EDAN SE-12 Series User Manual
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EDAN SE-12 Series User Manual

Electrocardiograph
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  • Page 2 This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User's operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
  • Page 3 Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Terms Used in this Manual This guide is designed to give key concepts on safety precautions.

  • Page 4: Table Of Contents

    Table of Contents Chapter 1 Safety Guidance ......................1 1.1 Indications for Use/Intended Use ................... 1 1.2 Warnings and Cautions ......................1 1.2.1 Safety Warnings ....................... 2 1.2.2 Li-ion Battery Care Warnings ..................5 1.2.3 General Cautions ......................6 1.2.4 Preparation and Operation Warnings (for SE-12 Express Exercise ECG) ....... 7 1.2.5 Contraindications (for SE-12 Express Exercise ECG).............
  • Page 5 Chapter 5 Entering Patient Information ................... 40 5.1 Entering Patient Information Manually ................40 5.2 Entering Patient Information by Using a Reader (Configurable) ......... 40 5.3 Entering Patient Information by Acquiring Orders .............. 40 Chapter 6 Printing ECG Reports ....................41 Chapter 7 Transmitting ECG Data.....................
  • Page 6 Chapter 14 Cleaning, Care and Maintenance ................82 14.1 General Points........................82 14.2 Cleaning ..........................82 14.3 Disinfection ........................83 14.4 Care and Maintenance ......................84 14.4.1 Recharge and Replacement of Battery ................. 84 14.4.2 Recorder Paper ......................85 14.4.3 Visual inspection ......................86 14.4.4 Maintenance of the Main Unit and the Patient Cable ..........

  • Page 7: Chapter 1 Safety Guidance

    1.1 Indications for Use/Intended Use The intended use of SE-12 series electrocardiograph is to acquire ECG signals from adult and pediatric patients (beginning at birth through 21 years of age) through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.

  • Page 8: Safety Warnings

    SE-12 Series Electrocardiograph User Manual Safety Guidance Safety Warnings 1.2.1 WARNING 1. The electrocardiograph is intended to be used by qualified physicians or personnel professionally trained. They should be familiar with the contents of this user manual before operation. 2. Only qualified service engineers can install this equipment, and only service engineers authorized by the manufacturer can open the shell.
  • Page 9 SE-12 Series Electrocardiograph User Manual Safety Guidance WARNING 13. Disposable electrodes must be used during defibrillation. 14. Electrodes of dissimilar metals should not be used; otherwise it may cause a high polarization voltage. 15. The disposable electrodes can only be used for one time.
  • Page 10 SE-12 Series Electrocardiograph User Manual Safety Guidance WARNING 26. Do not exceed the maximum permitted load when using the multiple portable socket-outlet(s) to supply the system. 27. Multiple portable socket-outlets shall not be placed on the floor. 28. Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it's specified as part of the system by manufacturer.

  • Page 11: Li-Ion Battery Care Warnings

    MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. 43. The electrocardiograph should be placed on a flat surface or EDAN’s trolley. Avoid it dropping down to cause strong shock. Li-ion Battery Care Warnings 1.2.2...

  • Page 12: General Cautions

    SE-12 Series Electrocardiograph User Manual Safety Guidance be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It is necessary to read the user manual carefully and pay more attention to warning messages. 2. Only qualified service engineers authorized by the manufacturer can open the battery compartment and replace the battery, and batteries of the same model and specification as manufacturer configuration should be used.
  • Page 13 Protecting personal health information is a major component of security strategy. To protect the personal information and ensure the proper device performance, the user should take necessary precautions in accordance with local laws and regulations and institution’s policies. EDAN recommends health care organizations or medical institutions to implement a comprehensive and multifaceted strategy to protect the information and systems from internal and external security threats.

  • Page 14: Preparation And Operation Warnings (For Se-12 Express Exercise Ecg)

    EDAN. Users should operate all EDAN deployed and supported electrocardiographs within EDAN authorized specifications, including EDAN approved software, software configuration, security configuration, etc. Protect all the passwords to prevent unauthorized changes. Only the manufacturer’s service personnel are allowed to modify the System Maintenance Setup.

