SD Biosensor STANDAR DM10 User Manual
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SD Biosensor STANDAR DM10 User Manual

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STANDARD
User Manual
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Summary of Contents for SD Biosensor STANDAR DM10

  • Page 1 STANDARD User Manual www.sdbiosensor.com...
  • Page 2 STANDARD M10 System User Manual Manufacturer : +82-80-970-9700 +82-31-300-0499 ts@sdbiosensor.com www.sdbiosensor.com...
  • Page 3 STANDARD...
  • Page 4 STANDARD Thank you for purchasing STANDARD M10. This user manual contains all information about the analyzer. Please carefully read this user manual and the instructions included in each test cartridge package before using the analyzer. In addition, please familiarize yourself with the necessary preparation and the procedures.

  • Page 5: Table Of Contents

    TABLE OF CONTENTS CHAPTER 1 General Information 1. Main Menu Structure 2. Symbols and Abbreviations 3. Precautions 4. Environment Conditions 5. Safety and Electromagnetic Compatibility (EMC) Compliance Information 6. Security 7. Warranty and Free Warranty Period Service Policy CHAPTER 2 Overview 1.
  • Page 6 STANDARD CHAPTER 4 Run Test Mode 1. Run Test 2. Result 3. Review CHAPTER 5 Calibration 1. Calibration CHAPTER 6 1. QC Test CHAPTER 7 Cleaning and Maintenance 1. Analyzer Cleaning 2. Maintenance and Transportation CHAPTER 8 Warnings and Messages of Info and Error 1.

  • Page 7: General Information

    CHAPTER 1 General Information 1. Main Menu Structure Login Test Review Settings Module Result Select General User Network Select List Summary Date/Time Login HIS/LIS Patient QC Mode Scan Select Amplification Language Sample Patient Add New Scan Scan Details Brightness Cartridge Sample Edit Scan...

  • Page 8: Symbols And Abbreviations

    2. Symbols and Abbreviations The symbols and abbreviations presented below are stated in the user manual, labels, and external packages of STANDARD M10 System. Symbols Electrical Symbols on instrument Symbols Description Indicates the ON switch of the main power switch. Indicates the OFF switch of the main power switch.

  • Page 9: Precautions

    Other Symbols Symbols Description Symbols Description Manufacturer Temperature limitation In vitro diagnostic medical device Keep dry Consult instructions for use Humidity limitation Reference number This way up Indicates a medical device that Date of manufacture can be broken or damaged if not handled carefully Serial Number Note...
  • Page 10 6. Do not touch the switch button or the power supply with your wet hands. 7. Use only the provided accessories and recommended cartridges by SD Biosensor. 8. Before use, check the latest software with your dealer or SD Biosensor. Then, start your updating.

  • Page 11: Environment Conditions

    To Reduce the Risk of Inaccurate Results • Only trained professionals should use the analyzer. • Do not use if error messages occur repeatedly. • Refer to the instructions that included in each test cartridge package for precautions to ensure accurate results for each assay.

  • Page 12: Safety And Electromagnetic Compatibility (Emc) Compliance Information

    Cyber Security measures are designed regarding IT, Information, and Operation to protect electronic information and systems from unauthorized access or theft. SD Biosensor assumes no liability for computer viruses, worms, trojans, malware, hacks, or any other type of cybersecurity breach.

  • Page 13: Overview

    The M10 Console displays the results of monitoring and diagnosis of the inserted specimen. It must be used with designated test cartridges produced by SD Biosensor Co., Inc. For details on specific tests, refer to the instructions included in each of test cartridge packages.
  • Page 14 [STANDARD M10 Cartridge] STANDARD M10 Assay Cartridge...

  • Page 15: Components Of Standard M10

    3. Components of STANDARD M10 1) STANDARD M10 Console (M10-01C) Front Side Back Item Name Description Displaying test screen and interacting with the Color TFT LCD screen graphic user interface. Used for scanning specimen IDs and cartridges Barcode reader barcodes. Speaker Audio output location.
  • Page 16 2) STANDARD M10 Module (M10-01M) Front Side Back Status notification LED for indicating Module status. Insert or remove the test cartridge from the Door chamber inside the door. Repair Cover Cover for manual rotation of the rotating motor. Cover for replacing the fan filter mounted on the Fan Filter Cover vent that discharges heat to the outside.

  • Page 17: Software Gui Description

    4 Software GUI Description Item Name Description Indicate the status of wired LAN connection Indicate the status of USB connection Indicate to recommend using Calibration Kit (It occurs when calibration needs to be performed.) Home Move to the Home screen Setting User setting Review...

  • Page 18: Components

    5. Components 5-1) Console Item Appearance Description Connect D-sub between D-sub cable console and module Connect AC power of AC power cable console 5-2) Module Item Appearance Description Connect AC power/ Gender D-sub between modules Terminate AC power of AC cover module (block the user contact) Connect upper side of...

