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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.
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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.
1.3 List of Symbols ........................6 Chapter 2 Introduction........................7 2.1 Assembling the System ....................... 7 2.1.1 SE-1010 PC ECG System ..................7 2.1.2 DP12 ECG Sampling Box of the Wired System............9 2.1.3 DX12 ECG Sampling Box of the Wireless System ..........12 2.1.3.1 Keys and Icons ....................
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4.3 Entering Patient Information..................... 27 4.3.1 Entering Patient Information Manually ..............28 4.3.2 Entering Patient Information by Using a Bar Code Reader........29 4.3.3 Entering Patient Information by Acquiring Orders..........29 4.4 Sampling ECG Data......................30 4.5 Sampling STAT ECG ......................31 Chapter 5 Analyzing ECG Data....................
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8.7 Data Maintenance Setup ....................58 8.8 GDT Setup ........................59 8.9 Other Setup........................60 8.10 Modifying the Glossary....................61 Chapter 9 Hint Information......................63 Chapter 10 Cleaning, Care and Maintenance ................65 10.1 Cleaning .......................... 65 10.1.1 Cleaning Tablet PC and the Patient Cable ............65 10.1.2 Cleaning the Reusable Electrodes.................
This chapter provides important safety information related to the use of SE-1010 PC ECG. 1.1 Intended Use SE-1010 PC ECG is a PC-based diagnostic tool intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. SE-1010 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals.
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SE-1010 PC ECG 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. 3. EXPLOSION HAZARD - Do not use the system in the presence of flammable anesthetic mixtures with oxygen or other flammable agents.
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SE-1010 PC ECG User Manual Safety Guidance WARNING 16. SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet supplying the system. 17. Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC/EN 60601-1-1 approved to the system.
SE-1010 PC ECG User Manual Safety Guidance WARNING 25. You should purchase computer, printer, and bar code reader from the manufacturer. Otherwise, the manufacturer will not be held responsible for the maintenance of the PC hardware, operating system and other accessories.
SE-1010 PC ECG User Manual Safety Guidance WARNING 6. When leakage or foul smell is found, stop using the battery immediately. If your skin or cloth comes into contact with the leakage liquid, cleanse it with clean water at once. If the leakage liquid splashes into your eyes, do not wipe them.
SE-1010 PC ECG User Manual Safety Guidance 1.3 List of Symbols Equipment or part of CF type with defibrillator proof Caution Consult Instructions for Use Recycle Part Number Serial Number Date of Manufacture Manufacturer Authorized Representative in the European Community...
Introduction Chapter 2 Introduction SE-1010 PC ECG is a mobile PC ECG workstation, which has similar functions with an ordinary electrocardiograph. ECG data can be sampled, analyzed and stored in a PC, and it can be saved in PDF, Word, BMP or JPG format. ECG waves can be frozen and reviewed. Auto measurement and diagnosis are available, and the diagnosis template can be edited.
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SE-1010 PC ECG User Manual Introduction 2. The Wireless System Patient Patient Cable Tablet PC DX12 ECG Sampling Box WARNING DX12 transmitter of the wireless system uses the Bluetooth technology, which could make the patient with the pacemaker uncomfortable. Keep DX12 transmitter far away from the pacemaker when using the wireless system of PC ECG.
SE-1010 PC ECG 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 60601-1-1.
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SE-1010 PC ECG User Manual Introduction Front Panel Lamp USB Socket Name Explanation When the ECG sampling box is powered by the PC, the lamp Lamp will be lit. USB Socket Connecting to the USB socket of the PC with a USB cable...
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SE-1010 PC ECG User Manual Introduction Back Panel Patient Cable Socket : Applied part of type CF with defibrillator proof : Caution Patient Cable Socket Definitions of corresponding pins: Signal Signal Signal C2 / V2 F / LL C3 / V3...
SE-1010 PC ECG User Manual Introduction Top Panel and Bottom Panel Screw Label Decorative Chip Wireless System 2.1.3 DX12 ECG Sampling Box of the DX12 Transmitter Appearance - 12 -...
