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15 Appendix
15.1 Network
Fresenius Medical Care multiFiltrate IFU-EN-UK 15A-2015
Warning
The network operator is responsible for protecting the device from
excessive network load (e.g., by accumulation of broadcast messages
or port scans). If necessary, the connection to the network must be
established via a router or a firewall, for example.
The system configurer is responsible for the secure further processing
of device data, e.g., in PC software applications.
The network operator is responsible for protecting data transferred
without encryption.
The data transfer of alarm states via the network must not be used for
the purpose of external alerts (staff call).
Warning
Before being applied, the treatment parameters which the device
receives via the network or the PatientCard must be checked by the
operator for plausibility and compliance with the medical prescription.
The data transfer of alarm states via the network must not be used for
the purpose of external alerts (staff call).
Warning
There are special requirements for further processing of the data.
The network operator is responsible for ensuring that the network is
available for the required data transfer.
Data corruption affecting the correctness, plausibility, and
completeness of the data that is caused by the network and the server
software is not detected by the device.
Note
For reasons of data protection, the operator is responsible for the
safekeeping of the PatientCard.
Chapter 15: Appendix
15-1
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