Melody Ii Operator'S Manual: (MOMLDII-U01)

MELODY II OPERATOR’S MANUAL
(MOMLDII—U01)
VILLA SISTEMI MEDICALI S.p.a.

Via Delle Azalee, 3
20090 Buccinasco (MI) - ITALY
Tel. (+39) 02 48859.1
Fax (+39) 02 4881844
Manufactured by: Metaltronica S.r.l. - X-Ray Equipment & Supplies - Via della Pisana, 431 - 00163 Rome - Italy
Phone: +39-0666160206 (10 lines) Fax: +39-0666160357 E-MAIL general@metaltronica.com
DOCUMENT STATUS SHEET

Title of Document: MELODY II OPERATOR’S MANUAL (MOMLDII-U01)
Version Release Date Reason of change
(dd/mm/yy)
ENGLISH 01 07/04/08 First dedicated release (93/42)
VILLA SISTEMI MEDICALI II

DECLARATION ACCORDING TO IEC 601-1 STANDARD EDITION 1992
Metaltronica declares its responsibility concerning safety, reliability end equipment features
included in this manual only if the following items are fully satisfied:
1)-installation;
- updates;
- recalibrations;
-repairs and/or modifications
carried out by technical personnel officially authorized.
2) Electrical preinstallation performed in the site where he system has to be put into operation,
carried out according to prescription given by IEC rules concerning Medical Application.
3) Use of the equipment according to instruction in this manual.
WARNING
Using and keeping X-Ray equipment and device must follow the local Regulations and national
laws concerning Medical X-Ray handling.
Note
According to CE 93/42 Directive for Medical Devices concerning product traceability, Metaltronica
as manufacturer, must be informed of any owner or installation address change.
Medical Devices traceability is prerequisite to assure their safety and reliability over the time.
VILLA SISTEMI MEDICALI III

INDEX
GENERAL DESCRIPTION............................................................................................ 1
GENERAL WARNINGS.................................................................................................2
GENERAL SPECIFICATIONS OF MAMMOGRAPHIC UNIT MELODY II...................... 3
ELECTROMAGNETIC INFORMATIONS ACCORDING TO IEC 601-1-2 .................... 10
DEVICE CLASSIFICATION......................................................................................... 14
IDENTIFICATION LABELS ......................................................................................... 15
OPERATING INSTRUCTIONS ....................................................... 16

WARNINGS ................................................................................................................ 17
MAIN PARTS MELODY II............................................................................................ 18
MELODY II DIMENSIONAL DRAWINGS ....................................................................20
MAIN PARTS MELODY/B II ........................................................................................ 21
MELODY/B II DIMENSIONAL DRAWINGS .................................................................23
CONTROL PANEL ......................................................................................................24
DISPLAY ..................................................................................................................... 26
TABLES ...................................................................................................................... 27
EXAMINATION ROOM................................................................................................ 27
SWITCHING ON .........................................................................................................27
SWITCHING OFF........................................................................................................28
VERTICAL MOVEMENT OF C-ARM ........................................................................... 28
ROTATING C-ARM .....................................................................................................28
TABLE INSERTION ....................................................................................................29
LABELS WHEELS.......................................................................................................29
COMPRESSION PLATES INSERTION.......................................................................30
COMPRESSION AND LIGHT BEAM INDICATOR ...................................................... 30
COMPRESSION WITH VARIABLE SPEED (OPTIONAL)........................................... 32
COLLIMATION PLATES INSERTION .........................................................................33
18X24 CM CASSETTE ADAPTER................................................................................ 34
FACE SHIELD PROTECTION..................................................................................... 34
INSERT DEVICE FOR GEOMETRIC MAGNIFICATION 1.5X OR 2X ......................... 35
VILLA SISTEMI MEDICALI IV

MAGNIFICATION DEVICE 1.5X OR 2X (OPTIONAL) ................................................. 35

KV SELECTION........................................................................................................... 36
MAS SELECTION ........................................................................................................36

FILM/SCREEN COMBINATION SELECTION ............................................................. 36
MANUAL DENSITY CONTROL................................................................................... 36
RADIOGRAPHIC EXPOSURE.................................................................................... 37
RESET COMMAND ....................................................................................................37
HEAT UNIT INTEGRATOR ......................................................................................... 37
EXPOSURE TECHNIQUES ............................................................ 38

DOSE MINIMIZATION.................................................................................................39
IMAGE QUALITY ........................................................................................................40
MANUAL MODE..........................................................................................................41
ZERO POINT MODE (FULLY AUTOMATIC KV AND MAS) .................................................. 42
ONE POINT MODE (MANUAL KV AND AUTOMATIC MAS) ................................................. 45
DOSE CALCULATOR .................................................................................................46
MO/RH FILTER (OPTIONAL)........................................................................................... 46
TYPICAL CONFIGURATIONS ....................................................... 47

CONFIGURATION FOR NORMAL BREASTS EXAMINATION...................................49
CONFIGURATION FOR LARGE BREASTS EXAMINATION WITH 2430 FILM SIZE 50
CONFIGURATION FOR MAGNIFICATION.................................................................51
CONFIGURATION FOR MAGNIFICATION (OPTIONAL) ........................................... 52
MAINTENANCE .............................................................................. 53
ERROR MESSAGES ..................................................................................................54
PERIODIC MAINTENANCE ........................................................................................ 58
A.E.C. TEST................................................................................................................ 59
SELF-DIAGNOSIS ......................................................................................................60
CLEANING.................................................................................................................. 61
MOVING THE UNIT TO ANOTHER PLACE ................................................................ 61
ACCESSORIES .............................................................................. 62
COLLIMATORS ..........................................................................................................64
PROTECTION SCREEN ............................................................................................. 64
VILLA SISTEMI MEDICALI V

COMPRESSION PADDLES........................................................................................ 65
AUTOMATIC MO/RH FILTER CHANGER....................................................................66
POTTER-BUCKY AND CASSETTE HOLDER ............................................................ 67
MAGNIFICATION DEVICES ....................................................................................... 68
COMPRESSION FOOT CONTROL ............................................................................ 68
COMPUTERISED STEREOTACTIC BIOPSY............................................................. 69
HINGED X-RAY GLASS SHIELD ................................................................................ 70
SEMITRANSPARENT X-RAY GLASS SHIELD........................................................... 71
FULLY TRANSPARENT X-RAY GLASS SHIELD ....................................................... 72
RIGHT SIDE KEYBOARD AND X-RAY GLASS SHIELD............................................. 73
REMOTE CONTROL PANEL ...................................................................................... 74
WARRANTY CONDITIONS ............................................................ 75

WARRANTY CONDITIONS ........................................................................................ 76
SAFETY FEEDBACK ..................................................................................................78
VILLA SISTEMI MEDICALI VI

GENERAL DESCRIPTION
MELODY II is a diagnostic X-ray equipment for the execution of X-ray examination of the breast
(mammography) with all the techniques currently used in clinical diagnostic application.
Thanks to the technical solution that have been adopted, the speed and effectiveness of operation,
the high repeatability of results, MELODY II is especially suited for screening programs.
Special care has been dedicated to patient comfort thanks to a “warm” breast support material, large
ergonomic handgrips, compressor paddles with edge-less corners.
In the effort to obtain the best diagnostic result, in MELODY II have been implemented technical
solution that make it a very high-performing equipment:
 Rotating anode X-ray tube with 0.1 and 0.3 mm focus and 300 kHU heat storage capacity
 Potter Bucky with carbon fibre grid and breast support to reduce patient dose.
 High frequency (50 kHz), constant potential generator with very low ripple (typical 2%) that
guarantees, together with the Molybdenum filter the optimal radiation quality for mammography
application
 The unit is equipped as standard with a highly sophisticated Automatic Exposure Control (AEC)
that allows the use of the zero points technique; that is, all the exposure parameters (kV, mAs)
are automatically selected by the AEC as a function of the real density of the examined breast.
 The zero points technique chooses the kV value in the range between 24 and 28.5, that, as
documented by several clinical studies, is the optimised value to maximise contrast in breast
tissues.
 An advanced calibration procedure is available to allow the unit to be “fine tuned” according to
the performances of the films, cassettes and film processor available on site.
 The operator’s interface is based on a clearly legible, wide, graphical LCD display. Messages
can be displayed in one of 8 languages.
 The equipment is provided with a number of safety features such as: protection against double
exposure or exposure without cassette, fast compressor release, automatic compressor release in
case of mains failure.
 Wide choice of accessories
 Display of the thermal load charged on the X-ray tube anode and protection against overload and
overheating.
 Memorisation of the parameters of the last 1300 exposures with the possibility of download to a
PC.
 Self-diagnosis with warning and alarm messages clearly displayed in the selected language.
 A phantom (included) allows the operator to perform a daily check of the unit, so to prevent
possible malfunctions.
 Precision and stability of X-ray parameters much better than standard requirements.
VILLA SISTEMI MEDICALI 1

