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SE-601 Series Electrocardiograph User Manual Safety Guidance

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Net port

Alternating Current

Battery check

Battery recharging indicator

Delete key

Enter key

Esc key

Space key/Feed paper key

Shift key

Fn key

Power On/Off key

1mV/COPY key

MODE key

RESET key

Summary of Contents for SE-601 Series

Page 1: ......

Page 2: ...s 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 in...

Page 3: ...lies with national standards and The instrument is used in accordance with the instructions for use Terms Used in this Manual This guide is designed to give key concepts on safety precautions WARNING...

Page 4: ...he Electrocardiograph 18 3 1 2 Connecting the Patient Cable to Electrodes 19 3 2 Preparing the Patient 19 3 2 1 Instructing the Patient 19 3 2 2 Cleaning the Skin 20 3 3 Attaching Electrodes to the Pa...

Page 5: ...Mode Setup 42 10 2 Filter Setup 42 10 3 Record Info Setup 43 10 3 1 Setup 1 43 10 3 2 Setup 2 44 10 4 Patient Information Setup 45 10 5 Transmission Setup 46 10 5 1 Basic Setup 46 10 5 2 WIFI Setup Co...

Page 6: ...64 Chapter 15 Warranty Service 66 15 1 Warranty 66 15 2 Contact information 66 Appendix 1 Technical Specifications 67 A1 1 Safety Specifications 67 A1 2 Environment Specifications 68 A1 3 Physical Sp...

Page 7: ...dvisory basis only SE 601 series is mainly used in ECG outpatient department PE department emergency department and inpatient department of hospitals or healthcare facilities WARNING 1 This equipment...

Page 8: ...other injuries may happen to the patient or operator 6 If the integrity of the external protective conductor is in doubt the equipment should be powered by an internal li ion rechargeable battery 7 Do...

Page 9: ...used in order to maintain compliance with the FCC RF exposure guidelines WIFI should be installed and operated with a minimum distance of 20cm between the radiator and the human body There should be...

Page 10: ...60601 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 ve...

Page 11: ...mation 36 Portable and mobile RF communications equipment can affect medical electrical equipment refer to the recommended separation distances provided in Appendix 2 EMC Information 37 Assembly of th...

Page 12: ...iograph when the electrocardiograph isn t used for a long time 10 If the battery is stored alone and not used for a long time we recommend that the battery be charged at least once every 6 months to p...

Page 13: ...t 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 pleas...

Page 14: ...fety Guidance 8 8 Net port 9 Alternating Current 10 Battery check 11 Battery recharging indicator 12 Delete key 13 Enter key 14 Esc key 15 Space key Feed paper key 16 Shift key 17 Fn key 18 Power On O...

Page 15: ...al symbol for recovery recyclable 27 Part Number 28 SERIAL NUMBER 29 Date of manufacture 30 MANUFACTURER 31 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY 32 CE marking 33 Caution Federal U S law...

Page 16: ...romagnetic radiation 38 Contains FCC ID YOPGS2011MIZ Federal Communications Commission Contains FCC ID YOPGS2011MIZ 39 Conforms to AAMI Std 60601 1 IEC Std 60601 2 25 Certified to CSA Std C22 2 No 606...

Page 17: ...5 6 5 7 multicolor TFT LCD screen SE 601C adopts 5 6 5 7 multicolor TFT LCD touch screen Configuration main unit power cord patient cable chest electrodes limb electrodes disposable electrodes clip sn...

Page 18: ...nt when Gender is selected in the Patient Information Setup window D Age Group Key Press to quickly select the age group on the main screen when you set Age to Age Group in the Patient Information Set...

Page 19: ...ing mode among the auto manual rhythm and R R analysis modes NOTE Only if more than one working mode is selected in the Work Mode Setup window can the working mode be selected by pressing the MODE key...

Page 20: ...cable B Serial Port 1 Connecting to a PC C USB Socket 1 Standard USB socket connecting to a PC D USB Socket 2 Standard USB socket connecting to a U disk a bar code reader or a USB printer recommended...

Page 21: ...ximum voltage applied should not exceed 15V DC CAUTION Only the USB equipment recommended by the manufacturer can be connected to the USB interface 2 5 Bottom Panel Figure 2 6 SE 601A B C Bottom Panel...

Page 22: ...ized by the manufacturer can open the battery compartment and replace the battery and batteries of the same model and specification must be used 4 Only when the device is off can the battery be instal...

Page 23: ...odes can be chosen freely Supporting order function only configurable for SE 601B C Supporting bar code reader Supporting ECG waves displaying with grid Convenient operation of system setup and file m...

Page 24: ...proper working condition 3 1 Connecting the Patient Cable to the Electrocardiograph and Electrodes WARNING The performance and electric shock protection can be guaranteed only if the original patient...

Page 25: ...ifiers and Color Codes European American Identifier Color Code Identifier Color Code R Red RA White L Yellow LA Black N or RF Black RL Green F Green LL Red C1 White Red V1 Brown Red C2 White Yellow V2...

Page 26: ...y with soap and water 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 Attaching Electrodes to the Patient Two kinds of...

