Roche 9180 - Warranty and Approvals; Warranty Information; Regulatory Approvals and Compliance

Roche Diagnostics
Instructions for Use · Version 10.0 3
9180 Electrolyte Analyzer
Warrant y Any customer modification to the system renders the warranty or service agreement
null and void.
For conditions of warranty, contact your local sales representative or refer to your
warranty contract partner.
Always leave software updates to a Roche Service representative, or perform such
updates with their assistance.
Copyright © 1996-2022, F. Hoffmann-La Roche Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:
SNAPPAK, ISETROL are trademarks of Roche.
All other trademarks are the property of their respective owners.
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 Due to the transition phase of IVDD to IVDR, one of the following (Directive or
Regulation) applies to the products in scope of this manual. The applicable one is
mentioned in every product's EU Declaration of Conformity.
Directive 98/79/EC of the European Parliament and of the Council of 27 October
1998 on in vitro diagnostic medical devices. (IVDD)
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. (IVDR)
The 9180 Electrolyte Analyzer meets the requirements laid down in:
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.
This instrument complies with the emission and immunity requirements described
in this part of the IEC 61326 series.
Compliance is provided by means of the Declaration of Conformity.
The following marks demonstrate compliance:
For in vitro diagnostic use.
Complies with the provisions of the applicable EU directives and
regulations.
Issued by TÜV SÜD for Canada and the US.
Laboratory Equipment is the product identifier as shown on the
name plate.