Using The System - Brainlab Buzz Navigation System And Technical User Manual

GENERAL INFORMATION
1.4

Using the System

Intended Use
The Buzz Navigation (Ceiling-Mounted) is a stationary navigation platform used for Image
Guided Surgery (IGS) incorporating an optical tracking system. The computing platform hosts one
or more software applications and facilitates the display and exchange of, as well as the
interaction with data. The Buzz Navigation (Ceiling-Mounted) also offers interaction with
external/additional devices or components within the defined performance specification while used
in the intended use environment.
Place of Use
The system is only for use indoors, in a professional healthcare environment.
Warning
Buzz Navigation (Ceiling-Mounted) has not been tested in HF Surgery environment.
User Profiles
The following lists the intended user profiles, differentiated by their interaction with the device
based on their role.
Clinical Team:
• Non-sterile preparation and set-up prior to use
• Non-sterile handling of ME device during surgery (e.g., re-positioning of camera)
• Sterile or non-sterile interaction with videos, images and data
• Shut down, tidying and storage of equipment after surgery
A more detailed user profile for the clinical team may depend on the application software running
on the device. For details please refer to the respective documentation of the application that will
run on the platform.
Cleaner:
• Cleaning of switched off device
Medical Technician:
• Brainlab trained service personnel:
• Maintenance
• Oversee electrical safety of device during service life
• Disposal of the device after service life
Patient Population
The intended patient population consists of patients that could be treated using Brainlab software
released for the Buzz Navigation (Ceiling-Mounted). For details refer to the relevant Software
User Guide.
Careful Handling of Hardware
System components and accessory instrumentation are comprised of precise mechanical
parts. Handle them carefully.
System and Technical User Guide Rev. 1.2 Buzz Navigation (Ceiling-Mounted) Ver. 1.0
- Installation of device including unpacking and transportation of device to its destination
- Training of users on device
- Troubleshooting and repair of device
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