Components And Accessories - Codman HAKIM Manual Del Usuario

All programmable valve configurations are designed for use with
components having the following dimensions:
Component
Ventricular Catheter
Drainage Catheter
SIPHONGUARD Device
CSF flows through the inlet valve and enters the SIPHONGUARD Device,
where it flows into two internal passages. Under normal conditions, the
majority of CSF flows through a central ruby ball and cone valve, and
exits directly out of the distal port of the SIPHONGUARD Device. The
remaining CSF travels through a spiral passage that surrounds the central
passage, and joins the fluid passing through 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 the SIPHONGUARD Device 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 the SIPHONGUARD Device never stops, regardless of the
patient's position.
Note: The SIPHONGUARD Device will not activate at low CSF flow rates.
The SIPHONGUARD Device has a rigid enclosing shell of polyethersulfone
to prevent inadvertent closure (and subsequent reduction or blockage of
CSF flow) caused by externally applied pressure.
How Supplied
The Valve includes a programmable valve, instructions for use, straight
connector(s)*, introducer**, and priming adapter***.
The Valve System includes a programmable valve, 14 cm ventricular
catheter, 120 cm peritoneal catheter, instructions for use, right angle
adapter, and priming adapter***.
The Valve System, Unitized, includes a programmable valve, 14 cm
ventricular catheter, 85 cm slit**** or 120 cm unitized peritoneal catheter,
instructions for use, straight connector(s)*, introducer**, right angle adapter,
and priming adapter***.
*Straight connectors provided with Cylindrical, Micro, and In-line with
SIPHONGUARD and Platform with Proximal Tube versions only.
**Introducers provided with Cylindrical versions only.
***Priming adapter provided with In-line, Right Angle, and Micro versions only.
****85 cm slit catheter packaged with 82-3853 only.

Components and Accessories

Valve Programmer
The valve programmer, available in 100/120 or 220/240 VAC, is
supplied with a transmitter head, transmitter cord, and carrying case.
The programmer is sold nonsterile and available separately. The
programmer is required for changing the pressure setting of the valves.
Ventricular Catheter and Right Angle Adapter (Figure 3)
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 right angle adapter, made of PROLENE
bending of the ventricular catheter at the burr hole site.
Priming Adapter (Figure 4)
The priming adapter, provided with the In-line, Right Angle, and Micro Valves,
facilitates preimplantation irrigation to the valve and catheters.
Straight Connector
The straight connector joins the proximal and distal catheters to the valve.
Valve Introducer
A disposable polyethylene valve introducer is supplied to aid in passing the
valve and drainage catheter from the burr hole site to a mastoidal incision,
when a two-step passage technique is used. Because of the malleability
of this introducer, it can be preformed to a desired curvature prior to
valve placement.
Sterility
The CODMAN HAKIM Programmable Valve Systems are intended for SINGLE
USE ONLY; DO NOT RESTERILIZE. Use aseptic technique in all phases of
handling. Integra will not be responsible for any product that is resterilized,
nor accept for credit or exchange any product that has been opened but not
used.
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 can
also compromise device performance and any usage beyond the design
intent of this single-use device can result in unpredictable use hazards or
loss of functionality. (THIS STATEMENT APPLIES TO NON-IMPLANTABLE
COMPONENTS ONLY.)
As long as the individual package is not opened or damaged, the product
is sterile.
Inner Diameter
1.4 mm
1.0 mm
®
Material, allows 90 degree
4
Outer Diameter
2.7 mm
2.2 mm