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9
9.1
This device is designed in accordance with Medical Device Directive
93/42/EEC, Class II a, and corresponds to protection class II. type BF
pursuant to DIN EN 60601-1
DIN EN 60601-1
General requirements for basic safety and essential performance
DIN EN 80601-2-30
Particular requirements for the basic safety and essential performance of
automated type non-invasive sphygmomanometers
DIN EN 60601-1-2
Electromagnetic compatibility: the device complies with the standard's
requirements for electromagnetic compatibility.
Other provisions:
requirements in the respective user's country apply for users outside the
Federal Republic of Germany.
a. Legend – icons on the device
2020
ERKA_Manual_ERKA125_PRO_11_2020.indd 36
ERKA_Manual_ERKA125_PRO_11_2020.indd 36
INFORMATION ON LABELLING AND SAFETY
LAWS AND PROVISIONS RELATED TO THE PRODUCT
The accident prevention measures, provisions and
Device name
Serial number:
Manufacturer with the year of manufacture.
CE mark
3752) to receive advice from our
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26.11.2020 10:56:54