Using The System - Brainlab CURVE System And Technical User Manual

GENERAL INFORMATION
1.4

Using the System

Intended Use
The Curve system is a navigation platform used for Image Guided Surgery (IGS) incorporating:
• A tracking system (optical or electromagnetic)
• A computer unit that runs the software
• Display units to display the navigation, including touch functionality for the user to interact with
the software.
Place of Use
The system is only for use indoors, in a hospital operating room.
No components can be used in HF surgical equipment environment.
Patient Population
The patient population consists of patients that could be treated via Brainlab application software
that are released for this Image Guided Surgery (IGS) device.
For details please refer to the relevant Software User Guide.
User Profile
The following describes the intended users of the system and their respective tasks:
• The clinical team (e.g., nurses) is responsible for transporting the Curve into the OR, setting up
and preparation of the system for sterile use prior to surgery with constant control of sterility
during surgery as well as shutting down, tidying and storage of the system after surgery.
• The clinical team (e.g., surgeons) is responsible for the configuration of the clinical setup and
the sterile use of Curve (interaction with Brainlab application Software and Hardware) during
image guided surgery.
• The cleaner is responsible for cleaning and storage of the device.
• The Brainlab medical technician is responsible for installation of the Brainlab device as well as
system maintenance, repair and support.
• The hospital medical technician is responsible for overseeing electrical safety of installed
devices and contacting Brainlab in case of additional support.
Frequency of Use
The frequency of use is defined according IEC 60601-1-6 to be between once per month and
several times per week.
Technical Specifications
The technical specifications of Curve hardware components are subject to change due to
technical developments.
Careful Hardware Handling
Warning
Only trained medical personnel may operate system components and accessory
instrumentation.
System and Technical User Guide Rev. 1.0 Curve Dual Navigation Station Ver. 1.2 13