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Bionet Cardio7e Operation Manual

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Cardio7e/ Cardio7
(ECG)
Operation Manual
Ver. 1.31
2021.05.31
www.ebionet.com
Copyright © 2021 By Bionet CO., LTD. All rights reserved

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  • Page 1 Cardio7e/ Cardio7 (ECG) Operation Manual Ver. 1.31 2021.05.31 www.ebionet.com Copyright © 2021 By Bionet CO., LTD. All rights reserved...
  • Page 2 V 1.31 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 Email: infor@cmcmedicaldevices.com Website: http://www.cmcmedicaldevices.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. ※ 'CE1434' only supports Cardio7e equipment.
  • Page 4 V 1.31 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 Fee charged: From the disassembling the product second time - For reinstalling due to poor installation by the...
  • Page 5 V 1.31 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 V 1.31 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 Near electronic (Use the equipment heaters between the ambient...
  • Page 7 Class A purposes. Mains power should be a typical commercial or hospital environment. NOTE Diagnosis provided by Cardio7e/Cardio7 must be confirmed by a qualified medical professional. NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A).
  • Page 8 V 1.31 Safety Messages The following messages apply to the product as a whole. Specific messages may also appear elsewhere in the manual. WARNING: ACCIDENTAL SPILLS — If liquids enter a device, take the device out of service and have it checked by a service technician before it is used again.
  • Page 9 V 1.31 WARNING: OPERATOR — Medical technical equipment such as this system must be used only by qualified and trained personnel. WARNING: SHOCK HAZARD — Improper use of this device presents a shock hazard. Strictly observe the following guidelines. Failure to do so may endanger the lives of the patient, user, and bystanders.
  • Page 10 DISPOSAL — At the end of its service life, the product described in this manual, as well as its accessories, must be disposed of in compliance with local, state, or federal guidelines regulating the disposal of such products. If you have questions concerning the disposal of the product, please contact bionet or its representative. CAUTION: EQUIPMENT DAMAGE —...
  • Page 11 V 1.31 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. Reading the instruction manual before starting work or before operating equipment.
  • Page 12 V 1.31 Symbols Contents Spirometry Connector 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 13: Table Of Contents

    V 1.31 Contents Chapter 1. General Information ..........15 1) Product Overview ................16 2) Indication for use ................16 3) Recording ECGs During Defibrillation ......... 17 4) Product Features ................17 5) Product Configuration ..............18 6) System Installation ................31 7) System Start..................
  • Page 14 V 1.31 6) Patient information ................. 142 7) Data search ..................143 8) Data transfer ..................144 9) Data import ..................146 Chapter 4. ECG worklist management ......149 1) Display and function ..............150 2) ECG Test ..................... 151 3) Data deleting ...................

  • Page 15: Chapter 1. General Information

    V 1.31 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 Power 6) System Installation Precautions for Installation Power Connection...

  • Page 16: 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 Cardio7e/Cardio7 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 17: Recording Ecgs During Defibrillation

    V 1.31 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; in these cases, hypoallergenic alternatives are available from various manufacturers. 3) Recording ECGs During Defibrillation This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery, as required by test standards.

