13
Instructions for Use
Copyright ©
2018 Products
DocumentID
Version
Date
13 / 34
Fiagon GmbH
E 01 1103
DOC-18-00147 1
09-2018
Before connecting the system to network or data coupling, identify, analyze evaluate and control
the resulting risk.
Do not connect equipment other than storage media to the USB interface.
The Network connection must be unplugged from the Fiagon Navigation System during surgery.
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. The device is not intended
to use wireless technology and the installation of external wireless devices connected to the
system is disabled for all user logins to prevent unauthorized usage.
Electromagnetic interference
The navigation unit and its applied parts comply with the international standard IEC 60601-1-2: 2007.
Risks associated with electromagnetic interference are related to
•
electromagnetic environment the system is operated.
To mitigate risks occurring from inappropriate environments the user of the system should assure that it
is used in an environment that is described in the section 12 – EMC statement.
•
Electrical equipment used in the direct vicinity or within the measuring field of the navigation system/
navigation sensor.
Please refer to the next section – Electromagnetic navigation to get information about identifying
interferences and ways to mitigate the risk of loss of navigation information due to interference detection
of the system.
•
Voltage dips (Dip>95% over 5s duration) from the mains supply, may lead to a power loss of the unit.
The unit and navigation software will restart automatically on return of the voltage to nominal level. After
approx. 40 seconds the unit is back to operation. The registration of the patient will be restored on
reloading the patient. Please refer to section - Troubleshooting – unintended power shut down for details
for mitigation of this risk.
Electromagnetic navigation
The navigation system uses an electromagnetic position measurement system with interference detection.
The position of the instruments is determined by means of an electromagnetic field generated by a field
generator. Frequencies of said field range from 800Hz to 10 kHz. Therefore, instruments emitting
electromagnetic signals (e.g., surgical turbines, RF surgery, diathermy devices) or mobile RF equipment (e.g.
DECT phones, cellular phones) can influence the system. Do not use the system stacked or adjacent other
devices, if adjacent or stacked use is necessary, the system should be observed to verify normal operation in
the configuration in which it will be used
The navigation system has an automatic interference detection that shows the user when an interference occurs
during navigation. Standard instruments such as endoscopes or forceps normally do not cause any interference.
If interference occurs, the navigation data are not displayed, because they may be inaccurate. Once the source
of interference has been eliminated, navigation will continue automatically.
If interference occurs repeatedly, check for and remove the metal parts that cause this interference such as
ferrous retractors near the patient localizer.
If the source of interference cannot be located, contact your service representative.
Possible sources of interference are
Directly in the measuring field: