Metaltronica MILADY OPERATOR’S MANUAL
OPERATOR’S MANUAL
MILADY/MILADY BYM
MILADY
BMI Biomedical International
24035 Curno (BG)
info@bmibiomedical.it
site: www.bmibiomedical.it
All rights are reserved. Reproduction
or transmission in whole or in part, in
any form or by any means, electronic,
mechanical or otherwise, is
prohibited without the prior written
consent of the copyright owner.
OPERATOR’S MANUAL
MOM10-U09
Via E. Fermi, 52Q/R Phone: +39-0354376381
Fax: +39-0354376401
E-mail:
Web-
Manufacturer’s web site
www.metaltronica.com
Manufacturer´s address
Metaltronica
X-Ray Equipment & Supplies
Via delle Monachelle, 66
00040 Pomezia (Rome)
Italy
© 2015
Metaltronica
- Italy
Printed in Italy
DOCUMENT STATUS SHEET
Title of Document: OPERATOR’S MANUAL (MOM10-U09)
Version Release Date Reason of change
ENGLISH 01 19th/March/2010 First release
ENGLISH 02 29th/Sep/2010 New labels
ENGLISH 03 16th/February/2012 Trade name change
ENGLISH 04 30th /May/2012 Update
ENGLISH 05 09th /November/2012 New Labelling, International Standard
reference update, MILADY drawings
update, other minor changes
ENGLISH 06 17
ENGLISH 07
ENGLISH 08
ENGLISH 09
th
/January/2013 Technical specifications update (manual
rotation range for ISO C-Arm)
14th/March/2014
Compliance to IEC 60601-1 III edition
06th/October/2014 New accessories, general review
09th/January/2015 Labeling update
OPERATOR’S MANUAL MOM10-U09
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DECLARATION ACCORDING TO IEC 60601-1 STANDARD
Metaltronica declares its responsibility concerning safety, reliability and equipment features included in
this manual only if the following items are fully satisfied:
1) Installation;
- room temperature and humidity;
- updates;
- recalibrations;
- repairs and/or modifications
carried out by technical personnel officially authorized from Metaltronica S.p.A.
2) Electrical pre-installation performed in the site where the system has to be put into operation, carried
out according to prescription given by IEC rules concerning Medical Application.
3)
Service personnel must ensure that they receive training on the mammographic unit with
the Manufacturer training programs prior to service the Unit.
4) Use of the equipment according to instruction in this manual.
interpretation, English translation shall prevail.
Using and keeping X-Ray equipment and device must conform
WARNING
the local Regulations and national laws concerning Medical X-
Ray handling.
According to CE 93/42 Directive for Medical Devices concerning
In case of difficulties concerning
product traceability, Metaltronica as manufacturer, must be
NOTE
informed of any owner or installation address change.
Medical Devices traceability is prerequisite to assure their safety
and reliability over the time.
OPERATOR’S MANUAL MOM10-U09
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Table of Contents
INDEX
SECTION 1: GENERAL INFORMATION .................................................................................................................................. 8
INTRODUCTION ...................................................................................................................................................................... 9
INTENDED USE ....................................................................................................................................................................... 9
CONTRAINDICATIONS ............................................................................................................................................................ 9
POTENTIAL ADVERSE EFFECTS ................................................................................................................................................ 9
SAFETY SYMBOLS.................................................................................................................................................................. 10
NOTICES ............................................................................................................................................................................... 11
SYMBOLS .............................................................................................................................................................................. 13
DEVICE CLASSIFICATION ....................................................................................................................................................... 17
MILADY IDENTIFICATION LABEL ........................................................................................................................................... 19
MILADY BYM IDENTIFICATION LABEL ................................................................................................................................... 20
ANTI – X – X SHIELD IDENTIFICATION LABEL ......................................................................................................................... 21
MILADY DIMENSIONAL DRAWINGS ...................................................................................................................................... 22
MILADY BYM DIMENSIONAL DRAWINGS ............................................................................................................................. 23
ANTI-X SHIELDS DIMENSIONAL DRAWINGS ......................................................................................................................... 24
PROTECTION AGAINST STRAY RADIATION............................................................................................................................ 26
SECTION 2: MAIN PARTS DESCRIPTION ............................................................................................................................. 27
MILADY MAIN PARTS ............................................................................................................................................................ 28
MILADY BYM MAIN PARTS ................................................................................................................................................... 30
CONTROL PANEL .................................................................................................................................................................. 32
DISPLAY OF CONTROL PANEL ............................................................................................................................................... 33
AUXILIARY DISPLAY .............................................................................................................................................................. 34
KNOB FOR FINE MANUAL COMPRESSION ............................................................................................................................ 34
C-ARM MOVEMENTS KEYBOARDS ........................................................................................................................................ 35
FOR MANUAL ROTATION VERSION ................................................................................................................................. 35
FOR MOTORIZED ROTATION VERSION ............................................................................................................................ 35
ONLY WITH SBD (STEREOTACTIC BIOPSY DEVICE) ........................................................................................................... 35
FOOT-CONTROLS FOR MOTORIZED COMPRESSION ............................................................................................................. 36
MULTIFUNCTION FOOT-CONTROLS (
OPTIONAL
) ..................................................................................................................... 36
SECTION 3: GENERAL OPERATIONS ................................................................................................................................... 37
EXAMINATION ROOM .......................................................................................................................................................... 38
RELEVANT INSTRUCTIONS BEFORE INITIAL START-UP .......................................................................................................... 38
SWITCHING ON..................................................................................................................................................................... 38
SWITCHING OFF ................................................................................................................................................................... 38
EMERGENCY PUSHBUTTONS ................................................................................................................................................ 39
C-ARM VERTICAL MOVEMENT ............................................................................................................................................. 39
C-ARM MANUAL ROTATION ................................................................................................................................................. 39
C-ARM MOTORIZED ROTATION ............................................................................................................................................ 40
C-ARM ROTATION FOR STEREO BIOPSY ................................................................................................................................ 42
TABLES ................................................................................................................................................................................. 44
ID LABELS WHEELS................................................................................................................................................................ 45
TABLE INSERTION ................................................................................................................................................................. 46
CASSETTE SIZE ADAPTOR ...................................................................................................................................................... 46
DEVICE FOR GEOMETRIC MAGNIFICATION (VARIABLE 1.5X/2X OR FIXED 1,8X) ................................................................... 47
COMPRESSION PADDLES INSERTION AND REMOVAL ........................................................................................................... 48
BREAST COMPRESSION SYSTEM ........................................................................................................................................... 49
MOTOR DRIVEN COMPRESSION ...................................................................................................................................... 49
MANUAL COMPRESSION WITH FINE ADJUSTMENT ........................................................................................................ 50
COMPRESSION RELEASE .................................................................................................................................................. 51
LIGHT BEAM INDICATOR ...................................................................................................................................................... 52
COLLIMATION PLATES INSERTION ........................................................................................................................................ 52
AUTOMATIC COLLIMATOR ................................................................................................................................................... 53
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Table of Contents
POLYCARBONATE SCREEN .................................................................................................................................................... 54
KV
SELECTION ....................................................................................................................................................................... 54
MAS
SELECTION ..................................................................................................................................................................... 55
FILM/SCREEN COMBINATION SELECTION ............................................................................................................................ 55
MANUAL DENSITY CONTROL ................................................................................................................................................ 55
RADIOGRAPHIC EXPOSURE .................................................................................................................................................. 55
DOSE CALCULATOR .............................................................................................................................................................. 56
ERROR MESSAGE RESET COMMAND .................................................................................................................................... 56
HEAT UNIT INTEGRATOR ...................................................................................................................................................... 57
END OF DAY PROCEDURE ..................................................................................................................................................... 57
SHUT DOWN PROCEDURE .................................................................................................................................................... 57
SECTION 4: EXPOSURE TECHNIQUES ................................................................................................................................. 58
DUTY CYCLE .......................................................................................................................................................................... 59
DOSE MINIMIZATION ........................................................................................................................................................... 59
IMAGE QUALITY ................................................................................................................................................................... 60
MANUAL MODE ................................................................................................................................................................... 61
ZERO POINT MODE (
ZERO POINT kV RANGE .................................................................................................................................................... 64
OPTICAL DENSITY (OD) CORRECTION .............................................................................................................................. 64
ONE POINT MODE (
AEC DETECTOR POSITION ..................................................................................................................................................... 67
AUTOMATIC FILTER DEVICE MO/RH ...................................................................................................................................... 68