  • Page 18: Product Configuration

    V 1.31 5) Product Configuration The Cardio7e/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 19 V 1.31 Optional components ① ① Battery (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. WARNING How to replace the battery: If the battery provided by us is not used, we are not responsible for any problems arising from it.
  • Page 20 V 1.31 Body Configuration ▣Top View ① ② ③ ④ ⑤ ①Handle ②Printer Cover ③Printer Cover Switch ④LCD ⑤Control Panel 2021. 05 20 / 171 Doc. # : BN-OP-C7...
  • Page 21 V 1.31 ▣Front View ① ①Printer Cover Switch 2021. 05 21 / 171 Doc. # : BN-OP-C7...
  • Page 22 V 1.31 ▣Rear View ① ② ③ ④ ⑤ ①Protective Ground Terminal ②Power Switch ③AC Power Connection Port (+ Fuse (250V, 3.15AL) x 2) ④USB Port ⑤RJ45 LAN Port NOTE Appliance inlet of separate power supply unit is used as mains disconnecting device.
  • Page 23 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. 2021. 05 23 / 171 Doc. # : BN-OP-C7...
  • Page 24 V 1.31 Front Panel Graphic display window Button Battery status Rotary key Power status During device boot up, you can see the system software version and the Bionet name. 2021. 05 24 / 171 Doc. # : BN-OP-C7...
  • Page 25 V 1.31 Graphic display LCD The following descriptions explain data on the graphic LCD. ① ② ③ ④ ⑤ ⑥ ⑦ ⑧ ①Select one ECG recording mode (10s, 1m, 3m, 5m, or 10m (seconds, minutes)) ②Displays the Heart Rate. ③Displays Patient ID. ④...
  • Page 26 V 1.31 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. and long-term readings (1min., 3min., 5min., 10min.) are ② saved and are printed as an output form after processing. Process the recorded data with or without revision and print them ③...
  • Page 27 V 1.31 ▣LED A light indicator lets you know that the battery is on and shows your current battery charging status. A red-light indicator lets you know ⑦ that the battery is charging, and a green light indicator lets you know the batter is fully charged.
  • Page 28 AC power is not supplied. NOTE - Bionet recommends replacing the lithium-ion battery after 24 months of use. - Battery life depends on usage. Continuing battery use will reduce battery life and increase the frequency of replacement.
  • Page 29 When AC power is connected in the monitor equipment, the battery doesn't work and doesn't supply power. Battery life may be less than 12 months. Bionet recommends it should be kept separate from the equipment during the moving.
  • Page 30 V 1.31 Battery recycles Replace the battery when it is no longer charged. This battery is a regenerative product. Remove the battery from the system and put it in a separate bin. WARNING Don't keep at high temperatures or burned of a battery due to there is a risk of explosion. You can wear serious injuries resulting from the explosion.

  • Page 31: System Installation

    Paper Installation - Push the printer cover release switch to the right to open the printer door of the Cardio7e/Cardio7. Install EKG paper with the side to be recorded appearing on top. Close the cover to finish the paper installation process.
  • Page 32 - If the device is used as a layer-2-switch or layer-3-switch, the port settings must be configured on the network switch. “Bionet device” must be configured so that the network settings are compatible with the specifications of the operating organization.
  • Page 33 V 1.31 When using an inappropriate network - If the network does not meet the requirements, the following situations can occur: Without firewall and anti-virus software: ⚫ Your data is not protected. Data is transmitted in an incomplete state or not transmitted at all. Data may be transmitted to the wrong server.

  • Page 34: System Start

    V 1.31 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. You can move to the main page of the chosen menu by touching the menu on the screen or rotating the key on the control panel.
  • Page 35 V 1.31 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. 2021. 05 35 / 171 Doc. # : BN-OP-C7...
  • Page 36 V 1.31 Menu Description Recording mode (marked as 10 s, 1 m, 3 m, 5 m and 10 m unit) Heart rate mark To Input or check the patient’s information Barcode reader or USB Keyboard connection mark Replaced by the icon when a network error occurs during transfer to the PACS server.
  • Page 37 V 1.31 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. Menu Description Going to Patient List...
  • Page 38 V 1.31 The following is the main page of ECG worklist management, shown when selecting the ‘worklist’ menu. If you remember the information shown below, it will be easier for you to use the main page of ECG worklist management. Menu Description Going to Patient List...
  • Page 39 V 1.31 The following is the initial screen of the Study Queue Data Management, which is where you will navigate to if you select the ‘Study Queue’ icon ( ). The Study Queue is managing data errors when an error occurs during transfer to the PACS server. Memorizing the following at the Study Queue Management screen will help more convenient use.

  • Page 40: Chapter 2. Preparation For Electrocardiography

    V 1.31 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 Printing speed Setup 5) LCD Monitor display 6) Disclosure 7) Rhythm Mode Printing...

  • Page 41: Location Of Electrodes

    V 1.31 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. RL (N): Right Leg LL (F): Left Leg RA (R): Right Arm...

  • Page 42: 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 43 - 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. 2021. 05 43 / 171 Doc.

