About this Manual P/N: 01.54.455911 MPN: 01.54.455911018 Release Date: Oct. 2016 © Copyright EDAN INSTRUMENTS, INC. 2013-2016. 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.
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.
Contents Chapter 1 Safety Guidance ........................................................................................................... 1 1.1 Indications for Use/Intended Use ........................................................................................ 1 1.2 Warnings and Cautions........................................................................................................ 1 1.2.1 General Warnings ....................................................................................
4.2.2 Entering Patient Information by Using a Bar Code Reader .................................... 39 4.2.3 Retrieve Patient Information ................................................................................... 39 4.3 Selecting the ECG Sampling Type .................................................................................... 39 4.4 ECG Sampling .................................................................................................................. 40 4.4.1 Resting ECG Sampling ..
.1.8 Export ...................................................................................................................... 73 6.2 Order List .......................................................................................................................... 74 6.2.1 New Order ............................................................................................................... 74 6.2.2 Inbox .............................................................................................
Appendix 2 EMC Information .................................................................................................... 99 Appendix 3 Abbreviations .........................................................................................................
SE-1515 PC ECG User Manual Safety Guidance Chapter 1 Safety Guidance This chapter provides important safety information related to the use of SE-1515. 1.1 Indications for Use/Intended Use SE-1515 PC ECG is intended to acquire, process and store ECG signals from adult and pediatric patients undergoing stress exercise test or resting test. The SE-1515 PC ECG is intended to be used only in hospitals and healthcare facilities by doctors and trained healthcare professionals.
SE-1515 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. 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. SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet. Never try to adapt the three-prong plug to fit a two-slot outlet.
SE-1515 PC ECG User Manual Safety Guidance WARNING 17.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. 18.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 system.
SE-1515 PC ECG User Manual Safety Guidance WARNING 27.You should purchase computer, printer, treadmill, ergometer, BP monitor 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. 28.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. 29.
SE-1515 PC ECG 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.
SE-1515 PC ECG User Manual Safety Guidance WARNING 9. Properly dispose of or recycle the depleted battery according to local regulations. 10. Remove the battery from the transmitter if the system won't be used for a long time. 1.2.4 Preparation and Operation Warnings (for Exercise ECG) WARNING 1. Test the safety stop (mushroom type) and safety stop (cord type) of the treadmill before using the system. 2.
SE-1515 PC ECG User Manual Safety Guidance 1.2.5 Contraindications (for Exercise ECG) Absolute Contraindications: 1. Acute MI (within 2 days) 2. High-risk unstable angina 3. Hemodynamic compromise caused by uncontrolled cardiac arrhythmia 4. Symptomatic severe aortic stenosis 5. Heart failure with clinic episode uncontrolled 6. Acute pulmonary embolus or pulmonary infarction 7. Acute myocarditis or pericarditis 8. Acute aortic dissection 9. The patient opposes the test. Relative Contraindications: 1.
SE-1515 PC ECG User Manual Safety Guidance 1.3 List of Symbols No.
SE-1515 PC ECG User Manual Safety Guidance 13 Start printing button (on DE15&DE18) 14 CE marking 15 Disposal method 16 Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
SE-1515 PC ECG User Manual Introduction Chapter 2 Introduction The SE-1515 system consists of the following equipment: 18-lead ECG sampling system (18-lead ECG sampling box) Or, 16-lead ECG sampling system (16-lead ECG sampling box) Or, 12-lead wired ECG sampling system (12-lead ECG sampling box) Or, 12-lead wireless ECG sampling system (wireless DX12 transmitter and receiver) PC ECG software Patient cable Disposable electrodes USB cable According to the configurations of different typ
SE-1515 PC ECG User Manual Introduction 2.1 Wired SE-1515 System 2.1.1 Wired System Connection Diagram 1. Resting ECG of Wired SE-1515 System 2.
SE-1515 PC ECG User Manual Introduction 2.1.
SE-1515 PC ECG User Manual Introduction 1) Insert plug 1 of the patient cable into socket 2 of DE15 ECG sampling box. 2) Insert plug 7 of the cable into socket 3 of DE15 ECG sampling box. 3) Insert plug 8 of the cable into the USB socket of the PC. 4) Connect plug 6 of the cable to the BP monitor (for exercise ECG only). 5) Connect a treadmill or an ergometer to the PC (for exercise ECG only). 6) Connect a printer to the PC.
SE-1515 PC ECG User Manual Introduction 2.1.3.2 DP12 ECG Sampling Box Front Panel Indicator USB Interface Name Explanation Indicator When the ECG sampling box is powered by the PC, the indicator will be lit. USB Interface Connecting to the USB socket of the PC with a USB cable 2.2 Wireless SE-1515 System WARNING This device complies with Part 15 of the FCC Rules.
SE-1515 PC ECG User Manual 2. Introduction 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. 2.2.1 Wireless System Connection Diagram The DX12 device which consists of transmitter and receiver has passed FCC certification. This device complies with Part 15 of the FCC Rules.
