Integra Licox IP1P Instrucciones De Uso página 8

SYSTEM DESCRIPTION
The complete brain probe kit REF IP1P
consists of a single lumen introducer kit REF
IP1 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 the cerebral
bt 2
white matter. For oxygen partial pressure and
temperature monitoring, the Licox probe is
used. The REF IP1P is used in conjunction with
the Licox PMOBOX, the Licox CMP monitor or
the Licox P O monitor.
t 2
The combined probe is inserted into brain
tissue through the "pO
single lumen introducer REF IP1 to a depth of
approximately 35mm below the dura (Fig. 15).
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 Oxygen Monitoring 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. It 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 probe is inserted into the brain tissue via
an introducer (Fig. 4, a, b, c) and bolt (Fig. 4, d).
The introducer seals the system hermetically
at the connection to the bolt and provides
mechanical protection and strain-relief to the
probe.
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 tissue
may be 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.
8
" labelled channel of the
2
• 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
Site Infections: 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.
• Apply an antiseptic in concentric circles,
beginning in the area of the proposed
incision. The prepared area should be
large enough to extend the incision or
create new incisions, if necessary. The
skin preparation procedure may need to be
modified depending on the condition of the
skin or location of the incision site.
• Estimate the thickness of the skull and
adjust the drill stop accordingly. Loosen
the drill stop (Fig. 4, f) with the hex wrench
(Fig. 4, g) about half to one turn, so that the
set screw is still in the groove of the drill-bit
(Fig. 4, e). Rotate the drill stop around the
drill-bit (Fig. 6) until the exposed tip of the
drill-bit is just long enough to completely
drill through the skull with its inner table.
The tip of the drill-bit should not penetrate
the inner table by more than 1 mm. Tighten
the drill stop.
• Attach the drill-bit to a hand drill. Do not
use a powered drill, such as those driven
by compressed air or electricity.