  • Page 44: 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 Cardio7e/Cardio7. Print out the rhythm data on A4 size or continuous paper. 10sec. and long-term readings (1min., 3min., 5min., 10min.) are saved and are printed as an output form after processing.

  • Page 45: Basic Setup

    V 1.31 4) Basic Setup General When turning on the system, it is displayed top and down menu bars and graphic window in the LCD screen. Top menu bar shows a measurement mode, heart rate, patient information, the status of the external connection and power state in, and down menu bar contains the output speed, size of the signal and setup.
  • Page 46 V 1.31 - 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 47 V 1.31 Patient Information Input In this menu, operators can input the patient’s ID, name, age, sex, height, weight, race and smoking habit. NOTE The patient's surname is available after changing the file version to 1.1 in the BMS Server settings. 2021.
  • Page 48 V 1.31 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. When the user wants to set the data after inputting, the user can press OK button on the keyboard and if the user wants to cancel the setting, pressing ESC button will do it and the keyboard window will disappear.
  • Page 49 V 1.31 When the user selects the line of Age, Birth, 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 50 V 1.31 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 51 V 1.31 When clicking the Race Line, the choices of White, Asian, Black will show up. After selecting the data which you want to, 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 52 V 1.31 You can decide whether or not to smoke by clicking Smoke. The default setting for Smoke is “No.” When you have completed inputting all information, you will see the window as shown below. After checking all information then pressing OK button, the information will be saved, while pressing cancel button will cancel the setting.
  • Page 53 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 whether it is supported by Bionet. • Input methods supported by Bionet: International standards, USB •...
  • Page 54 V 1.31 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. Users can set all 12 channels to 2.5mm/mV, 5mm/mV, 10mm/mV or 20mm/mV. Users can also set it to Auto which will automatically set the sensitivity level for each channel;...
  • Page 55 V 1.31 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. 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 56: Lcd Monitor Display

    V 1.31 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 57: Disclosure

    V 1.31 6) Disclosure The screen can be shifted to the 'Disclosure’ function by pressing and holding the LCD at ECG main screen state for 3 seconds. ‘Disclosure’ function means data is buffered in the Disclosure Buffer, and then is shown when running the Disclosure menu; 5-minute data which is already saved is fully displayed at 1CH (refer to setting Print ->...

  • Page 58: Rhythm Mode Printing

    V 1.31 7) 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 59: Record Mode Printing

    V 1.31 8) 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 60: Printing Form

    V 1.31 9) 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 / V4 ~ V6) - 6CH printing: To print 6 channels at the same time (I ~ aVF / V1 ~ V6) - 12CH printing: To print 12 channels at the same time (I ~ V6)
  • Page 61 V 1.31 (3CH) Rhythm Report Form (6CH) Rhythm Report Form 2021. 05 61 / 171 Doc. # : BN-OP-C7...
  • Page 62 V 1.31 (12CH) Rhythm Report Form (3CH + 1 RHY) Record Report Form 2021. 05 62 / 171 Doc. # : BN-OP-C7...
  • Page 63 V 1.31 (3 CH + 3 RHY) Record Report Form (6 CH + 1 RHY) Record Report Form 2021. 05 63 / 171 Doc. # : BN-OP-C7...
  • Page 64 V 1.31 (12 CH) Record Report Form (6 CH + 1 RHY (ST Map)) Record Report Form 2021. 05 64 / 171 Doc. # : BN-OP-C7...
  • Page 65 V 1.31 (BEAT REPORT - TEXT) Record Report Form (BEAT REPORT - VECTOR) Record Report Form 2021. 05 65 / 171 Doc. # : BN-OP-C7...
  • Page 66 V 1.31 (BEAT REPORT - GUIDE) Record Report Form (BEAT REPORT –ST Map (Dot)) Record Report Form 2021. 05 66 / 171 Doc. # : BN-OP-C7...
  • Page 67 V 1.31 (BEAT REPORT –ST Map (Bar)) Record Report Form 2021. 05 67 / 171 Doc. # : BN-OP-C7...
  • Page 68 V 1.31 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 69 V 1.31 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 70: Copy Mode Printing

    V 1.31 10) 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 71 V 1.31 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 72: System Setup