GENERAL WARNINGS
The equipment is designed and manufactured in observance of applicable safety
standards; in addition, Villa Sistemi Medicali gives all the information for a safe and reliable
use of the product. Nevertheless, it is assumed that the operator of this equipment has a
proper background of the risk related to the use of X-ray diagnostic devices.
The intended use of MELODY II is exclusively to perform X-ray examination of the

breast (mammography).
The equipment must be used in observance of the procedures herein contained and never
for purposes different from the intended use.
MELODY II is a medical device and shall only be operated under direct responsibility of
properly qualified medical personnel and with the necessary knowledge of x-ray protection.
The user is responsible for compliance to local and international rules and regulations
concerning ownership, installation and use of the x-ray equipment.
Personnel authorised to perform radiological examination must observe the instructions on
protection against ionising radiation. In particular, during the exam, they shall remain
behind the glass shield.
The user is responsible for application of local rules and regulations concerning protection
against ionising radiation.
For additional patient protection we suggest the use of suitable leaded aprons.
During the execution of the exam, only the patient and operator shall be present in the
room.
Although the equipment has been designed to have a reasonable degree of protection
against electro-magnetic interference, in accordance to IEC standards, the unit shall be
installed at a proper distance from high power transformers, uninterruptible power
supplies, home transceivers or professional broadcasting stations.
The use of cellular phones within 1.5 m from the equipment is forbidden.
Other medical devices in the vicinity of the equipment, shall comply with applicable
standards for Electromagnetic Compatibility. Non-compliant devices, or devices that are
known to be susceptible to electromagnetic interference, shall be installed at a distance of
at least 3 m from MELODY II and shall be powered by a separate mains line.
MELODY II must be switched off during the use of electric-lancet or similar devices in the
vicinity of the equipment.
The equipment is not suitable for use in presence of anaesthetic gas that are flammable
with air, oxygen or azote protoxide.
The parts of the equipment that come into contact with the patient, shall be cleaned
according to the instructions given in the present document.
Although the x-ray dose delivered by modern equipment is relatively low, during the
execution of the exams, the operator shall take all precautions and protections to minimise
the dose to himself and to the patient, according to local rules and regulation in force.

GENERAL SPECIFICATIONS OF MAMMOGRAPHIC UNIT MELODY II
MAINS CHARACTERISTICS
Line voltage 220/230/240 Vac 10% 50/60 Hz
(110 Vac optional)
Power 6.6 kVA (0.5 kVA stand-by)
Current absorption 30 A peak (2.4 A stand-by)
Number of phases 1 or 2 configurable
Connection Permanently installed (IEC 601-1)
Maximum apparent resistance 0.20 Ω
H.V.GENERATOR
Line voltage compensation AUTOMATIC
H.V. 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%
Nominal Power 3500 W 35 kVx100 mA
(5000 W optional)
kV range 20 / 35 kV
kV resolution (Man & Auto mode) 0,5 kV
kV precision 1%
kV repeatability  0,1%
kV risetime 1.5 ms from 0 to100%
kV display XX,X kV (3 digits)
Anode current max 100 mA (140mA optional)
mAs values according to series R’20 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 13, 16, 20, 25,
32, 40, 50, 63, 80, 100, 130, 160, 180, 200,
250, 320, 400, 500, 640
mAs range Small focus: 1/200 mAs (from 20 to 30 kV)
1/180 mAs (from 31 to 35 kV)
Large focus 1/640 mAs (from 20 to 30 kV)
1/500 mAs (from 31 to 35 kV)
mAs resolution (Automatic) 0,1 mAs
mAs display XXX,X mAs (4 digits)
Exposure Time Automatically selected in function of selected
mAs
Safety timer 10 s

X-RAY TUBE ASSEMBLY I.A.E. XM12i

Anode rotation speed 3000 rpm 50 Hz
Target material Molybdenum
Maximum Anode Heat Content 225 kJ (300 kHU)
Maximum Anode Cooling rate 500 W
Maximum X-Ray Tube Assembly Heat Content 320 kJ (384 kHU)
Housing continuous Heat Dissipation 80 W (108 HU/s)
Cooling method free air convection
Anode Disc Target Angle 12.5°
Anode Disc Diameter 80 mm
Power 4800 W large 1150 W small
Focal spot sizes according to IEC 336 0.1 small 0.3 large
X-RAY Window 0.5 mm Beryllium
Inherent filtration 0.0 mm Al IEC 522/1976
Fix Filter (standard) 30 m Molybdenum
Automatic Filter FILTROMAMM (optional) 30 m Molybdenum 30 m Rhodium
HVL measured at 28kV >0.3 mm Al equiv.
Total filtration >0.5 mm Al
X-RAY TUBE ASSEMBLY VARIAN M113 (optional)

Anode rotation speed 2800 rpm 50 Hz
Target material Molybdenum
Maximum Anode Heat Content 225 kJ (300 kHU)
Maximum Anode Cooling rate 714 W (60 kHU/min)
Maximum X-Ray Tube Assembly Heat Content 330 kJ (440 kHU)
Housing continuous Heat Dissipation 100 W (135 HU/s)
Cooling method free air convection
Anode Disc Target Angle 10°/16°
Anode Disc Diameter 77 mm
Power 3600 W large 800 W small
Focal spot sizes according to IEC 336 0,1 mm (small) 0,3 mm (large)
X-RAY Window 0,5 mm Beryllium
Inherent filtration 0,0 mm Al IEC 522/1976
Automatic Filter FILTROMAMM 30 m Molybdenum 30 m Rhodium
HVL measured at 28kV >0,3 mm Al equiv.
Total filtration >0.5 mm Al
FILTER PROPERTIES
30 m Molybdenum 0.38 mmAleq @ 28 kV, measured with
Mo target and no additional filter
30 m Rhodium (optional) 0.62 mmAleq @ 28 kV, measured with
Mo target and no additional filter
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.

AUTOMATIC EXPOSURE CONTROL (DEATA PLUS)

Controlled parameters Auto kV / Auto mAs (Zero Point Mode)
Manual kV / Auto mAs (One Point Mode)
Auto parameters selection criteria Selected in function of effective BREAST
DENSITY evaluated by pre-exposure X-ray
pulse  10msec
Auto kV range Function of the selected technique (standard-
extended-high contrast-low dose), the
Anode/Filter coupling and the precise
regulation +0.5 / +1 / +1.5 kV
Manual density control 11 steps 0  5
Programmable from PC independently for all
the operative techniques available
Film Screen combinations with Deata Plus 16 film/screen programmable for 512
independent calibrations
O.D. linearity over 2 to 6 cm of Plexiglas Better than  0.1 of O.D. (after field
calibration)
Reference O.D. Programmable during installation
A.E.C. short time stability measured over <3%
10 exposures taken at 28 kV 50 mAs
Detector PHTM 9000
SOLID STATE (9 active sensors)
Detector Positions 3 electronically selected positions
Erratic exposure protection Detector saturation
Excessive breast density
For both cases Dose Released < 1 mAs
Test Phantom 3x2 cm + 1 cm + 0.5 cm of Plexiglas for
calibration and daily self test procedure
Exposition Break For breast density higher max value
programmed during calibration with a dose
< 1mAs
A.E.C. Self Test Procedure Included in control panel functions
Average glandular dose measured in ACR < 3 mGy
method: 4.5 cm phantom of 50%
glandular tissue and 50% adipose tissue
exposure taken with 28 kV
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

