Contraindications - Integra Camino Flex Ventricular VTUN Mode D'emploi

• Forceps, sutures and needles, and scissors
for suturing scalp incisions after the
implantation procedure
A complete set of surgical instruments and
supplies are available from Integra in the
Integra Cranial Access Kits.

CONTRAINDICATIONS

ICP monitoring should not be conducted where
components of the monitoring system will
come in direct contact with any infected tissue.
This includes, but is not limited to: infections of
the scalp, bone, meninges, ventricles, and
blood stream.
contraindicated in patients who are receiving
anti-coagulants or are known to have a
bleeding diathesis.
contraindicated where trained personnel are
not available to
monitoring.
This device is not designed, sold, or intended
for any use except as indicated.
WARNINGS
• Ensure monitor is plugged into power source
prior to patient preparation.
• DO NOT use the Integra Camino Flex
Ventricular Catheter for more than 5 days. If
monitoring is continued for more than 5 days,
placement of a new Catheter through a new
twist drill hole is recommended. The Catheter
is classified as a prolonged exposure device
(i.e., less than 30 day exposure). To limit the
contact to less than 30 days, DO NOT implant
more than five Catheters consecutively.
• DO NOT use the drainage port with luer
lock for the intrathecal administration of
medication. The luer lock fitting on the
drainage port of the catheter is designed
for connection to an external ventricular
drainage device for the purpose of draining
cerebrospinal fluid from the ventricle.
• The Integra
Intracranial Pressure Monitoring Kit (Catheter
and Accessories) is designed for SINGLE-
USE ONLY. DO NOT RESTERILIZE OR
REUSE. All components are extremely
difficult to clean after being exposed to
biological materials and adverse patient
reactions may result from reuse.
• Use of catheter or cables other than those
specified for the Camino Advanced Monitor
(Monitor) fitted with a Camino Flex Adapter,
or Camino ICP Monitor (Monitor) may result
in malfunction of or damage to the monitor.
• Inspect the package for breaches prior to
opening and discard if a breach is detected.
Inspect the Catheter and accessories for
damage prior to use, and again, discard if
damage is detected.
Monitoring is
ICP monitoring
continuously supervise
Camino Flex Ventricular
The Catheter must be calibrated IN AIR prior to
implantation. Initialization procedures for
specific Camino Monitors are below.
• Camino Advanced Monitor fitted with
Camino Flex Adapter
The Integra Camino Flex Adapter
button must be pressed before catheter
implantation. If the button is not pressed
before implantation and a "Check Catheter
Connection" message is displayed on the
monitor, discard and replace the Catheter.
Camino ICP and Temperature Monitor
•
The Camino
also
(FLEXEXT) must be connected to the
Monitor prior to connecting the Catheter. If
the Catheter reads "Catheter Failure" after
is
initialization is completed, discard and
replace the Catheter.
• The sterile Catheter should remain in its
sterile packaging until the insertion site has
been fully prepared. This will reduce the
risks for bacterial contamination of the
Catheter body.
• The Camino Advanced Monitor fitted with
the Integra Camino Flex Adapter should be
connected to a power source and turned
on before any patient preparation is
started. This is recommended to minimize
the total time that the twist drill hole and
Catheter remain in communication with the
atmosphere while in the sterile field. DO
NOT immerse the tip of the Catheter or
Catheter connectors in any fluid prior to
implantation in the patient. Failure to follow
these instructions may lead to ICP
measurement error.
• Obstruction of ventricular catheters may
occur due to the presence of blood in the
CSF, collapse of the ventricles and/ or
dislocation of the catheter tip from the
ventricles, kinking of the catheter drainage
lumens/tubing, or clogging of the drain
holes by the choroid plexus.
• Punctures of the brain to insert a ventricular
catheter can predispose an intracerebral
hemorrhage and edema causing a further
rise in ICP.
• In patients with small ventricles, the
ventricular walls may collapse around the tip
of the catheter resulting in obstruction and
predisposing to tentorial herniation.
• The Catheter may be used in children, but
care must be taken to ensure adequate size
of the anterior horn of the lateral ventricle.
Ventricular size can vary widely in children
due to developmental variations and the
presence of disease states such as
Traumatic Brain Injury and Hydrocephalus.
Flex Extension Cable
5