Model SE-12, SE-12 Express User Manual Release 1.4 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 1.3 List of Symbols... 6 Chapter 2 Introduction... 9 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 ... 14 2.6 Bottom Panel ... 18 2.7 Function Features ... 20 Chapter 3 About the Electrocardiograph Application... 21 3.1 Selecting Menu Functions ... 21 3.2 Entering Data... 22 3.3 Selecting an Item ... 23 3.4 About the Main Interface ... 24 3.5 About the System Setup Interface ... 26 3.6 About the File Manager Interface ... 28 Chapter 4 Operation Preparations... 31 4.1 Power and Earthing ... 31 4.2 Loading/Replacing Recorder Paper... 32 4.3 Preparing the Patient... 36 4.3.1 Instructing the Patient ... 36 4.3.2 Preparing the Skin ... 37 4.4 Connecting the Patient Cable to the Electrocardiograph and Electrodes ... 37 4.5 Attaching Electrodes to the Patient... 38 4.5.1 Lead Placement ... 38 4.5.2 Electrode Placement... 40 4.6 Inspection Before Power-On ... 43 III

Chapter 5 Turning On the Electrocardiograph... 45 Chapter 6 Entering Patient Information ... 46 6.1 Entering Patient ID ... 46 6.2 Entering Other Information ... 47 6.3 Using a Bar Code Reader ... 49 Chapter 7 Freezing ECG Waves ... 53 Chapter 8 Printing ECG Reports ... 55 8.1 Auto Mode ... 55 8.2 Manual Mode... 59 8.3 Rhythm Mode ... 61 8.4 R-R Analysis Mode ... 63 8.5 Copy Printing... 65 8.6 ECG Reports... 66 8.6.1 ECG Reports in the Auto Mode ... 66 8.6.2 ECG Reports in the Rhythm Mode ... 71 8.6.3 ECG Reports in the Manual Mode... 72 8.6.4 ECG Reports in the R-R Analysis Mode... 73 8.6.5 ECG Reports Printed by the USB Printer ... 77 8.6.6 ECG Report of Patient with Pacemaker... 78 8.6.7 ECG Report of Nehb Lead... 79 Chapter 9 Transmitting ECG Data Automatically... 81 9.1 Transmitting ECG Data to the PC ... 81 9.1.1 Transmitting ECG Data in DAT Format Through Serial Cable ... 81 9.1.2 Transmitting ECG Data in DAT Format Through Net Cable... 83 9.1.3 Transmitting ECG Data in SCP/FDA-XML/PDF Format Through Net Cable ... 85 9.2 Exporting ECG Data to the U Disk Automatically... 88 9.3 Real-time Transmission to PC ECG ... 89 Chapter 10 Managing Files ... 91 10.1 Transmitting Files to the PC ... 93 10.1.1 Transmitting DAT Files Through Serial Cable ... 94 10.1.2 Transmitting DAT Files Through Net Cable ... 95 10.1.3 Transmitting SCP/FDA-XML/PDF Files Through Net Cable... 96 10.2 Exporting Files to the U Disk ... 97 10.3 Deleting Files... 98 10.4 Searching Files ... 99 IV

10.5 Importing Files ... 100 10.6 Editing Patient Information ... 100 10.7 Printing Files... 101 10.8 Previewing a File ... 101 Chapter 11 System Setup... 105 11.1 Work Mode Setup ... 105 11.1.1 Selecting Work Mode ... 106 11.1.2 Selecting Manual Style... 107 11.1.3 Selecting Rhythm Style ... 107 11.1.4 Selecting Auto Display Style... 107 11.1.5 Selecting Sampling Mode ... 108 11.1.6 Setting Interval and Duration ... 109 11.1.7 Selecting Preview Function... 109 11.1.8 Selecting Auto Extend Record ... 109 11.2 Filter Setup... 109 11.2.1 Setting AC Filter... 110 11.2.2 Setting DFT Filter ... 110 11.2.3 Setting EMG Filter ... 111 11.2.4 Setting Lowpass Filter... 111 11.3 Record Info Setup ... 112 11.3.1 Setup 1... 112 11.3.2 Setup 2... 116 11.4 Patient Information Setup ... 117 11.4.1 Selecting First/Last Name / Gender / D.O.B / Height / Weight / BP / Race / Pacemaker / Medication / Room No. / Department / Physician / Technician / Ref-Physician... 118 11.4.2 Selecting ID Mode ... 119 11.4.3 Selecting ID Hint... 119 11.4.4 Setting Prompt... 119 11.4.5 Selecting H/W Unit ... 119 11.4.6 Selecting BP Unit ... 120 11.4.7 Selecting Next Patient ... 120 11.4.8 Setting the Time to Clear Patient Information ... 121 11.4.9 Inputting Customized Information ... 121 11.5 Transmission Setup... 122 11.5.1 Setting Device No. ... 123 11.5.2 Selecting Auto Transmission... 123 11.5.3 Selecting Transmission Mode ... 123 11.5.4 Setting FTP Information... 124 V

