Preoperative Valve Test; Re-Implantation; Safety Measures; Functional Safety And Compatibility With Diagnostic Procedures - MIETHKE miniNAV Mode D'emploi

GB | INSTRUCTIONS FOR USE
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

Fig. 5: Patency test
a) Sterile, isotonic, physiological saline solution
The miniNAV can be filled by aspiration
through a sterile, single-use syringe attached
to the distal end of the catheter. The proximal
end of the valve is immersed in a sterile, iso-
tonic, physiological saline solution. The valve
is patent if fluid can be extracted in this way
(see fig. 5).
WARNING
Pressure admission through the single-use
syringe should be avoided, both at the proxi-
mal and the distal end. Contaminations in the
solution used for the test can impair the prod-
uct's performance.

RE-IMPLANTATION

Under no circumstances should products that
had previously been implanted in a patient
be subsequently reimplanted in another,
because a successful decontamination of the
device cannot be reached without functional
degradation.

SAFETY MEASURES

The patient must be monitored carefully after
the implantation. Reddened skin and tension
in the area of the drainage tissue could indi-
cate infections at the shunt system. Symp-
toms such as headache, dizzy spells, men-
tal confusion or vomiting are common occur-
rences in cases of shunt dysfunction. Such
symptoms as well as shunt system leakage
14
necessitate the immediate replacement of the
shunt component responsible or of the entire
shunt system.
FUNCTIONAL SAFETY AND
COMPATIBILITY WITH DIAGNOSTIC
PROCEDURES
These medical devices are constructed in
such a way as to ensure their precise and reli-
able operation over long periods of time. How-
ever, no guarantee can be given that these
medical devices may not require replacement
for medical or technical reasons. These med-
ical devices are able to resist positive and
negative pressures up to 200 cmH
ing and after implantation. These medical
devices have to be stored in a clean and dry
environment at all times. Nuclear magnetic
resonance (MRI) examinations up to a field
strength of 3 Tesla or computed tomography
(CT) examinations can be performed with-
out risk or impairment to the valve function.
The valve is MR Conditional. The supplied
catheters are MR Safe. Reservoirs, deflectors
and connectors are MR Conditional.
WARNING
If a magnetic field is being applied and pres-
sure is applied to the valve at the same time,
thus triggering the brake mechanism, it is not
possible to rule out valve adjustment. In MRI
imaging miniNAV creates artefacts which are
larger than the valve itself.
CAUTION
For people using cardiac pacemakers: It is
possible that the function of the pacemaker
is influenced by the implantation of a mini-
NAV.

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 Burrhole Reservoir allows
the shunt system to be tested by flushing or
pressure measurements.
miniNAV
O dur-
2