Instructions; Choice Of Valve Model; Adjustment Of A Sophy Valve Before Implantation: Selection Of The Operating Pressure - Sophysa Sophy Notice D'emploi

NOTE
Sophysa cannot be held responsible for the performance of
any product that has been re-sterilized and/or re-used, or
for any complications which might result from this.

9. Instructions

9.1. CHOICE OF VALVE MODEL

®
The choice of the Sophy
of 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 SM8A (antechamber), an SM8B (burr hole reservoir)
model, or one of the SM8 models combined with a
ventricular catheter with reservoir if the use of the shunt
system is desired to check the patency of the shunt, to
sample the CSF or for injections.
9.2. ADJUSTMENT OF A SOPHY
IMPLANTATION: SELECTION OF THE OPERATING
PRESSURE
Refer to §4 – Principle of the Sophy
For more information refer to the instructions for the
adjustment kit.
Before opening the packaging which guarantees the
sterility of the valve, it is necessary to adjust the rotor in the
position that corresponds to the pressure selected for the
implantation by the surgeon, depending on the patient's
needs.
The double sterile packaging for each Sophy
includes a housing provided specially for the components
®
of the Sophy adjustment kit, which makes it possible to
®
adjust the Sophy valve through the packaging.
10 – ENGLISH
valve model is left to the initiative
®
VALVE BEFORE
®
valve adjustment.
F
IGURE
PRECAUTION
Do not unpack or implant the valve without previously
adjusting it to the initial operating pressure defined by the
neurosurgeon.
WARNING
Do not use the Sophy
As the Sophy
during the operation would cause a high risk of infection for
the patient.
9.2.1. Identification of the valve model (
®
valve
Identify the reference and the pressure range for the
®
Sophy valve to be adjusted: refer to the labeling on the
packaging.
Confirm that the valve model and the Locator match.
9.2.2. Positioning the
Pressure (Step B)
If necessary, refer to §4 for the description of the Reading
Instrument.
Place the Compass in the shell of the external
packaging in the place provided for it, centered above the
valve.
On the shell of the external packaging read the operating
pressure value shown by the Compass needle.
NOTE
Reading of the setting position can also be performed
visually without using the Sophy
rotor is visible through the valve and the double sterile
packaging.
9.2.3. Positioning the Magnet and Adjusting the
Pressure (Step C)
If necessary, refer to §4 for the description of the Setting
5: D
ETAILS OF THE DOUBLE STERILE PACKAGING FOR A
®
S (SM8)
OPHY VALVE
®
adjustment kit in the operative field.
®
adjustment kit cannot be sterilized, using it
Compass
®
)
Step A
and Reading the
adjustment kit, as the