System Description; Indications For Use - Integra Licox REF IT2 Gebrauchsanleitung

SYSTEM DESCRIPTION

The complete brain tunneling probe kit
REF IT2/IT2EU consists of a parenchymal
probe guide with integral trocar REF VK52
and a combined oxygen and temperature
probe REF CC1P1. The system may
be used for monitoring of oxygen partial
pressure (p O ) as well as temperature in
bt 2
the cerebral white matter. For oxygen partial
pressure and temperature monitoring Licox
probe is used. The REF IT2/IT2EU is used
in conjunction with the Licox PMOBOX, the
Licox CMP monitor or the Licox
The parenchymal probe guide, a small
diameter plastic tube with attached trocar,
is designed to be "tunneled" under the scalp
and to provide fixation for the CC1P1 probe.
In this way the oxygen and temperature
probe may be implanted after craniotomy
through a burr or drill hole at the margin
of an existing bone flap. A drill bit is also
provided to allow for use of the system in
the absence of an existing cranial defect.
The probe's oxygen sensing part starts 4 to
6 mm from the tip of the probe. The probe's
temperature sensing part starts 13 to 15 mm
from the end of the probe's oxygen sensing
part. The system is designed for no more
than five days of continuous monitoring.

INDICATIONS FOR USE

The Licox Brain
System measures intracranial oxygen and
temperature and is intended as an adjunct
monitor of trends of these parameters,
indicating the perfusion status of cerebral
tissue local to sensor placement. Licox
System values are relative within an
individual and should not be used as the
sole basis for decisions as to diagnosis
or therapy. The Licox System is intended
to provide data additional to that obtained
by current clinical practice in cases where
hypoxia or ischemia are a concern.
INSTRUCTIONS FOR USE
The REF CC1P1 combined oxygen and
temperature probe may be introduced
into the brain via an existing bone flap
created during cranial surgery or it may
be introduced through a drill hole made
expressly for this purpose. A drill bit with drill
stop is provided with the parenchymal probe
guide REF VK52.
10
monitor.
P O
t 2
Oxygen Monitoring
Preparation
• Select an insertion site. Positioning
of the probe must be given careful
consideration due to the heterogeneity
of the oxygen partial pressure in brain
tissue. The probe should be placed in
viable tissue, when monitoring oxygen
availability. Viable
found in a peri-focal lesion, e.g. the
penumbra, or in undamaged tissue, e.g.
the contra lateral side of a focal lesion.
The probe should not be placed into a
hematoma or non-vital tissue. The user
should be aware of the current issues
in the pertaining scientific literature
when making the choice of catheter
placement and for interpretation of the
oxygen measurements obtained.
• If possible, place the probe 20 - 40 mm off
the midline, just anterior to the coronal
suture. Other locations may be chosen
according to the location of a lesion.
• The position of the drill hole should be
at least 10 mm away from other probes.
• To reduce the risk of infection, the use
of depilatory agents or no hair removal
is recommended.
• If shaving or clipping is performed it
should be done immediately before
the operation, preferably with electric
clippers. The scalp should be free of
gross contamination.
• To minimize the risk of surgical site
infections, it is recommended to prepare
the surgical area in accordance with
evidence-based guidelines, such as
Mangram et al. Guideline for Prevention
of Surgical Site Infection, 1999. Infection
Control and Hospital Epidemiology,
20(4), pp. 257-258, and Nichols RL.
Preventing Surgical
A Surgeon's Perspective. Emerging
Infectious Diseases. 7(2), Mar-Apr 2001.
• Use an appropriate antiseptic agent
available for preoperative preparation
of the skin at the incision site. Members
of the surgical team who have direct
contact with the sterile operating field
or sterile instruments or supplies used
in the field, should wash their hands
and forearms by surgical scrubbing
immediately before the procedure for
at least 2-5 minutes. After scrub, keep
hands up and away from body. Dry
hands with a sterile towel then don a
sterile gown and gloves.
tissue may be
Site Infections: