Measurement Unit And Calibration Of Operating Pressures; Behavior During Magnetic Resonance Imaging (Mri); Sterilization - Decontamination Of Sophy ® Valves And Valve Kits - Sophysa Sophy Notice D'emploi

The surgeon is responsible for filling in this Patient
Identification Card and giving it back to the patient.
6. Measurement Unit and Calibration of
Operating Pressures
The pressures mentioned are in mmH
1 mmH O corresponds to 9.807 Pa or 0.074 mmHg.
2
The valves are calibrated on the basis of a flow rate of 10
ml/h.
Each valve is tested individually: the measurement
concerns the upstream pressure of a 10 ml/h flow of water
passing through the valve and the Sophysa proximal and
distal catheters.
The calibration is performed disregarding the resistance of
the catheters.
Thus the pressures given on the valve labels correspond to
the resistance of the valve alone.
The catheters add their own resistance to the shunt.
The reservoirs are not considered to have any particular
resistance.
The calibration of Sophy
tolerance of -10/+15 mmH
F 4: F R -P
IGURE LOW ATE RESSURE
This curve is obtained by varying the applied pressure for
each pressure setting and measuring the resulting flow
rate. The values are given disregarding the resistance of the
catheters.
The effects on the device operating pressure of changes in
the position of the patient and of sub-cutaneous pressure
are negligible.
7. Behavior during Magnetic Resonance
Imaging (MRI)
A shunt consisting of a Sophy
and possible reservoirs) and its catheters, is considered to
be "MR Conditional" in accordance with the definition in
the standard, ASTM F2503.
A patient fitted with a Sophy
examination, even immediately after the device has been
implanted.
The results of in vitro tests have demonstrated that the
®
Sophy valve does not present any danger in the following
examination conditions:
— MRI with a static magnetic field limited to 3-Tesla and
O.
2
®
valves is performed with a
O on the measured pressures.
2
C SM8
URVES FOR THE
®
valve (including connectors
®
valve can undergo an MRI
with a spatial gradient magnetic field limited to 19 T/m;
— Whole body averaged SAR (Specific Absorption Rate)
limited to 2 W/kg for 15 minutes exposure at 3 Tesla.
— Whole body averaged SAR (Specific Absorption Rate)
limited to 2 W/kg for 15 minutes exposure at 1.5 Tesla.
— No gradient magnetic fields limitation.
NOTE
The patient must be informed that he/she is likely to feel
slight discomfort, which is completely inoffensive, during an
MRI examination.
PRECAUTIONS
For the Sophy
from an area of specific clinical interest, such as a tumor,
which
examinations. In fact, the Sophy
a potential source of artifacts on MRI images. The size of
these artifacts could be very large in size in relation to the
size and shape of the Valve.
WARNING
The adjustment of the pressure must be checked routinely
before and after MRI examinations. Please see additional
recommendation
MODEL
operating pressure after implantation.
The tests conducted in accordance with the standard,
ASTM F2182, showed that the rise in temperature caused
by exposure to 3-Tesla MRI (+ 2.2°C +/- 0.2°C) was
negligible and had no physiological consequences for the
patient.
Tests conducted in accordance with standards, ASTM
F2213 and ASTM F2052, showed that the torque and
displacement force induced by a magnetic field of 3 Tesla
or less did not present any risks for the patient.
The tests conducted in accordance with the standard,
ASTM F2119-07, showed that image artifacts may reach a
surface of 44 cm² for Spin Echo sequences and 128 cm²
for Gradient Echo sequences on a 3 Tesla MRI.
8. Sterilization – Decontamination of
Sophy
The Sophy
double peel-off, sterile, pyrogen-free packaging, sterilized
with ethylene oxide.
WARNING
Do not use the valves or valve kits if the sterile packaging is
open or damaged, or if the expiry date has passed.
This product is intended for SINGLE USE ONLY. It is
intended to be used once only for a single patient. Do not
re-sterilize or re-use after unpacking and/or explantation.
Resterilization can damage the product, potentially leading
to patient injury. Reuse of this device may change its
mechanical or biological features and may cause device
failure, allergic reactions or bacterial infections.
®
valve choose an implantation site away
may subsequently require
®
valve micro-magnets are
under section
®
Valves and Valve Kits
®
valves and valve kits are packed individually in
repeated MRI
§9.4.1-Reading of
ENGLISH – 9