Implantation; Safety Measures And Contraindications; Interaction With Products From Other Manufacturers; Compatibility To Diagnostic Procedures - MIETHKE Ventricular Catheter Mode D'emploi

Ventricular Catheter / Peritoneal Catheter

IMPLANTATION

When implanting a catheter, the physician
have to ensure that the catheter is secured
with ligatures. The ventricular catheter can
be implanted with the aid of an introducing
stylet. After removing the stylet, the patency
of the ventricular catheter can be checked by
dripping out CSF. The length of the catheter
that extends into the cranium can be pre-
determined with the help of the deflector,
after which it can be brought through the 90°
angle. The deflector (Burrhole Deflector) can
be ordered separately.
Under no circumstances should products
that have had previously been implanted
in a patient be subsequently reimplanted in
another, because a successfull decontamina-
tion of the device cannot be reached without
functional degradation.
SAFETY MEASURES AND
CONTRAINDICATIONS
To avoid cuts and scratches in the silicone
elastomer close attention should be payed
while using sharp instruments. Likewise atten-
tion should be payed not to tighten the liga-
ture too firmly. Damage may result in a loss
of integrity of the shunt and therefore may
require a revision.
Silicone is extremely electrostatic. You shall
ensure that the catheter does not come into
contact with dry towels, talcum or rough sur-
faces. Adherent particles may lead to tissue
reactions.
Following implantation of a shunt system, the
patient's condition should be carefully and
thoroughly monitored. Inflamed skin and ten-
sion in the area of the drainage tissues could
possibly be a sign of infection in the shunt
system. Symptoms such as headache, dizzi-
ness, disorientation, or vomiting often occur in
cases of shunt dysfunction. In the event such
symptoms occur, or if there is any leakage in
the shunt system, either individual shunt sys-
tem components or the entire shunt system
must be replaced without delay.
INSTRUCTIONS FOR USE | GB
Do not implant if an infection (f.e. meningi-
tis, vertriculitis, peritonitis, bacteremia, sep-
ticemia) or the suspicion of an infection is
diagnosed in a region of the patient's body
where the shunt system will be implanted.
INTERACTION WITH PRODUCTS FROM
OTHER MANUFACTURERS
When using accessory products of the
Christoph Miethke GmbH & Co. KG in com-
bination with valves from other manufactur-
ers it should be ensured that the connection
between products is secure. The combination
of products from different manufacturers in a
shunt system is generally not recommended.
COMPATIBILITY TO DIAGNOSTIC PROCE-
DURES
All catheters are made of silicone. MRI exam-
inations with field strengths of up to 3.0 tesla
and CT examinations can be carried without
endangering or impairing the functionality of
the shunt (ASTM F2503-2020). The catheters
are MR Safe. The provided Burrhole Deflec-
tors are MR Conditional.

FUNCTIONAL SAFETY

The medical products have been designed for
long-term reliable and precise operation. Still,
it cannot be excluded that the medical prod-
ucts need to be replaced for technical or med-
ical reasons. The medical products are able
to resist positive and negative pressure up to
200 cmH O during and after implantation.
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The medical products should be stored dry
and clean. The products should not be
removed from the packaging until they are
required.
ADVERSE REACTIONS AND
INTERACTIONS
In the treatment of hydrocephalus with shunts,
the following complications may arise (as
described in the literature): Infections, block-
ages caused by protein and/or blood in the
cerebrospinal fluid, over-/underdrainage or in
very rare cases noise development. Violent
shocks for the outside (accident, fall) may put
the integrity of the shunt system at risk.
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