  • Page 15: Contraindications (For Se-12 Express Exercise Ecg)

    SE-12 Series Electrocardiograph User Manual Safety Guidance assessment or compliance that may raise. 3. Make sure that there is necessary valid first-aid equipment such as defibrillators, blood-pressure meters etc, and necessary valid medication in the exercise test room. 4. Turn off the system power and disconnect the power cord from the wall outlet after using the system.

  • Page 16: List Of Symbols

    SE-12 Series Electrocardiograph User Manual Safety Guidance 5. Heart failure with clinic episode uncontrolled 6. Acute pulmonary embolus or pulmonary infarction 7. Acute myocarditis or pericarditis 8. The patient opposes the test. Relative Contraindications: 1. Left main coronary stenosis 2. Moderate stenotic valvular heart disease 3.
  • Page 17 SE-12 Series Electrocardiograph User Manual Safety Guidance Patient Cable Socket USB socket SD Card slot Computer network Alternating Current Battery check Battery recharging indicator Power On/Off key General symbol for recovery/recyclable Part Number SERIAL NUMBER Date of manufacture MANUFACTURER AUTHORISED...
  • Page 18 SE-12 Series Electrocardiograph User Manual Safety Guidance Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Disposal method Refer to instruction manual/booklet (Background: Blue; Symbol: White) General warning sign (Background: Yellow; Symbol & Outline: Black)
  • Page 19 SE-12 Series Electrocardiograph User Manual Safety Guidance Handle with care Do not step on Front NOTE: 1. 26*/27*: Apply to devices with wireless functions. 2. The user manual is printed in black and white. - 13 -...

  • Page 20: Chapter 2 Introduction

    Introduction Chapter 2 Introduction SE-12 series electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms. The 12-channel ECG waves can be viewed on the LCD screen and printed out by using a high-quality thermal recorder.

  • Page 21: Keyboard And Keys

    SE-12 Series Electrocardiograph User Manual Introduction 2.2 Keyboard and Keys Figure 2-2 SE-12 Express Keyboard Name Explanation NOTE: Only if the stress ECG function is activated, can these keys be available. When the main screen is displayed, press this key to display the main screen of the exercise test.
  • Page 22 SE-12 Series Electrocardiograph User Manual Introduction Name Explanation Press to enter the recovery phase. In the recovery phase, press this Recovery key to enter the next stage of the recovery phase. Press to display a pop-up dialog box, and then you can decide Test end whether the exercise test should be terminated.
  • Page 23 SE-12 Series Electrocardiograph User Manual Introduction Name Explanation Press to quickly select the gender for the patient when Gender is Gender Key selected in the Patient Information Setup window. Delete Key Press to delete characters. Press to quickly select the age group on the main screen when you Age Group Key set Age to Age Group in the Patient Information Setup window.

  • Page 24: Front Panel

    SE-12 Series Electrocardiograph User Manual Introduction Name Explanation Press to add a space between typed characters or select/deselect a Spacebar checkbox Press to cancel operation NOTE: A large polarization voltage may cause baseline drift. On the Esc/Reset main screen, pressing Esc can decrease the polarization voltage and draw the baseline to zero quickly.

  • Page 25: Rear Panel

    SE-12 Series Electrocardiograph User Manual Introduction Symbol Name Explanation Battery recharging When the battery is being recharged, this indicator is indicator lit. 2.4 Rear Panel Figure 2-4 SE-12 Express Rear Panel Name Explanation Mains Supply Socket AC SOURCE: alternating current supply socket...

  • Page 26: Right Panel

    SE-12 Series Electrocardiograph User Manual Introduction 2.5 Right Panel Figure 2-5 SE-12 Express Right Panel Name Explanation Patient Cable Socket Connecting to the patient cable Connecting to a PC Serial Port 1 In the exercise test, only the treadmill/ergometer recommended by the manufacturer can be connected.

  • Page 27: Bottom Panel

    SE-12 Series Electrocardiograph User Manual Introduction 2.6 Bottom Panel Figure 2-6 SE-12 Express Bottom Panel Name Explanation Speaker Hole Path for sound from speaker Battery Compartment Compartment for battery The specification is: T3.15AH250V, Ø5×20mm Fuse T1AL250VP, Ø5×20mm (for UL device)

  • Page 28: Features

    SE-12 Series Electrocardiograph User Manual Introduction 2.7 Features ♦ Supporting AC and DC power supply modes, internal rechargeable li-ion battery with professional battery powered circuit, battery management and protection systems ♦ Supporting multi-language ♦ Full alphanumeric keyboard (For SE-12 Express/SE-1200 Express/SE-1201, touch screen is available) ♦...
  • Page 29 SE-12 Series Electrocardiograph User Manual Introduction ♦ Supporting multiple QTc formulae including QTc (Bazett), QTc (Fridericia), QTc (Framingham), QTc (Hodges), and QTc (QRS) The following features are only for the exercise test function of SE-12 Express (configurable) ♦ Real-time analysis, ST segment and trend are applied while sampling ♦...

