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scil DB-1000 User Manual

Clinical chemistry analyzer for veterinary use
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User Manual
Element DC
Clinical Chemistry Analyzer
For veterinary use
_________________________________________________________________________________
Vers.: 20220216_ENG
1

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  • Page 1 User Manual Element DC Clinical Chemistry Analyzer For veterinary use _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 2 Copyright © Copyright 2022 Element DC The information in this manual is protected by copyright. Except as specifically permitted, no portion of this document may be distributed or reproduced by any means, or in any form, without the prior consent of Element DC. The contents of this User’s Manual and product specifications are subject to change without notice.

  • Page 3: Table Of Contents

    Table of Contents Safety Warnings and Cautions ......................6 1.1. User´s Manual and Labeled Symbols ..................6 1.2. Cautions for System Installation ....................8 1.3. Cautions for Moving the System ..................... 9 1.4. Cautions Before Use ....................... 9 1.5. Cautions During Use ......................10 1.6.
  • Page 4 Analyzer Settings – General Operator Settings ..............50 4.4. 4.4.1. Display Settings ......................52 4.4.2. Calibration (Touch Screen Calibration) ................. 52 4.4.3. LCD Brightness......................53 4.4.4. Screensaver Settings ....................53 4.4.5. LCD Off Settings ......................55 4.4.6. Volume Settings......................55 4.5.
  • Page 5 4.14.3. Setting EMR/Mobile ....................... 97 4.14.4. Setting Mobile Support ....................98 4.15. Setting Time........................... 99 4.16. Changing Time Format ......................100 4.17. System Settings ........................101 4.18. System Reset ........................102 4.19. USB Backup ........................103 4.20. Export Errors........................105 4.21.

  • Page 6: Safety Warnings And Cautions

    Safety Warnings and Cautions Follow the safety warnings and cautions in this manual for safe and appropriate use of the analyzer and its components. Repairs and maintenance work not discussed in this User Manual are to be performed by a designated Element DC service provider. Any attempt to repair the product by the user may result in injury.
  • Page 7 USB port CE Mark European Authorized Representative Catalog number Ethernet port Power adaptor connector Direct current Power On Power Off Power button This symbol indicates that the European Directive on Waste of Electrical and Electronic Equipment (WEEE) must be adhered to and the device must not be disposed of as unsorted municipal waste, but must be collected separately.

  • Page 8: Cautions For System Installation

    1.2. Cautions for System Installation – Install the analyzer in a secure location. Damage to the instrument or personal injury may result if the analyzer is dropped. – Use only the AC adaptors and power cables designated for the instrument. –...

  • Page 9: Cautions For Moving The System

    1.3. Cautions for Moving the System – Dropping the analyzer while moving or carrying it may cause damage to the instrument. – Avoid impact at all times when moving the analyzer. – When transporting the analyzer, use the shock absorber packaging. First, turn off the power and disconnect the AC adaptor from the analyzer.

  • Page 10: Cautions During Use

    1.5. Cautions During Use – This analyzer is for use by experienced medical personnel, such as veterinarian. – Avoid any outer impact when analyzing blood samples. – Do not open the covers while an analysis is being performed. The analysis will automatically stop if the cover is opened.

  • Page 11: Precautions For Preparing Blood Samples

    1.6. Precautions for Preparing Blood Samples – You can use either plasma or serum for the specimen. – Refer to the User Manual for the amount of sample required. – If more than the recommended amount of blood sample is inserted into the cartridge, the analyzer may become contaminated or may not work properly.

  • Page 12: Emc (Electromagnetic Compatibility) Information

    1.8. EMC (Electromagnetic Compatibility) Information – Do not use any wireless devices, including cellular phones, near the system. All wireless devices, whether they comply with the EMC standard or not, may emit electromagnetic interferences and cause the system to malfunction when they are used nearby. –...

  • Page 13: Introduction

    Introduction – Automates processing for fast, convenient, and accurate analysis. – Provides a convenient UI (User Interface) with minimal user interaction. – Convenient maintenance – Small analyzer size maximizes space efficiency. – Self-Test function minimizes maintenance costs. – Convenient mobile analysis –...

