VICTO EUA Instrucciones De Uso página 10

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 walls of control pump.
• activate the product injecting 3ml 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 test of efficacy (see: post-
pressurization continence tests).
• For additional adjustment of the product
inject 1ml of sterile saline solution each
time.
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
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 that 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
Following pressurization of the device, the
surgeon should show the patient how to pump
the device, in order to allow 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.
iMAGinG
X-rAY viSibilitY oF victo
ImPLANT
the victo does not contain a radio-opaque
solution and therefore, it cannot be imaged
using plain radiography (x-ray). However,
there are 2 other methods which can be used
to image the device in order to investigate
function.
mAGNETIC RESONANCE
the device can be imaged using magnetic
resonance imaging as described in the paper
by deng et al.
NOTE: see magnetic resonance (mr)
enviroment - references.
FlEXiblE cYStomEtrY
the function of the cuff can be visualized
using flexible cystometry with the cuff inflated
and deflated.
ULTRASOUND DIAGNOSTICS
the balloon of victo implant can be easily
visualized using ultrasound. With appropriate
settings, the
highlighted top and bottom of the balloon, can
be seen. the diameter of the balloon can be
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outline, particularly the