Case Of A Valve Preconnected To A Siphonx - Sophysa POLARIS SPV-SX Notice D'emploi

artifacts when an MRI examination is performed (cf. § 7 "
Behavior during Magnetic Resonance Imaging (MRI)").
PRECAUTION
Do not perform the implantation of a shunt without having a
replacement shunt system available in case it is required.
WARNING
Do not carry out an additional test before implantation: each
valve has been individually calibrated and checked.Any pre-
operative pressure tests will increase the risk of infection.
9.3.1. Ventricular Catheter
— Introduce the catheter into the ventricle using the
introducing stylet supplied for this purpose.
— If necessary, adjust the implantation depth of the
ventricular catheter with the right angle adapter
supplied. Position it in the axis of the burr hole.
— Purge the catheter of air with the CSF.
— If necessary, check that the reservoir is properly filled,
and then clamp.
— Connect and delicately ligate the catheter to the inlet
connector of the valve (or that of the reservoir for valve
models with integrated reservoirs). Check that the
arrow located on the upper surface of the valve is
correctly oriented in the direction of the flow. The clamp
can then be released.
WARNING
Ensure that the arrow on the upper surface of the valve
is correctly oriented in the direction of the flow: assembly
of the valve in the opposite direction would prevent any
drainage.
PRECAUTION
Due to the fragility of the silicone, using metallic forceps for
inserting catheters and for ligating them onto connectors
is not recommended. This would create a risk of cutting or
piercing the catheters.
9.3.2. Valve
PRECAUTIONS
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Polaris models must be implanted on a bony surface,
under sub-cutaneous tissue less than 8 mm thick.
The selected implantation site must be sufficiently
unencumbered to facilitate detection of the valve by the
Locator when adjustments are made later (space of at least
4 cm all around the valve, away from the ear and the neck).
If these precautions are not observed, there may be
difficulties with adjustment or it may even be impossible to
make an adjustment, due to poor localization of the valve
by the Locator or the Magnet moving the rotor insufficiently.
WARNING
In the case of valves with an integrated reservoir or catheter,
do not attempt to detach the reservoir or catheter from the
valve. Detachment of the reservoir or catheter may unscrew
the connector closure screw and uncalibrate the valve.
12 – ENGLISH
1. Purge the valve of air. To prevent any risk of
introducing an air bubble, it is recommended that the
valve be left to fill directly with the patient's CSF. In the
majority of cases, the valve fills immediately.
However, in patients with low intracranial pressure or
if the valve is set to a high pressure, the valve cannot
fill spontaneously. In this case :
— place a piece of catheter on the outlet connector
and slowly aspirate the CSF using a syringe fitted
with a Luer connector,
or even:
— press the dome of the reservoir to allow the CSF
to fill the valve (SPVA and SPVB models).
PRECAUTION
Do not fill or purge the valve with any liquid other than
the patient's CSF or water for injection (WFI) before
implantation to avoid any risk of deposits in the valve,
which could lead to an obstruction in the shunt system
or a blockage in the valve mechanism.
2. Check that the valve is correctly filled with CSF and
there are no air bubbles inside the valve. If this is
not the case, continue to purge. The presence of air
bubbles could cause a significant change to the
operating pressure initially chosen.
3. Check that the arrow on the upper surface of the valve
is visible and correctly oriented in the direction of the
CSF flow.
PRECAUTION
Do not implant the valve without suturing it to the
underlying tissues by its two connectors or by the suture
holes provided for this. If the shunt system migrates the
drainage may stop and other complications ensue.
WARNING
Before suturing the valve to the underlying tissues, check
that the arrow on the upper face of the valve is visible.
If the arrow is not visible this means that the valve has
been implanted the wrong way up (upside – down). In this
case, direct reading with the Compass will be reversed,
for example: a high reading (No.5) for a valve set to a
low position (No.1). This could cause serious clinical
consequences (over- or underdrainage). In this situation,
contact Sophysa for adjustment instructions.

9.3.2.1. Case of a valve preconnected to a SiphonX

gravitational anti-siphon device
To prevent any risk of introducing an air bubble, it is
recommended that the "Valve + SiphonX
left to fill directly with the patient's CSF. For this, make
sure it is kept horizontal. In the majority of cases the "valve
+anti-siphon device" assembly fills immediately.
PRECAUTION
For optimum operation of a Polaris
®
attached SiphonX gravitational anti-siphon device, make
sure the assembly is positioned parallel to the axis of the
body of the patient.
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®
" assembly be
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valve with a pre-