Object Management Object Manipulation

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Using the System

Intended Use

The Brainlab Elements Object Management are applications for the creation, refinement and combination of segmentation objects. The created segmentation objects can be used for further treatment planning.

Indications for Use

Brainlab Elements Object Management can be used in all clinical workflows that require the creation or manipulation of segmentation objects. The device itself does not have specific clinical indications.

Intended Patient Population

There are no demographic, regional or cultural limitations for patients.

Intended Part of the Body or Type of Tissue Applied to or Interacted With

The device is software only. It does not interact with any body parts or tissue.

The review, refinement, combination and margin features are not limited to any body part (i.e., that segmentation objects of any body part can be imported and used in the aforementioned way).

The actual availability of segmentation objects, and thus the intended part of the body, depends on licensing features of Elements Anatomical Mapping.

Intended User Profile

The application is intended to be used by medical professionals and their assistants working in the field of neurosurgery and radiotherapy planning.

Intended Use Environment

The Brainlab Elements Object Management shall be used:

  • In a hospital office environment or at any other location offering a computer

  • In an operating room / suite or in rooms appropriate for surgical interventions

The software can be installed on a standard Windows computer with the defined minimum requirements.

A more specific intended use environment (e.g. a specific planning station or navigation platform) may be present when the device is used in combination with other devices. The intended use environment is then stated in the technical file of the corresponding system.

Plausibility Review

Article No. 60917-69EN

Date of publication: 2018-05-07