    V 1.31 11) 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, Record Setup and Service Setup and you can change the setting at each window. The main page shows Basic Setup.
  • Page 73 V 1.31 Basic Setup When choosing Basic menu at the left side of the Setup page, you will see the page for Basic Setup. Basic Setup consists of Date, Time, Touch screen, Start Option, Unit, Date Type and Device Name menus. 2021.
  • Page 74 V 1.31 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. You can set up the information by using this keypad.
  • Page 75 V 1.31 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 76 V 1.31 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 77 V 1.31 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, WORKLIST, ECG, SPIRO. 2021.
  • Page 78 V 1.31 Units This menu is to select the units for height and weight of the patient. When you click Units’ button, cm/kg or Inch/Lbs will be shown. If you select Inch/Lbs unit, the patient’s height information will be expressed in *** Ft Feet) *** Inch.
  • Page 79 V 1.31 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 80 V 1.31 Network Setup When connecting the equipment with LAN to interface with the outside PC, network setup is needed. Network IP is required, and DNS is not used. When selecting the Network menu at the left side of the System Setup page, Network Setup page will show up at the right side.
  • Page 81 V 1.31 When selecting one of the ‘Device IP’, ‘Subnet Mask’, ‘Gate Way’, the keypad will show up. Then, input the information required and press 'OK' button to save or 'ESC' to cancel the information. It allows selecting the server which is available to link with the equipment in the 'Connect to' menu.
  • Page 82 V 1.31 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. The patient's surname is available after changing the file version to 1.1 in the BMS Server settings.
  • Page 83 V 1.31 Upon completion of BMS Server IP setup, the Ping Test can be conducted to check successful network connection. If choosing ‘Ping’ button, “Ping: 100% Succeeded” message will be shown for a successful connection, whereas “Ping: Failed” message will be shown for connection failure.
  • Page 84 PACS Server Setting When selecting the PACS Server, the additional information should be set through the Settings Menu. The screen for related settings such as the AE Title, IP and Port of Cardio7e/Cardio7, Worklist Server and Store Server will appear.
  • Page 85 V 1.31 When successful, the “Verify: Success” message will appear; when it has failed, “Verify: C-Echo Failed” will appear. Set the PACS option by pressing the More button when connection to the server is confirmed. Spiro Exam Code Enter the Exam Code of FVC, SVC and MVV for the Spiro test. 2021.
  • Page 86 V 1.31 Data Range The range of dates when the worklist is brought can be set at the Worklist Server. You can choose appropriate one from the options such as “Today,” “Yesterday ~ Tomorrow”, “One Week” and "A Week ago". For today (today-today), both the start and end dates are set to today, and for today (today-blank), only the start date is set to today to get the worklist.
  • Page 87 V 1.31 Data Format Set the data format for the file to be transferred to the PACS Server. You can select either “JPEG,” “PDF” or “RAW” after checking the format supported by the PACS Server. Retry Count Select the number of Retransmission attempts when a communication error occurs during transfer of data to the PACS Server.
  • Page 88 V 1.31 Character Set By selecting the Character Set, multiple selections of language are available; it should be selected according to the character set in order to present contents such as patient information by language when transferring a DICOM file to the PACS Server. Upon the completion of each setting, press the 'OK' button to save the changes or push the 'Cancel' button or the 'ESC' button of the Operating Panel to cancel them.
  • Page 89 Component name, File name, and Image type. Work type Set how the GDT function of the system works. - Server: Cardio7e/Cardio7 receives requests and commands. - Client: Cardio7e/Cardio7 sends requests and commands. Directory Enter the type format in which the shared folder information and date information to be used by the GDT protocol.
  • Page 90 V 1.31 Component For use GDT protocol, enter the EMR name and abbreviation and the name of Cardio7e/Cardio7 and abbreviation. File name Select the name form of the file to be shared by the GDT protocol. Image Select the image format of the data file to share with the GDT protocol.
