tecan MIO2 - Operating Company; User Qualification

2 - Safety
Operating Company
MIO2 Operating Manual, 394934, en, V3.0 2 - 3
 Risk of spillage. Microplate filled over the specified fill level will lead to spillage
during operation resulting in contamination.
– Make sure the microplate is not filled more than the specified fill level.
 The MIO2 has to be operated with heat-resistant microplates.
 Risk of deformation of microplates. Non heat-resistant microplates will get
deformed if heated up.
– Make sure only heat-resistant microplates are used for incubation.
 Caustic substances can cause burns and eye injury.
– Avoid exposure to caustic substances.
 Avoid the formation and accumulation of flammable vapors.
 Avoid the spillage of flammable material.
 Prior to using hazardous materials perform a risk assessment.
 Consider specific workplace conditions, such as temperature, air ventilation,
electrostatic discharge.
 Make sure that the risk is acceptable prior to use of the instrument.
 The MIO2 is a heated device. The outer surface may develop temperatures
up to a maximum of 45°C.
– Let the MIO2 cool down hand-hot before removal.
2.3 Operating Company
The operating company must ensure that the MIO2 and in particular the safety
features, function properly and that all the personnel in contact with the instrument
are adequately trained.
Responsibilities  Method and process validation.
 Defining the processes in compliance with the Standard Operating
Procedures.
 Ensuring that installation and operational qualifications (IQ OQs) have been
completed.
 Ensuring that all personnel in contact with the MIO2 are adequately trained.
 Ensuring the availability of appropriate protective clothing and equipment.
 Ensuring the maintenance and safe operation of the MIO2.
 Requiring adherence to laboratory safety regulations and directives.
2.4 User Qualification
The laboratory personnel must be fully qualified and trained to operate the MIO2.
The work described in this Operating Manual must only be performed by
authorized personnel with the qualifications prescribed below.
Laboratory personnel must:
 have suitable technical training,
 be familiar with the laboratory safety regulations and directives,
 be familiar with the instructions for the safety elements of the instrument,
 use protective clothing and equipment,
 be familiar with and adhere to good laboratory practices,