  • Page 14: Analysis Principle

    may not operate as intended, may produce inaccurate or no results, and may pose a safety hazard. 2.2. Analysis Principle The spectrophotometer is used to measure the absorbance of reacted samples in the detection portion of the cartridge. The analyzer's photometric detector detects the photometric changes caused by absorbance changes.
  • Page 15 – Please check the contents of the box after purchase. – If any of the contents are missing or damaged, do not use the analyzer. Contact your retailer for a replacement. – You need to centrifuge the sample for five minutes at the speed of 2500rpm to 3000rpm to achieve blood separation.

  • Page 16: Introduction Of Features

    2.4. Introduction of Features Front Body Front Cover: Slide-type Power button Printer Printer Feed button Front Cover Open Plunger Pad Cartridge Inlet Camera and LED _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 17 Back Power switch Power connector Ethernet port USB port (Host) USB port (Slave) _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 18: Installation

    3.0. Installation 3.1. Installation Carefully remove the analyzer from the packaging and check for any damage that may have occurred during transport. If it is damaged, contact your courier or retailer immediately. Check and make sure that the contents of the box match the contents described in the User Manual. Contact your retailer if any component is missing.
  • Page 19 4. Close the cover and check that the paper is located between the cover and the front of the printer. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 20: Connecting Wi-Fi Usb Dongle

    3.3. Connecting Wi-Fi USB Dongle To connect to a wireless network, purchase a Wi-Fi USB dongle separately and connect it to the USB port at the rear side of the analyzer. Connect the dongle before turning on the analyzer and disconnect it after turning off the analyzer. For more information on how to configure the analyzer, refer to the analyzer's network settings.

  • Page 21: Analyzing

    4.0. Analyzing 4.1. Analyzing 4.1.1. Turning Power On 1. To turn the instrument’s power on • Set the power switch on the back to ON and press the POWER button on the upper right of the instrument. • If the power doesn’t turn on, refer to 6. Troubleshooting. 2.
  • Page 22 Once you are logged in, the main screen will appear. – Results: Select Results to view the results of a completed analysis. Refer to 4. Analyzing - Viewing Results for more details. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 23 – Run: Select Run to view the Analysis Information screen where you can enter patient information and perform blood analysis. – QC Run: This is the start menu for QC Run. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 24 – Settings: Select Settings to adjust the display, volume, password, language, peripherals, and self-testing options. When logging in as an administrator, the status of the analysis, security (locking), network, time, and system settings can be viewed. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 25: Preparing An Analysis

    4.1.2. Preparing an Analysis Press the RUN button at the Home screen. – Up to 5,000 analysis results can be stored on the analyzer. The instrument shows a backup warning when the available space is less than 100 records. Refer to 4. Analyzing - USB Backup for instructions on backing up analysis results.
  • Page 26 – To display the Keypad, tap on an empty text field. If a cartridge is not present or the cover is open, a message instructing the user to insert a cartridge and close the cover is displayed. Once a cartridge is inserted and the cover is closed, the analyzer performs a Self- Test. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 27 Once the Self-Test has been completed without any problems, the instrument automatically begins the analysis. The remaining time and progress are displayed on the screen. Additional time may be required with a complete inspection. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 28: Canceling An Analysis In Progress

    4.1.3. Canceling an Analysis in Progress To cancel a test during the Blood Analysis Stage, or for a Cartridge Validity Check, press the Cancel button. Press the Yes button to cancel and the No button to resume the analysis. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 29: Analysis Completed

    – When an analysis in progress is canceled, the cartridge cannot be used again. 4.1.4. Analysis Completed When the analysis is complete, an audio notification plays and the analysis resultsare displayed on the screen. – Analytes and analysis results are displayed. –...

  • Page 30: Viewing Analysis Results

    the EMR/LIS server program. – Refer to Network Settings-Setting EMR/Mobile for instructions on setting the EMR/LIS. The following symbols are displayed when the results are not within normal range. When results exceed the reference range < > When results exceed the analyzer's detection range When QC fails The audio notification for completion of the test can be adjusted.
  • Page 31 To view detailed results of each analyte, press the Show detail button in the upper right corner. – Press the Up/Down arrows to select an analyte from the list. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 32: Viewing Results

    4.2. Viewing Results Press the Result button on the home screen to display the Results screen. Results are grouped by Patient, Material QC, and Electronic QC. If you logged in using an ordinary operator's ID, only those analysis results taken by that operator ID can be viewed.

