User manual
Version: v4.5.2
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 verification 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.
Active
markers
with batteries shall be handle with care. Op-
erator who gets in contact with battery leakage incurs a risk
of chemical burn. The integrator has to indicate in the end
user manual that the battery of an active
marker
has to be
removed after usage, especially in the case the active
marker
undergoes a sterilisation procedure.
The batteries used in active
markers
must comply with the
regulation standards.
Battery for active
markers
must be sterile. The integrator
has to indicate in the end user manual to use only sterilized
batteries according to ISO 14937.
Any electric defects on active
markers
such as explosion,
leakage, overheating might lead to operator or patient injury.
The integrator has to use an adequate protection (e.g. fuse)
that limits the current drawn from the battery. The integrator
has to ensure that active
markers
contain a polarity marking
and a polarity inversion circuit on the
marker
.
The measurement precision of an active
marker
can be deto-
riated because of liquids on its fiducials or IR-receptor. In-
structions about identifying and cleaning of active fiducial
must be clearly specified by the integrator in the end user
manual.
An active fiducial
marker
must be sterilised before each us-
age. Cleaning or sterilisation methods instructions must be
clearly specified by the integrator in the end user manual.
Atracsys / 2020-06-17 / 16:48:00
106 / 113
