Other; Storage Conditions; Processing Of The Products After Use; Destruction After Use - Sophysa Sophy Notice D'emploi

to come out of their insertion sites.
These malfunctions require the shunt to be put back in
place immediately.
Cases of tonsillar hernias linked to a lumboperitoneal shunt
have been reported,
Lumboperitoneal shunts are not advised in children.

11.5. OTHER

Failure of a shunt system may also be linked to
disconnection of its various components.
The ventricular catheter may migrate inside the ventricle.
The peritoneal catheter may migrate into the peritoneal
cavity under the action of the peristaltic waves of the
intestine, while an atrial catheter may migrate into the right-
hand cavities of the heart following the blood flow.
Perforation or occlusion of abdominal viscera by the
peritoneal catheter could occur.
Growth of the body may progressively cause the catheters
to exit their insertion sites.
These malfunctions
repositioned immediately.
Cases of cutaneous necrosis over the implantation site are
possible.
Over time fibrous adhesions may fix the ventricular
catheter in the choroid plexus or the cerebral tissue. If
removal is being considered, gentle rotation of the catheter
about its axis may make it possible to free it. The catheter
should never be withdrawn forcibly. If it cannot be taken
out without forcing, it is preferable to leave it in place rather
than risk an intra-ventricular hemorrhage.
Cases of allergy to silicone have been described.
Cases of epilepsy after implantation of a ventricular shunt
have been described.
The ruby ball in the valve can potentially take up an off-
center position on its housing due to the presence of a
cluster of cells or protein deposits. Among others, such
situations can cause :
— loss of regulatory function in the valve potentially
increasing the risk of overdrainage.
— an impaired anti-reflux function.
The mobility of the rotor could be impeded by an
aggregation of cells or a protein deposit. This could make
it impossible to adjust the valve with the Magnet.
Blood clots, cerebral cells or tumoral cells contained in
the CSF could lodge in the valve mechanism, which would
have the potential to cause changes in the operating
characteristics of the valve.

12. Storage conditions

Keep in the original packaging.
Keep in a cool, dry place, away from sun light and heat.

13. Processing of the products after use

13.1. DESTRUCTION AFTER USE

An unpacked, used or explanted Sophy
destroyed in accordance with the procedures in force in the
18 – ENGLISH
particularly in children.
require the shunt
®
valve must be
medical establishment.

13.2. RETURN OF PRODUCTS

If an explanted valve needs to be returned to Sophysa for
analysis, it must be returned immersed in water, indicating
if necessary whether cleaning has been performed.
Never use a saline solution likely to form deposits in the
valve body which could block the rotor.
In order to assess the returned product properly, it must
be accompanied by an explanatory Return to Manufacturer
Authorisation form.

14. Warranty

The performance of the Sophy
ensured with the Sophy
and manufactured by Sophysa.
Sophysa guarantees that this medical device is free of
any material and manufacturing defects. Apart from this
guarantee, Sophysa does not provide any other guarantee,
express
to be
adaptation for a particular use. Sophysa cannot be held
responsible for any incident, complication, damage or
prejudice occurring directly or indirectly from the use of this
device. Sophysa does not authorize anyone whomsoever
to take responsibility on its behalf for its products.
The performance of adjustable Sophy
guaranteed with the range of silicone catheters and
accessories designed, tested and manufactured by
Sophysa. However, it is possible to use other brands of
catheters provided that their internal diameter is identical
to that of the catheters recommended by Sophysa.

15. Symbols

®
®
range of valves, designed, tested
or implicit, including
Catalog reference
Manufacturer
Date of manufacture
Caution, see the Instructions for Use
Sterilized using Ethylene Oxide
Do not re-use
adjustment kit is only
commercialization or
®
valves is only