Eurograph s.n.

c -
IMAGE
 fi c fc o

IMAGE

M any thanks for having selected our G IO T T O IM A G E m am m ography unit.

I.M .S . is known across the w orld for its quality, high-tech radiology units.

The follow ing instructions w ill help you to fam iliarise y o u rself w ith the G IO T T O IM A G E unit, supplying you w ith all
necessary inform ation for correct use.

We also provide advice on m aintenance and safekeeping o f the u n i t .

Please read the follow ing descriptions carefully and always keep this m anual.
 Mammography appliance

S e r v ic e M a n u a l

MONTH
Jo
YEAR

SERIAL NUMBER
M 1 3 ft

SERIES

UDT : a _ i

S .r .l. - B o lo g n a - Ita ly

Via SAGITTARIO, 5
40044 - Pontecchio Marconi - Bologna - ITALY EDITION
Tel. (051) 846851 - Fax (051) 846856
E -M A IL :
N° 1
DATE
Export Dept.: [email protected] & \
Tecnical Dept.: [email protected]
REVISION
05
 f IMAGE

I.M.S. S.r.l.
Via SAGITTARIO, 5
40044 - Pontecchio Marconi
Bologna - ITALY
Tel. (051) 846851
F a x(051)846856
E - MAIL:
Export Dept.: [email protected]
Tecnical Dept.: [email protected]

This manual cannot be reproduced, transmitted, transcribed, archived in a retrieval system or translated into other languages
w ithout prior written approval by I.M .S.

T he buyer m ay reproduce copies for his/her/its internal use.

T his manual was produced and checked w ith utm ost care to supply reliable inform ation.

I.M .S. S.r.l. im plem ents a policy o f continuously developing its products.
In this light, I.M .S. S.r.l. reserves the right to change at any time and w ithout prior notice the technical and aesthetic
characteristics o f the products m entioned here - the said characteristics are, therefore, not binding or com m itting.
/ic tfo
/ IMAGE

IMAGE

REVISIONS OF THE MANUAL

N°REV. DATE SUBJECT OF REVISIONS

1 10/12/01 ISSUE

2 15/11/02 INVERTER 100 KHZDOCUMENT ENCLOSED

3 15/12/02 AUTOMATIC COLLIMATOR

4 15/07/03 NEW HOUSINGS

5 03/10/03 THE ANGLE MOUVEMENT POSITIONING HAS BEEN CHANGED

FROM + 90° TO 180°

MODIFIED PAGES P = p age - S = sec tio n

N°REV. P S N°REV. P S N°REV. P S N°REV. P S

2 31 1

3 18 1

3 19 1

3 31 1

5/12
 IMAGE

SYMBOLS USED FOR THIS ISSUE

• In order that the m anual m ay be read quickly and rationally, sym bols have been em ployed for highlighting practical
advice, sim ple inform ation or situations in which great care m ust be taken.

• Said sym bols can be found by the side o f a piece o f text (and therefore refer only to that text), by the side o f a figure (and
refer to the subject illustrated in the figure and to the relative text) or at the top o f the page (in which case they refer to all
the subjects treated on that page).

CAUTION! Pay maximum attention to the meaning of the symbols: their aim is not to have to repeat technical concepts or
safety w arnings and as such should be considered as proper “rem inders”. T h erefore, refer to the list o f the sym bols
w henever doubts arise as to their meaning.

N O T E - The sym bols show n in the follow ing pages are not found on the m achine or its accessory parts; in fact, they are
present only in this m anual. The series o f the m anuals supplied with the m achine usually contains som e docum ents not
m ade up by IM S, w hich could use edition sym bols, graphically different from the ones show n in this issue. T herefore, it is
advisable to consult all the docum ents supplied in order to “store” all the subjects for w hich the sym bols them selves have
been used.

It is im portant not to to confuse the edition sym bols with the “safety” plates, w hich are applied in points preset on the
m achine, auxiliary units, etc...

LIST OF SYMBOLS USED FOR THIS ISSUE

SYMBOLS FOR THE MANUALS

SYMBOL DESCRIPTION

THIS M A N U A L - D escriptions concerning this manual.

M A N U A L S O F SU B -SU PPL Y - C onsult the docum ents o f sub-supply herew ith enclosed.

Sch
ELECTRIC - PNEUM ATIC - HYDRAULIC DIAGRAM S. Consult the documents enclosed
(o f the M anufacturer).

TH IS M A N U A L - Consult the s e c tio n .....- page .... (descriptions “ sent” to previous or

follow ing paragraphs).
 / IMAGE

COMPULSORY CLOTHING ACCESSORIES

SYMBOL DESCRIPTION

S P E C IF IC C L O T H IN G - The jo b s described foresee the use o f suitable clothing and the

specified personal protections.

WARNING SYMBOLS

SYMBOL DESCRIPTION

A A T T E N T IO N ! - Inform ation about the o p erato r’s safety, the safety o f the m achine integrity
and potentially dangerous jo b s which m ay be hazardous for the patient or third persons, for
the environm ent, for the m achine or equipment.

A TTEN TIO N !-
Ionising radiation.

IM P O R T A N T ! - This sym bol draws the attention to a particularly im portant subject.

NO! - O perations to be absolutely avoided.

L IF T IN G O N LY F R O M T H E T O P - O perations which foresee the use o f qualified personnel

and specific equipm ents, and the respect o f the conditions stated by the M anufacturer and
current regulations.

L IF T IN G AND H A N D L IN G ONLY F R O M T H E B O T T O M - Operations which foresee the use

o f lift trucks, transpallets, having adequate features and driven by qualified personnel.

7/12
 / IMAGE

OPERATORS

SYMBOL DESCRIPTION

R adiological technician: the person in charge o f m achine preparation, patient positioning and
m am m ography exam ination, according to the indications given by the doctor.

Doctor: the person who visits the patient in advance in order to decide the exam ination
method. H e/she observes the plates taken by the radiological technician. I-Ie/she carries out
the invasive operations (biopsy) on the patient.

M echanical m aintenance personnel: qualified technician able to intervene on the m echanical

parts o f the m achine to m ake any necessary adjustm ents, interventions and repairs. He is not
qualified to intervene on live electrical circuits.

E lectrical m aintenance personnel: qualified technician able to carry out any necessary
adjustm ents, interventions and repairs o f an electrical nature. He is qualified to intervene on
live electrical circuits.

M an u factu rer’s technician: qualified personnel provided by the M anufacturer to undertake

com plex operations under particular situations or when agreed with the Buyer.
/to # 0
/ IMAGE

SYMBOLS PRESENT ON GIOTTO IMAGE

SYMBOL DESCRIPTION

© PROTECTIVE GROUNDING

A 230 Vac
DA NG ER O U S VOLTAGE or parts exposed to 230 Vac voltage

A IM PORTANT PROCEDURE for a machine safe operation.

C onsult annexed docum entation.

O O P E N (for part o f the appliance only).

Putting part o f the appliance out o f service.

© C L O SE D (for part o f the appliance only). Putting part o f the appliance into service.

* B TYPE APPLIED PART

 'i c f t o
IMAGE

S.
1 GENERAL DESCRIPTION
CONTENTS D 1
Presentation 2
Basic unit composition 3
Description of the radiological unit 6
Control table 24
Accessories 28
Technical data 30
2 PRE-INSTALLATION 1
Introduction 2
Packing characteristics 2
Dimensions and weight of the paking 3
Configuration of supply inside the paking 3
Lifting and handling of packing 4
Storage of packed machine 5
Overall dimensions and weights 6
Pre-installation information 8
Electrical system 8
Room shielding suggestions 14
Radiation safety 14
Manufacturer’s responsibility 14

Operator safety 14

3 INSTALLATION 1
Introduction 2
Installation procedure steps 2
Unit removal from packing 3
Unit lifting 4
Placing and fixing of the unit to the ground 5
Connections between radiological unit and control table 11
Installation and connection of X-ray tube 13
Connection with power supply line 16
Auxilliary connections for signals and security 16
Starting 17
 IMAGE

CHECKS AND REGULATIONS

CONTENTS □
1
Beam quality assessm ent (half-value layer measurement) 2
kVp accuracy and reproducibility 6
Breast entrance exposure, AEC reproducibility, average glandula dose and radiation 8
output rate
Check of light field intensity and uniformity 16
Procedure collimation assessment 17
Evaluation of system resolution 23
Automatic exposure control dell’AEC system performance assessment 26
Procedure system artifact evaluation 31
Procedure image quality evaluation 37
Procedure: compression 49
Compression paddle alignment 51
Check-Light Field Edge Contrast 52
X-ray shielding compliance 53
Leakage check-x-ray tubehead 54
5 FAILURE AND ERROR MESSAGE REASEARCH 1
Introduction 2
Alarm visualization 2
Alarm reset 2
Messages 2
Failure research when no alarms are on display 3
Error message list 9
Operator’s mistakes 15
6 MAINTENANCE 1
Preventive maintenance 2
Routine maintenancejobs 8
Extraordinary maintenance 16
Cases removal 18
Disposal and scrapping 30
NOTES
GENERAL DESCRIPTION

1. PRESENTATION
2. BASIC UNIT COMPOSITION
3. DESCRIPTION OF THE RADIOLOGICAL UNIT
4. CONTROL TABLE
5. ACCESSORIES
6. TECHNICAL DATA
1. GENERAL DESCRIPTION

1.1 PRESENTATION

IN MAMMOGRAPHY

THE MOST ADVANCED TECHNOLOGY FOR

THE BEST QUALITY OF THE IMAGE

2/32
1.2 BASIC UNIT COMPOSITION

1) Floor securing base.

2) Telescopic colum n for vertical m ovem ent

3) Circular arm

4) X -ray tube housing

5) C om pressor unit

6) Luminous collim ator

7) Bucky with radiographic cassette housing

8) Control table

9) A nti X -ray protection

10) M ultiple pedal unit (Vertical m vt./R otating m vt./ Inclination mvt.)

11) Pedal unit for com pressor up/dow n control.

3/32
1.2.1 INTENDED USE OF THE APPLIANCE

• T he G IO T T O IM A GE appliance was designed, built and protected for m am m ography exam inations and biopsies (only in
the version designed for effecting stereotaxic exam inations) o f the breast, and cannot be used for other exam inations or
for purpose other than those specified by the M anufacturer, which declines all liability for dam ages o f any kind caused by
non intended use o f the appliance. Practical use is, therefore, strictly for personnel specialised in radiological exam inations.

CE Certificate No.: 0372/B2P3/2

The G IO TT O IM A G E appliance also conform s to FDA - 21 CFR standard, subchapter J.

1.2.2 CLASSIFICATION OF THE APPLIANCE

IEC 601-1,EN 60601-1 class I

IEC 601-1,EN 60601-1 type B

93/42/CEE (MDD) class IIB

FDA class n

T. 1

1.2.3 CONFORMITY OF THE APPLIANCE

• The m achine referred to in this publication is declared and certified as a fixed installation electro-medical appliance and
w as built in conform ity with the applicable provisions o f directive 93/42/EEC concerning m edical devices and of Law
D ecree N o.46 o f 24.02.97 “Im plem entation o f D irective 93/42/EEC concerning m edical devices”, am ended by “Law
D ecree N o.95 o f 25.02.98.

A TT EN TIO N ! In accordance with EN 60 601 -1, G IO TTO IM AGE must be installed perm anently to the electrical mains.
(The protective earth conductor m ust be installed directly on the protective earth term inal o f the electrical panel).

reference D IRECTIVES AND LAWS

- D irective 93/42/EEC concerning m edical devices
- Law D ecree N o.46 o f 24/02/1997, im plem entation o f Directive 93/42/EEC concerning medical devices
- Law D ecree N o.95 o f 25/02/1998, m odifications o f Law D ecree 24 February 1997 N o.46 containing “Im plem entation o f
directive 93/42/EEC , concerning m edical devices” .

4/32
1.2.3.1 Protection grade
• C om m on appliance in IPX O protection grade.

NOTE - Non-waterproof cover, unsuitable for use in the presence o f an anaesthetic mixture made inflammable by air,
oxygen, or nitrous oxide.

1.2.3.2 Electro-magnetic compatibility

• The appliance does not influence the operation o f nearby appliances through its own electro-m agnetic em issions,
because it is built in com pliance w ith the EN 60 601-1-2 standard.
• The appliance is immune to electro-magnetic emissions o f other nearby appliances (conforming to EN 60 601 -1 -2 standard),
because it is built in com pliance w ith the EN 60 601 -1 -2 standard.
• The appliance must not be installed in places w here appliances altering such characteristics are present.

1.2.3.3 Atmospheric conditions of use

MIN. MAX.

Humidity
30% 75%

Temperature 10°C 40° C

50° F 104° F

Altitude
3000 m

Atmospheric pressure
8 6 0 - 1060 hPa
645 - 795 mmHg

T. 2

The appliance must be installed in atmospheric conditions observing the specifications o f table T. 2.

A It must not be installed in places where appliance altering such environmental characteristics are present.
Operating temperature must be maintained in the range 20°C to 35°C.

If the unit is subjected for m ore than 6 hours to a tem perature below 20°C or above 35°C, it m ay no longer com ply w ith its
initial construction characteristics.
Consequently, the unit m ust subsequently be brought back to its tem perature range (20°/35°C ) so that its efficiency is not
com prom ised by the off-range experience.
I f tem perature fell to below 15°C during transport, when the unit is being installed, wait for 4-5 hours to allow tem perature to
stabilise inside the room.
A fter this time has elapsed, the unit can be set or tested to ensure its efficiency.
1.3 DESCRIPTION OF THE RADIOLOGICAL UNIT

1.3.1 EM ERG ENCYSTOP

• 3 em ergency push-buttons are installed on the m achine described in this manual. I f pressed, they im m ediately stop all
functions o f the m achine.

1.3.1.1 Lay-out of emergency push-buttons

1) On the control table (F. 2)

6/32
 N ever use the em ergency push-button as a norm al stop device, but only in cases o f real em ergency, and if
m alfunctions occur, in order to im m ediately stop all functions o f the unit.

N O T E - After pressing one o f the three emergency push-buttons previously described, the following message appears on
the display ( A - F. I):

WARNING: 51 Em ergency ON

and an acoustic signal is generated at the sam e time.

1.3.1.2 Restoring after emergency stop

NO TE - Before restoring the operating conditions, identify and resolve the cause that tripped the em ergency
stop.

• Release the em ergency stop button, previously pressed, by turning it (m oderately). The acoustic signal will be silenced
and the “ alarm ” m essage will disappear on display.
• To restore the operating conditions, press the “O F F ” push-button on the control table, and then the “O N ” push-button.
If the stop cause has been elim inated, the m achine will be able to operate again.

1.3.2 MOVEMENTS OF THE CIRCLE

The vertical m ovem ent o f the circle is m otorized and set in motion by the operator by m eans o f the pedal board (free hands)
or using the keyboards placed on the circle itself or on the column.
The breast support plate height varies from 65 cm to 125 cm (with circle in vertical position), its stroke is equal to 60 cm.

The rotation m ovem ent o f the circle is m anual, release can be operated by the pedal board or by m eans o f the keyboards
placed on the circle or on the column. Rotation goes from 0° to + 90° and from 0° to -1 8 0 °, allowing every kind o f projections.

The inclination m ovem ent o f the circle is m anual, release can be operated by the pedal board or by m eans o f the keyboards
placed on the circle or on the colum n. Inclination goes from 0° to + 180° and from 0° to - 30°.

1.3.2.1 Circle inclination display (optional)

From display one can see the inclination and rotation o f the circle with respect to 0°, the visual indication o f the actual
position allow s to save tim e in positioning circle and a m ore accurate repetitiveness o f the test.
 1

1.3.3 LAY-OUT OF CONTROL AND CHECK DEVICES

1.3.3.1 Radiological unit

NOTE - There are control devices (push-button panels) on the machine, which act strictly on the movements o f the
machine and o f its accessories.

CAPTION

A - M ultiple pedal unit

B - Single pedal unit for controlling the com pressor.

C - Push-button panel on the central ring o f the “gantry’' (right side- operator side).

D - Push -button panel on the colum n o f the vertical m ovem ent (left side)

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 1

Pi11Al ■)N

I I

F. 5

f
la tr o

9/32
 1

1.3.4 PEDAL CONTROLS

1.3.4.1 Multiple pedal unit (F. 6)

1) (Upw ard) vertical m ovem ent pedal, (lifts the gantry-carrier arm).

2) (Dow nw ard) vertical m ovem ent pedal, (low ers the gantry-carrier arm).

3) Pedal for RH -LH rotation o f Bucky/X -ray tnbe-carrier axis.

4) Pedal for inclining B ucky/X -ray tube axis.

1.3.4.2 Single pedal unit for com pressor (F. 7)

1) C om pressor m ovem ent control pedal - upw ard (reduces com pression).

2) C om pressor m ovem ent control pedal - dow nw ard (increases com pression).

10/32
 1

1.3.5 GANTRY PUSH-BUTTON PANEL

1) U pw ard vertical m otorised m ovem ent

2) D ow nw ard vertical m otorised m ovem ent

3) R otation m ovem ent (0° + 90° / 0° -1 8 0 °).

4) Inclination ranges o f 0° to - 30° and 0° to + 180°,

5) Collimator lamp ON.

1.3.6 COLUMN PUSH-BUTTON PANELS

1) Collim atorlam pO N
2) Leftw ard m ovem ent o f X -ray tube (in the biopsy appliance version)
3) R ightw ard m ovem ent o f X -ray tube (in the biopsy appliance version)

A W henever the X -ray tube m oves out o f its 0° position (on the stereotaxic m ovem ent), the m anual rotation and
inclination m ovem ent is disabled.

4) Appliance ON LED.
5) Set o f LEDs indicating collim ation formats.
6) U pw ard vertical m otorised m ovem ent
7) D ow nw ard vertical m otorised m ovem ent
8) Rotation m ovem ent release (0° + 90° / 0° -1 8 0 °)
9) Inclination m ovem ent m anual releasen (0° - 30° / 0° + 180°)
10) E m ergency push-button.

&
© 18X24 24X30 SPOT S.F. BIOPSY

STEREOTACTIC
LIGHT MOVEMENT

d> <D
■c

UP

d> ROTATION INCLINATION

- 1

d>
H
F. 9

f 12/32
1.3.7 STEREOTACTIC MOVEMENT OF THE X-RAY TUBE (OPTIONAL)

The m otorized hunting m ovem ent o f the X -ray tube for stereotactic tests (optional), can be operated by the operator
through the keyboard placed on the column. The hunting m ovem ent goes from 0° to +24° and from 0° to -2 4 ° (+ the o ff field
thanks to the use o f m am m otone). It allows to carry out expositions w ith pre-fixed and steady inclinations, obtaining the
three-dim ensional individuation o f breast internal injuries (assisted by B iopsy-M or B iopsy D igit devices).

1.3.8 MOVEMENT OF THE COMPRESSOR AND RELEVANT DISPLAY

The m ovem ent o f the com pressor is m otorized and set in m otion by the operator through a pedal board (free hands) or
through the two handle controls placed on top o f the com pression system support column. O nce the X -ray exposition is
finished the com pressor autom atically runs upw ard (by the keyboard it is possible to stop this autom atism in order to carry
out bi-dim ensional biopsies on the com pressed breast). The com pression speed varies according to thickness and exerted
pressure; an acoustic alarm alerts when com pression is higher than 15 kilos, warning that too high a pressure is about to be
reached, system stops com pression autom atically at 20 kilos, as im posed by the regulation in force.
A display, placed at the base o f the unit, constantly shows com pressor altitude and the exerted pressure.
In case pow er supply suddenly stops or by sw itching an em ergency button, the com pression device will autom atically stop
the exerted pressure allow ing patient to move.

1.3.8.1 Compression
• M otorised com pression is effected either by the pedal controls (A - B - F. 10) or by the two knobs (C - F. 11) on the
com pression tower.
 1 I ]

When a force o f 5 K g is reached, all machine positioning controls are disabled.

A A ll compressors can support a maximum force o f 20 Kg.

• Digital indication o f com pression force m easured - through a sensor on the com pressor fitting - is show n on the display
(standard) (F. 12) or (F. 13).
- M inim um force: 4 Kg. visualized
- M axim um force: 20 Kg. visualized

F. 12

14/32
1.3.9 DIGITAL INDICATORS

1.3.9.1 Standard indicator (F. 12)

A - D igital indication o f com pression force.

B - Indication o f com pressor height, referred to the bucky potter surface.

1.3.9.2 Optional indicator (F. 13)

A - C om pression force digital indicator.

B - Com pression height digital indicator.

C - D igital indication o f the angle o f rotation o f the “gantry” .

D - D igital indication o f inclination angle.

A A t the end o f exposure, decompression is automatically activated, to free the patient's breast.

I f you w ish to exclude this function, use the push-button (1 - F. 14) (push-button panel on the control table).

F. 14
 1

1.3.10 SENSOR ADJUSTMANT FOR THE AUTOMATIC W ORKING OF THE EXPOSURE METER

T he X -ray sensor is the solid-state type (sem i-conductors) and has a surface o f about 1600 mm 2. B y m eans o f a lever, placed
beside the cassette holder, the sensor can be put in five different positions, w hich are reported on the com pressor and
visualized on the relative display. T his m eticulous positioning allow s to c a n y out the m ost accurate choice as far as the
areas o f interest are concerned.

A
mode.
If the breast does not cover the available range of the sensor (viewed on the surface (A-F.10) of the compressor) the
“ autom atic operation” m ode cannot be used. The operator m ust therefore set Kv and mAs values in “m anual”

Position the knob (A - F. 15) on one o f the five available positions (num bered) or at the o p erato r’s discretion, according
to the exam ination to be effected or the m am m ary part to be im pressed at a different contrast. The selected position is
show n by the indicator (B).

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 1

1.3.11 MANUAL LUMINOUS CENTER SQUARE

• The m anual center square allows the delim itation o f the radiological and luminous field according to the inserted diaphragm;
the standard diaphragm has been specially designed for form at 18x24.
• By using additional diaphragm s and relevant accessories (optional) form ats goes from 24x30 to the spot allow ing the
carrying out o f practically any kind o f exam inations.
• The collim ator (A - F. 16) is located on the outlet o f the X -ray tube. The following are housed inside it: the collim ation lamp,
the form at sensors, and - in the double filtering version - the M o/Rh filter change m otorised m echanism .

f
y ro
17/32
 1

1.3.11.1 Collimation
• T he LED corresponding to the form at o f the fitted diaphragm lights up (A - B - C - D - E - F. 17) (on the colum n push-button
panels).

,
Combine the exact slide fo rm a t with the film form at because the machine is equipped with safety devices that

A inhibit exposure as a result o f possible form at setting errors.

© 18X24 74X30 SPOT S.F. BIOPSY

Z !a For reasons o f safety, if no diaphragm is fitted, X -ray em ission is inhibited.

1.3.11.2 Replacement of the diaphragms

• Laterally extract the diaphragm from the center square and put it in a safe place, install the new diaphragm paying attention
to its direction top/bottom ; once the diaphragm has been com pletely inserted a m echanical clutch and a ball spring
determ ine its correct position, the sw itch-on o f the light o f the center square is necessary to m onitor the correct positioning
o f the diaphragm .
• T he form at o f the installed diaphragm can be checked by the silk-screen printing on the diaphragm itself and by the
lum inous panels placed on the column.

1.3.11.3 Fitting the diaphragm

• All diaphragm s (both standard and optional) are slide type.
• Insert the diaphragm (1 - F. 17/a) you intend to use well into the appropriate slit (2) placed on the collim ator by m eans o f
the light field. Verify its correct positioning.

1.3.11.4 Safety with diaphragms

• A series o f sensors positioned in the center square and in the potter guarantee the im possibility o f carrying out an
exposure w ith radiological field higher than the image receptor format.

j IMAGE 18/32
 1

1.3.12 AUTOMATIC LUM INOUSCENTERSQUARE

• The autom atic center square allow s the w holly autom atically delim itation o f the radiological and lum inous field according
to the kind o f exam ination in course; it can select all formats available for radiographies and biopsies.

1.3.12.1 A utom aticcollim ator

• The autom atic collim ator is m ade o f two m etallic discs, each o f them has a series o f calibrated apertures (eyes) and a series
o f positioning cams, read by specific sensors. The positioning cams allow placing both disc apertures, o f any com bination,
within the beam range; the com bination o f specific eyes form s a series o f passages which allow s the right irradiation o f the
different Potter sizes, spots and projections o f the biobsy images. Actually, it is possible to say that each single eye
com bination on the discs corresponds to a different 'size' o f the autom atic collimator.
• D uring each start-up test, the G iotto's control program initializes the autom atic collim ator, moving the two discs to a
specific position, called zero or original position, and then to a pre-defined position (18 x 24 F.G. size). At this point, the
control program starts m onitoring the param eters, in order to select the collim ator size w hich better fits the exam ination
being carried out. T hese param eters are:
- active focal point (for the tubes double-angle anode);
- P otter/cassette-holder size;
- x-ray tube position;
• W henever necessary, e.g. in case the Potter/cassette-holder is changed, the G iotto's control program selects the new right
size, determ ines w hich is the eye com bination needed, on the basis o f a series o f inner tables, and then m oves the
collim ator discs to their position, w ithin the beam range.
• The only operator's task is to select the SPO T size that the G iotto's control program is not able to select due to lack o f
inform ation. A ccording to the chosen size, the G iotto's control program enables to select only the com patible SPO T sizes:
the operator can select them cyclically by m eans o f the specific SPO T push-button (1 - F. 12/a) while the control program
selects the eye com bination and set them in position, within the beam range.

• The operator can select indifferently SPO T 1/SPOT 2 AND 18 X 24 sizes, through the push-button on the back o f the
cover.

•; -
.

y 19/32
 1

1.3.13 CENTER SQUARE LIGHT

• T he light o f the center square allow s to illum inate the radiological field with an intensity higher than 160 LUX.
• Sw itch the light on as follows:

- B y pressing the buttons placed on the keyboards in the column and in the circle (1 - F. 19 and 2 - F. 20) (also by the
keyboard placed on M am m obed, if connected)
- Starting the com pression process
- Changing the radiological field form at

• A tim er autom atically sw itches o ff the light after 20 seconds.

• The halogen lamp should be O SR A M X E N O PH O T long-life MOD: HLX 64638 - 24V 100W. Do not touch the lamp glass
w ith your fingers because it can be dam aged; in case it happens clean w ith care by using alcohol.

F. 19

A Whenever the gantry is positioned, or when the X-ray emission control is activated, or whenever the tube is
shifted fo r stereotaxic examinations, the light o f the centring device goes o ff automatically.

20/32
1.3.14 INSERTING THE BUCKY

1.3.14.1 Release of bucky and cassette-holder

• Press the release uncoupling lever (A - F. 21) under the com pression tower.

