KODAK DIRECTVIEW CR Mammography Feature Users Guide Ver 1.0 Sept 2010

Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 CARESTREAM, DIRECTVIEW, and DRYVIEW are trademarks of Carestream Health, Inc. The Kodak trademark and trade dress are used under license from Kodak. © Carestream Health, Inc. 2010

Table of Contents 1 CR Mammography Feature Document Conventions ... 1 About This Guide... 1 For European Markets ... 2 Safety and Related Information... 2 Mammography Imaging Chain... 4 Acquisition... 5 Capture and Processing... 5 Softcopy Viewing / Storage ... 6 Hardcopy Printing / Viewing... 6 CR Mammography Feature ... 6 Indications for Use... 6 CR Systems... 6 CR Mammography Cassettes... 7 Before You Begin ... 8 Workflow and Operation... 10 Performing a Mammography Exam ... 11 Preparing the Cassettes ... 11 Creating a Patient Record... 12 Using CR Mammography Cassettes ... 14 Exposing the Cassette ... 14 Compatibility with X-ray Systems ... 15 Technique Considerations... 16 X-ray Techniques ... 16 Automatic Exposure Control (AEC) ... 17 Automatic Exposure Control (AEC) Calibration ... 18 Exposure Index... 19 Recording Exposure Parameters ... 19 Mammography X-ray Interface ... 19 General Radiography Workflow... 20 Mammography Workflow... 20 Transmitted Data... 21 Scanning the Cassette ... 22

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Scanner Bar-Code Messages ... 22 Reviewing and Accepting Images... 22 Skin Line Enhancement... 25 Using the Image Processing Preference Editor ... 26 The Family of Looks... 27 For Software Versions 5.1 and 5.2 ... 27 For Software Version 5.2 Additional Looks Mammography Patch and Version 5.4 Default ... 28 For Software Version 5.4 Mammography Update 2010-01 License Enabled ... 28 For Software Version 5.4 SNP Parameter Database... 29 Preference Editor Controls... 30 Slider Control Behavior... 32 Defining a Look ... 32 Brightness... 32 Latitude... 33 Contrast ... 33 Sharpness ... 33 Noise ... 33 Delivering Mammography Images... 34 Justification of Right Mammography images... 34 Presentation of Images... 34 Printing Mammography Images ... 35 Creating Multi-format Prints... 35 Mammography Cassette Use Instructions ... 37 Opening the Cassette... 37 Cleaning the Cassette Shell ... 38 Handling and Maintaining the Screen... 39 Cleaning the Screen ... 40 Cleaning Method... 40 Disinfecting the Screen or the Cassette... 41 Disposing of the Screen ... 41 Quality Control... 42 Acceptance and Quality Control Testing ... 42 Troubleshooting ... 42 Black Surround Masking ... 43 Manual Black Surround... 43 Overscan Check ... 45 Getting Help... 45 Glossary... 46 Acronyms... 48

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CR Mammography Feature The information contained herein is based on the experience and knowledge relating to the subject matter gained by Carestream Health, Inc. prior to publication. No patent license is granted by this information. Carestream Health reserves the right to change this information without notice, and makes no warranty, express or implied, with respect to this information. Carestream Health shall not be liable for any loss or damage, including consequential or special damages, resulting from any use of this information, even if loss or damage is caused by Carestream Health’s negligence or other fault.

Document Conventions This manual uses three types of messages to emphasize information or potential risks to personnel or equipment: Notes, Important, and Caution. NOTE: Notes provide additional information, such as expanded explanations, hints, or reminders. IMPORTANT:

Important highlights critical policy information that affects how you use this manual and this product.

CAUTION:

Cautions point out procedures that you must follow precisely to avoid injury to yourself, others, damage to the system or any of its components, loss of data, or corruption of files in software applications.

About This Guide Use the KODAK DIRECTVIEW CR Mammography Feature User’s Guide for specific information on the use of the CR Mammography Feature. This guide does not provide all operational use information on KODAK DIRECTVIEW CR Systems and is intended to be used in conjunction with the following document: • KODAK DIRECTVIEW CR Systems User Guide information

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NOTE: All references in this document to CR Mammography Cassettes and screens apply to the following unless otherwise specified: • KODAK DIRECTVIEW CR Mammography Cassette with EHR-M Screen • KODAK DIRECTVIEW CR Mammography Cassette with EHR-M2 Screen • CARESTREAM CR Mammography Cassette with EHR-M3 Screen. • CARESTREAM CR Mammography Cassette with SNP-M1 Screen. NOTE: CR Mammography Cassettes are not available for sale in the United States. NOTE: See the Glossary section for a brief description of terms used in this guide. NOTE: Use of the term applicable regulations throughout this document means: as per current country, state, local, and/or facility-specific regulations applicable for use in mammography.

For European Markets Authorized European Agent:

Carestream Health France LES MERCURIALES 40, rue Jean Jaures 93176 BAGNOLET CEDEX France

Safety and Related Information NOTE: The following information applies to any KODAK DIRECTVIEW CR System that has the CR Mammography Feature installed. For more information, see the KODAK DIRECTVIEW CR System Safety and Regulatory Information included in your CR Systems User’s Guide. CAUTION:

A trained Service Representative is to install and verify the CR System is set up and functioning properly for use of the Mammography Feature. See: “Before You Begin” on page 1-8.

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CAUTION:

Calibrate all components in the Mammography Imaging Chain at the recommended intervals, according to the manufacturer’s instructions, and before use. See: “Mammography Imaging Chain” on page 1-4. CAUTION:

A Medical Physicist or qualified personnel is to establish or approve the exposure techniques used. A technique chart should be posted near the X-ray unit generator control panel. See: “Technique Considerations” on page 1-16. CAUTION:

The Medical Physicist or qualified personnel is to perform the Acceptance and Quality Control Tests as mandated by applicable regulations. CAUTION:

Follow and perform the Quality Control procedures for all components in the Mammography Imaging Chain at the recommended intervals, according to the manufacturer’s instructions and per applicable regulations. The facility must ensure that the image quality produced by all equipment in the Mammography Imaging Chain meets the requirements for clinical use. See: “Mammography Imaging Chain” on page 1-4. CAUTION:

Primary interpretation of softcopy images shall be performed on a workstation cleared for mammography and supporting the DICOM 3.0 standard. The workstation shall have at least two displays, each with a minimum image array size of five megapixels. CAUTION:

Primary interpretation of hardcopy images shall be performed on a printer cleared for mammography and supporting the DICOM 3.0 standard. The printer shall have a 50 micrometer m pixel pitch or less and maximum film optical density of at least 3.6.

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CAUTION:

Use CR Mammography Cassettes only for Mammographic Imaging. Do not use CR Mammography Cassettes for general radiography imaging applications. Do not use CR Cassettes, intended for general radiography, for Mammography imaging applications. CAUTION:

KODAK DIRECTVIEW CR Systems allow CR Mammography Cassettes with EHR-M, EHR-M2, EHR-M3, and SNP-M1 screen types to be scanned. Only scan cassettes with the same screen type on the CR System, and do not intermix the cassette/screen types when performing a patient exam. Intermixing the cassette/screen types may result in an inconsistency in the quality of the image. NOTE: For hardcopy printing of Mammography images, Carestream Health recommends that you configure the CR System for use with a KODAK DRYVIEW Mammography Laser Imager using KODAK DRYVIEW Mammography Laser Imaging Film. Contact your Carestream Health Sales Representative for more product information. NOTE: For softcopy viewing of Mammography images, Carestream Health recommends that you configure the CR System for use with a KODAK DIRECTVIEW Mammography Workstation. Contact your Carestream Health Sales Representative for more product information.

Mammography Imaging Chain The Mammography Imaging Chain with the KODAK DIRECTVIEW CR System diagram shows an overview of the equipment necessary for producing diagnostic quality mammograms. Obtaining high quality mammography images is dependent on many factors. All equipment in the Mammography Imaging Chain must be properly calibrated for use and quality control checked for proper functionality per each manufacturer's recommendations. The Technologist plays a key role in successfully achieving high quality digital mammograms by understanding the best exposure techniques to use, based on breast thickness and composition, and the capabilities of the equipment in the imaging chain. In addition to the KODAK DIRECTVIEW CR System with CR Mammography Feature, Carestream Health provides Mammography Workstation and Mammography Printer solutions, thus optimizing the system performance of this equipment in the Mammography Imaging Chain.

