EDAN INSTRUMENTS SE301EDAN Electrocardiograph User Manual

EDAN INSTRUMENTS, INC. Electrocardiograph

User Manual

I About this Manual P/N: 01.54.456718 MPN: 01.54.456718011 Release Date: July, 2015 © Copyright EDAN INSTRUMENTS, INC. 2015. 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-301, iSE-301 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
II 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.
III Table of Contents Chapter 1 Safety Guidance ....................................................................................................... 1 1.1 Indications for Use/Intended Use ..................................................................................... 1 1.2 Warnings and Cautions ..................................................................................................... 1 1.2.1 Safety Warnings ........................................................................................................ 2 1.2.2 Lithium 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 Bottom Panel ................................................................................................................... 11 2.3 Right Panel ...................................................................................................................... 11 2.4 Back Panel ...................................................................................................................... 11 Chapter 3 Operation Preparations ......................................................................................... 12 3.1 Loading/Replacing Recorder Paper ................................................................................ 12 3.2 Preparing the Patient ....................................................................................................... 13 3.2.1 Instructing the Patient ............................................................................................. 13 3.2.2 Cleaning the Skin .................................................................................................... 13 3.3 Connecting the Patient Cable to the Electrocardiograph and Electrodes ....................... 13 3.4 Attaching Electrodes to the Patient ................................................................................. 14 3.4.1 Reusable Electrodes ................................................................................................ 14 3.4.2 Disposable Electrodes ............................................................................................. 17 3.5 Inspection Before Power On ........................................................................................... 18 Chapter 4 Sampling and Printing ECG ................................................................................. 20 4.1 Entering Patient Information .......................................................................................... 20 4.1.1 Entering Patient Information Manually .................................................................. 20 4.1.2 Entering Patient Information by Acquiring Orders ................................................ 21 4.2 Printing ECG Reports ..................................................................................................... 21 4.3 Sample ECG Reports ...................................................................................................... 22 4.3.1 ECG Reports in the AUTO Mode ........................................................................... 22 4.3.2 PDF Report ............................................................................................................. 24 Chapter 5 Managing ECG Records ........................................................................................ 25 5.1 Transmitting ECG Records to the PC ............................................................................. 25 5.1.1 Transmitting ECG Records through the Network .................................................. 25 5.1.2 Transmitting ECG Records through WIFI Network (Optional) ............................. 26 5.2 Copying ECG Records between the ECG Machine and External Memory ................... 26 5.3 Deleting Patient Records ................................................................................................ 28 5.4 Printing a Patient Record in the File Manager screen..................................................... 28
IV Chapter 6 Settings .................................................................................................................... 29 6.1 Work Mode ..................................................................................................................... 29 6.2 Filter ................................................................................................................................ 29 6.3 Record Info Setup ........................................................................................................... 30 6.3.1 Setup 1 .................................................................................................................... 30 6.3.2 Setup 2 .................................................................................................................... 31 CAUTION ................................................................................................................................. 32 6.4 Patient Information Setup ............................................................................................... 33 6.5 Transmission Setup ......................................................................................................... 34 6.6 Lead Setup ...................................................................................................................... 34 6.7 File Setup ........................................................................................................................ 35 6.8 Date&Time Setup ........................................................................................................... 36 6.9 System Maintenance ....................................................................................................... 36 6.10 Other Setup ................................................................................................................... 36 6.11 Advanced Setup ............................................................................................................. 37 Chapter 7 Hint Information .................................................................................................... 38 Chapter 8 Troubleshooting ...................................................................................................... 39 Chapter 9 Cleaning, Care and Maintenance ......................................................................... 41 9.1 General Points ................................................................................................................. 41 9.2 Cleaning .......................................................................................................................... 41 9.2.1 Cleaning the Main Unit .......................................................................................... 42 9.2.2 Cleaning the Patient Cable ..................................................................................... 42 9.2.3 Cleaning the Reusable Electrodes .......................................................................... 43 9.3 Disinfection ..................................................................................................................... 43 9.3.1 Disinfecting the Main Unit ..................................................................................... 43 9.3.2 Disinfecting the Patient Cable ................................................................................ 44 9.3.3 Disinfecting the Reusable Electrodes ..................................................................... 44 9.4 Care and Maintenance .................................................................................................... 44 9.4.1 Recharge and Replacement of Battery ................................................................... 44 9.4.2 Recorder Paper ....................................................................................................... 45 9.4.3 Maintenance of the Main Unit, the Patient Cable and Electrodes .......................... 46 Chapter 10 Accessories ............................................................................................................ 48 Chapter 11 Warranty and Service .......................................................................................... 50 11.1 Warranty ........................................................................................................................ 50 11.2 Contact information ...................................................................................................... 50 Appendix 1 Technical Specifications ...................................................................................... 51 A1.1 Safety Specifications .................................................................................................... 51 A1.2 Environment Specifications ......................................................................................... 52
V A1.3 Physical Specifications ................................................................................................ 52 A1.4 Power Supply Specifications ....................................................................................... 52 A1.5 Performance Specifications ......................................................................................... 53 Appendix 2 EMC Information ................................................................................................ 55 Appendix 3 Abbreviation ......................................................................................................... 59
SE-301 Series Electrocardiograph User Manual Safety Guidance - 1 - Chapter 1 Safety Guidance This chapter provides important safety information related to the use of the 3-Channel Electrocardiograph. 1.1 Indications for Use/Intended Use The intended use of the 3-Channel Electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is intended to be used only in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the 3-Channel Electrocardiograph can help users to analyze and diagnose heart disease. However the 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 operations, 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.
SE-301 Series Electrocardiograph User Manual Safety Guidance - 2 - 1.2.1 Safety Warnings WARNING 1. The electrocardiograph is provided for the use of 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. Otherwise, safety hazards may happen. 3. Only qualified installation or service engineers can shift the mains supply shift switch (100V-240V~) according to local mains supply specifications. 4. The EQUIPMENT is protected against malfunction caused by electrosurgery. 5. EXPLOSION HAZARD - Do not use the electrocardiograph in the presence of flammable anesthetic mixture 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 operated by using the 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. 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. 10. The use of patient cable and other accessories not supplied by the manufacturer may result in increased emissions or decreased immunity of the equipment. 11. 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. 12. Make sure that all electrodes are connected to the patient correctly before operation. 13. Ensure that the conductive parts of electrodes and associated connectors, including neutral electrode, do not come into contact with earth or any other conducting objects.
SE-301 Series Electrocardiograph User Manual Safety Guidance - 3 - WARNING 14. To avoid a polarization or DC offset voltage, use non-polarizing electrodes(which will not form a DC offset voltage when subjected to a DC current) such as silver/silver-chloride types if there is a situation where there is a likelihood that a defibrillation procedure will be necessary. 15. There is no danger for patients with pacemakers. However, if a pacemaker is used, the results given by the equipment may be invalid, or lose the clinical significance. 16. 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. 17. Electrodes of dissimilar metals should not be used; it may cause a high polarization voltage. 18. The disposable electrodes can only be used for one time. 19. Do not touch the patient, bed, table or the equipment while using the ECG together with a defibrillator. 20. Do not touch accessible parts of electrical equipment and the patient simultaneously. 21. 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. 22. If WIFI technology is used, in order to maintain compliance with the FCC RF exposure guidelines, the wireless 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 WIFI is used. 23. Fix attention on the examination to avoid missing important ECG waves. 24. 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. 25. 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.
SE-301 Series Electrocardiograph User Manual Safety Guidance - 4 - WARNING 26. Do not connect any equipment or accessories that are not approved by the manufacturer or that are not IEC/EN 60601-1 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. 27. Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity (1.5m/6ft.). 28. Multiple portable socket-outlets shall not be placed on the floor. 29. 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. 30. 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. 31. 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. 32. 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.