ANODE/FILTER COMBINATIONS ...................................................................................................................................... 68
FILM/SCREEN OR CR CASSETTE SELECTION .......................................................................................................................... 69
SECTION 5: TYPICAL CONFIGURATIONS ............................................................................................................................. 70
C
ONFIGURATION FOR NORMAL BREAST EXAMINATION
C
ONFIGURATION FOR SMALL BREAST OR AXILLA EXAMINATION
C
ONFIGURATION FOR LARGE BREAST EXAMINATION
C
ONFIGURATION FOR GEOMETRIC MAGNIFICATION
C
ONFIGURATION FOR 2D BIOPSY
C
ONFIGURATION FOR 3D BIOPSY (ONLY WITH
SECTION 6: MAINTENANCE ............................................................................................................................................... 79
GENERAL CONCEPTS ............................................................................................................................................................ 80
ERROR MESSAGES ................................................................................................................................................................ 81
MAINTENANCE ..................................................................................................................................................................... 84
A.E.C. TEST ............................................................................................................................................................................ 85
SELF-DIAGNOSIS ................................................................................................................................................................... 86
GRID MOVEMENT TEST ........................................................................................................................................................ 87
CLEANING AND DISINFECTION ............................................................................................................................................. 88
MOVING THE UNIT TO ANOTHER PLACE .............................................................................................................................. 88
FULLY AUTOMATIC KV AND MAS
MANUAL KV AND AUTOMATIC MAS
..................................................................................................................... 72
........................................................................................................................ 74
......................................................................................................................... 75
................................................................................................................................................. 76
MILADY BYM) ......................................................................................................... 77
) ................................................................................................................. 63
) .............................................................................................................. 66
.......................................................................................................... 73
SECTION 7: ACCESSORIES .................................................................................................................................................. 89
LIST OF ACCESSORIES AND DEVICES ..................................................................................................................................... 90
COMPRESSION PADDLES ...................................................................................................................................................... 92
HOLDER FOR COMPRESSION PADDLES ................................................................................................................................. 93
POLYCARBONATE SCREEN .................................................................................................................................................... 94
COLLIMATION PLATES .......................................................................................................................................................... 95
POTTER BUCKY ..................................................................................................................................................................... 96
MAGNIFICATION DEVICE ...................................................................................................................................................... 97
FOOT-CONTROLS .................................................................................................................................................................. 98
STAND-ALONE ANTI-X PROTECTIVE BARRIER ....................................................................................................................... 99
STEREOTACTIC BIOPSY DEVICE (SBD) ................................................................................................................................. 101
SECTION 8: TECHNICAL SPECIFICATIONS ......................................................................................................................... 102
TECHNICAL SPECIFICATIONS ............................................................................................................................................... 103
35 KV; 90 MA (@ 0,3
OPERATOR’S MANUAL MOM10-U09
MM
) ..................................................................................................................................................... 109
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Table of Contents
O
PTIONAL: 40 KV; 90 MA (@
35 KV
AT 90 MA (OPTIONAL – 40 KV AT 90 M
ELECTROMAGNETIC INFORMATIONS ACCORDING TO IEC 60601-1-2 ................................................................................ 124
WEEE INFORMATIONS ACCORDING TO DIRECTIVE 2002/96/EC ......................................................................................... 127
0,3
MM
) ..................................................................................................................................... 109
A) ......................................................................................................................... 109
SECTION 9: WARRANTY CONDITIONS ............................................................................................................................. 128
WARRANTY CONDITIONS ................................................................................................................................................... 129
FAILURE REPORT ................................................................................................................................................................ 131
SAFETY FEEDBACK .............................................................................................................................................................. 133
OPERATOR’S MANUAL MOM10-U09
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SECTION 1:
GENERAL INFORMATION
OPERATOR’S MANUAL MOM10-U09
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General Information
INTRODUCTION
Proper use of this equipment presupposes that the operating personnel is thoroughly familiar with the
operating instructions, in particular the sections Safety, Function and Safety Check, and Protective
Measures.
