Artwork and Signature File for:

MAN-00327, "SecurViewDX V2-0-1 Release Notes”

Artwork consists of:

• Eight (8) 8 ½ inch x 11 inch pages.

REV AUTHORED BY DATE

A. FAND 06/17/05
REV DRAFTED BY DATE
DANBURY, CT 06810
A. FAND 06/17/05
PROPRIETARY INFORMATION: TITLE DOCUMENT NUMBER REV
The content of this document is the
exclusive property of Lorad and may AW, REL NOTES,
not, without prior written permission SECURVIEWDX V2-0-X
AW-00862 003
of Lorad, be reproduced, copied or
used for any purpose whatsoever. ARTWORK SIZE A SHEET 1 OF 1
ENG-0034-T33, Rev. 001
 SecurViewDX 2-0-X Release Notes

SecurViewDX 2-0-4 Release Notes

1.0 Introduction
This document is provided to give you a quick overview of the new features and
fixes in SecurViewDX 2-0-4 that were not in previous versions. It is not meant to
replace the User Guide.

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 [email protected]
with MAN-00327 Release Note in the Subject

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3.0 Changes in SecurViewDX 2-0-4

The SecurViewDX 2-0-4 software release fixes the following circumstances:
• There were fixes to the Auto-Deletion issues where orphan objects were
left behind by the auto-deletion process.
• There was a fix to the Serial Interface to reporting systems such as
PenRad.
• Multiple fixes have been made to the Auto-Fetch process.
• There was a fix so that sessions can be reassigned from one radiologist to
another without loosing the sort order of the session.

4.0 Changes in SecurViewDX 2-0-3

The SecurViewDX 2-0-3 software release fixes the following
circumstances:
• Films printed using Diagnostic Printing did not use the proper lookup table
so they were printed too dark.
• Under some circumstances, messages about FOR PRESENTATION
images replacing FOR PROCESSING images were incorrectly appearing.

5.0 Features
Multi Workstation functionality
Multiple SecurViewDX workstations can be configured as clients to work together
so that when a radiologist marks a case as read on one workstation the case will
be marked as read on all other workstations. Sessions created on one client
workstation can be read on any other client workstation. The manager
workstation that can be located in the technologist workroom can be used to
keep track of the status of cases, query / retrieve from PACS, and delete patients
from the database.

Multi Vendor
SecurViewDX workstations have FDA clearance to be used by a trained physician
for display, manipulation and interpretation of mammographic images for
screening and diagnostic mammography, as well as any other DICOM multi-
modality image, per our DICOM Conformance Statement.

Multi-Modality
Ultrasound and other basic DICOM studies can be diagnosed using
SecurViewDX. The advanced multimodality option that will be released later this
year will support diagnostic review of more complex studies like MRI and CT.

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Upgradeability
SecurViewDX is the new platform of the Hologic diagnostic review workstation. All
new features and additional functionality will be available only on the
SecurViewDX product line.

Sending Notices to Workstations

Annotations can be configured so that they can be sent as notices to other
SecurViewDX or SecurViewRT workstations. These notices will be identified by
the user that created them.

Intelligent Roaming
The Intelligent Roaming function offers possibilities to step through the full
resolution image by quadrants. It intelligently calculates the number of steps
needed for each image, ensuring that quadrants without breast tissue are
ignored. The Roaming Indicator displays the current position on the image. The
current position is identified by a window over the thumbnail with grey border.
The parts of the image that have been viewed are shown half transparent over
the thumbnail.

More information is available in Section 4.2 “Intelligent Roaming” of the User

Guide. Intelligent Roaming can also be inserted into the workflow defined for
each user. Refer to the User Guide for more information.

Note: some Selenia software versions have been found to have issues properly
filling the information necessary for correct behavior of Intelligent Roaming. The
next release of Selenia software (version 3.1.1) will resolve this issue.

Sending Annotations to PACS

When a study is read, the workstation can be configured to store the study state
(i.e. Read) and the radiologist’s annotations to PACS. The system may be
configured to store the study state and annotation, or just the study state, or
neither into PACS. If the study state is stored into PACS, then when the study is
retrieved as prior on the system, it will display as read and not as a new study. If
the annotations are stored into PACS, they will show up when the study is
retrieved and displayed as a prior on the SecurViewDX or SecurViewRT
workstation. These prior annotations will be identified with the user that created
them. See Chapter 2 section 4 in the User Guide for more information on how to
add users.

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DICOM Print (Screen Capture / Diagnostic Printing)

Two printing modes are provided: Screen Capture and Diagnostic printing. All
printing occurs in the background. Use the printer icon on the Toolbar to
check the status of the background printing.

In Screen Capture mode, the printed images appear on the film as they appear
on the monitor(s), e.g. moved images are moved/shifted on the printout as well.
The additional information required on the image is controlled by checkboxes in
the window. In Screen Capture mode the user has the ability to print CAD
markings, annotation, magnifiers and measurements together with each image.

In the Diagnostic mode, all of the patient’s studies are listed sorted by date and
time. Select the study to be printed from the list. Only Patient Info, Image Info,
and Image Comment are enabled for Diagnostic printouts. All Hologic MG
images in the selected study will be printed out in diagnostic quality. All other
image types in the selected study will not be printed.

