Integra Licox REF IT2 Gebrauchsanleitung Seite 6

PRECAUTIONS
► These Instructions are to be used in
conjunction with the Licox PMOBOX, the
Licox CMP Operations Manual or the Licox
P O monitor 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
intended only for use with the Licox
CMP, the Licox P
PMOBOX and all 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.
► 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
resulting from or related to resterilization.
► Only use the combined probe which has
been stored cool at a temperature between
2ºC and 10ºC.
► Do not discard the combined 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
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
longer function.
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specified herein
monitor or the Licox
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or punitive damages
► 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
with blood coagulation (e.g. hypothermia,
pharmacologic agents).
are
► 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 actual position of the sensor must be
considered for interpretation of data. It is
possible that the sensor may get displaced
from its original position.
► Inadequate opening of the dura mater may
also result in improper placement of the
probe.
► Use care in removing the probe and the
parenchymal probe guide from the patient
to avoid damaging tissues. In particular
cut sutures at the parenchymal probe
guide insertion site before removing the
parenchymal probe guide.
► Remove the tip protection by using forceps
to avoid potential injury caused by the
sharp tip of the trocar. Use forceps during
insertion of the distal end of the CC1P1
probe into the parenchymal probe guide.
► 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 combined probe is placed in
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.
maneuvers may interfere