SE-1515 PC ECG User Manual Introduction 1 Resting ECG of Wireless System 2 Exercises ECG of Wireless System NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. such modifications could void the user’s authority to operate this equipment. WARNING 1. Accessory equipment connected to the analog and digital interfaces must be certified according to the respective IEC/EN standards (e.g.
SE-1515 PC ECG User Manual Introduction service department or your local distributor. 2. The system should be installed by a qualified service engineer. Do not power on the system until all cables are properly connected and verified. 3. 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. 4.
SE-1515 PC ECG User Manual Introduction Resting ECG Cable Exercise ECG Cable Burglar Lock DX12 Belt Assembly Drawing 1) Insert plug 1 of the patient cable into socket 2 of DX12 transmitter. 2) Insert DX12 transmitter into pocket 3 of DX12 belt, and then wear the belt around the waist. 3) Insert plug 8 of the cable into socket 6 of the DX12 receiver. 4) Insert plug 9 of the cable into the USB socket of the PC. 5) Connect plug 10 of the cable to the BP monitor (for exercise ECG only).
SE-1515 PC ECG User Manual Introduction 6) Connect a treadmill or an ergometer to the PC (for exercise ECG only). 7) Connect a printer to the PC. 8) Insert the Sentinel into the USB socket of the PC if the sentinel is purchased. 9) Unlock burglar lock 11 and insert into the burglar lock keyhole of DX12 receiver, and fix the wireless system via the other end of the burglar lock.
SE-1515 PC ECG User Manual Button Introduction Explanation Switch on DX12 receiver and install batteries on DX12 transmitter. Press the button to start up DX12 transmitter, the main screen will be displayed.. When the main screen is displayed, press the button to return to previous menu. When the main screen or the setting screen is displayed, press the button to enter the next menu. Press the button first, and press keyboard. within 1.
SE-1515 PC ECG User Manual Back Light Introduction Select On to turn on the backlight of LCD screen. Select Off to turn off the backlight of LCD screen. Auto Sleep Select On to display Sleeping on the screen and make DX12 transmitter be in low power consumption mode after lead off for 5 minutes. Select Off to turn off auto sleep function. Language You can set the system language. Lead Electrode You can select IEC or AHA.
SE-1515 PC ECG User Manual Complied Standard Introduction IEC/EN 60950 NOTE: Ensure that there is a graphic driver installed in the PC. Otherwise, the displayed ECG waves may be abnormal. 2.3.2 About Installation Window Insert the installation CD into CD-ROM, double-click on Setup.exe and then follow the directions to finish the installation. For details on installing SE-1515 software, please refer to SE-1515 PC ECG Installation Guide. 2.
SE-1515 PC ECG User Manual Introduction Storing massive patient data in the computer, which enables you to review and analyze the exercise ECG in any time Automatically controlling and adjusting the speed and the elevation of the treadmill Supporting many kinds of treadmills and ergometers - 23 -
SE-1515 PC ECG User Manual Preparations Before Operation Chapter 3 Preparations Before Operation 3.1 Preparing the Patient NOTE: Correct operation for the best-quality ECG is very important. 3.1.1 Instructing the Patient 1. Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases the patient's anxiety. 2. Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area where others can't see the patient.
SE-1515 PC ECG User Manual Preparations Before Operation WARNING The performance and electric shock protection can be guaranteed only if the original patient cable and electrodes of the manufacturer are used. 3.
SE-1515 PC ECG User Manual Preparations Before Operation 3.3 Connecting the Electrodes of Wireless System Connecting to the ECG Sampling Box Connecting to Electrodes Main Cable Lead Wires Patient Cable (Snap Style) Lead Wires Main Cable Connecting to Connecting to Electrodes ECG Sampling Box Patient Cable (Banana Style) The patient cable includes patient cable plugs and lead wires which can be connected to electrodes according to the colors and identifiers.
SE-1515 PC ECG User Manual Preparations Before Operation 3.4 Attaching Electrodes 3.4.1 Attaching Electrodes for Resting ECG WARNING Make sure that the conductive parts of electrodes and associated connectors, including neutral electrodes, do not come in contact with earth or any other conducting objects. The quality of ECG waveform will be affected by the contact resistance between the patient and the electrode.
