Flat E Operator'S Manual

FLAT E OPERATOR’S MANUAL
(MOFLATE-U08)
FLAT E
X-Ray Equipment & Supplies

Via delle Monachelle, 66 - 00040 Pomezia
(Rome) - Italy
Phone: +39-0666160206
Fax: +39-0666160357
www.metaltronica.com
DOCUMENT STATUS SHEET

Title of Document: FLAT E OPERATOR’S MANUAL (MOFLATE-U08)
Version Release Date Reason of change
(dd/mm/yy)
ENGLISH 01 25/01/01 First dedicated release (93/42)

General Revision
ENGLISH 02 15/03/02
Double Deata plus
Dosemeter
Small field Digital system
New CPU 01-170-1
ENGLISH 03 15/05/03
Minimum mAs to 1
Minimum Kv to 20
New Potter- Bucky
Automatic collimator
Warnings revision
ENGLISH 04 15/05/04
Bym C-arm with fix F.F.D.
ENGLISH 05 11/10/05
Breast thickness on display
Deata Plus for Windows
Double X-ray emission signal
Safety feedback form
IEC 601-1-2 information
New topics
General revision
ENGLISH 06 26/09/06 C-arm rotation angle on display
Technical specifications
New chapters: Device identification,
Identification labels and Protected areas
100 kHz standard
Warnings
List of accessories
WEEE information
Address change
ENGLISH 07 16/12/2009
Trade Name change, new labels
ENGLISH 08 16/02/2012
METALTRONICA 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 from Metaltronica S.p.A. Pomezia(Rm)
Italy.
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) Use of the equipment according to instruction in this manual.
WARNING
Using and keeping X-Ray equipment and device must conform 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.
METALTRONICA III
INDEX
UNIT DESCRIPTION ......................................................................... 1

TECHNICAL SPECIFICATIONS OF MAMMOGRAPHY UNIT FLAT E ....... 2
ELECTROMAGNETIC INFORMATION ACCORDING TO IEC 601-1-2 ... 12
WEEE INFORMATIONS ACCORDING TO DIRECTIVE 2002/96/EC ...... 16
WARNINGS ............................................................................................ 17
DEVICE CLASSIFICATION ..................................................................... 18
IDENTIFICATION LABELS ...................................................................... 19
PROTECTED AREAS ............................................................................. 21
FLAT E GENERAL DESCRIPTION.......................................................... 22
MAIN PARTS FLAT E .............................................................................. 24
FLAT E DIMENTIONAL DRAWINGS ....................................................... 26
FLAT E BYM GENERAL DESCRIPTION ................................................. 27
FLAT E BYM DIMENTIONAL DRAWINGS............................................... 29
OPERATING INSTRUCTIONS ....................................................... 30

CONTROL PANEL .................................................................................. 31
DISPLAY ................................................................................................. 32
TABLES .................................................................................................. 33
EXAMINATION ROOM ............................................................................ 34
SWITCHING ON...................................................................................... 34
SWITCHING OFF .................................................................................... 34
VERTICAL MOVEMENT OF C-ARM ....................................................... 34
ROTATING C-ARM ................................................................................. 35
TABLE INSERTION ................................................................................. 35
INTEGRATED FILM ID LABELS .............................................................. 36
METALTRONICA IV
COMPRESSION PLATES INSERTION ................................................... 37

COMPRESSION AND LIGHT BEAM INDICATOR ................................... 38
COLLIMATION PLATES INSERTION...................................................... 40
AUTOMATIC COLLIMATION .................................................................. 40
18X24 CASSETTE ADAPTER ................................................................. 41
FACE SHIELD PROTECTION ................................................................. 42
INSERT DEVICE FOR GEOMETRIC MAGNIFICATION 1.5X OR 2X....... 42
KV SELECTION ...................................................................................... 43
MAS SELECTION..................................................................................... 43
FILM/SCREEN COMBINATION SELECTION.......................................... 43
MANUAL DENSITY CONTROL ............................................................... 44
RADIOGRAPHIC EXPOSURE ................................................................ 44
HIGH SPEED TUBE OPERATION (OPTION) .......................................... 45
RESET COMMAND ................................................................................. 45
HEAT UNIT INTEGRATOR...................................................................... 45
PAGE FOR NOTES ................................................................................. 46
EXPOSURE TECHNIQUES ............................................................ 47

DOSE MINIMIZATION ............................................................................. 48
IMAGE QUALITY..................................................................................... 49
MANUAL MODE ...................................................................................... 50
ZERO POINT MODE (FULLY AUTOMATIC KV AND MAS) ............................... 51
ZERO POINT KV RANGE ....................................................................................... 52
OPTICAL DENSITY CORRECTION .......................................................................... 52
DETECTOR POSITION .......................................................................................... 53
ANODE/FILTER COMBINATIONS ............................................................................ 54
FILM/SCREEN CASSETTE OR CR CASSETTE SELECTION ........................................ 54
ONE POINT MODE (MANUAL KV AND AUTOMATIC MAS)............................... 56
DIGITAL MODE (MANUAL MODE OR MANUAL KV AND AUTOMATIC MAS) ......... 57
DOSE CALCULATOR ............................................................................. 58
FILTROMAMM MO/RH FILTER ............................................................... 58
REMOTE CONTROL ............................................................................... 59
PAGE FOR NOTES ................................................................................. 60
TYPICAL CONFIGURATIONS........................................................ 61
METALTRONICA V
CONFIGURATION FOR NORMAL BREASTS EXAMINATION ................ 63

CONFIGURATION FOR SMALL BREASTS EXAMINATION ................... 64
CONFIGURATION FOR LARGE BREASTS EXAMINATION WITH 24×30
FILM SIZE ............................................................................................... 65
CONFIGURATION FOR 1.5X MAGNIFICATION ..................................... 66
CONFIGURATION FOR 2X MAGNIFICATION ........................................ 67
CONFIGURATION FOR 1.8X MAGNIFICATION ..................................... 68
ISOCENTRIC C-ARM WITH VARIABLE F.F.D. (OPTIONAL) ...................... 69
MAINTENANCE .............................................................................. 70
ERROR MESSAGES............................................................................... 71
MAINTENANCE ...................................................................................... 74
A.E.C. TEST ............................................................................................ 75
SELF-DIAGNOSIS .................................................................................. 76
CLEANING .............................................................................................. 77
MOVING THE UNIT TO ANOTHER PLACE............................................. 77
ACCESSORIES............................................................................... 78
LIST OF ACCESSORIES ........................................................................ 79
FLAT-E: STANDARD AND OPTIONAL DEVICES ................................... 82
COMPRESSION PLATES ....................................................................... 83
COLLIMATION PLATES, MAGNIFICATION PLATFORM, LEXAN SCREEN
................................................................................................................ 84
CASSETTE HOLDER AND POTTER BUCKY ......................................... 85
24X30 CM POTTER BUCKY WITH 18X24 CASSETTE ADAPTOR ......... 86
X1.8 MAGNIFICATION DEVICE .............................................................. 87
ANTI-X RUBBER APRONS ..................................................................... 88
WALL ACCESSORIES BEARING AND WALL POTTER BUCKY BEARING
................................................................................................................ 89
STEREOTASSIC BIOPSY DEVICE BYM-3D ........................................... 90
DIGITAL IMAGING SYSTEM ................................................................... 91
ANTI X SHIELD (MODEL 2SPDES-T) ........................................................ 92
ANTI X SHIELD (MODEL 2SPDES-F) ........................................................ 93
AUTOMATIC FILTER MO/RH ................................................................... 94
AUTOMATIC COLLIMATOR ................................................................... 95
METALTRONICA VI
REMOTE CONTROL PANEL .................................................................. 96
WARRANTY CONDITIONS ............................................................ 97

WARRANTY CONDITIONS ..................................................................... 98
FAILURE REPORT ............................................................................... 100
SAFETY FEEDBACK ............................................................................ 102
METALTRONICA VII
UNIT DESCRIPTION
METALTRONICA 1
TECHNICAL SPECIFICATIONS OF MAMMOGRAPHY UNIT FLAT E

MAINS CHARACTERISTICS
Line voltage 220/230/240Vac ±10% 50/60Hz
Power 6.6 kVA (0.5 kVA stand-by)
Current absorption 30 A peak
Number of phases 1 or 2 configurable
Connection Permanently installed (IEC 601-1)
Maximum apparent resistance 0.50Ω
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 optional
Ripple Frequency/Amplitude 100 kHz optional < 2%
Output power 3500 W 35 kVx100 mA
(5000W optional)
kV range 20 / 35 kV
kV resolution (Manual & Auto mode) 0.5 kV
kV precision ±1%
kV repeatability ± 0,1%
kV rise time ≤1.5 ms from 0 to100%
kV display XX,X kV (3 digits)
Anode current max 100 mA (140mA optional)
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 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 resolution (Automatic) 0,1 mAs
mAs display XXX,X mAs (4 digits)
Exposure Time Automatically selected in function of selected
mAs
Safety timer 10 sec
METALTRONICA 2
X-RAY TUBE ASSEMBLY (VARIAN M147)

Anode rotation speed 2800 rpm 50 Hz
Target material Molybdenum
Maximum Anode Heat Content 222kJ (300 kHU)
Maximum Anode Cooling rate 740 W (60 kHU/Min)
Maximum X-Ray Tube Assembly Heat 370kJ (500 kHU)
Content
Housing continuous Heat Dissipation 100 W (135 HU/Sec)
Cooling method free air convection
Anode Disc Target Angle 10°
Anode Disc Diameter 71mm
Power 3600 W large 800W small
Focal spots 2
Focal spot size according to IEC 336 0,1 small 0,3 large
X-RAY Window 0,75mm Beryllium
Inherent filtration 0,0mm Al IEC 522/1976
Fix Filter (standard) 30µm Molybdenum
Automatic Filter Filtromamm (optional) 30µm Molybdenum 30µm Rhodium
HVL measured at 28kV >0,3 mm Al equiv.
Total filtration >0.5mm Al
High Speed Starter option available
X-RAY TUBE ASSEMBLY (VARIAN M113)

Maximum Anode Cooling rate 740 W (60 kHU/Min)
Content
Housing continuous Heat Dissipation 100 W (135 HU/Sec)
Anode Disc Target Angle 10°/16°
Focal spots 2
METALTRONICA 3
X-RAY TUBE ASSEMBLY (I.A.E. XM12i)

Maximum Anode Cooling rate 500 W
Content
Housing continuous Heat Dissipation 80 W (108 HU/s)
Anode Disc Target Angle 12.5°
Focal spots 2
X-RAY TUBE ASSEMBLY (I.A.E. XM10-16)

Maximum Anode Cooling rate 500 W
Content
Housing continuous Heat Dissipation 80 W (108 HU/s)
Anode Disc Target Angle 10°/16°
Focal spots 2
METALTRONICA 4
X-RAY TUBE ASSEMBLY (SIEMENS PANTIX 40MoW-

100G)
Target material Molybdenum/Tungsten (RT)
Maximum Anode Heat Content 162 Khu
Maximum Anode Cooling rate 40,5 kHU/Min
Maximum X-Ray Tube Assembly Heat 1.100 KJ
Content
Housing continuous Heat Dissipation 100 W
Anode Disc Target Angle 20°
Anode Disc Diameter 100 mm
Power 0,7 kW (Mo) - 0,85 kW (RT) microfocus
3,75 kW (Mo) - 4,7 kW (RT) little focus
Focal spots 4
Focal spot size according to IEC 336 0,1 small, 0,3 large (both Mo and RT)
Nominal focal spot size at 27kV , 17°-20° 0,15 small, 0,3 large (both Mo and RT)
X-RAY Window 1 mm Beryllium
Inherent filtration 0,02 mm Al IEC 522/1976
Automatic Filter Filtromamm 30µm Molybdenum 50µm Rhodium
High Speed Starter integral part of PANTIX tube option
TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION

With active temperature sensor under Upper limit temperature 65° outside tube
main CPU control assembly. HU and °C display available in
technical menu.
METALTRONICA 5
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), and
Anode/Filter combination, and fine kV
regulation
Manual density control 11steps 0 ± 5
Programmable from PC independently for all
the operative techniques available
Film Screen combinations with DEATA 16 film/screen programmable for 768
PLUS independent calibration
Film Screen combinations with Reduced 3 film/screen with manual programmable
Deata optical density
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 28kV 50mAs
Detector PHTM 9000
SOLID STATE (9 active sensors)
Detector Positions 3 Electronically selected positions
Detector saturation protection Effective protection against erratic response
due to detector saturation
Test Phantom 3x2cm + 1cm + 0,5cm of Plexiglas for
calibration and daily self test procedure
Erratic exposure protection For breast density higher than max value
programmed during calibration.
For detector saturation dose released <
1mAs
A.E.C. Self Test Procedure Included in control panel functions
Average glandular dose measured in ACR < 3mGy
method: 4,5 cm phantom of 50%
glandular tissue and 50% adipose tissue
exposure taken with 28 kV
METALTRONICA 6
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
DIGITAL IMAGING SYSTEM

