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Zoncare U30 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 "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.
This manual is owned by manufacturer, 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 consequence by infringing copyright law or violating the
third party rights, manufacturer is not responsible.
Parts of the contents in this manual may be changed without notice.
The User Manual Version Number：1.0
Date of preparation：2021-03-10

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Summary of Contents for Zoncare U30

  • Page 1 Preface Welcome to use Digital Multi-Channel Electrocardiograph Machine (hereinafter referred to as ECG machine, also referred to as “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 #380, High-tech 2 road, Eastlake high-tech district, Wuhan, Hubei, P. R. China Production Date: See the label Operating Life: 10 years Tel: +86(27)87770581 Tel /Fax: +86(27)87770203 Post Code: 430206 After-sale Service Unit: Wuhan Zoncare Bio-medical Electronics Co., Ltd. Website： http://www.zoncare.com...
  • Page 3 All illustrations in the manual are provided as examples only. Depending on system configuration, screens in the manual may differ from the screens on your system. Manufacturer’s Responsibility 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 system. This manual uses the term WARNING, CAUTION, and NOTICE to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with the following definitions and their significance.

  • Page 5: Table Of Contents

    Contents Chapter 1 Safety Information and Introduction ................1 1.1 Security Information ......................1 1.1.1 Hazards ......................... 1 1.1.2 Warning ......................... 1 1.1.3 Cautions ........................ 4 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 .....................
  • Page 6 3.1.1 Open-package Inspection ................... 23 3.1.2 Environment Requirements ................. 24 3.2 Power Selection ......................26 3.2.1 Connecting to the AC Power ................26 3.2.2 Battery Power ...................... 26 3.3 Installing the Recording Paper ..................27 3.4 Connecting the Patient Cable ..................29 3.5 Power on ........................
  • Page 7 （ ） 4.2.19 General-WORKLIST ................57 4.2.20 E-Mail Setting ....................58 4.2.21 LAN Setting ....................... 59 4.2.22 WIFI Setting ....................... 59 4.2.23 Standard ECG setting ..................60 4.3 Machine Setting ......................64 4.3.1 First Time Setup ....................64 4.3.2 Setup before Use ....................65 Chapter 5 Connecting ECG Cable....................
  • Page 8 7.2.3 Previewing reports....................83 7.2.4 Printing Reports ....................83 7.2.5 Deleting Reports ....................84 7.3 Report Transmission ..................... 84 7.4 Report Refresh ......................85 Chapter 8 Troubleshooting ......................86 8.1 Interference Problem ..................... 86 8.1.1 AC Interference ....................86 8.1.2 EMG Interference ....................87 8.1.3 Baseline Drift .......................
  • Page 9 I.5 Environmental Conditions..................... 111 I.6 Adherence to Standards ....................111 Appendix II Electromagnetic (EMC) ..................113 Appendix III Environmental Statement ..................122...

  • Page 11: Chapter 1 Safety Information And Introduction

    Chapter 1 Safety Information and Introduction 1.1 Security 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 in order to guarantee that they work normally and safely.
  • Page 12 WARNING the 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 13 WARNING frequency equipment, please 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 14: Cautions

    1.1.3 Cautions CAUTION  Please used the accessories specified in this manual.  When the unit and accompanying will exceed their life time, dispose of them in accordance with relevant local laws and regulations or the regime of local hospitals. ...

  • Page 15: 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 CF Equipment Equipotential equipped with protector...

  • Page 16: Introduction

    Nonionizing electromagnetic radiation 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 17: Intended Application

    1.3.4 Intended Application The intended use of U30 12-lead electrocardiograph (hereinafter called U30) is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.

  • Page 18: Main Features

    provides other modules of the ECG machine with power sources, of which AC power is of priority to the rechargeable battery. When the ECG machine is powered by AC power, battery is charged provided there is no operation of the unit. 1.3.9 Main Features ...

  • Page 19: Safety Standards And Requirements

     ECG signal measurement is intended for users of different ages, but for the children, if there is crying and other uncoordinated factors, it will cause interference and ECG artifacts, which should be based on the diagnosis of the clinician. ...
  • Page 20 otherwise the precautions for grounding protection of the unit shall lose effectiveness and the patient may has the risk of electrical shock.  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.