Page 27: ...an Label Electrode Placement C1 V1 Fourth intercostal space at the right border of the sternum C2 V2 Fourth intercostal space at the left border of the sternum C3 V3 Fifth rib between C2 and C4 C4 V4...

Page 28: ...stal space on the left posterior axillary line Nap V4 Left mid clavicular line in the fifth intercostal space R RA Right arm Right deltoid L LA Left arm Left deltoid N or RF RL Right leg Upper leg as...

Page 29: ...e chest NOTE Long time measurement with a strong negative pressure on the suction bulb may cause reddening of the skin When using the electrode on kids or patients with delicate skin squeeze the sucti...

Page 30: ...ecords the following inspection procedures are recommended before operation WARNING The electrocardiograph is intended to be used by qualified physicians or personnel professionally trained and they s...

Page 31: ...the battery 2 Potential equalization conductor of the unit should be connected to the potential equalization bus bar of the electrical installation when necessary The electrocardiograph can be powere...

Page 32: ...e more frequent charging if these accessories are used with the electrocardiograph To turn off the Electrocardiograph When operating on AC power Hold down the key to display the hint System is shuttin...

Page 33: ...recorder paper runs out or is not loaded the hint message No Paper will appear on the screen Then you should load or replace the recorder paper immediately Loading Replacing Process of Folded Paper S...

Page 34: ...e facing the thermal print head and replace the casing on the recorder 5 Press down the recorder casing firmly 6 Advance the recorder paper When the main screen is displayed if Paper Marker is set to...

Page 35: ...Operation Keys To select options on the bottom panel of the screen Corresponding functional keys To move the cursor Tab Shift Tab F3 F4 To erase the typed information Bksp To input special characters...

Page 36: ...ectrocardiograph User Manual Basic Operation Guidance 30 4 2 About the Main Screen After the electrocardiograph is turned on the main screen appears Figure 4 1 Main Screen1 SE 601B C Figure 4 3 SE 601...

Page 37: ...ted The lead groups are switched automatically according to the lead sequence during the printing course After the ECG waves of one lead group are printed within a certain time the system switches to...

Page 38: ...isplayed scan the patient s bar code with the bar code reader and then the patient information will appear in the corresponding box NOTE Only the bar code reader recommended by the manufacturer can be...

Page 39: ...orts before changing the working mode 2 Within three seconds after returning to the main screen if you press the PRINT STOP key to print an ECG report in the auto quick mode or the manual mode the rec...

Page 40: ...ursuant 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...

Page 41: ...ransmission Setup window NOTE For more information on configuring network settings see your Network Administrator For Ethernet Transmission 1 Press Shift F1 in the Transmission Setup window to open th...

Page 42: ...nsmission Setup window 1 Press Shift F1 in the Transmission Setup window to open the Basic Setup window 2 Set Auto Transmission to On and Transmission Mode to Wired or Wireless 3 Set the Server IP ite...

Page 43: ...SE 601 Series Electrocardiograph User Manual Managing Orders 37 Chapter 8 Managing Orders Figure 8 1 Order Manager Screen1 SE 601B C Figure 8 2 Order Manager Screen2 SE 601B C...

Page 44: ...e an order examination next time To load order information 1 On the electrocardiograph configure the Order Setup screen 2 Connect the electrocardiograph to the PC installed with the DMS by using an Et...

Page 45: ...SE 601 Series Electrocardiograph User Manual Managing Files 39 Chapter 9 Managing Files Figure 9 1 File Manager Screen1 Figure 9 2 File Manager Screen2...

Page 46: ...file path ECGDATA Import CAUTION 1 Do not cut off the mains supply directly when no battery is installed in the device or else the stored data may be lost 2 When files are being printed transmitted de...

Page 47: ...Date and Time can be set in the Device No textbox in the Transmission Setup window 3 If you select Delete After Trans Or Export in the File Setup window the files will be deleted from the File Manage...

Page 48: ...R Display Style 6 2 3 4 1R Sampling Mode Real time Sample Real time Sample Rhythm Style Three Leads Three Leads Duration Periodic Sample 60 min 60 min Interval Periodic Sample 1 min 1 min Preview Off...

Page 49: ...Record Info Setup 10 3 1 Setup 1 Items Default Default Only in the U S Auto Record Style 6 2 3 4 1R Manual Style 6 channels 6 channels Rhythm Record Mode Save Paper Save Paper Record Sequence Sequent...

Page 50: ...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 evalu...

Page 51: ...PatInfo Refreshed On On Order Acquired Off Off User defined Cleared Cleared Item Description Patient Options Select the item displayed in the Patient Information window NOTE 1 Pacemaker appears in th...

Page 52: ...network transmission a Set the first two sections of the Local IP item to the first two sections of the IP of the PC b Set the third section of the Local IP item to the network segment of the electro...

Page 53: ...cessfully NOTE 1 Only if WIFI is disabled can Auto Get IP option be available 2 To use Auto Get IP DHCP function needs to be enabled on the routing end View MAC Address View the MAC address of the WIF...

