Integra LifeSciences CODMAN HAKIM Precision Fixed Pressure Valves Mode D'emploi page 10

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
CODMAN
Pressure Valves
Description
The CODMAN HAKIM
®
mechanism (Figures 1 & 2) that incorporates a flat 316L stainless steel spring
in which the calibration is accomplished by a combination between a pillar and
a micro-adjustable telescoping fulcrum. The valve chassis is made of titanium.
The ball and cone are manufactured from synthetic ruby. Intraventricular
pressure is maintained at a constant level by the ball and cone valve
seat design.
The operating pressures of the valve unit have been determined with
a flow rate of 10–25 ml H
operating pressure with a specified flow rate and not by the opening and
closing pressures. The pressure that a valve sustains with a given flow
is the parameter that reflects the operating pressure of the valve once
it is implanted. Before shipment, each valve is calibrated with special
equipment. Duplication of these test procedures cannot be accomplished
in the operating room.
Several models of the valve have been marked with an x-ray detectable
direction-of-flow indicator.
Indications
The CODMAN HAKIM Precision Fixed Pressure Valve Systems are
implantable devices that provide constant intraventricular pressure and
drainage of CSF for the management of hydrocephalus.
Contraindications
The CODMAN HAKIM Unitized Valve Systems are not recommended for
atrial placement. Use the nonunitized versions for this procedure.
These devices are contraindicated in patients receiving anticoagulants or
known to have a bleeding diathesis.
Avoid shunt implantation if infection is present within the body. Delay the
shunt procedure when infections such as meningitis, ventriculitis, peritonitis,
bacteremia, and septicemia are present.
WARNINGS
The valve unit contains components made from titanium and 316L stainless
steel. When tested with MRI magnets of up to 1.5 teslas, the valve
produced an insignificant amount of force and torque. This shunt system,
as with other implants containing metallic components, may produce an
artifact during MRI. The requesting physician must determine whether the
location of the artifact will affect the area of interest.
The SIPHONGUARD
It also reduces the ability to prime the shunt system during implantation to
a rate of approximately 0.5 cc/minute.
Precautions
Inspect the sterile package carefully. Do not use if:
• the package or seal appears damaged,
• contents appear damaged, or
• the expiry date has passed.
Use only with components compatible with the dimensions shown in the
Device Description section.
This is a fixed pressure valve. It functions on a fixed pressure system within
the indicated range.
Aseptic technique is necessary in all phases of the use of this product.
Silicone has a low cut and tear resistance; therefore, exercise care when
placing ligatures so as not to tie them too tightly. The use of stainless steel
ligatures on silicone rubber is not recommended.
Do not use sharp instruments when handling the silicone valve or catheter;
use shod forceps. Cuts or abrasions from sharp instruments may rupture or
tear the silicone components.
Do not fold or bend the valve during insertion. Incorrect insertion may rupture
the silicone housing.
HAKIM
® ®
Precision Fixed Pressure Valve includes a valve
®
O per hour. The valve is classified by its
2
device is intended to reduce the rapid flow of CSF.
®
Precision Fixed
2