Intended Purpose Of The Microscope - Leica DMI Series Instructions Manual

2. Intended Purpose of the Microscope

The Leica DMI Series microscopes covered in
this manual are designed for biological, routine,
and research applications. This includes the ex-
amination of samples taken from the human body
in order to provide information on physiological
or pathological states or congenital abnormali-
ties; to determine the safety and compatibility
with potential recipients; or to monitor therapeu-
tic measures.
The Leica DMI Series is an additional develop-
ment of Leica's proven inverted research mi-
croscopes, designed for cellular and tissue
examination, micromanipulation and microinjec-
tion techniques, microdissection, and confocal
microscopy. The Leica DMI Series is suitable
for universal deployment. All contrast methods
such as dark fi eld, bright fi eld, phase contrast,
DIC, fl uorescence, and modulation contrast are
integral to the microscope and can be adapted
or changed quickly and easily. Variable illumi-
nation and imaging beam paths, as well as HCS
optics, modular accessories, and a comprehen-
sive range of peripherals complement the Leica
Microsystems inverted research stand.
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2. Intended Purpose of the Microscope
IVD
The above-named microscopes comply with the
Council Directive 98/79/EEC concerning in vitro
diagnostics.
Caution!
The manufacturer assumes no liability for
damage caused by, or any risks arising from,
using the microscopes for purposes other
than those for which they are intended or not
using them within the specifi cations of Leica
Microsystems CMS GmbH.
In such cases the declaration of conformity
shall cease to be valid.
Caution!
These (IVD) devices are not intended for use
in the patient environment defi ned by DIN
VDE 0100-710. Neither are they intended for
combining with medical instruments accord-
ing to EN 60601-1. If a microscope is electri-
cally connected to a medical instrument
according to EN 60601-1, the requirements
defi ned in EN 60601-1-1 shall apply.
Not suitable for examining potentially infec-
tious specimens.
Only trained personnel may operate this type
of device.
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