Hologic Affirm Prone Breast Biopsy Guidance System User guide
- Type
- User guide
Affirm Prone Biopsy System
Addendum for Version 1.0.2 Changes
MAN-05543 Revision 001 December, 2017 Hologic, Inc. Page 1 of 3
36 Apple Ridge Road, Danbury, CT 06810 (800) 447-1856
© 2017 Hologic, Inc. The information contained in this document is proprietary. Unauthorized distribution is prohibited.
1.1 Introduction
This addendum updates your Affirm® Prone Biopsy system User Guide (MAN-04480) for
software version 1.0.2 changes.
Place this addendum with your User Guide for future reference.
1.2 Changes in Version 1.0.2
The following changes to the User Guide are based on the release of the v1.0.2 software:
Compression Lock-Out Feature
The following text modifies section 3.2.2 Control Handle Controls:
When the "system lock" switch [ ] on the control handle is enabled, the system:
• locks the C-arm
• locks out the motorized compression motion
• prevents x-ray images to be taken on the system
Motorized Compression Usability Improvements
The following text modifies section 3.2.2 Control Handle Controls, section 3.2.3 Footswitch
Controls, and section 4.2.1 Compression Functional Tests:
The system allows motorized motion to move the compression device back into the
travel range without first requiring an extra manual adjustment. This situation can
happen when the compression device has reached the end of its travel range and motion
is automatically stopped.
Affirm Prone Biopsy System
Addendum for Version 1.0.2 Changes
MAN-05543 Revision 001 December, 2017 Hologic, Inc. Page 2 of 3
36 Apple Ridge Road, Danbury, CT 06810 (800) 447-1856
© 2017 Hologic, Inc. The information contained in this document is proprietary. Unauthorized distribution is prohibited.
Ability to Hang Non-Biopsy Image Within a Biopsy Workflow
The following text modifies section 5.5.3 How to Add or Remove a View:
When selecting a prior view in the Procedure screen, the prior view (item A in the
following figure) shows on the image display monitor along with the current biopsy
view (item B) in a 2-up manner.
Auto-Select New View After Image Reject
The following text modifies section 7.1.1 Conventional Imaging Sequence of Events, and
section 7.1.2 Tomosynthesis Imaging Sequence of Events, and section 7.2 How to Acquire an
Image:
When rejecting an image in a Biopsy procedure, the system selects the newly created
view automatically.
Affirm Prone Biopsy System
Addendum for Version 1.0.2 Changes
MAN-05543 Revision 001 December, 2017 Hologic, Inc. Page 3 of 3
36 Apple Ridge Road, Danbury, CT 06810 (800) 447-1856
© 2017 Hologic, Inc. The information contained in this document is proprietary. Unauthorized distribution is prohibited.
Improved Exposure Recovery Time
The following text modifies section 7.1.2 Tomosynthesis Imaging Sequence of Events, section
7.2 How to Acquire an Image, and section 8.5 Lesion Targeting with Tomosynthesis:
When aborting a Tomosynthesis exposure, the wait time for the system to become Ready
for the next exposure is reduced.
Color Coded Needle Safety Margins
The following text modifies section 8.3.1 Biopsy Options (item 11 in Figure Legend):
Color-coded needle safety margins between the platform and the paddle apply to both
standard and lateral needle approaches.
View Editor Limited to Hologic Applications and Service Users
The following text modifies section 9.2 The Admin Screen:
View Editor is no longer available for Hologic customers and has been removed from the
Admin screen.
QAS Test Prompt with Coordinates
The following text modifies section 12.3 QAS Test and should be inserted after step 2:
The QAS screen opens. A dialog box prompts you to install the QAS phantom and
shows the position coordinates for the test.
Note
The dialog box says to install the QAS "needle" but is referring to the QAS phantom.
Figure 1: QAS Test Info Dialog Box
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Hologic Affirm Prone Breast Biopsy Guidance System User guide
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