SE-1515 PC ECG User Manual Preparations Before Operation C9 White/Yellow V9 Brown/Yellow H Light blue/Violet/ H Orange/Violet E Light blue/ Yellow E Orange/Yellow I Light blue/ Red I Orange/ Red M Light blue/ Black M Orange/Black Standard 12-Lead Placement Only for the Reusable Electrodes Only for the Disposable Electrodes IEC AHA Electrode Placement C1 V1 Fourth intercostal space at the right border of the sternum C2 V2 Fourth intercostal space at the left border of the s
SE-1515 PC ECG User Manual Preparations Before Operation R RA Right arm/Right deltoid F LL Left leg/Upper leg as close to torso as possible N RL Right leg/Upper leg as close to torso as possible Standard+XYZ IEC AHA Electrode Placement C1 V1 Fourth intercostal space at the right border of the sternum C2 V2 Fourth intercostal space at the left border of the sternum C3 V3 Fifth rib between C2 and C4 C4 V4 Fifth intercostal space on the left midclavicular line C5 V5 Left anterior
SE-1515 PC ECG User Manual Preparations Before Operation H H Back of neck, avoid the carotid artery and jugular vein. E E Mid-sternum on the same horizontal level as C4 and C6. I I Right mid-axillary line on the same horizontal level as C4 and C6.
SE-1515 PC ECG User Manual N Preparations Before Operation RL Right leg/Upper leg as close to torso as possible NEHB Placement IEC AHA Electrode Placement Nst/C3R A1/V3R Attachment point of the second rib to the right sternal edge Nax/C4R A2/V4R Fifth intercostal space on the left posterior axillary line Nap/C4 V4 Left mid-clavicular line in the fifth intercostal space V3R+V4R +V5R (Right) IEC AHA Electrode Placement C3R V3R Right anterior chest opposite of C3 C4R V4R Right an
SE-1515 PC ECG User Manual Preparations Before Operation V7+V8+V9 (Back) DE18: IEC AHA Electrode Placement C7 V7 Left posterior axillary line on the same horizontal level as C4 and C6 C8 V8 Left midscapular line on the same horizontal level as C4 and C7 C9 V9 Left paraspinal border on the same horizontal level as C4 and C8 DE15: IEC AHA C7 V7 Electrode Placement Left posterior axillary line on the same horizontal level as C4 and C6 C8/V5R V8/V5R Left midscapular line on the same horiz
SE-1515 PC ECG User Manual Preparations Before Operation The Precordial Electrodes' Positions on Body Surface: IEC AHA Electrode Placement C1 V1 Fourth intercostal space at the right border of the sternum C2 V2 Fourth intercostal space at the left border of the sternum C3 V3 Fifth rib between C2 and C4 C4 V4 Fifth intercostal space on the left midclavicular line C5 V5 Left anterior axillary line at the horizontal level of C4 C6 V6 Left midaxillary line at the horizontal level of C4 Th
SE-1515 PC ECG User Manual Preparations Before Operation 3.4.3.
SE-1515 PC ECG User Manual Preparations Before Operation 2) Clean the electrode areas on the body surface with 75% alcohol. 3) Attach the disposable electrodes to the electrode positions on the body surface. 4) Clip the disposable electrodes with the alligator clips. Snap/Banana Socket Adapters Disposable Electrode (Snap Style) Disposable Electrode Connection (Snap Style) 1) Align all lead wires of the patient cable to avoid twisting, and cnnect Snap/Banana Socket Adapters to connector of patient cable.
SE-1515 PC ECG User Manual Preparations Before Operation 2) Power Supply: Check whether the power cord is connected well. The grounded outlet should be used. 3) Ground Connection Check whether the ground cable is firmly connected. 4) Patient Cable: Check whether the patient cable is connected to the ECG sampling box firmly, and keep it far away from the power cord. 5) Electrodes: ♦ Check whether all electrodes are connected to lead wires of the patient cable correctly.
SE-1515 PC ECG User Manual ECG Sampling Chapter 4 ECG Sampling Plug in the right sentinel, and double-click screen will be displayed as follows: on the screen to start the software. The main Figure 4-1 Main screen 4.1 Initial Configuration When the software is started the first time after installation, an Initial Setting window will be displayed, and you can configure parameters such as the hospital name, lead mode, and sequence.
SE-1515 PC ECG User Manual ECG Sampling Figure 4-2 New Patient window You can also enter the New Patient window by clicking New Patient on the analysis screen. 2. New Order On the Archives screen, click Order List, and you enter patient information in the New Order area. NOTE: The Order List is not displayed in the Archives screen by default. You have to select Display Order List in the Basic Setting window of System Setting. 4.2.
SE-1515 PC ECG User Manual ECG Sampling 4.2.2 Entering Patient Information by Using a Bar Code Reader The procedure is as follows: 1. Configure the bar code For more detailed information about configuring the bar code, please contact the manufacturer or the local distributor. NOTE: If the two-dimensional bar code reader is used, you should install Symbol COM Port Emulation Driver manually. For details, please refer to SE-1515 PC ECG Installation Guide. 2. Connect the USB bar code reader to the computer.
SE-1515 PC ECG User Manual ECG Sampling 4.4 ECG Sampling 4.4.1 Resting ECG Sampling Click on OK after filling out the patient information and selecting the ECG sampling type, the ECG sampling screen will be displayed. NOTE: When placing a new order, if you want to start ECG sampling right after placing the order, select Start examination after order in the Display Setting of System Setting. Figure 4-3 Resting ECG Sampling 4.4.1.1 Buttons NOTE: 1.
