VICTO Replacement Kit Gebrauchsanweisung Seite 10

PRESSURIzATION PROCESS
• Fill the syringe with a sterile saline solution
for injection.
• Attach the non-coring needle 25G x 5/8"
to the syringe.
• With syringe pointed upward, flush 1.0ml
of sterile saline solution and expel excess
air.
• Fix the self-sealing port of the control
pump, using two fingers to pull 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
with the walls of the control pump.
• Activate the product, injecting 2ml of
sterile saline solution.
• remove the needle slowly.
• instruct the patient to pump the device
about 3 times to redistribute fluid. rapid
reinflation can be achieved by squeezing
the top of the control pump.
• perform the test of efficacy (please refer
to "post-pressurization continence tests.")
PoSt-PrESSurizAtioN
CONTINENCE TESTS
tEStS oF EFFicAcY
these can be done immediately following
pressurization process. After showing the
patient how to deflate the cuff for voiding, he
can be asked to fill his bladder by drinking
until a desire to void is reached.
the patient should be asked to perform
5 strong coughs, 5 seconds of valsalva
manoeuvre 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 that the
flow rate and volume can 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
subsequent to device pressurization, the
surgeon should show the patient how to pump
the device in order to allow urination.
the rapid reinflation capability can also
be demonstrated. if the patient is using
intermittent catheterization to empty the
bladder, the importance of pumping before
catheter insertion 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.
imaGinG
X-rAY viSiBilitY oF thE
vICTO IMPLANT
the viCto+/viCto does not contain radio-
opaque solution, and consequently it cannot
be imaged using plain radiography (x-ray).
However, there are 2 other methods that
can be used to image the device in order to
investigate function.
MAGNETIC RESONANCE
the viCto/viCto+ implant can be observed
imaged using mri (magnetic resonance
imaging) as described in the paper by deng
et al.
FlEXiBlE cYStoMEtrY
the function of the cuff can be visualized
using flexible cystometry with the cuff inflated
and deflated.
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