Indications; Contra-Indications; Description And Operating Principle Of The Polaris; A Precision Valve - Sophysa POLARIS SPV-SX 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 Polaris adjustable pressure valve is designed for the
treatment of hydrocephalus by shunting the Cerebrospinal
Fluid (CSF) to the abdominal cavity or right atrium of the
heart.

2. Contra-indications

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 with 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.
3. Description and Operating Principle of
®
the Polaris
F 3 : T
IGURE

3.1. A PRECISION VALVE

®
The Polaris adjustable pressure valve (Figures 1&3) is a
single use implantable device.
6 – ENGLISH
benefit outweighs
®
P
HE OLARIS VALVE
The Polaris
Cerebrospinal Fluid (CSF) in a given direction.
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 Polaris
natural rubber latex or synthetic latex.

3.2. ADJUSTABLE PRESSURE

these
The resistance of the Polaris
re-operating, in order to adapt it to the clinical evolution of
the patient.
The principle is based on the pressure variation exerted on
a ruby ball [7] by a flat, semi-circular spring [8] at different
points on its curvature.
The spring is attached to a rotor [9] which is able to rotate
inside the valve body on its central axis which is made of
ruby and titanium [11].
The operating pressure of the Polaris
by the angular position of its rotor.
There are 5 pressures available in each Polaris
These correspond to the 5 possible positions of the rotor.
For any Polaris
lowest pressure and position No. 5 to the highest pressure.
Titanium radio-opaque studs [10] inserted on the righthand
side of the valve body indicate the 5 positions of the
rotor/spring assembly (Cf. §9 - Post-operative X-ray
examination).
®
The Polaris
Table of pressure ranges).
To the left of the inlet connector there are radio-opaque
points [3] which identify the pressure range of the valve
(Figures 3 & 9, and §9 - Post-operative X-ray examination).
®
adjustable pressure valve allows drainage of
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valve is phthalate-free and is not made with
®
valve can be adjusted without
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model, position No. 1 corresponds to the
valve exists in 4 different pressure ranges (cf.
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valve is determined
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model.