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6366-006 GB/2020-09
1
electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
Ambient conditions according to EN 61 010-1
Overvoltage category:
II
Degree of contamination:
2
Permissible ambient temperature:
5 to 40°C
Permissible relative humidity up to 31°C:
80%
Permissible relative humidity up to 40°C:
50%
Altitude:
up to 2000 m above sea level
No dewing.
Only for indoor operation.
Speci
fi
cations for use as a medical device
Name: Ultrasonic
bath
UMDNS nomenclature (ECRI / DIMDI):
14-263
Purpose:
See chapter 1.2.
Classi
fi
cation according to Directive 98/79/EC
for in-vitro diagnostic equipment:
other IVD
Type, model, serial number, year of manufacture: See type plate on the rear side for information
The ultrasonic bath has been inspected pursuant to norms currently in e
ff
ect and is to be installed
and put into operation pursuant to EMC directions.
Speci
fi
cations pursuant to the Medical Devices Operator Ordinance (MPBetreibV):
Startup on location, functional check
and personnel training (section 4):
not required
Technical safety controls, (STK, section 11):
no speci
fi
cations
Technical measurement controls, (MTK, section 14): not applicable
1.4.1
Electromagnetic ambient conditions (EMC)
The device was tested to DIN EN 61326-1 for electromagnetic compatibility (EMC) and complies
with the requirements for class B devices according to EN 55011.
It is suitable for use in facilities and areas which are directly connected to a public low-voltage
supply network, e.g. medical laboratory facilities.
It may generate radio interferences or disrupt the operation of devices nearby. It may be necessary
to take remedial measures such as realigning the device or a recon
fi
guring the ultrasonic bath or
the shield.
During operation, portable or mobile HF communication systems in the vicinity of the ultrasonic
bath should be turned o
ff
- their operation may be disrupted.