DRG BioCheck DxDATA User Manual

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Page 1 Page 1 of 35...
Page 2 Version 1.0 DRG Instruments GmbH Frauenbergstrasse 18 35039 Marburg Germany Technical Support USA Phone: +1-973-564-7555 USA Fax: +1-973-564-7556 Email: drgsupport@drg-international.com International Phone: +49(0)6421/1700-0 International Fax: +49(0)6421/1700-50 Email: drg@drg-diagnostics.de Page 2 of 35...
Page 3: Table Of Contents
Version 1.0 Table of Contents Symbols List ................... 4 1. About this manual ................. 5 2. About DxDATA ................... 5 2.1 Intended Use ................... 5 2.2 Specifications and performance ............6 3. Details of DxDATA ................7 3.1 Principle of detection ................
Page 4: Symbols List
Version 1.0 Symbols List Symbol Description Symbol Description In Vitro Catalog Number Diagnostic equipment Consult Serial Number Instructions for Power on Power off European Caution Conformity Waste of electrical Manufacturer and electronic equipment High temperature, Biological hazard do not touch these areas Page 4 of 35...
Page 5: About This Manual
Version 1.0 1. About this manual This manual contains the necessary information for safe, proper, and effective operation of the DxDATA Automatic Chemiluminescent Immunoassay Analyzing System (hereinafter referred to as " DxDATA "). Please read this manual carefully before operating the DxDATA 2.
Page 6: Specifications And Performance
Version 1.0 2.2 Specifications and performance Instrument type Automated chemiluminescent immunoassay analyzing system Model DxDATA Number of Channels 8-channel parallel detection Sample material Whole blood, serum, plasma Sample volume 30-150l Wavelength 300-650nm Data storage Patient data: more than 100,000 samples (tests) QC data More than 100,000 results 400（W) * 610（D) * 645（H）mm...
Page 7: Details Of Dxdata
Version 1.0 3. Details of DxDATA This section describes the measurement principle, equipment structure, and accessories used in DxDATA 3.1 Principle of detection The detection principle used by DxDATA is Chemiluminescent Immunoassay (CLIA), and the reagents used in each test are stored in a special, individually packaged cassette sealed with aluminum foil.
Page 8: Dxdata Tm Components
Version 1.0 3.2 DxDATA components This section describes the components of the DxDATA and their functions. 3.2.1 Front of the Device The necessary components for operating the DxDATA are located at the front and side of the unit; see the figure below. Component names and functions are described as follows: Touchscreen Printer Door...
Page 9 Version 1.0 3.2.2 Back of the device DxDATA The supply voltage is 110VAC The supply voltage is 220VAC The input and output ports of the device are located on the back of the device, as shown in the figure above. Switch –...
Page 10 Version 1.0 3.2.3 Accessories Information on the main DxDATA accessories is shown in the table below. Main Accessories Description Quantity Remarks Picture Power cord Standard Fuse: F2AL250V/F3AL250V Alternate replacement Cartridge rack Standard Page 10 of 35...
Page 11: Storage And Operation Of The Equipment
Version 1.0 4. Storage and Operation of the Equipment 4.1 Environmental conditions and placement instructions 4.1.1 Normal working conditions Altitude: no more than 2000m Power supply voltage DxDATA : 110/220V 60/50 Hz 300W Ambient temperature: 10 °C ~ 30 °C; Relative humidity: ≤70%; Atmospheric pressure: 85.0 kPa to 106.0 kPa;...
Page 12: Software Description
Version 1.0 5. Software Description 5.1 Software Overview This section describes the software used with DxDATA instrument. 5.1.1 Software Environment Devise uses a custom 10-inch touch screen, with a resolution of 800X600 pixels. Pre-installed Microsoft Windows 10 Enterprise operating system. 5.2 System startup Power on the system using the power switch on the back of the instrument.
Page 13: Log In
Version 1.0 5.3 Log in 1) To log in, enter the username and password, you can select option to save the password. When the "Confirm" button is clicked, the system checks the username and password, and then login to the system is completed after meeting the system requirements.
Page 14: Initialization Check
Version 1.0 5.4 Initialization check After login the system will initialize. A dialogue box will show “Initialization complete” and click on the “Confirm” button will provide access the main window. If an error, like the ones below, is encountered contact our Technical Support or your local representative.
Page 15: Main Window
Version 1.0 5.5 Main window Click "Run" to enter the device running window Click "Samples" to go to the samples management window Click "Results" to enter the results query window Click "Settings" to proceed to the settings window Page 15 of 35...
Page 16: Run Window
Version 1.0 5.6 Run window The “Run” window is the core part of the normal operation and shows the status of the instrument. The whole operation process is carried out in this window. 5.6.1 Routine detection settings All the applicable information such as project, sample and batch number can be manually added on a channel-by-channel basis in the “Run”...
Page 17: Sample Window
Version 1.0 5.7 Sample window The “Sample” window allows you to add sample and project information for the cartridges as well as display sample and project information that has been set previously, edit patient information for samples and more. 5.7.1 Scan Accession number 1) Select the project(s) for the cartridges and scan the accession number into the “Autoscan”...
