BAX® System Q7 Version 5.0.1.16813 Features and Instructions

Software Assay Updates for Release v5.0.1.16813

There are no changes to the analysis for BAX assays compared to versions 4.21 and 4.22.

Two foodproof® assays now feature verified result interpretation, displayed as 'Certified' within the software:

foodproof assays with verified result interpretation do not require visual verification of the graphs. However, as a best practice, Hygiena recommends customers review all results.

Seven additional foodproof assays are available with experimental analysis files for assistance with result interpretation:

Additionally, foodproof/microproof® assays are available with improved experimental analysis files for assistance with result interpretation:

Important Note: All foodproof and microproof assays with experimental kit analysis files are designed to assist in result interpretation but require visual verification of the graphs.

Analysis files are now available for all assays (BAX, foodproof, microproof). By default, they are set to "None". Users can navigate to Operation → Analysis Settings to set the analysis file (Algorithm) to "Experimental" for targets without verified analysis files, enabling improved result interpretation.

All verified assays will display only one setting: "Certified." If using version 4.22 for foodproof assays, the selected setting will remain. New foodproof assays in version 5.0 require adjustment to preference.

Software Feature Updates for Release v5.0.1.16813

• Users can register the Q7 to the SureTrend® application available on the cloud.
• Ability to review data online both graphically and by result status with the SureTrend software. To use this feature, register a SureTrend account at ? https://suretrend.hygiena.com/Register
• Users can now export comma-delimited text files (.csv).
• A one-step compressed log file export is available.

The software will now check that the correct calibration file is imported for the instrument, especially in cases of equipment replacement (loaners or service units). Each Q7 has a unique calibration file and should only be used with that specific Q7.

Calibration files generated with software version 4.0 and higher store the serial numbers of the Q7 camera and thermal block. Upon importing a calibration file, the application compares these serial numbers to the instrument's. If they do not match, a pop-up message will appear. If this occurs, locate the correct calibration file (often found in the sleeve on the back of a recently replaced unit) or contact Hygiena. If the correct file cannot be found, calibrate the instrument as per the BAX Q7 User Guide.

If "Yes" is clicked in the calibration mismatch pop-up, a secondary warning message will appear:

!!! WARNING !!! The Calibration file for this instrument shows indications that it is not the correct calibration file for this instrument. If you choose to continue your data may be affected.

If 'Continue' is selected, the calibration will import without further warnings.

Software Upgrade Instructions

1. Required Prerequisites

• Regional Settings must be in English.
• Core Isolation setting should be turned off in Windows security settings.
• Read/Write Permissions are required for the following file locations for all users: C:\Program Files\MATLAB, C:\Program Files (x86)\BAX, C:\ProgramData\BAX Q7 System.
• All Power and Sleep Settings must be set to Never.
• The "Notify before restarting" option after a Windows upgrade should be enabled.

Obtain the HEX Calibration Kit (Product No.: KIT230340) from Hygiena if you plan to run foodproof/microproof assays that utilize the HEX dye (refer to kit instructions). This calibration plate is a standalone product and is not included with other calibration kits. Please visit the Contact Us page for ordering and technical support.

2. Calibration storage and removal of current software

• Back up the system's calibration file: Select Operations > BAX Maintenance > Export Calibration from the menu bar. Navigate to a new folder, store the backup file, and click Save. Name the file (e.g., Q7Cal_date.bqc).
• Uninstall the previous version of the BAX Q7 application: Navigate to Windows Settings and select Apps. A screenshot of Windows Settings showing the 'Apps' section, used for uninstalling applications.
• Click on BAX System Q7, select Uninstall, and agree (click Yes) on the next window to initiate removal.
• If updating from 4.21 or 4.22, removal of MATLAB is not required. If updating from earlier versions, click on the MATLAB application, select Uninstall, and click Agree (this may take several minutes).

Restart the computer BEFORE continuing to step 3.

3. Download 5.0.1.16813 software

Download the software by clicking the provided link or the button from the BAX Q7 Page. Transfer the download to a memory/USB stick if the computer lacks internet access. Click on the Q7 5.0.1.16813 icon to start the installation.

A 'Windows protected your PC' security alert dialog box may appear, advising that an unrecognized app is about to start and offering options to view more information or run the app anyway. Select 'More Info', then 'Run anyway'. On the subsequent pop-up, select 'Yes' to allow installation to begin. Screenshots illustrating the 'Apps & features' list within Windows Settings, showing how to locate and uninstall applications like BAX System Q7 and MATLAB.