  • Page 21: Chapter 2 Structure Identification

    Chapter 2 Structure Identification 2.1 Identification of Front Panel, Buttons, Symbols and Expansion Slot 2.1.1 Top View Fig. 2.1 Top View 1. Indicator Light: Indicating power supply status and battery charge status; for details, see the table below. 2. Operation Panel: Operation keys; for details, see the table below. 3.
  • Page 22 Identification of Function Keys Function Printing Key. When perform settings, us e direction key to select among the items， Press” ”key for selection confirmation，for details please see chapter 4.1. Character input key, shortcut function: Adjusting paper speed in main menu. Character input key, shortcut function: Adjusting gain in main menu.

  • Page 23: Side View

    Backspace key Identification of Indicator Light Indicator Function Light AC power indicator light On: AC power connected Off: AC power disconnected DC power indicator light On: Power supplied by battery Off: Power not supplied by battery, or no battery installed Charging status indicator light On: Battery being charged Off: No battery installed or battery fully charged...

  • Page 24: Rear View

    Fig. 2.3 Right Side View 1. ECG Cable Port: Connecting ECG cable. 2. USB Port: Connecting external USB devices. 3. USB Port: Connecting external USB devices. 4. LAN Port: Connecting internet, it’s used when connecting with other devices 2.1.3 Rear View Fig.

  • Page 25: Bottom View

    2.1.4 Bottom View Fig. 2.5 Bottom View 1. Battery Compartment: To contain the battery. 2. Nameplate. 2.2 Operation Mode 2.2.1 Standard Mode After the ECG machine is turned on, it enters into standard mode automatically. Then you can perform ECG signal acquisition, measure, record measured results, perform system settings, export data and perform configuration management under this mode.

  • Page 26: Demo Mode

    2. Click the direction key“ ”to select“ ”and then press“ ”key to enter Machine interface. 3. Click“ ”direction key，select the standby item on the setting interface； 4. Set the time to automatically go to standby mode； 5. After setting, click“ ”direction key to move the cursor to the upper right corner“...
  • Page 27 In the demo mode, there is a demo waveform for demonstration, which can be printed. Fig. 2.6 Demo Mode WARNING  Demo function is mainly used to display the machine performance and provide training for users. When the machine is connected to the patient in clinical practice, it’s prohibited to use the Demo function in case that the medical staff shall mistake the demo waveform as the patient’s, thus affecting the patient’s measurement and delaying his or her treatment.

  • Page 28: Interface Display

    2.3 Interface Display 2.3.1 Waveform Acquisition Interface Waveform Acquisition Interface show 6x2 layout only. Fig. 2.7 Waveform Acquisition Interface Patient and system information zone： Patient ID； Heart Rate Indication (tachycardia/bradycardia)； External printer indication. The icon being dark indicates that it is not connected；...
  • Page 29 Waveform zone: Displaying ECG waveform. Red lead indicates the lead falls off, while white indicates the lead is well connected; 3 Shortcuts zone： ”key to change the value；options： Paper speed，press“ 5mm/s，6.25mm/s，10 mm/s，12.5mm/s，25mm/s，50mm/s。 ”key to change the value， Gain amplitude，press“ options：2.5mm/mv，5 mm/mv，10mm/mv， 20 mm/mv，40 mm/mv，auto.

  • Page 30: Patient Info Interface

    2.3.2 Patient Info Interface In the waveform acquisition interface, you can press“ ”key to enter the patient information page, finish patient basic information input. Press “▲”or “▼”direction key to select different items，press “#”to change between Number, English and Symbol，and then input through the keyboard.（input method please refer section 4.1）.System will generate ID automatically when you enter patient info interface.
  • Page 31 Fig. 2.9 Patient Information Interface – Settings Fig. 2.10 Patient Information Interface - List...

  • Page 32: Report Management Interface

    2.3.3 Report Management Interface In the waveform acquisition interface directly clicks the “ ”button to enter the report management interface. See Chapter 7, Report Management for details. Fig. 2.11 Report Management Interface 2.3.4 Application Interface On Waveform Acquisition interface, directly click the key “ ”...

  • Page 33: 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 34: Environment Requirements

    Please open the package in a correct way. Carefully remove the device and other 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 35 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 36: Power Selection

    3.2 Power Selection This ECG machine can work by 100V-240V 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, then the AC input light is on, which indicates that AC power has been connected.

  • Page 37: Installing The Recording Paper

    CAUTION  To prevent data loss caused by accidental AC power interruption, a battery 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 38 D. Put roll paper into paper warehouse, and verify that both sides are located in warehouse groove. Open the starting point of paper; E. Close the printer door. 2. Steps of installing Folding paper: A. Press the printer door switch on the left side of ECG machine;...

