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EDAN INSTRUMENTS PADECG User Manual

Ios version 2.1
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PADECG
PCECG
(iOS) Version 2. 1
User Manua

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  • Page 1 PADECG PCECG (iOS) Version 2. 1 User Manua...
  • Page 2 About this Manual P/N: 01.54.001673 MPN: 01.54.001673021 Release Date: Jan. 2024 Statement 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 the manufacturer.
  • Page 3 Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure.

  • Page 4: Table Of Contents

    2.1.2 DX12(iOS) Transmitter ...................11 2.1.2.1 Keys and Icons ....................12 2.1.2.2 Setting the Menu ................... 13 2.2 Installing the PADECG App ..................... 13 2.2.1 System Running Environment ................13 2.2.2 About Installation ....................14 2.2.3 Matching DX12(iOS) Transmitter with iPad ............14 2.3 Features ..........................
  • Page 5 4.6.3 Filter Setting ......................29 4.6.4 Transmission Setting ....................30 4.6.5 Other Setting ......................30 Chapter 5 Hint Information ......................32 Chapter 6 Cleaning, Care and Maintenance ................33 6.1 General Points ........................33 6.2 Cleaning ..........................33 6.2.1 Cleaning the DX12(iOS) Transmitter ..............34 6.2.2 Cleaning the Patient Cable ..................34 6.2.3 Cleaning the Reusable Electrodes ................34 6.3 Disinfection ........................35...

  • Page 6: Chapter 1 Safety Guidance

    This chapter provides important safety information related to the use of PADECG. 1.1 Intended Use/Indications for Use The intended use of PADECG is to acquire resting ECG signals from adult and pediatric patients through body surface ECG electrodes. It is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals.
  • Page 7 PADECG User Manual Safety Guidance WARNING 2. Only qualified service engineers can install this equipment, and only service engineers authorized by the manufacturer can open the shell. Otherwise, safety hazards may happen. 3. EXPLOSION HAZARD - Do not use the system in the presence of flammable anesthetic mixtures with oxygen or other flammable agents.
  • Page 8 23. Make sure that there is no intense electromagnetic interference source around when using the wireless system of PADECG. Furthermore, Keep a unobstructed distance of at most 3 meters between DX12(iOS) Transmitter and the iPad. - 3 -...
  • Page 9 PADECG User Manual Safety Guidance WARNING 24. Do not open the battery cover of DX12(iOS) Transmitter when using the wireless system of PADECG. 25. The iPad shall comply with the valid version of the standard IEC 60950 and be used outside the patient environment (at least 2 meters away from the patient).

  • Page 10: Battery Care Warnings

    PADECG User Manual Safety Guidance 1.2.2 Battery Care Warnings WARNING 1. Improper operation may cause the internal battery to 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.

  • Page 11: List Of Symbols

    PADECG User Manual Safety Guidance CAUTION 3. Make sure that there is no intense electromagnetic interference source around the equipment, such as radio transmitters or mobile phones etc. Attention: large medical electrical equipment such as electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment etc.
  • Page 12 PADECG User Manual Safety Guidance General symbol for recovery/recyclable Part Number SERIAL NUMBER Date of manufacture MANUFACTURER AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY CE marking Disposal method Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
  • Page 13 PADECG User Manual Safety Guidance Keep dry Stacking limit by number Handle with care Do not step on Front Medical Device Unique Device Identifier NOTE: The user manual is printed in black and white. - 8 -...

  • Page 14: Chapter 2 Introduction

    Introduction Chapter 2 Introduction PADECG as mobile ECG Workstation has similar functions with an ordinary ECG Workstation. ECG data can be sampled, analyzed and stored in a Pad, ECG waves can be reviewed. Auto measurement and diagnosis are available, and the diagnosis template can be edited.
  • Page 15 PADECG User Manual Introduction WARNING 1. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore all configuration shall comply with the valid version of the standard IEC/EN 60601-1.