4. Prerequisites Installation

There may be prerequisites that need to be installed first to prepare your computer for the BAX application installation. You may need to restart multiple times to get these prerequisites installed before MATLAB Runtime can install. Checking memory integrity and Correct regional settings are the first two prerequisites that must be addressed for the Application to install successfully.

In case of the install error: VCRUNTIME140.dll was not found (shown below). Please download and install the patch: vc_redist.x64.exe from ? https://www.microsoft.com/en-us/download/details.aspx?id=52685. The installation will end when you click OK.

A system error message indicating that the 'VCRUNTIME140.dll' file was not found, suggesting reinstallation of the program.

InstallShield Wizard screens showing prerequisite checks for BAX System Q7, including pending installations for Microsoft Visual C++ Redistributables and MATLAB Runtime.

5. MATLAB Installation

MATLAB updates will be installed after prerequisites. Follow the prompts and select the default responses. After installing this patch, MATLAB Installation continues.

Screenshots of the Hygiena MATLAB Runtime Installer wizard, showing connection settings, installation options, and required software components. A license agreement dialog box for MATLAB Runtime, requiring user acceptance before proceeding with installation. A confirmation dialog for the Hygiena MATLAB Runtime Installer, specifying installation directories. Screenshots showing the installation progress and a completion message for the MATLAB Runtime installation.

6. BAX Q7 Application Installation

Following MATLAB installation, the BAX Q7 application installation will be initiated. Read the prompts carefully and choose the default responses.

• Welcome Window: Click Next. The welcome screen of the BAX System Q7 InstallShield Wizard, prompting the user to click 'Next'.
• Calibration File Warning: ENSURE YOU HAVE BACKED UP THE CALIBRATION FILE. Check the box and click Next. An InstallShield Wizard screen displaying a 'Calibration File Warning,' emphasizing the need to back up the calibration file before proceeding.
• License Agreement: Check 'Accept Terms' box and click Next. An InstallShield Wizard screen presenting the BAX System Software License Agreement, requiring acceptance of terms.
• Custom Setup: Click Next. An InstallShield Wizard screen for 'Custom Setup,' allowing users to select program features for installation.
• Password Protection: BAX default is disabled password protection. Choose an option for your lab, then click Next. An InstallShield Wizard screen for 'BAX Security,' offering options to enable or disable password protection for the BAX System.
• Ready to Install Program: Click Install. An InstallShield Wizard screen indicating that the wizard is ready to begin the installation of BAX System Q7.
• Installing BAX System Q7 Software: During installation, an Error Log Reporting window will pop up. It is recommended NOT to check the box so the system can collect software and/or hardware errors in the Log Files to assist Diagnostics Support in troubleshooting. However, please review and decide what is appropriate for your lab. Select Next to complete the installation. An InstallShield Wizard screen showing the progress of the BAX System Q7 installation. An InstallShield Wizard screen related to 'Error Log Reporting,' allowing the user to choose whether to upload log information to Hygiena servers.

InstallShield Wizard Complete: Select Finish. An InstallShield Wizard screen confirming that the BAX System Q7 installation is complete.

Click on the desktop icon to initiate the program. The new open screen will display software version 5.0.1.16813.

Enter the Instrument Name and Serial Number: This will appear on reports and should be utilized. A dialog box prompting the user to enter the Instrument Name and Instrument Number for the BAX System Q7.

7. Check system's calibration

From the menu bar, select Diagnostics > Calibration to open the Q7 Calibration Diagnostics window.

Click the Check Calibration button to determine the status:

• If calibration is available, no further actions are needed.
• If calibration is NOT optimal or NOT found: Import the backed-up calibration file by selecting Operations > BAX Maintenance > Import Calibration from the menu bar and selecting the backed-up calibration file from step 2.

To utilize many foodproof assays, additional calibration using the HEX calibration kit must be performed. Please follow the onboard instructions in the BAX Software to perform calibration.

Two Q7 Calibration Diagnostics windows are displayed. The first shows a 'Check Calibration' button and directory path. The second displays detailed calibration status, including 'ROI: Invalid,' 'Cal last modified' dates, and a list of assays for which dye coefficients are missing.

Appendix A: Algorithm Analysis across Software Versions

The table below provides information to identify algorithm consistency more easily across software versions and validations. There have been no changes to the assay-specific algorithm since the analysis version listed.