  • Page 39: Connecting The Patient Cable

    D. Unfold the first page of the folding paper; E. Close the printer door.  The black-marked end of recording paper should stay close to the black-marked detecting end of the recorder.  The grid side of recording paper should face up to the printer head. ...

  • Page 40: Power On

    CAUTION  Please use the dedicated patient cable configured by the manufacturer. If the cable is damaged, please contact the manufacturer in time to purchase a new one for replacement. 3.5 Power on 3.5.1 Checks before Power on In order to ensure safe examination and stable printout of electrocardiogram, you are required to make the above-mentioned checks before operating of the ECG machine.

  • Page 41: Power On

    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. 3.5.2 Power on After installation and checks, connect the power cable and turn on the ECG machine, then start to acquire and record the patient's ECG.

  • Page 42: Chapter 4 System Application

    Chapter 4 System Application 4.1 Enter into main menu In waveform acquiring interface, press “ ”to enter into system application interface. Please refer to chapter 2.3.4 for system application interface layout. By pressing the arrow button of “ ” and “ ”to confirm the target option.(Operation requires the combination use of arrow button and confirm button) 4.1.1 Button operation method...

  • Page 43: Application Interface Illustration

    4.2 Application interface illustration 4.2.1 Analysis Setting-Standard ECG Select “ ”, then select Standard ECG to enter standard ECG setting interface. Fig. 4.1 Standard ECG interface Standard ECG Menu Menu Default illustration operation Real time: Acquiring and measuring ECG signal in real time; Real time Pre sampling: Acquisition starting 10 Pre-sampling...
  • Page 44 Standard ECG Menu Menu Default illustration operation Auto: When recording the ECG waveform, the system automatically records each lead according to the sampling time and automatically switches the record; Simultaneous: record the ECG waveform 12-lead same time; Sequential: The 12-lead is divided into 4 averaging periods according to the record Auto-simulta format layout (such as 3×4), and recorded...

  • Page 45: Analysis Setting-Record Analyze

    Standard ECG Menu Menu Default illustration operation Periodic sampling 3-100 min 12 min Periodic sampling total time setting Total time Periodic sampling Each sampling period sampling time 3-100 min 3 min Interval setting time Sampling mode: Auto-Sync, 2.5s、5 s 、7 Printing 2.5 sec Auto-Sequence,...
  • Page 46 Fig. 4.2 Record analyze interface Recording analyze Menu Menu option Default illustration Demo mode Off/On On/Off demo mode On/Off auto diagnosis Auto diagnosis Off/On Under off mode, ECG report does not show diagnosis results On/Off auto diagnosis Auto Under offer mode, ECG report Off/On measurement does not show diagnosis...

  • Page 47: Analysis Setting-12 Lead

    4.2.3 Analysis Setting-12 lead Select “ ” option and then select 12 lead, click and enter into setting interface. Fig. 4.3 12 lead interface 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...

  • Page 48: General-Machine Setting

    4.2.4 General-Machine Setting Fig. 4.4 General-Machine setting interface Machine setting Menu Option Default illustration Adjust display screen backlight Brightness 10100 intensity Set the time when the ECG machine automatically enters standby mode. If there is no user operation within the Off, 5min, 10min, set standby time, the ECG machine Standby...
  • Page 49 Simplified Chinese, traditional Chinese, English, Ukrainian, Turkish, Russian, French, Portuguese, Language English Select the interface language. Spanish, German, Italian, polish, Romanian, Bulgarian, Croatian, Thai, Czech Date and Set the date and time of the machine. time Factory Restore Factory To restore Factory settings settings settings Burn verification is used to verify that...

  • Page 50: General-Report Setting

    4.2.5 General-Report Setting Fig. 4.5 General-Report setting Report Setting Menu Item Option Defaults Illustration Storage location Local/SD/USB Local See section 6.3.1 for details. Storage method Auto/Manual Auto See section 6.3.2 for details. After turn on Waveform Report, Waveform Report On/off report will show ECG waveform Local/USB/SD Card Display storage capacity...

