AGFA CR 85-XTM User manual

CR Mammography
User Manual
2344Q EN 20180406 1001

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 ........................................................... 9
Intended Use ...........................................................11
System Documentation ........................................... 12
Training .................................................................. 13
Compliance .............................................................14
Connectivity ............................................................15
Installation ..............................................................16
Installation of the CR Mammography System ...
17
Calibration of the X-Ray Modality ................ 19
X-Ray Modality Operating Guidelines .......... 22
Viewing conditions for hardcopy ..................23
Viewing conditions for softcopy ................... 24
Options and Accessories ..........................................25
Cleaning and Disinfection ....................................... 26
Safety Directions .....................................................27
Getting started ....................................................................28
Basic workflow ........................................................ 29
Micro Calcification Enhancement (MCE) and softcopy
reading stations ...................................................... 30
Micro Calcification Enhancement (MCE) and exporting
images to CD or DVD ...............................................31
Limitations ............................................................. 32
Technical data .....................................................................34
ii | CR Mammography | Contents
2344Q EN 20180406 1001

Legal Notice
0413
Agfa NV, Septestraat 27, B-2640 Mortsel - Belgium
For more information on Agfa products, please visit www.agfa.com.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or
its affiliates. 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.
Agfa NV makes no warranties or representation, expressed or implied, with
respect to the accuracy, completeness or usefulness of the information
contained in this document and specifically disclaims warranties of suitability
for any particular purpose. Products and services may not be available for
your local area. Please contact your local sales representative for availability
information. Agfa NV diligently strives to provide as accurate information as
possible, but shall not be responsible for any typographical error. Agfa NV
shall under no circumstances be liable for any damage arising from the use or
inability to use any information, apparatus, method or process disclosed in
this document. Agfa NV reserves the right to make changes to this document
without prior notice. The original version of this document is in English.
Copyright 2018 Agfa NV
All rights reserved.
Published by Agfa NV
B-2640 Mortsel - Belgium.
No part of this document may be reproduced, copied, adapted or transmitted
in any form or by any means without the written permission of Agfa NV
CR Mammography | Legal Notice | 3
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Introduction to this Manual
Topics:
•Scope of this manual
•Warnings, Cautions, Instructions and Notes
•Disclaimer
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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:
• Mammography Systems based on CR 35-X/CR 85-X Digitizers.
• Mammography Systems based on CR 25.0/CR 75.0 Digitizers.
• Mammography Systems based on the DX-M Digitizer.
• Mammography Systems based on CR 30-Xm Digitizer.
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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.
Caution: Cautions are directions which, if they are not followed,
can cause damage to the equipment described in this manual or
any other equipment or goods and can cause environmental
pollution.
Instruction: This sign is typically used in combination with the
warning sign when providing a specific instruction. If it is followed
exactly, it should avoid the subject of the warning.
Note: Notes provide advice and highlight unusual points. A note is
not intended as an instruction.
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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. However, Agfa assumes no responsibility or liability for errors,
inaccuracies or omissions that may appear in this document. To improve
reliability, function or design Agfa reserves the right to change the product
without further notice. This manual is provided without warranty of any kind,
implied or expressed, including, but not limited to, the implied warranties of
merchantability and fitness for a particular purpose.
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Introduction to the CR Mammography
System
Topics:
•Configuration
•Intended Use
•System Documentation
•Training
•Compliance
•Connectivity
•Installation
•Options and Accessories
•Cleaning and Disinfection
•Safety Directions
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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:
4
7
3
1
2
6
5
1. System components
2. Optional components
3. CR Digitizer
4. CR Mammography Detectors, Plates and Cassettes
5. CR Workstation
6. Diagnostic Workstation
7. Mammography Printer and Film
Figure 1: CR Mammography System Configuration.
The CR Mammography System supports different configurations specified in
the columns of the following table:
CR Digitizer
multi-plate CR 85-XTM CR 75.0TM DX-MTM
single plate CR 35-XTM CR 25.0TM CR 30-XmTM
CR Mammography Detectors, Plates and Cassettes
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available formats are
18x24cm and
24x30cm
CR MM3.0 CR MM3.0R CR MM3.0T
CR MM2.0 CR HM5.0
CR Workstation
NX for MammographyTM
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’.
