Operator's Manual

OPERATOR’S MANUAL
MELODY III D C
MELODY III D C
OPERATOR’S MANUAL
MODM10C-U02
© 2018 Metaltronica
VILLA SISTEMI MEDICALI S.p.a.
All rights are reserved.
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Reproduction or transmission in
20090 Buccinasco (MI) - ITALY
whole or in part, in any form or by
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Printed in Italy
www.metaltronica.com
Manufacturer´s address
Metaltronica
X-Ray Equipment & Supplies
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00071 Pomezia (Rome)
Italy
Customer contact
metaltronica@metaltronica.com
DOCUMENT STATUS SHEET
Title of Document: OPERATOR’S MANUAL (MODM10C-U02)

Date
Version Release Reason of change
(dd/mm/yy)
ENGLISH 01 05/06/2018 First release
ENGLISH 02 03/08/2018 Add technical details, new

temperature range for detectors,
corrections and general review
OPERATOR’S MANUAL
DECLARATION ACCORDING TO IEC 60601-1 STANDARD
The Manufacturer declares its responsibility concerning safety, reliability and equipment
features included in this manual only if the following items are fully satisfied:
1)-installation;
- room temperature and humidity;
- updates;
-recalibrations;
-repairs and/or modifications
carried out by technical personnel officially authorized from the Manufacturer.
2) Electrical pre-installation performed in the site where the system has to be put into
operation, carried out according to prescription given by IEC rules concerning Medical
Application.
3) Service personnel must ensure that they receive training on the mammographic unit with
the Manufacturer training programs prior to service the Unit.
4) Use of the equipment according to instruction in this manual. In case of difficulties
concerning interpretation, English translation shall prevail.
Using and keeping X-Ray equipment and device must
WARNING conform the local Regulations and national laws

concerning Medical X-Ray handling.
According to CE 93/42 Directive for Medical Devices

concerning product traceability, the Manufacturer must be
NOTE informed of any owner or installation address change.

Medical Devices traceability is prerequisite to assure their
safety and reliability over the time.

MODM10C-U02
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OPERATOR’S MANUAL
Table of Contents
SECTION 1: GENERAL INFORMATION ............................................................................................................................... 6
INTRODUCTION ..................................................................................................................................................................... 7
INTENDED USE ...................................................................................................................................................................... 7
CONTRAINDICATIONS ........................................................................................................................................................... 7
POTENTIAL ADVERSE EFFECTS ............................................................................................................................................... 7
GENERAL DESCRIPTION ......................................................................................................................................................... 8
SAFETY INFORMATION ........................................................................................................................................................ 13
INTERNATIONAL SYMBOLS .................................................................................................................................................. 15
ACRONYMS ......................................................................................................................................................................... 18
DEVICE CLASSIFICATION ...................................................................................................................................................... 19
MELODY III D C IDENTIFICATION LABELS ............................................................................................................................. 20
ANTI‐X BARRIER/AWS IDENTIFICATION LABELS .................................................................................................................. 21
MELODY III D C DIMENSIONAL DRAWINGS ......................................................................................................................... 23
MELODY III D C DIMENSIONAL DRAWINGS .......................................................................................................................... 24
ANTI‐X PROTECTIVE BARRIERS: DIMENSIONS AND WEIGHT (OPTIONAL) ............................................................................... 25
ACQUISITION WORKSTATION: DIMENSIONS AND WEIGHT (OPTIONAL) ................................................................................ 26
SECTION 2: CONFIGURATIONS ....................................................................................................................................... 28
“FULL DICOM” CONFIGURATION ......................................................................................................................................... 30
“FULL DICOM” CONFIGURATION + DIAGNOSTIC STATION .................................................................................................. 31
“MINI‐PACS” CONFIGURATION ............................................................................................................................................. 32
SECTION 3: MAIN PARTS DESCRIPTION .......................................................................................................................... 33
MELODY III D C MAIN PARTS ................................................................................................................................................ 34
MELODY III D C MAIN PARTS ................................................................................................................................................ 36
ACQUISITION WORK STATION MAIN PARTS ........................................................................................................................ 38
ANTI‐X PROTECTIVE BARRIER WITH OPTIONAL MONITOR AND KEYBOARD (ACQUISITION WORKSTATION) .............................. 39
C‐ARM MOVEMENTS KEYBOARDS....................................................................................................................................... 41
CONTROL PANEL (ACQUISITION SOFTWARE) ...................................................................................................................... 42
KNOB FOR FINE MANUAL COMPRESSION ........................................................................................................................... 44
FOOT‐CONTROLS ................................................................................................................................................................. 45
CONNECTOR PANEL ............................................................................................................................................................. 45
SECTION 4: GENERAL OPERATIONS ................................................................................................................................ 46
EXAMINATION ROOM ......................................................................................................................................................... 47
RELEVANT INSTRUCTIONS BEFORE INITIAL START‐UP ......................................................................................................... 47
SWITCHING ON.................................................................................................................................................................... 47
BLACK OUT .......................................................................................................................................................................... 51
SWITCHING OFF .................................................................................................................................................................. 53
EMERGENCY PUSHBUTTONS ............................................................................................................................................... 54
C‐ARM MOVEMENTS ........................................................................................................................................................... 55
C‐ARM VERTICAL TRASLATION ............................................................................................................................................ 55
THE OPERATOR CAN MOVE VERTICALLY THE C‐ARM BY MEANS OF THE BUTTONS N° 13 (PARAGRAPH “MAIN PARTS”). ................................ 55
C‐ARM ROTATION ............................................................................................................................................................... 55
OPTIONAL MOTORIZED ROTATION ................................................................................................................................ 55
C‐ARM ROTATION FOR STEREO BIOPSY (ONLY FOR MELODY III D C EQUIPPED WITH SBD FFDM) ............................................... 57
COMPRESSION PADDLES INSERTION AND REMOVAL .......................................................................................................... 60
BREAST COMPRESSION SYSTEM .......................................................................................................................................... 62
Motor driven compression ............................................................................................................................................. 62
Manual compression with fine adjustment .................................................................................................................... 64
Compression release ...................................................................................................................................................... 64
LIGHT BEAM INDICATOR ..................................................................................................................................................... 66
AUTOMATIC COLLIMATION DEVICE .................................................................................................................................... 67
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OPERATOR’S MANUAL
DEVICE FOR GEOMETRIC MAGNIFICATION (VARIABLE 1.5X/2X) .......................................................................................... 67
PROTECTIVE SCREEN ........................................................................................................................................................... 68
FOCAL SPOT SELECTION ...................................................................................................................................................... 69
RADIOGRAPHIC EXPOSURE ................................................................................................................................................. 69
DOSE CALCULATOR ............................................................................................................................................................. 70
OPERATING AND ERROR MESSAGES ................................................................................................................................... 70
OPERATING ERRORS ............................................................................................................................................................ 70
ERROR MESSAGES ............................................................................................................................................................... 72
SECTION 5: EXPOSURE TECHNIQUES .............................................................................................................................. 74
MANUAL MODE .................................................................................................................................................................. 76
AUTOMATIC EXPOSURE MODE ........................................................................................................................................... 77
AUTOMATIC FILTER DEVICE RH/AG ...................................................................................................................................... 79
SECTION 6: TYPICAL OPERATING CONFIGURATIONS ...................................................................................................... 81
MELODY III D C 24X30CM FORMAT ....................................................................................................................................... 83
CONFIGURATION FOR STANDARD EXAMINATION (LARGE BREAST) .............................................................................................. 83
CONFIGURATION FOR STANDARD EXAMINATION (NORMAL BREAST) .............................................................................................. 84
CONFIGURATION FOR SPOT CONTACT EXAMINATION .................................................................................................................. 84
CONFIGURATION FOR GEOMETRIC MAGNIFICATION ................................................................................................................... 86
CONFIGURATION FOR BIDIMENSIONAL BIOPSY .......................................................................................................................... 86
MELODY III D C 24X30 CM FORMAT ...................................................................................................................................... 88
CONFIGURATION FOR STEREOTACTIC BIOPSY ............................................................................................................................. 88
SECTION 7: ACQUISITION SOFTWARE OPERATING INSTRUCTIONS ................................................................................. 89
1. STARTING THE ACQUISITION SOFTWARE ........................................................................................................................ 91
2. USER INTERFACE DESCRIPTION ....................................................................................................................................... 92
2.1. Status Bar ................................................................................................................................................................ 93
2.2. Operation Bar .......................................................................................................................................................... 95
2.3. Menu Panel ............................................................................................................................................................. 96
3. OPENING STUDY ............................................................................................................................................................ 102
3.1 Opening study from Worklist ................................................................................................................................. 103
3.1.1 Remote Worklist ................................................................................................................................................................ 103
3.1.2 Local Worklist .................................................................................................................................................................... 108
3.2 Opening local study ................................................................................................................................................ 111
4. RADIOGRAPHIC EXPOSURE ............................................................................................................................................ 112
4.1 Setting the exposure parameters ........................................................................................................................... 115
4.2 Setting the ACR code .............................................................................................................................................. 116
5. IMAGE TOOLS ................................................................................................................................................................ 123
5.1 Display & Images .................................................................................................................................................... 124
5.2 Fit to Window, Pan/Scroll, 1:1, Effective size, Lens ................................................................................................ 126
5.3 Set anchor point ..................................................................................................................................................... 127
5.4 Window/Level, Contrast, Histo, Restore original ................................................................................................... 128
5.5 Process, Info, Change ACR settings ........................................................................................................................ 130
5.6 Downsize to 18x24, Delete, Recover 24x30, Measure, Plot Line, Alt Images ......................................................... 133
6. CLOSING STUDY ............................................................................................................................................................. 138
7. LOADING STUDY FROM PC ............................................................................................................................................. 139
8. DICOM FUNCTIONS ....................................................................................................................................................... 141
9. DAILY CHECK .................................................................................................................................................................. 154
SECTION 8: MAINTENANCE ......................................................................................................................................... 164
GENERAL CONCEPTS ......................................................................................................................................................... 165
GRID MOVEMENT TEST ..................................................................................................................................................... 166
CLEANING AND DISINFECTION .......................................................................................................................................... 167
DETECTOR FANS FILTERS CHECK AND REPLACEMENT ....................................................................................................... 169
MOVING THE UNIT TO ANOTHER PLACE ........................................................................................................................... 170
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OPERATOR’S MANUAL
SECTION 9: ACCESSORIES & OPTIONAL PARTS ............................................................................................................. 171
LIST OF PARTS .................................................................................................................................................................... 172
LIST OF OPTIONS ............................................................................................................................................................... 172
CONFIGURATIONS AVAILABLE ........................................................................................................................................... 174
COMPRESSION PADDLES ................................................................................................................................................... 177
DEVICE FOR GEOMETRIC MAGNIFICATION WITH VARIABLE (1,5X/2X) .............................................................................. 178
FOOT‐CONTROLS ............................................................................................................................................................... 178
PHANTOM FOR PERIODICAL SYSTEM CALIBRATION .......................................................................................................... 179
PHANTOM FOR DAILY CHECK WITH COMPRESSION .......................................................................................................... 180
STEREOTACTIC BIOPSY DEVICE .......................................................................................................................................... 180
ANTI‐X PROTECTIVE BARRIER ............................................................................................................................................ 181
ACQUISITION WORKSTATION ............................................................................................................................................ 181
SECTION 10: SPECIAL HINTS – IMAGE RECOVERY STRATEGY – TROUBLESHOOTING ...................................................... 182
PATIENT POSITIONING ...................................................................................................................................................... 183
IMAGE RECOVERY STRATEGY – TROUBLESHOOTING ........................................................................................................ 192
Incorrectly sized images acquired with 18x24 compression paddle ............................................................................. 192
Incorrectly sized images acquired with 24x30 compression paddle ............................................................................. 193
Images with metallic clips, surgical marker and cluster of micro calcification ............................................................ 194
Images with surgical anatomical parts ........................................................................................................................ 195
Images with breast specimen ....................................................................................................................................... 196
Wrong ACR setting ....................................................................................................................................................... 197
Spot compression device (if available) ......................................................................................................................... 198
SECTION 11: TECHNICAL SPECIFICATIONS .................................................................................................................... 201
TECHNICAL SPECIFICATIONS .............................................................................................................................................. 202
ELECTROMAGNETIC INFORMATIONS ACCORDING TO IEC 60601‐1‐2 ............................................................................... 214
WEEE INFORMATIONS ACCORDING TO DIRECTIVES 2012/19/EU AND 2002/96/EC ........................................................... 218
(WASTE ELECTRICAL AND ELECTRONIC EQUIPMENT) ..................................................................................................................... 218
SECTION 12: WARRANTY CONDITIONS ........................................................................................................................ 219
WARRANTY CONDITIONS .................................................................................................................................................. 220
FAILURE REPORT ............................................................................................................................................................... 222
SAFETY FEEDBACK ............................................................................................................................................................. 224
MODM10C-U02
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OPERATOR’S MANUAL
SECTION 1:
GENERAL INFORMATION
MODM10C-U02 Page 6 of 226

OPERATOR’S MANUAL
INTRODUCTION
Proper use of this equipment presupposes that the operating personnel is thoroughly familiar
with the operating instruction, in particular the sections Safety, Function and Safety Check,
and Protective Measures and able to use Personal Computers and their applications.
If legally-binding regulations govern the installation and/or the operation of the above
equipment, it is responsibility of the installer or the operator to observe these regulations.
INTENDED USE
The MELODY III D C is a system indicated for generating mammographic images that can be
used for screening and diagnosis of breast cancer or for needle localization in case of
stereotactic biopsy. The MELODY III D C is intended to be used in the same clinical
applications as traditional film/screen systems.
This Operator’s Manual is intended to give a detailed overview on Functions, Specifications,

Safety and all other important issues to know to get maximum utilization of mammography
system.
CONTRAINDICATIONS
No absolute contraindications are given for mammography. Due to the nature of X-ray
procedures the patient is exposed to radiation and adverse health effects exist and are
known.
POTENTIAL ADVERSE EFFECTS

The following is a list of potential effects applicable to the mammography:
 Excessive breast compression
 Excessive X-ray exposure
 Infection
 Skin irritation, abrasions or puncture wounds.
 Electric shock

OPERATOR’S MANUAL
GENERAL DESCRIPTION
The FFDM DIGITAL MELODY III D C is complete mammography solutions optimized for
digital imaging. They are composed of:
 Mammography Unit with X-Ray tube and Indirect Conversion Amorphous Silicon
detector 24x30 cm format or Direct Conversion Amorphous Selenium 24x30 cm format
with not Isocentric (MELODY III D C) or Isocentric C-Arm (MELODY III D C) usable for
Stereo biopsy in combination with SBD FFDM Stereo biopsy device;
 Integrated X-Ray control and image Acquisition Software (AS);
Although not as a part of the FFDM MELODY III D C and systems (which are just complete
mammography solutions when composed by components described above), an optional
acquisition station (Anti-x protective barrier equipped with devices for remote control of the
unit) may be provided on request.
Indirect Conversion Amorphous Silicon Detector is recommended for installation in mobile
environment (E.g. Truck, Van, etc) or critical installation in general.
The Mammography Unit is inclusive of:
• high voltage X-Ray generator:

- 100 kHz ripple – 5 kW power
- 20 ÷ 35 kV (0,5 kV step) (20 ÷ 40 kV optional)
- 1 ÷ 640 mAs
• MELODY III D C: not isocentric C-Arm with motorized vertical movement and manual
rotation (motorized rotation optional). Fixed focus-detector distance of 66 cm
• MELODY III D C: isocentric C-Arm with motorized vertical movement and manual rotation
(motorized rotation optional). 24x30 cm format upgradeable with motorized rotation for
biopsy projections +/-15° (only with SBD FFDM). Fixed focus-detector distance of 66 cm
• X-Ray tube with tungsten biangular anode:
- 0,1 and 0,3 mm focal spots
- 300 kHU maximum anode heat content
- 3.000 rpm (10.000 optional)

OPERATOR’S MANUAL
- Automatic Filter (50 μm Rhodium/50 μm Silver)

- Automatic collimation device from standard examination to geometric magnification
• Indirect Conversion Detector
- 24x30 cm format
- Technology: Amorphous Silicon (a-Si)
- Depth: 16 bit
- Pixel Pitch: 85x85 µm
- Resolution: 2816x3584 pixels (24x30 cm format)
- Active Area: 23.9x30.5 cm (24x30 cm format)
- Read time: <1.1 s (24x30 cm format)
- Fill factor: 80% geometric
- MTF (Modulation Transfer Function): >75% @ 1 lp/mm (typical 85%); >10% @ 5
lp/mm (typical 20%)
- DQE (Detector Quantum Efficiency): >45% @ 1 lp/mm (typical 50%); >10% @ 5 lp/mm
(typical 20%) for exposure of 28 kV
Direct Conversion Full Field Flat Panel Detector:

- Format: 24x30 cm
- Active Area: 23.9x30.5 cm
- Technology: Amorphous Selenium (a-Se)
- Depth: 16 bit
- Pixel Pitch: 85x85 μm
- Pixel Pitch in tomosynthesis: 85x85 μm (full resolution)
- Pixel Pitch in reconstructed slices: 85x85 μm
- Resolution: 2816x3584 pixels
- MTF (Modulation Transfer Function): > 90 % a 1 lp/mm; > 40 % a 5.8 lp/mm
- DQE (Detector Quantum Efficiency): > 50 % (@ 1 lp/mm for exposure of 28 kV); > 20
% (@ 5.8 lp/mm for exposure of 28 kV)
• Automatic Exposure Control (AEC) with full automatic kV/mAs, manual kV/auto mAs in
function of effective Breast Density evaluated by pre-exposure X-Ray pulse or breast
thickness for fast operation and/or special cases with silicone prosthesis. Dose limits
according to European Protocol for Dosimetry and EUREF protocol

OPERATOR’S MANUAL
• AGD (Average Glandular Dose) calculator

•Smart µPress (microPress) compression device:
- Motor-driven adjustable force and manual compression with safety release
- Force really exerted on the breast shown on double displays
- Breast thickness shown on four display
- Descending paddle speed proportionally reduced with increasing compression force
- Compression paddles with softly curved and smooth lines for higher patient comfort
• Potter-Bucky with removable anti-scatter grid (Ratio 6:1, 36 lp/cm)
• Device for geometric magnification (1,5x/ 2x factor) without anti-scatter grid and with
automatic selection of small focal spot (optional)
• Keyboard over the detector for automatic image tagging plus manual prefix/suffix according
to ACR protocol. Integrated display with “C” arm inclination, projections, compression force
selected/applied, breast thickness and laterality selection
• Two emergency push-buttons
• Acquisition Software complete of:
- Capability to display and viewing Off-line images
- Local operational mode
- Patient information local DataBase
- PC tools to make operations on the local PC:
 Local opening of new studies (i.e. not from the worklist)
 Local studies storing (i.e. in the internal computer memory)
 Local studies reloading (i.e. from the internal computer memory)
 Local DataBase managing
- Graphic tools to manipulate images:
 Selection and positioning of images to display
 Display protocol with ACR predefined views
 Current session loaded images
 Post-processing algorithm specific for mammography to enhance the quality of
the acquired images
 Fit to window, Zoom, Pan, Magnification lens
 1:1, Effective size
 DICOM W/L, High/Very High/Skin contrast

OPERATOR’S MANUAL
 Histograms
 Override ACR settings
 Mirroring operations on ACR standard views (CC, MLO)
 Post-processing filters dedicated to detection of metallic clips, specimens and
surgical breast parts
- DICOM tools:
 Worklist studies opening and closing
 Sending of locally stored studies to the appropriate RIS server
 Studies printing
 Studies recording on CD/DVD
 QC tools based on EUREF protocol
 Storage commitment (SC)
 Modality Performed Procedure Step (MPPS)
 2 MPixel Color LCD Display System (21.3” viewable size)
 Wireless Keyboard with touch pad
 Integrated UPS
- UPS 180 / 266 Vac, 650 VA (230 Vac) or 700 VA (115 Vac), 10 minutes
(typically)
- Intelligent power management system with safe automatic shutdown
 HIS-RIS-PACS Interface
 Conformities:
- FULL DICOM 3.0 MG:
- IHE (PIR-Patient Information Reconciliation, SWF-Scheduled Workflow, MI-
Mammography Image)
A Viewing/Reporting Station is available in option (not part of this Medical
Device)

OPERATOR’S MANUAL
SAFETY SYMBOLS
Indicates a risk of danger that may lead to death of serious

WARNING
physical injury.
Indicates a risk of danger that if disregarded leads to slight

CAUTION
or moderate physical injury and/ or property damage.
Should be understood as a tip. The user does not
NOTE absolutely have to observe these instructions. However,

there will be advantages if he does.

