EDAN SE-301 User Manual
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EDAN SE-301 User Manual

Se-301 series electrocardiograph
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Summary of Contents for EDAN SE-301

  • Page 2: About This Manual

    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) can not be held liable.
  • Page 3 The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.

  • 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 Lithium Battery Care Warnings ................5 1.2.3 General Cautions ...................... 6 1.3 List of Symbols ......................... 7 Chapter 2 Introduction ......................
  • Page 5 Chapter 6 Settings ........................29 6.1 Work Mode ........................29 6.2 Filter ..........................29 6.3 Record Info Setup ......................30 6.3.1 Setup 1 ........................30 6.3.2 Setup 2 ........................31 CAUTION ..........................32 6.4 Patient Information Setup ....................33 6.5 Transmission Setup ......................34 6.6 Lead Setup ........................
  • Page 6 A1.3 Physical Specifications ....................52 A1.4 Power Supply Specifications ..................52 A1.5 Performance Specifications ..................53 Appendix 2 EMC Information ....................55 Appendix 3 Abbreviation ......................59...

  • Page 7: Chapter 1 Safety Guidance

    SE-301 Series Electrocardiograph User Manual Safety Guidance Chapter 1 Safety Guidance This chapter provides important safety information related to the use of the 3-Channel Electrocardiograph. 1.1 Indications for Use/Intended Use The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes.

  • Page 8: Safety Warnings

    SE-301 Series Electrocardiograph User Manual Safety Guidance 1.2.1 Safety Warnings WARNING 1. The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained. They should be familiar with the contents of this user manual before operation. 2. Only qualified service engineers can install this equipment, and only service engineers authorized by the manufacturer can open the shell.
  • Page 9 SE-301 Series Electrocardiograph User Manual Safety Guidance WARNING 14. To avoid a polarization or DC offset voltage, use non-polarizing electrodes(which will not form a DC offset voltage when subjected to a DC current) such as silver/silver-chloride types if there is a situation where there is a likelihood that a defibrillation procedure will be necessary.
  • Page 10 SE-301 Series Electrocardiograph User Manual Safety Guidance WARNING 26. Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC/EN 60601-1 approved to the electrocardiograph. The operation or use of non-approved equipment or accessories with the electrocardiograph is not tested or supported, and electrocardiograph operation and safety are not guaranteed.

  • Page 11: Lithium Battery Care Warnings

    SE-301 Series Electrocardiograph User Manual Safety Guidance WARNING 33. If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your service personnel.

  • Page 12: General Cautions

    SE-301 Series Electrocardiograph User Manual Safety Guidance WARNING 3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when installing the battery. 4. Do not heat or splash the battery or throw it into fire or water.

  • Page 13: List Of Symbols

    SE-301 Series Electrocardiograph User Manual Safety Guidance CAUTION 5. Ruptured fuse must only be replaced with that of the same type and rating as the original. 6. The device and accessories are to be disposed of according to local regulations after their useful lives.
  • Page 14 SE-301 Series Electrocardiograph User Manual Safety Guidance Casing Button General symbol for recovery/recyclable Part Number SERIAL NUMBER Date of manufacture MANUFACTURER AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY CE marking Disposal method SD card slot USB socket Net port Power adapter port Caution: Federal (U.S.) law restricts this device...
  • Page 15 SE-301 Series Electrocardiograph User Manual Safety Guidance Warning (Background: Yellow; Symbol&Outline: Black) Federal Communications Commission: FCC ID: FCC ID: SMQSE301EDAN SMQSE301EDAN Non- ionizing electromagnetic radiation NOTE: 1. *Applicable to the Electrocardiograph configured with WIFI module. 2. For details about buttons of the keyboard, refer to Chapter 2.

  • Page 16: Chapter 2 Introduction

    The AUTO, MANU, RHYT, and R-R modes can be chosen freely. SE-301 series can be powered by the mains supply or a built-in rechargeable lithium battery. Two models are available: SE-301 with WIFI as an optional configuration, and iSE301 with WIFI as a standard configuration.

  • Page 17: Bottom Panel

    SE-301 Series Electrocardiograph User Manual Introduction 2.2 Bottom Panel The silk screen on the battery compartment indicates the rated voltage. 2.3 Right Panel Description Patient cable socket Power key (Long press: switch on/off; short press: sleep mode) Color when using the mains supply: Green...

  • Page 18: Chapter 3 Operation Preparations

    SE-301 Series Electrocardiograph User Manual Operation Preparations Chapter 3 Operation Preparations 3.1 Loading/Replacing Recorder Paper NOTE: 1. When the folded thermal paper is used, the paper roller is unnecessary and must be taken out. 2. The grid side of the paper should face the thermal print head, and the black marker on the paper should face the black marker detecting area.