Imaging receptor Digital cassette with standard dimension;
compatible with standard potter and cassette
holder
Detector CCD 50x50 mm 2048x2048 pixel(24 µm)
Dynamics 16000:1 14 bits
Imaging transfers time 2 Mpixels for second
C-ARM
F.F.D. 65cm for standard and BYM C-ARM.
Optional (only available for BYM C-ARM) 65
to 70 cm variable with motorized movement
Rotation Manual ±180° with disc brake
Vertical movement with respect to Breast 65cm F.F.D. STANDARD C-ARM
support (C-ARM in vertical position) 55 to 130 cm
65cm F.F.D. BYM C-ARM
83 to 149 cm
65/70 cm variable F.F.D. BYM C-ARM
83 to 149 cm F.F.D. 65 cm
78 to 144 cm F.F.D. 70 cm
Patient protection Face shield with plastic screen for patient’s
face protection
C-arm rotation angle Showed on C-arm by mechanical goniometer.
Optional showed on display
METALTRONICA 7
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 (standard) 18X24cm, Ø 14cm
Collimation plates (optional) 24x30, 10x24
COMPRESSION SYSTEM
Compression Plate movement Manual or motor driven
Compression Plates (standard) 16x22 shifted, 12x8 straight,
Compression Plates 10x22 shifted, 24x30 shifted, 10x8 shifted,
(optional) 12X22 straight 16x22 shifted for biopsy
Free space available between 65cm F.F.D. STANDARD OR BYM C-ARM
Compression Plate and image receptor 39,5 cm with shifted Compression Plates
65/70 cm variable F.F.D. C-ARM
39,5cm /44,5cm
in Magnification Mode F.F.D.= 65cm
MAG. X2 = 140mm
MAG. X 1.8 = 180mm
MAG. X1,5 = 240mm
Compression Thickness on Display 0-80 mm in steps of 5 mm.
Compression Paddle Release after Selectable from control panel, Automatic or
exposure Manual for 2D Biopsy
Compression plate aluminium Less than 0.2 mm Al (0.135 mm Al@30 kV)
equivalence
MAGNIFICATION
Magnification ratio x1,5 / x2 (standard) with Bucky table
x1.8 with automatic focal spot selection,
cassette holder without grid and cassette
detector (optional)
METALTRONICA 8
POTTER BUCKY
Bucky factor (grid) 1,96
Ratio 5:1
Lines/cm 36
Contrast factor 1,47
Cassette size 18x24 standard
24x30 optional
Cassette compatibility All the most diffused models with window as:
Agfa, Dupont, Fuji,Kodak,3M
Cassette detector switch With alarm in 8 languages to avoid double
exposure or exposure without cassette
Top Cover Carbon fiber
Film marker Integrated with 9 brass labels
Test with NORMI Phantom Typical 3,5 balls
Other features Easily interchangeable with other accessories
without tools
Grid movement synchronized with X-RAY
beam
DOSE CALCULATOR
Data visualization On display, label printer and data memory
METALTRONICA 9
CONTROL TABLE
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 8 languages
Serial port exposition data for Easylabel Dedicated for Film Labelling device Easylabel
(200 characters printed), A.E.C. / tube
calibration and last 100 exposures memory
download.
Calibration and service Serial port For service laptop
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.
Error and faulsts data logger.
Statistics funtion Average dose, amount of exposure for every
kV value, amount of exposure in every test
technique
PROTECTIVE GLASS
Protective glass (for shield model Stand Alone full size 210cm (h) x 70 cm (w)
2SPDES and 2SPDES-F) (optional) >0,34mm Pb equivalent @35kV
Protective glass (for shield model Stand Alone half size 115cm (h) x 70 cm (w)
2SPDES-T) (optional) >0,34mm Pb equivalent @35kV
Special features (optional) Wireless Infrared X-RAY push-button
Remote control panel glass backside
METALTRONICA 10
ENVIRONMENTAL CONDITIONS
Storage and delivery conditions (while temperature -20°C / + 70°C
packed) 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 load condition of 35 KV 264 Kcal/h
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
METALTRONICA 11
ELECTROMAGNETIC INFORMATION 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 FLAT E is intended for use in the electromagnetic environment specified below. The customer or the user of the
FLAT E should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance
The FLAT E 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 FLAT E is suitable for use in all establishments,
Class B including domestic establishments and those directly
CISPR 11 connected to the public low-voltage power supply
network that supplies buildings used for domestic
Harmonic emissions purposes.
Not applicable
IEC 61000-3-2 The FLAT E 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.
METALTRONICA 12
Guidance and manufacturer’s declaration – electromagnetic immunity

The FLAT E is intended for use in the electromagnetic environment specified below. The customer or the user of the FLAT E
should assure that it is used in such an environment.
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 FLAT E requires continued
power supply input lines operation during power mains interruptions,
40 % UT it is recommended that the FLAT E be
IEC 61000-4-11 (60 % dip in UT) powered from an uninterruptible power
for 5 cycles supply.
70 % UT The FLAT E 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.
METALTRONICA 13
Guidance and manufacturer’s declaration – electromagnetic immunity

The FLAT E is intended for use in the electromagnetic environment specified below. The customer or the user of the FLAT E
should assure that it is used in such an environment.
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 FLAT E,
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 FLAT E is used exceeds the
applicable RF compliance level above, the FLAT E should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the FLAT E.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
METALTRONICA 14
Recommended separation distances between portable and mobile

RF communications equipment and the equipment or system
The FLAT E is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the FLAT E can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the FLAT E 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.
METALTRONICA 15
WEEE INFORMATIONS ACCORDING TO DIRECTIVE 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 and 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.
METALTRONICA 16
WARNINGS
• FLAT E 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 BYM C-ARM WITH VARIABLE F.F.D. TAKE CARE OF STOPS

AT 65 and 70cm.
• USE LEAD APRON FOR PATIENT PROTECTION.
• DURING X-RAY EMISSION, OPERATOR MUST BE BEHIND THE

PROTECTIVE SCREEN 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.
METALTRONICA 17
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 Standard

FLAT E belongs to Class I type B applied parts.
Directive 93/42/EEC for Medical Devices

