13
Instructions for Use
Copyright © 2020
DocumentID
Version
Date
13 / 33
Fiagon GmbH
DOC-19-00169 2
08-2020
EN / US
WARNING:
During surgery, make sure not to touch the patient and the metallic housing of the
Navigation System simultaneously. Failure to do so may result in personal or patients injury.
2.5. Electromagnetic navigation
The Navigation System uses an electromagnetic position measurement system with interference detection.
The position of the instruments is determined using an electromagnetic field generated by a field generator.
Frequencies of said field range from 800Hz to 10 kHz with a magnetic field strength of 1 Am
-1
in a distance of
0,5m to the field generator. Therefore, instruments emitting electromagnetic signals (e.g., surgical turbines, HF
surgery, DECT phones) or mobile RF equipment (e.g. cellular phone) can influence the Navigation System.
WARNING:
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation of the Navigation System and/or other equipment. If such
use is necessary, the Navigation System and the other equipment should be observed to verify that
they are operating normally, e.g. ECG is commonly used adjacent to the Navigation System. Please
check for artefacts and verify proper operation. In case interference occurs contact Fiagon Service.
If EM disturbances occur:
The Fiagon Cube Navigation System has an automatic interference detection that shows the user when
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 dispose of 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:
•
surgical turbines
•
RF surgery
•
DECT phones, cellular phones
•
RFID tags
In close vicinity, (e.g. operating area/ 2 m radius, 3.3 feet)
•
Diathermy devices
•
Security systems such as metal detectors
•
Other image-guided surgery systems with EM tracking technology
In adjacent rooms:
•
MR scanner
For EMC technical specifications of the system refer to the related chapter in this document.
NOTE:
RFID tags are not likely to interfere with the system unless they are positioned directly
between the field generating device and the sensor. Make sure the instruments and equipment
used for the surgery do not contain any RFID tags that will be in the measuring field. Consult
the Instructions for use of the devices to check whether and where RFID technology is used.