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SE-1010 PC ECG User Manual Introduction Front Panel Patient Cable Socket Patient Cable Socket :Applied part of type CF with defibrillator proof :Caution Definitions of corresponding pins: Signal Signal Signal Signal C5/V5 L/LA F/LL C2/V2 C4/V4 R/RA C6/V6 C1/V1 C3/V3 N/RL NOTE: The left side of “/”...
SE-1010 PC ECG User Manual Introduction 2.1.3.1 Keys and Icons Main Screen Menu Screen Keys/Icons Description After batteries are installed, press this key to turn on/off DX12 transmitter. When the Menus screen is displayed, press this key to return to the previous screen.
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 SE-1010 PC ECG software. 2.1.3.2 Setting the Menu...
SE-1010 PC ECG User Manual Introduction 2.2.1 System Running Environment Windows7 ultimate Operating System Dual core 1.5GHZ or above CPU: 1G or above System Memory (RAM): 32G or above Hard Disk: 10.1” TFT (Resolution: 1280*800) Display: Built-in WIFI, IEEE802.11B/G/N Wireless Network Card: USB2.0...
Introduction Click on the Help button to see the installation guide. For details on installing PC ECG software, please refer to SE-1010 PC ECG Installation Guide. 2.2.3 Matching DX12 Transmitter with Tablet PC NOTE: Ensure batteries of DX12 transmitter and tablet PC are full, the tablet PC is powered on and enter the operating system before matching DX12 transmitter and the tablet PC.
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SE-1010 PC ECG User Manual Introduction 3. Select the computer name for the required tablet PC on the screen of DX12 transmitter, and then press to confirm. Initializing… will be displayed for 8s, and then Initialization is completed,the system will restart in 5s.
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SE-1010 PC ECG User Manual Introduction 5. Click on Enter the device’s pairing code, and then click on the Next button. 6. Input the default password (12345678), and then click on the Next button to confirm. - 19 -...
SE-1010 PC ECG User Manual Introduction 7. After a successful match, you can view the port on the Device Manager screen. 2.3 Features ♦ Supporting order function ♦ Transmitting ECG data to Smart ECG Net system over LAN ♦ Powerful functions, friendly windows and easy operation ♦...
SE-1010 PC ECG User Manual Operation 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.
SE-1010 PC ECG User Manual Operation Before Operation Connecting to Lead Wires ECG Sampling Box Main Cable Connecting Electrodes Patient Cable for Wired System Connect the patient cable to DP12 ECG sampling box of the wired system, and then secure them with two screws.
SE-1010 PC ECG User Manual Operation Before Operation Table 3-1 Electrodes and Their Identifiers and Color Codes European American WILSON FRANK Identifier Color Code Identifier Color Code Right arm Right arm White Left arm Left arm Yellow Black Right leg...
SE-1010 PC ECG User Manual Operation Before Operation European American Electrode Placement Label Label Fourth intercostal space at the right border of the sternum Fourth intercostal space at the left border of the sternum Fifth rib between C2 and C4...
SE-1010 PC ECG User Manual Operation Before Operation 3.3.2.2 Attaching the Chest Electrodes Suction Bulb Connecting to a Lead Wire Metal Cup Chest Electrode Chest Electrode Connection: 1) Ensure that the electrodes are clean; 2) Clean the electrode area on the chest surface with 75% alcohol;...
SE-1010 PC ECG User Manual Sampling Resting ECG Chapter 4 Sampling Resting ECG Double-click on on the desktop to display the main screen. NOTE: Do not use other software when using PC ECG software. Figure 4-1 Toolbar of Main Screen If you use PC ECG software for the first time, the following window will be displayed.
SE-1010 PC ECG User Manual Sampling Resting ECG 4.1 Viewing Lead Placement Information Click on on the main screen, and then click on Wilson lead system to view the lead placement information. 4.2 Viewing Patient Information You can view the patient information in one of the following two ways: 1.
