This User Guide provides step-by-step instruction for use of the LumiNE software. More details can be found in the Instructions for Use.

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Terminology

LumiNE does not contain true Holography, which involves recording and reconstructing the light field of an object to create a true 3D image. LumiNE uses stereoscopic image visualization through a stereoscopic head mounted display (Microsoft HoloLens 2). The Microsoft HoloLens 2 displays content at a fixed focal plane and does not have Holograms as 3D output. All technical performance testing has been performed according to the correct technological definitions (stereoscopic image visualization trough a stereoscopic head mounted display). However, in this User Guide the term ‘Hologram’ is still used for practical purposes, not following formal hologram definition, to represent the stereoscopic image of the patient, along with all its constituent parts, like the scan and 3D surface models visualized through the stereoscopic head mounted display.​ 

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Indications for Use

The LumiNE software is intended for the visualization of medical images to provide insights in anatomy and pathology in preparation of cranial surgical treatment. As such, the software allows for the conversion of 2D patient imaging into 3D models of the patient's head, and for the visualization of 2D and 3D patient imaging including Augmented Reality. When accessing the LumiNE software from a wireless Head-Mounted Display (HMD) or PC monitor, images viewed are for informational purposes only and not intended for diagnostic use.

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The LumiNE software is intended for use by a (neuro)surgeon, (neuro)surgical resident or a medical professional that is qualified by a hospital to prepare medical imaging for surgeons. For the conversion of medical imaging into 3D models, Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) imaging of adult patients are required. The LumiNE software is intended to be used for visualization in preparation of surgery, and not for diagnostic use. Therefore, segmentation and visualization of tumors or any other pathology can only be used for previously known and pre-diagnosed conditions.

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LumiNE can only be used for contrast-enhanced T1 MR scans (semi-automatic segmentation of known tumor, skin, brain, and ventricles), or for CT scans (threshold-based segmentation).

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The LumiNE MRI T1 tumor segmentation function can only be used in case of a single intracranial contrast enhancing tumor, diagnosed by a neuroradiologist or a neurosurgeon, with a minimal volume of 2.0 cc (0.1 in3) and a minimal diameter in any direction of 15 mm (0.6 inch), and a maximum volume of 100cc (6.1 in3)  and a maximal diameter in any direction of 75 mm (3.0 inch).

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Contra indications for Use

• The LumiNE software may not be used for diagnosis.

• The LumiNE software may not be used for measuring.

• The LumiNE software may only be used for patients at the age of 22 years or older.

• The LumiNE software cannot be used to project images and 3D models over a patient.

• The LumiNE software cannot be used within 1.5 meters from a sterile field, patient under anesthesia or medical apparatus.

• The LumiNE software may not be accessed from a wireless stereoscopic head-mounted display if the user is sterile.

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Warnings

• Patient health information and/or meta-data that might lead to patient identification cannot be uploaded in the LumiNE US software. Only anonymized patient data can be uploaded.

• The output data provided by the LumiNE US software must be subject to careful expert assessment. Segmentations should thereby always be verified by a qualified user in LumiNE US by outline analysis on the source medical image, since false positive and negative segmentation regions can occur. The user is responsible of the adequate evaluation of the results.

• The segmentation functions that create 3D models from 2D data do only support the usage of T1 Magnetic Resonance Images (MRI) or Computer Tomography (CT) images.

• It is recommended to use the software within a hardware and/or a network environment in which cybersecurity controls have been implemented including anti-virus and use of firewall.

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Cybersecurity

To ensure comprehensive protection, the following cybersecurity measures are implemented:

• Access Control and User Session Management: SSL connection is enforced with TLS 1.2, furthermore users are automatically logged out of the website after 60 minutes of inactivity.

• Anti-malware: LumiNE US software uses Azure’s built-in security features, including Microsoft Defender for Cloud, to protect against malware and other threats.

• Audit logfiles: LumiNE US software collects logfiles on both user and system level to capture activities and events that occur within LumiNE US software. These logfiles are monitored and reviewed to detect unauthorized access, security breaches, or unusual activities.

• Data Encryption: Data at rest and Cached data is AES-256 encrypted.

• Data Transmission Security: Data in transit is encrypted using HTTPS with TLS 1.2.

• Firewalls: Network security is enforced via Azure’s Virtual Networks, IP whitelisting, and Network Security Groups (NSGs) to control inbound and outbound traffic.

• Levels of authorization: Authorized clinical Users can access designated asset groups according to their authorized Role-Based Access Control (RBAC) permissions.

• Login with Microsoft HoloLens 2: Users can login in the HoloLens 2 with their username and password. This can be changed to login with a pin code or with the use of biometric authentication (iris scan).

• Password requirements for Administrators: Password policies adhere to Azure’s standards, requiring among others MFA for access to critical systems by administrators.

• Security event detection: The LumiNE software uses Microsoft Defender for Cloud and Azure Monitor to detect and respond to anomalies. Alerts are configured for unusual access patterns and other security events. This also includes alerts for Multi-Logins and suspicious activities.

• Sharing: In the Multiplayer functionality, stereoscopic image displays can be shared between multiple users. The data in transit is encrypted using HTTPS with TLS 1.2.

• Password Guidelines for New Users: When you first start, you will get an email with your Lumi login details and a temporary password. You will need to change this password the first time you log in. Our password rules follow Azure’s standards, so your new password will need to be a bit complex and you will have to update it regularly.

• Updating OS and Security Patches on HoloLens 2: Make sure your HoloLens 2 has the latest OS and security updates:

  • Open Settings: On your HoloLens 2, go to the Settings app.

  • Update & Security: Select Update & Security.

  • Advanced Options: Look for Advanced options or similar settings within the Update & Security menu.

  • Automatic Updates: Ensure that the option for automatic updates is enabled. This setting allows your HoloLens 2 to automatically download and install updates without requiring manual intervention.

• Windows/Mac OS Update on Computer: Ensure that your computer has the latest operating system and security updates installed:

  • Windows: Go to Settings → Update & Security → Windows Update and make sure that updates are set to download and install automatically.

  • macOS: Open System Preferences → Software Update, and enable Automatically keep my Mac up to date.

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Versions and Updates

Augmedit is responsible for all updates to the LumiNE US software, which are automatically deployed in the cloud environment and HoloLens app store once they have been approved, tested, verified, and validated according to the specified regulations and standards listed in section 4. Users will be informed if an update to the Augmented Reality application is required.

The software version number can be found in the "About" section of the 3D viewer, accessible via both the web browser application and the HMD (wireless stereoscopic Head-Mounted Display) application.

Daily backups of configurations and data are created and managed through Azure Backup Vault, with the backup data being immutable to prevent unauthorized changes. Administrators can restore configurations and data using these backups.

Secure Decommissioning: Decommissioning of Lumi for an end user involves uninstalling the Lumi application from the Microsoft HoloLens 2:

• Open Start Menu: On your HoloLens, say "Start" or use the Windows button to open the Start Menu.

• Find the App: Locate the app you want to remove in the list of installed apps.

• Select the App: Press and hold the app icon until a context menu appears.

• Uninstall: Select Uninstall from the menu.

• Confirm: Follow the on-screen instructions to confirm the removal of the app.

 

The app will be uninstalled from your HoloLens 2, freeing up storage space and removing its data. This includes any cached encrypted files