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As depicted in the diagram, the equipment can be described under these main functional categories: a. Acquisition b. Capture and Processing c. Softcopy Viewing and Storage d. Hardcopy Printing / Viewing

Mammography Imaging Chain

Acquisition

The Mammography X-ray Unit is used with the KODAK DIRECTVIEW CR System in the same manner as with conventional screen/film mammography. The techniques (target, filtration, kVp setting, proper positioning and compression, etc.) used are similar for exposing the CR Mammography Cassettes, and requires that the X-ray Unit components (i.e. X-ray generator, AEC, compression paddles, cassette holder/grid, etc.) are calibrated and maintained to function according to the manufacturer's stated requirements.

Capture and Processing

The KODAK DIRECTVIEW CR System with CR Mammography Feature, using CR Mammography Cassettes, provides the means to capture and process mammography images. Insert the CR Mammography Cassettes in the Mammography X-ray Unit's cassette holder for exposure, then place them in the KODAK DIRECTVIEW CR System, where they are scanned and image processed to produce high resolution images. The patient's exam record is created on the CR System and associated with the patient's images. A DICOM-compliant network connection with the CR System is used. You can

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search Patient Worklist information from a site's HIS/RIS and use it to create the patient's exam record on the CR System. The patient record and images are then sent via the DICOM network to the desired output destination for diagnostic interpretation.

Softcopy Viewing / Storage

From the KODAK DIRECTVIEW CR System, digital mammogram images can be sent to a DICOM-compatible Mammography Workstation where a diagnostic review can be performed in softcopy. The workstation consists of a mammography-capable, high-resolution display monitor, keyboard, mouse and computer. The Technologist uses the mouse and keyboard to select, review, and manipulate images for desired viewing. You can save preferences for selecting digital images and patient information and recall them for later use. The operator can send images from the workstation to an archive image storage system, or to other network DICOM compatible devices, including hardcopy printers.

Hardcopy Printing / Viewing

From the KODAK DIRECTVIEW CR System, digital mammogram images can be sent to a DICOM compatible Mammography Printer. The Mammography Printer can produce high-resolution, diagnostic quality, hardcopy (film) output of the digital mammogram images. The hardcopy print is then viewed for diagnosis on a View Box. The View Box must be of adequate brightness with uniform light output across the entire viewing area to ensure that the image captured on the film can be effectively diagnosed.

CR Mammography Feature Indications for Use

The CR Mammography Feature together with CR Mammography Cassette comprise a device which, when used in conjunction with a KODAK DIRECTVIEW CR System and a mammographic X-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

CR Systems

You can install and use the CR Mammography Feature in the following KODAK DIRECTVIEW CR Systems: • CR 850 • CR 950 • CR 975 • Classic/Elite CR NOTE: See the KODAK DIRECTVIEW CR System Hardware Guide for descriptions of these systems. Older manufactured CR 850/950/975 Systems may require hardware and software updates in order to use the CR Mammography Feature. Contact your Carestream Health Sales Representative for information.

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NOTE: The KODAK DIRECTVIEW CR System with CR Mammography Feature, using CR Mammography Cassettes is designed to work under normal room light conditions. IMPORTANT:

Keep the CR System, its surrounding area, and the storage locations for the CR Mammography Cassettes clean. This will help prevent dust or debris from entering the CR System and cassettes, which can result in image artifacts.

To enable the CR Mammography Feature: 1. Purchase and install the CR Mammography Feature Option. 2. Log on as the Key Operator. 3. Enter the Mammography Feature code to automatically enable the feature.

