User Manual
205 Pages
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Page 1
About this Manual P/N: 01.54.32423-17 Release Date: July 2010 © Copyright EDAN INSTRUMENTS, INC. 2007-2010. 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) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual.
Product Information Product Name: Electrocardiograph Model: SE-12, SE-12 Express
Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and I
The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable.
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.
II
Table of Contents Chapter 1 Safety Guidance ........................................................................................................... 1 1.1 Intended Use ........................................................................................................................... 1 1.2 Warnings and Cautions ........................................................................................................... 1 1.2.1 Safety Warnings ............................................................................................................... 1 1.2.2 Battery Care Warnings ..................................................................................................... 3 1.2.3 General Cautions.............................................................................................................. 4 1.2.4 Cleaning & Disinfection Cautions ................................................................................... 6 1.2.5 Preparation and Operation Warnings (for SE-12 Express Exercise ECG)....................... 6 1.2.6 Contraindications (for SE-12 Express Exercise ECG)..................................................... 7 1.3 List of Symbols....................................................................................................................... 8 Chapter 2 Introduction................................................................................................................ 11 2.1 Top Panel .............................................................................................................................. 12 2.2 Keyboard and Keys .............................................................................................................. 13 2.3 Front Panel............................................................................................................................ 17 2.4 Rear Panel............................................................................................................................. 18 2.5 Right Panel ........................................................................................................................... 19 2.6 Bottom Panel ........................................................................................................................ 23 2.7 Function Features ................................................................................................................. 25 Chapter 3 About the Electrocardiograph Application.............................................................. 27 3.1 Selecting Menu Functions .................................................................................................... 27 3.2 Entering Data........................................................................................................................ 28 3.3 Selecting an Item .................................................................................................................. 29 3.4 About the Main Interface ...................................................................................................... 30 3.5 About the Main Interface of Exercise ECG (Optional for SE-12 Express).......................... 32 3.6 About the System Setup Interface ........................................................................................ 36 3.7 About the File Manager Interface ......................................................................................... 38 Chapter 4 Operation Preparations............................................................................................. 41 4.1 Power and Earthing .............................................................................................................. 41 4.2 Loading/Replacing Recorder Paper...................................................................................... 42 4.3 Preparing the Patient............................................................................................................. 46 4.3.1 Instructing the Patient .................................................................................................... 46 4.3.2 Preparing the Skin .......................................................................................................... 47 4.4 Connecting the Patient Cable to the Electrocardiograph and Electrodes ............................. 48 4.5 Attaching Electrodes to the Patient (for Resting ECG) ........................................................ 49 III
4.5.1 Lead Placement .............................................................................................................. 49 4.5.2 Electrode Placement....................................................................................................... 51 4.6 Attaching Electrodes to the Patient (for Exercise ECG)....................................................... 54 4.7 Inspection Before Power-On ................................................................................................ 56 Chapter 5 Turning On the Electrocardiograph......................................................................... 58 Chapter 6 Entering Patient Information ................................................................................... 59 6.1 Entering Patient ID ............................................................................................................... 59 6.2 Entering Other Information .................................................................................................. 60 6.3 Using a Bar Code Reader ..................................................................................................... 62 Chapter 7 Freezing ECG Waves ................................................................................................. 66 Chapter 8 Printing ECG Reports ............................................................................................... 68 8.1 Auto Mode ............................................................................................................................ 68 8.2 Manual Mode........................................................................................................................ 72 8.3 Rhythm Mode ....................................................................................................................... 74 8.4 R-R Analysis Mode .............................................................................................................. 76 8.5 Copy Printing........................................................................................................................ 78 8.6 ECG Reports......................................................................................................................... 79 8.6.1 ECG Reports in the Auto Mode ..................................................................................... 79 8.6.2 ECG Reports in the Rhythm Mode ................................................................................ 84 8.6.3 ECG Reports in the Manual Mode................................................................................. 85 8.6.4 ECG Reports in the R-R Analysis Mode........................................................................ 86 8.6.5 ECG Reports Printed by the USB Printer ...................................................................... 90 8.6.6 ECG Report of Patient with Pacemaker......................................................................... 91 8.6.7 ECG Report of Nehb Lead............................................................................................. 92 Chapter 9 Transmitting ECG Data Automatically.................................................................... 94 9.1 Transmitting ECG Data to the PC ........................................................................................ 94 9.1.1 Transmitting ECG Data in DAT Format Through Serial Cable ..................................... 94 9.1.2 Transmitting ECG Data in DAT Format Through Net Cable......................................... 96 9.1.3 Transmitting ECG Data in SCP/FDA-XML/PDF Format Through Net Cable ............. 98 9.2 Exporting ECG Data to the U Disk Automatically............................................................. 101 9.3 Real-time Transmission to PC ECG ................................................................................... 102 Chapter 10 Managing Files ....................................................................................................... 104 10.1 Transmitting Files to the PC ............................................................................................. 106 10.1.1 Transmitting DAT Files Through Serial Cable .......................................................... 107 10.1.2 Transmitting DAT Files Through Net Cable .............................................................. 108 IV
10.1.3 Transmitting SCP/FDA-XML/PDF Files Through Net Cable................................... 109 10.2 Exporting Files to the U Disk ........................................................................................... 110 10.3 Deleting Files.................................................................................................................... 111 10.4 Searching Files ................................................................................................................. 112 10.5 Importing Files ................................................................................................................. 113 10.6 Editing Patient Information .............................................................................................. 113 10.7 Printing Files..................................................................................................................... 114 10.8 Previewing a File .............................................................................................................. 114 Chapter 11 System Setup........................................................................................................... 118 11.1 Work Mode Setup ............................................................................................................. 118 11.1.1 Selecting Work Mode ................................................................................................. 119 11.1.2 Selecting Manual Style............................................................................................... 120 11.1.3 Selecting Rhythm Style .............................................................................................. 120 11.1.4 Selecting Auto Display Style...................................................................................... 120 11.1.5 Selecting Sampling Mode .......................................................................................... 121 11.1.6 Setting Interval and Duration ..................................................................................... 122 11.1.7 Selecting Preview Function........................................................................................ 122 11.1.8 Selecting Auto Extend Record ................................................................................... 122 11.2 Filter Setup........................................................................................................................ 122 11.2.1 Setting AC Filter......................................................................................................... 123 11.2.2 Setting DFT Filter ...................................................................................................... 123 11.2.3 Setting EMG Filter ..................................................................................................... 