VICTO EUA Instrucciones De Uso página 7

select the starter kit after the correct
measurement of the urethral size using
the measurement tape provided in the
accessories kit.
the device is supplied with a number of
labels detailing the batch number and use by
date. these should be retained and placed in
the appropriate surgical and patient notes as
established in the hospital procedure.
EqUIPmENT PREPARATION
PREPARING HAEmOSTATS
during implantation, it is useful to clamp
some of the device tubes. in order to protect
the device tubing from damage when
clamping, cover the jaws of the hemostat with
small sections of silicone tubing provided in
accessories kit. all the teeth of the hemostat
should be covered. the jaws should only be
clamped to the first click to prevent excessive
pressure on the tubing.
SURGICAL PROCEDURES
bULbAR URETHRAL ExPOSURE
1. place an indwelling catheter (Foley 12)
into the urethra to facilitate identification
during the dissection.
2. make a perineal incision and dissect
around the bulbar urethra.
3. place some umbilical tape around the
urethra until the final cuff size is chosen and
placed in position.
mEASURE URETHRA SIzE
4. place the measurement tape around the
urethra where the cuff is to be implanted.
it should fit snugly without constricting
the urethra. note: Before measuring the
urethra, take out the indwelling catheter.
5. select the starter kit that corresponds to
urethra size.
PREPARATION OF THE DEvICE
6. place the whole device into a sterile tray.
7. Fill the device with 13 ml of sterile saline
solution using the non-coring needle 25g
x 5/8". (note: do not use a different needle
than the one provided in the starter kit.)
8. lift the pump upwards, with the filling port
at the top, clear of the other components in
the tray.
9. Whilst holding the control pump around
the filling port between the thumb and index
finger, take care when inserting the non-
coring needle 25g x 5/8" in-line through the
center of the self-sealing port until the tip is
just inside the pump chamber.
10. slowly inject all 13 ml sterile saline
solution into the device (perform the
process in two steps using the 10ml
syringe). the sterile saline solution will
enter each of the component parts of the
device together with some air. distribute
the sterile saline solution squeezing the top
of the control pump.
11. With the control pump raised gently,
squeeze the cuff and the prB. all the
air flows into the control pump and vent
through the syringe.
12. Finally, remove the non-coring needle
25g x 5/8". test the system by first pressing
the rapid refill valve to re-distribute fluid
inside the device, and then squeeze and
release the pump twice to check that the
cuff deflates. again, rapidly re-inflate to
refill the cuff. a final test is to squeeze and
release the pump twice again to deflate
the cuff and then check for automatic
slow re-inflation. victo is now ready for
Figure 3
implantation.
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