FLAT E belongs to Class IIb.
METALTRONICA 18
IDENTIFICATION LABELS
METALTRONICA 19
METALTRONICA 20
PROTECTED AREAS
To obtain the maximum protection against the stray radiation, significant zone
of occupancy and protected area can be identified according to the following
drawing.
According to local regulation for radiological protection, the access to the

equipment and to the controlled area must be restricted to the authorized
personnel only.
METALTRONICA 21
FLAT E GENERAL DESCRIPTION
The FLAT E has features that make the whole system particularly light and user-friendly, also for
inexperienced operators. So that it, and its accessories, are presented to the market using a low
price range for this class of product.
The FLAT E is equipped with an automatic exposure device (AEC), based on an extremely
advanced concept. The AEC allows, using special phantoms, PC and software, to memorize in the
mammographic unit, during installation, the typical calibration curves. For each available
film/screen and for each desired technique a curve is memorized, that is essential in order to
obtain constant iconographic results for all the examined breasts independently from their intrinsic
density.
METALTRONICA 22
This unit is extremely reliable, and allows to perform high quality diagnostic exams at low cost and
without any retakes. The purchasing price of this unit is very highly competitive compared with all
the other units of the same type in the market: in fact, the configuration of its accessories has been
perfected to facilitate the standard exams excluding accessories with special functions.
The FLAT E is particularly suitable for mammographic ″screening″ programs.
The FLAT E, is a completely independent radiological system. It is provided with H.F. generator
incorporated with an X-ray tube dual focus, Potter-Bucky with mobile carbon fibre grid, an efficient
magnification device, and a complete range of accessories that help the operator to do his job.
For Flat E a large optional accessory selection is available in order to expand its features to the
maximum levels achievable today.
Isocentric C-ARM with variable F.F.D. (film-focus distance) allows easy and fast operation for
every projection of the breast without moving the patient and without changing C-ARM vertical
position.
Stereo biopsy device BYM 3D for film or DIGITAL BYM for whether digital mode or film.
Easylabel daylight or darkroom film ID system with auxiliary display close to the unit for enhanced
patient comfort and check of personal data before printing on Film.
Using special accessories (Easylabel film printer, and bright display for patient identification), the
patient can check her name before exam so that she may be sure that the data printed on film are
correct.
METALTRONICA 23
MAIN PARTS FLAT E
METALTRONICA 24
1. STAND
2. C-ARM
3. X-RAY TUBE
4. COLLIMATION PLATE
5. C-ARM ROTATION HANDLES
6. COMPRESSION PLATE HOOKING
7. POTTER-BUCKY TABLE OR CASSETTE HOLDER 18x24 and 24x30
8. C-ARM ROTATION HUB
9. ON/OFF SWITCH
10. STAND-BY LAMP
11. CONTROL PANEL
12. COMPRESSION AND LIGHT BEAM DOUBLE-PEDAL CONTROL
13. REMOTE INFRARED X-RAY PUSHBUTTON RECEIVER (optional)
14. HAND HELD X-RAY PUSHBUTTON
15. SERIAL PORTS FOR EASYLABEL, DIGITAL IMAGING AND SERVICE
16. KNOB FOR MANUAL OPERATION OF MOVING CONTROL PANEL (optional)
17. C-ARM ROTATION BRAKE PUSHBUTTONS
18. A.E.C. DETECTOR
19. FILM-MARKER
20. C-ARM UP/DOWN MOVEMENTPUSHBUTTONS
21. EMERGENCY PUSHBUTTONS
METALTRONICA 25
FLAT E DIMENTIONAL DRAWINGS
METALTRONICA 26
FLAT E BYM GENERAL DESCRIPTION
The FLAT E BYM has the same main features of the Flat E: the whole system is particularly light
and user-friendly, also for inexperienced operators. It, and its accessories, are presented to the
market using a low price range for this class of product.
The isocentric C-Arm, called BYM C-Arm, is the feature that makes the FLAT E BYM even more
powerful than the FLAT E. As a matter of fact no changes in the position of the patient are
requested between one exposure and another. The BYM C-arm allows easy and fast operation for
every projection of the breast without moving the patient and without changing C-ARM vertical
position.
Moreover, the BYM C-arm allows to upgrade the mammography unit with the stereotassic biopsy
device BYM 3 D.
On the BYM C-arm also the variable F.F.D. (film-focus distance) from 65 to 70 cm is available as
an optional.
METALTRONICA 27
The FLAT E BYM is equipped with the same automatic exposure device (AEC) than the FLAT E,
that is based on an extremely advanced concept. The AEC allows, using special phantoms, PC
and software, to memorize in the mammographic unit, during installation, the typical calibration
curves. For each available film/screen and for each desired technique a curve is memorized, that is
essential in order to obtain constant iconographic results for all the examined breasts
independently from their intrinsic density.
This unit is extremely reliable, and allows to perform high quality diagnostic exams at low cost and
without any retakes. The purchasing price of this unit is very highly competitive compared with all
the other units of the same type in the market: in fact, the configuration of its accessories has been
perfected to facilitate the standard exams excluding accessories with special functions.
The FLAT E BYM is particularly suitable for mammographic ″screening″ programs.
The FLAT E BYM, is a completely independent radiological system. It is provided with H.F.
generator incorporated with an X-ray tube dual focus, Potter-Bucky with mobile carbon fibre grid,
an efficient magnification device, and a complete range of accessories that help the operator to do
his job.
For Flat E BYM a large optional accessory selection is available in order to expand its features to
the maximum levels achievable today.
Stereo biopsy device BYM 3D for film or DIGITAL BYM for whether digital mode or film.
Easylabel daylight or darkroom film ID system with auxiliary display close to the unit for enhanced
patient comfort and check of personal data before printing on Film.
Using special accessories (Easylabel film printer, and bright display for patient identification), the
patient can check her name before exam so that she may be sure that the data printed on film are
correct.
METALTRONICA 28
FLAT E BYM DIMENTIONAL DRAWINGS
METALTRONICA 29
OPERATING INSTRUCTIONS
METALTRONICA 30
CONTROL PANEL
1. LCD DISPLAY
2. FOCAL SPOT SELECTION ( large focus, small focus)
3. kV SELECTION (0.5 kV step)
4. mAs SELECTION
5. OPERATING MODE SELECTION (0 POINT, 1 POINT, MANUAL)
6. X-RAY EMISSION CONTROL LAMP
7. FILM/SCREEN SELECTION
8. A.E.C. FIELD SELECTION
9. MANUAL DENSITY CORRECTION
10. AUTOMATIC COMPRESSION RELEASE ENABLE / DISABLE
11. COMPRESSION FORCE SELECTION
12. ALARM RESET
13. C-ARM UP/DOWN PUSHBUTTONS
14. Mo/Rh FILTER SELECTION (optional)
15. DIGITAL MODE SELECTION (optional)
METALTRONICA 31
DISPLAY
20 19 18 17 16
21
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 Mo (standard) (W only for bimetallic tube)
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)Inclination of the C-arm
15)Dose indication
16)mAs value
17)Thickness of the compressed breast
18)Operating mode STD (standard), EXT (Extended), HC (High Contrast), LD (Low Dose)
19)Fine kV correction of selected kV range 0,+0.5,+1,+1.5 kV
20)kV value
21)kV range selected for Zero Point mode; kV range selectable for One Point Mode
METALTRONICA 32
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 white lever shown in the figure below. Cassette must be
inserted till the lever is released.
Exposure is disabled if cassette is not inserted, properly inserted or already exposed.
LED
LEVER
Proper insertion of the cassette is detected by means of the Kodak compatible notch,
shown in the picture below. If the used cassette has not a notch like this, internal sensing
switch can be disabled (refer to sevice).
LED functions on Table