C-ARM
F.F.D. 65 cm for MELODY II and MELODY/B II
65 to 70 cm variable with motorized
movement for MELODY/B II(optional)
Rotation Manual 180° with disc brake
Vertical movement with respect to Breast 65 cm F.F.D. C-ARM
support (C-ARM in vertical position) 55 cm min to 130 cm max
65/70 cm variable F.F.D. C-ARM
83 to 149 cm F.F.D. 65 cm
78 to 144 cm F.F.D. 70 cm
Patient protection (optional for MELODY Face shield with plastic screen for patient’s
II - standard for MELODY/B II) face protection
COLLIMATOR
Light beam With automatic switch ON when operating
compression and electronic timer
Light intensity  150 lux
Light beam collimation accuracy according to IEC 601-1-3
Mirror with automatic out of field function
Collimation plates 18X24 cm fixed (MELODY II)
Ø 14 cm, 18X24 cm, 24X30 cm
interchangeables (MELODY/B II)
COMPRESSION SYSTEM (standard)

Compression Plate movement Manual or motor driven
Compression Plates (standard) 18x24 cm shifted and Ø 7.5 cm straight for
spot (MELODY II)
18x24 cm shifted, Ø 7.5 cm straight for
spot, 9x21 cm straight, 10x24 cm shifted
(MELODY/B II)
Compression Plates (optional) 24x30 cm shifted, Ø 7.5 cm shifted,
18x24 cm shifted with metallic grid for
bidimensional biopsy
Maximum free space available between Standard C-ARM (MELODY II)
Compression Plate and image receptor 350 mm with shifted Compression Plates
Isocentric C-ARM (MELODY/B II)
350 mm with shifted Compression Plates
In Magnification Mode
MAG. X2 = 150 mm
MAG. X1.5 = 250 mm
Compression Thickness Display Display in mm
Compression plate release after exposure Selectable from control panel, automatic or
manual for 2D biopsy
Compression Holder Fast mechanical unlock
Compression plate aluminium equiv. Less than 0.2 mm Al (0.135 mm Al≈30 kV)
COMPRESSION SYSTEM (optional)
Compression Force Adjustment Adjustable from 4 to 15 kg or 20 kg
Compression Force Display Effective applied force with 0.1 kg
resolution
Maximum Compression Force Safety Triple safety device:
electronic, electro-mechanical, mechanical

MAGNIFICATION
Magnification support x1.5 / x2 (standard)
x1.5 and x2 with gridless cassette holder,

cassette detector and automatic focal spot
selection (optional)
POTTER BUCKY
Bucky factor (grid) 1.96
Ratio 5:1
Lines/cm 36
Contrast factor 1.47
Cassette size 18x24 cm standard
24x30 cm optional
Cassette compatibility All the most common models with window
as: Agfa, Dupont, Fuji,Kodak,3M
Cassette detector switch With alarm in different languages to avoid
double exposure or exposure without
cassette
Top Cover Carbon fiber
Film marker Integrated with two labels wheels
Test with NORMI Phantom Typical 3.5 balls
Other features Easily interchangeable with other accessories
without tools
Grid movement synchronized with X-RAY
beam
Same weight of different formats to maintain
C-Arm balancing
Aluminum equivalence Table: 0.1 mmAleq (carbon fiber)
Potter-Bucky: 0.3 mmAleq (carbon fiber and
grid)
DOSE CALCULATOR
Measured dose Average Glandular Dose (AGD)
Data visualization mGy on display, label printer and data
memory with average dose value on 1300
exposition to evaluate released dose

CONTROL PANEL
Technology Microprocessor controlled with unique safety
features exceeding IEC 601-1-4-, all
functions under active operator control
Display GRAPHIC LCD Display 240x128 dots
Alarm messages In several languages selectable
Serial port exposition data for Easylabel Dedicated for Film Labelling device Easylabel
film printer (200 characters printed on film) or Adhesive
Labels with Dose
Calibration and service Serial port For service laptop with dedicated software
Special features Last 1300 exposure memory;
Tube Thermal Unit display and active
protection.
Technical display for self-test and defective
block identification, firmware release,
exposure counter and last exposure
time/date.
Statistics function Average dose, amount of exposures for every
kV value, amount of exposure in every test
technique
Diagnostic functions Selectable service functions on LCD Display
for hardware testing of each specific board
with input status display, single status
display and ON/OFF function
FOOT PEDALS
For compression One pair (standard)
Two pair (optional)
EMERGENCY STOP/SHUTDOWN SWITCHES

Red push-buttons On both sides to switch the unit totally off
PROTECTIVE SHIELD
Protective glass shield (optional) Hinged
Size 200 cm (h) x 65 cm (w) :
> 0.24 mm Pb equivalent @35 kV
Semitransparent
Size 210 cm (h) x 70 cm (w) :
Fully transparent
Size 209 cm (h) x 70 cm (w) :
EXTERNAL CABLES
Power cable 5m
Exposer cable 3 m coiled cord

ENVIRONMENTAL CONDITIONS
Storage conditions (while packed) temperature -20°C / + 70°C
relative humidity 10% / 90%
barometric pressure 500 hPa/1060 hPa
Operating conditions temperature +10°C / + 40°C
relative humidity 30% / 75%
barometric pressure 700 hPa/1060 hPa
Protection degree according to standard IP 30
IEC 529
Heat dissipated in max load condition of 35 264 Kcal/h
KV 500 mAs (1 shot every 5 minutes)
ENVIRONMENT PROTECTION AND WASTE DISPOSAL

Device contains in some of its parts and subassemblies, solid and liquid substances that
must be disposed only by designated companies according to local laws.
More specifically, device contains:
Tube assembly Beryllium, lead, 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.
CLASSIFICATION (IEC 601-1)

Protection against electric shock: Class I, with type B applied parts.
Protection against harmful ingress of IPX0
water:
Degree of safety in the presence of Not suitable for use in the presence of
flammable anesthetics mixture with. air Flammable Anesthetics Mixture with air or
or with oxygen or with nitrous oxide: with oxygen or with nitrous oxide.
Mode of operation: Continuous operation with intermittent
loading.
NOTE:
The manufacturer reserves the right to make further improvements while
keeping main features unchanged

ELECTROMAGNETIC INFORMATIONS ACCORDING TO IEC 601-1-2
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 can not 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.
Warning: 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
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 II is intended for use in the electromagnetic environment specified below. The customer or the user of the
MELODY II should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The MELODY II uses RF energy only for its internal
RF emissions
function. Therefore, its RF emissions are very low
Group 1
and are not likely to cause any interference in nearby
CISPR 11
electronic equipment.
RF emissions The MELODY II is suitable for use in all
Class B establishments, including domestic establishments
CISPR 11 and those directly connected to the public low-voltage
power supply network that supplies buildings used for
Harmonic emissions domestic purposes.
Not applicable
IEC 61000-3-2 The MELODY II has a rated input current of more
than 16 A per phase.
Voltage fluctuations/
flicker emissions
Not applicable
IEC 61000-3-3
Warning: The equipment or system should not be used adjacent to or stacked with other
equipment and that if adjacent or 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

Immunity test IEC 60601 Compliance Electromagnetic environment –
test level level
guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood, concrete or ceramic
discharge (ESD) tile. If floors are covered with synthetic
8 kV air 8 kV air material, the relative humidity should be at
IEC 61000-4-2 least 30 %.
Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital environment.
IEC 61000-4-4 1 kV for input/output 1 kV for input/output

lines lines
Surge 1 kV differential 1 kV differential Mains power quality should be that of a
mode mode typical commercial or hospital environment.
IEC 61000-4-5
2 kV common mode 2 kV common mode
Voltage dips, short <5% UT Not applicable Mains power quality should be that of a
interruptions and (>95% dip in UT) typical commercial or hospital environment.
voltage variations on for 0.5 cycle If the user of the MELODY II requires
power supply input lines continued operation during power mains
40 % UT interruptions, it is recommended that the
IEC 61000-4-11 (60 % dip in UT) MELODY II be powered from an
for 5 cycles uninterruptible power supply.
70 % UT The MELODY II has a rated input current of
(30 % dip in UT) more than 16 A per phase.
for 25 cycles
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
for 5 sec for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be
(50/60 Hz) at levels characteristic of a typical location
magnetic field in a typical commercial or hospital
environment.
IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC 60601 test level Compliance Electromagnetic environment – guidance
level
Portable and mobile RF communications equipment
should be used no closer to any part of the MELODY II,
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance

Conducted RF 3 Vrms 3 Vrms d  1 .2 P
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 10 V/m
d  1 .2 P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz
d  2 .3 P 800 MHz to 2.5 GHz
where P is the maximum output power 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, a should be less than
the compliance level in each frequency range. b
Interference may occur in the vicinity of equipment

marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the MELODY II is used exceeds the
applicable RF compliance level above, the MELODY II should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the MELODY II.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile

RF communications equipment and the equipment or system
The MELODY II is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the MELODY II can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the MELODY II as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output Separation distance according to frequency of transmitter

power m
of transmitter
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
W d  1,2 P d  0,35 P d  0,7 P
0.01 0.12 0.035 0.07
0.1 0.38 0.11 0.22
1 1.2 0.35 0.7
10 3.8 1.1 2.2
100 12 3.5 7
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using 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.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.

