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Biocare iE 3 User Manual

Digital electrocardiograph
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User Manual
Digital Electrocardiograph
Model: iE 3 & iE 6
P/N: 02111563-02
Version: V1.2
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Date: 2022-05

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  • Page 1 User Manual Digital Electrocardiograph Model: iE 3 & iE 6 P/N: 02111563-02 Version: V1.2 Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Date: 2022-05...
  • Page 3 All rights reserved © Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Information contained in this document is proprietary to Shenzhen Biocare Bio-Medical Equipment Co., Ltd. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form, in whole or in part, by any means electronic, mechanical or other, including photocopying and recording, for any purpose without written permission of Biocare.
  • Page 4 Shanghai International Holding Corp. GmbH(Europe) Eiffestraße 80 20537 Hamburg GERMANY Shenzhen Biocare Bio-Medical Equipment Co., Ltd. #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 86 -755 -33005899 Fax: 86-755-27960643 Website: http://www.biocare.com.cn CAUTION: In US, Federal law restricts this device to sale by or on the order of a physician.
  • Page 5 Explanation of key words WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in minor personal injury or equipment failure. EXPLANATION Indicates other important information besides warning or caution.
  • Page 6 Explanation of part symbols Symbol Explanation Symbol Explanation Alternating Current SD Card Slot Directing Current Working Patient Cable Socket Battery Charging DC Socket Equipotentiality Caution USB Port LAN Port Type CF Applied Part Type CF Applied Part including Defibrillation-Proof Direct current Serial number Date of manufacture Manufacturer...

  • Page 7: Table Of Contents

    Contents Contents Foreword ..................................1 Chapter 1 Introduction .............................. 9 1.1 Equipment Overview ............................10 1.2 Equipment Description ..........................11 1.2.1 Front View ............................11 1.2.2 Back View ............................11 1.2.3 Top View ............................12 1.2.4 Left View ............................13 1.2.5 Right View ............................13 1.2.6 Keyboard View ..........................14 1.3 Waveform Display ............................16 1.3.1 Same screen display ..........................
  • Page 8 Contents 2.9.1 Electrodes Attachment ........................32 2.9.2 Lead signals formation scheme ......................34 Chapter 3 Entering Patient Information ....................... 35 3.1 Enter Patient Information ..........................35 3.2 Introduction of Input Method ........................36 3.2.1 Standard Character Keyboard ......................36 3.2.2 Digital Keyboard ..........................37 3.2.3 How to input quickly .........................38 Chapter 4 ECG Recording ............................
  • Page 9 Contents 5.7 Factory Maintain ............................64 Chapter 6 Data Management ..........................65 6.1 Open an ECG File ............................67 6.2 Edit an ECG File ............................67 6.3 Delete ECG Files ............................67 6.4 Copy and Move ECG files ........................... 68 Chapter 7 APPT List ..............................71 Chapter 8 Maintenance ............................75 8.1 Main Unit ..............................
  • Page 10 F.3 Guidance and manufacturer’s declaration-electromagnetic immunity ............116 F.4 Recommended separation distance between portable and mobile RF communications equipment and the iE 3 & iE 6 Digital Electrocardiograph ......................117 F.5 Cables ................................. 118 -- IV -- User Manual for Electrocardiograph...

  • Page 11: Foreword

    Foreword Foreword CAUTION This ECG machine shall be used by qualified health professionals in the medical units, who need to analyze  the ECG waveforms and give diagnostic results. In sequence to use this ECG machine correctly, safely and effectively, please read through the user manual ...
  • Page 12 Foreword have to be grounded. Do not use other electrical stimulators at the same time. If needed, it should be a professional technician to carry out the operation. Chest and limb electrodes along with the device in the packing box could not meet the requirements of ...
  • Page 13 Foreword To more accurately record the ECG, the equipment shall be placed in a quiet and comfortable environment.  The circuit of applied parts works based on floating ground and meets the safety standards in IEC60601-1 CF  Type. It can be used in acquiring the body surface ECG signals, but cannot be applied to the heart directly. Turn off the ECG machine if an accident happens.
  • Page 14 Foreword cables or wires. Put the lead wires in good order before connecting them to the electrodes.  Make sure the electrodes are in good contact with skin. Please refer to Apply Electrodes for details.  Make sure the patient’s skin contacted with the electrodes has been well pretreated. ...
  • Page 15 Foreword After operation: CAUTION Please return to the main interface before turning off the ECG machine.  Remove the electrodes gently and do not pull the lead wires emphatically.  Clear up the ECG machine and all the accessories for trouble-free operation of next use. ...
  • Page 16 Foreword rub the eyes, wash with clean water immediately, and then go to see a doctor. The user needs to check the battery working status regularly. When the battery reaches the end of its lifetime,  when it smells, deforms, discolor, contorts, the users should stop using and dispose of it according to local regulations.
  • Page 17 Foreword Instrument classification Methods Class By Type of Protection Against Electric Shock Class I, internal power supply By Degree of Protection Against Electric Shock Type CF applied part Ordinary equipment (enclosed device without By Degree of Liquid Proof liquid proof) This equipment is unsuitable for use in an By Level of Protection Against Explosion environment with air, oxygen or nitrous oxide...
  • Page 18 Foreword --Blank Page-- -- 8 -- User Manual for Electrocardiograph...

  • Page 19: Chapter 1 Introduction

    Chapter 1 Introduction Chapter 1 Introduction Composition The ECG machine is mainly composed of the main unit and accessories. The accessories include patient cables, limb electrodes, chest electrodes, and power adapter etc. Scope of application This ECG machine is used to extract the electrocardio complex from the human body to conduct waveforms and rhythm analysis for clinical diagnosis and research.

  • Page 20: Equipment Overview

    Chapter 1 Introduction 1.1 Equipment Overview 3-channel ECG machine: 6-channel ECG machine: Number Name Description Power the ECG machine on or off. Display the waveforms, patients’ information and the device status. Display Screen 6-channel ECG machine is equipped with a touch screen and 3-channel ECG machine is not.

  • Page 21: Equipment Description

    Chapter 1 Introduction Number Name Description Press to open the paper magazine for loading or unloading the Paper Magazine Button recording paper. 3-channel： Start or stop printing the ECG waveforms and report. 6-channel： Press to input patient information. 1.2 Equipment Description 1.2.1 Front View 3-channel ECG machine: 6-channel ECG machine:...

  • Page 22: Top View

    Chapter 1 Introduction 1.2.3 Top View 3-channel ECG machine: 6-channel ECG machine: Number Name Description Handle Help the user carry the ECG machine easily. Power the system on or off. Press to input patient information. Press to set recording mode and recording format. Press Up/Down/Right/Left button to select a menu or an option.

  • Page 23: Left View

    Chapter 1 Introduction 1.2.4 Left View 3-channel ECG machine: 6-channel ECG machine: Number Name Description Paper Magazine Place recording paper here. Press to open the paper magazine for loading or unloading the Paper Magazine Button recording paper. 1.2.5 Right View 3-channel ECG machine: 6-channel ECG machine: Number...

  • Page 24: Keyboard View

    Chapter 1 Introduction 1.2.6 Keyboard View Number Name Description Press to feed paper. It would stop automatically when it detects the black Paper Feed mark at the bottom of the paper, so that the report can be easier to read. During printing, press to mark abnormal waveforms by labeling black dot at Marker the bottom of the paper.
  • Page 25 Chapter 1 Introduction Number Name Description Print Speed Switch among different printing speeds. In manual mode, print the calibration waveforms of 1mV to check the 1mV/Copy current sensitivity. 2. In auto mode, copy the previous report. Exit the current interface and go back to previous one. It is invalid when the Exit ECG machine is already in the main interface.

  • Page 26: Waveform Display

    Chapter 1 Introduction 1.3 Waveform Display EXPLANATION Screen display may slightly differ from the product you purchased, which will not affect your usage. Please operate according to the actual functions of the product. In mode of same screen display, 12 lead waveforms will be displayed on one interface. In mode of split-screen display, 12 lead waveforms will be displayed on several interfaces, which make it possible to show the waveforms details more clearly.
  • Page 27 Chapter 1 Introduction Waveforms in same screen, Waveforms in same screen, 6×2 lead format: 12×1 lead format: In the menu [ECG Setting], select [Lead Mode], you can switch among “Standard Leads”, “Cabrera” and “Nehb” (available for iE 6 only). Cabrera lead mode is available in this ECG machine, in which the leads order is aVL, I, -aVR, II, aVF, III, V1 to V6.
  • Page 28 Chapter 1 Introduction The Nehb lead consists of three chest leads with three electrodes placed on the chest. V1 (C1), V2 (C2), V3 (C3) electrodes are used to record Nehb lead, with V1 representing the right arm electrode, V2 representing the left arm electrode and V3 representing the left leg electrode.

  • Page 29: Split-Screen Display

    Chapter 1 Introduction 1.3.2 Split-screen display Waveforms in split-screen, 6×2 lead format: For both 3×4 and 6×2 lead format, please press to change displayed waveforms. The split-screen lead format of Nehb lead is 3×2. The display and operation of Nehb lead in split-screen are the same way as the above picture shows.
  • Page 30 Chapter 1 Introduction --Blank Page-- -- 20 -- User Manual for Electrocardiograph...

  • Page 31: Chapter 2 Preparing Recording

    Chapter 2 Preparing Recording Chapter 2 Preparing Recording 2.1 Location Selection Please refer to the caution of foreword. 2.2 Installing Recording Paper  EXPLANATION Installation of recording paper may slightly differ from the product you purchased, which will not affect your usage, please operate according to the actual functions of the product.

  • Page 32: Installing Z-Fold Paper

    Chapter 2 Preparing Recording Put the paper into the paper magazine, pay special attention to the direction of paper. Pull the paper out from the outlet of paper magazine and put back the upper cover, and then the recorder is ready.
  • Page 33 Chapter 2 Preparing Recording See the descriptions below for option 2 to install the z-fold recording paper into the device: Press the button upside. The cover of paper magazine opens. Push the recording paper fitly into the paper magazine, pay special attention to the position of black mark, and then pull the paper from the outlet of paper magazine.

  • Page 34: Power Connection

    Chapter 2 Preparing Recording 2.3 Power Connection Please plug AC power cable and equipotential cable into the equipment. Please connect AC power cable to power adaptor. Please connect 3-core end of power adaptor with power supply socket of the room, and connect equipotential cable with equipotential terminal in the room.

  • Page 35: Patient Cable Connection

    Chapter 2 Preparing Recording 2.4 Patient Cable Connection Lead Wires Acquisition Module As the picture show, connect the patient cable into the ECG machine. The patient cable is composed of acquisition module and lead wires. CAUTION Do not use any other patient cable except the supplied one. The patient cable socket is exclusively used for connecting the patient cable and do not use it for other purposes.