• Green and yellow LED blink alternatively if cassette is already in at power on.
• Green LED is bright fix if cassette is ready for exposure.
• Yellow LED is bright fix if cassette is not inserted or not properly inserted or
exposed.
Note: the color and number of LEDs on the table can vary depending on the firmware
version.
METALTRONICA 33
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°21 are unlocked and
Blue Lamp n°10 is bright; if not, check main switch on the wall.
Press button n°9, 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°9 (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 only from the control panel by means of the two buttons n° 13, or
from the optional auxiliary up-down push-button for C-ARM n° 20 (see main parts plan).
If the C-arm is moved during compression, the compression is automatically released.
METALTRONICA 34
ROTATING C-ARM
To rotate C-arm unlock the brake pushing the buttons n° 17 (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 on the C-arm, or on the display, depending on the
configuration of the device.
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 (not applicable for BYM C-Arm).
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) and n°11(compression minus) of control panel at the same time.
To remove table simply pull it out.
Slide guide Slide guide
METALTRONICA 35
INTEGRATED FILM ID LABELS
Tables have integrated sliding ID labels to identify projections, magnification ratio etc.
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.
METALTRONICA 36
COMPRESSION PLATES INSERTION
To insert or remove compression plates push the locking system as shown in the picture
below.
METALTRONICA 37
COMPRESSION AND LIGHT BEAM INDICATOR
Motorized compression is operated by the pedal-control n°12. Compression force can be

adjusted by buttons n° 11 (see console panel). The number showed on display 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
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 console plan), and
the selected mode is shown on the display.
If the release of the compressor at the end of exposure is set manual, the compression
force can’t be changed. In this case set the compression in Auto Release, change the
compression force index, than set the compression in Manual Release.
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.
In the event of a power cut, compression force is annulled, letting the patient immediately
free.
METALTRONICA 38
During compression the breast thickness is written on the display as shown below:
Compression
thickness
Compression
Compression
release
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.
METALTRONICA 39
COLLIMATION PLATES INSERTION
To insert collimation plate, align the back edge and after push it up until it’s engaged by
the locking mechanism.
AUTOMATIC COLLIMATION
If the unit is provided with an automatic collimator, collimation is selected automatically in

function of image receptor size. Actually the mammography unit is able to detect
automatically the size of the table, and the detector size 18x24 or 24x30 is displayed at
right part of display central bar. If no image receptor is inserted 18x24 size is displayed.
When automatic collimator is moving, countdown is displayed in place of label READY.
METALTRONICA 40
18x24 CASSETTE ADAPTER
The cassette adapter, code 2PMX-55-xx, 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 2PMX-55-xx 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.
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 table with 18x24 cassette adapter
METALTRONICA 41
FACE SHIELD PROTECTION
To insert/remove Face Shield protection collimation plate must be removed in advance to

avoid handle interference during insertion/removal.
Take care that slide guides are aligned.
Face shield is not intended for magnification techniques.
Slide guide
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.
2x
1,5x
METALTRONICA 42
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 ÷
35kV, 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, the mammography unit 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 calibrated. To
modify selectable film/screen combinations or add more, service intervention is required.
The selection is obtained by button n° 7 on control panel (see console plan). Only the
film/screen combinations that have been programmed during installation can be selected
on the control panel. Some of the 16 film/screen combinations are dedicated to the use of
CR cassette, and must be calibrated during installation with the same concept of the
combinations dedicated to analogical cassettes for mammography.
METALTRONICA 43
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.
METALTRONICA 44
HIGH SPEED TUBE OPERATION (OPTION)
When high speed tube Pantix or others are in use, and more than two exposures Prep/Exp
per minute are performed, continuous rotation will start and continue for one minute. After
one minute tube will brake by itself. Don’t switch off the unit to stop the tube otherwise tube
will remain in rotation. To recover from such situation, if it occurs, switch on the unit again,
press the X-ray pushbutton and release it immediately. Tube will brake.
RESET COMMAND
The button n° 12 on control panel stops the acoustic error signal, that is related to the error
message on the display.
Some error messages are automatically reset when the cause of the alarm stops. Also
refer to the next chapter “Maintenance”, paragraph “Error messages”.
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.
METALTRONICA 45
PAGE FOR NOTES
METALTRONICA 46
EXPOSURE TECHNIQUES
METALTRONICA 47
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.
METALTRONICA 48
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.
METALTRONICA 49
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.
METALTRONICA 50
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.
During exposure an audible signal is emitted, to alert the operator that the X-rays are
emitted in that moment. In ZERO POINT MODE and ONE POINT MODE the signals are
two: the first corresponding to the pre-exposure pulse, and the second corresponding to
the exposure. The first is very short, and the seconds depends on the exposure time. Don’t
let the X-ray pushbutton till the end of the second audible signal.
After exposure the display shows kV, mAs and dose released during the exam.
METALTRONICA 51
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 at position 6 varies between -5 and +5. If the operator chooses
to increase optical density, a higher dose is released to the patient, and the darkness of
the film increases, and vice-versa. Any step of optical density set on the mammography
unit, 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.
METALTRONICA 52
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 at the first stop 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, selected position will be showed on the
display and by means of the three led on the C-arm.
METALTRONICA 53
Anode/filter combinations
If the mammography unit has an automatic Mo/Rh filter or a double track Mo/W tube, in
ZERO POINT mode the mammo can choose automatically the anode/filter combination 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 combination is showed on the
display on areas 2 (anode) and 3 (filter)
If the operator wants to choose the anode/filter combination by himself, he can set it in FIX
mode pushing the button over and over again. In zero point mode the mammography unit
can choose automatically the anode.
Film/screen cassette or CR cassette selection

It is possible to use several film/screen, and obtain the desired Optical Density over all the
possible range of breast thickness and density.
The selection is possible by pushing the n°7 button (see control panel): the numbers from
1 to 13 are dedicated to normal mammography cassettes with film and screen, whether
the numbers from 14 to 16 are dedicated to CR cassettes.
As the CR cassettes have a major attenuation to the X-rays than normal analogical
cassettes with film/screen, the 14, 15 and 16 technique, dedicated to CR cassette, have
an automatic compensation that guarantees the correct operations of the 0 Point
Technique.
If the Mammography unit is used both with analogical film/screen cassette and with CR
plates, it is mandatory to select the appropriate film/screen or CR technique depending on
the cassette that is used for the exam. As showed in the picture, the techniques dedicated
to CR cassettes are highlighted by the CR symbol.
METALTRONICA 54
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 as well automatic filter can
change for some projection and not for others of the same patient.
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.
To avoid what above described, after the first exposure/image in Zero Point mode, select
One Point mode and kV will be automatically selected at the same value of the last
exposure.
To avoid filter selection different from the previous, select FIX anode/filter with the same
previous combination.
METALTRONICA 55
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 loss of contrast 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.
After an exposure in ZERO POINT MODE, selecting the ONE POINT MODE the kV value
set on display is the value used for the previous exposure, and of course the operator can
change it in the range showed on the display.
For optical density correction, AEC detector position, anode/filter combination and audible
X-ray emission signal refer to previous ZERO POINT MODE paragraph
METALTRONICA 56
DIGITAL MODE (Manual mode or manual kV and automatic mAs)
If Digital Bym with digital cassette Option is installed, Digital Mode can be selected by
means of pushbutton 15 of control panel.
On the right of DIGITAL label S (scout), R,(right), L (left) appears depending of C-ARM
inclination during biopsy.
In Digital Mode only Manual and 1 Point modes are available.
KV selection can be critical for proper CCD operation and values not lower than 26 are
recommended.
During Digital Mode operation take care that on the bottom right corner of PC screen
“READY FOR X-RAY” is displayed.
For more details about Digital Mode, refer to online Help of Digimam software.
METALTRONICA 57
DOSE CALCULATOR
Unit is provided of Skin Dose or Average Glandular Dose (AGD) calculator upon request.
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.
Take note that with BYM C-arm and variable F.F.D. (film-focus distance; optional) breast
thickness and Average Galdulare Dose are displayed and valid only if F.F.D is 65 or 70
cm, and not in intermediate positions.
FILTROMAMM Mo/Rh FILTER
Mo/Rh automatic filter is an optional accessory and is not present in all the mammographic
units.
FILTROMAMM 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.
METALTRONICA 58
REMOTE CONTROL
The unit may be provided with infra-red remote control installed on the protective shield.
The remote control signal is encoded in such a way as to eliminate possibilities of
interference. 9VDC battery of the remote control needs to be replaced periodically as soon
as the error message “EARLY PUSHBUTTON RELEASE” appears on the display.
METALTRONICA 59
PAGE FOR NOTES
METALTRONICA 60
TYPICAL CONFIGURATIONS
METALTRONICA 61
The next typical configurations are intended to help the operator to avoid operating
mistakes.
Use of different configuration can result in bad images with unwanted artifacts due to
compression paddle 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.
Lexan face protection 2SCLx-XX can’t be used with magnification techniques not having
room enough to be fitted. Before to fit or remove it, collimation plate must be removed due
to handle interference.
The typical configurations are the same if isocentric C-ARM option is installed, in such
configuration take care of proper F.F.D (Film-Focus Distance).
DO NOT USE CONFIGURATIONS OTHER THAN

THOSE PRESCRIBED IN THIS CHAPTER
METALTRONICA 62
CONFIGURATION FOR NORMAL BREASTS EXAMINATION
Use of shifted compression plate makes pulling of the breast easy.
METALTRONICA 63
CONFIGURATION FOR SMALL BREASTS EXAMINATION
Use of shifted and reduced compression plate makes pulling of the small breast easy.
Compression plate back edge is masked out of the film by X-ray collimation plate with
reduced X-ray field depth.
METALTRONICA 64
CONFIGURATION FOR LARGE BREASTS EXAMINATION WITH 24×30

FILM SIZE
Use of shifted compression plate makes pulling of the breast easy.
METALTRONICA 65
CONFIGURATION FOR 1.5X MAGNIFICATION
Set F.F.D. to 65 cm with BYM C-Arm

Fit Magnification device to the lower position to achieve magnification x1.5
METALTRONICA 66
CONFIGURATION FOR 2X MAGNIFICATION

Fit Magnification device to the upper position to achieve magnification x2
METALTRONICA 67
CONFIGURATION FOR 1.8X MAGNIFICATION

Automatic focal spot selection is performed with 1,8x magnification device.
METALTRONICA 68
ISOCENTRIC C-ARM WITH VARIABLE F.F.D. (optional)
DEC REASE F.F.D.
INC REASE F.F.D.
M3 MT- DWG0 1 4 - 0 0
Flat E with Isocentric C-ARM and variable F.F.D. (film-focus distance) option allows easy
patient positioning and stereo biopsy operation by means of BYM-3D accessory capable of
Film or Digital imaging operation.
METALTRONICA 69
MAINTENANCE
METALTRONICA 70
ERROR MESSAGES
One of the features of the FLAT E CPU is that it displays TEXT ERROR MESSAGES and
no error codes. 8 languages are available for error messages.
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.
CASSETTE ALREADY EXPOSED

Replace film.
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.
LOW ANODE CURRENT

Call service if this alarm tends to be repeated in Manual Mode only.
NOT ENOUGH mAs WITH AEC

The exposure has been terminated 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 installing/using a more sensitive screen-film combination;
Change cassette before repeating exposure.
If such problem has been generated by breast with silicone prosthesis use Manual mode
with appropriate kV and mAs selection.
METALTRONICA 71
CASSETTE NOT INSERTED

Insert cassette in potter bucky or check if it is reversed if reverse switch is enabled.
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.
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
FILTER POSITION ERROR

A mechanical problem has been encountered during filter positioning. Call Service if
problem persists.
METALTRONICA 72
TECHNIQUE NOT PROGRAMMED

Selected FILM/SCREEN or specific operating mode (STD, EXT, HC, LD) has not been
programmed during installation. Refer to Technical Service for calibration extension.
BREAST TOO DENSE

Such problem can be due to silicone prosthesis, or wrong patient positioning, ribs in the
field, or technical reasons that can be immediately clarified by means of test procedure at
AEC test paragraph.
X-ray released has been less than 1 mAs, film must be replaced.
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 1 mAs, film must be replaced.
METALTRONICA 73
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.
METALTRONICA 74
A.E.C. TEST
During the test, the system should be configured as showed in the next figure.
USE FFD 65 cm WITH BYM C-ARM
- Select LARGE focus

