User Manual
173 Pages
Preview
Page 1
About this Manual P/N: 01.54.455422-10 Release Date: November 2011 © Copyright EDAN INSTRUMENTS, INC. 2011. 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-1200, SE-1200 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 ... 2 1.2.2 Li-ion Battery Care Warnings ... 5 1.2.3 General Cautions... 5 1.3 List of Symbols... 6 Chapter 2 Introduction... 10 2.1 Top Panel ... 11 2.2 Keyboard and Keys ... 12 2.3 Front Panel... 14 2.4 Rear Panel... 15 2.5 Right Panel ... 15 2.6 Bottom Panel ... 19 2.7 Function Features ... 21 Chapter 3 About the Electrocardiograph Application... 22 3.1 Selecting Menu Functions ... 22 3.2 Entering Data... 23 3.3 Selecting an Item ... 24 3.4 About the main screen ... 25 3.5 About the System Setup screen ... 27 3.6 About the File Manager screen... 29 Chapter 4 Operation Preparations... 32 4.1 Power and Earthing ... 32 4.2 Loading/Replacing Recorder Paper... 34 4.3 Preparing the Patient... 38 4.3.1 Instructing the Patient ... 38 4.3.2 Preparing the Skin ... 38 4.4 Connecting the Patient Cable to the Electrocardiograph and Electrodes ... 39 4.5 Attaching Electrodes to the Patient... 40 4.5.1 Lead Placement ... 40 4.5.2 Electrode Placement... 42 4.6 Inspection before Power-On ... 44 Chapter 5 Turning on the Electrocardiograph... 46 III
Chapter 6 Entering Patient Information ... 47 6.1 Entering Patient ID ... 47 6.2 Entering Other Information ... 48 6.3 Using a Bar Code Reader ... 50 Chapter 7 Freezing ECG Waves ... 54 Chapter 8 Printing ECG Reports ... 56 8.1 Auto Mode ... 56 8.2 Manual Mode... 60 8.3 Rhythm Mode ... 62 8.4 R-R Analysis Mode ... 64 8.5 Copy Printing... 66 8.6 ECG Reports... 67 8.6.1 ECG Reports in the Auto Mode ... 67 8.6.2 ECG Reports in the Rhythm Mode ... 72 8.6.3 ECG Reports in the Manual Mode... 73 8.6.4 ECG Reports in the R-R Analysis Mode... 74 8.6.5 ECG Reports Printed by the USB Printer ... 78 8.6.6 ECG Report of Patient with Pacemaker... 79 8.6.7 ECG Report of Nehb Lead... 80 Chapter 9 Transmitting ECG Data Automatically... 82 9.1 Transmitting ECG Data to the PC ... 82 9.1.1 Transmitting ECG Data in DAT Format through Serial Cable ... 82 9.1.2 Transmitting ECG Data in DAT Format through Net Cable... 84 9.1.3 Transmitting ECG Data in SCP/FDA-XML/PDF Format through Net Cable... 87 9.2 Exporting ECG Data to the U Disk Automatically... 89 9.3 Real-time Transmission to PC ECG ... 90 Chapter 10 Managing Files ... 92 10.1 Transmitting Files to the PC ... 94 10.1.1 Transmitting DAT Files through Serial Cable... 95 10.1.2 Transmitting DAT Files through Net Cable ... 96 10.1.3 Transmitting SCP/FDA-XML/PDF Files through Net Cable ... 97 10.2 Exporting Files to the U Disk ... 98 10.3 Deleting Files... 99 10.4 Searching Files ... 100 10.5 Importing Files ... 101 10.6 Editing Patient Information ... 101 IV
10.7 Printing Files... 102 10.8 Previewing a File ... 102 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 ... 118 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 ... 119 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... 121 11.5.1 Setting Device No. ... 122 11.5.2 Selecting Auto Transmission... 123 11.5.3 Selecting Transmission Mode ... 123 11.5.4 Setting FTP Information... 123 11.5.5 Setting IP Addresses ... 123 11.6 Lead Setup ... 124 V
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 ... 140 11.11 Other Setup ... 140 11.11.1 Entering Institution... 141 11.11.2 Selecting a Language... 141 11.11.3 Selecting Caps Lock ... 141 11.11.4 Setting External Input... 141 11.11.5 Setting External Output ... 142 11.11.6 Setting Pacemaker Detection Sensitivity ... 142 VI
Chapter 12 Turning off the Electrocardiograph ... 143 Chapter 13 Hint Information... 144 Chapter 14 Cleaning, Care and Maintenance ... 145 14.1 Cleaning... 145 14.1.1 Cleaning the Main Unit and the Patient Cable... 145 14.1.2 Cleaning the Reusable Electrodes... 145 14.1.3 Cleaning the Print Head ... 146 14.2 Disinfection ... 146 14.3 Care and Maintenance ... 147 14.3.1 Recharge and Replacement of Battery ... 147 14.3.2 Recorder Paper ... 148 14.3.3 Visual inspection ... 149 14.3.4 Maintenance of the Main Unit and the Patient Cable ... 149 Chapter 15 Accessory List ... 152 Chapter 16 Warranty & Service ... 154 16.1 Warranty... 154 16.2 Contact information ... 154 Appendix 1 Technical Specifications ... 155 A1.1 Safety Specifications ... 155 A1.2 Environment Specifications... 156 A1.3 Physical Specifications ... 156 A1.4 Power Supply Specifications ... 156 A1.5 Performance Specifications ... 157 Appendix 2 EMC Information... 160 Appendix 3 Abbreviation... 165