124 11.2.4 Setting Lowpass Filter................................................................................................ 124 11.3 Record Info Setup ............................................................................................................. 125 11.3.1 Setup 1........................................................................................................................ 125 11.3.2 Setup 2........................................................................................................................ 129 11.4 Patient Information Setup ................................................................................................. 130 11.4.1 Selecting First/Last Name / Gender / D.O.B / Height / Weight / BP / Race / Pacemaker / Medication / Room No. / Department / Physician / Technician / Ref-Physician................ 131 11.4.2 Selecting ID Mode ..................................................................................................... 132 11.4.3 Selecting ID Hint........................................................................................................ 132 11.4.4 Setting Prompt............................................................................................................ 132 11.4.5 Selecting H/W Unit .................................................................................................... 132 11.4.6 Selecting BP Unit ....................................................................................................... 133 11.4.7 Selecting Next Patient ................................................................................................ 133 11.4.8 Setting the Time to Clear Patient Information ........................................................... 134 11.4.9 Inputting Customized Information ............................................................................. 134 11.5 Transmission Setup........................................................................................................... 135 V
11.5.1 Setting Device No. ..................................................................................................... 136 11.5.2 Selecting Auto Transmission...................................................................................... 136 11.5.3 Selecting Transmission Mode .................................................................................... 136 11.5.4 Setting FTP Information............................................................................................. 137 11.5.5 Setting IP Addresses ................................................................................................... 137 11.6 Lead Setup ........................................................................................................................ 137 11.6.1 Setting Rhythm Lead1/2/3 ......................................................................................... 138 11.6.2 Setting Lead Sequence ............................................................................................... 139 11.6.3 Selecting Nehb ........................................................................................................... 139 11.7 Display&Sound Setup ...................................................................................................... 139 11.7.1 Setting Brightness ...................................................................................................... 140 11.7.2 Selecting Display Colors (Only for SE-12 Express).................................................. 140 11.7.3 Selecting Antialiasing................................................................................................. 140 11.7.4 Setting Key Volume.................................................................................................... 141 11.7.5 Setting Hint Volume ................................................................................................... 141 11.7.6 Setting QRS Volume .................................................................................................. 141 11.8 Date&Time Setup ............................................................................................................. 141 11.8.1 Setting Date and Time ................................................................................................ 142 11.8.2 Setting Date Mode...................................................................................................... 142 11.8.3 Setting Time Mode ..................................................................................................... 143 11.8.4 Setting Power-Off Time ............................................................................................. 143 11.8.5 Setting LCD Off Time................................................................................................ 143 11.9 File Setup .......................................................................................................................... 143 11.9.1 Selecting Auto Save ................................................................................................... 144 11.9.2 Setting Saving Path .................................................................................................... 144 11.9.3 Setting File Format..................................................................................................... 145 11.9.4 Selecting Deleting Files After Transmission or Export.............................................. 145 11.9.5 Selecting Replacing When Memory is Full ............................................................... 145 11.9.6 Selecting SCP File Compression................................................................................ 145 11.10 System Maintenance Setup............................................................................................. 146 11.10.1 Exporting System Settings to U Disk....................................................................... 146 11.10.2 Loading System Settings from U Disk..................................................................... 147 11.10.3 Backing Up Settings................................................................................................. 147 11.10.4 Loading Backup Settings ......................................................................................... 147 11.10.5 Printing System Settings .......................................................................................... 147 11.10.6 Loading Factory Settings ......................................................................................... 147 11.10.7 Setting System Password ......................................................................................... 151 11.11 Other Setup ..................................................................................................................... 152 VI
11.11.1 Entering Institution................................................................................................... 152 11.11.2 Selecting a Language................................................................................................ 152 11.11.3 Selecting Caps Lock ................................................................................................. 153 11.11.4 Setting External Input............................................................................................... 153 11.11.5 Setting External Output ............................................................................................ 153 11.11.6 Setting Pacemaker Detection Sensitivity ................................................................. 154 Chapter 12 Operation Instructions for Exercise ECG (Configurable for SE-12 Express) . 155 12.1 Activating Exercise ECG Function................................................................................... 155 12.2 Operation Preparation....................................................................................................... 156 12.3 Exercise Test ..................................................................................................................... 163 12.4 System Setup for Exercise Test ........................................................................................ 164 12.4.1 General Information Setup......................................................................................... 165 12.4.2 Record Information Setup .......................................................................................... 167 12.4.3 Protocol Manager ....................................................................................................... 169 Chapter 13 Turning Off the Electrocardiograph .................................................................... 173 Chapter 14 Hint Information.................................................................................................... 174 Chapter 15 Cleaning, Care and Maintenance ......................................................................... 176 15.1 Cleaning............................................................................................................................ 176 15.1.1 Cleaning the Main Unit and the Patient Cable........................................................... 176 15.1.2 Cleaning the Reusable Electrodes.............................................................................. 176 15.1.3 Cleaning the Print Head ............................................................................................. 176 15.2 Disinfection ...................................................................................................................... 177 15.3 Care and Maintenance ...................................................................................................... 177 15.3.1 Recharge and Replacement of Battery ....................................................................... 177 15.3.2 Recorder Paper ........................................................................................................... 178 15.3.3 Maintenance of the Main Unit and the Patient Cable ................................................ 179 Chapter 16 Accessories .............................................................................................................. 181 16.1 Standard Accessories ........................................................................................................ 181 16.2 Optional Accessories ........................................................................................................ 182 Chapter 17 Warranty & Service Policy.................................................................................... 184 17.1 Warranty............................................................................................................................ 184 17.2 Service Policy ................................................................................................................... 184 Appendix 1 Technical Specifications ........................................................................................ 186 A1.1 Safety Specifications ....................................................................................................... 186
VII
A1.2 Environment Specifications............................................................................................. 187 A1.3 Physical Specifications .................................................................................................... 187 A1.4 Power Supply Specifications ........................................................................................... 187 A1.5 Performance Specifications ............................................................................................. 188 Appendix 2 EMC Information.................................................................................................. 191 Appendix 3 Abbreviation........................................................................................................... 196
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12-Channel Electrocardiograph User Manual
Safety Guidance
Chapter 1 Safety Guidance This chapter provides important safety information related to the use of the 12-channel electrocardiograph.
