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Protected against access to hazardous parts
with tools; protected against solid objects with
a diameter of 2.5 mm or larger
Not protected
Protected against access to dangerous parts
with
fi
ngers Protected against solid foreign
bodies with a diameter of 12 mm or larger
Not protected
IP 20 according to DIN EN 60529
IP 30 according to DIN EN 60529
9 / 48
51376g GB/2018-04
1
electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
Environmental conditions pursuant to EN 61 010-1
Overvoltage category:
II
Degree of contamination:
2
Permissible relative humidity up to 31 °C: 80 %
Permissible relative humidity up to 40 °C: 50 %
Permissible ambient temperature:
5 to 40 °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:
Category 5 device (miscellaneous)
Type, model, serial number, year of manufacture:
See type plate on the generator for information
The homogeniser has been inspected pursuant to norms currently in effect 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 Medical Devices Operator Ordinance (MPBetreibV):
Start-up on location, functional check
and personnel training (section 5):
not required
Technical safety controls, (STK, section 6):
no speci
fi
cations
Technical measurement controls, (MTK, section 11): not applicable
e-procurement
e-cl@ss:
HD device classi
fi
cation:
32-08-02-02
HD accessories classi
fi
cation: 32-08-92-05
1.4.2
Degree of protections
Summary of Contents for Sonopuls HD 4050
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