  • Page 33: Viewing Results Of A Patient´s Analysis

    Electronic QC An electronic quality control filter is installed inside the analyzer. The system checks the filter automatically and determines the accuracy of the results and the filter function. 4.2.1. Viewing Results of a Patient´s Analysis Press the Results button, then select the desired patient line to view patient results. To view detailed results of each analyte, press the Show detail button in the upper- right corner.
  • Page 34 When you select the patient ID, the patient's date of birth and gender are displayed. To switch to the previous or next result screen, press the Arrows ( ) at the bottom left or right side of the screen. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 35: Viewing Qc Results (Qc Material/Electronic)

    4.2.2. Viewing QC Results (QC Material/Electronic) Select the Material QC/Electronic QC tabs under Results to view QC results. To view detailed results of each analyte, press the Show detail button in the upper right corner. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 36 To switch to the previous or next result screen, press the arrows at the bottom left or right side of the screen. Press the QC material name to check the information of each material including QC Value Version. Press each analyte to enter the QC chart screen. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 37: Searching Results

    The QC chart screen displays the QC results of each analyte in a graph. 4.2.3. Searching Results Press the Results button on the Home screen to display the Results screen. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 38 Press the Search button in the upper-right corner to enter the Search Results screen. Select Search type (Patient/QC/EQC), enter an ID or Date and press the OK button to see matching results. If you logged in using an ordinary operator's ID, only those analysis results taken by that operator ID can be searched.

  • Page 39: Printing Results

    To print the results, check the check box next to the results to be printed and press the Print button. To transfer the results to PC software (Element DC Data Manager) or EMR/LIS, check the check box next to the results to be transferred and select the Send button. 4.2.4.
  • Page 40 Select the desired print range option: Select all within the page or Select all across the pages. When you press the Print button, a confirmation pop-up window will be displayed. Press the OK button to begin printing. – Only results selected with a check in the check box will be printed. –...

  • Page 41: Printing Analysis Results By Analytes

    Once the data has been transferred, the printer will print the results. 4.2.5. Printing analysis results by analytes Specific analytes in analysis results can be selectively printed. On the Results screen, select the desired patient's results line to view the results _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 42 Select the Show detail button. Results for each analyte can be selectively printed by checking the boxes. Uncheck the Analyte to be excluded and press the Print button. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 43 Press the OK button to begin printing. While the data is printing, the transfer status is shown. When printing is complete, a confirmation window will appear. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 44: Transferring Results

    4.2.6. Transferring Results Results can be transferred to a PC or EMR/LIS. Select the results to be transferred from the Results screen. Check the boxes next to the selected results. – The device must be connected to a PC to transfer the results. For instructions on how to use Element DC Data Manager, please refer to the Element DC Data Manager manual –...

  • Page 45: Deleting Results

    • Connection error may occur when connection is made through two or more routers. Change the connection structure to using only one router. If Send is selected, a pop-up window will appear on the screen. Select the transfer option desired. –...
  • Page 46 Press OK to begin deleting results. Press Cancel to cancel deleting results. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 47: Quality Control

    Results deleted prior to pressing the Cancel button cannot be restored. 4.3. Quality Control Quality control is performed to monitor the analyzer's ability to accurately measure each sample. QC results must be compliant with the specified cut-off values for each control. To register QC materials in the system, click on the Settings tab located in the lower left corner of the home screen.
  • Page 48 The analyzer will perform a validity check. Once the Cartridge Validity Check is complete, the QC Run screen will appear displaying a list of QC material, product specification data, and associated analytes, currently stored in the system. Select the appropriate QC material and press the OK button to begin QC.
  • Page 49 Once QC is complete, the result screen shown below is displayed. – If the device is connected to the Element DC Data Manager, the analysis results are transferred automatically. – If auto-print is turned on, the analysis results are printed automatically. To print the results, press the Print button.

  • Page 50: Analyzer Settings - General Operator Settings

    4.4. Analyzer Settings – General Operator Settings Press the Settings button on the Home screen. General Operator Settings: This shows the settings items available to ordinary operators. To switch to the administrator's settings, log out and log in again using the administrator's account. Display Calibration, LCD Brightness, Screen Saver, and LCD Off settings can be adjusted.
  • Page 51 Header/Footer, Auto-print, starting point, and length after barcode scanning can be Peripherals selected. Language The analyzer language can be selected. A Self-Test of the analyzer can be performed to check whether it is operating Self-Test normally. Administrator Settings: Administrator settings require an admin login for security purposes. Analysis Analyte unit, printing order, reference range, and QC materials can be selected.

