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► The Licox probes and introducers specified
herein have not been tested for compatibility
with Magnetic Resonnance (MR) systems.
Therefore the use of these devices in MR
environments is not recommended. Integra
should be contacted if more information is
needed.
WARNINGS
► The use of excessive force on any
component of the Licox system may cause
damage and malfunction. All mechanical
features of the Licox system can be
operated without the use of excessive force.
► The anesthetic gas halothane disturbs
measurement
polarographic oxygen sensors. After an
initial exposure time of 5 to 20 minutes, the
displayed oxygen value is overestimated;
this effect is usually reversible. However,
other common anesthetic gases such
as nitrous oxide (N
isoflurane can be used without impairing
the accuracy of the measurement.
► Do not touch Licox probes with cautery
forceps or HF scalpels; this may damage
the preamplifier of the Licox CMP, the Licox
PMOBOX or the Licox P
► Strong electrical interference (e.g., during
cauterization) can cause a disturbance
of the measurement that outlasts the
interference by a few seconds.
► Do not use Licox probes or introducing
systems for more than 5 days.
► Only original Licox parts may be used with
the system. This applies in particular to
probes, cables and the power supply.
► When the front panel switch is used
to input intracranial temperature to the
Licox CMP monitor or the Licox P
differences between the set temperature
and the actual intracranial temperature will
lead to measurement errors. For example
if the set temperature is one degree higher
than the tissue temperature, the displayed
oxygen value will be underestimated by
approximately 4%.
► Cables, including extension cables, with
damaged isolation jacketing must not be
used. Connector contacts must be cleaned
after coming into contact with saline
solutions or body fluid. Measurement error
can occur if these recommendations are
not observed.
► Probe extension cables may not be used
when their connectors are wet or damp.
Measurement errors can occur if this
recommendation is not observed.
► Do not overtighten set screw in the drill
stop (see Fig. 6) to avoid stripping the
thread.
► Do not bend the probe around a radius of
curvature of less than 2 mm.
with
all
types
O), enflurane and
2
monitor .
O
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2
O
monitor ,
t
2
► Neurosurgery treatment facilities must be
available for monitoring related adverse
events, e.g. hemorrhage or infection.
► In rare cases, e.g. if a vessel is punctured
during implantation or when coagulation
is insufficient, hemorrhage can occur.
This may lead to a transient rise in tissue
oxygen values. Once bleeding stops tissue
oxygen values are usually decreased
in surrounding non-affected tissue if the
blood infiltration surrounding the puncture
is thicker than approximately 100 μm.
► If the patient has enlarged or shifted
ventricles, the probe or its introducer
may puncture the lateral ventricle when
inserted (the combined probe tip reaches
of
approximately 35 mm below the dura
level).If this occurs, the probe will create
a channel that directly connects the
ventricular system with the subarachnoid
space,
bypassing
pathways.
difference between the lateral ventricle
and the subarachnoid space, it is possible
that cerebrospinal fluid from the ventricle
could flow along the probe. The measured
value will correspond to the oxygen partial
pressure of the cerebrospinal fluid and will
not be representative of the tissue.
► The user must be aware that cerebral
oxygen pressure values differ between and
within patients depending on the nature of
the damage and the individual treatment
course. It is highly recommended that
users are aware of the current knowledge
relating to brain tissue oxygen pressure
(p
O
) measurements which has been
bt
2
published in the scientific literature.
► Special consideration must be given to
the maturity of the skull when using a bolt
fixation in paediatric patients.
COMPLICATIONS,
ADVERSE EVENTS
► Complications associated with intracranial
sensors may occur during the use of this
device. Complications include, but are
not limited to, infection, thrombosis and
hemorrhage.
CONTRAINDICATIONS
► Licox products are not intended for any use
other than that indicated.
► Contraindications for device insertion into
the body apply, e.g. coagulopathy and/or
susceptibility to infections or infected tissue.
A platelet count of less than 50 000 per μl
is considered a contraindication. This value
may differ according to different hospital
protocols.
the
natural
Because
of
the
CSF
pressure
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