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51346-007 GB/2020-08
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 ambient temperature:
5 to 35 °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 condensation allowed.
Only for indoor operation.
Speci
fi
cations for use as a medical device
Name: SONOCOOL
UMDNS nomenclature (ECRI / DIMDI):
14-263 (ultrasound cleaning unit)
Purpose: See chapter 1.2
Medical device pursuant to
Directive 98/79/EC for in-vitro diagnostic medical devices: Device category 5 bath
Type, model, serial number, year of manufacture:
See type plate for information
The ultrasonic bath has been inspected according to applicable standards and must be
installed and operated according to EMC directions; see appendix.
Speci
fi
cations pursuant to the Medical Devices Operator Ordinance (MPBetreibV):
Start-up on location, functional check
and personnel training pursuant to section 4:
not required
Technical safety controls (STK) pursuant to section 11:
no speci
fi
cations
(DIN EN 62353 / VDE 0750)
Technical measurement controls (MTK) pursuant to 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.