1.1 Intended Use The intended use of the 12-channel electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only.
1.2 Warnings and Cautions In order to use the electrocardiograph safely and effectively, and avoid possible dangers caused by improper operation, please read through the user manual and be sure to be familiar with all functions of the equipment and proper operation procedures before use. Please pay more attention to the following warning and caution information. Notes: 1 This device is not intended for home use. 2 The pictures and interfaces in this manual are for reference only.
1.2.1 Safety Warnings WARNING 1
The electrocardiograph is intended to be used by qualified physicians or personnel professionally trained. They should be familiar with the contents of this user manual before operation.
2
Only qualified service engineers can install this equipment, and only service engineers authorized by the manufacturer can open the shell. -1-
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WARNING 3
The results given by the equipment should be examined based on the overall clinical condition of the patient, and they can not substitute for regular checking.
4
This device is not intended for treatment.
5
EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of flammable anesthetic mixtures with oxygen or other flammable agents.
6
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.
7
If the integrity of the external protective conductor is in doubt, the equipment should be powered by a built-in rechargeable battery.
8
Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks.
9
This equipment is not designed for internal use or direct cardiac application.
10 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. 11 Make sure that all electrodes are connected to the patient correctly before operation. 12 Ensure that the conductive parts of electrodes and associated connectors, including neutral electrodes, do not come in contact with earth or any other conducting objects. 13 Electrodes with defibrillator protection should be used while defibrillating. 14 If reusable electrodes with electrode gel are used during defibrillation, ECG recovery will take more than 10 seconds. The manufacturer recommends the use of disposable electrodes at all times. 15 Electrodes of dissimilar metals should not be used; otherwise it may cause a high polarization voltage. 16 To the patient with a pacemaker, the results given by the equipment may be invalid. 17 Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator.
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WARNING 18 In order to avoid being burnt, please keep the electrodes far away from the radio knife while using electrosurgical equipment. 19 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. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor. 20 The summation of leakage current should never exceed leakage current limits while several other units are used at the same time. 21 The potential equalization bar can be connected to that of other equipment when necessary. Make sure that all these devices are connected to the potential equalization terminal. 22 The equipment is protected against malfunctions caused by electrosurgery according to the clause 36.202.101 in the standard IEC 60601-2-25. 23 The disposable electrodes can only be used for one time. 24 If the wireless AP technology is used, in order to maintain compliance with the FCC RF exposure guidelines, the wireless AP should be installed and operated with a minimum distance of 20cm between the radiator and the human body. Use the supplied antenna only. There should be no shield in or around the room where the wireless AP is used. 25 Fix attention on the examination to avoid missing important ECG waves.
1.2.2 Battery Care Warnings WARNING 1
Improper operation may cause the 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 -3-
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Safety Guidance
carefully and pay more attention to warning messages. 2
Only qualified service engineers authorized by the manufacturer can open the battery compartment and replace the battery, and batteries of the same model and specification should be used.
3
DANGER OF EXPLOSION -- Do not reverse the anode and the cathode when installing the battery.
4
Do not heat or splash the battery or throw it into fire or water.
5
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. Irrigate them with clean water first and go to see a doctor immediately.
6
Only when the device is off can the battery be installed or removed.
1.2.3 General Cautions CAUTION 1
Avoid liquid splash and excessive temperature. The temperature must be kept between 5 ºC and 40 ºC during operation, and it should be kept between -20 ºC and 55 ºC during transportation and storage.
2
Do not use the equipment in a dusty environment with bad ventilation or in the presence of corrosive.
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
Before use, the equipment, patient cable and electrodes etc. should be checked. Replacement should be taken if there is any evident defectiveness or aging symptom which may impair the safety or the performance.
5
The following safety checks should be performed at least every 24 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests. -4-
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Safety Guidance
CAUTION a)
Inspect the equipment and accessories for mechanical and functional damage.
b)
Inspect the safety related labels for legibility.
c)
Inspect the fuse to verify compliance with the rated current and circuit-breaking characteristics.
d)
Verify that the device functions properly as described in the instructions for use.
e)
Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1 ohm.
f)
Test the earth leakage current according to IEC/EN 60601-1: Limit: NC 500 μA, SFC 1000μA.
g)
Test the enclosure leakage current according to IEC/EN 60601-1: Limit: NC 100μA, SFC 500μA.
h)
Test the patient leakage current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
i)
Test the patient auxiliary current according to IEC/EN 60601-1: Limit: NC a.c. 10μA, d.c. 10μA; SFC a.c. 50μA, d.c. 50μA.
j)
Test the patient leakage current under single fault condition with mains voltage on the applied part according to IEC/EN 60601-1: Limit: 50μA (CF).
The data should be recorded in an equipment log. If the device is not functioning properly or fails any of the above tests, the device has to be repaired. 6
Ruptured fuse must only be replaced with that of the same type and rating as the original.
7
The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose of them together with house-hold garbage. At the end of their lives hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, please contact your local Civic Office, or the shop where you purchased the product.
8
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
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Safety Guidance
1.2.4 Cleaning & Disinfection Cautions CAUTION 1
Turn off the power before cleaning and disinfection. If the mains supply is used, the power cord should be dragged out of the outlet. Prevent the detergent from seeping into the equipment.
2
Do not immerse the unit or the patient cable into liquid under any circumstances.
3
Do not clean the unit and accessories with abrasive fabric and avoid scratching the electrodes.
4
Any remainder of detergent should be removed from the unit and the patient cable after cleaning.
5
Do not use chloric disinfectant such as chloride, sodium hypochlorite etc.
1.2.5 Preparation and Operation Warnings (for SE-12 Express Exercise ECG) WARNING 1
Ensure that the main unit and the treadmill/ergometer are effectively grounded.
2
Test the emergency stop switch of the treadmill before using the system.
3
During the exercise test, ensure that there are at least 2 experienced physicians present. One of them observes the patient and deals with the emergency.
4
Make sure that there is necessary valid first-aid equipment such as defibrillators, blood-pressure meters etc, and necessary valid medication in the exercise test room.
5
Turn off the system power and disconnect the power cord from the wall outlet after using the system.