If legally-binding regulations govern the installation and/or the operation of the above equipment, it is
responsibility of the installer or the operator to observe these regulations
.
INTENDED USE
MILADY is a universal system intended to produce radiographic images of the breast. Its intended use
is for diagnostic, screening and needle localization mammography.
The system is to be used in a radiology or clinic exam room environment in a hospital, outpatient clinic,
or a breast imaging center. Mammography technologists operate the system for the production of
mammograms. The system may also be used for quality control purposes and other clinical or
research related activities by medical physicists and radiologists certified in accordance with local
standards.
This Operator’s Manual is intended to give a detailed overview on Functions, Specifications, Safety
and all other important issues to know to get maximum utilization of mammography system.
CONTRAINDICATIONS
No absolute contraindications are given for mammography. Due to the nature of X-ray procedures the
patient is exposed to radiation and adverse health effects exist and are known.
POTENTIAL ADVERSE EFFECTS
The following is a list of potential effects applicable to the mammography:
• Excessive breast compression
• Excessive X-ray exposure
• Electric shock
• Infection
• Skin irritation, abrasions or puncture wounds
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General Information
SAFETY SYMBOLS
Indicates a risk of danger that may lead to death of serious
WARNING
CAUTION
physical injury.
Indicates a risk of danger that if disregarded leads to slight or
moderate physical injury and/ or property damage.
Should be understood as a tip. The user does not absolutely
NOTE
have to observe these instructions. However, there will be
advantages if he does.
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General Information
NOTICES
1. Read all information in this chapters carefully. you are responsible to take
safety precautions and to follow the safety instructions.
CAUTION
Please pay attention to the following cautions!
2. MILADY has not to be used by unskilled or untrained personnel. The manufacturer
does not accept responsibility for injury or damage associated with improper or
unsafe system operation. the user should refer to this operator manual for directions
on how to
use the mammography unit.
3. this machine must be used only for mammography.
4. MILADY can be operated only in a controlled area inside dedicated room provided
with x-ray protection that meets local standards and regulations.
5. this equipment used in the presence of flammable anaesthetic or oxygen may cause an
explosion
6. the mammography unit is classified as permanently installed according to IEC
60601-1 international standard. this means that it must be electrically connected by
means of permanent connections. in particular, for the maximum electrical safety,
the protective earth conductor must be fixed and permanently installed.
7. MILADY can be used by all categories of patient. for disable patients (on wheel chair) be
always careful to all automatic movement of c-arm (especially up/down movement)
8. before using, check always perfect state of all parts of Mammo unit
9. frequently verify the wear of the compression paddles to prevent damages as cracks
and tears, and consequent risks for the patient.
10. do not modify this equipment without authorization of the manufacturer
11. use only original accessories and spare parts.
12. don’t remove plastic coverings of mammography unit that give a protection against
the electrical, thermal and mechanical hazards.
13. do not insert in the x-ray beam devices other than compression paddles or
magnification platform.
14. use only cassettes with one screen and films dedicated for mammography
15. use lead apron for patient protection.
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General Information
16. During x-ray emission, operator must be behind the protective screen and in a
position where it is possible to watch patient and unit.
17. When mammography system is installed in mobile environment (e.g. truck), it’s necessary
before cruise remove any accessory from unit, move the c-arm to the bottom position and
lock it by means of its special support.
18. MILADY can be used by all categories of patient. for disable patients (on wheel chair) be
always careful to all automatic movement of c-arm (especially up/down movement)
19. the device incorporates class 1 laser device for light beam centering device having
320 µw power and wave length from 461 to 618 nm (according to CEI EN 60825-1)
Don’t watch directly the Laser device for light beam
CAUTION
centering
20. Never Leave Unsolved Problems That May Affect The Safety Of The Product
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General Information
SYMBOLS
The meaning of symbols appearing on the plate and on some components of the machine is specified
in the following table.
