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STAT-Dx DiagCORE User Manual

Software version 1.0
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DiagCORE
User manual
Software version 1.0
PL-009-05/2018-EN
Analyzer
®
110001 AM
110002 OM

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Summary of Contents for STAT-Dx DiagCORE

  • Page 1 DiagCORE Analyzer ® User manual Software version 1.0 110001 AM PL-009-05/2018-EN 110002 OM...

  • Page 2: Customer And Technical Support

    This document is to be used solely for the purpose of operating the DiagCORE Analyzer. No part of this document may be reproduced or transmitted by any means, whether electronic or mechanical, or for any purpose, without the express written permission of STAT-Dx Life, S.L.

  • Page 3: Table Of Contents

    4 Installing the DiagCORE Analyzer .............. 16 4.1 Site requirements ....................16 4.2 What is included with the DiagCORE Analyzer ..........17 4.3 Unpacking and installing the DiagCORE Analyzer ........18 4.4 Repackaging and shipping the DiagCORE Analyzer ......... 22 5 Running a test and viewing results ............
  • Page 4 6.7 Assay management ..................45 6.7.1 Managing available assays ..............45 6.7.2 Importing new assays ................46 6.8 Configuring the DiagCORE Analyzer system ..........47 6.8.1 Regional settings ................... 47 6.8.2 General settings ..................49 6.8.3 Printer settings ..................51 6.8.4 Network settings ..................
  • Page 5 7 Maintenance ....................58 7.1 Maintenance tasks ................... 58 7.2 Cleaning the DiagCORE Analyzer surface ........... 58 7.3 Decontaminating the DiagCORE Analyzer surface ........59 7.4 Replacing the air filter ..................60 7.5 DiagCORE Analyzer repair ................60 8 Troubleshooting ................... 61 8.1 Errors and warning messages .................

  • Page 6: Table Of Symbols

    Table of symbols The table below describes various symbols used throughout this user manual and on the DiagCORE Analyzer instrument and assay cartridges. Location Description Type plate on the back of the CE marking for European Conformity instrument Type plate on the back of the TÜV mark of the TÜV SÜD Product...

  • Page 7: Information About This User Manual

    The DiagCORE Analyzer should only be operated if it is on a flat, horizontal surface with no  angles or tilts. Do not re-run a DiagCORE assay cartridge if it has already been used successfully, or if it has  been associated with an error or an incomplete run.

  • Page 8: Sections Of The User Manual

    1.4 Sections of the user manual This user manual provides information about the DiagCORE Analyzer in the following sections: 1. Information about this user manual 2. Safety information 3. General background 4. Installing the DiagCORE Analyzer 5. Running a test and viewing results 6.

  • Page 9: Safety Information

    Safety information Before using the DiagCORE Analyzer, it is essential to read this user manual carefully and pay particular attention to the safety information. The instructions and safety information in the user manual must be followed to ensure safe operation of the instrument and to maintain the instrument in a safe condition.

  • Page 10: Diagcore Analyzer Transport Precautions

    Risk of personal injury and material damage CAUTION Do not open the housing of the DiagCORE Analyzer. The housing of the DiagCORE Analyzer is designed to protect the operator and to ensure proper operation of the DiagCORE Analyzer. Using the DiagCORE Analyzer without the housing leads to electrical hazards and DiagCORE Analyzer malfunction.

  • Page 11: Biological Safety

    COSHH: Control of Substances Hazardous to Health (United Kingdom)  Avoid contamination of the DiagCORE Analyzer and workspace by handling samples and DiagCORE cartridges with care. In the event of contamination (e.g., a leak from a cartridge), clean and decontaminate the affected area and the DiagCORE Analyzer. WARNING...

  • Page 12: Waste Disposal

    Contents, though not infectious, can be spread by normal activity and may contaminate further analytical results, leading to false positives. For instructions on cleaning and decontaminating the DiagCORE Analyzer, refer to sections 7.2 Cleaning the DiagCORE Analyzer surface and 7.3 Decontaminating the DiagCORE Analyzer surface.

  • Page 13: General Background

    Samples are inserted into a DiagCORE cartridge, which carries on board all reagents necessary to isolate and amplify nucleic acids from the sample.

