GE Senographe SecondLook Operator's Manual
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GE Senographe SecondLook Operator's Manual

GE Senographe SecondLook Operator's Manual

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

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Summary of Contents for GE Senographe SecondLook

  • Page 1 GE Healthcare Senographe SecondLook Digital CAD System Operator Manual SLDU CAD overlay Raw and/or processed images 5189820-5-C-1EN Revision 1 © Copyright 2009 by General Electric Company Inc. Manufactured by iCAD All Rights Reserved.
  • Page 2 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN This page is intentionally left blank. Page no. 2 Cover.fm...

  • Page 3: Regulatory Requirements

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator 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.
  • Page 4 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator 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 •...
  • Page 5 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Regulatory requirements Magnetic field amplitude limits are specified in the Pre-Installation Manual (pim) shipped with your system. Page no. 5 Regulatory.fm...
  • Page 6 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 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.).

  • Page 7: Table Of Contents

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Table of Contents Table of Contents Regulatory requirements ...........

  • Page 8: Table Of Contents

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Table of Contents 6-3-6. Adverse Effects ..........

  • Page 9: Foreword

    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.

  • Page 10: Glossary

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Glossary Terms used in this document: Term Definition Acquisition workstation Senographe RWS review workstation Seno Advantage Seno Advantage review workstation Computer-Aided Detection SecondLook Digital SLDU SecondLook Digital Unit...

  • Page 11: Cad In Mammography

    CAD should be used only after the initial reading by the radiologist. Only the 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.

  • Page 12: Cad Principles

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN CAD 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.
  • Page 13 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 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.

  • Page 14: Using Cad

    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.

  • Page 15: Which Images Can Be Cad-Analyzed

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Which 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.

  • Page 16: How Are Cad Overlays Displayed

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN How are CAD overlays Displayed? CAD label • 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:...

  • Page 17: Cad: Result Not Available

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 4-6-2 CAD: Result not available The CAD label is: CAD: Result not available Possible cause What to do The image has not been submitted for analysis. Check for CAD overlays in the Browser lists;...

  • Page 18: Cad: This Image Can Not Be Processed

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 4-6-3 CAD: This image can not be processed The CAD label is: CAD: This image can not be processed Possible cause What to do The image is not a type suitable for CAD processing...

  • Page 19: Printing Cad Results

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Printing CAD results • Make the CAD overlay visible and print the image using the Print screen option on the review workstation. Any CAD markers and labels present are printed.

  • Page 20: Specifications

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Specifications Technical Specifications Power Requirements ≤ 550 watts, 90/264 VAC, 50/60 Hz Dimensions and weights Main unit (SLDU): (approximate - may vary h 458 mm (18 in.), w 235 mm (9.25 in.), d 483 mm (19 in) according to the type of weight: 20.4 kg (45 lbs) without peripherals...

  • Page 21: Equipment Labels And Symbols

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Equipment Labels and Symbols 5-2-1 Symbols Protective ground (earth) Ground (earth) Dangerous voltage Type B equipment This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately.

  • Page 22: Sldu Labels

    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: TOP ASSEMBLY NO.:: SERIAL NO.: Page no. 22 CAD.fm...

  • Page 23: Radiologist Training And Sld Cad Algorithm Descriptions

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Radiologist Training and SLD CAD Algorithm Descriptions Overview This section is intended to describe the SecondLook Digital Computer-Aided Detection algorithms and provide training to radiologists using the SecondLook Digital system in breast cancer detection.

  • Page 24: Description Of Secondlook Digital

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN The sensitivity of mammography ranges from 70% to 90%. . Thus, for a woman with breast cancer, there is about a 70% to 90% probability that her cancer will be detected by screening mammography and a 10% to 30% probability it will not.
  • Page 25 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN SecondLook Digital 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 Digital has marked any areas of concern that were not observed on the initial review.

  • Page 26: Secondlook Digital Device Labeling

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN SecondLook Digital Device Labeling 6-3-1 Brief Device Description SecondLook is a mammographic Computer-Aided Detection (CAD) system that identifies and highlights potential areas of concern to assist radiologists in breast cancer detection. The CAD algorithms used in the SecondLook computer system include image processing, feature computations, and pattern recognition technology to detect mammographic features indicative of malignancies.

  • Page 27: Warnings

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 6-3-4 Warnings 6-3-4-1 Warnings: Radiological Interpretation • The SecondLook system assists in breast cancer detection, not interpretation or diagnosis. • Upon re-evaluation of the GEMS Senographe full-field digital mammography images at the locations of the CAD marks, the radiologist uses interpretive skills to determine if the area should be worked- up based on its mammographic appearance.

  • Page 28: Precautions

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN WARNING 6-3-5 Precautions 6-3-5-1 Precautions: System Operation • To prevent damage to the system, maintain equipment in a well-ventilated, air-conditioned environment. • Only images from a GEMS Senographe full-field digital mammography system that is maintained in accordance with MQSA standards should be used.