  • Page 36: Insert Or Remove The Sd Card

    Chapter 2 Preparing Recording 2.5 Insert or Remove the SD Card 2.5.1 Insert the SD Card Insert a SD card into the SD card slot as shown below. Push to insert a SD card into the SD card slot until a “clicking” sound. Card Slot 2.5.2 Remove the SD Card Push the SD card forward gently until a “clicking”...

  • Page 37: Power On/Off

    Chapter 2 Preparing Recording 2.6 Power On/Off Press and hold for three seconds to power on/off the ECG machine. The ECG machine enters standby mode if it is not in use for a certain duration. Set the time duration in [Standby Time] of [System Setting].

  • Page 38: Connecting To A Wired Network

    Chapter 2 Preparing Recording 2.7.1 Connecting to a Wired Network As shown in the following figure, the cable network system is composed of the ECG machine, the switchboard and the server. Set [Transfer Protocol] in [System Setting] according to the protocol of the server. Three options are: TCP, FTP and HL7.

  • Page 39: Connecting To A Wireless Network (Optional)

    Chapter 2 Preparing Recording 2.7.2 Connecting to a Wireless Network (Optional) As is shown in the following figure, the wireless network system is composed of the wireless AP on the ECG machine, the switchboard and the server. Set [Transfer Protocol] in [System Setting] to the protocol by the server. Three options are: TCP, FTP and HL7.

  • Page 40: Hl7 Configuration

    Chapter 2 Preparing Recording 2.8 HL7 Configuration EXPLANATION HL7 function should be rightly configured before use. The ECG machine should be able to communicate with the hospital’s HIS via HL7 interface protocol. Follow the two methods below to configure HL7 function. 1.
  • Page 41 Chapter 2 Preparing Recording Avoid the electrodes to be dragged by the lead wires.  Make sure the patient’s skin contacted with the electrodes has been well pretreated.  Clean the stain on the electrodes with medical alcohol whenever the electrodes are contaminated. ...

  • Page 42: Electrodes Attachment

    Chapter 2 Preparing Recording 2.9.1 Electrodes Attachment Limb Electrodes Placement Description Figure R Red RA White Right Arm L Yellow LA Black Left Arm N Black RL Green Right Leg F Green LL Red Left leg Standard 12-lead Attachment Description Figure Fourth inter-costal space at C1 Red...
  • Page 43 Chapter 2 Preparing Recording Nehb lead chest electrodes Description Figure Second costa at the right side of C1 Red V1 Red sternum Horizontal level angulus C2 Yellow V2 Yellow scapulae left posterior axillary line Prethoracic position opposite to the C3 Green V3 Green left angulus scapulae (near the apex of heart)

  • Page 44: Lead Signals Formation Scheme

    Chapter 2 Preparing Recording 2.9.2 Lead signals formation scheme Standard Limb leads Unipolar Limb leads Unipolar Chest leads -- 34 -- User Manual for Electrocardiograph...

  • Page 45: Chapter 3 Entering Patient Information

    Chapter 3 Entering Patient Information Chapter 3 Entering Patient Information 3.1 Enter Patient Information Entering patient information You can enter patient name, gender, ID Number etc. through the way mentioned above. Refer to Patient Information Setting to get more detail information. Get patient information: after inputting ID or sub-ID number, tap [Get patient information] to get the patient’s other information automatically (to successfully get the patient information, configure HL7 function first and make sure the ECG machine can communicate with the hospital’s HIS;...

  • Page 46: Introduction Of Input Method

    Chapter 3 Entering Patient Information EXPLANATION When Barcode Scanner is selected as the input mode, the soft keyboard will not pop. For the usage of the barcode scanner, please refer to the user manual of barcode scanner. CAUTION Improper patient information may cause misdiagnosis. Please check the information for each new patient. ...

  • Page 47: Digital Keyboard

    Chapter 3 Entering Patient Information Number Name Description Page Down Page Up Space Input null characters. Symbols Switch to symbols pad to input kinds of symbols. Caps Switch between uppercase and lowercase letters inputting. 3.2.2 Digital Keyboard Number Name Description Characters Area Input numbers or punctuations.

  • Page 48: How To Input Quickly

    Chapter 3 Entering Patient Information 3.2.3 How to input quickly Step Operation Button Select the item to be operated. Confirm and begin inputting. Software keyboard will appear but physical keyboard is recommended on non-touch screen. Switch to next item to be operated Exit from inputting.

  • Page 49: Chapter 4 Ecg Recording

    Chapter 4 ECG Recording Chapter 4 ECG Recording After the ECG machine has been powered on and all the leads are well connected, the following main interface will be displayed. The recording is ready. Number Name Description Display the location and state of the electrode in the human body. Selected for a larger view.

  • Page 50: Introduction Of Sensitivities, Filters, Paper Speed

    Chapter 4 ECG Recording Number Name Description Display recording mode and recording format. Record Setting Press to select other mode and format. Display text alarm information, including system failure about patient Alarm Area cable/Print head/Paper, lead off, AC interference, EMG interference, baseline wander, and data overflow, etc.

  • Page 51: Recording An Ecg

    Chapter 4 ECG Recording Filters setttings will not affect the algorithm analysis.  In order to reduce baseline wander, a baseline wander filter should be employed. To make sure the ST  segment is not distorted, the AAMI standards recommend that cut-off frequency of the baseline wander filter is lower than 0.67Hz.

