Individual Components - Promedon VICTO+ Instructions D'utilisation

• Haematoma
• Hydrocele
• Patient dissatisfaction
• Positional incontinence
• Wound infection
• Urinary retention
• Difficult deactivation
Clinical literature reports that a small
percentage of patients
experiencing incontinence after Artificial
Urinary Sphincter placement.
COMPONENTS
PACKAGING
The Starter Kit and Accessories Kit are
supplied sterile and packaged in double
plastic pouches to enable visualization of
the device. Each kit is delivered in a labeled
cardboard box for additional protection.

INDIVIDUAL COMPONENTS

STARTER KIT
The starter kit contains the VICTO+ implant,
which comes as a one-piece device, and the
device identification card. There are five cuff
sizes (3.7 cm, 4.0 cm, 4.5 cm, 5.0 cm, and
5.5 cm).
The implant comes empty and has to be
filled using a non-coring needle (specified
in "Equipment needed" section) with sterile
saline solution.
ACCESSORIES KIT
The Accessories Kit is delivered to enable
the implantation procedure. It includes the
following disposable items:
• 1 (one) cuff size selection tape, to
determine the starter kit that corresponds
to cuff size.
• 30 cm silicone tubing: protection caps for
the instruments used to handle the VICTO+
implant.
STERILIZATION – SUPPLIED STERILE
The implant in the Starter Kit and all the
accessories in the Accessories Kit are
supplied sterile. Sterility is maintained only
if the package is intact and undamaged.
THEREFORE, DO NOT USE THE PRODUCT IF
THE PACKAGE IS OPEN OR DAMAGED.
SHELF LIFE
For shelf life, refer to the label on the package
of individual components or the cardboard box
may continue
label.
DATE SPECIFIED ON THE PACKAGING.
SINGLE USE
All components are intended for
ONLY. DO NOT REUSE or RESTERILIZE
as this can potentially result in compromised
device performance and increased risk of
inappropriate
contamination.
CARE AND STORAGE OF
STERILIZED COMPONENTS
In order to protect the packaging integrity
and sterile condition of the device and
components, it is important that while stored
they remain in the cardboard box and are
placed on a protected shelf or inside a
cabinet. The environment should be clean,
dry, and near room-temperature.
IMPLANTATION
Prior
components must be handled only by
surgeons and/or operating room staff who
are familiar with the use of the device and its
surgical technique. Promedon recommends
reviewing
watching an overview of the device in the
official surgical procedure videos (uploaded
to the official website) prior to performing the
surgical procedure.
The patient should be fully informed of the
procedure and give consent. The surgeon
should discuss the possible risks associated
with the surgery, anesthesia, and device.
· 6 ·
DO NOT USE AFTER THE EXPIRATION
re-sterilization
to implanting VICTO+,
the information
SINGLE USE
them,
and cross-
the kit's
herein and