  • Page 30: Chapter 3 Operation Preparations

    SE-12 Series Electrocardiograph User Manual Operation Preparations Chapter 3 Operation Preparations WARNING Before use, the equipment, patient cable and electrodes should be checked. Replace them if there is any evident defectiveness or aging which may impair the safety or the performance, and make sure that the equipment is in proper working condition.

  • Page 31: Connecting The Patient Cable To The Electrocardiograph

    SE-12 Series Electrocardiograph User Manual Operation Preparations Connecting the Patient Cable to the Electrocardiograph 3.1.1 Connect the patient cable to the patient cable socket on the right side of the main unit, and then secure them with two screws. Connecting the Patient Cable to Electrodes 3.1.2...

  • Page 32: Preparing The Skin

    SE-12 Series Electrocardiograph User Manual Operation Preparations Preparing the Skin 3.2.2 Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifacts that distort the ECG signals. By performing methodical skin preparation, you can greatly reduce the possibility of noise caused by muscle tremor and baseline drift, ensuring high-quality ECG waves.

  • Page 33: Electrode Placement (For Resting Ecg)

    SE-12 Series Electrocardiograph User Manual Operation Preparations Electrode Placement (for Resting ECG) 3.3.1 The electrodes' positions on the body surface are shown in the following tables and figures. Standard 12-Lead Placement Electrode Placement Fourth intercostal space at the right border of the sternum...
  • Page 34 SE-12 Series Electrocardiograph User Manual Operation Preparations NEHB Placement Electrode Placement Attachment point of the second rib to the right sternal edge Fifth intercostal space on the left posterior axillary line Left mid-clavicular line in the fifth intercostal space Right arm...

  • Page 35: Electrode Placement (For Exercise Ecg)

    SE-12 Series Electrocardiograph User Manual Operation Preparations Electrode Placement Right mid-axillary line on the same horizontal level as C3 and C4 Sternum at the level of C3 and C4 Mid-clavicular line in the fifth intercostals space Left mid-axilary line on the same horizontal level as C3...

  • Page 36: Attaching The Reusable Electrodes (For Resting Ecg)

    SE-12 Series Electrocardiograph User Manual Operation Preparations Electrode Placement R / L RA / LA Below the right/left clavicle N / F RL / LL Below the right/left rib Attaching the Reusable Electrodes (for Resting ECG) 3.3.3 Connecting to a Lead Wire...

  • Page 37: Inspection Before Power-On

    SE-12 Series Electrocardiograph User Manual Operation Preparations CAUTION The disposable electrodes can only be used for one time. Disposable Electrode (clip style): Clip/Snap/Banana Socket Adaptors Disposable Electrode Connection (Clip Style) Align all lead wires of the patient cable to avoid twisting, and connect the clip/snap/banana socket adaptors to the patient cable.

  • Page 38: Turning On/Off The Electrocardiograph

    SE-12 Series Electrocardiograph User Manual Operation Preparations In order to avoid safety hazards and get good ECG records, the following inspection procedures are recommended before operation. WARNING The electrocardiograph is intended to be used by qualified physicians or personnel professionally trained, and they should be familiar with the contents of this user manual before operation.
  • Page 39 SE-12 Series Electrocardiograph User Manual Operation Preparations be powered by the battery. 2. Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary. The electrocardiograph can be powered by either the mains supply or the battery.