  • Page 52: Main Operation Process To Record Ecg

    Chapter 4 ECG Recording 4.2.1 Main operation process to record ECG Set the recording mode and recording format Observe the waveforms displayed Abnormal (Lead off, data overflow Normal and etc) Refer to Troubleshooting to find [Print]/ solutions. Recording an ECG [Stop]/ Exit the recording When the waveforms recording is about to finish (under any recording mode except manual mode), the system...

  • Page 53: Arrhythmia Detection

    Chapter 4 ECG Recording 4.2.2 Arrhythmia Detection If [Arrhythmia Mode] in [ECG Setting] is set to enable, when arrhythmia is detected, rhythm waveforms can manually be printed as following: Recording Waveforms and report Arrhythmia is detected. Print the rhythm waveforms? [Yes] [No] Print rhythm waveforms...

  • Page 54: Introduction Of Recording Mode

    Chapter 4 ECG Recording This ECG machine can detect the lead connecting status continuously, and if any leadoff is detected, the  corresponding lead code will be displayed in the Alarm Area on the main interface, accompanied by sound alarm. When “Lead off” continues, please check carefully the connections from skin to the ECG machine (including electrodes, lead wires and acquisition module).

  • Page 55: Automatic Recording Mode

    Chapter 4 ECG Recording 4.3.1 Automatic Recording Mode In automatic mode, the ECG machine can automatically print the waveforms and reports according to [Report Format] in [Print Setting]. Recording waveforms Simple Report/Detail Report/ Disable “Report Format” Manual Report Median Beat Report Disable 代表心搏报告...
  • Page 56 Chapter 4 ECG Recording EXPLANATION Function of resting ECG analysis analyzes just the waveforms in the latest 10 seconds.  If patient age is not inputted, the ECG machine will assume patient as adult during analyzing.  WARNING In the case for some special populations (such as pregnant women, the user of vascular drugs, etc.) or mixed ...

  • Page 57: Manual Recording Mode

    Chapter 4 ECG Recording 4.3.2 Manual Recording Mode In manual recording mode, press to begin or stop printing. You can switch by pressing from one lead group to another at any time to control the printing time of every lead group.

  • Page 58: Advanced Mode

    Chapter 4 ECG Recording 4.4 Advanced Mode 4.4.1 Rhythm Mode Operate as follows to enter rhythm mode: Main interface [Rhythm] Enter rhythm interface Enter rhythm report interface When entering rhythm interface, the ECG machine begins collecting waveforms of the Rhythm Lead. You can select single-rhythm and three-rhythm pattern.
  • Page 59 Chapter 4 ECG Recording EXPLANATION During the waveform collecting process, when the collecting time has been over 8 seconds, you can press  [RR Interval] to enter report interface manually. In Nehb lead mode, rhythm mode is disabled.  HRV waveform acquisition: in rhythm interface, tap [Rhythm Mode] and the system will begin HRV waveform acquisition as shown below (the fixed acquisition time is 300 seconds which is displayed in the interface).

  • Page 60: Analysis Report Mode

    Chapter 4 ECG Recording 4.4.2 Analysis Report Mode Operate as follows to enter analysis report mode: Main interface [Report] Enter analysis report In Standard 12 Leads and Cabrera lead modes, Report (1) includes simple measurement data, minnesota code, median beat waveforms, analysis result and rhythm waveforms; in Nehb mode, Report (1) includes simple measurement data and lead waveforms.
  • Page 61 Chapter 4 ECG Recording Analysis report interface is as following: Simple measurement Minnesota code Beat waveforms data Analysis result: press here, you can change the analysis result. Rhythm waveforms Simple measurement data Lead waveforms User Manual for Electrocardiograph -- 51 --...
  • Page 62 Chapter 4 ECG Recording In Standard 12 Leads and Cabrera lead modes, you can select to [Upload], [Page], [Save], and [Print] the report in the above three interfaces. In analysis report (1), [Analysis Result] can be manually edited by the user. Please refer to List of Interpretation codes and Corresponding Description for the details of analysis result.

  • Page 63: Freeze Mode

    Chapter 4 ECG Recording EXPLANATION Nehb lead report cannot be uploaded.  4.4.3 Freeze Mode Operate as follows to enter freeze mode: Main interface [Freeze] Enter freeze interface You can freeze waveforms for 300s. In the freezing interface, waveforms of different pages can be browsed through Pageup/Pagedown and step can be adjusted by the user.
  • Page 64 Chapter 4 ECG Recording --Blank Page-- -- 54 -- User Manual for Electrocardiograph...

  • Page 65: Chapter 5 Setting System Parameters

    Chapter 5 Setting System Parameters Chapter 5 Setting System Parameters In the main interface, press [Menu], or press , to enter main menu. EXPLANATION In the process of parameter settings, press and return to the previous page, step by step, until ...

  • Page 66: Ecg Setting

    Chapter 5 Setting System Parameters 5.1 ECG Setting Enter [ECG Setting] to set parameters about Electrocardiograph. See following table: Name Value Default Description Standard Leads, Cabrera, Lead Mode Nehb (available for iE 6 Standard Leads Select one option for lead mode. only) 25 Hz, 35 Hz, 75 Hz, 100 Low-pass Filter...
  • Page 67 Chapter 5 Setting System Parameters Name Value Default Description Set the pre-acquisition mode. Pre-acquisition Disable, Enable Disable If enabled, it can print out pervious waveforms. Set whether to automatically save the Auto-save Disable, Enable Enable report. ECG, XML, JPEG, DICOM, Data Format Select one option for data format.