11.5.5 Setting IP Addresses ... 124 11.6 Lead Setup ... 124 11.6.1 Setting Rhythm Lead1/2/3 ... 125 11.6.2 Setting Lead Sequence ... 126 11.6.3 Selecting Nehb ... 126 11.7 Display&Sound Setup ... 126 11.7.1 Setting Brightness (Optional)... 127 11.7.2 Selecting Display Colors (Only for SE-1200 Express)... 127 11.7.3 Selecting Antialiasing... 127 11.7.4 Setting Key Volume... 128 11.7.5 Setting Hint Volume ... 128 11.7.6 Setting QRS Volume ... 128 11.8 Date&Time Setup ... 128 11.8.1 Setting Date and Time ... 129 11.8.2 Setting Date Mode... 129 11.8.3 Setting Time Mode ... 130 11.8.4 Setting Power-Off Time ... 130 11.8.5 Setting LCD Off Time... 130 11.9 File Setup ... 130 11.9.1 Selecting Auto Save ... 131 11.9.2 Setting Saving Path ... 131 11.9.3 Setting File Format... 132 11.9.4 Selecting Deleting Files After Transmission or Export... 132 11.9.5 Selecting Replacing When Memory is Full ... 132 11.9.6 Selecting SCP File Compression... 132 11.10 System Maintenance Setup... 133 11.10.1 Exporting System Settings to U Disk... 133 11.10.2 Loading System Settings from U Disk... 134 11.10.3 Backing Up Settings... 134 11.10.4 Loading Backup Settings ... 134 11.10.5 Printing System Settings ... 134 11.10.6 Loading Factory Settings ... 134 11.10.7 Setting System Password ... 137 11.11 Other Setup ... 138 11.11.1 Entering Institution... 138 11.11.2 Selecting a Language... 138 11.11.3 Selecting Caps Lock ... 139 11.11.4 Setting External Input... 139 VI

11.11.5 Setting External Output ... 139 11.11.6 Setting Pacemaker Detection Sensitivity ... 140 Chapter 12 Turning Off the Electrocardiograph ... 141 Chapter 13 Hint Information... 142 Chapter 14 Cleaning, Care and Maintenance ... 143 14.1 Cleaning... 143 14.1.1 Cleaning the Main Unit and the Patient Cable... 143 14.1.2 Cleaning the Reusable Electrodes... 143 14.1.3 Cleaning the Print Head ... 143 14.2 Disinfection ... 144 14.3 Care and Maintenance ... 144 14.3.1 Recharge and Replacement of Battery ... 144 14.3.2 Recorder Paper ... 145 14.3.3 Maintenance of the Main Unit and the Patient Cable ... 146 Chapter 15 Accessories ... 148 Chapter 16 Warranty & Service Policy... 150 16.1 Warranty... 150 16.2 Service Policy ... 150 Appendix 1 Technical Specifications ... 152 A1.1 Safety Specifications ... 152 A1.2 Environment Specifications... 153 A1.3 Physical Specifications ... 153 A1.4 Power Supply Specifications ... 153 A1.5 Performance Specifications ... 154 Appendix 2 EMC Information... 157 Appendix 3 Abbreviation... 162

VII

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

Federal (U.S.) law restricts this device to sale by or on the order of a physician.

2

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.

3

Do not use the equipment in a dusty environment with bad ventilation or in the presence of corrosive.

4

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.

5

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.

6

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. 7

Ruptured fuse must only be replaced with that of the same type and rating as the original.

8

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.

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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.

1.3 List of Symbols External output

External input

Equipment or part of CF type with defibrillator proof

Caution

Consult Instructions for Use

Potential equalization

Mains supply

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12-Channel Electrocardiograph User Manual

Safety Guidance

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

START/STOP key

Tab key/Feed paper key

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12-Channel Electrocardiograph User Manual

Safety Guidance

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.

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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. 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-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, 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-1200 Express Indicators

LCD Screen Recorder

Keyboard

Figure 2-2 SE-1200

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12-Channel Electrocardiograph User Manual

Introduction

2.2 Keyboard and Keys A B

F

C

G H

D E

I

J

L

K

M

N

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

Name

Explanation

A

Function Key

Selecting menu functions on the screen

B

Delete

Deleting characters

C

Enter

Confirming operation Moving the cursor Pressing Tab can move the cursor forward, and pressing Shift + Tab can move the cursor backward.

D

Tab/Feed paper

E

Fn

F

Spacebar

G

Shift

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

Pressing Shift + Tab can move the cursor backward. - 11 -

or

12-Channel Electrocardiograph User Manual

Introduction

Press Shift and a number key to input the special character in the top right corner of the key. 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 H

Esc/Reset

I

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, manual, rhythm, R-R analysis, and off modes.

J

MODE

K

SLEEP/WAKE UP

L

COPY

M

START/STOP

Note: Only if a working mode is ticked on the Work Mode Setup interface, can the working mode be selected by pressing the MODE key when the main interface is displayed. 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)

N

Arrow Keys

In the manual mode, press the Up or Down arrow to switch the lead groups.

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12-Channel Electrocardiograph User Manual

Introduction

2.3 Front Panel

Figure 2-4 SE-1200 Express Front Panel

Figure 2-5 SE-1200 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.

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