Zeiss OPMI Lumera i, Instructions For Use Manual

Page: 151 / 184

Version 8.0
G-30-1720-en
Page 151
OPMI Lumera i Device data
Ethernet connection (option), requirements for integrating the device into an
existing IT network
• When connecting the device to an existing IT network, comply
with the following specifications and measures in accordance with
IEC 60601-1:
– The device can be connected to an existing IT network in order to
transfer device parameters.
– The IT network to which the device is to be connected must have the
following features:
– IPv4, static or dynamic address
– Any IP address.
– The IT network to which the device is to be connected must be
configured as follows:
– The firewall is open for inbound ports.
– Data is not intended to be transmitted from the device to external
networks.
– Requirements in relation to network connection with the device:
– The IT network has an Ethernet connection via RJ45, at least Cat.5,
100 Mbit/s.
– The device has a network isolator in compliance with IEC 60601-1
which means it is not connected to the network power supply.
– The operator is responsible for the flow of information and the routing
between the device, the IT network, and other devices:
– The essential performance features of the device do not require
a connection to the IT network or any data transfers.
– The operator is responsible for the topology of the IT network and
the necessary routing.
If the IT network cannot provide the features required to integrate the
device into the IT network, the following hazards may arise:
– Higher current at power output sockets; risk of electrical shock, if the user
touches a live part of the casing or a patient
– Virus infestation of the system represents a hazard for the patient due to
possible prolongation of operating and anesthetic times