  • Page 14: Diagcore Cartridge Description

    The following images show the locations of various DiagCORE Analyzer features. Front view of the DiagCORE Analyzer. The Operational Module is on the left, and the Analytical Module is on the right. Rear view of the DiagCORE Analyzer. The Operational Module is on the right, and the Analytical Module is on the left.
  • Page 15 DiagCORE Analyzer houses air filters for both incoming and outgoing air, further safeguarding the environment. After testing, the cartridge stays hermetically closed at all times, greatly enhancing its safe disposal. Within the cartridge, multiple steps are automatically performed in sequence using pneumatic pressure to transfer samples and fluids via the transfer chamber to their intended destinations.

  • Page 16: Installing The Diagcore Analyzer

    Installing the DiagCORE Analyzer 4.1 Site requirements Select a flat, dry and clean workbench space for the DiagCORE Analyzer. Ensure that the space is free of excessive drafts, moisture and dust, as well as protected from direct sunlight, large temperature fluctuations, heat sources, vibration and electrical interference. Refer to section 9.1 Technical specifications of the appendix for the weight and dimensions of the DiagCORE Analyzer and the correct operating conditions (temperature and humidity).

  • Page 17: What Is Included With The Diagcore Analyzer

    4.2 What is included with the DiagCORE Analyzer The DiagCORE Analyzer is delivered in two separate boxes and includes all the necessary components for setting up and operating the system. The contents of the boxes are described below. Box 1 contents:...

  • Page 18: Unpacking And Installing The Diagcore Analyzer

    CAUTION The DiagCORE Analyzer is a heavy instrument. To avoid personal injury or damage to the DiagCORE Analyzer, take care when lifting and use appropriate lifting methods. The analyzer must be lifted and handled by taking it from the base with two hands, as shown in the figure below.
  • Page 19 2. Remove the protective covers from the side of the Analytical Module using the protective cover removal tool delivered with the DiagCORE Analyzer. 3. Remove the Operational Module from its box and attach it to the left side of the Analytical Module.
  • Page 20 4. Reattach the protective covers on the side of the Analytical Module. 5. Connect the Analytical/Operational Module bridge at the back of the DiagCORE Analyzer to link the Operational and Analytical Modules together. 6. Connect the termination bridge at the back of the Analytical Module.
  • Page 21 7. Connect the power cord that was delivered with the DiagCORE Analyzer to the back of the Analytical Module. 8. Connect the power cord to a power outlet. 9. Turn the power switch on the back of the Analytical Module to the “I” position. Check that the status indicators of the Analytical and Operational Modules are blue.

  • Page 22: Repackaging And Shipping The Diagcore Analyzer

    4.4 Repackaging and shipping the DiagCORE Analyzer When repackaging the DiagCORE Analyzer for shipping, the original packaging materials must be used. If the original packaging materials are not available, contact Technical Support. Ensure that the instrument has been properly prepared (see section 7.2 Cleaning the DiagCORE Analyzer surface) prior to packing and that it poses no biological or chemical hazard.

  • Page 23: Running A Test And Viewing Results

    Running a test and viewing results 5.1 Starting the DiagCORE Analyzer Press the ON/OFF button on the DiagCORE Analyzer front to start the unit. NOTE The power switch at the back of the Analytical Module must be set in the “I”...
  • Page 24 Please refer to section 6.8.2 for further details. 3. When prompted, scan the barcode of the cartridge to be used. The DiagCORE Analyzer automatically recognizes the assay to be run, based on the cartridge barcode.
  • Page 25 7. Ensure that both sample lids of the cartridge are firmly closed. When the cartridge entrance port on the top of the DiagCORE Analyzer automatically opens, insert the cartridge with the barcode facing to the left and the reaction chambers facing down.
  • Page 26 There is no need to push the cartridge into the DiagCORE Analyzer. Position it correctly into the cartridge entrance port, and the DiagCORE Analyzer will automatically move the cartridge into the Analytical Module. Prompt to insert the DiagCORE assay cartridge.
  • Page 27 If the cartridge is not removed after a certain time, it will be automatically moved back into the DiagCORE Analyzer and the lid of the cartridge entrance port will close. If this occurs, press Eject to open the lid of the cartridge entrance port again and then remove the cartridge.