  • Page 19: Preparing The Patient

    SE-301 Series Electrocardiograph User Manual Operation Preparations 3.2 Preparing the Patient 3.2.1 Instructing the Patient Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases the patient’s anxiety. Reassure the patient that the procedure is painless.

  • Page 20: Attaching Electrodes To The Patient

    SE-301 Series Electrocardiograph User Manual Operation Preparations Screw Main Cable Lead Wires Connecting to Connecting to Electrocardiograph Electrodes 1. Connecting the Patient Cable to the Electrocardiograph Connect the patient cable to the patient cable socket on the right side of the main unit, and then secure them with two screws.
  • Page 21 SE-301 Series Electrocardiograph User Manual Operation Preparations Electrode Reed Clamp Limb Electrode The identifiers and color codes of electrodes used comply with IEC/EN requirements. In order to avoid incorrect connections, the electrode identifiers and color codes are specified in Table 4-1.
  • Page 22 SE-301 Series Electrocardiograph User Manual Operation Preparations Chest Electrode Connection: Ensure that the electrodes are clean; Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the corresponding electrodes according to the colors and identifiers;...

  • Page 23: Disposable Electrodes

    SE-301 Series Electrocardiograph User Manual Operation Preparations electrode clamp; Connect the electrode to the limb, and make sure that the metal part is placed on the electrode area above the ankle or the wrist; Attach all limb electrodes in the same way.

  • Page 24: Inspection Before Power On

    SE-301 Series Electrocardiograph User Manual Operation Preparations Disposable Electrode connection 1) Align all lead wires of the patient cable to avoid twisting, and connect the alligator clips to the lead wires. 2) Clean the electrode areas on the body surface with 75% alcohol.
  • Page 25 SE-301 Series Electrocardiograph User Manual Operation Preparations 1) Environment: ♦ Make sure that there is no electromagnetic interference source around the equipment, especially large medical electrical equipment such as electrosurgical equipment, radiological equipment, magnetic resonance imaging equipment etc. Switch off these devices when necessary.

  • Page 26: Chapter 4 Sampling And Printing Ecg

    SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG Chapter 4 Sampling and Printing ECG 4.1 Entering Patient Information 4.1.1 Entering Patient Information Manually On the main screen, the following information is displayed: patient information, system hints, heart rate, waveforms, current time, battery capacity, WIFI signal (optional), and functional keys.

  • Page 27: Entering Patient Information By Acquiring Orders

    SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG 4.1.2 Entering Patient Information by Acquiring Orders NOTE: To use the order function, the data management software (DMS) of the manufacturer must be installed in the PC. Operation procedures are as follows: 1.

  • Page 28: Sample Ecg Reports

    SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG 4.3 Sample ECG Reports 4.3.1 ECG Reports in the AUTO Mode Figure 4-1 ECG Reports in the AUTO Mode (a) Figure 4-2 ECG Reports in the AUTO Mode (b) Figure 4-1 and Figure 4-2 show an ECG report in the AUTO mode. Template is selected, and Record Style is set to 3×4.
  • Page 29 SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG P-R interval: the average P-R interval from several selected dominant beats; QRS complex duration: the average QRS complex duration from several selected dominant beats; QT/QTc Q-T interval: the average Q-T interval from several selected dominant beats / Normalized QT interval;...

  • Page 30: Pdf Report

    SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG 25mm/s (Paper Speed) 10mm/mV (Gain) 60 (Heart Rate) Electrocardiograph Model V1.0 (Software Version) SEMIP V1.8 (Algorithm Version) Institution Name 4.3.2 PDF Report Figure 4-3 PDF Report - 24 -...

  • Page 31: Chapter 5 Managing Ecg Records

    File Manager, the message MemFull will be displayed. 5.1 Transmitting ECG Records to the PC NOTE: To transmit ECG records to the PC, data management software (DMS) of EDAN must be installed in the PC. You should log into the Smart ECG Viewer software before the transmission.

  • Page 32: Transmitting Ecg Records Through Wifi Network (Optional)

    SE-301 Series Electrocardiograph User Manual Managing ECG Records same as the last number of the IP of the DMS. 5. In the AUTO or RHYT mode, ECG data can be transmitted through the net automatically after an ECG report is printed out.
  • Page 33 SE-301 Series Electrocardiograph User Manual Managing ECG Records Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Any changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.

  • Page 34: Deleting Patient Records

    SE-301 Series Electrocardiograph User Manual Managing ECG Records 5.3 Deleting Patient Records 1. Open the File Manager screen. 2. If you want to delete all the records, click More and select the Del All button, and then click 3. If you want to delete a record, choose the patient record in the table, and then click the delete symbol on the top.