  • Page 51: General-Recorder Setting

    4.2.6 General-Recorder Setting Fig. 4.6 General-Recorder setting Recorder Setting Menu Item Options Default Illustration Value In paperless mode, click Built-in/ key, the system will acquire and Printer external/ Built-in save ECG waveforms. No matter paperless there is recording paper in the printer or not, it will not print the waveforms.
  • Page 52 Recorder Setting Menu Item Options Default Illustration Value If the waveform acquisition interface selects automatic gain, the gain amplitude of each lead is automatically assigned. Set the grid when export PDF reports. When it is set “On”, the waveform zone and footer zone will display Printing Grid Off/On grid background.

  • Page 53: General-Filter Setting

    Recorder Setting Menu Item Options Default Illustration Value Supported printer models: HP Dest_Jet P1102 Supported printer HP Dest_Jet P1108 models HP Dest_Jet P1008 HP LaserJet Pro M202n 34，34+1, Select the lead layout for the Built-in print layout 34 built-in printing 112 4.2.7 General-Filter Setting Fig.
  • Page 54 Select whether to turn on the AC filter to AC Filter filter out AC power interference. AC Filter OFF、 50、 60 （Hz） should always be turned on, unless it is necessary to turn it off. Set the frequency of EMG. Turning on the EMG filter can filter out EMG interference, but it may reduce the bandwidth and cause OFF 、...

  • Page 55: General-Heartbeat Warning

    4.2.8 General-Heartbeat Warning Fig. 4.8 Heartbeat Warning Interface Heartbeat Warning Menu Item Options Default Illustration Value Bradycardia 40-80 Set the bradycardia threshold. Tachycardia 81-140 Set the tachycardia threshold.

  • Page 56: General-Institution Information

    4.2.9 General-Institution Information Fig. 4.9 Institution Information Interface 4.2.10 General-About the Machine Fig. 4.10 About the Machine Interface...

  • Page 57: General-Transfer Setting

    4.2.11 General-Transfer Setting Fig. 4.11 General–Transfer Setting Transfer Setting Menu Item Options Default Illustration Value Transmission format of ECG file. ZQECG、 PDF、 PNG、 JPG、XML、HL7、 Report transmission DICOM-WAVEFORM ZQECG format 、DICOM-IMAGE、 DICOM-PDF、GDT When it is OFF, you can manually select the ECG report transmission on the [Report Management] interface.

  • Page 58: General-Ftp Setting

    (You should ensure that the network is properly connected and the FTP/SAMBA/HTTP/DICOM transmission mode is successfully enabled) Note: The corresponding button will only be highlighted if the FTP/SAMBA/HTTP/DICOM transfer mode is enabled, otherwise it will be grayed out. 4.2.12 General-FTP Setting Fig.
  • Page 59 can be logged into the FTP directory， server. username, 2) The FTP path that you set password, must be a subdirectory that FTP test already exists in the root directory of the FTP server. Note: For more information about the FTP server, please consult your network administrator.

  • Page 60: General-Http Setting

    4.2.13 General-HTTP Setting Fig. 4.13 General-HTTP Setting Transfer Setting Default Menu Item Options Illustration Value 1) The HTTP username and password that you set must be the username and password that can be logged into the HTTP Enable, server. IP address, 2) The HTTP path that you set port number, must be a subdirectory that...

  • Page 61: General-Remote Diagnosis Settings

    can be connected. 4) After the test is passed, check the “ ” button to enable it. (Note: It can only be used in the transmission of the [Report Management] interface after it is enabled.) 4.2.14 General-Remote diagnosis settings Fig. 4.14 General-Remote diagnosis settings Transfer setting Default Menu Item...
  • Page 62 Reload test that you set must be a subdirectory that already exists in the root directory of the remote diagnosis server. Note: For more information about the remote diagnosis server, please consult your network administrator. 3) After setting, you can click the “...

  • Page 63: General-Samba Setting

    4.2.15 General-SAMBA Setting Fig. 4.15 General-SAMBA Settings Transfer Setting Default Menu Item Options Illustration Value 1) The SAMBA username and password that you set must be the username and password that can be logged into the SAMBA Enable, server. IP address, 2) The SAMBA path that you set must be a subdirectory that directory，...

  • Page 64: General-Dicom Ihe

    can be connected. 4) After the test is passed, check the “ ” button to enable it. (Note: It can only be used in the transmission of the [Report Management] interface after it is enabled.) 4.2.16 General-DICOM（IHE） Fig. 4.16 General-DICOM IHE（Integrating the Healthcare Enterprise）- DICOM SETTING Menu Item Options...

  • Page 65: General-Mpps Ihe

    2) After the test is passed, check the “ ” button to enable it. (Note: It can only be used in the transmission [Report Management] interface after it is enabled.) 4.2.17 General-MPPS（IHE） Fig. 4.17 General-MPPS IHE（Integrating the Healthcare Enterprise）–MPPS Setting Default Menu Item Options...

  • Page 66: General-Stocom Ihe

    can be connected. 2) After the test is passed, check the “ ” button to enable it. 4.2.18 General-STOCOM（IHE） Fig. 4.18 General-STOCOM IHE（Integrating the Healthcare Enterprise）– STOCOM Setting Default Menu Item Options Illustration Value A server that confirms whether Enable, the ECG file has been uploaded.

  • Page 67: General-Worklist Ihe

    4.2.19 General-WORKLIST（IHE） Fig. 4.19 General-WORKLIST IHE（Integrating the Healthcare Enterprise）– WORKLIST Default Menu Item Options Illustration Value The ECG machine imports Enable, patient information data from this IP address, server. Worklist port number, 1) After setting, you can click the Server remote AE title, Configuratio local AE title,...

  • Page 68: E-Mail Setting

    4.2.20 E-Mail Setting 1、 Click the " " button to open the mail dialog. Note: For more information on configuring your network and interfaces, please consult your network administrator. Use wired Ethernet or WIFI transmission: 1）Manually add the sender, recipient's account number, server address and port number. 2）Select and confirm the appropriate sender, recipient.

  • Page 69: Lan Setting

    4.2.21 LAN Setting Click the " " button to open the Wired Settings dialog box to make the appropriate network settings (Note: For details on configuring the network, please consult your network administrator). After setting, click the “ ” button to save and take effect. You can automatically obtain the local IP address or manually enter the local IP address.

  • Page 70: Standard Ecg Setting

    Fig. 4.22 WIFI Interface 4.2.23 Standard ECG setting Click the " " button to enter the waveform acquisition interface. 4.2.23.1 Auto mode The automatic mode refers to the automatic acquisition and printing of wave forms by the electrocardiograph. It is a common mode of the electrocardiograph and is used for routine electrocardiogram examination.
  • Page 71 4. Enter the [12-lead] interface and select the lead system and the single-ratio lead label; 5. According to your own needs, set other parameters, and exit the [Standard ECG] interface after the setting is completed. 6. Click the “ ” button on the panel to print the automatic mode ECG report. CAUTION ...
  • Page 72 ”then select 【Standard ECG】to Enter the system application interface, Click the “ enter the [Standard ECG] setting interface, select the auto-simultaneous or manual recording mode; 4. Enter the [12-lead] interface and select the lead system and the single-ratio lead label; 5.
  • Page 73 ”then select 【Standard ECG】 to enter 1. Enter the system application interface, Click the “ the [Standard ECG] setting interface, select the real-time sampling mode, rhythm recording mode and rhythm analysis time; 2. Click the “ ” button and select rhythm lead label. Or enter the [12-lead] interface and select the single-ratio lead label;...

  • Page 74: Machine Setting

    Fig. 4.25 2 minute rhythm analysis report Interface 4.3 Machine Setting 4.3.1 First Time Setup When using the ECG for the first time or use it after repair or update, be sure to check and improve the following settings:  Fill in the relevant device information in [Institution Information] for the convenience of centralized management and maintenance.

  • Page 75: Setup Before Use

    4.3.2 Setup before Use When using the ECG for the first time or use it after repair or update, be sure to check and improve the following settings: In the [12-lead] interface, select the lead system and the single rhythm lead label; In the [General-Filter Setting] setting interface, set the filter frequency;...

  • Page 76: 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.

  • Page 77: Preparation

     The patient’s bed should be of suitable size to ensure 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 78: 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 79  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 80  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 81: Electrode Placement

    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 82: Limb Lead Placement

    Chest Green Chest Brown Chest Black Chest Purple 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 83: 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 84: Lead-Off Handling

    occurs, please change other types of electrodes.  Automatic measurement and interpretations are for doctors’ reference only, and cannot be directly used as the basis for clinical treatment. 5.6 Lead-off Handling When the electrode is loose, or the electrode is not properly connected to the lead wire, or the ECG cable is loose from the machine side, the lead name on the ECG display will be red.