  • Page 28: Instructions To Abort A Test

    5.4 Viewing results The DiagCORE Analyzer automatically interprets and saves test results. After ejecting the cartridge, the Results Summary screen is automatically displayed. DiagCORE Analyzer User Manual...
  • Page 29 (e.g., amplification plots, melting curves and test details). Assay data can be exported by pressing Save Report in the bottom bar of the screen. A report can be sent to the printer by pressing Print Report in the bottom bar of the screen. DiagCORE Analyzer User Manual...

  • Page 30: Viewing Amplification Curves

    Press the Controls tab on the left side to view the controls and select which controls are shown in the amplification plot. Press the circle next to the control name to select or deselect it. Amplification Curves screen showing the Controls tab. DiagCORE Analyzer User Manual...

  • Page 31: Viewing Melting Curves

    The range of the X-axis and Y-axis can be adjusted using the gray pickers on each axis. Press and hold a picker and then move it to the desired location on the axis. Move a picker to the axis origin to return to the default values. DiagCORE Analyzer User Manual...

  • Page 32: Viewing Test Details

    List of analytes tested in the assay, with C and endpoint fluorescence  List of controls, with C and endpoint fluorescence  Example screen showing Test Data on the left panel and Test Details in the main panel. DiagCORE Analyzer User Manual...

  • Page 33: Browse Results From Previous Tests

    Unselect test results by pressing this checkmark. The entire list of results can be selected by pressing the button in the top row. Example of selecting test results in the View Results list. DiagCORE Analyzer User Manual...

  • Page 34: Exporting Results To A Usb Storage Device

    PDF format to a USB storage device. The USB port is located on the front of the instrument. 5.4.6 Printing results Select Print Report to send a copy of the test results to the system printer. DiagCORE Analyzer User Manual...

  • Page 35: System Reference

    System reference This chapter provides a description of all features and options available in the DiagCORE Analyzer that enable customization of the DiagCORE Analyzer settings. 6.1 Main screen In the Main screen, it is possible to view the status of the Analytical Modules and navigate to different sections (Log In, Run Test, View Results, Options, Log Out) of the user interface.

  • Page 36: Module Status Bar

    Analytical Module, no cartridge is inserted and the lid of the cartridge entrance port is closed. Test running User administrator is currently running the Resp_3018_19c test on Analytical Module 1. There are 32 minutes and 14 seconds remaining to complete the test. DiagCORE Analyzer User Manual...

  • Page 37: Main Menu Bar

    Button Description Run Test Starts the run test sequence (see section 5.3 Procedure to run a test). The DiagCORE Application Software automatically selects an Analytical Module from the ones available and starts the test preparation sequence. View Results Opens the View Results screen (see section 5.4 Viewing results).

  • Page 38: Content Area

    When User Access Control is enabled (refer to section 6.6 User management), users must identify themselves by logging in to access the DiagCORE Analyzer functions. The content area of the login screen includes a text box for entering the User ID. If the option “Show previous user logins”...
  • Page 39 If a user forgets his or her password, the system administrator can reset it. For security reasons, if a password is entered incorrectly three times, the system will lock for one minute before the user can try to log in again. DiagCORE Analyzer User Manual...

  • Page 40: Logging Out

    General settings of the Options menu (see section 6.8.2 General settings). 6.4 Screensaver The DiagCORE screensaver is shown after there has been no user interaction for a pre-defined period of time. This time can be configured in the Options menu (see section 6.5 Options menu).

  • Page 41: User Management

    “Multi-User” mode: User Access Control is enabled and users must log in before performing any  action on the DiagCORE Analyzer. The actions they are allowed to perform are limited and defined according to their user profiles. NOTE The user management option is available only to users with “Administrator”...

  • Page 42: Accessing And Managing The List Of Users

    Password: allows changing the password for that user  User Active (yes/no): allows changing whether the user is active or not. Inactive users are  not allowed to log in or perform any action on the system DiagCORE Analyzer User Manual...
  • Page 43 Assigning user profiles to users. Assign Assays: allows defining the assays from the assay database that the user is permitted  to run. Select the assays from the list on the right of the content area. Assigning assays to users. DiagCORE Analyzer User Manual...

  • Page 44: Adding Users

    6.6.2 Adding users Follow the steps below to add new users to the DiagCORE Analyzer: 1. Press the Options button and then the User Management button to configure users. The User Management screen appears in the content area of the display.