DEVICE CLASSIFICATION
The identification label is placed on the back of the device and a true copy of it is also
placed inside on it.
IEC 601-1 (CEI 62-5) Standard:

MELODY II belongs to Class I type B.
Directive 93/42/EEC for Medical Devices:

MELODY II belongs to Class IIb.

IDENTIFICATION LABELS

OPERATING INSTRUCTIONS

WARNINGS
 MELODY II MUST BE USED BY AUTHORISED PERSONELL AFTER

AN APPROPRIATE TRAINING
 THIS MACHINE MUST BE USED ONLY FOR MAMMOGRAPHY.
 DO NOT INSERT IN THE X-RAY BEAM DEVICES OTHER THAN

COMPRESSION PADDLES OR MAGNIFICATION PLATEFORM.
 USE ONLY CASSETTES WITH ONE SCREEN DEDICATED FOR

MAMMOGRAPHY.
 FOR ISOCENTRIC C-ARM RESPECT STOPS TO 65/70 cm.
 USE LEAD APRON FOR PATIENT PROTECTION.
 DURING X-RAY EMISSION, OPERATOR MUST BE BEHIND THE

PROTECTIVE GLASS AND IN A POSITION WHERE IT IS POSSIBLE
TO WATCH PATIENT AND UNIT.
 USE ONLY ORIGINAL ACCESSORIES AND SPARE PARTS
 FREQUENTLY VERIFY THE WEAR OF THE COMPRESSION

PLATES TO PREVENT DAMAGES AS CRACKS AND TEARS, AND
CONSEQUENT RISKS FOR THE PATIENT.
 THE MAMMOGRAPHY UNIT IS CLASSIFIED AS PERMANENTLY

INSTALLED ACCORDING TO IEC 601-1 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.

MAIN PARTS MELODY II
14
15
13
12
11 16
10 17
9
18
8
19
7
6
20
4 21
3 2 1
22

LEGEND
1. Patient support handle

2. Cassette extraction lever
3. Film markers
4. AEC
5. Potter-Bucky
6. Compressor removal lever
7. Compressor support
8. Collimator
9. Holes for magnification device centring and locking
10.Goniometer
11.X-ray tube assembly
12.C-arm
13.Push-button for C-arm rotation
14.Column
15.Double push-button for C-arm vertical movement
16.Accessory storage shelves
17.Display and control panel
18.On/off switch
19.X-ray emission push-button
20.Emergency shut-off buttons
21.Connections to external devices
22.Double foot-pedal compressor control

460 MELODY II DIMENSIONAL DRAWINGS
2082
max 1660
min. 910
max 1300
min. 550
1350
532
580
780
1350

MAIN PARTS MELODY/B II
14
13
12
11 15
10 16
9
8 17
7 18
6
19
4 20
3 2 1
21

LEGEND
1. Patient support handle

2. Cassette extraction lever
3. Film markers
4. AEC
5. Potter Bucky
6. Compressor removal lever
7. Compressor support
8. Collimator
9. Holes for magnification device centring and locking
10.Goniometer
11.X-ray tube assembly
12.Isocentric C-arm
13.Push-button for C-arm rotation release
14.Column
15.Accessory storage shelves
16.Display and control panel
17.On/off switch
18.X-ray emission push-button
19.Emergency shut-off buttons
20.Connections to external devices
21.Double foot-pedal compressor control

820 MELODY/B II DIMENSIONAL DRAWINGS
2082
max 1490
min. 830
1350
532
580
780
1350

CONTROL PANEL
V I L L A
M ELODY
S IS T EM I
M ED I C A L I
1 1
5 8
5 8
14 10
14 10
6
13
6
13
2 kV mAs
7
12
2
12
3 4 9 11
3 4 9 11

LEGEND:
1. Liquid crystal display

2. Focal spot selection
3. kV selection (only one point mode or manual mode). 0.5 kV increments
4. mAs selection (only manual mode). 25% increments
5. Technique selection (zero point mode, one point mode, manual mode)
6. X-ray emission signalling lamp
7. Film/screen combination selection
8. AEC field selection (only if the electronic AEC field selection is installed)
9. Film density (darkness) selection (11 values from -5 to +5)
10.Breast decompression modality (manual or automatic at the end of exposure)
11.Compression force pre-set (1 to 20)
12.Acoustic alarm stop and functions reset after error or warning
13.Vertical C-arm movement
14.Mo/Rh filter selection (option)
Notes:
A short sound is played each time a button is pressed.
It’s normal that the sound comes a few fractions of a second after the buttons have
been pressed. To be sure that the command has been accepted, keep the button
pressed until you hear the sound.

DISPLAY
19 18 17 16
20
15
1
14
2
13
3
12
4 5 6 7 8 9 10 11
1) Selected technique (Manual, Zero Point, One Point)

2) Anode material, Molibdenum
3) Filter material (Rh only for automatic filter)
4) Anode-filter combination selection
5) Focal spot selection
6) Optical density correction
7) Automatic decompression at the end of exposure enabled/disabled
8) Film/screen number
9) Compression force
10)A.E.C. detector position
11)Grid table inserted
12)AEC test enabled
13)HU level of tube assembly
14)Thickness of the compressed breast
15)Dose indication
16)mAs value
17)Operating mode STD (standard), EXT (extended), HC (High Contrast), LD (Low Dose)
(*)
18)Fine kV correction of selected kV range 0,+0.5,+1,+1.5 kV
19)kV value
20)kV range selected for Zero Point mode
(*) only with DEATA PLUS DIP5=OFF

TABLES
For any table size and model, radiographic cassette can be inserted from both sides, and
can be extracted even from the other side.
To insert cassette push back the knob showed in the figure below. Cassette must be
inserted till the knob is released.
Exposure is disabled if cassette is not inserted or already exposed.
KNOB
LED
KNOB
LED function on Table

 The LED is bright fix if cassette is ready for exposure.
 The LED blinks if the cassette is not inserted, or is already exposed, or is already in
at power on.
EXAMINATION ROOM
X-Ray units can only be operated inside dedicated room provided with X-ray protection
that meets local standards and regulations.
SWITCHING ON
Before switching ON the unit, check that Emergency Push Buttons n°20 are unlocked and
Green Lamp n°18 is bright; if not, check main switch on the wall.
Press button n°18, and keep it pressed until the lamp switches OFF.

The machine takes about 10 seconds to switch on; wait that LCD screen is completely
filled, so that the machine is ready for use.
If a cassette was inside the tables during switch on, the set up process is blocked, the
message “CHECK CASSETTE” appears, and a sound signal takes place.
In this case, the operator must either remove the cassette (for example because it is
already exposed or empty), then press the reset button, or press the reset button to use
the cassette.
SWITCHING OFF
Press button n°18 (see main parts plan).

After switching OFF the unit, control lamp blinks for few seconds during which switch ON
is not allowed to protect internal parts.
VERTICAL MOVEMENT OF C-ARM
This action is possible pressing the pushbuttons n°13 on the control panel, or from the
optional auxiliary up-down push-button on C-ARM n° 15 (see main parts plan).
For safety reasons, it is not possible to move the C-arm during compression. If the
command for the up/down movement of the C-arm is acted during compression, two
possibilities exist: either the compression is automatically released, and the C-arm moves,
or the compression is maintained but the C-arm does not move. It is possible to choose
one of the two possibility during installation or service.
ROTATING C-ARM
To rotate C-arm unlock the brake pushing the buttons n° 13 (see main parts plan) located
on the handles. The maximum rotation is 180°. When the unit is OFF the C-ARM can’t be
moved.
The rotation is showed by a goniometer.
If the C-arm is rotated during compression, the compression is automatically released.
For safety reasons, C-arm rotation is disabled if the table is not inserted, because the C-
arm is not balanced.

