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

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Tradename

This User Guide is for correct and safe use of LumiNE Lite, which is the tradename of the medical devices "Lumi Prepare" and "Lumi Segment". The accompanying IFU uses "Lumi Prepare" and "Lumi Segment".

This User Guide is for correct and safe use of LumiNE Elite, which is the tradename of the medical device "Lumi Referenced". The accompanying IFU uses "Lumi Referenced".

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Terminology

Lumi does not contain true Holography, which involves recording and reconstructing the light field of an object to create a true 3D image. Lumi 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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Intended Use

LumiNE Lite consists of Lumi Prepare and Lumi Segment. Lumi Prepare is intended for the preoperative investigation of medical scans and 3D models of anatomical and pathological structures of the head, with capabilities for shape editing of the 3D models and virtual surgical treatment planning, both on 2D displays and in Augmented Reality.

Lumi Segment is intended to generate 3D models from medical image data of the head, utilizing AI algorithms for automatic segmentation as well as manual segmentation functionalities. These models can be used for preoperative investigation of potential surgical treatment steps in conjunction with Lumi Prepare.

LumiNE Elite is intended to aid in the intra-operative surgical steps of placing an External Ventricular Drain (EVD). Herein, the device visualizes with Augmented Reality the Scan and 3D Models of the skin, skull, brain, ventricles, and drain in relation to each other during this procedure. While using LumiNE Elite, standard surgical indications and techniques for ventricular drain placement are maintained, ensuring compatibility with established clinical workflows. The device works in conjunction with LumiNE Lite to ensure accurate segmentation and preoperative planning, offering enhanced anatomical insight and support throughout the procedure.

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Indications for Use

LumiNE Lite is intended to be used by qualified surgeons, surgical residents, or medical professionals authorized by a hospital to review or prepare medical imaging data for surgical procedures.​

LumiNE Elite is intended for use in adult patients aged 18 years or older with symptomatic accumulation of cerebrospinal fluid (CSF) inside the cerebral ventricles, regardless of sex, ethnicity, or race.

Each user must be trained before use. The software is not intended for diagnostic use. All pathology visualized or segmented with the software must pertain to conditions that have been previously diagnosed.

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LumiNE Lite supports the conversion of Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) scans of adult patients into 3D models. Supported imaging types include:

• Contrast-enhanced T1 MRI scans (T1c Segmentation Function).

• Non-contrast-enhanced CT scans (CTnc Segmentation Function, Manual Segmentation).

• Contrast-enhanced CT scans (Manual Segmentation).

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The T1c Segmentation Function is indicated for use in patients with a single intracranial contrast-enhancing tumor diagnosed by a neuroradiologist or neurosurgeon. The tumor must meet the following criteria:

• Minimum volume of 2.0 cc (0.1 in³) and maximum volume of 100 cc (6.1 in³).

• Minimum diameter of 15 mm (0.6 inches) and maximum diameter of 75 mm (3.0 inches) in any direction.

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Contra indications for Use

• Diagnostic purposes

• Patients under 18 years of age

• Use during intraoperative surgical steps

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Warnings

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

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

• Next to this User Guide, also consult the Instructions for Use before using LumiNE Elite

• Use only 3D models automatically or manually segmented from the uploaded DICOM by Lumi's segmentation algorithms to create a 3D Patient for the EVD procedure. Externally created or modified 3D models are not supported in LumiNE Elite and may compromise the accuracy of the holographic visualization and EVD procedure.

• Confirm the created 3D Patient using the verification workflow to avoid relying on an incorrect 3D Patient for intraoperative visualization of the drain trajectory.

• Securely attach the reference device on the patients nose and forehead to prevent suboptimal drain visualization based on a misaligned reference device.

• Carefully perform calibration of the reference device to prevent suboptimal drain visualization based on a visual offset of the reference device.

• Check and confirm your planned drain trajectory to prevent deviation in the drain target.

• Do not hand over the HoloLens 2 during an ongoing EVD workflow to prevent potential application instability of crashes. Each EVD workflow should be completed by a single user using a properly calibrated HoloLens 2.

• In case of device failure, immediately disconnect and contact technical support of Augmedit B.V.

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Cybersecurity

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

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

• Audit logfiles: LumiNE Elite collects logfiles on both user and system level to capture activities and events that occur within LumiNE Elite. 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 in 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 Lumi 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.

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

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Versions and Updates

Users are advised to enable automatic updates (default setting). When automatic updates are enabled, the Windows OS on the HoloLens 2 will automatically check, download, and install updates. The device will install updates when the device is turned off or notify users a reboot is required.

Augmedit B.V. is responsible for all updates to LumiNE Lite and Elite, which are automatically deployed in the cloud environment and Microsoft Store once they have been approved, tested, verified, and validated according to the specified regulations and standards. 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 HoloLens 2 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.

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Decommissioning

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