Selenia 3.1.1.10 Release Notes MAN-00349 - 002 - 01

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Artwork and Signature File for:

MAN-00349, “MANUAL, SELENIA 3.1.1 RELEASE NOTES”

Artwork consists of:

• Ten (10) 8 ½ inch x 11 inch pages.

REV AUTHORED BY DATE


A. FAND 06/21/05
REV DRAFTED BY DATE
DANBURY, CT 06810
A. FAND 06/21/05
PROPRIETARY INFORMATION: TITLE DOCUMENT NUMBER REV
The content of this document is the
exclusive property of Lorad and may AW, MANUAL, SELENIA 3.1.1
not, without prior written permission RELEASE NOTES
AW-00919 002
of Lorad, be reproduced, copied or
used for any purpose whatsoever. ARTWORK SIZE A SHEET 1 OF 1
ENG-0034-T33, Rev. 001
Selenia 3.1.1 Release Notes

Selenia 3.1.1.10 Release Notes


1.0 Introduction
This document is provided to give you a quick overview of the new features of
the Selenia Version 3.1.1. It is not meant to replace the User’s Manual.

2.0 Release Note Support Call


If you are in the United States, you may schedule a telephone support call with
an Application Specialist by:

Fax 203-207-4596
the last page of this document

or

Call 800-447-1856
between 8:30am and 5:00pm EST
and ask for Leslie Smith

or

Call 203-731-8358
to leave a voice message

or

email lsmith@hologic.com
with MAN-00349 Release Note in the Subject

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 1
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes

3.0 Selenia 3.1.1.4 Issues Fixed in Selenia 3.1.1.10


This release fixes the following circumstances:
• The Time to Preview is now stable from exposure to exposure even if MG FOR
PRESENTATION images are being sent to output devices in the background.
• Further improvements have been made to the detection and processing of views
containing implants.
• The default collimation of spot contact views is now 18x24cm so that even the
uncompressed breast tissue is visible. The operator can choose to override this
default collimation with the collimation override button on the top of the tubehead.
• Issues resolved with printing priors regarding chest wall orientation. Prior views
acquired with the chest wall displayed on the right are now printed correctly.

4.0 Features in Selenia 3.1.1


4.1. Image Processing
This release updates image processing to fix the following circumstances:
• Improves processing of implant views, particularly silicon implants, so that the
tissue area will appear at a more appropriate Window/Level.
• Adjusts the processing of views with large breasts that may cover most or the
entire detector to display all the breast tissue correctly. There is no need to try to
have an uncovered detector area when imaging large breasts any more.
• Adjusts the processing of contact and magnification views so that they will
appear at a more appropriate Window/Level.

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 2
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes
4.2. Automatic Array Shutdown and Startup
The system can now be configured to automatically power down the the detector portion
of the system during night hours. The detector power down takes place at a
predetermined time during the evening, which is site configurable. At a predefined time
in the morning (also site configurable), the system will power the detector up to give it
enough time to come up to operating temperature prior to the site getting ready to image
patients. Please note that ONLY the detector is powered down during the night hours; the
rest of the system—acquisition workstation and gantry—stay powered on during the
night.
There are two time settings that dictate when the detector will be powered down. The
operator has the opportunity to override the shut down process of the detector. In that
case the detector will be powered down when the second time setting is reached. The
operator also has the opportunity to cancel the second system attempt to power down the
detector. In this case, the detector will not be powered down for that night.
After the system powers down the detector at one of the time settings during the night,
the system will power the detector up again in the morning to give it a chance to warm up
prior to patient imaging. It is important that the system is not shutdown during the night
all together so that it will be able to power up the detector in the morning automatically. If
the system is shut down at night, then the entire system will have to be booted up in the
morning, which will then require the warm-up interval to elapse prior to imaging patients.
This feature can be enabled and disabled, including setting the times for detector power
down and power up, by Hologic Field Service.

The system still needs to be rebooted every morning even if the array
has been automatically powered down and started up.

Do not allow the operating temperature range during the day to exceed
20-30oC (68-86oF). For optimal system performance. Hologic
recommends a 20-25oC (68-77oF) operating temperature range.
If the room temperature exceeds the operating limits at anytime the
detector is operational, the detector will be powered down automatically..
This is SEPARATE from the automatic detector power down/up during
the night hours.