  • Page 52: Display Settings

    4.4.1. Display Settings Display settings consist of Calibration, LCD Brightness, Screen Saver, and LCD Off settings. Press the Settings button on the Home screen. Press the Display button. Changes can be canceled by pressing the Black button prior to pressing the OK button. 4.4.2.

  • Page 53: Lcd Brightness

    – After being selected, the crosshairs (+) turn blue. – If the touch screen is not accurately calibrated after 2-3 calibrations, contact Element DC Technical Support. 4.4.3. LCD Brightness The brightness of the LCD can be adjusted between 5 levels of brightness. Press for the LCD Brightness.
  • Page 54 A screensaver is automatically activated after a designated period of time to protect the analyzer’s LCD screen. The screensaver can be turned on or off, and the time for activating the screensaver can be adjusted. Press to select when the Screensaver starts. Never →10 min →20 min →30 min →1 hr.

  • Page 55: Lcd Off Settings

    4.4.5. LCD Off Settings The LCD Off function protects the analyzer’s LCD screen and saves power by turning the LCD off after a designated period of time. Press to select when the LCD is to be turned Off. Never →30 min →1 hr →2 hrs →3 hrs. When set to Never, the LCD remains on.

  • Page 56: Setting The Password

    Press the OK button to set the volume. Press the Back button to cancel. 4.5. Setting the Password You can change the password for the logged-in operator's ID. Press the Settings button on the Home screen. Press the Password button. Enter the current password and the new password that is so to be set.

  • Page 57: Print Settings

    4.6. Print Settings Print settings allows the user to set the printed result paper. Press the Settings button on the Home screen. Press the Peripherals button. Header/Footer Settings Select Header and Footer text on the printed result paper. Press the Settings button on the Home screen. Select Header/Footer in Peripherals and enter the text.
  • Page 58 Print Format Settings Print Format settings allows the user to set output format of the printed result. Simple Format prints only patient information and analysis results. Simple Detailed Format prints patient information, analysis results and device Detailed information. Error results are set Detailed Format regardless of the print format. Auto Print Settings Auto print settings allows the user to set whether or not to print results automatically when an analysis is complete.

  • Page 59: Barcode Settings

    4.7. Barcode Settings Barcode settings allows the user to set the format of input values (Start Point, ID Length) when an ID is entered using a barcode scanner. Press the Settings button on the Home screen. Press the Peripherals button. Select the Barcode tab and Customized button, then set the Barcode format (Start Point, ID Length).

  • Page 60: Language Settings

    4.8. Language Settings Language settings allows the user to select the language used by the analyzer. Press the Settings button on the Home screen. Select the Language button. Select a language from the list displayed, and press the OK button. Press the Back button to cancel.

  • Page 61: Self-Test

    4.9. Self-Test The Self-Test function allows the user to test the hardware status of the analyzer. Press the Settings button on the Home screen. Press the Self-Test button. When performing a Self-Test without a cartridge, QR code is marked as N/A. When performing a Self-Test with a cartridge, the cartridge sensor is marked as N/A.
  • Page 62 Press the Diagnosis button. A pop-up window will confirm that some tests will not be performed without a cartridge. Insert a cartridge, if desired. Select Yes if you wish to perform the Self-Test. The Self-Test runs. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 63 Remove the cartridge and close the cover when the Self-Test is completed. If an H/W error occurred during an analysis, you cannot examine patients or perform QC. If the problem persists, contact the service center. Check the Self-Test results. Press the Print button to print the test results on the current page. The automatic printing of Self-Test results is not available.

  • Page 64: Analyzer Settings - Administrator Settings

    4.10. Analyzer Settings – Administrator Settings Administrator mode allows analyzer settings to be entered. Log in as admin. Press the Settings button on the Home screen. The Analysis, Lock, Network, Time, and System buttons are also displayed in the Settings options.

  • Page 65: Analysis Settings

    4.11. Analysis Settings In Analysis settings, the unit of analytes, printing order, reference range, and QC materials can be adjusted. Press the Settings button on the Home screen. After pressing the Analysis button, select Units& Order, Reference Range, or QC Material. 4.11.1.

