TECAN
2. General
2006-03 Instructions for Use for sunrise Absorbance Reader No. 30008746 Rev. No. 1.4 2-3
2.2 Area of Application
2.2.1 Intended Use
The sunrise Absorbance Reader is an optical 96-well microplate reader for the
measurement of absorbance, including turbidimetry (optical density) of samples
from biological or non-biological origin. According to the specifications described
in this manual, the instrument is intended for professional use in:
Diagnostic laboratories, Pharmaceutical, biotechnological and life science
industry, for research use, for food analysis, and veterinary applications.
Note
If the sunrise Absorbance Reader or Magellan software
are modified in any way the instrument loses its guarantee
and regulatory compliance.
Note
The operating authority must use only CE-labeled test kits for clinical
diagnostic applications. The operating authority must assure that the
combination of a particular CE-labeled test kit used with the CE-labeled
sunrise Absorbance Reader has been designed to meet the IVD directive
98/79/EC or other relevant national or local regulations.
If the
sunrise Absorbance Reader is used with other software other than
Magellan, additional validation must be carried out by the operating authority to
ensure the safety of the results. The operating authority is fully responsible for
any results obtained using software other than Magellan with the
sunrise
Absorbance Reader.
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