  • Page 91 V 1.31 WEB Setting When selecting Web transmission, additional information must be set through the Setting menu. The screen for related settings such as DNS Server, URL, ID, PW, Path appears. DNS Server The IP of the server that supports the domain name system. Web address to access.
  • Page 92 V 1.31 If you select the input window of each item, a keyboard window appears, and you can enter the content. After entering, you can check the connection between Worklist Server and Store Server by pressing the “Verify” button. The message “Verify: Success” is displayed on success, and the message “Verify: Fail” on failure.
  • Page 93 V 1.31 Wireless Network Setting 1) Connect the USB to the USB port of Cardio7e/Cardio7, and check whether or not the wireless icon ( ) appears in the Status bar on the top of the screen. 2) Navigate to System Setup -> Network, and Set the Device as “Wireless”.When selection is done properly, the "Survey"...
  • Page 94 V 1.31 Refresh : AP re-searching  << : Page up  >> : Page down  Connect : Attempting to connect  Close: Closing the window  4) Select the AP to be connected by using the rotary key or touching. Click the “Connect”...
  • Page 95 V 1.31 5) After clicking the Key Value input line by using the rotary key or touching, enter the security key. 6) Upon the completion of input, click the "OK" button; Connection will be attempted and the message describing the connection status will appear. 7) When the message reporting a proper connection appears, click the "Close"...
  • Page 96 V 1.31 9) 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). If it is entered in Korean or other languages, Mojibake or illegible characters can appear.
  • Page 97 V 1.31 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. 2021. 05 97 / 171 Doc. # : BN-OP-C7...
  • Page 98 V 1.31 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 99 V 1.31 [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’: To print out 10-second data in the form of Report. - ‘Continue’: The leads will be printed out continuously until you press the ‘ESC’...
  • Page 100 V 1.31 [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 101 V 1.31 [Recording Form] You can set up the recording form. If you choose the ‘Rec Form’ menu, a small POP-UP menu will appear below; once you choose either 3CH+1, 6CH+1, 12CH or 3CH+3, the POP-UP menu will disappear. The default is ‘3CH+3'.
  • Page 102 V 1.31 - ‘6CH+1(ST)’: 10-second ECG will be recorded as I, II, III, aVR, aVL and aVF for the first 4 seconds and V1, V2, V3, V4, V5 and V6 for the next 4 seconds. 1 channel of rhythm will be recorded for 10 seconds at the bottom . The amplitude of the measured ST wave is printed as an ST map.
  • Page 103 V 1.31 [Print Line] You can set the line thickness of the printouts. Three setting options are available: “Thin”, “Normal” and “Thick”. 2021. 05 103 / 171 Doc. # : BN-OP-C7...
  • Page 104 V 1.31 [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, Guide, ST Map(Dot) or ST Map(Bar).
  • Page 105 V 1.31 [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 106 V 1.31 [Preview] After performing measurements by using keys such as RECORD, AUTO and NET, the device can automatically show the outcome to the user. This function can be turned On or Off in this window. When the preview setting is set to “On”, the “Preview” screen will appear following data collection with RECORD, AUTO and NET keys.
  • Page 107 V 1.31 - The first page: ECG 0 - 6 seconds signal data, ID, Name, and Diagnosis - The next page: ECG 6 - 10 seconds signal data, ID, Name, Filter setup, Rhythm parameter values Note The preview screen will be shown with output speed set to 25mm/sec. The preview screen is available for 10-second recording only.
  • Page 108 V 1.31 [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 109 V 1.31 [Filter Setup] The signal output generated by the device may contain extra unwanted signals in addition to the EKG wave such as AC noise, baseline 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 110 V 1.31 Baseline drift is caused by the patient’s breathing. It can be seen as ECG signals being overlapped on a large parabola. The Baseline 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 111 V 1.31 There are three types of an AC power noise filter: 60Hz, 50Hz and OFF. When set to OFF, the filter will not be applied. If the filter is set to 50Hz or 60Hz, then the AC filter will remove 50Hz or 60Hz power noise correspondingly.