TABLE INSERTION
To insert table simply align it with slide guides, push till to the stop and check that table
front wall is aligned with support front wall.
After connecting tables with grid, check that grid moves pressing pushbuttons n°12 (alarm
reset, see the paragraph “control panel”) and n°11 (compression minus, see the paragraph
“control panel”) at the same time.
To remove table simply pull it out.
Slide guide
Slide guide
LABELS WHEELS
Tables have two labels wheels to identify projections.

R Righ breast L Left breast

CC Craniocaudal CC Craniocaudal
R Right breast L Left breast

OBL Oblique OBL Oblique

ML Mediolateral ML Mediolateral

LM Lateromedial LM Lateromedial
Note: the above table is not exhaustive of all possible mammographic views. For further
details, and for the correct positioning and compression of the patient, refer to the ACR
protocol or other official sources of information.
COMPRESSION PLATES INSERTION
To insert or remove compression plates push the locking system as shown below.
COMPRESSION AND LIGHT BEAM INDICATOR
Motorized compression is operated by the external foot-control n°22. Compression force

can be adjusted by buttons n° 11 (see control panel). The number showed on display (see
next picture) is only proportional to a force, it is not the result of any measurement or does

it expresses a physical dimension. Index can range from 0 to 15 or from 0 to 20 by means

of internal dip-switch, depending on local regulations.
For enhanced patient comfort, compression plate speed decreases when it gets in contact
with the patient.
Two operating modes may be selected for compression release at the end of exposure:
AUTO RELEASE (NORMAL MODE)
MANUAL RELEASE (FOR 2D BIOPSY)
Mode selection is effectuated with button n° 10 on panel control (see console plan), and
the selected mode is shown (see next picture) on the display.
Manual compression is possible pressing both pedals and acting on the compression plate
until obtaining the desired compression, then releasing both pedals in order to maintain
that level.
Every time the compression down pedal is used, the luminous field indicator light switches
on for about 20 seconds.
In the event of a power cut, compression force is annulled, letting the patient immediately
free.
During compression the breast thickness is written on the display as shown below:
Compression
thickness
Compression
release Compression
force
This value is displayed only if the operator chooses a correct exam configuration:
 For contact technique: select large focus, use grid tables and shifted compression
plates.
 For magnification technique: select small focus; use grid-less tables and straight
compression plates
If thickness measurement is outside limits the display shows:
---mm
The compression force previously set using the panel board is automatically restored
when the compressor is reactivated.

COMPRESSION WITH VARIABLE SPEED (OPTIONAL)
Motorized compression is operated by the external foot-control n°22. At the end of the
compression, a beep sound is emitted.
Compression force can be set by buttons n° 11 (see the paragraph “control panel”).
Setting the force, the number showed on the display changes, see picture below.
Compression force set on the control panel
Selected compression force (limit) from 4 to 15 or from 4 to 20 by means of internal

setting, depending on local regulations.
Two operating modes may be selected for compression release at the end of exposure:
AUTO RELEASE (NORMAL MODE)
MANUAL RELEASE (FOR 2D BIOPSY)
Mode selection is effectuated with button n° 10 on control panel (see the paragraph
“control panel”), and the selected mode is showed on the display.
Manual compression is possible pressing both pedals and acting on the compression plate
until obtaining the desired compression, then releasing both pedals in order to maintain
that level.
Every time the compression down pedal is used, the luminous field indicator light switches
on for about 20 seconds. The compressor starts moving with a little delay, so that if the
breast is already compressed and you want only switch on the light, you can do it, avoiding
additional pressing. The compression movement is immediate when the centering device
is already on.
For enhanced patient comfort, compression plate speed decreases when it gets in contact
with the breast.

The pre-selected force is displayed with an half-sized character. After compression the
effective applied force is displayed with full-sized character.
In the event of a power cut, compression force is annulled, letting the patient immediately
free.
During compression the breast thickness is written on the display as shown below:
COLLIMATION PLATES INSERTION
For 18x24 cm table no collimator is necessary. With interchangeable collimators option, for
18x24 cm table or for magnification technique or for particulars, use the appropriate
collimation. To insert collimation plate, align the back edge and after push it up until it’s
engaged by the magnet. The magnetic part of the collimator must be upside, turned
towards the tube. The angles of the collimator have different curvature, to avoid wrong
insertion, but pay attention that the collimator is inserted correctly.
The collimator cannot be inserted of removed if the face shield is in.

18x24 cm CASSETTE ADAPTER
The cassette adapter is an accessory that allows the operator to change cassette size
without changing the table. It is similar to a 24x30 Potter-Bucky, and 24x30 cassette can
be inserted normally, but the adapter is also provided of a special adaptor that allows to
use the 18x24 cassette.
This accessory is able to detect the cassette size inserted. This allows the automatic
collimation to work properly (if installed) .
After changing film size, wait for countdown before to operate X-ray exposure.
To avoid extra delay, insert cassette before patient positioning, collimator positioning will
take place during that time.
Do not insert adapter without cassette inside, detecting functions can be wrong.
24x30 cm Potter bucky with 18x24 cassette adapter
FACE SHIELD PROTECTION
To insert the face shield (standard for MELODY/B II and optional for MELODY II), insert
the pins in the appropriate holes and push the face shield to fix it. To remove the lexan
shield pull it to unlock.
Face shield is not intended for magnification techniques.

INSERT DEVICE FOR GEOMETRIC MAGNIFICATION 1.5X OR 2X
To insert the device for geometric magnification 1.5x or 2x, the screw and the coupling pin
of the magnification device must be inserted in the proper holes on the C-arm. To get a 2x
magnification, use the two higher holes; to get a 1.5x magnification use the two lower
holes. Than screw the magnification device as shown in the picture.
screw the magnification device as shown in the picture.
2x
1,5x
MAGNIFICATION DEVICE 1.5X OR 2X (OPTIONAL)
The optional device for geometric magnification has no grid because it is not requested in
magnification technique. It has neither carbon fiber to reduce dose.
The magnification can have 1.5x or 2x factor. To select the magnification factor pull the
two lateral knobs at the same time, and fix table height at requested position. Release the
knobs and verify that they lock the magnification device.
When inserting device, small focus is automatically selected.
Magnification table has cassette sensing functions and LED similar to grid tables (Bucky).

kV SELECTION
kV selection is possible only in MANUAL mode and ONE POINT mode. It increases and
decreases kV values through 0.5 kV steps. In MANUAL mode the selectable range is 20 ÷
35 kV, in ONE POINT mode the range is 23 ÷ 32 kV. Commands are n°3 in control panel.
In ZERO POINT mode the same buttons are used to fine tuning of kV range.
mAs SELECTION
This command is active only in MANUAL mode. mAs values can be selected in log scale
by buttons n° 4 on control panel (see console plan). In ZERO POINT mode the same
buttons are used to select the exposure technique (STD, EXT, HC, LD).
FILM/SCREEN COMBINATION SELECTION

