Automatic Registration iMRI

Versiune software: 1.0
Revizie: 1.0

Using the System

Intended Use

The Brainlab Cranial IGS System is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a magnetic sensor system or a passive marker sensor system to a virtual computer image space on patient image data being processed by the navigation workstation. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.

Intended Use Environment

The device is intended to be used in an OR environment.

The environmental requirements depend on the navigation station used and are specified for each navigation platform individually in their own documentation (refer to the corresponding technical documentation of the platform).

Intended User Profile

The intended user profile is defined as follows:

  • Neurosurgeons or their assistants having an iMRI acquisition system
  • Trained Brainlab personnel
    • Responsible for product maintenance and support

Patient Population

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.

Careful Handling of Hardware

Caution

Plausibility Review

Warning
Art-No. 60917-80EN

Data apariției: 2019-11-25