Bionet Cardio7 Operation Manual
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Bionet Cardio7 Operation Manual

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Cardio7 Operation Manual
Cardio7
Operation Manual
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1 / 89
Version 1.31

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Summary of Contents for Bionet Cardio7

  • Page 1 Cardio7 Operation Manual Cardio7 Operation Manual www.ebionet.com 1 / 89 Version 1.31...
  • Page 2 The warranty for this product runs for 1 year. (2 years in Euroupe). But the warranty for accessories runs for 6 months. Warranty repair or replacement will be made by the Bionet Service Center at no charge for the warranty period, if properly used under normal conditions, in accordance with the instructions for use.
  • Page 3 If you have any questions or comments relating to our products or purchasing, please contact our office at the telephone number or e-mail address below. You can talk to our sales people. Bionet always welcomes your inquiries. Please contact us. Product and purchasing  TEL: +82-70-7585-6418 ...
  • Page 4 Cardio7 Operation Manual Fee-based Service If you wish to make a claim when the product is damaged through misuse, we charge repair fees. Please read the manual before you make a claim. 1. The warranty does not cover cleaning, adjusting and instructions for use.
  • Page 5 Cardio7 Operation Manual Definition of WARNING, CAUTIONS and NOTE In order to stress the contents of this manual, we define the terms below.  Please follow the warning and caution instructions.  The manufacturer or service agents are not responsible for the damage resulting from inappropriate use or carelessness.
  • Page 6 Cardio7 Operation Manual Environment Instructions  Please do NOT use or place the product in such an environment explained below. Avoid placing in an area exposed to Avoid exposure to moisture. Do not direct sunlight. touch the equipment with wet hands.
  • Page 7 Compatibility Requirements) standard, noise level: B NOTE Diagnosis of Cardio7 needs to be confirmed by a medical specialist. NOTE The accessories connected to analog or digital connectors should be authorized in accordance with IEC standards (e.g. IEC 950 for data processing equipment and IEC 601-1 for medical equipment).

  • Page 8: Safety Symbols

    Cardio7 Operation Manual Safety Symbols Symbols Contents Isolated patient connection. (IEC 601-1-Type BF) Power on. Power off. ATTENTION: Refer to the user’s manual. Ground connection. External Signal IN/OUT Port 8 / 89 Version 1.31...

  • Page 9: Table Of Contents

    Cardio7 Operation Manual Contents Chapter 1. General Information ......... 11 1) Product Overview ................12 2) Product Features ................12 3) Product Configuration ..............13 Basic Components And Accessories ..............13 Optional components ....................14 Body Configuration ...................... 15 Front Panel ........................18 Control Panel........................
  • Page 10 Cardio7 Operation Manual Beat Report Setup ......................38 Diagnosis Printing Setup ....................39 Printing Setup........................39 Setup the Arrhythmia ....................40 Setup the HRV ........................ 40 Setup the Time ....................... 41 Rhythm Lead ........................41 Patient Information Input .................... 42 Pediatric Diagnosis .......................

  • Page 11: Chapter 1. General Information

    Cardio7 Operation Manual Chapter 1. General Information 1) Product Overview 2) Product Features 3) Product Configuration Basic Components And Accessories Optional Components Body Configuration Front Panel Control Panel Power 4) System Installation Precautions For Installation Power Connection Patient Cable Connection...

  • Page 12: Product Overview

    Cardio7 Operation Manual 1) Product Overview Cardio7 is an electrocardiogram (EKG) device capable of measuring and recording 12 channels of cardiac signals of patients. The device enables operators to record cardiac signals, review them using various viewing modes, and perform automatic detection of cardiac conditions.

  • Page 13: Product Configuration

    Cardio7 Operation Manual 3) Product Configuration The Cardio7 system consists of the items below. Unpack the package and check the items below are included. Also, be sure to check for any damage to the body and accessories. Basic Components And Accessories ②...

  • Page 14: Optional Components

    Cardio7 Operation Manual Optional components ① ③ ② ① Battery (1 EA) ② Hanger (1 EA) ③ Cart (1 EA) Caution You may have distortion or signal noise when you use nonstandard or other brand accessories. We strongly recommend you use only the authorized accessories which we supply.