Combination restrictions:
Digitizer support for detectors, plates and cassettes:
• CR 25.0 and CR 75.0 support both CR MM2.0 Mammo Plates and
Cassettes and CR MM3.0 Mammo Plates and Cassettes.
• CR 35-X and CR 85-X supports CR MM3.0 Mammo Plates and Cassettes
only.
• CR 30-Xm supports CR MM3.0T Plates and Cassettes only.
• DX-M supports CR HM5.0 or CR MM3.0R Plates and Cassettes.
• Mixed use of different mammo cassettes and plates is not allowed. In
particular the mixed use of CR MM3.0R and CR HM5.0 on DX-M is not
allowed.
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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.
• The CR Mammography System can be used for screening mammography,
in compliance to local regulations.
Intended use for Mammography Systems based on CR 25.0/ CR 75.0
Digitizers
• The CR Mammography System can be used for diagnostic mammography.
• The CR Mammography System is not intended for screening
mammography.
Diagnostic mammography
Diagnostic mammography is a radiographic examination. It is performed to
provide additional information about patients who have signs and/or
symptoms of breast disease or radiographic findings of concern. It can also be
performed in situations where direct supervision of the imaging is required by
the interpreting physician.
A diagnostic mammogram is performed under the direct supervision of a
qualified physician in mammography and may include mediolateral oblique
(MLO), craniocaudal (CC) and/or additional views.
Note: Direct supervision is defined as the physician being
present and immediately available to furnish assistance and
direction throughout the performance of the procedure.
Screening mammography
Screening mammography is a radiological examination to detect unsuspected
breast cancer in asymptomatic women. This examination may be performed
without a physician in attendance.
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System Documentation
The user documentation consists of a set of manuals providing an overview of
the complete CR Mammography System and manuals for the components of
the system.
The following table lists the user documentation that contains the instructions
required for safe and effective operation of the CR Mammography System.
CR Mammography System
CR Mammography System User
Documentation CD.
• CR Mammography System User
Manual (this document).
• Agfa Healthcare System Safety User
Manual (3100).
CR Digitizer
CR 35-X and CR 85-X User Docu-
mentation CD.
• CR 35-X User Manual (4454).
• CR 85-X User Manual (4450).
CR 25.0 and CR 75.0 User Docu-
mentation CD.
• CR 25.0 User Manual (2312).
• CR 75.0 User Manual (2242).
CR 30-X / CR 30-Xm User Manual (2386).
DX-G / DX-M User Manual (2321).
CR Mammography Plates and Cassettes
CR Plates and Cassettes User Doc-
umentation CD.
CR Plates and Cassettes Instruction Man-
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. NX User Manual (4420).
NX Online Help.
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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.
At the outcome of the training, a Customer Acceptance Document will be
endorsed accordingly.
A learning curve is needed to allow the Radiologist to get entirely familiar
with the CR Mammography digital images, which have a different 'look and
feel' or image rendering in comparison to conventional film/screen.
It is the responsibility of the Radiologist to determine the conditions needed to
fulfill the learning curve process and to implement them.
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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:
Note:
Manufacturer Declaration for the System and Declaration of
Conformity for the different components are available.
The CE-label is conform the Medical Device Directive (MDD)
93/42/EEC for a class IIa system.
European Notified Body approval is obtained.
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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.
Related Links
System Documentation on page 12
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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
•Calibration of the X-Ray Modality
•X-Ray Modality Operating Guidelines
•Viewing conditions for hardcopy
•Viewing conditions for softcopy
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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.
Topics:
•CR Digitizer
•CR Workstation
•Print Layouts
•CR Mammography Printer
•Diagnostic Workstation
CR Digitizer
After proper installation of the CR Mammography System, the mammography
scan mode on the Digitizer is activated automatically when a CR Mammo
image Cassette, correctly initialized and identified, is introduced into the
Digitizer.
CR Workstation
The CR Mammography Workstation software needs to be configured to
ensure that the mandatory:
• Scanning parameters will be provided for the Digitizer.
• Dedicated MUSICATM processing for mammography will be applied.
• The system allows adjustment to visualization preferences of local
departments.
• Valid examination tree with dedicated image processing settings is used.
Note: It is important that the correct exam is selected to allow
application of the appropriate image processing.
The CR Workstation provides the possibility to achieve a consistent grayscale
perception of the images, as described in the DICOM standards (known as
Pvalues).
The configuration will also take care that images are displayed in the proper
orientation and mammography specific hardcopy film layouts are used.
