Reading The Pressure; Setting A New Pressure - Sophysa SOPHY SAK Notice D'utilisation

4. Press the Locator against the valve so as to center and
immobilize it above the valve.
NOTE
If palpating the valve is difficult, orienting the Locator in
relation to the valve, may be difficult. In this case, the
stop method described in Section 10.1. Stop method
(p. 14) can ensure alignment.

8.2.5. Reading the pressure

1. Hold the Locator with one hand so as not to lose the ref-
erence position.
2. Insert the Compass fully into the Locator.
Align the lines on the Compass with the pressure values
printed on the Locator, if this is not already the case.
3. Center the shaft of the Compass needle in the circular
target by sliding the Locator-Compass assembly over
the skin until it is above the valve.
CAUTION
Being off-center could cause an incorrect pressure
reading. This may falsify the change of pressure.
The Compass needle aligns with one of the lines on the
contour of the Compass and the corresponding pres-
sure value in the reading area of the Locator.
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The Compass needle may be aligned between two posi-
tions due to the Locator incorrect orientation. In this
case:
a. Re-perform the positioning of the adjustment kit
components from the start.
b. The Compass should now be aligned on one posi-
tion only. If there is no change:
– if the initial pressure is known: turn the Locator-
Compass assembly slightly so as to align the
Compass needle on the indicator corresponding
to the initial pressure,
– if the initial pressure is unknown: perform the stop
method described in Section 10.1. Stop method
(p. 14).
4. On the Locator, read the pressure value shown by the
Compass needle.
Under the recommended implantation conditions, X-ray ex-
amination is optional as the pressure can be read directly via
the adjustment kit.
However, since X-ray examination provides absolute proof of
the valve adjustment, it is especially recommended in the fol-
lowing cases:
– If there is a disparity between the pressure read and the
value listed on the Patient Identification Card (PC-SM8)
and/or on the X-ray used to identify the valve model.
– If the valve was implanted too deeply, under more than
10 mm of subcutaneous tissue. See Instructions for Use
®
Sophy adjustable pressure valve, Section "Valve".
– If the user is not familiar with the use of the adjustment kit.

8.2.6. Setting a new pressure

1. To avoid losing the reference position, hold the Locator
with one hand until the end of the procedure.
2. Remove the Compass, memorizing the pressure that it
indicates.
3. Insert the Magnet, aligning the mark on the memorized
pressure.
4. Turn the Magnet until it reaches the position chosen as
the new valve pressure.
NOTE
Clockwise rotation increases the pressure of the
valve, while counter-clockwise rotation reduces it.