SE-1010 PC ECG User Manual Sampling Resting ECG 4.3.1 Entering Patient Information Manually NOTE: User-defined 1/2 can be set in the Basic Information window, items of Pacemaker and specific patient information can be selected in the Print Setting window. Before setting them, these items in the Patient Information window are unavailable.
For more detailed information about configuring the bar code, please refer to Section 8.4. NOTE: If the two-dimensional bar code reader is used, you should install Symbol COM Port Emulation Drive manually. For details, please refer to SE-1010 PC ECG Installation Guide.
SE-1010 PC ECG User Manual Sampling Resting ECG 4.4 Sampling ECG Data After inputting the patient information, click on the OK button in the Patient information window to open the ECG pre-sampling screen. Figure 4-3 Pre-Sampling Screen Start Click on this button to save the sampled ECG data to the designated directory.
SE-1010 PC ECG User Manual Sampling Resting ECG The system can review a 3-minute (at least) waveform (counted 3 minutes before clicking on the Freeze button). NOTE: The display modes in the Wave review window are the modes you select on the ECG sampling screen. 3*1 and 6*1 display modes are displayed in 3*4 and 6*2 modes.
SE-1010 PC ECG User Manual Analyzing ECG Data Chapter 5 Analyzing ECG Data You can open the ECG analysis screen in one of the following three ways: 1. Click on the Start button, and then the system will stop sampling ECG and display the ECG analysis screen automatically after the ECG sampling time is over.
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SE-1010 PC ECG User Manual Analyzing ECG Data 2. About the Average Template Window Click on the Average Template tab to open the Average Template window. Set the speed and the gain in Click on a lead button in display magnified average templates of this lead. Click on more than one lead button to display magnified average templates of these leads overlapped with the same central axis.
SE-1010 PC ECG User Manual Analyzing ECG Data 4. About the Rhythm Wave Window Click on the Rhythm Wave tab to open the Rhythm wave window. gain, speed lead displayed waves Click on the Previous Page or Next Page button to display the waves of the previous or next page.
SE-1010 PC ECG User Manual Analyzing ECG Data 5.3 Viewing Parameters and Diagnosis Double-click on a parameter, and then you can modify it. Then click on the Save button to save the modifications. These parameters are as follows. Designation Description...
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SE-1010 PC ECG User Manual Analyzing ECG Data Effect pictures of report title are as shown below: Report Title in One Line Report Title in Two Lines - 36 -...
SE-1010 PC ECG User Manual Analyzing ECG Data 5.5 Printing ECG Reports 1. Choose Start > Printers and Faxes, and then right-click on the icon of the printer used, and select Set as Default Printer. Then close the Printers and Faxes window.
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SE-1010 PC ECG User Manual Analyzing ECG Data If you select Send, the sampled data will be sent by Window Live Mail (Windows 7) when it is saved to the designated directory. During the saving and sending course, the system will give the hint information.
SE-1010 PC ECG User Manual Processing Orders Chapter 6 Processing Orders Click on on the main screen to display the Order Manager window. Figure 6-1 Order Manager Window 6.1 Loading Orders Before loading orders, please configure the Order Setup window. For details, please refer to Section 6.5.
SE-1010 PC ECG User Manual Processing Orders NOTE: 1) If orders are modified in Smart ECG Net system, the corresponding orders existing in the Order Manager window will be refreshed after you load orders from the system. 2) Ensure the software of Smart ECG Net is stared up when you load orders from the system.
SE-1010 PC ECG User Manual Processing Orders 6.5 Setting Orders Click on the Setup button in the Order Manager window to make settings of orders. Item Description Order Server IP Set this item to Server IP of Smart ECG Net Client.
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SE-1010 PC ECG User Manual Processing Orders Item Description Delete After Select this item, the order will be deleted from the Order Manager window after the order is examined. Examination Exam.Room Filter Select this item, and enter an exact exam.room in the textbox, such as Electrocardiograph.