  • Page 16: Dx12(Ios) Transmitter

    PADECG User Manual Introduction 2.1.2 DX12(iOS) Transmitter DX12(iOS) Transmitter Appearance Front Panel Patient Cable Socket - 11 -...

  • Page 17: Keys And Icons

    If no operation is taken, the Main screen will be displayed and the keyboard will be locked automatically in 8 seconds. Icon for Battery Capacity When the battery is weak, a hint will be displayed in PADECG App. - 12 -...

  • Page 18: Setting The Menu

    NOTE: The device information is for reference only. 2.2 Installing the PADECG App NOTE: This section is only for reference when the operating system of the iPad needs to be reinstalled or DX12(iOS) Transmitter is broken.

  • Page 19: About Installation

    2. Please consult the manufacturer's service engineer for PADECG App compatibility before you upgrade the iOS system. 2.2.2 About Installation Enter the App Store of the iPad, input PADECG to search for the application. The installation is the same as that of other applications available in the iPad. NOTE: 1.

  • Page 20: Features

    PADECG User Manual Introduction WARNING This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 21: Chapter 3 Preparations Before Operation

    PADECG User Manual Preparations Before Operation Chapter 3 Preparations Before Operation 3.1 Preparing the Patient 3.1.1 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 22: Attaching Electrodes

    PADECG User Manual Preparations Before Operation Lead Wires Main Cable Connecting Electrode Connector DX12(iOS) Transmitter The patient cable includes the main cable and lead wires which can be connected to electrodes. 1. Connect the patient cable to the socket of DX12(iOS) Transmitter.

  • Page 23: Electrode Placement

    PADECG User Manual Preparations Before Operation White/Yello Chest 2 Brown/Yellow Chest 3 White/Green Brown/Green White/Brow Chest 4 Brown/Blue Brown/Orang Chest 5 White/Black Chest 6 White/Violet Brown/Violet Electrode Placement 3.3.1 Electrode Placement Fourth intercostal space at the right border of the sternum...

  • Page 24: Attaching The Reusable Electrodes

    PADECG User Manual Preparations Before Operation Right leg 3.3.2 Attaching the Reusable Electrodes 3.3.2.1 Attaching the Limb Electrodes Connecting to a Lead Wire Reed Clamp Limb Electrode Limb Electrode Connection: 1) Ensure that the electrodes are clean; 2) Clean the electrode area which is a short distance above the ankle or the wrist with 75% alcohol;...

  • Page 25: Attaching The Disposable Electrodes

    PADECG User Manual Preparations Before Operation Chest Electrode Connection: 1) Ensure that the electrodes are clean; 2) Clean the electrode area on the chest surface with 75% alcohol; 3) Daub the round area of 25mm in diameter on each electrode site with gel evenly;...

  • Page 26: Chapter 4 Operation Instructions

    If no DX12(iOS) Transmitter is detected and no data exists on the file screen, a dialog box requiring password will be displayed. Enter the correct password and you will enter the login screen. NOTE: Do not run other applications when running PADECG, or the system response speed will be affected. 4.1 Entering Patient Information On the Patient screen, you can view or create patient orders.

  • Page 27: Sampling Ecg Data

    PADECG User Manual Operation instructions 3. Description for buttons Description STAT ECG Press to enter the ECG sampling screen directly. Options: Delete, Scan, Download, Download Setting  Delete: Press to delete one or multiple orders.  Scan: Press to input patient information by scanning a bar code.

  • Page 28: Analyzing Ecg Data

    PADECG User Manual Operation instructions enter the pre-sampling screen. Description Start/Stop Press this button to start/stop sampling ECG data. NOTE: At most 180s ECG data can be sampled. 100Hz Choose from：25 Hz,35 Hz,45Hz,75 Hz,100 Hz,150Hz NOTE: This setup modified on the pre-sampling screen is only effective for the current patient.
  • Page 29 PADECG User Manual Operation instructions Press on the Amplified Waveform screen to measure the ECG waveform. Press this button again to cancel measuring. 3. Modifying measure information Long press one parameter in the top left corner of the ECG Analysis screen, and the Modify measure information window pops up.