  • Page 40: Loading Recorder Paper

    SE-12 Series Electrocardiograph User Manual Operation Preparations Hold down the key to display the hint System is shutting down… on the screen. Then the device will be off a few seconds later. NOTE: 1. When turning off the device, follow the above sequence strictly, or else there may be something wrong on the screen.
  • Page 41 SE-12 Series Electrocardiograph User Manual Operation Preparations Groove Movable Movable Part 2 Part 1 Paper Tray Exit Edge (Edge for tearing paper) Casing Button Exit Paper Roller Casing SE-12/SE-12 Express/SE-1200/SE-1200 Express: Step 1 Step 2 Folded paper / Rolled paper Step 3 1) Press the casing button downwards and remove the casing to open the recorder.
  • Page 42 SE-12 Series Electrocardiograph User Manual Operation Preparations Step 1 Step 2 1) Press the casing button downwards to open the recorder. 2) Take off the wrapper of the new folded paper, and then put it in the paper tray with the grid side facing the thermal print head.

  • Page 43: Chapter 4 Basic Operation Guidance

    SE-12 Series Electrocardiograph User Manual Basic Operation Guidance Chapter 4 Basic Operation Guidance The following sections provide an overview of the main operations and functions. You can operate the electrocardiograph by using the touch screen (configurable). CAUTION Do not touch the LCD screen with sharp things such as pencils or pens; otherwise, it will be damaged.

  • Page 44: About The Main Screen

    SE-12 Series Electrocardiograph User Manual Basic Operation Guidance 4.2 About the Main Screen After the electrocardiograph is turned on, the main screen appears. Figure 4-1 SE-12 Express Main Screen1 Figure 4-2 SE-12 Express Main Screen2 NOTE: 1. The modification of filter, gain, or speed on the main screen is only effective for the current patient.

  • Page 45: Work Mode Description

    SE-12 Series Electrocardiograph User Manual Basic Operation Guidance 4.3 Work Mode Description There are five work modes in SE-12 series electrocardiograph. In the auto mode, the ECG data can be analyzed, saved, printed and AUTO: transmitted. The lead groups are switched automatically according to the lead sequence during the printing course.

  • Page 46: Chapter 5 Entering Patient Information

    SE-12 Series Electrocardiograph User Manual Entering Patient Information Chapter 5 Entering Patient Information 5.1 Entering Patient Information Manually 1. Configure the Patient Information Setup window. (Configurable) For details, please refer to Section 10.4 "Patient Information Setup". 2. Select Patient on the main screen1 to open the Patient Information window.

  • Page 47: Chapter 6 Printing Ecg Reports

    SE-12 Series Electrocardiograph User Manual Printing ECG Reports Chapter 6 Printing ECG Reports The operation procedure is as follows: Select a work mode Configure printing and system Press PRINT/STOP to stop parameters if necessary sampling MANU Press PRINT/STOP to start...

  • Page 48: Chapter 7 Transmitting Ecg Data

    6. Beware that the SE-12 series do not have built in anti-malware protection. Any USB devices connected to the SE-12 series should be verified as not being infected before being connected to the SE-12 series.

  • Page 49: Transmitting Ecg Data To The Pc

    SE-12 Series Electrocardiograph User Manual Transmitting ECG Data NOTE: 1. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.

  • Page 50: Real-Time Transmission To The Dms

    In real-time transmission, the electrocardiograph functions as an ECG sampling box to the DMS software. NOTE: To use the real-time transmission function, the ECG data management software (DMS) of EDAN must be installed in the PC. 1. Start the DMS. 2. In the Sampling Setting window, set Device Model to SE12.

  • Page 51: Chapter 8 Managing Orders

    SE-12 Series Electrocardiograph User Manual Managing Orders Chapter 8 Managing Orders NOTE: To use the order function, the ECG data management software (DMS) of EDAN must be installed in the PC. Operation procedures are as follows: 1. On the electrocardiograph, configure the Order Setup screen.
  • Page 52 SE-12 Series Electrocardiograph User Manual Managing Orders Name Explanation For example, 2/200 200 is the total number of orders that can be stored in the Order Count electrocardiograph. 2 is the current number of orders stored in the electrocardiograph. Orders will be loaded and displayed in the order list.

  • Page 53: Chapter 9 Managing Files

    SE-12 Series Electrocardiograph User Manual Managing Files Chapter 9 Managing Files Figure 9-1 File Manager Screen1 Figure 9-2 File Manager Screen2 - 47 -...
  • Page 54 SE-12 Series Electrocardiograph User Manual Managing Files Name Explanation For example, 0% (1) 0% is space occupancy of the files stored in the electrocardiograph. File Count 1 is the current number of files stored in the electrocardiograph. For 10s AUTO data, the upper storage limit is 800.
  • Page 55 SE-12 Series Electrocardiograph User Manual Managing Files CAUTION 1. When files are being printed, transmitted, deleted or exported, you cannot turn off the electrocardiograph. 2. Do not cut off the mains supply directly when no battery is installed in the device, or else, the stored data may be lost.

