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GE Healthcare

Senographe SecondLook Digital CAD System

Revision 1

Operator Manual 5189820-5-C-1EN

Regulatory requirements

Regulatory.fm

Page no. 5

Magnetic field amplitude limits are specified in the Pre-Installation Manual (pim) shipped with your

system.

Содержание Senographe SecondLook

Страница 1: ...Senographe SecondLook Digital CAD System Operator Manual 5189820 5 C 1EN Revision 1 Copyright 2009 by General Electric Company Inc Manufactured by iCAD All Rights Reserved SLDU CAD overlay Raw and or processed images ...

Страница 2: ...Page no 2 Cover fm GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN This page is intentionally left blank ...

Страница 3: ...g 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 doc...

Страница 4: ...ween 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 o...

Страница 5: ...SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN Regulatory requirements Regulatory fm Page no 5 Magnetic field amplitude limits are specified in the Pre Installation Manual pim shipped with your system ...

Страница 6: ...l 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 proce...

Страница 7: ...n image has been CAD analyzed 17 4 8 How do I Show Hide CAD overlays 18 4 9 How are CAD overlays Displayed 19 4 9 1 Image successfully analyzed 19 4 9 2 CAD Result not available 20 4 9 3 CAD This image can not be processed 21 4 10 Printing CAD results 22 4 11 Transferring the CAD overlay 22 4 12 Storing the CAD overlay 22 4 13 Access to historic CAD information 22 5 Specifications 23 5 1 Technical...

Страница 8: ...o Viewing CAD Marks 43 6 4 2 Radiologist Review with CAD Marks 43 6 5 Radiologist Training with Sample Cases 45 6 5 1 Training Instructions 45 6 5 2 Sample Cases 46 6 6 Summary of Radiologist Use of Second Look Digital 58 7 Actions to be taken in case of loss of power 61 7 1 Introduction 61 7 2 Loss of Mains power On battery alarm 61 7 3 Low battery alarm 61 7 4 UPS warnings and front panel 61 8 M...

Страница 9: ... 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 Healthcar...

Страница 10: ...ller IDC PROCESSED FOR PRESENTATION Processed image processed by AWS computer SCPT Secondary Capture Image ROI Region s of Interest questionable area of image containing possible abnormalities which may require investigation RTSS RadioTherapy Structure Set DICOM object type CAD analyzed image An image that has been successfully processed by the SLDU CAD overlay Results produced by the SLDU and del...

Страница 11: ... 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 2 What 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 aid to detection and not as an interpretive...

Страница 12: ... or the review 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 and delivers th...

Страница 13: ...iew workstation without CAD markers Original raw image created by a licensed AWS AWS Raw or processed image review monitors Raw or processed image CAD overlay Image displayed with overlay review monitors 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 vi...

Страница 14: ...uation 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 ...

Страница 15: ...ith CAD markers RAW images Processed images Premium View images for users who have the Premium View Option on the review workstation 4 5 Selecting 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 raw images can be CAD processed If you send an entire patient case to the SLDU the raw images are CAD processed othe...

Страница 16: ...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 CAD label Refer to 2 markers iCAD SecondLook V7 2 This indicates that the image has been successfully analyz...

Страница 17: ... to process an image 2 minutes for a 4 view exam Wait for process completion 3 The image was submitted for analysis but a transfer or network failure occurred Check for CAD overlays in the Browser lists push the image to the SLDU again 4 The CAD overlay has been removed from the review workstation Check for CAD overlays in the Browser lists push the image to the SLDU again 5 The CAD licence is not...

Страница 18: ...can not be processed Possible cause What to do 1 The image is not a type suitable for CAD processing Use a suitable type of image see section 4 3 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 The CAD label is CAD This image can not be processed ...

Страница 19: ...ons If the corresponding images are also present on the workstation the CAD results can be displayed 4 9 Storing the CAD overlay The CAD overlay itself can be saved as an image of type RTSS Displayed images RAW processed and Premium View with CAD overlays can be stored as SCPT images 4 10 Access to historic CAD information If you may require access to CAD information at a later date after current ...