  • Page 15: Body Configuration

    Cardio7 Operation Manual Body Configuration ▣ Top View ① ② ③ ④ ⑤ ① Handle ② Printer Cover ③ Printer Cover Opening Button ④ LCD ⑤ Control Panel 15 / 89 Version 1.31...
  • Page 16 Cardio7 Operation Manual ▣ Front View ① ① Printer Cover Opening Button ▣ Rear View ① ② ③ ④ ⑤ ⑥ ① Protective Ground Terminal ② Power Switch ③ USB Port ④AC Power Connection Port ⑤ RS-232C Serial Port ⑥RJ45 LAN Port 16 / 89 Version 1.31...
  • Page 17 ① ① Handle ▣ Right Side View ① ① Patient Cable Connection Port NOTE To avoid an expected electric shock, do not open the equipment cover or disassemble the equipment. Refer servicing to Bionet, Inc. 17 / 89 Version 1.31...

  • Page 18: Front Panel

    Cardio7 Operation Manual Front Panel Graphic display window Copy Battery status Rhythm Record Rotary key ECG/Spiro View Net/ESC Power status During device boot up, you can see the system version and the Bionet name. 18 / 89 Version 1.31...
  • Page 19 Cardio7 Operation Manual The following descriptions explain data on the graphic LCD. ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ① Displays The Heart Rate. ② Displays Patient ID ③ Displays The Date ④ Displays Battery Status or AC Power Connection Status ⑤...

  • Page 20: Control Panel

    Cardio7 Operation Manual Control Panel ① ② ③ ⑦ ④ ⑤ ⑥ ⑧ ⑨ ▣ Button ① Print out the rhythm data on A4 size or continuous paper. 10sec., 60sec. and long-term readings (3min., 5min., ② 10min.) are saved and are printed as an output form after processing.

  • Page 21: Power

    Cardio7 Operation Manual ▣ LED A light indicator lets you know that the battery is on and shows your current battery charging status. A red light ⑦ indicator lets you know that the battery is charging and a green light indicator lets you know the batter is fully charged.
  • Page 22 Cardio7 Operation Manual ▣ Display Battery Power Status : Battery Fully Charged  : Battery Charge Half-Full  : Battery Charge Low  : Battery Almost Fully Drained  NOTE If the battery condition is 'LOW' when operating battery mode without AC power, the screen can cause symptoms blinking.

  • Page 23: System Installation

    Paper Installation - Push the printer cover release button to the right to open the printer door of the Cardio7. Install EKG paper with the side to be recorded appearing on top. Close the cover to finish the paper installation process 23 / 89 Version 1.31...

  • Page 24: System Start

    System Start - After all installation processes are finished; turn on the power switch to see the Cardio7 logo, system firmware version, the company name, and icons for ECG or spirometer mode displayed on the LCD screen. - To select ECG mode, locate the selection box on the ECG and press the rotary key or touch the selection box on the screen.

  • Page 25: System Setup

    Cardio7 Operation Manual 5) System Setup Reset Press the VIEW key on the control panel for more than three seconds to initialize the system setup to the factory mode. In three seconds, the following messages are displayed for a second and then reset starts.
  • Page 26 Cardio7 Operation Manual Arrhythmia Time 5Min 26 / 89 Version 1.31...

  • Page 27: Chapter 2. Preparation For Electrocardiography

    Cardio7 Operation Manual Chapter 2. Preparation For Electrocardiography 1) Location Of Electrode 2) Electrode Connection Patient Cable Connection How To Attach Electrodes Countermeasures For Bad Lead Connection 27 / 89 Version 1.31...

  • Page 28: Location Of Electrode

    Cardio7 Operation Manual 1) Location Of Electrode Attach electrodes to the patient’s body to record an electrocardiogram of twelve standard leads [ I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 ], as shown below. Limb electrodes are located as follows.

  • Page 29: Electrode Connection

    Check all the devices to measure the patient Patient Cable Connection Connect the patient cable to the patient cable port of the Cardio7. How to Attach Electrodes Attach electrodes after placing the patient on the bed, helping him/her to be relaxed, and cleaning electrode contact points on the patient’s skin by using a disinfective...

  • Page 30: Countermeasures For Bad Lead Connection

    Cardio7 Operation Manual Countermeasures For Bad Lead Connection After turning on the power switch, enter the ECG test to check waveforms of all leads. On this menu, operators can check waveforms of all leads and their noise, and may see “Lead Fault” message displayed on the LCD screen.