  • Page 66: Change Order

    SI and Non-SI Conventional can be chosen for each analyte. Check the box on the upper left to select SI or Non-SI for all analytes. 4.11.2. Change Order In Change order, the order of analytes displayed when viewing analysis results can be adjusted. The changes affect the Results screen and print-outs.
  • Page 67 Press the Change Order button in the upper-right corner of the screen. Select the appropriate Cartridge. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 68: Reference Range Settings

    Select the desired analyte, make the changes by pressing the Up and Down arrows, then press the OK button. 4.11.3. Reference Range Settings In Reference range settings, the reference range of analytes can be adjusted. Press the Reference Range button. Select a species to configure the reference range, and press Edit button.
  • Page 69 Manufacturer does not provide any criteria of result for other species. A numeric keypad appears by pressing the Analyte entry field. An alphanumeric keypad appears by pressing the Species name. Change the name and a value of the analyte and press the OK button. –...

  • Page 70: Registering Species

    Main Frequently used species – Others 4.11.4. Registering Species Press the lower left Add button. A numeric keypad appears by pressing the Analyte entry field. An alphanumeric keypad appears by selecting the text field. Input the name and a value and press the OK button. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 71: Deleting Species

    4.11.5. Deleting Species Select the species to delete, and press the lower right Delete button. – The names of three default species (Canine/Equine/Feline) and the species asked to analyze from EMR cannot be removed. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 72: Qc Material

    4.12. QC Material QC material can be recorded by selecting the Settings icon from the home screen, then selecting the Analysis button, then the QC Material button. From the QC Material screen, QC material can be individually registered by adding the product name and description. Once registered, the QC material and product detail is stored in the system and is available under the QC Material section of the analyzer.
  • Page 73 To display the keypad to enter the control name, tap the text field on the screen. Keyboard _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 74 Numeric Keypad Select the Add Analyte button at the top right of the screen. Select the analyte to add and press OK. To add the QC information (mean, SD), press the empty text field. The Target Mean and Target SD fields are required, while the min/max values are optional. The default reference range of a QC result is set to the target mean ±3SD.
  • Page 75 To change the QC rules for the analyte, press the Yes button on the right. Set the rules and press the OK button. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 76: Changing Qc Material

    The quality control policy should comply with the Westgard multi-rule. For more details, refer to 7. Other Information. Press the OK button after inputting the values. Press the OK button in the pop-up confirmation window and QC material registration is complete. 4.12.2.
  • Page 77 Select the QC Material to change. If the QC material information was added via an analyzer update or from an XML file provided by the manufacturer, you need to select the QC Value Version additionally. Refer to the Viewing QC Results for QC Value Version.
  • Page 78 Change the QC Material Information. The name of the material, level, and Lot. No. cannot be changed. Make changes and press the OK button. Press the OK button in the pop-up confirmation window to save the QC Material changes. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 79: Deleting Qc Material

    4.12.3. Deleting QC Material Press the QC Material button. Select the QC Material to delete and press the Delete button. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 80: Importing Qc Material

    Press the OK button in the pop-up confirmation window to delete the QC Material. 4.12.4. Importing QC Material Register the QC material information on the analyzer automatically. Update the QC material XML file (control_material.xml) using the USB storage device or Internet. Select the FAT/FAT32 file system of USB storage device.
  • Page 81 Press the Import button. Select the option to update on the Import Confirmation pop-up. – USB Memory: Copy the QC material XML file into the USB storage device and plug it into the USB port on the rear of the analyzer. Contact the local service center for XML file. Contact the local service center for XML file.
  • Page 82 Import the QC material XML file to the analyzer. For update via USB storage device, remove the USB storage device when the importation is complete. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 83: Lock Settings

    4.13. Lock Settings Analyzer functions can be locked and operator IDs can be managed here. 4.13.1. Locking Quality Control Operators with administrator rights can lock the quality control feature. If QC has been locked, the system will not allow patient samples to be analyzed until a new QC has been entered into the system with a valid QC run.

  • Page 84: Setting The Lock

    Change the QC and EQC lock settings. Press the OK button to save any changes. Press the Back button to return to the previous screen without saving any changes. For testing facilities that require and/or follow a scheduled QC (i.e. QC is run every three (3) days), an Interval Setting for the number of days can be set according to the required QC schedule.

