Adjusting Without The Locator; Specific Case Of Valves Implanted Upside Down; Reading Of Valves Implanted In Conditions Other Than Those Recommended - Sophysa POLARIS Gebrauchsanweisung

If the valve is now set on the stop, the Compass needle indi-
cates the direction corresponding to the extreme position se-
lected.
If this correctly matches the indication of the Locator, it is
correctly oriented and the initial reading was correct.
Otherwise, as described below, it is possible to correct the
Locator orientation and to determine what the real initial
pressure actually was before correction, based on the model
of the implanted valve.
On the Locator, count the number of positions between the
previously selected stop and the position showed by the
Compass.
– If the needle is to the left of the desired stop, add this
number of positions to the position originally read.
– If the needle is to the right of the desired stop, subtract
this number of positions to the position originally read.
Example
In this example, the needle is offset by one position to the
right (in the reading direction) from the desired stop. There-
fore, you need to subtract one position to the initial reading
to know the real initial setting.
If a correction is necessary, follow the instructions below:
1. Turn the Locator-Compass assembly until the needle is
perfectly aligned with the extreme pressure value selec-
ted.
2. If necessary, recenter the shaft of the Compass needle
in the target.
From this point forward, the Locator is perfectly positioned in
relation to the valve, which makes final adjustment possible.

10.3. Adjusting without the Locator

In case of an implantation deeper than recommended, the
standard procedure may be performed without the Locator
when adjusting a new pressure. The Magnet is thus closer to
the valve.
NOTE
This technique without the Locator concerns pressure
adjustment only. Pressure levels must be read and con-
firmed in accordance with standard procedure and/or
by X-ray examination.
1. Follow the usual procedure to position the Locator using
the Compass.
2. Draw two marks on the skin with a marker:
– one indicating the axis corresponding to the current
pressure of the valve, indicated by Compass needle,
– the other indicating the axis corresponding to desired
pressure, known with the Locator.
3. Remove the Locator-Compass assembly and place the
Magnet in the same place, directly on the implantation
site, oriented in the direction corresponding to the cur-
rent pressure, located in the previous step.
4. Hold the base of the Magnet:
a. If necessary, slide the handle of the Magnet back
and forth multiple times along the axis of the current
pressure to unlock the rotor.
Ensure it remains correctly centered and in the axis
of the valve.
b. Recenter the handle of the Magnet.
5. Keeping the Magnet as centered as possible, turn it until
it reaches the axis corresponding to the desired pres-
sure.
6. Remove the Magnet vertically to ensure effective re-
locking of the valve rotor in the selected position.
7. Check the setting using the Compass and Locator or
with an X-ray.

10.4. Specific case of valves implanted upside down

Upside-down implantation (but with the flow direction re-
spected) will be recognizable on X-ray.
NOTE
For a valve implanted on the skull, the five radiopaque
dots should be either pointing toward the patient's nose
(if the valve is implanted on their right side) or pointing
away from their nose (if the valve is implanted on their
left side).
If the valve is implanted upside down, setting is possible but
must be performed using the following sequence:
1. Position the Locator in the opposite direction of the flow
(arrow towards the inlet connector).
2. Center the Locator-Compass assembly using the target
of the Compass.
3. Carry out the reading and then the adjustment in ac-
cordance with the steps described in Section 8.2. Read-
ing and/or changing the valve pressure after implantation
(p. 13), using the symmetrical indication on the Locator.
For example, the indication 200 mmH
a value of 30 mmH O.
2
4. Check the new adjustment by X-ray examination.
10.5. Reading of valves implanted in conditions other
than those recommended
The implantation of a valve not performed under the recom-
mended conditions may lead to a Compass reading of a
pressure value inconsistent with the patient's medical record
or clinical status.
See the Instructions for Use Polaris
tation Technique, for more information.
In this case, X-ray examination will dispel any doubts as it
provides absolute proof of the correct adjustment of the
valve and the correct direction of its implantation.
O corresponds to
2
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valve, Section "Implan-
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