SE-301 Series Electrocardiograph User Manual Safety Guidance - 5 - WARNING 33. 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. 34. The potential equalization conductor can be connected to that of other equipment when necessary, to make sure that all these devices are connected to the potential equalization bus bar of the electrical installation. 35. The electrocardiograph shall not be serviced or maintained while in use with a patient. 36. The appliance coupler or mains plug is used as isolation means from supply mains. Position the electrocardiograph in a location where the operator can easily access the disconnection device. 37. The medical electrical equipment needs to be installed and put into service according to Appendix 2 EMC Information. 38. The equipment should not be used adjacent to or stacked with other equipment, refer to the recommended separation distances provided in Appendix 2 EMC Information. 39. Portable and mobile RF communications equipment can affect medical electrical equipment, refer to the recommended separation distances provided in Appendix 2 EMC Information. 40. Assembly of the electrocardiograph and modifications during actual service life shall be evaluated based on the requirements of IEC60601-1. 1.2.2 Lithium Battery Care Warnings WARNING 1. Improper operation may cause the lithium battery (hereinafter called battery) to be hot, ignited or exploded, and it may lead to the declination of the battery capacity. It is necessary to read the user manual carefully and pay more attention to warning messages. 2. Only qualified service engineer 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.
SE-301 Series Electrocardiograph User Manual Safety Guidance - 6 - WARNING 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 over-discharge. 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, mobile phones etc. Attention: large medical electrical equipment such as electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment is likely to bring electromagnetic interference.
SE-301 Series Electrocardiograph User Manual Safety Guidance - 7 - CAUTION 5. Ruptured fuse must only be replaced with that of the same type and rating as the original. 6. 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. 7. Before use, the equipment, the patient cable and electrodes should be checked. Replace them if there is any evident defectiveness or aging which may impair the safety or the performance. Make sure that the equipment is in proper working condition. 1.3 List of Symbols No. Symbol Description 1 DEFIBRILLATION-PROOF TYPE CF APPLIED PART 2 Caution 3 Operating instructions 4 Equipotential grounding 5 Power key 6 Print/Stop key
SE-301 Series Electrocardiograph User Manual Safety Guidance - 8 - 7 Casing Button 8 General symbol for recovery/recyclable 9 Part Number 10 SERIAL NUMBER 11 Date of manufacture 12 MANUFACTURER 13 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 14 CE marking 15 Disposal method 16 SD card slot 17 USB socket 18 Net port 19 Power adapter port 20 Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician 21 Refer to User Manual (Background: Blue; Symbol: White)
SE-301 Series Electrocardiograph User Manual Safety Guidance - 9 - 22 Warning (Background: Yellow; Symbol&Outline: Black) 23* FCC ID: SMQSE301EDAN Federal Communications Commission: FCC ID: SMQSE301EDAN 24* Non- ionizing electromagnetic radiation NOTE: 1. *Applicable to the Electrocardiograph configured with WIFI module. 2. For details about buttons of the keyboard, refer to Chapter 2. 3. The user manual is printed in black and white.
SE-301 Series Electrocardiograph User Manual Introduction - 10 - Chapter 2 Introduction SE-301 3-channel electrocardiograph gathers ECG signals of 12 leads simultaneously. It displays the operation menu, ECG parameters as well as electrocardiograms. 3-channel ECG waves can be viewed on the LCD screen and printed out by using a high-quality thermal recorder. The AUTO, MANU, RHYT, and R-R modes can be chosen freely. SE-301 series can be powered by the mains supply or a built-in rechargeable lithium battery. Two models are available: SE-301 with WIFI as an optional configuration, and iSE301 with WIFI as a standard configuration. With a 32-bit processor and a large-capacity memorizer, SE-301 has advanced performance and high reliability. The compact size makes it suitable for clinic, hospital and ambulance use. Configuration: main unit, power cord, earth wire, patient cable, electrodes, and lithium battery 2.1 Top Panel Figure 2-1 SE-301 No. Description A Press to release the recorder casing B Press to start/stop ECG sampling
SE-301 Series Electrocardiograph User Manual Introduction - 11 - 2.2 Bottom Panel The silk screen on the battery compartment indicates the rated voltage. 2.3 Right Panel . No. Description A Patient cable socket B Power key (Long press: switch on/off; short press: sleep mode) Color when using the mains supply: Green Color when using built-in battery: Blue Color when recharging: Orange 2.4 Back Panel No. Description No. Description A USB socket D Equipotential grounding B Net port E SD card slot C Power adapter port - -
SE-301 Series Electrocardiograph User Manual Operation Preparations - 12 - Chapter 3 Operation Preparations 3.1 Loading/Replacing Recorder Paper NOTE: 1. When the folded thermal paper is used, the paper roller is unnecessary and must be taken out. 2. The grid side of the paper should face the thermal print head, and the black marker on the paper should face the black marker detecting area. Loading/Replacing Process of Rolled Thermal Paper Loading/Replacing Process of Folded Thermal Paper
SE-301 Series Electrocardiograph User Manual Operation Preparations - 13 - 3.2 Preparing the Patient 3.2.1 Instructing the Patient Before attaching the electrodes, greet the patient and explain the procedure. Explaining the procedure decreases the patient’s anxiety. Reassure the patient that the procedure is painless. Privacy is important for relaxation. When possible, prepare the patient in a quiet room or area where others can’t see the patient. Make sure that the patient is comfortable. The more relaxed the patient is, the less the ECG will be affected by noise. 3.2.2 Cleaning the Skin Thorough skin preparation is very important. The skin is a poor conductor of electricity and frequently creates artifact that distorts the ECG signal. By performing methodical skin preparation, you can greatly reduce the possibility of the noise caused by muscle tremor and baseline drift, ensuring high-quality ECG waves. There is natural resistance on the skin surface due to dry, dead epidermal cells, oils and dirt. To clean the skin 1. Shave hair from electrode sites, if necessary. Excessive hair prevents a good connection. 2. Wash the area thoroughly with soap and water. 3. Dry the skin with a gauze pad to increase capillary blood flow to the tissues and to remove the dead, dry skin cells and oils. 3.3 Connecting the Patient Cable to the Electrocardiograph and Electrodes WARNING The performance and electric shock protection can be guaranteed only if original patient cable and electrodes of the manufacturer are used.
