GE HealthcareSenographe SecondLook Digital CAD System
Revision 1Operator Manual 5189820-5-C-1EN
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GE HealthcareSenographe SecondLook Digital CAD System
Revision 1Operator Manual 5189820-5-C-1EN
Regulatory requirements
Regulatory requirements
This product complies with the regulatory requirements of the following:
•Council Directive 93/42/EEC concerning medical devices: the label affixed to the product
testifies compliance to the Directive.
For a system, the location of the CE marking label is described in the system manual.
iCAD European registered place of business:
Medical Device Safety Service GmbH
Attn: Ludger Moeller
Schiffgraben 41
30175 Hannover
Germany
Phone: +49 511 62628630
Fax: +49 511 62628633
•Underwriters' Laboratories, Inc. (UL), an independent testing laboratory.
•Canadian Standards Association (CSA).
•International Electrotechnical Commission (IEC), international standards organization, when
applicable.
Compliance with these standards is evidenced by the presence of the appropriate labels on the exterior
of the computer unit cabinet.
•USA/HHS:
CAUTION
United States Federal law restricts this device to use by or on the order of a physician.
•The original document was written in English.
Image annotations
Note:
Since the equipment allows the physician to store information on the patient with the function
IMAGE ANNOTATIONS, the European Directive regarding "the protection of the people with
regard of data management on their private life and to the free circulation of these data" requests
the computerized file users (radiologists, physicians) not to store data related to their:
-race,
-philosophical opinions,
-religious opinions,
-political opinions,
-etc.
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Revision 1Operator Manual 5189820-5-C-1EN
Regulatory requirements
Electromagnetic Compatibility (EMC)
This equipment complies with :
•FCC/ICES-003
•CISPR 22
•EN55022, EN55024
•EN61000-3-2, EN610003-3
•VCCI
•AS/NZS 3548
•BSMI CNS13438
•GOST R 29216-91, GOST R 50628-95
•Belarus License
•Ukraine License
•RRL MIC Notice No. 1997-41 (EMC) & 1997-42 (EMI)
•GB 9254, GB 17625 - CNCA Certification
This equipment generates, uses, and can radiate radio frequency energy. The equipment may
cause radio frequency interference to other medical and non-medical devices and radio
communications. To provide reasonable protection against such interference, this product
complies with radiated emissions as per CISPR22 , Class A standard limits.
Detailed requirements and recommendations about power supply distribution and installation are
listed in the Pre-Installation Manual (pim) shipped with your system. However, there is no
guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the
equipment on and off), the user (or qualified service personnel) should attempt to correct the
problem by one or more of the following measure(s):
-reorient or relocate the affected device(s)
-increase the separation between the equipment and the affected device
-power the equipment from a source different from that of the affected device
-consult the point of purchase or service representative for further suggestions
The manufacturer is not responsible for any interference caused by using other than
recommended interconnect cables or by unauthorized changes or modifications to this
equipment. Unauthorized changes or modifications could void the users' authority to operate the
equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded. Use of
cables not properly shielded and grounded may result in the equipment causing radio frequency
interference.
Do not use devices which intentionally transmit RF Signals (Cellular Phones, Transceivers, or
Radio Controlled Products) in the vicinity of this equipment as it may cause performance outside
the published specifications. Recommended separation distances are detailed in the PreInstallation Manual (pim) shipped with your system. Keep the power to this type of devices turned
off when near this equipment.
The medical staff in charge of this equipment is required to instruct technicians, patients, and
other people who may be around this equipment to comply fully with the above requirement.
Further data and recommendations for meeting Electromagnetic Compatibility requirements for a
typical installation are given in the Pre-Installation Manual (pim) shipped with your system. Note
that the magnetic field of an MRI device located nearby may cause a risk of interference.
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Regulatory requirements
Magnetic field amplitude limits are specified in the Pre-Installation Manual (pim) shipped with your
system.