  • Page 31: Chapter 3. Electrocardiography

    Cardio7 Operation Manual Chapter 3. Electrocardiography 1) To Start 2) Basic Setup General Sensitivity Setup Printing Speed Setup Channel Form Setup Grid On/Off Rhythm Printing Setup Beat Report Setup Diagnosis Printing Setup Rhythm Lead Patient Information Input Pediatrics Diagnosis 3) LCD Monitor Display...
  • Page 32 Cardio7 Operation Manual 8) Device Setup Basic Setup Network Setup Hospital Setup 9) Network Functions 10) Data Management 32 / 89 Version 1.31...

  • Page 33: To Start

    . To do monitoring signal by printer, press the RHYTHM . To stop the machine during the printing or saving processes, press the STOP The following buttons will be most commonly used when operating Cardio7. Rhythm Printing: Pause monitoring on the LCD display, and print real- time waveform using the printer.

  • Page 34: Basic Setup

    Cardio7 Operation Manual 2) Basic Setup General When the device is on, the current configuration values of the system will be shown on the LCD in the order of the heart rate, patient information, time, battery status, sensitivity, printing speed, application of the base line filter, application of the electromyogram filter, printing channel configuration, and selection of the rhythm lead.

  • Page 35: Sensitivity Setup

    Cardio7 Operation Manual Sensitivity Setup This is a functionality that can modify sensitivity of the output signal, when the outputting signal’s amplitude is too large to cause overlap with neighboring signals, or too small so that signal diagnosis is difficult.

  • Page 36: Channel Form Setup

    Cardio7 Operation Manual To modify EKG waveform’s printing speed, place the selection block to speed information menu ( ) by rotating the rotary key, then press it to select or touch the speed information menu directly. The above Printing Speed menu will be shown. Select desired speed using the rotary key or touch screen.

  • Page 37: Rhythm Printing Setup

    Cardio7 Operation Manual To select the printout channel form settings, place the selection block to the print setup menu. ( ) and press down using the rotary key or touch screen input to select the desired channel forms in the printing form menu.

  • Page 38: Grid On/Off

    A grid line will be shown for every 5mm X 5mm space and dots for every 1mm X 1mm space. If EKG paper supplied by Bionet is used, the grid option should be turned off as it already contains a grid on the paper.

  • Page 39: Diagnosis Printing Setup

    Cardio7 Operation Manual Diagnosis Printing Setup Under diagnosis printing mode, users can set whether diagnosis results will be printed alongside waveforms. Diagnosis printing can be turned ON or OFF in the Printing Form setting under Diag menu. ON sets diagnosis results to be printed and OFF disables diagnosis printing.

  • Page 40: Setup The Arrhythmia

    Cardio7 Operation Manual Setup the Arrhythmia Whether the Arrhythmia is printed out can be selected through the long-term recording function. Each time the Arrhythmia is selected, the Arrhythmia switches between ON or OFF and if ON is selected it is going to be printed, while the OFF selection does not do any printing work.

  • Page 41: Setup The Time

    Cardio7 Operation Manual Setup the Time With Arrhythmia and HRV performance recording the time period can be selected. The selectable time is 3min., 5min., and 10min. NOTE - If the Arrhythmia and HRV is printed out, the selected, single lead is printed out on a 20-second interval according to the fixed time of the ECG - The Sensivity is printed out at 5mm/mV and the Speed is printed out at 12.5mm/sec...

  • Page 42: Patient Information Input

    Cardio7 Operation Manual Patient Information Input In this menu, operators can input the patient’s ID, name age, sex, height, weight, race and smoking habit. In order to enter the patient’s information, move the selection block to the Patient Information input setting ( ) and select input fields using either the rotary key or touch screen.
  • Page 43 Cardio7 Operation Manual 〈Information Input Mode〉 〈Information Input Mode〉 43 / 89 Version 1.31...