  • Page 29: Adverse Effects

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 6-3-6 Adverse Effects The use of SecondLook adds no known additional risks to mammography. There is no direct contact with the patient. 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.
  • Page 30 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN ROSE-1 and ROSE-S1 The first pivotal study, ROSE-1, was a multi-institutional trial to assess Second Look Analog as an aid for radiologists in detecting breast cancer with screen-film mammography. A first supplemental study, ROSE-S1, used digitized images obtained during the ROSE-1 study to evaluate updated software in Second Look Analog.
  • Page 31 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Retrospective review of the 310 cases by the truthing radiologists showed that 239 had retrospectively visible lesions in the location of the subsequent cancer and 71 did not. These 239 cases included 174 cancers that at least one of the three panel radiologists deemed actionable plus 65 which none on the panel deemed actionable.
  • Page 32 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN ROSE-2 The second pivotal study, ROSE-2, was a multi-institutional prospective trial designed to show that the use of the original Second Look Analog system did not appreciably increase the number of suspicious regions recommended for further work-up by radiologists reading screening mammograms.
  • Page 33 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN ROSE-DS The second supplemental study, ROSE-DS, was conducted to assess the performance of SecondLook Digital. An original PMA and a PMA supplement for the Second Look Analog system were previously approved by the FDA’s Office of Device Evaluation for use with screen-film mammography.

  • Page 34: Principles Of Operation

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 6-3-8 Principles of Operation SecondLook uses Computer-Aided Detection (CAD) algorithms to identify suspicious lesions in mammograms. The GEMS Senographe full-field digital mammography system creates digital mammographic images that are input to SecondLook, and these CAD algorithms use advanced image processing, feature computations, and pattern recognition technology to analyze the images for potential areas of concern.
  • Page 35 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN The CAD algorithms begin with image enhancement of the digitized mammographic images to accentuate all areas that could be individual microcalcifications and densities. The microcalcification and density detectors then identify the areas that are most likely to be individual microcalcifications and densities, based on an initial analysis of morphological and intensity measurements.
  • Page 36 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Further analysis of detected areas is accomplished by clustering individual microcalcifications and region growing densities. Clusters include 3 or more individual microcalcifications that are each no more than Illustration 3 4.1 millimeters apart.
  • Page 37 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Illustration 4 Region Growing to Determine Shape of Density 6-3-9 • Page no. 37 CAD.fm...
  • Page 38 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN This page is intentionally left blank. Page no. 38 CAD.fm...

  • Page 39: Radiologist Use Of Secondlook Digital

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Radiologist Use of SecondLook Digital 6-4-1 Radiologist Review Prior to Viewing CAD Marks The radiologist first reviews the GEMS Senographe full-field digital mammograms without viewing the SecondLook Digital CAD marks, following her or his existing procedures of clinical practice. The radiologist will make an initial determination if a work-up is indicated for the patient prior to turning on and viewing the CAD marks with the softcopy review workstation.
  • Page 40 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Below is the recommended case review process with SecondLook Digital 1. Review patient history and evaluate GEMS Senographe full-field digital mammograms prior to turning on and viewing CAD marks with softcopy review workstation 2.

  • Page 41: Radiologist Training With Sample Cases

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Radiologist Training with Sample Cases 6-5-1 Training Instructions Three sample cases demonstrate the use of SecondLook Digital for the radiologist prior to clinical use. These cases are intended to familiarize the radiologist with the procedures for using the SecondLook Digital CAD marks.

  • Page 42: Sample Cases

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 6-5-2 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.
  • Page 43 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Mammograms with CAD Marks - Case 1 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...
  • Page 44 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Summary for Case 1 is on next page. Page no. 44 CAD.fm...
  • Page 45 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Case Summary - Case 1 History: 62 yo female for annual screening. No palpable 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.
  • Page 46 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 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...
  • Page 47 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Mammograms with CAD Marks - Case 2 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...
  • Page 48 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Summary for Case 2 is on next page. Page no. 48 CAD.fm...
  • Page 49 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Case Summary - Case 2 History: 43 yo female for annual 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.
  • Page 50 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator 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.
  • Page 51 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Mammograms with CAD Marks - Case 3 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...
  • Page 52 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Summary for Case 3 is on next page. Page no. 52 CAD.fm...
  • Page 53 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Case Summary - Case 3 History: 62 yo female with palpable mass 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).

  • Page 54: Summary Of Radiologist Use Of Secondlook Digital

    GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN Summary of Radiologist Use of SecondLook Digital The radiologist uses the SecondLook Digital CAD marks with mammography according to the following steps: 1. The radiologist first reviews the GEMS Senographe full-field digital mammograms without viewing the CAD marks, following her or his existing procedures of clinical practice.
  • Page 55 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN References 1. National Alliance of Breast Cancer Organizations (NABCO). Facts about breast cancer in the USA. Available at: http://www.nabco.org/index.php/index.php/137, dated February 2002, accessed October 21, 2002. Lancet 2. Gotzsche PC, Olsen O. Is screening for breast cancer with mammography justifiable? 2000;355:129-134.
  • Page 56 GE Healthcare Senographe SecondLook Digital CAD System Revision 1 Operator Manual 5189820-5-C-1EN 22. Tabar L, Fagerberg G, Duffy SW, et al. Update of the Swedish two-country program of Radiol Clin North Am mammographic screening of breast cancer. 1992;30:187-210. 23. Thurjell EL, Lernevall KA, Taube AA. Benefit of independent double reading in a population-based Radiology mammography screening program.

  • Page 57: Maintenance

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

  • Page 59: Revision History

    Deleting the unappropriated "0459" CE number because iCAD is Class I material. Substitution of Manufacturer’s address on last page from GE to iCADd’s. Deleting the GE supplier’s Chinese address on last page because Manufacturer’s address expected by Chinese mainland authorities.
  • Page 60 Manufactured by: iCAD 98, Spit Brook Rd., Suite 100 Nashua, NH 03062 U.S.A. Imagination at work...

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