Страница 20: ...y according to the type of processor Main unit SLDU h 458 mm 18 in w 235 mm 9 25 in d 483 mm 19 in weight 20 4 kg 45 lbs without peripherals Environmental Temperature Operating temperature range 5 to 40 C non operating temperature range 40 to 70 C Environmental Humidity Non operating humidity 35 C at 95 RH non condensing over full temperature range Environmental Altitude Max operating altitude 150...

Страница 21: ... electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment This symbol indicates that the product contains hazardous materials in excess of the limits established by the Chinese standard SJ T11363 2006 Requirements for Conc...

Страница 22: ... fm GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN 5 2 2 SLDU labels WARNING Connect only to a properly earth grounded outlet PRODUCT CODE SERIAL NO TOP ASSEMBLY NO ...

Страница 23: ...itial reading has been completed Thus the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review The SecondLook system was first developed for use with screen film mammography SFM For SecondLook to process full field digital mammography FFDM from the General Electric Medical Systems GEMS Senographe a new...

Страница 24: ...the SecondLook Digital computer system include image processing feature computations and pattern recognition technology to detect mammographic features indicative of malignancies Areas of concern marked include suspicious clusters of microcalcifications spiculated and non spiculated masses architectural distortions and focal asymmetric densities SecondLook Digital does not distinguish between beni...

Страница 25: ...ection and not in interpretation Therefore SecondLook Digital can assist a radiologist in detecting areas of concern that would have been missed without its use but used properly it cannot cause a radiologist to miss areas of concern that would have been detected without SecondLook Digital SecondLook Digital was developed by leaders in the fields of image processing and artificial intelligence Bel...

Страница 26: ...rintout of the CAD marks is another possible option SecondLook is intended to be used by a radiologist as follows The radiologist must first review the mammogram in the normal manner and only afterward consult the CAD marks to determine if SecondLook has marked any areas of concern that were not observed on the initial review SecondLook is designed to mark areas with the mammographic appearance of...

Страница 27: ...e The radiologist must still use diagnostic skills to differentiate benign from malignant lesions by working up the area which may include magnification compression mammography ultrasound or interventional procedures WARNING Therefore the radiologist s work up decision should not be altered if the system fails to mark an area that the radiologist has detected on the initial image review and has al...

Страница 28: ...splaced views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient Effectiveness and safety have not been established for non standard mammographic views e g magnification compression views When these views are analyzed by the system any resulting CAD marks should not be used by the radiologist in evaluating the patient 6 3 5 2 Precauti...

Страница 29: ...6 3 7 Clinical Studies Four comprehensive studies ROSE 1 ROSE S1 ROSE DS and ROSE 2 were conducted to evaluate the use of the Second Look system by radiologists for breast cancer detection ROSE 1 ROSE S1 and ROSE 2 evaluated the Second Look Analog system while ROSE DS assessed SecondLook Digital Second Look Analog is indicated for use with screen film mammography while SecondLook Digital uses GEMS...

Страница 30: ...to reach a consensus over initial disagreements They worked unblinded with the help of the subsequent mammogram that led to the diagnosis of cancer Of these 174 previously missed cancers approximately 66 were represented primarily by masses and 34 by microcalcifications The masses included spiculated and non spiculated masses architectural distortions and asymmetric densities The digitized images ...

Страница 31: ...cer cases showed that 23 0 95 CI 19 0 27 3 of women diagnosed with breast cancer who had prior screening mammograms within 9 24 months of diagnosis could have had their cancers discovered earlier by an average of 15 1 months with the use of SecondLook Screen Detected Study The Screen Detected Study examined the sensitivity of SecondLook in detecting diagnosed cancers on screening mammograms Sevent...

Страница 32: ...ard The 95 confidence intervals for these work up rates were 15 5 17 8 before SecondLook use and 16 0 18 4 with it This demonstrated that the 0 5 20 of 3 946 increase in work up rate due to the use of SecondLook was insignificant In 3 631 of 3 946 prospective cases 92 the estimated additional reading time to use SecondLook was 20 or less In addition historical work up rates for the same radiologis...

Страница 33: ...logist s effectiveness in detecting breast cancer with SecondLook Digital with input from a the GEMS Senographe full field digital mammography system will at least be statistically no different than the enhancement demonstrated with Second Look Analog Conclusions drawn from the studies The use of the Second Look Analog system led to a clinically significant reduction in missed cancers of at least ...

