Safety Measures; Compatibility With Diagnostic Procedures; Postoperative Valve Test; Functional Safety - B.Braun Aesculap MIETHKE paediGAV Mode D'emploi

paediGAV

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 imme-
diate replacement of the shunt component re-
sponsible, 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 function-
ality of the shunt. The paediGAV is MR Con-
ditional (ASTM F2503-20). All components are
visible via X-ray. The provided catheters are MRI
Safe. Reservoirs, deflectors and connectors are
MR Conditional.

POSTOPERATIVE VALVE TEST

The paediGAV 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.

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.

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.

RESTERILIZATION

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

PRESSURE-FLOW CHARACTERISTICS

In the following, the pressure-flow characteri-
stics for the available pressure settings of the
paediGAV are shown.
paediGAV 4/14 cmH
40
35
30
25
20
Pressure rating 14 cmH
15
10
O
2
5
Pressure rating 4 cmH
0 5 10
INSTRUCTIONS FOR USE |
O
2
O
2
O
2
15 20 25 30 35 40 45
Flow (ml/h)
GB
50 55
19