SE-1515 PC ECG User Manual Edit ECG Sampling Once clicked, the New Patient window will be displayed and you can edit the patient information. Once clicked, the frozen window will be displayed. Freeze Keep Event F5 Settings On the displayed window, you can review the ECG sampled before, and print the displayed ECG by clicking on the Print button. If this button has been clicked, the system continues the sampling when the sampling time extends the preset time.
SE-1515 PC ECG User Manual ECG Sampling 4.4.1.4 Sample Setup Click on Setting on the resting ECG sampling screen, and the System Setting window will be displayed. In the System Setting window, click Sampling Setting to enter the Sampling Setting window. Parameter Description Device Type Options provided are DP12, DX12, DE15, SE12, DE18, and DEMO. If DX12 is selected, you can view the address of the DX12 wireless receiver after clicking on Receiver Address.
SE-1515 PC ECG User Manual ECG Sampling Standard+NEHB І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, ND, NA, NI Standard+XYZ І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, X, Y, Z Children mode І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, V7 Under the 16-lead mode, you can choose Standard+Right. Lead Sequence Lead Group Standard+Right І, II, ІІІ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6, V3R, V4R, V5R, V7 Under the 18-lead mode, you can choose Standard+Right+Back.
SE-1515 PC ECG User Manual ECG Sampling all analysis screens. If OFF is selected, the system does not generate any automatic diagnosis results after the sampling is complete. Enter the analysis screen when sampling finishes If this function is selected, the system automatically switches to the analysis screen after the sampling is complete. Auto print when sampling finishes If this function is selected, the system automatically prints the report after the sampling is complete. 4.4.1.
SE-1515 PC ECG User Manual ECG Sampling The wave width can be set to 1, 2, 3, 4, or 5. A larger value means that the waveforms printed are wider. NOTE: This parameter affects the printing only, the waveforms displayed on the screen remains the same. Print Setting Sequence can be set to sequential or synchronous. If sequential is selected, the lead group will be sampled group by group. If synchronous is selected, all the leads will be sampled at the same time.
SE-1515 PC ECG User Manual ECG Sampling Parameter Description Enable Vector Calculation Once enabled, you can view the vector calculation results on the analysis screen for resting ECG. NOTE: Parameter Setting This function is unavailable Standard+XYZ mode.. in 9-Lead mode and Axis Calculation Method can be set to Area Method or Amplitude Method. Tachycardia Criterion (greater than): Manual input, default: 100 bpm.
SE-1515 PC ECG User Manual ECG Sampling No: No grid will be displayed on the waveform screens. Arrhythmia hint, can be set to On or OFF. If it is set to On, when arrhthmia data is sampled during the sampling process, the system will highlight the related waveforms and provides the arrhthmia type. Printer type You can select a type of printers in the operating system. Comment when marking an event When this function is selected, you can add a mark on an event. 4.4.
SE-1515 PC ECG User Manual ECG Sampling 4.4.3.1 Buttons NOTE: 1. You can use F1–F9 on the keyboard directly to control the ECG sampling screen. 2. No matter how many changes on the speed or slope you make in a stage, the software only saves the latest one. Button Description Pretest On the presampling screen, you can click Pretest to enter the pretest stage. F1 On the sampling screen, you can click Pretest to move into the next pretest stage.
SE-1515 PC ECG User Manual ECG Sampling (X<10), the system will print the waveforms in the last Xs. Freeze F6 During the presampling stage and test, Freeze is displayed. Click Freeze and the frozen window will be displayed. Edit/Event During presampling, you can click Edit to open the New Patient window and edit patient information. During the test, Event is displayed. You can click it to mark an event.
SE-1515 PC ECG User Manual ECG Sampling 4.4.3.2 Parameter Information Display Heart rate display Target HR Percentage of the current HR against the target HR Current HR NOTE: 1. If the background color of the current HR displayed is yellow, it indicates that the current HR excesses the target value and should be paid attention to. 2. If the current HR excesses the target value, you should click Recovery to move into the Recovery stage and observe the waveforms of in that stage.
SE-1515 PC ECG User Manual ECG Sampling When you click Re-identify after you have manually adjusted the measurement line, the system automatically calculates the place of the measurement line of the Q point and J point and their corresponding ST value and ST slope. The system also refreshes the place of the measurement line of the Q point and J point every 10s. 1. single amplified mean wave You can manage the lead to be displayed by system scan or manual configuration. 2.
SE-1515 PC ECG User Manual ECG Sampling 4.4.3.6 Device Setup Click on Settings on the exercise ECG sampling screen, and the System Setting window will be displayed. In the System Setting window, click Device to enter the Device window. Parameter Description Device Type Options provided are Treadmill or Ergometer. Device Model You can configure the device model based on the device used. If RUNNER RUN-2011/T treadmill is to be used, set the Device Model to Trackmaster Treadmill.
