VICTO Replacement Kit Gebrauchsanweisung Seite 6

STERILIzATION – SUPPLIED
STERILE
All components of the replacement kits are
supplied sterile.
sterility is maintained only if the packaging
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
packaging of each individual components or
the cardboard box label. do not use after the
expiration date specified in the packaging.
SINGLE USE
All components are intended for sinGle use
onlY. do not reuse or resterilize
them, as this can potentially result in
compromised device
increased risk of inappropriate re-sterilization
and cross-contamination.
CARE AND STORAGE OF
STERILIzED COMPONENTS
in order to protect the packaging integrity
and sterile condition of the components, it is
important that, during storage, they remain
in the cardboard box on a protected shelf or
inside a cabinet. the environment should be
clean, dry and near room-temperature.
implantatiOn
PrE-oPErAtivE
SURGICAL TEAM PREPARATION
the surgeon and operating-room staff should
be familiar with the operating procedure.
the members of the surgical team should
scrub their hands for ten minutes using a
povidone-iodine solution (provided the patient
is not iodine sensitive) or another approved
hospital scrub procedure.
performance and
· 6 ·
PATIENT PREPARATION
the patient should be fully informed of the
procedure and must give consent. the
surgeon should discuss the possible risks
associated with the surgery, anaesthetic and
device.
prior to surgery, prophylactic antibiotic
therapy should be administered according to
the hospital's approved procedures.
once in the operating room, the patient is
placed in the lithotomy position. Based on
the component to be replaced, the abdominal
and genital areas are shaved and cleansed
with povidone-iodine
an approved hospital preoperative scrub
procedure.
the patient is prepped and draped for perineal
and/or lower abdominal incision.
EqUIPMENT NEEDED
the implantation
urethroplasty surgical
Accessories kit
various other supplies. each surgeon may
also have preferences about what equipment
he/she requires.
Additional equipment is listed below:
• 12 Fr Foley catheter
• shod forceps (e.g., hemostats)
• sterile tray
• sterile 50 ml syringe
• sterile saline solution
• umbilical tape
uNPAcKiNg thE
COMPONENTS
the integrity of both packages should be
inspected. if there is a suspected breach of
sterility the device should be returned to the
distributor or manufacturer.
select the replacement cuff after the correct
measurement of the urethral size using
the measurement tape provided in the
Accessories kit.
A number of labels detailing the batch number
and use by date are supplied. these should
be retained and placed in the appropriate
solution or
requires a standard
kit, the viCto
(ref.: kit-AC-01),
using
and