75% ethanol.
  • Page 91 Cleaning ECG cables and lead wires:  Please remove the cables from ECG machine before cleaning them and the lead wires.  Use a soft cloth with some 75% ethanol to wipe the surface of the cables and lead wires. Avoid the metal connection parts; ...

  • Page 92: Disinfection

     Dry the recorder head gently with a clean cotton swab;  Dry the recorder head naturally, reinstall the recording paper and close the printer door. CAUTION  Please don’t clean the recorder head immediately after recording as the head might be extremely hot at this time.

  • Page 93: Regular Inspection

     All buttons are in good condition;  Ports, plugs and cables are not damaged or twined;  The power cord and ECG cable are firmly and respectively connected with the machine;  The recording paper is installed correctly, and sufficient for use; ...

  • Page 94: Battery Usage & Maintenance

    9.3 Battery Usage & Maintenance 9.3.1 Overview ECG machine is configured with rechargeable lithium-ion battery so as to ensure that it works normally while moving in the hospital or when the power fails. When the power fails suddenly, the system will automatically enable the battery to supply the ECG machine, thus the machine won’t stop working.

  • Page 95: Battery Charging

    Those two icons indicate that the battery works normally. The white grid shows the power capacity. This icon indicates that the battery power is extremely low. When battery power is extremely low, ECG machine will pop out a message ―Extremely Low Battery Power‖, and the recorder cannot work.

  • Page 96: Battery Maintenance

     Before the ECG machine is delivered or when it will not be used for more than 3 months, please take out the battery.  If the ECG machine has not been used for a long time with the battery installed in it, the battery’s life will shorten.
  • Page 97 3. Disconnect AC power, and supply ECG machine with battery power until it is power off. 4. Connect ECG machine with AC power again, and continuously charge the battery to full capacity, then the light goes out. CAUTION  As the time of using the battery increases, its actual power capacity will decrease.

  • Page 98: Battery Recycling

    9.3.6 Battery Recycling If the battery is obviously damaged or cannot be charged, it should be replaced and recycled properly. When disposing of the used battery, please follow relevant laws and regulations. . WARNING  Do not disassemble the battery or throw it into fire or short it out. Its burning, explosion or leakage may cause personal injury.

  • Page 99: Chapter 10 After-Sale Service

    Chapter 10 After-sale Service When users begin to use the ECG machine, they should fill the details in warranty card and send it back to the manufacturer by mail or email in time, the manufacturer will build the users’ profiles and regularly contact them to know about the usage, which will help provide targeted first-rate services constantly.

  • Page 100: Chapter 11 Accessories

    Chapter 11 Accessories WARNING  Use the accessories stipulated in this manual only. Other accessories may damage this ECG machine or cannot meet the specification declared in this manual.  Disposable accessories can be used only once; Reuse will cause performance degradation or cross infection.

  • Page 101: Performance Index

    Appendix I I.1 Performance Index Performance Description Min/Max Unit Min/Max Value Input Dynamic Range: Linear working range of input signal ±5 Slew rate change mV/s DC bias voltage range ±610 Allowable amplitude variation during DC ±5 bias Gain control, accuracy and stability: Gain selection At least mm/mV...
  • Page 102 Track visibility (recording rate) mm/s 1600 Track width (Only permanent record) Aligned offset of time axis Pre-printed paper grids div/cm Time mark error ±2 Accuracy of rebuilt input signal: Total error of signals of ±5mV and 125mV/s ±5 μV ±40 Frequency and pulse response: Rated input amplitude 1.0mV, frequency Range...
  • Page 103 240Hz～500Hz, sine wave Rated input amplitude 1.5mV1.5mV, Range +0,-10 ≤1Hz,200ms, triangular wave Lead weighting factor error ±5 Lag behind 15mm baseline deflection Response to min signal μV Calibration voltage: Rated value Inapplicable Rise time Fall time Amplitude Error ±5 Performance Specification Min/Max Unit Min/Max Value...
  • Page 104 10s return time after reset Return time after lead change Baseline stability: μV/s Baseline drift rate RTI μV Total baseline drift（2min cycle） Overload protection: Apply differential voltage, 50Hz, (peak-to-valley value), 10s，no damage damage after discharge analog defibrillator, Overload voltage Inapplicable 5000 Energy Inapplicable...

  • Page 105: Safety Index

    Front–end acquisition mode Adopting A/D sampling bits Valid sampling 32000 32000 a) It pulses to square waves only, inapplicable for triangular waves. b) Pace-making pulse with the amplitude of at least 0.2mV RTI can be visible on the record, except for those pulses whose interval is 0.2ms ～ 2ms, enter the parameters as stipulated.

  • Page 106: Environmental Conditions

    I.5 Environmental Conditions Operation ﹢5℃～﹢40℃ Ambient Temperature Ambient Humidity 20%~85% Atmospheric Pressure 70kpa～106kpa Shipment and Storage －20℃～+55℃ Ambient Temperature Ambient Humidity 10%～95% Atmospheric Pressure 50kpa～106kpa...

  • Page 107: Adherence To Standards

    I.6 Adherence to Standards GB/T 191-2008 Labels on package, storage and shipment GB/T 9969-2008 Instructions for industrial products General Principle Environmental requirement and test methods for GB/T 14710-2009 medical electrical equipment YY 1139-2013 Diagnostic electrocardiographic devices Medical electrical equipment Part 2-25:Particular IEC 60601-2-25: 2011 requirements for the safety of ECG machine...

  • Page 108: Appendix Ii Electromagnetic (Emc)

    Appendix II Electromagnetic (EMC) The product meets the requirements of Electromagnetic-Medical Electrical Equipment in EMC standard: IEC 60601-1-2. NOTE  Use of accessories, transducers, and cables other than those specified may result in increased emission and/or decreased immunity of the equipment. ...
  • Page 109 purposes. Voltage Fluctuation/Flicker Compliance emissions IEC 60601-1-2 WARNING ● This device is only for professional doctors. Other electric devices/systems might interfere or disturb the operation of this device. If necessary, please take measures to alleviate this interference such as adjust the direction, replace this device or shield relevant places.
  • Page 110 ±1 kV differential Mains power quality should ±1 differential mode that typical Surge IEC 61000-4-5 mode ±2 kV common commercial hospital ±2 kV common mode mode environment. <5% U <5% U Mains power quality should (>95% dip in U (>95% dip in U be that of typical commercial for 0.5 cycle for 0.5 cycle...
  • Page 111 IEC 60601 Compliance Electromagnetic environment Immunity test Test level level guidance Portable and mobile RF communications Conduced 3 Vrms 3Vrms Equipment should be used no closer to any RF IEC 150kHz to part of the device, including cables, than 61000-4-6 80MHz recommended separation...
  • Page 112 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the equipment is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation.
  • Page 113 For transmitters at a maximum output power not listed above, the recommended separation distanced in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 114: Appendix Iii Environmental Statement

    Appendix III Environmental Statement Names and Contents of Hazardous and Noxious Substances: Hazardous and Noxious Substances or Elements Hexavalent Name Lead Mercury Cadmium Chromium PBDE (Pb) (Hg) (Cd) (CrVI) ○ ○ ○ ○ ○ ○ Built-in PCB ○ ○ ○ ○...

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