SE-301 Series Electrocardiograph User Manual Operation Preparations - 14 - 1. Connecting the Patient Cable to the Electrocardiograph Connect the patient cable to the patient cable socket on the right side of the main unit, and then secure them with two screws. 2. Connecting the Patient Cable to Electrodes Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the corresponding electrodes according to the colors and identifiers. Firmly attach them. 3.4 Attaching Electrodes to the Patient There are two types of electrode for you to choose, one is the reusable electrodes, and the other is the disposable electrodes. The uses of the two types of electrode are as shown below: 3.4.1 Reusable Electrodes Reusable Electrodes is divided into Limb electrode and Chest Electrode, as the following figure shows: Chest Electrode Suction Bulb Electrode Metal Cup Connecting to ElectrocardiographScrew Main Cable Connecting to Electrodes Lead Wires
SE-301 Series Electrocardiograph User Manual Operation Preparations - 15 - Limb Electrode The identifiers and color codes of electrodes used comply with IEC/EN requirements. In order to avoid incorrect connections, the electrode identifiers and color codes are specified in Table 4-1. Moreover the equivalent codes according to American requirements are given in Table 4-1 too. Table 3–1 Electrodes and Their identifiers and color codes European American Electrodes Identifier Color code Identifier Color code Right arm R Red RA White Left arm L Yellow LA Black Right leg N or RF Black RL Green Left leg F Green LL Red Chest 1 C1 White/red V1 Brown/red Chest 2 C2 White/yellow V2 Brown/yellowChest 3 C3 White/green V3 Brown/green Chest 4 C4 White/brown V4 Brown/blue Chest 5 C5 White/black V5 Brown/orangeChest 6 C6 White/violet V6 Brown/violet As the following figure shows, the positions of chest electrodes on the body surface are C1: Fourth intercostal space at the right border of the sternum C2: Fourth intercostal space at the left border of the sternum C3: Fifth rib between C2 and C4 C4: Fifth intercostal space on the left midclavicular line C5: Left anterior axillary line at the horizontal level of C4 C6: Left midaxillary line at the horizontal level of C4 Reed Electrode Clamp
SE-301 Series Electrocardiograph User Manual Operation Preparations - 16 - Chest Electrode Connection: 1) Ensure that the electrodes are clean; 2) Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the corresponding electrodes according to the colors and identifiers; 3) Clean the electrode area on the chest surface with 75% alcohol; 4) Daub the round area of 25mm in diameter on each electrode site with gel evenly; 5) Place a small amount of gel on the brim of chest electrode’s metal cup; 6) Place the electrode on the chest electrode site and squeeze the suction bulb. Unclench it and the electrode is adsorbed on the chest; 7) Attach all chest electrodes in the same way. NOTE: Long-time measurement with a strong negative pressure on the suction bulb may cause reddening of the skin. When using the electrode on small children or patients with delicate skin, squeeze the suction ball lightly. Limb Electrode Connection: 2) Ensure that the electrodes are clean; 3) Align all lead wires of the patient cable to avoid twisting, and connect the lead wires to the corresponding electrodes according to the colors and identifiers; 4) Clean the electrode area which is a short distance above the ankle or the wrist with alcohol; 5) Daub the electrode area on the limb with gel evenly; 6) Place a small amount of gel on the metal part of the limb C6 C1C2C5 C4 C3
SE-301 Series Electrocardiograph User Manual Operation Preparations - 17 - electrode clamp; 7) Connect the electrode to the limb, and make sure that the metal part is placed on the electrode area above the ankle or the wrist; 8) Attach all limb electrodes in the same way. 3.4.2 Disposable Electrodes Disposable Electrode Alligator Clip Disposable electrode must be used together with the alligator clip. The electrodes’ positions on body surface are as the following table and figures: American label European label Electrode placement RA R Right deltoid LA L Left deltoid RL N or RF Above right ankle (Alternate placement, upper leg as close to torso as possible) LL F Above left ankle (Alternate placement, upper leg as close to torso as possible) V1 C1 Fourth intercostals space at right border of sternum V2 C2 Fourth intercostals space at left border of sternum V3 C3 Fifth rib between V2 and V4 V4 C4 Fifth intercostals space on left midclavicular line V5 C5 Left anterior axillary line at the horizontal level of V4 V6 C6 Left midaxillary line at the horizontal level of V4
SE-301 Series Electrocardiograph User Manual Operation Preparations - 18 - Disposable Electrode connection 1) Align all lead wires of the patient cable to avoid twisting, and connect the alligator clips to the lead wires. 2) Clean the electrode areas on the body surface with 75% alcohol. 3) Attach the disposable electrodes to the electrode positions on body surface. 4) Clip the disposable electrodes with the alligator clips. The quality of ECG waveform will be affected by the contacting resistance between the patient and the electrode. In order to get a high-quality ECG, the skin-electrode resistance must be minimized when you attach electrodes to patients. CAUTION The disposable electrodes can only be used for one time. WARNING 1. Make sure that all electrodes are connected to the patient correctly before operation. 2. Make sure that the conductive parts of electrodes and associated connectors, including neutral electrode, do not come in contact with earth or any other conducting objects. 3.5 Inspection Before Power On In order to avoid safety hazards and get good ECG records, the following inspection procedure is recommended before power-on and operation. V6V1V2V5V4V3
SE-301 Series Electrocardiograph User Manual Operation Preparations - 19 - 1) Environment: ♦ Make sure that there is no electromagnetic interference source around the equipment, especially large medical electrical equipment such as electrosurgical equipment, radiological equipment, magnetic resonance imaging equipment etc. Switch off these devices when necessary. ♦ Keep the examination room warm to avoid muscle action voltages in ECG signals caused by cold. 2) Power Supply: ♦ If the mains supply is used, please check whether the power cord is connected to the unit well. The grounded three-phase outlet should be used. ♦ When the battery capacity is low, recharge the battery before use. 3) Patient Cable: ♦ Check whether the patient cable is connected to the unit firmly, and keep it far away from the power cord. 4) Electrodes: ♦ Check whether all electrodes are connected to lead wires of the patient cable correctly. ♦ Ensure that the chest electrodes do not contact. 5) Recorder Paper: ♦ Ensure that there is enough recorder paper loaded correctly. 6) Patient: ♦ The patient should not come into contact with conducting objects such as earth, metal parts etc. ♦ Ensure the patient is warm and relaxed, and breathe calmly. WARNING The electrocardiograph is provided for the use of qualified physicians or personnel professionally trained, and they should be familiar with the contents of this user manual before operation.
SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG - 20 - Chapter 4 Sampling and Printing ECG 4.1 Entering Patient Information 4.1.1 Entering Patient Information Manually On the main screen, the following information is displayed: patient information, system hints, heart rate, waveforms, current time, battery capacity, WIFI signal (optional), and functional keys. Click the patient symbol to enter the patient information window, enter the patient information, or you can configure the patient information items in system setup first. NOTE: The patient information cannot be set or changed during the printing course. Item Description Pacemaker Select Yes to detect very small pacemaker pulses. However, when Pacemaker is set to Ye s , the system is very sensitive, and should not be close to equipment emitting high frequency radiation. High frequency radiation can interfere with pacemaker pulse detection and normal ECG acquisition. NOTE: Pacemaker is recommended to be set to No unless it is known that the majority of the electrocardiograph usage will be on patients with pacemakers.
SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG - 21 - 4.1.2 Entering Patient Information by Acquiring Orders NOTE: To use the order function, the data management software (DMS) of the manufacturer must be installed in the PC. Operation procedures are as follows: 1. Connect the electrocardiograph to the PC through the network. 2. Log into the DMS. 3. Set Remote IP, Local IP, Gateway and Subnet Mask in the Transmission Setup window. 4. Click the patient symbol on the main screen to open the patient information window, and then click Order to open the Order screen. 5. Click Load to download order records from the server. 6. Select an order and click Examine to enter the presampling screen. 4.2 Printing ECG Reports The operation procedure is as follows: Manually switch lead groupMANU modeConfigure printing and system parameters if necessarySelect a work modePress PRINT/STOP to start samplingPress PRINT/STOP to stop sampling NOTE: 1. The printing mode cannot be changed during the printing course. Stop printing reports before changing the printing mode. 2. In the MANU mode, press the 1mV/COPY key to print out 1mV mark in the ECG report.S
SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG - 22 - 4.3 Sample ECG Reports 4.3.1 ECG Reports in the AUTO Mode Figure 4-1 ECG Reports in the AUTO Mode (a) Figure 4-2 ECG Reports in the AUTO Mode (b) Figure 4-1 and Figure 4-2 show an ECG report in the AUTO mode. Template is selected, and Record Style is set to 3×4. The ECG report includes: 3×4 ECG waves ID, Current Date and time Patient Information: ID, Name, Age, Gender, Height, Weight, BP, Race, Department, Exam Room, Medication Measure Information: HR Heart Rate P P wave duration: the average P-wave duration from several selected dominant beats;
SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG - 23 - PR P-R interval: the average P-R interval from several selected dominant beats; QRS QRS complex duration: the average QRS complex duration from several selected dominant beats; QT/QTc Q-T interval: the average Q-T interval from several selected dominant beats / Normalized QT interval; P/QRS/T Dominant direction of the average integrated ECG vectors; RV5/SV1 The maximum of the amplitude of R or R’ wave of one selected dominant beat from lead V5 / The maximum absolute value of the amplitude of S or S’ wave of one selected dominant beat from lead V1; RV5+SV1 (optional) Sum of RV5 and SV1; RV6/SV2 (optional) The maximum of the amplitude of R or R’ wave of one selected dominant beat from lead V6 / The maximum absolute value of the amplitude of S or S’ wave of one selected dominant beat from lead V2; QTcFd (Optional) Use the Fridericia formula to calculate the QTc interval QTcFm (Optional) Use the Framingham formula to calculate the QTc interval Average Template: Average template shows the average value of 10s sampled ECG signals of every lead. The broken lines on the template are position markers. They respectively mark the start and end points of the P and QRS waves, and the end point of the T wave. Diagnosis Information: Diagnosis information shows the auto diagnosis result. Report Confirmed by Confirmed by the physician Bottom Information: 0.67~100Hz (0.67Hz DFT Filter, 100Hz Lowpass Filter), AC50 (50Hz AC Filter)
SE-301 Series Electrocardiograph User Manual Sampling and Printing ECG - 24 - 25mm/s (Paper Speed) 10mm/mV (Gain) 60 (Heart Rate) Electrocardiograph Model V1.0 (Software Version) SEMIP V1.8 (Algorithm Version) Institution Name 4.3.2 PDF Report Figure 4-3 PDF Report
SE-301 Series Electrocardiograph User Manual Managing ECG Records - 25 - Chapter 5 Managing ECG Records If you want to save the ECG records, you should set the Auto Save to To EC G or Ext. Memory. The default value is To ECG. Then the ECG records will be saved in the File Manager or in the external memory automatically. Click File on the main screen to enter the file manager screen. The File Manager allows records to be stored, deleted, printed and transmitted. When there is no space for more records to be stored in the File Manager, the message MemFull will be displayed. 5.1 Transmitting ECG Records to the PC NOTE: To transmit ECG records to the PC, data management software (DMS) of EDAN must be installed in the PC. You should log into the Smart ECG Viewer software before the transmission. 5.1.1 Transmitting ECG Records through the Network Connect the PC to the electrocardiograph with an Ethernet cable recommended by the manufacturer.  Auto Transmission: 1. Choose Setup > Transmission to enter the Transmission Setup window. 2. Set Auto Transmission to On and set Transmission mode to Ethernet. 3. Set the Server IP to the IP of the DMS. 4. Set the first three numbers of the Local IP to the first three numbers of the IP of Smart ECG Viewer. The last number of the Local IP item can be set at random, but it can’t be the
SE-301 Series Electrocardiograph User Manual Managing ECG Records - 26 - same as the last number of the IP of the DMS. 5. In the AUTO or RHYT mode, ECG data can be transmitted through the net automatically after an ECG report is printed out.  Manual Transmission: 1. Choose Setup > Transmission to enter the Transmission Setup window. 2. Set Auto Transmission to Off and set Transmission mode to Ethernet. 3. For IP address setting, refer to step 3 and 4 for auto transmission. 4. To transmit all the data files to the PC, choose More > Trans All in the file management window. To transmit a single file, select it and click Trans. NOTE: The transmission process is long, and please be patient to wait. 5.1.2 Transmitting ECG Records through WIFI Network (Optional) If the WIFI module is configured, ECG records can also be transmitted through WIFI network. WARNING This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation. NOTE: 1. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: - Reorient or relocate the receiving antenna. - Increase the separation between the equipment and receiver.
SE-301 Series Electrocardiograph User Manual Managing ECG Records - 27 - - Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. - Consult the dealer or an experienced radio/TV technician for help. 2. Any changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. 5.2 Copying ECG Records between the ECG Machine and External Memory 1. Connect the external memory to the electrocardiograph. 2. Click File to open the File Manager screen. 3. Choose More > Trans All, and click OK, all the records will be transmitted to the external memory automatically. During the transmission, if something wrong happens, the electrocardiograph will give the error information. Then you should check whether the external memory is connected to the electrocardiograph well. 4. If you want to import records from the ECGDATA folder of the external memory to the electrocardiograph, click the Import button, the extended-name of imported records should be “.dat”. NOTE: To import records from the external memory to the electrocardiograph, there should be some records in the folder named ECGDATA in the external memory. The folder name ECGDATA must be capital letters. You should not change the name of records in the ECGDATA folder. 5. If you want to export only one record, choose the patient record in the table and click Export. NOTE: 1. The transmission process is long, and please be patient to wait. 2. During the transmission, the external memory should not be pulled out. 3. Only FAT or FAT32 format can be used when formatting the external memory.
SE-301 Series Electrocardiograph User Manual Managing ECG Records - 28 - 5.3 Deleting Patient Records 1. Open the File Manager screen. 2. If you want to delete all the records, click More and select the Del All button, and then click OK. 3. If you want to delete a record, choose the patient record in the table, and then click the delete symbol on the top. 5.4 Printing a Patient Record in the File Manager screen 1. Open the File Manager screen. 2. If you want to print the patient record, choose the patient record in the list, and then press PRINT/STOP. NOTE: If you use USB printer to print the patient record, when the PRINT/STOP key is pressed, the electrocardiograph begins to analyze data. Then the USB printer begins to print the ECG record after 8 seconds.
SE-301 Series Electrocardiograph User Manual Settings - 29 - Chapter 6 Settings Click Setup on the main screen to display the System Setup screen. NOTE: The underlined values are system default values. 6.1 Work Mode Item Description Sampling Mode (Only available in the AUTO mode) Choose from: Pre-Sample and Real-time Select Pre-Sample, 10s ECG data sampled before pressing the PRINT/STOP key will be printed out. NOTE: When Sampling Mode is set to Pre-Sample, if you press the PRINT/STOP key before the electrocardiograph samples for 10s, the recorder will not respond. Auto Arrhythmia Detection When enabled, if arrhythmia is detected in the AUTO mode, a hint will pop up to ask you whether to print an extra rhythm report after the 12-lead ECG report. 6.2 Filter Item Description AC Filter Choose from: On or Off AC filter is used to suppress interference of AC power supply. NOTE: AC frequency can be set to 50Hz or 60Hz on the Advanced Setup screen according to local mains supply specifications. DFT Filter Choose from: 0.01Hz, 0.05Hz, 0.32Hz, or 0.67Hz DFT Filter greatly reduces the baseline fluctuations without affecting the ECG signals. The purpose of this filter is to keep the ECG signals on the baseline of the printout. The set value is the low limit of the frequency range. EMG Filter The cutoff frequency can be set to 25Hz, 35Hz, 45Hz or Off EMG Filter suppresses disturbance caused by strong muscle tremor.
SE-301 Series Electrocardiograph User Manual Settings - 30 - Lowpass Filter The cutoff frequency can be set to 75Hz, 100Hz, 150Hz, 270Hz or 300Hz Lowpass Filter restricts the bandwidth of input signals. All the input signals whose frequency is higher than the set cutoff frequency will be attenuated. NOTE: Only when EMG Filter is set to Off, can the setting of Lowpass Filter be effective. NOTE: To pass the distortion test, the electrocardiograph has to be configured with the highest bandwidth in filter settings. Otherwise, ECG signal may be distorted. 6.3 Record Info Setup 6.3.1 Setup 1 Item Description Print Out Choose from: On, Off Select Off to disable the print function in the AUTO or RHYT mode. Speed Choose from: 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s and 50mm/s NOTE: The speed is corresponding with the work mode. Gain Choose from: 1.25mm/mV, 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV, 10/5mm/mV and 20/10mm/mV 10/5mm/mV means that the gain of limb leads is set to 10mm/mV, while the gain of chest leads is set to 5mm/mV. Auto Record Style Choose from: 3×4, 3×4+1R, 1×12, 1×12+1R and 3×2+2×3 Auto Record Sequence Choose from: Sequential or Synchronous Select Sequential, the lead group is printed one by one in a certain sequence. The start time of a lead group is just the end time of the previous lead group. Select Synchronous, the lead group is printed one by one in a certain sequence. All leads are printed with the same start time. AGC AGC means auto gain control. Choose from: On or Off Select On, the gain can be automatically adjusted according to actual signals.
