Using the System
Abbreviated Device Description
Cranial IGS System Ultrasound Navigation is software that runs on a Brainlab IGS platform or Brainlab navigation system, which consists of a computer, a display and an infra-red (IR) tracking camera. It can be used in conjunction with other Brainlab Image Guided Surgery (IGS) software. Designed to assist during surgeries it provides intra-operative ultrasound functionality by:
- Linking the 2D ultrasound view to preoperative patient image data by overlaying the 2D ultrasound image with the patient image data (e.g., CT/MR and derived data such as segmented objects, fibers, etc.)
- Acquisition of 3D ultrasound data sets consisting out of 2D ultrasound image slices and enabling other Brainlab IGS software navigating and viewing as well as further processing this data.
The Cranial IGS System, when used with a compatible navigation platform and compatible instrument accessories, is intended as image guided planning and navigation system to enable navigated surgery. It links instruments to a virtual computer image space on patient image data being processed by the navigation platform.
Indications for Use
Ultrasound Navigation is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (CT, CTA, X-ray, MR, MRA and ultrasound) of the anatomy, including:
- Resection of tumors and other lesions
- Resection of skull-base tumor or other lesions
Place of Use
The application is developed to run on Brainlab IGS Platform or navigation system, which shall be used in hospital environments, specifically in rooms which are appropriate for surgical interventions; e.g., operation rooms.
The intended user profile is defined as follows:
- Brainlab software, hardware and platforms are used by neurosurgeons, surgeon’s assistants and OR-nurses.
- Brainlab hardware and platforms are handled by trained OR staff and maintained by trained Brainlab personnel
There are no demographic, regional or cultural limitations for patients. It is up to the surgeon to decide if the system shall be used to assist a certain treatment.