SE-1515 PC ECG User Manual ECG Sampling 4.4.3.7 Protocol Editing In the Device window, select a protocol and click Edit to enter the editing window for non-default protocols. In this window, you can change any parameter of each stage or delete the non-default protocols. 4.4.3.8 Parameter Setup Item Description Target HR You can configure the Max predicted HR and the calculation method of the target HR. Normal BP range You can configure the systolic and diastolic to the value in the normal range.
SE-1515 PC ECG User Manual ECG Sampling If Print/Print and Save/Save is selected, the 12-lead report of the Exercise stage will be Print/Print and Save/Save. Event Report Options provided are OFF, Print, Print and Save, Save. If OFF is selected, the system will not print or save the event marker report during the exercise test, but it will save the event marker report to the summary and analysis screen.
SE-1515 PC ECG User Manual ECG Analysis Chapter 5 ECG Analysis Three methods can be used to enter the ECG analysis screen: 1. When the ECG sampling time has met the planed value, the system automatically stop ECG sampling and enters the ECG analysis screen. 2. Click Stop on the sampling screen, the system will automatically displays the analysis screen. 3. In the patient record area on the All List screen, double-click on a record to enter the analysis screen.
SE-1515 PC ECG User Manual 2. ECG Analysis Click Pharma to open the pharma study screen start pharma study. Test Time Setting In the parameter setup window for pharma study, you can set the report output time mode. The default value is 0-1-3-5-10-15. It means the system will automatically output a report in the beginning, 1st, 3rd, 5th, 10th, and 15th minute. This function is available only when the report format for pharma study is set to All-Lead ECG Report. You can also customize new time modes.
SE-1515 PC ECG User Manual ECG Analysis On the magnified waveform screen, drag the mouse and an electronic measurement ruler (hereinafter called ruler) and corresponding measurement data will be displayed. You can move the ruler by pressing Up/Down/Left/Right arrow keys. NOTE: The mark line and ruler cannot be used at the same time, please right -click to disable either of them first. To enable it, right-click again. 8.
SE-1515 PC ECG User Manual ECG Analysis 5.1.4 About the Rhythm Wave Window Click on Rhythm to enter the Rhythm screen. On this screen, you can view the rhythm waves. Item Description Event Review Click to view the strips about arrhythmia and strips saved when marking an event. 5.1.5 History Record On the analysis screen for resting ECG, click History and the History Record window will be displayed. You can view all the history records of the current user.
SE-1515 PC ECG User Manual ECG Analysis 5.2 Exercise ECG 5.2.1 About the Summary Screen 5.2.1.1 Stage Information The stage information includes: 1. 2. 3. 4. 5. 6. 7. Stage information list: If a treadmill is used, you can view the information such as stage, stage time, speed, slope, Workload, BP, PVC/min, Max ST and Min ST, etc. in every stage of the exercise test in the list.
SE-1515 PC ECG User Manual ECG Analysis DUKE score It is automatically calculated by the system and is used to evaluate the follow-up conditions after the exercise test. DUKE Value Risk Level >5 Low -10~5 Medium <-10 High NOTE: The DUKE value cannot be changed manually, but it automatically changes after you manually change the Max ST Change or Pectoralgia Type. HR Only integers from 0 to 350 are allowed. BP When in the unit of mmHg, only integers from 0 to 350 are allowed.
SE-1515 PC ECG User Manual ECG Analysis 5.2.1.3 Trend On the summary analysis area, you can view the following: HR Trend BP Trend DP Trend Workload Trend 5.2.2 About the All View Screen On the All View screen, you can view the ECG wave of one lead throughout the whole test and easily locate the abnormal waveforms. The All View screen consists of the Thumbnail ECG Display and Original ECG Display areas. 5.2.2.
SE-1515 PC ECG User Manual ECG Analysis 5.2.2.3 12-Lead ECG Panorama Click Full Screen on the All View screen and the all view window for 12-lead ECG will be displayed; more information about the leads will be displayed. On the 12-lead ECG panorama window, you can click Return to return to the PSI ECG window. 5.2.3 About the ECG Strip Screen 5.2.3.
SE-1515 PC ECG User Manual ECG Analysis 5.2.5 ST Trend On the ST Trend window, you can view: ST change trend ST trend STj trend ST slope trend ST/HR trend Click on any point of the curve and you can view the ST value corresponding to the point. Double-click on any point of the curve and you can open the all-lead waveform screen. 5.3 VCG Vector ECG displays 3D image of ECG activity. You can choose the plane and the vector loop on the VCG analysis screen.
SE-1515 PC ECG User Manual ECG Analysis 5.3.1 Displaying Vector ECG with All Plane and All Loop Set the plane to ALL and the loop to ALL. A B E D C F G Figure 5-2 Vector ECG - Plane of ALL and Loop of ALL Figure 5-2 displays Vector ECG with the plane of ALL and the loop of ALL. A- Vector ECG of Frontal B- Vector ECG of Horizontal C- Vector ECG of Sagittal D- Average templates of X, Y and Z leads. Double-click on this figure to display the magnified average template.