SE-1010 PC ECG User Manual Processing Records Chapter 7 Processing Records Click on on the main screen to display the Data Manager screen. Figure 7-1 Data Manager Screen All names of the physicians are displayed in this column. Click on one physician, all the patient records examined by this physician will be displayed in the patient information list.
SE-1010 PC ECG User Manual Processing Records Click on this button to display the Search Condition window, and then enter the search conditions. Click on the Search button, and all the patient records which meet the conditions will be displayed in the patient information list.
SE-1010 PC ECG User Manual Processing Records 7.3 Deleting Records NOTE: The deletion of records is permanent, and you can’t restore the records deleted. Please use this operation cautiously. Click on a patient record in the patient information list, and then click on the Delete button to delete the selected patient record.
SE-1010 PC ECG User Manual Processing Records Item Description Select the leads, and set the speed and gain to be compared from the this pull-down list. Select this item to display the waves of the two examination records. The black wave is the original wave and the blue wave is the compared wave.
SE-1010 PC ECG User Manual Processing Records 7.7 Exporting ECG Data from the Data Manager Screen Select examination records and click on the Export button on the Data Manager screen to display the Report Save window. Assign the file name, saving path and export file format (SCP, FDA-XML, DICOM, dat, pdf), and then click on the OK button to export the data into the selected path.
SE-1010 PC ECG User Manual Configuring the System Chapter 8 Configuring the System Click on on the main screen to open the System Setting window. After you modify some information in the System Setting window, 1. Click on the OK button to save these modifications and exit.
SE-1010 PC ECG User Manual Configuring the System Item Description Memory Select this item, the content of User-Defined 1 in the Patient Information or Search Condition windows is the information you input last time. Deselect this item, the content of User-Defined 1 is empty when you open the Patient Information or Search Condition windows every time.
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SE-1010 PC ECG User Manual Configuring the System Item Description ♦ DFT Filter: DFT filter greatly reduces the baseline fluctuations Filter Setting without affecting ECG signals. Choose from: Weak and Strong. NOTE: If DFT filter is set to Strong, the ECG data displayed on the screen is 0.85 seconds later than the real-time ECG...
SE-1010 PC ECG User Manual Configuring the System Item Description Auto printing Select this item, if Arrhythmia ECG data, including Ventricular Tachycardia, 5>PVCS>=3, Paired PVCS, Bigeminy, Trigeminy, R ON T, when arrhymia single PVC and Missed Beat, is detected during the sampling course, printing will be triggered automatically.
SE-1010 PC ECG User Manual Configuring the System Item Description Sampling Device Choose from: DP10 Wired Sampling Box, DP12 Wired Sampling Box, DX12 Wireless Sampling Box, SE Serial Machine or DEMO Select DX12 wireless sampling box, you can click on the Address button to view the address.
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SE-1010 PC ECG User Manual Configuring the System Item Description Auto upload Select this item, the system will automatically upload files to Smart ECG Net system when sampling finishes. when sampling stops Auto upload Select this item, the system will automatically upload files to Smart ECG Net system when making diagnosis.
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Human Interface Devices to view port information. 4. In the Barcode Setting window, set Device to the port you view on the Computer Management screen, and then click on the OK button to confirm. 5. Restart the SE-1010 PC ECG software. - 54 -...
SE-1010 PC ECG User Manual Configuring the System 8.5 Print Setup Figure 8-6 Print Setting Window Item Description Patient Options Select the item displayed in the Patient Information window and the report printed out. Select First Name/Last Name, the Patient Name textbox in the Patient Information window will change into the First Name and Last Name textboxes.
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SE-1010 PC ECG User Manual Configuring the System Item Description Diagnosis Select the diagnosis item displayed on the preview screen and in the report printed out. NOTE: Position Mark should be selected together with Average template, because the position mark is only used to mark the position of ECG waves in the average template.
SE-1010 PC ECG User Manual Configuring the System 8.6 Output File Setup Figure 8-7 Output File Setup Window Item Description File Naming Each field of File Name includes ID, Name, ExamTime, Age and Sex items. Deselect Modify File Naming, File name is set to Exam Time-ID by default.