6
Press down the emergency stop switch of the treadmill before defibrillating to avoid the hazard to the patient and the operator.
7
Keep the treadmill/ergometer on a horizontal place and make sure it’s stably working.
8
Make sure that the power cable of the treadmill/ergometer is grounded. Don’t use other electrical equipment with the same power supply line. -6-
12-Channel Electrocardiograph User Manual
Safety Guidance
WARNING 9
Keep the power cable far away from the running treadmill area and the heat surface.
10 Examine the treadmill/ergometer carefully before using it. 11 Do not take an exercise test if the treadmill/ergometer is wet. 12 Do not use the treadmill/ergometer in the open air. 13 The patient undergoing the stress exercise test should wear suitable clothes and shoes. 14 During the stress exercise test, the patient should not get on or off the treadmill. 15 Remind patients to take care not to fall down from the treadmill. 16 Keep hands, hair, jewelry and loose clothing away from moving parts of the treadmill. 17 After the exercise test, slow the speed of the treadmill to the minimum, and then stop the treadmill. 18 Children are prohibited from approaching the treadmill/ergometer alone. 19 Don’t insert anything into the treadmill, or place anything on its surface. 20 Press down the emergency stop switch to stop the treadmill immediately an emergency happens.
1.2.6 Contraindications (for SE-12 Express Exercise ECG) Absolute Contraindications: 1
Acute MI (within 2 days)
2
High-risk unstable angina
3
Hemodynamic compromise caused by uncontrolled cardiac arrhythmia
4
Active endocarditis
5
Symptomatic severe aortic stenosis
6
Decompensated symptomatic heart failure
7
Acute pulmonary embolus or pulmonary infarction
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Safety Guidance
Acute noncardiac disorder that may affect exercise performance or be aggravated by exercise (eg, infection, renal failure, thyrotoxicosis)
9
Acute myocarditis or pericarditis
10 Physical disability that would preclude safe and adequate test performance 11 The patient opposes the test. Relative Contraindications: 1
Left main coronary stenosis or its equivalent
2
Moderate stenotic valvular heart disease
3
Electrolyte abnormalities
4
Tachyarrhythmias or bradyarrhythmias
5
Atrial fibrillation with uncontrolled ventricular rate
6
Hypertrophic cardiomyopathy
7
Patients can not cooperate because of mental impairment
8
High-degree AV block
1.3 List of Symbols External output
External input
Equipment or part of CF type with defibrillator proof
Caution
Consult Instructions for Use
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Safety Guidance
Potential equalization
Mains supply
USB port
Battery indicator
Battery recharging indicator
Delete key
Enter key
Esc key/Reset key
Shift key
Fn key
Power On/Off key
COPY key
MODE key
SLEEP/WAKE UP key
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Safety Guidance
START/STOP key
Tab key/Feed paper key
UP/DOWN/LEFT/RIGHT Arrow key
Recycle
Part Number
Serial Number
Date of Manufacture
Manufacturer
Authorized Representative in the European Community
The symbol indicates that the device complies with the European Council Directive 93/42/EEC concerning medical devices.
Rx only (U.S.)
Federal (US) law restricts this device to sale by or on the order of a physician. It indicates that the device should be sent to the special agencies according to local regulations for separate collection after its useful life. - 10 -
12-Channel Electrocardiograph User Manual
Introduction
Chapter 2 Introduction The 12-channel electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms. The 12-channel ECG waves can be viewed on the LCD screen and printed out by using a high-quality thermal recorder. The sampled ECG data can be saved, transmitted and exported. The manual, auto, rhythm, R-R analysis or off mode can be chosen freely. For SE-12 Express, the exercise ECG function is optional. When a patient with coronary heart disease runs, the added heart load will cause myocardium hypotension, and then the ECG will change abnormally. Therefore, the exercise ECG function of SE-12 Express can be used to diagnose concealed coronary heart disease and atypical angina pectoris, prescribe the workload for patients with myocardial infarction before they leave hospital, and assess the effect of the treatment. The 12-channel electrocardiograph can be powered by the mains supply or a built-in rechargeable lithium battery. With a high resolution thermal recorder, a 32-bit processor and a large-capacity memorizer, the 12-channel electrocardiograph has advanced performance and high reliability. The compact size makes it suitable for clinic and hospital uses. The 12-channel electrocardiograph has two models: SE-12 and SE-12 Express. SE-12 adopts 320×240 dot single color LCD screen; SE-12 Express adopts 800×600 multicolor LCD screen. Configuration: main unit, power cord, patient cable, chest electrodes, limb electrodes, disposable electrodes, alligator clips, thermal recorder paper, fuses, lithium battery. WARNING 1 This equipment is intended for use on adult and pediatric patients only. 2 This equipment is not designed for internal use or direct cardiac application. 3 The results given by the equipment should be examined based on the overall clinical condition of the patient, and they can not substitute for regular checking.
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12-Channel Electrocardiograph User Manual
Introduction
2.1 Top Panel Indicators LCD Screen
Recorder
Keyboard
Figure 2-1 SE-12 Express Indicators
LCD Screen Recorder Keyboard
Figure 2-2 SE-12
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12-Channel Electrocardiograph User Manual
Introduction
2.2 Keyboard and Keys B
A
C
G
D
H I
E F
J
K
M
L
N
O
Figure 2-3 SE-12 Express Keyboard B C
G D H I
E F
J
K
M
L
Figure 2-4 SE-12 Keyboard - 13 -
N
O
12-Channel Electrocardiograph User Manual
Introduction
Name A Note: Only if the stress ECG function is activated, can these keys be available.
Explanation When the main interface is displayed, press this key to display the main interface of the exercise test.
Pretest
When the main interface of the exercise test is displayed, press this key to enter the pretest phase. The length of the pretest phase is not fixed.
Exercise
Press this key to enter the exercise phase. In the exercise phase, press this key to enter the next stage of the exercise phase.
Recovery
Press this key to enter the recovery phase. In the recovery phase, press this key to enter the next stage of the recovery phase.
Test end
Press this key to display a pop-up dialog box, and then you can decide whether the exercise test should be terminated.
Enter BP
Press this key to display the Input BP dialog box, and then enter the BP values manually.
Recall
During the exercise test, press this key to review 10s data and print out the 12-channel ECG report of the reviewed 10s data.