SE-1515 PC ECG User Manual ECG Analysis Designation Definition Max Vector The position of the maximal amplitude of QRS/P/T loop (ms) Amplitude The amplitude of the Max vector of QRS/P/T loop (mV) Angle The angle of the Max vector of QRS/P/T loop (degree) Direction Rotation direction of QRS/P/T loop CW Clockwise CCW Counter-clockwise 8 ‘8’ font ring 0.01 (amplitude) The amplitude at 0.01s from QRS loop 0.01 (angle) The angle at 0.01s from QRS loop 0.02 (amplitude) The amplitude at 0.
SE-1515 PC ECG User Manual ECG Analysis 0.03 (angle) The angle at 0.03s from QRS loop 0.04 (amplitude) The amplitude at 0.04s from QRS loop 0.04 (angle) The angle at 0.
SE-1515 PC ECG User Manual ECG Analysis The percent values in the square represent the area percentages of QRS loop in every quadrant. 20 mm/mV indicates the magnified multiple (gain). The red curve is QRS loop. You can click on the Zoom in button or the Zoom out button to change the gain of the displayed graphics. You can click on the Play button to watch the forming process of the QRS loop. 5.3.3 Displaying 3D Vector ECG Click on 3D to display the 3D VCG graph.
SE-1515 PC ECG User Manual ECG Analysis 5.4 HRV The HRV ECG analysis screen includes two tabs: Auto Diagnosis result and Waveform. NOTE: 1. The HRV sampling time can be set in the Sample Setting window. 2. The HRV analysis lead can be selected in the Sample Setting window.
SE-1515 PC ECG User Manual ECG Analysis Doctor Diagnosis Field 1. Enter your own opinions in the Diagnosis textbox, and then click on the OK button. 2. Or, double-click on the necessary results required to be added in the Glossary textbox, the selected results will be displayed in the Diagnosis textbox, and then click on the OK button. HRV waveform is displayed in the Waveform window. You can drag the mouse in the window to choose the wave field to be previewed or printed.
SE-1515 PC ECG User Manual ECG Analysis If you select Send, the sampled data will be sent by Window Live Mail (Windows 7/Vista) when it is saved to the designated directory. NOTE: In Windows 7/Vista, only if Window Live Mail is installed, can the report be sent by Email. WARNING The printouts need to be done with no scaling or sizing done to fit the page.
SE-1515 PC ECG User Manual Archives Chapter 6 Archives 6.1 All List Click Archives and then click All List, the following window will be displayed: Figure 6-1 Archives window 6.1.1 Record Display The All List screen can be displayed in two ways: focus on examination and focus on patient, which can be configured by selecting or deselecting Focus on patient. 6.1.2 Modifying Patient Information Select a patient record in the patient list and click Modify, the New Patient window will be displayed.
SE-1515 PC ECG User Manual Archives 6.1.3 Viewing Examination Records Double-click on an examination record in the examination record list to open the ECG analysis screen. You can determine whether the examination record is confirmed by the doctor by checking the examination status in the examination record list. Unconfirmed: The physician has not confirmed the diagnosis result, that is, the physician did not click on OK on the analysis screen to confirm the diagnosis result.
SE-1515 PC ECG User Manual Archives 6.1.6.2 Advanced Search Click More and the Exam. Record Advanced Search window will be displayed as follows: 6.1.7 Import Click Select File, select the right directory and the patient data to be imported, and click Import to import the patient data to the Archives screen. NOTE: Only ECG data in DAT format can be imported. 6.1.
SE-1515 PC ECG User Manual Archives 6.2 Order List Choose System Setting > Basic Setting, select Display Order List, and restart the system, the Order List will be displayed in the Archives screen. 6.2.1 New Order Fill out the patient information based on the patient and click OK. If the order is successful, the patient record will be displayed in the Order List below. 6.2.2 Inbox In the inbox, the doctor can quickly locate all the orders that are related to him/her. 6.2.
SE-1515 PC ECG User Manual Statistics Chapter 7 Statistics On the toolbar of the main screen, click Statistics to enter the Statistics window. The Statistics window contains the following categories: Examination Department Workload Count, Request Department Workload Count, Ref-Physician Count, Staff Workload Count, Operating Device Count, Cost Count, and Measurement Analysis Count.
SE-1515 PC ECG User Manual System Setup Chapter 8 System Setup Click on the System Setting button on the main screen to open the System Setting window. There are eight tabs in the System Setting window: Basic Information, Display Setting, Transmission Setting, File Output Setting, GDT Setting, DicomWorklist Setting, Barcode Setting, and Other Setting.
