Locating Instrument; Reading Instrument; Setting Instrument; Demonstration Valve - Sophysa Sophy Notice D'emploi

4.1. LOCATING INSTRUMENT

The Locating Instrument (Locator) is used to locate the
valve under the skin, an essential step in reading and
adjusting the operating pressure.
The Locator houses the Reading Instrument and the
Adjustment Instrument in turn.
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It enables Sophy valves to be adjusted whatever their
pressure range (see Table of Operating Pressures).
Two locators are available:
— SAK-LI1 for the adjustment of SM8 valves
— SAK-LI2 for the adjustment of SM3 valves
WARNINGS
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Do not use a Sophy
identified the valve model and making sure that the
Locator
and the pressure range shown on the
corresponds to this model.
Over-drainage or under-drainage can result from taking a
reading and/or an adjustment with a pressure range on the
Locator
different from that of the implanted valve model.
To adjust a valve the Locator must display the pressure
range for the valve model to be adjusted. The Locator
must be perfectly positioned above the implant.
The red arrow shows the direction of the CSF flow, and
makes it possible to position the Locator correctly in
relation to the valve.
The central cut-out in the shape of an imprint of the valve
is used to position the Locator as close as possible to the
implant.

4.2. READING INSTRUMENT

The Reading Instrument (Compass) fits into the Locator
and enables a reliable, accurate direct reading of the
operating pressure value for the valve.
PRECAUTION
When reading the pressure setting, make sure that the
Magnet
or any other ferromagnetic object is not less than
0.5 m away from the compass so that this reading cannot
be falsified by the influence of magnetic fields.
The Compass shows the position of the valve rotor. This
corresponds to the operating pressure read.
The operating pressure reading is determined by the
alignment of the Compass needle with one of the lines
on the contour of the Compass and the corresponding
pressure value in the reading area of the Locator.

4.3. SETTING INSTRUMENT

The Setting Instrument (Magnet) is made up of a specific
assembly of magnets designed to enable the operating
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pressure of the Sophy valve to be adjusted.
PRECAUTION
Changing the valve pressure must only be done by a
neurosurgeon, or other qualified person.
The Magnet fits into the Locator.
8 – ENGLISH
adjustment kit without having
Locator
The insertion of the Magnet into the Locator makes it
possible:
— to adjust the operating pressure by rotating the
Magnet.
A red marker pointing to the pressure values in the Locator
reading area and the "clicks" produced when the Magnet
rotates make it possible to determine the successive
operating pressures set by the Magnet.
Clockwise rotation increases the operating pressure of the
valve, while counter-clockwise rotation reduces it.
PRECAUTIONS
Do not store or handle the
to be altered by a powerful magnetic field.
Magnet
Do not move the
field (e.g. MRI). It could become a dangerous projectile or
its performance could be affected.
Magnet
Handle the with care near metal objects (e.g.
hospital furniture). They could be violently attracted.

4.4. DEMONSTRATION VALVE

A demonstration valve is supplied in the adjustment kit to
provide training and display of the changes in the position
of the rotor during the adjustment procedure.
5. Configurations of the adjustable Sophy
valve
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The adjustable Sophy
pressure ranges, each of which offers 8 pressures (see §3 -
Table of Operating Pressures).
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The adjustable Sophy
ranges (30-200 mmH O) are available in 3 models:
2
— without a reservoir (SM8),
— with an integral reservoir of the antechamber type
(SM8A),
— with an integral reservoir of the burr hole type (SM8B).
These 3 models are available in the form of:
— valve only,
— complete kit, including a proximal catheter (straight
or elbow) and a pre-connected peritoneal catheter
(Figures 2a & 2b).
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The adjustable Sophy
ranges (10-140, 50-300, and 80-400 mmH
without a reservoir (SM8-140, SM8-300 and SM8-400).
These "special pressure" valves are only available in the
valve only form and are not available as complete kits or
with a reservoir.
Sophysa offers a complete range of ventricular and distal
radio-opaque catheters which allow the CSF to flow to the
valve and from the valve to the peritoneum or right atrium
respectively, depending upon the type of shunt chosen by
the neurosurgeon.
To be complete an adjustable Sophy
consist of a ventricular catheter, an adjustable Sophy
valve and a distal catheter (atrial or peritoneal).
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Each adjustable Sophy
Identification Card (PIC) and traceability labels.
Magnet
near any device likely
close to a powerful magnetic
valve is available in 4 different
valves in the "standard" pressure
valves in the "special" pressure
O) are available
2
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shunt system must
valve is packaged with a Patient
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