  • Page 68: Print Setting

    Chapter 5 Setting System Parameters 5.2 Print Setting Enter [Printer Setting] to set parameters about printer. See following table: Name Value Default Description Gray Level 1～8 Select one option for gray level. Select one option for waveforms Baseline Width 1～4 thickness.

  • Page 69: Display Setting

    Chapter 5 Setting System Parameters Name Value Default Description the equipment your purchased. Refer to the appendix Technical Specification and Record Format 3×4 Select one option for report mode. the equipment your purchased. Print Data Type Real Time , Synchronous Real Time Select one option for print data type.

  • Page 70: Patient Information Setting

    IEC Standard Select a lead standard to display. Standard Set the brightness for display (available Brightness 1~10 for iE 3 only). Set the contrast for display (available for Contrast 1~10 iE 3 only). 5.4 Patient Information Setting Enter [Patient Information Setting] to set patient information. See following content: Sub-ID No., Gender, Age, Date of birth, Height, Weight, BP, Race, Pacemaker, Medication, Accession No.,...

  • Page 71: System Setting

    Chapter 5 Setting System Parameters 5.5 System Setting Enter [System Setting] to set system parameters. See following table: Name Value Default Description Select a waveform type displayed in the main Normal ECG, Arrhythmia Demo Mode Disable interface as a demo. Arrhythmia ECG is ECG, Disable selected for demonstrating auto trigger mode.
  • Page 72 Chapter 6 Data Management Name Value Default Description Set the silent mode Disable or Enable. Silent Mode Disable, Enable Disable If silent mode is enabled, all sound, including alarm tone and key tone will be off. QRS Tone Select one option for three sound tones. If all Alarm Tone 0～10 three options are zero, a silence icon will be...
  • Page 73 Chapter 5 Setting System Parameters Name Value Default Description Touch Make calibration to the touch screen. Calibration Factory Restore to factory default. Default Hospital Input the name of hospital. Device No. Input the number of this ECG machine. CAUTION Demo mode is designed for representation only. Do not use this mode in clinical analysis, for demo ...

  • Page 74: Remote Report

    Chapter 5 Setting System Parameters 5.6 Remote Report Press [Setting] to input the “Start Time” and “End Time”, and then press [Load], the ECG files of that duration can be downloaded into the ECG machine and displayed on the interface below: File Attributes Area Select All Shortcut Button...

  • Page 75: Chapter 6 Data Management

    Chapter 6 Data Management Chapter 6 Data Management Press [Data Management] in the main menu interface to enter the data management interface. Select one source of storage medium from Local (ECG machine itself), U disk and SD card, the ECG files will be uploaded.
  • Page 76 Chapter 6 Data Management Name Description Select-All Shortcut Check to select all the ECG files in the current page. Button Select any file attribute, and sort files by pressing File Attributes Area ECG Files Display Display basic patient information of all the ECG files. Area Open Open one patient’s ECG file.

  • Page 77: Open An Ecg File

    Chapter 6 Data Management 6.1 Open an ECG File Check an ECG file, and then press [Open] or press the shortcut left or right direction key of , the file will be opened. EXPLANATION When you select more than one file to open, the default file is the first selected file. 6.2 Edit an ECG File After opening the ECG file, you can edit the patient information and analysis result, can also upload, save and print the file.

  • Page 78: Copy And Move Ecg Files

    Chapter 6 Data Management 6.4 Copy and Move ECG files Select one or more ECG files, operate as following to transfer the ECG files. [Data Management] Select one or several files [Operate] Select [Copy] or [Move] Choose destination medium ECG files are copied or moved to the selected medium -- 68 -- User Manual for Electrocardiograph...
  • Page 79 Chapter 6 Data Management EXPLANATION Files can be copied or moved between the local ECG machine and external storage medium. ECG files on  the local machine will be deleted if the user moves them. After selecting files and a path, the files will be copied to the selected path. When copying files to SD card ...
  • Page 80 Chapter 6 Data Management --Blank Page-- -- 70 -- User Manual for Electrocardiograph...

  • Page 81: Chapter 7 Appt List

    Chapter 7 APPT List Chapter 7 APPT List You can use APPT list after HL7 is rightly configured (refer to HL7 Configuration). If the HL7 transit server has received the checking request information from the hospital information system, tap [Menu] > [APPT List] to enter the APPT List interface which displays the patient information list as shown below.
  • Page 82 Chapter 7 APPT List Start Test: check one patient information and then tap [Start Test]. This patient information will be set as system’s current patient information and the ECG machine will return to the main interface automatically. You can start ECG acquisition of this patient and upload the report needless of inputting patient information. Tap [Exit] to return to APPT list interface.
  • Page 83 Chapter 7 APPT List Refresh: tap [Refresh] to obtain the latest patient information. Search: when they are too many patient information in the list, you can search patient information by ID, subID or name. Operate: it is used to mark the checking request status. Those marked with “Checked” or “Suspend” will not be displayed in the list.
  • Page 84 Chapter 7 APPT List -- 74 -- User Manual for Electrocardiograph...

  • Page 85: Chapter 8 Maintenance

    Chapter 8 Maintenance Chapter 8 Maintenance 8.1 Main Unit CAUTION Gently disconnect the acquisition module and power cable without forcibly pulling the lead wires.  Clean the ECG machine as well as the accessories periodically and cover it from dust. ...