SE-301 Series Electrocardiograph User Manual Settings - 31 - Auto Record Length Choose from: Short (2.5s), Medium (5s) and Long (10s) NOTE: Auto Record Length is corresponding with Record Device, Sampling Mode and Record Sequence. Manual Style Choose from 3 channels and 1 channels Select a style to print the ECG waves in the manual mode. Rhythm Record Mode Choose from: Save Paper or Quickly Select Save Paper, 10s after pressing the PRINT/STOP key on the main screen, an ECG report is printed in the RHYT mode. Select Quickly, pressing the PRINT/STOP key on the main screen to begin printing an ECG report immediately in the RHYT mode. Paper Marker Paper Marker is used to identify the start point of each page of the recorder paper. Choose from: Yes or No Select Ye s if the paper with black markers on the bottom is used, and the device can identify the start point of each page of the recorder paper while printing ECG reports. 6.3.2 Setup 2 Item Description Measure Choose from: On or Off When it is set to On, the Measure information will be printed in the ECG report. Analysis Choose from: On or Off When it is set to On, the Analysis information will be printed in the ECG report. Template Choose from: 2×6+1R, 3×4 or Off When it is set to Off, the template will not be printed in the ECG report Position Marker Choose from: On or Off When it is set to Off, the template printed in the ECG report will not have position marker. Minnesota Code Choose from: On or Off
SE-301 Series Electrocardiograph User Manual Settings - 32 - When it is set to On, the Minnesota Code will be printed in the ECG report. Device No. Choose from: On or Off When it is set to On, the Device No. will be printed in the ECG report. Baseline Adjustment Choose from: Horizontal, Auto or Off Select Horizontal, the baselines of the lead groups are adjusted simultaneously, and the baselines of the leads in the same row are on the same line. Select Auto, the baselines of the lead groups are adjusted respectively. Select Off, the baselines of the lead groups are adjusted equally in the ECG reports. Record Device Choose from: Thermal, HP 1010/1510/2010/1050/2000, HP M401/2015/2035/1525, HP1020/1020PLUS/1106, or HP 1505 You should connect the corresponding USB printer to the electrocardiograph before printing with the selected record device. WARNING If the printer used is not the type listed above, additional safety measures (such as applying an isolation transformer to supply the medical system) should be taken when the safety of the medical system has not been evaluated. If in doubt, consult our technical service department or your local distributor. CAUTION It is forbidden to connect or disconnect an external memory or a USB printer during the transmission course. NOTE: 1. During the USB printing course, pressing the PRINT/STOP key again cannot stop printing ECG reports. 2. For details of the ECG report printed by the USB printer, please refer to section 4.3.2 "PDF Report". 3. USB printing is ineffective in the AUTO mode and RHYT mode. 4. Make sure that paper is installed in the USB printer before printing. Error may occur if no paper is loaded in the USB Printer.
SE-301 Series Electrocardiograph User Manual Settings - 33 - 5. Make sure the type of USB printer connected is matched with the type you choose in the Record Device. Error may occur if the USB printer type is not matched. USB Record Style Choose from: 3×4, 3×4+1R, 3×4+3R, 6×2, 6×2+1R or 12×1 It defines the style of USB report. Grid of Report Choose from: On or Off When it is set to On, the grid will be printed while printing ECG reports with the thermal recorder or USB printer. 6.4 Patient Information Setup Item Description First/Last Name Choose from: On or Off When it is set to On, patient name will be divided into first name and last name. ID Choose from: Auto, Time or Manual ID Hint Choose from: On or Off In the AUTO or RHYT mode, when ID is set to Manual and ID Hint is set to On, if you do not input the patient ID before pressing the PRINT/STOP key, a hint will pop up to remind you to input the patient ID. Age Choose from: Age, D.O.B or Age Group PatInfo Refreshed Choose from: On or Off Select On, the patient information will be refreshed after the ECG report is printed out and all the leads are off. H/W Unit Choose from: cm/kg or inch/lb BP Unit Choose from: mmHg or kPa Order Acquired Choose from: On or Off Select On, the Order item will be displayed in the Patient Information window and you can acquire orders by clicking it.
SE-301 Series Electrocardiograph User Manual Settings - 34 - 6.5 Transmission Setup NOTE: 1. To transmit ECG data to the PC, the Smart ECG Viewer software produced of EDAN must be installed in the PC. You should log into the Smart ECG Viewer software before transmission. 2. If the power supply suddenly breakdown during data storage or transmission, file system error may occur. In this case, the file system should be formatted. Item Description Device No. Enter Device No., it should be within 7 ASCII characters. Auto Transmission Choose from: On or Off Select On, ECG data will be transmitted automatically after an ECG report is printed out in the AUTO or RHYT mode. Transmission Mode Choose from: Ethernet or Wireless FTP Information Enter data in the FTP Path, FTP User Name textboxes. IP Addresses Set Server IP, Local IP, Set Gateway, Set Subnet Mask For details, please refer to Section 5.1: "Transmitting ECG Records to the PC". 6.6 Lead Setup Item Description Rhythm Lead1/2/3 Choose from: І, П, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, or V6, the default NOTE: Rhythm Lead 1/2/3 must be different from each other. Lead Sequence Choose from: Standard or Cabrera Lead Sequence Lead group 1 Lead group 2 Lead group 3 Lead group 4 Standard І, II, III aVR, aVL, aVF V1, V2, V3 V4, V5, V6 Cabrera aVL, І, -aVR II, aVF, III V1, V2, V3 V4, V5, V6 Lead off hint When it is set to On and lead off waves are detected in the presampled waves, a lead off hint message will be displayed.
SE-301 Series Electrocardiograph User Manual Settings - 35 - 6.7 File Setup Item Description Auto Save Choose from: Off, To ECG or Ext. Memory Select Off, ECG data will not be saved. Select To ECG, ECG data in the AUTO or RHYT mode will be saved in the ECG automatically. Select Ext. Memory, ECG data in the AUTO or RHYT mode will be automatically saved to the directory of ECGDATA\ECG-X\Store\Examination Date of the external memory after an ECG report is printed out. NOTE: 1. Please insert the external memory recommended by the manufacturer. Please set the format to FAT or FAT32 when formatting the external memory. 2. X in the directory of ECGDATA\ECG-X\Store\Examination Date can be set in the Device No. textbox in the Transmission Setup window. File Format Choose from: DAT, PDF, SCP, FDA-XML and DICOM To select SCP/FDA-XML/DICOM, you should first activate the SCP/FDA-XML/DICOM function on the Advanced Setup screen. For details, please contact the manufacturer or the local distributor. Del. After Trans. Or Export Choose from: On or Off Select On, the files will be automatically deleted from the File Manager screen after they are transmitted to the PC or exported to the external memory. Replace When Memory Full Choose from: On or Off Select On, if the stored files reaches 200, the files will replace the earliest one automatically. SCP File Compression Choose from: On or Off Select On, the SCP file will be compressed.
SE-301 Series Electrocardiograph User Manual Settings - 36 - 6.8 Date&Time Setup NOTE: Please set DATE&TIME correctly when it’s the first time you use the electrocardiograph. Item Description Date Mode Choose from: DD-MM-YYYY, MM-DD-YYYY or YYYY-MM-DD Time Mode Choose from: 24 Hours or 12 Hours Date&Time Enter the current date and time displayed on the main screen and in the ECG reports. Power off time Set to 0-120 This function is only available when the electrocardiograph is powered by using the mains supply. LCD off time Set to 0-120 6.9 System Maintenance  Import/export the system settings, backup the settings, or load the backup settings  Load factory settings  Set the password to access system settings 6.10 Other Setup Item Description Institution Input the institution name manually within 40 ASCII characters. NOTE: The total number of supported characters may be fewer if special Latin characters are entered. Demo Setup Choose from: Normal, abnormal or Off When it is set to Normal, the main screen will display demo of normal ECG signal.