  • Page 85: Setting An Operator Id

    Press the OK button to save any changes. Press the Back button to return to the previous screen without saving any changes. 4.13.3. Setting an Operator ID You can create and manage operator IDs. Press the Lock button on the Settings screen. Lock settings only appear in Admin Login mode. Press the Operator Settings button.

  • Page 86: Creating An Operator Id

    4.13.4. Creating an Operator ID Adds a new Operator ID. You can register up to 100. Press the Lock button on the Settings screen. Lock settings only appear in Admin Login mode. Press the Operator Settings button at the top right of the screen to enter the operator setup screen.

  • Page 87: Deleting An Operator Id

    Press the Lock button on the Settings screen. Lock settings only appear in Admin Login mode. Press the Operator Settings button at the top right of the screen to enter the operator setup screen. Select the desired ID and press the Edit button to change the account's expiration date (Information tab).

  • Page 88: Exporting Operator Ids

    Press the Lock button on the Settings screen. Lock settings only appear in Admin Login mode. Press the Operator Settings button at the top right of the screen to enter the operator setup screen. Select the desired operator ID to be deleted and press the Delete button. If you create a new operator ID identical to the deleted one, only analysis results from the point of entry of the new ID will be available to it.
  • Page 89 Insert the USB storage device into the analyzer and click the Export/Import button on the Operator Settings screen. When a window pops up, select the Export button. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 90: Importing Operator Ids

    When the exportation is complete, remove the USB storage device. 4.13.8. Importing Operator IDs Import all Operator IDs in the list file (File name: sba_operatorlist.dat) saved in the USB storage device to automatically register them in the analyzer. Select the FAT/FAT32 file system of USB storage device. From the Settings screen, select the Lock button.
  • Page 91 Insert the USB storage device into the analyzer, and click the Export/Import button on the Operator Settings screen. When a window pops up, select the Import button. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 92 When the importation is complete, remove the USB storage device. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 93: Network Settings

    4.14. Network Settings Network selection, IP address, subnet mask, gateway, and DNS servers can be set in Network settings. (These settings are used to connect to the Element DC Data Manager and EMR/LIS.) 4.14.1. Connecting to a Network Press the Settings button on the Home screen. Network settings only appear in Admin Login mode.
  • Page 94 The analyzer will try to connect to the network. Once connected, the network name will be displayed in bold at the top of the list. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 95: Setting Network Connections

    4.14.2. Setting Network Connections Select the desired network. The network connection setup screen will be displayed. _________________________________________________________________________________ Vers.: 20220216_ENG...
  • Page 96 If the selected network is protected, the password screen will appear. Enter the password and the IP setting button will be enabled. Press the IP setting button to move to the connection setup screen. Select Auto or Manual. Select Manual to provide the IP Address, Subnet Mask, Gateway and DNS Server manually.

  • Page 97: Setting Emr/Mobile

    DNS server can only be changed if the IP address is entered manually. Enter DNS Server a DNS server address according to your network settings. Entering a DNS server address is optional. Press the OK button to save your network settings, then attempt to make a network connection. If the IP address is set to Automatic, the address may be set incorrectly and may not work with EMR or the Element DC Data Manager.

  • Page 98: Setting Mobile Support

    Enter the Server IP and Port. Press the OK button to save the changes and access the EMR/LIS server program. 4.14.4. Setting Mobile Support Press the EMR/Mobile button. The Mobile Support tab will be shown. – When a mobile device connects to the analyzer, the operator ID will appear in the list. –...

  • Page 99: Setting Time

    4.15. Setting Time Press the Settings button on the Home screen. Time settings only appear in Admin Login mode. Press the Time button. Enter the date and time, then press the OK button. Press the Back button to cancel changes. The year can be set between 2000 and 2037.

  • Page 100: Changing Time Format

    4.16. Changing Time Format Select the format of the date and time displayed by the analyzer. Press the Settings button on the Home screen. Time settings only appear in Admin Login mode. Press the Time button. Select the Format tab. Select display format by pressing , then press the OK button.

