evolution of the patient.
The principle is based on the pressure variation exerted on
a ruby ball [7] by a flat, semi-circular spring [8] at different
points on its curvature.
The spring is attached to a rotor [9] which is able to pivot
inside the valve body around its central axis [11].
A notched indexing system makes it possible to select
different positions corresponding to different operating
pressures. Two safety stops included in the valve body
limit any possibility of rotation beyond the pre-determined
positions.
The operating pressure of the Sophy
by the angular position of its rotor.
3.1.1. 8 pressures available for SM8
Eight pressures are available for each SM8 Sophy
These correspond to the eight possible rotor positions.
®
For each SM8 Sophy
model, position No. 1 corresponds
to the lowest pressure and position No. 8 to the highest
pressure.
3.1.2. 3 pressures available for SM3
Three pressures are available for each SM3 Sophy
These correspond to the three possible rotor positions.
®
For each SM3 Sophy
model, position No. 1 corresponds
to the lowest pressure and position No. 3 to the highest
pressure.
3.1.3. Pressure ranges
Titanium radio-opaque studs [10] inserted on the right-
hand side of the valve body indicate the 8 or 3 positions of
the rotor/spring assembly (See §9.5 - Post-operative X-ray
control).
®
The SM8 Sophy
valve exists in 4 different pressure ranges
(see Table of pressure ranges).
To the left of the inlet connector there are radio-opaque
points [3] which are used to identify the pressure range of
the valve (Figures 3 & 9, and §9.5 - Post-operative X-ray
control).
®
valve is determined
®
model.
®
model.
Table of Operating Pressures for SM8 valves
Note on the
SM8-140
Locator
References
SM8-140
concerned
Identification
0 point
of the range
1
10
2
25
3
40
Available
4
60
pressures
(mmH
O)
5
80
2
6
100
7
120
8
140
Table of Operating Pressures for the SM3 valve
Note on the
Locator
References
concerned
Available
pressures
(mmH
O)
2
4. Principle of the Sophy
For more information, refer to the instruction for use of the
Adjustment Kit.
The operating pressure of a valve can be adjusted in order
to adapt to the clinical evolution of the patient.
Changing the operating pressure of the Sophy
carried out percutaneously using an adjustment kit made
up of 3 parts:
— Locating Instrument (Locator),
— Reading Instrument (Compass),
— Setting Instrument (Magnet).
The components of the Sophy
packaged non-sterile in a re-usable box with magnetic
shielding.
®
The Sophy
adjustment kit is not made with natural or
synthetic latex.
®
The Sophy
adjustment kit is specifically for setting
®
adjustable Sophy
valve pressures.
SM8
SM8-300
SM8-400
SM8,
SM8-2010
SM8A,
SM8A-2010
SM8B,
SM8B-2010
SM8-300
SM8-400
SM8-2020,
SM8-2021
SM8-2030,
SM8-2031
SM8-2040
1 point
2 points
3 points
30
50
50
75
70
100
90
125
110
150
140
180
170
220
200
300
SM3
SM3
1
50
2
110
3
170
®
valve adjustment
®
®
adjustment kit are
ENGLISH – 7
80
120
150
190
230
270
330
400
valve is