- Select ZERO POINT MODE
- Take care that, on the display, is not selected a film/screen combination dedicated
to a CR cassette.
- Remove the compressor
- Install Bucky table (with grid).
- Use the 18X24 or 24X30 collimator
- Remove the cassette
- Disable compressor release at exposure end (see the picture above, icon n°1) and
press the "Compression +" key (see the picture above, icon n°2); the symbol
XXXXX will appear on the display
- Select the first field of the AEC detector (patient side)
- Position the 7-cm-thick Phantom so as to completely cover the detector.
- Expose
- Read the [o] and [r] values on the display and compare them with the values on the
Phantom. The deviation for the [r] value has to be within ± 10. For the [o] value
must result 4 < [o] < 15. If not, call for service.
- Repeat the test for each one of the three fields of the AEC detector.
METALTRONICA 75
This configuration was so chosen as 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 appear on the
display regarding the state of the unit:
METALTRONICA FLAT MAMMO

------------------------------------------------------------
------CPU FUSES------- ------SW1------SW2------
F2=OK F4=OK 00000000 00000
------------------------INVERTER------------------------
Vdc in = 550V SERVICE = OK
------------FILAMENT POWER SUPPLY------------
>>GOOD<<
--------------------ROTOR SUPPLY---------------------
>>GOOD<<
FIRMWARE REV FLAT XX TUBE MODEL
Tube Housing KJYY 25°C
n. .............. date hour
These data concern:

• the state of CPU fuses;
• The Dip switches of the CPU board setting;
• the working state of the inverter, filaments and anode starter;
• 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.
METALTRONICA 76
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.
METALTRONICA 77
ACCESSORIES
WARNING
USE ONLY ORIGINAL ACCESSORIES
METALTRONICA 78
LIST OF ACCESSORIES
Note: The following list of accessories, and the distinction between standard or optional,
can vary depending on the availability and on the commercial agreement. For an updated
list or more details contact Metaltronica.
Standard accessories
Code Description
2CM16x22-xx 16x22 cm Shifted Compression paddle
2CM12x8P-xx 12x8 cm Straight Compression paddle
2CLSV18x24-xx 18x24 cm Interchangeable collimator plate
2CLSVD14-xx ∅ 14 cm interchangeable collimator plate
or or
2CL113D14-xx ∅ 14 cm interchangeable collimator plate for M113 X-ray tube
2SUPCOL-xx Kit interchangeable collimation plates (including 2CLSV18x24-xx and
2CLSVD14-xx/2CL113D14-xx)
2INFL-xx Device for geometric magnification 1,5x and 2x
2SCLX-xx Lexan screen for protection from parts not to do examine
2PMX-25-xx 18x24 cm potter bucky with carbon fiber grid with marking device of
projections
KTSVA0105-xx First pair of motorized compression foot-controls
KTSVA0105-xx Second pair of motorized compression foot-controls
PHTM9000-xx Automatic exposure control
PL/C2U RX pushbutton with extensible cable
CV0095-xx PC connection cable
MEEQ3514-xx Methacrylate phantom
MTFLATE-Uxx Technical manual
MOFLATE-Uxx Operator’s manual
METALTRONICA 79
Optional accessories
Code Description
3-INFL-xx x1.8 Magnification platform with cassette holder and film lab. device
2CMB16x22-xx 16x22 cm Shifted Compression paddle with metallic grid for
bidimensional biopsy
2CM10x8S-xx 10x8 cm Shifted Compression paddle
(*) 2CM10x22-xx 10x22 cm Shifted Compression paddle
(*) 2CM12x22-xx 12x22 cm Straight Compression paddle
2CM24X30-xx 24x30 cm Shifted Compression paddle
2CLSV24X30-xx 24x30 cm Interchangeable collimator plate
2CLAUTO-xx Automatic collimator
2SPDES Free standing and fully transparent anti-X shield for operator
(*) 2SPDES-F-xx Free standing and fully transparent anti-X shield for operator iron base
2SPDES-T-xx Free standing semi-transparent anti-X shield for operator
2TRIF-xx IR X-ray pushbutton for remote control
GRPB/EI-xx Ant-X rubber aprons for pelvis protection of the patient (medium)
GRPB/EI-xx Anti-X rubber aprons for pelvis protection of the patient (large)
2PMX-1-xx 18x24 cassette holder for exam. without grid with marking device of
projections
2PMX-35-xx 24x30 cm potter bucky with carbon fibre grid with marking device of
projections
2PMX-55-xx 24x30 cm potter bucky with sliding marking device equipped of 18x24
cm cassette adaptor (without cassette)
(*) KTFE/PMX-35 Kit PMX 3500 including collimator plate and compression paddle
MEEQ3833-xx 18x24 cm cassette adaptor (without cassette) for 24x30 Potter-Bucky
or Cassette holder
(*) 2FLMAMM-xx FILTROMAMM motorized change filter device (standard for PANTIX
tube)
2PAFL-xx Wall accessories bearing
2PPFL-xx Wall bearing for Potter Bucky
2PCBFL-xx Remote control panel to fix on the glass shield
2PCBFLW-xx Remote control panel to fix on the wall
KTTELIFL-00 Protection covers kit
MATRFL-xx Transport handles
Cassettes, different trademarks and models
KT/DELE-xx Display identificaz paziente
Chair for exams with sitting patient
(*) = Standard for FLAT BYM
METALTRONICA 80
C-arm
Code Description
Non-isocentric C-arm - standard for FLAT E
AMLFC- xx Isocentric C-Arm with fix F.F.D. for biopsy device
(called “BYM C-arm”) - optional
AMLFC- xx Isocentric C-Arm with variable F.F.D. for biopsy device (called “BYM C-
arm”) - standard for FLAT BYM
X-ray tubes
Code Description
IAE XM12i IAE tube - optional
VARIAN M147 Varian tube - standard for FLAT E
VARIAN M113 Biangular Varian tube - standard for FLAT BYM
IAE XM 10/16 Biangular IAE tube - optional
PANTIX 40MoW- SIEMENS double track Mo/W X-ray tube Kit (including 9000 rpm kit and
100G Filtromamm) - optional
Optional devices
Code Description
KT/HS-FLT-xx 9000 rpm kit (standard for PANTIX tube)
2BY-3D-xx BYM 3D stereotactic biopsy device (only available with isocentric C-arm)
1ELUSC EASY LABEL film printer with base foot, without base foot (for desk) or
for darkroom
STAMP/SPR-LP1 S’PRINT adhesive label printer
DIGITALBYM Digital Imaging system with small field digital detector
METALTRONICA 81
FLAT-E: STANDARD AND OPTIONAL DEVICES
METALTRONICA 82
COMPRESSION PLATES
METALTRONICA 83
COLLIMATION PLATES, MAGNIFICATION PLATFORM, LEXAN SCREEN
METALTRONICA 84
CASSETTE HOLDER AND POTTER BUCKY
METALTRONICA 85
24X30 CM POTTER BUCKY WITH 18X24 CASSETTE ADAPTOR
METALTRONICA 86
x1.8 MAGNIFICATION DEVICE
2 cm
Device f or geom etric

