TECAN 2. General2006-03 Instructions for Use for sunrise Absorbance Reader No. 30008746 Rev. No. 1.4 2-32.2 Area of Application2.2.1 Intended UseThe sunrise Absorbance Reader is an optical 96-well microplate reader for themeasurement of absorbance, including turbidimetry (optical density) of samplesfrom biological or non-biological origin. According to the specifications describedin this manual, the instrument is intended for professional use in:Diagnostic laboratories, Pharmaceutical, biotechnological and life scienceindustry, for research use, for food analysis, and veterinary applications.NoteIf the sunrise Absorbance Reader or Magellan softwareare modified in any way the instrument loses its guaranteeand regulatory compliance.NoteThe operating authority must use only CE-labeled test kits for clinicaldiagnostic applications. The operating authority must assure that thecombination of a particular CE-labeled test kit used with the CE-labeledsunrise Absorbance Reader has been designed to meet the IVD directive98/79/EC or other relevant national or local regulations.If the sunrise Absorbance Reader is used with other software other thanMagellan, additional validation must be carried out by the operating authority toensure the safety of the results. The operating authority is fully responsible forany results obtained using software other than Magellan with the sunriseAbsorbance Reader.
