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Related Manuals for AGFA CR 85-XTM
Summary of Contents for AGFA CR 85-XTM
- Page 1 CR Mammography User Manual 2344Q EN 20180406 1001...
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Page 2: Table Of Contents
ii | CR Mammography | Contents Contents Legal Notice ................3 Introduction to this Manual ........... 4 Scope of this manual ..........5 Warnings, Cautions, Instructions and Notes ....6 Disclaimer ..............7 Introduction to the CR Mammography System ......8 Configuration ............ -
Page 3: Legal Notice
CR Mammography System, CR 30-Xm, CR 25.0, CR 75.0, CR 35- X, CR 85-X, DX-M, NX and MUSICA are trademarks of Agfa NV, Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement. -
Page 4: Introduction To This Manual
4 | CR Mammography | Introduction to this Manual Introduction to this Manual Topics: • Scope of this manual • Warnings, Cautions, Instructions and Notes • Disclaimer 2344Q EN 20180406 1001... -
Page 5: Scope Of This Manual
CR Mammography | Introduction to this Manual | 5 Scope of this manual This User manual describes the features of the CR Mammography System. It explains how the different products of the CR Mammography System work together. The manual covers the following Mammography Systems: •... -
Page 6: Warnings, Cautions, Instructions And Notes
6 | CR Mammography | Introduction to this Manual Warnings, Cautions, Instructions and Notes The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use. Warning: Warnings are directions which, if they are not followed, can cause fatal or serious injuries to a user, engineer, patient or any other person or can lead to a mistreatment. -
Page 7: Disclaimer
CR Mammography | Introduction to this Manual | 7 Disclaimer Agfa assumes no liability for use of this document if any unauthorized changes to the content or format have been made. Every care has been taken to ensure the accuracy of the information in this document. -
Page 8: Introduction To The Cr Mammography System
8 | CR Mammography | Introduction to the CR Mammography System Introduction to the CR Mammography System Topics: • Configuration • Intended Use • System Documentation • Training • Compliance • Connectivity • Installation • Options and Accessories • Cleaning and Disinfection •... -
Page 9: Configuration
CR Mammography | Introduction to the CR Mammography System | 9 Configuration The Agfa CR Mammography System consists of a digitizer, detectors, plates and cassettes and a CR workstation. It supports hardcopy devices and softcopy reading stations as optional components:... - Page 10 10 | CR Mammography | Introduction to the CR Mammography System available formats are CR MM3.0 CR MM3.0R CR MM3.0T 18x24cm and CR MM2.0 CR HM5.0 24x30cm CR Workstation NX for Mammography The CR MM2.0 Mammo plates and cassettes, CR MM3.0 Mammo plate and cassette, CR MM3.xR Mammo plate and cassette and CR HM5.x Mammo detector are generically referred to as ‘plates and cassettes’.
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Page 11: Intended Use
CR Mammography | Introduction to the CR Mammography System | 11 Intended Use Intended use for Mammography Systems based on CR 35-X/ CR 85-X; DX-M and CR 30-Xm Digitizers • The CR Mammography System can be used for diagnostic mammography. •... -
Page 12: System Documentation
CR Plates and Cassettes Instruction Man- umentation CD. ual (2199). CR 30-X / CR 30-Xm Plates and Cassettes User Manual (2387) AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x, CR MM3.xR) User Manual (2322). CR Workstation NX User Documentation CD. -
Page 13: Training
CR Mammography | Introduction to the CR Mammography System | 13 Training Agfa provides training and support for installation, calibration and use of the CR Mammography System and components. The Agfa training does not cover the interpretation of the diagnostic images. -
Page 14: Compliance
Agfa has performed a clinical study for diagnostic mammography. Regulatory requirements for digital mammography are still changing in many countries; therefore, Agfa cannot guarantee that the use of the CR Mammography System will be in compliance with evolving requirements. The CR Mammography System is marked with the CE-label:... -
Page 15: Connectivity
CR Mammography | Introduction to the CR Mammography System | 15 Connectivity Refer to the CR Workstation User Documentation for information on connectivity aspects of RIS/PACS systems and mammography modalities. References to these documents can be found under ‘System Documentation’. For further information also refer to the respective documentation. -
Page 16: Installation
16 | CR Mammography | Introduction to the CR Mammography System Installation The System components and the modality AEC (Automatic Exposure Control) have to be configured before mammography examinations will be performed. Topics: • Installation of the CR Mammography System •... -
Page 17: Installation Of The Cr Mammography System
CR Mammography | Introduction to the CR Mammography System | 17 Installation of the CR Mammography System The Agfa mammography application specialist configures all components of the CR Mammography System. Following remarks/instructions should be taken into account when installing the CR Mammography System: Caution: When deviating from the recommended settings, Agfa cannot guarantee optimal performance of the system. - Page 18 The softcopy reading station shall be installed and configured in presence of the CR Mammography specialist. In case of deviation from these recommended settings, Agfa does not guarantee optimal performance of the system. Softcopy reading stations of diagnostic quality require a dual head five mega- pixel mammo display system.