In ZERO POINT and ONE POINT mode, MELODY II selects kV and mAs depending not
only by breast density, focal spot, anodic and filter material and other geometric
parameters, but also depending by the film/screen response to X-rays. A total of 16
Film/Screen combinations, programmed during installation, can be selected. To modify
memorized combinations or add more, service intervention is required. The selection is
obtained by button n° 7 on control panel (see console plan).
If only one film screen and one operating technique is used, the used technique can be
frozen by internal dip-switch. If the techniques are not frozen, and you select a not
programmed technique, exposure is not possible and the alarm “In-active” comes.
MANUAL DENSITY CONTROL
With this command it is possible, in ZERO POINT or ONE POINT mode, to increase or
decrease the darkness of the exposed film. During calibration the operator chooses a
desired optical density. The obtained darkness may change and diverge from the chosen
darkness for many reasons (development chemicals, sensitivity of film and supporting
screen, performance of X-ray tube, operating temperature etc.). It is also possible that the
operator wants a darker or brighter exposure. So that, it is possible to correct the exposure
to obtain the most satisfactory optical density value. Commands are buttons n° 9 on
control panel (see console plan), and the range is from -5 to +5. The optical density

difference between two adjacent steps is set during calibration and usually varies from 0.1
to 0.2.
RADIOGRAPHIC EXPOSURE
X-ray push-button has a single action (PREP + EXP). The button must be kept pressed
until the exposure is over. Exposure is announced by a sound signal and by light n° 6 on
control panel.
If the X-ray pushbutton is released, the X-ray emission stops immediately.
The CPU is able to recognize the cassette status. In case of no cassette inserted, if the X-
ray push-button is pressed, the alarm CASSETTE NOT INSERTED appears on the
display. In case of cassette already exposed, if the X-ray push-button is pressed, the alarm
CASSETTE ALREADY EXPOSED appears on the display. Before starting exposure check
that on the display the notice READY is present in the lower right corner.
RESET COMMAND
The button n° 12 on control panel stops the acoustic error signal, that is related to the error
message on the display.
HEAT UNIT INTEGRATOR
At the end of each exposure, the microprocessor calculates the heat units accumulated by
the RX tube. Two values appear on the display areas n° 13 and 12:
“HU xx% TD xx”, which refer respectively to the total heat units accumulated by the tube
and to the time in seconds that must elapse before next exposure is possible. The
exposure is not permitted until the value relating to TD is zero. When 90% of the maximum
thermal capacity of the tube is reached, an alarm sounds and the exposure is not
permitted until the HU drops below the maximum permitted value.
If ambient temperature is higher than 25°C, HU can be greater than zero even if no
exposures have been released for a long time.

EXPOSURE TECHNIQUES

DOSE MINIMIZATION
Dose released to the patient is function of each one of the parts composing the
mammographic system.
To reduce the dose take care of the following points:
Film Processor
Temperature and process time have to be selected according to film manufacturer’s
specifications; if not available, adjust temperature to 35 C° and process time for extended
process.
Chemicals
Be careful to replace them when aged and unable to guarantee the optimal performances.
We recommend the use of sensitometer, densitometer and sensitometric chart for daily
processor check.
Film/Screen
Actual state of the art can reduce the dose to ½ with respect to older types.
Optical Density
Refer to the most diffused Quality Protocols to select reference O.D. and take into
consideration that dose and film darkness are directly related.
Mammo Unit
Be sure that ADVANCED CALIBRATION PROCEDURE has been performed to assure
max O.D. linearity.

IMAGE QUALITY
The image quality is the final product of a Mammographic system, so that it is of course
the last and most important aspect.
Film Processor
Supposing that all the components have been selected and tuned properly, the film
processor covers a very important role among them.
A dirty processor or with damaged rolls can generate artifacts on the film that reduce
dramatically the image quality.
kV selection
ZERO POINT MODE kV range has been selected in order to remain below 30 kV when
taking pictures with very large and dense breasts.
Everybody knows that image contrast reduces when kV increase.
Test phantom
To check image quality, several test phantom and related procedures are available from
the market.
If RMI 156 phantom is used, a score is associated to each detail, total score is used to
judge image quality.
Using phantom, the role of each component can be investigated and the final image
quality enhanced.

MANUAL MODE
In MANUAL MODE the operator can select mAs and kV and the UNIT itself take care of
Max loading conditions.
At the actual state of the art, having the unit a very powerful A.E.C., MANUAL MODE is
not used for routine examination.
MANUAL MODE is used for special purposes like breasts with silicone prosthesis.

ZERO POINT MODE (fully automatic kV and mAs)
This is the most used operating mode and it is recommended because it is able to
guarantee the maximum performances of the unit.
In ZERO POINT MODE kV and mAs depend on the real breast density measured by a
short X-ray pre-exposure.
Optical density repeatability, over a very large breast density range, is assured by
advanced A.E.C. calibration.
Using ZERO POINT MODE, the operator has only to take care of patient positioning and a
top quality image is assured, examination time and retake are minimized.
KV range in ZERO POINT MODE has been selected so that even with large and dense
breasts kV value if far enough from 30kV and image contrast is not reduced.
After exposure the display shows kV, mAs and dose released during the exam.
Zero point kV range

When ZERO POINT mode is selected, 4 different operating mode STD (standard), EXT
(extended), HC (high contrast), LD (low dose) are available each one having a specific and
dedicated kV range.

Selection of STD, EXT, HC, LD is possible by mAs push-buttons.

By means of kV push-buttons it’s possible to shift up of +0.5, +1 and +1.5 kV the selected
kV range as above described.
+0 + 0.5 +1 + 1.5
By means of the two above described functions, operator has a very powerful tool to
manage the examination with the most appropriate technique.
Optical density correction

Using pushbuttons n°9 (see console plan) the operator can increase or decrease the
darkness that is normally produced on the film.
The number on the display in position 6 varies between -5 and +5. If the operator chooses
to increase optical density, a grater dose is released to the patient, and the darkness of the
film increases, and vice-versa. Any step of optical density set on the mammograph,
corresponds to a definite value of optical density, normally between 0.1 and 0.2. This value
of any single step is chosen during calibration.
AEC Detector position
Depending on the breast size and morphology the operator can manage detector position.
Be careful to avoid that detector remains partially out of breast, in this case exposure will
be shorter than necessary and picture will be useless, too bright.
Normal position is with the first field active (patient side).
Compression plates have silk screen to locate AEC position on the breast.
When selecting AEC position take care that it’s not outside the breast, if it happens
DETECTOR OVER EXPOSED alarm is generated.

The unit is equipped with PHTM9000 detector, operating field/position can be selected
from the control panel by means of push button 8 (see the paragraph “control panel”),
selected position will be showed on the display.
Anode/filter combinations
If the mammographic unit has an automatic Mo/Rh filter, in ZERO POINT mode the
mammographic unit can choose automatically the filter material to use for the exam. Use
button 14 so that in the area n°4 of the display is written AUTO. After exposure the EXP
notice appears, and the used filter is showed on the display on area 3.
If the operator wants to choose the filter material by himself, he can set it in FIX mode
pushing the button over and over again.
Note
Due to little difference in breast density related to different projections, for the same patient
kV may differ of 0.5 kV between one projection and another.
This is due to the breast density that can be close to the trip point between a kV value and
another, of course a difference in mAs is normal too.

ONE POINT MODE (manual kV and automatic mAs)
Is a semiautomatic mode recommended only when the user needs to select kV manually
for special purposes under his control.
To avoid that contrast is too low, we recommend to select kV not higher than 30.
ONE POINT MODE is derived by ZERO POINT MODE and is based on the same concept
of breast density measurement by means of a short pre-exposure.
For optical density correction, AEC detector position and anode/filter combination refer to
previous ZERO POINT MODE paragraph

DOSE CALCULATOR
Unit is provided of Average Glandular Dose (AGD) calculator.

After each exposure, dose in mGy is displayed in the dedicated area of the display, is
recorded in the Last 1300 exposures memory and can be printed on the film if the
Easylabel film printer is available and such function has been enabled during installation.
For proper dose calculator operation, it’s necessary to use the appropriate compression
plates as described in the next chapter “tipical configurations”.
Shifted plates have to be used with large focus and straigh plates with small focus
because focal spot to skin distance measurement depend on it and dose calculation too.
Also refer to the Typical Configurations chapter.
Mo/Rh FILTER (optional)
Automatic Mo/Rh filter is an optional accessory and is not present in all the
mammographic units.
Automatic Mo/Rh filter is used to have a double combination ANODE/FILTER (Mo/Mo
Mo/Rh). It optimizes the spectral characteristic of X-rays in function of real density of the
breast.
Breast density is detected with a short pre-exposure X-ray pulse in ZERO POINT and
ONE POINT techniques. So that the appropriate TARGET/FILTER, other than the
exposure parameters, will be automatically selected.
Mo/Mo combination is used for normal density breasts while Mo/Rh combination is used
for others having high density. Trip point after which Mo/Rh combination is selected,
corresponds to about 6 cm of Tissue Equivalent RMI phantom.

