Precautions For The Daily Life Of The Patient; Complications / Side Effects - Sophysa POLARIS SPV-SX Notice D'emploi

PRECAUTION
It is necessary to ensure that the Locator is correctly
centered above the valve and that its base is parallel to the
valve surface.
Being off-center by more than 2 mm or any inclination
in relation to the valve could cause an incorrect pressure
reading or incomplete unlocking of the rotor, making it
impossible for the rotor to rotate and thus the pressure to
be changed.
However, there may be other causes for difficulties in
adjustment:
— Excessively thick sub-cutaneous tissue above the
valve (8 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.
A special procedure may then be applied to facilitate the
adjustment of the valve, possibly using a fluoroscopic
examination:
1. Palpate the valve implantation site in order to
determine both the location and orientation of the
valve.
The inlet and outlet connectors at each end of the
valve and the reservoir (if fitted) are the easiest
components to locate. Find these first.
2. Place the Compass without the Locator directly onto
the implantation site and centered above the valve in
the best possible manner.
Note the direction of the Compass needle, aligned on
the axis of the rotor of the implanted valve.
3. Remove the Compass and place the Magnet directly
on the implantation site, oriented in the direction of the
rotor located in the previous step.
4. Slide the Magnet back and forth quickly along the
axis of the current position to unlock the valve rotor.
Ensure that the Magnet remains in the plane of the
valve. Repeat this procedure several times if
necessary until the valve rotor is unlocked. Then
reposition the Magnet in a position centered over the
valve.
5. Then turn the Magnet until the new position desired is
reached. Confirm the new setting using the Compass
or with an X-ray.
The implantation of a valve not performed under the
recommended conditions (cf. §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 a successful adjustment and the correct direction
of the implantation.
Finally, pressure adjustment is impossible if the valve is
positioned the wrong way up (upside down).
16 – ENGLISH
10. Precautions for the Daily Life of the
Patient
A Patient Identification Card (PC-SPV) is supplied with the
®
Polaris 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-SPV) at all times .
This card gives information on the medical situation of the
patient to all medical personnel.
The magnetic self-locking system of the Polaris
designed to make the magnetic rotor insensitive to the
influence of standard magnetic fields.
As a result, the following are not likely to affect the valve
operating pressure:
— magnetic fields generated by walk-through scanners in
airports, microwave ovens, cordless telephones, high
tension cables, and TV
— permanent household magnets such as those present
in toys, audio headsets and loudspeakers
— magnetic fields created by electric motors operating in
equipment such as razors, hairdryers, hair trimmers...
The doctor is responsible for informing the patient or
his/her family that the person fitted with a shunt must avoid
any activity that may subject this shunt to direct shocks
(violent sports, etc.) as these are likely to damage it.
PRECAUTION
The patient must be warned that vibrations due to the CSF
flow may possibly be felt because of the implantation of the
valve on the skull.

11. Complications / Side effects

Complications which may result from the implantation of
a CSF shunt system include the inherent risks in the use
of drugs, any surgical intervention and the insertion of a
foreign body.
PRECAUTION
Patients treated with a shunt system must be closely
monitored post-operatively in order to detect any signs of
complications early.
The doctor is responsible for educating the patient or
his/her family about CSF shunt systems, in particular
describing the complications linked to implanted shunt
systems as well as giving explanations about possible
alternative therapies.
The main complications of shunts are obstruction, infection
and over-drainage. These complications require the rapid
intervention of a doctor.
®
valve is