1.3.15 FITTING THE RADIOGRAPHIC CASSETTE

• The m am m ography radiographic cassette should be inserted so that the film lays above the reinforcing screen with
respect to the direction o f rays; the loophole for the identification o f p atien t’s data should then be in the low er part, by the
com pression’s turret side. The cassette insertion and extraction should be smooth, avoiding to force the com ers o f the
cassette holder.
• A sensor inside the cassette holder inhibits exposition w hen the cassette has not been put in position or replaced after
last exposition (exposed film)
• T he cassette holders allow the use o f m am m ography thin-type cassette (standard m odel), the old bigger cassettes
(w ithout the loophole for patien t’s identification) cannot be used any longer.

1.3.15.1 Fitting bucky and cassette-holder

• Fit the device in the guide housing at the base o f the tow er (F. 22).
• Insert the radiographic cassette (B - F. 23) (as shown in the figure) checking if it is correctly “hooked” by the stop tab
(C - F. 24), w hich acts also as a release device when the cassette is being rem oved.

A I f there is no cassette, or i f it is incorrectly fitted in the bucky (or cassette-holder) housing, X-ray exposure is
prevented.
The film m ust be replaced in the radiographic cassette after every exposure.
The unit is equipped with a safety device preventing double exposure on the same film .

22/32
1.3.16 MARKERS

• M agnetic m arkers allow radiographs to bear indication on the projection w hich has been carried out.
• M arker m ust be inserted before the carrying out o f the com pression on the appropriate support, letters should be placed
within the lum inous area o f the center square (inside the radiological field).
• The G IO TTO IM A G E unit is supplied w ith a set o f radio-opaque film m arkers (F. 25 - 26).
• T hey have a m agnetic part w hich acts as a support when they are located on the cover o f the Bucky or cassette-holder.
• A slot prevents them from m oving in oblique or lateral direction.

1.3.17 HEAD-REST

• The head-rest is necessary to avoid that the face parts enter into the radiological field during the exposition.
• D uring the exam inations carried out with the magnifying technique, the head-rest should be removed.
• T here are no sensors m onitoring the use o f the head-rest, the operator should then rem em ber to install it when necessary.
1.4 CONTROL TABLE

• The push-button panel (D - F. 27) is located on the control table (console) containing the control and check devices for
em ission o f X-rays.
• (E) M ain switch. W hen the unit m ust be sw itched off, take the sw itch in position “0” .
1.4.1 CONTROLTABLE

• The follow ing are housed in the control console:

- Electrical pow er circuits

- Card S 564 (terminal/logic card)

- Card S 565 (term inal/IO pow er supply card)

- Piloting inverter and high voltage transform er

- X -ray section control table

- Anti X -ray protection for operator.

1.4.2 ION I OFF SWITCH

• ON/OFF
• X -ray push-button

1.4.3 PROTECTION BY ANTI X-RAY GLASS PANEL

P rotection against radiation:

Protection suitable for reducing ionising radiation o f m am m ography appliances at maximum load in com pliance w ith standard
EN 60 601-1-3.

1.4.4 EMERGENCY PUSH-BUTTONS

See chapter 1.3.1

1.4.5 KEYBOARD AND DISPLAY

1.4.5.1 Push-button panel on console (Control table)

1) “O N ” push-button - if pressed, the control keyboard is enabled. The LED on the button lights up.

2) “O FF push-button - if pressed, the control keyboard is disabled. The unit sw itches o ff and all functions are
disabled.

3) Selection o f w ork techniques: m anual - sem iautom atic - autom atic 1 - autom atic 2.
N O TE - A utom atic function 2 is enabled only in the G IO TTO IM A G E version with M o/Rh double filtering facility.

4) kV (+ / -) adjustm ent - T his push-button increases and reduces voltage. The scale o f values ranges from 22 to 35
kV in steps o f ±0,5 kV and w ith rapid advance by holding the button down. The values are show n on the display
and flash when scale end is reached. W ith the sem i-autom atic technique, the high-voltage range is lim ited to 23 to
32 kV in 1 kV steps.

5) m As (+ / -) A djustm ent - T his push-button increases and reduces mAs. The scale o f values ranges from 4 to 600
inAs (the m axim um value depends on the type o f tube installed). The values are shown on the display and flash
w hen scale end is reached.

6) Selection o f type o f X -ray tube (Small focus: 0.1 -L a r g e Focus: 0.3).

The type o f selected “focus” is show n on the display as follows:
A S.F. (sm all focus)
L.F. (large focus)

N O TE - W henever the m agnification support is fitted, the m achine autom atically locates on the Small Focus, and
the operator m ay then select Large Focus if necessary
W hen pow ered up, the m achine autom atically locates on Large Focus, and the operator may then select Small
Focus if necessary

7) F ilter selection - Press this key to select the type o f filter - Mo or Rh (only on m odels where this option is available).

8) Film screen selection (O nly for sem i-autom atic and autom atic operation m odes)

9-10) Exposure density ( + / - ) - Press this key to select the degree o f film exposure. 11 values (fro m -5 to +5) are available.
The values are show n on the display and flash when scale end is reached.

11) A larm s display/reset.

W hen this w ord appears on the right o f the display: “ ER R O R ” , you can view the type o f error by pressing the key.
I f you press the key w hen the alarm is active, the alarm is reset.

12) C om m unication w ith “outside w orld ” active - Press this key to access com m unication with a personal com puter
in order to receive or store, via the dedicated program , the data and param eters o f a given patient. In this way,
you can create a p a tie n t’s sheet containing data and param eters used during a radiography or retrieve a sheet
that w as created previously. T he LED on the table lights up.

13) D isable decom pression - If you press this key, autom atic decom pression at end o f exposure is disabled. T his
function is particularly useful for traditional biopsy exam inations. The LED on the table lights up. I f you press it
again, the inhibition is disabled and the LED goes off.

14) X -ray em ission push-button - I f you press this push-button, X -ray em ission is enabled (the push-button m ust be
held dow n until the end o f radiography)

If this push-button is pressed, X -rays are not em itted im m ediately, but are delayed by about 2 seconds (ray
A preparation time).
W hile the rays are being emitted, the operator must take refuge behind the anti X-ray glass panel and observe the
specified safety regulations.
The push-button must be held down during the whole exposure time.

26/32
 1

15) X -ray transit indicator - An indicator-light. If lighted, it indicates that the m achine is em itting rays (it stays lighted
during the entire X -ray em ission period).

16) Appliance ON Led

It lights up after the “O N ” (1) push-button is pressed.

17) Luminous LED

“ Com m unication active”

18) Luminous LED

“ D ecom pression function” deactivated.

19) Display
R adiological param eters for m achine and operator alarms.

20) Safety plate

N O TE - For information about the display , consult Section: "Displays". See chapter 1 - plates on the unit.
1.5 ACCESSORIES

1.5.1 MAGNIFICATION

A In mammography examination with magnification devices, the dose supplied to the patient increases noticeably
with respect to normal exposure.

• The m agnification device consists o f a breast support (1 - F. 29) w hich effects the geom etric m agnification o f x 1.8, and
the relevant com pressor (2). The m agnification technique with magnification factor o f x 1.5 is available as an optional item.
To effect the exam ination w ith m agnification, prepare the units as follows:
1) Fit the m agnification technique com pressor (2) in the com pressor seat (C) on the com pression tower (3). Take com pressor
up on top.
2) Fit the device in its seats (B) on the com pression tow er (3).

NOTE - When the magnification support is fitted, this automatically activates the Sm all Focus.
Use o f 0.1 mm focu s fo r this examination makes it possible to obtain a high quality mammography image.
It is not advisable the use o f the Wide Focus, in fa c t this could bring to a decrease in special resolution.
We reccomend not to the bucky for this examination but the cassette-holder without grid.
As the breast is fa r from the film, there are no deleterious effects produced by diffused radiation.
So by elim in a tin g the grid, the p a tie n t receives a m uch low er dose o f rays, exposure time is reduced, and
less use is made o f the thermal capacity o f the X-ray tube.
The magnification examination can be made on the 18x24 or 24x30 cm cassette-holder (or on the bucky at the operator s
discretion).

A We advise you not to use the bucky fo r the magnification examination hut a cassette-holder without grid.

T he com pressor for m agnified details (optional accessory) is used to enlarge only the relevant part o f the mamma.
 1

1.5.2 CASSETTE E COMPRESSORS

• The unit is equipped w ith a set o f com pressors to be selected by the operator according to the type o l exam ination.

T he set includes:

A
18 x 24 com pressor
C 24x30 com pressor
0
C A rm pit com pressor
P
E C om pressor for details
T
S C om pressor w ith graduated scale
1
S C om pressor w ith circular holes
O
0 Anatom ic com pressor
N
R C om pressor for m agnification technique
A
C om pressor for m agnification technique for details
1
L C om pressor for anatom ic details
E
C om pressor for anatom ic m agnification technique for details.
S

1.5.2.1 Filtering
- 0.03 nunM O Fixed on the single filtering appliance
- 0.03 mmMO
- 0.025 mmRh
M obile on the double filtering appliance w ith both m anual and autom atic selection
- Equivalent filtering o f the m agnification technique surface + carbon fibre + grid = ....................... < 0.3 mmAl
- M irror filtering......................................Eq. 0 mm Al

1.5.3 OPTIONAL ACCESSORIES

• Electronic collimator
• B iopsy exam ination bed
• BTOPSY-M biopsy unit
• B IO PSY D IG IT-M A M biopsy unit
• C onfiguration o f accessories for various types o f exam ination.

7 «■«» 29/32
1.6 TECHNICAL DATA

1.6.1 GENERAL DESCRIPTION

• G IO T T O IM A GE is a m odern m am m ography unit with a unique design and solutions on the cutting-edge o f technology.
Ideal for screening, specialist exam inations and biopsy in prone position.
• G IO T TO IM A GE can be used w ith radiographic cassettes in form ats 18 x 24 cm and 24 x 30 cm, with m arking window.
• The G IO T T O IM A GE m am m ography appliance is classified as follows:

- according to directive 93/42/E E C concerning m edical devices: C lass lib.

- according to standard EN 60601-1 Electro-m edical A ppliances/G eneral safety Regulations:
C lass I appliance w ith B type applied parts suitable for fixed installation, with protective conductor not rem ovable
w ithout using a tool.

1.6.2 RADIOLOGICAL UNIT

• Stand designed for securing to the floor, with vertical, telescopic m ovem ent.
• C ircular arm (patented) containing the X -ray tube, com pression device, support for bucky, and cassette-holder.
• B ucky vertical movement: 600 m m + 150 m m (as consequence o f gantry inclination).
Minimum distance Bucky - floor: 650 mm; maximum distance in vertical position: 1 .250 mm; maximum distan­
ce in inclination position: 1 .400.
• R otation, from + 90° to -1 8 0 °, with operator controlled m anual movement.
• Inclination, from + 180° to - 30°, with operator controlled m anual movement.
• P ositioning and com pression o f breast perform ed at the front o f the patient.
• Com pression: 180 mm travel with operator controlled m otor driven movement.
M otor driven com pression, servo-assisted.
• Grid: 8 mm travel w ith m otor driven m ovem ent controlled by m achine Software.
• Tube sw ing movement: +/-24° operator controlled m otor driven m ovem ent (optional).
• Exposure technique: autom atic with “0” points.
• Facility for transm itting radiological data to a film m arking dedicated appliance.
• Focal length: 65 cm.
• L ight collim ator: sw itched on autom atically and manually, including protection o f p atien t’s head.
• M anagem ent o f all param eters by dedicated software.
• Fixed part (console or control table) including anti X-ray protection for the operator during the mam m ography examination.

1.6.3 FEATURES OF THE X-RAY TUBE

1.6.3.1 X-ray tube Comet MCS 50MO/focus values 0 .1 -0 .3

• M olybdenum anode, 3000 rpm.
• Focus values: 0.1/0.3 mm (IEC 336/EN 60336) m easurem ent earned out: focus 0.1 25kv/30mA - focus 0.3 25kv/120m A
• Power: 1/5 KW
• Current: 28 mA Focus 0.1 m m / 100mA Focus 0.3 mm
• Inherent filtering: 0.5 mm B e
• Additional filtering: 0.03 mm M olybdenum / 0.25 m m Rhodium (optional)
• X -ray tube by COM ET, CE certificate No. CE 0123.

30/32
 1

1.6.3.2 X-ray tube Varian m l 13sp/focus values 0.1 - 0.3

• M olybdenum anode, 3000 rpm
• Focus values: 0.1/0.3 m m (IEC 336/EN 60336) measurem ent carried out: focus 0.1 25kv/30m A - focus 0.3 25kv/100m A
• Power: 1/5 KW
• Current: 27 mA Focus 0.1 mm / 100mA Focus 0.3 nun
• Inherent filtering: 0.76 mm Be
• Additional filtering: 0.03 m m M olybdenum /0.25 mm Rhodium (optional)
• X-ray tube by VARIAN, CE certificate, No. CE 0086.

1.6.3.3 X-ray tube I.A.E. C339CXM 12/focus values 0.1 - 0.3

• M olybdenum anode, 3000 rpm
• Focus values: 0.1/0.3 mm (IEC 336/EN 60336) m easurem ent carried out: focus 0.1 25kv/30mA - focus 0.3 25kv/100mA
• Power: 1/5 KW
• Current: 28 mA Focus 0.1 mm / 100mA Focus 0.3 mm
• Inherent filtering: 0.76 mm Be a 40 Kv
• A dditional filtering: 0.03 m m M olybdenum / 0.25 m m Rhodium (optional)
• X -ray tube by I. A.E., CE certificate, No. CE 0051.

1.6.4 GENERATO R40 kHz INVERTER

Single-phase E -40M G IIF Single-phase 230 + /-1 0 % 50/60Flz
O perating freq u en cy : 40kH z M ax absorbed current: 20A
Power: 5 Kw O perating frequency: 40kH z
Kv: from 22 to 35 in 0.5 Kv steps. Power: 5 Kw
mAs: from 4 to 600
O perating power: 3.5 Kw.
ripple < 1 %

1.6.4.1 GENERATOR 100 kHz INVERTER

• S ingle-phase E -100M G HF • Inverter E -9 0 100M HF
• O perating fre q u en c y : lOOkllz • Single-phase 230 + /-1 0 % 50/60Hz
• Power: 5 K w • M ax absorbed current: 22A
• Kv: from 22 to 35 in 0.5 K v steps. • O perating frequency: 100kH z
• mAs: from 4 to 600 • Power: 5 Kw
?A
• O perating power: 3.5 Kw.
• ripple < 1 %

1.6.5 MANUAL COLLIMATOR SIZES

- 18x24
- 24x30
- Spot
- 15 x 24 small focus

1.6.5.1 AUTOMATIC COLLIMATOR SIZES

- 18 x 24 F.G. /1 8 x 24 F. P.
- 2 4 x 3 0 F.G
- B iopsy C .C ./B io p sy d x /B io p s y sx
- Spot 1 / Spot 2 F.G.
- Spot 1 / Spot 2 F.P.

1.6.6 FEATURES OF THE CASSETTE HOLDER GRID

• 18x24 Bucky potter w ith 5:1 grid/361/cm , 65 cm focussing.

'iotro
f 31/32
NOTES
 2
PRE-INSTALLATION
1. INTRODUCTION
2. PACKING CHARACTERISTICS
3. DIMENSIONS AND WEIGHT OF THE PACKING
4. CONFIGURATION OF SUPPLY INSIDE THE PACKING
5. LIFTING AND HANDLING OF PACKING
6. STORAGE OF PACKED MACHINE
7. OVERALL DIMENSIONS AND WEIGHTS
8. PRE-INSTALLATION INFORMATION
9. ELECTRICAL SYSTEM
10. ROOM SHIELDING SUGGESTIONS
11. RADIATION SAFETY
12. MANUFACTURER’S RESPONSIBILITY
13. OPERATOR SAFETY
 2

2. PRE-INSTALLATION

2.1 INTRODUCTION

T his section contains the pre-installation inform ation for G iotto Im age system.
A fter having read these instructions you m ay proceed to the installation o f the unit.

2.2 PACKING CHARACTERISTICS

• T he m achine is shipped fitted on a w ooden pallet on w hich the control console is also placed.

• In the standard configuration, the different units are protected by plastic, w hereas the m achine and its accessories are
protected by a w ooden case, also containing several packets o f dehum idiiying salt.

• On request, the m achine can be protected, inside the w ooden case, by a herm etic plastic cover (barrier sack), also
containing the dehum idiiying salts,

• T he conditions to be observed for correct storage and transport (see F. 1 w ordings and sym bols) are stam ped on the
packing case.

• W hen the supply is delivered, run a visual check (in the carrier’s presence) to see if there is any evident dam age reflecting
“ difficult” shipm ent. A ny dam age to the containm ent case should lead to doubts about the condition o f its contents.
A dvise any faults/trouble to I.M .S.

f
Y ’1"
FRAGILE
r. 1
•? r v j ) RH<95%

UMIDITA
F R A G IL E T E M P E R A TI IRA
X-RAY EQUIPMENT

2/14
2.3 DIMENSIONS AND WEIGHT OF THE PACKING (F. 2)

O FF-SC A LE DRAWING
Kg 550
-1 6 0 0

° f t nA u.
I T A

I
iw
T

F. 2
L DACCA

\
2.4 CONFIGURATION OF SUPPLY INSIDE THE PACKING

N O TE - Irrespective o f the type o f protective packing used fo r the machine, fo r individual parts or fo r accessories, the
packing case contains the follow ing components:

• A - M achine secured to w ooden pallet, suitably oriented to limit the occupied space.

• B - C ontrol C onsole, protected by a plastic cover.

• C - G lass panel for protection against X-rays, suitably protected by plastic.

• D - Pedal controls protected by plastic.

• E - Accessories supplied with m achine (BUCKY 18 x 24 compressor - film markers - head-rest - diaphragm for collimation),
packed in cardboard boxes.

F - X -ray em ission tube, packed separately in a dedicated box.

• G - Trolley to rem ove m achine from packing.

One o f the sides o f the packing case acts as a chute to allow the machine to exit.
E Important: before starting to unpack, check which side o f the case is equipped in this way.
2.5 LIFTING AND HANDLING OF PACKING

2.5.1 WARNINGS

• Consider the packing characteristics very carefully (dimensions and weight).

• All the inform ation below concerning lifting and handling o f the packing, should be understood as an aide-m em oir guide;
these operations m ust be strictly entrusted to qualified operators who, according to the characteristics o f the load, lifting
tackle, m eans o f transport, and available space, m ust organise all the operating procedures, using the m ost adequate
m eans and observing current legal regulations to the full.

N O TE - The packing case can be lifted from above by a crane, hoist, bridge crane, etc.., or from below by a fork lift truck;
in both cases, take great care (since the contents are “delicate”) as regards sudden m anoeuvres, jerks, im pacts, etc ...

• The M anufacturer declines all liability for damage of any kind caused by incorrect lifting or handling.

2.5.2 FORBIDDEN MEANS OF LIFTING

• T he lifting m eans or system s having the characteristics indicated below, cannot be used:

- Lifting capacity three tim es below m achinew eight.

- Inadequate m echanical characteristics (e.g. forks too short).

- W orn bearing structures.

- Lifting ropes, cables and belts, either w orn or not up to standard.

Keep the packing vertical! If the packing is inclined or rested on one o f the sides, this could seriously com prom ise
the condition o f the machine.

4/14
 2

2.6 STORAGE OF PACKED MACHINE

• The packed appliance may be stored for not over 15 weeks, under the follow ing environm ental conditions:

2.6.1 STORAGE CONDITIONS

• Table T. 1 indicates the conditions w hich m ust be observed during storage o f the appliance.

MIN. MAX.

Humidity
10% 95%

Temperature -20° C 70° C

68° F 158° F

Altitude
3000 m

Atmospheric pressure
da 500 a 1060 hPa

T. 1

I f the m achine is stored while packed, do not place the packing cases on top o f each other (F. 3).
2.7 OVERALL DIMENSIONS AND WEIGHTS

2.7.1 RADIOLOGICAL UNIT (COMPLETE) (F.4)

F. 4 * m inim um dim ension distances

6/14
 2

-=]
2.7.2 CONTROL PANEL

600

o
CO
O)
Kg 100
IB - - ai

r a | Bwira ” il f -
a CD
CM
J822_

F. 5

f
lo tr o
7/14
 2

2.8 PRE-INSTALLATION INFORMATION

2.8.1 TYPICAL ARRANGEMENT OF THE RADIOLOGICAL ROOM

R em em ber to consider the follow ing inform ation on pre-installation when y o u ’ll be about to install G iotto Image System.
The radiological room should be generally large enough to allow personnel to operate efficiently and safely. The follow ing
factors should be took into consideration during on-the-spot inspection o f the room.
M ake reference to paragraph 2.10, suggestion for the shielding o f the room.
M ake sure the floor to be flat enough so that it w on’t be necessary to use too m uch m aterial for the levelling o f the unit.
Position the u n it’s com ponents so that to avoid accidental contacts with operating control parts (such as feeding and
connection cables, em ergency buttons).
Leave the necessary space around each device.
M ake sure that no obstacles could prevent the use o f those rem ovable devices (such as the “B iopsy” and the “M am m obed”)
Place the feeding cables and any other cable into protection channels so that to prevent risks for the operator.

N O TE - The room where the radiological unit will be installed and where future examinations will be held, must
absolutely possess all the requirements prescribed by current, specific legal regulations. Therefore, the machine cannot
be installed and used in rooms that are not specifically equipped.

,
A M asonry work electrical systems, water systems, lighting points and miscellaneous accessories are the sole
responsibility o f the client.

2.8.2 MASONRY WORK

M asonry w orks m ust not be effected during and after installation o f the appliance, because the resulting dust could
8 j# dam age both m oving m echanical parts and electrical/electronic com ponents.

2.9 ELECTRICAL SYSTEM

A The electrical system o f the radiological room must be executed according to the CEI 64-4 Standard.

A rrange for the “E n tran ce d oor” safety electrical connections and install light indicator outside the entrance
doors.

A I.M.S. does not accept any liability fo r damage o f any kind caused by fitting up o f the radiological room and the
electrical system in a manner not conforming to legal regulations, and by incorrect characteristics o f the
electrical pow er supply.

8/14
 2

Note: the electric system of the radiology room, must be carried

out in conformity with 64-4 CEI regulation.
© ELECTRIC PANEL
Feeding tension 230 V AC ___
Maximum power absorbed 4.6 KVA
Minimum nominal power of the line 4.6 KVA at 1.50 mt from ground level
Fuses 25A
Stand-by working voltage 1A - 230 VAC ___
Temporary current max. 20A - 230 VAC
(2) X-RAY INHIBITOR DOOR SAFETY CONTACT
Giotto provides for clean contacts for X-ray lamp (do not enter)
(3 ) MAMMOGRAPHY DEVICE
(4 ) MAMMOBED
© COMPUTER

F. 6

f
la te
— I . - . . . . . - ............. 9 /14
 2

2.9.1 INSTALLATION

Note: the electric system of the radiology room, must be carried out in
conformity with 64-4 CEI regulation.

(T) ELECTRIC PANEL

Feeding tension 230 V AC
Maximum power absorbed 4.6 KVA
Minimum nominal power of the line 4.6 KVA
Fuses 25A
Stand-by working voltage 1A - 230 VAC
Temporary current max. 20A- 230 VAC

(2) X-RAY INHIBITOR DOOR SAFETY CONTACT

Giotto provides for clean contacts for X-ray lamp (do not enter)

0 MAMMOGRAPHY DEVICE

For application please see chapter 2/4 in the use and maintenance manual

10/14
2.9.1.1 Characteristics of electrical system

P ow er supply voltage 230 V A C

In special cases (on p atient’s request) 240/208/200 V A C
F requency 50-60 Hz
C alculated variations for pow er supply voltage ± 10%
M axim um absorbed pow er 4.6kVA
Line minimum nominal pow er 4.6kVA
M axim um apparent line resistance 0,4 Ohm
C urrent for stand-by operation 1A -2 3 0 V AC
M ax tem porary current 20 A -2 3 0 VAC
F u ses 25 A
Line max daily variation ±5%

T. 2

• Single-phase 230 V line with protective earth.

• The diam eter o f the conductors m ust guarantee a line resistance o f not below 0.4 omh. See table 3.

Length of connection (in metres) Section Conductor(in mm2)

40 4
100 10
T. 3

NO TE - The apparent resistance (R) o f the line can be calculated as follows:

where:

V° = Voltage m easured w ithout any load betw een the two phases
V, = Voltage m easured w ith a load betw een the two phases
T = Current during loading (exposition)

The pow er supply line m ust be protected with:

• a 2-pole autom atic sw itch with nom inal current o f 25 A
• a differential switch w ith tripping current o f 30 mA..

2.9.1.2 Auxiliary circuits

• The lighting controls o f the room m ust be located near the m ain entrance and close to the control table.
• T he lighting m ust be as follows:
Strong white light (100-150 Lux)
Weak white light (50 Lux)
• At least two pairs o f 6A and 15A sockets m ust be present in the room , one near the control console and the other near the
stand.
• A luminous sign with the words “C O N T R O L L ED Z O N E ” (diagnostics in progress, and flashing light indicating transit o f
X -rays) m ust be present outside the room w here the appliance is installed.
• Install, on every door o f the radiology room , a switch preventing rays from transiting w ith the door open.
• Connect the door contact and indicator-light w ires to the electrical panel (see w iring lay-out).
2.9.2 ENVIRONMENTAL PROTECTION CHARACTERISTICS FOR 35 KV MAMMOGRAPHY
APPLIANCE

• Walls: equivalent thickness in Pb 0.3 mm

• Door: equivalent thickness in Pb 0.3 mm

• Floor: equivalent thickness in Pb 0.3 mm

• Ceiling: equivalent thickness in Pb 0,1 m m

• A 2 -lig h t X -ra y in d ic a to r m u st be fitte d o u tsid e th e d o o r: the firs t (w h ite) lig h t g o es on w hen the a p p lia n c e is
p o w e re d up; the s e c o n d (fla sh in g re d ) lig h t g o es on w hen the ra d io lo g ic a l tu b e is p re p a re d ad sta y s o n u n til
th e su p p ly o f X -ra y s h as fin ish e d .

• The m am m ography room is norm ally indicated as a “CO N TRO LLED ZO N E’'.

• The authorised personnel is norm ally in “ CATEGORY B ” radiation exposure.

NOTE - The masonry work, even i f perforated, usually ensures the above equivalent values without additional thickness
in Pb.

2.9.3 IDENTIFIED SIGNIFICANT ZONES OF OCCUPANCY

• RADIOLOGICAL A PPLIANCES specified for any RADIOLOGICAL examination requiring the presence o f an OPERATOR
or personnel beside the PATIENT for N O R M A L U SE, or otherw ise not conform ing to 29.208.1 or 29.208.2, m ust have at
least one S IG N IFIC A N T ZO N E OF O C C U PA N C Y for use by the OPERATO R and personnel, as defined in the USE
INSTRUCTIONS.