SE-1010 PC ECG User Manual Configuring the System Item Description PDF/JPG Setting Select Output PDF when making diagnosis, the system will automatically output PDF files when making diagnoses. Select Output JPG when making diagnosis, the system will automatically output JPG files when making diagnoses.
SE-1010 PC ECG User Manual Configuring the System Item Description Database Rebuild Click on the Rebuild Database button, click on … button in the Database-rebuild Setting window to select the path, and then click on the OK button to rebuild database.
SE-1010 PC ECG User Manual Configuring the System Item Description Select this item to enable GDT features. GDT Path Click on the Browse button to design the path to exchange files with EDP. Input file name Enter information in this textbox to set command file name assigned by EDP to the PC ECG system.
SE-1010 PC ECG User Manual Configuring the System Item Description Unit You can set the units of Height, Weight, BP, Slope, Speed, Time and Date. Color You can set the colors of the background, waves, grid (5mm), grid (1mm), mark and text.
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SE-1010 PC ECG User Manual Configuring the System 2. Adding a subitem Click on the item you wanted to add a subitem, enter a diagnosis subitem, such as bb in the textbox, and then click on the Add button. The added subitem will be displayed under aa.
SE-1010 PC ECG User Manual Hint Information Chapter 9 Hint Information Hint information and the corresponding causes provided by the system are listed as follows. Table 9-1 Hint Information and Causes Hint Information Causes Electrodes fall off the patient or the patient Lead off: X cable falls off the ECG sampling box.
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SE-1010 PC ECG User Manual Hint Information MSDE 2000 or SQL Server 2005 Express is not Sorry, Can not Connect to the Database! started up. Fail to create database! The system fails to create database. - 64 -...
SE-1010 PC ECG User Manual Cleaning, Care and Maintenance Chapter 10 Cleaning, Care and Maintenance 10.1 Cleaning CAUTION Turn off the tablet PC before cleaning. The mains supply must be switched off when using the adapter to charge the tablet PC.
SE-1010 PC ECG User Manual Cleaning, Care and Maintenance 10.2 Disinfection Disinfection of the main unit is not necessary need in daily maintenance, it is only necessary in operating room. In that case, please use hospital standard disinfectant. NOTE: Clean and disinfect the chest and limb electrodes after each use.
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SE-1010 PC ECG 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) Tablet PC ♦...
SE-1010 PC ECG User Manual Accessories Chapter 11 Accessories WARNING Only the patient cable and other accessories supplied by the manufacturer can be used. Or else, the performance and electric shock protection can not be guaranteed. Table 11-1 Standard Accessory List for Wired System...
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.
Guidance and manufacture’s declaration - electromagnetic emission SE-1010 PC ECG is intended for use in the electromagnetic environment specified below. The customer or the user of SE-1010 PC ECG should assure that it is used in such an environment. Emission test...
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Guidance and manufacture’s declaration - electromagnetic immunity SE-1010 PC ECG is intended for use in the electromagnetic environment specified below. The customer or the user of SE-1010 PC ECG should assure that it is used in such an environment. Electromagnetic...
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Guidance and manufacture’s declaration - electromagnetic immunity SE-1010 PC ECG is intended for use in the electromagnetic environment specified below. The customer or the user of SE-1010 PC ECG should assure that it is used in such an environment. Immunity...
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RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which SE-1010 PC ECG is used exceeds the applicable RF compliance level above, SE-1010 PC ECG should be observed to verify normal operation.
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RF communications equipment and SE-1010 PC ECG SE-1010 PC ECG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of SE-1010 PC ECG can help prevent...
SE-1010 PC ECG User Manual Abbreviation Appendix 3 Abbreviation Abbreviation Statement Electrocardiograph/Electrocardiogram Blood Pressure Heart Rate P-wave Duration P-R Interval QRS Complexes Duration QT/QTc Q-T Interval of the Current Lead / Normalized QT Interval Dominant Direction of the Average Integrated ECG...
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