  • Page 44: Pediatric Diagnosis

    Normally barcode scanners are compatible with all products. However, because because of inconsistensies in barcode scanner manufacturers implementation of input methods, you need to verify the scanner is supported by Bionet. • Input methods supported by Bionet : International standards, USB •...
  • Page 45 Cardio7 Operation Manual 3) LCD Monitor display Monitor mode display shows the currently measured electrocardiogram signal in real time. The monitor mode display function is used for the following two purposes: One is to check whether the signals from the all channels are coming out properly; the other one is to see the status of the electrocardiogram of the patient for a long time.
  • Page 46 Cardio7 Operation Manual Note Display output mode can be set in Basic Setup under the Device Setup menu. (Please refer to the Device Setup) * * Displayed heart rate is the average of 4 heartbeats 46 / 89 Version 1.31...

  • Page 47: Rhythm Mode Printing

    Cardio7 Operation Manual 4) Rhythm Mode Printing In rhythm mode printing, the measured ECG signals would be printed in real-time. Rhythm mode printing allows operators to perform the following two functions: one is to verify that signals in all channels are active before recording ECGs, and the other is to print the ECGs rhythm status of the patient for a longer duration.

  • Page 48: Record Mode Printing

    Cardio7 Operation Manual 5) Record Mode Printing For the record mode display, save the electrocardiogram in the memory first, and apply the filter which is set up by the user to the saved electrocardiogram, and then extract the parameters for the heart rate, PR interval, QRS duration, QT/QTc, and P-R-T axes.

  • Page 49: Seconds Ecg Recording

    Cardio7 Operation Manual 60 seconds ECG recording When the channel form is set to 60 sec 1rhy, pressing the RECORD ( ) key will make the device record EKG data, while printing record duration for 60 seconds on a predetermined rhythm channel.

  • Page 50: Long-Term Ecg Recording

    Cardio7 Operation Manual Long-term ECG recording If the ‘Arrhythmia’ or ‘HRV’ is selected as ‘ON’ and if the diagnosis printing ( ) key is pushed, the save time is displayed like the picture below. Also, the data of the designated time in selected rhythm channel are printed out.

  • Page 51: Printing Form

    Cardio7 Operation Manual 6) Printing Form In this section, descriptions and samples of various printing forms are provided. Rhythm Report Form 51 / 89 Version 1.31...
  • Page 52 Cardio7 Operation Manual - Record Report Form (3ch+1rhy) - Record Report Form (3ch+3rhy) 52 / 89 Version 1.31...
  • Page 53 Cardio7 Operation Manual - Record Report Form (6ch+1rhy) - Record Report Form (12ch rhy) 53 / 89 Version 1.31...
  • Page 54 Cardio7 Operation Manual - Record Report Form (60 sec. 1rhy) - Record Report Form (3min 1rhy) 54 / 89 Version 1.31...
  • Page 55 Cardio7 Operation Manual - Record Report Form (5 min 1rhy) - Record Report Form (10min 1rhy) 55 / 89 Version 1.31...
  • Page 56 Cardio7 Operation Manual - Record Report Form (Beat Report) 56 / 89 Version 1.31...
  • Page 57 Cardio7 Operation Manual * Beat Report Parameters PR : PR Interval PA : P Amplitude PD : P Duration QA : Q Amplitude QD : Q Duration RA : R Amplitude RD : R Duration SA : S Amplitude SD : S Duration...

  • Page 58: Copy Mode Printing

    Cardio7 Operation Manual 7) Copy Mode Printing Copy Mode Printing is a function to print out the same report as the previously printed report. In Copy Mode, users can also print out the same previous data but with changed settings such as filter type, sensitivity, printing speed, channel form, and rhythm number if more than one rhythm is recorded.
  • Page 59 Cardio7 Operation Manual When the filter application is completed, the following message will be displayed, and the printing process will start: SYSTEM MESSAGE Printing… If the device encounters a problem before it finishes printing, the following message will be displayed for 1 second before returning to previous menu:...