Page 54: ...0 Key Volume Medium Medium Hint Volume Medium Medium QRS Volume Off Off Notify Volume Medium Medium Display Colors Option 1 Option 1 Antialiasing Off Off Grid On On Item Description Antialiasing Reser...

Page 55: ...or rhythm mode will be automatically saved to the directory of ECGDATA ECG X Store Examination Date of the U disk after an ECG report is printed out NOTE 1 Please insert the U disk recommended by the...

Page 56: ...Item Description External Output The external output socket is equipped in the electrocardiograph through which the electrocardiograph can send rhythm lead signals to the external equipment Choose fr...

Page 57: ...d can not find the next black marker the hint Paper Error is displayed Sampling Analyzing R ecording ECG signals are being sampled analyzed recorded Learning The self study process of arrhythmia arith...

Page 58: ...on The ECG data will be collected and saved without printing In the same way if the transmission settings are configured the ECG data could be transmitted to the PC without printing Q4 I want to input...

Page 59: ...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 If it happened several times it might have something to do w...

Page 60: ...ble to start the printing by pressing the PRINT STOP key If you wait for a few seconds but you still unable to start the printing by pressing the PRINT STOP key please check whether there is any error...

Page 61: ...tarted the machine several times but there is no better change A1 The reason for this problem might be there is a key pressed down without springing up Find that key and make it spring up the problem...

Page 62: ...e 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 D...

Page 63: ...cloth or towel dampened with tap water after cleaning until no visible cleaning agent remains 4 Dry the electrocardiograph patient cable and reusable electrodes in a ventilated and cool place CAUTION...

Page 64: ...are and Maintenance CAUTION Operate the cardiograph charge the battery and store the battery at a temperature of 40 104 F or lower Exposure to higher temperature may reduce battery life damage the bat...

Page 65: ...the manufacturer or the local distributor for replacement WARNING 1 Only qualified service engineers authorized by the manufacturer can open the battery compartment and replace the battery and the ba...

Page 66: ...nd Maintenance 60 13 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 The deteriorated print head may lead...

Page 67: ...cables and connectors for fraying or other damage Verify that all cords and connectors are securely seated Inspect keys and controls for proper operation 13 4 4 Maintenance of the Main Unit and the P...

Page 68: ...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 1 Main U...

Page 69: ...om 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 qua...

Page 70: ...nd 01 13 036641 Power cord American 01 13 037122 Patient Cable European 01 57 471500 Patient Cable American 01 57 471499 Chest electrodes 01 57 040163 Limb electrodes 01 57 040162 Thermal recording pa...

Page 71: ...1864 Clip Snap Banana Socket Adapter 01 57 040172 U disk 01 18 052275 SE 601 Backpack 01 56 465627 LS4208 Bar Code Reader One Dimension 01 23 068023 1900GSR 2 Bar Code Reader Two Dimension 21 18 05231...

Page 72: ...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 com...

Page 73: ...ee CF type with defibrillation proof Degree of protection against harmful ingress of water Ordinary equipment Sealed equipment without liquid proof Disinfection sterilization method Refer to Chapter 1...

Page 74: ...play SE 601A 3 5 single color LCD screen SE 601B 5 6 multicolor TFT LCD screen SE 601C 5 6 multicolor TFT LCD touch screen A1 4 Power Supply Specifications Mains Supply Operating Voltage 100V 240V Rat...

Page 75: ...ges Effective Width 104mm Paper Speed 5mm s 6 25mm s 10mm s 12 5mm s 25mm s 50mm s 3 HR Recognition HR Range 30 bpm 300 bpm Accuracy 1 bpm ECG Unit Leads 12 standard leads Acquisition Mode Simultaneou...

Page 76: ...601A 150Hz 100Hz 75Hz SE 601B C 300Hz 270Hz 150Hz 100Hz 75Hz CMRR SE 601A 115dB AC OFF SE 601B C 123dB AC OFF Sampling Frequency SE 601A 1 000 sec channel SE 601B C 16 000 sec channel Pacemaker Detect...

Page 77: ...ansmitting Frequency 2400 2497MHz Frequency Band 2400 2497MHz Wireless protocol IEEE 802 11b g n Modulation Type DSSS CCK OFDM Transmitting Power 6 17dBm Effective Radiated Power 6 17dBm NOTE Operatio...

Page 78: ...Electromagnetic environment guidance RF emissions CISPR 11 Group 1 SE 601 series electrocardiograph uses RF energy only for its internal function Therefore its RF emissions are very low and are not l...

Page 79: ...lectrical fast transient burst IEC EN 61000 4 4 2 kV for power supply lines 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC EN...

Page 80: ...ph is intended for use in the electromagnetic environment specified below The customer or the user of SE 601 series electrocardiograph should assure that it is used in such an environment Immunity tes...

Page 81: ...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 transmit...

Page 82: ...raph b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m c The ISM industrial scientific and medical bands between 0 15 MHz and 80 MHz are 6 765 MHz to 6 795 MHz 13...

Page 83: ...0 5800 WLAN 802 11 a n Pulse modulationb 217 Hz 0 2 0 3 9 5500 5785 Note If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM...

Page 84: ...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 P...

Page 85: ...lood 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...

Page 86: ...80...

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