SYMBOLS
CEI–IECSTANDARD
DEFINITION
ISO 7000-0434A
Caution
IEC 60417-5008
“OFF” Power
IEC 60417-5010
“ON” Power
IEC 60417-5840
Type B Applied Part
IEC 60417-5032
Alternating Current
IEC 60417-5019
Protective Earth (ground)
IEC 60417-5017
Earth (ground)
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U0
General Information
NOTE On ME EQUIPMENT
“Follow instructions for use”
and Electronic Equipment)
Indication of radiation field
ISO 15223-1
Manufacturer
ISO 7010-M002
Refer to instruction
manual/booklet
IEC 60417-5036
Dangerous Voltage
WEEE (Waste Electrical
IEC 60417-5367
c-ARM POSITION
IEC 60417-5638
Emergency Stop
IEC 60417-5326
Large Focus
IEC 60417-5325
Small Focus
IEC 60417-5384
by light
IEC 60417-5349
Radiodiagnostic
compression device,
movement
OPERATOR’S MANUAL MOM10-
9
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General Information
IEC 60417-5350
Radiodiagnostic
compression device,
pressure applied
IEC 60417-5351
AUTOMATIC
COMPRESSION RELEASE
IEC 60417-5381
FILTER DEVICE MODE
IEC 60417-5353
Grid movement
IEC 60417-5339
X-ray source assembly,
emitting
IEC 60417-5172
Class II equipment
(according to IEC 60536)
C-arm rotation angle
Breast THICKNESS
Automatic Modality
SELECTION
ALARM RESET
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General Information
x-RAY EMISSION
CONTROL LAMP
EXPOSURE TECHNIQUE
SELECTION
Focal Spot
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General Information
DEVICE CLASSIFICATION
The identification label is placed on the back of the device and a true copy of it is also placed inside
220/230/240 Vac MAINS (STANDARD)
MILADY
MILADY BYM
IEC 60601-1 Standard
MILADY belongs to Class I type B applied parts.
Directive 93/42/EEC for Medical Devices
MILADY belongs to Class IIb.
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General Information
115 Vac MAINS (OPTIONAL)
MILADY
MILADY BYM
OPERATOR’S MANUAL MOM10-U09
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U0
MILADY
provided in
case of optional tube chosen)
GENERATOR
COMPRESSION
( alternative accessory)
filter
filter
filter
FILTER
the labels
provided
depending by
tube, collimation
and filtering
system chosen
INTERNAL LABELS
General Information
Identification
safe use of mammography unit.
IDENTIFICATION LABEL
X-RAY TUBE
C-ARM
(alternative labels are
Mo30
Rh25 filter
Mo30
Rh25 filter
Mo30
Rh50 filter
LED RAD IATION
DO NOT STARE INTO B EAM
CLASS 2 LED PR ODUCT
Emission wavelen ghts: 4 60 - 62 0 nm
Maximum emitted power: 5,9 m W
CEI EN 608 25-1: 2003
ETPV029 1-00
X-RAY tube
STARTER iae
(optional)
COLLIMATION
DEVICE
(
SYSTEM
)
LED RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LED PRODUCT
Emission wavelenghts: 460 - 620 nm
Maximum emitted power: 5,9 mW
CEI EN 60825-1:2003
ETPV0291-00
MOTORIZED
ROTATION
OF C-ARM
INVERTER
UNIFIED FRAME
H.V.
POTTER BUCKY OR MAGNIFICATION DEVICE
labels are important for a
NOTE
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9
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U0
MILADY
INTERNAL LABELS
GENERATOR
COMPRESSION
( alternative accessory)
UNIFIED FRAME
filter
filter
filter
(alternative labels are provided in
case of optional tube chosen)
FILTER
the labels
provided
depending by
tube, collimation
and filtering
system chosen
General Information
IDENTIFICATION LABEL
Identification labels are important for a
safe use of mammography unit.
