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6416h GB/2021-01
1
electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • [email protected]
1.8
Technical data
The ultrasonic bath is interference-free and marked with CE.
Safety: EN 61010-1,
EMC: EN 61326-1
Ambient conditions pursuant to EN 61 010-1
Overvoltage category:
II
Degree of contamination:
2
Permissible ambient temperature:
15 to 35°C
Permissible relative humidity up to 31°C 80%
Permissible relative humidity up to 40°C: 50 %
Altitude:
up to 2,000 m above sea level
No condensation allowed.
For indoor operation only.
Speci
fi
cations for use as a medical device
Name:
Ultrasonic bath
UMDNS nomenclature (ECRI/DIMDI):
14-263
Purpose:
see Section 1.6.
Classi
fi
cation (pursuant to Medical Devices
Directive 93/42/EEC, Annex IX):
Class I; active, non-invasive,
non-implantable medical device
Type, model, serial number, year of manufacture: See type plates for information
The ultrasonic bath has been inspected according to applicable standards and must be
installed and operated according to EMC directions; see Section 1.8.2.
Speci
fi
cations pursuant to the German Medical Devices Operator Ordinance
(MPBetreibV):
On-site commissioning, function check and
personnel instruction (§ 4):
not required
Technical safety control (STK) (§ 11):
Every 2 years by the manufacturer or
authorised skilled personnel
(DIN EN 62353/VDE 0750)
Technical measurement controls (§ 14):
N/A