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Regulatory requirements
Recycling
-Machines or accessories at end-of-life:
The elimination of machines and accessories must be in accordance with national regulations
for waste processing.
All materials and components that could pose a risk to the environment must be removed from
the end-of-life machines and accessories (examples: dry and wet cell batteries, transformer
oil, etc.).
Please consult your local General Electric Medical Systems representative before discarding
these products.
-Packing materials:
The materials used to pack our equipment are recyclable. They must be collected and
processed in accordance with the regulations in force for the country where the machines or
accessories are unpacked.
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GE HealthcareSenographe SecondLook Digital CAD System
GE HealthcareSenographe SecondLook Digital CAD System
Revision 1Operator Manual 5189820-5-C-1EN
1Foreword
1-1The Aim of This Manual
This manual is provided for operators using Senographe Acquisition Full Field Digital Mammography
(FFDM) systems equipped with the SecondLook Digital (SLD) Computer-Aided Detection (CAD) system
option.
It describes the flow of images and explains how to use the CAD options on the Acquisition Workstation
(AWS) and GE Healthcare the review workstations (RWS or Seno Advantage). It also provides
guidelines for the use of CAD in different situations, and information on problem solving.
This manual provides training information for radiologists, including descriptions of the SLD CAD
algorithms.
This manual does not contain information on CAD installation or configuration. Please refer to the
appropriate service manuals for information on these subjects.
This manual assumes that the reader is familiar with the Senographe Acquisition Workstation and the
GE Healthcare review workstations to be used.
•Senographe review workstation Seno Advantage Operator Manual, 5182593-4-S-1EN
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1-3Glossary
Terms used in this document:
TermDefinition
AWSAcquisition workstation
RWSSenographe RWS review workstation
Seno AdvantageSeno Advantage review workstation
CADComputer-Aided Detection
SLDSecondLook Digital
SLDUSecondLook Digital Unit
CAD systemA product composed of the SLDU and optional features on the AWS and the review
workstation
RAW FOR
PROCESSING
PROCESSED FOR
PRESENTATION
SCPTSecondary Capture Image
ROIRegion(s) of Interest; questionable area of image (containing possible abnormalities
RTSSRadioTherapy Structure Set (DICOM object type)
CAD-analyzed imageAn image that has been successfully processed by the SLDU
CAD overlayResults produced by the SLDU and delivered to the review workstation. An overlay
CAD MarkerA symbol (ellipse or rectangle) used in a CAD overlay to identify a region of interest.
CAD LabelInformation on a CAD overlay indicating the image status
CAD IdentifierThe part of a CAD label which indicates the CAD software version
Raw (original image produced by Image Detection Controller (IDC)
Processed (image processed by AWS computer)
which may require investigation)
consists of a
CAD label
(always) and
CAD markers
(as required).
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2CAD in mammography
2-1What CAD can do
Detecting and diagnosing breast cancer is a complex clinical problem. The combination of viewing a
large number of cases (99.5% of which are expected to be non-cancerous in a screening population),
radiologist fatigue (and the resulting observational oversights), the complex image structure of the breast
on a mammogram, and the subtle nature of certain observational characteristics of the disease, may
result in false negative mammographic readings.
The SecondLook Digital Computer-Aided Detection system developed for use with GE’s Full Field Digital
Mammography system is designed to minimize observational oversights made by the radiologist.
Intended to be an aid for a radiologist reading routine screening and diagnostic mammograms,
SecondLook Digital identifies areas, or "regions of interest" (ROIs), on the digital image which show
features that may be associated with cancer, and may warrant a second review. These ROIs are brought
to the attention of the radiologist after he or she has completed normal interpretation of the digital
mammogram.
2-2What CAD cannot do
It is important to note that CAD is not meant to be used for primary diagnosis. CAD is not meant to
replace the expertise of the radiologist. It is meant to be used as an
interpretive
mammogram images provided directly by the GE Senographe may be used for interpretation by the
radiologist. By design, the Senographe Review Workstations only allows the display of ROI markers
after the images are presented, free of markers, to the radiologist for his/her primary diagnostic
interpretation.
