Accessories; How Supplied - Integra Codman CERTAS Plus Mode D'emploi

EN – ENGLISH
and exits directly out of the distal port of SIPHONGUARD. The
remaining CSF travels through a spiral passage that surrounds
the central passage, distal to the ball and cone valve.
A sudden increase in CSF flow will close the ball and cone
valve and the entire volume of CSF will be forced through the
longer spiral passage, effectively slowing the rate at which
CSF is shunted from the brain. Once the flow rate entering
SIPHONGUARD decreases, the ruby ball separates from the valve
seat, opening the central passage. As long as CSF continues to be
shunted from the ventricles, flow through the spiral passage of
SIPHONGUARD never stops, regardless of the patient's position.
See Graphs 1 and 2 for pressure flow characteristics.
Note: SIPHONGUARD will not activate at low CSF flow rates.
SIPHONGUARD has a rigid enclosing shell of polyethersulfone
to prevent inadvertent closure (and subsequent reduction or
blockage of CSF flow) caused by externally applied pressure.

Accessories

Accessory components supplied with some models of the valve
include:
Ventricular catheter
Distal catheter (unitized or separate)
Right angle adapter
Priming adapter
Catheters
The ventricular catheter is a 14 cm straight ventricular catheter
molded of radiopaque silicone elastomer with x-ray detectable
dots and a preassembled stainless steel introducing stylet.
The distal catheter is 120 cm long, molded of radiopaque silicone
elastomer with x-ray detectable dots.
The BACTISEAL Catheters that are supplied with some models of
the valve are made of radiopaque barium-impregnated silicone
tubing that is subjected to a process by which the silicone is
impregnated with rifampin and clindamycin hydrochloride.
The quantities of rifampin and clindamycin hydrochloride
used to impregnate the catheters are only a small fraction of a
therapeutic dose of these two antibiotics, and have no potential
for systemic therapeutic effect.
BACTISEAL Catheters are also available separately.
Right Angle Adapter
The right angle adapter, made of PROLENE Material, allows
®
90-degree bending of the ventricular catheter at the burr hole
site.
Priming Adapter
The priming adapter with inlet tubing facilitates pre-implantation
irrigation of the valve and catheters.

How Supplied

The valve and its accessories are for SINGLE USE ONLY; DO
NOT RESTERILIZE . Integra single-use devices have not been
designed to undergo or withstand any form of alteration, such
as disassembly, cleaning, or re-sterilization, after a single patient
use. These devices are intended to come into contact with the
central nervous system and the ability does not currently exist
to destroy possible contaminates, such as Creutzfeldt-Jakob
Disease. Reuse might also compromise device performance and
any usage beyond the design intent of this single use device
might result in unpredictable use hazards or loss of functionality.
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