  • Page 112 V 1.31 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 113 V 1.31 Select 'ON' when applying ‘EMG’ filter; otherwise, select 'OFF.' Setup values will be shown on the bottom of the printout form as ‘EMG: On’ or ‘EMG: Off’ when applying the filter. NOTE Applying filters may distort the original signal. Therefore, the proper use when the recording signal is in bad condition can reduce ECG signal distortion.
  • Page 114 V 1.31 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 115 V 1.31 The following message for Lead Fault will be shown with affected channels: 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.
  • Page 116 V 1.31 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 117 V 1.31 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 118 V 1.31 Method of Leads Place ‘Leads Place’ menu shows how to connect electrodes on the graphic display. Focusing on and selecting ‘Leads Place’ menu will bring the screen shown below. At that time, enter the screen-touch, rotary or 'ESC' key; and then the 'how to connect electrodes' screen will disappear while going back to the ‘ECG Setup’...
  • Page 119 V 1.31 Demo Mode Setting This menu puts Cardio7e/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. Users can test rhythm, diagnostic, copy printing functions as well as PC communication and other miscellaneous functions in Cardio7e/Cardio7.
  • Page 120 V 1.31 Record Setup When selecting the ‘Record’ menu at the left side of the Setup page, the record setup page will show up at the right side. Record Setup menu consists of the ‘AUTO’ key on the control panel setup item and auto diagnosis setup item.
  • Page 121 V 1.31 When the ‘Print Out’ 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 print out, but when ‘No’...
  • Page 122 V 1.31 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 123 V 1.31 Auto diagnosis setting ‘When selecting the ‘Diagnosis’ menu, a small menu window as below will appear and it will disappear when selecting one of OFF, Standard or Professional. When ‘OFF’ is selected, the content of diagnosis will not be printed out, whereas when ‘Standard’...
  • Page 124 V 1.31 When selecting the ‘ST Level’ menu, a small menu window as below will appear and it will disappear when selecting one of AUTO, 60msec or 80msec. When ‘AUTO’ is selected, J Point associated with ST Level will be automatically set up at the time of printing.
  • Page 125 V 1.31 ‘V Change’ menu is used to set up the V3 ~ V6 on the printing paper when diagnosing children in which the location of V3 ~ V6 electrodes need to be changed from left to right. Basically, the ‘V Change’ is set as ‘None’ and when you click this menu, a ‘Leads Change’...
  • Page 126 V 1.31 Long Time setting Duration of Arrhythmia and HRV recording can be set up. It can be selected as 1, 3, 5 or 10 min. NOTE - For Arrhythmia and HRV, only 3, 5 or 10 min are available. - Upon output of Arrhythmia and HRV, ECG with pre-setup duration will be printed out by one choice of Lead a line at 20-second interval.
  • Page 127 V 1.31 Arrhythmia setting When performing Long Time recording, arrhythmia printout options can be configured. If 'Arrhythmia’ option is selected as ON, printout will be performed; if OFF, it will not be performed. 2021. 05 127 / 171 Doc. # : BN-OP-C7...
  • Page 128 V 1.31 setting When performing Long Time recording, HRV printout options can be configured. If 'HRV’ option is selected as ON, printout will be performed; if OFF, it will not be performed. 2021. 05 128 / 171 Doc. # : BN-OP-C7...
  • Page 129 Use the electrodes same as the provided ones or with biocompatibility certificate authorized by the international standard. Caution When the patient, who had an operation to have a heart assist device, uses Cardio7e/Cardio7, it should be done under the supervision of a health care professional. 2021. 05 129 / 171...
  • Page 130 ‘User Security Set’ and ‘Manufacture Set’ will appear. 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. 2021. 05 130 / 171...
  • Page 131 V 1.31 Factory (Reset Settings) In order to reset to factory conditions, press the ‘Factory’ button and enter the Password. Reset will proceed, with the message below appearing on the LCD screen for 1 second. The initialized values are as follows. Contents Setting Value Gain...
  • Page 132 V 1.31 Rec Form 3ch + 3 Paper Size Print Line Normal Beat Form Rhythm II, V1, V5 Base Filter For ENG and KOR language, ‘60Hz’ AC Filter For other languages, ‘50Hz’ Low Pass Filter 150Hz EMG Filter ECG Store Print Out Export None...
  • Page 133 V 1.31 Data Erase All data in Files and Worklist will be deleted. For the data erasure function, a password must be entered 2021. 05 133 / 171 Doc. # : BN-OP-C7...
  • Page 134 V 1.31 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. 2021.