12 ld
During the exercise test, press this key to sample 10s data and print out the 12-channel ECG report of the sampled 10s data.
Medians
During the exercise test, press this key to print out the average template report.
Comment
Press this key to display the Comment dialog box, and then you can annotate in the dialog box. The annotations will be displayed in the summary report. Press this key again to close the dialog box.
Speed +/-W
Press Speed +/-W to change the speed of the treadmill during the exercise phase. Note: The two keys are available for the customized treadmill protocol only. Press Grade +/- to change the grade of the treadmill during the exercise phase.
Grade +/-
Note: The two keys are available for the customized - 14 -
12-Channel Electrocardiograph User Manual
Introduction
treadmill protocol only.
Start/Stop tmill
Before the exercise test, press Start tmill to test the connection between the electrocardiograph and the treadmill, and then press Stop tmill to stop the connection test.
B
Function Key
Selecting menu functions on the screen
C
Delete
Deleting characters
D
Enter
Confirming operation Moving the cursor Pressing Tab can move the cursor forward, and pressing Shift + Tab can move the cursor backward.
E
Tab/Feed paper
F
Fn
G
Spacebar
Feed paper: when the main interface is displayed, if Paper Marker is set to Yes, you can press the Tab key to advance the recorder paper to the next black marker; if Paper Marker is set to No, you can press the Tab key to advance the paper for 2.5cm. Press the Tab key again to stop advancing the paper. Inputting special characters. Press Fn + a to type è. Adding a space between typed selecting/deselecting a checkbox
characters
or
Pressing Shift + Tab can move the cursor backward. Press Shift and a number key to input the special character in the top right corner of the key. H
Shift
If Caps Lock is set to Off, pressing Shift + P can type a capital P. If Caps Lock is set to On, pressing Shift + P can type a lowercase p. Canceling operation
I
Esc/Reset
J
Power On/Off
Note: A large polarization voltage may cause baseline drift. On the main interface, pressing the ESC key can decrease the polarization voltage and draw the baseline to zero quickly. Power-on/Power-off Press this key to select a working mode among the auto,
K
MODE
manual, rhythm, R-R analysis, and off modes. Note: Only if a working mode is ticked on the Work - 15 -
12-Channel Electrocardiograph User Manual
Introduction
Mode Setup interface, can the working mode be selected by pressing the MODE key when the main interface is displayed. L
SLEEP/WAKE UP
M
COPY
N
START/STOP
Resting/wakening the electrocardiograph In the auto mode, pressing the Copy key can print the ECG report which was printed out last time. Start/Stop printing reports Moving the cursor (Up, Down, Left, Right) In the manual mode, press the Up or Down arrow to switch the lead groups.
O
Arrow Keys
During the exercise test, pressing the Up or Down arrow can switch the display style. When the display style is 3×1, pressing the Left or Right arrow can switch the lead group.
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12-Channel Electrocardiograph User Manual
Introduction
2.3 Front Panel C
B
A
Figure 2-5 SE-12 Express Front Panel
A
B
C
Figure 2-6 SE-12 Front Panel
Symbol A
B
C
Name
Explanation
Mains supply indicator
When the device is powered by the mains supply, this indicator is lit.
Battery indicator
When the device is powered by the built-in rechargeable lithium battery, this indicator is lit.
Battery recharging indicator
When the battery is being recharged, this indicator is lit. - 17 -
12-Channel Electrocardiograph User Manual
Introduction
2.4 Rear Panel
A
B
D
C
Figure 2-7 SE-12 Express Rear Panel
A
B
C
D
Figure 2-8 SE-12 Rear Panel
Name A
Mains Supply Socket
Explanation AC SOURCE: alternating current supply socket
B Potential Equalization Conductor
Potential equalization conductor provides a connection between the unit and the potential equalization bus bar of the electrical installation.
C
Handle
Part for people to hold
D
Heat Emission Hole
Path for internal heat emission
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12-Channel Electrocardiograph User Manual
Introduction
2.5 Right Panel
C
D G
A
B
E
F
Figure 2-9 SE-12 Express Right Panel
D
C
G
A
B
E
F
Figure 2-10 SE-12 Right Panel
A
Name
Explanation
Patient Cable Socket
Connecting to the patient cable
B
C
Connecting to a PC Serial Port 1
In the exercise test, treadmill/ergometer
USB Socket 1 (Optional)
Standard USB socket, connecting to a PC
USB Socket 2 (Optional)
Standard USB socket, connecting to a U disk, a bar code reader or a USB printer recommended by the manufacturer
External Input / Output Socket
Connecting to the external signal device
D
E
- 19 -
connecting
to
the
12-Channel Electrocardiograph User Manual
F G
Introduction
Serial Port 2
In the exercise test, connecting to the stress BP monitor
Net port
Standard net port, connecting to a PC
1) Patient Cable Socket
: Applied part of type CF with defibrillator proof : Caution Definitions of corresponding pins: Pin
Signal
Pin
Signal
Pin
Signal
1
C2 / V2
6
SH
11
F / LL
2
C3 / V3
7
NC
12
C1 / V1
3
C4 / V4
8
NC
13
or NC C1 / V1
4
C5 / V5
9
R / RA
14
RF (N) /RL or NC
5
C6 / V6
10
L / LA
15
RF (N) / RL
Note: The left side of “/” is European standard, and the right side is American standard. 2) Serial Port 1 WARNING The isolated intensity of serial port 1 is 1500V AC and the maximum voltage applied should not exceed +15V DC.
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12-Channel Electrocardiograph User Manual
Introduction
Definitions of corresponding pins: Pin
Signal
Pin
Signal
Pin
Signal
1
NC
4
NC
7
NC
2
RxD (input)
5
GND
8
NC
3
TxD (output)
6
NC
9
NC
3) Serial Port 2 6 8
2
7
1
5
3 4
Definitions of corresponding pins: Pin
Signal
Pin
Signal
1
TxD (output)
5
NC
2
RxD (input)
6
NC
3
NC
7
GND
4
NC
8
GND
4) External Input/Output Socket
Definitions of corresponding pins: Pin
Signal
Pin
Signal
1
GND
4
GND
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12-Channel Electrocardiograph User Manual
Introduction
2
GND
5
ECG Signal (input)
3
GND
6
ECG Signal (output)
5) USB Socket 1/USB Socket 2 (Optional)
CAUTION Only the USB equipment recommended by the manufacturer can be connected to the USB interface. Definitions of corresponding pins: Pin
Signal
Pin
Signal
1
+5V
3
D+
2
D-
4
GND
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. Therefore anybody, who connects additional equipment to the signal input or output connector to configure a medical system, must make sure that it complies with the requirements of the valid version of the system standard IEC/EN 60601-1-1. If in doubt, consult our technical service department or your local distributor.
