Reading And/Or Changing The Operating Pressure Of A Sophy; Implantation - Sophysa Sophy Notice D'emploi

to fill the valve (for SM8A and SM8B 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
e.g. reading of a high position (No.8) 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.
9.3.3. Peritoneal Catheter
1. Make a short peritoneal incision in the peri-umbilical
region.
2. Tunnel the distal catheter.
3. Connect the proximal end of the catheter to the valve
outlet connector and ligate it delicately.
4. Check the flow of CSF.
5. Adapt the length of the catheter.
6. Bury the distal end of the catheter in the peritoneal
cavity.
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.
9.3.4. Specific characteristics linked to the
implantation of the SM8-2040 pre-connected
lumboperitoneal kit
9.3.4.1. Lumbar Catheter
1. Make a small vertical skin incision between two
spinous processes at the chosen level.
2. Insert the 14GTuohy needle into the centre of the
incision, push the
12 – ENGLISH
Compass
will be reversed,
needle into the lumbar
subarachnoid space using an appropriate technique.
3. Pass the open end of the catheter with multiple
perforations through the Tuohy needle. The first
graduation placed at 11 cm corresponds to the length
of the needle. The following graduations indicate the
length of catheter effectively inserted into the lumbar
sub-arachnoid space.
4. Check the flow of CSF.
5. Remove the Tuohy needle while leaving the catheter in
place.
6. Make an incision in the lower side part of the thorax
on the axillary axis.
7. Tunnel the catheter from the lumbar incision to the
thoracic incision.
8. Purge the catheter of air with the CSF and then clamp.
WARNING
Avoid implanting a lumboperitoneal shunt in children.
PRECAUTION
Do not use any Tuohy needle other than that supplied in
each kit by Sophysa.
9.3.4.2. Valve with pre-connected peritoneal catheter
1. Make a small peritoneal incision in the peri-umbilical
region.
2. Form a subcutaneous pocket for the valve from the
thoracic incision.
3. Tunnel the peritoneal catheter from the thoracic
incision to the peritoneal incision.
4. Adapt the length of the lumbar catheter. Connect it to
the intermediate catheter connector. Adapt the length
of the intermediate catheter and connect it to the
valve.
5. Ligature delicately.
6. Remove the clamp.
7. 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 Medium or 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.
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.
9.4. READING AND/OR CHANGING THE
OPERATING PRESSURE OF A SOPHY
AFTER IMPLANTATION
Refer to §4 – Principle of the Sophy
For more information refer to the instructions for the
®
VALVE
®
valve adjustment.