About this Manual P/N: 01.54.000805 MPN: 01.54.000805015 Release Date: February 2017 © Copyright EDAN INSTRUMENTS, INC. 2014-2017. All rights reserved. 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 EDAN INSTRUMENTS, INC. (hereinafter called EDAN) cannot be held liable.
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. NOTE A NOTE provides useful information regarding a function or a procedure.
Table of Contents Chapter 1 Safety Guidance ........................................................................................................... 1 1.1 Intended Use/Indications for Use ........................................................................................ 1 1.2 Warnings and Cautions........................................................................................................ 1 1.2.1 General Warnings ...........................................................................
4.6.3 Filter Setting ............................................................................................................ 28 4.6.4 Transmission Setting ............................................................................................... 28 4.6.5 Other Setting ........................................................................................................... 29 Chapter 5 Hint Information ...............................................................................................
PADECG User Manual Safety Guidance 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.
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. 4. Only the patient cable and other accessories supplied by the manufacturer can be used.
PADECG User Manual Safety Guidance WARNING 16. Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.). 17. 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.
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 iOS tablet 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). The iOS tablet shall be charged outside the patient environment, and no operations are permitted during the charging. 26. The device shall not be serviced or maintained while in use with a patient.
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. 2. Batteries of the same model and specification as manufacture configuration should be used. 3. DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when installing the battery. 4.
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. is likely to bring electromagnetic interference. 4. The device and accessories are to be disposed of according to local regulations after their useful lives.
PADECG User Manual Safety Guidance 7 General symbol for recovery/recyclable 8 Part Number 9 SERIAL NUMBER 10 Date of manufacture 11 MANUFACTURER 12 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 13 CE marking 14 Disposal method 15 Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
PADECG User Manual 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. PADECG includes the following equipment, you can also purchase the iOS tablet.
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.
PADECG User Manual Introduction 2.1.
PADECG User Manual Introduction 2.1.2.1 Keys and Icons Main Screen Menu Screen Keys/Icons Description After batteries are installed, press this key to turn on/off DX12(iOS) Transmitter. When the Menu screen is displayed, press this key to return to the previous screen. When the Main or Menu screen is displayed, press this key to enter the next menu. Press this key, and then press keypad. in 1.2 seconds to lock / unlock the When the Main screen is displayed, press this key to switch the lead.
PADECG User Manual Introduction NOTE: ECG waveforms displayed on the DX12(iOS) Transmitter only indicates whether the electrodes are attached properly. Diagnosis and evaluation of the ECG should be done based on the display on the iPad. 2.1.2.2 Setting the Menu Menu Description Back Light Select On to turn on the backlight of LCD screen. Select Off to turn off the backlight of LCD screen.
PADECG User Manual Introduction WARNING 1. Use the PADECG system only on the tablet that is installed with the official operating system (OS) versions released by the tablet's manufacturer. 2. When upgrading the tablet OS, consult EDAN service engineer if necessary. 2.2.2 About Installation Enter the App Store of the iOS tablet, input PADECG to search for the software. The installation is the same as that of other software available in the iOS tablet. NOTE: 1.
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. 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.
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. Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area where others can’t see the patient. Make sure that the patient is comfortable.
PADECG User Manual Preparations Before Operation Lead Wires Main Cable Connecting to DX12(iOS) Transmitter Electrode Connector 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. 2. Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the electrodes. Firmly attach them. 3.
PADECG User Manual Preparations Before Operation White/Yello w White/Green V2 V3 Brown/Yello w Brown/Green V4 Brown/Blue C5 White/Brow n White/Black V5 C6 White/Violet V6 Brown/Orang e Brown/Violet Chest 2 E C2 Chest 3 C C3 Chest 4 A C4 Chest 5 M Chest 6 H 3.3.
PADECG User Manual Preparations Before Operation F LL Left leg/Upper leg as close to torso as possible N RL Right leg/Upper leg as close to torso as possible 3.3.2 Attaching the Reusable Electrodes 3.3.2.
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; 4) Place a small amount of gel on the brim of the chest electrode’s metal cup; 5) Place the electrode on the chest electrode site and squeeze the suction bulb.
PADECG User Manual Operation instructions Chapter 4 Operation Instructions 1. Turn on the iOS tablet and enable the Bluetooth function in iPad>Settings>Bluetooth. 2. Connect to the required DX12(iOS) Transmitter. 3. Start the PADECG Analysis Software. 4. Input the user name and password, and then click Login. The default password is ecg (case sensitive). Click Setting, you can change the password, or enable or disable the Remember Password function.
