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Bionet CardioTouch3000 Operation Manual

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CardioTouch3000
Operation Manual
Ver. 7.00
2019.05.23
www.ebionet.com

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Summary of Contents for Bionet CardioTouch3000

  • Page 1 CardioTouch3000 Operation Manual Ver. 7.00 2019.05.23 www.ebionet.com...
  • Page 2 CardioTouch3000 Operation Manual Warranty - This product was made through strict quality control and examination. The repair and compensation standards follow the consumer damage compensation regulations of the Ministry of Finance and Economy. - The warranty for this product runs for 1 year. (2 years in EU) But the warranty for accessories runs for 6 months.
  • Page 3 • E-mail: Sales@ebionet.com Service@ebionet.com • URL: http://www.ebionet.com ※ In the event of a malfunction or failure, contact Service Dept. Of Bionet Co., Ltd. along with the model name, serial number, date of purchase and explanation of failure. 3 / 120...
  • Page 4 CardioTouch3000 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. - For simple inspection without giving instruction or...
  • Page 5 CardioTouch3000 Operation Manual Definition of WARNING, CAUTIONS and NOTE In order to stress the contents of this manual, we define the terms as below.  Please follow the warning and cautions instruction.  The manufacturer or service agents are not responsible for damage resulting from inappropriate use or carelessness.
  • Page 6 CardioTouch3000 Operation Manual Environment Instructions Please do NOT use or place the product in such environments explained below.  Steamy environment. Do not use the Direct sunlight. product with wet hands. Place where the temperature and humidity condition are extreme...
  • Page 7 It is not proper to use this product near a flammable anesthetic or solvent. Continuous operation. IEC/EN60601-1-2 (Electromagnetic Compatibility Requirements) standard : Class A NOTE Diagnosis provided by CardioTouch3000 must be confirmed by a qualified medical professional. 7 / 120 E3KOM-7.00...
  • Page 8 CardioTouch3000 Operation Manual NOTE Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Furthermore all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3 Ed. of IEC 60601-1, respectively).
  • Page 9 CardioTouch3000 Operation Manual WARNING Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  • Page 10 CardioTouch3000 Operation Manual Safety Symbols Symbols Contents ATTENTION : Consult accompanying documents Consult instructions for use: This symbol advises the reader to consult the operating instructions for information needed for the proper use of the device. Safety Sign : To signify that the instruction manual must be read.
  • Page 11 CardioTouch3000 Operation Manual Symbols Contents Local Area Network(LAN) Connector Power Off Power On Battery Operation Indicator AC Power Connection Indicator Manufacturer name and address Authorized European representative Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately.

  • Page 12: Table Of Contents

    CardioTouch3000 Operation Manual Contents Chapter 1. General Information ..........14 1) Product Overview ................15 2) Indication for Use ................15 3) Recording ECGs during Defibrillation.......... 16 4) Product Features ................16 5) Product Configuration ..............17 6) System Installation ................27 7) System Start..................
  • Page 13 CardioTouch3000 Operation Manual 4) System Setup ..................97 5) Switching menu ................. 99 6) Patient information ................. 100 7) Data search ..................100 8) Data transfer ..................101 9) Data import ..................103 Chapter 4. System Management ......... 105 1) Maintenance and Cleaning ............106 2) Regular Check-up ................

  • Page 14: Chapter 1. General Information

    CardioTouch3000 Operation Manual Chapter 1. General Information 1) Product Overview 2) Indications for Use 3) Recording ECGs during Defibrillation 4) Product Features 5) Product Configuration Basic Components and Accessories Optional Components Body Configuration Front Panel Graphic Display LCD Control Panel...

  • Page 15: Product Overview

    QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The CardioTouch3000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional‘s facility.

  • Page 16: Recording Ecgs During Defibrillation

    CardioTouch3000 Operation Manual conjunction with ambulatory ECG monitoring, is of particular use in the diagnosis of disorders of the cardiac rhythm and the evaluation of syncope. Contraindications No absolute contraindications to performing an electrocardiogram, other than patient refusal, exist. Some patients may have allergies, or more commonly, sensitivities to the adhesive used to affix the leads;...