CAD is a highly sophisticated system, but it cannot identify all abnormalities. You should base your
interpretation upon the original mammogram images and use CAD only as an aid to detection.
Individual practice patterns may influence the results obtained when using this system. Therefore, each
facility and radiologist should carefully monitor the results that this device has on their practice of
mammography in order to optimize its effectiveness.
aid. CAD should be used only after the initial reading by the radiologist. Only the
aid to
detection
, and not as an
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3CAD Principles
The CAD system includes three sub-systems: the SecondLook Digital Unit (SLDU), the Review
Workstation (RWS or Seno Advantage ), and the Acquisition Workstation (AWS).
CAD processing functions are provided by the SLDU, a dedicated computer which runs the CAD
processing algorithms and generates the CAD results as an overlay. The review workstation displays the
overlay with the associated image.
The CAD image workflow, illustrated below, includes three main steps:
1.
RAW images are pushed to the SecondLook Digital Unit (SLDU
workstation, or from an image storage system if present. Each image must have been produced by a
licensed workstation, declared in the CAD configuration. Images may be pushed individually or in
groups. Corresponding images (RAW or PROCESSED) from the AWS must also be pushed to the
review workstation before results can be viewed.
2.
The SLDU performs its analysis on each image
workstation in the form of a CAD overlay.
CAD processing of an image is not instantaneous. The SLDU takes an average of 30 seconds
(maximum 120 seconds) to process a 19 x 23 cm RAW image and generate a CAD overlay, or 2
minutes for a group of four images. Additional time may be required if there are multiple processing
requests.
3.
The
CAD
overlay is displayed with the associated images
and delivers the results of the analysis to the review
) from the AWS or the review
in the form of markers and labels.
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CAD Image workflow
Step 1. The raw image is pushed to the SLDU for analysis.
The image (raw and/or processed) must also be pushed to the review workstation before CAD results can be
viewed.
The user first views the processed image on the review workstation without CAD markers.
Original (raw) image created by a
licensed AWS
Raw or processed
image
Image from storage or
archiving device (PACS,
RADSTORE, etc.)
AWS
Raw and/or processed images
Step 2. When the SLDU has performed its analysis on each image, it
sends an overlay to the review workstation, showing the location and
type of any regions of interest that were found.
Step 3. While viewing the image, the user presses the CAD button or
the U2 button on the dedicated keypad (if configured) to display the
CAD overlay.
SLDU
review monitors
Raw or processed
image
CAD overlay
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AWS
SLDU
CAD overlay
Raw and/or processed images
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Image displayed
with overlay
review monitors
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4Using CAD
4-1How do I know if CAD is available on this system?
4-2
When the CAD option is installed and operational, CAD icons are displayed in the Network
Panels of the AWS and review workstation Browser screens.RWSViewerAdvanced Card
CAD
On Demand/CAD Auto Push
CAD on demand (manual triggering of CAD analysis) is always available. CAD analysis of an image may
be requested whenever CAD evaluation is required, on a case-by-case basis . If you wish to use CAD
only from time to time for help in detecting abnormalities in individual questionable images, use CAD On
Demand.
CAD Auto Push may be configured at installation time, by the GE installation Engineer.
When CAD Auto Push is configured, CAD processing is applied automatically to all images as soon as
they are acquired by the AWS and pushed to the SLDU, so that the CAD information is systematically
available when reviewing the results on the review workstation. The CAD overlay, however, is not
displayed until after the original mammogram images generated by the Senographe (without CAD
markers) have been presented for interpretation by the radiologist.
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4-3Which images can be CAD-analyzed?
All images to be analyzed by the SLDU must have been generated on a licensed Senographe system.
The SLDU algorithm will analyze any raw (RAW) full breast mammographic image.
The following images cannot be analyzed:
•Processed (PROCESSED) and secondary capture (SCPT) images.
