Guarantee; Processing Of The Products After Use; Destruction After Use; Return Of Products - Sophysa DE-106 Notice D'emploi

Frequent punctures of the brain to insert the ventricular
catheter can predispose to intracerebral hemorrhage and
edema causing a further rise in ICP.
In patients with small ventricles, the ventricle walls may
collapse around the tip of the catheter resulting in
obstruction and predisposing to tentorial herniation. It is
therefore extremely important to avoid excessive release of
CSF before the catheter is attached to the patient line.

8. 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 specific 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 ventricular catheter is only guaranteed
with the range of devices and accessories designed, tested
and manufactured by Sophysa. However, it is possible to
use other brands of drainage system provided that they are
suitable with Sophysa ventricular catheter.

9. Processing of the products after use

9.1. DESTRUCTION AFTER USE

An unpacked, used or explanted ventricular catheter must
be destroyed in accordance with the procedures in force in
the medical establishment.

9.2. RETURN OF PRODUCTS

If an explanted ventricular catheter 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.
In order to properly assess the returned product, it must
be accompanied by an explanatory Return to Manufacturer
Authorization form.

10. Symbols

Manufacturer
Catalog number
Serial number
Batch code
Use by
6 – ENGLISH
Caution, consult accompanying documents
Sterilized using ethylene oxide
Do not resterilize
Do not reuse
CE conformity marking

11. References

Ventricular catheter for external drainage of CSF
DE-106
External ventricular catheter
DE-105
External ventricular catheter (large lumen)
External drainage systems
DE-210
External neurological drainage system
DE-410
External drainage and CSF monitoring system
Complete kit for external drainage
DE-306
Complete kit for
(DE-210+DE-106)
DE-305
Complete kit for external ventricular drainage (large lumen
ventricular catheter) (DE-210+DE-105)
DE-406
Complete kit for external ventricular drainage and CSF
monitoring (DE-410+DE-106)
Product Description Subject To Change
external ventricular drainage