General Information; Device Function; Contraindications - Victo Replacement Kit Gebrauchsanweisung

GeneRal
inFORmatiOn
INDICATIONS FOR USE
viCto and viCto+ are adjustable artificial
urinary sphincters (Aus) used to treat male
stress urinary incontinence
intrinsic sphincter deficiency (isd) in cases
such as post-prostatectomy incontinence.
the replacement
to be used as
pump or pressure
of viCto and viCto+.
Kit chArActEriSticS
Cuff replacement kit (ref.: kit-rC-37-10-06;
kit-rC-40-10-06; kit-rC-45-10-06;
rC-50-10-06).
this kit contains the materials for replacement
of the cuff of viCto and viCto+.
Balloon replacement kit (ref.: kit-rB-01)
this kit contains the materials for replacement
of the pressure regulating Balloon of viCto
and viCto+.
pump replacement
rp-03-10-06)
this kit contains the materials for replacement
of the pump of viCto and viCto+.

DEvICE FUNCTION

the viCto implant has been developed to
simulate the normal function of the urethral
sphincter and thereby maintain continence.
the device keeps the urethra closed by
means of a urethral cuff, which prevents
the passage of urine. the pressure in the
cuff is regulated by a small silicone balloon
(pressure-regulating balloon, or prB). When
the patient wants to void the cuff, it can be
deflated by manual operation of the control
pump, which is placed in the scrotum. the
fluid in the cuff is transferred to the prB, thus
allowing the urine to pass through the urethra.
caused
kits are intended
replacement of cuff,
regulating balloon
kit-
kit (ref.: kit-
enGlish
the cuff automatically reinflates via a slow-
bleed valve in the control pump. Additionally,
it can be manipulated for quick reinflation.
the base of the control pump contains a
self-sealing port, which enables the device
by
to be interrogated percutaneously in order
that extra fluid can be added to increase the
pressure.
viCto+ has an additional balloon placed
in series with the cuff (stress-relief balloon,
or srB) to transfer additional fluid to the
cuff during periods of high intra-abdominal
pressure such as coughing and sneezing.
this feature is called Conditional occlusion.
the replacement kits are used during
viCto/viCto+ post-surgical replacement
procedures of its parts, thereby allowing the
surgeon to have flexibility once the product
is implanted. this way, if replacement of the
cuff/pump/balloon is necessary, the surgical
procedure will be less invasive.
Components replacement might be due to
an incorrect use/selection of the device, or
product´s component failure.

CONTRAINDICATIONS

the main
implantation of the viCto+ and viCto are
listed below:
1. unmanaged detrusor instability;
2. problems affecting manual dexterity or
motivation, which may prevent the patient
from operating the device;
3. Acute urinary tract infection which may
lead to post- operative complications;
4. patients whom the surgeon determines to
be not suitable due to risks associated with
open surgical procedures and/ or with the
patients' medical history (physical or mental
problems);
5. known sensitivity to silicone rubber.
· 3 ·
contraindications for the