  • Page 101: System Settings

    Date Date Separator YYYY-MM-DD e.g.) 2012-10-31 e.g.) 2012/10/31 MM-DD-YYYY e.g.) 10-31-2012 e.g.) 2012-10-31 DD-MM-YYYY e.g.) 31-10-2012 e.g.) 2012. 10. 31 Time Time Separator 12 hour, 24 hour e.g.) 12:30 PM e.g.) 12.30 PM e.g.) 12,30 PM 4.17. System Settings System information checks, license notification, updates, and initializations of analyzer can be performed.

  • Page 102: System Reset

    4.18. System Reset In System Reset, the analyzer system can be initialized. To initialize the system to its factory defaults, press the Initialization button in the upper right corner of the screen. A pop-up window ‘Initialize the device now?’ prompts the user to initialize the system. Select the desired initialization options and press the OK button.

  • Page 103: Usb Backup

    Press the Yes button to confirm the initialization. Press the No button to cancel the initialization. When Delete all results is selected, the home screen is displayed when the initialization completes. – When Delete all results and settings is selected, the analyzer reboots when the initialization completes.
  • Page 104 – Select the FAT/FAT32 file system of USB storage device. Press the USB Backup button in the lower-left corner of the screen. Press the Yes button to Confirm backup. Check the Delete the internal memory after backup is complete check box to delete the internal memory on the analyzer. Press the Cancel button to cancel the USB backup.

  • Page 105: Export Errors

    When a pop-up window confirms that backup has been completed, press the OK button, then remove the USB storage device. 4.20. Export Errors Save the Cartridge’s error records on the USB storage device during the inspection. – Select the FAT/FAT32 file system of USB storage device. Press the Export Error button on the home screen.
  • Page 106 Press the Yes button when a confirmation window pops up. Press the OK button to remove USB storage device when a completion window pops up. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 107: System Update

    4.21. System Update How to update the blood analyzer system: – Select the FAT/FAT32 file system of USB storage device. Press the Update button in the lower-right corner of the screen. The system can be updated using a PC, a USB storage device, or online. Select the desired update source.

  • Page 108: License Notification

    the update files to the USB storage device and plugging it into the USB port on the rear of the analyzer. The analyzer reboots when the update is completed. The system does not reboot when only the cartridge information (XML) has been updated. 4.22.
  • Page 109 Press the License Notification button. Check the license information. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 110: Turning Power Off

    4.23. Turning Power Off Press the Power button on the upper right of the analyzer. Press the OK button in the system shutdown confirmation pop-up window. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 111: Maintenance

    Maintenance 5.1. Daily Maintenance 5.1.1. Care Instructions for Analyzer – If the surface of the analyzer is contaminated, wipe off the contaminant with a soft cloth. – If the LCD screen is dirty, using a lens cleaner is recommended. – Use 30% isopropyl alcohol if necessary.

  • Page 112: Camera And Led Window Maintenance

    After cleaning, wipe the plunger pad with a dry cloth. Make sure that it is completely dry before attaching it back onto the plunger arm. If the plunger pad isn’t attached back properly, the sample loading error may occur. In case of any damages (tears, dents, changes, contaminations, etc.) caused by user’s carelessness, the user will be responsible for the cost of replacement.

  • Page 113: Maintenance For Extended Storage

    5.2. Maintenance for Extended Storage – Clean the analyzer. – Store the analyzer on a flat surface. Avoid storing where there is dust, moisture, chemical materials, combustible gas, and direct sunlight. _________________________________________________________________________________ Vers.: 20220216_ENG...

  • Page 114: Troubleshooting

    Troubleshooting 6.1. Troubleshooting 6.1.1. Check Before Requesting Repair – The power switches of the blood analyzer are located on the upper right and back of the instrument. The upper right power switch only responds when the rear power switch is turned on.
  • Page 115 – Ventilate the room after using the spray in an enclosed area. – Check if an error occurs while booting the device and re-do it for three times as a Self-Test. Recommended Products Model Name Manufacturer DB-1000 Nabakem CRC 32315 RC 846-698 RS Component –...