  • Page 30: Printing Reports

    To print a report, the tablet should be connected to a PC which is installed with the SE-1515 analysis software or an FTP server by setting the IP address and FTP parameters of the PADECG App. For details, please refer to "FTP Setting" in section 4.6.4"Transmission Setting".

  • Page 31: Processing Patient Records

    PADECG User Manual Operation instructions local distributor or the manufacturer. NOTE: 1. This function is available only under network connection. 2. Not all options related to SE-1515 are available. WARNING The printouts need to be done with no scaling or sizing done to fit the page.

  • Page 32: Configuring The System

    PADECG User Manual Operation instructions 4.6 Configuring the System The system will automatically save the modifications after you make the related settings. 4.6.1 Patient Information Setting Item Description ID Generating Choose from: Auto or Manual Input Select Auto, the patient ID can be automatically generated according to Method the examination date.

  • Page 33: Sampling Storage Setting

    PADECG User Manual Operation instructions the First Name and Last Name textboxes. Choose from: Manual or Date of Birth You can configure the items to be displayed on the New Patient window, Other Display including: height, weight, blood pressure, race, medication, department, Settings room number, request number, exam.

  • Page 34: Filter Setting

    PADECG User Manual Operation instructions Choose from: SCP, FDA-XML, DICOM, PDF, JPG, BMP. File Format If selected, files in the selected format will be generated when sampling finishes. NOTE: This item only applies to the local mode. Choose from: ID, Name, Date of Birth, Exam. Time, and blank.

  • Page 35: Transmission Setting

    PADECG User Manual Operation instructions highest bandwidth in filter settings. Otherwise, ECG signal may be distorted. 4.6.4 Transmission Setting Item Description Device No. Type the Device No., within 30 ASCII characters. Auto Upload Select this item, the system will automatically upload files to the server when sampling finishes.
  • Page 36 PADECG User Manual Operation instructions defaults Device Info View or edit the information of sampling devices. NOTE: If a DX12(iOS) Transmitter is connected, its information (name and address) will be displayed on the screen, otherwise, the hint "No sampling device is connected" will be displayed.

  • Page 37: Chapter 5 Hint Information

    PADECG User Manual Hint Information Chapter 5 Hint Information Hint information and the corresponding causes provided by the system are listed as follows. Table 5-1 Hint Information and Causes Hint Information Causes Electrodes fall off the patient or the patient Lead off: X cable falls off the DX12(iOS) Transmitter.

  • Page 38: Chapter 6 Cleaning, Care And Maintenance

    PADECG User Manual Cleaning, Care and Maintenance Chapter 6 Cleaning, Care and Maintenance Use only the manufacturer-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 39: Cleaning The Dx12(Ios) Transmitter

    PADECG 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 40: Disinfection

    PADECG User Manual Cleaning, Care and Maintenance dampened with the cleaning solution until no visible contaminants remain. 3. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains.

  • Page 41: Disinfecting The Patient Cable

    PADECG User Manual Cleaning, Care and Maintenance 6.3.2 Disinfecting the Patient Cable 1. Wipe the patient cable with a soft cloth dampened with the disinfectant solution. 2. Wipe off the disinfectant solution with a dry cloth after disinfection. 3. Leave the patient cable to air dry for at least 30 minutes.
  • Page 42 PADECG User Manual Cleaning, Care and Maintenance WARNING Failure on the part of the responsible individual hospital or institution employing this equipment to implement a satisfactory maintenance schedule may cause undue equipment failures and possible health hazards. 1) iPad and DX12(iOS) Transmitter ♦...

  • Page 43: Chapter 7 Accessories

    PADECG User Manual Accessories Chapter 7 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 7-1 Accessory List Accessory Part Number ECG Cable, DX12 Patient Cable (IEC) 01.57.471030...

  • Page 44: Chapter 8 Warranty And Service

    PADECG User Manual Warranty and Service Chapter 8 Warranty and Service 8.1 Warranty The manufacturer warrants that the manufacturer's products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period.