  • Page 17: Product Configuration

    CardioTouch3000 Operation Manual 5) Product Configuration The CardioTouch3000 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 ①...
  • Page 18 CardioTouch3000 Operation Manual Optional Components ① ③ ② ① Battery (1 EA) – Replaceable and Rechargeable, Lithium ion, 11.1V, 2600mA ② Hanger (1 EA) ③ Cart (1 EA) CAUTIONS You may have distortion or signal noise when you use nonstandard or other brand accessories.
  • Page 19 CardioTouch3000 Operation Manual Body Configuration ▣ Top View ① ② ③ ④ ⑤ ① Handle ② Printer Cover ③ Printer Cover Switch ④ LCD ⑤ Control Panel 19 / 120 E3KOM-7.00...
  • Page 20 CardioTouch3000 Operation Manual ▣ Front View ① ① Printer Cover Switch ▣ Rear View ① ② ③ ④ ⑤ ① Protective Ground Terminal ② Power Switch ③ AC Power Connection Port ( Fuse : 250V , 5A ( High breaking type )) ④...
  • Page 21 Do not use the product and immediately ask the manufacturer and the seller for repair NOTE To avoid an expected electric shock, do not open the equipment cover or disassemble the equipment. Refer servicing to Bionet, Inc. 21 / 120 E3KOM-7.00...
  • Page 22 CardioTouch3000 Operation Manual Front Panel Graphic display window Battery status Power status Button Rotary key During device boot up, you can see the system software version and the Bionet name. 22 / 120 E3KOM-7.00...
  • Page 23 CardioTouch3000 Operation Manual Graphic display LCD 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 USB Connection Status (USB Memory, Barcode) ④...
  • Page 24 CardioTouch3000 Operation Manual Control Panel ⑦ ⑧ ① ② ③ ④ ⑤ ⑥ ⑨ ▣ Button ① Print out the rhythm data on A4 size or continuous paper. ② 10sec.are saed and are printed vas an output form after processing.
  • Page 25 CardioTouch3000 Operation Manual ⑤ It transfers the test data, or saved data to the server PC. Cancel commands or change into the former mode for main menu ⑥ printing. ▣ LED A light indicator lets you know that the battery is on and shows your current battery charging status.
  • Page 26 CardioTouch3000 Operation Manual ▣ Battery Power The device will get its power from the battery and the unit will display the battery power icon (shown above), when the system is powered on, the battery is connected to the device and the AC power is disconnected. When the battery power is low, an alarm sound will ring from the device speaker and LCD display will show a ―Battery Low‖...

  • Page 27: System Installation

    Paper Installation - Push the printer cover release switch to the right to open the printer door of the CardioTouch3000. Install EKG paper with the side to be recorded appearing on top. Close the cover to finish the paper installation process.

  • Page 28: System Start

    CardioTouch3000 Operation Manual 7) System Start When every preference is set, the company name will be displayed when the switch is turned on, and then after approx. 10 seconds, the initial menu selection will appear on the screen, as shown in the figure below.
  • Page 29 CardioTouch3000 Operation Manual The following is the main page of ECG menu. If you remember the information shown below, it will be easier for you to use the main page of ECG. Menu Description Heart rate mark To Input or check the patient‘s information...
  • Page 30 CardioTouch3000 Operation Manual The following is the main page of ECG file management, shown when selecting the ‗File‘ menu. If you remember the information shown below, it will be easier for you to use the main page of ECG file management.

  • Page 31: Chapter 2. Preparation For Electrocardiography

    CardioTouch3000 Operation Manual Chapter 2. Preparation For Electrocardiography 1) Location of Electrodes 2) Electrode Connection Patient Cable Connection How to Attach Electrodes Countermeasures for Bad Lead Connection 3) Starting ECG recording 4) Basic Setup General Patient Information Input Sensitivity Setup...