  • Page 45: Assay Management

    6. Press Save and confirm to save and store the new information. The new user has been set up and is immediately allowed to log in to the DiagCORE Analyzer. 6.7 Assay management From the Assay Management menu, it is possible to manage assays and access assay-related information and statistics.

  • Page 46: Importing New Assays

    6.7.2 Importing new assays 1. Insert the USB storage device with assay file to import into the USB port of the DiagCORE Analyzer. 2. To import the new assay(s) to the DiagCORE Analyzer, press the Options button and then the Assay Management button.

  • Page 47: Configuring The Diagcore Analyzer System

    5. A dialog will appear to confirm upload of the file. 6.8 Configuring the DiagCORE Analyzer system In the System Configuration menu, it is possible to manage the DiagCORE Analyzer system and define region-specific parameters. 6.8.1 Regional settings 1.
  • Page 48 Setting the system date. Setting the system date format. Setting the system date separator. DiagCORE Analyzer User Manual...

  • Page 49: General Settings

    Only active if User Access Control is enabled. This setting defines time the time interval after which a user is automatically logged out of the system because the DiagCORE Analyzer receives no more user input. The allowed range is from 5 minutes up to 99:59 hours. Default: 30 minutes.
  • Page 50 Setting Description Use patient ID With Use Patient ID activated, the DiagCORE Application Software will provide the option for users to enter a Patient ID or scan a Patient ID when preparing to run a test (see section 5.3 Procedure to run a test).

  • Page 51: Printer Settings

    Enables resetting the system back to all factory default settings. default 6.8.3 Printer settings The Printer settings option enables selection of the system printer. The DiagCORE Analyzer allows use of networked printers or printers connected to the Operational Module via the USB ports on the back of the instrument.
  • Page 52 Defines the primary DNS server. This option is only active if “Obtain Server DNS address automatically” is disabled. Alternate DNS Defines the secondary DNS server. This option is only active if “Obtain Server DNS address automatically” is disabled. DiagCORE Analyzer User Manual...

  • Page 53: His/Lis Settings

    Log to access the system log information. The System Log Capacity is shown in the center of the screen followed by the log content. Press Export Log File to export the content. Accessing the system log. DiagCORE Analyzer User Manual...

  • Page 54: Technical Log

    Accessing the technical log. 6.8.8 Version information Press the Options button and then the System Configuration button followed by Version Info to view the DiagCORE Application Software version, the serial numbers and the firmware versions for the installed Analytical Modules. 6.8.9 System update To update the DiagCORE Analyzer system, press the Options button and then the System Configuration button followed by System Update.

  • Page 55: System Backup

    A message will appear recommending to perform a system backup first (refer to 6.8.10 System backup). Performing a system update. After the update, the user may be requested to shut down the DiagCORE Analyzer and start it again. 6.8.10 System backup To back up the DiagCORE Analyzer system, press the Options button and then the System Configuration button followed by System Backup.

  • Page 56: Change Passwords

    First step of the password change process. Entering and confirming the new password. 6.10 DiagCORE Analyzer status The status of the Operational and Analytical Modules is indicated by the color of the status indicators (LEDs) at the front of the DiagCORE Analyzer. DiagCORE Analyzer User Manual...

  • Page 57: Shutting Down The Instrument

    Analytical module is running 6.11 Shutting down the instrument The DiagCORE Analyzer is designed to operate continuously. If the unit will not be used for a short time (less than a day), we recommend placing the DiagCORE Analyzer in standby mode by pressing the ON/OFF button on the front of the instrument.

  • Page 58: Maintenance

    Maintenance This chapter describes the maintenance tasks required for the DiagCORE Analyzer. 7.1 Maintenance tasks The table below provides a list of maintenance tasks to be performed on the DiagCORE Analyzer. Description Frequency Cleaning or Decontaminating To be performed in case liquids, chemicals or biological...

  • Page 59: Decontaminating The Diagcore Analyzer Surface

    2. Wet a paper towel in mild detergent and wipe down the DiagCORE Analyzer surface, as well as the surrounding workbench area. Take care not to wet the touchscreen. To clean the touchscreen, use the screen suede provided with the DiagCORE Analyzer.

