natus 110-4B Mode D'emploi page 4

RISK AND COMPLICATIONS
Maintenance of sterility during placement and
subsequent handling of the Camino Bolt is
essential. Sterile technique should be used at all
times when inserting, correcting, or adjusting the
Camino Bolt and the Camino Transducer-Tipped
Pressure Monitoring Catheter.
If monitoring is continued for more than 5
days, placement of a new system under sterile
conditions is recommended.
Placement of the Camino Bolt must be carried
out by a qualified neurosurgeon to avoid
penetration of the cerebral cortical surface
during the drilling process, which requires
standard surgical procedure and skill.
Hemorrhage from the dura or cortical surface
at the bolt insertion site may occur. Patients
should be tested for normal blood clotting
function prior to bolt placement. Determination
of possible extracerebral, subarachnoid, or
intracerebral hemorrhage at the bolt insertion
site will be the responsibility solely of the
operating neurosurgeon. Appropriate steps
and 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. Exercise caution when 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 catheter design incorporates a small
lumen and an intricate sensor that is likely
to make it difficult to assure removal of all
contamination. Additionally, reprocessing
is likely to damage the delicate sensor that
may result in impaired function (e.g. no or
inaccurate measurements).
• Use aseptic technique throughout procedures.
• Maintain the insertion site with regular
meticulous redressing using aseptic 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.
2
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.
incision will be carried behind the hairline
in the majority of patients and therefore be
cosmetically acceptable (Figures A and B).
• After the insertion site has been chosen,
the area is shaved and prepped in a sterile
fashion, usually with a Betadine
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 mid-
pupillary line is infiiltrated subcutaneously
with 1% Xylocaine
centimeter linear incision is made and
carried to the bone. A small mastoid type of
retractor is then inserted to 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
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.
INCISION
MIDLINE
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