  • Page 32: Location Of Electrodes

    CardioTouch3000 Operation Manual 1) Location of Electrodes 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 33: Electrode Connection

    ECG signals. WARNING Use only electrodes and patient cables provided from Bionet, Inc. Bionet America, Inc. will take no responsibility for any accidents involving 3 party accessories.
  • Page 34 - Second case, signal conductivity between leads and the patient‘s body is low. In this case, replace the electrodes. If the two above cases have been performed and the operator is still experiencing noise or lead fault conditions, the patient cable may be faulty. Please contact the Bionet service center. 34 / 120...

  • Page 35: Starting Ecg Recording

    LCD. - Press the ‗ESC‘ key to stop the operation while printing or recording. The following buttons will be most commonly used when operating CardioTouch3000. Print out the rhythm data on A4 size or continuous paper. 10sec. are saved and are printed as an output form after processing.

  • Page 36: Basic Setup

    CardioTouch3000 Operation Manual 4) Basic Setup General When turning on the system, LCD will display component values set by the current system in order of heart rate, patient information, connection status of external device, power state, size of ECG signal and output speed.
  • Page 37 CardioTouch3000 Operation Manual - Menu Navigation Operate by rotating the rotary key. Menu movement will occur in the same direction as the direction of the key‘s rotation. - Menu Selection Initiate by pressing the rotary key. Menu box for setting of the selected menu will be displayed.
  • Page 38 CardioTouch3000 Operation Manual Patient Information Input In this menu, operators can input the patient‘s ID, name, age, sex, height, weight. When the user selects the line of ID, NAME, Department , a keyboard will show up on the screen. The default of every line is a blank and if there is a certain figure on the line, it should be shown exactly when loading the keyboard window.
  • Page 39 CardioTouch3000 Operation Manual When the user selects the line of Age, Height or Weight, a keypad will show up on the screen. The default of every line is a blank and if there is a certain figure on the line, it should be shown exactly when loading the keypad window.
  • Page 40 CardioTouch3000 Operation Manual When clicking the Gender Line, the letter Male or Female will be shown respectively. After selecting the data which you want, input all the information of the patient. When pressing OK button, the information will be saved, while pressing cancel button will cancel the setting.
  • Page 41 Normally barcode scanners are compatible with all products. However, because of inconsistencies 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 42 CardioTouch3000 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 and causes overlap with neighboring signals, or too small so that signal diagnosis is difficult.
  • Page 43 CardioTouch3000 Operation Manual Printing speed Setup This is a function to adjust the width of the printing signal. The values are available in 12.5mm/sec, 25mm/sec and 50mm/sec, 100mm/sec. If you set 25mm/sec up, the ECG signal will be recorded in 25mm for one second. Therefore, the 12.5 mm/sec width is equal to half of the 25 mm/sec width;...

  • Page 44: Lcd Monitor Display

    CardioTouch3000 Operation Manual 5) 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 all channels are coming out properly; the other one is to see the status of the electrocardiogram of the patient for an extended time.
  • Page 45 CardioTouch3000 Operation Manual Press ‘ESC‘ key to stop printing the ECG rhythm. After pressing the key, the system will stop printing and the display system setting after indicating the following message. NOTE Even if ECG output speed is set as 100 mm/sec, it is not supported when outputting monitoring.

  • Page 46: Record Mode Printing

    CardioTouch3000 Operation Manual 7) 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. Then, print out the heart rate according to the sensitivity, printing speed, and channel form that are set up by the user.