Страница 34: ... potential areas of concern are displayed for the radiologist by overlying CAD marks at the appropriate locations of the GEMS Senographe full field digital mammography images within the softcopy review workstation or on a paper printout The CAD marks are used by the radiologist as an additional tool in breast cancer detection An overview of the SecondLook CAD algorithms is shown in Illustration 1 ...

Страница 35: ...ividual microcalcifications and densities based on an initial analysis of morphological and intensity measurements The types of densities detected are depicted in Illustration 2 and include spiculated and non spiculated masses architectural distortions and focal asymmetric densities Illustration 2 Densities Detected by SecondLook Note Focal asymmetric densities are difficult to depict pictorially ...

Страница 36: ...etermine Shape of Density After clustering for microcalcifications analysis and region growing for density analysis clinically relevant and mathematical features are then computed to describe each detected cluster of microcalcifications and density For example the variability in size and shape of the calcifications in a cluster are good features to describe clusters of microcalcifications These fe...

Страница 37: ...GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN CAD fm Page no 37 Illustration 4 Region Growing to Determine Shape of Density 6 3 9 ...

Страница 38: ...Page no 38 CAD fm GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN This page is intentionally left blank ...

Страница 39: ... work up decisions are based upon review of the mammograms supporting clinical information and CAD marks by the radiologist Areas of concern marked by SecondLook Digital include suspicious clusters of microcalcifications spiculated and non spiculated masses architectural distortions and focal asymmetric densities The usefulness of CAD marks for the radiologist is due to the synergy between radiolo...

Страница 40: ...itial interpretation 3 Turn on and view CAD marks with softcopy review workstation and identify potential areas of concern 4 Review mammograms re evaluating areas of concern highlighted by CAD marks with softcopy review workstation 5 Render decision It is very important to remember that it is the radiologist who makes the final decision about a case When a radiologist decides to work up a case the...

Страница 41: ... use the radiologist would first review the mammograms without viewing the CAD marks following her or his existing procedures of clinical practice The radiologist would make an initial determination if a work up were indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation 2 The second page contains printed versions of the mammograms with CAD mar...

Страница 42: ... 5 2 Sample Cases 6 5 2 1 Case 1 Case History and Mammograms Case 1 History 62 yo female for annual screening No palpable abnormalities Family history of postmenopausal breast cancer in mother and maternal grandmother DURING CLINICAL USE THE INITIAL MAMMOGRAPHY REVIEW AND INITIAL WORK UP DECISION WOULD BE ACCOMPLISHED ...

Страница 43: ... Note The softcopy review workstation may use symbols other than rectangles calcifications and ellipses masses for the CAD marks DURING CLINICAL USE THE AREAS OF CONCERN HIGHLIGHTED BY THE CAD MARKS WOULD BE RE EVALUATED USING THE SOFTCOPY REVIEW WORKSTATION FROM THIS RE EVALUATION OF THE MAMMOGRAMS THE RADIOLOGIST MAKES THE FINAL WORK UP DECISION ...

Страница 44: ...Page no 44 CAD fm GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN Summary for Case 1 is on next page ...

Страница 45: ...able abnormalities Family history of postmenopausal breast cancer in mother and maternal grandmother Mammographic Findings 1 3 cm irregular mass in the right axillary tail This is a new finding from a mammogram two years prior Pathology Invasive ductal carcinoma moderately differentiated arrows show location Sixteen negative axillary lymph nodes upon mastectomy and axillary dissection ...

Страница 46: ...Operator Manual 5189820 5 C 1EN 6 5 2 2 Case 2 Case History and Mammograms Case 2 History 43 yo female for annual screening No palpable abnormalities No family history of breast cancer DURING CLINICAL USE THE INITIAL MAMMOGRAPHY REVIEW AND INITIAL WORK UP DECISION WOULD BE ACCOMPLISHED ...