TYPICAL CONFIGURATIONS

The next typical configurations are intended to help the operator to avoid operating
mistakes.
Use of different configurations can result in bad images with unwanted artifacts due to
compression plates arms in the picture, wrong x-ray field coverage, wrong dose
measurement and others.
Proper collimator selection is essential to guarantee correct X-ray field and patient
protection according to applicable IEC standards.
The typical configurations are the same if isocentric C-ARM option is installed.
DO NOT USE CONFIGURATIONS OTHER THAN

THE ONES PRESCRIBED IN THIS CHAPTER

CONFIGURATION FOR NORMAL BREASTS EXAMINATION
Use of shifted compression paddle makes pulling of the breast easy.

CONFIGURATION FOR LARGE BREASTS EXAMINATION WITH 2430

FILM SIZE
Use of shifted compression paddle makes pulling of the breast easy.

CONFIGURATION FOR MAGNIFICATION
Install the magnification device in the upper slots for 2X magnification, or in the lower slots
for 1.5X magnification.

CONFIGURATION FOR MAGNIFICATION (OPTIONAL)
Fit Magnification device instead of Potter-Bucky and choose the lower position to achieve
magnification x1.5 or the upper position to achieve magnification x2.

MAINTENANCE

ERROR MESSAGES
One of the features of the MELODY II CPU is that it displays TEXT ERROR MESSAGES
and no error codes. Message languages can be selected by Service personnel within
those available from current firmware version.
Not clearable messages:

The following message can’t be cancelled and operation is no more allowed for clinical
use. Call Service.
Gas spring defective.

Safety of suspended masses, C-arm, is not guaranteed, gas spring must be replaced. This
alarm can’t be cancelled and operation is no more allowed for clinical use. Call Service.
Messages clearable restoring normal operative conditions:

The following message are automatically cleared if the reason for witch they arose has
been removed.
Check cassette
A cassette that might already have been exposed is present in the potter when the
machine is turned on. Remove cassette before to reset alarm.
Cassette already exposed

Replace film.
Cassette not inserted

Insert cassette in Potter-Bucky.
Absence of collimator cone

Put in place collimation plate.

Check foot pedal switch, Check brake push buttons,

Check arm push buttons
There is probably a fault of an electrical nature or mechanical blockage of the respective
buttons. Attempt to remedy by keeping buttons/pedals depressed; should the fault persist,
call Service. In this event, all other functions are not permitted.
Door open
Close the door of diagnostic room.
Messages manually clearable:

The following message can be cleared pressing button n° 12 (alarm reset) on control
panel.
Mirror position error

Mirror of light field indicator has not moved out of field during preparation. Call customer
service if problem persists.
Filter position error

A mechanical problem has been encountered during filter positioning. Call Service.
Early push button release

X-ray pushbutton button has been released before the exposure has been terminated by
CPU
Low anode current

Call service if this alarm tends to be repeated in Manual Mode only.
Not active
Selected FILM/SCREEN or specific operating mode has not been programmed during
installation. Refer to Technical Service for calibration extension.

Not enough mAs with AEC

The exposure has been terminated:
1. by the timer because exposure requested a mAs value greater than the tube can
handle. Repeat exposure in ONE POINT mode by raising KV or by using a more
sensitive screen-film combination;
2. by early detection of density too high. In such condition about 1 mAs only has been
released.
Change film before repeating exposure.
AEC detector over exposed

AEC detector is partially or totally out of the breast and has been exposed to direct X-ray
beam.
Check for proper detector and breast positioning.
X-ray released has been less than 1mAs, film must be replaced.
Breast too dense

Such problem can be due to silicone prosthesis, or wrong patient positioning, ribs or bones
in the field, or technical reasons.
X-ray released has been less than 1 mAs, film must be replaced.
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.

Technical error
Depending on the specific technical error, the technical menu can appear on the display:
------------------------------------------------------------------
------------------------------------------------------------------
-------------CPU-----------------sw1--------sw2---------
F2= OK 00000000 00000
-------------------------INVERTER--------------------------
Vdc(in)= 527 SERVICE = OK
-------------FILAMENT POWER SUPPLY-------------
>>GOOD<<
----------------------ROTOR SUPPLY---------------------
>>GOOD<<
------------------------------------------------------------------
FIRMWARE REV XXX_____XX TUBE
Tube Housing kJ000 15°C
n XXXXX DATE HOUR:MIN
------------------------------------------------------------------
If technical error occurs, inform Customer Service. In some conditions, when technical
menu appears, reset could not be possible. Switch the unit off and on again.

PERIODIC MAINTENANCE
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.
Other facultative procedures that the user can carry on by himself, mainly intended to
guarantee dose minimization and image quality optimization are the followings:
 Densitometric check DAILY
 A.E.C. [o] and [r] DAILY
 Image Quality Phantom Test SIX MONTH
Furthermore a daily sensitometric check is also recommended.

A.E.C. TEST
During the test, the system should be configured as shown in the next picture.
- Install Bucky table 18x24 with grid

- Remove cassette
- Select large focus
- Remove compression plate
- Install 18x24 collimation plate
- Select ZERO POINT technique
- Select test mode pressing the two buttons of the picture above (automatic
compression release enable/disable, and compression force plus) at the same time
- Position detector at first stop on patient side
- Position the 7-cm-thick Phantom to completely cover the detector.
- Expose
- Compare with value on phantom label. Deviation has to be within ± 7 of the [r]
value,
4< [o] <15
- Repeat the test for each one of the three fields of the detector position. If out of
range call for service.

This configuration was chosen to exclude all variable elements, which may exist between
the X-ray source and the detector.
The phantom supplied with the unit can be used for the test.
SELF-DIAGNOSIS
Pressing pushbuttons 12 and 7 at the same time, the following information appears on the
display regarding the state of the unit:
------------------------------------------------------------------
------------------------------------------------------------------
-------------CPU-----------------sw1--------sw2---------
F2= OK 00000000 00000
-------------------------INVERTER--------------------------
Vdc(in)= 527 SERVICE = OK
-------------FILAMENT POWER SUPPLY-------------
>>GOOD<<
----------------------ROTOR SUPPLY---------------------
>>GOOD<<
------------------------------------------------------------------
FIRMWARE REV XXX_____XX TUBE
Tube Housing kJ000 15°C
n XXXXX DATE HOUR:MIN
------------------------------------------------------------------
These data concern:

 The state of CPU fuses;
 CPU board 01-170 DIP switches settings
 Conditions of Filament >> PASS<< or >>FAIL<<
 Conditions of Rotating Anode >> PASS<< or >>FAIL<<
 Inverter supply voltages
 Inverter low voltage supply status
 Firmware release
 X-ray tube model installed;
 Tube housing thermal level kJ and temperature
 Total number of exposures carried out;
 Time and date of last radiographic exposure.

CLEANING
External Surfaces
Use only a soft cloth or, for more efficient cleaning, a neutral detergent to avoid damage to
painted surfaces and compression plate.
During cleaning operations, do not use excess of detergent and be careful that detergent
doesn’t enter the unit.
Parts in contact with the patient

Facility must establish and follow a protocol for cleaning and disinfecting mammography
equipment that has come in contact with blood fluids or potentially infectious material.
WARNING: Particular care must be dedicated to disinfection of Biopsy Compression Plate

(perforated) due to it’s interventional use
To assure hygiene of these parts, we recommend using disposable hygienic serviette.
Compression plates
Use only neutral soap. Chemical detergents can damage polycarbonate getting it hard with
risks of cracks.
MOVING THE UNIT TO ANOTHER PLACE

Refer to Technical Manual and qualified personnel.