  • Page 47: Printing Form

    CardioTouch3000 Operation Manual 8) Printing Form In this section, descriptions and samples of various printing forms are provided.  Rhythm Printing Form - 3CH printing: To print 3 channels at the same time (I ~ III / aVR ~ aVF / V1 ~ V3 /...
  • Page 48 CardioTouch3000 Operation Manual Rhythm Report Form (3CH) Rhythm Report Form (6CH) 48 / 120 E3KOM-7.00...
  • Page 49 CardioTouch3000 Operation Manual Rhythm Report Form (12CH) Record Report Form (3CH + 1 RHY) 49 / 120 E3KOM-7.00...
  • Page 50 CardioTouch3000 Operation Manual Record Report Form (3 CH + 3 RHY) Record Report Form (6 CH + 1 RHY) 50 / 120 E3KOM-7.00...
  • Page 51 CardioTouch3000 Operation Manual Record Report Form (12 CH) Record Report Form (BEAT REPORT - TEXT) 51 / 120 E3KOM-7.00...
  • Page 52 CardioTouch3000 Operation Manual Record Report Form (BEAT REPORT - VECTOR) Record Report Form (BEAT REPORT - GUIDE) 52 / 120 E3KOM-7.00...
  • Page 53 CardioTouch3000 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 ...
  • Page 54 CardioTouch3000 Operation Manual NOTE Dextrocardia The human heart is normally located on the left side of the chest. However, in rare cases it is located on the right side chest, which is a condition called Dextrocardia. There is potential for dextrocardia if: - P, QRS and T are all reversed on Lead I.

  • Page 55: Copy Mode Printing

    CardioTouch3000 Operation Manual 9) 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 56 CardioTouch3000 Operation Manual If you change the filters on a previously saved ECG, it will adapt to the new filter. When the new filter is adapted completely, it will start printing after showing the message as below. When printing is abnormally completed, the state of the system setting will be displayed after showing the message as shown below for a second.