When the CR Mammography Feature is enabled, the KODAK DIRECTVIEW CR System produces high-resolution Mammography images using CR Mammography Cassettes. Only CR Systems with the CR Mammography Feature enabled will support the use of the CR Mammography Cassettes. Digital images are produced as follows: Cassette Size

Sampling Rate

Image Size (approximate)

Pixel Spacing

18 x 24 cm

20 pixels/mm

34 MegaBytes / image

48.5 microns

24 x 30 cm

20 pixels/mm

57 MegaBytes / image

48.5 microns

CR Mammography Cassettes

CR Mammography Cassettes are designed for Mammography applications only. They contain a high-resolution Mammography storage phosphor screen and are available in two sizes: 18 x 24 cm and 24 x 30 cm. To readily identify that a CR System can accept a CR Mammography Cassette, one of the following two labels will be attached to the CR System:

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The Mammography storage phosphor screen is not physically contacted when transported or scanned by the CR System. Not withstanding possible wear conditions, there is no established total number of times the CR Mammography Cassette can be used for image exposure before replacement is required. IMPORTANT: CR Mammography Cassettes should not be stored or left unattended in the exam room. When an X-ray exposure occurs, scatter radiation can expose the cassettes that are located in the exam room, resulting in fogged or low contrast appearance in image quality. You can use the Erase Cassette function on the CR System to assure the cassette is fully erased prior to using for patient exposure.

Before You Begin After installing the CR Mammography Feature in the CR System and before clinical use: 1. A trained Service Representative should check that the CR System:

– Is properly configured and contains KODAK DIRECTVIEW CR Software Version 5.1 or higher. – Has the CR Mammography Feature enabled. – Is calibrated for use with CR Mammography Cassettes. – Operates within specification to produce expected image quality. 2. A Medical Physicist or, if permitted by applicable regulations, qualified personnel

under direction of a Medical Physicist, should: – Performs the necessary acceptance testing according to applicable regulations. – Check the Mammography X-ray Unit’s Automatic Exposure Control (AEC) is properly calibrated for use with CR Mammography Cassettes and meets applicable regulations. AEC calibration is to be performed by a qualified X-ray equipment service representative. – Establish and/or approve the use of an exposure technique control chart. 3. A Carestream Health Applications Consultant can: – Configure various interface features and functions as desired. – Train Key Operators/Radiographers on use of the CR System, CR Mammography Cassettes, and on the use of an established technique control chart. – Work with Key Operators/Radiographers/Radiologists to make X-ray exposures, modify mammography views, and optimize image quality.

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IMPORTANT:

See the KODAK DIRECTVIEW CR System User Guide Information for information on operating parameters and configuring the CR System. Recommended Mammography-specific configurations include Mammography views to use for producing mammography images.

IMPORTANT:

New CR Systems are configured from the factory with default views to be used for General Radiography and Mammography applications.

• Breast Type – Breast – Breast Homogeneously Dense – Breast Heterogeneously Dense – Breast Implant – Breast Fatty • Mammography Projection – Cranio-Caudal (CC) – Mediolateral Oblique (MLO) – Lateral (ML and LM) – MLO_Mag (Mediolateral Oblique_Magnification) – CC_Mag (Craniocaudal_Magnification) NOTE: These 36 combinations, with both Left and Right laterality, result in 72 Mammography Views. Select the view that matches the exam.

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Workflow and Operation Collect patient demographic data.

HIS/RIS Broker?

YES

NO

Manually enter the Patient data on the ROP CR System, or Remote Patient Data Entry Station.

Enter Patient Data Scan the Patient ID bar code. Query the Local database. Query the HIS/RIS database.

1. Enter Exam data. 2. Scan the cassette bar code label. 3. Touch Save Changes.

Scheduled Workflow Option?

YES

Message sent to HIS/RIS that the Procedure Step is started. Status on CR changes from Scheduled to Started.

Status on CR changes from Scheduled to Started.

5. Position the patient. 6. Collimate properly. 7. Expose the cassette.

Expose additional cassettes if necessary.

Load the cassette(s) in the CR System.

Review and evaluate images. If acceptable, send to destinations and release patient.

Select End Study when complete or D/C to cancel Procedure Step. 000EC

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Performing a Mammography Exam This section describes the steps necessary to perform a typical four-view breast exam using the CR System: • CC • MLO IMPORTANT:

Preparing the Cassettes

See the KODAK DIRECTVIEW CR Systems User Guide Information for configuration use differences, entering patient and exam data, viewing and maintaining image quality, and printing and managing images.

