Indications; Contraindications; Description And Operating Principle Of The Sophy ® Valve; Adjustable Pressure - Sophysa Sophy Notice D'emploi

WARNING
Federal (USA) Law restricts this device to sale by or on the
order of a physician.
Read the Instructions for Use carefully before adjusting the
valve operating pressure.

1. Indications

®
The adjustable Sophy valve is intended for the treatment
of hydrocephalus by shunting the Cerebrospinal Fluid
(CSF) to the abdominal cavity or the right atrium of the
heart.

2. Contraindications

The contra-indications 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 of the body whatsoever,
— patients on anticoagulant therapy, or presenting with
bleeding diathesis, or with hemorrhagic CSF, as the
presence of blood in the system could lead to an
obstruction in the system),
— ventriculo-atrial shunts in patients suffering from
congenital cardiopathies or other malformations of the
cardio-pulmonary system.
However, if the clinical
contraindications, 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.
WARNING
Do not use an external shunting device (drainage bag, etc.)
in series with a valve as the two systems could interfere with
each other and disrupt control of the drainage.
6 – ENGLISH
benefit outweighs these
3. Description and Operating Principle of
®
the Sophy valve
F 3: T
IGURE
®
The Sophy adjustable pressure valve (Figures 1&3) is a
single use implantable device.
®
The Sophy adjustable pressure valve allows single
direction drainage of the Cerebrospinal Fluid (CSF).
The CSF arrives in the valve through the inlet connector
[1], passes through the body of the valve [5] and leaves
through the outlet connector [6].
The connectors are made of stainless steel and the body of
the valve is in polysulfone.
On either side of the inlet connector [1] are suture holes
[2] which make it possible to attach the valve to the sub-
cutaneous tissues to prevent the valve from migrating.
On the upper surface of the valve an arrow [4] shows
the direction of CSF flow through the valve. This helps to
position the valve correctly during implantation.
On the lower surface of the valve there is an individual
serial number.
The valve body contains a ball-in-cone mechanism which
determines the operating pressure of the valve.
In conditions of normal use this mechanism provides an
anti-reflux function and is not sensitive to temperature
variations.
The valve body, which cannot be deformed, protects the
mechanism from mechanical shocks.
It also prevents attempts at pumping or puncturing the
valve and makes it insensitive to variations in percutaneous
pressure.
®
The Sophy adjustable valve is phthalate-free and does not
contain natural or synthetic latex.

3.1. ADJUSTABLE PRESSURE

The resistance of the Sophy
a further operation, in order to adapt it to the clinical
®
S
HE OPHY VALVE
®
valve can be adjusted without