  • Page 57: System Setup

    CardioTouch3000 Operation Manual 10) System Setup Choose the 'Setup' button on the initial ECG main screen to change preferences. Setup menu consists of Basic Setup, Network Setup, Hospital Setup, ECG Setup, Service Setup and you can change the setting at each window. The main page shows Basic Setup.
  • Page 58 CardioTouch3000 Operation Manual Setup date and time After choosing the Setup menu, press the Basic button then the focus will go to the 'Date' item. By using the touch screen or rotating the rotary switch, choose the Date (yyyy/mm/dd) or Time (hr/min/sec), then the keypad will show up.
  • Page 59 CardioTouch3000 Operation Manual Touch Setup This is a menu to set up the coordinates of the touchpad. When selecting the 'Touch' menu at the Basic Setup page, setup page will disappear and the coordinates for setting calibration will appear as shown below. Follow the instructions shown on the screen, and then the coordinates will be set up.
  • Page 60 CardioTouch3000 Operation Manual Language As shown below, when selecting 'Language menu at the Basic Setup page, you can choose the language among English, French, German, Italian, Korean, Polish, Portuguese, Rumanian, Russian, Spanish and Turkish. Select the language you want to use and click the OK button and then you can use the service in the chosen language.
  • Page 61 CardioTouch3000 Operation Manual Start Option You can set up the index page shown at the time of initial boot up, according to the common dialog. When clicking the ‗Start Option‘ button, a small menu window will appear and you can select the initial page you want to have among MAIN, FILE, ECG.
  • Page 62 CardioTouch3000 Operation Manual Date Type As seen in the figure below, the date format on the top of the paper can be changed while printing out monitoring and recording results if you choose 'Date Type' from the Basic Setup menu. Choose the date format to be used, and then click the 'OK' button; the date format is converted to the one selected and can be seen on the output.
  • Page 63 CardioTouch3000 Operation Manual Color Setup The device offer two type of LCD screen for easy reading of wave form. In case of choosing "Black" color, it reflect wallpaper as black color and wave color turn to green color. In case of choosing "White" color, the wallpaper reflect white, wave color turn to black.
  • Page 64 Then, input the information required and press 'OK' button to save or 'ESC' to cancel the information. The server interlocking device can be selected as BMS Server of Bionet. After selecting the type of interlocking server, select the 'Setting' button; an appropriate setup window to the choice of server will be displayed.
  • Page 65 CardioTouch3000 Operation Manual BMS Server Setting IP setup on BMS Server-installed PC can be performed by choosing either Automatic IP (DHCP) or Fixed IP (Manually) in 'Configure‘ setup. If ‗DHCP‘ is chosen, the IP of the BMS Server-installed PC will be shown on the input box.
  • Page 66 CardioTouch3000 Operation Manual Wireless Network Setting Connect the USB wireless LAN card to the USB port of CardioTouch3000, and check whether or not the wireless icon ( ) appears in the Status bar on the top of the screen. 1) Navigate to System Setup -> Network, and Set the Device as ―Wireless‖.
  • Page 67 CardioTouch3000 Operation Manual : AP re-searching  : Page up  : Page down  : Attempting to connect  : Closing the window  3) Select the AP to be connected by using the rotary key or touching. Click the ―Connect‖ button. At that time, the security key input window will appear if the ―Encrypt‖...
  • Page 68 CardioTouch3000 Operation Manual 4) After clicking the Key Value input line by using the rotary key or touching, enter the security key. 5) Upon the completion of input, click the "OK" button; Connection will be attempted and the message describing the connection status will appear.
  • Page 69 CardioTouch3000 Operation Manual 8) When connection with the AP is successful, set the Device IP, Subnet Mask, Gateway, etc. by selecting manually or Configuring with DHCP. Refer to the Network Setup part of the User Manual for more details. NOTE It is recommended to use English for the name of the AP wireless network (SSID).
  • Page 70 CardioTouch3000 Operation Manual ECG Setup When selecting the ‗ECG‘ menu at the left side of the Setup page, ECG Setup page will show up at the right side. In ECG Setup menu, there is 'AUTO' button to set up and change set up related automatic diagnosis.
  • Page 71 CardioTouch3000 Operation Manual Printing channel setting [Print Setup] [Monitoring Form] Set up real time-printout form. Click ‗Mon Form,‘ and then a POP-UP window for channel list will be displayed. Default is set as ‗12CH‘. - 3CH printing: To print 3 channels at the same time (I ~ III / aVR ~ aVF / V1 ~ V3 / V4 ~ V6) If you want to change the channel, press ‗RHYTHM‘...
  • Page 72 CardioTouch3000 Operation Manual [Monitoring Size] You can set up the real time printing size. When you click the ‗Mon Size‘ menu, ‗Report‘ will be selected and when clicking it again, ‗Continue‘ will be selected. Default is set as ‗Continue‘. - ‗Report‘...
  • Page 73 CardioTouch3000 Operation Manual [Grid] If general fax paper is used for printout, it needs to be marked with a grid. A 5mm X 5mm grid must be in a solid line with the point mark on the 1mm X 1mm location. If using standard ECG recording paper instead of general fax paper(thermal paper), undo the grid marking setup as the recording paper will already have it.
