zebris Medical GmbH
FDM-T Technical Data and Operating Instructions
Page 58/65
8
Safety standards and classification of the system
The following information and warnings are based on requirements of the Standard DIN
EN 60601-1:2006, Section 11 for Medical Electrical Equipment and for the application of
the FDM-T system for medical purposes.
NOTE
The sections 8.1
– 8.3 are only applicable for the FDM-T sensor in-
tegrated in the treadmill and the accessories listed in this User Man-
ual. Please find information concerning the disposal of the treadmill
in the Operating Instructions of the treadmill manufacturer.
8.1
Classification acc. to Annex IX of Directive 93/42/EEC
If a CE mark with a four-digit number (0535) is imprinted on the type plate of your FDM-T
system it is classified as a medical product of
Class I with measuring function
.
8.2
Safety of medical electrical device
The system meets the requirements of the standards DIN EN 60601-1:2006
Classification according to DIN EN 60601-1
Type BF
Safety class II
Steady state conditions
Unsuitable for use in an oxygen-enriched atmosphere
8.2.1 Coupling of the FDM-T measuring system with other electrical devices
(also refer to DIN EN 60601-1:2006 Par. 16 Medical electrical equipment)
WARNING
The FDM-T System may only be coupled with other electrical devic-
es 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 a measuring system, care must
be taken to avoid any danger arising from the summation of the
leakage currents.
In the case of devices that the patient comes into direct contact with,
and that are used together in one medical, electrical system, they
must adhere as a whole to all the requirements of DIN EN 60601-
1:2006 Section 11.
There is a danger of an electric shock if devices are touched that
have not been connected to ground separately.