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| INSTRUCTIONS FOR USE
GB
SURGICAL PROCEDURE
Positioning the ventricular catheter
Several surgical techniques are available for po-
sitioning the ventricular catheter. The necessary
skin incision should be carried out, preferably,
in the shape of a lobule pedicled towards the
draining catheter or as a straight skin incision.
To avoid CSF leakage, care should be taken
that the dura opening is kept as small as possi-
ble after applying the borehole. The ventricular
catheter is stiffened by the introducing stylet
supplied with the product.
The paediGAV is available in different shunt vari-
ants: When using a paediGAV SHUNTSYSTEM
with borehole reservoir, the ventricular catheter
is implanted first. Once the introducing stylet
has been removed, the patency of the ventri-
cular catheter can be tested by checking if CSF
is dripping out. The catheter is shortened and
the borehole reservoir is connected, with the
connection secured with a ligature. The skin in-
cision should not be located directly above the
reservoir.
The paediGAV SHUNTSYSTEM with precham-
ber comes with a deflector. This deflector is
used for adjusting the position of deflection be-
fore implantation of the ventricular catheter. The
catheter is deflected; the prechamber is put into
place. The position of the ventricular catheter
should be inspected again by postoperative CT
or MR imaging.
Positioning the valve:
The paediGAV operates in different modes
depending on the patient's position. Hence
it is important that the valve is implanted par-
allel to the body axis. A suitable implant site
is behind the ear. Following the skin incision
and the tunneling through the skin, the cathe-
ter is pushed forward to the implantation site
chosen for the valve. If necessary, the cathe-
ter is shortened and fastened at the paedi-
GAV by means of a ligature, taking care that
the valve does not lie directly under the skin
incision. The valve is marked with an arrow
pointing towards the feet of the patient (towards
the distal end or downwards respectively).
Positioning the peritoneal catheter
The access site for the peritoneal catheter is left
to the surgeon's discretion. It can be applied
18
paediGAV
e. g. para-umbilically in a horizontal direction
or transrectally at the height of the epigastrium.
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 intended position of the catheter. The
peritoneal catheter, which is usually securely
attached to the paediGAV, 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. 6: Patency test
The paediGAV can be filled most gently by aspi-
ration through a sterile, single-use syringe atta-
ched to the distal end of the catheter. The pro-
ximal 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. 6).
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.
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.
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 F2503-13). 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 borehole 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.
INSTRUCTIONS FOR USE |
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 double wrap-
ping 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.
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
O
2
40
35
30
25
20
Pressure rating 14 cmH
O
15
2
O
2
10
5
Pressure rating 4 cmH
O
2
0
5
10
15
20
25
30
35
40
45
Flow (ml/h)
GB
50
55
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