  • Page 74 CardioTouch3000 Operation Manual - ‗3CH+1‘: 10-second ECG will be recorded as I, II and III for the first 2.5 seconds, aVR, aVL and aVF for the next 2.5 seconds, V1, V2, V3 for the next 2.5 seconds and V4, V5, V6 for the next 2.5 seconds. 1 channel of rhythm will be recorded for 10 seconds at the bottom.
  • Page 75 CardioTouch3000 Operation Manual [Print Line] You can set the line thickness of the printouts. Three setting options are available; ―Thin‖, ―Normal‖ and ―Thick‖. [Beat Form] You can set up the additional beat report printing. When you select the ‗Beat Form‘ menu, a small POP-UP menu will appear at the bottom and it will disappear when choosing OFF, Text, Vector or Guide.
  • Page 76 CardioTouch3000 Operation Manual [Rhythm] You can set up the rhythm leads for printing out the diagnosis of 3CH+1, 6CH+1, 3CH+3 and Long Time(1,3,5,10 Minute). You can choose 3 rhythm leads and when ‗3CH+3‘ is chosen, you can use all of the 3 leads, while when ‗3CH+1‘, ‗6CH+1‘ or ‗Long Time‘ is chosen, you can use the first value only.
  • Page 77 CardioTouch3000 Operation Manual [Quick Print] Set up the Quick Print Options. Output time can be saved by using the buffering function during selection of 0 - 10 seconds. NOTE If setting up as ON, diagnosis button should be used only after signalling is stabilized.
  • Page 78 CardioTouch3000 Operation Manual [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 79 CardioTouch3000 Operation Manual Base line drift is caused by the patient‘s breathing. It can be seen as ECG signals being overlapped on a large parabola. The BASE LINE filter provides 0.05Hz, 0.1Hz and 0.2Hz, and its set values will appear as Base:0.05Hz, Base:0.1Hz and Base:0.2Hz at the bottom of the Output Form.
  • Page 80 CardioTouch3000 Operation Manual If the recorded EKG signal contains a lot of noise, Low Pass Filter (LPF) may help to clear it. For Low Pass Filter, 40Hz, 100Hz, 150Hz and OFF option is offered. Here, 40Hz option means the filter will remove any unwanted signal with frequencies above 40Hz. Low Pass Filter values will appear on the bottom of the printout form;...
  • Page 81 CardioTouch3000 Operation Manual Lead fault Signal Display Setting When the connection between the patient and Leads is improper, lead fault can occur. In that case, you can choose whether to have the lead fault message on the ECG Main page or not. Selecting ‗Lead Fault‘ 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 82 CardioTouch3000 Operation Manual NOTE If ‗RA‘ Lead becomes Fault, the wave types of all Leads will not be indicated. If ‗LA‘ Lead becomes Fault, the wave types of I and V1-V6 Leads will not be indicated. If ‗RA‘ Lead becomes Fault, Lead Fault message might not be shown and the wave types of all Leads might be indicated.
  • Page 83 CardioTouch3000 Operation Manual Pacemaker signal printing In case of using the pacemaker signals, you can choose whether to print out the location of the pacemaker when monitoring or recording . You can select ON or OFF by clicking the ‗Pacemaker‘ item. When it is on, the location of the pacemaker will be printed out, while when it is off, it will not be printed out.
  • Page 84 CardioTouch3000 Operation Manual QRS Sound Setup In this menu, users can set the device to ring an alarm sound when a QRS beat has generated while it is in waiting mode. Users can either set the alarm ON or OFF by selecting the menu with ON turning on and OFF turning off the alarm sound.
  • Page 85 CardioTouch3000 Operation Manual Demo Mode Setting This menu puts CardioTouch3000 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. Users can test rhythm, diagnostic, copy printing functions as well as PC communication and other miscellaneous functions.
  • Page 86 CardioTouch3000 Operation Manual ‘AUTO’ key setting When the ‗Store‘ menu has the focus, click it to set up ‗Yes‘ or ‗No‘. When ‗Yes‘ is selected, you can operate the ECG test by pressing the ‗AUTO‘ key on the control panel and the ECG data will be automatically saved, but when ‗No‘...
  • Page 87 CardioTouch3000 Operation Manual When selecting the ‗Export‘ menu, a small menu window as below will appear and it will disappear when selecting one of None, Server, USB. If it is ‗None,‘ ECG data will not be externally transferred; if is 'USB,' ECG data will be automatically saved to the external USB memory.
  • Page 88 At ‗User Security Set‘ setup, it is possible to change Factory Setting and User Password. At ‗Manufacture Set‘ setup, it is possible to change Upgrade and Device Options; please contact the Bionet Service Center. Factory (Reset Settings) In order to reset to factory conditions, press the ‗Factory‘ button and enter the Password.
  • Page 89 CardioTouch3000 Operation Manual The initialized values are as follows. Contents Setting Value Gain 10mm/mV Speed 25mm/s Start Option Main Unit Height : cm, Weight : kg Date Type YYYY-MM-DD Patient Info (File) Delete Device Name CardioTouch3000 Net Device Wired Configure...
  • Page 90 CardioTouch3000 Operation Manual Low Pass Filter 150Hz EMG Filter ECG Store Print Out Export None Target Method Manual Format Delete JPEG Size 1024 x 768 Patient information initialized 90 / 120 E3KOM-7.00...
  • Page 91 CardioTouch3000 Operation Manual Data Erase All data in Files will be deleted. Change PW User Password can be configured. User Password is the number entered for Factory and Data Erase. The password should be a 4-digit number. NOTE The default User Password is ‗1234‘. If you forget the password, enter ‗1234‘ and reset.
  • Page 92 Use electrodes with products such as those provided or with a biocompatibility certificate certified by international standards. CAUTIONS Use CardioTouch3000 in the presence of a specialist(health care professional) for use by patients undergoing cardiac assist device surgery. 92 / 120...