SE-1515 PC ECG User Manual System Setup 8.2 Display Setup In the Display Setting window, you can select the items to be displayed on the New Patient and order window. You can also configure the order function. 8.3 Transmission Setup Item Description UART Transmission Enable UART transmission and select transmission protocol. When Ymodem is selected, choose UART (Ymodem) When EdanSerial is selected, choose UART.
SE-1515 PC ECG User Manual Interval System Setup to Sound. Options provided are Hint once, Hint every 30s, Hint every 60s, Hint every 120s and Continuous Hint. When Hint once is selected, the system reminds the user only when data is received. Auto Diagnosis When this function is selected, the diagnosis results automatically displays on the analysis window after the data has been received.
SE-1515 PC ECG User Manual System Setup 8.5 GDT Setup NOTE: This is an optional advanced function. To activate it, please contact the local distributor. Item Description Enable GDT Select Enable GDT and then select .GDT or .001 according to the actual work stream. GDT Path Click on Browse to specify a path to exchange files with the EDP. Input File Name The command file name sent to the software from the EDP. Output File Name The data file name sent to the EDP from the software.
SE-1515 PC ECG User Manual System Setup Server IP/Server Port/Server AE/Client AE Set Server IP/Server Port/Server AE/Client AE to the server IP/server port/server AE/client AE used for the DICOM Worklist system. DICOM Store Setting Set the time when DICOM files are stored to the server. 8.7 HL7 Setup NOTE: This is an optional advanced function. To activate it, please contact the local distributor. The ECG workstation allows obtaining patient information and uploading files through the HL7 workflow.
SE-1515 PC ECG User Manual System Setup 3) In the Computer Management window, click Device Manager and select Human Interface Devices to view the ports. 4) After setting the device port to the viewed port on the Barcode Setting window, click Yes to restart the SE-1515 software. 8.9 Other Setup Item Description System Maintenance Production Activation System Password Setting After the password has been changed successfully, you have to enter the new password to enter the System Settings window.
SE-1515 PC ECG User Manual System Setup pressure, height and weight can be configured. Theme To set the system color scheme. Automatically set If enabled, the system automatically changes the status of a exmination to normal after record from Emergent to Normal after printing its report. printing 8.9.1 Product Authorization For details, refer to SE-1515 PC ECG Installation Guide. 8.9.2 Advanced Setting 8.9.2.1 Examination Department and Device Management On the Exam. Dept.
SE-1515 PC ECG User Manual System Setup The name of the backup folder does not allow special characters or letters in languages other than English. 8.9.2.5 Request Department Management Click on Request Dept. Management, you can modify the department name, add or delete department data.
SE-1515 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 Lead off: X Electrodes fall off the patient or the patient cable falls off the ECG sampling box. No sentinel detected! The sentinel is not inserted. No sampling box detected, enter DEMO The software is started without connecting the display? sampling box.
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance Chapter 10 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.
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper towel. 10.2.1 Cleaning the Sampling Box WARNING When the DX12 transmitter is used, turn off the power, disconnect the patient cable, and take out the battery before cleaning. 1. Wipe the exterior surface of the equipment using a soft cloth dampened with the cleaning solution until no visible contaminants remain. 2.
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance 10.3 Disinfection 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.
SE-1515 PC ECG User Manual Cleaning, Care and Maintenance 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. 10.4 Maintenance of ECG Sampling Box CAUTION Besides the maintenance requirements recommended in this manual, comply with local regulations on maintenance and measurement.
SE-1515 PC ECG User Manual Accessories Chapter 11 Accessories Accessory Part Number DE15 ECG Sampling Box (IEC) 02.01.210720 DE15 ECG Sampling Box (AHA) 02.01.210727 DE18 ECG Sampling Box (IEC) 02.01.211212 DE18 ECG Sampling Box (AHA) 02.01.211213 18-Lead Patient Cable (AHA) 01.57.471393 18-Lead Patient Cable (IEC) 01.57.471394 16-Lead Patient Cable (IEC) 01.57.471306 16-Lead Patient Cable (AHA) 01.57.471305 Adult Chest Electrodes 01.57.040163 Adult Limb Electrodes 01.57.
SE-1515 PC ECG User Manual Accessories 12-Lead Patient Cable (AHA) 01.57.471499 12-Lead Patient Cable (AHA) 01.57.471614 12-Lead Patient Cable (IEC) 01.57.109850 12-Lead Patient Cable (AHA) 01.57.109851 Pediatric Chest Electrodes 01.57.040168 Pediatric Limb Electrodes 01.57.040169 Disposable Adult Snap Socket Electrode 01.57.471056 Disposable Pediatric Snap Socket Electrode 01.57.471057 Disposable Clip-on Electrode Adapter 01.57.471031 Disposable Snap Socket Electrode 01.57.
SE-1515 PC ECG User Manual Accessories Recommended Optional Accessories Model: TM-400 Manufacturer: EDAN INSTRUMENTS, INC. China CE marking Model: Valiant Manufacturer: Lode B.V. The Netherlands CE marking Model: h/p/cosmos (all medical models) with coscom interface Manufacturer: Full Vision Inc. USA Treadmill: CE marking Model: mercury med 4.0, mercury 4.
