Special features of the operating table column
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4990113_030_01 — 2069106 — 2017–11–02
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Special features of the operating table column
The hybrid type operating table column can be combined with
another medical device (e.g. imaging system or central control
panel). Note information from the manufacturer of the medical
device.
9.1
Networks
The network into which the operating table column is to be
integrated has to meet the following requirements:
– The network for the operating table and the medical device has
to be isolated. It may not be connected to any other network.
– All network resources have to be available exclusively for the
operating table and the medical device.
– The network must be nearly 100 % available. Interruptions to the
network may only take a few minutes per year.
– Only one system agent or PEMS manufacturer may be
responsible for the network.
– The operating table and medical device have to meet the
requirements of the system contractor/PEMS manufacturer.
Connecting the PEMS to an IT network, which connects to other
devices, can represent previously unknown risks for patients,
operators or third parties.
The system contractor has to determine, analyze, assess, and
eliminate these risks.
Subsequent changes on the IT network can lead to new risks and
therefore require additional analyses. Changes to the IT network
include the following:
• Changes to the IT network configuration;
• Connecting additional elements to the IT network;
• Removing elements from the IT network;
• Updating devices connected to the IT network;
• Upgrading devices connected to the IT network;