SE-1200 Series Electrocardiograph User Manual Ver 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.

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Table of Contents Chapter 1 Safety Guidance ... 1 1.1 Intended Use ... 1 1.2 Warnings and Cautions ... 1 1.2.1 Safety Warnings ... 2 1.2.2 Li-ion Battery Care Warnings ... 5 1.2.3 General Cautions... 6 1.3 List of Symbols... 7 Chapter 2 Introduction... 10 2.1 Top Panel ... 10 2.2 Keyboard and Keys ... 11 2.3 Front Panel... 13 2.4 Rear Panel... 14 2.5 Right Panel ... 15 2.6 Bottom Panel ... 18 2.7 Features... 20 Chapter 3 Operation Preparations... 21 3.1 Connecting the Patient Cable to the Electrocardiograph and Electrodes ... 21 3.1.1 Connecting the Patient Cable to the Electrocardiograph ... 21 3.1.2 Connecting the Patient Cable to Electrodes ... 21 3.2 Preparing the Patient... 22 3.2.1 Instructing the Patient ... 22 3.2.2 Preparing the Skin ... 22 3.3 Attaching Electrodes to the Patient... 23 3.3.1 Electrode Placement... 23 3.3.2 Attaching the Reusable Electrodes... 25 3.3.2.1 Attaching the Limb Electrodes ... 25 3.3.2.2 Attaching the Chest Electrodes... 26 3.3.3 Attaching the Disposable Electrodes... 26 3.4 Inspection Before Power-On ... 27 3.5 Turning On/Off the Electrocardiograph... 28 3.6 Loading/Replacing Recorder Paper... 30 Chapter 4 Basic Operation Guidance ... 34 4.1 Navigation Tips... 34 III

4.1.1 Selecting Menu Functions... 34 4.1.2 Entering Data ... 35 4.1.3 Selecting an Item... 36 4.2 Configuring the Electrocardiograph ... 36 4.3 Screen Description... 37 4.3.1 About the Main Screen... 37 4.3.2 About the System Setup Screen ... 41 4.3.3 About the Order Manager Screen... 42 4.3.4 About the File Manager Screen... 43 4.4 Work Mode Description... 46 Chapter 5 Entering Patient Information ... 47 5.1 Entering Patient Information Manually... 47 5.2 Entering Patient Information by Using a Bar Code Reader (Optional)... 48 5.3 Entering Patient Information by Acquiring Orders ... 48 Chapter 6 Printing ECG Reports ... 50 6.1 Printing an ECG Report... 50 6.1.1 Auto Mode... 50 6.1.2 Manual Mode ... 51 6.1.3 Rhythm Mode... 52 6.1.4 R-R Analysis Mode ... 53 6.1.5 VCG Mode (Only Configurable for SE-1200 Express) ... 54 6.2 Copy Printing... 56 6.3 Freezing ECG Waves... 56 6.4 Printing a Stored ECG Report ... 58 6.4.1 Printing on the File Manager Screen1/2... 58 6.4.2 Printing on the Preview Screen ... 58 6.5 ECG Reports... 59 6.5.1 Auto ECG Report ... 59 6.5.2 Rhythm ECG Report ... 64 6.5.3 Manual ECG Report... 65 6.5.4 R-R Analysis ECG Report ... 66 6.5.5 VCG Report ... 69 6.5.6 Auto ECG Report Printed by the USB Printer ... 73 6.5.7 Auto ECG Report of Patient with Pacemaker ... 74

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6.5.8 Nehb Lead ECG Report ... 75 Chapter 7 Transmitting ECG Data... 76 7.1 Transmitting ECG Data to the PC ... 76 7.1.1 Transmitting ECG Data in DAT Format Through Serial Cable ... 76 7.1.2 Transmitting ECG Data in DAT Format through Ethernet Cable ... 77 7.1.3 Transmitting ECG Data in SCP/FDA-XML/PDF/DICOM Format through Ethernet Cable ... 77 7.2 Real-time Transmission to PC ECG ... 78 Chapter 8 Managing Orders ... 80 8.1 Loading Orders ... 80 8.2 Examining Orders... 81 8.3 Deleting Orders... 81 8.4 Searching Orders ... 81 8.5 Setting Orders ... 82 8.5.1 Factory Defaults of Orders... 82 8.5.2 Order Setup ... 82 Chapter 9 Managing Files ... 84 9.1 Transmitting Files ... 84 9.2 Exporting Files ... 84 9.3 Deleting Files... 85 9.4 Searching Files ... 85 9.5 Importing Files ... 86 9.6 Editing Patient Information ... 86 9.7 Printing Files... 86 9.8 Previewing a File ... 86 Chapter 10 System Setup... 89 10.1 Factory Defaults ... 89 10.2 Work Mode Setup ... 94 10.3 Filter Setup ... 95 10.4 Record Info Setup... 96 10.4.1 Setup 1... 96 10.4.2 Setup 2... 100 10.4.3 Setup 3... 101 10.5 Patient Information Setup ... 102 V

