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low
controls
and
the
baseline
control
and
thereby
on
the
immunoassay,
the
results
are
not
displayed
and
erroneous
results
are
not
reported.
The
Timing
Control
Zone
monitors
assay
completion.
If
an
inadequate
amount
of
specimen
is
added
to
the
test
device
or
if
a
specimen
clots
in
the
device,
this
control
will
prevent
the
display
of
the
results.
A
Trace
QC
algorithm
has
been
programmed
which
evaluates
the
size,
location
and
signal
to
noise
ratio
of
each
zone
on
the
device.
Aberrations
in
zone
quality
exceeding
preset
limits
will
cause
rejection
of
one
or
more
of
the
assay
results.
Meter
Quality
Assurance
The
Self
Ͳ
Test
Mode
is
initiated
each
time
the
meter
is
turned
ON.
In
the
self
Ͳ
test
mode
the
meter
scans
an
Internal
Calibration
Chip.
Each
calibration
chip
scan
is
used
to
validate
and
adjust,
if
necessary,
the
meter
calibration.
In
the
self
Ͳ
test
mode,
the
available
memory
for
patient
results
is
checked.
When
the
capacity
is
below
a
pre
Ͳ
set
limit,
the
remaining
capacity
is
related
via
a
screen
message.
The
software
program
is
evaluated
and
is
terminated
if
corrupted.
Software
test
results
and
CODE
CHIP
module
data
are
verified
for
integrity
before
each
use.
A
QC
Device
is
provided
with
each
meter
to
allow
the
user
to
further
check
the
integrity
of
the
meter.
The
simulator
contains
six
fluorescent
zones
of
varying
intensity
that
are
measured
by
the
meter.
There
are
pre
Ͳ
programmed
acceptable
ranges
for
the
six
zones.
In
addition,
the
zones
allow
the
meter
to
check
for
horizontal
and
vertical
alignment
of
the
zone
measurement
to
verify
laser
alignment
and
device
transport.
The
QC
Device
also
confirms
laser
stability.
A
Bar
Code
is
printed
on
the
bottom
of
every
test
device
to
identify
the
reagent
lot
number
and
to
prevent
the
use
of
expired
reagents.
Software
Quality
Assurance
The
software
QA
is
controlled
through
a
variety
of
software
features,
some
of
which
can
be
optional
depending
on
the
environment
in
which
the
assay
is
performed.
In
a
Point
Ͳ
of
Ͳ
Care
location,
a
designated
supervisor
can
select
program
parameters
to
ensure
adherence
to
quality
standards.
In
a
central
laboratory
location,
selected
parameters
can
be
bypassed
if
desired.
A
Supervisor
CODE
CHIP
module
is
provided
with
each
meter.
This
CODE
CHIP
module
allows
access
to
meter
functions
not
available
to
the
routine
user.
The
additional
functions
are
selection
of
parameter
settings
and
downloading
and
deletion
of
results
from
the
meter
memory.
A
User
ID
can
be
assigned
in
the
software
to
limit
access
to
the
patient
testing
mode
to
only
those
individuals
who
have
been
properly
trained
and
have
demonstrated
testing
proficiency.
A
User
ID
and
expiration
date
are
programmed
into
the
meter
memory
and
are
subsequently
associated
with
all
patient
results
generated
by
the
user.
This
allows
the
supervisor
to
review
users’
testing
frequency,
and
in
the
event
of
frequent
test
failures,
to
identify
potential
problems
in
training.
An
additional
security
feature
of
the
User
ID
is
the
partial
masking
of
the
ID
on
displays
and
printouts.
This
prevents
unauthorized
individuals
from
detecting
and
using
an
existing
User
ID.
This
feature
is
overridden
when
the
Supervisor
CODE
CHIP
module
is
installed.
Содержание Triage MeterPro
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