Recording The Pressure Selected For The Implantation; Reading And/Or Changing The Valve Pressure After Implantation; Identifying The Valve Model; Displaying The Correct Pressure Range On The Locator - Sophysa Sophy Notice D'utilisation

8.1.4. Recording the pressure selected for the implanta-
tion
Note the pressure value read in the previous step on the Pa-
tient Identification Card (PC-SM8) and make sure to hand the
card to the patient.
8.2. Reading and/or changing the valve pressure after
implantation
CAUTION
The operation scar and/or post-operative edema can
make positioning the Locator painful and inaccurate.
This could then cause difficulties in adjustment or even
make it temporarily impossible.

8.2.1. Identifying the valve model

1. Check the model and pressure range of the Sophy valve
to be adjusted:
– on the Patient Identification Card or in the patient's
medical record (traceability label),
– and/or with an X-ray examination of the valve.
See Instructions for Use Sophy
valve, Section "Post-operative X-ray control: Identifi-
cation of the valve model and pressure reading".
2. Check under the Locator that it is compatible with the
valve model used:
– reference is SAK-LI-1,
– sentence says "Designed exclusively for use with SO-
®
PHY SM8 series".
8.2.2. Displaying the correct pressure range on the Loca-
tor
CAUTION
Do not use an adjustment kit without ensuring that the
pressure range visible on the Locator corresponds to
the valve model to be adjusted.
1. Check that the pressure range displayed in the Locator
reading area corresponds to the previously identified
valve model.
2. If this is not the case, display the pressure range corre-
sponding to the implanted valve model:
a. Hold the Locator with one hand.
b. Turn the rotating ring until a "click" is heard. This
click guarantees that a complete pressure range is
displayed.
c. Repeat the operation until the valve model used ap-
pears at the left end and the 8 pressures are visible.
®
adjustable pressure

8.2.3. Positioning the patient

CAUTION
Make sure the patient stays still during the adjustment
of the pressure.
If the patient moves, it could lead to a slight offset in re-
lation to the valve, when positioning the Locator. Thus,
being off-center could create a gap between the pres-
sure originally selected by the surgeon, and the pres-
sure set in the end, potentially leading to overdrainage
or underdrainage.
Position the patient so that the valve is as horizontal as pos-
sible and the implantation site is easy to access.

8.2.4. Positioning the Locator

1. Palpate the valve implantation site in order to determine
both the location and orientation of the valve.
First find the inlet and outlet connectors, at each end of
the valve, and the reservoir (if fitted). These are the easi-
est components to locate.
2. Place the Locator on the implantation site with its axis
aligned with that of the valve connectors, and with the
arrow of the Locator pointing in the direction of the CSF
flow.
3. Center the Locator as well as possible over the valve: lo-
cate the valve by palpating it through the central cut-out
of the Locator.
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