  • Page 93: Chapter 3. Ecg File Management

    CardioTouch3000 Operation Manual ECG File Management Chapter 3. 1) Display and Function 2) Data Printing 3) Data Deleting 4) System Setup 5) Switching Menu 6) Patient Information 7) Data Search 8) Data Transfer 9) Data Import 93 / 120 E3KOM-7.00...

  • Page 94: Display And Function

    CardioTouch3000 Operation Manual 1) Display and Function ⓛ ② ③ ④ ⑤ ⑥ ⑦ ⑧ ⑨ ⑩ ① Page information - For example, [1/20] means that you see the first page among total 20 pages. 1 Page contains 24 lines of Data.

  • Page 95: Data Printing

    CardioTouch3000 Operation Manual - Menu direction (Rotary Key‘s right spin) Print  Delete  Setup  Main  Page information  [<]  [>]  Info  Search  Print - Menu direction (Rotary Key‘s left spin) Print  Search  Info  [>]  [<]  Page information  Main  Setup  Delete  Print...

  • Page 96: Data Deleting

    CardioTouch3000 Operation Manual 3) Data Deleting When pressing the ‗Delete‘ button, a small pop-up menu will show up. You can choose to press the ‗select‘ or ‗all‘ button. When you press the ‗Select‘ button, one data will be deleted, but if you press the ‗All‘...

  • Page 97: System Setup

    CardioTouch3000 Operation Manual 4) System Setup When clicking the ‗Setup‘ button at the ECG data file management page, you will see a ‗System Setup‘ window as shown below. ‗PAT Info.‘ menu is to set up whether the patient information is retained or not, when you move the main screen of the ECG.
  • Page 98 CardioTouch3000 Operation Manual When clicking the ‗Export‘ button, you will see ‗Export‘ window as shown below. When clicking the ‗Target‘ button, a POP-UP window will show up and it will disappear when selecting one of BMS Server or USB. - BMS Server : To save the data in the BMS Server or USB memory.

  • Page 99: Switching Menu

    CardioTouch3000 Operation Manual NOTE If ‗Format‘ menu has only ‗EKG‘ options, it is possible to select 'All' or 'All New' in 'Method‘ menu; for other formats, ‗Selected‘ is the only option. 5) Switching Menu When selecting the ‗Main‘ button at the main page of ‗File management‘, a line window will show up.

  • Page 100: Patient Information

    CardioTouch3000 Operation Manual 6) Patient Information When selecting a saved data at the ECG file management page by using a rotary key or a touch screen, the focus will appear at the data list. Press the ‗Info‘ button. Then you will see a ‗Patient Information‘ window as shown below.

  • Page 101: Data Transfer

    CardioTouch3000 Operation Manual 8) Data Transfer You can transfer the saved data to the external device at the ECG data file management page by using the ‗NETWORK‘ key on the control panel. When pressing the ‗NETWORK‘ key, a message will show up, asking which menu you want to select.
  • Page 102 CardioTouch3000 Operation Manual NOTE When transmitting multiple sets of data to PC after saving, a network error could occur which may cause transmission halt and subsequent loss of data. Therefore, we recommend users to practice following procedures to minimize such loss.

  • Page 103: Data Import

    ‗RECORD‘ key on the control panel. When pressing the ‗RECORD‘ key, 'Import File List‘ screen will be shown as below. If the external device is not connected to CardioTouch3000, the error message will be shown as below.
  • Page 104 CardioTouch3000 Operation Manual If you select the ‗All‘ menu in the ‗Import File List‘ screen, a system message with progress speed will be shown as below. After receiving all data from the external device, a system message will be shown as below.

  • Page 105: Chapter 4. System Management

    CardioTouch3000 Operation Manual Chapter 4. System Management 1) Maintenance and Cleaning 2) Regular Check-up 3) Trouble Shooting 4) Manufacturer Declaration 105 / 120 E3KOM-7.00...

