Behavior During Magnetic Resonance Imaging (Mri); Sterilization - Decontamination Of Polaris ® Valves And Valve Kits; Instructions; Choice Of Valve Model - Sophysa POLARIS SPV-SX Notice D'emploi

7. Behavior during Magnetic Resonance
Imaging (MRI)
A shunt consisting of a Polaris
connectors, and possibly reservoirs and SiphonX
gravitational anti-siphon device) and its catheters, is
considered as " MR Conditional " in accordance of the
definition in the standard, ASTM F-2503.
A patient fitted with a Polaris
examination, even immediately after the device has been
implanted.
The results of in vitro tests have demonstrated that the
®
Polaris valve does not present any danger in the following
examination conditions :
— MRI with a static magnetic field limited to 3-Tesla and
with a spatial gradient magnetic field limited to 19 T/m;
— Whole body averaged SAR (Specific Absorption Rate)
limited to 2 W/kg for 15 minutes exposure at 3 Tesla.
— Whole body averaged SAR (Specific Absorption Rate)
limited to 2 W/kg for 15 minutes exposure at 1.5 Tesla.
— No gradient magnetic fields limitation.
WARNING
Even though the self-locking system of the valve was
designed not to be sensitive to magnetic fields, it is
recommended that the pressure setting of the valve is
checked before and after the MRI examination or following
exposure to a powerful magnetic field. Please see
additional recommendation under section §9.4.1-Reading
of operating pressure after implantation.
NOTE
The patient must be informed that he/she is likely to feel
slight discomfort, which is completely inoffensive, during an
MRI examination.
PRECAUTIONS
During MRI examinations, make sure the patient remains
immobile in the immediate proximity to the tunnel and
inside it.
If there is a rotational movement on the valve simultaneous
with exposure to a powerful magnetic field (for example:
3-Tesla MRI) there is a possible risk of the pressure being
accidentally changed.
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Choose a Polaris valve implantation site away from areas
of significant clinical interest, such as a tumor, that may
require repeated future MRI examinations. Indeed the
micro-magnets in Polaris
artifacts on MRI images. The size of these artifacts could
be very large in size in relation to the size and shape of the
Valve.
Tests have demonstrated that the performance (operating
pressures calibration),
functionality (valve can still be adjusted and self-locking
mechanism of the rotor remains functional) of the Polaris
valve are not affected by repeated exposure to MRI
examinations from 1.5-Tesla to 3-Tesla (30,000 Gauss).
®
The Polaris valve's mechanism is designed to prevent
accidental changes in operating pressure under standard
conditions for MRI examination at 3-Tesla or less, as long
10 – ENGLISH
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valve (including
®
valve can undergo an MRI
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valve are a potential source of
magnetic properties
as there is no rotational movement on the valve during MRI
exposure.
The tests conducted in accordance with the standard,
ASTM F 2182, showed that the rise in temperature caused
by exposure to 3-Tesla MRI was negligible and had no
®
physiological consequences for the patient.
Tests conducted in accordance with standards, ASTM F
2213 and ASTM F 2052, showed that the torque and
displacement force induced by a magnetic field of 3 Tesla
or less did not present any risks for the patient.
8. Sterilization – Decontamination of
®
Polaris Valves and Valve Kits
®
The Polaris valves and valve kits are packed individually in
double peel-off, sterile, pyrogen-free packaging, sterilized
with ethylene oxide.
WARNING
Do not use the valves or valve kits if the sterile packaging is
open or damaged, or if the expiry date has passed.
This product is intended for SINGLE USE ONLY. It is
intended to be used once only for a single patient. Do not
re-sterilize or re-use after unpacking and/or explantation.
Resterilization can damage the product, potentially leading
to patient injury. Reuse of this device may change its
mechanical or biological features and may cause device
failure, allergic reactions or bacterial infections.
NOTE
Sophysa cannot be held responsible for the performance of
any product that has been re-sterilized and/or re-used, nor
for any complications which might result from this.

9. Instructions

9.1. CHOICE OF VALVE MODEL

The initiative of chosing the Polaris
the neurosurgeon and depends upon the clinical needs of
the patient.
PRECAUTIONS
Do not use pre-connected valve kits (valves with pre-
attached distal catheter) for ventriculo-atrial shunts.
There could be implantation difficulties relating to the shunt
length adaptation at the atrium.
Use an SPVA (antechamber) type model, an SPVB (burr
hole reservoir) type model, or one of the SPV models
combined with a ventricular catheter with reservoir if it is
desired to use the shunt system to check the patency of the
shunt, to sample the CSF or for injections.
9.2. ADJUSTMENT OF A POLARIS
and
BEFORE IMPLANTATION: SELECTION OF THE
®
OPERATING PRESSURE
Refer to §§4 – Principle of the Polaris
and for more information, refer to the instruction for use of
the Adjustment Kit.
Before opening the packaging which guarantees the
sterility of the valve, it is necessary to adjust the rotor in the
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valve model is left to
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VALVE
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Valve Adjustment, ,