10.6 Transmission Setup... 104 10.7 Lead Setup ... 105 10.8 Display&Sound Setup ... 106 10.9 Date&Time Setup ... 107 10.10 File Setup... 108 10.11 System Maintenance Setup... 110 10.12 Other Setup ... 111 Chapter 11 Hint Information ... 113 Chapter 12 FAQ ... 114 Chapter 13 Cleaning, Care and Maintenance ... 118 13.1 Cleaning... 118 13.1.1 Cleaning the Main Unit and the Patient Cable... 118 13.1.2 Cleaning the Reusable Electrodes... 118 13.1.3 Cleaning the Print Head ... 119 13.2 Disinfection ... 119 13.3 Care and Maintenance ... 119 13.3.1 Recharge and Replacement of Battery ... 120 13.3.2 Recorder Paper ... 121 13.3.3 Visual inspection ... 121 13.3.4 Maintenance of the Main Unit and the Patient Cable ... 122 Chapter 14 Accessories ... 124 Chapter 15 Warranty & Service ... 126 15.1 Warranty... 126 15.2 Contact information ... 126 Appendix 1 Technical Specifications ... 127 A1.1 Safety Specifications ... 127 A1.2 Environment Specifications... 127 A1.3 Physical Specifications ... 128 A1.4 Power Supply Specifications ... 128 A1.5 Performance Specifications ... 129 Appendix 2 EMC Information... 131 Appendix 3 Abbreviation... 136

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SE-1200 Series Electrocardiograph User Manual

Safety Guidance

Chapter 1 Safety Guidance This chapter provides important safety information related to the use of SE-1200 series electrocardiograph.

1.1 Intended Use The intended use of SE-1200 series 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. WARNING 1. This equipment is not designed for intracardiac use or direct cardiac application. 2. This equipment is not intended for home use. 3. This equipment is not intended for treatment or monitoring. 4. This equipment is intended for use on adult and pediatric patients only. 5. 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.

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.

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SE-1200 Series Electrocardiograph User Manual

Safety Guidance

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. 3. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of flammable anesthetic mixtures with oxygen or other flammable agents. 4. SHOCK HAZARD - The power receptacle must be a hospital grade grounded outlet. Never try to adapt the three-prong plug to fit a two-slot outlet. 5. Make sure that the power is turned off and the power cord is disconnected from the AC socket before connecting or disconnecting equipment. Otherwise, electrical shock or other injuries may happen to the patient or operator. 6. If the integrity of the external protective conductor is in doubt, the equipment should be powered by an internal li-ion rechargeable battery. 7. Do not use this equipment in the presence of high static electricity or high voltage equipment which may generate sparks. 8. 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. The electrocardiograph has been safety tested with the recommended accessories, peripherals, and leads, and no hazard is found when the electrocardiograph is operated with cardiac pacemakers or other stimulators. 9. Make sure that all electrodes are connected to the patient correctly before operation. 10. 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. 11. If reusable electrodes with electrode gel are used during defibrillation, the electrocardiograph recovery will take more than 10 seconds. The manufacturer recommends the use of disposable electrodes at all times.

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SE-1200 Series Electrocardiograph User Manual

Safety Guidance

WARNING 12. Electrodes of dissimilar metals should not be used; otherwise it may cause a high polarization voltage. 13. The disposable electrodes can only be used for one time. 14. Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator. 15. Do not touch accessible parts of non-medical electrical equipment and the patient simultaneously. 16. The use of equipment that applies high frequency voltages to the patient (including electrosurgical equipment and some respiration transducers) is not supported and may produce undesired results. Disconnect the patient data cable from the electrocardiograph, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment. 17. 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. There should be no shield in or around the room where the wireless AP is used. 18. Fix attention on the examination to avoid missing important ECG waves. 19. SHOCK HAZARD - Don’t connect non-medical electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer. 20. SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet supplying the system. 21. Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC/EN 60601-1-1 approved to the electrocardiograph. The operation or use of non-approved equipment or accessories with the electrocardiograph is not tested or supported, and electrocardiograph operation and safety are not guaranteed. 22. Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.).

