Guarantee; Processing Of The Products After Use; Destruction After Use; Return Of Products - Sophysa SiphonX Manual De Instrucciones

Cases of allergy to silicone have been described.
The presence of a aggregation of cells or a protein deposit on the seat of the anti-
siphon device could keep it open. This could then induce a loss of the regulatory
function of the anti-siphon device in the vertical position, potentially increasing the
risk of overdrainage.
Blood clots, cerebral cells or tumoral cells contained in the CSF could lodge in the
SiphonX® gravitational anti-siphon device, which would have the potential to
cause changes in the operating characteristics of the SiphonX®, or even to cause its
obstruction.
11.

Guarantee

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 performances of SiphonX® gravitational anti-siphon devices are 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 or
valves provided that the internal diameter of the catheters is identical to that of the
catheters recommended by Sophysa.
12.

Processing of the products after use

Destruction after use

An unpacked, used or explanted SiphonX® gravitational anti-siphon device must be
destroyed in accordance with the procedures in force in the medical establishment.

Return of products

If an explanted device 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 anti-siphon body which
could block the device.
In order to properly assess the returned product, it must be accompanied by an
explanatory Return to Manufacturer Authorization form.
13.

Symbols

Catalog reference
Manufacturer
Caution, see the Instructions for Use
Sterilization Method using Ethylene Oxide
2
Do not re-use
Do not re-sterilize
Use by
LOT
Batch code
Serial number
CE Conformity Marking
8