• Any S IG N IFIC A N T ZO N E OF O CC U PA N C Y defined according to this paragraph m ust have a floor area o f not less than
60 cm x 60 cm, and a height o f not less than 200 cm.

T he designation o f the SIG N IFIC A N T ZO N E OF O CCUPA NCY defined according to this paragraph m ust include the
following information:

• the type o f R A D IO LO G IC A L exam ination for which the SIG N IFICA NT ZO N E OF OCCUPANCY is intended to be used;
• the position o f the SIG N IFIC A N T ZO N E OF OCCUPANCY, shown on a draw ing indicating its outline, and the location o f
its lim its in relation to the clearly recognisable characteristics o f the R A D IO LO G IC A L A PPLIA N CE;
• identification of ALL REMOVABLE PROTECTIVE DEVICES specified for the use with the RADIOLOGIC AL APPLIANCE, together
with appropriate information concerning their application and use.

NOTE - For recommendations on the information regarding the level o f Radiation dispersed in the significant occupied
areas and on the efficiency o f the protective devices, please contact a qualified expert.

12/14
 2

2.9.4 MINIMUM SPACE

NOTE - F. 8 shows the dimensions o f what is considered as "minimum space " fo r using the radiological unit described
in this manual.

NOTE - The spaces here decribed are indicative and also advisable fo r a correct installation o f the IMS. The customer
might choose to consider other configurations taking always care to take into consideration the minimum safety spaces
as indicated.

f1e» ---------------------- ----- 13/14

2.10 ROOM SHIELDING SUGGESTIONS
The X-ray room and all associated structures w here the X-ray
equipm ent is to be installed m ust have the necessary radiation
shielding to prevent any individual from receiving m ore than the
m axim um perm issible dose o f radiation. T o com ply w ith this safety
precaution, structural shielding o f the X-ray room m ust conform to
the requirem ents and specifications set forth by the N ational C ouncil
on Radiation Protection
In general, the structures w hich m ust conform are doors, w alls,
ceilings, floors, observation w indow s, protective barriers inside the
X -ray room , structural jo in ts, electrical service equipm ent,
ductw ork, pipes, and conduit.
C orrect equipm ent installation begins with adequate structural
shielding. T he ceiling, floor, doors, w indow s, and in terio r p artitions
o f the radiological area m ust be evaluated and designed to include
necessary attenuating barrier m aterials.

In addition to these considerations, radiological installations m ust

com ply with all applicable local, m unicipal, and state electrical
codes and laws.

2.11 RADIATION SAFETY

X -ray equipm ent generates ionizing radiation w hich is potentially
hazardous to the patient and personnel. If not properly used. X -ray
equipm ent m ay be dangerous. D ue to the potentially adverse effects
o f ionizing radiation, the follow ing recom m endations should be read
and understood before attem pting to operate this X -ray equipm ent.

T he X -ray equipm ent w as designed to com ply w ith the

standard recom m endations.

2.12 MANUFACTURER’S RESPONSIBILITY

A lthough this eq u ip m e n t in co rp o rates pro tectio n ag ain st X -ra d ia tio n
o th er than the usefu l beam , practical design does not p ro v id e
c o m p lete p ro tec tio n . E q u ip m e n t design d o es not co m p e l the
o peration o r a ssista n ts to take the n e ce ssa ry p re ca u tio n s, n o r d o e s it
prev en t the p o ssib ility o f im p ro p e r use.

2.13 OPERATOR SAFETY

O nly authorized and p roperly trained ind iv id u als should o p erate this
equipm ent. All in d iv id u als au th o rized to use this eq u ip m e n t m u st be
aw are o f the d a n g e r o f ex cessiv e e x p o su re to radiation.

P atient dose sh o u ld be kept as low as possible w ithout

co m p ro m isin g th e q uality o f the procedure. A uth o rized o p erato rs
sho u ld avoid e x p o su re to the prim ary beam at all tim es. A ny object
in the path o f the p rim ary beam p roduces seco n d ary o r scattered
radiation. P ro tectiv e m easures should be taken to safeg u ard against
secondary radiation.

T h is equipm ent is sold w ith the und erstan d in g that IMS SRL
its agents, and rep resen tativ es, do not accept any resp o n sib ility
for o v er exposure o f p atients o r personnel to X - radiation.

14/14
 3

INSTALLATION

1. INTRODUCTION
2. INSTALLATION PROCEDURE STEPS
3. UNIT REMOVAL FROM PACKING
4. UNIT LIFTING
5. PLACINGAND FIXING O FTH EU N ITTO TH E GROUND
6. CONNECTIONS BETWEEN RADIOLOGICALUNITAND CONTROL
TABLE
7. INSTALLATIONANDCONNECTIONOFX-RAYTUBE
8. CONNECTION WITH POWERSUPPLYLINE
9. AUXILLIARYCONNECTIONS FO RSIGNALSANDSECURITY
10. STARTING
3. INSTALLATION

3.1 INTRODUCTION

T his section supplies inform ation for the installation o f G iotto Image m am m ography system; before installing review pre­
installation section in order to determ ine that all o f the requisites have been satisfied.

3.1.1 PRELIMINARY ROOM INSPECTION

Before beginning installation, inspect the X-ray room to verify
compliance with specifications for the following items. Refer to
Section 2 Preinstallation, for details concerning these
specifications.
• incoming line
• main switch
• wall boxes
• conduit
• space requirements

3.2 INSTALLATION PROCEDURE STEPS

3.2.1 REQUIRED TEST EQUIPMENT

HAM M ER DRITL
BITS TO DRILL CONCRETE FROM 10 M M .-18 MM . DIAM ETER
WRENCHES IN DIFFERENT SIZES, MM. PITCHES
SOCKET HEAD SCREW IN DIFFERENT SIZES, MM. PITCHES
STANDARD AND CROSS-HEADED SCREW DRIVERS, DIFFERENT SIZES
H A M M ER
PINCERS, DIFFERENT SIZES
LEVEL

3.2.2 UNPACKING

• Proceed very carefully at this stage, because some machine parts could be very close to the internal walls o f the wooden case.
• D o not, on any account, break open the case w ith sharp tools and do not perforate the panels.
• L ocate the side w all to be used as a chute to help the m achine exit from the w ooden pallet.
• Free the base o f the case, rem oving the front and rear panels, the cover and the panel opposite the “chute” .
• B ew are o f any nails, especially on the top o f the packing.
• R em ove protective plastic and check if the contents correspond to the annexed packing list; prom ptly notify I.M.S. o f any
m issing item s or dam age to the appliance.
• Rem ove the bags containing the dehum idifying salts and store them in a dry place.
• R em ove the other packing items from the w ooden pallet and open them w ith caution.

3.2.2.1 DISPOSAL OF PACKING

• Separate the packing m aterials and dispose o f them in com pliance w ith current laws on disposal o f solid waste.
• T he packing m aterials (wood, cardboard and pluribool) are 100% recyclable.

3.2.3 ISPEZIO N ED ELL’UNITA

Before beginning the installation, verify that all hardware and
internal w iring is secure; the configuration received is the one
ordered; and that all item s on your order are included in your
shipment.
'idtro
f —— ■ 2/18 ■ ■ ■■ --------------
3.3 UNIT REMOVAL FROM PACKING

NOTE - We recommend that at least two people should be used to remove the machine from the wooden pallet.

• Rem ove the control table from the w ooden pallet, and position it vertically.
• P osition the two slides (A - F. 1) on the base plate (B) - the slides will form the m achine transport trolley; this system is
identical for both m achine versions (display 1 - standard - display 2 - optional).
• Loosen the four nuts (C ) and m oderately screw the four screw s (D) on the base plate up to reaching the nut top.
• Release the m achine base plate from the w ooden pallet, by unscrew ing the screw s (E). T he m achine rem ains sustained by
the supports (A) w ith w heels (F).
• Fasten the nuts (C ), operating crossw ays to keep the levelling o f the trolley/m achine assem bly as horizontal as possible.
In this way, the m achine will rise by a few centim etres from the w ooden pallet.
• Very cautiously, allow the m achine to descend from the w ood chute fixed to the pallet. D ispose of packing w aste as
described above.
3.4 UNIT LIFTING

NOTE - Lifting can be carried out by a small crane, an electric hoist, or a fo rk lift truck (used for lifting from above), etc..
- in any case, check i f the means is adequate fo r lifting the machine's declared weight. Lifting the machine should be
considered as an "exceptional” operation, and can be undertaken only for the machine version with "plug''.

• C heck that there is no unrestrained object on the m achine that could fall w hile the unit is being m oved.

• R em ove the fairings, using the appropriate screws.

• M a n u a lly c o m p r e ss th e sp rin g (1 - F. 2), to r e le a s e th e “ b r a k e ” on th e r o ta tio n o f th e c ir c u la r b o d y

(2 - F. 3) and, sim ultaneously, locate the circular body in vertical position.

• F it the lifting belts on the upper part (A - F. 3) o f the bearing frame and on the eye-bolt (B - F. 2).

• C autiously lift the m achine a few centim etres o ff the ground and check if the w eight is correctly distributed and balanced,
and then proceed to lift as specified, checking that the person m anoeuvring can always see the machine.

4/18
3.5 PLACING AND FIXING OF THE UNIT TO THE GROUND

Once the room is ready for installation, move all equipment in and
position the units as close to their final locations as possible. Leave
working area around each unit until final assembly is com plete.
Before locating the unit, check if the floor o f the room is able to bear
the declared weight (with the safety m argins specified by current legal
regulations) and if the surface is as uniform as possible.

3.5.1 SUPPORT SURFACE

• Radiological unit (250 Kg) support surface 690 x 400 mm

• Glass panel ( 100 Kg) support surface: 600 x 260 mm

N O T E - Selection o f the position where to install the machine must not depend only on the machine s effective dimensions,
but one should also consider perim eter space sufficient to ensure that all preparation, inspection, routine and extraor­
dinary maintenance operations are carried out in a highly rational manner, and also check if the operational area is
ergonomic.

3.5.1.1. Radiological unit levelling

Levelling is necessary only for those units w hich operate in co-operation with B iopsy exam ination table, in fact circle should
be parallel to the exam ination table during the carrying out o f the exam ination itself. For a correct levelling install Biopsy,
position circle horizontally, adjust rotation in the sam e position in which it will be used; it norm ally corresponds with
cranium -claudal position (CC), at 90° with respect to 0°. Position the exam ination table as if to perform a normal exam ination,
see picture.
Regulate the levelling screw s in order to obtain a correct levelling and parallelism betw een circle (A) and the exam ination
table (B).

____________________

I I
I I
I I
I I
I I
I I

I I
o

)— J------ k
r ------------------>

Q
X " - - -
r
v . '

F. 4
 Levelling screws can protrude o f about 1 cm, i f limit is not sufficient, interpose a spacer.

A Should the unit be not correlated by Biopsy, use levelling screws (B - F. 5) in order to balance the unit in case o f
an imperfection o f the floor.

3.5.2 FIXING RADIOLOGICAL UNIT

• W hen you have certainly determ ined the position where the m achine will be perm anently installed (fixed), position the
base o f the m achine and drill the holes (A - F. 5) in the floor for anchoring the base-plate (F. 5).

A Before going ahead, we advise you to have at least 2 persons ca n y out the listed operations.

• Place the m achine near its installation area.

• L oosen the four nuts (D - P. 6) and unscrew the four screws (C - F. 6) securing the trolley to the threaded holes (A - F. 5),
on the base-plate, w orking crossw ays in order to sim ultaneously free the two rods (E - F. 6) o f the trolley.
• A lign the holes (A - F. 5) o f the base-plate with the holes drilled in the floor; fit the expansion plugs (supplied) and tighten
them.
• Level the unit by acting on screw s (B - F. 5).
3.5.3 FIXING OF THE UNIT CONTROL TABLE

• A pproach the anchoring plate (A - F. 7) to the control table (1), to the bracket (B - F. 7) permanently secured to the m achine
base-plate.
• Level the cabinet w ith the adjustm ent feet (2 - F. 6 - 7).
• Fit the screw s (C - F. 7) in the slots o f the bracket (B) and screw them on the plate (A - F. 7). Before tightening the screws,
check again if the control table is correctly levelled.
3.5.4 ANTI X-RAY GLASS INSTALLATION

A The screen protecting the radiological technician during the m am m ography exam ination must be handled very
carefully.

Installation procedure :

- R em ove the front panel ( A - F . 8) o f the electric cabinet.

- Fit (with extrem e care) the anti X -ray glass panel (B) inside the housing (C) on the control table (D).

- H old on to the glass panel w ith both hands until it reaches the end o f its travel.

8/18
NOTE - Install the anti X-ray glass panel, with the word “Giotto ” at the top and legible from the side opposite the
operator.

A *\
The protective screen conforms to the following standards:
EN 60 601-2-45 / EN 60 601-1-3 and is equivalent to 0.1 mm Pb.
NOTE - The weight o f the glass and the “ obliged" housing would be sufficient to ensure the stability o f the glass.
However, the glass panel must be anchored to the structure o f the electric cabinet by fo u r screws (in nylon) (A - F. 10).

• A fter installing the panel, re-position and secure the electric cabinet panel.

A?\ Use o f the radiological unit without the electric cabinet closing pan el is absolutely forbidden.

10/18
3.6 CONNECTIONS BETWEEN RADIOLOGICAL UNIT AND CONTROL TABLE

The electric cabinet can be supplied in three different configurations:

A - B - M achine connectors.

C- Prog. SW param. connector.

D- Bed connector (optional) for exam inations in prone position.

3.6.1 CONNECTION OF HIGH-TENSION CABLE WITH HIGH-TENSION TRANSFORMER

N O TE - The machine is supplied with the high-voltage cable connected (F. 11).

• R em ove the fro n t p anel o f the electric cabinet (A) and co n n ect the high -v o ltag e cable (1) to the h ig h -v o ltag e
transform er (2). A pply a film o f silicon or Vaseline for high-voltage connections to the high-voltage head (1).

• R e-position the electric cabinet panel (A).

12/18
3.7 INSTALLATION AND CONNECTION OF X-RAY TUBE

N O TE - To install the X-rciy tube, position the circular body vertically (as shown in F. 12) proceeding according to one
o f the possible systems. This system B is standard.

A- Manual positioning - separate and remove the housings (A - B).

O perating manually, release the brake on the m ovem ent and rotate the arm until vertical (F. 12).

B- E lectrical positioning - by push-button (1 - F. 13).

 Protective gloves m ust be w orn to install the X -ray tube.

• Position the circular body vertically (F. 12)

• R em ove the housings (A - B - F. 14) protecting the X -ray tube.

• R em ove the X -ray tube from its protective cover.

• Look for any dam age caused during transport, or oil leaks.

• Carefully clean the high voltage socket (C - F. 15) with a clean cloth.

• C over the high voltage head (D - F. 16) w ith a silicon film or Vaseline for high voltage conduction and insulation (supplied
w ith the X -ray tube).
 O

O'-
• Carefully fit the X -ray tube (1 - F. 17), inside the support (2) (but not to the end o f its travel).

• Working from the front o f the X -ray tube-carrier support, first connect the low -voltage cable (A) and then the high-voltage
cable (B).

Connect the earth cable (C) to the sheath o f the X-ray tube. Connect the earth wire o f the high-voltage cable to

A the earthing point on the sheath o f the X-ray tube.

Press (with caution) on the X -ray tube (1) to position it fully inside the support (2).

Secure the X -ray tube w ith the screw s (D), (from both sides).

Re-fit the protective housings (A - B) you had rem oved and secure them with screws

Re-fit (if rem oved) the side housings (E)

A It is absolutely forbidden to use the mammography unit without the protective housings.
3.8 CONNECTION WITH POWER SUPPLY LINE

A In compliance with EN 60 601-1 "GIOTTO IMA G E ” must be permanently connected to the electrical mains. (The
protective earth conductor must be connected to the appropriate terminal directly inside the electric cabinet).

A A special a n tista tic bracelet must be worn fo r any operations entailing hand contact with electronic cards.

NOTE - The machine is supplied with the pow er cables connected, but without a plug fo r connecting the machine to the
com pany’s electrical line.
The electrical system is built with components and according to criteria guaranteeing maximum reliability and safety o f
use.

C onnection o f cables to the electrical m ains m ust be carried out by specialised technical personnel, who m ust check
in advance that m ains voltage and frequency m atch those indicated on the m achine rating-plate (+/- 5 % ).
I f the values are o ff tolerance, install a voltage stabiliser on the line supplying pow er to the machine.

• The annexed w iring lay-outs enable identification o f the connection points and com ponents used.

• B efore use, check if the earth wire is efficient.

D o not add extensions to the pow er cable. I f necessary, fully replace the pow er cable, using one o f the sam e
diam eter and guaranteed “fla m e p ro o f’.

A C heck if the m ains line to be used by the m achine is equipped with a safety circuit breaker. Also check if there are
any overcurrents and electro-m agnetic noise on the m ains

W ith the exception o f the m ains connection, do not do anything aim ed at m odifying circuits, settings, com ponents,
etc...
I f this instruction is breached, this will be considered as tam pering w ith the supply.

3.9 AUXILLIARY CONNECTIONS FOR SIGNALS AND SECURITY

3.9.1 CONNECTION OF D O O RCO NTACT WITH LUMINOUS SIGNAL

Inside control table has been arranged a term inal board for the connection o f signalling and security devices, pins 1-2-5-6-
7-8.
D oor contact should be com posed by a lim it sw itch positioned on entry-doors to the radiological room, norm ally w ith
closed contacts, term inals should be connected w ith pins nr. 7 and 8 o f the term inal board.

NOTE - There must not be any tension on these wires.

Lum inous signalling should be com posed by 2 lights, a fix w hite light w hich points out that device is w orking, sw itch o ff
pow er supply 230 Volt AC from pins 1 and 2, a blinking red light w hich signals that unit is in phase o f preparation, connect
w ires to pins 5 and 6, attention, relay ’s contact is equal to 5 A m pere m axim um .
For further inform ation see general diagram .

16/18
3.10 STARTING

• Before unit pow er supplying, verify that all connections have been perform ed correctly.

• During starting phase unit will perform a test on com pressor and tu b e's oscillation m ovem ent (if pre-determ ined), m ake
sure that there are no obstacles, for exam ples covers w hich have not been correctly fixed; do not bring hands near the
oscillating tube.

• Verify that all em ergency push buttons have not been pressed.

• Position the m ain sw itch in “close” position (1), control table display will lit up and “ PLEA SE W AIT" will pop up on
display, w hen m essage disappears it will be possible to press the push button placed on the control table (push button 1).

• G iotto will perform the here above described tests and if no difficulties will be perceived by system, display will visualize
the autom atic mode.

• U nder this condition all G iotto’s functions must be operative.

N O T E - The alarm signalling fie ld will visualize “ERROR ” because in automatic mode it is necessary that the compres­
sion value is higher than 4 Kilos and that cassette is inserted into Potter to allow the exposure.

Check the following before powering up the machine:

1) The earthing circuit o f the electrical system is adequate and conform ing to current standards.

2) The voltage and frequency o f the line are com patible with the construction characteristics o f the m achine, i.e. 230 VAC
Single-phase + Earth / 50-60 Hz..

3) T here is no visible dam age on the cables or com ponents o f the appliance

4) All connections conform to the wiring diagram s annexed to the manual.

5) All m echanical parts are correctly fitted.

f
'icfio • ----- - - ----- 17/18
NOTES
 4

CHECKS AND REGULATIONS

1. BEAM QUALITY ASSESSMENT

(HALF-VALUE LAYER MEASUREMENT)
2. KVp ACCURACY AND REPRODUCIBILITY
3. BREAST ENTRANCE EXPOSURE, AEC REPRODUCIBILITY,
AVERAGE GLANDULA DOSE, AND RADIATION OUTPUT RATE
4. CHECK OF LIGHT FIELD INTENSITY AND UNIFORMITY
5. PROCEDURE COLLIMATION ASSESSMENT
6. EVALUATION OF SYSTEM RESOLUTION
7. AUTOMATIC EXPOSURE CONTROL DELL’AEC SYSTEM
PERFORMANCE ASSESSMENT
8. PROCEDURE SYSTEM ARTIFACT EVALUATION
9. PROCEDURE IMAGE QUALITY EVALUATION
10. PROCEDURE: COMPRESSION
11. COMPRESSION PADDLE ALIGNMENT
12. CHECK-LIGHT FIELD EDGE CONTRAST
13. X-RAY SHIELDING COMPLIANCE
14. LEAKAGE CHECK-X-RAY TUBEHEAD
4. C O N T R O L L IE R EG O LA ZIO N I

4.1 BEAM QUALITY ASSESSMENT (HALF-VALUE LAYER MEASUREMENT)

OBJECTIVE To assure that the half-value layer (HVL) of the X-ray beam is adequate
to minimize patient breast dose, while not so excessive that contrast is
lost in the resultant image.

REQUIRED TEST Ionization chamber and electrometer calibrated at mammographic X-ray

EQUIPMENT beam energies (the calibration factor should be constant to within ±1%
over the HVL range from 0.2 to 0.6 mm Al)
Five or six 0.1-mm-thick sheets of 99.9% pure aluminum (type 114$
aluminum alloy) or 99% pure aluminum (type 1100 aluminum alloy) of
length and width sufficient to cover the ionization chamber fully. The
stated thicknesses should be accurate to within ±1%.

NOTE: The use o f type 1100 alum inum alloy for HVL m easurem ent

can give (depending on specific sam ples) HVL values up to 7.5%

low er than those m easured using type 1145 alum inum .

If type 1100 alum inum is used, results should be corrected to agree

w ith those obtained using type 1145 alum inum alloy.

TEST PROCEDURE 1. Place the breast compression paddle as close as possible to the X-ray
STEPS tube.
2. Place the ionization chamber approximately 4.5 cm above the image
receptor holder assembly, centered left to right and 4 cm in from the
chest-wall edge of the image receptor. The ionization chamber should
be fully within the X-ray field.
3. Select the most commonly used clinical kVp and record on the data
form. If appropriate, assure that the filtration normally used for
that kVp setting is in place.
When starting the unit set the function of continuous exposure.
4. Set the unit to manual timing, with a time setting sufficiently long
to provide an exposure of approximately 500 mR, and record
the mAs.
5. Use a diaphragm to collimate the X-ray beam so that the ionization
chamber is just fully exposed (to minimize backscatter production).
6. Make an exposure without any aluminum sheets between the X-ray
tube and the ionization chamber.

2/56
 - — ---- --------------------------------- □
7. Add 0.2 mm of aluminum between the X-ray tube and the ioniza­
tion chamber by placing the aluminum on top of the compression
paddle. Use the light field to verify that the X-ray path to the
ionization chamber is fully blocked by the aluminum sheet.
Make an exposure and record the ionization chamber reading.
8. Repeat step 7 with additional 0.1-mm sheets of aluminum between
the X-ray tube and ionization chamber, recording the ionization
chamber reading each time until the reading is less than one-half the
original exposure reading (taken without any added aluminum sheets
between the X-ray tube and chamber).
9. Remove all aluminum sheets from the top of the compression paddle,
make a final exposure and record the chamber reading. If the result
of this final exposure differs by more than 2% from the exposure in
step 6, repeat the measurement sequence.
10. Repeat steps 4 through 9 for other kVp-target-filter settings ranging
from the lowest to the highest used clinically.

DATA ANALYSIS AND To calculate the HVL by logarithmic interpolation, use the following
INTERPRETATION notation and procedure. Denote the direct exposure reading, without
any added aluminum, as EQ. Divide this value in half and find the two
exposure readings and added aluminum thicknesses that bracket the
E0/2 exposure. Let Ea be the exposure reading that is just greater than
one-half of EQand ta be the corresponding aluminum thickness. Let Eb
be the exposure reading that is just less than one-half of EQ and tb the
corresponding aluminum thickness. Ea will be greater than Eb, while t
will be less than tb. With this notation, the HVL may be computed
using the formula:

«b ln[2Ea/E0] - t, ln[2Eb/E0]
HVL----------------------------------------
ln[Ea/Eb]

where the HVL will be given in the same units as t and tb, usually
millimeters of aluminum.
 RECOMMENDED At a given kVp setting in the mammographic kilovoltage range (below
PERFORMANCE 50 kVp), the measured HVL with the compression paddle in place must
CRITERIA AND be equal to or greater than the value:
CORRECTIVE ACTION
kVp
HVL > ------+ 0.03 (in units of mm of aluminum)
100

For example, if the nominal tube potential is 28 kVp, the HVL must
equal or exceed 0.31 mm of aluminum. If the measurement is made
without the compression paddle in the beam to simulate mammography
performed without a full compression paddle in place (e.g., in needle
localization procedures), then the HVL should meet the Federal perfor­
mance standard: HVL > kVp/100 (in units of mm of aluminum). For
example, at 28 kVp without a compression paddle, the HVL must equal
or exceed 0.28 mm of aluminum. If the measured HVL is below these
limits at any kVp setting, service personnel should be contacted to check
whether appropriate filtration is in place.

If the HVL for screen-film units is excessive, both subject contrast and
image contrast will be reduced. For screen-film units using Mo/Mo, Mo/
Rh, or Rh/Rh target/filtration combinations, it is recommended that the
HVL be within a constant value (C) of the minimum acceptable HVL:

kVp
HVL < ------+ C (mm of aluminum)
100

where C = 0.12 mm A1 for Mo/Mo, C = 0.19 mm Al for Mo/Rh,

C = 0.22 mm Al for Rh/Rh and C = 0.30 for W/Rh. (Note: these HVL
upper bounds are based on molybdenum filter thicknesses of 30 jum or
less and rhodium filter thicknesses of 25 pm or less.)

For example, for Mo/Mo, the upper limit is HVL < 0.40 mm of alumi­
num at 28 kVp. Excessive HVL violates no Federal standards but should
prompt a check by service personnel to assure that the X-ray tube has
an appropriate (beryllium) window and that mirror and filtration are
correctly installed.

CORRECTIVE Verify kV value with invasive system (high-tension probe and

ACTION oscilloscope).
Replace filterof X-ray tube window.
ReplaceX-raytube.
 Beam Quality (HVL) Measurement
Dosimetry system used:

Nominal kVp setting 28 25 30 28 * 30

Target material Mo Mo Mo Mo Mo
Filter Mo Mo Mo Mo RH
mAs
Exposure measurements (mR):
No aluminum filtration, E(0a)
0.2 mm of added aluminum, E(2)
0.3 mm of added aluminum, E(3)
0.4 mm of added aluminum, E(4)
0.5 mm of added aluminum, E(5)
0.6 mm of added aluminum, E(6)
No aluminum filtration, E(0b)
Average E(0)
Average E(0)/2
Calculated HVL (mm Al)
Minimum allowed HVL
Maximum allowed HVL
* Without compressor
tb ln[2Ea/E0] - ta ln[2Eb/E0]
HVL = -----------------------------------------
ln[Ea/Eb]

ACTION LIMIT: ACR - If measured HVL < (kVp/100) + 0.03 (in mm Al);
or if measured HVL > (kVp/100) + C (in mm Al), where
C = 0.12 for Mo/Mo; C = 0.19 for Mo/Rh; C = 0.22 for Rh/Rh;
and C = 0.30 for W/Rh, then seek service correction.
MQSA - The HVL must meet the specifications of FDA’s
Performance Standards for Ionizing Radiation Emitting
Products (Part 1020.30)
4.2 KVp ACCURACY AND REPRODUCIBILITY

OBJECTIVE To assure that the actual kVp is accurate (within ±5% of the indicated
kVp) and that the kVp is reproducible, having a coefficient of variation
equal to or less than 0.02.

REQUIRED TEST Test device capable of measuring kVp to an accuracy of ±1.5 kVp and a
EQUIPMENT precision of 0.5 kVp within the mammographic kVp range.

TEST PROCEDURE 1 T u rn o n the unit, im p o stan d o la fu n z io n e d i e s p o siz io n e co n tin u a, in m an u al

STEPS m o d e , se lec t 28 kV - 4 0 m A s

2. Set up the test device follow ing th e m a n u fa c tu re r’s in stru ctio n s

p la c e th e in stru m e n t o n th e c a sse tte lo ld e r re m o v e th e co m p re sso r.

3. Make four exposures in the same manual mode settings and record
the measured kVp values.
4. Repeat the procedure at other clinically important kVps but make
only one exposure at each setting. (Reproducibility needs to be
checked at only the most commonly used clinical kVp unless vari­
ability is suspected at other settings.) These measurements should
include the lowest clinically used kVp that can be measured by the
kVp test device and the highest available clinically used kVp.

DATA ANALYSIS AND To determine kVp accuracy, average the four kVp readings for each kVp
INTERPRETATION setting tested and compare this average value with the value of the preset
nominal kVp. If the average measured kVp differs by more than ±5%
(±1.5 kVp at 30 kVp) from the nominal kVp setting;

Regulate reference tension values so that they can be within the requested
tolerance values.

To determine kVp reproducibility, compute the standard deviation of

the kVp values for each kVp setting and then calculate the coefficient of
variation (standard deviation divided by the average value). If the coeffi­
cient of variation exceeds 0.02 for any kVp setting,

CORRECTIVE Check that feed tension, 230V AC ± 10%, is within the required limits especially
ACTION during exposures. Check anodic current regulation.
Check kV and mA wave shapes on inverter control sheet test points (by means of
thePARAM IMAGE).

6/56
 KVp ACCURACY AND REPRODUCIBILITY
E q u ip m e n t u se d : ___________________________________________ C a lib ra tio n ex p iry d ate:

P ro to ty p e te s t EH O u tp u t te st I I

k V p se ttin g

M a c h in e fo c a l siz e s

E x p o s u r e tim e

m A s s e ttin g

k V p m e a s u re d v a lu e s
kV p,
kV p,
kV p,
kV p,
k V p a v e ra g e <kV p>
S ta n d a rd d e v ia tio n akV p

A d d itio n a l k V p siz e s (w h e n n e c e s s a ry )
kV p5

kV p6

kV p7

kV pg
kV p9

kV P m
R e c a lc u la tio n

k V p a v e ra g e <kV p>
S ta n d a rd d e v ia tio n akV p
( u s e 10 r e a d in g s )
< k V p > n o m in a l k V p

0 .0 5 n o m in a l k V p

k V p c o e f fic ie n t o f v a r ia tio n

S A M P L IN G P L A N : le v e l 2

A c c e p ta b ility lim its:

± 4 % o ± 1 k V p o n n o m in a l v a lu e C. V.: > 0 .0 2

C o r r e c tiv e a c tio n : re p la c e g e n e r a to r

DATE S IG N A T U R E
4.3 BREAST ENTRANCE EXPOSURE, AEC REPRODUCIBILITY, AVERAGE
GLANDULA DOSE, AND RADIATION OUTPUT RATE

OBJECTIVE To measure the typical entrance exposure for an average patient

(approximately 4.2-cm compressed breast thickness— 50% adipose, 50%
glandular composition), to calculate the associated average glandular dose,
to assess short-term AEC reproducibility, and to measure the air kerma
rate.

REQUIRED TEST Ionization chamber and electrometer calibrated at mammographic X-ray

EQUIPMENT beam energies (calibration factor constant to within ±1% over the HVL
range from 0.2 to 0.5 mm Al). In order to determine radiation output
rate, the electrometer should also be able to measure exposure time. If
this feature is not available on the instrument, a separate device may be
necessary to measure time.
Mammographic phantom (equivalent to approximately 4.2-cm compressed
breast tissue— 50-50 c o m p o sitio n — at screen-film energies; for
example, Radiation Measurement, Inc., RMI 156 or Nuclear Associates,
18-220 mammographic phantom)
A phantom made of either acrylic or BR-12 and consisting of at least
four 2-cm-thick slabs to provide thicknesses of 2, 4, 6 and 8 cm of linear
dimensions representative of typical breast sizes may be used to deter­
mine doses for other breast thicknesses, (optional)
Mammographic cassette loaded with mammography film (film will not
be processed or reviewed).

TE S T PROCEDURE Breast Entrance Exposure, AEC Reproducibility and Average Glandular

STEPS Dose
1. Prepare the mammography system for operation in its most com­
mon imaging m ode.

Attention: Giotto mammography machines carry out impulsive exposures,

some instruments may turn out to be unfit to measure the correct dose
values, in fact they reset automatically once an exposure is finished and
the following begins.

2. Record the source-to-detector and the source-to-bucky top distances.

(This will permit inverse-square corrections of exposure if necessary.)

8/56
3. Position a loaded cassette in the image receptor holder
assembly:

4. Select the AEC density control setting that is normally used clini­
cally for an average patient. Place the phantom on the cassette holder,
positioning the phantom so that the chest-wall edge of the phantom
is aligned with the chest-wall side of the image receptor. Center the
phantom, left to right. Position the AEC sensor under the center of
the phantom (position 3).

5. Position the ionization chamber in the X-ray field beside the mam-
mographic phantom, centered 4 cm in from the chest-wall edge of
the image receptor and with the center of the chamber level with the
top surface of the phantom. Assure that the entire chamber is
exposed and that its radiographic shadow does not overlap the active
area of the AEC sensor (Figure 1).

Figure 1 Schematic drawing o f placement o f the phantom and

ionization chamber for measurement o f breast entrance
exposure. The center o f the ionization chamber should be
at the same height as the top surface o f the phantom.

6. Secure the chamber in position and do not change the position of

the chamber during the following measurements.
□
NOTE: Mammographic imaging system have a significant X-ray
intensity gradient in the X-ray field along the anode-cathode direction.
Maintaining a constant chamber position during measurements is critical.
When measurements are to be compared with others made previously, it
is also critical that the original measurement position be re-established as
closely as possible.

7. Position the compression device in the X-ray beam, just in contact

with or slightly above the phantom and chamber, as shown in Figure 1.

8. Select the kVp, target material, and filtration at which the system is
most commonly used clinically and record the settings on the data
form. Also, record the HVL (previously measured in beam quality
assessment test) for those same parameters on the data form.
9. Make an exposure and record the measured exposure and the indi­
cated mAs on the data form.
10. Repeat step 9 until four exposures have been recorded. There is
no need to change the cassette or film between exposures removed
and re-inserted to override exposure interlocks on units.

11. If desired, repeat steps 4 through 9 for other phantom thicknesses;

and appropriate kVp-target-filter combinations, and density control
settings. Be sure to follow the facility’s technique chart. Assure that
HVL values have been measured and recorded at any additional kVp
and target-filter combinations tested. Additional space is available
on the data form if exposure reproducibility (step 10) needs addi­
tional evaluation at these other techniques.

Radiation Output Rate

1. To measure the unit’s radiation output, prepare the mammographic
imaging system for operation in manual mode using the 18 x 24 cm
image receptor. Set the kVp to 28 and use the Mo/Mo target-filter
combination. Adjust the mAs of exposure to be at least 30/50mAs
Record the conditions on the data form.
2. Remove the phantom and position the ionization chamber 4.5 cm
above the breast support plate, centered 4 cm in from the chest wall.
Assure that the entire chamber is exposed. Position the compression
device in the X-ray beam, just in contact with or slightly above the
chamber.

10/56
 3. Secure the chamber in position and do not change the position of
the chamber during the following measurements.
4. Make an exposure and record the measured exposure and measured
exposure time on the data form. (If the electrometer does not mea­
sure exposure time

Use PARAM program. “Last exposure5' data displayed value.

5. Repeat steps 1 through 4 for all other clinically used SID settings.
6. Make sure the exposed film in the cassette is replaced before the
cassette is returned to clinical use.

DATA ANALYSIS AND Compute the mean values and standard deviations for both exposure and
INTERPRETATION mAs for the four exposures acquired under identical conditions to
test AEC reproducibility. Record the values. Determine the coefficient
of variation (standard deviation divided by the mean) for the exposure
measurements and mAs.

Using each average exposure value, calculate the average glandular dose
as follows:
If necessary, correct the average exposure with the chambers appro­
priate energy correction factor and with an inverse-square correction
factor to obtain the exposure at the skin entrance.
Find the appropriate column in Tables 1, 2, or 3 for the target and
filtration combination used clinically.
Find the HVL of the system (see the beam quality assessment test) in
the left-hand column of Tables 1 through 3. In the right-hand
column of the table appropriate for the target, filter, and kVp set­
ting, find the exposure to average glandular dose conversion factor
for a 4.2-cm compressed breast thickness. Multiply this factor by the
average entrance exposure value (in roentgens) computed above. The
product obtained represents the mean dose received by the glandular
tissue for that specific energy, breast composition, and compressed
thickness and is an approximation of the actual patient dose.
□
Table 1. GLANDULAR DOSE (IN mrad) FOR 1 ROENTGEN ENTRANCE EXPOSURE
TO A 4.2-CM BREAST THICKNESS— 50% ADIPOSE-50% GLANDULAR BREAST
TISSUE— USING A Mo/Mo TARGET-FILTER COMBINATION*

X-Ray Tube Voltage (kVp) W/Al

Target-Filter
HVL 23 24 25 26 27 28 29 30 31 32 33 Combination

0.23 116
0.24 121 124
0.25 126 129 131
0.26 130 133 135 138
0.27 135 138 140 142 143
0.28 140 142 144 143 147 149
0.29 144 146 148 150 151 153 154
0.30 149 151 153 155 156 157 158 159 170
0.31 154 156 157 159 160 161 162 163 164 175
0.32 158 160 162 163 164 166 167 168 168 170 171 180
0.33 163 165 166 168 169 170 171 173 173 174 175 185
0.34 168 170 171 172 173 174 175 176 177 178 179 190
0.35 174 175 176 177 178 179 180 181 182 183 194
0.36 179 181 182 183 184 185 185 186 187 199
0.37 185 186 187 188 189 190 191 191 204
0.38 190 191 192 193 194 195 195 208
0.39 196 197 198 198 199 200 213
0.40 201 202 203 204 204 217
0.41 206 207 208 208 221
0.42 211 212 212 225
0.43 215 216 230
0.44 220 234
0.45 238

To convert from entrance exposure in air in roentgens to mean glandular breast dose in millirads,
multiply the entrance exposure by the factor shown in the table for the appropriate kVp and beam
quality (HVL) combination. For example, a measured entrance exposure of 0.50 rontgens from a
Mo/Mo target/filter system at 30 kVp with a measured HVL of 0.36 mm. aluminum yields an
average glandular dose of (0.50R) x (185 mrad/R) = 93 mrad or 0.93 mGy.

* Adapter from: Wu X. Breast dosimetry in screen-film mammography. In Barnes GT, Frey GD

(eds), Screen-film m am m ography: Im aging C onsiderations and M edical P hysics
Responsabilities. Madison, Wis: Medical Physics Publishing; 1991; 159-175. W/Al sconversion
factors are derived from fits to data from Stanton L., et. Al. Dosage evaluation in mammography.
Radiology 1984; 150: 577-584.

§ IMAGE
12/56
Table 2. GLANDULAR DOSE (IN mrad) FOR 1 ROENTGEN ENTRANCE EXPOSURE
TO A 4.2-CM BREAST THICKNESS—50% ADIPOSE-50% GLANDULAR BREAST
TISSUE— USING A Mo/RhTARGET-FILTER COMBINATION*

X-Ray Tube Voltage (kVp)

HVL 25 26 27 28 29 30 31 32 33 34 35

0.28 149 151 154

0.29 154 156 158 159
0.30 158 160 162 162 162 163
0.31 163 164 166 166 166 167 167
0.32 167 169 171 171 171 171 172 172
0.33 171 173 175 176 176 176 176 177
0.34 176 178 179 179 180 180 180 181 181
0.35 180 181 183 183 184 185 185 186 187
0.36 185 186 187 187 188 188 189 190 191 191
0.37 189 190 191 191 192 193 193 194 195 195
0.38 193 194 196 196 197 197 197 198 199 199 200
0.39 198 199 200 200 201 201 202 202 203 203 204
0.40 202 203 204 204 205 205 206 207 208 208 208
0.41 206 207 208 208 209 209 210 211 212 212 212
0.42 211 211 212 212 213 213 214 215 216 216 217
0.43 215 216 217 217 218 218 219 219 220 220 221
0.44 220 220 221 221 222 222 223 223 224 224 225
0.45 224 224 225 225 226 226 227 227 228 228 229
0.46 228 229 229 230 231 231 232 233 233 234
0.47 233 233 234 235 235 236 237 237 238
0.48 238 238 239 240 240 241 241 242 242
0.49 242 243 243 244 244 245 245 246
0.50 247 247 248 248 249 250 251
0.51 251 252 253 254 254 255
0.52 257 257 258 258 259
0.53 261 261 262 263 264
0.54 265 266 267 268
0.55 269 270 271 272
0.56 275 276 276
0.57 279 280 281
0.58 284 285
0.59 288 289
0.60 293

* Adapted from: Wu X, Gingold EL, Barnes GT, Tucker DM. Normalized average glandular dose in Mo/Rh and Rh/Rh target-filter
mammography. Radiology. 1994;193:83-89.

y ■ 13/56
 Calculate the exposure rate for each clinically used SID by dividing the
measured exposure by the measured (or indicated) exposure time. To
compute the air kerma rate, multiply the measured exposure rates by the
conversion factor.

Air kerma (mGy/s) = Exposure rate (mR/s) x 0.00873 mGy/mR

RECOMMENDED The maximum acceptable coefficient of variation for both exposure and
PERFORMANCE mAs (or time) in the AEC reproducibility test is 0.05. If this value is
CRITERIA exceeded, the unit should be checked by appropriate service personnel.

The average glandular dose to an average (4.2-cm compressed) breast

must not exceed 3 mGy (0.3 rad) per view for screen-film image recep­
tors. If the values exceed these levels, action must be taken to evaluate
and eliminate the cause of excessive dose.

The radiation output of the mammography system should not be less

than 7.0 mGy air kerma per second (800 mR/sec) over a 3 second
period of time when operating at 28 kVp in the standard mammography
(Mo/Mo) mode at any clinically used SID. If values are less than these
levels, the unit should be checked by the appropriate service personnel.

CORRECTIVE Check kV wave shapes using invasive system or by means of the visualization
ACTION of PARAM IMAGE program graphics; dose wave shape should be perfectly
flat. For further information please contact IMS technical service support
center.

X-RAY SENSOR SIGNAL

14/56
 Breast Entrance Exposure, AEC Reproducibility, Average
Glandular Dose, and Radiation Output Rate
Imaging mode: SID (cm):
Screen type: Source-detector distance (cm):
Film type: Source-bucky distance (cm):
Cassette size(cm): Dosimeter used:
Field Restriction: Energy correction factor:

Breast thickness (cm) 4.2

Phantom
Nominal kVp setting
Target material Mo
Filter Mo
AEC mode
Density control setting
Measured HVL (mm Al)

Breast Entrance Exposure and AEC Reproducibility:

R mAs R mAs R mAs R mAs
Exposure #1
Exposure #2
Exposure #3
Exposure #4
Mean values
Standard deviations (SD)
Coefficient of
variation (CV)

ACTION LIMIT: ACR/MQSA - If coefficient of variation for either R or mAs exceeds 0.05, seek service.

Average Glandular Dose:

Inv Sq corrected skin exp
Dose conversion factor
from Tables 1-3 (mrad/R)
Computed average
glandular dose (mrad)

ACTION LIMIT: ACR/MQSA - If average glandular dose exceeds 300 mrad (3 mGy) for 4.2 cm effective
breast thickness, seek service or technique adjustment. Corrective action must be
taken before futher examinations are performed if the test results fail MQSA regulations.

Radiation Output Rate:_________________________________________ _

SID Exp Time Rate Kerma
3 sec, kVp Anode Filter (cm) (mR) mAs (sec) (mR/s) (mGy/s)
4.5 cm above 28 Mo Mo
breast support 28 Mo Mo

A ir Kerma (mGy/sec) = Exp Rate (mR/s) x 0 . 0 0 8 7 3 mGy/mR

ACTION LIMIT: If output rate is less than 800 mR/s (7.0 mGy/s), seek service.

/ i c t f 0
y image ■ ■ i -— 15/56
 4.4 CHECK OF LIGHT FIELD INTENSITY AND UNIFORMITY

The following checks and adjustments are used to ensure that

the alignment o f the x-ray field and light field are within the
specifications set forth by the FDA, 21CFR, and the
recommendations by the ACR/CDC.

Check & Adjustment - Light Field

Illuminance
Intensity and consistency o f the Light Field is checked by
performing the follow ing procedure.

1. Place a light meter probe at position "A" (Figure 3 )

2. Take a background light reading, with the light field

lamp OFF, and record the results. Take a light reading
with the light field lamp O N and record the results.

3. Convert both readings to lux values (use the conversion

table on the meter or in the meter manual). Subtract the
background lux value from the light field lux value and
record the difference.

4. Repeat this illuminance test for the remaining positions

("BM, "C", and "D” in Figure 3 / a ) .

5. The difference between the background reading and the

illuminated reading (in any quadrant) must be 160 lux
or greater.

6. I f necessary rem ove the tubchead cover, loosen the two screw
that secure the lam p socket to the lam p cradle (F igure 3/a).
Increase the light field illum inance by adjusting the lamp
position w ithin the cradle. M ove the lam p collim ato r so that
the lamp filam ent is centered with reference to the hole. Tighten
the screw, replace the tubehcad cover, then repeat the test.

Tighten the screws, replace the tubehead cover, then

repeat the test.

7. Verify that the length to width ratio o f the light field is

not altered.

CORRECTIVE ACTION

8. If the check still fails, replace the lamp and repeat the
entire check.

T ------- -------- 16/56

4.5 PROCEDURE COLLIMATION ASSESSMENT

OBJECTIVES To assure tha^ the X-ray field aligns with the light field, that the collima­
tor allows for full coverage of the image receptor by the X-ray field but
does not allow significant radiation beyond its edges, and that the chest-
wall edge of the compression paddle aligns with the chest-wall edge of the
film.

REQUIRED TEST Five coins, or graffette four of one size and one of a larger size .
EQUIPMENT
Four mammographic cassettes with film: one small 18x21 and three large
24x30.
Approximately a 2 cm -thick sheet of acrylic or BR-12 large enough to
cover the surface of the cassette (if necessary).

TEST PROCEDURE 1. Place an appropriately sized cassette loaded with film in the normal
STEPS orientation in the image receptor holder.
2. Load film in the large cassette with the emulsion side of the film
away from the intensifying screen (reverse position).
3. Place the large cassette on top of the image receptor holder with the
back of the cassette toward the X-ray source and assure that the large
cassette extends beyond the image receptor holder on the chest-wall
side by about 1 cm.
4. Place the collimator to be evaluated in position.
5. Remove the compression paddle. (The compression paddle should
be removed before placement of the coins to assure a sharp demarca­
tion at the edges of the light field.)
6. Turn on the collimator light and place the four identical smaller
coins inside the light field with one edge of each coin just touching
the edge of the light field. The coin on the chest-wall side should be
shifted to the right of center about 2 inches so it does not superim­
pose the AEC detector.
7. Replace the compression paddle and position it 4.2 cm from the
breast support.
8. Tape the larger coin underneath the compression paddle shifted about
2 inches to the left so it does not superimpose the AEC detector. Be
sure the coins outer edge is tangent to the inner lip of the chest-wall
side of the compression paddle. This coin marks the chest-wall edge
of the paddle.

17/56
□
9. Place a sheet of acrylic or BR-12 attenuating material on top of the
paddle, so that all radiation reaching the cassettes must pass through
the attenuator. Make an exposure using AEC.
10. Repeat steps 1 through 9 for all routinely used collimator/bucky/
compression paddle combinations and target materials. When test­
ing the large image receptor, the top cassette may be positioned
diagonally to capture all four edges of the X-ray field, or two large
cassettes may be used on top of the image receptor holder. (The
collimator test may also be done using a non-screen cassette on top
of the breast support, no attenuator, and a manual technique of
approximately 26 kVp and 12 mAs.)

F. 4 LEGEND

A - 18x24 cassette properly inserted

B - 24x30 reveresed cassette

C - nr. 4 coins (or clips) placed on cassette, on the light field edge.

D - nr. 1 coin (or clip) placed on compressor, on the breast side

(compressor at 4,5 cm. from breast support plate).

18/56
DATA ANALYSIS AND From the film exposed in the top cassette, measure the deviation between
INTERPRETATION the X-ray field (dark portion of the film) and the edge of the light field
defined by the exterior edges of the four smaller coins) for all four sides
of the field (Figure 5 ). The magnitudes of the deviations at the left
edge and right edge (ignoring + or - signs) should be entered on the data
form and added together. Similarly, the deviations at the anterior and
posterior (chest-wall) edges should be entered (without regard to sign)
and the magnitudes added together. Record the unit source-to-image
distance (SID) on the data form and calculate the % SID by dividing
each sum by the SID and multiplying by 100.

Measure the deviations between the edges of the X-ray field and all four
sides of the image receptor. If possible, use the film that was placed in
the image receptor holder for this measurement; if not, use the top film.
This can be done by individually aligning the outer edges of the smaller
coin on both films and measuring the distance that the X-ray field edge
of the top film extends beyond the film in the image receptor holder.
(Figures 5 and 6 ). Note that slight magnification differences between
the two films should be taken into account. Enter the measured devia­
tions between the X-ray field and image receptor holder film on the data
form. If the X-ray field extends beyond the film, it should be given a “+”
sign; if it falls within the film, it should be given a sign. Calculate
the % SID for each side, retaining the + or —signs.

Next, measure the deviation between the edge of the compression paddle
(delineated by the outer edge of the large coin) and the edge of the image
receptor. When measuring the distance, note the difference in sizes of
the larger coin on the two films. (The coin image will be bigger on the
bottom film.) Distances should be measured on or referred to the film
in the image receptor holder cassette.

/ i c f t o
* 1,H A G E --------------- --------------- 20/56
 □
FILM 24 X 30

F ig u re 5 Sample collimation assessment film. A film exposed in

the top cassette; the exposed area indicates the extent of
the X-ray field. The outer edges o f the four smaller coins
indicate the edges of the light field. The outer edge of the
larger coin (lower left) indicates the inner chest-wall edge
o f the compression paddle.

FILM 1 8 X 2 4

F ig u re 6 Sample collimation assessment film. A film exposed in

the cassette holder assembly. The film itself defines the
location of the image receptor recording area.
/ I

7 ■■ ■ ----- 21/56 —
□
Ail systems shall have beam-limiting devices that allow the entire
chest-wall edge of the X-ray field to extend to the chest-wall edge of
the image receptor and provide means to assure that the X-ray field
does not extend beyond any edge of the image receptor by more
than 2% of the SID.
If a light field that passes through the X-ray beam limitation device
is provided, it shall be aligned with the X-ray field so that the total
of any misalignment of the edges of the light field and the X-ray
field along either the length or the width of the visually defined
field at the plane of the breast support surface shall not exceed 2%
of the SID.
The chest-wall edge of the compression paddle shall not extend
beyond the chest-wall edge of the image receptor by more than 1%
of the SID when tested with the compression paddle placed above
the breast support surface at a distance equivalent to standard breast
thickness. The shadow of the vertical edge of the compression
paddle shall not be visible on the image.
If the test results fall outside the action limits, the source of the
problem shall be identified and corrective actions shall be taken
within 30 days of the test date.

CORRECTIVE Adjust X-ray field by acting on the fastening screws.

ACTION Adjust light field in the anode-cathode direction by acting on the inclination of
the mirror.
Act on light position for right-left adjustment (see F. 7).

22/56
COLLIMATION ASSESSMENT

Source to image receptor distance (SID): cm

Deviation between X-ray field and lia tit field:

Target material Mo Mo
Collimator (cm) 18x24 24x30
Left edge deviation
Right edge deviation
Sum of left and right edge deviations
Sum as % of SID
Anterior edge deviation
Chest edge deviation
Sum of anterior and chest edge deviations
Sum as % of SID

ACTION LIMIT: ACR/MQSA • If sum of left plus right edge deviations or anterior plus chest
edge deviations exceeds 2% of SID, seek service adjustment.

Deviation between X-rav field and ed<aes of the image recepitor:

Left edge deviation
% of SID (retain sign)
Right edge deviation
% of SID (retain sign)
Anterior edge deviation
% of S ID iretain sign)
Chest edge deviation
% of S ID ^retain jsicjn ^

ACTION LIMIT: ACR/MQSA - If X-ray field exceeds image receptor at any side by more
than 2% of SID or if X-ray field falls within image receptor on the chest wall
side, seek service adjustment.
ACR - If X-ray field falls within image receptor by more than -2% on the
left and right sides, or by more than -4% on the anterior side, seek service
adjustment.

Alignment of chest-wall edges of compression paddle and film

Difference between paddle edge and film I
Difference as % of SID

ACTION LIMIT: ACR/MQSA - If chest-wall edge of compression paddle is within the

image receptor or projects beyond the chest-wall edge of the image
receptor by more than 1% of SID, seek service correction.

24/56
4.6 EVALUATION OF SYSTEM RESOLUTION

OBJECTIVE To evaluate limiting resolution of the entire mammography system,

including effects from geometric (focal spot) blurring and screen-film
combination.

REQUIRED TEST High-contrast resolution pattern providing a resolution test up to 16 lp/

EQUIPMENT mm and preferably 20 lp/mm (either a bar pattern, a star pattern, or a
wedge pattern marked to identify the number of lp/mm in the image at
the appropriate points).