PADECG User Manual 3. Operation instructions Description for buttons Key STAT ECG Description 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. Download: Press to download patient orders. Download Setting: Press to set the filter conditions for downloading patient information from the server.
PADECG User Manual Key Start/Stop Operation instructions Description Press this button to start/stop sampling ECG data. NOTE: At most 180s ECG data can be sampled. 100Hz EMG Filter: Off, 25Hz, 35Hz or 45Hz Lowpass Filter: Off, 75Hz, 100Hz or 150Hz NOTE: This setup modified on the pre-sampling screen is only effective for the current patient. 10mm/mV 25mm/s Patient File Gain: 2.5 mm/mV, 5 mm/mV, 10 mm/mV or 20 mm/mV Speed: 5mm/s, 12.5mm/s, 25mm/s or 50mm/s Press to enter the patient screen.
PADECG User Manual Operation instructions Long pressing the waveform on the ECG Analysis screen can amplify the ECG waveform. 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. Make the related settings, and then click on the OK button to save the modifications.
PADECG User Manual 6. Operation instructions Hiding or displaying measure information and diagnosis results On the ECG Analysis screen, you can slide the ECG waveforms upward to hide measure information and diagnosis results or downward to display them again. 7. Email Click on on the analysis screen, and then you can Email files by clicking on the Send Email button. The procedure is as follows: 1) Add an Email account.
PADECG User Manual Operation instructions 4.5 Processing Patient Records 1. Search Input the patient name in the search area, click on , and all the examination records which meet the conditions will be displayed in the examination record list. NOTE: Fuzzy search by patient name is supported in the search area. 2. Upload and Delete Long press one examination record in the examination record list, and you can perform the following operations on the selected record: view, upload, modify, or delete.
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 Method Select Auto, the patient ID can be automatically generated according to the examination date. Select Manual Input, you should enter the patient ID manually on the New Patient screen.
PADECG User Manual Operation instructions First/Last Name If enabled, the Name textbox on the New Patient screen will change into the First Name and Last Name textboxes. Age Choose from: Manual or Date of Birth Other Settings Display You can configure the items to be displayed on the New Patient window, including: height, weight, blood pressure, race, medication, department, room number, request number, exam. room, technician, physician, and priority.
PADECG User Manual Rhythm Definition Operation instructions Lead It can be set to any one of the leads. The default value is II. Edit Analysis If selected, you can modify the measurement information and diagnosis results locally. Result Locally 4.6.3 Filter Setting Item Description DFT Filter DFT filter greatly reduces the baseline fluctuations without affecting ECG signals. The purpose of this filter is to keep the ECG signals on the baseline of the printout. Choose from: 0.05Hz, 0.32Hz or 0.
PADECG User Manual Auto Upload Operation instructions Select this item, the system will automatically upload files to the server when sampling finishes. NOTE: This item only applies to the local mode. Under the network mode, the system automatically uploads files when sampling finishes. Delete file after uploading Select this item, the system will automatically delete files from the examination record list after they are uploaded. Order Server Address Set it to IP address of the order server.
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 Lead off: X Electrodes fall off the patient or the patient cable falls off the DX12(iOS) Transmitter. Lead wire reversal The limb leads are reversed. Order server connection fails! The order server is not enabled or the network connection is abnormal.
PADECG User Manual Cleaning, Care and Maintenance Chapter 6 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. Edan Instruments has validated the cleaning and disinfection instructions provided in this User Manual.
PADECG User Manual Cleaning, Care and Maintenance Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper towel. 6.2.1 Cleaning the DX12(iOS) Transmitter WARNING Turn off the power and take out the battery before cleaning. 1. Switch off the DX12(iOS) Transmitter and take out the battery. 2. Wipe the exterior surface of the equipment using a soft cloth dampened with the cleaning solution until no visible contaminants remain. 3.
PADECG User Manual Cleaning, Care and Maintenance 6.3 Disinfection If the equipment or accessory has been in contact with the patient, then disinfection is required. To avoid permanent damage to the equipment, it is recommended that disinfection is performed only when it is considered as necessary according to your hospital' regulations. Clean the equipment and reusable accessories before they are disinfected.