  • Page 35: Chapter 6 Settings

    SE-301 Series Electrocardiograph User Manual Settings Chapter 6 Settings Click Setup on the main screen to display the System Setup screen. NOTE: The underlined values are system default values. 6.1 Work Mode Item Description Sampling Mode Choose from: Pre-Sample and Real-time...

  • Page 36: Record Info Setup

    SE-301 Series Electrocardiograph User Manual Settings Lowpass Filter The cutoff frequency can be set to 75Hz, 100Hz, 150Hz, 270Hz or 300Hz Lowpass Filter restricts the bandwidth of input signals. All the input signals whose frequency is higher than the set cutoff frequency will be attenuated.

  • Page 37: Setup 2

    SE-301 Series Electrocardiograph User Manual Settings Auto Record Choose from: Short (2.5s), Medium (5s) and Long (10s) Length NOTE: Auto Record Length is corresponding with Record Device, Sampling Mode and Record Sequence. Manual Style Choose from 3 channels and 1 channels Select a style to print the ECG waves in the manual mode.

  • Page 38: Caution

    SE-301 Series Electrocardiograph User Manual Settings When it is set to On, the Minnesota Code will be printed in the ECG report. Device No. Choose from: On or Off When it is set to On, the Device No. will be printed in the ECG report.

  • Page 39: Patient Information Setup

    SE-301 Series Electrocardiograph User Manual Settings 5. Make sure the type of USB printer connected is matched with the type you choose in the Record Device. Error may occur if the USB printer type is not matched. USB Record Style Choose from: 3×4, 3×4+1R, 3×4+3R, 6×2, 6×2+1R or 12×1 It defines the style of USB report.

  • Page 40: Transmission Setup

    Settings 6.5 Transmission Setup NOTE: 1. To transmit ECG data to the PC, the Smart ECG Viewer software produced of EDAN must be installed in the PC. You should log into the Smart ECG Viewer software before transmission. 2. If the power supply suddenly breakdown during data storage or transmission, file system error may occur.

  • Page 41: File Setup

    SE-301 Series Electrocardiograph User Manual Settings 6.7 File Setup Item Description Auto Save Choose from: Off, To ECG or Ext. Memory Select Off, ECG data will not be saved. Select To ECG, ECG data in the AUTO or RHYT mode will be saved in the ECG automatically.

  • Page 42: Date&Time Setup

    SE-301 Series Electrocardiograph User Manual Settings 6.8 Date&Time Setup NOTE: Please set DATE&TIME correctly when it’s the first time you use the electrocardiograph. Item Description Date Mode Choose from: DD-MM-YYYY, MM-DD-YYYY or YYYY-MM-DD Time Mode Choose from: 24 Hours or 12 Hours Date&Time...

  • Page 43: Advanced Setup

    SE-301 Series Electrocardiograph User Manual Settings When enabled, the waveforms on the main screen will be displayed with a Grid background grid. Language Select the language displayed on the main screen and in the ECG reports. Display Colors Set the interface display color...

  • Page 44: Chapter 7 Hint Information

    SE-301 Series Electrocardiograph User Manual Hint Information Chapter 7 Hint Information Hint information provided by SE-301 and the corresponding causes are listed in Table 10-1. Table 7–1 Hint Information and Causes Hint Information Causes Lead off Electrodes fall off the patient or the patient cable falls off the unit.

  • Page 45: Chapter 8 Troubleshooting

    SE-301 Series Electrocardiograph User Manual Troubleshooting Chapter 8 Troubleshooting 1) Operating Problems Q1: I want to save the ECG data without any printing, could it be possible? A1: Yes, in the Record Info setup, set Print Out to Off. In the same way, if the transmission settings have been configured, the ECG data could be transmitted to the PC without printing.
  • Page 46 SE-301 Series Electrocardiograph User Manual Troubleshooting A5: Please check whether there is any error information displayed on the screen. If the hint Paper? or PaperErr is shown on the screen, please deal with it according to the above-mentioned measures. If the hint Transfer is shown on the screen, which means that the ECG is transmitting the data to the PC, please wait a few seconds.

  • Page 47: Chapter 9 Cleaning, Care And Maintenance

    SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance Chapter 9 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 48: Cleaning The Main Unit

    SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance Mild near neutral detergent Ethanol (75%) Isopropanol (70%) The validated cleaning agent for cleaning the reusable electrodes is: Mild near neutral detergent Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper towel.

  • Page 49: Cleaning The Reusable Electrodes

    SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance 9.2.3 Cleaning the Reusable Electrodes 1. Wipe off with a soft cloth to remove residual gel. 2. Wipe the suction bulbs of chest electrodes and the clamps of limb electrodes with a soft cloth dampened with the cleaning solution until no visible contaminants remain.

