2 Safety
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Instructions for use
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MERGITE!
2
Safety
2.1 Intended purpose
MERGITE! is an in vitro diagnostic device that standardizes and
automates the washing processes of indirect immunofluorescence
tests using the Titerplane
™
technique.
Carriers support the handling of primary samples on glass plates, the
incubation and the mounting of the slides.
MERGITE! is intended exclusively for immunofluorescence tests by
EUROIMMUN AG which use the Titerplane technique.
It does not provide any diagnostics or suggestions for diagnosis.
The system has to be used in laboratory conditions in a defined place
and may not be used in an environment close to the patient. The
system can be used several times per day. It encompasses the
device and the software and may only be used by trained
professional staff.
All results have to be checked by trained medical staff. The diagnosis
or ruling out of an illness as well as an assessment of its likelihood
require a combination of epidemiological, anamnetic, medical and
diagnostic results which have to be taken into account for the
interpretation of the test results.
2.2 Validity
The immunofluorescence tests of EUROIMMUN AG and the
washing processes (assays) on MERGITE! system are subject to
ongoing development. The document YG_0064_UK_WXX (or
YG_0064_CA_WXX for Canada) contains a list of all validated
immunofluorescence tests for the device. It is included in the scope
of delivery.
For further information on using the device with specific test sets,
contact your customer support or visit our customer portal
(www.euroimmun.de).
2.3 Technical safety
2.3.1 Introduction
Dangers can arise for the user if the device is not used correctly, or is
used without due care.
