2. Intended Use
2. Intended Use
PAULA the Personal Automated Lab Assistant has been designed for cell culture routine cell checks and ba-
sic cell assays. It can be placed inside the cell culture incubator or outside on a clean bench or standard lab
bench. Up to 4 digital imagers can be combined to acquire simultaneously images and t-lapse series.
Directives of European Community (EC-Directives)
The PAULA system described here fulfills the requirements of EU Directive 2014/53/EU concerning Radio
Equipment Devices and has been declared accordingly. The microscope also fulfills the EU Directive 2014/35/
EU concerning the safety of electrical equipment and 2014/30/EU concerning electromagnetic.
The complete system does not conform to the requirements of an IVD device according to 98/79/EC According
to the VO1194/2012 regulation regarding the implementation of the Ecodesign Directive 2009/125/EC, micro-
scopes are considered special products. The light sources in this instrument are special lamps which are only
suitable for microscopes. They are not suitable for general lighting purposes or room lighting.
Reasonably foreseeable misuse
The following are prohibited:
Using PAULA system for any purpose not in accordance with the Declaration of Conformity (e.g. using it as
an in-vitro diagnostic product according to Council Directive 98/79/EC or as a medical product according to
Council Directive 93/42/EEC)
Cleaning PAULA ( digital imager and NUC PC) in a way other than specified in the manual
Using another power supply that Leica Microsystems CMS GmbH has not provided or permitted
Allowing unauthorized personnel to open the device
Installing PAULA in a way other that Leica Microsystems CMS GmbH has specified in this manual
Using cables that Leica Microsystems CMS GmbH has not provided or permitted
Using PAULA in other environmental conditions than specified in this manual
Using combinations with non-Leica components that go beyond the scope of the manual
To put the power supplies, Intel NUC PC or Monitor/Tablet in the incubator
Caution!
The manufacturer assumes no liability for damage caused by, or any risks arising from, using the microscope
for other purposes than those for which they are intended or not using them within the specifications of Leica
Microsystems CMS GmbH.
In such cases, the Declaration of Conformity shall be invalid.
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