Intended Use; Using The System - Brainlab CURVE DUAL System User's Manual

GENERAL INFORMATION
1.4

Intended Use

1.4.1

Using the System

System Use The Curve system is a navigation platform used for Image Guided Surgery (IGS) incorporating:
• An optical tracking system
• A computer unit that runs the software
• Display unit(s) to display the navigation, including touch functionality for the user to interact with
Place of Use
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:
• Trained hospital personnel (e.g., nurses) are responsible for setting up the system before the
• Sterile nurse is responsible for maintaining sterility during surgery, including the draping of
• Surgeons and/or surgical assistants steer and interact with the Brainlab software running on the
• Brainlab personnel are responsible for system maintenance (see page 29) and support (see
Careful Hardware
Handling
Frequency of Use The frequency of use is defined to be between once per month and several times per week.
System User Guide Rev. 1.0 Curve Dual Display, Curve Single Display Ver. 1.0
the software.
The system is only for use indoors, in a hospital operating room.
surgical procedure and for removing the system after the surgical procedure.
- System setup and removal includes: moving and positioning, plugging cables in/out, startup/
shutdown, cleaning of the system, connecting/disconnecting 3rd party devices.
devices.
system using the system touchscreen(s). For detailed information on use of the software, see
the relevant Software User Guide.
page 8).
System components and accessory instrumentation comprise precise mechanical
parts. Handle them carefully.
Only trained medical personnel may operate system components and accessory in-
strumentation.
11