SE-301 Series Electrocardiograph User Manual Settings - 37 - Grid When enabled, the waveforms on the main screen will be displayed with a background grid. Language Select the language displayed on the main screen and in the ECG reports. Display Colors Set the interface display color Key Volume When enabled, the electrocardiograph gives a short sound when you press keys. Hint Volume When enabled, the electrocardiograph gives a sound when a hint such as Lead Off, Overload, Battery Weak etc. is displayed. QRS Volume When enabled, the electrocardiograph gives a sound when an R wave is detected. Notify Volume When enabled, the electrocardiograph gives a sound after ECG report is printed. 6.11 Advanced Setup View the device information, perform system test, etc. Activate purchased advanced functions.
SE-301 Series Electrocardiograph User Manual Hint Information - 38 - Chapter 7 Hint Information Hint information provided by SE-301 and the corresponding causes are listed in Table 10-1. Table 7–1 Hint Information and Causes Hint Information Causes Lead off Electrodes fall off the patient or the patient cable falls off the unit. Paper? Recorder paper runs out or is not loaded. PaperErr The system doesn't detect any black signs while the paper style is set as "Folded" on the System Setup Screen. BAT WEAK The built-in battery is weak. Demo The system is in the demonstration mode. Sampling/Analyzing/Recording ECG signals are being sampled / analyzed / recorded. Transmitting ECG data is being transmitted from the electrocardiograph to the PC through the net or serial cable in the AUTO or RHYT mode. Transmitting fails! Transmitting ECG data fails. MemoryFull There is no space for saving more records. USB Printer / USB Scanner An external USB printer or a bar code reader is connected to the USB interface.
SE-301 Series Electrocardiograph User Manual Troubleshooting - 39 - Chapter 8 Troubleshooting 1) Operating Problems Q1: I want to save the ECG data without any printing, could it be possible? A1: Yes, in the Record Info setup, set Print Out to Off. In the same way, if the transmission settings have been configured, the ECG data could be transmitted to the PC without printing. 2) Printing Problems Q1: There was double impression in printing when I printed ECG reports by using an ink-jet printer. What’s wrong with it? A1: It may be the result of the coexisting black and color ink cartridges. Taking out the color ink cartridge may solve the problem. Q2: I was encountered with paper-jam, what was I supposed to do? A2: If it happened for the first time, it might be the result of an inappropriate placement of the paper. In this case, please open the paper casing, pull the paper out of the paper tray, tear the pages with rumples, and then put the paper in the paper tray again, adjust the position of the paper carefully and close the casing. Q3: The hint PaperErr is displayed on the screen, what should I do? A3: Check if the paper maker setting is right or might be the result of unsuccessful detection of the black markers, first open the paper casing so as to clear the error information, and then check whether the black marker is on the top of the paper. Reload the paper in the paper tray. If it doesn’t work, change the paper. If the problem still exists, please contact the manufacturer or the local distributor for further disposal. Q4: The hint Paper? is displayed on the screen, what should I do? A4: Check whether the paper runs out, or the black marker is just facing the black maker detection window on the thermal printing head. Reload the paper in the paper tray, close the paper casing firmly. If the problem still exists, please contact the manufacturer or the local distributor for further disposal. Q5: I pressed the PRINT/STOP key, but the ECG didn’t start printing, what’s wrong with it?
SE-301 Series Electrocardiograph User Manual Troubleshooting - 40 - A5: Please check whether there is any error information displayed on the screen. If the hint Paper? or PaperErr is shown on the screen, please deal with it according to the above-mentioned measures. If the hint Transfer is shown on the screen, which means that the ECG is transmitting the data to the PC, please wait a few seconds. You can start the printing after the data has been transmitted. If the problem still exists, please contact the manufacturer or the local distributor for further disposal. 3) Transmitting Problems Q1: The ECG doesn’t respond to any keys after a long time of transmitting. It transmits nothing for there is no new data appearing on the interface of the PC software. What should I do? A1: Some error may occur during the transmission course, for example, the connection between the ECG and the net cable may loosen. In this case, please restart the ECG. If it doesn’t work, please restart the PC. If the problem still exists, please contact the manufacturer or the local distributor for further disposal. 4) Main Unit Problems Q1: I was doing the examination when the machine suddenly gave out a sound and displayed the hint Lead Off. What should I do? A1: The leads are not connected well. Please check whether the electrodes are connected to the patient skin well, and then make sure that the patient cable socket is connected to the patient cable firmly. If none of the above-mentioned measures take effect, please contact the manufacturer or the local distributor for further disposal. Q2: The touch screen is not sensitive after restoring to factory defaults. What should I do?A2: Hold down the PRINT/STOP key while switching on the electrocardiograph, the system will enter the touch screen calibration screen. Operate as indicated on the screen.
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance - 41 - Chapter 9 Cleaning, Care and Maintenance Use only the EDAN-approved substances and methods listed in this chapter to clean or disinfect your equipment. Warranty does not cover damage caused by using unapproved substances or methods. Edan Instruments has validated the cleaning and disinfection instructions provided in this User Manual. It is the responsibility of the healthcare professional to ensure that the instructions are followed so as to ensure adequate cleaning and disinfection. 9.1 General Points Keep your electrocardiograph and accessories free of dust and dirt. To prevent the device from damage, please follow the instructions:  Use only the recommended cleaning agents and disinfectants listed in this manual. Others may cause damage (not covered by warranty), reduce product lifetime or cause safety hazards.  Always dilute according to the manufacturer's instructions.  Unless otherwise specified, do not immerse any part of the equipment or any accessories in liquid.  Do not pour liquid onto the equipment.  Do not allow liquid to enter the case.  Never use abrasive material (such as steel wool or silver polish).  Inspect the electrocardiograph and reusable accessories after they are cleaned and disinfected. CAUTION If you spill liquid on the equipment or accessories, or they are accidentally immersed in liquid, contact your service personnel or EDAN service engineer. 9.2 Cleaning If the equipment or accessory has been in contact with the patient, then cleaning and disinfection is required after each use. The validated cleaning agents for cleaning the electrocardiograph and patient cable are:
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance - 42 -  Mild near neutral detergent  Ethanol (75%)  Isopropanol (70%) The validated cleaning agent for cleaning the reusable electrodes is:  Mild near neutral detergent Cleaning agents should be applied or removed using a clean, soft, non-abrasive cloth or paper towel. 9.2.1 Cleaning the Main Unit WARNING Turn off the power before cleaning. The mains supply must be switched off if it is used. 1. Switch off the main unit and disconnect it from the power cord. 2. Wipe the exterior surface of the equipment using a soft cloth dampened with the cleaning solution until no visible contaminants remain. 3. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains. 4. Dry the main unit in a ventilated and cool place. 9.2.2 Cleaning the Patient Cable 1. Wipe the patient cable with a soft cloth dampened with the cleaning solution until no visible contaminants remain. 2. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains. 3. Wipe off with a dry cloth to remove residual moisture. 4. Leave the patient cable to air dry. CAUTION Any remainder of cleaning solution should be removed from the main unit and the patient cable after cleaning.
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance - 43 - 9.2.3 Cleaning the Reusable Electrodes 1. Wipe off with a soft cloth to remove residual gel. 2. Wipe the suction bulbs of chest electrodes and the clamps of limb electrodes with a soft cloth dampened with the cleaning solution until no visible contaminants remain. 3. Wipe off the cleaning solution with a fresh cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains. 4. Wipe off with a dry cloth to remove residual moisture. 5. Leave the suction bulbs and clamps to air dry. 9.3 Disinfection To avoid permanent damage to the equipment, it is recommended that disinfection is performed only when it is considered as necessary according to your hospital's regulations. Clean the equipment and reusable accessories before they are disinfected. The validated disinfectants for disinfecting the electrocardiograph and patient cable are:  Ethanol (75%)  Isopropanol (70%) The validated disinfectant for disinfecting the reusable electrodes is:  Isopropanol (70%) If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required to be used for the disinfection step. CAUTION 1. Do not use high-temperature, high-pressure vapour or ionizing radiation as disinfection methods. 2. Do not use chloric disinfectant such as chloride, sodium hypochlorite etc. 3. Clean and disinfect reusable electrodes after each use. 9.3.1 Disinfecting the Main Unit WARNING Turn off the power before disinfection. The mains supply must be switched off if it is used.