  • Page 56: Chapter 10 System Setup

    SE-12 Series Electrocardiograph User Manual System Setup Chapter 10 System Setup Select Setup on the main screen1 to display the System Setup screen. 10.1 Work Mode Setup Items Default Default (Only in the U.S.) Mode Options Auto, Manual, Rhythm Auto, Manual, Rhythm, R-R Display Style 6×2...

  • Page 57: Record Info Setup

    SE-12 Series Electrocardiograph User Manual System Setup 10.3 Record Info Setup Setup 1 10.3.1 Items Default Default (Only in the U.S.) Auto Record Style 6×2 3×4+1R Manual REC Style 6 channels 6 channels Record Mode Save Paper Save Paper Record Sequence...

  • Page 58: Setup 2

    SE-12 Series Electrocardiograph User Manual System Setup WARNING If the printer used is not the type listed above, additional safety measures (such as applying an isolation transformer to supply the medical system) should be taken when the safety of the medical system has not been evaluated. If in doubt, consult our technical service department or your local distributor.

  • Page 59: Setup 3

    SE-12 Series Electrocardiograph User Manual System Setup Setup 3 10.3.3 Items Default Default (Only in the U.S.) XYZ Wave / Measure / Analysis QRS Gain 20mm/mV 20mm/mV NOTE: 1. Only if the VCG function is activated, can the Record Info Setup3 window appear.

  • Page 60: Transmission Setup

    SE-12 Series Electrocardiograph User Manual System Setup Item Description Patient Options Select the item displayed in the Patient Information window. Child Mode is available only when Glasgow algorithm is used. In the Child Mode, lead V3 is used to sample ECG signals of V4R.

  • Page 61: Basic Setup

    SE-12 Series Electrocardiograph User Manual System Setup Setup (without WIFI Module) 10.5.1 Item Description Device No. Input the maximum of 30 letters or numbers. Transmit After Saving Choose from: On or Off. This setting is only available in the SE-12 Express.

  • Page 62: Wifi Setup (Configurable)

    SE-12 Series Electrocardiograph User Manual System Setup Subnet Mask Set subnet mask in the format of XXX.XXX.XXX.XXX. XXX is a number from 0 through 255. Setup (with Configurable WIFI Module) 10.5.2 NOTE: 1. The WIFI transmission function is only available for the machine configured with the WIFI module.

  • Page 63: Lead Setup

    SE-12 Series Electrocardiograph User Manual System Setup 10.6 Lead Setup Items Default Default (Only in the U.S.) Lead Sequence Standard Standard Nehb Rhythm Lead 1 Rhythm Lead 2 Rhythm Lead 3 Lead Off Hint Item Description Lead Sequence Choose from: Standard or Cabrera...

  • Page 64: File Setup

    SE-12 Series Electrocardiograph User Manual System Setup NOTE: Please set DATE&TIME correctly when it's the first time you use the electrocardiograph. Items Default Default (Only in the U.S.) Date Mode DD-MM-YYYY DD-MM-YYYY Time Mode 24 Hours 24 Hours Power Off/ LCD Off...
  • Page 65 SE-12 Series Electrocardiograph User Manual System Setup Memory Full Select On, once the maximum storage of File Manager is reached, the device will automatically delete the oldest record to make room for the new record (first in, first out). Select Off, a message will be prompted to ask you to delete or not.

  • Page 66: Other Setup

    SE-12 Series Electrocardiograph User Manual System Setup 10.11 Other Setup Items Default Default (Only in the U.S.) External Input External Output Caps Lock Item Description External Output The external output socket is equipped in the electrocardiograph, through which the electrocardiograph can send rhythm lead signals to the external equipment.