A loaded mammographic screen-film cassette from the facility. For best

screen-film contact, be sure thai the cassette has been loaded an adequate
length of time prior to the test to allow trapped air to escape. This time
is typically at least 15 minutes, but the cassette manufacturer should be
consulted for accurate information.

Lead marker to designate the anode-cathode axis direction.

A 7x to lOx magnifier.

Approximately 2,5 mm of aluminum or 4 cm of acrylic uniform attenu­

ator to place in the beam to allow the test to be performed at a typical
mAs.

TEST PROCEDURE 1. Place the resolution pattern 4,5 cm above the breast support plate
STEPS
2. Position the pattern within 1 cm of the chest-wall edge o f the image
receptor, centered laterally. The pattern’s bars should lie parallel to
the anode-cathode axis for the first image. It is important that the
test pattern be positioned in a reproducible manner.

3. Approximately 4 cm of acrylic should be used to allow the test to

be done at a typical mAs so that grid lines, which can appear if the
exposure time is too short, do not interfere with the visibility
of the pattern.

4. Place the image receptor in the holder for contact mammography

at the SID most commonly used clinically.

5. Position X-ray sensor within an area which is not covered by pattern but in
any case covered by 4 cm acrylic.

2 5 /5 6
□
6. Make an exposure and process the film. The resultant film density
should be between 1.20 to 1.60.
7. Repeat step 6 with the bars oriented perpendicular to the anode-
cathode axis and the highest line frequency of the bar pattern (e.g.,
20 lp/mm) positioned towards the chest wall, 1 cm from the edge.
8. Repeat steps 1 though 7 for other target materials and other clini­
cally used focal spot sizes. Small focal spots should be tested in the
same mode that they are used clinically, i.e., with the bar pattern
positioned 4.5 cm above the magnification stand breast support sur­
face and at the kVp and technique factors most commonly used for
a magnification view of the standard breast. Use the magnification
factor most commonly used clinically and record.

DATA ANALYSIS AND Under masked conditions, view the high-contrast resolution pattern
INTERPRETATION images with 7x to lOx magnification.
Starting from the lowest frequency bar pattern note the highest frequency
pattern whose lines are distinctly visible throughout at least half of the
bar length. Note that the bars may entirely blur out and then reappear
at a higher frequency, with a reversal in the light and dark bars in the
image. This “spurious resolution” should not be interpreted as system
resolution. Using this criterion, record the highest frequency visible for
each test image.

RECOMMENDED In the contact mode, measurements made with the bars parallel to the
PERFORMANCE anode-cathode axis must resolve at least 13 lp/mm; measurements with
CRITERIA AND the bars perpendicular to the anode-cathode axis must resolve at least
CORRECTIVE ACTION 11 lp/mm. In the magnification mode, the limiting spatial resolution
must be no lower than the above specifications.

If the above specifications are not met, try to determine the cause by
changing one variable at a time and retesring. For example, use a differ­
ent cassette, remove the compression paddle, remove the grid, or try a
non-screen technique, If the results are still below the above specifica­
tions, confirm that the correct test geometry is in use. A more detailed
investigation of the focal spot size may be made using a slit camera.
The resolution of the screen-film combination can also be evaluated
by placing the cassette on top of the breast support and placing the
resolution bar pattern directly on top of the cassette. (Only one-third
to one-half the mAs is required for this test relative to an in-bucky expo­
sure.)

26/56
 CORRECTIVE R e p la c e x -ra y tu b e .
ACTION

Evaluation of System Resolution

X-ray Tube Manufacturer: I_____________________ Model#:

Nominal focal spot size (mm)

Target material
Nominal kVp setting
Nominal mA setting
Density control setting
mAs
Magnification factor CONTACT

Limiting resolution bars parallel to A-C axis

in line-pairs per mm bars perpendicular to A-C axis

ACTION LIMIT: ACR/MQSA - If limiting resolution with the bars parallel to

the anode-cathode axis is < 13 line-pairs/mm or with the
bars perpendicular to the anode-cathode axis is < 11 line-
pairs/mm, then a more detailed investigation of the reason
should be made and corrective action should be taken.
MQSA - Until October 28, 2002, MQSA allows system
resolution to also be evaluated by measuring focal spot
dimensions. See Section VII for performance criteria.

7 IM
AGE■ ■■ ... . ■ 2 7 /5 6
4.7 AUTOMATIC EXPOSURE CONTROL DELL’AEC SYSTEM PERFORMANCE
ASSESSMENT

OBJECTIVE To assess the performance of the mammography unit’s AEC system, to

maintain consistent image optical density as breast thickness and imag­
ing modes change, and to alter optical density using the density control
selector function.

REQUIRED TEST A phantom made of either acrylic or BR-12 and consisting of at least
EQUIPMENT four 2-cm-thick slabs to provide thicknesses of 2, 4, 6 and 8 cm of linear
dimensions representative of typical breast sizes
Image receptor (i.e., cassette with screen(s) and film) of the type and size
routinely used with the mammographic imaging system being evaluated
Lead numbers or letters (in order to have reference points on films).
A densitometer

TEST PROCEDURE Performance Capability

STEPS Performance capability refers to the ability of an AEC system to main­
tain a constant image optical density over a broad range of imaging tech­
niques and patient variables. The following test procedures are designed
to assess the ability of a given mammographic system to achieve this goal
as well as to determine the range of conditions over which the system
will not perform adequately.
1. Prepare the mammographic imaging system for operation in the
automatic mode.

2. Use format (e.g., 18 x 24 cm) and grid.

3. Select a single mammographic cassette and a full box of film of the
type normally used and of the appropriate size for use in this test
and record the cassette identification number on the data form.

4. Load the cassette identified in step 4 with film from the box identi­
fied and set aside in step 4.

28/56
 □
6. Place the loaded cassette in the cassette holder assembly. Place a lead
number in the upper right quadrant on top of the cassette holder
assembly to provide identification of the specific image.
7. Position a 2-cm-thick phantom on the cassette holder assembly at
the position that would normally be occupied by the patients breast.

Carry out compression 5Kilos minimum to start exposition.

Make sure that the phantom completely covers the active area of
the AEC system sensor.
8. Make an exposure and record the target material, filter, kVp, density
control setting and mAs used on the data form.
9. Process the exposed film in the film processor normally used for
mammographic images.
10. Repeat steps 5 through 9 for a range of breast thicknesses (simulated
by varying the phantom thicknesses) from 2-8 cm. Clinically appro­
priate targets, filters, kVps^ mas and density control setting
should be selected for each thickness.
11. Repeat steps 5 through 9 for the 4-cm-thick phantom but use the
various imaging modes that are used clinically (e.g., small image
receptor and grid, large image receptor and grid, magnification mode
with small focal spot, and no grid).
12. Measure the image optical density at the center of each phantom
image and record the values on the data form.

Density Control Function

1. Follow steps 1 through 9 of the performance capability procedure
but use the 4-cm-thick phantom and the most commonly used clini­
cal kVp.
2. Repeat exposures for all clinically used settings of the AEC system's
density/control/selector. Measure the image optical density at the
center of each phantom image and record the values on the data
form.
3. Using the recorded data for measured mAs and image optical den­
sity, calculate the relative mAs (ratio of mAs at each density control
setting to that at the “Normal” setting) and relative image optical
density (difference between the optical density at each density con­
trol setting and the optical density at the “Normal” setting).

29/56
DATA ANALYSIS AND Calculate the mean optical density over all performance capability tests
INTERPRETATION and determine the range of densities measured. The performance capa­
bility data should be reviewed with respect to mAs and image optical
density. In evaluating the performance capability of the system, several
general trends should be noted. First, kVp should increase (either manu­
ally or automatically) for increasing breast (phantom) thickness. Second,
, in order to minimize motion unsharpness, exposure times should be
approximately 1 second or less for thin or average breast (phantom) thick­
nesses and no longer than 3 seconds for larger thicknesses. Third, and
perhaps most important, the image optical density should ideally remain
constant within ±0.15 as phantom thickness and clinical technique
factors are varied; however, variations of up to ±0.30 or greater may be
seen in older equipment. Until October 28, 2002, an AEC technique
chart can be used to compensate for those breast thickness (2-6 cm) and
technique factor combinations that do not fall within ±0.30 of the mean.
Variations no greater than ±0.30 should be observed over all imaging
modes.

To evaluate the density control performance, calculate the fractional change

in mAs and the difference in image optical density with respect to the
“NORMAL” or “ZERO” density control value and record.
It is recommended that there be a sufficient number of + and - density
settings (at least two plus and two minus settings) and that each step
should result in a 12% to 15% change in mAs, or approximately a 0.15
change in film optical density.

30/56
 One last comment needs to be made concerning the overall performance
of an AEC system. In a system that has been properly set up and cali­
brated, the optical density of all performance capability test films should
be at least 1.20 if clinically acceptable mammographic images are to be
obtained. Most mammography sites, however, choose an AEC setup that
yields a much higher optical density target for average breast tissues, so
that glandular tissues are adequately exposed and have optimal contrast.
This approach also requires adequate viewbox intensity for appropriate
film viewing and is the recommended approach to improving clinical
image quality in mammography.

RECOMMENDED An AEC system with appropriate compensation circuits is functioning

PERFORMANCE properly if it can maintain constant film optical density to within
CRITERIA AND ±0.30 of the average over the phantom thicknesses (2 to 8 cm), and
CORRECTIVE ACTION imaging modes tested. Within a narrower range of conditions (2 to 6 cm
with the small bucky), the optical density must be maintained to within
±0.15. It is important to note that because some older systems may not
have adequate compensation circuits, this level of performance may not
be achieved unless the operator makes adjustments to the systems density
control selector. If the film optical density cannot be maintained to
within ±0.30 of the average over the clinically used techniques tested, a
technique chart should be developed that alters density control settings
(in addition to kVp, anode, and filter) as a function of breast thicknesses
and composition. The medical physicist should assist with the prepara­
tion of a revised technique chart if revisions are necessary to meet the
AEC performance criteria.

The optical density of the film in the center of the phantom image must
not be less than 1.20.

As the density control setting tested is increased above or decreased below

the normal setting, the mAs and image optical density should increase or
decrease, respectively. It is recommended that there be a sufficient num­
ber of + and - density settings (at least two plus and two minus settings)
and that each step should result in a 12% to 15% change in mAs, or
approximately a 0.15 change in film optical density.

CORRECTIVE Carry out AEC calibration by using PARAM IMAGE program.

ACTION

y 31/56
□
Automatic Exposure Control (AEC) System Performance
AEC position: Density control:
Small c a sse tte ID: Large c a s s e tte ID:

Performance Capability:

Thickness-kVp Tracking
Imaqinq mode: small im aqe receptor with qrid
Focal spot: larqe focal spot
mA:
Im age AEC Density Control Film Optical
Phantom thickness ID# Mode Target-Filter kVp Settinq mAs Density
2 cm
4 cm
6 cm
8 cm
M ean O ptical D en sity (2-6 cm) Optical Density Range MQSA Allowed Optical Density Range
to to

Image Mode Tracking

mA:
Phantom thickness:
Tarqet-Filter: Mo/Mo
Im age AEC Density Control Film Optical
Im aqe Mode ID# Mode Focal Spot kVp Settinq mAs Density
small qrid
larqe qrid
Maqnification/no qrid

Overall AEC Performance

Mean Optical Density Optical Density Range Recommended Optical Density Range
to to

ACTION LIMIT: ACR - The AEC system should be able to maintain constant film optical density
to within +0.30 of the average over the phantom thicknesses and Imaging modes
tested.
ACR/MQSA - The AEC system must be capable of maintaining film optical
density within +0.30 of the mean (+0.15 after 10/28/2002) when the thickness of
the phantom Is varied over 2 - 6 cm and the kVp is varied over the range of
those used clinically for those thicknesses. The optical density in the center
of the phantom Image must not be less than 1.20. If these standards are not met,
seek service adjustment.

Density Control Function:

Imaqinq mode: sm all qrid Focal spot: larqe

mA: kVp:
Phantom thickness: C a sse tte ID:
Relative to Normal
Im age % mAs Optical Density
Density Control Setting ID# mAs M easured Optical Density change Change
-4 * *
-3
-2
-1
0 (normal)
+1
+2
+3
+4

ACTION LIMIT: ACR - Each step should result In a 12 to 15% change In mAs, or approximately a
0.15 change In film optical density. If not, seek service.

32/56
4.8 PROCEDURE SYSTEM ARTIFACT EVALUATION

OBJECTIVE To assess the degree and source(s) of artifacts visualized in mammograms

or phantom images. This procedure isolates the source of the artifact so
that appropriate measures to eliminate the artifact can be taken.

REQUIRED TEST A uniform 4-cm-thick (approximately) cassette-sized phantom made of

EQUIPMENT either acrylic or BR-12
Mammography cassette and film 2 or more.

A mask appropriate for full-field mammographic films

A densitometer

TEST PROCEDURE 1. Select nel mammographic wholly automatic mode.

STEPS
Be sure that the density control setting results in an optical density
greater than 1.20. Use the most commonly used image receptor size
(usually 18 x 24 cm). Record these technique factors on the data
form.
2. Place a uniform sheet of acrylic or BR-12 that is large enough to
cover the mammographic cassette and thick enough to have an
exposure time of 0,5 second or greater on the image receptor holder
assembly. Use a collimator that permits irradiation o f the entire
cassette.
3. Use a single mammographic cassette that is known to have good
screen-film contact. Load the cassette with the mammography film
used clinically.
4. Position a lead marker on the acrylic sheet in a corner of the
radiation field, preferably outside the normal location of the breast,
and pointing along the long axis of the film and cassette.

5. Make an exposure.
6. Process the film, taking care to insert the film lengthwise into the
processor as shown in the upper part of Figure 8 (so that the film
travels parallel to the direction of the arrow on the latent image).
Also note the orientation of the film emulsion on the processor feed
tray (up or down). Measure the optical density in the center of the
film, verifying that it is greater than 1.20, and record on the data
form for this test.
□

*
Direction of
Film Feed

Figure 8 Direction o f insertion of film into the film processor. The

first exposed film should be inserted lengthwise, parallel to
the direction of the arrow on the latent image. The second
film should be inserted widthwise, again parallel to the
direction o f the arrow on the latent image.

7. Load a new cassette with film; place it in the image receptor

holder assembly under the sheet of acrylic but move sheet so
so that imperfections, if any, will change place. Orient the lead
marker at 90° to its original direction so that the marker runs paral­
lel to the short axis of the film. Repeat the exposure using exposure
factors identical to the previous image.
8. Process this film, taking care to insert the film widthwise into the
processor as illustrated in the lower part o f Figure 8 (at right angles
to the previous film) so that the film travels through the processor
parallel to the direction of the arrow on the latent image.
9. Repeat this process for other image receptor sizes, using the image
receptor holder and compression device appropriate for the other
image receptor sizes. Also repeat for the small focal spot used with
magnification and each filter used clinically. (Note that some units
may have multiple filters of the same material.)

34/56
DATA ANALYSIS AND Orient each pair of films acquired under the same imaging conditions
INTERPRETATION for viewing at right angles to one another so that the arrows indicating
the direction that they were run through the processor are parallel, as
shown in Figures 9 and 10 Using appropriate masking, examine the two
processed images acquired for each image receptor size for density varia­
tions, especially those that might simulate or mask visualization of breast
structures or breast pathology.

Processing
Artifacts

*
Direction of
Film Feed

F. 9_________________________________________________________

Figure 9. Orient the films for viewing at right angles to one another,
so that the arrows or markers indicating the direction o f the
film travel through the processor are parallel. Any artifacts
running parallel in the two films are due to the processor.
 X-ray Unit
Artifacts

*
Direction of
Film Feed

F. 10______________________________________________________________

Figure 10 Orient the two films at right angles to one another, as in

Figure 9. Any artifacts running perpendicular in the two
films are due to X-ray equipment.

Any artifacts that are parallel in the two films, as illustrated in Figure 9,
are localized to the processor. This is true whether the artifacts run paral­
lel to or perpendicular to the direction of film travel. For example, film
processor artifacts due to dirty or defective rollers can produce plus or
minus density streaks running parallel to the direction of film travel
or plus density bands running perpendicular to the direction of film
travel . Furthermore, if processing artifacts are more severe when the
film is processed emulsion side up, the artifacts may be caused by the
inner rollers of the developer rack.

Any artifacts that are oriented perpendicular between the two films, as
illustrated in Figure 10, are localized to the X-ray equipment or cassette.
Artifacts localized to the X-ray equipment can be due to several sources,
including the grid, the image receptor holder, the compression paddle,
the collimator, the filter, or the X-ray tube itself. Changing or removing
one component at a time can help to determine the specific source within
the X-ray equipment that is causing the artifact.
 Other artifacts may appear sporadically in mammography images, having
no consistent appearance in artifact evaluation images. These artifacts
may be due to other sources, such as the patient, film handling, a defec­
tive cassette screen (that was not used in these tests), or moving grid
artifacts that show up only under certain patient or timing conditions.
Additional testing under specific conditions may be necessary to isolate
the causes of sporadically occurring artifacts.

Most daylight processors allow films to be processed in only one direc­

tion. In order to identify processing artifacts, creative approaches can be
taken such as running the film through a different processor or exposing
a cassette in different orientations on top of the bucky.

RECOMMENDED If significant film processor artifacts are detected, contact the person main­
PERFORMANCE taining the processor or the film processor service organization or dealer.
CRITERIA AND Contact the X-ray equipment service person for suggestions on addi­
CORRECTIVE ACTION tional testing procedures and for help in correcting X-ray equipment
artifacts.

CORRECTIVE If grid v isu a liza tio n p rob lem s arise, carry out m ov em en t adjustm ent;

ACTION I f u n iform ity p ro b lem s arise, replace grid or carbon fiber;

I f filtration p ro b lem s arise, clea n filters all o v er w ith care, or r ep la ce collim ator;

In c a s e there is a p ro b lem on x-ray tube, d isa sse m b le the added filtration , 0 .0 3

m m M 0 and clea n x-ray tube w in d o w ;

A T T E N T IO N M Qis to x ic; do not tou ch w ith hands, a ccu rately w a sh y o u r s e lf in

c a se o f con tact w ith it.

/ic $ o
y -------- 3 7 /5 6
Artifact Evaluation
Type of attenuator:
Attenuator thickness:
kVp setting:
Density control setting:

Image receptor size 18x24cm 24x30cm MAG (18x24cm)

Cassette #
Tarqet Mo Mo Mo
Filter Mo Mo Mo
Focal spot large large small
Emulsion orientation
Resultant film optical
density
Artifacts visible?
Processor?
Acceptable?
Describe

Cassette-film-
screen?
Acceptable?
Describe

X-ray equipment?
Acceptable?
Describe

ACTION LIMIT: ACR/MQSA - If significant artifacts are visible, contact the appropriate
person maintaining or servicing the processor or X-ray equipment.

38/56
4.9 PROCEDURE IMAGE QUALITY EVALUATION

OBJECTIVE To assess mammographic image quality and to detect temporal changes

in image quality.

REQUIRED TEST Mammographic phantom (approximately equivalent to a 4.2 cm thick

EQUIPMENT compressed breast consisting of 50% glandular, 50% adipose tissue)
containing appropriate details ranging from visible to invisible on the
mammographic image. At the time of publication, either the Radiation
Measurement, Inc. RMI-156 or Nuclear Associates 18-220 mammo­
graphic phantom may be used for the ACR Mammography Accredita­
tion Program (MAP). These phantoms have fibers with diameters of 1.56,
1.12, 0.89, 0.75, 0.54, and 0.40 mm; specks with diameters of 0.54,
0.40, 0.32, 0.24, and 0.16 mm; and masses with decreasing diameters
and thicknesses of 2.00, 1.00, 0.75, 0.50, and 0.25 mm.
Acrylic disc (4-mm thick, 1-cm diameter) placed on the top of the phan­
tom in a consistent location in the image area so it will not obscure
details in the phantom and where it cannot cast a shadow on any portion
of the AEC detector (Figure 8). With current equipment, significant vari­
ability in film optical density can result from placing the disc along the
central anode-cathode axis, where a varying fraction of the AEC detector
area might be covered by the discs shadow, depending on the exact posi­
tion of the phantom and the detector. A suitable location is between and
slightly below the first and second largest fibers. A glue such as “SuperGlue”
may be used to attach the disc permanently to the phantom.
Cassette and film of the types used clinically for mammography. Use the
same cassette used by the facility for their phantom QC to compare
results.
Appropriate masking to eliminate light reaching the viewer’s eye from
beyond the borders of the exposed phantom image. Images should be
viewed on the same viewbox(es) used clinically. If a 14 x 17 inch viewbox
is used, a film mask can be made by exposing a 14 x 17 inch film to light,
processing it, and cutting a hole the size and shape of the phantom being
used.
A magnifying lens of 2x or higher
Densitometer
Previous annual phantom image and the original phantom image
(acquired when the equipment was new or the QC program began)
Figure 11 Photograph of phantom with 1-cm diameter, 4-mm-thick
disc for contrast measurement.

Figure 12 Radiograph o f phantom shown in Figure 11. Arrows

indicate points where density measurements should
be made.
 TEST PROCEDURE 1. Load film from the film bin into the cassette. Be sure to wait an
STEPS adequate length of time for good screen-film contact to occur.
2. Place the cassette in the cassette holder.
3. Place the phantom on the cassette holder, positioning the phantom
so that the chest-wall edge of the phantom is aligned with the chest-
wall side of the image receptor. Center the phantom, left to right.
4. Comprimere a 5 Kg in quanto se si utilizza il modo automatico,
senza la compressione i raggi sono inibiti.

5. Verify that the AEC detector is located beneath the center of the
phantom and in the same location as used for previously acquired
phantom images (position 3).
6. Make an exposure using the automatic.mode.

7. Record all technique factors on the image quality evaluation form.

8. Process the film in the processor normally used for mammography
films.
9. Measure the film optical densities at three locations. The background
optical density should be measured at the geometric center of the
phantom image. To determine the density difference, measure the
optical density inside the disc and directly adjacent to the disc, to its
left or right, perpendicular to the anode-cathode axis. The density
difference is the difference between the optical density measured in­
side the disc and that measured outside the disc. For consistent re­
sults, these measurements must be made in the same locations each
time.
10. Record all measurements on the image quality evaluation form.

*7 —■ 41/56
DATA ANALYSIS AND Figures 13 through 17 illustrate the use of the following criteria to score
INTERPRETATION the phantom:
1. When scoring the image of one of the ACR-approved accreditation
phantoms, e.g., Radiation Measurement, Inc. (RMI 156) or Nuclear
Associates (18-220), each object type is scored separately. Always
count the number of visible objects from the largest object of a given
type (i.e., fiber, speck group, or mass) downward until a score of 0
or 0.5 is reached, then stop counting for that object type.

333 333

/ \ /
Fibers: 6
* ♦
Speck groups: 5
• « ♦ *
Masses: 5

■ B

Fibers: 3.5
(not all but at least half of
the 4th fiber is visible)

F. 13

Figure 13 Phantom diagrams of fiber scoring example.

42/56
 □
Fibers: 3.5
(the entire, unbroken
length of the 4th fiber
is not visible)

Fibers: 4.0 (4.5 - 0.5)

(the fiber-like artifact
between the 1st and 2nd
fiber must be subtracted
from the last real fiber
scored)

Fibers: 5.0 (6.0 - 1.0)

(the fiber-like artifact above
the 6th fiber must be subtracted
from the last real fiber scored)

F. 14

Figure 14 P h a n to m diagrams o f fiber scoring examples (continued).

/iotro
y image ■ 4 3 /5 6
 Speck groups: 3.5
(only 3 specks in the 4th
speck group are visible)

Speck groups: 3.5

(although 5 specks in the
• • * ♦
5th speck group are visible,
only 3 are visible in the
4th group)

Speck groups: 3.0 (3.5 - 0.5)

(speck-like artifacts around
the 5th and 6th fibers must
be subtracted one for one
from the specks in the last
real speck group)

F. 15

F ig u re 15 Phantom diagrams of speck group scoring examples.

44/56
 □

Masses: 3.0

Masses: 3.5
(greater than 3/4 of the
round perimeter should
be visible for a full point)

Masses: 3.0 (3.5 - 0.5)

(the mass-like artifact
between the 4th and 5th
speck groups must be
subtracted from the last
real mass scored)

Figure 16 Phantom diagrams o f mass scoring examples.

Z icfio
y »*** m i 45/56
 Masses: 4.0
(the 4th mass is given a full
point in spite of the linear
artifact since it is still generally
circular)

Masses: 3.0
(although the 3rd mass has
less contrast, it is still generally
circular and is given a full
point)

Masses: 2.5
(the 3rd mass is of less contrast
and is not generally circular)

Figure 17 Phantom diagrams o f mass scoring examples (continued).

46/56
- ---------------------— □
2. Count each fiber as 1 point if the full length of the fiber is visible
and the location and orientation of the fiber are correct. Count a
fiber as 0.5 point if not all, but more than half, of the fiber is visible,
and its location and orientation are correct. Add each full or partial
fiber to the total fiber score, from largest down to smallest visible,
until a score of 0 or 0.5 is reached. Record the “raw” fiber scores
before artifact deduction.
3. After determining the last fiber to be counted, look at the overall
background for artifacts. If a fiber-like artifact appears anywhere in
the wax insert area of the image, but not in an appropriate location
or orientation, deduct the “artifactual” fiber from the last “real” half
or whole fiber scored if the artifactual fiber is equally or more appar­
ent. Deduct only from the last real fiber, not from additional fibers.
(Figures 9A and B). Record the final score after artifact deduction in
the appropriate space on the form.
4. Use a large-field-of-.view magnifying lens (approximately 2x or higher)
to assist in the visualization of specks. Starting with the largest speck
group, count each speck group as 1 point if four or more of the six
specks in the group are visible in the proper locations. Count a
speck group as 0.5 if two or three of the six specks in the group are
visible in the proper locations. Add each full or partial speck group
to the total speck group score, from the largest down to smallest
visible group, until a score of 0 or 0.5 is reached. Record this “raw”
speck score before artifact deduction.
5. After determining the last speck group to be counted, look at the
overall background for artifacts. If noise or speck-like artifacts are
visible in the wrong locations within the area of the wax insert and
are as apparent as the “real” specks, deduct them one for one from
the individual specks counted in the last whole or half speck group
scored and adjust the score of the last group appropriately (Figure
9C). Record the final score after artifact deduction in the appropri­
ate space on the form.
6. Count each mass as 1 point if a minus density object is visible in the
correct location and the mass appears to be generally circular against
the background (i.e., greater than 3/4 of the perimeter is visible). A
mass is counted as 0.5 point if a minus density object is visible in
the correct location, but the mass does not have a generally circular
appearance. Add each full or partial mass to the total mass score,
from the largest mass down and until a score of 0 or 0.5 is reached.
Record the “raw” mass score before artifact deduction.

