natus Camino 110-4HM Instrucciones De Uso página 4

Micro Ventricular Pressure Monitoring Kit is
essential. Sterile technique should be used
at all times when inserting, adjusting, and
securing the Camino Catheter. Infection,
subcutaneous leakage of CSF, neurological
sequelae, and blockage by intraventricular
debris (including bloody and/or highly
proteinic CSF) have occurred during the use
of ventricular catheters.
• If monitoring is continued for more than
5 days, placement of a new system under
sterile conditions is recommended.
• Placement of the tip openings within the
reach of choroid plexus has resulted in
blockage of ventricular catheters.
• The ventriculostomy must be carried out by
a qualified neurosurgeon using 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. Appropriate measures to
avoid infections and complications are the sole
responsibility of the neurosurgeon in charge.
• This device utilizes PVC tubing which is
known to contain DEHP in a portion of the
drainage path which on occasion is used
for sampling and fluid injection. The risk of
exposure to the male fetus, male neonate,
and peri-pubescent male is not considered
significant for the following reasons: Sampled
and drained CSF is not intended to be
reintroduced into the patient. Injected fluids
such as anti-coagulants and saline solution
are only used as needed to eliminate or
reduce blockage of the ventricular catheter
and thus are not continuous in use.
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 110-4HM 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).
• It is imperative that the ventricular catheter
not be handled with bare fingers or come
into contact with linty surfaces. Silicone
elastomers are
2
very electrostatic
therefore susceptible to contamination by
airborne or surface particles. The presence
of these contaminants could cause adverse
tissue reaction. Rubber-shod clamps or
washed, gloved hands are the best means
of handling implantable silicone devices.
• Use
procedures.
• Maintain the insertion site with regular
meticulous
technique.
• Do not attach anything to the 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
The recommended frontal placement is 3–4 cm
off the midline, just anterior to the coronal
suture. After the site has been chosen, the
area is shaved and prepped in a sterile fashion,
usually with a Betadine
and prepared area is then draped. The area
of the incision is infiltrated subcutaneously
with 1% Xylocaine
centimeter linear incision is made and carried
to the bone. A self-retaining retractor is then
inserted to provide good bone exposure and
hemostasis of the skin edges.
Adjust the safety stop on the drill bit to the
estimated skull thickness and secure firmly
with the hex wrench.
Drill a hole through the outer and inner tables of
the skull, taking care to minimize any potential
for parenchymal injury. Penetrate the dura
under direct vision with a #11 blade, securing
hemostasis as necessary.
Using the stylet, insert the ventricular catheter
into the ventricle. When the CSF is obtained,
hold the catheter securely, remove the stylet,
slide the bolt down and screw in, using bone
wax to insure a tight seal. Do not over tighten,
as stripping of the threads may cause loss of
seal.
Continue to hold the catheter securely, and
turn the compression cap clockwise to lock the
catheter in place. Slide the strain relief down
and attach to the compression cap. Cap the
catheter with Luer cap to prevent CSF loss.
and
aseptic technique
redressing
solution. The shaved
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throughout
using aseptic