  • Page 86: Recording Paper

    Chapter 8 Maintenance CAUTION While cleaning and disinfection, do not splash liquid into the ECG machine and the accessories.  Disinfections may cause damage to the ECG machine or accessories to a certain degree. It is suggested that  only when necessary, disinfect the ECG machine and accessories. Neutral cleanser or disinfectant is recommended.

  • Page 87: Battery

    Chapter 8 Maintenance 8.5 Battery The ECG machine is equipped with a built-in rechargeable battery to assure continuous operation when AC power is unavailable. Charging, capacity indication and replacement of the battery are described below: Charging  The ECG machine is designed with a charger and protector for the battery. Please turn off the machine first before charging the battery.

  • Page 88: Silicon Rubber Shaft For Printing

    Chapter 8 Maintenance EXPLANATION Refer to Foreword for other warning information of battery. 8.6 Silicon Rubber Shaft for Printing The silicon rubber shaft shall be kept clean, smooth and free from dirt. Otherwise, the ECG machine may print out unsatisfied ECG trace. To clean dirt from the shaft, wipe the shaft with soft cotton moistened with medical alcohol and at the same time rotate shaft until it is clear enough.

  • Page 89: Chapter 9 Troubleshooting

    Chapter 9 Troubleshooting Chapter 9 Troubleshooting 9.1 Lead Fault 1. Data saturation or overflow happens. Solution: Ensure that all leads are in good contact, and wait for half a minute or the waveforms on the screen are stable, and then start printing. 2.

  • Page 90: Printer Failure

    Chapter 9 Troubleshooting 9.2 Printer Failure Unclear printing. Solution: Whenever a printer fault occurs, such as poor or incorrect ECG recording, you may try to clean the thermal printer head with soft cotton dipped with medical alcohol. If the quality of the thermal paper is poor or the paper is not used for a long time, which may result in reduced performance of thermal layers.

  • Page 91: Indication Of Lead Off

    Chapter 9 Troubleshooting 9.4 Indication of Lead Off This ECG machine can detect the lead connecting status continuously. When the leads are not well connected to the main unit, it means that the signals cannot be transferred correctly, thus there is “lead off:*” indication, accompanied by voice alarm.

  • Page 92: Emg Interference

    Chapter 9 Troubleshooting 9.6 EMG Interference Irregular trembling of ECG waveforms due to EMG interference is shown as below. Causes of baseline wander are varied, please do following checks one by one: Make sure that the exam room is comfortable for examination. Soothe the patient from irritation or excitement.

  • Page 93: The Ecg Machine Cannot Be Turned On

    Chapter 9 Troubleshooting Keep the patient silent and motionless, and keep the patient from hyperventilation. Used electrodes shall not be utilized with new ones in patient examination. CAUTION If the problem still can’t be cleared, please turn up the baseline wander filter, keep in mind that the recorded ECG waveforms, particularly T wave and ST segment, will be somewhat distorted.

  • Page 94: Paper Feeding Failure

    Chapter 9 Troubleshooting 9.9 Paper Feeding Failure Press , but paper is not fed. Solution: Check if the keyboard has been damaged and replace damaged keyboard. Press , the paper is not fed, and there is abnormal sound from recorder. Solution: First check if the recording paper is installed properly, and if the gear on the cover of paper magazine is in good condition.

  • Page 95: Wrong Analysis Result

    Chapter 9 Troubleshooting 9.11 Wrong Analysis Result For the case for some special populations (such as pregnant women, the user of vascular drugs, etc.) or mixed by obvious interference in the recording process, the analysis result of the resting ECG analysis of this ECG machine may be inaccurate.
  • Page 96 Chapter 9 Troubleshooting --Blank Page-- -- 86 -- User Manual for Electrocardiograph...

  • Page 97: Appendix A Package And Accessories

    Appendix A Package and Accessories Appendix A Package and Accessories A.1 Packing List Type Ite m ECG machine 1 unit acquisition module 1 set limb electrode 1 set chest electrode 1 set power cable 1 piece power adaptor 1 piece Standard equipotential cable 1 piece...

  • Page 98: Dimensions And Weight

    Appendix A Package and Accessories A.2 Dimensions and Weight 324 mm×264 mm×95 mm (3-channel) Length × Width × Height 257 mm×291 mm×106 mm (6-channel) About 2.3 kg (3-channel) Net Weight About 2.5 kg (6-channel) CAUTION Please open the package according to instructions on the packing box. ...

  • Page 99: Appendix B Technical Specification

    Appendix B Technical Specification Appendix B Technical Specification B.1 Specifications B.1.1 Main unit Lead Standard 12-lead, Nehb (available for 6-channel machine only) Acquisition Mode Simultaneous 12-lead Acquisition 1×12, 1×12+1R, 3×4, 3×4+1R (3-channel) 3×4,3×4+1R,3×4+3R,6×2,6×2+1R (6-channel, Standard leads) Recording Format 6×1, 3×2 (6-channel, Nehb lead) Auto, Manual, Upload (3-channel) Record Mode Auto, Manual, Upload, Cycle, Trigger (6-channel)

  • Page 100: Recorder Specification

    Appendix B Technical Specification Sensitivity Threshold 20 μV Auto, 1.25 mm/mV, 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 40 mm/mV, Sensitivity 10/5 mm/mV, 20/10 mm/mV Standard Sensitivity 10 mm/mV ± 2% Calibration Voltage 1 mV±5 % Using the method described in 4.2.7.1 of AAMI EC11 to test the overall system error, which is within ±5%;...

  • Page 101: Wireless Network (Optional)

    Appendix B Technical Specification B.1.3 Wireless Network (Optional) Applicable Standard IEEE 802.11b/g/n (2.4G) IEEE 802.11a/n (5G) Frequency Range 2.412 GHz～2.472 GHz 4.9 GHz～5.975 GHz Band Width 20~40MHz 20~40MHz Radiated Power +18dBm +13.5dBm Signal Path 1-13 (China) Type Frequency Characteristics CCK/DSSS/OFDM/MCS7/MCS0 Modulation B.1.4 Other Specification Acquisition Module...

  • Page 102: Environment Requirements

    Appendix B Technical Specification B.2 Environment Requirements Transportation Environment Temperature -20 ℃～+55 ℃ Relative Humidity ≤95 % (No condensation) Air Pressure 70 kPa～106 kPa Transportation: avoid direct sunshine and rain. Storage Environment Temperature -20 ℃～+55 ℃ Relative Humidity ≤95 % (No condensation) Air Pressure 70 kPa～106 kPa The packed ECG should be stored in the well-ventilated room without corrosive gases.

  • Page 103: Appendix C Working Principle And Block Diagram

    Appendix C Working principle and block diagram Appendix C Working principle and block diagram C.1 Power supply subsystem (1) Working principle: By ways of AC to DC high frequency power switching technique, the switching power supply output 20V DC voltage. This voltage works to charge the built-in rechargeable battery at constant voltage and limited current, and at the same time, applies to the power switchover circuitry together with the battery output.

  • Page 104: Acquisition Module

    Appendix C Working principle and block diagram (2) Block diagram (Schematics and parts of list of this unit are only provided for qualified service center under supervision of the manufacturer.) C.2 Acquisition module (1) Working principle Acquisition Module is connected to the main unit by ECG port which provides power supply and communication interface.
  • Page 105 Appendix C Working principle and block diagram (2) Block diagram: (3) Leads of acquisition module: Lead nomenclature Definition Name of lead Ⅰ Ⅰ=L-R Biopolar limb leads Ⅱ Ⅱ=F-R (Einthoven) Ⅲ Ⅲ=F-L aVR=R-(L+F)/2 Augmented leads aVL=L-(R+F)/2 (Goldberger) aVF=F-(L+R)/2 V1=C1-(L+R+F)/3 V2=C2-(L+R+F)/3 V3=C3-(L+R+F)/3 Unpolar chest leads V4=C4-(L+R+F)/3 (Wilson)

  • Page 106: Control System

    Appendix C Working principle and block diagram C.3 Control system (1) Working principle The control system consists of controllers for printer, keyboard, LCD screen and a CPU subsystem. Through high-speed photo-couplers, CPU subsystem receives lead signal from the Data acquisition subsystem and applies them to the printer controller after digital filtration, gain adjustment and printer driving, and then complete the ECG waveforms printing.

  • Page 107: Appendix D List Of Interpretation Codes And Corresponding Description

    Appendix D List of Interpretation codes and Corresponding Description Appendix D List of Interpretation codes and Corresponding Description 8 Arrhythmia 8002 Marked rhythm irregularity 8110 Sinus rhythm 8102 Sinus arrhythmia 8108 Marked sinus arrhythmia 8120 Sinus tachycardia 8130 Sinus bradycardia 8200 Atrial rhythm 8210...
  • Page 108 Appendix D List of Interpretation codes and Corresponding Description 8475 with frequent supraventricular premature complexes in a pattern of bigeminy 8500 Ventricular rhythm 8520 Ventricular tachycardia 8570 with occasional ventricular premature complexes 8574 with frequent ventricular premature complexes 8575 with frequent ventricular premature complexes in a pattern of bigeminy 8901 Undetermined regular rhythm 8902...
  • Page 109 Appendix D List of Interpretation codes and Corresponding Description Right bundle branch block, plus RVH Right bundle branch block Incomplete right bundle branch block RSR' in lead V1/V2, consistent with right ventricular conduction delay Left anterior fascicular block Left posterior fascicular block Nonspecific intraventricular conduction block Nonspecific intraventricular conduction delay 1 Myocardial...
  • Page 110 Appendix D List of Interpretation codes and Corresponding Description 1314 Cannot rule out anterolateral myocardial infarction, age undetermined 1321 Possible anterolateral myocardial infarction, possible acute 1322 Possible anterolateral myocardial infarction, probably recent 1323 Possible anterolateral myocardial infarction, probably old 1324 Possible anterolateral myocardial infarction, age undetermined 1331 Anterolateral myocardial infarction, possible acute...
  • Page 111 Appendix D List of Interpretation codes and Corresponding Description 1614 Cannot rule out inferior myocardial infarction, age undetermined 1621 Possible inferior myocardial infarction, possible acute 1622 Possible inferior myocardial infarction, probably recent 1623 Possible inferior myocardial infarction, probably old 1624 Possible inferior myocardial infarction, age undetermined 1631 Inferior myocardial infarction, possible acute...
  • Page 112 Appendix D List of Interpretation codes and Corresponding Description Minimal voltage criteria for LVH Possible left ventricular hypertrophy left ventricular hypertrophy Left ventricular high voltage(moderate) Left ventricular hypertrophy, probably repolarization abnormality Possible left atrial enlargement Left atrial enlargement Possible right atrial enlargement Right atrial enlargement 3120 Biventricular hypertrophy...
  • Page 113 Appendix D List of Interpretation codes and Corresponding Description 2114 Anteroseptal injury or acute infarct 2115 Possible anterolateral subepicardial injury 2116 Anteroseptal subepicardial injury 2117 Possible septal subepicardial injury 2118 Septal subepicardial injury 2119 Possible lateral subepicardial injury 21110 Lateral subepicardial injury 21111 Possible inferio injury or acute infarct 21112...
  • Page 114 Appendix D List of Interpretation codes and Corresponding Description 2155 Nonspecific T wave abnormality, probably digitalis effect 2161 Nonspecific ST elevation Others Low voltage Low voltage in limb leads Low voltage in chest leads Long QT interval Short QT interval Dextrocardia ? LIMB LEADS REVERSED Abnormal QRS-T angle...

