Data Hierarchy, Intended Use, and Safety

Data Hierarchy

LeaRes organizes medical data in a hierarchical structure:

Patient  (one document in the `patients` collection of a tenant database)
└── Events — keyed by a server-generated event ID
    └── Acquisitions — fixed modality buckets, not user-created
        │   (CTscan, XRay, Spirometry, ECG, ABG, Vital Signs, …)
        └── Series — one per DICOM series (radiological buckets only)
            ├── metaD          — DICOM tags (PHI encrypted at rest)
            ├── content        — the 3D volume (stored in GridFS)
            ├── imgX/imgY/imgZ — orthogonal thumbnails
            ├── anatomy        — segmentations
            ├── measures       — rulers, annotations, ellipses
            ├── poses          — saved viewer configurations
            ├── cprs           — saved CPR definitions
            ├── virtualspirometry — virtual spirometry runs
            └── reinflation    — reinflation runs

Non-radiological acquisitions (ABG, ECG, Vital Signs, spirometry reports) have no series level — their records hang directly off the acquisition bucket.

Understanding this hierarchy is essential for navigating and managing patient data effectively. Note that acquisitions are fixed modality buckets — you do not create them, and their names are fixed by the platform.

What the Medical Workflow Is For

The Medical Workflow supports, within the declared intended use:

• Data consistency and plausibility: confirm that acquired imaging data is complete and coherent
• Anatomical reconstruction: build 3D geometry of anatomical structures from imaging
• Digital Twin simulation for study and investigation: model airflow and lung mechanics on reconstructed geometry
• Training: train healthcare operators on anatomy and on the platform itself
• Visualization: generate 3D views for study, discussion, and patient education

Intended Use — What This Means for Patient Data

The full statement of intended use and regulatory status is in Welcome to LeaRes. In short: LeaRes is a CE Class I medical device software whose declared intended use covers confirmation of data consistency and plausibility, Digital Twin simulation for study and investigation, and operator training. It does not provide diagnosis.

Applied to the Medical Workflow, three consequences matter day to day:

• What you reconstruct is geometry, not a report. Segmentation and 3D reconstruction produce anatomical structures. They do not produce findings about pathology — that capability is outside the device perimeter and disabled.
• Simulation results describe the model, not the patient’s future. Treat them as the output of an experiment on reconstructed geometry.
• Two chapters in this section document RUO modules. Virtual Spirometry (chapters 10–11) and Reinflation Analysis (chapters 12–13) sit outside the declared intended use. Their output must not inform a diagnostic or therapeutic decision about an individual patient. Each of those chapters repeats this at the top.

Data protection

Handling patient data with LeaRes carries obligations independent of the device status. Ensure compliance with local regulations on medical data handling and patient privacy (GDPR, HIPAA, and any national requirements). Note that AI-assisted features may transmit data to third-party model providers — see AI Assistant — Basics for scope and limits.

Ready to begin? Proceed to the next tutorial to learn how to upload DICOM data into LeaRes.