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9 INFORMATION ON LABELLING AND SAFETY
9.1 LAWS AND PROVISIONS RELATED TO THE PRODUCT
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:
The accident prevention measures, provisions and
requirements in the respective user‘s country apply for users outside the
Federal Republic of Germany.
a. Legend – icons on the device
Device name
Serial number:
Manufacturer with the year of manufacture.
2020
CE mark
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