Contraindications - Promedon VICTO+ Instructions D'utilisation

Pump
Cuff
Pressure-
A
regulating
Stress relief
balloon
After use, the non-implanted product and
packaging should be disposed of in accordance
with hospital, administrative, and/or local
government policy.
A) The cuff is deflated by squeezing the control
pump unit located in the scrotum; fluid is
transferred to the PRB, leaving the cuff empty
and allowing the patient to void.
B) The cuff slowly re-inflates through a slow
bleed valve. Rapid re-inflation can be achieved
by squeezing the top of the control pump.
The cuff exerts sufficient pressure to maintain
continence without compromising the urethral
tissues.
C) During periods of increased intra-abdominal
pressure, the fluid from the stress relief balloon
(SRB) is transferred temporarily to the cuff
to provide additional pressure and maintain
continence during these moments.

CONTRAINDICATIONS

The main contraindications for the implantation
of VICTO+ are listed as follows:
1. Unmanaged detrusor instability.
2. Problems affecting manual dexterity or
PRB
SRB
B
balloon
Cuff
Pump
C
Figure 1
motivation, which may prevent the patient
from operating the device.
3. Acute/chronic urinary tract infection, which
may lead to post-operative complications.
4. Acute/chronic infections at the surgical site
and systemic infections (sepsis) which may
lead to post-operative complications.
5. Prior abdominal surgery leading to post-
operative peritonitis, and other conditions
resulting in peritoneal adhesions, fibrosis, and
scars could potentially affect the product's
performance.
6. Patients the surgeon determines not
suitable due to risks associated with open
surgical procedures and/or with the patient's
medical history (physical or mental problems).
7. Known sensitivity to silicone rubber.
WARNINGS
Improper cuff sizing may cause low efficacy
for treatment or tissue damage.
Improper filling of components may cause
poor performance of the product or implant
permanent damage.
All components are for single use. Therefore,
they should not be reused or re-sterilized as
this can potentially result in compromised
device performance and
of inappropriate re-sterilization and cross
contamination.
The product must not be used if the package
is open or damaged.
The product must not be used after the
expiration date specified on the packaging.
VICTO+ is not
implanted simultaneously with other surgical
procedures.
There is no clinical evidence of VICTO+'s
performance using a transcorporal approach
in the surgical procedure.
PRECAUTIONS
Improper cuff sizing may result in tissue
damage, migration
continued incontinence.
Unsuccessful
improper sizing and/or filling of components.
The kit's components must be handled only
by surgeons and/or operating room staff who
· 4 ·
increased
recommended
of components,
outcomes may result
risk
to be
or
in