Integra LifeSciences Codman RICKHAM Manual página 7

Sterility
This product is for SINGLE USE ONLY; DO NOT RESTERILIZE.
Use aseptic technique in all phases of handling. Integra
LifeSciences will not be responsible for any product that is
resterilized, nor will we accept for credit or exchange any product
that has been opened but not used.
Codman 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 of the Ventriculostomy Reservoir
Set is not opened or damaged, the product is sterile.
Recommended Instructions for Use
The instructions printed below are a general guide intended
for informational purposes only. The physician may wish to
alter procedural details in light of his own clinical judgment and
experience.
1. Incise and reflect the scalp and pericranium in the usual manner.
2. Place a burr hole so that the reservoir will lie under the flap
and not under the incision. The burr hole should be 6 mm for the
standard RICKHAM and SALMON-RICKHAM designs and 9 mm
for the large RICKHAM design.
3. Electrocoagulate the dura and arachnoid, then penetrate them
using a ventricular needle.
NOTE: If the dura opening is somewhat smaller than the
catheter, the snug fit should prevent subsequent leakage of the
cerebrospinal fluid around the incision.
4. Using the stainless steel stylet, introduce the ventricular catheter
through the dura, and advance it into the lateral ventricle or other
intracranial cavity.
5. With removal of the stylet, free flow of the cerebrospinal fluid
should occur. Clamp the catheter with a rubber-shod clamp or other
device suitable for use on silicone rubber.
Simple Ventriculostomy
Secure the stainless steel or nylon plug in the lumen of the side
1.
arm with 2-0 or 3-0 non-absorbable ligatures.
Connect the reservoir to the ventricular catheter using 2-0 or 3-0
2.
non-absorbable ligatures. Remove the clamp and seat the reservoir
in the burr hole.
Pull the pericranium over the reservoir, and suture in place to
3.
maintain the position of the reservoir in the skull.
Close the scalp using suture material of the surgeon's choice.
4.
5