OPERATOR’S MANUAL
SAFETY INFORMATION
CAUTION Please pay attention to the following cautions!
1. MELODY III D C has not to be used by unskilled or untrained personnel. The

manufacturer does not accept responsibility for injury or damage associated
with improper or unsafe system operation. the user should refer to this
operator manual for directions on how to use the MELODY III D C.
2. A correct use of this Mammographic Unit assumes that operators (technicians
and radiologists) hold the necessary technical and specialist knowledge and
they have been properly trained for Good Clinical Practice.
3. It is supposed that the reader of this manual is used to the general operations
of the windows® operating system, it is also assumed that the concepts of
PACS, RIS, DICOM, server etc. are well-known.
4. This machine must be used only for mammography.
5. This machine must be used only in a controlled area inside a dedicated room
provided with x-ray protection that meets local standards and regulation.
6. This equipment used in the presence of flammable anesthetic or oxygen may
cause an explosion
7. The mammography unit is classified as permanently installed according to IEC
60601-1 international standard. This means that it must be electrically
connected by means of permanent connections. In particular, for the maximum
electrical safety, the protective earth conductor must be fixed and permanently
installed.
8. To guarantee the isolation of the mammo unit circuits from supply mains, a
locking mechanism has to be provided by the responsible organization (e.g. a
padlock) capable of being locked in the off position.
9. MELODY III D C can be used by all categories of patient. For disable patients
(on wheel chair) be always careful to all automatic movements of c-arm
(especially up/down movement).
10. Patients with disabilities or temporary disablement must remain seated during
the positioning and the mammographic examination.
11. Keep away foot controls from the patient’s feet and/or exam chair, especially
for disable patient on wheel chair and with disability in general. The
manufacturer recommends to keep foot controls in a safe area outside the
patient ambient (approximately 1,5 m, as defined by IEC 60601-1 ).
12. Before using, check the state of all parts of mammo unit: they have to be
perfect.

OPERATOR’S MANUAL
13. Frequently verify the wear of the compression paddles to prevent damages as
cracks and tears, and consequent risks for the patient.
14. Do not modify this equipment without authorization of the manufacturer
15. Use only original accessories and spare parts.
16. Do not remove plastic coverings of mammography unit that give a protection
against the electrical, thermal and mechanical hazards.
17. Do not insert in the x-ray beam devices other than compression paddles or
magnification device.
18. Use lead apron for patient protection.
19. During x-ray emission, operator must be behind anti-X protective barrier and in
a position where it is possible to watch patient and unit.
20. Respect the storage conditions.
21. Pay attention to video monitor of mammography unit that: it is the most fragile
part of the system.
22. Use the mammography unit and its software according to the instruction given
in this manual. Do not try to install unauthorized software, access to operating
system configuration or perform other potentially dangerous operations.
23. Do not use other equipment or network/data couplings (to which a signal
input/output part may be connected), other than those forming part of
MELODY III D C.
24. This is a medical equipment and it should not be considered to be a general-
purpose computer: when operating the system, do not attempt to make any
change to system software and do not use it as a personal internal PC. Any
modification or attempt to modify the operating system software will make the
unit unsuitable for its intended use.
25. No computer virus protection or network security is provided. anti-virus
protection and network security are the ongoing responsibility of the user.
26. When Mammography System Is Installed In Mobile Environment (E.G. Van,
Truck), It’s Necessary Before Cruise Remove Any Accessory From Unit, Move
The C-Arm To The Bottom Position And Lock It By Means Of Its Special
Support.
27. The device incorporates a low risk LED (risk group 1) for light beam centering
device (according to CEI EN 62741).
28. Never Leave Unsolved Problems That May Affect The Safety Of The Product.
29. The pictures present in this manual are only indicative and may be subjected
to changes (for example the background color) which are not significant for the
procedure described

OPERATOR’S MANUAL
INTERNATIONAL SYMBOLS
The meaning of symbols appearing on the plate and on some components of the machine is
specified in the following table.
SYMBOLS CEI–IECSTANDARD DEFINITION
ISO 7000-0434A
Caution
IEC 60417-5008
“OFF” Power
IEC 60417-5010
“ON” Power
IEC 60417-5840
Type B Applied Part
IEC 60417-5032
Alternating Current
IEC 60417-5019
Protective Earth (ground)
IEC 60417-5017
Earth (ground)
ISO 15223-1
Manufacturer
ISO 15223-1
Date of Manufacture
ISO 15223-1
Serial Number
ISO 7010-M002
Refer to instruction
manual/booklet
NOTE On ME EQUIPMENT “Follow
instructions for use”

OPERATOR’S MANUAL

IEC 60417-5036
Dangerous Voltage
WEEE (Waste Electrical and Electronic

Equipment)
IEC 60417-5367
C-ARM POSITION
IEC 60417-5638
Emergency Stop
IEC 60417-5326
Large Focus
IEC 60417-5325
Small Focus
IEC 60417-5384
Indication of radiation field by light
IEC 60417-5349
Radiodiagnostic compression device,
movement
IEC 60417-5350
Radiodiagnostic compression device,
pressure applied
IEC 60417-5351
AUTOMATIC COMPRESSION RELEASE

OPERATOR’S MANUAL

IEC 60417-5381
FILTER DEVICE MODE
IEC 60417-5353
Grid movement
IEC 60417-5339
X-ray source assembly, emitting
IEC 60417-5172
Class II equipment (according to IEC
60536)
C-arm rotation angle
Breast THICKNESS
Automatic Modality SELECTION
ERROR MESSAGE
x-RAY EMISSION CONTROL LAMP
EXPOSURE TECHNIQUE SELECTION
Focal Spot

OPERATOR’S MANUAL
ACRONYMS
ACR: American College of Radiology
AEC: Automatic Exposure Control
AGD Average Glandular Dose
AOI: Area Of Interest
AS: Acquisition Software
DICOM: Digital Imaging and Communications in Medicine
DME Digital Mammography Equipment
FFDM: Full Field Digital Mammography
FTSE: Function of tissue strenght evaluation
GUI: Graphical User Interface
MMI: Man-Machine Interface (it has the same meaning of GUI)
OD Optical density
PACS: Picture Archiving and Communications Systems
RIS: Radiology Information System
ROI: Region Of Interest

OPERATOR’S MANUAL
DEVICE CLASSIFICATION
The identification label is placed on the back of the device and a true copy of it is also placed
inside.
220/230/240 Vac MAINS (STANDARD)
MELODY III D C MELODY III D C (isocentric)
115 Vac MAINS (OPTIONAL)
MELODY III D C MELODY III D C (isocentric)
IEC 60601-1 Standard

MELODY III D C belongs to Class I type B applied parts.
Directive 93/42/EEC for Medical Devices

MELODY III D C belongs to Class IIb.

OPERATOR’S MANUAL
MELODY III D C IDENTIFICATION LABELS
X-RAY TUBE
(alternative labels are
provided in case of optional
tube chosen)
X-RAY tube
H.S. STARTER
(optional)
COLLIMATION
DEVICE
C-ARM
COMPRESSION
SYSTEM
MOTORIZED
ROTATION
OF C-ARM (optional)
POTTER-BUCKY
INVERTER
UNIFIED FRAME
DETECTOR
Z150-dwg050-00
MAGNIFICATION DEVICE
HIGH VOLTAGE
GENERATOR
INTERNAL LABELS
Identification labels are
NOTE important for a safe use of the
mammographic unit.

OPERATOR’S MANUAL
MELODY III D C (isocentric) IDENTIFICATION LABELS
X-RAY TUBE
(alternative labels are
provided in case of optional
tube chosen)
X-RAY tube
H.S. STARTER
(optional)
COLLIMATION
DEVICE
C-ARM
COMPRESSION
SYSTEM
MOTORIZED
ROTATION
OF C-ARM (optional)
INVERTER POTTER-BUCKY
UNIFIED FRAME
DETECTOR
Z150-dwg051-00
H.IGH VOLTAGE
GENERATOR
Identification labels are

NOTE important for a safe use of
INTERNAL LABELS
the mammographic unit.

OPERATOR’S MANUAL
ANTI-X BARRIER/AWS IDENTIFICATION LABELS

OPERATOR’S MANUAL
MELODY III D C DIMENSIONAL DRAWINGS
When carrying out the necessary support calculation,

weight of patient and operator must be taken into
CAUTION
consideration.
Weight: 315 Kg
The mechanical indication given in drawings above are

nominal, they have a tolerance of ±10% (depth) and ±1
NOTE
mm (wide) due to the sum of overall tolerance during
assembling

OPERATOR’S MANUAL
MELODY III D C DIMENSIONAL DRAWINGS
Weight: 360 Kg
When the stereotactic biopsy device SBD FFDM is

installed on MELODY III D C the C-Arm maximum rotation
is limited to ± 90°
NOTE
During normal operations C-arm maximum rotation is
always limited to ± 130°.

OPERATOR’S MANUAL
The mechanical indication given in drawings above

correspond to nominal values, they have a tolerance of
NOTE
±10% (depth) and ±1 mm (wide) due to the sum of overall
tolerance during assembling.
ANTI-X PROTECTIVE BARRIERS: DIMENSIONS AND WEIGHT (optional)
DIMENSIONS IN mm
Weight: 77 kg Weight: 105 kg

OPERATOR’S MANUAL
ACQUISITION WORKSTATION: DIMENSIONS AND WEIGHT (optional)
DIMENSIONS IN mm
Weight: 85 kg

OPERATOR’S MANUAL
PROTECTION AGAINST STRAY RADIATION
If examination room is not already provided with operator protection barrier, standalone
protective glass is available as accessory.
According to local regulation for radiological protection, the access to the equipment and to
the protected area must be restricted to the authorized personnel only.

OPERATOR’S MANUAL
SECTION 2:
CONFIGURATIONS

OPERATOR’S MANUAL
Digital Imaging and Communications in Medicine (DICOM) is a standard for handling, storing,
printing, and transmitting information in medical imaging. It includes a file format definition
and a network communications protocol. The communication protocol is an application
protocol that uses TCP/IP to communicate between systems. DICOM files can be exchanged
between two entities that are capable of receiving image and patient data in DICOM format.
DICOM enables the integration of scanners, servers, workstations, printers, and network
hardware from multiple manufacturers into a picture archiving and communication system
(PACS). DICOM has been widely adopted by hospitals and is making inroads in smaller
applications like doctors' offices.
DICOM consists of many different services, most of which involve transmission of data over a
network, and the file format below is a later and relatively minor addition to the standard.
MELODY III D C is classified FULL DICOM 3.0 MG; it means that this device implements the
totality of the Classes of Service provided for mammography.
Depending on the installation site and preferences, MELODY III D C can be configured as
described in the following pages.
Three different configurations are possible. The differences are based on the presence or not
of the DICOM net and on the supplying or not of the diagnostic station.

OPERATOR’S MANUAL
“FULL DICOM” CONFIGURATION
This configuration of the MELODY III D C can be used when a DICOM net and a remote
diagnostic station are already available on the installation site.
The mammography system, connected to the PACS, allows to open a study from the Worklist
(remotely generated); closing the study, the acquired images and all exam parameters are
sent to the PACS, synchronized with the Worklist and stored on the appropriate server of the
RIS. Then, the images can be examined and reviewed from remote diagnostic station.
If the DICOM Worklist server is out of service, the mammography system is anyway able to
work. In this case, the images and study data are stored in internal memory of computer.
When the normal functionality of the net is reactivated, the studies are newly synchronized
with the Worklist and stored on the server.

OPERATOR’S MANUAL
“FULL DICOM” CONFIGURATION + DIAGNOSTIC STATION
This configuration of the MELODY III D C can be used when a DICOM net already exists on
the installation site but there is not a remote diagnostic station specific for mammographic
review.
With the mammography system, set up as in the “FULL DICOM” configuration, is supplied
also a diagnostic station with a dual headed display system at very high resolution and a
review software dedicated to the mammography.
Mammography system and diagnostic software are both connected to the RIS/PACS servers.
The Software can be configured to use mammographic specific hanging protocol and reading
workflow. It displays also images from other modalities (digitized prior mammogram films,
breast US, breast MRI, breast NM, breast CT) and allows selection, display, manipulation,
markup, print composition and media exchange of breast images.
The software can be integrated with an optional Computer Aided Detection (CAD).

OPERATOR’S MANUAL
“mini-PACS” CONFIGURATION
This configuration of the MELODY III D C must be used when a DICOM net is not available
on the installation site.
MELODY III D C in mini-PACS configuration represents a complete individual island of digital
imaging. It has the form of a localized, modality-specific network of modalities and storage
directly connected to reading workstations without long-term storage or management.
Often, Full Field Digital Mammography (FFDM) request a similar approach, due to the large
image size, highly specialized reading workflow and display requirements.
Also in this case, the mammography system supports connections with all DICOM modalities.

OPERATOR’S MANUAL
SECTION 3:
MAIN PARTS DESCRIPTION

OPERATOR’S MANUAL
MELODY III D C MAIN PARTS
5
2
12
3
8
18
4
14
13
7
15 10 16
17
6
11
MAMMOGRAPHY UNIT

OPERATOR’S MANUAL
1. STAND
2. C-ARM
3. X-RAY TUBE
4. PROTECTIVE SCREEN
5. C-ARM ROTATION HANDLES (on both sides)
6. FULL FIELD FLAT PANEL DETECTOR 24x30 cm FORMAT
7. MAMMO UNIT SWITCH ON
8. LCD COLOR MONITOR (if provided)
9. COMPRESSION FOOT PEDALS
10. CONTROLLER FOR FINE MANUAL COMPRESSION (on both sides)
11. AUXILIARY DISPLAY
12. C-ARM ROTATION PUSH-BUTTONS
13. C-ARM UP/DOWN
14. EMERGENCY PUSH-BUTTONS (on both sides)
15. COMPRESSION PADDLE
16. WIRELESS KEYBOARD
17. CONNECTOR PANEL
18. X-RAY PUSH-BUTTON

OPERATOR’S MANUAL
MELODY III D C MAIN PARTS
1
2
5
3 12
18
4 13
10
14
7
15
16
6
17
11
MAMMOGRAPHY UNIT

OPERATOR’S MANUAL
1. STAND
2. C-ARM
3. X-RAY TUBE
4. PROTECTIVE SCREEN
5. C-ARM ROTATION HANDLES (on both sides)
6. FULL FIELD FLAT PANEL DETECTOR 24x30 cm FORMAT
7. MAMMO UNIT SWITCH ON
8. LCD COLOR MONITOR (if provided)
9. COMPRESSION FOOT PEDALS
10. CONTROLLER FOR FINE MANUAL COMPRESSION (on both sides)
11. AUXILIARY DISPLAY
12. C-ARM ROTATION PUSH BUTTONS
13. C-ARM UP/DOWN
14. EMERGENCY PUSH-BUTTONS (on both sides)
15. COMPRESSION PADDLE
17. CONNECTOR PANEL

OPERATOR’S MANUAL
ACQUISITION WORK STATION MAIN PARTS
22
21
20
19

21. LCD COLOR MONITOR
22. ANTI-X BARRIER

OPERATOR’S MANUAL
ANTI-X PROTECTIVE BARRIER WITH OPTIONAL MONITOR AND

KEYBOARD (Acquisition workstation)
The unit configuration available depends on the option

NOTE chosen. See paragraph “configuration available” in section
9: Accessories & optional parts, for more details
Mammo unit Acquisition work

station
Double configuration

OPERATOR’S MANUAL
AUXILIARY DISPLAY
1 2 3 6
deg cm N
CC MLO ML LM LMO FB SIO M
L R
XCC CV AT ID TAN S RL RM
5 4
1. C-ARM INCLINATION
2. COMPRESSED BREAST THICKNESS (mm)
3. SELECTED COMPRESSION FORCE (less bright)
REALLY EXERTED COMPRESSION FORCE (most bright)
4. LATERALITY L/R SELECTION
5. PROJECTIONS, PREFIXES AND SUFFIXES (ACR protocol)
6. COMPRESSION FORCE ADJUSTMENT

OPERATOR’S MANUAL
C-ARM MOVEMENTS KEYBOARDS
FOR MANUAL ROTATION VERSION A
Z150-dwg055-00
FOR MOTORIZED ROTATION VERSION A
1
ON BOTH SIDES
Z150-dwg056-00
1. UP/DOWN VERTICAL MOVEMENT

OPERATOR’S MANUAL
CONTROL PANEL (ACQUISITION SOFTWARE)
10 11
2
13
3
5
6 7 8 9 12

OPERATOR’S MANUAL
1. SELECTED TECHNIQUE (MANUAL, FULL AUTO, AUTO mAs)

2. FILTER DEVICE MODE AND ANODE/FILTER COMBINATION
3. SPECIAL PROJECTION SELECTION
4. PROJECTION (ACR protocol)
5. MAGNIFICATION RATIO
6. INCLINATION OF THE C-ARM (degrees)
7. COMPRESSED BREAST TICHKNESS (mm)
8. COMPRESSION FORCE (N)
9. DOSE INDICATION ( Average Glandular Dose)
10. kV VALUE
11. mAs VALUE
12. SELECTED FOCAL SPOT (AUTOMATIC)
13. COMPRESSION AUTOMATIC RELEASE ENABLE/DISABLE

OPERATOR’S MANUAL
KNOB FOR FINE MANUAL COMPRESSION
1
2
ON BOTH SIDES
1. ROTATING CONTROLLER (TO SELECT COMPRESSION FORCE OR TO ALLOW FINE
MANUAL COMPRESSION)
2. PUSH-BUTTON TO ACTIVATE THE FUNCTION:
 COMPRESSION FORCE TARGET SELECTION (ON)
 FINE MANUAL COMPRESSION (OFF)

OPERATOR’S MANUAL
FOOT-CONTROLS
1. COMPRESSION PADDLE DOWN

2. COMPRESSION PADDLE UP
3. FAST RELEASE
CONNECTOR PANEL
1. UPS SWITCH ON 2
2. RX PUSHBUTTON CONNECTOR
3. LAN 3
4. USB
5. FOOT-CONTROLS CONNECTORS 4
(one for standard configuration)
5
OPTIONAL

OPERATOR’S MANUAL
SECTION 4:
GENERAL OPERATIONS

OPERATOR’S MANUAL
EXAMINATION ROOM
X-Ray units can only be operated inside dedicated room provided with X-ray protection that meets
local standards and regulations.
RELEVANT INSTRUCTIONS BEFORE INITIAL START-UP

The initial start-up must be performed only the Technical Service or by a person authorized by the
manufacturer.
In case of first installation, the Technical Service or the person authorized has to follow the specific
instructions contained in the Service Manual.
SWITCHING ON
Before switching ON the unit, check that all emergency

WARNING
push buttons are unlocked.
Verify that switch on the wall is ON.

Switch ON the Wireless keyboard.
1. Switch ON internal UPS by means back side push button n°1 on connector panel (see
the dedicated paragraph) with integrated lamp, lamp is bright when UPS is ON.
2. Switch ON the unit by means of push button n°7 (see paragraph “main parts”), system
initialization procedure is performed automatically.
The procedure is detailed in chapters 3-5 of technical manual.

OPERATOR’S MANUAL
The software runs automatically. At the beginning, it shows a thermo graph with temperature
room trend in the time. If room temperature exceeded upper or lower limits, according to the
range fixed with detector on board, an error message appears (refer to Section 7:
Maintenance).
Lens buttons let to the user to zoom in or zoom out the
NOTE thermo graph. The two red lines in the thermo graph window
indicate the acceptable temperature range of FFDM unit
The thermo graph window disappears in few second, then the home page of DME (Digital
Mammography Equipment) launcher is shown.
The DME Acquisition Software start automatically (after 10 seconds).

OPERATOR’S MANUAL
The operator can select the fast launch of DME Acquisition software clicking on icon at the
middle of display.
DME Acquisition
DME Toolkit
Do not click on the icon located on the lower left corner of the display (crossed tools), this is a
service function only for technicians.
If the operator wrongly clicks on the icon DME Toolkit, he can easily return on the main menu
clicking on the following icon, located in the upper right corner of the next window:
During system initialization, after the DME Acquisition software launch, the unit checks the
presence and the functionality of all devices and components to which is connected.

OPERATOR’S MANUAL
If one of the following warning icons appears, start sequence will proceed after clicking “OK”
on both icons.
If both icons are displayed, switch off the unit and restart it again.
The unit will not be usable for normal use e.g. image acquisition as evident by the lower bar
shown below:

OPERATOR’S MANUAL
After about 5 minutes, the User Interface is shown on display of acquisition Software and a
green message on the down bar reveals that mammography system is “ready” to use.
BLACK OUT
The unit is provided of Intelligent Power Management (IPM) with Automatic shutdown
capability.
During a black out, the operator is advised by an audible sizzle noise and by a series of four
short beeps emitted by UPS every 30 seconds. Beeps become continuous when the battery
is low and it is about to switch off.
In case of intermittent or permanent black out there is no need of closing the study in
progress and manually shutting down the unit, it will be done automatically on low battery
condition (manufacturer set 50% percentage of battery charge as lower limit for automatic
shutdown) .
If blackout persist, please switch off the UPS for saving the
NOTE
remaining battery charge after automatic shutdown.

OPERATOR’S MANUAL
If necessary, percentage of available battery charge (%) can be read by clicking on the
specific icon of Windows OS
During black out no C-arm movements, compression and exposure are possible.
Emergency patient release is possible by means of fast unlock of compression paddle holder
as described in section 4: General operation - “Emergency patient release”
When the emitted beeps become continuous, the UPS has
WARNING only one minute of autonomy.

OPERATOR’S MANUAL
SWITCHING OFF
Verify that any study, open locally or from worklist (see Section 7 of this manual), is closed.
Switch OFF takes place in two steps:
1. Close DME Acquisition software clicking on red icon located on the upper right
corner of the display.
1 2
2. Switch OFF the mammography system by clicking again on the upper right
corner of the display.
Never switch OFF the UPS system while mammography

WARNING
unit is switched ON.
Periodically, do not switch OFF the UPS to recharge internal

NOTE
battery. Typical charging time is 8 hours.
Do not leave the system permanently ON to avoid an useless

dust collection on fans filters and a shortening of detector life (see
NOTE
also Section 8: Maintenance).
Switch OFF the keyboard to preserve battery life.

OPERATOR’S MANUAL
EMERGENCY PUSHBUTTONS
There are two emergency push-buttons on the MELODY III D C, one on each side of the
Mammography Unit (n° 14 – paragraph “Main Parts”).
In case of emergency, to immediately stop any movement and disable HV generator, press
one of the emergency push buttons.
The following message appears immediately when the emergency pushbutton is pressed:
Once the emergency has been solved, before to re-use the mammography system, it’s
necessary to follow these steps:
 turn the Emergency push-button (one-quarter rotation) to restore it;
wait 30 seconds until power to motors and HV generator is restored.
If the above error message is not due to emergency

pushbutton call for service.
NOTE
After each emergency pushbutton reset, allow 35
seconds before moving C-Arm and making exposure.

OPERATOR’S MANUAL
C-ARM MOVEMENTS
All movements UP/DOWN and rotation are disabled when compression force is applied.
On the MELODY III D C the C-Arm rotation is isocentric. It allows all breast projections
without moving the patient and without adjusting the height of the C-Arm.
C-ARM VERTICAL TRASLATION

The operator can move vertically the C-Arm by means of the buttons n° 13 (paragraph “main
parts”).
“ ” = UP “ ” = DOWN
C-ARM ROTATION
Manual rotation is available operated by means of push button n°12 (see paragraph “main
parts”). The mammography unit has a safety system with a sliding clutch calibrated on a
limited force to avoid any lesion or damage if C-Arm during rotation runs into a person or an
object.
MELODY III D C version has limited rotation +/-130°.
OPTIONAL MOTORIZED ROTATION
The rotation is available operated by means of push button n°12 (see paragraph “main parts”)
PRE-SELECTABLE ANGLES (buttons n° 2 - paragraph “C-Arm Movements Keyboard”)
With a single pressure on “CC” button the C-Arm rotates automatically to “0°” angular position
(factory default).
With a single pressure on “LAT” or “ OBL” button the C-Arm rotates automatically at pre-
selected angular positions.

OPERATOR’S MANUAL
The default angular position settings are:
“CC” = 0°
“OBL CCW” = - 45° “OBL CW” = + 45°
“LAT CCW” = - 90° “LAT CW” = + 90°
When the C-Arm is being automatically rotated, the
NOTE movement may be immediately stopped by pressing any

“LAT”, “ OBL”, “CC” button.
Pre-selectable angles can be modified by a procedure described in Technical Manual.
FINE ADJUSTMENT ANGLE (buttons n° 3 - paragraph “C-Arm Movements Keyboards” and

buttons n°12 – paragraph “Main parts”)
A continuous pressure of “CW” or “CCW” buttons rotates the C-arm in ±180° (±130° for
isocentric C-arm) range respect to 0° position.
“ ” = CW “ ” = CCW
(continuous rotation) (continuous rotation)
After a rotation movement on a pre-selected angle (“LAT” or “OBL”) the operator can adjust
the C-Arm inclination pressing the Fine Adjustment angle buttons”.
In this case, the pressure of opposite “OBL” button activates the C-Arm rotation at the
opposite position respect to Fine Adjusted angle.
The rotation angle and the standard code of mammography view (according to ACR
standard) are shown on all displays.

OPERATOR’S MANUAL
deg cm N
L R
C-ARM ROTATION FOR STEREO BIOPSY (only for MELODY III D C

equipped with SBD FFDM)
The MELODY III D C (equipped with isocentric C-Arm) is upgradable with the Stereotactic
Biopsy Device (SBD FFDM)
The stereographic exam permits to calculate the exact three-dimensional coordinates X, Y, Z
of a breast lesion detected with a general diagnostic exam.
Before inserting SBD FFDM, it is necessary turn off the Mammo Unit and only after the
insertion it has to be turned on.
C-Arm can be positioned at the most appropriate inclination and height to reach the lesion
inside the breast by means of the UP/DOWN and Rotation push buttons provided for normal
use.
After positioning the lesion in correspondence of the window of SBD FFDM compression
paddle, two exposures are carried out with the x-ray source at -15° (Right) and +15° (Left)
with respect to the reference axis of the system.
Right means that acquired images is on the right respect SCOUT

position, Left means on the left. In right position the C-arm is
NOTE
rotated of -15°C respect the operator/patient placed in front of it.

OPERATOR’S MANUAL
RIGHT SCOUT LEFT

±15° inclinations of C-Arm respect to SBD FFDM axis are motorized and can be operated by
means of dedicated virtual pushbuttons displayed on control panel by the acquisition
software.
When the stereotactic biopsy device BYM-3D FFDM is

installed on Helianthus C Bym the C-Arm maximum
NOTE
rotation is limited to ± 90°, as shown in the following figure.

OPERATOR’S MANUAL
“S” = SCOUT
“R” = RIGHT “L” = LEFT
Three pushbuttons are provided: SCOUT, RIGHT, LEFT.

When SBD FFDM is inserted, C-Arm vertical movement and rotation are disabled and only
+/-15° rotation for stereo views is possible.
If C-Arm position has to be changed, safety interlock switch on board of SBD FFDM NPU has
to be activated (for further details see Operator’s Manual MO_SBD-FFDM-UXX).
At Power ON C-Arm returns automatically at SCOUT

position. After Bym-3D FFDM removing the C-Arm returns
WARNING
automatically at SCOUT position.

OPERATOR’S MANUAL
COMPRESSION PADDLES INSERTION AND REMOVAL
To insert a compression paddle tighten the internal knobs of locking system in order to retract
the four pins.
Place the compression paddle on locking system and release the knobs to lock it.
To remove compression paddle tighten the internal knobs of locking system and pull it.

OPERATOR’S MANUAL
In order to examine a small/medium breast in lateral projections is available a 18x24 cm

compression paddle with lateral shifting.
TO LEFT TO RIGHT
To move the compression paddle with lateral shifting from middle to right or to left push it
towards desired direction. The paddle stops into place with an audible click.
Using the 18x24 cm compression paddle with lateral shifting,
NOTE the acquired image is conveniently resized and displayed in

18x24 cm format
Using a 24x30 cm compression paddle to examine a
NOTE small/medium breast, the acquired image isn’t resized and is

displayed in 24x30 cm format
The above described removal of compression paddle allows

also a fast mechanical unlock and then an emergency
NOTE decompression of breast in case of power failure or in case of

patient physical discomfort, to guarantee her maximum
safety.

OPERATOR’S MANUAL
BREAST COMPRESSION SYSTEM
The mammographic unit is equipped with an advanced compression system.

The breast compression can be motor driven or manual with fine adjustment.
In case of motor driven compression, function of tissue strength evaluation (FTSE) allows to
modulate the force depending on breast density.
Motor driven compression
The compression force can be set by Control Panel by means of buttons n° 8 (see the
paragraph “Control Panel”) or rotating the encoder for fine manual compression (see the
paragraph “controller for fine manual compression”) after having activated the function by
means of push-button n° 2.
The selected value (in N) is shown on all displays:
deg cm N
L R
The range of compression can be set from 70 to 200 N by means of internal setting.
Motorized compression is operated by the foot –controls n°9 (see the paragraph “Main
Parts”).

OPERATOR’S MANUAL
1 3
Pushing the pedal n°1 (see the paragraph “foot control for motorized compression”), the
compression paddle goes down with a speed that decrease at a certain height from the table.
When the compression paddle comes in contact with the breast, it has a very brief stop and
start to apply an increasing force.
With the function of Tissue Strength Evaluation FTSE, a microprocessor checks the breast
tissue strength.
 if the breast is soft, the compression force increases up until value set by the operator.
 if the breast is dense, the compression force stops to 100 N. In this case, the operator
can proceed the compression up until the force value set releasing and pushing again
the pedal n°1.
If the operator release and push again the pedal n°1, the compression force increases
up to the maximum value set (200 N).
Pushing the pedal n°2, the operator reduces the compression force.
Pushing the pedal n°3, he operates a fast release of breast compression.

OPERATOR’S MANUAL
Manual compression with fine adjustment
Manual compression is possible acting on the controllers placed on both sides of C-arm.
The continuous rotation of the controller n° 1 in a direction (see the paragraph “Controller for
fine manual compression”) allows to bring down the paddle, touch the breast and press it until
to reach the desired force value. The compression force can increase up to maximum value
set (200 N).
The continuous rotation of the controller n° 1 in the other direction (see the paragraph
“controller for fine manual compression”) allows to rise the paddle reducing the force.
In any time, the operator can pass from motor driven to manual compression and vice versa.
The force really exerted on the breast at the end of compression is shown both on the display
of control panel and on the auxiliary display.
Compression release
There are two different operating modes for compression release at the end of the exposure:
- AUTO SOFT RELEASE (normal mode)
- MANUAL RELEASE (for 2D breast biopsy)
The operator can choose the release mode on control monitor by means of button n° 7 (see
the paragraph “Control Panel”). The selected mode is shown on the area n° 6 of the display.
Auto release enabled Auto release disabled

OPERATOR’S MANUAL
When necessary and when it is present, is possible to rise quickly and automatically the
compression paddle, pushing the button n° 3 of foot-controls (in case of motorized
compression).
In case of power failure and breast just under compression, the operator may get free the
patient using the fast mechanical unlock as described in the previous paragraph
“Compression Paddle insertion and removal”.
In case of power failure: backup battery is provided to maintain the

compression of the patient’s breast. The compression release is
NOTE
possible by pushing the n°3 of foot-control. This operation will
move upwards the compression paddle.
In case of emergency stop or black out with breast under
NOTE compression to operate a fast release of breast, push the button

n.3 of the foot-control
In case of power failure of mammography system with breast under compression, the
operator may get free the patient using the fast mechanical unlock.
To remove compression paddle tighten the internal knobs of locking system and pull it.

OPERATOR’S MANUAL
LIGHT BEAM INDICATOR
CAUTION Don’t watch directly the collimation lamp
Every time the compression down pedal is used, the luminous field indicator light switches on
for about 20 seconds. The compressor paddle goes down with a little delay, so that if the
breast is already compressed the operator can switch on the light, avoiding additional
pressing. The compression movement is immediate when the light beam is already on.

OPERATOR’S MANUAL
AUTOMATIC COLLIMATION DEVICE

The unit is provided with an automatic collimation device. With 24x30 cm detector, inserting
device for geometric magnification, system automatically selects the suitable collimation field
(10x14 cm).
With 24x30 cm detector, using the 18x24 cm compression paddle with lateral shifting, the
acquired image is conveniently resized and displayed in 18x24 cm format.
DEVICE FOR GEOMETRIC MAGNIFICATION (VARIABLE 1.5x/2x)
Magnification ratio 1,5x or 2x is selected by pulling the two lateral spring-loaded plungers at
the same time, and fix table height at requested position. Release the plungers and verify that
locator pins lock the device for geometric magnification.
Inserting the device for geometric magnification, small focus

NOTE
and collimation field are automatically selected.

OPERATOR’S MANUAL
PROTECTIVE SCREEN
Mammography unit is provided of a protective screen to keep patient’s face and extraneous
parts (i.e. shoulder, earring, hairs, etc.) out of X-Ray beam. The presence of extraneous parts
in the image filed negatively affects the functioning of presentation algorithm, with impact on
breast border recognition, worse contrast and dynamic range.
In order to fix the protective screen, insert the rear side of his frame in the guide ways under
the X-Ray window and push the protective screen reward to lock it.
To remove the protective screen pull it frontward to unlock.
The protective screen is not intended for magnification

NOTE
techniques.

OPERATOR’S MANUAL
FOCAL SPOT SELECTION
On MELODY III D C the selection of focal spot is automatic; large focus with Potter-Bucky
and small focus with device for geometric magnification.
No manual selection allowed.
The selected focal spot is shown on control panel.
Large Focus Small Focus
RADIOGRAPHIC EXPOSURE
Radiographic exposure is allowed only when study is open from Acquisition Software and
breast is compressed. Otherwise error messages like “Open study first” or “Apply
compression force” alarm will appear.
In semi-automatic and fully automatic exposure technique (see Section 5 of this Manual), the
pre-exposure pulse is announced by a short sound signal and by a bright signal (see
paragraph “Control Panel”).
Exposure is announced by a long sound signal and by a bright signal on control panel (see
paragraph “Control Panel”).
After X-ray pushbutton is pressed there’s a few delay, depending on the detector
synchronization, before the tube starts running.
If the X-ray pushbutton is released, the X-ray emission stops immediately.
At the end of exposure, the compression is released (with the function “Auto release”
enabled) and the paddle rises automatically.

OPERATOR’S MANUAL
DOSE CALCULATOR
The MELODY III D C mammography unit automatically provides calculated values of the
Average Glandular Dose (AGD).
After each exposure, the dose in mGy is stored in the DICOM header and total dose is
displayed in real time after any exposure on the Operation Bar (Menu Panel of Acquisition
Software).
For proper dose calculator operation, it’s necessary to use the appropriate compression
paddle as described in the chapter “Typical Configurations”.
Shifted paddles have to be used with large focus and straight paddles with small focus
because focal spot to skin distance measurement depend on it and dose calculation too.
OPERATING AND ERROR MESSAGES
All the functions of MELODY III D C Mammography System are controlled by microprocessor
with unique safety features. The monitor shows textual error messages (in several languages
selectable in installation phase) related to an acoustic signal.
OPERATING ERRORS
APPLY COMPRESSION FORCE
Before making exposure breast must be compressed and compression force must be higher
than 0
BREAST THICKNESS OUT OF RANGE

Compressed Breast Thickness is more than 15 cm. It could depend by patient selection (out
of intended use) or compression procedure. In that case, refer to technical service.
DOOR OPEN
Close the door of diagnostic room.

OPERATOR’S MANUAL
EARLY PUSH BUTTON RELEASE

X-ray pushbutton button has been released before the exposure has been terminated by
CPU. kV and mAs released will be displayed
OPEN STUDY FIRST

Before making exposure open patient study from Acquisition Software.
TECHNIQUE NOT ALLOWED

Compression without Potter-Bucky(study open)
TUBE THERMAL LIMIT REACHED

90% of the maximum thermal capacity of the X-ray tube has been reached: exposure not
allowed until said value is sufficiently reduced through dissipation.
C-ARM SAFETY ENGAGED

Switch off Mammo unit and call technical Assistance.
MOVE C-ARM UP
Only for ISO C_ARM move UP to avoid collision with floor when rotating more than 130
degrees to Caudo Cranial position.
REMOVE COLLIMATOR
Additional magnetic collimation plate must be removed for a proper operation of current
operating configuration
EMERGENCY PUSHBUTTON ACTIVATED
Emergency RED pushbutton/s has been activated; C-arm movements, compression and
exposure are disabled. Emergency pushbutton/s require a manual action for restoring normal
position and normal operation will be available after 30 seconds delay.

OPERATOR’S MANUAL
MAINS UNSTABLE
Mains unstable message appears when the supply conditions are not satisfactory because
supply voltage is low or supply voltage is unstable. The operative conditions are not
guaranteed with this error message.
ERROR MESSAGES
DMELauncher
Thermo Alert (optional)
In case of this kind of warning message please follow the instruction shown and turn off the
unit. Numbers and message shown are purely illustrative
In case of this kind of warning message please follow the instruction. Numbers and
message shown are purely illustrative

OPERATOR’S MANUAL
All other messages are technical errors, for which operator

can only restart the machine, and if the problem persist,
NOTE
technical support must be called.
Click “OK” to reset error if the reason for it has been removed.
If not, after few seconds, it will show up again except for messages related to power
problems or black out for which error messages, if persistent, will not show up again after first
reset but only when attempting to star x-ray exposure.

OPERATOR’S MANUAL
SECTION 5:
EXPOSURE TECHNIQUES

OPERATOR’S MANUAL
MELODY III D C has three different Exposure Techniques:
EXPOSURE TECHNIQUE ADJUSTABLE PARAMETERS
 20-35 kV std. or 20-40 kV (optional)

 mAs (1-640)
Manual
 Filter: FIX Rh
FIX Ag
 Mode: PRE (based on breast density)

FAST (based on breast thickness)
Fully Automatic (Full Auto)  Filter: AUTO (Rh/Ag)
FIX Rh
FIX Ag
 Mode: PRE (based on breast density)

FAST (based on breast thickness)
 20-35 kV std. or 20-40 kV (optional)
Semi-Automatic (Auto mAs)
 Filter: AUTO (Rh/Ag)
FIX Rh
FIX Ag
To select the Exposure Technique, press repeatedly the button n° 5 (paragraph “Control
Panel”) on mammography unit or click on the button n°1 (paragraph “Remote Control Panel”)
on Acquisition Software.

OPERATOR’S MANUAL
MANUAL MODE
In manual mode the operator can select kV and mAs in the appropriate range allowed. The
unit takes care automatically of max tube loading conditions.
Manual mode selected is shown by small round hand-shape icon, as shown below:
In manual mode the exposure parameters (kV and mAs) can be selected on the control panel
of the Acquisition Software, clicking on the arrow icons shown below:
The kV values change through 0.5 kV steps. The selectable standard range is 20 ÷ 35 kV
(20-40 kV optional). The mAs values change in log scale.
A Fast selection of mAs and Kv can be used in manual mode holding down the left button of
keypad or the button on arrow icons shown below:
Fast increase of kV or mAs
Fast decrease of kV or mAs

OPERATOR’S MANUAL
Manual mode is not recommended for normal use.

Patient dose is not guaranteed within recommended dose
NOTE
limits as is for the following AEC mode. Use it only for
special applications, under operator’s control.
AUTOMATIC EXPOSURE MODE
The Automatic Exposure mode (AEC) is the normal operating mode of the unit, having Full
Auto (kV, mAs) and Auto mAs (manual kV and automatic mAs) modes.
Exposure parameters are defined by two different techniques as follows:
 PRE-exposure technique is based on breast density identified by means of a short X-
ray pre-exposure. Breast density is averaged over a mosaic of 96 sensitive areas and
exposure parameters (kV, mAs) are selected accordingly.
 FAST exposure technique is based on compressed breast thickness and kV, mAs are
selected accordingly.
Manual, Auto mAs, Full Auto, Pre/Fast are selected by means of pushbuttons below, modes
and techniques currently selected are shown by means of small round hand-shape icon:

OPERATOR’S MANUAL
Exposure parameters in Automatic mode
Exposure parameters and Dose are automatically selected in order to full fill the EUREF
Protocol limits.
AGD in mGy and W/Rh Anode/filter combination: W/Rh
AGD in mGy and W/Rh Anode/filter combination: W/Ag

OPERATOR’S MANUAL
Pre and Fast techniques are provided to manage specific conditions as follows:
 Pre is the standard technique for screening and is also recommended for post surgical
intervention examination for which compression force could be painy or dangerous.
 Fast is highly recommended for breast inplant being kV and mAs, thickness related.
Do not use Pre with breast inplant.

Do not use Fast with light compression force.
WARNING
In both cases, Dose released will be too high and resulting
image most probably unusable.
AUTOMATIC FILTER DEVICE Rh/Ag
The automatic filter Rh/Ag provides the most appropriate ANODE/FILTER (W/Rh-W/Ag) to
guarantee the lowest Dose to the patient.
W/Rh anode/filter combination is the standard for small and medium breasts.
W/Ag anode/filter combination is provided for large or dense breast.
Trip point after which W/Ag combination is selected, corresponds to combination of thickness
and density corresponding to about 6 cm of RMI Tissue Equivalent phantom.

OPERATOR’S MANUAL
Anode/filter combinations
Anode/Filter combinations are selected automatically and combination used for the last
exposure will be shown at the right side of the icon of Control Panel.
Manual selection is possible by means of below pushbutton of Control Panel:
Selected mode will be shown at the right side of the icon of Control Panel:
Manual mode can be used to fix Anode/Filter combination

in order to guarantee the same for all the images of the
NOTE
study in case after the first image a condition close to the
trip point Rh/Ag is identified by the operator.

OPERATOR’S MANUAL
SECTION 6: TYPICAL
OPERATING
CONFIGURATIONS

OPERATOR’S MANUAL
The different exposure techniques available with mammography unit MELODY III D C are
shown in the next six pictures.
Each exposure technique has a unique combination of

table, collimation device, compression paddle, focal
NOTE
spot, magnification device etc.
Use of different configuration can result in operating

error messages, bad images with unwanted artifacts
due to compression paddle arms in the picture, wrong
WARNING
x-ray field coverage, wrong dose measurement and
others.

OPERATOR’S MANUAL
MELODY III D C 24x30cm FORMAT

CONFIGURATION FOR STANDARD EXAMINATION (LARGE BREAST)
LARGE FOCUS
PROTECTIVE SCREEN
24x30 cm FORMAT SHIFTED

COMPRESSION PADDLE
24X30 cm FORMAT
POTTER-BUCKY
Use of shifted compression paddle makes pulling of the breast

NOTE
easy.

OPERATOR’S MANUAL
CONFIGURATION FOR STANDARD EXAMINATION (NORMAL BREAST)
LARGE FOCUS
PROTECTIVE SCREEN

COMPRESSION PADDLE
24x30 cm FORMAT
POTTER-BUCKY
Use of shifted compression paddle makes pulling of the breast

NOTE
easy.

OPERATOR’S MANUAL
CONFIGURATION FOR SPOT CONTACT EXAMINATION
PROTECTIVE SCREEN
18X24 cm FORMAT SPOT

COMPRESSION PADDLE
24X30 cm FORMAT
POTTER-BUCKY

OPERATOR’S MANUAL
CONFIGURATION FOR GEOMETRIC MAGNIFICATION
SMALL FOCUS
9X21 cm FORMAT STRAIGHT

COMPRESSION PADDLE
24x30 cm GEOMETRIC
Protective screen can’t be used with magnification techniques not

NOTE
having room enough to be fitted.
10x14 cm FORMAT collimation and selection of small focus are

NOTE
automatic with the insertion of geometric magnification device..

OPERATOR’S MANUAL
CONFIGURATION FOR BIDIMENSIONAL BIOPSY
0,3 mm
LARGE FOCUS
PROTECTIVEE SCREEN

COMPRESSION PADDLE
FOR 2D BIOPSY
24X30 cm FORMAT
POTTER-BUCKY

OPERATOR’S MANUAL
MELODY III D C 24x30 cm FORMAT
CONFIGURATION FOR STEREOTACTIC BIOPSY
STEREOTACTIC
BIOPSY DEVICE
SBD FFDM 24X30

OPERATOR’S MANUAL
SECTION 7: ACQUISITION
SOFTWARE OPERATING
INSTRUCTIONS

OPERATOR’S MANUAL
The MELODY III D C mammography system is a medical

equipment and PC of Acquisition Station should not be used
WARNING as a general purpose computer. Do not attempt to make any

change to system software and do not try to install
unauthorized software
The installation of a specific software (under the user

responsibility) to protect the Acquisition Software from virus
and spywares coming from the servers or external devices
WARNING connected by USB ports (i.e. portable Hard Disks, flash

drives, etc.) is highly recommended.
Antivirus exception list must be used during configuration,
refer to specific technical note.

OPERATOR’S MANUAL
1. STARTING THE ACQUISITION SOFTWARE

Switching ON the unit (see section 4: General Operations), the software runs automatically,
the software runs automatically, the mammography system is initialized, detector and
mammography unit are turned on.
A the end of tuning phase, after about 5 minutes, the User Interface is shown on display of
Acquisition Software and a green message on the down bar reveals that mammography
system is “ready” to use.

OPERATOR’S MANUAL
2. USER INTERFACE DESCRIPTION
The User Interface is configured in order to show information regarding the functionality of
mammography system and all applicable items.
It is divided in three areas: “Status Bar”, “Operation Bar” and “Menu Panel”.
Operation Bar
Menu Panel
Status Bar

OPERATOR’S MANUAL
2.1. Status Bar
The Status Bar is divided in five sections and includes a calendar with local time.
The first section indicates the “Status” of the device. The possible states are:
Message Meaning
Operational Normal condition. The system is ready and able to
make exposures.
Emission unavailable The mammography unit does not respond to the

signals of the Acquisition Software. The cause can
be that the connection with the mammography unit
is down, or simply the mammography unit is
switched off, or technical problems. If this message
appears in the Status Bar, the “Mammo tool” menu
in the Main Menu is not selectable. In this case the
“Mammo tool” menu should be not available and
grey-colored.
And/or
The detector does not respond to the signals of the
mammography unit. The reasons can be that the
connection with the detector unit is down, or simply
the detector is switched off, or technical problems.
The second section indicates the operating state of the device. The possible states are:
Message Meaning
DICOM Normal operating mode; the connection of the
mammography unit from and towards the outside
(DICOM net or Diagnostic Subsystem, depending on
the configuration) is working correctly.
Local A problem is occurred to the connection from and

towards the DICOM net. The problem can be due,
for example, to the PACS of the medical center that
is temporarily not available, or to the connection
cable. In this case the menu button “DICOM” has a
question point on. In this case it is not necessary to
stop working. Actually it is possible to continue
acquiring images and store studies locally, on the
internal memory of the computer, and when the
DICOM connection has been restored the studies
can be send to the PACS. In this state the MELODY
III D C does not recognize automatically that the
DICOM connection is available: to verify the
presence of the connection, click on the “DICOM”
menu button (having the question point on).

OPERATOR’S MANUAL
The messages of this section define the different

and successive phases corresponding to the Study
recording on a CD/DVD disk.
They automatically follow one other until the end of
the process. In this last phase, the indication
“Completed” will be displayed on the status bar
together with the message “Media can be safely
removed”.
The third section indicates if the mammography system is sending a study to a DICOM
server. The possible states are:
Message Meaning
First phase of building of the DICOM file.
Successive and progressive phases of sending to

the server.
The fourth section indicates the temperature of the detector:
The fifth section indicates the status of the detector. The possible states are:
Message Meaning
ready The detector is ready to receive the X-rays. This is
the normal condition when there is an open study
(and no elaboration is going on).
not ready The detector is not ready to receive the X-rays. After
the detector receives the X-rays and acquires the
image, it passes through this state before being ready
for a new exposure.

OPERATOR’S MANUAL
The following status diagram shows the sequence of states which the detector passes
through.
2.2. Operation Bar
The Operation Bar indicates data of study either current or loaded.
The Operation Bar contains also the button to log off the software.

OPERATOR’S MANUAL
2.3. Menu Panel
The Menu Panel includes the most important tools to operate with the Acquisition Software.
It includes four submenus: “Mammo”, “PC”, “Graphic” and “DICOM”.
MELODY III D C MELODY III D C
After switching the unit, during the initial tuning of the system, the menus are not available.
Then, all the menus are available, but two exception exist:

OPERATOR’S MANUAL
1. The “Mammo” menu is not available and is grey-colored

This state depends on the fact that the mammography unit does not respond to the
signals of the Acquisition Software. This event can occur if the connection with the
mammography unit is down or for other technical problems.
In such circumstance only Load study function is available, for loading and reviewing
studies from the local archive.
2. The “DICOM” menu is not available and all buttons of this menu are grey-colored
The problem can be due, for example, to the PACS of the medical center that is
temporarily not available, or to the connection cable that has been cut. Click on the
menu to verify if the connection with the DICOM net has been restored,. If after a few
seconds the question point disappears, the connection is available and it is possible to
open the menu clicking on it. Otherwise the question point persists and the menu is not
available. In this case it is not necessary to stop working. Anyway, it is possible to
continue acquiring images and store studies locally, on the internal memory of the
Computer, and when the DICOM connection is restored the studies can be sent to the
PACS.
A quick description of each menu follows; the functions are explained better in other sections
of this manual, or other chapters of this section.

OPERATOR’S MANUAL
 Mammo: it serves to set the exposure parameters, to choose the achievable dose
and to check the ACR view.
Clicking on upper side of Mammo menu the Control Panel appears, and related commands
are available.
Clicking on lower side of Mammo menu the operator can choose between “Low dose” and
“High contrast” operating modality.
Both modalities allow to obtain dose values less then established by European Guidelines;
the “High contrast” modality is preferable to view micro-calcifications, the “Low dose” modality
in preferable in screening or diagnostic routine exams in order to reduce X-ray emission to
the patient.

OPERATOR’S MANUAL
The button “Low dose/High contrast” is ever active, but is
NOTE preferable that all projections are performed with the same
operating modality to obtain the maximum omogeneity of images.
 PC: it serves to make operations on the local PC of the Acquisition Software.
By means of this menu it is possible to open new studies locally (i.e. not from the worklist),
save the studies locally (i.e. in the internal memory), reload the local studies (i.e. resident in
the internal memory), perform three-dimensional biopsy procedures (only on MELODY III D C
with isocentric arm). The functions are available depending on the status of the device.
Moreover, always by means of the PC menu, it is possible to insert the following information:
 Operator’s name;
 Institution’s name.
To allow this data integration: click on PC label (CTRL right + mouse double click), fill the
corresponding fields and then click on “OK” to save them:

OPERATOR’S MANUAL
The “Biopsy devices” function is available only on MELODY III D
NOTE C mammography system equipped with isocentric arm. Regarding

the use of this function, refer to “SBD FFDM Operator’s Manual”.
 Graphic: this menu serves to manipulate the images shown on the display.

OPERATOR’S MANUAL
It is used to select the images to display, to position them in a desired layout. The
functions are available only if there is a study open (from worklist or locally) or loaded,
otherwise the menu is partially disabled.
 DICOM: this menu includes all the commands of the Acquisition Software that
involve DICOM functions.
It is used to open and close a study from the Worklist, send studies stored on the local PC
to an appropriate server of the RIS, change the exam typology of the study, integrate a
study with other images, print images and make CD of the studies according to the
DICOM protocol.
The menu functions are available depending on the state of the device. In particular, the
menu items are available or not if there is a study presently open, or there is a study
presently loaded, or nothing.

OPERATOR’S MANUAL
3. OPENING STUDY
To acquire radiological images, it is necessary that a new study is opened either from the
Worklist (that is remotely generated), or from the local data storage system using the
Acquisition software.
The normal operating mode is opening the study from the Worklist, but if the patient’s data
are not available from the Worklist (as for example because the DICOM Worklist server is out
of service), the unit is able to work: the acquired images and the data of the study are stored
in its internal memory.
When the connection with the Worklist server is restored, the data previously memorized in
the internal memory of the local PC are sent to the PACS and synchronized with the Worklist.
Then the memory of the local PC gets free.
To open a study from the Worklist, it is necessary to know the functions of the “Worklist
Query Dialog” window. To open a study from the local database, it is necessary to know the
functions of the “Study Data” window.

OPERATOR’S MANUAL
3.1 Opening study from Worklist
3.1.1 Remote Worklist
To open a study from the Remote Worklist, click on the “Worklist” button and a new submenu
appears.
Clicking on “Remote” button, a “Worklist Query Dialog” window will appear, the Software
automatically will ask the Worklist to the configured server and it will be possible charge data.

OPERATOR’S MANUAL
The window is subdivided in three different sections:
Section Title Function

Remote Worklist Server To choose the worklist server by
1 means of a combo-box.
Query Parameters To filter the data provided by the
2 worklist server.
Result It shows the results of the query.
3 Any row represents a scheduled
study and contains its main
information.
To open a study from the worklist, first of all it is necessary to query the worklist server to
obtain the data. For this scope, it is necessary to set the query parameters using one or more
fields present in the “Query Parameters” section.
It’s possible choose between:

 From/To: click on the box near the field “From”, “To” or both and change the time
references in order to select the period of the acceptance date in which the results
have to be researched.
 Patient name: pay attention to insert the name exactly as it was inserted in the
worklist.

OPERATOR’S MANUAL
 Patient ID: identification number.

 Issuer of Patient ID: identifier of the Assigning Authority (system, organization, agency,
or department) that issued the Patient ID.
 Patient sex: the possible chooses are F (female), M (male), O (other)
 Patient Birth date
 Scheduled Station AE Title: modality on which the Scheduled Procedure Step is
scheduled to perform. This field is empty until an information will be inserted. After
every data entry, the information will remain automatically saved and it will be still
present at the following Worklist Query.
If you do not want set any parameters for this field, it’s
NOTE necessary, before clicking on the button “Worklist Query”, delete

any information just present inside it.
 Modality: the modality for mammography is MG

 Scheduled Performing Physician’s Name: if the acceptance of the medical site
schedules the name of the physician who will perform the exam, it is possible to filter
the worklist by means of this information.
 Requested Procedure ID: when the acceptance creates and inserts a new study in the
worklist, this information is automatically created and associated to the study. It is
possible to filter the query to the worklist server with this information.
 Requested Procedure Description: this field identifies the kind of procedure (for
example 4 views ACR CC…...)
 Accession Number: when the acceptance creates and inserts a new study in the
worklist, this information is automatically created and associated to the study. It is
possible to filter the query to the worklist server with this information.
Once set the parameters, click the button “Worklist Query” and all search results will be
presented.

OPERATOR’S MANUAL
To open a study double click on the corresponding row or select it and press the button
“Done”. If you want to exit without opening any study, do not select any row and click “Done”.
To open more studies in automatic mode, it is sufficient to select all their correspondent rows
and then press the button “Done”.

OPERATOR’S MANUAL
In this way, the selected studies from remote Worklist will be automatically and sequentially
opened when closing the previous one.
If a query to the worklist server does not provide any result,
NOTE verify that the windows of the query parameters section are
correctly filled in.
The Acquisition Software loads the data of the patient, and the Operation Bar shows the data
of the currently open study.

OPERATOR’S MANUAL
3.1.2 Local Worklist
To open a study from the Local Worklist, click on the “Worklist” button and a new submenu
appears.

OPERATOR’S MANUAL
Clicking on “Local” button, a window will appear and the operator will be able to create a new
study without a Worklist item and perform an unscheduled IHE operation later.
To allow that any study locally generated and stored in the

local PC, later can be matched correctly to the
corresponding study of the worklist, take care to identify
WARNING clearly and univocally each study locally open.
The wrong association between studies stored locally and
studies of the worklist can cause wrong diagnosis and loss
of clinical information.

OPERATOR’S MANUAL
It is possible to identify the local study by means of the Accession Number.

In this case, select the related window and write the number in the box:
Additionally, it is possible to identify the local study also by means of an Other Patient ID.
In this case, select the related window and write inside it the other’s identification number or
code used to identify the patient univocally:
After fulfilling the form, click on OK button to open the study.
The Accession Number associated to the study is saved with the

study till it is present in the Acquisition Software. When the local
study will be associated to a Worklist request and transferred to
NOTE
the RIS, the accession number will be deleted and the data
associated to the mammograms will be the ones supplied by the
Worklist.


OPERATOR’S MANUAL
3.2 Opening local study
To open a study locally, click on the “Local Study” button of the “PC” menu.
Identify the study associating to it a unique accession number, then click on OK button.
Before acquiring images, it is possible to abort the study by clicking on the “Abort Study”
button of the “PC” menu. After the first image has been acquired, this button becomes
disabled.
Opening a local study, at the end of the study the data and
radiological images are saved only in the internal memory.
The study is not yet matched with the worklist request and
WARNING the images are not yet sent to the store server of the RIS.
To complete the work, making the information safe and
available, it is necessary to send the study to the RIS by
means of the DICOM menu, as explained in next chapters.

OPERATOR’S MANUAL
4. RADIOGRAPHIC EXPOSURE
With a study open (from the Worklist or locally, as explained in the previous chapter 3), it is
possible to expose the patient to the X-rays to acquire the diagnostic image. If there is no
study open, the exposure is not possible.
The operator must position the patient and then set the exposure parameters (operating
mode, kV and mAs) from the control panel of the mammography unit or from the control
panel of the Acquisition Software (as explained in the following paragraph 4.1).
After settings, the breast can be exposed by means of the X-rays pushbuttons on Acquisition
Software. The operator must press down them at the same time up to the end of acoustic
signal.
After few seconds for processing, the image is displayed by Acquisition Software and the
related Average Glandular Dose is reported on Operation Bar.
If the quality of image is good, the operator can proceed with the next exposure positioning
newly the patient and setting the parameters, otherwise will be necessary repeat the
exposure trying to obtain a better quality.

OPERATOR’S MANUAL
The new image is displayed on the main part of screen, meantime the overall dose of the
study is updated in real time on the Operation Bar.
Thumbnails of acquired images are displayed on upper bar in exposure order.

To change the image displayed: select another thumbnail and drag & drop it in the main part
of the screen.
The orientation of the image depends on the laterality: if the laterality set in the ACR code is
“R” (refer to the following paragraph 4.2), the image is shown with the nipple on the left side;
if the laterality is “L”, corresponding to the left breast, the image is shown with the nipple on
the right.
Repeat the steps “Position the patient – set the exposure parameters – expose – evaluate
the quality”, till the end of the views needed.

OPERATOR’S MANUAL
NOTE For any study the operator can acquire a maximum of ten images.
To review a previous exposure is enough to select the image clicking on its thumbnail.

OPERATOR’S MANUAL
4.1 Setting the exposure parameters
The exposure parameters (operating mode, kV and mAs, and anode/filter combination) can
be set on the control panel of the Acquisition Software.
To access the control panel of the Acquisition Software, click on the “Mammo” icon of the
Menu Panel. The control panel will appear to the side.
The operator must choose the preferred operating technique (Full Auto mode, manual mode
or Auto mAs mode), the operating modality (Low dose or High contrast) and choose the
values of kV and mAs. To make this operation refer to the previous section 5 “Exposure
Techniques”.

OPERATOR’S MANUAL
4.2 Setting the ACR code
The ACR code is a standard code created by the American College of Radiology (ACR) to
identify the view, the operating technique and other information of the mammographic image.
Any code is composed by three parts: the prefix, the name of the view, and the suffix.
The complete list of codes is:
A C R C O D E
PREFIX VIEW SUFFIX
CODE MEANING CODE MEANING CODE MEANING
R Right CC CranioCaudal ID Implant Displaced
L Left ML MedioLateral S Spot
M Magnification MLO MedioLateral RM Roll Lateral
Oblique
LM LateroMedial RL Roll Medial
LMO Lateromedial TAN Tangential
Oblique
FB From Below
SIO Superlateral to
Inferomedial
Oblique
XCC Exaggerated
CranioCaudal
CV Cleavage
AT Axillary tail
A complete ACR code that identifies an image contains at least the laterality (“R” or “L”) and
the view, while the other information are not mandatory. For example, to identify a
MedioLateral Oblique projection on the right breast, without other information, the complete
ACR code is:
RMLO
Some codes exclude each other, for example, the prefixes of the laterality “R” and “L” can’t
be present both in the same string. There are also codes that do not exclude any other code;
for example the code for magnification “M” can be present or not in any view. Each code of
the view exclude all the others, for example if a view is “LM”, it can’t be also “CC”, “ML”,
“MLO”, “LMO” etc.

OPERATOR’S MANUAL
The name of the projections can be identified by the following table:
R Righ breast; L Left breast

CC Craniocaudal CC Craniocaudal
Righ breast; Left breast;
R L
Exaggerated Exaggerated
XCC Craniocaudal XCC Craniocaudal
Left breast;
Righ breast;
Superolateral
R Superolateral L
to
SIO to Inferomedial SIO Inferomedial
Oblique
Oblique
R Right breast; L Left breast;

LM Lateromedial LM Lateromedial
Right breast; Left breast;

R L
Lateromedial Lateromedial
LMO Oblique LMO Oblique

FB From Below FB From Below

ML Mediolateral ML Mediolateral
Right breast; Left breast;

R L
Mediolateral Mediolateral
MLO Oblique MLO Oblique
AT Axillary Tail AT Axillary Tail

CV Cleavage CV Cleavage
The arrow represents the X-ray beam direction (from the tube
NOTE
to the detector).

OPERATOR’S MANUAL
The previous table is only a reference for the radiologist. For
NOTE the correct positioning and compression of the patient refer to

the ACR protocol or other official sources of information.
According to the DICOM standard, a mammographic image must have an header containing
many information, including the ACR code.
MELODY III D C is able to set some codes automatically, but other codes must be selected
by the operator. For example the insertion of the magnification device automatically sets the
code “M” in the prefix (Magnification); and the inclination of the C-arm automatically sets the
name of the view (but some of them depend also on the laterality, and others are not unique
and can be changed).
In the following list it is evidenced which codes are automatically selected and which not.
CODE AUTOMATIC SELECTION NOTES

L No
PREFIX
R No
M Yes, when the magnification device is
inserted
CC Yes, depending on inclination of C-arm
ML Yes, depending on laterality and inclination
of C-arm
MLO Yes, depending on laterality and inclination
of C-arm
LM Yes, depending on laterality and inclination
of C-arm
LMO Yes, depending on laterality and inclination
of C-arm
VIEW
FB Yes, depending on inclination of C-arm Available only for standard

C-arm
SIO Yes, depending on laterality and inclination
of C-arm
XCC No Manually set alternatively
to CC
CV No Manually set alternatively
to CC
AT No Manually set alternatively
to MLO
ID No
S Yes, when the magnification device is
SUFFIX
inserted
RM No
RL No
TAN No
OPERATOR’S MANUAL
The following circles show the sectors of C-arm rotation in which any ACR Code is
selectable:
IF THE LATERALITY IS “R” (RIGHT BREAST)
*: For the right breast the inclination of

the C-arm between -100° and -170°
should not be used, because it does not
correspond to any clinical view according
to the ACR protocol. However the LMO
code is selected.
IF THE LATERALITY IS “L” (LEFT BREAST)
*: For the left breast the inclination of the

C-arm between 100° and 170° should not
be used, because it does not correspond
to any clinical view according to the ACR
protocol. However the LMO code is
selected.

OPERATOR’S MANUAL
After positioning the patient, the C-arm inclination and the related default ACR code are
shown both on the auxiliary display and on the control panel of the Acquisition Software.
To set the laterality, click the little patient icon, highlighting the desired breast or push the
button on auxiliary display.
To set an alternative view (different from the default view) click on the ACR code. It changes
cyclically.
To set a further ACR code, select it from the list of the control panel of the Acquisition
Software or from auxiliary display.
After the X-ray exposure, the following message will be shown:
Answering “Yes” or “No”, the operator will confirm or not the previous selection.

OPERATOR’S MANUAL
Clicking on “Yes”, the laterality, chosen before the exposure, will be maintained.
Whereas, clicking on “No”, the SW will rotate the image automatically adapting it to the new
one and correcting, if necessary, the corresponding ACR projection.
The tag relative to the confirmed laterality, will be shown on the corresponding acquired
image as below:

OPERATOR’S MANUAL
After the confirmation, the operator will modify again the laterality
of an acquired image using the pushbutton “Change ACR
NOTE settings” (for a complete description, see the paragraph “5.5

Process, Info, ACR settings” , Section 6 of this operator’s
manual).

OPERATOR’S MANUAL
5. IMAGE TOOLS
When one or several images are displayed, it is possible to manipulate them in terms of
visualization as contrast, sharpness, zoom etc. It is also possible to visualize the desired
images choosing among the ones of the currently open study, and set up them in the
preferred position on the screen.
The modifications are not permanent: it is always possible to return to the initial visualization
by means of the “Restore Original” function. The manipulated images are never saved: the
copies of the images saved and stored are the same preexisting before the graphic
manipulation.
To manipulate the images shown on the display, the operator must open a pop-up menu
clicking with the mouse right button on the image

OPERATOR’S MANUAL

5.1 Display & Images
When a study is open (locally or from Worklist), and the images are obtained by exposing the
patient, they are visualized in the same order as they are acquired. The number of graphic
windows, in which the display is subdivided, increases as the images increase.
When a study is loaded from the local database, the display is soon subdivided in enough
graphic windows to contain all the images of the study. The order in which the images are
set-up in the windows is the same order in which the images have been acquired.
It is also possible to choose the number and position of the graphic windows in which the
screen is divided. And it is possible to position any image in any window, with the maximum
flexibility.
The “Display” submenu of the “Graphic” menu let you choose the number and shape of the
windows in which the screen should be divided.

OPERATOR’S MANUAL
From the “Display” submenu the operator can select the preferred number and shape of
windows to divide the screen clicking on the corresponding icon. For example, clicking on
“2x2”, the screen is divided as in the following picture.
Any window shows an image, otherwise is empty (black). It is also possible to insert the same
image in more than one window. The operator must drag and drop the same thumbnail to
several graphic windows and the same desired image will be visualized in the chosen
windows.
To understand how the graphic windows are engaged, suppose that they are numbered from
1 to 25 (25 is the maximum number of windows that can be shown at the same time). Any
display visualizes the windows from the number 1 to the number of the displayed images. For
example in the visualization “1x1” only one graphic image is visualized, and it is the number
1; in the visualization “1x2” two windows are shown, so they must be the number 1 and
number 2. And so on.
For example suppose that more than one graphic window is engaged, as for example six
graphic windows contain images.
Now if we choose to divide the screen in less graphic windows than the presently engaged,
for example we choose the “2x2” visualization, the windows remaining are the number 1, 2, 3
and 4, and they remain taken by the same images that were present before.
OPERATOR’S MANUAL
Now if we change again the number of windows visualized, the windows remain taken with
the same concept just explained.
Four further visualization exist: “ACR CC”, “ACR MLO”, “ACR x 4” and “USER”. This
visualizations serve to show the images of the right and left breast having the same ACR
view code. Selecting the “ACR CC” view, the screen visualizes the two images of the
CranioCaudal view for the right and left breast, as shown below.
Selecting the “ACR MLO” view, the two MLO images are visualized.
Selecting the “ACR x 4” view, the two CC and the two MLO images are displayed.
In this window select the checkbox corresponding to the couples of images that you want
see, than click OK. The couples of images selected will be visualized.

5.2 Fit to Window, Pan/Scroll, 1:1, Effective size, Lens
To access these functions right click with the mouse on the desired image. All the function
are active only for the window from which the pop-up menu has been activated.

OPERATOR’S MANUAL
The “Fit to Window” function changes the magnification of the image so that it is adapted to
the graphic window in which is contained.
The “Pan/Scroll” function is active only if the image is not fitted to the window. After selecting
that tool, move the mouse up and down keeping the left button pressed to scroll (i.e. move
the image upward and downward), and right and left to pan (i.e. move the image rightward
and leftward). The operator can use this function even during the execution of another
function by pushing [Alt] and clicking on image.
The “1:1” function visualizes each pixel of the detector on one pixel of the monitor.
The “Effective size” function makes the image displayed as the same size of breast when
exposed.
The “Lens” function opens a square window of 300 x 300 dpi where the image is magnified
with a ratio of 3x. The window can be positioned on any side of the image according to the
mouse position.
5.3 Set anchor point
This function is not activated yet .

OPERATOR’S MANUAL
5.4 Window/Level, Contrast, Histo, Restore original
To access these functions right click with the mouse on the desired image. All the functions
are active only for the window from which the pop-up menu has been activated.
The “Window/Level” function allows to modify contrast and brightness of image.

Click on “Window/Level” button and, keeping the left button pressed, move the mouse up and
down to increase/decrease contrast, or right and left to increase/decrease brightness.
The “Contrast” function allows to modify the contrast of image in a specific side of breast.
Clicking on “Contrast” button, a submenu appears.
Click on “High” button to set high value of contrast on thorax side; click on “Very High” button
to set very high value of contrast on thorax side; click on “Skin” button to set high value of
contrast at skin level; click on “Flat” button to undo all contrast changes; click on “Restore
original” button to go back to original image before any manipulation.

OPERATOR’S MANUAL
The “Histo” function allows to display the histogram of grey level distribution of the whole
image and of a selected range of the same.
Click on “Histo” button to open a window with two diagrams.
The upper diagram represents the grey level distribution of the whole image. The lower
diagram represents the grey level distribution of selected range in the above diagram.
In order to select the range click on the left or right edge of the above histogram window to
drag the rulers.
Then, click on “Apply” button to save changes or click “Cancel” button to exit.

OPERATOR’S MANUAL
The modifications applied by means of all the functions above

described (“Window/Level”, “Contrast” and “HIsto”), are
permanent and they will change also the images that will be
NOTE printed.
Operator is prompted to accept or not window level manual
changes when closing study.
In the DICOM fields visible on the review station, Window level/width is included.
In the upper left image default values of “Window level/width: 4096/8192”.
In the upper right image manually modified values of “Window level/width: 6574/9781”.
Images for which Window level/width has been manually modified and saved, will look
different in the same study.
5.5 Process, Info, Change ACR settings
To access these functions right click with the mouse on the desired image.

OPERATOR’S MANUAL
The “Process” function allows to modify some parameters of reconstruction algorithm in order
to enhance all structures and reducing noise to show the images on display of Acquisition
Software with a reading better quality.
Clicking on “Process” button, a submenu appears.
The operator can choose between five optimized algorithm for magnification, biopsy,
examination of surgical anatomical parts, examination of specimen and in case of metallic
clips, surgical makers or numerous clusters of micro calcifications.
Clicking on “Full image” button, the original image contrast is recovered.
Clicking on “Info” button, a window appears showing all DICOM data and parameters
regarding the selected image.

OPERATOR’S MANUAL
The “Change ACR settings” function allows to modify the preset viewing configuration.
Clicking on “Change ACR settings” button, a window appears showing the ACR settings
about the image from which the Pop-up menu has been reached.
.
View and laterality of image can be changed selecting new identification codes and clicking
on “OK” button to accept the new configuration.

OPERATOR’S MANUAL
5.6 Downsize to 18x24, Delete, Recover 24x30, Measure, Plot Line, Alt Images
To access these functions right click with the mouse on the desired image.
The downsize is automatically performed by the acquisition sw with 18x24 cm compression

paddle. In case of incorrectly size recognition can be used by the operator the “Downsize to
18x24” function that allows to downsize an acquired image to 18x24 cm format on a specific
region selectable by operator.
Clicking on “Downsize to 18x24” button a 18x24 cm rectangle appears. The operator may
move it with the mouse up to select the region of image under study in order to crop it.

OPERATOR’S MANUAL
Then clicking newly, a window appears to confirm the choice.
Clicking on “Yes” button, the image is downsized permanently.
An image downsized cannot be reconverted in original

WARNING
size
The “Recover 24x30” function is available only for the mammography unit with 24x30 cm
detector, when an images is incorrectly downsized to 18x24 cm format. It allows to restore
the original 24x30 cm format of acquired image.
Clicking on “Recover 24x30” button, the image is restored at original acquisition format.
The automatic downsize malfunctioning may depend on a
NOTE misalignment of compression paddle. If necessary, please

contact technical service

OPERATOR’S MANUAL
The “Delete” function allows to remove the selected image from the study transfer it in a local
storage.
Clicking on “Delete” button a 18x24 cm a window with 16 reason codes appears.
The operator must select the reason of deletion and clicking on “OK” the image will be erased
from the study.
The “Measure” function allows to take some measures on selected image.

Clicking on “Measure” button a Pop-up menu appears to choose between linear or area
measure.
Clicking on desired kind of measure, a little hand symbol appears on the image.
Click on one edge of the detail and drag the hand symbol till reaching the other edge of the
object to measure. Releasing the button, a window with the measurements results appears.

OPERATOR’S MANUAL

OPERATOR’S MANUAL
The “Plot line” and “Alt images” functions allow to make preliminary investigations on image
quality.
Clicking on “Plot line” button, a little hand symbol appears on the image.
Click on one edge and drag the hand symbol till draw a line. Releasing the button, a window
with a profile of the gray levels on the drawn line appears.
Clicking on “Alt images” button, the unprocessed image (RAW format before the application
of enhancement algorithm) is displayed.

OPERATOR’S MANUAL
6. CLOSING STUDY
For any study it is possible to acquire a maximum of ten images. If the maximum number of
images is reached, a pop-up message appears to inform the operator.
When the images acquisition is complete the operator must close and save the study.
If the study has been open locally (by means of the “Study Data” window), it is saved locally.
The study can be saved also on DICOM server in a second time by “Resend” function.
If the study has been open from the Worklist (by means of the “Worklist Query Dialog”
window), it is saved on DICOM server. A copy of the study is also saved locally for a time
configurable in installation phase.
At the end of time of local storage, all studies are erased from
NOTE
the Hard Disk.
6.1 Close Study (open from Worklist)
At the end of exam, clicking on “Close Study” button of “DICOM” menu a window appears to
allow to send and save study with data and images into store server.
However, if the connection is not available or the net is busy, data are stored locally and sent
to the server when connection is newly available.

OPERATOR’S MANUAL
6.2 Save Study (open locally from PC)
A study open locally is saved on the internal memory of local PC clicking on the “Save Study”
button of “PC” menu.
7. LOADING STUDY FROM PC
It’s possible to load the studies saved into the internal memory of local PC only for reading.
Clicking on the “Load Study” button of the “PC” menu a window appears with the list of
studies saved locally in the local PC.

OPERATOR’S MANUAL
Studies that were open from the Worklist (by means of the “Worklist Query Dialog“ window)
are displayed on light green background; the studies opened locally (by means of the “Study
Data” window) are displayed on orange background.
On those Studies, it is possible to do a search setting one or more parameters between the
following:
 Patient Name;
 Patient ID;
 Birthdate;
 Study Date
and checking the corresponding box on the right.

In particular, filled the data fields (one or both) of:
 Birthdate and
 Study date
will be displayed all the Studies with date corresponding or following the selected one/ones.
Double click on desired study to open it.
As the study is read only, no permanent actions can be released on it.
To exit from the study, simply make the next operation (load or open another study, etc.).

OPERATOR’S MANUAL
8. DICOM FUNCTIONS
By “DICOM” menu, various functions (Resend, Append, Print, Make CD and export) can be
applied on the studies open from the Worklist or locally.
8.1 Resend
The “Resend” function allows to send a local stored study to the DICOM server.
Clicking on “Resend” button, a window appears with the list of studies saved locally in the
Acquisition Software.

OPERATOR’S MANUAL
Studies open from the Worklist are displayed on light green background; the studies open
locally are displayed on orange background.
Select the study that has to be resend to the PACS checking the corresponding box on the
left and then click on “OK”.
Selecting a study open locally, the “Worklist Query Dialog” window appears; the operator can
associate the study at a patient and send the images to the server.
Selecting a study open from the Worklist, it is sent directly to the server.

OPERATOR’S MANUAL
8.2 Append
The “Resend” function allows to recall a study earlier open from Worklist in order to integrate
it with other images. In any case, the information associated to the study are not modifiable.
Clicking on “Append” button, a window appears with the list of studies.
The studies open locally (by means of the “Study Data” window) are displayed on grey
background and they are not selectable.
The studies open from the Worklist are displayed on light green background. The operator
must double click on desired study to open it.
The study images are shown on display and the mammography system is already to take X-
rays exposures.
Once the study has been integrated, close it according to the foreseen modalities. It is always
possible to iterate the “Append” function until the study remains locally stored on the local
PC.

OPERATOR’S MANUAL
8.3 Print
The “PRINT” function allows to send to a DICOM printer the images of an open study.
Pushing on the “PRINT” button the following window appears:
The thumbnail of the images, acquired in the current study, are displayed on its left side while
the printer parameters are displayed on the upper side. The parameters adjustable by the
operator are the following:
 Printer model
 Film type and size
 Direction (landscape or portrait)
 Resolution (DPI)
The operator can, for example, increase the number of rows and columns in which the area
will be separated:

OPERATOR’S MANUAL
In some particular case, the system could go out of resource (e.g. if the operator increase
both the film size and the DPI to an high value). In this case, the following pop-up message
appears:
to inform the operator that he has to reduce the film size.

The operator can also assemble the images to print in a customized layout, choosing the
views and drawing their corresponding thumbnail:

OPERATOR’S MANUAL
Choosing an image from the customized print layout and clicking on the corresponding icon,
the following window will be displayed:

OPERATOR’S MANUAL
in which it will be possible to modify the image view features by means of the commands bar
at the bottom. Clicking on “OK” it will be possible to exit and save.
The images can be printed integrating them with many exposure parameters.
Clicking on “Set tags” button on the bottom-left, a window appears with a list of printable
parameters:
In particular, it is possible to choose, between the available tags (left column “Available”),
those ones which have to be included moving them to the right column “Print” using the
pushbuttons “◄” or “►”. Once selected, their order of presentation can be modified using the
pushbuttons “▲” or “▼” and their dimensions clicking on “+” or “-“.
It is also possible to insert a ruler of 10 cm on the image to print:

OPERATOR’S MANUAL
Finally, clicking on “PRINT” button, all the images in the customized layout are sent to the
printer.
For diagnosis, use only images with scale factor of 1:1,

printed on film for mammography and with printers specific
WARNING
for mammography.
8.4 Make CD
All the CD/DVD functions require external driver connected to

NOTE
USB back side connector (see paragraph “connector panel”)
An open study can be saved on a CD/DVD disk or on a removable drives as DICOMDIR; in

both cases an essential viewer is also included.
This function is typically used for delivering the images to the patient.
Click on “Make CD” button:
Insert a CD/DVD or a removable drive of adequate capacity (approximately 100 Mb for each
patient’s study).

OPERATOR’S MANUAL
The system automatically shows one of the following messages after finding the drive
inserted:
For an anonymous recording of the study select “Anonymize”.

Clicking on OK, the process starts and may take several minutes.
Only when recording succeed, the following message appears and the media can be
removed.
In case of CD/DVD inserted will be automatically ejected.
8.5 Export
The “Export” function allows to export the DICOM studies on CD/DVD or removable drives.
It drives in native format for PACS Store and is mainly used for patient studies transfer from
Mobile VAN to PACS at the end of working day.
Clicking on “EXPORT” button, a window appears with the list of studies saved locally in the
internal memory of local PC.

OPERATOR’S MANUAL
Select the study to send to the media checking the corresponding box on the left and then
click on “OK”.
The following message appears:
Insert a CD/DVD or a removable drive.

The system automatically shows one of the following messages after finding the drive
inserted:

OPERATOR’S MANUAL
For an anonymous recording of the study select “Anonymize”.

Clicking on OK, the process starts and may take several minutes.
removed.
In case of CD/DVD inserted will be automatically ejected.
If the same removable support is used more and more

times, it is recommended to make a copy of previous
exported studies or to rename the folder containing exported
CAUTION
studies. Folders will be overwritten in the following export
procedure. In case of multiple selection, the exported
previous studies will not be automatically overwritten.
To select all studies insert tick into virtual box “select all”, to
NOTE
unselect all studies push the tick into “unselect all”

OPERATOR’S MANUAL
8.5.1 Export of “for processing images”
It is highly recommended to follow the below described

steps for the raw images export exclusively in particular
NOTE
case like the verification of image quality. It is not a routine
procedure.
To allow the export of “for processing” images, click on DICOM label (CTRL right + mouse
double click) and open the DICOM server list:
Select the CDBOX Server associated to the EXPORT FUNCTION, enable the flag “send “for
processing” images and click on OK to save:

OPERATOR’S MANUAL
In this way, the study/ studies chosen will be exported with the “for processing” and “for
presentation” images.
Follow the same procedure detailed in the previous paragraph 8.5.
At the end of EXPORT, the previous flag must be disabled.

OPERATOR’S MANUAL
9. DAILY CHECK
Daily, prior to start to perform the exams, the operator must verify the right operating of
mammography unit, through a specific tool achievable from “Operation Bar”.
To perform the check procedure is necessary to use an optional phantom (see Section 8:
accessories) to place on Potter-Bucky.

OPERATOR’S MANUAL
The correct procedure to perform this test is the following:

1. open a Local Study;
2. select the Exposure technique FULL AUTO, PRE mode;
3. place the 50 mm PMMA phantom over the carbon fiber of the Potter-Bucky;
4. make a compression on the phantom until to make in contact its surface with that
one of the compression paddle;
5. make an exposure;
6. at the end of the exposure, take note of kV and mAs released. Those values are
shown on both the display available (Mammo Unit and Acquisition Software);
7. close the study;
8. select the MANUAL MODE Exposure technique;
9. click on “Daily Check” button. The following window appears with a brief description
of the test:
10. click on “OK” button;

11. place the 50 mm PMMA phantom over the carbon fiber of the Potter-Bucky;
12. make a compression on the phantom until to make in contact its surface with that
one of the compression paddle;
13. select values of kV and mAs closer to those ones released with the previous
automatic exposure;
14. make an exposure and wait that a windows with the measurement results appears:

OPERATOR’S MANUAL
This tool has been developed according with Euref Protocol point 2b.2.2.3.1“Image
Receptor Homogeneity”.
Detector health percentage is related to the number of ROI passing the test , if the value is
lower than 100% call Service for periodic Detector Calibration.
This tool has been developed for daily check and cannot
NOTE be used in replacement of calibration tools dedicated to
quality control.

OPERATOR’S MANUAL
10. EXPORT LOGS
In case of occurrence of SW problems, the Technical Assistance may ask the operator to
send some files which may be useful for their analysis and troubleshooting.
Using the available function “Export Logs”, the operator can export the requested files on
a removable drive.
Before starting this export, it is advisable to make sure

NOTE
that the removable drive does not contain other files.
Click on “Export Logs” button:
Insert a removable drive.

The system automatically shows the following message after finding the drive inserted:

OPERATOR’S MANUAL
Clicking on “OK”, the process starts and may take several minutes.
removed.

OPERATOR’S MANUAL
11. CALIBRATE
Depending of the specific detector mounted on the Mammo Unit, the SW may automatically
enables the “Calibrate” push button of the “Menu Panel” as shown in the following figure:
NOTE The “calibrate” procedure is only for a-Si detector
In this case, daily and before starting with the exams, the operator must perform the
following check through a specific tool achievable on the SW interface.
To perform this procedure is necessary to use the phantom for periodical system calibration
without compression (see Section 8: accessories) in place of Potter-Bucky and protective
screen. Moreover, it is necessary select the anode filter/combination (W/Rh or W/Ag) and
perform the calibrate procedure only with large Focus
Before to perform the procedure the operator must clean the

NOTE
surface of detector.

OPERATOR’S MANUAL
The procedure to perform is the following:
1. Click on “Calibrate” button:
2. Remove Potter Bucky:

OPERATOR’S MANUAL
3. Remove Protective screen:
4. Plug calibration phantom in:
5. Place it as shown in the following picture:
6. Select “Go ahead”:

OPERATOR’S MANUAL
7. Press exposure button when required:
8. At the end of X-ray exposure, the following interface is displayed and the test
automatically runs showing the “Wait” message:

OPERATOR’S MANUAL
9. After few seconds, the message “Done” appears in place of “Wait” and the window
automatically disappears at the end of the test:
Repeat from point 6 to 9 for other A/F combination

NOTE
available (W/Ag anode/filter combination in this case).

OPERATOR’S MANUAL
SECTION 8:
MAINTENANCE

OPERATOR’S MANUAL
GENERAL CONCEPTS
The expected service life of mammography unit is defined and based on Service and
Maintenance Instructions contained in the Technical Manual and on applicable official QC
protocols for image quality.
Maintenance procedures and checklist are included in Technical Manual and can be carried
out only by qualified personnel.
General maintenance procedures are suggested every 6 months or recommended every 1

year as better described in Technical Manual.
Image quality inspection will be established according to locally applicable standards and QA
protocols but periodicity must be less than six months.
User should be daily (or before every switching ON of Mammo unit) check:
 External damages to shield or unit
 Check of mains and earth connections, cables and corrugated tube

OPERATOR’S MANUAL
GRID MOVEMENT TEST
The Potter-Bucky (24x30 cm format) is provided with an anti-scatter vibrating grid for limiting
the amount of radiation scatter created in a radiographic exposure reaching the detector.
The operator can verify the functionality of grid moving it, without exposure, pressing the
pushbuttons of ACR panel until the grid starts moving for 4 seconds.

OPERATOR’S MANUAL
CLEANING AND DISINFECTION
MAMMOGRAPHY UNIT
Regular cleaning of the compression paddle and Potter-Bucky (or magnification device) is
necessary prior to proceed with examination.
Use only a soft cloth and distilled water to avoid damage polycarbonate plate of compression
paddle getting it hard with risks of cracks. For other surfaces use cleaning agents that do not
damage plastics, aluminum and carbon fiber.
Do not use abrasive detergents or harsh cleaners.

Do not use excess of liquid and be careful washing liquid
does not drip inside Detector or mammography unit.
CAUTION Do not use steam or high temperature liquid on equipment
parts.
Do not use cleaning sprays directly to avoid to damage
electronic components.
Wipe any parts that contact the patient using a clean lint-free or pad.
To cleaning and disinfecting parts that has come in contact

with blood or other potentially infectious materials follows a
WARNING
protocol assigned by your Infection Control representative.
To avoid electrostatic dust collection over the plastic covers, use anti-static dashboard wet-
wipes.

OPERATOR’S MANUAL
LCD SCREEN
To clean the LCD screen use a microfiber cloth to remove any obvious dust and gently brush
off any dirt particulars.
Although use a 50/50 solution of distilled water/isopropyl alcohol, using a clean soft, lint-free
cloth. Very, very gently wipe the screen in a circular motion. Do not press hard on the cloth.
Let the cleaning solution do its job.
It is recommended acquire a proper cleaning kit (with an alcohol and ammonia-free solution)
to clean and keep LCD screen in a crisp clear pristine condition.
Never spray any cleaning solutions directly onto the

screen, spray it into the cleaning cloth.
CAUTION
Do not press hard or touch the screen with to avoid leave
oily prints and smears.
KEYBOARD
If wireless keyboard doesn’t work check ON/OFF switch at rear side GREEN=ON RED=OFF
and internal batteries subject to periodic replacement.
Use only two AA alkaline long life batteries taking care of polarity.
Keyboard Switch ON
To clean the keyboard first hold it upside down to release any debris from the spaces in-
between the keys (pressing the keys is a good way to release it). Use a can of compressed
air to blow any debris from around and under the keys, then use the hose of a vacuum
cleaner to remove it. Finally, clean the keys surface using a wipe made humid with a neutral
detergent.

OPERATOR’S MANUAL
Do not use excess of detergent and be careful detergent

CAUTION
liquid does not drip inside keyboard.
TRANSPARENT ANTI-X PROTECTIVE BARRIER
To clean the transparent anti-X protective barrier use any specific glass cleaner and a clean
soft, lint-free cloth. Then wipe carefully the surface with another dry cloth.
Never spray any cleaning solutions directly onto the anti-X

CAUTION protective barrier, spray it into the cleaning cloth.
Be careful detergent liquid does not drip on desk.
DETECTOR FANS FILTERS CHECK AND REPLACEMENT

The air-flow for Detector cooling is protected from dust by washable and reusable
Polyurethane Foam filters (1/4" Thick, 45 Pores/Inch).
Dust affects reliability because a thick layer of dust can exhibit a certain amount of electrical
capacitance and conductivity. Just as seriously, it will reduce the working life of fans and
increase the risk of overheating.
The Foam density has designed to be high enough to catch dust, but low enough not to
reduce airflow.
In particularly dusty places, every month, it’s advisable to verify filters cleaning to avoid a dust
accretion. If filters are dirty must be replaced quickly with new others.
In any case, the filters must be changed periodically with a frequency depending by the
installation environment.
The dirty filters can be washed (only with water) and reused totally dry in the next
replacement. The filters replacement procedure is described on Technical Manual and must
be carried out only by Qualified Personnel.
If periodic inspection is not carried out and filters gaps are obstructed the cooling fans can
periodically oscillate with a rate of about 2/3 s generating a typical audible noise that can
recall the operator attention.

OPERATOR’S MANUAL
Filters obstruction cause a Detector overheating. In this case the temperature can go out of
calibration range and a red message is visible on Status Bar of Acquisition Software (see
also the Section 5-Paragraph 2.1 of this Manual).
Detector fans filters must be replaced only by Service

CAUTION
Technicians and only with original filter kit..
MOVING THE UNIT TO ANOTHER PLACE
Refer to Technical Manual and use only qualified personnel.

OPERATOR’S MANUAL
SECTION 9: ACCESSORIES &

OPTIONAL PARTS

OPERATOR’S MANUAL
LIST OF PARTS
Description
Standard parts
 24X30 cm format Potter-Bucky with vibrating grid

 24x30 cm format shifted compression paddle
 18x24 cm format shifted compression paddle with lateral shifting
 Digital Flat Panel Detector (a-Si)
 Fast lock and extended protective screen to keep patient’s face out of X-Ray beam
 N°1 foot-controls
 Full-Optional collimator device (automatic filter and collimation)
 Phantom for periodical system calibration without compression
 Technical manual
 Operator’s manual
LIST OF OPTIONS
Description
Options
 VARIAN M113T biangular tube with tungsten anode (low speed only)
 IAE XM12THigh speed voltage generator with wide range [20-40] Kv
 Motorized rotation
 High speed starter
 115Vac Power Supply
 Digital Flat Panel Detector (a-Se)
WARNING Use only original accessories and spare parts.

OPERATOR’S MANUAL
Description
Optional parts
 Acquisition Workstation (Transparent Anti-X Protective Barrier with support for monitor + Keyboard
supporting surface), see configurations available
 24x30 cm device for geometric magnification with variable (1,5x and 2x) factor
 9x21 cm format compression paddle
 18x24 cm format spot compression paddle
 18x24 cm format shifted compression paddle for 2D biopsy
 Bearing for compression paddle (up to n°3 paddles)
 Phantom for daily check with compression
 SBD 3D FFDM Stereotactic biopsy device (only for MELODY III D C 24x30 cm format)
 Kit for digital mammographic unit (with not isocentric C-Arm) installation on VAN
 Kit for digital mammographic unit (with isocentric C-Arm) installation on VAN
 Transparent Anti-X Protective Barrier
 10 kVA Uninterruptible Power Supply (UPS) system
 Patient chair (height adjustable)
 Patient bed/chair
WARNING Use only original accessories and spare parts.

OPERATOR’S MANUAL
CONFIGURATIONS AVAILABLE
Control monitor and wireless keyboard are provided with the unit
NOTE
and can be placed as shown in typical configurations below:
CONFIGURATION DESCRIPTION TYPICAL CONFIGURATION PROVIDED

AVAILABLE
BASE
Control monitor and wireless keyboard
are placed on the unit stand.
Mammo unit is equipped with:

 2 Mpx diagnostic color monitor
(21,3’’)
 Wireless keyboard
 X-ray pushbutton
AA
Control monitor and wireless keyboard
are available on a stand-alone half-
transparent anti-X barrier for operator
protection.
This is equipped with:
(21,3’’)
 wireless keyboard

OPERATOR’S MANUAL
AB
Double management configuration.
Mammo unit is equipped on the stand
with:
(21,3’’)
Acquisition workstation for operator

protection and device managing is
equipped with:
(21,3’’)
 wireless keyboard
AC
Control monitor, a wireless keyboard
and an X-ray pushbutton are provided
with a dedicated support to be
mounted on wall as shown in typical
configuration
AD
Double management configuration.
Mammo unit is equipped on the stand
with:
(21,3’’)
Control monitor, a wireless keyboard
and an X-ray pushbutton are provided
with a dedicated support to be
mounted on wall as shown in typical
configuration workstation for

OPERATOR’S MANUAL
AE
Control monitor and an X-ray
pushbutton are provided with specific
support for desktop placement. A
wireless keyboard is provided
The wireless keyboard is one for each configuration and can be

NOTE
placed as preferred.
Anti-x barrier must be supplied before use: It is mandatory use an

anti-X barrier in configuration BASE, AC, AD, AE for operator’s
NOTE safety (the manufacturer does not provide protections/barrier). Do
not use the mammographic unit without appropriate safety
measures.

OPERATOR’S MANUAL
COMPRESSION PADDLES
18x24 cm FORMAT 24x30 cm FORMAT 18x24 cm FORMAT

COMPRESSION PADDLE COMPRESSION PADDLE COMPRESSION PADDLE
WITH LATERAL SHIFTING
9x21 cm FORMAT 18x24 cm FORMAT SPOT 18x24 cm FORMAT

COMPRESSION PADDLE COMPRESSION PADDLE COMPRESSION PADDLE
FOR MAGNIFICATION FOR 2D BIOPSY

OPERATOR’S MANUAL
DEVICE FOR GEOMETRIC MAGNIFICATION WITH VARIABLE (1,5x/2x)
24x30 cm FORMAT MAGNIFICATION DEVICE
FOOT-CONTROLS
FOOT-CONTROLS FOR MOTORIZED COMPRESSION

OPERATOR’S MANUAL
PROTECTIVE SCREEN
PHANTOM FOR PERIODICAL SYSTEM CALIBRATION
PHANTOM FOR PERIODICAL

SYSTEM CALIBRATION

OPERATOR’S MANUAL
PHANTOM FOR DAILY CHECK WITH COMPRESSION
PHANTOM FOR DAILY CHECK

WITH COMPRESSION
STEREOTACTIC BIOPSY DEVICE

(only for MELODY III D C equipped with isocentric arm)
 24x30 cm format
SBD FFDM

OPERATOR’S MANUAL
ANTI-X PROTECTIVE BARRIER
Half-Transparent Full-Transparent
ACQUISITION WORKSTATION

OPERATOR’S MANUAL
SECTION 10:
SPECIAL HINTS – IMAGE
RECOVERY STRATEGY –
TROUBLESHOOTING

OPERATOR’S MANUAL
The Acquisition Software provides the customer with different strategies for images recovery
which for various reasons were acquired improperly, avoiding to expose again the patient.
PATIENT POSITIONING
An adequate patient positioning permits to:

 Simplify the image reading process
 Use the specular systematic viewing techniques in an optimal way (binocular
magnification, Tabar's masks, etc.)
 Guarantee the best performances of the image presentation algorithms
From the poor care in positioning result:

 Asymmetric images
 Skinfolds
 Presence of extraneous parts in the image field (shoulder, hairs, earrings, etc.)
Often, to worsen the situation:

 Inadeguate breast compression
Symmetry

OPERATOR’S MANUAL
Symmetry
Symmetry

OPERATOR’S MANUAL
Symmetry
Symmetry

OPERATOR’S MANUAL
Symmetry
Symmetry

OPERATOR’S MANUAL
Skinfolds
Skinfolds

OPERATOR’S MANUAL
Skinfolds
Extraneous parts in the image field

OPERATOR’S MANUAL
Extraneous parts in the image field: Dynamic Range
Extraneous parts in the image field: Dynamic Range

OPERATOR’S MANUAL
Extraneous parts in the image field: Border recognition
Extraneous parts in the image field: Border recognition

OPERATOR’S MANUAL
Compression
 Clinical assessment of positioning in digital mammography matches that required for

screenfilm and evaluates the retromammary aspects of the breast between the
craniocaudal (CC) and mediolateral oblique (MLO) views. On the CC view, the
posterior nipple line of the breast (the distance between the nipple and the posterior
edge of the image) should be no more than 1 cm less (approximately) than that on the
MLO view (the distance between the nipple and the anterior edge of pectoral muscle).
The anterior edge of the pectoral muscle on the MLO view should be convex, and it is
desirable for the muscle to extend to the level of the nipple. The posterior nipple line
should be drawn at an angle, perpendicular to the muscle, usually at about 45 degrees
on the MLO image.
 Large breasts may require imaging of the breast in sections. The resulting multiple
images in the same projection must be viewed together to form the complete
mammogram. An increase in radiation dose occurs to regions of the breast that are
exposed to X-rays in more than one image in the same view projection. Standard tiling
methods that double expose the least possible amount of breast tissue should be
used.