  • Page 45: Appendix 1 Technical Specifications

    PADECG User Manual Technical Specifications Appendix 1 Technical Specifications A1.1 Safety Specifications IEC 60601-1:2015+A1:2012+A2:2020 EN 60601-1:2006/A2:2021 Comply with: IEC 60601-1-2:2014+A1:2020 EN 60601-1-2:2015/A1:2021 IEC 60601-2-25 Anti-electric-shock type: Internally powered equipment Anti-electric-shock degree: Type CF with defibrillation-proof Degree of protection against harmful...

  • Page 46: A1.3 Physical Specifications

    PADECG User Manual Technical Specifications A1.3 Physical Specifications Dimensions DX12(iOS)Transmitter:63mm(L)×107mm(W) ×23mm(H) (2.5in×4.2in×0.9in) Weight DX12(iOS) Transmitter: Approx. 113g (not including battery) A1.4 Power Supply Specifications DX12(iOS) Transmitter: Input Power: 2×1.5V Excell Alkaline AA IEC Power Supply: LR6;Operation life of battery≥12 hours A1.5 Performance Specifications...
  • Page 47 PADECG User Manual Technical Specifications Defibrillation voltage: ±5 kV *Defibrillation protection Recovery time after defibrillation: < 5s Fulfil subclause 201.12.1.101 *Amplitude measurements IEC60601-2-25:2011 Input Impedance: ≥20MΩ (10Hz) Input Circuit Current: ≤0.05μA Input Voltage Range <±5mVp-p Calibration Voltage: 1mV±2% DC Offset Voltage: ±500mV...

  • Page 48: Appendix 2 Emc Information

    Guidance and manufacture’s declaration - electromagnetic emission The PADECG is intended for use in the electromagnetic environment specified below. The customer or the user of the PADECG should assure that it is used in such an environment. Emission test Compliance...
  • Page 49 PADECG User Manual EMC Information Electrical fast Not applicable Not applicable  2 kV for power transient/burst supply lines IEC/EN 1kV for input/output 61000-4-4 lines Surge Not applicable Not applicable 1 kV line to line IEC/EN 2 kV line to ground...
  • Page 50 Guidance and manufacture’s declaration - electromagnetic immunity The PADECG is intended for use in the electromagnetic environment specified below. The customer or the user of the PADECG should assure that it is used in such an environment. Immunity IEC/EN 60601 test...
  • Page 51 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PADECG is used exceeds the applicable RF compliance level above, the PADECG should be observed to verify normal operation.
  • Page 52 PADECG User Manual EMC Information Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment IMMUNITY Test Brand Modulation Maximum Distance TEST Frequency Service (MHz) Power(W) LEVEL (MHz) (V/m) Pulse 380-390 TETRA 400 modulation 18Hz GMRS 460, ±5 kHz...
  • Page 53 Recommended separation distances between portable and mobile RF communications equipment and the PADECG The PADECG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PADECG can help prevent...

  • Page 54: Appendix 3 List Of Serious Diseases

    PADECG User Manual Abbreviation Appendix 3 List of Serious Diseases Serious Diseases Second-degree Atrioventricular Block (Mobitz type II) Third-degree Atrioventricular Block Marked ST Depression Marked ST Elevation Acute Anterior Myocardial Infarction Acute High Lateral Myocardial Infarction Acute Inferior Myocardial Infarction...

  • Page 55: Appendix 4 Abbreviation

    PADECG User Manual Abbreviation Appendix 4 Abbreviation Abbreviation Statement Electrocardiograph/Electrocardiogram Blood Pressure Heart Rate P-wave Duration P-R Interval QRS Complexes Duration QT/QTc Q-T Interval / Normalized QT Interval The Axis of P Wave, QRS Complex, and T Wave in the...
  • Page 56 Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537 Hamburg Germany +49-40-2513175 FAX: +49-40-255726 TEL: E-mail: shholding@hotmail.com EDAN INSTRUMENTS, INC. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District, 518122 Shenzhen, P. R .China Email: info@edan.com TEL: +86-755-2689 8326 FAX: +86-755-2689 8330...

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