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Page 19: Calibration Of The X-Ray Modality
26-30 kV 28-32 kV 27-32 kV 27-32 kV 27-32 kV 32-34 kV 28-32 kV 28-34 kV 28-34 kV 34-35 kV Table 2: Target AGD Values as recommended by Agfa PMMA Equiva- Target Target Target Target thickness lent AGD for AGD for... - Page 20 20 | CR Mammography | Introduction to the CR Mammography System PMMA Equiva- Target Target Target Target thickness lent AGD for AGD for AGD for AGD for (cm) breast CR35-X/ DX-M with DX-M with DX-M with thickness CR85-X/ HM5.0 HM5.0 HM5.0 (cm) CR30-Xm/...
- Page 21 CR Mammography | Introduction to the CR Mammography System | 21 Caution: These above mentioned alignments are mandatory because they were used for validation of the powder-based CR Mammography Systems. In addition the EUREF based alignments are in-line with the EUREF recommendations for digital mammography.
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Page 22: X-Ray Modality Operating Guidelines
22 | CR Mammography | Introduction to the CR Mammography System X-Ray Modality Operating Guidelines Agfa advises to use X-ray modalities with AEC functionalities. The full automatic mode of the X-ray modality, aligned for CR Mammography, shall be used. Caution: Do not use the film density adjustment of the X-ray modality. -
Page 23: Viewing Conditions For Hardcopy
CR Mammography | Introduction to the CR Mammography System | 23 Viewing conditions for hardcopy Diagnostic quality of the system is validated and guaranteed under the clinical viewing conditions specified. This viewing condition is written in the text area on the hardcopy film: •... -
Page 24: Viewing Conditions For Softcopy
• If you can consult prior studies, an overview of both new and prior studies. • A one-on-one comparison view of images (e.g. right and left CC, left CC and left MLO,...). Other settings should be discussed by the customer with the Agfa mammography application specialist. Warning: Good viewing conditions are essential for the... -
Page 25: Options And Accessories
CR Mammography | Introduction to the CR Mammography System | 25 Options and Accessories Accessories are documented in the User Manuals of the components of the CR Mammography System. The Mammography Printer and the Diagnostic Workstation are optional components of the CR Mammography System. Micro Calcification Enhancement (MCE) Note: MCE is not licensed for sale in Canada. -
Page 26: Cleaning And Disinfection
The following maintenance recommendations must be applied for optimal performance of the cassette: • For the CR MM2.0/CR MM3.0/CR HM5.0 Mammo plate, use Agfa CR Phosphor Plate Cleaner and Polynit wipes or a lint-free cellulose cloth to clean the plate. -
Page 27: Safety Directions
CR Mammography | Introduction to the CR Mammography System | 27 Safety Directions For general safety directions, refer to the Agfa HealthCare System Safety User Manual, document 3100. For product safety directions, refer to the User Manuals listed in ‘System Documentation’. -
Page 28: Getting Started
28 | CR Mammography | Getting started Getting started Topics: • Basic workflow • Micro Calcification Enhancement (MCE) and softcopy reading stations • Micro Calcification Enhancement (MCE) and exporting images to CD or DVD • Limitations 2344Q EN 20180406 1001... -
Page 29: Basic Workflow
CR Mammography | Getting started | 29 Basic workflow The following procedure describes the workflow that will be followed when using the CR Mammography System. 1. At the Mammography modality: Expose the cassette at the X-ray modality. The operator is responsible for manual labelling of the cassettes. -
Page 30: Micro Calcification Enhancement (Mce) And Softcopy Reading Stations
30 | CR Mammography | Getting started Micro Calcification Enhancement (MCE) and softcopy reading stations On the CR workstation, two archive destinations can be configured: • a destination intended for softcopy reading and archiving, receiving two instances of the image. Both are available on the PACS workstation: the original image and the MCE enhanced image. -
Page 31: Micro Calcification Enhancement (Mce) And Exporting Images To Cd Or Dvd
CR Mammography | Getting started | 31 Micro Calcification Enhancement (MCE) and exporting images to CD or DVD MCE enhanced images cannot be exported to CD or DVD. 2344Q EN 20180406 1001... -
Page 32: Limitations
32 | CR Mammography | Getting started Limitations Limitations for image appearance • Absolute measurements are not supported (even on true size prints). There is a deviation caused by the X-ray projection. This phenomenon is identical to conventional film/screen situations. This is also the case on the softcopy reading station. - Page 33 CR Mammography | Getting started | 33 • Micro Calcification Enhancement (MCE) is only supported on systems based on CR 35-X/CR 85-X/DX-M/CR 30-Xm digitizers. • Micro Calcification Enhancement (MCE) is not supported on speciality examinations (e.g. magnification-spot, biopsy, stereotaxy). 2344Q EN 20180406 1001...
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Page 34: Technical Data
34 | CR Mammography | Technical data Technical data The digitizers scan standard general radiology images as well as high resolution mammography images. The CR Mammo plate is scanned under special conditions: • 50µm pixel size for high resolution scanning, •...