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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.
2.4.2 User Qualification Matrix
The User Qualification Matrix represents an overview for activities associated with the
device during its life cycle.
Activity
Transport
Installation
Operation
Cleaning
Decontamination
Maintenance
Technical
Service
Uninstalling
Packing
Disposal
2.5 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 sun light should be avoided.
•
Operating temperature range:
•
Relative humidity:
2.6 Prohibition and warning signs on the device
The following prohibition and warning signs have been affixed to the device.
CyFlow™ Cube 6 V2m | Operating Manual | February 2020
Table 3: User Qualification Matrix
Instructed
personnel
✓
✓
✓
15 °C to 30 °C
between 20 % and 85 %, non-condensing.
Qualified
Authorised service
personnel
✓
✓
✓
✓
✓
✓
✓
✓
2 Safety
personnel
✓
✓
✓
✓
✓
✓
✓
✓
✓
✓
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