Compatibility With Diagnostic Procedures; Postoperative Valve Test; Functional Safety; Adverse Reaction - MIETHKE proGAV Instrucciones De Manejo

| INSTRUCTIONS FOR USE
GB
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 proGAV is MR Conditional
(ASTM-F2503-20). All components are visible
via X-ray. The provided catheters are MRI Safe.
Reservoirs, deflectors and connectors are MR
Conditional.
Warning note: When using a magnetic field
and simultaneous pressing on the valve an
adjustment of the valve cannot be excluded.
The proGAV will produce artifacts or signal-
intensity voids in MR images larger than the
physical size of the device.

POSTOPERATIVE VALVE TEST

The proGAV has been designed as a safe and
reliable unit even without the provision of a
pumping device. However, there are ways of
testing the unit if a shunt system with a prech-
amber or a Burrhole Reservoir is used. Valve
tests can be carried out by flushing or pressure
measurements.

FUNCTIONAL SAFETY

The valves have been designed for long-term
reliable and precise operation. Still, it cannot
be excluded that the shunt system needs to be
replaced for technical or medical reasons. The
valve and the valve system are able to resist po-
sitive and negative pressure up to 200 cmH
during and after implantation.
Warning note for carriers of pacemakers:Due to
the implantation of a proGAV the function of a
pacemaker can be affected.

ADVERSE REACTION

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 fluid, over/under drainage or in very rare
ases, noise development.
34
Due to violent shocks from the outside (acci-
dent, fall, etc.) the integrity of the shunt may be
endangered.

STERILIZATION

The products are sterilized with steam under
closely monitored conditions. The expiry date
is printed on the wrapping of each individu-
al product. Products taken from a damaged
wrapping must not be used under any circum-
stances.

RESTERILISATION

The functional safety and reliability of resterilized
products cannot be guaranteed, therefore re-
sterilisation is not recommended.

NOTE ON THE INSTRUCTIONS FOR USE

The descriptions and explanations given in this
document are based on the clinical experience
available to date. It is for the surgeon to deci-
de if surgical procedures should be changed
according to his or her experience and to sur-
gical practice.

REQUIREMENTS OF THE MDD 93/42/EEC

The MDD calls for the comprehensive docu-
mentation of the whereabouts of medical pro-
ducts that are applied in human beings, es-
pecially the whereabouts of implants. For this
O reason, the individual identification numbers
2
of any implanted valves are to be noted in pa-
tients' records, so that in the event of any in-
quiries, the implant can be traced without any
difficulties. Each valve is outfitted with a sticker
for this purpose.
proGAV