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SE-1200 Series Electrocardiograph User Manual

Safety Guidance

WARNING 23. Do not exceed the maximum permitted load when using the multiple portable socket-outlet(s) to supply the system. 24. Multiple portable socket-outlets shall not be placed on the floor. 25. Do not use the additional multiple portable socket-outlet or extension cord in the medical electrical system, unless it’s specified as part of the system by manufacturer. And the multiple portable socket-outlets provided with the system shall only be used for supplying power to equipment which is intended to form part of the system. 26. 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 configurations 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. 27. Connecting any accessory (such as external printer) or other device (such as the computer) to this electrocardiograph makes a medical system. In that case, additional safety measures should be taken during installation of the system, and the system shall provide: a) Within the patient environment, a level of safety comparable to that provided by medical electrical equipment complying with IEC/EN 60601-1, and b) Outside the patient environment, the level of safety appropriate for non-medical electrical equipment complying with other IEC or ISO safety standards. 28. All the accessories connected to system must be installed outside the patient vicinity, if they do not meet the requirement of IEC/EN 60601-1. 29. You should purchase computer, printer, treadmill, ergometer and BP monitor from the manufacturer. Otherwise, the manufacturer will not be held responsible for the maintenance of the PC hardware, operating system and other accessories. 30. If multiple instruments are connected to a patient, the sum of the leakage currents may exceed the limits given in the IEC/EN 60601-1 and may pose a safety hazard. Consult your service personnel. -4-

SE-1200 Series Electrocardiograph User Manual

Safety Guidance

WARNING 31. The potential equalization bar can be connected to that of other equipment when necessary. Make sure that all the equipment is connected to the potential equalization terminal.

1.2.2 Li-ion Battery Care Warnings WARNING 1. Improper operation may cause the internal li-ion battery (hereinafter called battery) to be hot, ignited or exploded, and it may lead to the decrease of the battery capacity. It is necessary to read the user manual carefully and pay more attention to warning messages. 2. 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 as manufacturer configuration 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. Do not destroy the battery; Do not pierce battery with a sharp object such as a needle; Do not hit with a hammer, step on or throw or drop to cause strong shock; Do not disassemble or modify the battery. 6. When leakage or foul smell is found, stop using the battery immediately. If your skin or cloth comes into contact with the leakage liquid, cleanse it with clean water at once. If the leakage liquid splashes into your eyes, do not wipe them. Irrigate them with clean water first and go to see a doctor immediately. 7. Properly dispose of or recycle the depleted battery according to local regulations. 8. Only when the device is off can the battery be installed or removed. 9. Remove the battery from the electrocardiograph when the electrocardiograph isn’t used for a long time. 10. If the battery is stored alone and not used for a long time, we recommend that the battery be charged at least once every 6 months to prevent overdischarge. -5-

SE-1200 Series Electrocardiograph User Manual

Safety Guidance

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. Ruptured fuse must only be replaced with that of the same type and rating as the original. 5. 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. 6. Federal (U.S.) law restricts this device to sale by or on the order of a physician.

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SE-1200 Series Electrocardiograph User Manual

Safety Guidance

1.3 List of Symbols External output

External input

Equipment or part of CF type with defibrillator proof

Caution

Consult Instructions for Use

Potential equalization

Patient Cable Socket

USB socket

Net port

Mains supply

Battery indicator

Battery recharging indicator

Delete key

Enter key

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SE-1200 Series Electrocardiograph User Manual

Esc key/Reset key

Shift key

Fn key

Power On/Off key

1mV/COPY key

MODE key

SLEEP/WAKE UP key

PRINT/STOP key

Tab key/Feed paper key

UP/DOWN Arrow key

LEFT/RIGHT Arrow key / Lead switch key

Gender key

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Safety Guidance

SE-1200 Series Electrocardiograph User Manual

Safety Guidance

Age Group 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. With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1and CAN/CSA C22.2 No. 601.1 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.