You will need four unexposed CR Mammography Cassettes, 18 x 24 cm or 24 x 30 cm, as needed, for the four views. NOTE: If you have purchased the X-ray Interface, it is not necessary to apply a reusable sticker on each cassette to indicate the image view (RCC, LCC, LMLO, or RMLO) that will be exposed on the cassette, or the kVp and mAs settings used for the exposure, or a possible comment regarding the patient exam. See “Mammography X-ray Interface” on page 1-19. IMPORTANT:

Erase CR Mammography Cassettes each day prior to clinical imaging, when you suspect the cassettes have been exposed to any X-ray radiation, or when you use the local user interface on the Classic/Elite CR System. Insert the cassette into the CR System. This procedure erases all information on the cassette.

Main Menu

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Creating a Patient Record

To create a patient record (at the CR System or on a Remote Operations Panel (ROP): 1. At the Main Menu, touch Study Data. The Patient Query Screen appears.

Patient Query Screen

2. To search for an existing patient (already in the system):

– Use the bar-code scanner or virtual keyboard to enter known search criteria. – Touch Find Local to search the CR System’s database. – Touch Find Remote to search the HIS/RIS. The Patient Worklist Screen appears with a list of patient studies that match the search criteria. To open the patient record you searched for, touch anywhere in the row. For more information about using the Patient Worklist Screen, see the CR System Online Help. 3. To create a record for a new patient (not in the system or unavailable): a. Touch New Patient. The button appears on the Main Menu or in Study Data. The Patient Input Screen appears. b. Enter the required (yellow highlighted) information using the virtual keyboard, or by using the bar-code scanner. Select the Mammography category for Procedure. • If your system uses Procedure Mapping, the four views will appear automatically (RCC, LCC, RMLO, LMLO) or, as programmed by your Key Operator.

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• If your system does not use Procedure Mapping, select Add View and manually add each view, and configure the Laterality for each image. c. The image icons appear for the four views. These icons are associated when you scan the cassette bar code.

Mammography View Selection

d. Select the cassette for the RCC view. e. Scan the cassette’s bar code and confirm that the Cassette ID field displays the

bar-code number. f. To change the default view, select the image and go to the Image Viewer Screen. g. Select View Name and select the appropriate view from the list. h. Select Reprocess. i. Select the proper Laterality. Use Right for RCC and RMLO views and Left for LCC

and LMLO views. j. Touch Save Changes. This records all of the patient, exam, and cassette ID information in the CR System database. NOTE: For more information about search techniques or entering patient data, see the CR System Online Help.

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Using CR Mammography Cassettes

• Use only CR Mammography Cassettes for creating Mammograms. • Do not use CR Mammography Cassettes for general radiography imaging applications. • Do not use CR Cassettes, intended for general radiography, for Mammography imaging applications. See “CR Mammography Cassettes” on page 1-7. • Carestream Health recommends using the same type of CR Mammography screen for all images within the study.

Exposing the Cassette

Take the CR Mammography Cassettes to the Mammography X-ray unit, where the patient is prepared for the exam. 1. Insert the cassette into the Mammography unit’s cassette holder the same way you would insert a traditional mammography screen-film cassette. Chest Wall Edge

T

U

B

E

S

ID

E

Tube Side Label

Bar Code 2. Make sure the cassette is oriented with the narrow edge next to the chest wall and

the Tube Side label is facing up. IMPORTANT: Make sure the collimator blades are fully open to cover the image receptor. 3. Position the breast for the selected View and ensure adequate compression is

applied. 4. Select the appropriate exposure technique for the breast thickness and type. See “Compatibility with X-ray Systems” on page 1-15. 5. Repeat the above steps for each cassette.

