Presentation - VARIXIO Pod Air Gebrauchsanweisung

EN
Description
VARIXIO is a system for the preparation of sclerosing foam
®
for the treatment of varicose veins. VARIXIO
customised magnetic stirring device (VARIXIO
a sterile disposable mixing capsule (VARIXIO
the foam is made.

Presentation

VARIXIO Pod Air are transparent plastic capsules provided
®
sterile in single-unit bags packaged in boxes of ten units for
single use. Capsules have a port, closed by a Luer stopper, for
loading the sclerosing agent and removing the sclerosing foam
produced. Inside the capsules there is also a magnetic rotating
stirring disc. On the top of the capsule there is a removable
seal for the equilibration of pressures before removal of the
sclerosing foam.
VARIXIO Pro Mag is a reusable, digitally-programmable
®
electronic stirrer device with a docking site designed to
accommodate VARIXIO Pod Air capsules. The device contains
®
a rotating magnetic element that aligns with the magnetic
stirrer in the VARIXIO Pod Air to make it rotate at a predefined
®
speed and time according to the sclerosing agent type and
concentration selected by the user.
Reference Description
VB03ES Box of 10 disposable VARIXIO
VB04ES Adapted magnetic stirring device VARIXIO
Indications
VARIXIO is a system for the preparation of sclerosant foam from
®
sclerosing agents commonly used in sclerotherapy treatment.
The concentration of sclerosant to be used for foam preparation
will be decided by the doctor, taking into consideration the sum-
mary of product characteristics of the sclerosing agent and the
clinical guidelines on sclerotherapy.
4
consists of a
®
Pro Mag) and
®
Pod Air) in which
®
Pod Air capsules
®
® Pro Mag
INSTRUCTIONS FOR USE
The system provides an alternative to the conventional method
for the manual preparation of sclerosing foam, combining sterile
air with different concentrations of sclerosing agents such as
polidocanol (POL) or sodium tetradecyl sulphate (STS) as
shown below.
Gas Sclerosant
POL
Air
STS
Instructions for use
VARIXIO must be used only by doctors and nurses experienced
®
in sclerotherapy protocols for the treatment of varicose veins.
The procedure must be undertaken following general principles
of asepsis and handling common in sclerotherapy, following the
steps indicated below:
Remove the VARIXIO Pod Air from its
1 ®
bag and place it in the docking site in
the VARIXIO Pro Mag in the right or
®
left-handed position, as preferred.
Load a 5 ml or 10 ml syringe with a
2
standard Luer tip with 2 ml of sclerosant
liquid (POL or STS). Depending on the
ampoule or vial of sclerosing agent
used, a hypodermic needle may be
required to facilitate loading. Remove
the Luer cap, attach the syringe firmly
to the capsule and load the capsule
with the 2 ml of sclerosant liquid.
IMPORTANT NOTE: Silicone syringes should not
be used as they negatively affect the quality and
stability of the resulting foam, especially when STS
is used as a sclerosing agent.
EN
Concentration
<1%
≥ 1%
< 0.5%
≥ 0.5%
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