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SE-1200 Series Electrocardiograph User Manual

Introduction

Chapter 2 Introduction SE-1200 series 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 VCG (only configurable for SE-1200 Express) mode can be chosen freely. SE-1200 series electrocardiograph can be powered by the mains supply or battery. With a high resolution thermal recorder, a 32-bit processor and a large-capacity memorizer, SE-1200 series electrocardiograph has advanced performance and high reliability. The compact size makes it suitable for clinic and hospital uses. SE-1200 series electrocardiograph has two models: SE-1200 and SE-1200 Express. SE-1200 adopts 320×240 dot single color LCD screen; SE-1200 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, battery. NOTE: The pictures and windows in this manual are for reference only.

2.1 Top Panel Indicators

LCD Screen Recorder

Keyboard

Figure 2-1 SE-1200 Express

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SE-1200 Series Electrocardiograph User Manual

Introduction

Indicators

LCD Screen Recorder

Keyboard

Figure 2-2 SE-1200

2.2 Keyboard and Keys

A

B C D

E P F

O

G

N

M

L

K

G

I

Figure 2-3 SE-1200 Express/SE-1200 Keyboard

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H

SE-1200 Series Electrocardiograph User Manual

Name A

Introduction

Explanation

Function Key

Press to select menu functions on the screen.

B

Gender Key

Press to quickly select the gender for the patient when Gender is selected in the Patient Information Setup window.

C

Delete Key

Press to delete characters.

D

Age Group Key

E

Enter

Press to quickly select the age group on the main screen when you set Age to Age Group in the Patient Information Setup window. Press to confirm operation. Press to move the cursor: Pressing Tab can move the cursor forward, and pressing Shift + Tab can move the cursor backward.

F

Tab/Feed paper

Press to feed paper: If Paper Marker is set to Yes, pressing Tab can advance the recorder paper to the next black marker; if Paper Marker is set to No, pressing Tab can advance the paper for 2.5cm. Pressing Tab again can stop advancing the paper.

G

Fn

Press Fn and a letter key to type special characters. Pressing Fn + a can type è. Press to move the cursor (Up, Down, Left, Right)

H

Arrow Keys

In the manual mode or on the previewing screen, press the Left or Right arrow to switch the lead groups. Pressing Shift + Up/Down can turn pages on the Order Manager screen and the File Manager screen. Press to start or stop printing reports

I

PRINT/STOP

Pressing Shift + PRINT/STOP can quickly enable or disable the print out function in the auto or rhythm mode. In the manual mode, pressing the 1mV/COPY key can insert a 1mV calibration mark during the printing course.

J

1mV/COPY

K

SLEEP/WAKE UP

In the auto, rhythm or VCG (only configurable for SE-1200 Express) mode, pressing the 1mV/COPY key can print the ECG report which was printed out last time. Press to rest/waken the electrocardiograph

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SE-1200 Series Electrocardiograph User Manual

Introduction

Press to select a working mode among the auto, manual, rhythm, R-R analysis and VCG (only configurable for SE-1200 Express) modes. L

MODE

M

Power On/Off

N

Spacebar

NOTE: Only if a working mode is selected in the Work Mode Setup window, can the working mode be selected by pressing the MODE key when the main screen is displayed. Power-on/Power-off Press to add a space between typed characters or select/deselect a checkbox Press to cancel operation

O

Esc/Reset

NOTE: A large polarization voltage may cause baseline drift. On the main screen, pressing Esc can decrease the polarization voltage and draw the baseline to zero quickly. Press Shift + Tab to move the cursor backward. Press Shift and a number key to input the special character in the top right corner of the key.

P

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.

2.3 Front Panel

Figure 2-4 SE-1200 Express Front Panel

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SE-1200 Series Electrocardiograph User Manual

Introduction

Figure 2-5 SE-1200 Front Panel

Symbol

Name

Explanation

A

Mains supply indicator

When the device is powered by the mains supply, this indicator is lit.

B

Battery indicator

When the device is powered by battery, this indicator is lit.

C

Battery recharging When the battery is being recharged, this indicator indicator is lit.

2.4 Rear Panel

Figure 2-6 SE-1200/SE-1200 Express Rear Panel

Name A

B

Mains Supply Socket

Explanation AC SOURCE: alternating current supply socket

Potential Equalization Potential equalization conductor provides a Conductor 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 - 14 -