zebris Medical GmbH
FDM Technical Data and Operating Instructions
Page 48/54
7
Safety standards and system classification
The following information and warnings are listed according to the requirements of the stand-
ard DIN EN 60601-1:2006, section 11 for medical, electrical systems and must be applied
when operating the FDM system for medical purposes.
7.1
Classification acc. to Annex IX of Directive 93/42/EEC
If your FDM platform features a CE sign on the nameplate with a four-digit identification
number of a notified body (0535), the system is then classified as medical product
Class I
with measuring function
.
7.2
Safety of medical electrical devices
The FDM platform fulfils the requirements of the standard DIN EN 60601-1:2006.
Classification of the FDM Sensor according to DIN EN 60601-1
Type BF
Safety class II
Steady state conditions
Unsuitable for use in an oxygen-enriched atmosphere
7.2.1 Connecting the FDM-System to other electrical devices
(siehe auch DIN EN 60601-1:2006 Abs. 16 Medizinische Elektrische Systeme)
WARNING
The FDM System may only be coupled with other electrical devices if
these conform to the provisions of DIN EN 60950 or DIN EN 60601-1
or zebris Medical GmbH has confirmed their compatibility.
WARNING
When coupling several devices to one measuring station, please note
that no danger through summation of leakage currents can occur.
Devices that are in direct contact with the patient and that are com-
monly used in a medical electrical system, as a whole have to fulfil all
requirements of DIN EN 60601-1:2006 section 11.
There is a danger of electric shock when touching devices that are
not grounded separately.
