Preoperative Valve Test; Safety Measures; Re-Implantation; Compatibility With Diagnostic Procedures - MIETHKE miniNAV Instrucciones De Manejo

| INSTRUCTIONS FOR USE
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Likewise, various surgical techniques are
available for positioning the peritoneal catheter.
We recommend pulling through the peritoneal
catheter, using a subcutaneous tunneling tool
and perhaps with an auxiliary incision, from the
shunt to the intended position of the catheter.
The peritoneal catheter, which is usually secu-
rely attached to the miniNAV, has an open distal
end, but no wall slits. Following the exposure
of, and the entry into, the peritoneum by means
of a trocar, the peritoneal catheter (shortened,
if necessary) is pushed forward into the open
space in the abdominal cavity.

PREOPERATIVE VALVE TEST

Isotonic sterile sodium chloride solution
Fig. 5: Patency test
The miniNAV can be filled by aspiration through
a sterile, single-use syringe attached to the di-
stal end of the catheter. The proximal end of
the valve is immersed in a sterile, physiological
saline solution. The valve is patent if fluid can be
extracted in this way (see Fig. 5).
Caution: Pressure admission through the
single-use syringe should be avoided, both
at the proximal and the distal end.
Contaminations in the solution used for the
test can impair the product's performance.

SAFETY MEASURES

The patients must be carefully monitored after
the implantation. Reddened skin and tension
in the area of the drainage tissue could indicate
infections at the shunt system. Symptoms such
as headache, dizzy spells, mental confusion or
vomiting are common occurrences in cases of
shunt dysfunction. Such symptoms, as well as
shunt system leakage, necessitate the immediate
replacement of the shunt component responsible,
or of the entire shunt system
16

RE-IMPLANTATION

Under no circumstances should products that
have had previously been implanted in a patient
be subsequently reimplanted in another, because
a successfull decontamination of the device can-
not be reached without functional degradation.
COMPATIBILITY WITH DIAGNOSTIC PRO-
CEDURES
MRI examinations with field strengths of up to
3.0 tesla and CT examinations can be carried
without endangering or impairing the functiona-
lity of the shunt. The miniNAV is MR Conditional
(ASTM-F2503-08). All components are visible
via X-ray. The provided catheters are MRI Safe.
Reservoirs, deflectors and connectors are MR
Conditional.

POSTOPERATIVE VALVE TEST

The miniNAV has been designed as a safe and
reliable unit even without the implantation of a
pumping device. However, the inclusion of a
prechamber or a borehole reservoir allows the
shunt system to be tested by flushing or pres-
sure measurements.

ADVERSE REACTIONS

In the treatment of hydrocephalus with shunts,
the following complications may arise (as de-
scribed in the literature): infections, blockages
caused by protein and/or blood in the cerebro-
spinal mfluid, over/under drainage or in very
rare cases noise development.
Violent shocks from the outside (accident, fall)
may put the integrity of the shunt system at risk.

STERILISATION

The products are sterilized with steam under
closely monitored conditions. Double wrapping
in sterile bags ensures sterility for a period of
five years. The expiry date is printed on the
wrapping of each individual product. Products
taken from a damaged wrapping must not be
used under any circumstances.
miniNAV