Patient Education - Promedon VICTO+ Instructions D'utilisation

PRESSURIZATION PROCESS
• Fill the syringe with a sterile saline solution
for injection.
• Attach the non-coring needle 25G x 5/8"
to the 6 ml Luer-lock syringe.
• With syringe pointed upward, flush 1.0 ml
of sterile saline solution and expel excess
air.
• Fix the self-sealing port of the control
pump using two fingers, pulling the skin
taut over the end of the control pump.
• Push the needle slowly through the skin
into the center of the control pump self-
sealing port. Just prior to reaching the
control pump, clear the end of the needle
by injecting 0.1 ml of sterile saline solution
into the tissue space.
• Push the needle into the self-sealing port,
ensuring that the needle remains parallel to
the walls of the control pump.
NOTE: Hold the self-sealing port between
the thumb and index finger while pushing
the needle, in order to keep the pump in
place. This will prevent piercing the wall of
the pump.
• Activate the product by injecting 4 ml of
sterile saline solution.
• Remove the needle slowly.
• Instruct the patient to pump the device
about 3 times to redistribute fluid. Rapid re-
inflation can be achieved by squeezing the
top of the control pump.
• Perform the efficacy test (See: Post-
pressurization continence tests).
• For additional adjustment of the product
inject 1 ml of sterile saline solution each
time.
POST-PRESSURIZATION
CONTINENCE TESTS
TESTS OF EFFICACY
These can be done immediately following the
pressurization process. After showing the
patient how to deflate the cuff for voiding, he
should be asked to fill his bladder by drinking
until a desire to void is reached.
The patient should be asked to give 5 strong
coughs, 5 seconds of Valsalva maneuver,
and if possible 5 squats. The volume leaked
can be measured and recorded. The patient
should then be asked to void into a flow
machine in order for flow rate and volume to
be measured and recorded.
LONGER-TERM TESTS OF
EFFICACY
The patient can be asked to continue wearing
pads (or conveen leg bag) to record pad use
and/or leaked volume by weight.

PATIENT EDUCATION

Following pressurization of the device, the
surgeon should show the patient how to pump
the device allowing urination. The rapid re-
inflate capability can also be demonstrated. If
the patient is using intermittent catheterization
to empty the bladder, then the importance of
pumping before inserting the catheter should
be stressed.
A flow rate test should be performed to ensure
that the patient is pumping down sufficiently.
An emergency card should be issued to inform
healthcare professionals that the patient has
an implant and that catheterization should
only be performed after pumping down the
device to deflate the cuff.
NOTE: The deactivation procedure guide is
uploaded to the official website.
EXPLANTATION
SURGICAL PROCEDURE
If a surgical, physical, psychological, or
mechanical complication occurs, removal of
the prosthesis may be necessary following
this surgical procedure:
• Make a perineal incision.
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