Affirm Instructions for Use
Preface
Product Complaints
Part Number MAN-02866
xiii
Your
Hologic
representative
can
arrange
for
training
by
a
clinical
services
specialist.
All
users
must
ensure
that
they
receive
training
on
proper
use
of
the
system
prior
to
use
on
patients.
Hologic
does
not
accept
the
responsibility
for
injury
or
damage
from
wrong
system
operation.
5.0 Product
Complaints
Report
any
complaint
or
problem
in
the
quality,
reliability,
safety,
or
performance
of
this
product
to
Hologic.
If
the
device
has
caused
or
added
to
patient
injury,
immediately
report
the
incident
to
Hologic.
(See
the
title
page
for
contact
information.)
6.0 Technical
Support
Refer
to
the
title
page
of
this
manual
for
contact
information
for
product
support.
7.0
Terms and Definitions
Affirm
The
breast
biopsy
guidance
system
for
the
Selenia
Dimensions
Biopsy
Control
Module
The
user
control
device
for
the
Affirm
breast
biopsy
guidance
system
Biopsy
Guidance
Module
Holds
and
operates
the
biopsy
device.
Responds
to
commands
from
the
Biopsy
Control
Module
to
move
the
device
into
position
and
do
the
biopsy.
Comm
Communication
Diff
Differential
C
‐
Arm
Mode
Lets
the
C
‐
arm
and
Tube
Arm
to
move
together
to
the
Needle
Approach
angle
for
the
Localization
procedure.
Exposure
Technique
Combination
of
x
ray
parameters
(kVp,
mAs,
filter)
for
an
acquired
image
Needle
Approach
Angle
The
angle
of
incidence
of
the
needle
to
the
breast
QAS
Quality
Assurance
Standard
Safety
Margins
The
minimum
space
allowed
between
the
biopsy
device
needle
that
is
installed
and
components
of
the
Selenia
Dimensions
system.
Stereo
Mode
Lets
the
Tube
Arm
rotate
for
acquisition
of
stereotactic
images
while
the
C
‐
Arm
stays
in
position.
Stereotactic
Procedure
A
type
of
examination
that
allows
stereotactic
views
at
the
Acquisition
Workstation.
Stereotactic
View
A
specialized
image
view
that
causes
the
application
to
capture
a
stereotactic
images.
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