12
Instructions for Use
Copyright © 2020
DocumentID
Version
Date
12 / 33
Fiagon GmbH
DOC-19-00169 2
08-2020
EN / US
2.3. Safety measures at the installation location
The Navigation Unit Cube
4D
is suitable for a professional healthcare environment.
The Navigation System may only be used in medical environments that are installed in compliance with
nationally applicable regulations.
The Navigation System is not designed for use in potentially explosive atmospheres. When using the Navigation
System with, e.g., easily inflammable and explosive anesthetics make sure that it is not operated in a danger
zone as defined by the manufacturer of these anesthetics.
The Navigation System may only be operated when connected to an outlet with protective earth contact and
when using the appropriate plug.
Take care that the main power cord can be unplugged easily and that the ventilation slots at the rear and bottom
side (Navigation Unit Cube
4D
) of the enclosure stay clear (at least 5 cm) to prevent overheating of the housing
or other components. The navigation module has to be set up accordingly.
Place the device per the table „Recommended separation distances”, chapter 11 “EMC Compliance statement”,
to avoid interferences from other equipment.
All components (Navigation Unit Cube
4D
, VirtuLink splitter cable are suitable for use within the patient
environment. Accessory equipment connected to the analog and digital interfaces must be certified according
to the respective IEC standard (e.g. IEC 60950 for mouse and keyboard or IEC 60601-1 for medical equipment).
Furthermore, all configurations must comply with the system standard IEC 60601-1 (ed 3.1), Clause 16.
By connecting additional equipment to the signal input port or signal output port, a medical electrical system is
configured. It has to be ensured that the Navigation System complies with the requirements of the Navigation
System standard 60601-1 (ed. 3.1) Clause 16.
Prior to each use, the user must check the functionality and the proper condition of the Navigation System, check
for loose components and damage. DO NOT use the Navigation System if these conditions exist. If service is
required, contact your Fiagon Navigation sales or service representative immediately.
2.4. Safety measure when using the system
Prior to its use, the user must check the functionality and the proper condition of the Navigation System.
Treatment may only be carried out if the appropriate use of the Navigation System can be ensured.
If you notice visible or audible deviations from normal conditions during the operation of the system, do not use
the Navigation System until these deviations have been eliminated by a service representative.
WARNING
:
Connecting the system to the network or with other devices via data coupling may result
in compromising the essential performance of the Navigation System caused by e.g. viruses, data
loss, corrupt files, unauthorized access. The data coupling of the Navigation System is the USB
interface. Before connecting the Navigation System to network or data coupling, identify, analyze,
evaluate, and control the resulting risk.
WARNING:
Do not connect devices other than storage media or Fiagon approved devices to the USB
interface.
CAUTION:
The Network connection must be unplugged from the Fiagon Navigation System during
surgery.
CAUTION:
Make sure Storage media are free of viruses before connecting to the system.
Do not connect any third-party wireless capabilities to the device, for instance by placing a wireless
dongle (e.g. Bluetooth or WiFi) into the USB or LAN ports.
WARNING:
Do not unplug mains cable during surgery.
