1.3 Intended Use
1.3.1 Using the System
System Use
The Curve system is a navigation platform used for Image Guided Surgery (IGS) incorporating:
• An 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.
Technical Specifications
The technical specifications of Curve hardware components are subject to change due to
technical developments.
Careful Hardware Handling
Only trained medical personnel may operate system components and accessory
instrumentation.
System components and accessory instrumentation comprise precise mechanical parts.
Handle them carefully.
Changes to the System
No modifications of the systems are allowed. Making changes to the specified product and
its intended use may result in severe harm to the patient, user or third-party.
MR Environment
The Curve system has not been tested in an MR environment.
Plausibility Review
Before patient treatment, review the plausibility of all information input to and output from
the system.
ME Systems
Additional equipment connected to medical electrical equipment must comply with the
respective IEC or ISO standards (e.g., IEC 60950 for data processing equipment and IEC
60601-1 for medical equipment). Furthermore, all configurations shall comply with the
requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of edition 3.1
of IEC 60601-1, respectively). Anyone connecting additional equipment to the Curve
System configures a medical system and is therefore responsible that the system complies
with the requirements for medical electrical systems. Please note that local laws take
priority over the above-mentioned requirements. In doubt, consult your local
representative or the technical service department.
GENERAL INFORMATION
Technical User Guide Rev. 1.1 Curve Dual Navigation Station Ver. 1.2 13
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