OPERATOR’S MANUAL
IMAGE RECOVERY STRATEGY – TROUBLESHOOTING
Incorrectly sized images acquired with 18x24 compression paddle
In case of incorrect size of images acquired with 18x24 compression paddle, it is possible
downsizing to 18x24 cm format with the right click on image. Clicking on “Downsize to 18x24”
button a 18x24 cm rectangle appears: moving it with the mouse select the region of image
under study in order to crop it.
An image downsized cannot be reconverted in original

WARNING
size

OPERATOR’S MANUAL
Incorrectly sized images acquired with 24x30 compression paddle
I In case of incorrect size of images acquired with 24x30 compression paddle, it is possible
recovering 24x30 cm format with the right click on image. The “Recover 24x30” function is
available only for the mammography unit with 24x30 cm detector, when an images is
incorrectly downsized to 18x24 cm format.
It allows to restore the original 24x30 cm format of acquired image. Clicking on “Recover
24x30” button, the image is restored at original acquisition format.

OPERATOR’S MANUAL
Images with metallic clips, surgical marker and cluster of micro calcification
In case of image with metallic clips, surgical marker and numerous cluster of micro
calcification, in which image contrast could be not adequate for radiologist physician, you
have to right click on image and select Process → OTSU → Marker, as shown in following
image.
To recover the original image contrast, you have to right click on image and select Process →
Marker
The “marker” filter can be used also in that case in which
NOTE the patient is not properly positioned and earrings or other

object are in the image plane.

OPERATOR’S MANUAL
Images with surgical anatomical parts
In case of image with surgical anatomical parts, in which image contrast could be not
adequate for radiologist physician, you have to right click on image and select Process →
OTSU → Surgery, as shown in following image
To recover the original image contrast, you have to right click on image and select Process
→ Surgery

OPERATOR’S MANUAL
Images with breast specimen
In case of image with breast specimen (i.e. vacuum assisted biopsy, trucut biopsy) , in which
image contrast could be not adequate for radiologist physician, you have to right click on
image and select Process → OTSU → Specimen, as shown in following image
To recover the original image contrast, you have to right click on image and select Process→
Specimen

OPERATOR’S MANUAL
Wrong ACR setting
In case of wrong ACR settings, click right on image and select Change ACR settings and
modify laterality, as shown in following image

OPERATOR’S MANUAL
Spot compression device (if available)
In the following we are considering the use of the so called spot shifted compression paddle,
shown in the following figure, designed to be used in contact mode (not for magnification).
In its current conformation, this spot compression device is made by an almost round
compression plate in polycarbonate, supported by a metal structure. This structure is heavily
radio-opaque and can be considered an extraneous part clearly visible in a wide standard
image of which only a little ROI is usable.
Furthermore, an important number of gray levels is sacrificed in favor of the metal part.
See for example following figures. On the left, the image of a TOR MAM phantom is shown
with its resulting histogram. On the right, you can see the same phantom imaged with the
spot compression device. The large part of metal in the image field causes a loss of dynamic,
noticeable as a compressed histogram of the part of the image corresponding to the
phantom, highlighted in red. The blue indicates the part of dynamic stolen by the metal from
the relevant object.

OPERATOR’S MANUAL
Operative indications
The image presentation algorithm has been revised to face this particular situation and to
offer the best result in all the possible configurations. Nevertheless, since this feature is not
much used anymore in our clinical context, it has been tested on phantoms only.
Whenever a loss of contrast in the spot region is perceived, the operator can enhance the
image further by means of tools like Window/Level or Histo in the MELODY III D C software.
An operative example is illustrated below.
Once an exposure is executed and the image is shown in the image window, right click on it:
a menu as shown in following image will appear.

OPERATOR’S MANUAL
From here, select Histo: a new window will appear, where the operator can lower the
maximum displayed value (the “white point”) to increase contrast in the region of interest, as
shown in following image.
New White
Click on Preview and evaluate the result. Adjust further, if needed. Please note that also the
lowest displayed level can be adjusted. Once the result is satisfying, click on Apply.
We must also advise you that the exposure modality “Automatic – Pre” cannot be used when
imaging with the spot compression device inserted, since this AEC algorithm, due to the
presence of metal parts in a relevant area of the image, will erroneously recognize a high
breast density delivering too much dose to the patient.
When using the spot compression device, please select Manual or Automatic – Fast
mode.
The Manufacturer will remain on hand in case the image quality needs further improvements.
Clinical cases with comments, suggestions and eventual requests are highly welcome.
Fine tunings and/or modifications are possible on the presentation algorithm and we do not
exclude to design a new spot compression device with less invasive arm.
OPERATOR’S MANUAL
SECTION 11:
TECHNICAL SPECIFICATIONS

OPERATOR’S MANUAL
TECHNICAL SPECIFICATIONS
The manufacturer reserves the right to make further

NOTE
improvements while keeping main features unchanged.
CLASSIFICATION (IEC 60601-1)

Protection against electric shock Class I, with type B applied parts
Applied parts  Potter-Bucky/Biopsy Device carbon fiber
 Compression Paddles
 Magnification Device
Protection degree according to IEC 529 IP X0
IPX1 (Foot-Controls)
Degree of safety in the presence of Not suitable for use in the presence of Flammable
flammable anesthetics mixture with. air or Anesthetics Mixture with air or with oxygen or
with oxygen or with nitrous oxide with nitrous oxide
Mode of operation Continuous operation with intermittent loading
POWER SUPPLY
Line voltage 220/230/240 Vac 10% 50/60 Hz
115 Vac 10% 50/60 Hz (optional)
Power 6.6 kVA (<0.2 kVA stand-by)
Current absorption 30 A peak (at 230 Vac)
Number of phases 1 or 2 configurable
Connection Permanently installed (IEC 60601-1)
Wall connection 20 A Thermal-magnetic circuit breaker
(40 A Thermal-magnetic circuit breaker in 115 Vac
option)
NOTE: for more details about this specification,

please refer to the planning guide
Mains resistance <0.50 Ω
ENVIRONMENTAL CONDITIONS
Mammography Unit Temperature: -20°C÷+70°C
Transit/Delivery and Storage Conditions Relative humidity: 10%÷90%
Barometric pressure: 500 hPa÷1060 hPa
Detector Conditions during: Temperature for a-Si Detector:
 Transfer to Transport Terminal -15°C÷+65°C
 Destination Terminal Custom Temperature for a-Se Detector:
Clearance Period +5°C÷+40°C
 Door Delivery
Note: Detector packed in the original crate Relative humidity for a-Si detector:
10%÷85%
Relative humidity for a-Se detector:
10%÷90%
Barometric pressure: 700÷1060 hPa
Detector Conditions during:
 International Air Transport a-Si Detector
Note: Detector packed in the original crate Temperature: -18°C÷+70°C (under 36h)
Relative humidity: 10%÷85%

OPERATOR’S MANUAL
a-Se Detector
Temperature: -20°C÷+60°C (24h)
Operating Conditions Temperature for a-Si Detector:
 Mammo unit switched on +5°C÷+40°C
Relative humidity: 30%÷ 85%
Temperature for a-Se Detector:

+20°C÷+25°C

Detector Maximum rate of temperature
change 10°c in 20 min
Heat dissipated in max load condition of 35 316 kCal/h

kV 500 mAs (1 shot every 5 minutes)
ENVIRONMENT PROTECTION AND WASTE DISPOSAL

System contains in some of its parts and subassemblies, solid and liquid substances that must be
disposed only by designated companies according to local laws.
Tube assembly Beryllium, glass, dielectric oil (PCB free), other
metals and plastic.
H.V. transformer Dielectric oil (PCB free), plastic, copper other
metals
Other subassemblies Plastic, other metals, electronic components
glass-epoxy printed circuits.
Silicon / amorphous selenium (optional)

OPERATOR’S MANUAL
MAMMOGRAPHY UNIT
HIGH VOLTAGE GENERATOR

Line voltage compensation AUTOMATIC
high voltage generator with kV closed loop and line
Feed forward compensation
Inverter Technology Current fed, Mosfet bridge with output current limit
capability and short circuit protection
Inverter Frequency 50 kHz
Ripple Frequency/Amplitude 100 kHz < 2%
Generator Output Power 5 kW (@ 35 kV)
kV range 20/35 kV
(20/40 kV optional)
kV resolution (Manual & Auto mode) 0.5 kV
kV precision 1%
kV repeatability  0.1%
kV risetime 1.5 ms from 0 to 100%
kV display XX,X kV (3 digits)
Lowest Current Time Product 1 mAs
IEC 60601-2-45:201.7.9.2.1.f)
mAs maximum value 640 mAs
mAs resolution (Automatic) 0,1 mAs
mAs values in accordance with R’20 series
(Note: values rounded down on the base of
standards tolerance and series limited to 640 mAs)
mAs resolution (Automatic) 0,1 mAs
mAs display XXX.X mAs (4 digits)
Exposure Time range 0.02/4.7 s (640 mAs@135 mA)
Automatically selected in function of selected mAs
Safety timer 10 s

OPERATOR’S MANUAL
STANDARD X-RAY TUBE I.A.E. XM1016 T

(X-RAY TUBE ASSEMBLY C 339 V)
Anode rotation speed 3000 rpm 50 Hz
10000 rpm 150 Hz (optional)
Target material Tungsten
Focal track: RT (Tungsten+Rhenium)
Bulk: TZM (Molibdenum+Titanium+Zirconium)
Anode Heat Storage Capacity 300 kHU (225 kJ)
Maximum Anode Heat Dissipation Rate 60 kHU/min (750 W)
X-Ray Tube Assembly Heat Storage Capacity 425 kHU (320 kJ)
X-Ray Tube Assembly Heat Dissipation Rate 108 HU/s (80 W)
Cooling method Free air convection
Anode Disc Target Angle 10° (Small focus)/16° (Large focus)
Anode Disc Diameter 80 mm
Focal spots 2
Focal spot size according to IEC 336, 0,1x0,1 mm (Small)/0,3x0,3 mm (Large)
EN60336
Power 1400 W (Small)/5600 W (Large) (3000 rpm)
(Nominal Anode Input Power) 2400 W (Small)/9600 W (Large) (10000 rpm)
Nominal X-Ray Tube Voltage and Highest X- 35 kV; 100 mA (@ 0,3 mm)
Ray Tube Current available at that Optional: 40 kV; 80 mA (@ 0,3 mm)
voltage (IEC 60601-2-45: 201.7.9.2.1.a)
Highest X-Ray Tube Current and Highest X- 34 kV; 135 mA (@ 0,3 mm)-> 4590 W
Ray Tube Voltage available at that Optional: 40 kV; 80 mA (@ 0,3 mm)-> 3200 W
current (IEC 60601-2-45: 201.7.9.2.1.b)
Corresponding combination of X-Ray Tube
Voltage and X-Ray Tube Current which results
in Highest Electric Output Power (IEC 60601-
2-45:201.7.9.2.1.c)
Nominal electric power given as the highest 30 kV; 135 mA (@ 0,3 mm) ->4050 W
constant electric output power in kilowatts 2,96 s loading time (400 mAs)
which the X-Ray Generator can deliver at an
X-Ray Tube Voltage of 30 kV, for a Loading
Time of 1 s, a Cycle Time of 1,0 minute and
for an indefinite number of cycles, or if these
values are not selectable, at an X-Ray Tube
Voltage nearest to 30 kV, for a Loading Time
nearest to but not less than 1 s and a Cycle
Time of 1,0 minute and for an indefinite
number of cycles
(IEC 60601-2-45: 201.7.9.2.1.d)
Nominal electric power shall be given
together with the combination of X-Ray Tube
Voltage and X-Ray Tube Current and Loading
Time
(IEC 60601-2-45: 201.7.9.2.1.e)
Lowest Current Time Product 1 mAs (for all kV values)
(IEC 60601-2-45: 201.7.9.2.1.f)
For Mammographic X-Ray Equipment 8 mAs (using 20 mm PMMA phantom)
provided with automatic Exposure Control
controlling Loading Time, shortest Loading
Time and/or the lowest resulting Current
Time Product
(IEC 60601-2-45: 201.7.9.2.1.h)

OPERATOR’S MANUAL
Range of X-Ray Tube Voltage when X-Ray 25-35 kV

Tube Voltage is controlled by AEC Optional: 25-40 kV
(IEC 60601-2-45: 201.7.9.2.1.i)
mAs range Small focus: 1÷80 mAs (from 20 to 21 kV)
1÷140 mAs (from 22 to 30 kV)
1÷100 mAs (from 31 to 34 kV)
1÷100 mAs (from 35 to 40 kV)
Large focus: 1÷320 mAs (from 20 to 24 kV)
1÷400 mAs (from 25 to 27 kV)
1÷640 mAs (from 28 to 30 kV)
1÷560 mAs (from 31 to 34 kV)
1÷320 mAs (35 kV)
1÷250 mAs (from 36 to 40 kV)
X-Ray Window 0,5 mm Beryllium
Housing X-Ray protection >=0,5 mm Pb equivalent
Inherent filtration 0,0 mm Al IEC 60522:1999-02
HVL measured at 28 kV >0,4 mm Al equiv.
Total filtration >0.5 mm Al
TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION

With active temperature sensor under main Upper limit temperature 65° outside tube
CPU control assembly. HU and °C display available in technical
menu.
FILTER PROPERTIES
50 m Silver 0.55 mm Al eq. @ 28 kV,
measured with W target
50 m Rhodium 0.51 mm Al eq @ 28 kV,

OPERATOR’S MANUAL
OPTIONAL X-RAY TUBE VARIAN M113T

(X-RAY TUBE ASSEMBLY B 115)
Anode rotation speed 3000 rpm 50 Hz
Target material Tungsten

Focal track: W-Re-Mo
Anode Heat Storage Capacity 300 kHU (225 kJ)
Maximum Anode Heat Dissipation Rate 60 kHU/min (750 W)
X-Ray Tube Assembly Heat Storage Capacity 500 kHU (376 kJ)
X-Ray Tube Assembly Heat Dissipation Rate 135 HU/s (100 W)
Cooling method Free air convection
Anode Disc Target Angle 10° (Small focus)/16° (Large focus)
Anode Disc Diameter 77 mm
Focal spots 2
Focal spot size according to IEC 336, 0,1x0,1 mm (Small)/0,3x0,3 mm (Large)
EN60336
Power 1400 W (Small)/5900 W (Large) (3000 rpm)
(Nominal Anode Input Power)
Nominal X-Ray Tube Voltage and Highest X- 35 kV; 100 mA (@ 0,3 mm)
Ray Tube Current available at that Optional: 40 kV; 80 mA (@ 0,3 mm)
voltage (IEC 60601-2-45: 201.7.9.2.1.a)
Highest X-Ray Tube Current and Highest X- 34 kV; 135 mA (@ 0,3 mm) -> 4590 W
Ray Tube Voltage available at that Optional: 40 kV; 80 mA (@ 0,3 mm)-> 3200 W
current (IEC 60601-2-45: 201.7.9.2.1.b)
Corresponding combination of X-Ray Tube
Voltage and X-Ray Tube Current which results
in Highest Electric Output Power (IEC 60601-
2-45:201.7.9.2.1.c)
Nominal electric power given as the highest 30 kV; 135 mA (@ 0,3 mm) ->4050 W
constant electric output power in kilowatts 2,96 s loading time (400 mAs)
which the X-Ray Generator can deliver at an
X-Ray Tube Voltage of 30 kV, for a Loading
Time of 1 s, a Cycle Time of 1,0 minute and
for an indefinite number of cycles, or if these
values are not selectable, at an X-Ray Tube
Voltage nearest to 30 kV, for a Loading Time
nearest to but not less than 1 s and a Cycle
Time of 1,0 minute and for an indefinite
number of cycles
(IEC 60601-2-45: 201.7.9.2.1.d)
Nominal electric power shall be given
together with the combination of X-Ray Tube
Voltage and X-Ray Tube Current and Loading
Time
(IEC 60601-2-45: 201.7.9.2.1.e)
Lowest Current Time Product 1 mAs (for all kV values)
(IEC 60601-2-45: 201.7.9.2.1.f)
For Mammographic X-Ray Equipment 8 mAs (using 20 mm PMMA phantom)
provided with automatic Exposure Control
controlling Loading Time, shortest Loading
Time and/or the lowest resulting Current
Time Product
(IEC 60601-2-45: 201.7.9.2.1.h)

OPERATOR’S MANUAL
Range of X-Ray Tube Voltage when X-Ray 25-35 kV

Tube Voltage is controlled by AEC Optional: 25-40 kV
(IEC 60601-2-45: 201.7.9.2.1.i)
mAs range Small focus: 1÷100 mAs (from 20 to 22 kV)
1÷130 mAs (from 23 to 30 kV)
1÷100 mAs (from 31 to 35 kV)
1÷80 mAs (from 36 to 40 kV)
Large focus: 1÷300 mAs (from 20 to 24 kV)
1÷640 mAs (from 25 to 35 kV)
1÷250 mAs (from 36 to 40 kV)
X-Ray Window 0,63 mm Beryllium
Housing X-Ray protection >=0,5 mm Pb equivalent
Inherent filtration 0,0 mm Al IEC 60522:1999-02
HVL measured at 28 kV >0,4 mm Al equiv.
Total filtration >0.5 mm Al
TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION

With active temperature sensor under main Upper limit temperature 65° outside tube
CPU control assembly. HU and °C display available in technical
menu.
FILTER PROPERTIES
50 m Silver 0.55 mm Al eq. @ 28 kV,
50 m Rhodium 0.51 mm Al eq @ 28 kV,
AUTOMATIC COLLIMATION DEVICE

Light Source LED ( Risk Group 1 - Low Risk - according to IEC
62471)
Light beam Switch ON by push-button or automatic when
operating compression (selectable by service)
Electronic timer
Light intensity  150 lux
Light beam collimation accuracy according to IEC 60601-2-45:203.8.5.4
Mirror with automatic out of field function
Formats (with device for geometric 24x30 cm and 10x14 cm for magnification
magnification) (Detector 24x30 cm format)
Protection of examination field Fast lock and extended protective screen to keep
patient’s face out of X-ray beam
GRID
Type Linear, Vibrating
Interspace Material Carbon Based Polymer
Bucky factor 2.1 (W/Rh); 1.92(W/Ag)
Ratio 6:1
Lines/cm 36
Contrast factor 1,54

OPERATOR’S MANUAL
OPTIONAL DEVICE FOR GEOMETRIC MAGNIFICATION

Type Gridless
Interchangeable with Potter-Bucky
Top Cover Carbon fiber 0.1 mm Al equivalent (18x24 cm)
Polycarbonate 0.2 mm Al equivalent (24x30 cm)
Magnification ratio x1,5 / x2 (variable)
Small focus selection Automatic once fitted
DIGITAL FLAT PANEL DETECTOR

Detector Tecnology a-Si TFT Array + PIN Photodiode
Amorphous Selenium (a-Se)
Case dimensions 35,9x34,6 cm (24x30 cm format)
Top Cover Carbon fiber 0.1 mm Al equivalent
Chest Gap 3,9 mm
Cooling Method Air + Fan (integrated)
NOTE: The detector blowers will typically create a
difference of around 4-5 degrees with respect to
the ambient temperature.
Digitalization type Logarithmic
Pixel Pitch 85x85 m
Active Area 23.9x30.5 cm (24x30 cm format)
Image Matrix 2816x3584 (24x30 cm format)
Image Depth 16 bit
Fill factor 88 % geometric (for Detector a-Se)
80% geometric (for a-Si Detector)
MTF (Modulation Transfer Function) For a-Se Detector:
>90% @ 1 lp/mm
>40% @ 5,8 lp/mm
For a-Si Detector:
>75% @ 1 lp/mm (typical 85%)
>10% @ 5 lp/mm for a-Si Detector (typical 20%)
DQE (Detector Quantum Efficiency) For a-Se Detector:
(for exposure of 28 kV) >50% @ 1 lp/mm
>20% @ 5,8 lp/mm)
For a-Si Detector:
>45% @ 1 lp/mm (typical 50%)
>10% @ 5 lp/mm (typical 20%)
Maximum Spatial Resolution 7 lp/mm
Nyquist Frequency 5,88 lp/mm
Signal to Noise Ratio (SNR)
(with 45mm PMMA Phantom) 15,19 (28,5 kV-10 mAs)
Ghost Image factor For a-Se Detector:

(Point n°2b.2.4.5 of “European Guidelines”) 0,02
For a-Si Detector:
0,05
Detector Read Time < 1.1 s (24x30 cm)
Image Display Time on Acquisition Software < 15 s
Time Between Two Images Acquisition < 20 s

OPERATOR’S MANUAL
IMAGE QUALITY
Spatial resolution Conformity with:
“European Guidelines for quality assurance in
mammography screening”, third edition,
and with
”Recommended specifications” for Quality
assurance in mammography of American College of
Radiology
AUTOMATIC EXPOSURE CONTROL

Controlled parameters Auto kV / Auto mAs (Full Auto Mode)
Manual kV / Auto mAs (Auto mAs Mode)
Auto parameters selection criteria Dual mode: PRE and FAST
PRE: tissue composition based (parameters
evaluated by short X-Ray exposure)
FAST: compressed breast thickness based
Sensitive area (only for PRE mode) Mosaic of 96 areas of detector automatically
selected in function of brest size and projection
DOSE CALCULATOR
Method of Calculation Average Glandular Dose (AGD) according to: “D.R.
Dance et al.”
Data visualization (mGy) On display
Method of recording Image Header (DICOM)
AGD with a 4 cm PMMA phantom 1,216 mGy
Dose Rate (28 kV-80 mAs) 36,63 R/min without Compression Paddle
29,80 R/min with Compression Paddle
C-ARM
F.F.D. (Focus Detector Distance)/S.I.D. 66 cm
(Source to image receptor Distance)
Motorized Movements Vertical and rotation (optional)
Range of Vertical movement (from floor) From 43 to 128 cm (travel of 85 cm)
Range of C-arm rotation +/-180°
(CW, CCW continuous to any position)
Projection preset position N° 5 Programmable projections
(LAT, OBL, CC, OBL, LAT)
Speed of C-arm Rotation 90°/7,2 s with acceleration and deceleration ramp
for smooth operation
Display of angle rotation On auxiliary Display (ACR)
On Display of controllers for manual compression

OPERATOR’S MANUAL
ISOCENTRIC C-ARM
F.F.D. (Focus Detector Distance)/S.I.D. 66 cm
(Source to image receptor Distance)
Motorized Movements Vertical and rotation
+/- 15° Rotation (only with BYM 3D FFDM)
Range of Vertical movement (from floor) From 75 to 160 cm (travel of 85 cm)
Range of C-arm rotation +/-130°
(CW, CCW continuous to any position)
Projection preset position N° 5 Programmable projections

(LAT, OBL, CC, OBL, LAT)
Speed of C-arm Rotation 90°/9,6 s with acceleration and deceleration ramp
for smooth operation
Display of angle rotation
On auxiliary Display (ACR)
On Display of controllers for manual compression
AUXILIARY DISPLAY AND TAGGING KEYBOARD

3 displays (7 segments) + 18 Leds
Display type
Tagging Keyboard (ACR protocol) Ten pushbuttons: R/L laterality and
prefixes/suffixes
Informations Compression force
C-arm rotation angle
Compression breast thickness
Laterality, Projection, ACR prefixes and suffixes
“SMART µPRESS” COMPRESSION DEVICE

Compression Paddle movement Motor driven or manual with fine adjustment by
double rotating controller
Standard Compression Paddles 18x24 cm shifted for normal breasts
(for 18x24 cm format)
Standard Compression Paddles 24x30 cm shifted for large breasts
(for 24x30 cm format) 18x24 cm with lateral shifting for normal breasts
Optional Compression Paddles 9x21 cm straight for magnification
18x24 cm for spot contact examination
18x24 cm shifted for bidimensional biopsy
Compression Paddle Holder Fast mechanical unlock
Maximum free space available between 325 mm with shifted Compression Paddles
Compression Paddle and image receptor In Magnification Mode
(straight compression paddle)
MAG. X 1.5 = 197,5 mm
MAG. X 2 = 97,5 mm
Compression Force Adjustable from 70 to 200 N
Compression Force Display Effective applied force with 1 N resolution
Compression Paddle Descent Speed Proportionally decreasing compressing the breast
Maximum Compression Force Safety Device Triple safety device:
electronic, electro-mechanical, mechanical
Soft Compression paddle release after Selectable from Acquisition Software
exposure
Compression Thickness Display Displayed in mm
Compression paddle aluminum equivalence Less than 0.2 mm Al (0.135 mm Al≈30 kV)
Special function for 0 compression force for oncology procedures

OPERATOR’S MANUAL
CONTROLLERS FOR MANUAL COMPRESSION

Number and type (standard) Two rotating wheels with central push-button
on both sides of C-Arm
FOOT-CONTROLS
Number and type One with two pedals and one push-button for
motor driven compression unlock
Two with two pedals and one push-button for
motor driven compression unlock (optional)
Control Actions Vertical movement of Compression Paddle
Motor driven compression unlock
EMERGENCY STOPS
Number and Type Two red push-buttons on both sides of
mammography unit
Function To Switch OFF C-Arm motors and HV generator

OPERATOR’S MANUAL
PERSONAL COMPUTER
Operating Systems Windows 7 Professional 64-bit
CPU Intel Core i7 2600 3,4 GHz
RAM 8 GB (optionally 16 GB available)
HDD 1 TB SATA for Operating System, Software, studies
storage (~25.000 images)
DVD recorder 48x SATA DVD +/-RW DL
Power Pack 400 W
UPS (uninterruptible Power Supply) 650 VA
AirFlow 178 m³/h
STANDARD COLOR MONITOR (2 MP)

Technology TFT color LCD
Screen Size (diagonal) 21,3” (541 mm)
Display Resolution (pixels) 1600 x 1200
Pixel pitch 270 μm
Viewing Angle 178° horizontal and vertical
Response Time 20 ms
Brightness 440 cd/m² max (250 cd/m² DICOM calibrated)
Contrast ratio 1500:1 Typical
ANTI-X PROTECTIVE BARRIER (Optional)

Type Stand Alone
Pb equivalence > 0.34 mm Pb @35 kV (IEC 60601-2-45)
=0.26 mm @ 49 kV
Dimensions 773x2100x583 mm
Glass Thickness 20 mm
ANTI-X PROTECTIVE BARRIER WITH OPTIONAL MONITOR AND

KEYBOARD (Acquisition Workstation)
Type Integrated
Pb equivalence > 0.34 mm Pb @35 kV (IEC 60601-2-45)
=0.26 mm @ 49 kV
Dimensions 773x2100x583 mm
Glass Thickness 20 mm
PC monitor support Fixed on glass
Desk dimensions L=580mm; H=200mm
Features Acquisition Station
X-Ray pushbutton
UPS (UNINTERRUPTIBLE POWER SUPPLY)

Input voltage 180/266 Vac
Output voltage 230 Vac ± 8%
115 Vac ± 8%
Power 650 VA
700 VA (115 V)
Duration 10 minutes (typically)

OPERATOR’S MANUAL
ELECTROMAGNETIC INFORMATIONS ACCORDING TO IEC 60601-1-2
Medical electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the accompanying
documents.
Portable and mobile RF communications equipment can affect medical electrical equipment.
Information: Fixed equipment or system cabling, which cannot be removed by the user, is
not listed. This cabling is part of the system and was present at all EMC-measurements.
Without this cabling there is no complete functionality of the system.
The use of accessories, transducers and cables other than

those specified, with the exception of transducers and
cables sold by the manufacturer of the equipment or
WARNING
system as replacement parts for internal components, may
result in increased emission or decreased immunity of the
equipment or system.
Guidance and manufacturer’s declaration – Electromagnetic emissions

The MELODY III D C is suitable for use in the specified electromagnetic environment. The purchaser or user of the MELODY III D C
should assure that it is used in an electromagnetic environment as described below:
Emissions test Compliance Electromagnetic environment – guidance
The MELODY III D C uses RF energy only for its internal
RF emissions
function. Therefore, its RF emission is very low and not
Group 1
likely to cause any interference in nearby electronic
CISPR 11
equipment.
RF emissions The emission characteristics of MELODY III D C is
Class A suitable for use in industrial areas and hospitals (CISPR
CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required), this
Harmonic emissions equipment might not offer adequate protection to radio-
Not applicable frequency communication services. The user might need
IEC 61000-3-2 to take mitigation measured, such as relocating or re-
Voltage fluctuations/ orienting the equipment.
flicker emissions
Not applicable
IEC 61000-3-3

OPERATOR’S MANUAL
The equipment or system should not be used adjacent to or

stacked with other equipment and that if adjacent or
WARNING stacked use is necessary, the equipment or system should

be observed to verify normal operation in the configuration
in which it will be used.
Guidance and manufacturer’s declaration – Electromagnetic immunity

The MELODY III D C is suitable for use in the specified electromagnetic environment. The purchaser or user of the MELODY III D C
should assure that it is used in an electromagnetic environment as described below:
Immunity test IEC 60601-1-2 Compliance Electromagnetic environment
test level level
Electrostatic 8 kV contact IEC 60601-1-2 Floors should be wood, concrete or
discharge (ESD) 15 kV air test level ceramic tile. If floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity
should be at least 30 %.
Electrical fast 2 kV for power IEC 60601-1-2 Mains power quality should be that of a
transient/burst supply lines test level typical commercial or hospital environment.
IEC 61000-4-4
1 kV for input/output
lines>3 m
Surge 1 kV differential IEC 60601-1-2 Mains power quality should be that of a
IEC 61000-4-5 mode test level typical commercial or hospital environment.
2 kV common mode
Voltage dips, short 0% Un for 0.5 cycle( at IEC 60601-1-2 Mains power quality should be that of a
interruptions and voltage 0°,45°,90°,135°,180°,225°,270°, test level typical commercial or hospital environment.
variations on power supply and 315°) If the user of the MELODY III D C requires
input lines 0% Un for 1 cycle continued operation during power mains
IEC 61000-4-11 interruptions, it is recommended that the
70% Un for 25 cycle MELODY III D C be powered from an
0% Un for 5 s uninterruptible power supply or battery.
Power frequency 30 A/m IEC 60601-1-2 Power frequency magnetic fields should be
(50/60 Hz) test level at levels characteristic of a typical location
magnetic field in a typical commercial or hospital
environment.
IEC 61000-4-8

OPERATOR’S MANUAL
Guidance and manufacturer’s declaration – electromagnetic immunity

The MELODY III D C is intended for use in the electromagnetic environment specified below. The customer or the user of the
MELODY III D C should assure that it is used in such an environment.
Immunity Test IEC 60601-1-2 Compliance Electromagnetic environment
Test level level
Portable and mobile RF communications equipment

should be used no closer to any part of the MELODY III D
C, including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Radiated RF 3 V/m 3 V/m d  1 .2 P 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to 2700 MHz
d  2 .3 P 800 MHz to 2.5 GHz
Conducted RF 3V 3V d  1 .2 P
IEC 61000-4-6 150 kHz to 80 MHz*
Where P is the maximum output rating of the transmitter
in watts (W) according to the transmitter manufacturer
and d is the recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as determined

by an electromagnetic site survey, should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment

marked with the following symbol:
* 6 V RMS in the ISM band (6,765 to 6,795, 13.553 to 13.567, 26.957 to 27.283 and 40.66 to 40.70 MHz)
Frequency Range and Level: RF wireless communication equipment

Test Frequency Immunity Level
(MHz) Modulation
(V/m)
385 **Pulse Modulation: 18Hz 27
450 *FM 28
+ 5Hz deviation: 1kHz sine
745
780
870
930
1845
1970
5500
5785

OPERATOR’S MANUAL
Recommended separation distances between portable and mobile RF

communications equipment and the MELODY III D C
The MELODY III D C is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of the MELODY III D C can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitter) and the MELODY III D C as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum output power m
of transmitter
(W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d  1,2 P d  1,2 P d  2 .3 P
0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be
estimated the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE
(1) at 80 MHz and 800 MHz, the separation distance for the higher frequency range applies
(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
Do not use the MELODY III D C in electromagnetic
CAUTION environments in which radiated RF disturbances are not

controlled.
It is strictly recommended to keep no closer than 30 cm

(12 inch) portable RF communication equipment, including
CAUTION
antennas, mobile phones or other emitting EMC waves to
prevent EMC interferences.

OPERATOR’S MANUAL
WEEE INFORMATIONS ACCORDING TO DIRECTIVES 2012/19/EU and

2002/96/EC
(Waste Electrical and Electronic Equipment)
The following crossed-out wheeled bin symbol,
that is present on the device, means that within the European Union the product must be
taken to separate collection at the product end-of life. Therefore, at the end of the life-cycle of
the device, the user should deliver the device to the proper collection facilities of the Electric
and Electronic Equipments. Alternatively, the user can return the device to the seller, on a
one-to-one basis, as long as he is buying a new one of equivalent type and that fulfills the
same functions as the old one.
Disposing of the device separately avoids possible negative consequences for the
environment and health deriving from inappropriate disposal and enables the constituent
materials to be recovered to obtain significant savings in energy and resources.
Who disposes any Electric and Electronic Equipment, reporting the above symbol, as
unsorted municipal waste, instead of collecting it separately, incurs the administrative
sanctions in accordance with law.

OPERATOR’S MANUAL
SECTION 12:
WARRANTY CONDITIONS

OPERATOR’S MANUAL
WARRANTY CONDITIONS
The Manufacturer is committed to replacing, free of charge, any part of the machine that
proves to be faulty, for a period of twelve months from the date of installation.
THIS WARRANTY DOES NOT PROVIDE FOR DEFECTS DUE TO:
 damage caused during transportation
 damage for storage/operation outside temperature and humidity limits
 damage caused by the incorrect installation of the unit, if not carried out by personnel
trained by the Manufacturer
 damage caused by inappropriate connection to other units
 damage caused by improper use, negligence, carelessness or inability to use unit.
 use of not original spare parts or accessories
GLASS PARTS are excluded by any kind of warranty.
THE WARRANTY DOES NOT APPLY TO MATERIAL SUBJECT TO WEAR AND TEAR .
X-Ray tube is covered by pro rata temporis warranty
THE WARRANTY EXPIRES AUTOMATICALLY IN THE EVENT OF TAMPERING AND/OR

INTERVENTION BY PERSONNEL THAT IS NOT EXPRESSLY AUTHORIZED BY THE
MANUFACTURER.
The aforesaid terms are to be considered valid except as otherwise set forth in the contract.

OPERATOR’S MANUAL
THE MANUFACTURER RESERVES THE RIGHT TO MAKE FURTHER IMPROVEMENTS

WHILE KEEPING MAIN FEATURES UNCHANGED.

OPERATOR’S MANUAL
To:
FAILURE REPORT
IMPORTANT NOTICE:
This report shall be submitted whenever a failure occurs. Information given through this form
will expedite manufacturer’s technical assistance.
In case of warranty claim this report is mandatory: warranty will not be processed without
receiving this form properly filled in.
DISTRIBUTOR: NAME
ADDRESS
USER: NAME
ADDRESS
X-RAY EQUIPMENT: TYPE
SERIAL NUMBER
DATE OF PURCHASE
DATE OF INSTALLATION
SOFTWARE RELEASE
NUMBER OF EXPOSURES
FAILURE: DESCRIPTION

OPERATOR’S MANUAL
FAILURE: EXPOSURE TECHNIQUE AT THE MOMENT OF THE FAILURE

OCCURRENCE:
MANUAL  FULL AUTO  AUTO mAs 
kV mAs mm
EVENTUAL PREVIOUS FAILURES SIMILAR TO THE PRESENT ONE:
DETAILED DESCRIPTION OF X-RAY EQUIPMENT OPERATING

CONDITIONS AT THE MOMENT OF THE FAILURE OCCURRENCE:
EVENTUAL REPAIRS TEMPORARILY CARRIED OUT:
DEFECTIVE AND/OR DAMAGED COMPONENTS:

(Please specify Manufacturer code and description)
MECHANICAL
ELECTRICAL
ELECTRONIC
DATE OF FAILURE ____/____/____
DATE ____/____/____ REPORT FILLER SIGNATURE
SEAL OF THE COMPANY AND SIGNATURE OF AUTHORIZED PERSON

OPERATOR’S MANUAL
To:
SAFETY FEEDBACK
In order to continuously improve quality and safety of our medical products, we kindly ask you
to quickly signal us, filling in this form, any potential cause of risk bound to our medical
devices.
DISTRIBUTOR: NAME
ADDRESS
USER: NAME
ADDRESS
EQUIPMENT: TYPE
SERIAL NUMBER
PURCHASE DATE
INSTALLATION DATE
SOFTWARE REVISION
NUMBER OF EXPOSURES
PROVIDE US WITH A DETAILED DESCRIPTION OF THE REVEALED RISK (REAL OR

POTENTIAL) HIGHLIGHTING THE RELATED OPERATING CONDITIONS. EVENTUAL
SUGGESTION ARE WELL ACCEPTED.
DATE ____/____/____ FILLER SIGNATURE

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OPERATOR’S MANUAL

Title of Document: OPERATOR’S MANUAL (MODM10C-U02)

ENGLISH 02 03/08/2018 Add technical details, new

DECLARATION ACCORDING TO IEC 60601-1 STANDARD

Using and keeping X-Ray equipment and device must

WARNING conform the local Regulations and national laws

According to CE 93/42 Directive for Medical Devices

NOTE informed of any owner or installation address change.

MODM10C-U02 Page 6 of 226

This Operator’s Manual is intended to give a detailed overview on Functions, Specifications,

POTENTIAL ADVERSE EFFECTS

MODM10C-U02 Page 7 of 226

The Mammography Unit is inclusive of:

• high voltage X-Ray generator:

MODM10C-U02 Page 8 of 226

- Automatic Filter (50 μm Rhodium/50 μm Silver)

Direct Conversion Full Field Flat Panel Detector:

MODM10C-U02 Page 9 of 226

• AGD (Average Glandular Dose) calculator

MODM10C-U02 Page 10 of 226

MODM10C-U02 Page 11 of 226

Indicates a risk of danger that may lead to death of serious

Indicates a risk of danger that if disregarded leads to slight

Should be understood as a tip. The user does not

NOTE absolutely have to observe these instructions. However,

MODM10C-U02 Page 12 of 226

CAUTION Please pay attention to the following cautions!

1. MELODY III D C has not to be used by unskilled or untrained personnel. The

MODM10C-U02 Page 13 of 226

MODM10C-U02 Page 14 of 226

MODM10C-U02 Page 15 of 226

SYMBOLS CEI–IECSTANDARD DEFINITION

WEEE (Waste Electrical and Electronic

MODM10C-U02 Page 16 of 226

SYMBOLS CEI–IECSTANDARD DEFINITION

X-ray source assembly, emitting

C-arm rotation angle

Automatic Modality SELECTION

x-RAY EMISSION CONTROL LAMP

EXPOSURE TECHNIQUE SELECTION

MODM10C-U02 Page 17 of 226

ACR: American College of Radiology

AEC: Automatic Exposure Control

AGD Average Glandular Dose

AOI: Area Of Interest

AS: Acquisition Software

DICOM: Digital Imaging and Communications in Medicine

DME Digital Mammography Equipment

FFDM: Full Field Digital Mammography

FTSE: Function of tissue strenght evaluation

GUI: Graphical User Interface

MMI: Man-Machine Interface (it has the same meaning of GUI)

PACS: Picture Archiving and Communications Systems

RIS: Radiology Information System

ROI: Region Of Interest

MODM10C-U02 Page 18 of 226

220/230/240 Vac MAINS (STANDARD)

MELODY III D C MELODY III D C (isocentric)

115 Vac MAINS (OPTIONAL)

MELODY III D C MELODY III D C (isocentric)

IEC 60601-1 Standard

Directive 93/42/EEC for Medical Devices

MODM10C-U02 Page 19 of 226

MELODY III D C IDENTIFICATION LABELS

Operator's Manual

Operator's Manual