  • Page 67: Chapter 11 Operation Instructions For Exercise Ecg (Configurable For Se-12 Express)

    SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG Chapter 11 Operation Instructions for Exercise ECG (Configurable for SE-12 Express) Exercise ECG test contributes to discover myocardial ischemia, including the treadmill test and the ergometer test. The patients with stable chest pain or unstable chest pain but drug controlled, the heart blood reserve function and myocardial ischemia existence to be estimated after myocardial infarction or coronary artery reconstruction surgery need to do exercise test.
  • Page 68 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG Figure 11-1 Main Screen of ST Trend Figure 11-2 Main Screen of Template - 62 -...
  • Page 69 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG Figure 11-3 Closeup View of Template When ID Mode is set to Manual, the length of the patient ID plus the length of the default ID is within 30 ASCII characters.
  • Page 70 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG If more than one fault occurs, only the hint information with a higher priority will be displayed. Lead X Off, DEMO, Module Error, Overload, TM-400 Treadmill hint information (including Lanyard...
  • Page 71 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG : Good signal (-70dBm ＜transmit power ≤-50dBm); : Great signal (-50dBm ＜transmit power) NOTE: For successful data transmission, please transmit data when the WIFI signal is good or great. The left number is the current heart rate, and the right number is the target heart rate.

  • Page 72: Operation Preparations

    SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG No testing: This button changes into Hold, and it does not respond to any operations. Test is terminated: This button changes into Trans, press it to transmit the file to the Press to open the Patient Information window.
  • Page 73 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG 2. Connect the electrocardiograph to the treadmill or the ergometer. CAUTION Only the treadmill/ergometer recommended by the manufacturer can be connected to Serial Port 1 and Serial Port 2. 1) Connect the electrocardiograph to the treadmill...
  • Page 74 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG 4. Connect the power cords, and connect the earth wire (when necessary) 5. Load the recorder paper 6. Turn on the stress BP monitor and treadmill/ergometer 7. Set the electrocardiograph 1) Activate the stress ECG function.

  • Page 75: Exercise Test

    SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG c) Select, by using the Up/Down keys, the menu SYSTEM PARAMETER and press Enter d) Select, by using the Up/Down keys, the menu SETTINGS and press Enter e) Select, by using the Up/Down keys, the menu RS232 PROTOCOL and press...
  • Page 76 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG Operation Method: 1. Instruct the patient, attach the disposable electrodes to the patient, and then apply the stress BP monitor to the patient. For details, please refer to Chapter 3 Operation Preparations.

  • Page 77: Factory Defaults Of Exercise Ecg

    SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG 11.4 Factory Defaults of Exercise ECG General Information Setup Items Default Default (Only in the U.S.) Display Style 6×2 3×4+1R Speed Unit Post J 60ms 60ms Device Style Treadmill Treadmill...
  • Page 78 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG Manual Report Print Print Pretest Report Print Print Exercise Report: Auto Report Print Print Exercise Report: Print Time Late Stage Late Stage Recovery Report: Auto Report Print Print Recovery Report: Start Time...

  • Page 79: Managing Protocols

    SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG 3. You should test whether the treadmill is controlled by SE-12 Express well when SE-12 Express is connected to the treadmill for the first time. 4. Do not stand on the treadmill when testing it for the first time.
  • Page 80 SE-12 Series Electrocardiograph User Manual Operation Instructions for Exercise ECG 3. Setting Default Protocols Select a protocol on the Protocol Manager screen by pressing the Up or Down arrow, and press Select to set the selected protocol as the default protocol.

  • Page 81: Chapter 12 Error Messages

    SE-12 Series Electrocardiograph User Manual Error Messages Chapter 12 Error Messages Hint information and the corresponding causes provided by the electrocardiograph are listed in Table 12-1. Table 12-1 Error Messages and Causes for Resting ECG Message Cause Electrodes fall off the patient or the patient cable falls off the unit, or Lead off a high polarization voltage occurs.
  • Page 82 SE-12 Series Electrocardiograph User Manual Error Messages Message Cause U Disk / USB Printer / USB A U disk, a USB printer or a bar code reader / security reader / ID Scanner / Reader card reader is connected to the USB interface.
  • Page 83 SE-12 Series Electrocardiograph User Manual Error Messages Message Cause The speed set in the electrocardiograph is different from the actual Abnormal Speed speed of the running belt; the signal cable is not connected well, parts, the speed sensor are loose, or great magnetic field exists.