Страница 47: ... Note The softcopy review workstation may use symbols other than rectangles calcifications and ellipses masses for the CAD marks DURING CLINICAL USE THE AREAS OF CONCERN HIGHLIGHTED BY THE CAD MARKS WOULD BE RE EVALUATED USING THE SOFTCOPY REVIEW WORKSTATION FROM THIS RE EVALUATION OF THE MAMMOGRAMS THE RADIOLOGIST MAKES THE FINAL WORK UP DECISION ...

Страница 48: ...Page no 48 CAD fm GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN Summary for Case 2 is on next page ...

Страница 49: ... screening No palpable abnormalities No family history of breast cancer Mammographic Findings 7 mm spiculated mass in the right breast at 1 o clock posteriorly This a new finding from a mammogram one year prior Pathology Invasive ductal carcinoma poorly differentiated arrows show location Thirteen negative axillary lymph nodes upon mastectomy and axillary dissection ...

Страница 50: ...or Manual 5189820 5 C 1EN 6 5 2 3 Case 3 Case History and Mammograms Case 3 History 62 yo female with palpable mass in upper outer quadrant of right breast No family history of breast cancer DURING CLINICAL USE THE INITIAL MAMMOGRAPHY REVIEW AND INITIAL WORK UP DECISION WOULD BE ACCOMPLISHED ...

Страница 51: ... Note The softcopy review workstation may use symbols other than rectangles calcifications and ellipses masses for the CAD marks DURING CLINICAL USE THE AREAS OF CONCERN HIGHLIGHTED BY THE CAD MARKS WOULD BE RE EVALUATED USING THE SOFTCOPY REVIEW WORKSTATION FROM THIS RE EVALUATION OF THE MAMMOGRAMS THE RADIOLOGIST MAKES THE FINAL WORK UP DECISION ...

Страница 52: ...Page no 52 CAD fm GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN Summary for Case 3 is on next page ...

Страница 53: ...ass in upper outer quadrant of right breast No family history of breast cancer Mammographic findings 3 cm circumscribed mass with partially obscured borders in the right breast at 10 o clock shown to be a cyst on ultrasound Linear distribution of pleomorphic calcifications in the right breast at 2 o clock posteriorly Pathology Ductal carcinoma in situ arrows show location ...

Страница 54: ... prior to turning on and viewing the CAD marks with the softcopy review workstation 2 The radiologist turns on and views the CAD marks with the softcopy review workstation after determining whether or not a work up is indicated from her or his initial review of the patient mammograms 3 The radiologist will take a second look at the mammograms corresponding to any CAD marks From this re evaluation ...

Страница 55: ...ce TW Yankaskas BC Analysis of cancers missed at screening mammography Radiology 1992 184 613 617 10 Fletcher SW Black W Harris R et al Special article Report of the International Workshop on Screening for Breast Cancer J Natl Cancer Inst 1993 85 1644 1656 11 Goergen SK Evans J Cohen GP et al Characteristics of breast carcinomas missed by screening radiologists Radiology 1997 204 131 135 12 Robert...

Страница 56: ...ard C et al Interval carcinomas in the Malmo mammographic screening trial Radiographic appearance and prognostic considerations AJR Am J Roentgenol 1992 159 287 294 28 Baines CJ McFarlane DV Miller AB The role of the reference radiologist Estimates of inter observer agreement and potential delay in cancer detection in the National Breast Screening Study Invest Radiol 1990 25 971 976 29 Harvey JA F...

Страница 57: ...enance 7 1 Planned maintenance performed by the Field Service Engineer Planned Maintenance PM procedures should be performed regularly by your service representative or similarly qualified and trained personnel The procedures and their frequency are listed below Task Title Interval months Clean and check the CAD computer 12 ...

Страница 58: ...Page no 58 CAD fm GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820 5 C 1EN This page is intentionally left blank ...

Страница 59: ...d table explaining the RoHS symbols Added section showing SLDU labels Removed non official formats added new Caption formats in illustrations New UPS label DANGER and CAUTION removed 5189820 4 C 1EN rev 1 February 12 2009 Litchi2k project First translation to 9 languages BG CS ET HR LT LV RO SK SR Arial Unicode font conversion Deleting the unappropriated 0459 CE number because iCAD is Class I mate...

Страница 60: ...Manufactured by iCAD 98 Spit Brook Rd Suite 100 Nashua NH 03062 U S A Imagination at work ...

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