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 3
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes
4.3. Image Preview Window
This release improves the display of preview images on the acquisition workstation
display by implementing full image processing for the preview images, including
peripheral contrast enhancement (PCE). Immediate Zoom/Pan has been incorporated
that allows the operator to zoom at 140 micron resolution image immediately after the
preview appears. Full resolution Zoom/Pan and display of exposure index will be
available a few seconds after the preview image appears on the display.
The tools in the image preview window have been rearranged.
1. Immediate Zoom/Pan
2. Full Zoom/Pan
3. Display AEC Regions
4. Dose Display
5. Accept Reject

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 4
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes
4.3.1. Immediate Zoom / Pan
Click the Immediate Zoom/Pan button to activate this feature which is available as soon
as the exposure preview image is displayed on the screen. When Immediate Zoom/Pan
is active, a 140 micron magnification of the Preview Image is shown using the entire
screen. Pan through the Image by dragging with the right mouse button. Click the
Immediate Zoom/Pan button again to return to the full image on the Preview window.
Any crosshairs or line measurements are retained through activationa dn deactivation of
this feature.

4.3.2. Full Zoom / Pan


Click Full Zoom/Pan to activate this feature which is available after the final image is
ready. When Full Zoom/Pan is active, a 70 micron magnification of the Preview Image is
shown using the entire screen. Click the right mouse button again to return to the full
image on the Preview window. Any crosshairs or line measurements are retained through
activation and deactivation of this feature.

4.3.3. Display AEC Regions


Once an AEC exposure is made, the user can check the Display AEC Regions checkbox
in the Preview Window to display the AEC region(s) selected by the system/user.
Manual sensor positioningshows as a rounded white rectangle overlaid on the image.
The two Auto Sensor regions are shown as 1cm by 1cm white squares overlaid on the
image.

4.3.4. Dose Display


An estimate of the average glandular organ dose and the entrance surface exposure are
now displayed on the Preview Image Window. The average glandular dose estimate
always assumesa 50/50 breast composition.

4.3.5. Accept / Reject


These buttons have been moved from underneath the Preview Image to the right to make
room for the larger size of the Preview Image.

4.4. Hanging of Displayed Views on Acquisition Station


The acquisition station can now be configured to display left views oriented with the chest
wall on the left side. Service can make this change so that left and right views will be
shown with chest wall to chest wall in the Procedure View screen. This is particurly
helpful for diagnostic workstations other than SecurView that do not have the ability to
orient the chestwall correctly and depend on the AWS to perform this task.

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 5
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes

4.5. Automatic Exposure Control (AEC)

4.5.1. AEC modes


There are three AEC modes: Auto-Time, Auto-kV, and Auto-Filter.
AEC Mode Techniques
Filter = user selected
Auto-Time kV = user selected
mAs = calc from Scout Pulse
Filter = user selected
Auto-kV
kV = calc from thickness and TEC table
mAs = calc from Scout Pulse
Filter = calc from thickness and TEC table
Auto-Filter
kV = calc from thickness and TEC table
mAs = calc from Scout Pulse

4.5.2. AEC Sensor


The location of the seven manual AEC sensor positions are marked on the screening
paddles. The operator can also choose Auto Sensor which will automatically select the
two densest 1cmx1cm regions inside the active AEC detector as the AEC sensor.
Auto sensor selects the densest portion of the paddle specific region of the sampled
breast and uses that for the AEC calculations

In addition to using the buttons on the compression device, you can use the AEC position
arrows on the Acquisition Station display to change the AEC position selection.
When viewing an image on the Preview Window, the user can choose to display the AEC
sensor position whether Manual or Automatic Sensor was used for the exposure.

4.5.3. AEC Exposure Settings


The AEC Exposure Setting adjusts the exposure of the image by 15% per individual step.
This increase affects the final mAs and dose. Unlike analog systems, the resultant image
density is independent of the AEC Exposure Setting used. Image density for digital
images will always be the same no matter which exposure setting you select.
Adjustments to the AEC Exposure Setting during a procedure will reset to 0 when the
procedure is closed.
Increasing the AEC Exposure Setting will increase patient dose to
higher levels. Decreasing the AEC exposure may result in increased
image noise or degraded image quality.
Increased Exposure adjustment leads to higher dose to patient.
Keep patient dose as low as practical to obtain good image quality.
.

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 6
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes
4.5.4. AEC Error Messages
The AEC calculation may display error messages under certain circumstances.
When the AEC sensor position is blocked by something metallic, then the error message
“Exposure Time exceeds max” will be displayed in the Generator status. The Manual
AEC sensor position should be used in a position where it will not be blocked by metal.
When the AEC sensor position is over an unattenuated area, then the error message
“Calculated exposure time less than min” will be displayed in the Generator status. The
Manual AEC sensor position should be used that is over breast tissue in this case.

The operator should always be aware of the position of the AEC sensor
when making AEC exposures.