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance - 44 - 1. Switch off the main unit and disconnect it from the power cord. 2. Wipe the exterior surface of the equipment using a soft cloth dampened with the disinfectant solution. 3. Wipe off the disinfectant solution with a dry cloth after disinfection if necessary. 4. Dry the main unit for at least 30 minutes in a ventilated and cool place. 9.3.2 Disinfecting the Patient Cable 1. Wipe the patient cable with a soft cloth dampened with the disinfectant solution. 2. Wipe off the disinfectant solution with a dry cloth after disinfection. 3. Leave the patient cable to air dry for at least 30 minutes. 9.3.3 Disinfecting the Reusable Electrodes 1. Wipe the suction bulbs of chest electrodes and the clamps of limb electrodes with a soft cloth dampened with the disinfectant solution. 2. Wipe off the disinfectant solution with a dry cloth after disinfection. 3. Leave the suction bulbs and clamps to air dry for at least 30 minutes. 9.4 Care and Maintenance 9.4.1 Recharge and Replacement of Battery 1) Capacity Identification The battery capacity can be identified according to the battery symbol in the top right corner of the LCD screen. -> -> -> Capacity is from full to empty. 2) Recharge SE-301 is equipped with the recharge control circuit together with the built-in rechargeable lithium battery. When the unit is connected to the mains supply, the battery will be recharged automatically. During the recharging course, the battery symbol flashes in the top right corner of the LCD screen. When the battery capacity is full, the symbol stops flashing. Because of the capacity consumption during the storage and transport course, the battery
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance - 45 - capacity is not full when it is used for the first time. Battery recharge should be considered before the first use. NOTE: If the battery has not been used for more than two months, it should be recharged before use. 3) Replacement When the useful life of the battery is over, or foul smell and leakage are found, please contact the manufacturer or the local distributor for replacement. WARNING 1. Only qualified service engineer authorized by the manufacturer can open the battery compartment and replace the battery, and the battery of the same model and specification provided by the manufacturer must be used. 2. Danger of explosion -- Do not reverse the anode and the cathode when installing the battery. 3. Remove the battery from the electrocardiograph when the electrocardiograph is not used for a long time. 4. 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. 5. When the battery’s useful life is over, contact the manufacturer or the local distributor for disposal or dispose of the battery according to local regulations. 9.4.2 Recorder Paper NOTE: Recorder paper provided by the manufacturer should be used. Other paper may shorten the life of the thermal print head. And the deteriorated print head may lead to illegible ECG reports and block the advance of paper. Storage Requirements: ♦ Recorder paper should be stored in a dry, dark and cool area, avoiding excessive temperature, humidity and sunshine. ♦ Do not put the recorder paper under fluorescence for a long time. ♦ Make sure that there is no polyvinyl chloride or other chemicals in the storage environment, which will lead to color change of the paper.
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance - 46 - ♦ Do not overlap the recorded paper for a long time, or else the ECG reports may trans-print each other. 9.4.3 Maintenance of the Main Unit, the Patient Cable and Electrodes 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. 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 rated current and breaking characteristics. d) Verify the device functions properly as described in the instructions for use. e) Test the protection earth resistance according to IEC/EN 60601-1: Limit: 0.1ohm. 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). k) Test the essential performance according to IEC/EN 60601-2-25, or methods recommended by the hospital or local distributor. The leakage current should never exceed the limit. 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. WARNING Failure on the part of the responsible individual hospital or institution employing this equipment to implement a satisfactory maintenance schedule may cause undue equipment failures and possible health hazards.
SE-301 Series Electrocardiograph User Manual Cleaning, Care and Maintenance - 47 - 1) Main Unit ♦ Avoid excessive temperature, sunshine, humidity or dirt. ♦ Put the dustproof coat on the main unit after use and prevent shaking it violently when moving it to another place. ♦ Prevent any liquid from seeping into the equipment, otherwise the safety and performance of the electrocardiograph can not be guaranteed. 2) Patient Cable ♦ Integrity of the patient cable, including the main cable and lead wires, should be checked regularly. Make sure that it is conductible. ♦ Do not drag or twist the patient cable with excessive stress while using it. Hold the connector plug instead of the cable when connecting or disconnecting the patient cable. ♦ Align the patient cable to avoid twisting, knotting or crooking in a closed angle while using it. ♦ Store the lead wires in a big wheel to prevent any people from stumbling. ♦ Once damage or aging of the patient cable is found, replace it with a new one immediately. 3) Electrodes ♦ Electrodes must be cleansed after use and make sure there is no remainder gel on them. ♦ Keep suction bulbs of chest electrodes away from sunshine and excessive temperature. ♦ After long-term use, the surfaces of electrodes will be oxidized because of erosion and other causes. By this time, electrodes should be replaced to achieve high-quality ECG records. CAUTION 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.
SE-301 Series Electrocardiograph User Manual Accessories - 48 - Chapter 10 Accessories WARNING Only the patient cable and other accessories supplied by the manufacturer can be used. Or else, the performance and electric shock protection cannot be guaranteed. Table 10-1 Accessories List Accessory Part Number Power cord (IEC) 01.13.036638 Power cord(AHA) 21.13.036384 Patient Cable (IEC) 01.57.107402 01.57.471500 Patient Cable (AHA) 01.57.110375 01.57.471499 Adult Chest electrodes 01.57.040163 Adult Limb electrodes 01.57.040162 Thermal Recorder Paper 01.57.78076 Paper roller 01.51.19993 Rechargeable Li-ion Battery 21.21.064149 Patient Cable (IEC) 01.57.106902 01.57.107581 01.57.107583 Patient Cable (AHA) 01.57.107048 01.57.107582 01.57.107584 Pediatric Chest Electrodes 01.57.040168 Pediatric Limb Electrodes 01.57.040169 Snap/Banana Socket Adapters 01.13.107449
SE-301 Series Electrocardiograph User Manual Accessories - 49 - Clip/Snap/Banana Socket Adapter 01.57.040172 Alligator Clip/Banana Socket Adapters 01.57.040173 Adult Disposable Adhesive Electrodes 01.57.471056 Pediatric Disposable Adhesive Electrodes 01.57.471057 Disposable Resting electrodes 01.57.471031 Net Cable 01.13.20096 Thermal Recorder Paper 01.57.78079 Grounding Wire 01.13.114114 U Disk 01.18.052275 SE-301 and accessories are available by contacting the manufacturer or your local distributor. NOTE: 1. The adult chest electrodes, adult limb electrodes, pediatric chest electrodes and pediatric limb electrodes are not available in the U.S. 2. The part name may differ in documents, but the part number shall prevail for all purposes.
SE-301 Series Electrocardiograph User Manual Warranty and Service - 50 - Chapter 11 Warranty and Service 11.1 Warranty EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be free from defects in materials and workmanship that occur within warranty period. The warranty is void in cases of: a) damage caused by mishandling during shipping. b) subsequent damage caused by improper use or maintenance. c) damage caused by alteration or repair by anyone not authorized by EDAN. d) damage caused by accidents. e) replacement or removal of serial number label and manufacture label. If a product covered by this warranty is determined to be defective because of defective materials, components, or workmanship, and the warranty claim is made within the warranty period, EDAN will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide a substitute product for use when the defective product is being repaired. 11.2 Contact information If you have any question about maintenance, technical specifications or malfunctions of devices, contact your local distributor. Alternatively, you can send an email to EDAN service department at: support@edan.com.cn.
