Intended Purpose Of Microscopes - Leica DM2000 Operating Manual

2. Intended Purpose of Microscopes

The Leica DM2000 and DM2500 microscopes, to
which this user manual belongs, are designed
for biological routine and research applications.
This includes the examination of samples taken
from the human body with a view to provide in-
formation on physiological or pathological
states or congenital abnormalities, or to deter-
mine the safety and compatibility with potential re-
cipients, or to monito therapeutic measures.
All the above-named microscopes comply with
the Council Directive 98/79/EEC concerning in
vitro diagnostics. They also conform to the
Council Directives 73/23/EEC concerning electri-
cal apparatus and 89/336/EEC concerning elec-
tromagnetic compatibility for use in an industrial
environment.
2. Intended Purpose of Microscopes
Caution!
The manufacturer assumes no liability for
damage caused by, or any risks arising from
using the microscopes for other purposes
than those for which they are intended or
not using them within the specifications of
Leica Microsystems Wetzlar GmbH.
In such cases the conformity declaration
shall cease to be valid.
Caution!
These (IVD) devices are not intended for use
in the patient environment defined by DIN
VDE 0100-710. Neither are they intended for
combining with medical devices according
to EN 60601-1. If a microscope is electrically
connected to a medical device according to
EN 60601-1, the requirements defined in
EN 60601-1-1 shall apply.
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