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Figure 7: Flow Rate - Pressure Curves for the SiphonX® gravitational anti-siphon device
(SX-200 Model)
Flow Rate (ml/h)
This curve is obtained, for each tested angle, by varying the applied pressure and
measuring the resulting fl ow rate.
The values are given disregarding the resistance of the catheters.
In conditions of normal use this mechanism is not sensitive to temperature
variations.
The anti-siphon device body, which cannot be deformed, makes the device insensitive
to variations in percutaneous pressure.
The connectors and the anti-siphon device body are made of polysulfone.
The SiphonX® gravitational anti-siphon device is a latex-free product.
The tantalum ball is clearly visible on an X-ray.
Figure 8: Radiographic image of the SiphonX® SX-200
4.
Confi gurations of the SiphonX®
The SiphonX® gravitational anti-siphon device, Model SX-200, is supplied on its own
without a catheter.
Sophysa off ers a range of both adjustable and monopressure valves on which the
SiphonX® can be fi tted, as well as a complete range of radio-opaque catheters
which allow the CSF to fl ow to the valve and anti-siphon device, and then on to the
reabsorption site chosen by the neurosurgeon.
A complete shunt system that includes a SiphonX® gravitational anti-siphon device
must consist of a proximal catheter, a valve, an anti-siphon device and a distal
catheter.
The SiphonX® operating pressures has a tolerance interval of +/-15mmH
with the pressures shown on the label.
5.
Measurement Unit and
Control of Operating Pressures
The operating pressures mentioned are in mmH
90°
1 mmH
O corresponds to 9.807 Pa.
60°
2
30°
Each SiphonX® gravitational anti-siphon device is tested individually: the
(horizontal)
0°
measurement concerns the upstream pressure of a 10ml/h fl ow of water passing
through the anti-siphon device and the Sophysa proximal and distal catheters.
This measurement is performed for three diff erent inclinations of the device:
0° (horizontal), 90° (vertical) and 30° (intermediate angle).
The control measurement is performed disregarding the resistance of the catheters.
Thus the pressures given on the SX-200 model labels correspond to the resistance of
the SiphonX® alone, the catheters and the valve, which must be combined with the
SiphonX®, adding their own resistance to the shunt.
6.
Behavior during Magnetic Resonance
Imaging (MRI)
The performance and functionality of the SiphonX® gravitational anti-siphon device
are not aff ected by repeated exposure to MRI examinations at 3 Tesla (30,000 Gauss)
or less.
The SiphonX® gravitational anti-siphon device is considered as "MR Safe" in
accordance with the defi nition in the standard, ASTM F-2503-05.
The rise in temperature caused by exposure of the SiphonX® to 3 Tesla MRI is
negligible and has no physiological consequences for the patient.
The torque and displacement force induced by a magnetic fi eld of 3 Tesla or less are
nil and so do not present a risk for the patient.
P
:
RECAUTION
D
S
O NOT IMPLANT A
IPHON
NEED TO BE EXAMINED UNDER
T
HE TANTALUM WEIGHTING BALL IN A
SOURCE OF ARTIFACTS ON
7.
Sterilization and Packaging
The SiphonX® gravitational anti-siphon devices are provided sterile and pyrogen free.
The SiphonX® are provided individually in double sterile packaging. The product is
sterilized using ethylene oxide.
W
:
ARNINGS
D
O NOT USE THE DEVICES IF THE STERILE PACKAGING IS OPEN OR DAMAGED
.
HAS PASSED
A
-
NTI
SIPHON DEVICES ARE SINGLE USE DEVICES
/
.
AND
OR EXPLANTATION
O compared
2
N
:
OTE
S
OPHYSA CANNOT BE HELD RESPONSIBLE FOR THE PERFORMANCE OF ANY PRODUCT THAT HAS BEEN
-
/
RE
STERILIZED AND
OR RE
6
O.
2
X®
-
GRAVITATIONAL ANTI
SIPHON DEVICE IN AN AREA THAT IS LIKELY TO
MRI.
S
X®
-
IPHON
GRAVITATIONAL ANTI
SIPHON DEVICE IS A POTENTIAL
MRI
. T
IMAGES
HE SIZE OF THIS COULD BE AS LARGE AS THE IMPLANT
. D
-
O NOT RE
STERILIZE OR RE
-
,
USED
NOR FOR ANY COMPLICATIONS WHICH MIGHT RESULT FROM THIS
.
,
OR IF THE EXPIRY DATE
-
USE AFTER UNPACKING
.
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