User manual
Version: v4.5.2
Any degradation of optical elements due to the cleaning
method or scratches during transport can lead to wrong
measurements. Optical elements should be handled with
care during transport and storage. The integrator has to
mention in the end user manual the cleaning methods for
optical elements as described in Chapter 17.
Instability of the fusionTrack device can cause injury by falling
on patient or operator. Attachment between feet and hold-
ing mechanism must be perfectly stable. Instructions indi-
cating how to fixate fusionTrack using the threads in the feet
are provided in Section 5.4.
Polluting light in the field of view might lead to wrong mea-
surements. The integrator can access the camera images to
visualize the scene of view. A segmentation overflow mech-
anism and status flags in the frame structures can be used
by the integrator to detect any perturbation. The integrator
is suggested to periodically check the camera pictures.
The fusionTrack is not intended to be sterilised. An initial
level of contamination could lead to patient contamination.
The cameras have to be placed outside of the sterile field
and cleaned after every single use. Methods of cleaning are
indicated in Chapter 17.
The integrator must check that the fusionTrack device and
the position of the fusionTrack device is well-suited to the
application / surgery, and that required regulations are re-
spected.
At any time, the hardware (i.e. the fusionTrack device), the
firmware and the software (i.e. the
SDK
) must be compati-
ble.
A software dysfunction due to software crash might cause
wrong measurements causing patient injury. The integrator
has to indicate in the end user manual that the fusionTrack
device must be restarted when the software freezes or
crashes.
A software dysfunction such as frozen pictures might cause
wrong measurements causing patient injury. The integra-
tor has to implement a software mechanism to detect such
cases (e.g. check timestamps, etc.).
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