Integra CAMINO 110-4B Instrucciones De Uso página 4

responsibility solely
neurosurgeon. Appropriate
proceedings to control such hemorrhage
should be taken when indicated by the
neurosurgeon in charge.
PRECAUTIONS
• Extreme bending and/or kinks can impair the
performance of the Fiber Optic Pressure
Transducer.
handling the catheter.
• The catheter is designed for SINGLE USE
ONLY. DO NOT RESTERILIZE OR REUSE.
Camino 110-4B is supplied in a single use
package and is guaranteed to be sterile and
non-pyrogenic unless opened or damaged.
The product is intended for use as an
intracranial pressure monitor and is not to be
reused. Any attempts to resterilize or reuse
the product will damage the catheter and
impair its ability to function as intended.
• Use aseptic
procedures.
• Maintain the insertion site with regular
meticulous redressing
technique.
• Do not attach anything to transducer air
vent. Vent must remain open for proper
operation (Figure 1).
CAUTION
• Federal (U.S.A.) law restricts this device to
sale by or on the order of a physician.
INSTRUCTIONS FOR USE
INSERTION METHOD FOR THE CAMINO ICP BOLT
Figure A
CORONAL
SUTURE
SHAVED
AREA
Figure B
HAIRLINE
CORONAL
SUTURE
SHAVED
AREA
• Area of insertion: The standard right and left
prefrontal areas are the primary areas of
insertion. This region allows the patient to
have his head rotated from side to side and
still remain in a supine position without
interference with the intracranial pressure
monitoring function. In addition, the incision
will be carried behind the hairline in the
majority of patients and therefore
cosmetically acceptable (Figures A and B).
• After the insertion site has been chosen, the
area is shaved and prepped in a sterile
2
of the operating
steps
Exercise caution
technique throughout
using
INCISION
MIDLINE
fashion, usually with a betadine solution.
and The shaved and prepared area is then
draped with sterile towels. The area of the
incision, which usually lies two to three
centimeters anterior to the coronal suture in
the
subcutaneously with 1% Xylocaine. An
approximately half centimeter linear incision
is made and carried to the bone. A small
mastoid type of retractor is then inserted to
when
provide a good bone exposure and
hemostasis of the skin edges.
• The safety stop on the drill bit provided in the
kit can be positioned as desired by loosening
the setscrew with the hex wrench, sliding the
stop into position, and retightening the
setscrew.
• The drill bit is then secured to a twist drill
and, in a standard fashion, a twist drill hole is
made through the outer and inner tables of
the skull. The surgeon needs to be careful
when penetrating the inner table to minimize
any potential for parenchymal injury.
• After penetration of the inner table, the drill is
aseptic
removed and the hole is irrigated with sterile
saline. An 18G spinal needle is then used to
open the dura in a cruciate fashion. The
stylet can be inserted to ensure adequate
opening of the dura.
• Following opening of the dura, the Camino
Bolt is screwed manually into the skull. The
seating depth of the Camino Bolt will be at
the surgeon's discretion pending the
thickness of the skull. This will be appro-
ximately 2-3 mm for the neonatal age group,
3-5 mm for the pediatric age group and 5
mm to 1 cm for adults. If desired, the spacer
can be used as a guide, otherwise the
spacer can be removed and discarded.
• The stylet provided in the kit is
through the Camino Bolt and the dura to
clear
Transducer-Tipped Catheter.
• The Camino Bolt is irrigated with non-
bacteriostatic sterile saline.
CAMINO TRANSDUCER-TIPPED
PRESSURE MONITORING CATHETER
PREPARATION PRIOR TO INSERTION
• The Camino Catheter can be used with the
Camino V420/420 series or with Camino
MPM series pressure monitors. For Camino
monitor set-up and use, refer to the appropriate
Camino monitor Directions For Use.
• Remove the Camino Catheter from its
sterile package and firmly attach the
transducer
be
connector (Figure 2). If the monitor display
does not read zero after a short system self-
check delay, use the tool from the catheter
kit to turn the zero adjustment on the bottom
mid- pupillary line
the passage for
connector
is infiiltrated
inserted
the Camino
to the preamp