  • Page 85: 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 86: Acquisition And Recording

    5）Whether instruments are in good condition.  Whether the ECG machine is damaged;  Whether ECG machine is inspected and maintained regularly:  Whether recording paper is sufficient. 6.2 Acquisition and Recording 6.2.1 Recording Setting After the checks are all right, power on the ECG machine, it enters into Waveform Acquisition interface, and then you can observe the waveform when they become stable.

  • Page 87: Ecg Report

     During the process of ECG signal acquisition, if waveforms become cluttered or unstable, please refer to chapter 8. 6.2.2 ECG Report The following are the reports printed in real-time auto-simultaneous mode: Fig. 6.1 ECG Report This ECG report contains the following information: The ECG waveform 3×4 layout, patient information, date of inspection, and measurement information.

  • Page 88: Ecg Waveform Description

    AC 50Hz (AC filter) 25mm/s (paper feed speed) 10mm/mV (gain) U30 (machine model) 1.0.25 (software version) Simultaneous (recording order) Inspection date Confirm report and sign WARNING  Auto-measurement precision of this machine conforms to the measurement standards of ECG machine (refer to the appendixes in this manual). Diagnostic structure is derived from measuring relevant parameters of each band.

  • Page 89: Report Storage

     QRS waveform group: it indicates the changes of potential and time during ventricular muscle depolarization. R wave is high and narrow without notch, and its segments are completely above or below the base point.  S-T segment: a horizontal line from the end point of QRS wave group (J point) to the start point of T wave is called S-T segment.

  • Page 90: Report Storage Mode

    USB (SD card): you can select USB (SD card) only when it is inserted. Reports are stored in .ECG format and can be viewed from this ECG Machine or dedicated software workstation. CAUTION  Local storage has limited capacity, thus USB (SD card) is recommended to store the reports.

  • Page 91: Chapter 7 Report Management

    Chapter 7 Report Management 7.1 Report Storage The report is default to be saved locally, but the local storage capacity is limited. It is recommended to use USB storage. The USB has large storage capacity, which is convenient for category management and storage. To avoid damage or loss of external storage devices, you can back up the reports in the storage device to a dedicated computer server.

  • Page 92: Searching Reports

    7.2.2 Searching Reports （3） （2） （1） Fig. 7.1 Searching Reports Searching Reports: (1) Click the up arrow next to the “ID” button, all reports will be sorted in ascending order by ID number; click the down arrow, all reports will be sorted by ID number in descending order; click the “ID”...

  • Page 93: Previewing Reports

    7.2.3 Previewing reports Choose report with“ , then you can check the all the reports. You can click “ ”or “ ” to preview the ECG wave in different time. The preview can only be shown in “6x2”. Fig. 7.2 ECG Preview CAUTION ...

  • Page 94: Deleting Reports

    7.2.5 Deleting Reports Select a report and press the key to delete it. (1) Check to select all the reports in [Report Management] (2) Check to select all the reports in the current page. Fig. 7.3 Delete Reports 7.3 Report Transmission Here are steps of transmitting reports: 1.

  • Page 95: Report Refresh

    means upload successful； means upload failed； means report reload successful; Fig. 7.4 Report Transmission 7.4 Report Refresh Report brush operation steps: 1) Successfully enable HTTP and remote diagnosis on the [General-Transfer Settings] screen. (For details, see Chapter 4 [General-Transfer Settings]); 2) Select the report that needs to be transmitted;...

  • Page 96: 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 97: Emg Interference

    sites with medical alcohol, apply conductive cream on the sites evenly, conductive cream on each electrode can't be cross-linked  Check whether the patient cable is too close to or intertwined with the power cord.  Check whether the metal part on the connection of lead wire and electrode is rusty or dirty, if it is, please clean it.

  • Page 98: Baseline Drift

    8.1.3 Baseline Drift Fig. 8.3 Baseline Drift Waveform Graph 1）Environment Cause:  Check whether the exam room is comfortable,  Check whether the indoor temperature is too low,  Check whether the bed is small and narrow. 2）Patient Cause:  Explain to the patient that ECG examination is very simple, which will not injury his or her body, or have sequelae;...

  • Page 99: Recorder Failure

    8.2 Recorder Failure Failure Possible Cause Solutions As the paper-feeding device has been Tighten the transmission unit, used for a long time, its transmission and apply some lubricating oil on ability is degraded by worn gear or loose the gear and both ends of paper connector.
  • Page 100 Failure Possible Cause Solutions Recording paper is out of specification. Replace it with our paper or with better paper same specification. prints unclear or with Paper shaft is dusty. Clean the paper shaft. breakpoints Print head is dusty. Clean the print head. Recording paper is installed backwards.