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Compatibility with X-ray Systems The KODAK DIRECTVIEW CR System with CR Mammography Feature, using CR Mammography Cassettes, is specifically designed to be compatible with mammography X-ray systems and all other system accessories (such as anti-scatter grids and magnification options) that use screen-film cassettes. The CR Mammography Cassettes are intended to be used in the same manner as mammographic screen-film cassettes. They operate over the same range of kVp and target filter combinations as screen-film cassettes and can be exposed under manual or automatic exposure control. • The X-ray tube must have as a minimum a molybdenum target and molybdenum filter (Mo/Mo) combination (needed for calibration of the CR System) and, as is clinicially practiced with screen-film, support use of the following anode target and filter combinations: molybdenum target with rhodium filter (Mo/Rh), rhodium target with rhodium filter (Rh/Rh), and tungsten target with rhodium filter (W/Rh). • Automatic Exposure Control (AEC) may be of the type controlling mAs only, or mAs and kVp, or mAs, kVp and filter, or mAs, kVp, filter, and target. The following items list some of the features of the CR Mammography Cassettes that allow their use in place of conventional screen-film cassettes: • The physical dimensions of the CR Mammography Cassettes are the same as screen-film mammography cassettes (18 x 24 cm and 24 x 30 cm) and comply with the ISO 4090 standard for cassette design. Therefore, CR Mammography Cassettes are physically compatible with modern mammography X-ray unit 18 x 24 and 24 x 30 cassette holders. • The CR Mammography Cassettes are specifically designed for use with the Mammography X-ray unit's Automatic Exposure Control (AEC). The cassettes contain a low absorption region for compatibility with the X-ray systems Automatic Exposure Control (AEC) detector. The dimensions of the low absorption region comply with the ISO 4090 standard for possible placements of the AEC detector. NOTE: Adjustment of the AEC configuration may be necessary to account for the transmission of the CR Mammography Cassette. This is similar to the adjustment necessary when a new screen-film system is first introduced into the clinic. This should be done under guidance of the X-ray equipment service personnel and/or a qualified Medical Physicist. • The CR Mammography Cassettes are constructed to provide chest wall imaging access. The distance between the edge of the storage phosphor screen to the outside edge wall of the cassette is specified to be 3 mm or less. IMPORTANT: Mammography X-ray systems use anti-scatter moving grids or cassette holders. As with screen-film systems, failure of the grid to reciprocate, especially during a short exposure time, may result in a wavy artifact in the produced image known as a moire‘pattern, when using a CR Mammography Cassette. Ensuring proper operation of the reciprocating grid will prevent this artifact from occurring.

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Technique Considerations

• The KODAK DIRECTVIEW CR System has a wide exposure latitude and will operate over a broad range of mammographic exposure conditions, but is intended for use with acquisition techniques similar to those used with modern screen-film systems. • When using the CR System the same care and attention to detail should be taken to ensure high-quality images as was practiced with screen-film systems. • Medical Physicist should be consulted for assistance with technique factor selections and to ensure that the patient dose complies with applicable regulations. • When using the Automatic Exposure Control (AEC) of the X-ray machine, the facility should ensure the AEC is appropriately calibrated. • A technique chart should be produced and posted near each X-ray unit. The chart should summarize the acquisition parameters for producing X-ray images that comply with all local and national regulations on patient dose. It should also ensure the image quality is consistent with the local clinical expectations. IMPORTANT:

The dose shall be determined with technique factors and conditions used clinically for a standard breast. The maximum dose must comply with applicable regulations.

The following sections provide general guidance on X-ray techniques to use with the CR System and on configuration of the AEC.

X-ray Techniques

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The selection of X-ray technique includes the selection of specific beam parameters (kilovoltage, target, filtration) and the exposure level (mAs) as a function of patient thickness and glandularity. • Personnel familiar with screen-film mammography have become accustomed to X-ray technique factors designed for the screen-film image receptor. For example, if film processing is maintained in control, the use of insufficient X-ray technique produces images that are too light. Likewise the use of excessive X-ray technique produces images that are unacceptably dark. As with all digital imaging modalities, CR Mammography images may not appear too light or too dark if inappropriate X-ray technique is used. Hence, it is essential to develop and consistently utilize an appropriate X-ray technique chart to avoid suboptimal image quality or excessive radiation dose. • Due to the wide variety of different X-ray machine capabilities, user preference for noise and image sharpness, and the range of applicable regulations that control the allowed patient dose, there is no single specific recommendation for acquisition techniques that can be provided for use with the CR System. As a guide, a “typical” acquisition technique for a “standard” 4.5 cm thick breast with 50/50 composition might be 26 kVp, Mo/Mo and ~100 mAs. This technique produces a mean glandular dose (MGD) of ~2 mGy. There could be considerable variation from this typical technique as an institution adjusts for its local preferences.

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