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 7. After determining the last mass to be counted, look at the overall
background for artifacts. If a mass-like artifact is seen in the wrong
location within the area of the wax insert, deduct the “artifactual”
mass from only the last “real” whole or half mass scored if the artifac­
tual mass is equally or more apparent (Figures 9D and E). Record
the Final score after artifact deduction on the appropriate space on
the form.

PRECAUTIONS This test measures contributions from all components of the imaging
AND CAVEATS chain, other than breast positioning by the technologist and patient-
induced errors such as motion. Changes in image quality may be due to
any component, e.g., the film, cassette and screen, X-ray generator, added
filtration, processor, or viewbox. As a result, other tests may be needed to
determine the component(s) of the imaging chain that is at fault and in
need of corrective action. For example, if the film optical density is too
high or too low, it will be necessary to test the processor sensitometrically,
determine whether the mAs or exposure time has changed, check the
consistency of the screens used, and check to see whether a new film
emulsion batch is being used, etc.

Subjective judgments about images are always difficult. Different indi­

viduals will perceive different numbers of test objects in the image. The
same individual may count a different number of objects in the same
image at different times. Consequently, the same individual should view
the images each time using the same criteria for better consistency. In
addition, the same viewbox, viewing conditions, and magnification should
be used each time, and these should be the same as those used for reading
mammograms. If a different number of objects are noted, then the cur­
rent image should be compared with previous images and the original
image to determine if a change has really occurred.

Note: If more than one type of film is used for mammography

imaging, it is necessary to carry out this test with each type of film
used clinically for a breast thickness of 4.2 cm.

Because the medical physicist may not have the opportunity to measure
phantom image quality as frequently as the Q C technologist, it is impor­
tant to review a sample of the phantom images acquired by the technolo­
gist since the previous visit, comparing results with your own assessment
of image quality. Any apparent problems in scoring the phantom should
be included as a corrective action and lead to a discussion with the QC
technologist about phantom scoring.

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 RECOMMENDED
PERFORMANCE
CRITERIA AND
CORRECTIVE ACTION

• At a minimum, the four largest fibers, the three largest speck

groups, and the three largest masses must be visible.

• The phantom image background optical density should be at

least 1.40.

• The density difference due to the 4.0-mm-thick acrylic disc should

be at least 0.40.

The optical density of the film at the center o f an image ot a stan­

dard FDA-accepted phantom shall be at least 1.20 when exposed
under a typical clinical condition. T he optical density of the film
shall not change by more than ±0.20 from the established operat­
ing level. T he phantom image shall achieve at least the m inim um
score established by the accrediting body and accepted by FDA.
The density difference between the background of the phantom
and an added test object used to assess image contrast shall be
measured and shall not vary by more than ±0.05 from the estab­
lished operating level.
If the test results fall outside of the action limits, the source of the
problem shall be identified and corrective action shall be taken
before any further examinations are performed or any films are
processed using the com ponent of the m ammography system that
failed the test.

CORRECTIVE Use a different technique.

ACTION

y 'amge i— .1 . . . —— 49/56
 □
Image Quality Evaluation
Phantom used:
AEC detector position:
Cassette size:
Cassette #:

Previous Current
Film Film Comments
Date
kVp setting
Density control
Phototimed mAs
mAs change
% mAs change = mAs change/mAsx100
Background density
Background density change
Density outside disc
Density inside disc
Density diff = outside-inside
Density difference change
Number of fibers seen
Fibers seen after deduction
Fiber change
Number of speck groups seen
Speck groups after deduction
Speck group change
Number of masses seen
Masses seen after deduction
Mass change

ACTION LIMIT: ACR/MQSA - The largest 4 fibers, 3 speck groups, and 3 masses
must be visible. Background optical density must be at least 1.20.
Corrective action must be taken before any further examinations
are performed if the results of this test fail any MQSA regulations.
ACR - The density difference should be at least 0.40 for a 4-mm
thick acrylic disk. Background optical density should be at least
1.40 and must be at least 1.20. If % mAs change exceeds +15%,
if background density change exceeds +0.20, if density difference
change exceeds +0.05, or if fiber, speck group or mass score
decreases by more than 0.5, the source of change should be
identified and corrected.

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 □
4.10 PROCEDURE: COMPRESSION

OBJECTIVE To assure that the mammography system can provide adequate compres­
sion in the manual and powered mode and that the equipment does not
allow too much compression to be applied.

Adequate compression is essential for high-quality mammography.

Compression reduces the thickness of tissue that must be penetrated by
radiation, thereby reducing scattered radiation and increasing contrast,
while reducing radiation exposure to the breast. Compression improves
image sharpness by reducing the breast thickness, thereby minimizing
focal spot blurring of structures in the image, and by minimizing patient
motion. In addition, compression makes the thickness of the breast more
uniform, resulting in more uniform image densities and an image that is
easier to interpret.

FREQUENCY This test should be carried out initially, then every 6 months (semiannu­
ally), and whenever reduced compression is suspected.

REQUIRED TEST Bathroom scale. The scale should be a flat, conventional, analog type.
EQUIPMENT Digital scales sample the data and may not respond properly as addi­
tional pressure is applied slowly to the scale. Digital scales designed
specifically to measure compression force may be used.
Several towels

TEST PROCEDURE Power Mode

STEPS
1. Place a towel on the cassette holder (to protect the cassette holder),
then place the bathroom scale on the towel with the dial or read-out
positioned for easy reading. Locate the center of the scale directly
under the compression device (Figure 14).
2. Place one or more towels on top of the scale to prevent damage to
the compression device.
3. Using the initial power drive, activate the compression device and
allow it to operate until it stops automatically.
4. Read and record the compression force on the monthly, quarterly
and semiannual checklist.
5. Release the compression device.

/ic fio
y imoe 51/56
 PRECAUTIONS If the safety mechanism is not properly adjusted, it may be possible to
AND CAVEATS damage the compression device and associated components. If the com­
pression exceeds 200 newtons (20 Kg or 45 pounds) in the initial
power drive mode, immediately release the compression device and
ask a service engineer to make the appropriate adjustments.

11. Verify that autodecompression can be overridden to maintain com­

pression (for procedures such as needle localizations) and its status
displayed continuously (if autodecompression is available).
12. Verify that compression can be manually released in the event of
a power failure or automatic release failure by turning power off to
the equipment with a phantom under compression and using manual
controls to release the compression.

CORRECTIVE A djust com pression force by using PARAM IM AGE program.

ACTION If necessary set the highest com pression value, but lower than the one previously
adjusted.

4.11 COMPRESSION PADDLE ALIGNMENT

T he deform ation o f a com pressor subjected to the highest pressure can be visualized
and m easured using high-density polyfoam.
M easure distances betw een carbon fiber surface and com pressor at every angles. The
four distances should be ideally the same.

Limit value O nly deform ations o f a few 111111 (5 m m m axim um ) can be acceptable.

Equipment 10 x 10 x 10 cm high density polyfoam ; m illim eter ruler.

52/56
IRIS

Figure 18 Bathroom scale being use,

used to measure compression force.
 □
4.12 CHECK-LIGHT FIELD EDGE CONTRAST

This check ensures the contrast o f the lighted x-ray field

com plies to the performance standard set forth by FDA 21 OFF
Sub-Chapter J. Always perform this test with the ambient 3mm
Light reduced (darken the room). The following equipment is
required for this test:

♦ Light Detector Model 268P

♦ Light meter (UDT Instruments, Model 351)

♦ Aluminum Filter with 1mm diameter aperture (or

equivalent)

1. Place the probe of a light detector on the potter and

center it. Place the aluminum filter (with 1mm aper­
ture) directly on the probe. Position it so that the
aperture is centered on the probe's sensor. Tum the
. 1mm
room lights OFF and record the ambient light reading APERTURE
FILTER
as IA.
PROBE

2. Place the light detector in area "A” (see Figure 19)-

Orient the center o f the probe 3mm from the edge
of the defined light field toward the center of the F. 19
field (II). Collimate the light probe so that only a
1-square centimeter area (near the center) is visible. F ig u r e 1 9 C h e c k - L ig h t F ie ld E d g e C o n tr a s t

3. Press the light field button and record the inside lux
value (II). Move the probe 3mm from the edge of the
defined light field away from the center of the field.
Reposition the aluminum filter, press the light field
switch, then record the outside lux reading (12).

4. Subtract both edge readings from the ambient reading

and record eac h o f the differences:
( IA - II =D1 & IA - 12 = D2).

5. Divide the inside difference by the outside difference

and record the ratio:
(D1 / D2 = R).

6. Repeat the procedure for the remaining light field

edges. Place the light meter probe at positions B, C,
and D for these checks. A contrast ratio less than 4 at
any edge is cause for rejection.

CORRECTIVE ACTION Contact the technical service support center at IM S.

54/56
 4.13 X-RAY SHIELDING COMPLIANCE

Lead sh ield in g in the x-ray tube h ou sin g, and in the low er

tubehead enclosure, m in im izes scatter radiation.
T he follow in g p rocedu res check the sh ield in g perform ance
o f the cassette holder support and the tubehead.

Leakage Check
This ch eck is perform ed at the factory and is not required at
installation. However, it w ill b e n ecessary to perform this
check after repairing or rep lacin g the cassette holder.

/ t \ WARNING ! Observe all safety precautions while

making an X-ray exposure.

1. C on n ect a radiation scatter probe (1 00-square cm ) to

the readou t/logic m od u le o f a radiation ratemeter. S et
the m eter’s operating m o d e to read in mR/hr. P lace the
read ou t/logic m odu le so that it can be v iew ed from
behind the radiation sh ield .

2. M ou n t an 18cm x 2 4 cm B u c k y to the support

P la ce a (1.6 m m ) sh eet o f lead w ith (1 2 .7 cm )
diam eter h ole in it on the porta ca ssette. S lid e this
lead sheet to p osition the h o le at the p osition m arked
"A" C olli m ate the x-ray field to the 18cm x 2 4 cm F ig u r e 2 0 C h e c k c a s s e tt e h o ld e r s u p p o r t
field size.

3. P o sitio n the probe b en eath th e support relative to the

cen ter o f the h ole in the le a d sheet. R aise or lo w er the
support stand until the p rob e is exactly 5 centim eters
b e lo w the bottom o f the tray structure. F ace the probe's
d etector surface toward th e x-ray source.

4. A p p ly pow er to the unit. S e t the system for a M anual

m od e exposure at 35 kV, 2 5 0 m A s,u sin g the Large focal
spot.

5. M ak e an exp osu re and record the mR reading. I f the

reading ex ceed s 0 .0 5 m R , co rrective action is in dicated .

6. R epeat steps 2 through 5 fo r p osition s "B", "C", and

"D".

7. M ou n t a 24cm x 30 cm B u c k y on the su p p o rt. R epeat

step s 2 through 6 for p o sitio n s "E", "F", "G" and "H"
R ep lace any im a g e receptor holder i f there are any
readings ab ove 0 .0 5 m R.

C O R R E C T IV E A C T IO N C ontact the technical service support center

at IM S.
 4.14 LEAKAGE CHECK-X-RAY TUBEHEAD

This check is performed at the factory and is not required at 3. Apply power to the unit. Set the system for a Manual
installation. However, it will be necessary to perform this mode exposure at 35kV , 200m As, using the Large focal
check after repair, removal, or replacement of the tubehead spot. Make an exposure and record the mR reading.
housing or the lower tubehead cover.
4. Make exposures, using the same technique factors, for

A WARNING ! Observe all safety precautions while

making an X-ray exposure.
positions "B" through "H".
Record each mR reading.

1. Connect a radiation scatter probe (100-square cm) to

the readout/logic module o f a radiation ratemeter. Set
the meter's operating mode to read in millirocntgens per
hour (mR/Hour). Place the readout/logic module so
A ATTENTION ! Any reading above 45.0 mR is
unacceptable.
that it can be viewed from behind the radiation shield
C O R R E C T IV E A C T IO N C o n ta c t th e te c h n ic a l s e rv ic e
2. Use fixturing to hold the probe in position with relation support cen ter at IM S.
to the tubehead as shown in Figure. Position the R eplace X -ray tube
probe at location "A". Make sure the distance between
the probe and the surface o f the tubehead cover is
exactly one meter.
 5

FAILURE AND ERROR

MESSAGE REASEARCH

1. INTRODUCTION
2. ALARM VISUALIZATION
3. ALARM RESET
4. MESSAGES
5. FAILURE RESEARCH WHEN NO ALARMS ARE ON DISPLAY
6. ERROR MESSAGE LIST
7. OPERATOR’S MISTAKES
5.1 INTRODUCTION

Controls and adjustments in the present chapter have to be carried out by personnel authorized and trained by IMS. The
firm IMS releases itself from any responsibility whatsoever regarding any obligation of warranty in case the machine is
damaged by improper use or tampering. For a correct use of the reported information, it is necessary to consult the manuals
of the “Electric diagrams”, “Connection cables” and the user's manual of the “Param Image Program”.

5.2 ALARM VISUALIZATION

Alarm messages are visualized on the display of the control board in two different formats:

1) Activated alarm = “WARNING” + (ID Number) + (Description of the type of alarm)

2) Latent or reset alarm = “ERROR”

• The alarm field is m ainly used to inform the operator on the possibility or Im possibility to carry out the exposition; these
two events are visualized w ith the m essages “R E A D Y ’- or “E R R O R ” .
• The presence o f “ ER R O R ” does not necessarily m ean that there has been a failure w ithin the u n i t , but that not all o f the
requisites have been satisfied in order to allow the m achine to carry out the exposure.
• To determ ine the reasons for the presence o f the “E R R O R ” m essage press the button “R eset” , the com plete description
o f the type o f alarm will be visualized for 3 seconds.

5.3 ALARM RESET

Depending on the type of alarm, this could be reset as follow:

1) Elim inating the reason o f the alarm , alarm s such a s ...

2) P ressing the R eset button, alarm s such a s...

3) Sw itching o ff the unit by the buttons 0 and 5 on the control board, alarm s such a s ...

4) Sw itching o ff the unit by the m aster sw itch, alarm s such a s ...

• M achine errors are show n on the control table display.

W arning (Identification N o .) : nam e

M achine errors: m achine error or trouble
O perator errors: incorrect m anoeuvres or operations.

2/18
5.5 FAILURE RESEARCH WHEN NO ALARMS ARE ON DISPLAY

5.5.1 DIFFICULTIES IN THE UNIT’S SWITCHING ON

Verify the presence o f pow er supply on the clamps nr. I and nr. 3 o f the m aster sw itch with sw itch in ON position.
correct voltage 230 Volt AC +/- 10%.
Verify that the differential sw itch “l.D .” is in ON position.
C heck the 4 Am pere-fuse F4
C heck voltage in pins 3 and 4 o f the X20 connector, and com pare with board S565. C heck fuses F2, F9 and F 10.
Verify sw itching on o f the follow ing LED:
LED H 13 when on indicates the presence o f pow er supply “+24 V L O G ”
LED H 10 w hen on indicates the presence o f pow er supply “+5 V ” .
If they are not sw itched on replace board S565.
Verify connection am ong board S565, connector X I 7 and board S564, connector X I 8, connection carried out by m eans o f a
16 pole-flat cable.
Check tension V cc=5 Volt D C, m easure voltage at the ends o f the condenser C 164 in the board S564, if there is no voltage,
disconnect all the connectors o f the board, apart from X 18 and verify voltage Vcc. I f there is no voltage, replace board S564.
If the board S564 is correctly pow er-supplied and the program is going there is the continuous blinking o f LED H4 and an
acoustic alarm, which lasts one second during starting process.

5.5.2 NO DATAON DISPLAY, CONTRAST ADJUSTMENT

Verify that LED H4 on board is blinking, should it not blink see instructions at 6.1.1.
Verify connections am ong board S564, the connector X I and connector on display. B e careful with the direction o f insertion
o f the connectors.
Verify the correct adjustm ent o f contrast; m easure between pin nr. 1 G N D and pin nr. 3 o f the connector X4 (not installed),
voltage should be 0.5 Volt DC +/- 0.1 Volt, regulate trim m er R4 in order to obtain the correct voltage.

5.5.3 NO BACKGROUND DISPLAY ILLUMINATION

Verify connections betw een the X2 connector o f the S564 board and display.
M easure voltage on the X2 connector, betw een pin 1 and pin 4voltage should be 4 Volt DC +/- 0.2 Volt.

5.5.4 THE CONTROL KEYBOARD IS NOT WORKING

verify that LED H4 on S564 board is blinking, if not, see instructions at 6.1.1.
Verify connections am ong the S564 board, X3 connector and connector on d isp lay
If the problem does not involve the starting button “I” or the ray-button, these two buttons are not included in the printed
circuit o f the keyboard, but im plem ented singu larly so they can be replaced.

5.5.5 NO BACKGROUND KEYBOARD ILLUMINATION (OPTIONAL)

Verify the presence o f pow er supply for background illum ination , 24 Volt DC.

5.5.6 UNIT AUTOMATIC SW ITCHING OFF

The autom atic sw itching o ff is activated w hen inside G iotto Program there are incom patible data.
R estore back-up after having sw itched o ff and then re-started the m aster sw itch unit.
Call IM S ’s technical service support center.

3/18
5.5.7 BLOCKED MOVEMENTS

Vertical movements, rotation and inclination are blocked when com pression is higher than 4 kilos. On S563 board, when LED
H I is on m eans that com pression is blocking m ovem ents, intervention can be adjusted through the potentiom eter R3.
R otation and inclination m ovem ents are blocked w hen ray-tube is not in central position; take the ray-tube to its central
position w ith hunting m ovem ents.

5.5.8 THE VERTICAL MOVEMENT IS BLOCKED

T he vertical m ovem ent is pow ered by a sym m etric single-phase motor, two lim it sw itches determ ine the lim it o f m ovem ent,
both devices are placed inside the colum n (they ca n ’t be reached).
The m otor is m ade o f two identical w indings, a com m on term inal and the other two that are connected through a condenser.
For further inform ation please refer to the general electric diagram .
D irection is determ ined by supplying a w inding or the other.
Pow er supply, 240 Volt AC, com es from the transform er T R 1 and enter the S565 board from X 16 connector, pins nr. 3 and nr.
4; w hen LED H I 1 is on, it indicates the presence o f voltage.
The m ovem ent control carried out by the keyboard or pedal board, is m anaged by com puter which closes relays K % or K6
according to the selected direction.
Check if there is pow er supply when you operate m ovem ent, connector X 10, pins nr. 1; nr. 2; nr. 3. V oltage, 240 V AC + /-1 0 % ,
betw een the com m on pin 3 and pin 1= upstroke or pin 2= dow nstroke.
The m otor is protected by the sw itch TM1 “overload cutout” calibrated to cutout at 3 am peres; the voltage w ithin the m otor
cannot exceed 2.7 +/- 0.2 A, verify that the sw itch is in ON position.
W inding m otor resistance should be about 15 ohm, and the lim it sw itches should not be activated.
For lubrication please refer to the chapter on M A IN TEN A N C E.

5.5.9 ROTATION M OVEMENT IS NOT WORKING

V erily if rotation is blocked by ball-bearings or by braking o f the blocked tim ing belt o f the electrom agnet EM 2.
C lean with care the surface o f circle and rollers in order to avoid rotation friction.
I f one acts on the belt pow er supply regulation, verify the blocking o f rotation as follows:
Exert a pressure force on potter equal to 15 kilos, circle cannot slide on the belt.
R otation is m anual, the block o f its m ovem ent is operated by an electrom agnet placed on the circle support, on the p atien t’s
side.
The electrom agnet is connected with the X4 connector, pins nr. 1 and nr. 2, o f board S565, voltage output should be equal
to 24 Volt DC and is visualized by LED F15.
The electrom agnet resistance is about 20 ohms.
For lubrication and m echanical adjustm ents please consult M A IN T E N A N C E section.

5.5.10 INCLINATION M OVEMENT IS NOT WORKING

Inclination is m anual, the blocking o f its m ovem ent is perform ed by an electrom agnet placed on top o f the column.
Verify w hether inclination m ovem ent cannot be operated follow ing to the m ovem ent hardening caused b y friction or
blocking exerted by rack, which has been perform ed by EM l electrom agnet.
The electrom agnet is connected with the X4 connector, pins 3 and 4 o f the board S565; pow er supply output should be equal
to 24 Volt DC and visualized by the lighting o f H 4LED .
The electrom agnet resistance is about 10 ohms.
For lubrication and m echanical adjustm ent please refer to the M A IN T E N A N C E section.

4/18
5.5.11 CENTER SQUARE LIGHT IS NOT WORKING

Center square light lamp should be an “OSRAM XENO PHO T LONG LIFE HLX 64638 24 V 100W", this lamp only is capable
to satisfy all specifications for m am m ography exam inations.
F or replacem ent, rem ove center square cover and install a new lam p being very careful not to touch lamp glass; should this
happen clean glass w ith alcohol.
Verify that cables do not com e into contact with lamp cover.
For adjustm ent please refer to instructions in the CA LIBRA TION A ND LAY-OUT chapter.
C enter square light is connected w ith X 20 connector by board S567.

5.5.12 DIGITAL INLETS AND OUTLETS VISUALIZED BY PARAM

In order to verify the correct working o f keyboards, pedal boards, limit sw itch devices or any other devices w hich em it or
receive an open/close signal, connect with PARAM program , D iagnosis section, D IG ITA L I/O.
A G REEN disk indicates that inlet or outlet is open, LOW level (0 VOLT). To check.
A RED disk indicates that inlet or outlet is closed, high level (+24 VOLT). To check.
B y pointing the m ouse cursor on inlet or outlet num ber you w ish to check, Param visualizes the associated function.

S563 BOARD INLET LIST

S563: INPUT BIT(O) “R ay control sw itch state direct reading”

S563: INPUT BIT(l) “E m ergency m ushroom -head push button state”
S563: INPUT BIT(2) “E m ergency activation circuit tension reading”
S563: INPUT BIT(3) “Block board S564”
S563: INPUT BIT(4) “S 564 board distance control sw itch control"
S563: INPUT BIT(5) “S567 board filament current alarm ”
S563: INPUT BIT(6) “ S567 board anodic current alarm ”
S563: INPUT BIT(7) “R otating anode not in m otion alarm "
S563: INPUT BIT(8) “C ollim ator identification switch”
S563: INPUT BIT(9) “C ollim ator identification switch”
S563: INPUT BIT( 10 “C assette holder identification sw itch”
S563: INPUT BIT( 11 “Input 11”
S563: INPUT BIT( 12) “ Inserted film cassette sw itch”
S563: INPUT BIT( 13) “ Inner cam era sw itch”
S563: INPUT BIT( 14) “ M agnification x l .5 recognition sw itch”
S563: INPUT BIT( 15) “C om pressor top-position sw itch”
S563; INPUT BIT( 16) “C om pressor bottom -position sw itch”
S563: INPUT BIT( 17) “M agnification x l .8 recognition sw itch”
S563: INPUT BIT( 18) “24x30 Cassette film identification sw itch”
S563: INPUT BIT( 19) “ 18x24 Cassette film identification sw itch”
S563: INPUT BIT(20) “D igital system identification sw itch”
S563: INPUT BIT(21) “ C ollim ator identification sw itch”
S563; INPUT BIT(22) “ Inserted collim ator identification sw itch”
S563: INPUT BIT(23) “C ollim ator identification switch”
S563: INPUT BIT(24) “T ube stereo m ovem ent S2 direction push button”
S563: INPUTBIT(25) “ Irradiated field light sw itch-on push button”
S563: INPUT BIT(26) “T ube stereo m ovem ent SI direction push button”
S563: INPUT BIT(27) “R hodium position filter identification sw itch”
S563: INPUT BIT(28) “M olybdenum position filter identification sw itch”
S563: INPUT BIT(29) “Blocked inverter alarm ”
S563: INPUTBIT(30) “Further than 85% pre-set KV tension inverter signal5
S563; INPUT BIT(31) “Input 31”
S563: INPUT BIT(32) “ Input 32”
 5

S563 BOARD OUTLET LIST

S563: Output bit(O): “M otor control qualification”

S563: Output bit( 1): “P ow er supply rem ote control sw itch pow er up”
S563: Output bit(2): “ O utput 2”
S563: Output bit(3): “O utput 3”
S563: Output bit(4): ’’O utput 4 ”
S563: Output bit(5): “O utput 5”
S563: Output bit(6): “ X -ray tube pow ered focus type selection”
S563: Output bit(7): “C om pressor m otor qualification”
S563: Output bit(8): “O utput 8”
S563: Output bit(9): “X -ray filam ent pow er supply pow er up”
S563: Output bit( 10): “ O utput 10”
S563: Output bit(l 1): “ X -ray tube stereo m ovem ent m otor pow er up”
S563: Output bit( 12): ’’O utput 12”
S563: Output bit( 13): “X -ray tube stereo m ovem ent direction selection”
S563: Output bit( 14): “Irradiated field illum ination lamp pow er up”
S563: Output bit( 15): “ filter m ovem ent m otor pow er up”
S563: Output bit( 16): “O utput 16”
S563: Output bit( 17): “Filter m ovem ent direction selection”
S563: Output bit( 18): “O utput 18”
S563: O utputbit( 19): “H igh-frequency inverter adjusting”
S563: Output bit(20): “X -ray irradiation pow er u p ”
S563: Output bit(21): “O utput 21”
S563: Output bit(22): “O utput 22”
S563: Output bit(23): “O utput 23”
S563: O utputbit(24): “O utput 24”
S563: Output bit(25): “O utput 25”
S563: Output bit(26): “O utput 26”
S563: O utputbit(27): “O utput 27”
S563: Output bit(28): “O utput 28”
S563: Output bit(29): “O utput 29”
S563: Output bit(30): “O utput 30”
S563: Output bit(31): “O utput 31”
S563: Output bit(32): “O utput 32”
S563: Output bit(33): “O utput 33”
S563: Outputbit(34): “O utput 34”
S563: Output bit(35): “O utput 35”
S563: O utputbit(36): “O utput 36”
S563: O utputbit(37): “O utput 37”
S563: Output bit(38): “O utput 38”
S563: Output bit(39): “O utput 39”

6/18
 5

S564 BOARD INLET LIST

S564 Input bit(O): “Circle colum n lifting control push button"

S564 Input bit(l): “Circle colum n sinking control push button”

S564 Input bit(2): “Circle inclination m ovem ent release push button”

S564 Input bit(3): “Circle rotation m ovem ent release push button”

S564 Input bit(4): “ C om pressor sinking control pedal”

S564 Input bit(5): “ C om pressor lifting control pedal”

S564 Input bit(6): “Input 6”