  • Page 101: Chapter 9 Maintenance

    Chapter 9 Maintenance 9.1 Cleaning and Disinfection Please keep the ECG machine and 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 102: Cleaning

    9.1.1 Cleaning Available detergents for cleaning the host are listed as follows: Ethanol (75%) It is recommended to clean the accessories with 75% ethanol. Cleaning the host: The ECG machine should be cleaned regularly. In those areas where the environment is seriously polluted or the sand blows heavily, it should be cleaned more frequently.
  • Page 103 naturally. Cleaning reusable electrodes:  Reusable electrodes must be cleaned after each use.  Use a soft cloth with some 75% ethanol to wipe the surface of the electrodes;  Wipe off the remaining detergent with a dry cloth if necessary; ...

  • Page 104: Disinfection

    9.1.2 Disinfection Disinfection may cause some damage to the ECG machine or its accessories. It’s recommended to perform disinfection only when it is necessary for the service plan in your hospital. Perform cleaning before disinfection. The recommended disinfectant for host and accessories is: 75% ethanol. Please use 75% alcohol cotton ball to wipe the surface of the suction cup when disinfecting the chest electrode.

  • Page 105: Regular Inspection

     The battery is installed and fully charged;  Chest bulbs are free of cracks, and limb clamps clamp well with adequate force. 9.2.2 Regular Inspection When used continuously for 6 to 12 months, or after maintenance or upgrading, the ECG machine should be tested completely by the qualified service personnel, ensuring that the ECG machine works normally.
  • Page 106 b. Measure the amplitude of the input signal and calculate the gain by output/input. The calculated gain must be within ± 5% of the nominal 10mm/mV. c. Deflect the output of 40mm, 30mm, 20mm, 10mm and 5mm, and repeat steps a and b. d.

  • Page 107: Battery Usage & Maintenance

    j. At least 10 cycles, verify that the output waveform amplitude remains within + 5% and -30% of the amplitude recorded at 10 Hz. k. Adjust the input amplitude to get a 5mm (peak-valley) output at 10Hz. Without changing the input amplitude, the signal frequency can be changed within the range of 350 Hz to 500 Hz.

  • Page 108: Battery Charging

    Battery icons on the screen indicate its status: 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, the message “Extremely Low Power” will pop out from the ECG machine. When the battery is nearly exhausted, the message [The battery is low and the machine is about to shut down] will pop out from the ECG machine.

  • Page 109: Battery Replacement

    9.3.4 Battery Replacement The battery installed in this ECG machine should be replaced by authorized service engineers. Please contact our service engineers if it is demanded for battery replacement. 9.3.5 Battery Usage Guide The battery’s life depends on its usage frequency and time. If the lithium-ion battery is properly maintained and stored, its life will last for about 2 years.

  • Page 110: Battery Maintenance

    CAUTION  Put the battery in a place out of children’s reach.  Only use the battery designated by the manufacturer. 9.3.6 Battery Maintenance Battery Performance Optimization The battery should be optimized for its initial use. A complete optimization period is continuously charging the battery to full capacity.

  • Page 111: Battery Recycling

    2. Connect ECG machine with AC power, and constantly charge the battery to full power, then the light goes out. 3. Disconnect AC power, supply ECG machine by battery until it is power off. The Battery’s supply time reflects its performance. After announced charging time, if its actual supply time is obviously lower than the time declared in specification, please contact the maintainer to replace the battery.

  • Page 112: Maintenance Of Electrodes And Lead Wires

    9.5 Maintenance of Electrodes and Lead Wires Conduction of each lead wire will directly affect ECG traces. If it conducts poorly (any one lead conducts poorly), it will cause virtual image of corresponding lead wire on ECG traces. Therefore the conduction must be inspected regularly, at least once a month. Slightly bending or entangling the lead wire will shorten its life.

  • Page 113: Chapter 10 After-Sale Service

    Chapter 10 After-sale Service 1. 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 114 If warranty label is damaged, the manufacturer has rights to exempt free service within stipulated time on warranty card. For chargeable services out of warranty period, it’s recommended to continue “Service Contract Rules”. For details, please consult the customer service center of the manufacturer.

