Reading And Adjusting The Valve; Adjusting The Pressure Prior To Implantation; Reading The Pressure; Adjusting The Pressure - Sophysa Sophy Notice D'utilisation

8. Reading and adjusting the valve

WARNING
Do not use the adjustment kit in the operative field. As
the adjustment kit cannot be sterilized, using it during
the operation would cause a high risk of infection for
the patient.
CAUTION
Changing the valve pressure must only be done by a
neurosurgeon.
CAUTION
When reading or adjusting the pressure, make sure that
the Magnet, or any other ferromagnetic object, is loca-
ted more than 50 cm away from the Compass so that
this reading cannot be falsified by the influence of mag-
netic fields.
CAUTION
Do not use an adjustment kit without previously check-
ing under the Locator that it corresponds to the valve
model used.
Overdrainage or underdrainage can result from taking a
reading and/or adjustment with a pressure range on the
Locator different from that of the implanted valve mod-
el.
Figure 2. Bottom of the Locator
The reference "SAK-LI-1" and the sentence "Designed exclu-
sively for use with SOPHY
sure to use the Locator with the right valve model.

8.1. Adjusting the pressure prior to implantation

CAUTION
Do not unpack or implant the valve without previously
adjusting it to the initial pressure defined by the neuro-
surgeon.
Before opening the sterile packaging, it is necessary to
adjust the rotor in the position that corresponds to the pres-
sure selected by the surgeon for the implantation.
The double sterile packaging for each Sophy valve includes
a housing specifically for adjusting the valve through the
packaging.
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8.1.1. Reading the pressure

1. Insert the Compass fully into the dedicated housing.
Align the lines on the Compass with the pressure values
printed on the housing, if this is not already the case.
2. On the housing, read the pressure value shown by the
Compass needle.
NOTE
Reading of the pressure can also be performed visually
without using the adjustment kit, as the rotor and the
radiopaque dots are visible through the valve and the
double sterile packaging.

8.1.2. Adjusting the pressure

1. Remove the Compass.
2. Align the mark of the Magnet with the pressure read in
the previous section, and slide the Magnet vertically into
the housing without changing the orientation of the
Magnet.
3. Turn the Magnet until it reaches the position chosen as
the pressure for the valve to be implanted.
NOTE
Do not attempt to turn the Magnet if it is not com-
pletely inserted into the Locator. The drive could
otherwise be compromised.
4. Place the Magnet more than 50 cm from the valve.

8.1.3. Checking the pressure setting

Reinsert the Compass in order to check the pressure, or
check the setting visually on the valve.