Checking The Pressure Setting; Recording The New Pressure; Post-Adjustment Monitoring; Checking The Performances Of The Adjustment Kit - Sophysa Sophy Notice D'utilisation

5. Remove the Magnet vertically to keep the proper orien-
tation of the rotor.
6. Place the Magnet more than 50 cm from the valve.

8.2.7. Checking the pressure setting

Verification is performed using the Compass in accordance
with the procedure described previously.
CAUTION
Adjusting the pressure using an adjustment kit requires
experience. If you are not familiar with the kit, it is rec-
ommended that you check the pressure adjustment via
X-ray.
CAUTION
The pressure setting may not always be performed on
first attempt. Do not hesitate to repeat the adjustment
procedure several times from the beginning, starting
from the positioning of the Locator, in order to be sure
that the desired pressure setting is obtained.
In case of difficulties with adjustment, make sure that:
– the patient is positioned so that the valve is fully horizontal,
– the centering operations were properly carried out.
If adjustment difficulties persist, see Section 10. Solutions in
case of difficult adjustment (p. 15), which explains the
measures to be taken if adjustment is difficult.

8.2.8. Recording the new pressure

Note the pressure value read during verification on the Pa-
tient Identification Card (PC-SM8).

8.2.9. Post-adjustment monitoring

It is advisable to monitor the patient carefully for 24 hours
following any change in pressure setting.
9. Checking the performances of the
adjustment kit
Although, there is no maintenance to perform on the adjust-
ment kit, it is recommended to check it with each use. The
following checks will ensure that the adjustment kit is fully
functional, and that it is not damaged in any way.
Failure to perform the checks described in this section may
cause injuries to the patient, the major risk being overdrain-
age or underdrainage, which would require medical treat-
ment.
NOTE
The use of the adjustment kit has been tested over 5
years. However, the results of the following checks pre-
vail. They will indicate whether or not the adjustment kit
can still be used.

9.1. Visual checks

Make sure the markings and labels on the components of
the kit are complete and readable.
NOTE
Air bubbles may appear inside the Compass. They do
not have any impact on the product performances.

9.2. Functional check

Perform several adjustments on the demonstration valve
supplied with the adjustment kit to make sure the adjustment
kit works properly.

10. Solutions in case of difficult adjustment

The following situations may lead to inaccurate reading of
the pressure by the Compass and/or adjustment difficulties
with the Magnet:
– the patient is in a position that prevents the valve from be-
ing horizontal,
– the Locator is offset from the center of the valve by more
than 2 mm,
– the Locator is poorly oriented in relation to the flow path,
– the base of the Locator and the surface of the valve are
not parallel.
Before doing anything else, check that the Locator is cor-
rectly positioned and oriented above the valve. See Sec-
tion 8.2.3. Positioning the patient (p. 13) and Section 8.2.4.
Positioning the Locator (p. 13).
However, other causes may intervene and cause adjustment
difficulties.
Special procedures, described below, may then be applied
to facilitate adjustment of the valve, possibly using fluoro-
scopic control.
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