  • Page 84: Chapter 13 Faq

    ECG data could be transmitted to the PC without printing. Q4: The screen of SE-12 series electrocardiograph is too shiny. Could it be possible to weaken the brightness of the screen? A4: There is a setup item named brightness in the Display & Sound Setup window, you can press the Left or Right arrow to change the value, which would lead to the change of the brightness of the screen.
  • Page 85 SE-12 Series Electrocardiograph User Manual Q6: Memory Full is displayed on the main screen; Or, the hint Memory full! Replace the earliest file? pops up every time when I save an ECG report to the electrocardiograph. What am I supposed to do? A6: Memory Full is used to remind you that the amount of stored file reaches the upper limit.
  • Page 86 SE-12 Series Electrocardiograph User Manual Reload the paper in the paper tray, close the recorder casing firmly. If the problem still exists, please contact the manufacturer or the local distributor for further disposal. Q4: I want to print the hospital name in the report, but I can't find the place to enter it, where is A4: Please open the Other Setup window, and move the cursor to the Institution textbox, and then input the hospital name.
  • Page 87 SE-12 Series Electrocardiograph User Manual 3. Transmitting Problems Q1: The ECG doesn't respond to any keys after a long time of transmission. It transmits nothing for there is no new data appearing on the screen of the PC software. What should I do? A1: Some error may occur during the transmission course, for example, the connection between the ECG and the net cable may loosen.

  • Page 88: Chapter 14 Cleaning, Care And Maintenance

    SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance Chapter 14 Cleaning, Care and Maintenance Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods.

  • Page 89: Disinfection

    SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance If the equipment or accessory has been in contact with the patient, then cleaning and disinfection is required after each use. The validated cleaning agents for cleaning the electrocardiograph and reusable accessories are: ...

  • Page 90: Care And Maintenance

    Capacity is from full to empty. 2) Recharge SE-12 series electrocardiograph is equipped with the recharge control circuit together with the battery. When the unit is connected to the mains supply, the battery will be recharged automatically. Then the battery recharging indicator ( ) and the mains supply indicator ) will be lit at the same time.

  • Page 91: Recorder Paper

    SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance Because of the capacity consumption during the storage and transport course, the battery capacity is not full when it is used for the first time. Battery recharge should be considered before the first use.

  • Page 92: Visual Inspection

    SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance ♦ Make sure that there is no polyvinyl chloride or other chemicals in the storage environment, which will lead to color change of the paper. ♦ Do not overlap the recorder paper for a long time, or else the ECG reports may trans-print each other.
  • Page 93 SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50μA (CF). k) Test the essential performance according to IEC/EN 60601-2-25, or methods recommended by the hospital or local distributor.
  • Page 94 SE-12 Series Electrocardiograph User Manual Cleaning, Care and Maintenance ♦ After long-term use, the surfaces of electrodes will be oxidized because of erosion and other causes. By this time, electrodes should be replaced to achieve high-quality ECG records. CAUTION The device and accessories are to be disposed of according to local regulations after their useful lives.

  • Page 95: Chapter 15 Accessories

    SE-12 Series Electrocardiograph User Manual Accessories Chapter 15 Accessories WARNING Only the patient cable and other accessories supplied by the manufacturer can be used. Or else, the performance and electric shock protection cannot be guaranteed. 15.1 Standard Accessories Table 15-1 Standard Accessories List...
  • Page 96 Bar Code Reader (One-Dimension) 01.23.068023 Bar Code Reader (Two-Dimension) 21.18.052311 SE-12 series electrocardiograph and accessories are available at your request. NOTE: * Currently not available in the U.S. The chest electrodes, limb electrodes, pediatric chest electrodes and pediatric limb electrodes are not available in the U.S.

  • Page 97: Chapter 16 Warranty & Service

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

  • Page 98: Appendix 1 Technical Specifications

    SE-12 Series Electrocardiograph User Manual Technical Specifications Appendix 1 Technical Specifications A1.1 Safety Specifications IEC 60601-1:2005/A1:2012 EN 60601-1:2006/A1:2013 Comply with: IEC 60601-1-2:2014 EN 60601-1-2:2015 IEC/EN 60601-2-25 Class І with internal power supply Anti-electric-shock type: Anti-electric-shock degree: CF type with defibrillation-proof...

