Indications; Contra-Indications; Description And Operating Principle Of The Siphonx - Sophysa SiphonX Manual De Instrucciones

Figure 1: SiphonX® gravitational anti-siphon device (Model SX-200)
W :
ARNINGS
F (USA) L
EDERAL AW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
R
EAD THE INSTRUCTIONS FOR USE CAREFULLY BEFORE IMPLANTING THE DEVICE
1.

Indications

The SiphonX® gravitational anti-siphon device is designed to control the siphon eff ect
during the treatment of hydrocephalus by shunting Cerebrospinal Fluid (CSF).
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ARNING
The SiphonX® gravitational anti-siphon device must absolutely be used in conjunction
with a CSF shunt valve.
2.

Contra-indications

As it is absolutely essential that the SiphonX® gravitational anti-siphon device is
combined with a CSF shunt valve, the contra-indications for the device are the
following:
- established or suspected infections along the length of the shunt (meningitis,
ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in
any part whatsoever of the body
- patients on anticoagulant therapy or presenting with bleeding diathesis
- ventriculo-atrial shunts in patients with congenital cardiopathies or other
malformations of the cardio-pulmonary system
- hemorrhagic CSF, as the presence of blood in the system could lead to an
obstruction in the system.
SX-200
However, if the clinical benefi t outweighs these contra-indications, the implantation
. of a shunt in such cases is performed under the responsibility of an experienced
neurosurgeon. The clinical condition of the patient must, therefore, be subject to
.
increased surveillance.
3. Description and Operating Principle
of the SiphonX®
Figure 2: The SiphonX® gravitational anti-siphon device
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