Ma gnif ica tion 1 .8 X
( cod. 4 INFL )
M3 MT- DWG0 4 9 - 0 0
1.8x magnification device with cassette holder (without grid) and film labeling device
Code 4-INFL-XX
Automatic focal spot selection is performed with this accessory.
Small focal spot selection when 4-INFL-xx is in.
To be used only with 2CLSVD 14-XX collimation plate and 2CM12x8P-XX compression
paddle.
For BYM C-Arm use F.F.D. 65 cm
METALTRONICA 87
ANTI-X RUBBER APRONS
Recommended for maximum patient protection.
METALTRONICA 88
WALL ACCESSORIES BEARING AND WALL POTTER BUCKY BEARING
METALTRONICA 89
STEREOTASSIC BIOPSY DEVICE BYM-3D

(FOR BYM C-ARM ONLY)
METALTRONICA 90
DIGITAL IMAGING SYSTEM
METALTRONICA 91
ANTI X SHIELD (model 2SPDES-T)
METALTRONICA 92
ANTI X SHIELD (model 2SPDES-F)
METALTRONICA 93
AUTOMATIC FILTER Mo/Rh
Filter thickness Mo = 30µm

Filter thickness Rh = 30µm (50µm with Pantix tube)
METALTRONICA 94
AUTOMATIC COLLIMATOR
METALTRONICA 95
REMOTE CONTROL PANEL
METALTRONICA 96
WARRANTY CONDITIONS
METALTRONICA 97
WARRANTY CONDITIONS
METALTRONICA S.p.a. 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 METALTRONICA
• 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 METALTRONICA S.p.a.
The aforesaid terms are to be considered valid except as otherwise set forth in the
contract.
METALTRONICA 98
THE MANUFACTURER RESERVES THE RIGHT TO MAKE FURTHER

IMPROVEMENTS WHILE KEEPING MAIN FEATURES UNCHANGED.
METALTRONICA 99
To: METALTRONICA S.p.A.

Technical Department
Via delle Monachelle, 66
00040 Pomezia (Rome) –
ITALY
Tel. +39/0666160206
Fax. +39/0666160357
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
METALTRONICA 100
FAILURE: EXPOSURE TECHNIQUE AT THE MOMENT OF THE FAILURE

OCCURRENCE:
MANUAL ο ZERO POINT ο ONE POINT ο

kV mAs [o] [r]
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 Metaltronica code and description)
MECHANICAL
ELECTRICAL
ELECTRONIC
DATE OF FAILURE ____/____/____
DATE ____/____/____ REPORT FILLER SIGNATURE
SEAL OF THE COMPANY AND SIGNATURE OF AUTHORIZED PERSON
METALTRONICA 101
To: METALTRONICA S.p.A.

Technical Department
Via delle Monachelle, 66
00040 Pomezia (Rome) –
ITALY
Tel. +39/0666160206
Fax. +39/0666160357
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
METALTRONICA 102
METALTRONICA 103

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FLAT E OPERATOR’S MANUAL

X-Ray Equipment & Supplies

DOCUMENT STATUS SHEET

Version Release Date Reason of change

ENGLISH 01 25/01/01 First dedicated release (93/42)

DECLARATION ACCORDING TO IEC 601-1 STANDARD EDITION 1992

UNIT DESCRIPTION ......................................................................... 1

OPERATING INSTRUCTIONS ....................................................... 30

COMPRESSION PLATES INSERTION ................................................... 37

EXPOSURE TECHNIQUES ............................................................ 47

CONFIGURATION FOR NORMAL BREASTS EXAMINATION ................ 63

REMOTE CONTROL PANEL .................................................................. 96

WARRANTY CONDITIONS ............................................................ 97

TECHNICAL SPECIFICATIONS OF MAMMOGRAPHY UNIT FLAT E

X-RAY TUBE ASSEMBLY (VARIAN M147)

X-RAY TUBE ASSEMBLY (VARIAN M113)

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

X-RAY TUBE ASSEMBLY (I.A.E. XM10-16)

X-RAY TUBE ASSEMBLY (SIEMENS PANTIX 40MoW-

TUBE ASSEMBLY THERMAL OVERLOAD PROTECTION

AUTOMATIC EXPOSURE CONTROL (DEATA PLUS)

DIGITAL IMAGING SYSTEM

ENVIRONMENT PROTECTION AND WASTE DISPOSAL

CLASSIFICATION (IEC 601-1)

ELECTROMAGNETIC INFORMATION ACCORDING TO IEC 601-1-2

Guidance and manufacturer’s declaration – electromagnetic emissions

Guidance and manufacturer’s declaration – electromagnetic immunity

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

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

Recommended separation distances between portable and mobile

Rated maximum output Separation distance according to frequency of transmitter

WEEE INFORMATIONS ACCORDING TO DIRECTIVE 2002/96/EC

The following crossed-out wheeled bin symbol,

• FLAT E MUST BE USED BY AUTHORISED PERSONELL AFTER AN

• THIS MACHINE MUST BE USED ONLY FOR MAMMOGRAPHY.

• DO NOT INSERT IN THE X-RAY BEAM DEVICES OTHER THAN

• USE ONLY CASSETTES WITH ONE SCREEN DEDICATED FOR

• FOR BYM C-ARM WITH VARIABLE F.F.D. TAKE CARE OF STOPS

• USE LEAD APRON FOR PATIENT PROTECTION.

• DURING X-RAY EMISSION, OPERATOR MUST BE BEHIND THE

• USE ONLY ORIGINAL ACCESSORIES AND SPARE PARTS

• FREQUENTLY VERIFY THE WEAR OF THE COMPRESSION

• THE MAMMOGRAPHY UNIT IS CLASSIFIED AS PERMANENTLY

IEC 601-1 Standard

Directive 93/42/EEC for Medical Devices

According to local regulation for radiological protection, the access to the

FLAT E GENERAL DESCRIPTION

The FLAT E is particularly suitable for mammographic ″screening″ programs.

MAIN PARTS FLAT E

FLAT E DIMENTIONAL DRAWINGS

FLAT E BYM GENERAL DESCRIPTION

The FLAT E BYM is particularly suitable for mammographic ″screening″ programs.

FLAT E BYM DIMENTIONAL DRAWINGS