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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. Conditions for storage
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 Polaris
destroyed in accordance with the procedures in force in the
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
Authorization form.
14. Guarantee
The performance of the Polaris
®
ensured with the Polaris
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
or
implicit,
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 Polaris
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
Catalog number
Manufacturer
18 – ENGLISH
®
valve must be
®
adjustment kit is only
range of valves, designed, tested
including
commercialization
®
valves is only
or
Caution, see the Instructions for Use
Sterilized using Ethylene Oxide
Do not re-use
Do not re-sterilize
Use by
Batch code
Serial number
CE Conformity Marking
MR Conditionnal
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