  • Page 60: Replacing The Air Filter

    Follow these steps to exchange the air filter: 1. Set the DiagCORE Analyzer in standby mode by pressing the front ON/OFF button. 2. Place a hand below the air filter drawer at the front of the DiagCORE Analyzer and use fingers to push slightly up.

  • Page 61: Troubleshooting

    Troubleshooting This section provides information on some issues that may occur with the DiagCORE Analyzer, along with possible causes and solutions. The information is specific to the instrument. For troubleshooting relevant to a DiagCORE cartridge, see the instructions for use of the respective cartridge.
  • Page 62 Problem Possible Cause Solution The touchscreen does not The DiagCORE Analyzer is in Press the ON/OFF button on respond. standby mode (status indicator the Operational Module. is blue). Call Technical Support. Hardware failure. Barcode reader does not Sample ID barcode feature is Contact a laboratory scan.

  • Page 63: Errors And Warning Messages

    Technical Support. Unexpected behavior of AM General system failure. Restart the system. nnn. If the problem persists, contact Technical Support. Update data aborted, error Unexpected error occurred Contact Technical Support. occurred. while updating the DiagCORE Analyzer. DiagCORE Analyzer User Manual...
  • Page 64 Assay <assay_id> not The assay corresponding to Import the assay to the available. the cartridge has not been DiagCORE Analyzer (see imported to the DiagCORE section 6.7.2 Importing new Code: 0x400 Analyzer. assays). Assay <assay_name> not The assay is not active.
  • Page 65 Technical Support. USB Device not found. USB storage device is not Insert a USB storage device in detected in the DiagCORE the USB port. Analyzer. Barcode reading failed. Barcode reader malfunction. Contact Technical Support. Failed to scan barcode.
  • Page 66 Failed to create file. The backup file could not be The USB storage device is not created. working. Retry using a different USB storage device. DiagCORE Analyzer User Manual...

  • Page 67: Appendices

    1 front and 3 rear 9.2 Disposal information Recycling of the DiagCORE Analyzer can be provided by STAT-Dx Life upon request at additional cost. In the European Union, in accordance with the specific WEEE recycling requirements and where a replacement product is being supplied, free recycling of its WEEE-marked electronic equipment is provided.

  • Page 68: Declaration Of Conformity

    Assay Definition File: An Assay Definition File is a file need in order to execute an assay on a DiagCORE analyzer. The content of the file describes what can be measured, how to measure it and how to evaluate the raw measurement results. The file should be imported in the DiagCORE Analyze before executing an assay the first time GUI: Graphical user interface.

  • Page 69: Patent Statement

    DiagCORE Analyzer as specified in this DiagCORE Analyzer User Manual. 9.8 Software License Agreement STAT-Dx Life, S.L. is the owner, or licensee with right to sublicense, of all rights necessary to provide to the Purchaser of the DiagCORE Analyzer and associated DiagCORE cartridges, a license to the...
  • Page 70 DIAGCORE ANALYZER. THE FOREGOING LIMITATIONS WILL APPLY EVEN IF THE ABOVE STATED REMEDY FAILS OF ITS ESSENTIAL PURPOSE. To the extent that any terms and conditions in this DiagCORE Analyzer User Manual differ from the terms and conditions in the Purchase or Sale Agreement for the DiagCORE Analyzer, the terms and conditions in the Purchase or Sale Agreement will control.

  • Page 71: Index

    General status bar ........35 Main menu bar ........... 37 Declaration of conformity ......69 Module status bar ........36 DiagCORE Analyzer status ......56 Maintenance ........... 58 Disposal information ........68 Analyzer repair ..........60 Cleaning the Analyzer ....... 58 Decontaminating the Analyzer ....
  • Page 72 Technical log ..........54 Language ............ 48 Version information ........54 Time ............... 47 System description .......... 13 Repackaging for shipment ......21 DiagCORE Analyzer ........13 Results DiagCORE cartridge ........14 Amplification curves ........30 System features ..........35 Controls ............31 Logging out ..........
  • Page 74 DiagCORE ® Analyzer DiagCORE System, Revision 1.0 © 2017 STAT-Dx Life S.L. All rights reserved. STAT-Dx Life S.L. · Baldiri Reixac 4, Barcelona, Spain +34 93 448 51 24 · http.support.qiagen.com...

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