zebris Medical GmbH
FDM Technical Data and Operating Instructions
Page 32/36
8 Safety standards and system classification
8.1 Classification acc. to Annex IX of Directive 93/42/EEC
Class I with measurement function
8.2 Safety of medical electrical devices
The system meets the requirements of the standards DIN EN 60601-1
Electrical Safety Standard
BF
Safety class II
Steady state conditions
8.3 Connecting the FDM-System to other electrical devices
Important notes on medical electronically systems
NOTE
You are allowed to combine the system only with additional tools
that fulfill the regulations EN 60950 / EN 60601 part 1.
The electrical combination of the complete system is to be done
according to EN 60601-1-1.
WARNING
The computer and other non-medical tools have to be located
beyond the reach of the patients (1.5 m).