  • Page 99: A1.2 Environment Specifications

    SE-12 Series Electrocardiograph User Manual Technical Specifications A1.2 Environment Specifications Transport & Storage Working Temperature: -20º C (-4º F) ~ +55º C (+131º F) +5º C (+41º F) ~ +40º C (+104º F) 25% RH~93% RH 25% RH~80% RH Relative Humidity:...

  • Page 100: A1.5 Performance Specifications

    SE-12 Series Electrocardiograph User Manual Technical Specifications Rated Voltage = 14.8V Typical Capacity = 5000mAh or 2500mAh 5000mAh battery pack is configurable for SE-1200 Express and SE-12 Express only. Rated Capacity 100% Charge Time 90% Charge Time 2500mAh 3 hours...
  • Page 101 SE-12 Series Electrocardiograph User Manual Technical Specifications SE-12, SE-12Express, SE-1200, SE-1200 Express: Folded thermal paper: 210mm×295mm×100pages Folded thermal paper: 215mm×280mm×100pages (Configurable) Rolled thermal paper: 210mm×30m (Configurable) Recorder Paper: SE-1201: Folded thermal paper: 210mm×140mm×144 pages Folded thermal paper: 210mm×295mm×100 pages (Configurable)
  • Page 102 SE-12 Series Electrocardiograph User Manual Technical Specifications ≥100MΩ (10Hz) Input Impedance: ≤0.01μA Input Circuit Current: ≤± 5 mVpp Input Voltage Range Calibration Voltage: 1mV± 2% DC Offset Voltage: ± 900mV 20 μVp-p Minimum Amplitude: ≤12.5 μVp-p Noise: ≤0.5mm Multichannel crosstalk...
  • Page 103 SE-12 Series Electrocardiograph User Manual Technical Specifications Modulation Type DSSS, CCK, OFDM Transmitting Power 6~17dBm Effective Radiated Power 6~17dBm NOTE: Operation of the equipment below the minimum amplitude may cause inaccurate results. - 97 -...

  • Page 104: Appendix 2 Emc Information

    SE-12 Series Electrocardiograph User Manual EMC Information Appendix 2 EMC Information Electromagnetic emissions Guidance and manufacture's declaration – electromagnetic emission The 12-channel electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of the 12-channel electrocardiograph should assure that it is used in such an environment.
  • Page 105 SE-12 Series Electrocardiograph User Manual EMC Information Electromagnetic immunity Guidance and manufacture's declaration – electromagnetic immunity The 12-channel electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of 12-channel electrocardiograph should assure that it is used in such an environment.
  • Page 106 SE-12 Series Electrocardiograph User Manual EMC Information power mains interruptions, it is 70 % U ; 25/30 25/30 recommended that cycles ) cycles ) 12-channel electrocardiograph Single phase: at Single phase: at 0° powered from 0° uninterruptible power supply or a battery.
  • Page 107 SE-12 Series Electrocardiograph User Manual EMC Information 61000-4-3 80 MHz to 2.7 GHz 80 MHz to 800 MHz to 2.7 GHz 2.7 GHz wireless communications equipment bands (Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be...
  • Page 108 SE-12 Series Electrocardiograph User Manual EMC Information Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 109 SE-12 Series Electrocardiograph User Manual EMC Information 800/900,TETRA modulation 800, iDEN 820, 18 Hz CDMA 850, LTE Band 5 1720 GSM 1800; 1845 CDMA 1900; Pulse GSM 1900; 1700-1990 modulation DECT; LTE 1970 217 Hz Band 1, 3, 4,25; UMTS Bluetooth, WLAN,802.11...
  • Page 110 SE-12 Series Electrocardiograph User Manual EMC Information Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM Recommended separation distances between portable and mobile RF communications equipment and the 12-channel Electrocardiograph The 12-channel electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

  • Page 111: Appendix 3 Abbreviations

    SE-12 Series Electrocardiograph User Manual Abbreviations Appendix 3 Abbreviations Abbreviation Full Description Liquid Crystal Display Blood Pressure Electrocardiogram/Electrocardiograph Heart Rate Left Foot Augmented Lead Left Arm Augmented Lead Right Arm Augmented Lead Left Arm Left Leg Right Arm Right Leg...
  • Page 112 - 106 -...

This manual is also suitable for:

Se-12Se-12 expressSe-1200Se-1200 expressSe-1201

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