3.4.1 User qualification groups
Instructed personnel
Instructed personnel have to be trained by qualified personnel or personnel authorised by
Sysmex to operate the device within the scope of the intended use. They have to be able
to assess if the device can be safely used and are proficient in handling hazardous
substances.
Qualified personnel
Qualified personnel have in-depth knowledge of the device and the applications. They
have been trained by personnel authorised by Sysmex to operate the device, to perform
cleaning and certain maintenance operations. Qualified personnel have a scientific or
technical education and several years of experience in flow cytometry and are proficient in
handling hazardous substances.
Authorised service personnel
Personnel conducting technical service must be authorised by Sysmex. Please contact
the service department of your local Sysmex representative.
3.4.2 User Qualification Matrix
The User Qualification Matrix represents an overview for activities associated with the
device during its life cycle.
Table 3: User Qualification Matrix
3.5 Environmental conditions
The device may only be used in laboratories. The specified ambient temperature and
relative humidity conditions must be maintained at all times.
The laboratory environment must be clean. Direct sunlight should be avoided.
• Operating temperature range: 15 °C to 30 °C
• Relative humidity: between 20 % and 85 %, non-condensing.
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