Precautions For The Daily Life Of The Patient - Sophysa Sophy Notice D'emploi

Before doing anything else check that the Locator is
correctly positioned and oriented above the valve (see
Steps 0 (Positioning of the Patient), 3 (Positioning the
Locator) and 5 (Orientation of the Locator) in §9.4 - Setting
the operating pressure after implantation).
NOTE
Any off-centring of more than 2 mm or any inclination in
relation to the valve could cause an incorrect pressure
reading making its rotation impossible, and so making it
impossible to change the pressure.
However, there may be other causes for difficulties in
adjustment:
— Excessively thick sub-cutaneous tissue above the
valve (10 mm) caused, for example, by post-operative
edema, a hematoma or cicatricial tissue would make
the localization of the valve inaccurate, thus causing
complications in the pressure adjustment procedure.
— The presence of debris or deposits inside the valve
could also make adjustment using the usual procedure
difficult.
Special procedures may then be applied to facilitate the
adjustment of the valve, possibly using fluoroscopic
control.
9.8.1. Adjustment without the Locator
If the implantation is deep, the standard procedure
described above may be adapted so that the use of the
Locator is no longer needed when adjusting a new
pressure. The Magnet is thus closer to the valve.
NOTE
This technique without the Locator concerns pressure
Adjustment only. Reading and confirmation of the pressure
level must be done in accordance with the standard
procedure and/or by X-ray control.
1. Follow the usual procedure (Steps 1 to 4) to position
the Locator using the Compass.
2. On the skin locate the axis corresponding to the
current pressure of the valve (indicated by the
Compass needle) and the axis corresponding to the
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,
corresponding to the current pressure located in the
previous step.
4. Turn the Magnet until it reaches the orientation
corresponding to the desired pressure.
5. Confirm the adjustment by a brief press on the
Magnet.
6. Remove the Magnet vertically.
7. Check the setting using the Compass and Locator or
with an X-ray.
8. If the pressure has not changed repeat the adjustment
holding the Magnet in the bottom position (hold down
continuously) during rotation. Then check the new
setting using the Compass and Locator or with an X-
ray.
9.8.2. Adjustment of valves implanted in
16 – ENGLISH
oriented in the direction
conditions other than those recommended
The implantation of a valve not performed under the
recommended conditions (see §9 – Implantation technique)
may lead to a Compass reading of a pressure value
inconsistent with the patient record or the clinical status of
the patient.
In this case, an X-ray removes any doubt. It is the absolute
proof of correct adjustment and the correct direction of the
implantation.
9.8.3. Specific case of valves implanted upside
down.
Upside-down implantation (but with the flow direction
respected) will be recognizable on X-ray :
With valve correctly implanted, the 5 radio-opaque dots
must be located near the nose if the valve is implanted on
the patient's right side, and opposite the nose if the valve
is implanted on the patient's left side.
If the valve is implanted upside down, setting is performed
using the following sequence:
1. Position the Locator in the opposite direction to the
flow (red arrow towards the inlet connector).
2. Centre the Locator-Compass assembly using the
Compass target (and not the shape of the Locator).
3. Carry out the reading and then the adjustment, in
accordance with Steps 4 and 6, using the opposite
indication on the Locator (e.g. the indication 65
mmH O corresponds to a value of 150 mmH
2
4. Verify the new setting with an X-ray.
10. Precautions for the Daily Life of the
Patient
A Patient Identification Card (PC-SM8) is supplied with
®
the Sophy valve. It enables the neurosurgeon to consult
and update information relating to the implanted device
(reference, operating pressure, implantation site, etc.)
systematically and to ensure that the illness is properly
monitored.
PRECAUTION
The patient should be warned that it is important to carry
his/her Patient Identification Card (PC-SM8) at all times.
This card gives information on the medical situation of the
patient to all medical personnel.
The doctor is responsible for informing the patient or
his/her family that any activity exposing the patient to a
powerful magnetic field may cause the device settings to
be disrupted.
Magnetic fields generated by walk-through detectors in
airports, microwave ovens, cordless telephones, high
tension cables, and TV etc. must not affect the operating
pressure.
Permanent household magnets, in some toys, audio
headphones, loudspeakers as well as magnetic fields
created by electric motors in razors, hairdryers, clippers,
etc. may upset the valve adjustment when they are in
operation. It is therefore recommended that they are not
allowed too close to the valve implantation site to prevent
any risk of changing the valve pressure.
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