Using The System - Brainlab Buzz 2.0 System And Technical User Manual

GENERAL INFORMATION
1.4

Using the System

Intended Use and Indications for Use/Intended Purpose
Buzz 2.0 is intended for use as a stationary computing platform hosting one or more software
applications. Buzz 2.0 facilitates the display and exchange of, as well as the interaction with data.
Buzz 2.0 also offers interaction with external/additional devices or components within the defined
performance specification while used in the intended use environment.
The intended medical indication depends on the application software running on the device. For
details please refer to the respective system documentation.
Place of Use
The system is only for use indoors, in a professional healthcare environment.
Frequency of Use
The frequency of use is defined to be between once per week and several times per day.
User Profile
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 usage of videos, images and data
• Shut down and tidying of equipment after surgery
A more detailed user profile for the clinical team may depend on the application software running
on the platform incorporating the Wall Display. For details please refer to the respective system
documentation.
Cleaner:
• Cleaning of switched off device
Medical Technician:
• Maintenance
• Oversee electrical safety of device during service life
• Disposal of the device after service life
Patient Population
The intended patient population is not limited to a specific patient group. There are no
demographic limitations for patients.
Essential Performance
The device has no clinical functions, especially no functions where loss or degradation lead to a
risk beyond basic safety aspects. Therefore the device has no essential performance
characteristics.
Clinical Benefit
Buzz does not have any clinical benefits nor clinical performance. In combination with the
software applications running on Buzz, it supports the clinical performance of these software
applications.
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