  • Page 60: Device Setup

    Cardio7 Operation Manual 8) Device Setup Basic Setup consists of Date, Time, Touch screen (Touch Setup), Unit, Language, Save, Screen, Filter, QRS, P/M, L/F, Line, Demo and QikPrint menus. Use the rotary key or touch screen to select a desired menu item, which would then open its submenu to allow the user to enter the desired input values.
  • Page 61 Cardio7 Operation Manual ① Setup date and time You can set month, date, hour, minute and second information using the rotary key in Date/Time menu. (Touch screen functionality update planned) ② Touch Setup You can calibrate the touch screen by setting the coordinates.
  • Page 62 No keys will be operational until the Touch Setup is complete. ③ Unit You can set units of height and weight information in Cardio7. Currently, users can choose between metric and U.S. standard units; cm/Kg and in/lb ④ Language You can set up the language for displaying and printing in Cardio7.
  • Page 63 Cardio7 Operation Manual ⑤ Saving In this menu, users can decide whether a message box to ask the user about saving data should appear or not. If ON is selected, there will be a message box asking users about saving data. If OFF is selected, the message box will not appear and no data will be saved..
  • Page 64 Cardio7 Operation Manual ⑥ Screen Mode Setup For screen mode, users can choose either portrait or landscape layouts.. < Portrait Mode > < Landscape Mode > 64 / 89 Version 1.31...
  • Page 65 Cardio7 Operation Manual ⑦ Filter Setup The signal output generated by the device may contain extra unwanted signals in addition to the EKG wave such as AC noise, base line drift caused by respiration, noise generated by an electrical field nearby, etc. Applying filters could help to reduce or remove those unwanted signals from the output of the device.
  • Page 66 ECG output may not be clear. In Cardio7, electromyogram can be eliminated by using the Muscle Filter. Select ON to apply the filter to the output and OFF to get the unfiltered output.
  • Page 67 Cardio7 Operation Manual The use of filters can distort the original output. Therefore, you may reduce the possibility of signal distortion, if you set the filters OFF when the signals are clear. For your reference, we recommend that Baseline and AC filters be set to ON most of the time.
  • Page 68 ⑩ Pacemaker Signal Display Setting When a signal from the patient’s pacemaker is registered by Cardio7, users can set whether to print location of the pacemaker device in rhythm and diagnostic printing modes or not. In [P/M] menu within the Device Setup, users can set it to either ON or OFF.
  • Page 69 Cardio7 Operation Manual ⑪ Lead fault Signal Display Setting When there is a lead fault event, this setup sets whether ‘Lead fault’ message will be displayed on the LCD screen of the device or not. Selecting [L/F] menu will switch between ON and OFF in the menu, with ON turning on the message display and OFF switching off the message display.
  • Page 70 Thick is bold lines ⑬ Demo Mode Setting This menu puts Cardio7 in demo mode. When it is set to ON, 60bpm Sinus Normal Rhythm signal will be displayed on the device and DEMO sign will appear on the upper part of the LCD screen.
  • Page 71 Cardio7 Operation Manual ⑬ QikPrint (Quick Printing) Setting In this mode, users can choose to set or cancel the QikPrint rapid printing function. When the function is ON, Cardio7 will save printing time by utilizing 5-second buffering. Note When the ON setting is used, you should operate by pressing the Diagnostic Printing button after the signal is stabilized.

  • Page 72: Network Setup

    Cardio7 Operation Manual Network Setup The network information of the equipment can be setup. The automatic IP(DHCP) or fixed(Manually) can be selected through the Configure IP. If the Configure IP is setup as DHCP, the IP Address, Subnet Mask, Gateway, Server IP value is received automatically from the DHCP server on your network.

  • Page 73: Data Deletion Setup

    Cardio7 Operation Manual * The network information can only be setup through the rotary key. Note If the setting related to the network changes, "The unit will now restart to apply your new settings." message will be displayed and restart the unit within 5 sec..

  • Page 74: Hospital Setup

    Cardio7 Operation Manual Hospital Setup Enter names of the hospital (clinic) and attending doctor which will be recorded and printed along with the EKG data. 74 / 89 Version 1.31...

  • Page 75: Network Functions

    Cardio7 Operation Manual 9) Network Functions Any previously acquired or newly taken measurements from the device can be transmitted to the server PC/workstation for comprehensive data management. (1) Entering Patient Information In order to transmit patient data from the device to a PC/workstation, patient information should be entered first.