VII
SE-1200 Series 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. WARNING 1. This equipment is not designed for internal 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.
-1-
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 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. 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. Electrodes with defibrillator protection should be used while defibrillating. 12. If
reusable
electrodes
with
electrode
gel
are
used
during
defibrillation,
electrocardiograph recovery will take more than 10 seconds. The manufacturer recommends the use of disposable electrodes at all times. 13. Electrodes of dissimilar metals should not be used; otherwise it may cause a high polarization voltage. -2-
SE-1200 Series Electrocardiograph User Manual
Safety Guidance
WARNING 14. The disposable electrodes can only be used for one time. 15. No hazard is found when the electrocardiograph is operated with cardiac pacemakers or other stimulators. 16. Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator. 17. Do not touch accessible parts of non-medical electrical equipment and the patient simultaneously. 18. 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. 19. 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. 20. Fix attention on the examination to avoid missing important ECG waves. 21. 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. 22. SHOCK HAZARD - Don’t connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlets supplying the system. 23. 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. 24. Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.). 25. Do not exceed the maximum permitted load when using multiple portable socket-outlets to supply the system. -3-
SE-1200 Series Electrocardiograph User Manual
Safety Guidance
WARNING 26. Multiple portable socket-outlets shall not be placed on the floor. 27. 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. 28. 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. 29. Parts and accessories used must meet the requirements of the applicable IEC/EN 601 series safety standards, and/or the system configuration must meet the requirements of the IEC/EN 60601-1-1 medical electrical systems standard. 30. 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. 31. 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. 32. 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.
-4-
SE-1200 Series Electrocardiograph User Manual
Safety Guidance
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 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 is not used for a long time. 10. If the battery is stored alone and not used for a long time, we recommend that the battery should be charged at least once every 6 months to prevent overdischarge.
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.
-5-
SE-1200 Series Electrocardiograph User Manual
Safety Guidance
CAUTION 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.
1.3 List of Symbols External output
External input
Equipment or part of CF type with defibrillator proof
Caution
Consult Instructions for Use
-6-
SE-1200 Series Electrocardiograph User Manual
Potential equalization
Mains supply
USB socket
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
-7-
Safety Guidance
SE-1200 Series 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. With respect to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1and CAN/CSA C22.2 No. 601.1
-8-
SE-1200 Series Electrocardiograph User Manual
Rx only (U.S.)
Safety Guidance
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.
-9-
SE-1200 Series 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 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, battery. NOTE: The pictures and windows in this manual are for reference only.
- 10 -
SE-1200 Series 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
- 11 -
SE-1200 Series 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 screen 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. - 12 -
or
SE-1200 Series 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 screen, 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 in the Work Mode Setup window, can the working mode be selected by pressing the MODE key when the main screen 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.
- 13 -