9 / 3851406c GB/2019-07
1 electronic GmbH & Co. KG • Heinrichstraße 3-4 • 12207 Berlin • Deutschland • info@bandelin.com
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
No dewing allowed.
Only for indoor operation.
Specifi cations for use as a medical device
Name: Ultrasonic Homogenizer
UMDNS nomenclature (ECRI / DIMDI): 17-125
Purpose: homogenizing, emulsifying, cell disruption
and suspension
Medical device pursuant to
Directive 98/79/EC for in-vitro diagnostics: Category 5 device (miscellaneous)
Type, model, serial number, year of manufacture: See type plate on the generator for
information
The homogenizer has been inspected pursuant to norms currently in effect and is to be installed
and put into operation pursuant to EMC directions; information in this respect is found in the
appendix.
Specifi cations pursuant to the Medical Devices Operator Ordinance (MPBetreibV):
Commissioning on site, functional check and
personnel instruction (section 5): Not required
Technical safety controls (section 6): No specifi cations
Technical measurement controls (section 11): N/A
e-procurement
e-cl@ss:
HD device classifi cation: 32-08-02-02
HD accessories classifi cation: 32-08-92-03
1.4.1.1 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.
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