Roche cobas c 513 User Manual

Roche Diagnostics
cobas c 513 analyzer · Software Version 02-05 · Safety Manual · 6.0
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Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of
this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any such feedback.
Approvals The cobas c 513 analyzer complies with the following
directives and regulations:
Directive 98/79/EC of the European Parliament and of the
Council of 27 October 1998 on in vitro diagnostic medical
devices.
Regulation (EU) 2017/746 of the European Parliament and
of the Council of 5 April 2017 on in vitro diagnostic
medical devices and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU.
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.
Directive (EU) 2015/863 of 31 March 2015 amending
Annex II to Directive 2011/65/EU of the European
Parliament and of the Council as regards the list of
restricted substances.
Directive 2014/53/EU of the European Parliament and of
the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
Regulation (EU) No 517/2014 of the European Parliament
and of the Council of 16 April 2014 on fluorinated
greenhouse gases and repealing Regulation (EC) No
842/2006.
Compliance of specific instruments with the respective
directives or regulations is provided by means of the
Declarations of Conformity where applicable.
Check the serial number of the instruments to identify the
applicable directives and/or regulations.
Fluorinated greenhouse gases specifications can be
found in supporting information identified by serial
number of the instruments.
All documents are available under eLabDoc on the Roche
DiaLog website: www.dialog.roche.com.
If you are unable to access Roche DiaLog, contact your
Roche Service representative.

Roche cobas c 513 Specifications

General

Brand	Roche
Model	cobas c 513
Category	Measuring Instruments
Language	English