  • Page 135: Chapter 3. Ecg File Management

    V 1.31 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 2021. 05 135 / 171 Doc.

  • Page 136: Display And Function

    V 1.31 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. If Rotary is selected, the focus will be moved to Data list.

  • Page 137: Data Printing

    V 1.31 ⑦ Button to print out the chosen saved data ⑧ Button to delete the data ⑨ Button to set up the environment of ‘File Management’ ⑩ Button to move to other main screen from ‘File Management’ At the initial file management page, the first data of the list has the focus. The focus will automatically move to the menu bar at the bottom of the screen, when you click the data by touching the screen or rotating the rotary key on the control panel.

  • Page 138: Data Deleting

    V 1.31 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 139: System Setup

    V 1.31 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 140 V 1.31 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/PACS Server : To save the data in the BMS Server or PACS Server.

  • Page 141: Switching Menu

    V 1.31 When clicking the ‘Format’ button, a line window will show up and it will disappear when selecting EKG/FVC/SVC/MVV, MFER(ECG), XML(ECG), JPEG, PDF. ‘Format’ menu is used to select the user’s options when transferring the data. - EKG/FVC/SVC/MVV: To save the data by type of ‘***. ekg'/ ‘***.fvc'/ ‘***.svc'/ ‘***.mvv' - MFER: To save the data by type of ‘***.mwf' - XML: To save the data by type of ‘***.xml'...

  • Page 142: Patient Information

    V 1.31 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 143: Data Search

    V 1.31 7) Data search When clicking the ‘Search’ button at the ECG data file management page, you will see a ‘Patient Search’ window as shown below. If you rotate the rotary key, the ‘search condition’ button will have focus. Press the ‘Find’ button after inputting the information about ID, Name, Date or Age.

  • Page 144: Data Transfer

    V 1.31 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 145 V 1.31 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. 1.

  • Page 146: Data Import

    V 1.31 9) Data import You can import the saved data from the external device at the ECG data file management page by using the ‘RECORD’ key on the control panel. When pressing the ‘RECORD’ key, 'Import File List’ screen will be shown as below. 2021.
  • Page 147 If 2 different USB memory devices are connected, a system message window prompting you to select one of them will appear. If the external device is not connected to Cardio7e/Cardio7, the error message will be shown as below. If you select the ‘Selected’ menu in the ‘Import File List’ screen, after receiving the selected data from the external device a system message will be shown as below.
  • Page 148 V 1.31 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. 2021.

  • Page 149: Chapter 4. Ecg Worklist Management

    V 1.31 ECG worklist management Chapter 4. 1) Display and function 2) ECG Test 3) Data deleting 4) System Setup 5) Switching menu 6) Patient information 7) Data search 2021. 05 149 / 171 Doc. # : BN-OP-C7...

  • Page 150: Display And Function

    V 1.31 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 Data. If Rotary is selected, the focus will be moved to Data list. ②...

  • Page 151: Ecg Test

    V 1.31 ⑦ Go to test window for the requested choice of data ⑧ Button to delete the data (After interlocking with the PACS Server, press the ‘Update’ button) ⑨ Button to set up the environment of ‘Worklist Management’ ⑩ Button to move to another main screen from ‘Worklist Management’ At the initial file management page, the first data of the list has the focus.

  • Page 152: Data Deleting

    V 1.31 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 153: System Setup

    V 1.31 4) System Setup When clicking the ‘Setup’ button at the ECG data worklist management page, you will see the ‘worklist System Setup’ window as shown below. Note The steps for Network, Hospital and Service Setting are identical with the steps for ECG Main setting.

  • Page 154: Switching Menu

    V 1.31 5) Switching menu When selecting the Main button at the main page of the ECG file management, a line window will show up. You can choose ECG or FILE to go to the chosen page. The patient’s information of selected data does not transmit, when moving to another main screen.

  • Page 155: Data Search

    V 1.31 7) Data search When clicking the ‘Search’ button at the ECG data order management page, you will see a ‘Patient Search’ window as shown below. If you rotate the rotary key, the ‘search condition’ button will have focus. Press the ‘Find’...