Screen Capture vs
Diagnostic

List of studies

Additional
information on the
printed image

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Local Search
The Local Search provides access to all data available on the SecurViewDX
workstation. The operator can enter search criteria and then click on the Select
button. All search results are selected with other patients being deselected. The
Patient List is scrolled so that the first selected patient is visible.

DICOM Auto-Fetching
It is possible to automatically fetch DICOM mammography related data from an
archive when the SecurViewDX system receives a new study. When enabled, the
SecurViewDX automatically Query/Retrieves the PACS for prior images and CAD
structured reports that correspond to the current mammography study. The
default setting for Auto-Fetching is “Off”. This setting can be configured by
service.

When Auto-Fetching is “On”, the system can be configured to retrieve all studies
up to a specified number of years back or a specified number of most recent
studies. Auto-Fetching can also be configured to only take place when the user
is not logged if the prior studies will not be used immediately.

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Log Tab
The Log Tab in the Patient List window contains notifications about auto-fetching
failures, if a notice or CAD report arrives and the corresponding images could not
be fetched from the PACS. This information will remain in this tab for 7 days.

6.0 Changes
Patient List
There are some new columns to support new features:
AF indicates if a patient is selected for Auto Fetching (see Section 5.3.1 in
the User Guide)
P indicates with a “+” sign if a patient is protected against Automatic
Deletion
Notice indicates with a “+” sign if a notice is available for a patient/study that
has been received from another DICOM node

The SecurViewDX system can be configured to sort the patient list (and the list in
the viewer) alphabetically instead of chronologically. (This can be configured by
service).

Sessions
The patients within a session can be arranged in any order now. To rearrange
the cases:
1. Click on the Edit Order button.
If the Edit Order button is not enabled, then reschedule the session for
some time in the future. This behavior will occur if the a.s.a.p. button was
used to create the session.
2. Select the patient to be moved.
3. Use one of the arrow buttons to moved the patient within the list.
4. Click on the Apply Order button to save the changes.
5. To restore the original list, click on the Reload Order button.

For more information, refer to Chapter 2, Section 6.0 in the User Guide.

Report Flow
There is a new hanging configuration available in the Standard View and Report
Flow that has the CCs on the left screen and MLOs on the right screen.

The Report Flow portion of the User Preferences window was changed to add
two new possible steps in the user’s workflow: Intelligent Roaming and
Communication with External Reporting system.

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Additional Features
As soon as the first marking/annotation has been made on a "Not Read" or
"Read Once" case, the lock state of the patient is set to "In Progress". This is a
lock state additionally to Pending, Additional Views Required, and Consultation
Required.

Also, if a case has been marked as “Additional Views Required” (abbreviated

Add. In the state column), when the additional images arrive, the state column
will display that images have arrived (abbreviated “Arr.” in the state column) ).
Also patients that have images which have arrived are marked with a “++” prefix
in the worklist.

iCAD
Display of markings from iCAD is possible.

Individual Users versus Generic Users

It is now possible to view annotations that were made by other users after the
study has been marked as read. So it is no longer necessary to have all
radiologists to use generic user. The generic user will not work in multiple
workstation configurations. See Chapter 2 section 4 in the User Guide for more
information on how to add users.

Hanging Implants with the Advanced Hanging Protocol

Changes have been made to the advanced hanging protocol to improve the
hanging protocol of implant studies.

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7.0 Windows Updates

The following Windows® 2000 operating system updates are included and
installed with this release:
• Microsoft Internet Explorer 6 Service Pack 1 (Windows 2000)
• Cumulative Security Update for Internet Explorer 5.01 Service Pack 4
(KB867282)
• Cumulative Security Update for Internet Explorer 6 Service Pack 1
(KB890923)
• Security Update for Windows 2000 (KB891781)
• Security Update for Windows 2000 (KB885250)
• Security Update for Windows 2000 (KB888113)
• Security Update for Windows 2000 (KB890047)
• Security Update for Windows 2000 (KB873333)
• Security Update for Windows 2000 (KB890175)
• Security Update for Windows 2000 (KB891711)
• Security Update for Windows 2000 (KB873339)
• Security Update for Windows 2000 (KB871250)
• Security Update for Windows 2000 (KB885836)
• Security Update for Windows 2000 (KB885835)
• Microsoft GDI+ Detection Tool (KB873374)
• Security Update for Windows 2000 (KB841356)
• Security Update for Windows 2000 (KB840987)
• Security Update for Windows 2000 (KB841533)
• Security Update for Microsoft Data Access Components (KB832483)
• Security Update for Windows 2000 (KB894320)
• Security Update for Windows 2000 (KB893066)
• Security Update for Windows 2000 (KB893086)
• Security Update for Windows 2000 (KB890859)
• Security Update for Windows 2000 (KB891781)
• Security Update for Windows 2000 (KB885250)
• Update for Background Intelligent Transfer Service (BITS) 2.0 and
WinHTTP 5.1 (KB842773)

Please consult the Microsoft® Support website (support.microsoft.com) for more

details about each of these updates.

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SecurViewDX 2-0-X Release Notes