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The Sonowand Invite System is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone ultrasound scanner. The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.

The 510(k) cleared SonoWand Invite System is a neuronavigation system with intraoperative imaging capabilities. An ultrasound scanner is physically integrated with a neuronavigation system in a single rack of equipment. SonoWand Invite can be used as a conventional neuronavigation system based on preoperative MR or CT-images, or as a stand-alone ultrasound scanner for real-time 2D imaging or as a combined system where 3D ultrasound data can be transferred to the navigation system for direct navigation. SonoWand Invite has basically two functionalities. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images. It also makes it possible for the surgeon to acquire ultrasound images during operation, which can be compared with other images (such as MR or CT) and can be used for supporting the surgeon by showing the position of tools and pointers. The control is primarily by a graphical touch screen. The secondary control is by a footswitch. The new accessories, General purpose localizers with adapters, shall be used to attach surgical tools manufactured by other vendors. SonoWand Invite will then display position and orientation of the tools in the medical images on the screen in the same way as the previous 510(k) cleared Navigator tool. The localizers with adapters are designed to fit surgical tools normally used in the operating room. There are no changes to the Intended use, function or technological aspects including software of the SonoWand Invite. The additional accessories are being added to increase usability of the SonoWand Invite system.

The Sonowand is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. The Sonowand is intended for use as a standard neuronavigation system. The Sonowand is intended for use as a stand-alone ultrasound scanner.

Invite is an integrated neuronavigation system with intraoperative imaging capabilities. The main components of the system are a navigation computer running the Invite software application, an ultrasound scanner and a tracking system in a single rack of equipment. Invite can be used as a conventional neuronavigation system based on preoperative MR or CTimages, or as a stand-alone ultrasound scanner for real-time 2D imaging. It can also be used as a combined system where high-quality 3D ultrasound data can be transferred to the navigation system for direct navigation. Thus, the surgeon can navigate not only on a preoperative 3D map (MR or CT), but also on an intraoperative 3D ultrasound map which is only a few seconds old. The acquisition time is less than one minute, which means that the surgeon can typically update the navigation map 5-10 times during the surgery. The problem with brain shift is therefore practically eliminated. The system is contained on a trolley with lockable wheels. This trolley contains power supply, power restrictor, on/off main switch, network and USB ports, an industrial standard PC (navigation computer), the ultrasound unit (GE Vivid-i), probe interface, wiring and cabling. Attached to the trolley is a steel tube column which supports two pendant arms. One of these arms supports an infrared camera (NDI Polaris Spectra). The other arm supports a touch screen. which is the primary user interface. Invite has two functions. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images (which will normally show features such as brain tumors). It also makes it possible for the surgeon to acquire ultrasound images during operation which can be compared with other images (such as MR or CT) and can be used for supporting the surgeon by showing the position of tools and pointers. The control is primarily by a graphical touch screen (which can be draped). The secondary control is by a footswitch. Data sets (preoperative MR/CT and intraoperative 3D ultrasound) can be used for planning the surgery as well as to navigate in the brain. As the surgery progresses, the accuracy and value of the preoperative images will normally decrease, while ultrasound images will maintain a more precise representation of the true anatomy if these images are updated regularly. Digital snapshots of the screen can easily be stored during surgery for documentation purposes. It is also possible to review the data sets and to store images after surgery.