Reading The Pressure; Setting A New Pressure - Sophysa Sophy Notice D'emploi

adjustment kit.
WARNING
The operation scar and/or post-operative edema can make
Locator
positioning the
then cause difficulties in adjustment or even make it
impossible.
9.4.1. Positioning the patient (Step 0)
For the adjustment, the patient should be positioned so
that the valve implantation site is easy to access and the
valve is as horizontal as possible.
F 6 – R
IGURE ECOMMENDED POSITIONING OF THE PATIENT
HORIZONTAL

9.4.2. Reading the pressure

9.4.2.1. Identification of the valve model (Step 1)
Identify the reference and the pressure range for the
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Sophy valve to be adjusted: refer to the Patient
Identification Card or to the patient's medical record
(traceability label) and/or perform an X-ray control of the
valve (see §9.5. Post-operative X-ray control).
Confirm that the valve model and the Locator match.
9.4.2.2. Display of the pressure range on the Locator
(Step 2)
If necessary, refer to §4 for the description of the Locating
Instrument (Locator)
Check that the pressure range displayed in the Locator
window corresponds to the previously identified valve.
If this is not the case, display the pressure range
corresponding to the implanted valve on the Locator.
— Hold the Locator with one hand.
— Turn the ring until a "click" is heard. This click
guarantees that a complete pressure range is
displayed.
— Repeat the operation until the range required is found
amongst the 4 ranges available.
WARNING
Cases of over-drainage or under-drainage can result from a
reading and/or an adjustment with a
correspond to the type of valve implanted.
painful and inaccurate. This could
)
Locator
that does not
9.4.2.3. Positioning the Locator (Step 3)
Palpate the valve implantation site in order to determine
both the location and orientation of the valve.
The valve inlet and outlet connectors at each end of the
valve and the reservoir (if fitted) are the easiest
components to locate. Find these first.
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.
Centre the Locator above the valve as well as possible:
locate the valve by palpating it through the central cut-out
(
VALVE
of the Locator.
Press the Locator firmly against the valve so as to centre
and immobilize the valve.
9.4.2.4. Positioning the Compass and Reading the
Pressure (Step 4)
If necessary, refer to §4 for the description of the Reading
Instrument
Hold the Locator with one hand.
Place the Compass in the Locator using the guide pins:
align the lines on the Compass with the pressure values
engraved on the Locator.
To ensure the Locator is perfectly centred above the valve,
centre the shaft of the Compass needle in the circular
target by planar movements of the Locator-Compass
assembly parallel to the valve.
If the Compass needle is aligned between two positions,
turn the Locator slightly with the Compass so as to align
the Compass needle on the nearest position (if the needle
is exactly between two positions, choose one and align
the needle on it; the real orientation of the Locator will be
adjusted during Step 5).
On the Locator read the operating pressure shown by the
Compass needle.
9.4.2.5. Confirmation of the reading
In the recommended implantation conditions, X-ray control
is optional because the pressure can be read directly using
the adjustment kit. However, X-ray confirmation is
recommended in the following cases:
— if there is a discrepancy between the pressure read in
Step 4b and the value read in Step 1b on the Patient
Identification Card (PC-SM8) and/or on the X-ray taken
to identify the valve model,
— if the valve has been implanted too deeply, under
subcutaneous tissue more than 10 mm thick (see
§9.3.2 - Implantation technique - Valve),
— if the user is not familiar with the use of the Sophy
adjustment kit
— after an MRI examination.

9.4.3. Setting a new pressure

After reading the pressure level, as described above, keep
the Locator in place to perform the valve adjustment.
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ENGLISH – 13