Roche Multiplate - Page 3

Roche Diagnostics
Operator’s Manual · Version 3.0 3
Multiplate® analyzer
License information
Multiplate
®
analyzer software is protected by contract law, copyright law, and
international treaties. Multiplate
®
analyzer contains a user license between
F. Hoffmann-La Roche Ltd. and a license holder, and only authorized users may
access the software and use it. Unauthorized use and distribution may result in civil
and criminal penalties.
Open-source and commercial
software
Multiplate
®
analyzer may include components or modules of commercial or open-
source software. Copyright and other notices and licensing information regarding
such Software programs can be found on the Multiplate
®
analyzer.
This open-source and commercial software and Multiplate
®
analyzer as a whole can
constitute a device regulated in accordance with applicable law. For more detailed
information, refer to the corresponding user documentation and labeling.
Note that the respective authorization is no longer valid according to the
corresponding legislation should any unauthorized changes be made to Multiplate
®
analyzer.
Trademarks The following trademarks are acknowledged:
Multiplate is a trademark of Roche. Transferpette is a trademark of BRAND.
All other trademarks are the property of their respective owners.
Approvals
The Multiplate
®
analyzer meets the requirements laid down in:
Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices.
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011
on the restriction of the use of certain hazardous substances in electrical and
electronic equipment.
The Multiplate
®
analyzer is manufactured and tested according to the following
international standards:
o IEC 61326-2-6
o 61010-1
o 61010-2-101
Compliance with the applicable directive(s) is provided by means of the Declaration
of Conformity.
The following mark demonstrates compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU directives.