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Depending on clinical observations and medical imaging, the doctor can
reduce the symptoms of overdrainage and correct the ventricle size by
changing the operating pressure of the Polaris® valve. However, immediate
drainage of a subdural hematoma may be indicated.
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 fl ow.
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 require the shunt to be replaced immediately.
Cases of cutaneous necrosis over the implantation site are possible.
Over time fi brous adhesions may fi x the ventricular catheter in the choroid plexus
or the cerebral tissue. If removal is envisaged, 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 The catheter should never be withdrawn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 an aggregation of cells or a protein deposit. Among others,
such situations can cause:
-
loss of regulatory function in the valve potentially increasing the risk of
overdrainage.
-
an impaired anti-refl ux 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.
13. Guarantee
The performance of the Polaris® adjustment kit is only guaranteed with the range of
Polaris® valves, designed tested and manufactured by Sophysa.
Sophysa guarantees that this medical device is free from defects in material or
manufacturing. Apart from this guarantee, Sophysa does not grant any other
guarantee, express or implicit, including marketing or adaptation for a specifi c
use. Sophysa cannot be held responsible for any incident, complication, damage or
prejudice resulting directly or indirectly from the use of this device. Sophysa does not
authorize anyone to take responsibility on its behalf for its products.
The performance of Polaris® valves is only 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.
14. Processing of the products after use
Destruction after use
An unpacked, used or explanted Polaris® valve must be destroyed in accordance with
the procedures in force in the medical establishment.
Return of products
If an explanted valve needs to be returned to Sophysa for analysis, it must be returned
immersed in water (non-saline), 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 properly assess the returned product, it must be accompanied by
an explanatory Return to Manufacturer Authorization form.
15. Symbols
18
Catalog reference
Manufacturer
Caution, see the Instructions for Use
Sterilization Method using Ethylene Oxide
Do not re-use
Do not re-sterilize
Use until
Batch code
Serial number
CE Conformity Marking
Powerful magnet
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