Page 18 Version 1.0 5.7.2 Edit record 1) Double-click the sample record to open information edit interface. 2) Fill in the corresponding data, click the "Continue" button in order to save the current data and load data for the next cartridge slot. 3) Click the "Cancel"...
Page 19 Version 1.0 5.7.3 Set up project portfolio 1) Double-click the “Project portfolio” button at the top to open the portfolio settings window. 2) Enter the portfolio name and select or deselect the reagents. Blue is selected, white is deselected. Click the "Confirm" button to save the current item information. 5.7.4 Delete 1) In the “Sample”...
Page 20 Version 1.0 Select the testing date range and click “Search” button to display the results of the samples search. Double-click the sample record to go to the information edit screen. 5.7.6 Exit In the “Sample” window click “Exit” button to exit the current interface. Page 20 of 35...
Page 21: Results Window
Version 1.0 5.8 Results window In the "Results" window, you can search for test results, calibration results and quality control results. 5.8.1 Search Sample 1) After entering the "Results" window, the software automatically displays "Search Sample" interface. Page 21 of 35...
Page 22 Version 1.0 2) Under this interface, you can select “Detection Date”, “Project Name”, “Sample ID” and “Patient Name” for your search. The “Detection Date” is mandatory to see the results, while all other search criteria is optional. If you do not enter information, you do not select the condition.
Page 23 Version 1.0 2) Select “Project Name”, “Start Time”, and “End Time” as required items, the rest are optional. 3) Click the “Search” button to retrieve all the quality control results for the selected conditions. Page 23 of 35...
Page 24: Settings Window
Version 1.0 4) Click “Save QC chart” to save the currently displayed quality control charts. print list format. 5) Click “Print” to 6) Click “Export PDF” to save as PDF document. 7) Click “Export-TXT” to export data and save as a text document. 5.9 Settings window The “Settings”...
Page 25 Version 1.0 5.9.1 Reagent Management In the “Parameter setting” click “Reagent Management” button to go to reagent management interface where you can enable and disable projects, select project parameters and add new batch of reagents To Add a new batch of reagents •...
Page 26 Version 1.0 • Scan: with the handheld external bar code scanner, scan the QR code on the kit box. After the scan is successful, confirmation is window displayed, the current scan information is automatically added. • Manual Input: If unable to be scanned, the information can be manually added via the “Manual Input”...
Page 27 Version 1.0 5.9.2 Port Setting Click “Port Setting” button for printer and LIS settings • Select or deselect “Built-in printer” option for internal printer use. • Select or deselect “Automatic Printing” • Enter the settings data for Port ID, Baud Rate. •...
Page 28 Version 1.0 • Click the “LIS Setting” button to enter the LIS setting menu. In the LIS setting menu fill in all the information required for the LIS set up. Click “Confirm”. 5.9.3 Hospital Information Setting Click “Hospital Information Setting” button for end-user settings •...
Page 29 Version 1.0 5.9.4 Alarm Record Click “Alarm Record” button for instrument alarm records history • Select the alarm record Start and Expiry dates and Alarm Level in the drop-down menus. • Click the “Search” button in order to display all the alarm records for selected time and alarm level.
Page 30: Start Initialization
Version 1.0 5.10 Start initialization • Click the “Initialization “button in the main window. System will be re-initialized. Page 30 of 35...
Page 31: Shut Down
Version 1.0 • Click “Confirm” button for successful instrument`s initialization. 5.11 Shut down • Click the “Shut Down" button in the main window to access the instrument`s shutdown options. • Click the "Shut Down" button to directly close the display interface. •...
Page 32: Instrument Warnings And Precautions
Version 1.0 6. Instrument warnings and precautions 6.1 Precautions Only trained, qualified laboratory personnel are authorized to use the instrument. Authorized personnel must wear appropriate protective gear (gloves, lab coat, safety goggles) and exercise standard precautions for handling and disposing of infectious or potentially infectious materials (e.g.
Page 33: Troubleshooting
Version 1.0 7. Troubleshooting Issue Causes of Issue Solution The operator turns the machine on and off Magnetic rod motor once, so that the instrument is reset again or magnetic sleeve to see if the fault persists. Z motion magnetic sleeve If the fault persists, please contact abnormality motor movement...
Page 34 Version 1.0 Issue Causes of Issue Solution authorized technical service representative. The operator turns the machine on and off once, so that the instrument is reset again to see if the fault persists. PMT motor movement If the fault persists, please contact the motion abnormality factory after-sales engineer or an...
Page 35: Instrument Maintenance
Version 1.0 8. Instrument maintenance When servicing the instrument, turn off the power and wear appropriate safety equipment (gloves, lab coats, goggles, etc.) to ensure the safety of the lab personnel. a. Weekly maintenance 1) Clean the Reagent Rack • Gently clean the surface of the reagent rack with a lint free wipe soaked with disinfectant 70% alcohol.