SE-12, SE-12 Express User Manual Release 1.7 with sw rev 1.8

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-

12-Channel Electrocardiograph User Manual

Safety Guidance

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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12-Channel Electrocardiograph User Manual

Safety Guidance

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-

12-Channel Electrocardiograph User Manual

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-

12-Channel Electrocardiograph User Manual

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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12-Channel Electrocardiograph User Manual

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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12-Channel Electrocardiograph User Manual

8

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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12-Channel Electrocardiograph User Manual

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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12-Channel Electrocardiograph User Manual

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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