2. General
2021-07
Instructions for Use for SUNRISE No. 30086638 Rev. No. 2.9
13
2.2
Area of Application
2.2.1
Intended Use
The SUNRISE instrument is a 96-well absorbance reader for the measurement of
light absorbance (optical density) of liquid media. The instrument is intended to
be used primarily in in-vitro diagnostic analysis of samples from the human body
to obtain information on physiological and pathological states.
For applications in human clinical diagnostic uses, only the Magellan software is
intended for the use with the instrument. Software and instrument have been
validated for measurement and for the evaluation of qualitative and quantitative
Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled
diagnostic parameters and instrument specifications; they are therefore for
professional use in in-vitro diagnostics.
Note
If the SUNRISE or the Magellan software is modified in any way, the
warranty will no longer be valid and the instrument will lose regulatory
conformity.
Note
Results obtained using the SUNRISE are influenced by the proper use of
the instrument and microplates, according to the instructions given in
this document, as well as the liquid compounds used (reagents,
chemistry). The instructions for use, storage, and applications involving
samples or reagents must be followed strictly. Results must therefore be
interpreted carefully.
