Аппарат искусственного кровообращения: система ECMOLIFE (ECMOLIFE SYSTEM) с принадлежностями, аксессуарами и расходными материалами: аксессуары:

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Eurosets S.r.l., ИТАЛИЯ

класс:

медицинская техника

Производитель:

Eurosets S.r.l.

Дата Авторизация:

2023-03-01

Характеристики продукта

5
EN
DESCRIPTION
The device is a disposable tubing set manufactured
to user specifications to be used during an E.C.L.S.
procedure for the connection of patient arterial and
venous cannulae with the pumping system.
The device consists of a set of tubing made of PVC.
The tubing’s inner contact surfaces are coated with
A.G.I.L.E. (Advanced Generation Inert Layer E.C.C.)
system, based on Phosphoriylcoline (PC).
The tubing set comprises:
•
an inflow line, connecting the drainage cannula
to the centrifugal pump, and
•
an
outflow
line,
connecting
the
outlet
of
the
centrifugal pump to the return cannula.
and may optionally include a centrifugal pump and a
soft or hard shell reservoir with accessory lines for
priming solution.
Some configurations may contain a centrifuge pump
or other devices by a manufacturer different from
Eurosets. In such a case refer to the instructions
for use of the relevant device, which accompany
the set.
The
device
is
single-use,
non-pyrogenic,
and
is
supplied STERILE, sterilized by ethylene oxide.
TECHNICAL FEATURES
Device technical features are given in Table 1.
_RECOMMENDED MINIMUM_
_BLOOD FLOW RATE_
0.2 L/MIN
_RECOMMENDED MAXIMUM_
_BLOOD FLOW RATE_
7.0 L/MIN
_MAXIMUM BLOOD_
_CONTACT SURFACE AREA_
0.3 M
2
_TUBING:_
INTERNAL DIAMETER, MM
WALL THICKNESS, MM
VOLUME PER 1 M LENGTH
3/8” (9.53 MM)
71 CM
3
1/4” (6.35 MM)
3/32”(2.38 MM)
32 CM
3
3/16” (4.76 MM)
18 CM
3
TABLE 1
The list of materials in contact with blood is available
upon request, contact EUROSETS or the authorized
local representative.
INTENDED USE
The
E.C.L.S.
tubing
set
is
intended
for
use
on
patients in extracorporeal circulation during E.C.L.S.
procedure,
which
in
current
clinical
practice,
provides assisted extracorporeal circulation of the
patient’s blood during conditions consistent with
cardiac failure, usually in cases where the patient is
unresponsive to pharmacologic management.
The device is indicated for use on patients with
acute, severe reversibile respiratory and/or cardiac
failure,
refractory
to
conve