Intended Use - Brainlab KICK 2 System And Technical User Manual

GENERAL INFORMATION
1.4

Intended Use

Intended System Use
Kick 2 is intended for use as a mobile computing platform hosting one or more software
applications. Kick 2 facilitates the display and exchange of, as well as the interaction with data.
Kick 2 also offers interaction with external/additional devices or components within the defined
performance specification while used in the intended use environment.
Integrating a suitable tracking unit and using a suitable application software, Kick 2 can be used
as navigation station.
Intended User Profile
The following describes the intended users of the system and their respective tasks.
Clinical team:
• Non-sterile preparation and set-up prior to surgery
• Non-sterile handling of device during surgery e.g., re-positioning of cart
• Sterile or non-sterile interaction with videos, images and data
• Shut down, tidying and storage of equipment after surgery
Cleaning staff:
• Cleaning of device after shut down
Hospital technician:
• Maintenance
• Oversee electrical safety of device during service life
• Disposal of the device after service life
Brainlab service:
• Installation of device including unpacking and transportation of device
• Training of users on device
• Troubleshooting and repair of device
Patient Population
The intended patient population consists of patients that could be treated via Brainlab application
software that are released for the Kick 2.
For details refer to the relevant Software User Guide.
Place of Use
The system is only for use indoors, in a professional healthcare facility.
Frequency of Use
The frequency of use is defined to be between once per month and several times per week.
Essential Performance
As essential performance is defined by the clinical function(s), it is dependent on the Brainlab
application used and the clinical procedure. Consult the corresponding Software User Guide to
see if an essential performance is defined, and if so, which essential performance.
System and Technical User Guide Rev. 1.3 Kick 2 Navigation Station 13