1 Introduction
Instructions for use
•
MERGITE!
17/84
1.5 Guidelines, laws, standards
Information on complying with the regulations on device safety
pursuant to the EC declaration of conformity.
MERGITE! was developed and manufactured for
in vitro
diagnostics in accordance with the current state of the art in
compliance with the requirements in EC Directive 98/79/EC
The product has been tested for compliance with the relevant
standards for IVD laboratory devices,
EN 61010-1 (IEC 61010-1)
and
EN 61010-2-101
and corresponds to the specific safety requirements
defined by the regulations on device safety.
Moreover, the product satisfies the requirements of the
EN 61326-1
standard (electrical equipment for measurement, control and
laboratory use – EMC requirements) and complies with the limit
values in accordance with DIN EN 55011, Group 1,
Class A
.
The product also fulfils the
ANSI C63.4:2014
(FCC Part 15, Subpart
B) and complies with its limit values.
1.6 Warranty
The statutory warranty periods applicable in the Federal Republic of
Germany, where the product was manufactured, apply.
1.7 Limitation of liability
The validation carried out by the EUROIMMUN Medizinische
Labordiagnostika AG (hereinafter referred to as EUROIMMUN AG
for short) comprises MERGITE! as a system for supporting IFA
protocols in combination with certain EUROIMMUN reagents. As a
result, the acceptance of liability requires that only EUROIMMUN AG
reagents are used together with the system subject to the standard
operating procedures released by EUROIMMUN AG.
By contrast, no liability is accepted if the device is validated in
combination with reagents provided by other manufacturers. An
acceptance of liability also requires that protocols processed using
the MERGITE! are always checked for their correctness by the user.
EUROIMMUN AG is generally liable for breaches of contractual
obligations of its legal representatives or vicarious agents and for tort
only for intentional or grossly negligent actions, and otherwise only in
the event of breach of an essential contractual obligation but limited
in amount to damages foreseeable at the time of conclusion of the
agreement and typical for the agreement.