S564 Input bit(7): “X -ray tube therm al alarm ”

S564 Input bit(8): “Exam ination table colum n lifting control push button”

S564 Input bit(9): “ E xam ination table colum n sinking control push button”

S564 Input bit( 10) “ Exam ination table horizontal m ovem ent release push button”

S564 Input bit(l I) “ Exam ination table longitudinal m ovem ent release push button”

S564 Input bit( 12) “ E xam ination table horizontal and longitudinal m ovem ents release push button’

S564 Input bit( 13) “Exam ination table presence recognition”

S564 Input bit( 14) “ Lifting circle anticollision device sw itch”

S564 Input bit( 15) “Sinking circle anticollision device sw itch”

S564 Input bit( 16) “Input 16”

S564 Input bit( 17) “ Input 17”

S564 Input bit( 18) “Input 18”

S564 Input bit( 19) “Input 19”

S564 Input bit(20) “ Input 20”

S564 Input b it(21) “ Input 21”

S564 Input bit(22) “ Input 22”

S564 Input bit(23) “ Input 23”

S564 Input bit(24) “O pen door-room sw itch”

S564 Input bit(25) “ Input 25”

S564 Input bit(26) “ Input 26”

S564 Input bit(27) “ Input 27”

S564 Input bit(28) “Input 28”

S564 Input bit(29) “R ay-control push button direct reading”

S564 Input bit(30) “ Input 30”

S564 Input b it(31) “ E m ergency activation circuit tension reading”

latro
f — 7/18
 5

S564 BOARD OUTLET LIST

S564: O utputbit(0 : “ O utput 0”

S564: O utput b it(l : “O utput 1”

S564: O utput bit(2 : “O utput 2”

S564: O utput bit(3 : “O utput 3”

S564: O utput bit(4 : “O utput 4 ”

S564: O utput bit(5 : “O utput 5”

S564: O utput bit(6 : “Circle inclination un-blocking electrom agnet pow er up'’

S564: O utput bit(7 : “O utput 7”

S564: O utput bit(8 : “Exam ination table lifting colum n m ovem ent direction selection’

S564: O utput bit(9 : “Exam ination table lifting m otor pow er up5'

S564: O utput bit( 10): “Output 10”

S564: O utput b it(l 1): “Output 11”

S564: O utput bit( 12): “Exam ination table horizontal un-blocking electrom agnet pow er up”

S564: Output bit( 13): “Exam ination table longitudinal un-blocking electrom agnet pow er up'

S564: O utput bit( 14): “Exam ination table rotation un-blocking electrom agnet pow er up”

S564: O utput bit( 15): “X -ray in progress room blinking light pow er up”

S564: O utput bit( 16): “O utput 16”

S564: O utput bit( 17): “Output 17”

S564: O utput bit( 18): “Output 18”

S564: O utput bit( 19): “Output 19”

S564: O utput bit(20): “Output 20”

S564: O utput bit(21): “Output 21”

S564: O utput bit(22): “Output 22”

S564: O utput bit(23): “Output 23”

S564: O utputbit(24): “Output 24”

S564: O utput bit(25): “Film printer data em ission light pow er up”

S564: O utput bit(26): “Output 26”

S564: O utput bit(27): “Output 27”

S564: O utput bit(28): “Output 28”

S564: O utput bit(29): “Output 29”

S564: O utput bit(30): “Output 30”

S564: O utput b it(3 1): “ X -ray in progress phase light pow er up”

8/18
5.6 ERROR MESSAGE LIST

5.6.1 MACHINE ERRORS

5.6.1.1 ERROR NR. 1 6 - T H E FILTER IS NOT IN POSITION

D ESC RIPTIO N : the alarm indicates that the filter change M o/Rh m ovem ent does not work properly; G iotto perform s this
test during the sw itching on process, during preparation or after filter replacem ent.
POSSIBLE CAUSES: m ovem ent hardening or jam m ing and/or clutch slipping.
Engine stoppage for failure or pow er supply shortage.
L im it switch devices are not working.
CO N TRO LS: Verify if problem is caused by filter support disk rotation im possibility to move.
D isk m ovem ent verification: switch o ff the unit by the m aster switch, rem ove the outer center square’s cover, rem ove front
collim ator’s cover so that you will be able to see inside the collim ator itself. M anually verify that there aren ’t any difficulties
in the rotation o f the disk, rotating it m anually o f about 180°.
V erily also the correct activation o f the two limit sw itches placed at the very end o f the rotation cycle, see the electric
diagram o f the collim ator’s connection in order to determ ine the points o f m easurem ents.
M otor operation verification and lim it switches reading: for further inform ation on m otor operation see die electric diagram
o f S567 board, X I 2 connector.
The m otor o f the filter M o/R h change gear is pow er supplied by a voltage o f 24 Volt DC during the initial test and during the
exposition; m ovem ent inversion can be achieved by inverting pow er supply polarity. In case o f a shortage in pow er supply
voltage, verify F2-2 A m pere fuse on S576 board (fuse with printed circuit “P.C.B.”).
B y m eans o f the Param program , D iagnosis/I/O digital/S563 section, control the outlets:
S563: Output bit( 15) “ Filter m ovem ent m otor pow er up”
S563: Output bit( 17) “Filter m ovem ent direction selection”
S563: Output bit(27) “Rhodium -position filter identification sw itch”
S563: O utput bit(28) “ M olybdenum -position filter identification sw itch”
SOLUTION: replace collimator.

5.6.1.2 ERROR NR. 17 - GRID IS NOT IN POSITION

D E SC R IPTIO N : grid m ovem ent is controlled during unit start up phase (by pressing push button “I" on the control board),
during potter installation and during preparation phase; should the test be not successful, display visualizes the error
m essage w ith the subsequent blocking o f the exposition process.
T he test perform ed by G iotto consists in moving the grid for its total stroke and control the reading o f the sensor, which
senses its relevant position; in case the electric stroke does not correspond to 34000 + /-2380, the alarm will turn on
automatically.
PO SSIBLE CAUSES: m ovem ent hardening or jam m ing, with or w ithout com pression.
Engine stoppage for failure or pow er supply shortage. G rid stroke or position sensor signal not correct.
C O N TRO LS: rem ove, if any, the radiological cassette from inside the potter.
R em ove the m arkers' support cover in order to reach the m otor unit, sensor.
M anually m ove the grid from its supports , m ovem ent must be sm ooth for the w hole m echanical stroke, that is to say 8 mm.
I f the alarm activates during m am m ography examination, it is likely that breast support carbon fiber is com e into contact w ith
the grid because o f com pression. U sing a 25 cm 2 puppet, positioned in the center o f the carbon fiber, exert m axim um
com pression (20 K ilos) and verify grid sliding as above.
P erform the previous test w ith the radiographic cassette on.
F or m ovem ent lubrication carefully follow specifications described in M A IN T E N A N C E section.
In case o f the m ovem ent hardening because o f the carbon fiber flexion, verify that all fastening screw s are well fastened or
replace the fiber itself.
For further inform ation on m otor operation please see the electric diagram o f S567 board, X 17 connector.
G rid m otor consists o f a special electrom agnet; it is pow er supplied w ith variable tension and frequency according to the
speed one decides to reach during m ovem ent operations. In case o f pow er supply shortage, verify F4-2 A m pere fuse on
S576 board (fuse for printed circuit “P.C.B.”).
Should there be a break in the m otor, this would be quite evident because m ovem ent will suddenly stop, grid w ill be blocked
as well.
M anually verify that no m ovem ent difficulties are actually the cause o f the failure; by m eans o f param verify that the grid
stroke is about 34000, regulate R10 trim m er in order to obtain the correct value. Stroke should be calculated as difference o f
the readings betw een the position w ith the grid on the right and the position with the grid on the left.
SOLU TIO N : replace carbon fiber; replace grid motor; perform m ovem ent calibration.

9/18
5.6.1.3 ERROR NR. 18-HIGH-TENSION SHORTAGE
D E SC R IPT IO N : the alarm indicates that the inverter is blocked; the cause o f the blocking can be visualized thanks to the
lighting o f the three red LED , placed on the inverter’s control board, Ld3 (KV > 110%), Ld4 (K V M in), Ld5 (I M ax).
PO SSIB L E CAUSES: if the alarm is KV > 110%: the inverter is broken or the reference tension is higher than 4 Volt.
If the alarm is KV Min.: the inverter high-tension fuse is broken or the connection cable betw een the generator and the
inverter, for control signals, is broken.
If the alarm is I M ax: high-voltage generator short-circuited, X -ray tube short-circuited.
CO N T R O LS: control connections betw een H.T. transform er and the inverter control logic board. Verify the high-voltage
fuse.
C ontrol the reference voltage for kV, for further inform ation please refer to section regarding generator.
Control the w ave shape o f KV and inA by m eans o f the oscilloscope on the inverter board.
kV signal on T p 3 :1 Volt DC = 10 kV.
mA signal on Tp6: 1 Volt DC = 20 mA (anodic current).
P erform the expositions at a value o f 27 kV w ith circle in different positions.
If the fuses keep on breaking, the problem could be caused by the short-circuit o f the high-voltage cable.
D isconnect the high-voltage cable from the g enerato r’s side and verify the possibility to have high-voltage.
I f one m ight be convinced o f the fact that short circuit has occurred within the X -ray tube, disconnect the high-voltage cable
from the ray tube’s side and try to perform an exposition.
SO LU TIO N : replace the inverter’s fuse; replace the high-voltage cable; replace generator.

5.6.1.4 ERROR NR. 1 9 -H IG H E S T ANODIC CURRENT

D E SC R IPT IO N : the alarm indicates that the anodic current has reached the highest m axim um value allow ed, causing the
hardw are intervention (sw itching o ff o f the pow er supply filam ent). The alarm indicates that the value o f the m easured
anodic current on S567 board during exposition is higher than 130 mA.
PO SSIB L E CAUSE: too high preparation values, problem s o f high-voltage discharges on generator.
C O N TRO LS: Verify kV and mA (anodic current) w ave shapes from the m easure points on the inverter control board, or
visualize graphics by means o f Param Im age program ; current flow should be o f square type, no oscillations, apart from the
first 50 mS. o f exposition in w hich stabilization occurs.
Verify that the table values “PREPARATION VALUE S\present P W M ” are sim ilar to the default PW M values; if necessary,
load back up in order to restore original calibration values.
In case o f anodic current oscillations, m om entarily deactivate PID and retroaction on preparation values.
Com pare mA wave shapes, measured by an oscilloscope, with those visualized in Param Image program, function D IAGNOSIS/
G R A PH IC S; the two w ave shapes should be similar.
SO LU TIO N : in case o f a wrong PW M value, increase value o f about 20 bit at a tim e until the correct value will be reached.
In case o f anodic current oscillations because o f PID, please contact IMS technical service support center in order to receive
further inform ation on the subject; replace S567 board.
In case o f anodic current oscillation caused by high-voltage discharges, please see instructions at error nr. 18 H IG H -
VOLTAGE SHORTAGE.

5.6.1.5 ERROR NR. 2 0 - FILAMENT HIGHEST VOLTAGE

D E SC R IPTIO N : the alarm indicates that the filam ent current has reached the highest value allow ed, causing hardw are
intervention (sw itching o ff o f the pow er supply filament).
P O SSIB LE CAUSES: the filam ent is broken, incorrect pow er supply o f the filam ent, Param program lim it variation, PW M
value oscillation because o f PID.
CO N TRO LS: control the filam ent current value by Param Im age program , function “D IA G N O SSIS\FIL A M E N T \Piloting
PW M preheating” ; com pare this value w ith lim its set out in function “piloting lim its and alarm s” .
I f alarm occurs during X-ray phase, perform controls described in alarm 3 4 IR R EG U A LR A N OD IC CURRENT.
Verify filament pow er supply tension, S567 board test point 1-2 o f X7; tension should be o f 8 Volt DC +/- 0.2 Volt “attention,
do not use oscilloscopes which are connected to ground” .
SO LU TIO N : in case o f a wrong PW M value, regulate value o f about 20 bit at a tim e until the correct value w ill be reached.
In case o f anodic current oscillations because o f PID, please contact IMS technical service support center in o rder to receive
further inform ation on the subject; replace S567 board.
In case o f anodic current oscillation caused by high-voltage discharges, please see instructions at error nr. 18 H IG H -
VOLTAGE SHORTAGE.

10/18
5.6.1.6 ERROR NR. 21 - MOTIONLESS ROTATING ANODE
D E SC R IPTIO N : the alarm indicates that the rotating anode start up has tailed: S565 board sensed that there is no current in
the rotating anode motor.
PO SSIBLE CAUSES: dam aged thermal protection inside X -ray tube; failure in S565.
CO N TRO LS: verify sta to r’s resistance, (for further inform ation please refer to the X -ray tube technical m anual); repeat
control from X I 5 connector, pins 1-2-3.
In case o f intervention on therm al protection, it will be necessary to wait for the cooling o f the tube before reactivating
circuit; it is advisable not to stop the m achine pow er supply, in fact there is a forced ventilation, w hich speed up cooling
process.
V erity the existence o f pow er supply to stator, 230 Volt AC during start up phase on X I 5 connector, pins 1-2-3.
Verify F 1 and F2 fuses on S565 board, verify the existence o f tension, 230 Volt AC on X 16 connector.
SOLU TIO N : w ait for X -ray tube cooling and replace S565 board.

5.6.1.7 ERROR NR. 22 - HUNTING MOVEMENT IS NOT WORKING

D E SC R IPTIO N : the alarm sw itches on if during the hunting m ovem ent autom atic test, at the starting o f G iotto, the value o f
the potentiom eter, w hich controls m ovem ent, is not w ithin the m inim um and m axim um values and w hen it is not possible to
achieve the value o f C e n te r.
PO SSIBLE CAUSES: defective POT 2 potentiometer, defective potentiom eter reading circuit (S567 - S563).
CO N TRO LS: by the program Param Image, G IA G N O SlS\X -ray tube movement, control that the m easured value is within the
required range; w hen the X -ray tube is in center position the filtered value should correspond to the m em orized value +/- 400
bit.
SOLUTION: fix the potentiom eter so that with the centered X-ray tube, the measured value by Param is equal to 40000 +/- 400
bit, m em orize the new values in the correspondent fields for all o f the four positions.
In case problem s should arise on S567 board, replace it.
5.6.1.8 ERROR NR. 23 - EXCEEDED MAXIMUM EXPOSURE TIME
D E SC R IPT IO N : the alarm sw itches on w hen the exposure time exceeds 6 seconds. A fter 6 seconds the exposure is
disconnected.
PO SSIB LE CA U SES: decrease o f the mA value with respect to original values; this implies the prolongation o f the exposure
times.
In case o f w orking in com bination w ith the D igital Biopsy, the absence o f cutting during exposure by biopsy system because
o f an under exposure, a w rong param eters setting, incorrect use or biopsy failure.
CO N TRO LS: verity anodic current calibration.
If the value has been voluntarily reduced, it w on’t be possible to achieve a mAs value, which cause the exposure tim e to
exceed 6 seconds.
SO LU TIO N : try to reduce the exposure time by using a different technique.

5.6.1.9 ERROR NR. 2 4 - ERROR IN THE COMPRESSOR MOVEMENT

D E SC R IPT IO N : the alarm sw itches on w hen at the step by step m ovem ent o f the m otor does not correspond an identical
m ovem ent o f the POT1 potentiom eter w hich controls the position o f the com pressor or vice-versa.
A t the unit starting is autom atically carried out a control and m ovem ent test: if the alarm sw itches on, the display o f the
visualization o f force and height o f the com pressor rem ain sw itched o ff and the com pressor is free to move.
PO SSIB L E C A U SES: forcing on the com pressor support unit, exceeding the highest blocking force o f the m otor step by
step.
Sliding o f the driving belts.
E rror in m easuring by P O T l potentiom eter connected with S563 board, X7 connector, for failure or incorrect fastening.
Top or bottom limit sw itches com pression m ovem ents not working.
CO N TRO LS: when the unit is sw itched o ff verify the sliding o f the com pressor unit for the whole o f its stroke, sliding should
be constant during all stroke.
B y means o f the program Param Image, control in “DI AG NO SIS\CO M PRESSO R\M ovem ent and thresholds o f com pression” :
verify the correspondence am ong the m em orized values as the values o f the potentiom eter at the low er land upper lim it
sw itch.
Rem ove covers from com pression colum n and verify the correct fastening o f the potentiom eter P O T 1 .
Control that there is no sliding o f m ovem ent transm ission gears.
SO LU TIO N : fix the potentiom eter so that with the com pressor there on top resistance betw een the com m on term inal
(term inal nr. 3) and term inal 1 is equal to 200 ohms + /-1 0 ohms.
Take note o f the new low er and upper lim it switch values.
5.6.1.10 ERROR NR. 2 5 - HIGH TUBE TEMPERATURE
D E SC R IPT IO N : the alarm indicates that the high tem perature o f the X -ray tube has caused the intervention o f its inner
therm al sensor (tem perature higher than 70° C).
P O S SIB L E CA U SES: Perform m any exposures. N o ventilation. Anode m otor over pow er supplied.
CO N T R O LS: Verify the actual high tem perature o f the X -ray tube. Control by m eans o f the program Param , the digital input
o f S564 board, input 7.
V erify the connection betw een the tem perature sensor and S565 board.
Verify that in absence o f exposures rotating anode stops after a few m inutes from last exposure. Verify the absence o f pow er
supply w ithin the stator, “ 230 volt A C” on X I 5 connector, pins 1-2-3, in absence o f ray control.
N ote: should the anode m otor be continuously pow er supplied, the stator w inding can easily b um w ithin a short tim e; it is
therefore necessary to keep the device sw itched on only when used to perform controls, otherw ise rem ove X I 5 connector
from S565 board.
Verify that the cooling fan works.
SO LU TIO N : wait for the X -ray tube to cool. Replace S564 or S565 board.

5.6.1.11 E R R O R N R .26-C O M M U N IC A T IO N ERROR

D E SC R IPT IO N : the alarm indicates that there are com m unication problem s between S564 board “X 22connector” and S563
board “ X9 connector” , com m unication is perform ed by serial connections.
P O S SIB L E CA U SES: discontinued com m unication, sending o f data w hich are not correct.
CO N T R O LS: by m eans o f the Param program verify back up.
SOLU TIO N : restore back up. Replace S564 or S563 board.

5.6.1.12 ERROR NR. 27 - STEREO DIGIT ERROR

D E SC R IPT IO N : the alarm indicates the absence o f synchronization betw een G iotto and the Biopsy, w hen about to perform
the exposure G iotto asks for perm ission; if B iopsy does not give its “ready m essage” the alarm sw itches on.
P O S SIB L E CA U SES: B iopsy is not ready to perform exposure and subsequently to receive images; interruption o f G iotto
and B iopsy connection; G iotto is not configured to use D igital Biopsy.
C O N T R O L S: before perform ing the exposure, verify that the digital program is ready to receive images, “RE A D Y F O R X-
RAY” .
Verify, together w ith the program Param Im age, the settings o f the m achine, kind o f related biopsy.
C ontrol the connection betw een the m am m ography and B iopsy com puter “ C O M I” .
C ontrol COM1 port w orking by connecting it w ith another device.
SOLUTION: replace COM 1 port.

5.6.1.13 ERROR NR. 2 8 -A N T IC O L L IS IO N PUSH BUTTON IS NOT WORKING

D ESC R IPTIO N : the alarm indicates that the system which controls anticollision betw een G iotto’s circle and the exam ination
table has not been inserted yet.
P O S SIB L E CAUSE: anticollision system not inserted w ithin the appropriate support, limit sw itch w hich should sense its
p ositioning is not w orking or com iection w ith m am m ography interrupted, S564 board main input is broken.
CO N TRO LS: control by m eans o f Param Image program , function “ DIAGNOSISU/O DIGITAL, SL” S564 input, input 14; it
should be green w hen the anticollision system is not inserted and red when inserted.
C ontrol connections on connector betw een the exam ination table and the m am m ography and verify the limit sw itch signal.
SO LU TIO N : replace the limit switch, restore connection, replace S564 board.

5.6.1.14 ERROR NR. 2 9 - MECHANICAL BLOCK OF THE INSERTED EXAMINATION TABLE

To be defined.

12/18
5.6.1.15 ERROR NR. 30 - LIFTED STABILIZER’S PISTON
D ESCRIPTION : the alarm indicates that the stabilizer’s piston in the exam ination table is not com pletely lowered; this alarm
prevents the exam ination table to continue its low ering process.
PO SSIBLE CA U SE: the lim it sw itch w hich senses the correct positioning o f the piston is defective, m echanical problem
preventing the correct positioning.
CONTROLS: control by means o f the Param Image program, function “D IA G N 0 S IS \I/0 DIGITAL, SL” S564 input, input 15;
it should be green when the piston is on top and red when on bottom .
Control connections on connector betw een the exam ination table and the m am m ography and verify the lim it sw itch signal.
SOLUTION: replace the limit switch, restore connection, replace S564 board.

5.6.1.16 ERROR NR. 31 - REFERENCE TENSION ERROR

D ESC R IPTIO N : reference tension for A /D converter on S567 boards is not correct, unstable.
POSSIBLE CAUSE: unstable pow er supply on S567 board; problem s on A/D converter; reading failure o f the value betw een
S567 and S563 boards.
CONTROLS: verify tensions +24 V DC a n d -2 4 V DC on X I 6 connector o f S567 board.
SOLUTION: replace S567 or S563 board.

5.6.1.17 ERROR NR. 3 2 - ROTATING ANODE START UP FAILURE

D ESC RIPTIO N : the alarm indicates the im possibility to turn o ff pow er supply to the X -ray tu b e’s stator at the end o f the
exposure; pow er supply to rotating anode m otor cannot be suspended.
N ote: should the anode m otor be continuously pow er supplied, the stator w inding can easily bum w ithin a short tim e; it is
therefore necessary to keep the device sw itched on only when used to perform controls, otherw ise rem ove X I 5 connector
from S565 board.
PO SSIBLE CA U SE: failure o f the relays which select the rotating anode; wrong reading o f the alarm signal.
CO N TRO LS: verify the presence o f tension within the stator “230 Volt AC” on X I 5 connector, pins 1-2-3, in absence o fray -
control.
SOLUTION: replace S565 board.

5.6.1.18 ERROR NR. 3 3 -C O M P R E S S IO N SENSOR ERROR

D ESC RIPTIO N : the alarm indicates that the reading o f the com pression value is not w ithin the predeterm ined lim its.
PO SSIB LE CA U SE: it is caused by the com pression reading IIA L L sensor; m agnet or S568 have been moved.
CONTROLS: connect the Param Image program, C O N F IG U R A T IO N S ACHINE DATAVCOMPRESSOR, verify the sensor
reading, in absence o f com pression value should be about 10000 +/- 500 bit and with the highest com pression (20 K ilos) the
value o f the sensor reading should be about 45000 +/- 2000 bit.
In com plete absence o f signal, verify connections betw een S568 and S563 boards X 4 connector.
Control pow er supplies and the output signal on X I connector o f S568 board:
P in 4 V cc= + 1 5 V D C
P in5 Vee = -15V D C
Pin 6 GND
Pin 2 signal, at 0 K ilos = 0 Volt, at 20 K ilos - 3 Volt.
Verify the presence and/or the correct fastening o f the magnet.
SOLU TIO N : if signal is absent, replace S568 board.
In case o f an incorrect reading proceed at the regulation o f R2 and R10 potentiom eters and calibration o f the com pression
sensor value table.
P otentiom eters calibration:
In absence o f com pression regulate P2 potentiom eter until the reading o f the sensor corresponds to 10000 +/- 500 (0 K ilos),
position the com pression m easuring device on the cassette holder and press up to the achievem ent o f 20 K ilos; in such
condition regulate R 10 potentiom eter until the sensor reading corresponds to 45000 +/- 500.
G o back to the com pression absence condition and verify that the sensor reading always correspond to 10000 +/- 500.

13/18
5.6.1.19 ERROR NR. 34-IRREGULAR ANODIC CURRENT
D E SC R IPT IO N : the alarm indicates that the value o f the m easured anodic current on S567 board during exposure is low er
than 25 mA if large focus has been selected and 10 mA if small focus has been selected.
PO SSIB L E CA U SE: too low a preparation value, high-voltage discharges on generator.
CO N T R O LS: verify kV and m As (anodic current) wave shape from the m easure points on the inverter control board, or
visualize graphics by m eans o f the Param Im age program , the current flow should be o f square type, no oscillations, apart
from the first 50 mS. o f exposition in w hich stabilization occurs.
Verify that the table values “PREPA RA TIO N V ALUES\present PW M ” are sim ilar to the default PW M values; if necessary,
load back up in order to restore original calibration values.
In case o f anodic current oscillations, m om entarily deactivate PID and retroaction on preparation values.
Com pare mA wave shapes, measured by an oscilloscope, with those visualized in Param Image program, function DIA G N OSIS/
G R A PH IC S; the two w ave shapes should be similar.
SO LU TIO N : in case o f a wrong PW M value, increase value o f about 20 bit at a time until the correct value w ill be reached.
In case o f anodic current oscillations because o f PID, please contact IMS technical service support center in order to receive
further inform ation on the subject; replace S567 board.
In case o f anodic current oscillation caused by high-voltage discharges, please see instructions at error nr. 18 H IG H -
VOLTAGE SHORTAGE.

5.6.1.20 ERROR NR. 3 5 - IRREGULAR FILAMENT CURRENT

D ESC RIPTIO N : the alarm indicates that the current within the filament is higher or low er than the Param Image program pre­
set limits.
G iotto perform s this control at the unit starting and during the ray preparation phase.
PO SSIB L E CA U SE: incorrect filam ent pow er supply, interrupted filam ent, oscillation o f PW M value because o f the PID.
CO N TRO LS: by Param Image program , function “D IA G N O SIS\FILA M EN T\“D IA G N O SSIS\FILA M EN T\PiIotm g PW M
preheating” , control the filament current value, com pare this value with limits set out in function “piloting limits and alarm s” .
If the alarm turns on during the X -ray phase, perform controls described in the alarm 34 IR R EG U LA R A N O D IC CURRENT.
Verify the filament pow er supply, S567 board test point l -2 o f X7, tension should be equal to 8 Volt DC +/- 0.2 Volt “attention,
do not use oscilloscopes connected to ground” .
Verify filam ent resistance, S567 board, betw een X3 connector and X8 connector (GND).
SO LU TIO N : in case o f a wrong PW M value, increase value o f about 20 bit at a tim e until the correct value will be reached.
In case o f anodic current oscillations because o f PID , please contact IM S technical service support center in order to receive
further inform ation on the subject; replace S567 board.
In case o f anodic current oscillation caused by high-voltage discharges, please see instructions at error nr. 18 H IG H -
VOLTAGE SHORTAGE.

