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PRECAUTIONS
► These Instructions are to be used in
conjunction with the Licox PMOBOX, the
Licox CMP Operations Manual or the Licox
P
O
monitor's User's manual.
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► Integra intends that this device should be
used only by physicians with educational
and training background enabling the
proper use of the device.
► The Licox introducing system is intended for
use only with the probes specified herein.
► The Licox probes are intended for use
only with the introducing system specified
herein.
► Licox products specified herein are intended
only for use with the Licox CMP, the Licox
PMOBOX or the Licox P
corresponding Licox cables.
► After implantation of a probe it takes
1 - 2 minutes before the local brain oxygen
tension is correctly displayed. However, due
to the micro trauma of implantation, the initial
values displayed may not represent the
oxygen tension of the surrounding tissue.
After implantation, the tissue stabilization
time (time until the oxygen tension values
are representative of the surrounding region
of the brain) may be as long as two hours.
► Do
not
attempt
introducer.
► Only use probes and introducing systems if
their sterile packaging is not open, damaged
or broken.
► Only use probes and introducing systems
before their expiration date labelled on the
package.
► These devices are intended for single use
only. All components are extremely difficult
to clean after being exposed to biological
materials and adverse patient reactions
may result from reuse.
► Caution – Do not resterilize. Integra will not
be liable for any or all damages including,
but not limited to, direct, indirect, incidental,
consequential or punitive damages resulting
from or related to resterilization.
► Only use the combined oxygen and
temperature probe which has been stored
cool at a temperature between 2ºC and
10ºC.
► Do not discard the combined oxygen and
temperature probe packaging before the
smart card has been removed. Probe
calibration data is stored on the smart card.
► Use only the smart card supplied with the
combined probe. Cross check serial number
on probe and smart card. Use of the wrong
smart card can cause measurement errors.
► The smart card is not required if using the
Licox PMOBOX.
► Do not cut or tear the catheter body. A
catheter with a cut or torn body will no
6
O
monitor and all
t
2
to
disassemble
the
longer function.
► Only use the drill bit provided with the
introducing system. If a drill bit other than
that delivered with the kit is used, the hole
may be too large or too small.
► Do not use a power drill.
► Adequate blood coagulation must be
ensured before inserting an invasive
cerebral monitoring probe.
► In order to avoid intracranial hemorrhage,
blood coagulation must be checked before
probe insertion and must be carefully
monitored when measuring in patients in
hepatic coma or with other diseases which
could impair blood coagulation properties.
This also applies to conditions in which
therapeutic
maneuvers
with blood coagulation (e.g. hypothermia,
pharmacologic agents).
► If the dura mater is not opened before the
stylet is advanced, the dura mater could be
torn away from the skull, possibly resulting
in hemorrhage/hematoma.
►
Inadequate opening of the dura
mater may also result in improper placement
of the probe.
► The device must not be placed too near
the sagittal line in order to avoid the sagittal
sinus and major cerebral veins near the
sagittal line.
► The
introducer
avoid infection. If the seal is not made,
cerebrospinal fluid may appear within
the outer tube of the introducer. The
compression cap must be tightened further
to avoid leakage (see instructions for use).
► The actual position of the sensor must be
considered for interpretation of data. It is
possible that the sensor may gets displaced
from its original position.
► When monitoring is complete, remove
probes and introducer prior to bolt removal.
► The tip of the oxygen sensing catheter
may not lie in the cerebral white matter
after implantation if it is inserted in a sulcus
of the brain or in an atrophic brain. In this
case the probe may not respond to an
oxygen challenge performed after the initial
stabilization time of at least 20 min. The
location of the probe may be verified via CT
scan. Remove probe if it does not respond
to the oxygen challenge or if its tip is not
within parenchyma or lies on the surface of
brain. Please note that if the probe tip lies
within the cortex, the measured oxygen
values may be higher and less stable than
measurements made with the probe tip
within the white matter.
► If
the
oxygen
cerebrospinal fluid (CSF) the readings will
be false high. This may occur if the sensor
is placed in the subcortical CSF space or if
it is placed in ventricular CSF spaces, e.g. in
hydrocephalic patients.
may
interfere
must
be
sealed
probe
is
placed
to
in
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