System performance is not assured for the following views:
•Segmented views of the breast.
•Implant views with the full implant imaged. Implant Displaced views with a maximum of 25 mm (1") of
breast implant imaged can be analyzed.
•Special diagnostic images (e.g., magnification views, or spot compression views).
•Cleavage views.
•Images with hook wires.
•Collimated images.
•Coned images.
4-4Which image formats can be displayed with CAD markers?
The following image formats can be displayed with CAD markers:
•RAW images
•Processed images
•Premium View images, for users who have the Premium View Option on the review workstation.
4-5Selecting images for CAD analysis
•You can choose to use CAD to process an individual image, a set of images, a series, or an entire
patient case.
•Only
•To obtain the best analysis of available information, send entire patient cases (rather than individual
•To minimize the elapsed time before CAD overlays are available, send only raw images.
raw
images can be CAD-processed. If you send an entire patient case to the SLDU, the raw
images are CAD-processed; other images present (processed or secondary-capture images) are
ignored, but increase the time required to obtain the overlays.
images) to be CAD-processed. The SLDU takes advantage of all available information during
analysis. If different views of the same breast are present, the SLDU uses all screening views in its
analysis, just as a clinician would.
However, note that this increases the time required to obtain the overlays; processing a 4-view exam
takes two minutes, as opposed to 30 seconds for a single view.
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4-6How are CAD overlays Displayed?
•Each image being viewed is displayed with its associated CAD overlay, if one exists. A
the bottom of each image gives its status. Refer to the following sections for more information:
CAD labelRefer to
CAD label
at
2 markers - iCAD SecondLook V7.2
This indicates that the image has been successfully analyzed.
CAD: Result not availableSection
CAD: This image can not be processed: Section
Section
4-6-1
4-6-2
4-6-3
4-6-1Image successfully analyzed
•If the image has been successfully analyzed, the CAD label is in the form
SecondLook V7.2.
It indicates the number of CAD markers present as well as the CAD software
2 markers - iCAD
version in use.
•When the SLDU identifies ROIs (regions of interest) on an image, the overlay includes a marker
to indicate each ROI:
SecondLook Digital CAD markers
The system uses two different markers to identify
ROIs for the radiologist's review:
•A rectangle surrounding a cluster of bright
spots, corresponding to a cluster of possible
microcalcifications.
•An ellipse surrounding a density with or
without radiating lines, corresponding to a
possible mass or architectural distortion.
CAD label with software identifier
2 markers - iCAD SecondLook V7.2:
•CAD markers are linked to specific points on the image and cannot be moved. Changing the
image orientation, zooming, drawing objects, adding text, etc. does not change the display of the
markers relative to the image; they move with the image as it is rotated.
Note:
CAD markers are automatically sized according to the size of the ROI.
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4-6-2CAD: Result not available
The CAD label is: CAD: Result not available
Possible causeWhat to do
1.The image has not been submitted for analysis.Check for CAD overlays in the Browser lists;
push the image to the SLDU.
2.The CAD overlay is not yet available on the review
workstation because analysis has not been completed
(it takes an average of 30 seconds to process an image;
2 minutes for a 4-view exam).
3.The image was submitted for analysis but a transfer or
network failure occurred.
4.The CAD overlay has been removed from the review
workstation.
5.The CAD licence is not valid for the workstation which
created the image (this problem should be indicated by
a "
Network problem ....
the image(s) to the SLDU).
" message when trying to push
Wait for process completion.
Check for CAD overlays in the Browser lists;
push the image to the SLDU again.
Check for CAD overlays in the Browser lists;
push the image to the SLDU again.
Consult your GEMS Field Engineer
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4-6-3CAD: This image can not be processed
The CAD label is: CAD: This image can not be processed
Possible causeWhat to do
1.The image is not a type suitable for CAD processing Use a suitable type of image (see section
2.The CAD algorithm was unable to create an overlay
within the pre-determined time (normally 30 seconds).
Use another image of the same patient
4-3
).
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