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51506-002 GB/2020-10
1
electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
Ambient conditions pursuant to EN 61 010-1
Overvoltage category:
II
Degree of soiling:
2
Permissible relative humidity up to 31 °C 80 %
Permissible relative humidity up to 40°C: 50 %
Permissible ambient temperature:
5 to 40°C
Temperature in storage:
0 to 50 °C
Altitude:
up to 2000 m
No condensation allowed.
Only for indoor operation.
Speci
fi
cations for use as a medical device
Name:
Ultrasonic
homogeniser
UMDNS nomenclature (ECRI / DIMDI):
17-125
Purpose:
See Chapter 1.2
Medical device pursuant to
Directive 98/79/EC for in-vitro diagnostic medical devices: other IVD
Type, model, serial number, year of manufacture:
See type plate on the ultrasonic
generator for information
The homogeniser has been inspected pursuant to norms currently in e
ff
ect and must be
installed and put into operation pursuant to EMC directions; information in this regard is
found in the Appendix.
Speci
fi
cations pursuant to the German Medical Devices Operator Ordinance (MPBetreibV):
Start-up on location, functional check
and personnel training (section 5):
not required
Technical safety checks, STK (section 6):
no speci
fi
cations
Technical measurement checks, MTK (section 11): not applicable
e-procurement
e-cl@ss:
HD device classi
fi
cation:
32-08-02-02
HD accessories classi
fi
cation: 32-08-02-05