  • Page 19: Specifications

    STANDARD M10 Verify the STANDARD M10 Calibration Kit system hardware functionality 6. Specifications Item Description Input voltage AC100~240V, 50/60Hz Display control Graphic User Interface (TFT LCD) - STANDARD M10 Console : 84W Power consumption - STANDARD M10 Module : 84W (Maximum 700VA when connecting 8 modules) Number of memory 5,000...

  • Page 20: Unpacking

    These vents must not be blocked when installing the instrument. Avoid placing the instrument in direct sunlight. Inspect for any obvious signs of damage. Report any damages immediately to SD BIOSENSOR. Allow the instrument to equilibrate to room temperature at least 30 minutes before operating.

  • Page 21: Log On And Setting

    CHAPTER 3 Log On and Setting 1. Initial Setup 1.1 Installation 1) M10 Console - M10 Module • Place the analyzer in a suitable environment. • Connect the supplied communication cable (D-sub cable) at the back of the M10 Console and M10 Module to link them together. •...
  • Page 22 2-1) Installing additional M10 Modules • Connect the M10 Modules using the bracket and screws supplied with M10 Module. Bracket • Connect the supplied gender at the back of the M10 Module (#1) and M10 Module (#2) to link them together. Gender...
  • Page 23 2-2) Installing additional M10 Modules • Connect multiple modules using bracket and side bracket. Upper Bracket Left/Right Side Side Bracket...

  • Page 24: Analyzer Log On

    1.2 Analyzer Log On • To start, log on after power on. • Click the input box to create a virtual keyboard. • Log on ID is "admin" and password is "1111" (Change password "admin" account at initial log on for further security).
  • Page 25 • If you enter an incorrect ID or password, the icon may turn red and the warning pop-up may appear. • If you log in successfully, an installation will proceed automatically. • installed modules recognized in the order in which they are connected.

  • Page 26: Instrument Status Light

    1.3 Instrument Status Light State Yellow Indication Not connected Installing LED sign State Blue Green Indication Connected Running LED sign...
  • Page 27 When the connection is completed, you can use the analyzer. • Re-installation is required for following situations. - When the number of M10 Module has changed. - When the position of M10 Module has changed. - If the number of connected M10 Module and the number of M10 Module recognized on UI are different.

  • Page 28: Instrument Settings

    1.4 Instrument Settings • For the cyber security, the admin password must be changed at initial log in. • Important functions of the system, including updating of the system, can be changed and applied only by admin account (After resetting the admin's password, it is very recommended to be noted).
  • Page 29 1. Select on the main menu screen to enter the Settings menu. 2. Settings menu consists General, User, and Network.
  • Page 30 3. In General category, you can set Date/Time, Language, Brightness/Volume, process updates, and module installation. Menu Description You can set the year, month, day, hour, and minute. If you click the Date/Time input box, a number keyboard will appear. Language English is the default.
  • Page 31 4. In User category, Operator ID can be registered, edited, and deleted. 5. If you click the input box, a keyboard will appear. In User category, the password is same as the Password when you logged in. 6. In User category, you can add an Operator ID by clicking the Add New button.
  • Page 32 • Enter the ID and password to be added. Click the ‘Add’ button. • If the password is incorrect, the ‘Please check password' will appear.
  • Page 33 • If the same ID exists, 'User ID is already used' will appear. • Make sure that PW consist of 8 to 15 characters including numbers and lowercase letters. 7. To edit the Operator ID, select the ID to be modified. Press Edit button, and then click the OK button after editing on the Edit screen.
  • Page 34 8. To delete the Operator ID, select the ID to be deleted and press Delete button. Then press the OK button on Delete screen. 9. In Network category, you can set the Network of HIS/LIS and analyzer. • Set the network IP, Netmask, Gateway, Port of the M10 Console. Apply it through the 'Save' button.
  • Page 35 • This is the UI for TCP/IP, DHCP, and Additional to use extensions. This is not currently used. • Protocol has Off/HL7/LAW methods. Select the desired communication method among them. After that, click the "Save" button to apply the desired results (If Off is selected, the result data for the patient will not be transmitted even if the Auto send function is activated).
  • Page 36 • Security can be set to Off or SSL. If SSL(Off) is selected, it operates according to the protocol Off/HL7/LAW set above. If SSL(Off) is selected, a pop-up window will appear. • When you click Import, the *.crt file in the USB memory will install the certificate into the M10 console.
  • Page 37 • Auto Send sets whether to send the result data after testing the patient to the server, applying the set protocol and security. When set to On, the setting is activated (For example, if protocol HL7 setting and Security Off are set, the patient's test result is transmitted to the server without security through HL7 communication).

