4
1
Introduction
Always
read
the
user
manual
prior
to
use.
1.1
General
information
This
cushion
is
a
medical
device
in
accordance
to
MDD/93/42/EEC.
According
to
statutory
regulations
made
by
the
authorities
regarding
medical
devices,
the
manufacturer
is
required
to
report
all
accidents
or
incidents
involving
there
products.
We
would
be
very
grateful
for
all
information
involving
accidents
or
incidents
relating
to
our
products,
by
reporting
them
immediately
to
us,
here
at
Care
of
Sweden.
1.2
Intended
use
CuroCell®
S.A.C.
is
a
static
seat
cushion
that
offers
comfort
and
pressure
relief.
It
is
intended
for
use
in
a
wheelchair
to
assist
in
the
prevention
and
treatment
of
pressure
ulcers
up
to
and
including
category
2
(1)
but
can
also
be
used
on
other
types
of
seat.
The
maximum
recommended
user
weight
is
160
kg.
The
cushion
must
always
be
disinfected
between
users.
(1)
National
Pressure
Ulcer
Advisory
Panel,
European
Pressure
Ulcer
Advisory
Panel
and
Pan
Pacific
Pressure
Injury
Alliance.
Prevention
and
Treatment
of
Pressure
Ulcers:
Quick
Reference
Guide.
Emily
Haesler
(Ed.).
Cambridge
Media:
Osborne
Park,
Western
Australia;
2014.
1.3
Other
information
Action
plan
Pressure
ulcers
To
achieve
the
best
possible
result
for
this
product
it
is
recommended
that
a
well
‐
planned
and
well
‐
structured
working
environment
be
used.
In
our
guideline
"Action
plan"
you
will
find
examples
which
can
be
applied
and
put
into
practice
when
using
our
products.
This
information
can
be
found
on
our
website
www.careofsweden.com
or
you
can
order
a
copy
from
our
Customer
services
by
sending
your
details
to
info@careofsweden.se.
2
Product
description
CuroCell®
S.A.C.
is
available
in
the
following
sizes:
45x45x4
cm,
50x50x4
cm.
Material:
Polyurethane
Classification:
ISO
code
04
33
03
(pressure
relieving)
Fire:
EN
597
‐
1,
EN
597
‐
2