  • Page 76: Data Management

    Cardio7 Operation Manual 10) Data management (1) Window and function description           Currently Selected Data ID, Name, measured time, measured data category, display the data condition, data condition (ST) is displayed as E, C, S.
  • Page 77 Cardio7 Operation Manual  Display Information Of Highlighted Patient Wrong ID’s can be corrected through the selected patient information screen. However, the data waiting for inspection cannot be corrected. If an ID among the data waiting for inspection needs to be corrected, such data needs to be corrected in the PC where the data waiting for inspection were sent to.
  • Page 78 Cardio7 Operation Manual Transmitting data to PC/ workstation  SYSTEM MESSAGE Sending Saved Data[**] Indicating that the data transmission is finished  SYSTEM MESSAGE Transmission Complete! * System Message: if a connection to the PC has failed SYSTEM MESSAGE Connection Error...
  • Page 79 Cardio7 Operation Manual System message : if a USB flash drive is not connected.  SYSTEM MESSAGE Please, checking the device. System messages : the reasons when the data copy failed  SYSTEM MESSAGE File Copy Failed – File Busy SYSTEM MESSAGE File Copy Failed –...
  • Page 80 Cardio7 Operation Manual Inspection screen  The Inspection screen, when the patient ID is selected.  SYSTEM MESSAGE Cannot be edited. NOTE The IP in the data waiting for inspection cannot be edited. If you hope to edit the ID of the data waiting for inspection, you need to select, edit and resend the data to the PC where the data waiting for inspection were sent to.
  • Page 81 Cardio7 Operation Manual If the “TEST” button is pushed for data which are data not waiting for inspection  SYSTEM MESSAGE Not an Data waiting for inspection If the connection to the worklist server is cancelled  SYSTEM MESSAGE Check the worklist server If the Print, Copy or Net function is executed on the uncompleted data waiting for ...
  • Page 82 Use the provided ECG patient cable for measuring ECG in the operating room. The patient cable cannot be used for measuring respiration. WARNING Do not use the Cardio7 in combination with any Electro-Surgical (ES) equipment. WARNING Users must use the same type of electrode or any other electrodes with biocompatibility certification proven by one of the international standards.

  • Page 83: Chapter 4. System Management

    Cardio7 Operation Manual Chapter 4. System Management 1) Maintenance and Cleaning 2) Regular Check-up 3) Trouble Shooting 83 / 89 Version 1.31...

  • Page 84: Maintenance And Cleaning

    2) Regular Check-up Perform the safety inspection on the Cardio7 periodically (at least once a year). See the service manual (provided by Bionet upon receipt of written request) for details on the inspection of Cardio7.
  • Page 85 It is the reason that almost fully drained battery. Turn the device on again after connecting AC power makes the symptom disappear. * If you continue to have problems even after following the aforementioned points, or other problems that are not mentioned above, contact Bionet’s customer service. 85 / 89 Version 1.31...

  • Page 86: Chapter 5. Specification

    Cardio7 Operation Manual Chapter 5. Specification ECG leads 12 standard leads, acquired simultaneously and continuously Dimension 296(W) x 305.5(H) x 92.5(D)mm, approx. 3.5kg 3, 6, 12 channels 10 second recording and beat report Recording channel 1 channel 60 second or 5 minute recording Sensitivity 2.5, 5, 10, 20, auto(I~aVF: 10, V1~V6: 5) mm/mV...
  • Page 87 Cardio7 Operation Manual Operating humidity: 30~85% Environment Operating temperature: 10 ~ 40℃(50 to 104℉) Atmospheric pressure: 70 ~ 106KPa Power cord 1 EA, Patient cable 1ea, Standard accessory Limb 1 set(4 EA), Chest ball 1 set(6 ea), Chart paper 1 EA, Operation manual 1 ea...
  • Page 88 Cardio7 Operation Manual WARRANTY Product Name Electrocardiograph Model Name Cardio 7 License Number License Date Serial Number 1 year from the date of purchase Warranty period (2years in Europe) Date of purchase (yyyy/mm/dd) Hospital: Address: Customer Name: Contact No: Seller’s Name Manufacturer’s...
  • Page 89 Cardio7 Operation Manual International Sales & service Bionet Co., Ltd. : #1101 11F E&C Venture Dream Tower3, 38-21, Digital-Ro, 31-Gil, Guro-Gu, Seoul 152-719, REPUBLIC OF KOREA Tel : +82-70-7585-6418 / Fax : +82-2-6499-7789 / e-mail: sales@ebionet.com Website: www.ebionet.com U.S.A sales & service representative Bionet America, Inc.

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