14/18
5.7 OPERATOR’S MISTAKE

5.7.1 ERROR NR. 36 -T H E COLLIMATOR IS NOT INSERTED

DESCRIPTION: the alarm indicates that the collimator is not inserted; it is emitted by a sensor inside the center square which, if not
inserted, inhibits the preparation sequence and rays.
POSSIBLE CAUSES: broken sensor inside the center square which senses the presence o f the collimator; problem on S563 board.
CO N TRO LS: reset the alarm. Verify that the collim ator is correctly inserted. Control by m eans o f the Param Im age program ,
opening D IA G N 0 S IS \I\0 D IG IT A L \S563\ INPU TS input bit (22) “collim ator identification switch inserted” . Verily that the
switch inside the center square is pressed when the collim ator is inserted. Verily cable X 23-pin 15 on S563, w hich connects
ju st on the switch.
SOLU TIO N : replace switch; replace S563, replace connection cable.

5.7.2 ERROR NR. 37 - COLLIMATOR FORMAT IS NOT CORRECT

D E SC R IPTIO N : the alarm indicates a form at incom patibility betw een the bucky and the collim ator w hich have been used.
POSSIBLE CAUSES: incorrect use o f the collim ator with selected bucky; bucky format not correctly perceived, broken S563
board, connection failures betw een collim ator and S563 board, the collim ator has not been inserted co rrectly
CO N TRO LS: Also see 5.7.1 reset alarm s, verify the correct format o f the limiting slab with inserted bucky format. Control by
the Param Image program \D IA G N 0S IS \I\0\S 563\IN P U T S input bit conditions (8), (9), (21), (23) “collim ator identification
sw itch” . Verify that to each inserted collim ator corresponds its code o f selected sensors within the center square, and
consequently digital input on S563 board, (see S563 inputs at paragraph 5.5.12). Input bit (18) “24x30 film cassette identification
sw itch” or input bit (19) “ 18x24 film cassette identification sw itch” according to which o f them we are using at the moment.
SOLUTION: S563replacem ent, switch replacement.

5.7.3 ERROR NR. 3 8 - COLLIMATOR NOT CORRECT FOR SELECTED FOCUS

D E SC R IPT IO N : the alarm indicates an incom patibility betw een selected focus and collim ator used.
PO SSIB L E CA U SES: incorrect use by the operator, problem s on board inputs S563.
C O N TRO LS: reset alarm and verify w hether lim iting device used is adequate to the focus which has been used. Control by
m eans o f the Param Im age program \D IA G N 0S IS \I\0\S 563\IN P U T S the conditions o f inputs relevant to the collim ator (see
paragraph 5.5.12), verify collim ator’s switches.
SOLUTION: replace S563, replace switches.

5.7.4 ERROR NR. 39 - CASSETTE NOT INSERTED

D ESC RIPTIO N : the alarm indicates that m achine perceived the cassette was not inside the cassette holder during exposure.
PO SSIB L E CA U SES: cassette w as not present during exposure, problem s on the bucky sw itch w hich senses the presence
o f the cassette, problem on S563 board.
CO N TRO LS: reset alarm and verify that the cassette is inside the potter (18x24 or 24x30 according to w hich potter we are
using), control by m eans o f the Param Im age program D IA G N 0 S IS \I\0 \S563\IN PU T S input bit (12) “ film cassette sw itch
inserted” .
Electrically check the sw itch inside the bucky.
SOLUTION: bucky switch replacem ent, S563 replacement.

5.7.5 ERROR NR. 40 - POTTER NOT INSERTED

D E SC R IPT IO N : the alarm indicates that the m achine has not perceived the presence o f bucky.
PO SSIB L E CA U SES: incorrect potter insertion on its seat, problem on p o tte r’s connector XP\f-m , problem on S563 board.
CO N TRO LS: reset alarm and verify that potter is correctly inserted on its seat, control connector X P\f-m and its connection,
test signals that from connector go to S563 X22 pins 5-6-14.
SOLUTION: potter replacem ent, S563 replacement.

15/18
5.7.6 ERROR NR. 4 1 -N O COMPRESSION

D E SC R IPT IO N : the alarm indicates that m achine perceived no com pression during the X -ray phase, by m ean o f the
autom atic and sem iautom atic technique, (this alarm s also activates w hen com pression is low er than 5 Kilos).
P O S SIB L E CA U SES: o p erato r’s inadvertence, problem s on the m echanical gears o f the com pression system, broken
com pression sensor.
CO N TRO LS: reset alarm and verify if the error on display has not actually been an inadvertence by the operator, consequently
control relevant parts o f paragraph 5.6.1.9 CO M PRESSO R M O V EM EN T ERROR.
SOLUTION: See paragraph 5.6.1.9.

5.7.7 ERROR NR. 42 - INTERRUPTED EXPOSURE

D E SC R IPT IO N : the alarm indicates that m achine perceived that X -ray sw itch has been released by operator during X -ray
p hase.
PO SSIBLE CAUSES: aware X -ra y switch release by the operator, broken ray switch.
CO N TRO LS: reset alarm and repeat ray sequence paying attention not to release ray switch before the end o f the exposure.
Control if there is a contact on ray switch. Verify by means o f Param Image program \D IA G N 0SIS \I\0\S563\IN P U T S input bit
(0) “Ray control switch condition direct reading” and on S564 input bit (29) “Ray control switch condition direct reading” .
SO LU TIO N : replace ray switch, replace radiographic cassette.

5.7.8 ERROR NR. 4 3 - INTERRUPTED PREPARATION

D E SC R IPT IO N : the alarm indicates that m achine perceived that ray sw itch has been released by the operator during
preparation phase.
PO SSIB L E CA U SES: aw are release o f the ray sw itch by the operator, broken ray switch.
CONTROLS: see paragraph 5.7.7
SOLUTION: see paragraph 5.7.7

5.7.9 ERROR NR. 4 4 -O V E R E X P O S U R E

D E SC R IPT IO N : the alarm indicates that the m achine selected a value o f K V w hich is too high with respect to the thickness
read by cam era, only during the autom atic and sem i-autom atic operation.
PO SSIB L E CAUSES: incorrect AEC calibration, broken X -ray sensor, problem on S563 board.
CO N T R O LS: reset the alarm and set a KV value low er than the one it has been previously used (then shift to the sem i­
autom atic technique), repeat exposure. If the alarm disappears, problem is on AEC calibration or on regulation o f those KV
w hich resulted in being too high, otherw ise we may have problem s on X -ray sensor or S563 board.
K V regulation and AEC re-calibration: first check table “C” , by m eans o f Param Im age program - exposure m eter - F.G
M olybdenum , that is to say K V with respect to thickness.
U se PM X III or equivalent, (d o n ’t forget that G iotto interrupts exposures and som e devices cannot perform reading),
connect oscilloscope on the in v erter’s test points, m easure KV on TP3 (1 KV = 10 KV ), and M a on T p6 (1 V = 20 M a) with
T P 1 1 = G N D. Shift to G iotto control table m anual m ode, after each exposure com pare the read K V w ith the pre-set ones,
verify to be w ithin tolerance values (+/- 1 KV); control wave shape on the oscilloscope and if necessary act on the
g en erato r’s potentiom eters, P I and P2 (see the electric diagram o f the generator), for adjustm ent.
O nce verified and calibrated the KV, re-calibrate AEC, starting from “A” tables, (see paragraph 3.3.3 “A table autom atic
com putation” in Param Im age manual).
C ontrols on X -ray sensor and S563 board: verify the cam era reading by follow ing instructions in paragraph 3.3.8. X -ray
reading correction on Param Im age m anual. Control connections betw een S563 board and the X -ray sensor.
If necessary disconnect the X -ray sensor and check it as a diode.
SOLU TIO N : AEC re-calibration, X -ray sensor replacem ent, S563 board replacement.

5.7.10 ERROR NR. 4 5 - UNDEREXPOSURE

DESCRIPTION: the alarm indicates that the machine has selected a KV value which is too low with respect to the examination
table thickness from sensor Rx, only during automatic and semiautomatic mode.
POSSIBLE CAUSES: incorrect AEC calibration, broken Rx sensor, problem on S563 board.
CONTROLS: reset alarm and seta KV value higher than the one previously used, then shift to the semiautomatic mode and
repeat exposure. See paragraph 5.7.9 OVEREXPOSURE.
SOLUTION: see paragraph 5.7.9 OVEREXPOSURE.

16/18
 5

5.7.11 ERROR NR. 4 6 - LOW KV FOR RH FILTER

D ESC RIPTIO N : the alarm indicates that the operator selected a KV value w hich is too low for Rh filter.
PO SSIBLE CAUSES: Incorrect technique used by the operator.
SOLU TIO N : reset alarm and set higher KV value or change filter.

5.7.12 ERROR NR. 47 - RAY TUBE NOT IN POSITION

D ESC RIPTIO N : the alarm indicates that the operator did not take X -ray tube to central position (0°) or to +/- 24 (in case o f
stereotropism ).
PO SSIB LE CAUSES: incorrect technique used by the operator.
SOLU TIO N : reset alarm and take tube to position 0° or to +/- 24°.

5.7.13 ERROR NR. 4 8 - COMPRESSOR UNDER MAGNIFYING PLATE

D ESC RIPTIO N : the alarm indicates that the operator installed com pressor under magnifying plate.
PO SSIBLE CAUSES: incorrect technique used by the operator.
SOLU TIO N : reset alarm and install com pressor upon m agnifying plate, taking com pressor connection up on top.

5.7.14 ERROR NR. 4 9 - OPEN DOOR DURING RAYS

D ESC RIPTIO N : the alarm indicates that the m achine perceived that the room door was open during exposure.
CONTROLS: verify limit sw itch installed on the door. Verify input S564 bit 24.
SOLU TfO N : reset alarm and close the door.

5.7.15 ERROR NR. 5 0 - EXCEEDED THERMAL CAPACITY

D ESC RIPTIO N : the alarm indicates that m achine perceived that the tube therm al capacity has been exceeded. T his can
happen when therm al units reach 10% (percentage shown on display).
PO SSIBLE CAUSE: excessive exposures with too highK V and mAs.
SO LU TIO N : wait for the tube to cool, it is advisable not to switch o ff pow er supply to the unit, because in this way
ventilation on Rx tube will keep to be on. Wait for the Rx tube therm al units decrease under 80% in order to have the
possibility to perform another exposure.

5.7.16 ERROR NR. 5 1 - EMERGENCY ON

D ESC R IPTIO N : the alarm indicates that the operator activated the em ergency alarm.
PO SSIB L E CAUSES: the operator activated the em ergency push button, softw are problem , activation o f the hardw are
em ergency measures.
CO N TRO LS: M ake sure to elim inate the em ergency push button intervention cause, restore it and sw itch off/on keyboard.
Take m aster sw itch to O FF position and subsequently to O N position.
If the problem is caused by softw are restore m achine back up, by using Param fm age program .

5.7.17 ERROR NR. 52 - FILM HAS BEEN ALREADY EXPOSED

D ESC RIPTIO N : the alarm indicates that the operator has not replaced the radiographic cassette since last exposure.
SOLUTION: replace cassette.

5.7.18 ERROR NR. 5 3 - CASSETTE HOLDER USED W ITHOUT MAGNIFYING PLATE

D ESC RIPTIO N : the alarm indicates that the operator is using cassette holder w ithout m agnifying plate.
SOLU TIO N : rem ove cassette holder and install potter with grid.

A tfo
y -« . . . . 17/1g
5

NOTES

18/18
 'i<0
IMAGE

6
MAINTENANCE

1. PREVENTIVE MAINTENANCE
2. ROUTINE MAINTENANCE JOBS
3. EXTRAORDINARY MAINTENANCE
4. CASES REMOVAL
5. DISPOSAL AND SCRAPPING

f
'icfio
— 1/32
6.1 PREVENTIVE MAINTENANCE

For any type of preventive or routine maintenance, always disconnect the machine from the mains to avoid damage
A to persons and/or to the electrical - electronic part of the m am m ography unit. M aintenance jobs must be carried
out only by authorized personnel.

6.1.1 CLEANING
W hen cleaning, take care not to allow solvent to reach inside the unit, because it could seriously damage the parts.

A
D o not use chem ical products, thinners or solvents to clean the appliance.
S3

A fter the appliance has been installed, clean the fairings, control table and transparent plastic com ponents (com pressor,
m agnification technique table), using “fresh” cloths or cleaning paper, soaked in or in a w ater and liquid soap solution.
Clean the carbon fibre surface o f the bucky and cassette-holder w ith a disinfecting product.

D o this before every radiological exam ination.

A
N ever use alcohol to clean the acrylic com ponents (com pressor, surface for m agnification technique, head-rest).
• The anti X -ray glass panel should be cleaned w ith a glass cleaning product, or denatured alcohol.

To keep G IO TT O IM A G E perfectly efficient and to avoid m alfunctions and/or trouble, arrange system atic, rational
cleaning o f m achine parts and o f the room where it is installed.

2/32
6.1.2 WARNINGS ON MAINTENANCE
NOTE - The GIOTTO IM AGE mammography unit requires only minimum maintenance. The normal precautions in using
the appliance will ensure excellent, on-going, reliable operation. Nevertheless, we advise you to run periodic checks and
controls on the operation o f the appliance and its parts, in order to ensure that its performance and reliability are
maintained.

W henever the appliance is started, m ake sure that the safety devices are efficient.

A If you note any faults or malfunctions, stop using the appliance immediately and contact the Authorised Technical
Service.

6.1.3 PREVENTIVE MAINTENANCE CHECKS

A Plan preventive scheduled m aintenance - this job should be assigned to a specialised technician suitably trained
by the Service Department.

• Tim e interval recom m ended for preventive m aintenance : 1 year

• C hecks:

C/ 0 o
iv u y MECHANICAL

J v

O CONFORMITY OF
SETTING
PARAMETERS

T. 1

6.1.4 CASES REMOVAL

NOTE - Some operations o f routine and extraordinary maintenance, can only be carried out by removing the protection
cases o f those devices on which it will be necessary to operate.

The rem oval and positioning o f the cases (see page 18), have to be carried out exclusively by the maintenance
engineer and only after having previously selected the energy sources.

3/32
 6

6.1.5 DAILY I ROUTINE CHECKS FOR THE OPERATOR

Before beginning any cleaning jobs, disconnect pow er to the unit.
Be extrem ely careful w hen cleaning, m aking sure that the liquids do not reach inside the unit.
" M ake sure that there is not too m uch liquid on the pieces o f fabric used for cleaning.
DO N O T use 90° alcohol or products containing turpentine or polish.
Before each examination, using a dedicated disinfectant, carefully clean the parts o f the appliance which come into contact
with the patient.
DO N O T clean.

Description Check the following:

Cleaning - Bucky surface

- Compressor surface
- Magnification technique surface
- Head-rest surface
- Parts that came into contact with the patient
Emergency switches - Check the emergency switches and refer to chapter No. 2 concerning
control and resetting procedures fo r the unit.
Visual check efficiency and integrity
- Compressors surface
- Magnification technique surface
- Head-rest surface
- Parts that came into contact with the patient
- Markers
- Diaphragms
- Bucky surface
- Visual check o f external parts o f the unit
Displays - Indicators - Check o f unit indicator-/ights and acoustic signals
- Check o f ray push-button
- Check o f ray signals on control table
- Check o f indications on fo rm a t o f installed limiter
- Efficiency check o f collimator light
- Efficiency check o f ray transit light outside the room
- Check o f correct indication o f compressor height
- Check o f correct indication o f compression force

T. 2

,
A I f you note any faults or malfunctions stop using the appliance immediately and contact the Authorised Technical
Service.

Z 'iicfio
4/32
N O T E - Table T.3 p rovide a sum m ary o f the m ain scheduled and p reventive m aintenance jo b s. The m ain specific jo b s are
described in detail on the fo llo w in g pages.

6.1.5.1 MAINTENANCE PROGRAMME

Frequency
Description Type of use Procedure
Diagnosis Screening
Vertical movement
- Clean and lubricate the slides
15000 15000 - lubricate the movement screw
exposures or exposures or - check movement speed of elevator
12 months 6 months

Compression system - check belt tension

- lubricate the compression bar (grease the
15000 15000 bearings)
exposures or exposures or - check compression force setting
12 months 6 months - check maximum compression force (20 kg)
- check extreme force of programmed
compression (5 kg)
- check resistance of belts at decompression
- check value of thickness during
compression

Compression system 90000 90000 replace the two belts of the compression
exposures or exposures or system Arm
3 years 18 months
Arm - check inclination brake
- check rotation brake
- check locking efficiency between arm
support and receptor support arm
12 months 6 months - check tension of rotation brake belt
- Clean the part of the circle where the
rotation brake belt operates.
- clean and lubricate the bearings of the circle
sliding rollers.
clean the roller contact surface
the circle.
Arm / Rotation brake - replace rotation brake belt
3 years 2 years replace the mechanical lock (rack) of the
rotation brake
 Frequency
Description Type o f use Procedure
Diagnosis Screening
Image quality check the range covered by the X-ray
beam
Once a week check the range covered by the
1 month and wherever centring light
required each measure the 50% layer
day before measure quantity of received radiation
starting to check density (reference exposure)
scan quality controls with the control
procedures specified by sanitary
physics for the mammography
appliance (see table recommended by
IMS)
15000 15000 clean the format measuring devices
exposures or exposures or check the accessories (including grids)
6 months 3 months general cleaning of accessories

cleaning Always keep clean the area near the

Every day Every day radiological unit to prevent dust and dirt
from accumulating.
cleaning - Periodically clean the light collimation
mirror - inside the collimator - to
12 months 6 months prevent a film of electrostatic dust.
To remove dust, use a brush with
very soft bristles.
Cleaning / HV transformer Keep clean the (upper and side)
/Electric cabinet surfaces o f the high voltage
12 months 18 months transformer, inside the electric
cabinet.
Keep the parts inside the electric
cabinet clean.

T. 4

6/32
6.1.6 IMAGE QUALITY CONTROL PROGRAMMES

Test Permissible limits *

Type of control
No.
** N.A.
MECHANICAL MOVEMENTS CONTROL

2 ** Kv ACCURACY ERROR < 4 %

3 ** Kv REPRODUCTION CAPABILITY COEF. VAR. < 2 %

4 * TOTAL FILTLERING S E V a t 28 KV > 0,30 mm AL

5 * X-R AY TUBE EFFICIENCY > 30 mGy/mAs at 1 metre

6 * INPUT DOSE IN AIR < 12 mGy

7 * AVERAGE GLAND DOSE < 3 mGy

8 * FOCAL SPOT CHARACTERISTICS (0.1 mm - 0.3 mm ) 0.15 x 0.15 mm

0.45 x 0.65 mm

9 ** SPATIAL RESOLUTION > 1 2 l/mm

10 ** SHORT AND LONG-TERM REPRODUCTION CAPABILITY SHORT D D O < 10%

LONG DDO < 15%

DENSITY CONTROL 15% < ADO < 25%

INCREMENTAL VALUE
12 ** < 2 0 % ofD .O .
VOLTAGE DIFFERENCE COMPENSATION

13 ** THICKNESS DIFFERENCE COMPENSATION < 2 0 % ofD .O .

14 ** BEAM - CASSETTE ALIGNMENT Thorax side not projecting

Other sides < 5 mm

15 * CORRECT GRID OPERATION AND ARTEFACTS CHECK Blades not visible

None

16 ** COMPRESSOR ALIGNM ENT Deformat. < 5 mm

COMPRESSION FORCE 13 Kg < Comp. < 20 Kg

17* * SENSITOMETRIC TEST BASE < 0 . 2 A Velocity < 1 0 %

Contrast (y ) >2, 6

*/ ^*** IMAGE ASSESSM ENT A Image contrast < 10%

Contrast discr. Threshold <1,3%
Visible details
Exposure time < 2 s

^P *** < 1 mGy/ora

RADIATION LEAKS

FREQUENCY : ( * ) = ANNUAL ; ( * * ) = 6-M O NTHLY; ( ***) = A T DISCRETION

T. 5

* NOTE - Keep to the regulations presently in force in the country where it will be perform ed installation. Limits can
undergo variations.
6.2 ROUTINE MAINTENANCE JOBS | at max frequency of 12 months \

6.2.1 VERTICAL MOVEMENT

6.2.1.1 L ubrication
• Lift the vertical colum ns (1 - F. 1) to reveal the hole (A).
• Rem ove the plug (B) and fill up with lubricating oil:

OPTIMOL LONGTIME-PDZ

6.2.2 COMPRESSION SYSTEM

6.2.2.1 C om pressorfixing verification and adjustment
Press your linger on the ball (A - F. 2) - if spring force is insufficient, proceed as follows:
• unscrew the two screws (B) and remove the support (C).
• The adjustment screw (hexagon socket head) (D - F. 3) is located at the rear o f the support (C - F. 3); screw it m oderately to
restore correct spring pressure on the ball.

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6.2.2.2 Belt tension
• Rem ove com pressor and handles.
• Rem ove the protective housing o f the com pression tow er

Drivetransm ission belt

• C heck correct tension o f the drive belt (A - F. 4) and, if necessary, restore tension by turning the three screw s (B).

Vertical movement belt

• C heck correct tension o f the belt (C ) and, if necessary, restore tension by, m anually lilting the trolley (D) and using the
adjustm ent system (E).
6.2.3 M ICROSW ITCHESCHECK(Com pressiontower)
• W h e n c h e c k in g th e tim in g b e lts , a ls o c h e c k e f f ic ie n c y a n d c o r r e c t f a s te n in g o f th e m ic r o s w itc h e s
( F - G - F .5).

Gear lubrication

• L ubricate the gears w ith silicon grease.

6.2.3.1 Microswitch check (bucky support)

• U nscrew the four securing screw s (A - F. 6).
• C heck efficiency and correct fastening o f the m icrosw itch (B).

6.2.3.2 Bucky lubrication

• R em ove the bucky unit (F. 7).
• R em ove the cover(C ) by unscrew ing the screw s (D) (from the opposite side).

10/32
 Place the bucky unit on a flat surface and lubricate the unit on the points indicated in figure (8).

O ilN Y O IL

F. 8

A # >
/ IMAQE 12/32
6.2.4 ROTATION BRAKE UNIT
6.2.4.1 Lubrication
• Lubricate the rod (A - F. 9) o f the electro-m agnet (B) with oil.

6.2.4.2 Belt tension

C heck the tension o f the “ rotation brake” tim ing belt and, if necessary, restore tension as follows:

• Loosen the four screw s (C) and m ove the support on the slots (D).
• A fter tensioning, tighten the screw s (C ) in a cross way.
• Tension is correct when potter-tube unit can stand a 20 K ilos thrust.
6.2.5 GANTRY UNIT

6.2.5.1 Belttension
• C heck the tension o f the tim ing belt (A - B - F. 10) and, if necessary, restore tension w ith the belt tensioning device:
- screw s (1) for belt (A)
- screw s (2) for belt (B).

6.2.5.2 Cleaning

• C arefully clean (with w ater and liquid soap) the “grooves” o f the rollers (upper and lower) (B - F. 12) and the sliding
surfaces o f the gantry (upper and lower) (C).
• Also clean the rollers inside the gantry.

6.2.5.3 Lubrication of bearings

• L ubricate all the bearings (A - F. 11) o f the sliding rollers w ith oil: N Y O IL (not use a grease o f m iddle-consistency).

A Check i f the Seeger ring (B) o f each sliding roller is correctly fitted in its seat.

f
\< fiO
6.2.5.4 Centring the sliding rollers

N O T E - Through p ro lo n g e d use o f the appliance, the considerable size o f the "g a n try ” could cause slight signs o f
"deform ation ” and, i f these are not remedied, they could pro d u ce frictio n or excessive p la y on gan try rotation.

• The installed sliding rollers can be o f two types: fixed (A - F. 13) fitted on two ball bearings;
adjustable (B) fitted on a roller bearing.

Roller identification

• The fixed rollers are installed on a sm all plate (C - F. 13) with a blind central hole.
• The adjustable rollers are installed on a small plate (C) with a socket head adjusting screw (D) at the centre.

6.2.5.5 G an try slidin g check

• A fter clean in g the g antry and the ro lle rs (and lubricatin g the b earin g s), turn the gantry (E - F. 13) m an u ally in both
d irec tio n s, and look fo r any abnorm al frictio n , ex cessiv e play, “w an d er” and any o th er slid in g faults.
• A djust the ad ju sta b le ro lle rs w ith the screw (D - F. 13), until the ro lle rs slide u n ifo rm ly on the gantry.

A The rollers m ust be lightly in contact with the sliding surfaces to compensate fo r the inevitable albeit slight
irregularity o f the gan tiy diameter.

N O T E - The rollers inside the g antry do not usually require any adjustm ent, but, i f this is necessary, use the securing nut
a n d m ove the roller shaft along the slot.

111

6.3 EXTRAORDINARY MAINTENANCE

• T his includes jo b s on worn, faulty or m alfunctioning parts.

A A ll jo b s must be carried out strictly by specialised personnel.

N O T E - I.M .S. declines all responsibility f o r dam age o f any kin d caused by inadequate m aintenance a n d use o f non­
original spare parts, or spare p a rts not com patible with the quality sta n d a rd a n d the electro-m echanical characteristics
o f the m achine in question.

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6.4 CASES REMOVAL

6.4.1 ELECTRIC PANEL

• T he front case (A - F. 14) is secured b y two upper screw s(l) (in the low er part, the case is fixed).

• the case (B - F. 14/a) is secured by the four screw s (2).

F. 14/a
 6.4.2 “GIOTTO IMAGE” BASE CASE
• U nscrew the two screw s (2 - F. 15) and take out the back small case (B).
• U nscrew the two screw s (3 - F. 16) and rem ove the base case (C) o f the m achine.

By overturning the base case (C), it is possible to reach the electronic card (D), fixed by the screws (4 ).

_
F. 16/a

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6.4.3 COM PRESSO R’S TURRET CASE
N O T E - In order to fa c ilita te the rem oval o f the com pression turret case ( A - F 17), it is advisable to rem ove beforehand,
the two side knobs, by loosening the grub screw s (I).

F. 17

• In the low er part, unscrew te two screw s (2 - F. 17/a)

• Lift the carter and extract it upw ards (A - F. 18).

N O T E - D uring reassem bling, take care to insert correctly the case on its guides (B) not dam aging the electric cables (C)
which are in the low er part.
6.4.4 POTTER HOLDER UNIT CASE

• Rem ove the potter unit

• U nscrew all the tightening screw s (2 - F. 19).
• Rem ove the case (D).

6.4.5 X-RAY TUBE CASE

• U nscrew the screw (3 - F. 20) (on both sides).

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• U nscrew the screw (1).
• U nscrew the screw (2).

• U nscrew the screw (3).

• Inside the cases, there are the Plexiglas protection fastening stirrups (A), fixed by the screws (4).

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