User manual
Version: v4.5.2
For single-use markers, the end user manual must clearly
state that the markers should not be reprocessed. The
markers packaging must be marked with a label indicating
they cannot be reprocessed.
For single-use ducials, instructions about replacing new
ducials after every (single) use must be clearly specied by
the integrator in the end user manual. Packages of passive
ducials have to be marked with a label indicating that they
cannot be reprocessed.
A passive ducial could be damaged due to a shock /
scratch of the reecting material. Instructions about not us-
ing deteriorated ducials and how to replace a deteriorated
passive ducial must be clearly specied by the integrator in
the end user manual.
Integrator has to specify in the end user manual instructions
how to screw / plug ducials on markers.
7.6.2 Active markers
The active markers consist of IR-LEDs mounted in a rigid structure. The LEDs can either emit continuously
or be synchronised with the fusionTrack cameras. In the latter case, the marker also contains an IR receiver.
An active
marker
is powered by a battery, or from the equipment to which it is attached. Those
markers
can either be wired or wireless.
The fusionTrack device IR communication sends a pattern which is recognised by the IR receiver of
the active marker. Once the IR pulse is detected by the marker, the marker emits IR radiations, which is
detected by the fusionTrack device.
Active marker electronics has to be completely sealed in or-
der to avoid liquid penetration due to cleaning. The inte-
grator has to indicate in the end user manual instructions to
clean active markers. The integrator has to specify in the
end user manual that the operability verication procedure
(see Chapter 12) must be done after each cleaning.
A geometrically deformed active marker due to a manufac-
turing defect could lead to wrong measurements causing
patient injury. The integrator has to perform individual test-
ing during marker calibration.
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