Cedex HiRes - Contact Addresses; Declaration of Conformity; Intended Use; Warranty

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Cedex HiRes Analyzer Operator’s Guide
II. Contact Addresses
Manufacturer Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Distribution Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
Distribution in USA Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana
USA
III. Declaration of Conformity
Instrument
approvals
The Cedex HiRes Analyzer meets the protection requirements laid down in:
c
Directive 2014/30/EU of the European Parliament and Council of 26. February 2014 relating to
electromagnetic compatibility (EMC)
c
Directive 2014/35/EU of the European Parliament and Council of 26. February 2014 relating to
electrical equipment designed for use within certain voltage limits
c
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.
Compliance with the applicable directive(s) is provided by means of the Declaration of Conformity.
Regulatory compliance is demonstrated by the following marks:
c Complies with the provisions of the applicable EU directives
c RoHS (Restriction of Hazardous Substances) compliant from Serial No. G037E0001.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US. ‘Laboratory Equipment’ is
the product identifier as shown on the type plate.
IV. Warranty
The warranty conditions are specified in the sales contract. Contact your Roche representative for further
information.
Any unauthorized modification of the Cedex HiRes Analyzer and/or the Cedex HiRes Software will result in
invalidity of the guarantee and service contract.
V. Intended Use
The Cedex HiRes Analyzer automatically determines the cell concentration and viability of cell suspensions. It
must be used exclusively by laboratory professionals who are trained in laboratory techniques and have studied
the Instructions for Use of this system.
The Cedex HiRes Analyzer is for use in quality control/manufacturing process only.
It was neither developed nor validated by the manufacturer for any kind of in vitro diagnostic application.
Contact Addresses