4.6.

4.7. Quality Control

4.7.1. Quality Control Manual


The Quality Control manual has been updated:
• Many of the forms have been reformatted to make it easier to fill out.
• If AEC mode is used for clinical examinations, then Phantom Image, SNR and
CNR tests should now be performed using AEC. Auto-Filter with a compression
thickness of 4.5 cm should be used to determine clinical values of kV and filter.
Auto-Time with the above values of kV and filter should be used to expose the
phantom with and without the dosimeter.
• The line “Aborted AEC Exposure” has been added to the Mammography Repeat-
Reject Analysis report
When AEC is used for clinical examinations, QC technologists MUST obtain a new
baseline value using AEC procedure for Phantom Image and CNR /SNR values which
should be plotted on a new form.

4.7.2. Test Pattern


Test patterns now can ONLY be printed from the Admin > Test Patterns menu.

4.7.3. Preview of ACR Phantoms


The changes to the preview window will affect the appearance of the ACR Phantom due
to PCE processing. The SNR / CNR values calculated using the ROI tool are not
affected by either normal or pan /zoom modes. The ACR Phantom images must be
scored on either the laser camera or diagnostic workstation.
If for some reason the compression thickness cannot be set to 4.5cm with the ACR
phantom, then remove all objects from the breast platform and set the compression
thickness to 4.5cm. Record the filter and kV shown with Auto-Filter and use those values
with Auto-Time to expose the ACR phantom which will be equivalent to using Auto-Filter
at 4.5cm.

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 7
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes
4.8. Collimation of Spot contact views
The default collimation of spot contact views is now 18x24cm allowing radiologist to see
the breast tissue outside of the compressed area.
Current New
Paddle Paddle
3.1.0.x 3.1.1.x
Name ID
Collimation Collimation
NONE 000d 24x29 cm
COMP. PADDLE 18X24 001d 18x24 cm
10cm SPOT MAG PDL. 002d 18x24 cm
10cm PERF. LOCAL PDL. 003d 10x10 cm 18x24cm
10cm RECT. LOCAL PDL. 004d 10x10 cm 18x24cm
10cm SPOT CONTACL PDL. 005d 10x10 cm 18x24cm
15cm MAG PDL. 006d 18x24 cm
15cm PERF. LOCAL PDL. 007d 15x15 cm 18x24cm
15cm RECT. OPEN PDL. 008d 15x15 cm 18x24cm
Allow 24x29
COMP. PADDLE 24X30 009d 24x29 cm
collimation*
15cm CONTACT PDL. 011d 15x15 cm 18x24cm
7.5cm SPOT MAG PDL. 012d 18x24 cm
7.5cm SPOT PDL. 014d 7.0x8.5 cm 18x24cm
SMALL BREAST PDL. 016d 18x24 cm
FRAMLESS SPOT PDL. 017d 7.0x8.5 cm 18x24cm
Ultrasound PDL. 018d 15x15 cm 18x24cm
F.A.S.T. PADDLE 18X24 019d 18x24 cm
Allow 24x29
F.A.S.T. PADDLE 24X30 020d 24x29 cm
collimation*

Also 24x29cm collimation is now not allowed for any paddles other than the 24x29
paddles.

4.9. Connectivity
The following connectivity improvements have been made:
• Improvements have been made in the method for sending images to Mammography
CAD servers.
• Issues with occasional DryView 8900 alarms has been resolved.

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 8
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
Selenia 3.1.1 Release Notes

5.0 Pre-Installation Checklist


o A medical physicist visit must be scheduled for AEC evaluation for all sites that
enable AEC with this upgrade.
o As all images will be deleted as part of this upgrade, all images must be archived
BEFORE the upgrade can be started.
o While the Repeat /Reject analysis data will not be lost, it is a good idea to make
sure that this data is recorded.
o The times for the automatic detector power down, backup detector power down,
and automatic detector power up need to be communicated to the Field Service
Engineer prior to the upgrade.

Automatic Detector Power Down Time ____________

Backup Automatic Detector Power Down Time ____________

Automatic Detector Power Up Time ____________

o This upgrade will take 8 hours to be completed per system. Scheduling of


patients should be adjusted accordingly.
o Make the Field Service Engineer aware of any special changes that have been
made to the Selenia system:

______________________________________________________________

______________________________________________________________

______________________________________________________________

®
MAN-00349 Revision 002 Manufactured by LORAD, A Hologic Company Page 9
36 Apple Ridge Road, Danbury, CT 06810 (203) 207-4500
MAN-00349/Rev. 002
Selenia 3.1.1.10 Release Notes

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