Catheter Blocked; Overdrainage; Guarantee; Processing Of The Products After Use - Sophysa PRESSIO PSO-PVT Manual De Instrucciones

Catheter blocked

The implantation of the end of the catheter within reach of the choroid plexus may
cause blockages in the inlet openings for the CSF. This phenomenon can also occur
when the CSF has a high protein content, contains blood, or if there is intra-ventricular
debris, blood clots or tissues.
This obstruction may have an impact on CSF drainage but will not have any eff ect
on the reliability on the measurement of intracranial temperature or pressure.

Overdrainage

Overdrainage is a complication specifi c to the use of an intraventricular ICP
monitoring catheter.
Overdrainage can result in a collapse of the ventricles and the appearance
of a subdural hematoma.
10.

Guarantee

The performances of the Pressio® monitoring kit are only guaranteed with the range
of Pressio® monitoring systems and the accessories 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.
11.

Processing of the products after use

Destruction after use

An unpacked, used or explanted Pressio® monitoring kit must be destroyed
in accordance with the procedures in force in the medical establishment.

Return of products

If an explanted Pressio® monitoring kit needs to be returned to Sophysa for analysis,
indicating if necessary whether cleaning has been performed.
In order to properly assess the returned product, it must be accompanied
by an explanatory Return to Manufacturer Authorization form.
N :
OTE
F ,
OR MORE EFFECTIVE ANALYSIS IT IS RECOMMENDED THAT THE DEVICE IS NOT CLEANED
12.
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10

Symbols

Catalog reference
Manufacturer
Sterilization Method using Ethylene Oxide
Do not re-use
Do not re-sterilize
Use until
Batch code
Serial number
CE Conformity Marking
Refer to the instructions for use
BF TYPE EQUIPMENT: Procuring an appropriate
degree of protection against electric shock,
having a Type F insulated applied section
(fl oating).
Temperature conditions for storage
and transport
Store in a dry place
Fragile, handle with care