Indications For Use; System Description - Integra Camino Flex Ventricular VTUN Mode D'emploi

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INTEGRA
PROTECTION TUBE
DEPTH MARKINGS
SUTURE LOOPS (2)
Figure 1: Contents of the Kit

INDICATIONS FOR USE

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Use of the Integra
Intracranial Pressure
indicated when
intraventricular intracranial pressure (ICP)
monitoring and cerebrospinal fluid (CSF)
drainage are required. ICP monitoring, using
this device, is an invasive method for
measuring intracranial pressure.

SYSTEM DESCRIPTION

The system is designed for use in a hospital
environment, such as intensive care units, by
clinicians with experience in neurological/
intracranial pressure monitoring.
The Integra Camino
Intracranial Pressure Monitoring Kit contains a
sterile, non-pyrogenic 9/10 French catheter
embedded with a micro miniature silicon strain
gauge pressure transducer that is used to
monitor ICP and drain CSF. In addition to the
catheter, the following sterile, non-pyrogenic
accessories are included: (Fig. 1).
• One (1) 0.125" (3.17 mm) diameter stainless
steel trocar with scalp tunneling sheath.
• One (1) 0.029" (0.7 mm) diameter stainless
steel catheter introducer stylet.
• Two (2) suture loops.
• One (1) 7 mm diameter drill bit with drill stop.
• One (1) Hex wrench.
This Catheter interfaces with the following
Integra Camino ICP Monitoring Systems:
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• Integra Camino
(CAM01) fitted with the Integra
Flex Adapter (FLEXADR)
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• Integra Camino
Monitor (CAM02)
4
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CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE
MONITORING KIT (VTUN)
TROCAR
DRILL BIT WITH STOP
STYLET
CATHETER
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Camino Flex Ventricular
Monitoring Kit
direct and continuous
Flex Ventricular
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Advanced Monitor
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Camino
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ICP and Temperature
TUNNELING SHEATH
HEX WRENCH
PRESSURE
TRANSDUCER
NOTE: In addition to the accessories provided
in this kit, various surgical instruments and
supplies are required to place the Integra
is
Camino Flex Ventricular Catheter (Catheter).
The following surgical instruments and supplies
are recommended for preparation of the
surgical sites (Not included in Kit):
• Hair clippers
• Sterile drapes, towels or similar
• Antiseptic solution for scalp such as
povidone-iodine
• Ruler, used to locate insertion and tunneling
exit sites
• Marker, used to mark insertion and
tunneling exit sites
The following
supplies are recommended for tunneling and
subsequent
included in Kit):
• Scalp anesthetic such as 1% Xylocaine
similar
• Syringe and needle for administration of
scalp anesthetic
• Scalpel for scalp incisions at catheter
insertion and tunneling exit sites
• Sterile gauze or similar absorbent materials
• Self retaining type retractors or similar to
provide bone exposure
• Hand drill
• Syringe and sterile saline for irrigation of
twist drill hole to remove bone fragments,
blood, etc.
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• Sharp instrument to open the dura, such as
an 18 gauge spinal needle, 11 blade scalpel,
or similar.
DRAINAGE PORT WITH LUER LOCK
CONNECTOR
surgical instruments
catheter implantation
and
(Not
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or