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Print Layouts
For NX CR Workstation standard layouts are used.
These layouts optimize the hanging order of the films of the left and right
breast on the light box, by minimizing the borders at the thorax side of both
images.
Warning: For Diagnostic mammography use, true size
printing is essential. In this case, use only the proper
dedicated mammography printer layouts. If you use other
printer layouts, diagnostic information can be lost.
CR Mammography Printer
Hardcopies with a maximum optical density of at least 3.6 are recommended
to display the image details properly.
Diagnostic Workstation
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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Calibration of the X-Ray Modality
AEC of the X-ray modality must be calibrated for the appropriate Mammo
Cassette and Plate (MM2.0/MM3.0/MM3.0R/MM3.0T) or CR HM5.0 by the
X-ray modality field engineer to ensure the correct diagnostic image quality.
The CR Mammography specialist will assist in or verify this process. To reach
the optimal image quality the AEC must be in conformance with the following
exposure settings:
Table 1: Recommended kV-Ranges
PMMA
thickness
(cm)
Equiva-
lent
breast
thickness
(cm)
Spectrum
Mo-Mo Mo-Rh Rh-Rh W-Rh
20 21 24-27 kV
30 32 25-28 kV
40 45 26-29 kV 26-29 kV 26-29 kV 28-30 kV
45 53 26-30 kV 26-30 kV 26-30 kV 28-30 kV
50 60 26-30 kV 26-30 kV 26-30 kV 28-32 kV
60 75 27-32 kV 27-32 kV 27-32 kV 32-34 kV
70 90 28-32 kV 28-34 kV 28-34 kV 34-35 kV
Table 2: Target AGD Values as recommended by Agfa
PMMA
thickness
(cm)
Equiva-
lent
breast
thickness
(cm)
Target
AGD for
CR35-X/
CR85-X/
CR30-Xm/
DX-M with
MM3.0R
Target
AGD for
DX-M with
HM5.0
Standard
Target
AGD for
DX-M with
HM5.0
Dose Opti-
mized
Target
AGD for
DX-M with
HM5.0
Image
Quality
Optimized
20 21 0.85 0.7 0.6 0.85
30 32 1.3 1.1 0.9 1.3
40 45 1.7 1.45 1.2 1.7
45 53 2.2 1.9 1.6 2.2
50 60 2.6 2.2 1.8 2.6
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PMMA
thickness
(cm)
Equiva-
lent
breast
thickness
(cm)
Target
AGD for
CR35-X/
CR85-X/
CR30-Xm/
DX-M with
MM3.0R
Target
AGD for
DX-M with
HM5.0
Standard
Target
AGD for
DX-M with
HM5.0
Dose Opti-
mized
Target
AGD for
DX-M with
HM5.0
Image
Quality
Optimized
60 75 3.9 3.3 2.7 3.9
70 90 5.5 4.7 4.5 5.5
These settings are based on the recommendations of the EUREF guidelines for
digital mammography.
Alternatively, a PVI log-based dose setting or a less restrained EUREF dose
setting is possible with the DX-M and CR 30-Xm system. With these settings
the system is operated within a wider range of dose and hence image quality,
still providing sufficient image quality and acceptable dose or close-to-EUREF
adjustment respectively.
Note: Dose and image quality variation with the PVI log setting
are not necessarily compliant with EUREF or similar guidelines.
The use of W/Rh is restricted to cases in which low dose is applied (Target
AGD for DX-M with HM5.0 Dose Optimized). For a thickness less than 3 cm,
W/Rh is not recommended as this exposure technique might lead to
inadequate results. In order to avoid long exposure times, the use of
considerably higher kV is necessary (28 kV or more for medium thickness, 32
kV or more for 6 cm, 34 kV or more for a thickness more than 6 cm). W/Rh is
not recommended for magnification exposures.
Caution: When switching to a different type of plates and
cassettes, the AEC has to be recalibrated.
For Mammography Systems based on CR MM2.0 (CR 25.0/CR 75.0
Digitizers)
Caution: We strongly recommend to use the same settings as for
the CR35-X/CR 85-X digitizers, simply because they optimize
the overall system performance.
For Mammography Systems based on CR MM3.0 (CR 35-X/CR 85-X
Digitizers); CR MM3.0R (DX-M Digitizer) and CR MM3.0T (CR 30-Xm
Digitizer)
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