  • Page 156: Chapter 5. System Management

    V 1.31 Chapter 5. System Management 1) Maintenance and Cleaning 2) Regular Check-up 3) Trouble Shooting 4) Manufacturer Declaration 2021. 05 156 / 171 Doc. # : BN-OP-C7...

  • Page 157: Maintenance And Cleaning

    V 1.31 1) Maintenance and Cleaning There are many ways to clean Cardio7e/Cardio7, 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 158: Regular Check-Up

    Connect the external USB keyboard to the USB port before you turn on the power of Cardio7e/Cardio7. If you connect the external USB keyboard to the USB port after you turn on the power of Cardio7e/Cardio7, you should turn off the power of Cardio7e/Cardio7 and turn on again.
  • Page 159 System message Cause Solution Please contact CS (Customer Please check Internal coin battery Support) team of Bionet to date and time discharged. replace old coin type battery with new one When wrong network Address is not Check the right network address...
  • Page 160 V 1.31 -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 - Check system setup and network When there is failure - Check PC network setup Verify: C-Echo between PACS Server...
  • Page 161 V 1.31 Transmission failed When the transmission Delete the failed file after file is existing. failed file to PACS store transmitting the file to PACS store Are you sure to server needs to be server delete? deleted When the battery level is Please connect power cable or Recharge Battery! charge battery...

  • Page 162: Manufacturer Declaration

    V 1.31 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 Pst: 1 Voltage change, Plt: 0.65...
  • Page 163 Electromagnetic compatibility_ Guidance and manufacturer's declaration Guidance and manufacturer’s declaration – electromagnetic emissions The Cardio7e/Cardio7 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardio7e/Cardio7 should assure that it is used in such an environment. Emissions test...
  • Page 164 Guidance and manufacturer’s declaration – electromagnetic immunity The Cardio7e/Cardio7 is intended for use in the electromagnetic environment specified below. The customer or the user of the Cardio7e/Cardio7 should assure that it is used in such an environment. IMMUNITY IEC 60601...
  • Page 165 0,5 cycle environment. 40 %UT 40 %UT If the user of the voltage (60 %dip in UT) (60 %dip in UT) Cardio7e/Cardio7 requires variations for 5, 6 cycles for 5, 6 cycles continued operation during 70 %UT 70 %UT on power...
  • Page 166 V 1.31 Guidance and manufacturer’s declaration – electromagnetic immunity The Cardio7e/Cardio7 is intended for use in the electromagnetic environment specified below. The customer or the user of the should assure that it is used in such an environment. IEC 60601...
  • Page 167 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Cardio7e/Cardio7 is used exceeds the applicable RF compliance level above, the Cardio7e/Cardio7 should be observed to verify normal operation.

  • Page 168: Chapter 6. Specification

    V 1.31 Chapter 6. Specification ECG Leads Simultaneous 12 Leads Resting ECG Recording Channel 3CH+1RHY, 3CH+3RHY, 6CH+1RHY, 12CH, 6CH+ST map 1CH Long Time (1min, 3min, 5min,10min) and Special Beat Report (Text, Guide, Vector, ST map) Gain 2.5, 5, 10, 20, Auto (I~aVF: 10, V1~V6: 5) mm/mV Printing Speed 5, 12.5, 25, 50, 100 mm/sec Sampling Rate...
  • Page 169 V 1.31 Battery type Replaceable and Rechargeable, Lithium ion, 10.8V, 3250mA Battery Capacity 6 hours of normal use or print 200 ECG pages (12 channel format at 25mm/s and 10mm/mV) The battery will charge to its full capacity within 3 hours with the power off.
  • Page 170 Name: Contact No: Seller’s Name Manufacturer’s Name ※Thanks for purchasing Cardio7e/Cardio7. ※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 171 CMC Medical Devices & Drugs S.L.: Horacio Legno N° 18, CP 29006, Malaga, Spain Tel: +34-951-214-054/ Fax: +34-952-330-100 / e-mail: infor@cmcmedicaldevices.com Website: http://www.cmcmedicaldevices.com/ ※ 'CE1434' only supports Cardio7e equipment. Bionet Co., Ltd Model Name: Cardio7e/Cardio7(ECG) 2021. 05 171 / 171...

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