Re-Implantation; Safety Measures; Compatibility With Diagnostic Procedures; Postoperative Valve Test - MIETHKE GAV Mode D'emploi

EN | INSTRUCTIONS FOR USE

RE-IMPLANTATION

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

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 im-
mediate replacement of the shunt component
responsible, or of the entire shunt system
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 GAV is MR Conditional. All
components are visible via X-ray. The provided
catheters are MR Safe. Reservoirs, deflectors
and connectors are MR Conditional. The con-
ditions for MR compatibility of the products can
be found on our website:
https://www.miethke.com/downloads/

POSTOPERATIVE VALVE TEST

The GAV has been designed as a safe and relia-
ble unit even without the provision of a pumping
device. However, there are ways of testing the
unit if a shunt system with a prechamber or a
burrhole reservoir is used. Valve tests can be
carried out by flushing or pressure measure-
ments.

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
20
replaced for technical or medical reasons. The
valve and the valve system are able to resist po-
sitive and negative pressure up to 200 cmH2O
during and after implantation.

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
cases, noise development.
Due to violent shocks from the outside (acci-
dent, fall, etc.) the integrity of the shunt may be
endangered.

STERILISATION

The products are sterilised 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 resteri-
lised products cannot be guaranteed, therefore
resterilisation is not recommended.

MEDICAL PRODUCTS CONSULTANT

In compliance with the European Directive con-
cerning medical devices (Directive 93/42/ EEC),
Christoph Miethke GmbH & Co. KG has nomi-
nated medical devices consultants as contacts
for all product-related questions.
You can contact our medical devices
consultants via:
Tel. +49 331 62083-0
info@miethke.com
GAV