2
The summation of leakage current should never exceed leakage current limits while several other units are used at the same time.
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12-Channel Electrocardiograph User Manual
Introduction
2.6 Bottom Panel D C
D
E B
A
Figure 2-11 SE-12 Express Bottom Panel D
C
D
E
B
A
Figure 2-12 SE-12 Bottom Panel
Name
Explanation
A
Speaker Hole
Path for sound from speaker
B
Battery Compartment
Compartment for lithium battery
C
Fuse
The specification is: T1AL250VP Ø5×20
D
Heat Emission Hole
Path for internal heat emission
E
Label
Position for product information label
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12-Channel Electrocardiograph User Manual
Introduction
1) Battery Compartment The rated voltage and the rated capacity of the rechargeable lithium battery pack are as follows: SE-12 Express: Rated Voltage: 14.8V; Rated Capacity: 4400mAh SE-12: Rated Voltage: 14.8V; Rated Capacity: 2200mAh WARNING 1. Improper operation may cause the battery to be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. Therefore, it is necessary to read the user manual carefully and pay more attention to warning messages. 2. 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. Irrigate them with clean water first and go to see a doctor immediately. 3. Only qualified service engineers authorized by the manufacturer can open the battery compartment and replace the battery, and batteries of the same model and specification must be used. 4. Only when the device is off can the battery be installed or removed. Note: If the battery has not been used for two months or more, you should recharge it before using it again. 2) Fuse There are two fuses of the same specification installed on the bottom of the main unit. The specification is: T1AL250VP Ø5×20. WARNING Ruptured fuses must only be replaced with those of the same type and rating as the original.
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12-Channel Electrocardiograph User Manual
Introduction
2.7 Function Features ♦
Supporting multi-language
♦
Full alphanumeric keyboard (For SE-12 Express, touch screen is available)
♦
Built-in rechargeable lithium battery with large capacity
♦
ECG signals of 12 leads are gathered and amplified simultaneously, 12-channel waves are displayed and recorded simultaneously
♦
High resolution thermal recorder, recording frequency response ≤150Hz
♦
Supporting external USB printer
♦
Flexible printing formats
♦
The auto, manual, rhythm, R-R analysis and off modes can be chosen freely
♦
Automatic baseline adjustment for optimal printing
♦
Convenient operation of system setup and file management
♦
Multiple file formats: DAT/SCP/FDA-XML/PDF
♦
Measurement function and interpretation function
♦
Hint information of lead off, lack of paper, low battery capacity etc.
♦
Supporting bar code reader
♦
ECG data can be transmitted to the PC software through the serial cable, net cable, or wireless AP (optional).
♦
Real-time transmission to PC ECG
The following features are only for the exercise test function of SE-12 Express (optional) ♦
Real-time analysis, ST segment and trend are applied while sampling;
♦
Real-time display and print of 12-lead simultaneous ECG waveforms; - 25 -
12-Channel Electrocardiograph User Manual
Introduction
♦
ST segment analysis while sampling; ST position is adjustable while sampling;
♦
Providing average templates of three rhythm leads in every stage to observe the change of ST segments between every two stages
♦
Automatically forming elaborate reports, including Summary Report, ST Scope Report and Trend Graph Report
♦
Providing classical exercise protocols; exercise protocols can be edited and created
♦
Automatically controlling and adjusting the speed and grade of the treadmill or the power of the ergometer
♦
Supporting multi-types of treadmill or ergometer
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
Chapter 3 About the Electrocardiograph Application The following sections provide an overview of the main operations and functions. You can operate the electrocardiograph by using the keyboard. For SE-12 Express, you can also carry out the operations by using the touch screen. CAUTION Do not touch the LCD screen with sharp things such as pencils or pens; otherwise, it will be damaged.
3.1 Selecting Menu Functions
Press F7 below File to select File and open the File Manager interface.
To select Patient, press the function key F1 below Patient. To select Setup, press the function key F6 below Setup.
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
3.2 Entering Data
1. When the main interface is displayed, press the function key F1 below Patient to open the Patient Information window. 2. Press Tab or Shift + Tab to move the cursor to the Name textbox.
3. Press
on the keyboard to erase the typed information.
4. Press the letter or number keys on the keyboard to input patient name. Press Fn and a letter key to input the special character in the top right corner of the key. Press Shift
and a number
key to input the special character in the top right corner of the key. For example, press Fn + a to input è, and press Shift + 3 to input #. If Caps Lock is set to Off, pressing Shift letter key can input a capital letter. If Caps Lock is set to On, pressing Shift
and a and a letter
key can input a lowercase letter.
5. Press and then press
to confirm, or press Tab or Shift + Tab to move the cursor to the OK button, to confirm.
6. Press ESC to cancel the operation, or press Tab or Shift + Tab to move the cursor to the Cancel button, and then press
to cancel the operation.
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
3.3 Selecting an Item When the main interface is displayed, press the function key F6 below Setup to open the System Setup window. The cursor is on Work Mode. Press
to open the Work Mode Setup
interface.
1. Press Tab or Shift + Tab to move the cursor to R-R, press Spacebar to select it, and then a check mark √ appears in the box before R-R. 2. Press Tab or Shift + Tab to move the cursor to the Rhythm Style list box. Press the Up or Down arrow to highlight Single Lead or Three Leads. 3. Press and then press
to confirm, or press Tab or Shift + Tab to move the cursor to the OK button, to confirm.
