Codman UNI-SHUNT, Руководство пользователя

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Sterility
Every UNI-SHUNT with Reservoir Catheter is
supplied double-wrapped sterile. This product is
for SINGLE USE ONLY; DO NOT RESTERILIZE.
Codman & Shurtleff 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
UNI-SHUNT with Reservoir Kit is not opened or
damaged, the product is sterile.
The following components have been tested and
were determined to be nonpyrogenic:
UNI-SHUNT with Reservoir Catheter, 17 gauge
blunt tip needle, and anchoring clips.
Handling
UNI-SHUNT Products are manufactured in a clean
environment. The catheters are made of high tear-
resistant silicone rubber. Due to the electrostatic
properties of silicone rubber, the following steps
should be taken in handling this product:
1. All UNI-SHUNT Products should be left in
their original package until such time as they
are needed.
2. Directions for opening sterile package are printed
on the packages.
3. Silicone rubber should be handled with gloved
hands. It is recommended that gloves be changed
before handling the catheter.
4. Exercise extreme care to prevent the silicone
rubber from coming in contact with towels, drapes,
talc, or other granular or linty surfaces.
Recommended Preimplantation Valve
Patency Test
Although we pretest all UNI-SHUNT Valve
Catheters to help insure proper function, we
recommend the following procedure, which
duplicates our testing procedure, be followed prior
to implantation.
1. Remove valve catheter from package. GENTLY
ROLL THE SLITS BETWEEN YOUR THUMB AND
INDEX FINGER.
2. Gently “pop” the slits open by holding the
catheter on either side of the slits and pushing
your fingers together.
3. Gently roll the slits a second time as in Step 1.
4. Affix a 17 gauge blunt needle (such as that
provided in the UNI-SHUNT with Reservoir Kit)
to a syringe. For ease of insertion, use one of the
ventricular holes furthest away from the tip. It may
be helpful to
slightly
stretch the catheter during
this procedure. Flush and fill the catheter through
the ventricular holes of the system with sterile
demineralized water or saline to assure patency.
(Vigorous flushing may distort the slits and give
false pressure readings. To correct, gently roll the
slits before testing.)
5. Hold both ends of the catheter in one hand
and fill the catheter lumen with fluid through the
ventricular end, forcing fluid out of all four slits by
applying a slight pressure on the syringe. Be sure
to eliminate all air bubbles. See Figure 3.
6. Slowly lower the distal slit valve end of the
catheter until it is hanging vertically. Once the fluid
has stopped dripping, measure the column of fluid
from the top of the slits and compare with the
assigned closing pressure. See Figure 4.
The following information concerning the
UNI-SHUNT with Reservoir is for reference only,
to provide general procedures when the catheter
is used with the UNI-SHUNT with Reservoir Kit.
Instructions for Use
Prior to creating the sterile field, use a surgical
marker to insure accurate identification of the
incision site and the path of the shunt before actual
implantation. The patient should be measured to
determine the proper catheter length required.
If hypodermic injection is required, inject with
a 25 gauge, or smaller, HUBER type needle into
the self-sealing reservoir domes only.
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