BYM
X-RAY TUBE
X-RAY tube
STARTER iae
(optional)
COLLIMATION
DEVICE
LED RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LED PRODUCT
Emission wavelenghts: 460 - 620 nm
Maximum emitted power: 5,9 mW
CEI EN 60825-1:2003
ETPV0291-00
Mo30
Rh25
Mo30
Rh25
Mo30
Rh50
filter
filter
filter
(
)
LED RADIATION
DO NOT STARE INTO BEAM
CLASS 2 LED PRODUCT
Emission wavelenghts: 460 - 620 nm
Maximum emitted power: 5,9 mW
CEI EN 60825-1:2003
ETPV0291-00
C-ARM
SYSTEM
MOTORIZED
ROTATION
OF C-ARM
INVERTER
H.V.
POTTER BUCKY OR MAGNIFICATION DEVICE
NOTE
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9
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General Information
ANTI – X
– X SHIELD IDENTIFICATION LABEL
OPERATOR’S MANUAL MOM10-U09
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Main Parts Description
MILADY DIMENSIONAL DRAWINGS
Weight: 286 kg
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Main Parts Description
MILADY BYM DIMENSIONAL DRAWINGS
(*) When the distance of the C-Arm
lower edge from the floor is ≤135 mm
the rotation range is limited at +/-135°
to avoid crushing of the patient feet
Weight: 330 kg
NOTE
When stereotactic biopsy device (SBD) is installed on MILADY
BYM, the C-Arm maximum rotation is limited to ± 90°
When carrying out the necessary support calculation,
CAUTION
weight of patient and operator must be taken into
consideration.
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Main Parts Description
ANTI-X SHIELDS DIMENSIONAL DRAWINGS
HALF-TRANSPARENT ANTI-X SHIELD
Weight: 77 kg (upper part transparent)
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X SHIELD
Main Parts Description
FULL-TRANSPARENT ANTI-
OPERATOR’S MANUAL MOM10-
9
Weight: 105 kg
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Main Parts Description
PROTECTION AGAINST STRAY RADIATION
The MILADY mammography system incorporates a barrier to protect the operator against stray
radiation. The control of X-Ray equipment must be implemented from the protected are placed behind
the Anti-X shield (International Standard IEC 60601-1-3 point 13.2).
According to local regulation for radiological protection, the access to the equipment and to the
controlled area must be restricted to the authorized personnel
only.
WARNING
For electrical protection, do not install or operate any
device different from Mammographic unit
distance from the patient.
electrical
within 1,5 m
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Main Parts Description
SECTION 2:
MAIN PARTS DESCRIPTION
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Main Parts Description
17
MILADY MAIN PARTS
2
5
1
3
7
8
4
13
12
13 13
11
10
14
6
18
15
9
16
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Main Parts Description
1. STAND
2. C-ARM
3. X-RAY TUBE
4. POLYCARBONATE SCREEN
5. C-ARM HANDLES (on both sides)
6. POTTER-BUCKY (18x24 cm or 24x30 cm)
7. MAMMOGRAPHY UNIT SWITCH ON BUTTON/ (
8. CONTROL PANEL
9. FOOT-CONTROLS FOR MOTORIZED COMPRESSION
10. FILM-MARKERS
11. C-ARM ROTATION BRAKE BUTTONS
(on both sides for Manual Rotation version)
12. C-ARM FINE ADJUSTMENT ANGLE BUTTONS
(on both side for Motorized Rotation version)
C-ARM UP/DOWN BUTTONS
(on both sides for Manual Rotation version)
C-ARM UP/DOWN, PRE-SELECTABLE ANGLES, FINE ADJUSTMENT ANGLE BUTTONS
(on both sides for Motorized Rotation version)
13. EMERGENCY PUSH-BUTTONS (on both sides)
14. COMPRESSION PADDLE
15. SERIAL AND USB PORTS
16. AUXILIARY DISPLAY
stand-by LAMP)
17. KNOBS FOR FINE MANUAL COMPRESSION (on both sides)
18. X-RAY PUSH BUTTON
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U0
Main Parts Description
1
17
MILADY BYM MAIN PARTS
5
2
3
7
8
10
4
14
6
12
13
11
18
19
15
16
OPERATOR’S MANUAL MOM10-
9
9
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