4. Press ESC to cancel the operation, or press Tab or Shift + Tab to move the cursor to the Cancel button, and then press
to cancel the operation. - 29 -
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
3.4 About the Main Interface After you turn on the device, the main interface pops up.
Figure 3-1 SE-12 Express Main Interface
B
D
F
E
C
G
H
I J
A
R
K Q
P
O
N
M
L
Figure 3-2 SE-12 Main Interface - 30 -
12-Channel Electrocardiograph User Manual
A
About the Electrocardiograph Application
Name
Explanation
Name
Patient Name: within 60 ASCII characters or the equivalent number of other characters that can be supported by equivalent memory used by 60 ASCII characters When ID Mode is set to Manual, the patient ID is within 30 ASCII characters.
B
ID
When ID Mode is set to Auto, the patient ID is 0~1999, 999, 999. When ID Mode is set to Time, the patient ID is within 10 characters. Patient Age
C
Age
D
Gender
The patient age value and the age unit can be set in the Patient Information window. Patient Gender (Male/Female/Empty)
Hint Information 1
Including DEMO, Module Error, Overload, Lead Name (When the leads are off, the lead names will be shown in black on a yellow background in SE-12 Express, while in SE-12, they will be shown in black on a white background.)
F
Hint Information 2
Including No Paper, Paper Error, Battery Weak, Sampling, Analyzing, Recording, Testing, Learning, Transmitting, Transmit Fail, Detecting, Memory Full, U Disk, USB Printer, Lead Off, USB Scanner
G
Work Mode
Manual, Auto, Rhythm, R-R Analysis or Off
H
Heart Rate
Actual Heart Rate
I
Current Time
J
Battery Symbol
K
File
Press the function key F7 below File to open the File Manager interface. For details, please refer to Chapter 10, “Managing Files”.
L
Setup
Press the function key F6 below Setup to display the System Setup interface. For details, please refer to Chapter 11, “System Setup”.
E
Current examination time. Refer to Section 11.8.1, “Setting Date and Time”. Identify the current capacity of the rechargeable battery
EMG Filter: 25Hz, 35Hz or 45Hz M
Filter
Lowpass Filter: 75Hz, 100Hz or 150Hz Note: This setup can’t be saved if it is modified on the main interface.
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12-Channel Electrocardiograph User Manual
N
O
Gain
Speed
About the Electrocardiograph Application
Gain: 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 10/5 mm/mV or AGC Note: This setup can’t be saved if it is modified on the main interface. In the manual mode, you can set Speed to 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s or 50mm/s. In the auto and rhythm modes, only 25mm/s and 50mm/s are available. In the R-R analysis mode, only 25mm/s is available. Note: This setup can’t be saved if it is modified on the main interface.
Freeze
Freezing ECG waves. For details, please refer to Chapter 7, “Freezing ECG Waves”.
Q
Patient
Press the function key F1 below Patient to open the Patient Information window. For details, please refer to Chapter 6, “Entering Patient Information”.
R
ECG waveform
P
Display ECG waveform
3.5 About the Main Interface of Exercise ECG (Optional for SE-12 Express) After turning on the electrocardiograph, press Pretest on the keyboard to open the main interface of the exercise test (Figure 3-3). During the exercise test, the main interface of ST Trend (Figure 3-4) or the main interface of Template (Figure 3-5) will appear.
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12-Channel Electrocardiograph User Manual
D
E
About the Electrocardiograph Application
F
G
H
I
J K
C
L
B
M
A
U
T
S
R
Q
P
N
O
Figure 3-3 Main Interface of Exercise Test
X
V Figure 3-4 Main Interface of ST Trend
- 33 -
W
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
Z
Y Figure 3-5 Main Interface of Template
When ID Mode is set to Manual, the patient ID is within 30 characters. A
ID
When ID Mode is set to Auto, the patient ID is 0~1999, 999, 999. When ID Mode is set to Time, the patient ID is within 10 characters.
B
Name
Patient Name: within 60 ASCII characters or the equivalent number of other characters that can be supported by equivalent memory used by 60 ASCII characters
C
Hint Information1
HR Overrange!, Sys. Overrange!, Dia. Overrange!, Battery Weak, No Paper, Paper Error
D
Hint Information2
DEMO, Module Error, Lead X Off, Overload
E
Current Protocol
The selected protocol name No Testing, Testing…, Testing Stop
F
Hint Information3
During the exercise test, the count from 0 to 9 is displayed after the 12ld key on the keyboard is pressed.
G
Current Phase and Stage
The current phase and stage of the exercise test
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12-Channel Electrocardiograph User Manual
H
I
J
Total Time and Stage Time
About the Electrocardiograph Application
The left number is the total time, which is counted from the beginning of the pretest phase to the end of the exercise test. The right number is the stage time, which shows the running time of the current stage.
When the treadmill is used, the current speed, grade and Current Speed or workload of the treadmill will be displayed on the main interface; Rotation Speed, Grade When the ergometer is used, the current rotation speed and power or Power, Workload of the ergometer will be displayed on the main interface. Current Time
Current examination time. Refer to Section 11.8.1, “Setting Date and Time”. Identify the current capacity of the rechargeable battery
K
Battery Symbol
: Full capacity;
: 2/3 capacity;
: 1/3 capacity;
: Low capacity
L
M
N
Systolic Blood Pressure and Diastolic Blood Pressure Current Heart Rate and Target Heart Rate
Exit
O
Setup
P
Filter
Q
Gain
R
The left number is the systolic blood pressure, and the right number is the diastolic blood pressure.
Post J: 80ms
The left number is the current heart rate, and the right number is the target heart rate. 30% is the percentage of the current heart rate to the target heart rate. Press the function key F7 below Exit to exit the main interface of the exercise test. In the exercise test, the Exit button changes into the ST Trend or Template button. Press the function key F6 below Setup to open the System Setup interface. In the exercise phase, the Setup button changes into the Lead button. EMG Filter: 25Hz, 35Hz or 45Hz Lowpass Filter: 75Hz, 100Hz or 150Hz Gain: 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV, 10/5 mm/mV or AGC Post J is the length after J point of ST segment. Press the function key F3 below Post J to set Post J to 0, 20ms, 40ms, 60ms or 80ms. Note: J point is the connection point between the end of QRS complex and the start of ST segment. It is the standard point to - 35 -
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
fix the position of ST segment. Please select a proper option based on the patient’s actual ECG waves.
S
Hold
Press the function key F2 below Hold, and then the system will not follow the previous settings to change the speed and grade of the treadmill, but keep the current speed and grade until this key is pressed again.
