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/
19
Caution
The
system
is
intended
for
use
outside
the
body
(in
vitro
diagnostic
use).
It
is
for
single
‐
patient
use.
It
should
be
used
only
for
testing
glucose
(sugar)
and
only
with
fresh
capillary
whole
blood
samples
taken
from
the
finger
and
the
alternative
sites
including
the
palm,
the
forearm,
the
upper
arm,
the
calf
and
the
thigh.
The
system
is
intended
for
use
at
home.
It
should
not
be
used
for
the
diagnosis
of
diabetes
or
for
the
testing
of
newborns.
The
System
is
to
be
used
by
a
single
person
and
should
not
be
shared.
The
System
is
intended
for
self
‐
testing
outside
the
body
(in
vitro
diagnostic
use)
by
people
with
diabetes
at
home
as
an
aid
to
monitor
the
effectiveness
of
diabetes
control.
Alternative
site
testing
should
be
done
only
during
steady
–
state
times
(when
glucose
is
not
changing
rapidly).
The
“
Bioland
”
Test
Strips
are
for
use
with
the
Blood
Glucose
Meter
to
quantitatively
measure
glucose
in
fresh
capillary
whole
blood
samples
drawn
from
the
fingertips,
palm,
forearm,
upper
arm,
calf
and
thigh.
The
Bioland
control
solutions
is
intended
for
use
with
the
System,
to
check
that
the
glucose
meter
and
test
strips
are
working
properly
and
that
you
are
doing
the
test
correctly.
These
solutions
contain
a
known
range
of
glucose,
as
indicated
on
the
strips
vial
bottles.
This
device
is
not
intended
for
use
in
healthcare
or
assisted
‐
use
settings
such
as
hospitals,
physician’s
offices,
or
long
‐
term
care
facilities
because
it
has
not
been
determined
to
be
safe
and
effective
for
use
in
these
settings,
including
for
routine
assisted
testing
or
as
part
of
glycemic
control
procedures.
Use
of
this
device
on
multiple
patients
may
lead
to
transmission
of
Human
Immunodeficiency
Virus
(HIV),
Hepatitis
C
Virus
(HCV),
Hepatitis
B
Virus
(HBV),
or
other
bloodborne
pathogens.
AST
in
this
system
can
be
used
only
during
steady
‐
state
blood
glucose
conditions
described
in
the
section
of
“About
AST”.
Test
principle
The
test
is
based
on
the
measurement
of
electrical
current
generated
by
the
reaction
of
glucose
with
the
reagent
of
the
strip.
The
meter
measures
the
current
and
displays
the
corresponding
blood
glucose
level.
The
strength
of
the
current
produced
by
the
reaction
depends
on
the
amount
of
glucose
in
the
blood
sample.
ABOUT
ALTERNATIVE
SITE
TESTING
(AST)
Important.
There
are
limitations
for
doing
AST.
Please
consult
your
healthcare
professional
before
you
do
AST.
