zebris Medical GmbH
FDM-T Technical Data and Operating Instructions
Page 49/65
6.4
Computer Requirements
If the FDM-T system is not delivered with a computer that includes pre-installed zebris
FDM software, the user must then inquire whether the intended coupling guarantees the
necessary safety for the test person, the operator and the surroundings by consulting the
manufacturer, the authorized zebris sales partner or by asking a specialist.
The requirements for the PC are specified in the User Manual of the zebris FDM software.
WARNING
If the computer is not supplied with the measuring system, the man-
ufacturer shall not be held liable for any damage or malfunctions that
result from defective software installation or incompatible hardware.
Should additional hardware be built into the computer or third party
software be installed, the manufacturer shall not be liable for any
malfunctions or damage occurring thereof.
The computer must carry CE mark and meet the provision of the
standards DIN EN 60950 or DIN EN 60601-1.
WARNING
The FDM-T Measuring System is not intended for operation in a
network/data network. Connecting the system to a network/data
network can cause unforeseen risks for the patient or third persons.
If the database of the zebris FDMT software is to be installed in a
network/data network, the operator is then obligated to determine,
analyse, assess and overcome any risks in this connection. Of par-
ticular importance are aspects concerning data protection, virus se-
curity, updates of the operating system and regular backups. The
risk considerations must also include any changes made to the net-
work/data network, e.g. update/upgrade of devices and components
that are connected to the network.