T
Patient
Press the function key F1 below Patient to open the Patient Information window. It is invalid in the exercise test.
U
ECG waveforms
V
Lead
Press the function key F6 below Lead to open the Lead Setup interface.
W
Template Button
Press the function key F7 below Template, and then the 3-lead average templates will be displayed, and the Template button will change into the ST Trend button.
X
ST Trend
Y
Z
ST Trend Button
Average Template
Display real-time ECG waveforms
Display 3-lead ST trends Press the function key F7 below ST Trend, and then the 3-lead ST trends will be displayed, and the ST Trend button will change into the Template button. The 3-lead average waves which are updated every 10 seconds, and the positions of the calibration lines The 3 leads can be selected on the Lead Setup interface of the exercise test.
3.6 About the System Setup Interface When the main interface is displayed, press the function key F6 below Setup to display the System Setup interface. Note: If you set the system password on the System Maintenance interface, you need enter the password before opening the System Setup interface. For details, refer to Section 11.10.7, “Setting System Password”.
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12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
On the System Setup interface, press Tab or Shift + Tab, or the Up, Down, Left or Right arrow to move the cursor. When the cursor is on an item, press
to open the setup interface of
the item. Take the Work Mode Setup interface for example:
Check Box Textbox
Dropdown List Box
1. On the Work Mode Setup interface, press Tab or Shift + Tab to move the cursor among different check boxes. Press Spacebar to select a check box, and a check mark √ appears in the box. - 37 -
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
2. On the Work Mode Setup interface, press Tab or Shift + Tab to move the cursor to a list box or dropdown. Press the Up or Down arrow to highlight an option. 3. On the Work Mode Setup interface, press Tab or Shift + Tab to move the cursor to a textbox. Fill in the selected textbox.
4. Press and then press
to confirm, or press Tab or Shift + Tab to move the cursor to the OK button, to confirm.
5. Press ESC to cancel the operation, or press Tab or Shift + Tab to move the cursor to the Cancel button, and then press
to cancel the operation.
3.7 About the File Manager Interface When the main interface is displayed, press the function key F7 below File to open the File Manager interface1. Press the Up or Down arrow to highlight a file on the File Manager interface1, and then press the function key F4 below Select to select the file and display the File Manager interface2. Then press the function key F7 below Return to return to the File Manager interface1. Press the function key F7 below Return on the File Manager interface1 to return to the main interface.
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12-Channel Electrocardiograph User Manual
A
B
C
About the Electrocardiograph Application
D
E
F
G
Figure 3-6 File Manager Interface1
H
I
J
K
L
M
Figure 3-7 File Manager Interface2
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N
12-Channel Electrocardiograph User Manual
About the Electrocardiograph Application
Name
Explanation
A
Trans All
Press the function key F1 below Trans All to transmit all the files to the PC.
B
Export All
Press the function key F2 below Export All to export all the files from the electrocardiograph to the U disk.
C
Del All
Press the function key F3 below Del All to delete all the files from the electrocardiograph.
D
Select
Press the Up or Down arrow to highlight a file on the File Manager interface1, and then press the function key F4 below Select to select the file and display the File Manager interface2.
E
Search
Press the function key F5 below Search to open the SearchInfo Setup window.
F
Import
Press the function key F6 below Import to import files from the U disk to the electrocardiograph.
G
Return
Press the function key F7 below Return to return to the main interface.
H
Edit
Press the function key F1 below Edit to open the Patient Information window. Then you can edit the patient information.
I
Record
J
Trans
Press the function key F3 below Trans to transmit the selected file to the PC.
K
Export
Press the function key F4 below Export to export the selected file from the electrocardiograph to the U disk.
L
Delete
Press the function key F5 below Delete to delete the selected file from the electrocardiograph.
M
Preview
Press the function key F6 below Preview to open the file preview interface.
N
Return
Press the function key F7 below Return to return to the File Manager interface1.
Press the function key F2 below Record to print the selected file.
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12-Channel Electrocardiograph User Manual
Operation Preparations
Chapter 4 Operation Preparations WARNING Before use, the equipment, patient cable and electrodes should be checked. Replace them if there is any evident defectiveness or aging which may impair the safety or the performance, and make sure that the equipment is in proper working condition.
4.1 Power and Earthing WARNING If the integrity of the external protective conductor is in doubt, the equipment should be powered by the built-in rechargeable battery. Power Supply The electrocardiograph can be powered by either the mains supply or the built-in rechargeable lithium battery. ♦ Mains Supply The mains socket is on the rear panel of the unit. If the mains supply is used, connect the power cord to the socket first, and then connect the power cord to the hospital grade outlet. Operating voltage:
100V-240V~
Operating frequency:
50Hz/60Hz
Input power:
70VA
Make sure that the mains supply meets the above requirements before power-on, and then press
on the keyboard to power on the unit. The mains supply indicator ( ) is lit.
If the built-in rechargeable battery is weak when the mains supply is used, it will be recharged automatically at the same time. Both the mains supply indicator ( ) and the battery recharging indicator (
) will be lit.
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12-Channel Electrocardiograph User Manual
Operation Preparations
♦ Built-in Rechargeable Battery When the built-in rechargeable lithium battery is used, turn on the unit by pressing on the keyboard. Then the battery indicator (
) will be lit and the battery symbol will be
displayed on the LCD screen. Because of the consumption during the storage and transport course, the battery capacity may not be full. If the symbol
and the hint information
Battery Weak are displayed, which means the battery capacity is low, please recharge the battery first. CAUTION If the electrocardiograph is turned off automatically because of low battery capacity, the settings may not be saved. When the battery is fully charged, SE-12 can work normally about 4 hours, and print about 300 ECG reports of 3×4+1R in the auto mode; SE-12 Express can work normally about 5 hours, and print about 350 ECG reports of 3×4+1R in the auto mode. Please refer to the maintenance section for how to recharge the battery. When the battery is being recharged, the electrocardiograph can be powered by the mains supply. WARNING Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary.
4.2 Loading/Replacing Recorder Paper Two kinds of recorder paper can be used. One is the folded thermal paper, and the other is the rolled thermal paper. Notes: 1. When the folded thermal paper is used, the paper roller is unnecessary and must be taken out. 2. When using the paper of 216mm in width, the two movable parts should be removed. 3. The exit edge can help you tear the recorder paper.
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