Brainlab ExacTrac - Legal Information

1.1.2 Legal Information
Copyright
This guide contains proprietary information protected by copyright. No part of this guide may be
reproduced or translated without express written permission of Brainlab.
Brainlab Trademarks
•
ExacTrac
®
is a registered trademark of Brainlab AG in Germany and/or the US.
•
Brainlab
®
is a registered trademark of Brainlab AG in Germany and/or the US.
Non-Brainlab T
rademarks
•
Microsoft
®
and Windows
®
are registered trademarks of Microsoft Corporation in the United
States and other countries.
•
Exact
®
, Truebeam
®
, TrueBeamSTx
®
and PerfectPitch
®
are registered trademarks of Varian
Medical Systems, Inc.
CE Label
• The CE label indicates that the Brainlab product complies with the essential re-
quirements of European Council Directive 93/42/EEC, the Medical Device Di-
rective (MDD).
• According to the rules established by the MDD, ExacTrac is a Class IIb prod-
uct.
NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.
Disposal Instructions
The collimators contain lead and should only be disposed of in accordance with statutory
regulations.
Only dispose of electrical and electronic equipment in accordance with statutory regu-
lations. For information regarding the WEEE (Waste Electrical and Electronic Equip-
ment) directive, visit:
www.brainlab.com/en/sustainability
Sales in the US
US federal law restricts this device to sale by or on the order of a physician.
Electronic Product Radiation Control (EPRC) Program (US Only)
According to the product classification for medical devices of the FDA Center for Devices and
Radiological Health, ExacTrac is defined as a medical charged-particle radiation therapy system
(product code IYE).
Based on 21 CFR (Code of Federal Regulations T
itle 21) of the CDRH, no performance standard
is applicable and General Radiological Health requirements apply (21 CFR 1000 - 1005).
Contact Data and Legal Information
8 Site Planning Manual Rev
. 1.0
ExacTrac Ver. 6.x