  • Page 50: Disinfecting The Patient Cable

    Capacity is from full to empty. 2) Recharge SE-301 is equipped with the recharge control circuit together with the built-in rechargeable lithium battery. When the unit is connected to the mains supply, the battery will be recharged automatically. During the recharging course, the battery symbol flashes in the top right corner of the LCD screen.

  • Page 51: Recorder Paper

    SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance capacity is not full when it is used for the first time. Battery recharge should be considered before the first use. NOTE: If the battery has not been used for more than two months, it should be recharged before use.

  • Page 52: Maintenance Of The Main Unit, The Patient Cable And Electrodes

    SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance ♦ Do not overlap the recorded paper for a long time, or else the ECG reports may trans-print each other. 9.4.3 Maintenance of the Main Unit, the Patient Cable and Electrodes The following safety checks should be performed at least every 24 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.
  • Page 53 SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance 1) Main Unit ♦ Avoid excessive temperature, sunshine, humidity or dirt. ♦ Put the dustproof coat on the main unit after use and prevent shaking it violently when moving it to another place.

  • Page 54: Chapter 10 Accessories

    SE-301 Series Electrocardiograph User Manual Accessories Chapter 10 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. Table 10-1 Accessories List Accessory...
  • Page 55 Grounding Wire 01.13.114114 U Disk 01.18.052275 SE-301 and accessories are available by contacting the manufacturer or your local distributor. NOTE: 1. The adult chest electrodes, adult limb electrodes, pediatric chest electrodes and pediatric limb electrodes are not available in the U.S.

  • Page 56: Chapter 11 Warranty And 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 57: Appendix 1 Technical Specifications

    SE-301 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 60601-1-2:2007 EN 60601-1-2:2007/AC:2010 IEC 60601-2-25:2011 Anti-electric-shock type: Class І with internal power supply Anti-electric-shock degree: Type CF Degree of protection against...

  • Page 58: A1.2 Environment Specifications

    SE-301 Series Electrocardiograph User Manual Technical Specifications A1.2 Environment Specifications Transport & Storage Working Temperature: -20ºC (-4ºF) ~ +55ºC (+131ºF) +5ºC (+41ºF) ~ +40ºC (+104ºF) 15%RH–95%RH 15%RH–95%RH Relative Humidity: Non-Condensing Non-Condensing Atmospheric Pressure: 70kPa–106kPa 70kPa–106kPa A1.3 Physical Specifications Dimensions 224 mm×143 mm×54 mm, ±2 mm Weight <...

  • Page 59: A1.5 Performance Specifications

    SE-301 Series Electrocardiograph User Manual Technical Specifications A1.5 Performance Specifications Recording Thermal dot-matrix recorder Recorder: 8 dots per mm / 200 dots per inch (amplitude axes) Printing Density 40 dots per mm / 1000 dots per inch (time axes, @ 25 mm/s) Folded thermal paper, 80mm×70mm×200pages...
  • Page 60 SE-301 Series Electrocardiograph User Manual Technical Specifications DC Offset Voltage: ±600mV Minimum Amplitude: 20 μVp-p Noise: ≤12.5μVp-p Multi-channel Crosstalk ≤0.5mm AC Filter: On / Off DFT Filter: 0.01Hz, 0.05Hz, 0.32Hz, or 0.67Hz Filter EMG Filter: 25Hz / 35Hz / 45Hz / OFF LOWPASS Filter:300Hz / 270Hz / 150Hz / 100Hz / 75Hz ≥140dB (AC: ON)

  • Page 61: Appendix 2 Emc Information

    SE-301 Series Electrocardiograph User Manual EMC Information Appendix 2 EMC Information Electromagnetic emissions Guidance and manufacture’s declaration – electromagnetic emission The Electrocardiograph is intended for use in the electromagnetic environment specified below. The user of the Electrocardiograph should assure that it is used in such an environment.
  • Page 62 SE-301 Series Electrocardiograph User Manual EMC Information ±1 kV line to line ±1 kV line to line Surge Mains power quality ±2 kV line to ground ±2 kV line to ground IEC 61000-4-5 should be that of a typical commercial or hospital environment.
  • Page 63 SE-301 Series Electrocardiograph User Manual EMC Information Electromagnetic immunity Guidance and manufacture’s declaration – electromagnetic immunity The Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of Electrocardiograph should assure that it is used in such an environment.
  • Page 64 SE-301 Series Electrocardiograph User Manual EMC Information environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Electrocardiograph is used exceeds the applicable RF compliance level above, the Electrocardiograph should be observed to verify normal operation.

  • Page 65: Appendix 3 Abbreviation

    SE-301 Series Electrocardiograph User Manual Abbreviation Appendix 3 Abbreviation Abbr English 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 Identification Alternating Current Universal Serial Bus...

This manual is also suitable for:

Ise-301

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