PADECG User Manual Cleaning, Care and Maintenance 6.3.3 Disinfecting the Reusable Electrodes 1. Wipe the suction bulbs of chest electrodes and the clamps of limb electrodes with a soft cloth dampened with the disinfectant solution. 2. Wipe off the disinfectant solution with a dry cloth after disinfection. 3. Leave the suction bulbs and clamps to air dry for at least 30 minutes. 6.
PADECG User Manual Cleaning, Care and Maintenance 1) iOS Tablet and DX12(iOS) Transmitter ♦ Avoid excessive temperature, sunshine, humidity and dirt. ♦ Put the dustproof coat on the DX12(iOS) Transmitter after use and prevent shaking it violently when moving it to another place. ♦ Prevent any liquid from seeping into the equipment; otherwise the safety and the performance of the ECG workstation cannot be guaranteed.
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 DX12 Patient Cable (IEC) 01.57.471030 DX12 Patient Cable (AHA) 01.57.471055 Patient Cable (IEC) 01.57.471278 Patient Cable (AHA) 01.57.471279 Chest electrodes 01.57.040163 Limb electrodes 01.57.
PADECG User Manual Warranty and Service Chapter 8 Warranty and Service 8.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) Damage caused by mishandling during shipping. b) Subsequent damage caused by improper use or maintenance. c) Damage caused by alteration or repair by anyone not authorized by EDAN. d) Damage caused by accidents.
PADECG User Manual Technical Specifications Appendix 1 Technical Specifications A1.
PADECG User Manual Relative Humidity: Atmospheric Pressure: Technical Specifications 15%RH ~ 95%RH 15%RH ~ 95%RH Non-Condensing Non-Condensing 70 kPa ~ 106 kPa 70 kPa ~ 106 kPa A1.3 Physical Specifications Dimensions Weight DX12(iOS) Transmitter: 63mm(L)×107mm(W) ×23mm(H) (2.5in×4.2in×0.9in) DX12(iOS) Transmitter: Approx. 113g (not including battery) A1.4 Power Supply Specifications DX12(iOS) Transmitter: Power Supply: Input Power: 2×1.
PADECG User Manual Technical Specifications Time Constant: ≥3.2 s Frequency Response: 0.05Hz ~ 150Hz Gain: 2.5, 5, 10, 20 (mm/mV) (±5%) Speed: 5mm/s, 12.5mm/s, 25mm/s or 50mm/s Input Impedance: ≥20MΩ (10Hz) Input Circuit Current: ≤0.
PADECG User Manual EMC Information Appendix 2 EMC Information Electromagnetic Emissions 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.
PADECG User Manual EMC Information Electrical fast 2 kV for power Not applicable transient/burst supply lines IEC 61000-4-4 1kV for input/output lines Surge 1 kV line to line IEC 61000-4-5 2 kV line to ground Power frequency 30A/m Not applicable Not applicable 30A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
PADECG User Manual EMC Information PADECG, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC61000-4-6 3 Vrms 3 Vrms 150 kHz to 80 MHz 150 kHz to 80 MHz d 1.2 P 6Vrmsc) in ISM 6Vrmsc) in bands between 0,15 MHz and 80 ISM bands between MHz 0,15 MHz and 80 MHz Radiated RF 3 V/m IEC61000-4-3 80 MHz to 2.7 GHz See Table 1 3 V/m 80 MHz to 2.
PADECG User Manual EMC Information frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
PADECG User Manual 710 EMC Information 704-787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0,2 0,3 9 800-960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse modulation b) 18 Hz 2 0,3 28 1700-1990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS Pulse modulation b) 217 Hz 2 0,3 28 2450 2400-2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 2 0,3 28 5240 5100-5800 WLAN 802.
PADECG 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 PADECG The PADECG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
PADECG User Manual Abbreviation Appendix 3 Abbreviation Abbreviation Statement ECG Electrocardiograph/Electrocardiogram BP Blood Pressure HR Heart Rate P P-wave Duration PR P-R Interval QRS QRS Complexes Duration QT/QTc Q-T Interval of the Current Lead / Normalized QT Interval P/QRS/T Dominant Direction of the Average Integrated ECG Vectors aVF Left Foot Augmented Lead aVL Left Arm Augmented Lead aVR Right Arm Augmented Lead LA Left Arm LL Left Leg RA Right Arm RL Right Leg