  • Page 115: 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 116: 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 ± 950 Allowable amplitude variation during DC ± 3 bias Gain control, accuracy and stability: Gain selection At least...
  • Page 117 Display width Track visibility (recording rate) mm/s 1600 Track width (Only permanent record) Aligned offset of time axis Pre-printed paper grids div/cm Scale error ± 2 Time mark error ± 2 Accuracy of rebuilt input signal: Total error of signals of ± 5mV and 125mV/s ±...
  • Page 118 150Hz～350Hz, sine wave Rated input amplitude 0.5mV, frequency Range +5,-100 350Hz～500Hz, sine wave Rated input amplitude 1.5mV, ≤1Hz,200ms, Range +0,-10 triangular wave Lead weighting factor error ± 5 Lag behind 15mm baseline deflection Response to min signal(At 25mm/s time base and 10mm/mV gain Settings, a visible μV recording deflection of a minimum 10Hz sinusoidal signal is produced...
  • Page 119 Baseline control and stability: 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...

  • Page 120: Safety Index

    μs Rise time Frequency Pulses/min Front–end acquisition mode Adopting A/D sampling bits Valid sampling 32000 32000 μs Time deviation of ECG axis channel 0.24 Μs/LSB Amplitude quantification 0.08 Relative to 10Hz output. Relative to 200ms output. I.2 Safety Index Safety Class I, type CF, with protective circuit of defibrillation and pace-making Continuous operation time...

  • Page 121: Appearance Parameters

    I.4 Appearance Parameters Size (L × W × H) 264.4mm×183.9mm×87.6mm Weight about 1.3 kg I.5 Environmental Conditions Operation ﹢5℃～﹢40℃ Ambient Temperature Ambient Humidity 20%~85%(no condensation) Atmospheric Pressure 57kpa～106kpa Shipment and Storage －20℃～+55℃ Ambient Temperature Ambient Humidity 10%～95% Atmospheric Pressure 500hPa～1060hPa I.6 Adherence to Standards Medical devices-quality...
  • Page 122 Biological evaluation of medical devices-Part 10:Tests for ISO 10993-10:2010 irritation and skin sensitization Information supplied by the manufacturer of medical EN 1041:2008 devices Medical electrical equipment Part General EN 60601-1:2006+A1:2013 requirements for basic safety and essential performance Medical Electrical Equipment - Part 2-25: Particular IEC 60601-2-25: 2011 Requirements For The Basic Safety And Essential Performance of Electrocardiographs;...

  • Page 123: Appendix Ii Electromagnetic (Emc)

    Appendix II Electromagnetic (EMC) Electromagnetic compatibility (EMC) is defined as the ability of a product, device, or system to function properly in electromagnetic environment without posing unacceptable electromagnetic disturbances to anything in the environment. Anti-electromagnetic interference is the ability of a product, device, or system to function properly in the presence of electromagnetic interference (EMI).
  • Page 124 provided with the ECG.  This section includes information on electromagnetic radiation and immunity to electromagnetic systems. Ensure that the operation of the electrocardiograph meets the conditions specified in the reference information. Operating an electrocardiograph in an environment that does not meet these conditions may degrade the performance of the system.
  • Page 125 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the U30 machine, including cables specified by the manufacturer. Otherwise, degradation of the...
  • Page 126 Guidance and manufacturer´ s declaration – electromagnetic emission The U30 machine is intended for use in the electromagnetic environment specified below. The customer or the user of U30 machine should assure that it is used in such an environment. Emissions test...
  • Page 127 Guidance and manufacturer´ s declaration – electromagnetic immunity The U30 machine is intended for use in the electromagnetic environment specified below. The customer or the user of the U30 machine should assure that it is used in such an environment.
  • Page 128 IEC 61000-4-11 Single phase: at 0° power supply or a battery. 0 % UT; 250/300 cycle 0 % UT; 250/300 cycle Power frequency Power frequency magnetic fields (50/60 Hz) should be at levels characteristic of a magnetic field 30 A/m 30 A/m typical location in a typical commercial or hospital environment.
  • Page 129 Guidance and manufacturer´ s declaration – electromagnetic immunity The U30 machine is intended for use in the electromagnetic environment specified below. The customer or the user of the U30 machine should assure that it is used in such an environment.
  • Page 130 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 U30 machine is used exceeds the applicable RF compliance level above, the U30 machine should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the U30 machine.
  • Page 131 RF communications equipment and the U30 machine The U30 machine is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the U30 machine can help prevent electromagnetic interference by...

  • Page 132: 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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