  • Page 115: Appendix E Measurement, Diagnosis, Analysis And Assessment Of Ecg Machine

    Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine E.1 Methods to determine the amplitude of P, QRS, ST and T wave (1) P wave amplitude P On is the starting position of P wave, P Off is the ending position of P wave, and dashed line is the reference baseline To measure P wave amplitude: the line from the starting point to the ending point of P wave is the reference baseline, as shown in Figure E-1.

  • Page 116: Processing Method Of Isoelectric Segment In Qrs Complex

    Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine The measurement of QRS complex, ST segment and T wave amplitude uses the horizontal line of QRS complex beginning part as the reference baseline QRS Onset is the starting position of QRS wave E.2 Processing method of isoelectric segment in QRS complex Isoelectric segment between dash lines are in QRS complex As shown above, the isoelectric segment beginning from the starting position of QRS complex is processed as a...

  • Page 117: Low Incidence Heart Disease Not Included In Testing And Diagnosis Database

    Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine E.3 Low incidence heart disease not included in testing and diagnosis database Test with CSE database, but this database doesn’t have sufficient number of acute myocardial infarction and myocardial ischemia ECG. E.4 ECG diagnosis categories and the number of ECG test of each category The accuracy of disease diagnosis and non-ECG means used to verify the effectiveness of heart disease diagnosis, as well as the patients statistics data (e.g.

  • Page 118: The Smallest Waveform Identified By The Device And The Stability Of Measurement When Noise Exists

    Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine E.5 The smallest waveform identified by the device and the stability of measurement when noise exists   If the area of certain waveform is greater than or equal to 160 , it is considered as meaningful wave, otherwise it is meaningless.

  • Page 119: Ecg Rhythm Diagnosis Categories And Ecg Test Number Of Each Category

    Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine E.7 ECG rhythm diagnosis categories and ECG test number of each category Accuracy of rhythm diagnosis and the patient statistics data (e.g. age, gender, race) of each group Table E-3 gives the rhythm categories, ECG test number of each category and accuracy of disease diagnosis. The test database sample properties are as follows: Total number of sample: 4500 (male: 2847, female: 1653) Race: Yellow...

  • Page 120: Distortion Test

    Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine -the waveform amplitude of sensitivity; -input signal amplitude if the inspected ECG machine Make ECG machine set in lead I, the sensitivity is set as 20 mm/mV. EGC-1C transmits the Uin as 0.5 mV, frequency 10 Hz sine wave signal to the ECG machine.
  • Page 121 Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine on the ECG machine records, the difference between recorded amplitude and the original amplitude (the original amplitude of the waveform with 2 mV amplitude should be 20 mm under 10 mm/mV gain) does not exceed 20 %, and the location of the pacemaker pulse can be clearly identified in the ECG machine records.
  • Page 122 Appendix E Measurement, Diagnosis, Analysis and Assessment of ECG Machine --Blank Page-- -- 112 -- User Manual for Electrocardiograph...

  • Page 123: Appendix F Emc-Guidance And Manufacturer's Declaration

    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 iE 3 & iE 6 Digital Electrocardiograph, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

  • Page 124: Guidance And Manufacturer's Declaration-Electromagnetic Emissions

    The iE 3 & iE 6 Digital Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the iE 3 & iE 6 Digital Electrocardiograph should assure that it is used in such an environment.
  • Page 125 0.5 cycle for 0.5 cycle hospital environment. If the user 0% U 0% U of the iE 3 & iE 6 Digital (100% dip in U (100% dip in U Voltage dips and Electrocardiograph requires...

  • Page 126: Guidance And Manufacturer's Declaration-Electromagnetic Immunity

    The iE 3 & iE 6 Digital Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the iE 3 & iE 6 Digital Electrocardiograph should assure that it is used in such an environment.

  • Page 127: Recommended Separation Distance Between Portable And Mobile Rf Communications Equipment And The

    If the measured field strength in the location in which the iE 3 & iE 6 Digital Electrocardiograph is used exceeds the applicable RF compliance level above, the iE 3 & iE 6 Digital Electrocardiograph should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the iE 3 &...

  • Page 128: Cables

    Appendix F EMC-Guidance and manufacturer’s declaration For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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 129 Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Address: #16-1, Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan New District, 518122 Shenzhen, PEOPLE'S REPUBLIC OF CHINA Tel: 86 -755 -33005899 Fax: 86-755-27960643 Website: http://www.biocare.com.cn...

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