SE-301 Series Electrocardiograph User Manual Technical Specifications - 51 - Appendix 1 Technical Specifications A1.1 Safety Specifications Comply with: IEC 60601-1:2005/A1:2012 EN 60601-1:2006/A1:2013 IEC 60601-1-2:2007 EN 60601-1-2:2007/AC:2010 IEC 60601-2-25:2011 Anti-electric-shock type: Class І with internal power supply Anti-electric-shock degree: Type CF Degree of protection against harmful ingress of water: Ordinary equipment (Sealed equipment without liquid proof) Disinfection/sterilization method: Refer to the user manual for details Degree of safety of application in the presence of flammable gas: Equipment not suitable for use in the presence of flammable gas Working mode: Continuous operation EMC: CISPR 11 Group 1, Class A Patient Leakage Current: NC <10μA (AC) / <10μA (DC) SFC <50μA (AC) / <50μA (DC) Patient Auxiliary Current: NC <10μA (AC) / <10μA (DC) SFC <50μA (AC) / <50μA (DC)
SE-301 Series Electrocardiograph User Manual Technical Specifications - 52 - A1.2 Environment Specifications Transport & Storage Working Temperature: -20ºC (-4ºF) ~ +55ºC (+131ºF) +5ºC (+41ºF) ~ +40ºC (+104ºF)Relative Humidity: 15%RH–95%RH Non-Condensing 15%RH–95%RH Non-Condensing Atmospheric Pressure: 70kPa–106kPa 70kPa–106kPa A1.3 Physical Specifications Dimensions 224 mm×143 mm×54 mm, ±2 mm Weight < 1kg (Excluding recorder paper and battery) Display 800×480 LCD Screen A1.4 Power Supply Specifications Mains Supply: Operating voltage =100V--240V~ Operating frequency = 50Hz / 60Hz Power adapter output voltage: 19V, 2A Built-in Lithium Battery Pack: Rated voltage = 14.8V Rated capacity = 2500mAh When the battery is fully charged, the 3-channel electrocardiograph can work normally about 8.5 hours. It can continuously record about 5 hours in Manual mode, and record at least 500 reports at most in the AUTO mode. Necessary Charge time: ≤ 3.5 hours Cycle life ≥ 300 times
SE-301 Series Electrocardiograph User Manual Technical Specifications - 53 - A1.5 Performance Specifications Recording Recorder: Thermal dot-matrix recorder Printing Density 8 dots per mm / 200 dots per inch (amplitude axes) 40 dots per mm / 1000 dots per inch (time axes, @ 25 mm/s)Recorder Paper: Folded thermal paper, 80mm×70mm×200pages Rolled thermal paper, 80mm×20m Effective Width: 72mm Paper Speed: 5mm/s, 6.25mm/s, 10mm/s, 12.5mm/s, 25mm/s, 50mm/s (±3%) Accuracy of data: ±5% (x-axis), ±5%(y-axis) HR Recognition Technique: Peak-Peak Detection HR Range: 30 BPM ~ 300 BPM Accuracy: ±1BPM ECG Unit Leads: Standard 12 leads Acquisition Mode: simultaneously 12 leads A/D: 24bits Resolution: 0.1575 μV/LSB Time Constant: ≥3.2s Frequency Response: 0.01Hz ~ 300Hz (-3dB) Sensitivity: 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV, 10/5mm/mV, 20/10mm/mV, AGC Input Impedance: ≥50MΩ(10Hz) Input Circuit Current: ≤0.01μA Input Voltage Range ≤±5 mVpp Calibration Voltage: 1mV±3%
SE-301 Series Electrocardiograph User Manual Technical Specifications - 54 - DC Offset Voltage: ±600mV Minimum Amplitude: 20 μVp-p Noise: ≤12.5μVp-p Multi-channel Crosstalk ≤0.5mm Filter AC Filter: On / Off DFT Filter: 0.01Hz, 0.05Hz, 0.32Hz, or 0.67Hz EMG Filter: 25Hz / 35Hz / 45Hz / OFF LOWPASS Filter:300Hz / 270Hz / 150Hz / 100Hz / 75Hz CMRR ≥140dB (AC: ON) ≥110dB (AC: Off) Sampling Frequency 16000Hz Pacemaker Detection Amplitude -2mV to -700mV & +2mV to +700mV Width 0.1ms ~ 2.0ms Sampling Frequency 16,000/sec/channel WIFI (Optional) Transmitting Frequency 2.4GHz Frequency Band 2.400-2.500GHz (2.4 GHz ISM band) Modulation Type OFDM with BPSK, QPSK, 16-QAM, and 64-QAM 802.11b with CCK and DSSS Transmitting Power 17 dBm for 802.11b DSSS 17 dBm for 802.11b CCK 15 dBm for 802.11g/n OFDM NOTE: 1 Operation of the equipment below the minimum amplitude may cause inaccurate results. 2 The DE12 ECG board is not available in the U.S.
SE-301 Series Electrocardiograph User Manual EMC Information - 55 - Appendix 2 EMC Information Electromagnetic emissions Guidance and manufacture’s declaration – electromagnetic emission The Electrocardiograph is intended for use in the electromagnetic environment specified below. The user of the Electrocardiograph should assure that it is used in such an environment.Emission test Compliance Electromagnetic environment – guidance RF emissions CISPR 11 Group 1 The Electrocardiograph uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emission CISPR 11 Class A The Electrocardiograph is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies building used for domestic purposes.Harmonic emissions IEC 61000-3-2 Class A Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Electromagnetic immunity Guidance and manufacture’s declaration – electromagnetic immunity The Electrocardiograph is intended for use in the electromagnetic environment specified below. The user of Electrocardiograph should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC 61000-4-2 ±6 kV contact ±8 kV air ±6 kV contact ±8 kV air It is recommended the use of antistatic materials. If floor are covered with synthetic material, the relative humidity should be at least 50%. Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±2 kV for power supply lines It is recommended the use of filters on power input lines and enough separation between signal lines and power lines.
SE-301 Series Electrocardiograph User Manual EMC Information - 56 - Surge IEC 61000-4-5 ±1 kV line to line ±2 kV line to ground ±1 kV line to line ±2 kV line to ground Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8 3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.
SE-301 Series Electrocardiograph User Manual EMC Information - 57 - Electromagnetic immunity Guidance and manufacture’s declaration – electromagnetic immunity The Electrocardiograph is intended for use in the electromagnetic environment specified below. The customer or the user of Electrocardiograph should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the electrocardiograph, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distanceConducted RF IEC/ 61000-4-6 3 Vrms 150 kHz to 80 MHz 3 Vrms Pd 2.1= Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 3 V/m Pd 2.1= 80 MHz to 800 MHz Pd 3.2= 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
SE-301 Series Electrocardiograph User Manual EMC Information - 58 - environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Electrocardiograph is used exceeds the applicable RF compliance level above, the Electrocardiograph should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Electrocardiograph. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM Recommended separation distances between portable and mobile RF communications equipment and electrocardiograph The electrocardiograph is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the electrocardiograph can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the electrocardiograph as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to frequency of transmitter (m) 150 kHz to 80 MHz Pd 2.1= 80 MHz to 800 MHzPd 2.1= 800 MHz to 2.5 GHz Pd 3.2= 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
SE-301 Series Electrocardiograph User Manual Abbreviation - 59 - Appendix 3 Abbreviation Abbr English BP Blood Pressure ECG Electrocardiogram/Electrocardiograph HR Heart Rate aVF Left Foot Augmented Lead aVL Left Arm Augmented Lead aVR Right Arm Augmented Lead LA Left Arm LL Left Leg RA Right Arm RL Right Leg ID Identification AC Alternating Current USB Universal Serial Bus AGC Auto Gain Control NC Normal Condition SFC Single Fault Condition

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