ACCESSORIES
WARNING
USE ONLY ORIGINAL ACCESSORIES

The following accessories are available, to satisfy every diagnostic need.
Please note that some of the accessories are supplied as standard equipment, while
others are available only upon request.
Code Description
4695905000 Biangular X-Ray tube
4695910800 Interchangeable diaphragm set complete with 18x24 cm, 24x30 cm,
Ø14 cm format
4695911000 Automatic collimator 18x24 cm and 24x30 cm formats
4695912500 18x24 cm shifted compressor (standard)
4695911200 9x21 cm compressor
4695911100 Φ 7.5 cm shifted compressor
4695912600 24x30 cm shifted compressor
4695912700 Φ 7.5 cm compressor (for magnification) (standard)
4695911300 10x24 cm shifted compressor
4695911400 18x24 cm shifted compressor with holes and grid for 2-D biopsy
4695911800 Compression device with variable speed
4695911900 Variable Focus-Film distance
4695911500 Lexan protection screen
4695912800 Magnification device 1.5x and 2x (standard)
4695911600 Magnification device 1.5x and 2x with cassette holder
4695910900 Automatic Mo/Rh filter changer
4695910600 18x24 cm cassette holder without film markers
4695910700 24x30 cm Potter Bucky complete with film marker + 24x30 cm
shifted compressor
4695912900 18x24 Potter Bucky complete with film marker (standard)
4695912000 Computerised stereotactic biopsy and needle guidance device
4695912100 Wall support for biopsy device
4695911700 Second pair of compression foot-control
7181193501 Hinged X-ray glass shield
4695913100 Semitransparent X-ray glass shield
4695913400 Fully transparent X-ray glass shield
4695913200 Right side keyboard and X-ray glass shield
4695913300 Remote control panel

COLLIMATORS
INTERCHANGEABLE DIAPHRAGM AUTOMATIC COLLIMATOR

SET COMPLETE (3 FORMATS) 18x24 AND 24x30 cm FORMAT
(Code: 4695910800) (Code: 4695910900)
PROTECTION SCREEN
LEXAN PROTECTION SCREEN

(Code: 4695911500)

COMPRESSION PADDLES
NORMAL BREAST LARGE BREAST

COMPRESSION PADDLE COMPRESSION PADDLE
(Code: 4695912500) (Code: 4695912600)
SMALL BREAST AND AXILLA SMALL BREAST AND AXILLA

SHIFTED COMPRESSION PADDLE COMPRESSION PADDLE
(Code: 4695911300) (Code: 4695911200)

COMPRESSION PADDLE SHIFTED COMPRESSION PADDLE

FOR MAGNIFICATION FOR MAGNIFICATION
(Code: 4695912700) (Code: 4695911100)
COMPRESSION PADDLE FOR 2D BIOPSY

(Code: 4695911400)
AUTOMATIC Mo/Rh FILTER CHANGER
AUTOMATIC Mo/Rh FILTER CHANGER

(Code: 4695910900)

POTTER-BUCKY AND CASSETTE HOLDER
18x24 cm POTTER-BUCKY 24x30 cm POTTER-BUCKY

COMPLETE WITH FILM MARKER COMPLETE WITH FILM MARKER
(Code: 4695912900) (Code: 4695910700)
18x24 cm CASSETTE HOLDER

WITHOUT FILM MARKER
(Code: 4695910900)

MAGNIFICATION DEVICES
DEVICE FOR GEOMETRIC DEVICE FOR GEOMETRIC

MAGNIFICATION WITH 1.5x AND 2x MAGNIFICATION WITH 1.5x AND 2x
(Code: 4695912800) WITH CASSETTE HOLDER
(Code: 4695911600)
COMPRESSION FOOT CONTROL
PAIR OF COMPRESSION
FOOT CONTROL
(Code: 4695911700)

COMPUTERISED STEREOTACTIC BIOPSY

(only for MELODY/B II)
-
+
- +
A GO
RE S E T + 10m m + 1m m
NE E DL E
Biopsia stereotassica computerizzata con guida ago
Computerised Stereotactic biopsy needle guidance system

COMPUTERISED STEREOTACTIC BIOPSY
cod. 4695906700
AND NEEDLE GUIDANCE DEVIANCE
(Code: 4695912000)
WALL SUPPORT FOR

BIOPSY DEVICE
(Code: 4695912100)

HINGED X-RAY GLASS SHIELD
HINGED X-RAY
GLASS SHIELD
(Code: 7181193501)

SEMITRANSPARENT X-RAY GLASS SHIELD
SEMITRANSPARENT
X-RAY GLASS SHIELD
(Code: 4695913100)

FULLY TRANSPARENT X-RAY GLASS SHIELD
FULLY TRANSPARENT
X-RAY GLASS SHIELD
(Code: 4695913400)

RIGHT SIDE KEYBOARD AND X-RAY GLASS SHIELD
RIGHT SIDE KEYBOARD AND

X-RAY GLASS SHIELD
(Code: : 4695913200)

REMOTE CONTROL PANEL
REMOTE CONTROL PANEL

(Code: : 4695913300)

WARRANTY CONDITIONS

WARRANTY CONDITIONS
VILLA SISTEMI MEDICALI 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 caused by the incorrect installation of the unit, if not carried out by personnel
trained by VILLA SISTEMI MEDICALI
 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 VILLA SISTEMI MEDICALI.
The aforesaid terms are to be considered valid except as otherwise set forth in the
contract.

THE MANUFACTURER RESERVES THE RIGHT TO MAKE FURTHER

IMPROVEMENTS WHILE KEEPING MAIN FEATURES UNCHANGED

To: METALTRONICA S.r.l.

Technical Department
Via della Pisana, 431
00163 Rome – ITALY
Tel. +39/06/66160206
Fax. +39/06/66160357
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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MELODY II OPERATOR’S MANUAL

VILLA SISTEMI MEDICALI S.p.a.

DOCUMENT STATUS SHEET

Version Release Date Reason of change

ENGLISH 01 07/04/08 First dedicated release (93/42)

VILLA SISTEMI MEDICALI II

DECLARATION ACCORDING TO IEC 601-1 STANDARD EDITION 1992

VILLA SISTEMI MEDICALI III

OPERATING INSTRUCTIONS ....................................................... 16

VILLA SISTEMI MEDICALI IV

MAGNIFICATION DEVICE 1.5X OR 2X (OPTIONAL) ................................................. 35

MAS SELECTION ........................................................................................................36

EXPOSURE TECHNIQUES ............................................................ 38

TYPICAL CONFIGURATIONS ....................................................... 47

VILLA SISTEMI MEDICALI V

WARRANTY CONDITIONS ............................................................ 75

VILLA SISTEMI MEDICALI VI

VILLA SISTEMI MEDICALI 1

The intended use of MELODY II is exclusively to perform X-ray examination of the

VILLA SISTEMI MEDICALI 2

GENERAL SPECIFICATIONS OF MAMMOGRAPHIC UNIT MELODY II

VILLA SISTEMI MEDICALI 3

X-RAY TUBE ASSEMBLY I.A.E. XM12i

X-RAY TUBE ASSEMBLY VARIAN M113 (optional)

TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION

VILLA SISTEMI MEDICALI 4

AUTOMATIC EXPOSURE CONTROL (DEATA PLUS)

VILLA SISTEMI MEDICALI 5

COMPRESSION SYSTEM (standard)

VILLA SISTEMI MEDICALI 6

x1.5 and x2 with gridless cassette holder,

VILLA SISTEMI MEDICALI 7

EMERGENCY STOP/SHUTDOWN SWITCHES

VILLA SISTEMI MEDICALI 8

ENVIRONMENT PROTECTION AND WASTE DISPOSAL

CLASSIFICATION (IEC 601-1)

VILLA SISTEMI MEDICALI 9

ELECTROMAGNETIC INFORMATIONS ACCORDING TO IEC 601-1-2

Guidance and manufacturer’s declaration – electromagnetic emissions

VILLA SISTEMI MEDICALI 10

Guidance and manufacturer’s declaration – electromagnetic immunity

IEC 61000-4-4 1 kV for input/output 1 kV for input/output

VILLA SISTEMI MEDICALI 11

Guidance and manufacturer’s declaration – electromagnetic immunity

Recommended separation distance

d  2 .3 P 800 MHz to 2.5 GHz

where P is the maximum output power rating of the

Field strengths from fixed RF transmitters, as determined

Interference may occur in the vicinity of equipment

VILLA SISTEMI MEDICALI 12

Recommended separation distances between portable and mobile

Rated maximum output Separation distance according to frequency of transmitter

VILLA SISTEMI MEDICALI 13

IEC 601-1 (CEI 62-5) Standard:

Directive 93/42/EEC for Medical Devices:

VILLA SISTEMI MEDICALI 14

VILLA SISTEMI MEDICALI 15

VILLA SISTEMI MEDICALI 16