  • Page 116: Error List

    – Please contact to the local distributor if the error is not corrected by the above two methods. 6.2. Error List Error Code Problem Solution 201001A – 201003A 1. Reboot and try again. Software Internal 2. Update software to the latest version. Operational Error 3.
  • Page 117 1. Reboot and try again. 2. Update software to the latest version. Internal Module 3. Back up the test results on the tester to a USB storage 203003A Communication device or PC and reset the analyzer. Error 4. Contact the customer service center if the problem persists after the measures described above have been performed.
  • Page 118 1. Connect a USB storage device and try again in 5 seconds. 2. Reboot with the USB storage device connected and try USB Storage again. Device 204014C 3. Use a compatible USB storage device. Recognition Error 4. Contact the customer service center if the problem persists after the measures described above have been performed.
  • Page 119 1. Check analyzer-PC connection. Make sure that the cable is securely connected. Analyzer-PC 2. Check the network connection (Ethernet, Wi-Fi) and DNS 205102B Connection Error settings. 3. Contact the customer service center if the problem persists after the measures described above have been performed. 205300B, 205302B –...
  • Page 120 1. Insert a new Cartridge and test again. Cartridge QR 206004A 2. Contact the customer service center if the problem persists Code Error after the measures described above have been performed. 206007A 1. Insert a new Cartridge and test again. Cartridge QR 206010A 2.
  • Page 121 1. Insert a new Cartridge and test again. 207046A Cover is opened. 2. Contact the customer service center if the problem persists after the measures described above have been performed. 1. Reboot and try again. 2. Back up the test results on the tester to a USB storage 207100A Internal File Error device or PC and reset the analyzer.
  • Page 122 1. Update software to the latest version. 207119A, Calculation 2. Contact the customer service center if the problem persists 207121A Validity Error after the measures described above have been performed. 1. Insert a new Cartridge and test again. 2. Perform a Self-Test. Calculation 207120A 3.
  • Page 123 1. Insert a new Cartridge and test again. 2. Perform a Self-Test. Calculation 207128A 3. Perform Quality Control. Validity Error 4. Contact the customer service center if the problem persists after the measures described above have been performed. 1. Perform a Self-Test via Settings on the main screen. 2.
  • Page 124 1. Insert a new Cartridge and test again. 2. Perform a Self-Test. Calculation 208003B 3. Perform Quality Control. Validity Error 4. Contact the customer service center if the problem persists after the measures described above have been performed. 1. Check the amount of the loaded blood sample. 2.
  • Page 125 1. Check again after washing the plunger’s surface which contacts to the cartridge or replacing the plunger with a new 208504B Cartridge Error one. 2. If the issue persists, please contact our Customer Service. 1. Reboot and try again. 2. Update software to the latest version. 208505A Internal File Error 3.
  • Page 126 1. Connect a USB storage device and try again in 5 seconds. 2. Reboot with the USB storage device connected and try USB Storage again. 209003C Device 3. Use a compatible USB storage device. Connection Error 4. Contact the customer service center if the problem persists after the measures described above have been performed.
  • Page 127 QR Code Reader 306009A Contact the customer service center. Error 306011A Plunger Error Contact the customer service center. 1. Make sure that printer paper is loaded properly and close 307001C Internal Printer the cover. – 307005C Error 2. Contact the customer service center if the problem persists after the measures described above have been performed.

  • Page 128: Other Information

    Other Information 7.1. Quality Control Policy 7.1.1. Westgard Multi-rule Technique Levey-Jenning Approach – Warning rule: 1 control outside 2SD and 1 control within 2SD. – Rejection rule (random error): 1 of the controls is outside 3SD. – Rejection rule (systematic error): 2 consecutive controls are outside 2SD.

  • Page 129: Accessories (Sold Separately) Information

    Printer Built-in Thermal Printer (2-inch) Ethernet 10/100 Base-T Interface USB Host USB 2.0 port USB Client USB 2.0 port Light Source Photometer Detector Photo Diode Maximum number of Storage Capacity 5,000 normal analysis analysis results stored Input: 100 V – 240 Vac, 1.5 A, 50 – 60 Hz Power AC Adaptor Output: 19 Vdc , 4.736 A, 90 W...

  • Page 130: Other Information

    7.4. Other Information Product Name Clinical Chemistry Analyzer Model Name Element DC Precision Biosensor, Inc. Name and Address of Manufacturer 306, Techno 2-ro, Yuseong-gu, Daejeon, Korea Operating System Linux 2.6.32.9 7.5. Warranty Please contact your retailer for warranty information. 7.6. Address and Information Manufacturer Address Precision Biosensor, Inc.

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Crc 32315Rc 846-698

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