  • Page 38: Run Test

    CHAPTER 4 Run Test Mode Check the followings before performing assays. • Is the power cable connected to the analyzer? • Is the set date and time on the analyzer correct? • Have you checked the analyzer settings? 1. Run Test 1.
  • Page 39 2. Select the M10 Module to drive press to move to the next step (Only M10 modules in Completed or Available status can be operated). LED light of the selected Module will blink 'green'. 3. Scan the barcode of the sample or manually type the sample ID. If the input is successful, it automatically moves to the next step.
  • Page 40 4. Scan the barcode of the cartridge to be used. If the input is successful, it automatically moves to the next step. 5. Inject the specimens into the test cartridge. Then touch the screen or wait 9 seconds. Place the cartridge in the STANDARD M10 Module immediately (Refer to Procedure in the assay specific STANDARD M10 Cartridge instructions for further details).
  • Page 41 6. If the cartridge is inserted into the M10 module, the next screen will be displayed. Select 'OK' to proceed, or select 'Reset' to restart. Caution: Ensure proper sample loading into the cartridge 7. It automatically checks the surface temperature of the cartridge and the proper operation of the optical module.
  • Page 42 8. When the assay is completed, the STANDARD M10 Module Door opens automatically. Once the operation is completed, remove the used cartridge immediately. Dispose of as biohazardous waste and dispose of immediately.

  • Page 43: Result

    2. Result In Result, you can check the test results. 1. You can check the summary of a result in the Summary tab. 2. You can check the target amplification graph for each item in the Amplification tab.

  • Page 44: Review

    3. You can check detailed result information in the Details tab. 3. Review You can check the accumulated test results in Review . You can check the detailed results of each test.

  • Page 45: Calibration

    CHAPTER 5 Calibration Calibration of an instrument is required to ensure the optimal performance of an analyzer. It can make sure if this instrument works properly as doing this procedure. However, it doesn't need to execute a calibration procedure when the initial system is set up.
  • Page 46 Notification of STANDARD M10 Calibration • When the warning message to run the calibration test popped up with the calibration symbol at the top of the screen, it is time to calibrate STANDARD M10. • Calibration symbol will disappear when the calibration test is done.

  • Page 47: Qc Test

    CHAPTER 6 Check the following before performing measurements. • Is the power cable connected to the analyzer? • Is the set date and time on the analyzer correct? • Have you checked the analyzer settings? • Is the QC control solution ready? 1.
  • Page 48 3. The barcode of the specified QC Solution should be scanned. If the barcode of the QC to be tested is recognized, it automatically moves to the next stage. If you scan the QC barcode provided by the SD biosensor, the QC check box is automatically checked.
  • Page 49 4. The next step will be proceeded the same as the Run Test. 5. If the test is completed, the result will be recorded in Review. If you click the QC filter, you can review only QC results.

  • Page 50: Cleaning And Maintenance

    CHAPTER 7 Cleaning and Maintenance 1. Analyzer Cleaning To prevent malfunction of analyzer, a test cartridge inlet should be free of humidity or dust from the specimen. Clean the analyzer using lint-free cloth and appropriate cleaning solution (ex: mild soapy water, 70% of ethanol or isopropyl alcohol etc.).

  • Page 51: Warnings And Messages Of Info And Error

    CHAPTER 8 Warnings and Messages of Info and Error 1. Warning Messages Indication Warning Description Warning: Not connected USB USB is not connected to analyzer. Solution Confirm that USB is correctly inserted into analyzer. Warning: Wrong ID or Password Wrong ID or password is input. Solution Input the correct ID or password.
  • Page 52 Warning: Please reject cartridge Please remove any cartridges or stuck material inside the M10 module before proceeding the test. Solution After removing the cartridge or stuck material inside the M10 module, click the OK button. Warning: Not registered USB The USB memory stick inserted into the M10 console is not registered.

  • Page 53: Info Messages

    2. Info Messages Indication Info Description Information: Check updates. Solution Check for updates. Information: Check if M10 module is reinstalled. Solution Check for reinstall. Information: Please scan patient barcode. Solution As this error occurs when scanning the STANDARD M10 cartridge, please scan the patient barcode. Information: Please scan sample barcode.
  • Page 54 Information: Have no *.crt file in USB memory. Solution Copy the certificate file (*.crt) you want to install into the USB memory and try again. Information: Please eject all USB memory sticks, then Then re-insert it. Solution This is an alarm when trying to register USB security.

  • Page 55: Error Messages

    3. Error Messages Indication Error Description Error: Contaminated Device Test cartridge is damaged or inaccurately inserted into the analyzer. Solution Discard the failed test cartridge and re-test with a new test cartridge and new specimen. Error: Expired Device Expired test cartridge is used. Solution Re-run the test with a new test cartridge that has not expired.
  • Page 56 Error: Operation module Piston Encoder Error While operating the cartridge in the M10 module there was a problem with the operation of the vertical piston motor. Solution If error occurs, the tests will be canceled and the door of M10 module will be opened. Proceed the test with a new cartridge.
  • Page 57 Error: Not Supported Device Solution Use the cartridge barcode provided by SD Biosensor. Error: Optic Detail Error Error in M10 Optical Measurement Module. Solution Turn off the power of M10 console and M10 and check if the cable and gender are properly connected.
  • Page 58 M10-01S, M10-01C, M10-01M Manufacturer SD Biosensor, Inc. Head office C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA Manufacturing site 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA www.sdbiosensor.com Authorized Representative Ernst-Heckel-Straße 7 66386 St. Ingbert Germany...
  • Page 62 STANDARD Manufacturer SD BIOSENSOR, Inc. Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA www.sdbiosensor.com...

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