  • Page 106: Maintenance And Cleaning

    CardioTouch3000 Operation Manual 1) Maintenance and Cleaning There are many ways to clean CardioTouch3000, but it is best to use our recommendation to avoid damage or sanitary issues. The warranty does not cover problems resulting from the use of harmful substances (unauthorized substances).

  • Page 107: Trouble Shooting

    Connect the external USB keyboard to the USB port before you turn on the power of CardioTouch3000. If you connect the external USB keyboard to the USB port after you turn on the power of CardioTouch3000, you should turn off the power of CardioTouch3000 and turn on again.
  • Page 108 CardioTouch3000 Operation Manual System message Cause Solution Please contact CS (Customer Please check Internal coin battery is Support) team of Bionet to date and time discharged. replace old coin type battery with new one When wrong network Address is not...
  • Page 109 CardioTouch3000 Operation Manual - Check System setup and When there is connecting network Ping : Failed failure between network - Check PC network setup and PC with BMS Server -Check LAN cable or wireless environment Please contact ‗Network Team‘ to...
  • Page 110 CardioTouch3000 Operation Manual When the lead is off from Please reattach the electrode on Lead Fault! the patient body patient body When the conductivity Apply some water to reusable between patient body electrodes, and reattach them and electrode is weak...

  • Page 111: Manufacturer Declaration

    CardioTouch3000 Operation Manual 4) Manufacturer Declaration Electromagnetic Compatibility Information Basic EMC Phenomenon standard or test Test level/requirement method Mains terminal CISPR 11 Group1, Class A disturbance voltage Radiated disturbance CISPR 11 Group1, Class A Harmonic Current Emission IEC 61000-3-2 Class A...
  • Page 112 Electromagnetic compatibility - Guidance and manufacturer's declaration Guidance and manufacturer’s declaration – electromagnetic emissions The CardioTouch3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the CardioTouch3000 should assure that it is used in such an environment. Emissions test...
  • Page 113 CardioTouch3000 Operation Manual Guidance and manufacturer’s declaration – electromagnetic immunity The CardioTouch3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the CardioTouch3000 should assure that it is used in such an environment. IMMUNITY...
  • Page 114 CardioTouch3000 Operation Manual Guidance and manufacturer’s declaration – electromagnetic immunity The CardioTouch3000 is intended for use in the electromagnetic environment specified below. The customer or the user of the CardioTouch3000 should assure that it is used in such an environment. IEC 60601...
  • Page 115 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the CardioTouch3000 is used exceeds the applicable RF compliance level above, the CardioTouch3000 should be observed to verify normal operation.
  • Page 116 CardioTouch3000 Operation Manual 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.

  • Page 117: Chapter 5. Specification

    CardioTouch3000 Operation Manual Chapter 5. Specification ECG Leads Simultaneous 12 Leads Resting ECG Recording Channel 3CH+1RHY, 3CH+3RHY, 6CH+1RHY, 12CH, 1CH Long Time (1min) and Beat Report Gain 2.5, 5, 10, 20, Auto (I~aVF: 10, V1~V6: 5)mm/mV Printing Speed 5, 12.5, 25, 50, 100mm/sec Sampling Rate Analysis Sampling Rate –...
  • Page 118 CardioTouch3000 Operation Manual 200 ECGs in 12 channel format at 25mm/s and 10mm/mV with a battery charged during approximately 3 hours from total discharge (with display off) Communication LAN, WIFI (option) Safety Conformity Class I, Type CF Defibrillation-proof applied Part.
  • Page 119 Name: Contact No: Seller‘s Name Manufacturer‘s Name ※ Thanks for purchasing CardioTouch3000. ※ This product is a medical machine. ※ This product meets the strict quality requirements thoroughly. ※ The repairing and compensation standards follow the consumer damage compensation regulations of the Ministry of Finance and Economy.
  • Page 120 CardioTouch3000 Operation Manual International Sales & service Bionet Co., Ltd. : 5F, Dreammark1 Data center 61 Digital-ro 31 gil, Guro-gu, SEOUL 08375, REPUBLIC OF KOREA Tel : +82-2-6300-6410 / 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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