SE-1515 PC ECG User Manual Accessories WARNING 1. 2. 3. 4. The electrical outlet and the isolating transformer shall only be used for supplying power to the part of the system. It will harm the wall outlet to connect the non-medical electrical equipment of the SE-1515 system directly to the wall outlet, because the non-medical electrical equipment of the system is intended to be powered by using the electrical outlet and the isolating transformer.
SE-1515 PC ECG User Manual Warranty & Service Chapter 12 Warranty & Service 12.1 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: 1. damage caused by mishandling during shipping. 2. subsequent damage caused by improper use or maintenance. 3. damage caused by alteration or repair by anyone not authorized by EDAN. 4.
SE-1515 PC ECG User Manual Technical Specifications Appendix 1 Technical Specifications A1.
SE-1515 PC ECG User Manual Technical Specifications DX12 ECG sampling box: -20ºC (-4ºF)~+55ºC (+131ºF) Relative Humidity: 25%RH~93%RH Non-Condensing 25%RH~80%RH Non-Condensing Atmospheric Pressure: 70 kPa ~106 kPa 86 kPa ~ 106 kPa A1.
SE-1515 PC ECG User Manual Technical Specifications A1.5 Performance Specifications HR Recognition HR Range 30 bpm ~300 bpm Accuracy ±1 bpm ECG Sampling Box Performance Leads Acquisition Mode DE18 18 leads DE15 16 leads DP12/DX12 12 leads DE18 simultaneously 18 leads DE15 simultaneously 16 leads DP12/DX12 simultaneously 12 leads 1kHz (Analysis) DE18/DE15 Sample Frequency 16kHz (Sampling) 1kHz (Analysis) DP12 1kHz (Sampling) 0.
SE-1515 PC ECG User Manual CMRR Technical Specifications DE18/DE15 ≥123dB (AC OFF) DP12 ≥115dB (AC OFF) DX12 ≥100dB (AC OFF) DE18/DE15 0.01Hz~300Hz (-3dB) DP12/DX12 0.05Hz~150Hz (-3dB) Frequency Response Gain 2.5, 5, 10, 20, 10/5, AGC (mm/mV) Input Impedance DE18/DE15 ≥100MΩ DP12 ≥50MΩ DX12 ≥20MΩ Input Circuit Current ≤10 nA Calibration Voltage 1mV ± 2% DE18/DE15/DP12 ±600mV DX12 ±500mV DC Offset Voltage Minimum Amplitude: 20 μVp-p DE18/DE15/DP12 ≤12.
SE-1515 PC ECG User Manual Insulation Filter Technical Specifications 4000Vrms/min AC DE18/DE15/DX12 50Hz/60Hz/Off EMG DE18/DE15/ DX12 25Hz/35Hz/45Hz/Off DX12 0.05Hz/0.32Hz/0.67Hz DE18/DE15 0.01Hz/0.05Hz/0.32Hz/0.67Hz DX12 150Hz/100Hz/75Hz DFT LOWPASS Filter Pacemaker Detection 300Hz/270Hz/150Hz/100Hz DE18/DE15 /150Hz/100Hz/75Hz DE18/DE15 ±750uV ~ ±700mV, 50us ~ 2.0ms DP12 ±2mV ~ ±700mV, 0.1ms ~ 2.0ms DX12 ±2mV ~ ±500mV, 0.1ms ~ 2.
SE-1515 PC ECG User Manual EMC Information Appendix 2 EMC Information Electromagnetic Emissions Guidance and manufacture's declaration - electromagnetic emission SE-1515 PC ECG is intended for use in the electromagnetic environment specified below. The customer or the user of SE-1515 PC ECG should assure that it is used in such an environment.
SE-1515 PC ECG User Manual Electrical transient/burst EMC Information fast 2 kV for supply lines power Not applicable Not applicable IEC 61000-4-4 Surge 1 kV line to line IEC 61000-4-5 2 kV line to ground Power frequency Not applicable Not applicable 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
SE-1515 PC ECG User Manual Immunity test EMC Information IEC 60601 Compliance test level level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of SE-1515 PC ECG, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Conducted RF 3 Vrms Recommended separation distance IEC610004-6 150 kHz to 80 MHz 3 Vrms d 1.
SE-1515 PC ECG 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 SE-1515 PC ECG is used exceeds the applicable RF compliance level above, SE-1515 PC ECG should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating SE-1515 PC ECG.
SE-1515 PC ECG User Manual Abbreviations Appendix 3 Abbreviations Abbreviation Full Description LCD Liquid Crystal Display BP Blood Pressure ECG Electrocardiogram/Electrocardiograph HR Heart Rate AC Alternating Current USB Universal Serial Bus AGC Auto Gain Control NC Normal Condition SFC Single Fault Condition - 103 -