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      AVITI OS Dx 4.0.1 Release Notes

      Summary of Changes

      AVITI OS Dx v4.0.1

      Applies exclusively to AVITI Dx IVD MODE

      This release is the initial general availability (GA) of AVITI Dx software in IVD mode.

      • AVITI Dx instrument support: AVITI Dx OS supports the AVITI Dx instrument, with a dedicated configuration and simplified run settings validated for IVD use. AVITI Dx OS only operates in an offline mode.
      • Dual-mode operation: A single AVITI Dx instrument can switch between IVD and RUO modes. Maintenance and wash tracking information are shared across both modes.
      • Local user accounts: Administrators can create and manage local user accounts on the instrument, with Administrator and Regular User roles.
      • Light and dark display modes: The interface uses a light theme in IVD mode and a dark theme in RUO mode, so the current mode is clear at a glance.
      • Consumable validation: Consumables are checked against the current mode. In IVD mode, the system blocks mismatched, expired and RUO consumables.
      • Audit trail: User actions and consumable scans are recorded for full traceability. The audit log can be exported to a USB drive by an Administrator user.
      • Language support: The interface is available in English, Czech, Dutch, French, German, Italian, and Spanish.
      • Instrument workflows: The software includes workflows for Cloudbreak Freestyle Dx™ sequencing, monitoring, wash runs (service, stand-by, recovery, and maintenance), as well as other maintenance features and settings.
      • The instrument supports writing data to USB or SMB.
      • End-user license agreement (EULA): The EULA is presented at first login and is unique per mode.

      Known Issues, v4.0.1:

      • Simultaneous leak errors on both sides of the instrument prevent AVITI™ OS from unlocking the waste module door.
      • Runs can proceed even if polony map generation fails under specific undetected conditions.
      • The UI may begin to lag after several days of uptime. If this occurs, refresh the UI by pressing Ctrl+Shift+Z on a connected keyboard on the home screen. Logging out and back in, or power cycling the instrument, will also resolve the issue. To help prevent this issue, power cycle the instrument once per week as recommended in the instrument user guide.
      • The on-screen keyboard may become unresponsive. This does not affect ongoing instrument operations. Once the instrument is in a safe state, restart the system to restore normal keyboard functionality.

      Dependency Updates, v4.0.1:

      Additional software updates accompany AOS 4.0.1. Please ensure you update the following software and review the corresponding release notes: